There have been several advancements in pacemaker technologies over the past few years. This is an overview of some of the most recent advances. 

The technologies that will have the most impact on patient care can be grouped into the following areas:

• Tracking device data and patient health through wireless remote monitoring systems;

• Models that are magnetic resonance imaging (MRI)-safe;

• Longer battery life and technology to help reduce pacing requirements to conserve battery power;

• New data recording functionality to provide more information on patient health and device status; and

• The introduction of single-chamber, transcatheter-delivered, leadless pacemaker systems. 

About 3 million people worldwide are living with a pacemaker, and each year about 600,000 pacemakers are implanted to treat bradycardia patients.[1]

MRI-Safe Pacemakers

One of the biggest trends in pacemaker technology in the last few years has been the introduction of U.S. Food and Drug Administration (FDA)-cleared MRI-conditional models. These allow patients to undergo MR imaging exams without harm to the device or changes to the device settings. Pacemakers without MRI-conditional use technology usually prevented patients from being able to get an MRI. 

More than 6 million people aged 65 or older undergo an MRI scan in the United States every year, and 20 percent of pacemaker patients need an MRI within the first two years of implant, according to Biotronik. According to the Mayo Clinic, approximately 75 percent of patients who have an implantable cardiac device will need an MRI in their lifetime.

Biotronik is the first company in the United States to offer both single- and dual-chamber pacemakers approved for use in an MRI environment. In May 2015, the company reported 60 percent of the pacing devices it sold were MRI-approved, showing the importance of this capability. Biotronik received clearance for its Entovis pacemaker system with ProMRI technology in May 2014, and for its ProMRI Eluna pacemaker system in late March 2015. 

“The majority of pacemaker patients are over the age of 65 and most are likely to have a clinical need for an MRI scan after their device is implanted,” said J. Rod Gimbel, M.D., cardiac electrophysiologist at Cardiology Associates of East Tennessee. “The pacemaker patient population typically has multiple orthopedic, oncologic, neurologic and cardiovascular co-morbidities that are best understood with MRI; thus, it is crucial that we implant pacemakers that allow continued unfettered access to MRI. In my practice, I implant MRI-conditional devices and leads at every opportunity to do so, as I believe MRI-conditional devices are the standard of care.”

In April 2016, Boston Scientific received FDA clearance for a suite of products deemed safe for use in MRI environments. The ImageReady MR-Conditional Pacing System includes the Accolade MRI and Essentio MRI pacemakers, as well as the new Ingevity MRI pacing leads. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. The newly-approved family of Ingevity MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.  

The ImageReady System offers automatic daily monitoring via the Latitude NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers. The Latitude NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.

In February 2017, Abbott gained FDA clearance for its MR-conditional labeling for both the Assurity MRI pacemaker and the Tendril MRI pacing lead. During an MRI scan, the pacemaker works with Abbott's MRI Activator handheld device to trigger pre-programmed MRI settings appropriately tailored to individual patients. This technology can help eliminate the effort, time and patient inconvenience commonly associated with conventional pre- and post-scan pacemaker reprogramming.

"A long-lasting and small wireless pacemaker that allows patients to undergo MRI scans is an important step forward in growing our available treatment options for patients," said David Sandler, M.D., director of electrophysiology at the Oklahoma Heart Institute in Tulsa, Okla. "The ability to choose a device to best address a patient's cardiac condition no longer has a tradeoff with MRI compatibility. It's the best of both worlds."

Medtronic’s Advisa MRI SureScan pacing systems are FDA-approved for 1.5T and 3.0T full-body MRI scans. 

Delaying AFib

Data presented as a late-breaking clinical trial at the 2014 Heart Rhythm Society (HRS) annual meeting showed Medtronic’s Reactive Antitachycardia Pacing (ATP) algorithm in its pacemakers can significantly delay the progression of persistent atrial fibrillation (AF) in patients with bradycardia. Results from the MINERVA (MINimizERight Ventricular pacing to prevent Atrial fibrillation and heart failure) study found that the algorithm reduced the development of persistent AF by a 58 percent relative reduction compared to standard pacemakers.[2] The algorithm restores the heart back to its normal rhythm by pacing during abnormally fast atrial rhythms. It can slow the progression of the disease by successfully terminating atrial tachycardia/AF episodes. Patients benefiting from the advanced pacing also showed a 52 percent relative reduction in AF-related hospitalizations and emergency room visits. Reduction of these costly care episodes has an estimated potential to save approximately $1,218 per patient in healthcare costs over a 10-year span.

New Pacemaker Functionality

An example of the capabilities available on the newer, high-end pacemakers is Boston Scientific’s Accolade pacemaker. It provides actionable data that may enable earlier interventions. It offers a new atrial arrhythmia report that provides a comprehensive view of the patient’s AT/AF status and information for assessing AF treatment efficacy. These pacemakers also carry forward the HF Perspectiv System, a comprehensive suite of diagnostics that can provide insight into HF disease progression including respiratory rate trend (RRT). This measurement and tracking of respiration, heart rate variability (HRV) footprint, SDANN, autonomic balance monitor and heart rate trend shows long-term maximum, minimum and average heart rates. 

The Boston Scientific Accolade and Essentio pacemakers also offer a new post-operative system test (POST) feature, providing a fully automatic system evaluation to check lead impedances, intrinsic amplitudes and capture thresholds prior to discharge. The devices enable a new snapshot capability for real-time review of electrogram (EGM)/electrocardiogram (ECG) data and pacing threshold test results. 

Abbott’s Endurity dual-chamber pacemaker has technology to help reduce unnecessary right ventricular (RV) pacing with beat-by-beat ventricular support to optimize patient safety and support intrinsic heart rhythm. The Ventricular Intrinsic Preference (VIP) technology has been shown to reduce RV pacing and heart-failure hospitalization. The device also uses beat-by-beat analysis to keep output as low as possible to maximize pacemaker battery longevity.

The Abbott Assurity MRI pacemaker uses real-time EGM waveform monitoring and can be set with event markers that precede and follow a specific triggering event. These events can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options.

Improving Battery Life

Vendors have worked on improving implantable device battery life in pacemakers and other types of implantable devices. As older pacemaker patients are now living longer, and pacemakers are implanted into younger patients, battery lifespan has become an important topic of discussion, since battery/device replacement requires surgery. Battery life is highly dependent on pacing needs. Some vendors have developed algorithms to monitor the heart in real time and reduce pacing as much as possible to extend the battery life.

Boston Scientific projects the longevity of its latest pacemaker batteries to be about 12.1 years. 

Abbott said its Endurity pacemaker technology should have a service life of about 14.4 years. The Abbott Assurity MRI pacemaker is expected to have a battery life of about 9.4 years.

Medtronic’s Advisa DR SureScan has a listed battery lifespan of up to 11.8 years.

Wireless, Automated Pacemaker Monitoring

Many of the current generation of pacemakers are equipped with wireless connectivity to external monitoring systems. This can eliminate the need for the patient to come in for office visits just to have their devices interrogated. These systems allow for daily monitoring of device function and the patient’s health status. These remote interrogations allow physicians to monitor patients between infrequent, face-to-face office visits and can alert them to any issues.

In May 2015, the Heart Rhythm Society (HRS) released a consensus statement recommending remote monitoring (RM) systems become the new standard of care for patients with cardiovascular implantable electronic devices (CIEDs).[3] The HRS said over the past decade, several new technologies have created the ability for devices to monitor their own function, record arrhythmias and communicate this information to healthcare providers without participation of the patient. The expert consensus statement included:

• Remote monitoring should be combined with at least an annual in-person evaluation and all patients with CIEDs should be offered remote monitoring as part of the standard follow-up management strategy;

• Before implementing RM, it is recommended that each patient be educated about the nature of RM, responsibilities and expectations, potential benefits, limitations and an explanation of how RM information may be used;

• All CIEDs should be checked through direct patient contact 2-12 weeks after being implanted; and

• Have specific policies in place to govern program operations, roles and responsibilities of those involved and the expected timelines for service provision.

Most of these remote monitoring systems use a bedside base unit that collects and sends the patient information at night when the patient is sleeping. However, vendors are starting to move toward interfacing the implantable devices to mobile devices or the patient’s smartphones to enable constant monitoring.

“The clinical and economic benefits of remote monitoring have been well established over a decade of clinical studies,” stated Niraj Varma, M.D., in reference to the 2015 HRS expert consensus statement on remote monitoring. “But these benefits are only realized if patients consistently use the technology. When we make the remote monitoring process easy for patients, we increase the likelihood of patient adherence, which has been demonstrated to improve health outcomes.” Varma was lead investigator for the TRUST Trial, which laid the foundation for the guidelines, and co-chair of the HRS committee.

In 2016, Biotronik launched its CardioMessenger Smart in the United States. The portable monitoring device, about the size of a modern smartphone, keeps pacemaker, implantable cardioverter defibrillator (ICD) and insertable cardiac monitor (ICM) patients connected to their physician remotely, enabling more efficient care management anywhere in the world. It automatically transmits vital information from a patient’s cardiac implant to their physician via Biotronik Home Monitoring. This includes daily, automatic reports and fully customizable alerts that can be programmed to the physician’s specifications. The portability of CardioMessenger Smart helps ensure patient compliance and the consistent transmission of data necessary for physicians to identify and prevent potential cardiac events.

The first implantable device to offer a direct interface with the patient’s smartphone for monitoring was the Abbott/St. Jude Medical Confirm implantable cardiac monitor. It was cleared by the FDA in 2017. Experts say this is the first of many new EP devices that will directly link to an app on the patient’s phone. Since patients usually carry their phones all the time, it offers an existing platform that will have much better patient compliance and offer true, 24/7 monitoring of the device and patient’s health.

Leadless Pacemakers

One of the biggest issues with implantable EP devices is the leads that connect the device to the heart. Leads are frequently cited as the weakest component of pacing, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) due to wearing out or complications due to infection. Traditional implantable devices also require surgery to install the leads and the can, increasing the complexity of the procedure, adding cost and exposing the patient to infection risks. Wireless technologies and the miniaturization of both electronic components and the batteries have enabled the development of transcatheter implantable pacing and now CRT systems, eliminating the need for surgery or the placement of venous leads. 

In early 2016, the U.S. Food and Drug Administration (FDA) approved the Medtronic Micra device, the first leadless, catheter-implanted pacemaker approved in the United States. It is the world’s smallest pacemaker at 0.8 cc in size, being a little smaller than its competitor, the Abbott/St. Jude Medical Nanostim. The device has a 20 French diameter and uses a 27 French introducer in the femoral vein, allowing catheter access to the right ventricle. Micra has four self-expanding nitinol hooks that extend as it is unsheathed from its delivery catheter. These act as an anchor, hooking into the trabeculation at the apex of the right ventricle. The operator performs a tug on it to ensure it will not embolize prior to final release. Out of more than 1,600 patients in the post-FDA approval study of the device, there has only been one embolization of a Micra. The battery, while small, is expected to have a 12-year life. 

The Abbott/St.Jude Medical Nanostim pacemaker is currently pending final FDA review. The single-chamber pacemaker device is designed to be fully retrievable. It has a docking button on the top of the device which can be grasped by a snare catheter and twisted to turn the device and unscrew the corkscrew-like anchor in the myocardium. 

There were recent battery issues with the Nanostim device, causing its distribution in Europe, where it is currently approved, to be paused in 2016. St. Jude said it has now updated the battery technology. The battery life is expected to be nine to 10 years, depending on the pacing requirements for the patient. 

It is an 18 French device that is delivered via catheter directly into the apex of the right ventricle. Vascular access is gained through the femoral vein and device guidance is done under angiography. 

One issue with these two leadless pacing systems is that they are single-chamber devices, which only account for about 10-15 percent of the U.S. pacemaker market. Medtronic said it views the Micra system as a stepping-stone platform to the next generation of cardiac pacing. This may include the implantation of a Micra pacemaker in each ventricle of the heart and enabling wireless communications between the devices to synchronize their pacing. 

“The problem with regular pacemakers is the wire that goes to the heart, because as the heart is beating and the wire has all this motion, over the course of time you can hear breaks in the wires. The idea with a leadless pacemaker is that you take the whole wire out of the equation,” said Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospital, N.Y.

Reddy said as a single-chamber pacing system, both the Micra and the Nanostim perform very well according to clinical trial data, and Medicare is now reimbursing use of these devices. He said the main limitation to wider adoption is the single-chamber pacing. “Today, the main limitation with these devices is that we do not have the possibility of doing atrial pacing, and most importantly dual-chamber pacing. These devices are just the first step and the companies are working on ways to do atrial/ventricular pacing,” he explained.  “Ultimately, the goal is to avoid the use of a lead, which has always been the weak link in pacemaker systems.”

Watch the VIDEO “Current State of Leadless Pacemaker Technology,” an interview with Vivek Reddy, M.D., at HRS 2017.

Related EP Technology Content:

What is New in Electrophysiology Technologies

Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases

First Fully-Implantable Micropacemaker Designed for Fetal Use
 

References: 

1. Mark A. Wood, Kenneth A. Ellenbogen. Cardiac Pacemakers From the Patient’s Perspective. Circulation. 2002;105:2136-2138.

2. Boriani G, Tukkie R, Manolis AS, Mont L, Pürerfellner H, Santini M, Inama G, Serra P, de Sousa J, Botto GL, Mangoni L, Grammatico A, Padeletti L; MINERVA Investigators. Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial. Eur Heart J. 2014 Sep 14;35(35):2352-62. doi: 10.1093/eurheartj/ehu165. Epub 2014 Apr 25.

2. HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices. www.hrsonline.org/Policy-Payment/Clinical-Guidelines-Documents/Expert-Consensus-on-the-Monitoring-of-Cardiovascular-Implantable-Electronic-Devices/2015-Expert-Consensus-Statement-on-Remote-Interrogation-and-Monitoring-for-CIEDs. Accessed Feb. 12, 2018.

February 27, 2018 — Medical devices, including cardiovascular implantable electronic devices, could be at risk for hacking. In a paper published online in the Journal of the American College of Cardiology, the American College of Cardiology’s Electrophysiology Council examines the potential risk to patients and outlines how to improve cybersecurity in these devices.

Cybersecurity in the medical field refers to the integration of medical devices, computer networks and software. While there have been no actual clinical reports of malicious or inadvertent hacking or malware attacks affecting cardiac devices, recent reports have discovered this possibility. Reasons for hacking include political, financial, social and personal motives. Devices can be hacked locally or remotely. The U.S. Food and Drug Administration (FDA) has issued both pre-market and post-market guidance for the security of medical devices, and legislative proposals related to medical device security have been advanced in the U.S. Congress.

“True cybersecurity begins at the point of designing protected software from the outset, and requires the integration of multiple stakeholders, including software experts, security experts and medical advisors,” said Dhanunjaya R. Lakkireddy, M.D., professor of medicine at the University of Kansas Hospital, a member of the Electrophysiology Council and the corresponding author of the paper.

Medical devices have been targets of hacking for over a decade. The increasing number of medical devices using software has created the need to protect devices from intentional harmful interference on their normal functioning. Advanced wireless communications between healthcare providers and patients’ devices have created the theoretical possibility for the deactivation of features, the alteration of programming, and the delaying, interfering or interrupting of communications.

There are a number of possible clinical consequences that may result from the hacking of a cardiac device. In patients with pacemakers, concerns mostly consist of oversensing or battery depletion. For patients with implantable cardioverter-defibrillators (ICDs), it is possible for hackers to interrupt wireless communications, inhibiting the value of telemonitoring and allowing any clinically relevant events to go undetected by the system. Oversensing may inhibit pacing or result in inappropriate or life-threatening shocks. Battery depletion can lead to a device being unable to deliver therapies during life-threatening arrhythmias.

“At this time, there is no evidence that one can reprogram a cardiovascular implantable electronic device or change device settings in any form,” Lakkireddy said. “The likelihood of an individual hacker successfully affecting a cardiovascular implantable electronic device or being able to target a specific patient is very low. A more likely scenario is that of a malware or ransomware attack affecting a hospital network and inhibiting communication.”

The council said that cybersecurity needs should also be addressed during product testing both pre- and post-market. Because cybervulnerabilities can emerge quickly, strong post-market processes must be in place to monitor the environment for new vulnerabilities and to respond in a timely manner. The council suggests that firmware may be useful in devices with possible vulnerabilities. Physicians who manage cardiac devices should be aware of both documented and possible cybersecurity risks. Systems should be established to communicate updates in these areas quickly and in an understandable way to the rest of the clinical team that manage patients with devices.

The council members said they do not feel that enhanced monitoring or elective device replacement is necessary at this time.

“Given the lack of evidence that hacking of cardiac devices is a relevant clinical problem, coupled with evidence of the benefits of remote monitoring, one should exercise caution in depriving a patient of the clear benefit of remote monitoring,” Lakkireddy said.

For more information: www.onlinejacc.org

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April 30, 2018 — LivaNova announced it completed the sale of its cardiac rhythm management (CRM) business to MicroPort Scientific Corp. for $190 million in cash. 

The CRM business was previously owned by Sorin, which merged with Cyberonics Inc. in 2015 to form LivaNova. Sorin had previously purchased to the CRM portfolio of Ela Medical. 

“With the completion of the CRM sale to MicroPort, LivaNova’s portfolio is now concentrated on our areas of strength and leadership — cardiac surgery and neuromodulation,” said Damien McDonald, LivaNova’s chief executive officer. “This transaction enables us to concentrate our efforts on developing market-leading businesses in these areas, and will assist us in enhancing LivaNova’s position as an innovative medical device company that improves the lives of patients around the world and creates value for our shareholders.”

LivaNova first announced the intent to sell to Microport in January 2018. The CRM Business Franchise develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures. CRM products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers. The CRM Business Franchise generated approximately $249 million in net sales in fiscal year 2016 and has approximately 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic.

In 2014, LivaNova (formerly Sorin Group) and MicroPort founded a China-based joint venture called MicroPort Sorin CRM (Shanghai) Co. Ltd. to market CRM devices, including implantable pacemakers, defibrillators and cardiac resynchronization devices, in China. During the past four years, the Joint Venture has achieved many milestones in the development, manufacture and promotion of CRM products for the China market. In September 2017, the Joint Venture announced the China Food and Drug Administration approval of the Rega pacemaker family, the smallest sized pacemakers available on the Chinese market.

MicroPort Chairman and CEO Zhaohua Chang, M.D., said that the strong position of LivaNova’s CRM business franchise in Europe complements MicroPort’s leadership position in China and growing presence in the United States and emerging markets, enabling both parties to expand their worldwide reach.

LivaNova previously announced on Sept. 14, 2017, that it was reviewing strategic options for the CRM Business Franchise, including a potential divestiture.

The companies expect the transaction to close in the second quarter of 2018.

For more information: www.livanova.com, www.microport.com

May 16, 2018 — The Heart Rhythm Society (HRS) released communication recommendations to assist healthcare professionals to understand and prepare for potential cybersecurity vulnerabilities of cardiovascular implantable electronic devices (CIEDs). The statement was released during Heart Rhythm 2018 conference last week. 

The statement outlines four key communication themes: 
   1. When to notify patients;
   2. Whom to notify;
   3. How to communicate with patients; and 
   4. What elements to discuss with patients.  

The relative novelty of cybersecurity threats in CIEDs is raising questions among patients and the heart rhythm care community. The rapidly changing healthcare environment and increasing global interconnectivity expose information technology to new vulnerabilities. Hackers can potentially use these vulnerabilities to gain unauthorized access to medical equipment. 

The proceedings statement includes detailed guidance on patient-centered communication strategies when a specific threat is identified. The authors first call for an assessment of the threat by experts from manufacturers and U.S. federal agencies. If a vulnerability is validated, the discussion between the healthcare professional and patient should include five topics: 
   1. Potential consequences if the vulnerability is exploited;
   2.Strategies to mitigate the risks;
   3. Technical challenges to exploit the vulnerability;
   4. Long-term solutions to eliminate the threat; and
   5. Benefits provided by the CIED compared with the risk if the vulnerability is exploited.
 
The authors note that if the claim of a new vulnerability is released directly to the public, instead of directly to the manufacturer or the U.S. Food and Drug Administration (FDA), there is the potential for a period of uncertainty and anxiety during the evaluation of the claim. U.S. federal agencies and manufacturers must rapidly assess both the validity of the claim and the potential risks to patients to prevent improper action or exploitation of the situation.  

"As we look ahead and plan for ways to deal with potential risks to CIEDs, preparedness is the best approach," said lead author David Slotwiner, M.D., FHRS, New York-Presbyterian Queens. "Like other technology such as smartphones or computers, device software needs to be regularly updated. As healthcare professionals, we are inclined to first address hardware issues with the battery or leads, but the software is equally important. The healthcare community must reach a point where routine software updates are considered the standard of care to minimize the threat and ultimately eliminate risks." 

The authors also state the importance of managing patient expectations at the time of implant. Patients should know that CIEDs will require software updates until the battery is depleted. By educating patients prior to CIED implant and in advance of a threat announcement, patients will have a better understanding of the systems and be more prepared to respond to a potential vulnerability. HRS will work with its partners to help educate health care professionals on best practices for patient-centered conversations and mechanisms to minimize cybersecurity risks.

The statement captures the proceedings of the 2017 Leadership Summit on Cybersecurity Vulnerabilities: Communications Strategies for Clinicians and Patients that was attended by patient representatives, subject matter experts, HRS and American College of Cardiology (ACC) leadership, FDA and Federal Bureau of Investigation (FBI) officials, and leadership from CIED manufacturers. 

The full document was published with an accompanying editorial commentary in the online edition of HeartRhythm, the official journal of HRS. Review the full document and editorial commentary by FDA.

Find links to all the Heart Rhythm 2018 Late-breaking Studies

Related Cardiovascular Device Cybersecurity Content:

Can Your Cardiac Device Be Hacked?

Raising the Bar for Medical Device Cyber Security

The State of Healthcare Cyber Security

FDA Seeks Management of Cybersecurity in Medical Devices

Cybersecurity Threats in Medical Imaging

FDA Announces New Medical Device Safety Action Plan

Reference:

1. David J. Slotwiner, David J. Slotwiner, David J. Slotwiner, et al.  Cybersecurity Vulnerabilities of Cardiac Implantable Electronic Devices: Communication Strategies for Clinicians—Proceedings of the Heart Rhythm Society's Leadership Summit. HeartRhythm. DOI: https://doi.org/10.1016/j.hrthm.2018.05.001
 

#HRS2018  #HRS18

May 10, 2018 – A new study is the first to test the clinical effectiveness of incremental peri-operative antibiotics as a method to reduce potential infection of cardiac implantable electronic devices (CIEDs). The trial compared the novel peri-operative antibiotics strategy to the conventional treatment of pre-procedural cefazolin, a common antibiotic. The Prevention of Arrhythmia Device Infection Trial (PADIT) study included 19,603 patients from 28 centers and is the first time a randomized cluster cross-over design has been used in CIED patients. The results of the study were presented at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.

CIED devices, like pacemakers and implantable cardioverter-defibrillators, are a common treatment option for patients suffering from cardiac arrhythmias. Today, about 400,000 devices are implanted annually, and more than 3 million Americans have CIEDs.[1] Infection of implanted medical devices can have serious consequences for patients. Currently, antibiotics are often administered before the procedure as a precaution but are not guaranteed to protect against common pathogens found in device infections. This is the first study to evaluate the effectiveness of incremental peri-operative antibiotics to reduce device infection.

Twenty-eight centers were randomized to use either conventional or incremental antibiotic treatment in all patients at the time of device implant over four six-month periods. The trial included 19,603 patients, of whom 12,842 were high-risk. The mean patient age was 72 ± 13.1 years old and 40 percent had a history of heart failure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intra-procedural bacitracin pocket wash and two-day post-procedural oral cephalexin. The primary outcome was one-year hospitalization for device infection analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects.

Infection occurred in 99 patients (1.03 percent) receiving conventional treatment, and in 78 (0.78 percent) receiving incremental treatment. In higher risk patients, hospitalization for infection occurred in 77 (1.23 percent) patients receiving conventional antibiotics and in 66 (1.01 percent) receiving incremental antibiotic. The observed difference in infection rates was not statistically significant but was consistent with a modest benefit from incremental antibiotics.

“Infections of these devices, while not very common, can have a long-lasting and devastating impact on patients. It’s really important that we explore robust measures to prevent infections from occurring,” said lead author Andrew Krahn, M.D., head of the division of cardiology and professor of medicine at the University of British Columbia. “Our results show that incremental antibiotics strategy can have a modest, positive effect when the infection rate is low. We hope that our study will help clinicians identify patients that may benefit from this treatment option and utilize a targeted, high intensive antibiotic strategy to reduce and prevent infections.”

The authors note that this topic will continue to be investigated with another clinical study “World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT),” which examines an antibiotic envelope device that is put into the pocket where the surgery is performed to assess the efficacy of reducing infections. Results of this study are expected to be published in 2019.

Find links to all the Heart Rhythm 2018 Late-breaking Studies

Reference:

1. Eric Buch, Noel G. Boyle and Peter H. Belott. Pacemaker and Defibrillator Lead Extraction. Circulation. 2011;123:e378-e380, originally published March 21, 2011.
 

2. A.D. Krahn, F. Philippon, D.V. Exner, et al. 766 Prevention of Arrhythmia Device Infection Trial (PADIT): Pilot Study Results. Canadian Journal of Cardiology. September–October, 2012Volume 28, Issue 5, Supplement, Page S394. DOI: https://doi.org/10.1016/j.cjca.2012.07.691
 

#HRS2018

Here is an aggregation of all the news and late-breaking studies presented at the 2018 Heart Rhythm Society (HRS) Scientific Sessions in May. 

Late-breaking Studies:

• Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Multicenter International Randomized Clinical Trial

• Prevention of Arrhythmia Device Infection Trial (PADIT) — Novel Antibiotics Can Help Lower EP Device Infection Rates

• A Prospective, Blinded Evaluation of a Novel Filter Designed to Reduce Inappropriate Shocks by the Subcutaneous Implantable Defibrillator

• Three-year Outcomes After Botulinum Toxin Injections into Epicardial Fat Pads for Atrial Fibrillation Prevention in Patients Undergoing Coronary Artery Bypass Grafting

• Myocarditis Is an Underrecognized Etiology of Symptomatic Premature Ventricular Contractions - Insights from The Myocarditis and Ventricular Arrhythmia (MAVERIC) Registry

• Lower Adherence Direct Oral Anticoagulants Use Is Associated with Increased Risk of Thromboembolic Events Than Warfarin - Understanding the Real-world Performance of Systemic Anticoagulation in Atrial Fibrillation

• Atrial Fibrillation Burden and Impact on Mortality and Hospitalization — The CASTLE-AF Trial

• Device-related Thrombus After Left Atrial Appendage Closure with Watchman: Incidence, Predictors and Outcomes

• Randomized Controlled Trial of Cardiac Contractility Modulation in Heart Failure: The FIX-HF-5C Study

• Targeted Left Ventricular Lead Implantation in Non-Left Bundle Branch Block Patients: Primary Results of The Enhance CRT Pilot Study

• Intramural Needle Ablation for Refractory Ventricular Arrhythmias: 6-month Safety and Outcomes

• First In-human Data on the Globe Combined Multi-Electrode Contact Mapping and Ablation System for Treatment of Atrial Fibrillation

• A Randomized Pragmatic Trial of Strategies of Permanent Pacemaker Versus Implantable Cardiac Monitor in Older Patients with Syncope and Bifascicular Block

• Feasibility of Extravascular Pacing, Sensing and Defibrillation from a Novel Substernal lead: The Acute Extravascular Defibrillation, Pacing and Electrogram (ASD2) Study

• AV Synchronous Pacing with a Ventricular Leadless Pacemaker: Primary Results from the Marvel Study

• First Clinical Report of Atrial Fibrillation Ablation with Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation

Other Key Heart Rhythm 2018 News: 

Five Key Takeaways From Heart Rhythm 2018

Heart Rhythm Society Recommends How to Prepare for Cybersecurity Threats to Cardiac Implantable Devices

Link Found Between Post-Traumatic Stress, Increased Risk of AFib

Marijuana Use Does Not Increase Risk of Arrhythmias, Might Reduce AFib Risk

Exposure to Air Pollution on Cold Days Can Trigger Sudden Cardiac Death in Women

Consumer Smart Watches Accurately Measure Paroxysmal Supraventricular Tachycardia

Radiofrequency Transseptal Needle Associated With 40 Percent Decrease in Silent Cerebral Embolism

FDA Clears Abbott's High-density Advisor HD Grid EP Mapping Catheter

Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath

View photos from HRS 2018

Follow other HRS news

Link to the Heart Rhythm Society 2017 Late-Breaking Electrophysiology Trials
 

 
#HRS2018, #HRS18

May 24, 2018 — New clinical study results demonstrate that an investigational algorithm, utilizing the accelerometer signal in the Medtronic Micra Transcatheter Pacing System (TPS) may restore AV synchrony. This would improve cardiac function in patients with sinus rhythm and atrioventricular (AV) block. The results from the MARVEL (Micra Atrial TRacking Using A Ventricular AccELerometer) feasibility study were presented during a late-breaking session at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions, and simultaneously published in Heart Rhythm.

"The results of MARVEL indicate that this novel mechanical sensor may allow more patients to benefit from a miniaturized leadless pacemaker," said Larry Chinitz, M.D., MARVEL study principal investigator and cardiac electrophysiologist and director of NYU Langone's Heart Rhythm Center in New York City. "Although single-chamber pacing in the ventricle is quite safe for these patients, the preferred option is to treat them with a wired pacemaker in two chambers to maintain synchrony and cardiac function. However, patients with these traditional pacemakers are at risk of experiencing complications related to the pocket and the leads, and leadless pacemakers remove these risks."

The MARVEL study evaluated 64 patients who already had a Micra TPS at 12 centers in nine countries. Investigators evaluated the ability for the Micra's accelerometer to monitor and detect contractions in the atrium, even though the device is implanted in the ventricle. Investigators also evaluated Micra's ability to pace the ventricle to contract in sequence with the atrium, creating AV synchrony. AV synchrony was measured using continuous device telemetry and an electrocardiogram via a Holter monitor.

The study showed the percentage of AV beats in synchrony during pacing with the AV algorithm was 87 percent among all study patients (while they were at rest for 30 minutes), 80 percent in high-degree AV block patients, and 94.5 percent in patients with predominantly intact AV conduction during the study. In patients with high-degree AV block who would benefit the most from AV synchrony, the algorithm yielded significantly greater AV synchrony (P<0.001) compared to VVI pacing without the algorithm. In addition, AV block patients had a statistically significant improvement (P=0.004) in stroke volume (blood flow out of the left ventricle) during AV algorithm pacing (23.9cm LVOT VTI) compared to VVI pacing (21.8cm).

Medtronic first introduced the Medtronic Micra TPS commercially in Europe in 2015 and in the United States in 2016 for patients who need a single-chamber pacemaker. Comparable in size to a large vitamin, the Micra TPS is less than one-tenth the size of traditional pacemakers, yet it delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, it is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.

Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to such leads and pocket are eliminated — as are any visible signs of the device. Micra TPS utilizes a miniaturized sensor inside the device to measure patient movement (also known as an accelerometer) and determines appropriate pacing rates based on patient activity levels.

Earlier results presented at HRS 2018 from the Micra Post-Approval Registry demonstrated major complications with Micra TPS were infrequent with a 63 percent lower risk for major complication (P<0.001) compared to traditional pacing systems.

For more information: www.hrssessions.org

Read more about HRS 2018 late-breaking studies

May 24, 2018 — Syncope with bifascicular block may be caused by intermittent complete heart block, but competing diagnoses may coexist. A new study tested whether a strategy of empiric permanent pacing (PM) reduces major adverse events more effectively than acting on the results of an implantable cardiac monitor (ICM). Results of the study were presented at Heart Rhythm 2018, the 39th annual scientific sessions of the Heart Rhythm Society (HRS), May 9-12 in Boston.

In a multinational, randomized, pragmatic trial, 56 subjects under 50 years old with bifascicular block, preserved left ventricular function, and less than or equal to one syncope in the preceding year, received PM and 59 received an ICM. The primary outcome measure was a composite of Major Adverse Study-Related Events (MASRE), comprised of death, syncope, symptomatic bradycardia, asymptomatic actionable bradycardia and device complications.

The PM and ICM groups were similar in age, sex, lifetime syncopes, syncope in prior year, duration of symptoms, no prodrome and baseline systolic BP. Forty patients had left bundle branch block and 75 had right bundle branch block and a left hemiblock. Patients were followed for a median 30 months, and 21 exited the study — eight patients died, six withdrew consent after 2 years, four withdrew due to cancer and three due to dementia.

PM effectively prevented the primary outcome with end study MASRE-free survivals in PM (63 percent) and ICM (22 percent) group (p<0.001). The proportions of patients with syncope were similar in PM and ICM groups (27 vs 31 percent, p=0.50, Wilcoxon). Fully 35 out of 59 ICM patients (59 percent) crossed over to PM. There were five pacemaker complications requiring reintervention.

The researchers concluded that permanent pacing compared to ICM is a preferred strategy in elderly patients with few but recent syncopal spells and bifascicular block. This is driven by the high proportion of mildly symptomatic bradycardias detected on ICMs leading to pacemaker insertion.

For more information: www.hrssessions.org

Read more about HRS 2018 late-breaking studies

June 28, 2018 — Investigators at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) have demonstrated the feasibility of implanting a micropacemaker system in the pericardial sac surrounding the heart. The development represents a breakthrough that may open up new cardiac pacing options for children and adults.

The micropacemaker — inserted through a single, tiny incision — avoids an invasive surgical procedure and the complications related to long pacemaker leads. The study, "Minimally Invasive Implantation of a Micropacemaker into the Pericardial Space," was recently published online, in advance of publication by Circulation: Arrhythmia and Electrophysiology.

"Much about this device and its implantation is novel — starting with implanting an entire pacing system in the pericardial space in a minimally-invasive fashion, which has never been done before," said CHLA cardiologist Yaniv Bar-Cohen, M.D., director of the Southern California Consortium For Technology and Innovation in Pediatrics and professor of clinical pediatrics and medicine, Keck School of Medicine of USC.

Bar-Cohen and Gerald E. Loeb, M.D., professor in the Department of Biomedical Engineering at the USC Viterbi School of Engineering, are lead investigators on the study. Along with Ramen Chmait, M.D., associate professor of obstetrics and gynecology at USC, the research team is also collaborating on the invention of the first micropacemaker to treat fetuses in utero.

"Our work on the fetal pacemaker served as a bridge to this development," said Bar-Cohen. Unlike the fetal system, the micropacemaker has the potential to benefit a much larger population, including children, people born with congenital heart disease and adults for whom traditional pacemakers are less than ideal.

Traditional systems – called transvenous – have been a primary solution for permanent pacing. However, many patients with slow or irregular heartbeats are not considered good candidates for such devices. The electrode wires are passed through veins into the right ventricle or atrium, often traveling long distances, making lead failure a challenge. Leadless systems are located inside blood vessels, which increases the risk of dislodgement and infection.

The CHLA-USC research team performed percutaneous implantations in a model system, with a focus on improving the implantation tools and techniques from one experiment to the next. In the final procedure, they implanted a functional pacing system, achieving up to five days of pacing.

The investigators are seeking an industry partner to collaborate on further development of the device, which features several innovations. A flexible short lead acts as a spring-loaded hinge between the pacemaker body and a corkscrew electrode implanted perpendicularly into the heart surface. A sheath developed by the team secures positioning with retractable features. After deployment, the hinge returns to a 90-degree angle, as the micropacemaker orients itself to minimize system stress.

The new micropacemaker enables pacing of the left ventricle (LV); most systems only pace the right ventricle. A growing body of research supports the benefits of LV pacing for better cardiac synchrony.

In addition, the design allows formation of a biological support matrix that results from natural fibrosis. "As a mechanical support, this living connective tissue has benefits over the use of synthetic polymer, which can degrade over time," said Loeb. He added that further testing of the device is ongoing.

Additional contributors to the study include Michael J. Silka, Allison C. Hill, Jay D. Pruetz, Li Zhou, Sara M. Rabin and Viktoria Norekyan. This work was supported in part by the National Institutes of Health (1R01HD075135), the Southern California Clinical and Translational Science Institute, the Coulter Foundation, and the L.K. Whittier Foundation.

For more information: www.circep.ahajournals.org

Reference

Bar-Cohen Y., Silka M.J., Hill A.C., et al. “Minimally Invasive Implantation of a Micropacemaker Into the Pericardial Space,” Circulation: Arrhythmia and Electrophysiology. June 26, 2018. https://doi.org/10.1161/CIRCEP.118.006307

October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150 mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.

Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).

"The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.

The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:

• Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.
  • 14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months
  • 23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years
• High responder rate in a population where 78 percent of patients had isolated systolic hypertension.
  • 85 percent AMB BP reduced >5mmHg
  • 74 percent AMB BP reduced >10 mmHg
• Safety Outcomes: The study met the safety endpoint.
  • Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function
  • Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity

“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”

To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control.  The company is expecting results on the first cohort of patients in 2019.

BackBeat's CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS).  Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.

Links to TCT 2018 Late-breaking Cardiovascular Clinical Trials, News and Videos

For more information: www.orchestrabiomed.com

October 17, 2018 — The U.S. Food and Drug Administration (FDA) has reviewed information about potential cybersecurity vulnerabilities associated with the internet connection of Medtronic's cardiac implantable electrophysiology device (CIED) programmers. The FDA said it has confirmed that these vulnerabilities could allow an unauthorized user to change the programmer's functionality or the implanted EP device during the device implantation procedure or during follow-up visits.

The FDA reported Oct. 11 that Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection between the Carelink 2090 and Carelink Encore 29901 programmers used to download software from the Medtronic software distribution network (SDN) . This update is a voluntary recall correction by the manufacturer to address the safety risk caused by the cybersecurity vulnerability.

The cybersecurity vulnerability is associated with using an internet connection to update software between the CareLink and CareLink Encore programmers and the SDN. Software updates normally include new software for the programmer's functionality as well as updates to implanted device firmware. Although the programmer uses a virtual private network (VPN) to establish an internet connection with the Medtronic SDN, the FDA said the vulnerability identified with this connection is that the programmers do not verify that they are still connected to the VPN prior to downloading updates.

To address this cybersecurity vulnerability and improve patient safety, on Oct. 5, 2018, the FDA approved Medtronic's update to the Medtronic network that will intentionally block the currently existing programmer from accessing the Medtronic SDN.

As such, attempting to update the programmer through the internet by selecting the "Install from Medtronic" button on the programmer will result in error messages such as "Unable to connect to local network" or "Unable to connect to Medtronic." These errors are due to disabling the SDN and are not a result of a programmer or local information technology (IT) issue.

To date, there are no known reports of patient harm related to these cybersecurity vulnerabilities.

There are no updates to the CareLink 2090 or CareLink Encore 29901 programmers at this time. However, the FDA said Medtronic is working to create and implement additional security updates to further address these vulnerabilities.

Medtronic CareLink and CareLink Encore programmers are used during implantation and regular follow-up visits for CIEDs. These devices include include pacemakers to provide pacing for slow heart rhythms, implantable defibrillators to provide an electrical shock or pacing to stop dangerously fast heart rhythms, cardiac resynchronization devices to pace the heart to improve contraction to treat heart failure, and insertable cardiac monitors for long-term cardiac monitoring for irregular or abnormal heart rhythms.

Medtronic programmers allow physicians to obtain device performance data, check battery status, and adjust or reprogram device settings from a CIED. When necessary, the programmers are also used by Medtronic staff to update software in the implanted device. The programmer software can be downloaded and updated either through internet connection to the Medtronic SDN or by a Medtronic representative plugging a universal serial bus device (USB) into the programmer.

Read the completed FDA safety alert.

Recommendations for Healthcare Providers

The FDA said providers should continue to use the programmers for programming, testing and evaluation of CIED patients. Network connectivity is not required for normal CIED programming and similar operation. Other Medtronic-provided features that require network connections are not impacted by these vulnerabilities (e.g.,SessionSync). 

The FDA warned not to attempt to update the programmer through the SDN. If you select the "Install from Medtronic" button, it will not result in software installation, because access to the external SDN is no longer available. Future programmer software updates must be received directly from a Medtronic representative with a USB update.

The FDA recommends maintain control of programmers within the provider's facility at all times according to your hospital's IT policies, and to operate the programmers within well-managed IT networks. 

For recommended actions to better secure your computer network environment, refer to www.nist.gov/cyberframework or other applicable cybersecurity guidance.

Reprogramming or updating of CIEDs is not required as a result of this correction and prophylactic CIED replacement is not recommended, the FDA stated.

Recommendations for Patients and Caregivers

The FDA said there are no actions recommended for patients or caregivers related to this software update or cybersecurity vulnerability.
Consult with your physician for routine care and follow-up.

The FDA reminds patients, patient caregivers, and healthcare providers that any medical device connected to a communications network (for example: wi-fi, public, or home internet) may have cybersecurity vulnerabilities that could be exploited by unauthorized users. However, the increased use of wireless technology and software in medical devices can also offer safer, timely and more convenient healthcare delivery.

For more information — www.medtronic.com/content/dam/medtronic-com/us-en/corporate/documents/REV-Medtronic-2090-Security-Bulletin_FNL.pdf, or contact Medtronic Technical Services at 1-800-638-1991.

FDA Takes Cybersecurity Seriously

Medtronic is the second EP device maker to have an EP recall due to cybersecurity vulnerabilities of its technologies. The first major public discussion of the potential hacking of pacemakers and implantable defibrillator (ICDs) was in 2016 when a business market intelligence firm reported St. Jude Medical's EP technologies could be hacked. The FDA then raised serious concerns over these vulnerabilities. St. Jude Medical was purchased by Abbott during that time. The FDA cleared fixes for Abbott's cybersecurity vulnerabilities in August 2017. 
 

Related Cardiac EP Device Cybersecurity Content:

Heart Rhythm Society Recommends How to Prepare for Cybersecurity Threats to Cardiac Implantable Devices

Raising the Bar for Medical Device Cyber Security

The State of Healthcare Cyber Security

Can Your Cardiac Device Be Hacked?

FDA Announces New Medical Device Safety Action Plan

To extract or abandon broken or infected implantable, venous electrophysiology (EP) device leads has been a debate for more than 20 years. Some EPs argue there is a major risk to patients if old pacemaker or implantable cardioverter defibrillator (ICD) leads are extracted. Heavy scar tissue encases the leads after implant, and rough tugging to pull them out may cause the large veins to tear, which can be catastrophic. Supporters of lead extraction say it is necessary to remove the leads in many patients to prevent venous occlusion or the spread of infection. 

In the past decade, the scales appear to be tipping in favor of lead extraction as the safety for procedure improves. The Heart Rhythm Society (HRS) lead management guidelines updated most recently in 2017, along with new studies on lead extraction, have made many take a closer look at balancing risk versus benefit.

"A critical mass of people are becoming trained and comfortable with the idea, but it is a big investment," explained Bruce Wilkoff, M.D., FHRS, CCDS, director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic. He also served as the vice chair of the HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction.

A Brief History of Lead Management

"We started doing lead extraction in the late 1980s, and at first it was just a few people trying to solve some problems, but a lot of people really just thought we were crazy," Wilkoff said.

He explained the first consensus document for lead management was created in the mid-1990s, but there were still few EPs who wanted to take on the potential patient safety risks. "In 2010, we re-did that consensus document, and by that time we had really come to a point when we really had a community of people who accepted it as the thing to do, but no one was really doing this in any volume. However, in the last five to six years it has really taken off. People are starting to become comfortable and they are willing to take on some risk to solve some important problems."

The biggest of these problems include lead infection, because it has an ongoing mortality risk. "We get the impression that infection is something you can cure with antibiotics, but it turns out subsequent 30, 60 and 90 days and subsequent year or two, you have ongoing mortality risk," Wilkoff said. "And if you don't take it out, infection will be universal. So, there is a mandate, you need to take it out when you have infection."

Infection is rare, only occurring in about 2 percent of patients who get an initial lead placement or an upgraded lead, he said, with infection more common with cardiac resynchronization therapy (CRT). 

Increasing Number of Leads in Patients is an Issue

An additional problem with it is faulty or broken leads. Over time, due to constant movement in body, the wires inside the leads can break. EP devices are increasingly being placed in younger patients, and most leads will not last more than 10-20 years. Wilkoff also noted with an increase use of CRT, these devices require several leads, which becomes an issue with how much room there is in the venous system to put more hardware in later during a replacement. 

"So, you have the issue with filling up the venous system with leads, broken leads and issues with venous occlusions, so these are issues we have to take care of," Wilkoff explained. 

Creating a Lead Management Team

Once a center decides lead extraction is a service they want to offer, Wilkoff said it is not something an operator just does, they need training and they need to assemble a team. 

"You have to understand the risks that are involved and it is a collaboration between the nurses, the anesthesiologist, the surgeon, the operator, the echocardiography and the infectious disease expert," he explained. "There are a number of people you need to assemble as a team to work together."

Etiology of Lead Scarring

Soon after most leads are placed in patients there is usually some clotting that forms on them. Over time, this becomes firmer with fibrosis and might even have calcification. Scarring generally occurs any place where the lead touches the endothelium, either in the vein or in the heart.

"There is lead-to-lead scarring, so they become attached to each other, and there is lead-to-vein fibrosis, so this becomes stiffer and stiffer over time," Wilkoff described. 

Use of Lead Management Techniques

The goal of lead extraction procedures is to peel away that fibrosis without tearing the vein. Wilkoff said a cutting sheath is used to release the lead from scar tissue all the way to the heart before attempting to tug on it to pull it out of the body. 

A stylet is used to increase the tensile strength of the lead so if you are pulling it from the outside, then the whole lead comes together so it does not stretch and pull apart. 

The second tool is a set of telescoping sheaths. These have a hollow lumen and are placed over the lead, using a guidewire to follow the course of the lead and only cut the tissue that is immediately touching the lead. These come in a set of two flexible plastic sheaths that have a beveled cutting edge to separate the lead from the surrounding tissue using manual rotation of the sheath. Wilkoff said today, it is more common to see use of a mechanical version of this system, where a small, circular, rotary cutting blade is actuated with a pistol grip trigger mechanism. These devices are offered by Cook Medical and Spectranetics, which is now part of Philips Healthcare. 

Spectranetics also has an FDA-cleared excimer laser sheath system to cut through tissue to release the leads.

Potential Complications of Electrophysiology Device Lead Extraction

One of the biggest safety concerns in removing old device leads is the possibility of tearing the superior vena cava (SVC). This requires immediate emergency surgical repair to stop the bleeding and the complication currently has a 50 percent mortality rate.

"Most of the time lead extraction works out really well, and in 98 percent of cases there are no major complications," Wilkoff said. "But, in 1.5 to 2 percent range there can be a tear to the venous system or the heart and cause a surgical emergency."

Unfortunately, he said you cannot tell which patients will do well and which will not, so you always need to be ready. This is why it is so important to have clear coordination with an echocardiography and a surgeon on a team in case there is tear that need immediate open surgical repair. 

Increasing the Safety of Lead Extractions

The most serious location to get a tear is the SVC, Wilkoff explained. "A laceration in the SVC is what can cause the most problems," he stressed. "If it bleeds into the chest is will cause a hemothorax, or into the pericardium, causing a pericardial tamponade. If it starts bleeding there, it goes very quickly and opening up a person's chest in time is very difficult."

However, with the introduction of the Spectranetics Bridge Occlusion Balloon in 2016, the there is a new level of safety that can be achieved. It offers a safety net during procedures, allowing rapid inflation of an intravascular balloon to seal the tear and allow the surgical team time to prep and perform a repair without fear of the patient bleeding out. The device was credited with saving about 20 lives in the first year after gaining market clearance. 

A guidewire is placed prior to the procedure through the femoral vein to the SVC. If needed, the balloon is advanced up the wire and is inflated using iodine contrast so it can clearly be seen on angiography. The balloon seals the tear and makes it much easier for the surgeon to see and make the repair.

Setting Standards for Lead Management Centers

Lead extraction procedures now number in the tens of thousands per year, but Wilkoff said standards need to be set. This is now included as part of the most recent 2017 revision of the HRS consensus document on lead management. 

"Everybody should be able to tell their patients how many of these procedures they do, what there success rate is and what their complication rate is," Wilkoff said. 

He noted the European Lead Extraction ConTRolled (ELECTRa) registry showed performance of centers performing 30 or more extractions a year were better than centers performing fewer than 30 per year.[2] As with any procedure, the more a center does, the better they become, he explained. "Our previous estimates that 20 procedures a year was good might be too low, which tells us that people who want to do this really need to make a commitment to do this or don't do it at all," Wilkoff said. 

New 2017 HRS Expert Consensus on Lead Management and Extraction

In September 2017, the HRS published an updated Expert Consensus Statement on Cardiovascular Implantable Electronic Device Lead Management and Extraction.

It was developed in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), Asia Pacific Heart Rhythm Society (APHRS), American Society of Anesthesiologists (ASA), European Heart Rhythm Association (EHRA), Infectious Diseases Society of America (IDSA), Latin American Heart Rhythm Society (LAHRS), Pediatric and Congenital Electrophysiology Society (PACES) and Society of Thoracic Surgeons (STS). It is intended to help clinicians in their decision-making process for managing leads and builds on the 2009 Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications and Patient Management document. It provides practical clinical guidance in the broad field of lead management, including lead extraction.

The document features a clinician summary and a pocket card. It is available across multiple platforms, including print, electronic media, and the Guideline Central mobile app at www.guidelinecentral.com.

The statement focuses on identifying the presence of lead malfunction, deciding on whether to abandon or to extract a lead that is no longer clinically necessary or at higher risk for failure, offering guidance on whether a cardiovascular implantable electronic device (CIED) is involved in an infectious process, providing recommendations on when lead extraction should be considered, and discussing specific clinical considerations for patient management when a lead extraction is performed.

The document includes specific recommendations in the following areas: 
   • Lead Survival
   • Existing CIED Lead Management
   • Indications for Lead Extraction (Infectious)
   • Indications for Lead Extraction (Noninfectious)
   • Outcomes and Follow-up

Expanding Lead Management Training via the Web

A few years ago, in an effort to expand lead extraction training to a greater audience, Wilkoff and others created a an online group called LeadConnection.org. The goal was to reduce the economic barriers to getting training for EP operators who cannot attend the annual HRS or other larger EP meetings. The site includes a collection of all the literature on lead management, cases and offers a platform for sharing communication. The group also offers debates and webinars. 

Related Lead Management Content:

Dr. Bruce Wilkoff Explains His Lead Management Learnings Over 20+ Years

Study Shows Occlusion Balloon Saves Lives During Lead Extraction

VIDEO: EP Lead Extraction Strategies — Interview with Bruce Wilkoff, M.D.

VIDEO: Demonstration of How the Bridge Occlusion Balloon Seals SVC Tears

Advances in Transvenous Lead Extraction — Article by Avi Fischer, M.D., FACC, FHRS

Strategies, New Technologies Aid Lead Management.

References:

1. Kusumoto F.M., Schoenfeld M.H., Wilkoff B.L., et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15.

2. Bongiorni M.G., Kennergren C., Butter C., et al. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080.

February 20, 2019 — Medtronic is recalling its dual chamber implantable pulse generators (IPGs) due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting and even death.

Medtronic’s dual chamber IPGs are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a healthcare professional.

The recall impacts Medtronic’s Adapta, Versa, Sensia, Relia, Attesta, Sphera and Vitatron A, E, G and Q series IPGs. All affected products were manufactured between March 2, 2017, and Dec. 18, 2018; they were distributed between March 6, 2017, and Jan. 7, 2019. A total of 13,440 devices have been recalled in the U.S.

Beginning Jan. 17, 2019, Medtronic’s field representatives have hand-delivered “Field Corrective Action Notification” letters to implanting and follow-up physicians.

For healthcare providers:

• Medtronic recommends programming to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed;
• Additional patient risk assessment and programming recommendations are included in Medtronic’s advisory letter;
• In addition to the field correction notification, Medtronic’s field representatives will:
  • Hand-deliver an additional “Supplemental Letter” alongside an “Urgent Medical Device Recall” letter to physicians with patients whose devices have shown evidence of a pacing pause that may be related to this circuit error;
  • Request physicians return all unused and unopened affected product to Medtronic for replacement;
  • Confirm notifications are received by implanting or follow-up physicians using Medtronic’s electronic tracking system in conjunction with confirmation via a paper form; and
  • Conduct effectiveness checks to ensure that all identified implanting or follow-up physicians and risk managers have been notified or proof of at least three attempts to notify them is obtained.

The letter recommends that patients remaining in a susceptible mode should seek immediate medical attention if experiencing any new or unexpected symptoms consistent with a pause in pacing.

Customers who have questions or need additional information regarding this recall may contact Medtronic’s Technical Services at 1-800-505-4636.

Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Healthcare professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

For more information: www.medtronic.com

March 21, 2019 — The U.S. Food and Drug Administration (FDA) approved Impulse Dynamics’ Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure to restore a normal timing pattern of the heartbeat. The device is indicated for patients who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy. The FDA gave the Optimizer Smart system a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The device helped 81.5 percent of patients in the system's most recent study went down 1 NYHA class or more, the company said.

About 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. The leading causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes. Treatment for heart failure includes treating the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physical activity difficult. Doctors may prescribe medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta blockers to lower blood pressure and reduce strain on the heart as well as diuretics to reduce fluid buildup in the lungs and swelling in the feet and ankles.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

“With the FDA’s approval of the Optimizer System for the delivery of CCM [cardiac contractility modulation], we finally have available in the U.S. an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Prof. William T. Abraham, M.D., professor of medicine, physiology and cell biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the U.S. who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”

The FDA evaluated data from two randomized, multi-center clinical trials with a total of 389 patients with moderate-to-severe heart failure. All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements on standard assessments to measure heart failure symptoms, such as how much the symptoms affect a patient’s quality of life and how much the symptoms impede daily physical activities compared to those who received only medical therapy.

The Optimizer Smart system is indicated to improve six-minute hall walk distance, quality of life and functional status of certain heart failure patients. These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy. Patients should also have a regular heart rhythm, not be candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction of 25 to 45 percent, which is considered below the normal ejection fraction of 55 to 75 percent.

Potential complications associated with the use of the device include infection, bleeding, worsened heart failure or problems with the device itself, such as a dislodgement or fracture of the leads implanted in the heart.

Early versions of the system have had CE Mark approval in the European Union since 2002.  The current version, Optimizer Smart has had the EU CE Mark since 2016. The system is referenced in the European Society of Cardiology clinical guidelines for heart failure.

For more information: www.impulse-dynamics.com

March 29, 2019 — A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of patients with faulty cardiac rhythm devices in an emergency setting. The software has been able to identify the make and model of different devices, such as pacemakers and defibrillators, within seconds.

The study, published in JACC: Clinical Electrophysiology,1 took place at Hammersmith Hospital, part of Imperial College Healthcare NHS Trust.

James Howard, Ph.D., clinical research fellow at Imperial College London and lead author of the study, said: "Pacemakers and defibrillators have improved the lives of millions of patients from around the world. However, in some rare cases these devices can fail and patients can deteriorate as a result. In these situations, clinicians must quickly identify the type of device a patient has so they can provide treatment such as changing the device's settings or replacing the leads. Unfortunately, current methods are slow and out-dated, and there is a real need to find new and improved ways of identifying devices during emergency settings. Our new software could be a solution, as it can identify devices accurately and instantly. This could help clinicians make the best decisions for treating patients."

More than 1 million people around the world undergo implantation of a cardiac rhythm device each year, with over 50,000 being implanted per year in the U.K. These devices are placed under the patients' skin to either help the heart's electrical system function properly or measure heart rhythm. Pacemakers treat slow heart rhythms by 'pacing' the heart to beat faster, while defibrillators treat fast heart rhythms by delivering electric shocks to reset the heartbeat back to a normal rhythm.

However, in some rare cases these devices can lose their ability to control the heartbeat, either because the device malfunctions or the wires connecting it to the heart move out of the correct position. When this happens, patients may experience palpitations, loss of consciousness or inappropriate electric shocks.

In these situations, clinicians need to determine the model of a device to investigate why it has failed. Unless they have access to the records where implantation took place, or the patient can tell them, staff must use a flowchart algorithm to identify pacemakers by a process of elimination. The flowchart contains a series of shapes and circuit board components of different pacemakers designed to help clinicians identify the make and model of a patient's pacemaker. Not only is this time-consuming, but these flow charts are now outdated and therefore inaccurate. This can result in delays to delivering care to patients, who are often in critical conditions.

In the new study, researchers trained the software program called a neural network to identify more than 1,600 different cardiac devices from patients.

To use the neural network, the clinician uploads the X-ray image containing the device into a computer and the software reads the image to give a result on the make and model of the device within seconds.

The team used the program to see if it could identify the devices from radiographic images of more than 1,500 patients at Hammersmith Hospital between 1998 and 2018. They then compared the results with five cardiologists who used the current flowchart algorithm to identify the devices.

The team found that the software outperformed current methods. It was 99 percent accurate in identifying the manufacturer of a device, compared with only 72 percent accuracy for the flow chart. The team suggests the software could greatly speed up the care of patients with heart rhythm device problems.

The researchers will aim to carry out a further trial to validate the results in a larger group of patients and investigate ways to create a more portable device that can be used on hospital wards.

For more information: www.electrophysiology.onlinejacc.org

Reference

1. Howard J.P., Fisher L., Shun-Shin M.J., et al. Cardiac Rhythm Device Identification Using Neural Networks. JACC: Clinical Electrophysiology, March 27, 2019. https://doi.org/10.1016/j.jacep.2019.02.003

May 7, 2019 — The U.S. Food and Drug Administration (FDA) issued a safety communication to alert healthcare providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected without warning.

Medtronic Pacemaker Battery Depletion Issue Identified

Medtronic has identified a rare but potentially serious failure mode in some of its Azure and Astra pacemakers, and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P), manufactured with a specific multilayer ceramic capacitor. The company said these electrophysiology (EP) devices continue to perform within reliability projections.  

Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batteries. One of the key electronic components is a capacitor, which stores electrical energy before discharge to pace the heart.

The company said a known failure mode of these capacitors is the potential for internal cracking, which can be caused by thermal-mechanical stress during manufacturing. Under rare conditions, internal cracking within a capacitor may result in the development of a power leakage pathway, causing high current drain and leading to rapid battery depletion. While the issue presents as rapid battery depletion, Medtronic said this is not a battery performance issue.

As of April 26, 2019, three battery depletion reports were filed out of about 266,700 devices distributed worldwide since February 2017. However, one of these events contributed to a patient death. Battery depletion due to this issue can range from several days to several weeks.  

The FDA said in all three medical device reports it received, Medtronic reported that healthcare providers were unable to communicate with the device due to battery depletion, resulting in loss of pacemaker function. Medtronic also reported these events occurred within one year after the patient was implanted with the pacemaker or CRT-P, on average within seven months of getting the device implanted. The devices are designed to last between approximately 7.5 and 15 years or 6 and 10 years before requiring battery replacement, depending on the device and the amount of pacing.

One of the reported events resulted in the death of a pacemaker-dependent patient, the FDA said. In a second reported event, the patient experienced dizziness during follow-up and the provider was unable to communicate with the device, which resulted in the patient getting their device replaced. In the third reported event, there was no harm to the patient because the device was not implanted when the provider became aware that a connection with the device could not be established.

Medtronic said the three confirmed failures occurred within nine months post-implant. The projected rate for this issue is 0.0028 percent, with the most susceptible period for a leakage pathway to develop in the capacitor being the first 12 months post-implant.

Device Replacement is Not Recommended

Based on the low predicted rate of failure and the recent implementation of process and component enhancements, Medtronic expects few, if any, additional events to occur. The company said it consulted with its Independent Physician Quality Panel and does not recommend device replacement.

The FDA said prophylactic removal and replacement of affected devices is not recommended, but some patients who depend on pacing for survival may determine, in consultation with their physician, that device replacement is appropriate for their needs. The FDA said providers should consider whether elective device replacement is warranted due to pacemaker-dependent status or other high-risk features.

The FDA recommends replacing any pacemaker or CRT-P immediately if they receive an

Elective Replacement Indicator (ERI) CareAlert notification when the battery level drops below a certain limit. Currently, the FDA said there is not a factor, method or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears. Once ERI is reached, an affected device is unlikely to have the standard three months of battery life remaining.

The FDA said providers should treat any ERI for pacemaker-dependent patients as a medical emergency.

Patients and Providers Should be Monitoring for Battery Status

Medtronic said physicians should continue normal patient follow-up in accordance with standard practice, and where possible, continue to utilize the low battery voltage wireless CareAlert (shipped ON), together with remote monitoring via CareLink home monitor or the MyCareLink Heart mobile app.

Per the instructions for use, at each follow-up, verify the status of the implanted system as well as the clinical effectiveness of the device. The company said clinicians should pay attention to any unexpected changes in remaining longevity estimates, or the inability to interrogate the device and/or transmit data.

The FDA said patients can use the remote monitoring systems, including Medtronic’s MyCareLink Monitor, to help their healthcare providers monitor battery status and general functioning of their implanted pacemaker or CRT-P. Providers receive CareAlert notifications through manual transmissions from the patient or wirelessly connecting to the patient’s implanted pacemaker or CRT-P when the patient’s device has CareAlerts programmed “ON.”

For Azure, Percepta, Serena and Solara, the FDA said these devices have wireless CareAlerts programmed by the healthcare provider. The monitor must remain powered on to ensure automatically scheduled transmissions are sent. CareAlerts should be programmed to “ON.”

For Astra, the FDA said these devices do not have wireless capability and require manual transmission by the patient. To ensure timely transmission of any CareAlerts done manually by the patient, the patient should have a transmission schedule and CareAlerts should be programmed “ON.”

Steps Taken for Newly-Manufactured Devices

This year, Medtronic received the FDA’s approval for a new step in the manufacturing process developed to better detect capacitor failures. A different type of capacitor is also being used to reduce the risk of rapid battery depletion in newly-manufactured devices.

Reporting Premature Battery Depletions

Medtronic Technical Services can be contacted with any questions at rs.techservices@medtronic.com, or (800) 505-4636.

The company said confirmed premature battery depletions, regardless of cause, are reported in Medtronic's semi-annual product performance report under the confirmed “malfunctions” section for each device model. Product Performance information can be accessed directly at http://wwwp.medtronic.com/productperformance/

Specific Models Affected

Specific models this applies to are:

• W1DR01 Azure XT DR
• W1SR01 Azure XT SR
• W1TR01 Percepta CRTP MRI
• W1TR02 Serena CRTP MRI
• W1TR03 Solara CRTP MRI
• W1TR04 Percepta CRTP MRI
• W1TR05 Serena CRTP MRI
• W1TR06 Solara CRTP MRI
• W2DR01 Azure XT DR
• W2SR01 Azure XT SR
• W3DR01 Azure S DR
• W3SR01 Azure S SR
• W4TR01 Percepta Quad CRTP MRI SureScan
• W4TR02 Serena Quad CRTP MRI SureScan
• W4TR03 Solara Quad CRTP MRI SureScan
• W4TR04 Percepta Quad CRT-P MRI SureScan
• W4TR05 Serena Quad CRTP MRI SureScan
• W4TR06 Solara Quad CRTP MRI SureScan
• X2DR01 Astra XT DR MRI SureScan
• X2SR01 Astra XT SR MRI SureScan
• X3DR01 Astra S DR
• X3SR01 Astra S SR

Read the full FDA warning letter.

Link to Medtronic's warning letter to customers. 

May 13, 2019 – Results from a new survey are the first to report a large discrepancy in patient’s knowledge of their cardiac implantable electronic device (CIED). The study reviewed patients’ overall knowledge of data from their devices as well as their perceptions on what is most important. Participants in this study have a strong desire to better understand their device and its data, with more guidance on battery life as the most important aspect for patients. The study was presented at Heart Rhythm 2019, the  Heart Rhythm Society's 40th Annual Scientific Sessions.

In the United States, cardiac arrhythmias impact an estimated 14.4 million patients.[1] Today, CIEDs have evolved to be a prevalent treatment option for these patients, with more than 300,000 individuals receiving new CIED implants every year in the U.S. alone.[2] As new technology innovations emerge, patients have greater or unprecedented access to real-time data and information about their health from their devices. With advancing technology and increasing use of CIEDs, there is a need to better understand patients' knowledge of their devices and their perceptions of what data elements are most important.

The study initially screened 400 patients between July and December 2018 who attended an in-person device evaluation at the Cleveland Clinic outpatient clinic. The mean patient age was 62.9±12.8 years and 64 percent were male. Patients received a one-page questionnaire asking multiple choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks. Their answers were then compared to their interrogation report to assess accuracy. Patients were also asked to share what data would be most important to them as the device user.

"Our research uncovered a discrepancy between patients’ perception of their own knowledge of their devices and their actual knowledge about their device. While some patients have lived with these devices for years, our results show that there is still a general lack of knowledge," said lead author Divyang Patel, M.D., Cleveland Clinic. "As digital health evolves, patients are able to access their own health data in real-time. By equipping device users to be active participants in their health, we hope they will be able to utilize their own data and be empowered to be more engaged in their care and live a healthier life."

In this cohort, 344 or 86 percent of patients agreed to take the survey. From this group, 62 percent agreed or strongly agreed that they were knowledgeable about their device, however, 84 percent missed at least one question. 48 percent of survey participants missed at least two questions about their device. Patients agreed or strongly agreed that they had a desire to have more information regarding each of the following: battery life (81 percent), activity level (76 percent), heart rate trend (73 percent) and ventricular arrhythmias (71 percent). The results of this study show a discrepancy in patients’ knowledge regarding their CIEDs and their wish to better understand the device.

"Despite the advancement in remote monitoring of CIEDs, up until recently it has been a process between clinicians and manufacturers, with patients on the receiving end. Now that patients have access to data in real-time, especially with the advancement of digital health technologies and increased use of smart devices, we need to help guide patients, clinicians, and manufacturers on how to make the most out of their information to help advance patient care and lead to positive outcomes," said senior author Khaldoun Tarakji, M.D., MPH, FHRS, Cleveland Clinic. "Our study is one of the first to give insight into the voice of the patient and what they desire to know. Now, the physician community along with device manufacturers and medical societies need to work together on a plan for optimal education and success."

All the HRS 2019 late-breaking studies 

Link to other HRS 2019 news

References:
1. Roger VL, Go AS, Lloyd-Jones DM, et al. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2011 update: a report from the American Heart Association. Circulation 2011;123:e18-e209.
2. Greenspon A.J., Patel J.D., Lau E., et al. (2011) 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol 58:1001–1006.

May 14, 2019 – Results from new research show that passengers with cardiac implantable electronic devices (CIEDs), such as pacemakers or implantable cardioverter defibrillators (ICDs), can safely travel through airport security checkpoint scanners. This is the first study to look at the relationship between body scanners and the impact on functionality of devices. The results were presented at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions and show no negative interference after analyzing more than 1,000 scans.

More than 3 million people across the world have pacemakers, a common CIED, as treatment for abnormal heart rhythms.[1] Body scanners are increasingly being used worldwide and are replacing conventional metal detectors. These scanners represent a potential new source of electromagnetic interference (EMI). EMI is a disturbance known to cause pacing inhibition or inappropriate shock therapy. Patients are advised to manage this potential risk by limiting their exposure to certain technologies including metal detectors, magnets, MRI scans and other medical procedures.

Prior to conducting the study, the authors surveyed more than 1,000 patients and found that 80 percent have fears or concerns about passing through body scanners at the airport. The survey information further reinforces the need to clarify the safety of airport security body scans for passengers with CIEDs.

The study included 375 patients enrolled between May 2017 and October 2018. The devices studied included implantable cardioverter defibrillators (ICD) (n=175, 47 percent), conventional pacemakers (PM) (n=127, 33 percent), subcutaneous ICD (S-ICD) (n=52, 14 percent), and leadless pacemakers (LCP) (n=21, 6 percent). The sensitivity levels of the devices were not altered, ICD shock therapy was disabled and permanent ventricular pacing were ensured to facilitate the detection of EMI. The primary endpoint was EMI events including pacing inhibition, upper rate tracking, tachycardia detection and spontaneous reprogramming. The secondary endpoint was the incidence of CIED detection by the body scanner.

Results from more than 1,000 body scans reported no interference with patient devices. There were no events of EMI during the body scans across 375 devices. Further, no CIEDs were detected by the body scanners (EMI-prevalence 0 percent [95 percent CI; 0 percent 1 percent]).

"We were surprised to learn that so many patients expressed concerns about the functionality of their devices while travelling. We wanted to help put their minds at ease by testing the potential interference body scanners could have on common devices like pacemakers and defibrillators," said lead author, Carsten Lennerz, M.D., MSci, German Heart Centre Munich. "Our study results show that now patients can travel worry-free knowing they can safely go through security checkpoints without the need of disclosing personal medical information."

The authors place importance on studies with larger patient populations and different types of body scanners. In addition, the studied the possible interference between devices and electric cars. "Do Electric Cars Impact Pacemakers and Defibrillators?" is also being presented at the meeting.

Read the related article "Driving a Tesla Car Does Not Cause Defibrillator Shocks."

All the HRS 2019 late-breaking studies 

Link to other HRS 2019 news

Reference:
1. Wood, M. A., & Ellenbogen, K. A. (2002). Cardiac Pacemakers From the Patient’s Perspective. Circulation, 105(18), 2136-2138. doi:10.1161/01.cir.0000016183.07898.90

May 15, 2019 — A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] The new scoring system was presented as a follow up to that study during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

"We developed a novel infection risk score in the largest cardiovascular implantable electronic device (CIED) trial to date, with five independent predictors that are readily adopted into clinical practice," explained Andrew D.. Krahn, M.D., FHRS, professor in the Division of Cardiology at the University of British Columbia, who presented the study. He said the PADIT infection score warrants validation in an independent cohort study.

CIED infection is a major complication, usually requiring device removal. The Prevention of Arrhythmia Device Infection Trial (PADIT) was a large cluster crossover trial of standard versus incremental antibiotics. Krahn said the study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score. Device procedures were performed in 19,603 patients and hospitalization for infection occurred in 177 (0.90%) within one year. 

Over four six-month periods, 24 centers used either conventional or incremental antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within one year with blinded end-point adjudication. Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The model was internally validated with bootstrap methods.

The final prediction model identified five independent predictors of device infection (previous procedures (N), age, decreased renal function, immuno-compromised, and type of procedure) with optimizm-corrected C-statistic of 0.704 (95% CI, 0.660-0.744).

The PADIT infection risk score ranging from 0 to 14 points classified patients into three risk groups:

   • Low (0-4)

   • Intermediate (5-6)

   • High (≥7)

The risk groups had rates of hospitalization for infection of 0.51%, 1.42% and 3.41%, respectively (also see figure 1). Subgroup analysis by PADIT infection risk score of the two antibiotic regimes showed no treatment effect (pinteraction = 0.37).

All the HRS 2019 late-breaking studies 

Link to other HRS 2019 news

Reference: 

1. Krahn AD, Longtin Y, Philippon F, et al. Prevention of Arrhythmia Device Infection Trial: The PADIT Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3098-3109. doi: 10.1016/j.jacc.2018.09.068.