May 15, 2019 — The Heart Rhythm Society (HRS) had 21 late-breaking study presentations at the 2019 Heart Rhythm Scientific Sessions. Here is a completed list of the studies presented with links to more information. This includes the latest in clinical research, techniques and technologies in cardiac electrophysiology (EP). For more details on HRS 2019, visit www.hrssessions.org.

Late Breaking Clinical Trials Session I
Thursday, May 9, 8 – 9:30 a.m.
   • Transcutaneous Electrical Vagus Nerve Stimulation To Suppress Atrial Fibrillation (TREAT AF): A Randomized Clinical Trial 

   • Prospective Randomized Comparison Of Rotor Ablation vs. Conventional Ablation For Treatment Of Persistent Atrial Fibrillation - The REAFFIRM Trial 

   • Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibillation (ERADICATE-AF) Trial  

   • Baroreflex Activation Therapy In Patients With Heart Failure With A Reduced Ejection Fraction  

   • His Corrective Pacing Or Bi-ventricular Pacing For Cardiac Resynchronization In Heart Failure: A Randomized Pilot Trial (HIS SYNC)

Late Breaking Clinical Trials Session II: New Data for Device Therapies
Friday, May 10, 1:30 – 3 p.m.
   • Update From The Prevention Of Arrhythmia Device Infection Trial (PADIT); Development Of The PADIT Infection Risk Score 

   • Decline In Ventricular Arrhythmia Events And Mortality In The Multicenter Automatic Defibrillator Implantation Trials  

   • After RAFT: Long Term Outcomes Of Cardiac Resynchronization Therapy  

   • Cardiac Resynchronization Therapy In Chemotherapy-induced Cardiomyopathy: Results Of The Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-induced Cardiomyopathy (MADIT-CHIC) Study

   • Understanding Outcomes With The S-ICD In Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Study: High Conversion Efficacy And Low Adverse Event Rate During The First 30 Days 

 
Late Breaking Clinical Trials Session III: Late-Breaking Science
Friday, May 10, 4:30 – 6 p.m.
   • Prospective Evaluation Of Feasibility, Electrophysiological And Echocardiographic Characteristics Of Left Bundle Branch Area Pacing 

   • Is Nonselective His Bundle Pacing Good Enough? Long-term Outcomes From The Geisinger-Rush HBP Registry

   • Preventive Ablation Of Ventricular Tachycardia In Patients With Myocardial Infarction: The BERLIN-VT Trial

   • Five-year Outcomes In Cardiac Surgery Patients With Atrial Fibrillation Undergoing Concomitant Surgical Ablation Versus No Ablation. The Long-term Follow-up of the Prague-12 Study  

   • Real-time Electrogram Analysis For Drivers Of Atrial Fibrillation (Radar): A Multi-center, FDA-IDE, Clinical Trial Of Persistent AF

   • Pulsed Field Ablation For Pulmonary Vein Isolation: Lesion Durability And Chronic Safety  

Late Breaking Clinical Trials Session IV: Innovations
Saturday, May 11, 10:30 a.m. - Noon 
   • First-in-human Chronic Implant Experience Of The Medtronic Substernal Extravascular Implantable Cardioverter Defibrillator

   • DIGITAL-AF II: Results From A Real-life Digital Atrial Fibrillation Screening Using Smartphones And Outcome Registry In The General Population

   • Non-invasive Localization Of Cardiac Arrhythmias Using Electromechanical Wave Ultrasound Imaging

   • A Novel Percutaneous Carotid Coil Filter For Stroke Prevention In Atrial Fibrillation: Outcomes Of The First-in-human CAPTURE Trial

   • Bipolar Catheter Ablation For The Treatment Of Refractory Scar-related Ventricular Tachycardia: A Multicenter, Prospective FDA IDE Study

Other HRS 2019 News:

Survey Shows Big Need for Patient Education on Their Implantable Electrophysiology Devices

Airport Security Body Scanners Do Not Interfere With Pacemakers, ICDs 

Studies Find Race and Gender Disparities in Implantable Heart Devices

HRS Releases New Expert Consensus Statement on Arrhythmogenic Cardiomyopathy

New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias

VIDEO: Use of an Antibacterial Envelope to Reduce Infections for Pacemakers, ICDs — Interview with Khaldoun Tarakji, M.D.

VIDEO: Key Trends in Electrophysiology — Apple Watch to Detect AF and the CABANA Trial— Interview with Christine Albert, M.D.,

Find links to other Heart Rhythm Scientific Sessions news

Industry News at HRS 2019:

Philips and Medtronic Collaborate on Image-guided Atrial Fibrillation Treatment

Abbott Launches Next-generation Confirm RX Implantable Cardiac Monitor

FDA Approves Attain Stability Quad MRI SureScan Lead from Medtronic

Biosense Webster Launches Cartonet Analytics Software for Electrophysiology

Murj Launches Murj 2.0 Implantable Cardiac Device Management Software

Acutus Medical Receives FDA Clearance for Second-generation AcQMap Platform

CardioFocus Announces European CE Mark Approval Of HeartLight X3 System

Biocardia Receives FDA Clearance for Avance Steerable Introducer Family

Spacelabs Debuts Sentinel 11 Cardiology Information Management System

Stereotaxis Announces Next-generation Robotic Magnetic Navigation and Imaging Systems

Preventice Solutions Presents Real-World Performance Data on BodyGuardian Remote Monitoring System With AI

CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study

June 4, 2019 — Orchestra BioMed Inc. announced the presentation of two-year clinical data from the European Moderato I study of BackBeat Cardiac Neuromodulation Therapy (“BackBeat CNT”) for hypertension at the EuroPCR Conference, May 21-24 in Paris, France. Prof. Petr Neužil, M.D., Ph.D., CSc., FESC, head of the department of cardiology of Na Homolce Hospital in Prague, Czech Republic, presented data which showed a strong safety profile of BackBeat CNT and its ability to immediately, substantially and chronically lower blood pressure in patients with persistent hypertension (office BP > 150 mmHg) despite two or more anti-hypertensive medications and an indication for a pacemaker.

"In the Moderato I study, BackBeat CNT demonstrated an impressive 14.2 mmHg reduction in 24-hour ambulatory systolic blood pressure at three months as well as a substantial and sustained 23.4 mmHg reduction in office cuff systolic blood pressure out to two years. These statistically significant results are very exciting as they support the potential for BackBeat CNT to become a broadly applicable therapy for device-based hypertension management,” said Neužil, one of the principal investigators of the study.

BackBeat CNT is applicable to a wide range of hypertensive patients, including isolated systolic disease and patients with high blood pressure despite medical therapy. The Moderato I study enrolled patients with uncontrolled hypertension despite multi-drug medical management and who are also indicated for a pacemaker.

“We are encouraged by the data from Moderato I study showing substantial reduction in systolic blood pressure which could potentially reduce the risk of heart attack and stroke,” said Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed. “We recently completed enrollment of patients in the Moderato II study to further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension and are on track to present 6-month data later this year.”

Orchestra BioMed recently completed enrollment in the Moderato II study. The study is a prospective, 1:1 randomized double-blind active treatment with BackBeat CNT versus standard medical therapy trial in pacemaker-indicated patients with uncontrolled blood pressure and treated with at least one antihypertensive medication. The primary efficacy and safety endpoints will be assessed at six months.

“We are looking forward to Moderato II six-months results and the long-term potential of this exciting therapy to benefit high-risk patients with uncontrolled high blood pressure,” stated Neužil.

In 2019, Orchestra BioMed plans to initiate enrollment in a randomized, double-blind study to assess the clinical safety and effectiveness of BackBeat CNT in patients with hypertension in the absence of antihypertensive medications. The primary efficacy endpoint will be the difference in the average 24-hour ambulatory systolic blood pressure in the active group compared to control at three months after randomization.

Read the article "BackBeat Cardiac Neuromodulation Therapy Reduces Blood Pressure at Two Years"

For more information: www.orchestrabiomed.com

July 31, 2019 — The chances of patients experiencing complications after having a cardiac device implanted vary according to where they have the procedure.

A study of 174 hospitals in Australia and New Zealand published in the Annals of Internal Medicine shows that the quality of care people receive may account for the wide variation in the rate of complications after having a cardiovascular implantable electronic device (CIED) insertion.

“The study included 81,304 patients who received a new CIED with 65,711 permanent pacemakers and 15,593 implantable cardioverter-defibrillators,” said the study’s lead author, University of Adelaide’s Isuru Ranasinghe, Ph.D., senior cardiologist, Central Adelaide Local Health Network. “Permanent pacemakers and implantable cardioverter-defibrillators are among the most common and costly devices implanted in hospitals.

“CIED complications are common with 8.2 percent of patients implanted with new devices having a major device-related complication within 90 days of their operation. Complications experienced by patients vary between two- and three-fold among hospitals, which suggests that there is significant variation in CIED care quality,” added Ranasinghe

Nearly 19,000 pacemakers and more than 4000 defibrillators were implanted in Australia alone last year. Pacemakers are often fitted to elderly people who suffer from bradycardia where their heart beats too slowly. They use electrical pulses to prompt the heart to beat at a normal rate. Cardioverter-defibrillators track a person’s heart rate, and if an abnormal heart rhythm is detected, the device delivers an electric shock to restore the heart rhythm to normal.

“Serious complications can cause considerable patient harm and adds to avoidable healthcare costs. About 60 percent of these complications occur after leaving the hospital so many doctors and hospitals may not be fully aware of the complications experienced by patients,” said Ranasinghe.

Associate Prof. Anand Ganesan, a study co-investigator and a cardiac electrophysiologist at Flinders Medical Centre said, “What this study really shows is that we should be routinely reporting hospital complication rates to make these fully visible to clinicians, hospitals and the community at large. We should also invest in strategies proven to reduce these, such as optimizing procedural technique, adopting better infection control measures and managing blood thinning drugs peri-procedure.”

Ranasinghe said, “Encouraging hospitals to take part in quality improvement activities such as auditing complications and engaging in clinical quality registries also reduce complications over time.”

This study was funded by the HCF Research Foundation, with additional funding support from the National Heart Foundation of Australia and The Hospital Research Foundation.

For more information: www.annals.org

Reference

1. Ranasinghe I., Labrosciano C., Horton D., et al. Institutional Variation in Quality of Cardiovascular Implantable Electronic Device Implantation: A Cohort Study. Annals of Internal Medicine, published online July 30, 2019. DOI: 10.7326/M18-2810

August 19, 2019 — The U.S. Food and Drug Administration (FDA) granted market clearance the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device 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.

“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The FDA continues to work with manufacturers through our Breakthrough Devices Program to provide patients and healthcare providers with timely access to medical devices that have the potential to lead to a clinical improvement in patients, such as those with this irreversibly debilitating condition, while ensuring these devices meet our regulatory requirements for safety and effectiveness.”

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 Barostim Neo System includes a pulse generator that is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck. After the device is implanted, a physician tests and programs the device, which delivers electrical impulses to cells in the neck called baroreceptors, which sense how blood is flowing through the carotid arteries and relays information to the brain. The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

The FDA evaluated data from a prospective, multi-center, two-arm, randomized clinical trial with a total of 408 patients with advanced heart failure. All patients received guideline-directed medical therapy, including medication, and 125 patients also received a Barostim Neo System implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements in how symptoms impacted their quality of life. Also in the trial, 120 randomized subjects with less severe chronic heart failure found benefit in lowering levels of a biomarker that measures heart failure.

Potential complications associated with the implantation or use of the device include: infection; need for reoperation; low blood pressure that may cause dizziness, fainting, and/or falls; nerve damage; surgical or anesthetic complications; allergic reaction; arterial damage; exacerbation of heart failure; stroke; and death.

The Barostim Neo System is indicated for patients who have a regular heart rhythm, are not candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction (the total amount of blood pumped out in each heart beat) of less than or equal to 35 percent, which is considered below the normal ejection fraction of 55 to 75 percent. The device is contraindicated for patients with anatomy that would impair implantation of the device, certain nervous system disorders, uncontrolled and symptomatic slow heart rate, atherosclerosis or ulcerative plaques near the implant location, and patients with a known allergy to silicone or titanium.

The device was approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

As part of the approval of this device, the FDA is requiring the manufacturer to conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization.

The FDA granted the Barostim Neo System a Breakthrough Device designation, meaning the agency provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. All designated devices must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The FDA granted approval of the Barostim Neo System to CVRx Inc.

For more information: www.cvrx.com

Related Barostim Content:

Device Technologies to Reduce Heart Failure Readmissions

FDA Grants HDE For Pacemaker That Regulates Hypertension

CVRx Barostim Therapy Clinical Trial Results Presented at ESC-Heart Failure Conference

First Implant Made for Barostim neo Device to Treat Hypertension

Barostim Therapy Projected to be Cost-Effective in Treating Resistant Hypertension

October 10. 2019 — Late-breaking results from its MODERATO II double-blind, randomized study of BackBeat Cardiac Neuromodulation Therapy (CNT) demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in hypertensive patients also indicated for a pacemaker. The results were presented as late-breaking science at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 annual conference. 

Results showed the study met its primary efficacy endpoint, with patients randomized to BackBeat CNT experiencing an 11.1 mmHg (p<0.001) reduction in mean 24-hour ambulatory systolic blood pressure (ASBP) at six months follow-up, resulting in a significant difference of 8.1 mmHg compared to control patients who were managed only with antihypertensive medications  (p=0.01). The study also met its primary safety endpoint with no statistical difference in rate of major cardiac adverse events (MACE) between the two groups at 6 months follow-up.

“Achieving a statistically significant blood pressure reduction with BackBeat CNT in this patient population is particularly exciting given that over 70% of pacemaker patients have high blood pressure as well as other known co-morbidities,” said Karl-Heinz Kuck, M.D., Ph.D., director of cardiology at the Lans Medicum, Hamburg, Germany and study principal investigator who presented the results at TCT. “This is a particularly challenging at-risk population with a very high rate of isolated systolic hypertension and persistently elevated blood pressure despite multi-drug therapy. BackBeat CNT appears to be a promising treatment to significantly reduce systolic blood pressure and has a favorable risk benefit profile as the device is already required for rhythm management.”

All patients enrolled in the MODERATO II study, a European prospective, multi-center, double-blind, randomized study of BackBeat CNT vs. control in 47 patients with persistent hypertension (ASBP ≥130 mmHg and office systolic blood pressure (OSBP) ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication, were implanted with Orchestra BioMed’s Moderato® System, an implantable pulse generator that delivers BackBeat CNT as well as standard rhythm management functions that recently received CE mark approval. Following a 30-day run-in period during which patients received only standard pacing along with anti-hypertensive medications, patients who met follow-up screening criteria for daytime ASBP, were randomized to BackBeat CNT or control groups. Prior to randomization, mean ASBP for both groups were 136.3 mmHg with patients, on average, treated with over 3 prescribed anti-hypertensive drugs. After 6 months, mean ASBP was reduced by 11.1 mmHg (p<0.001) in the BackBeat CNT group as compared to a reduction of 3.1 mmHg in the control group (p=0.17). The treatment group saw a high (85%) overall response rate, with approximately 54% of the BackBeat CNT-treated patients experiencing ASBP reduction at 6 months of greater than 10 mmHg, an amount associated with a clinically meaningful reduction in risk of heart attack and stroke. The BackBeat CNT group also experienced significantly greater reduction, 12.4 mmHg, in OSBP over the control group (p=0.02). There were no MACE events in the BackBeat CNT group and 3 events in 2 patients in the control group. Additionally, there were no notable differences in echo parameters between the two arms. Diastolic blood pressure and heart rate did not change between groups during the study period.

“Achieving an 11.1 mmHg reduction in mean 24-hour ambulatory systolic blood pressure in the BackBeat CNT arm is a remarkable result, and clinically significant,” said David E. Kandzari, M.D., FACC, FSCAI, chief scientific officer and director, Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA. “This data offers compelling preliminary evidence that this therapy may provide a safe and effective means to help the pacemaker population achieve target blood pressure levels and reduce cardiovascular risk.”

Over 1.1 million pacemakers are implanted annually worldwide. Patients indicated for a pacemaker have a particularly high rate of elevated blood pressure, with more than 70 percent of these patients suffering from hypertension. Based on 2017 American College of Cardiology/American Heart Association high blood pressure guidelines, it is estimated that over 60 percent of pacemaker patients have uncontrolled hypertension despite medical therapy.

BackBeat CNT is the flagship therapy of Orchestra BioMed Inc. It is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS). Orchestra BioMed’s CE mark-approved Moderato implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker.

Find more late-breaking news and video from TCT 2019

November 13, 2019 — Texas Heart Institute (THI) was awarded a prestigious four-year, $2.39 million grant from the National Institutes of Health (NIH) to explore further the development of a novel pacemaker system that is both leadless and wirelessly powered. 

Mehdi Razavi, M.D., director of electrophysiology clinical research and innovations at THI, co-principal investigator professor Aydin Babakhani at UCLA Integrated Sensors Laboratory (ISL), and co-principal investigator Behnaam Aazhang, Ph.D., J.S. Abercrombie Professor, electrical and computer engineering, Rice University, will lead the device development and research studies. The new pacemakers allow simultaneous pacing and sensing from multiple sites in the heart to help reduce the complications associated with the traditional pacemakers in use today.

“Current wireless pacemakers can be effective for patients with certain types of atrial fibrillation and in patients with a medical condition or anatomy that blocks access to the vessels where traditional pacemaker leads are attached," Razavi, said. "However, if the patient needs dual-chamber pacing, we are forced to use a traditional pacemaker with leads. Pacemaker wires called leads are prone to fracturing, dislodging and migrating away from the original location. Our technology could overcome this problem and make wireless, leadless, battery-less pacemakers available to these patients.” 

The pacing and sensing devices will be based on silicon-based integrated microchips that were built in Babakhani’s laboratory at UCLA. Post-doctoral scholar Hongming Lyu and Ph.D. students Hamed Rahmani and Yuxiang Lyu of Babakhani’s laboratory at UCLA designed the earlier version of the device. Babakhani’s laboratory has pushed the limits of miniaturization so that an entire pacemaker can fit inside a vein. The miniaturized pacemaker eliminates the need for bulky batteries as it receives energy and commands wirelessly through electromagnetic waves from an external controller. 

“One of the major challenges of this technology is maintaining the efficiency of wireless power transfer as the device becomes very small and the antenna becomes inefficient," explained Babakhani. "We have addressed this issue by significantly lowering the power consumption of the electronics used in the pacemaker, integrating all the elements on a single chip, and designing antennas that resonate strongly with the input circuitry of the pacing chips."

A Short History of Pacemakers 

Pacemakers are used to treat slow heart rates (bradycardia). An American physiologist built the first device referred to as an "artificial pacemaker” in 1932. Powered by a spring-wound, hand-cranked motor, the device was dismissed as nothing more than a gadget and was met with opposition at a time when using technology to alter the natural course of life was highly controversial. Pacemaker advances exploded in the late 1950s and early 1960s with several landmark firsts, including pacemakers that were battery-operated and wearable, totally implantable and self-contained. New battery technology in the 1970s dramatically improved the lifespan of the pacemaker.

After decades of steady pacemaker improvements since the 1970s, a new era of explosive growth for the pacemaker could dramatically improve outcomes and quality of life for millions of people suffering from heart rhythm disorders.

Development of Leadless, Wireless Pacemakers

New leadless systems are now available, such as the Medtronic Micra, that can provide pacing to one chamber of the heart. However, pacing therapy is typically delivered to multiple chambers of the heart in a synchronized manner, and the bulky size and shape of the new leadless pacemakers do not allow for multi-chamber pacing. Miniature, battery-less devices are being tested in clinical trials, but these devices can only deliver effective therapy in combination with another pacemaker.

Razavi and the team overcome all of these challenges with their wireless, leadless, battery-less pacemaker design.

The pacemaker they are developing also will learn from the data it generates, identify patterns and make adjustments to enable constant optimal patient-specific therapy, according to THI research engineers Allison Post, Ph.D., and Mathews John.

“Our pacemaker is a diagnostic and treatment-delivering device with the ability to constantly read the heart’s electrical needs and self-correct or continuously adjust and recalibrate to deliver a unique pacing treatment, in real time, for each individual,” added Razavi.

Receiving Funding to Develop New Cardiovascular Technologies

Beginning with the first artificial heart implant by Dr. Cooley in 1969, THI has addressed significant research gaps and secured critical funding from the National Heart, Lung and Blood Institute (NHLBI) and other government and non-government sources. The NHLBI has been a substantial source of support for THI, stimulating discoveries and enabling the translation of these discoveries into clinical practice.

“THI has a long track record of receiving funding awards from the NIH that have resulted in significant device development and led to productive partnerships with industry,” according to Emerson Perin, M.D., Ph.D., Texas Heart Institute’s medical director.

“Arrhythmias can be devastating and difficult to manage in patients with multiple comorbidities and complicated cardiovascular conditions such as heart failure. Dr. Razavi’s pacemaker is highly innovative, and this transformational funding from the NIH underscores the importance and relevance of his work,” added James T. Willerson, M.D., FACC, Texas Heart Institute president emeritus.

Razavi will oversee the device development and all preclinical studies. Babakhani will oversee the development of the pacing and sensing nodes. Aazhang will supervise the development of the data-driven algorithm, and Joseph R Cavallaro, Ph.D., professor of electrical and computer engineering and director of the Center for Multimedia Communication, and Yingyan Lin, Ph.D., assistant professor, will each contribute to the design of the external controller that processes the signals.

Research reported in this publication is supported by the NHLBI under Award Number 1R01HL144683-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

For more information: www.texasheart.org

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November 15, 2019 — Results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study shows that an investigational set of algorithms in the Medtronic Micra Transcatheter Pacing System (TPS) significantly improves synchrony and cardiac function in patients with atrioventricular (AV) block. This is an impaired electrical conduction between the chambers of the heart. 

The results from the MARVEL 2 study will be presented Nov. 16 during a featured science session at American Heart Association (AHA) 2019 Scientific Sessions and were published Nov. 11 in JACC: Clinical Electrophysiology.[1]

Based on positive results from both the MARVEL and MARVEL 2 studies, Medtronic submitted a new leadless pacemaker, Micra AV, to expand the indicated population to AV block and normal sinus rhythm. This submission is currently under U.S. Food and Drug Administration (FDA) review. The Micra AV submission is not approved and the product is not currently available for sale in the United States. By federal law, Micra AV is investigational use only.

“While leadless pacing has many advantages compared to traditional pacemakers - including fewer infection-related complications - leadless pacemakers are currently only capable of single-chamber ventricular sensing and pacing,” said Larry Chinitz, M.D., MARVEL 2 study co-principal investigator, cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City. “Our investigation shows that accelerometer-based atrial-sensing algorithms can sense signals from the atrium in the heart and make calculated adjustments to when ventricular pacing occurs, thus improving coordination between the atrium and ventricle. These results provide further evidence that these novel investigational algorithms added to the Micra TPS may allow more patients, including those with normal sinus rhythm and AV block, to benefit from a leadless pacemaker.”

Details of the MARVEL 2 Study for Micra's New Pacing Algorithms

The MARVEL 2 study evaluated 75 patients with a Micra TPS at 12 centers in Hong Kong, Malaysia, Europe and the United States. Investigators evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms, which were downloaded to the Micra TPS device. Forty patients had complete heart block and normal sinus rhythm and were eligible for inclusion in the primary efficacy analysis while all 75 patients were included in the primary safety objective. Investigators evaluated the ability of the Micra accelerometer to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. 

Using continuous device telemetry and an electrocardiogram Holter monitor, patients’ AV synchrony was measured during 20 minutes of rest and during single-chamber ventricular (VVI) pacing. The study’s primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having >70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for proportion of patients with >70% synchrony). The median percent AV synchrony was 94.3% during AV synchronous pacing compared to 26.9% during VVI pacing.

In addition, blood flow from the left ventricle (velocity time integral, a proxy for stroke volume), increased by 1.7 cm (on an absolute scale, 95% CI: 0.7-2.7 cm, P=0.002; or 8.8% on a relative scale) during AV synchronous pacing compared with single-chamber ventricular pacing mode in patients with normal sinus rhythm with complete heart block.

The study’s primary safety objective was met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing in any of the 75 patients. 

What is the Micra Transcatheter Pacing System (TPS)?

Approved by the FDA in April 2016 for patients who need a single-chamber pacemaker, the Micra TPS is the only leadless pacemaker approved for use in the U.S. 

Comparable in size to a large vitamin, the Micra TPS is less than one-tenth the size of traditional pacemakers yet delivers the most 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.

The Micra design incorporates a retrieval feature which can be enabled, if necessary; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS can be permanently turned off, allowing it to remain in the body so a new device can be implanted without risk of electrical interaction. The Micra TPS is the first and only leadless pacing system to be approved for both 1.5 and 3 Tesla full-body magnetic resonance imaging (MRI) scans. 

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Medtronic strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

For more information: www.medtronic.com

Links to the 2019 AHA late-breaking trials

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VIDEO: Current State of Leadless Pacemaker Technology— Interview with Vivek Reddy, M.D.

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Leadless Pacemaker Gains Medicare Reimbursement

Safety, Performance of the World's Smallest Pacemaker Reinforced in Real-world Patients

Reference:

1. Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, et al. Atrioventricular synchronous pacing using a leadless ventricular pacemaker: Results from the MARVEL 2 study. JACC: Clinical Electrophysiology, November 2019, DOI: 10.1016/j.jacep.2019.10.017.
 

February 13, 2020 — The U.S. Food and Drug Administration (FDA) has approval of Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The leadless Micra AV device is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. 

Medtronic said it now offers the first FDA-approved leadless pacemaker portfolio, expanding the number of potential candidates for this groundbreaking technology in the U.S.

“With the approval of Micra AV, more pacemaker patients qualify for a new treatment option that offers the advantages of leadless pacing – including a minimally invasive implant procedure and a cosmetically invisible device,” said Larry Chinitz, M.D., cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City. “Although complications with traditional pacemakers are infrequent, when they occur, they’re expensive to treat and can be invasive for the patient. Real-world use of Micra has shown a 63% reduction in major complications compared to traditional pacemakers.

Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called “leads.” Identical in size and shape to the original Micra Transcatheter Pacing System (TPS), Micra AV has several additional internal atrial sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing “AV synchronous” pacing therapy to patients with AV block.

MARVEL 2 Data Supported FDA Clearance Mica AV to Coordinate Pacing Between the Atrium and Ventricle

The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. Results from the study, presented at the American Heart Association 2019 Scientific Sessions and published simultaneously in JACC: Clinical Electrophysiology,[1] showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients with normal sinus rhythm having >70% AV synchrony during algorithm-mediated AV synchronous pacing (38 of 40 patients, 95%) than VVI pacing (0 patients, P<0.001 for proportion of patients with >70% synchrony). The study’s primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm mediated AV synchronous pacing.

Medtronic will begin training field personnel and physicians, and will activate a limited number of implanting centers in the coming weeks, with full launch anticipated later this spring.

About the Micra Transcatheter Pacing System (TPS)

Approved by the FDA in 2016, the Micra TPS is a leadless pacemaker option for patients who only require pacing in the right ventricle. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device 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, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are eliminated - as are any visible signs of the device.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Medtronic strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

View an animation of the Micra AV in use.

For more information: www.medtronic.com

Related Micra Leadless Pacemaker Content:

FDA Clears Medtronic Micra AV to Treat AV Block

VIDEO: Current State of Leadless Pacemaker Technology— Interview with Vivek Reddy, M.D.

Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System Detects Atrial Contractions, Restores AV Synchrony

VIDEO: How to Implant the Micra Leadless Pacemaker

New Algorithms in Medtronic Micra Pacemaker May Improve Synchrony and Cardiac Function in AV Block

FDA Approves World's Smallest Pacemaker for U.S. Patients

Safety, Performance of the World's Smallest Pacemaker Reinforced in Real-world Patients

One-Year Results for Micra TPS Pacemaker Trial Presented at ESC 2016

Leadless Pacemaker Gains Medicare Reimbursement

Wireless and Leadless Pacemaker Being Developed by Texas Heart Institute With Federal Grant
 

Reference:

1. Clemens Steinwender, Surinder Kaur Khelae, Christophe Garweg, et al. Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker
Results From the MARVEL 2 Study. JACC: Clinical Electrophysiology. Volume 6, Issue 1, January 2020.DOI: 10.1016/j.jacep.2019.10.017.
 

June 16, 2020 - Biotronik has today announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP) tools in a limited number of centers starting now with a full launch later in 2020.

The gradual launch will help ensure physicians who are adopting Biotronik's tools have the adequate training opportunity during implantation.

Biotronik has an ongoing commitment to collaborating with electrophysiology (EP) physicians to help improve the lives of patients across the globe. An advisory board including HBP pioneers from over 13 countries have been working closely with Biotronik's developers to advise on optimal catheter design solutions for gaining smoother access to the tricky bundle of His.

Inconsistent procedure success remains a key concern for physicians when considering HBP implantation. Biotronik wants to help overcome this challenge and provide physicians with alternative tools they can rely on during clinical procedures.

"Achieving a pacing strategy that closely resembles intrinsic rhythm is well known to guarantee a superior clinical outcome," said Francesco Zanon, M.D., from Santa Maria della Misericordia in Rovigo, Italy. "But having the right tools has been one of the most important factors during HBP implantation."

There is a continued search for alternative pacing sites, and naturally, more flexible tools that may assist access to these sites. Pacing via the His Bundle uses the natural conduction system and therefore shows a normal QRS duration.

Studies have shown that long-term right ventricular pacing can result in a high incidence of myocardial perfusion defects that may increase with the duration of pacing.[1] Long-term right ventricular pacing is also associated with higher rates of atrial fibrillation, heart failure and mortality.[2-4]

"In the His-Bundle Pacing project we involved physicians from day one, co-creating product designs and receiving constant feedback to offer the tools our physician need to unlock higher rates of success," said Volker Lang, Biotronik senior vice president research and development CRM. "We are translating our proven product quality into innovations that help improve outcomes in the operating room."

Read about His-bundle pacing in the late-breaking Heart Rhythm Society 2020 meeting study Left Bundle Branch Pacing is Feasible as a Novel Strategy For Cardiac Resynchronization Therapy.

This technology is also iscussed in the VIDEO: Top New EP Technologies at Heart Rhythm Society 2020 — Interview with Andrew Krahn, M.D.

References: 

1. Tse, Hung-Fat; Lau, Chu-Pak (1997): Long-Term Effect of Right Ventricular Pacing on Myocardial Perfusion and Function. In Journal of the American College of Cardiology 29 (4), pp. 744–749. DOI: 10.1016/S0735-1097(96)00586-4.

2. Sweeney, Michael O.; Hellkamp, Anne S.; Ellenbogen, Kenneth A.; Greenspon, Arnold J.; Freedman, Roger A.; Lee, Kerry L.; Lamas, Gervasio A. (2003): Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. In Circulation 107 (23), pp. 2932–2937. DOI: 10.1161/01.CIR.0000072769.17295.B1.

3. Wilkoff, Bruce L.; Cook, James R.; Epstein, Andrew E.; Greene, H. Leon; Hallstrom, Alfred P.; Hsia, Henry et al. (2002): Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator. The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. In JAMA 288 (24), pp. 3115–3123. DOI: 10.1001/jama.288.24.3115.

4. Nielsen, Jens C.; Kristensen, Lene; Andersen, Henning R.; Mortensen, Peter T.; Pedersen, Ole L.; Pedersen, Anders K. (2003): A randomized comparison of atrial and dual-chamber pacing in177 consecutive patients with sick sinus syndrome. In Journal of the American College of Cardiology 42 (4), pp. 614–623. DOI: 10.1016/S0735-1097(03)00757-5.
 

October 27, 2020 – Magnetic resonance imaging (MRI) examinations can be safely performed in patients with non-MR compatible cardiac devices, including pacemakers, abandoned pacing leads, and implantable cardioverter defibrillators (ICDs), according to a new study published in Radiology: Cardiothoracic Imaging.[1]

Millions of people around the world rely on implanted cardiac devices like pacemakers and ICDs to help control abnormal heart rhythms. MRIs are discouraged or prohibited in many of these people over fears that the powerful magnet of the scanner will heat the metal in the devices, potentially damaging heart tissue and harming the devices. 

The U.S. Food and Drug Administration (FDA) has identified a subset of implanted cardiac devices as MR conditional, meaning they pose no known hazard under specified conditions. Pacemakers or ICDs that have not met the criteria are considered non-MR conditional. In these patients, clinicians are forced to choose between removing a necessary cardiac device or getting an alternate and potentially less-effective imaging test.

“While all devices implanted in patients today are MRI compatible, millions of people worldwide, including many young people, have older devices considered not compatible,” said study lead author Sanjaya K. Gupta, M.D., an electrophysiologist from Saint Luke’s Mid America Heart Institute in Kansas City, Mo. “It’s unfair to tell these people that they can’t get an MRI for the rest of their lives.”

Prior research has demonstrated the safety of performing MRI exams in patients with non-MR conditional devices. However, those studies did not account for pacemaker-dependent ICD patients, or patients whose hearts won’t function if the defibrillator is removed or stops working. Other groups not accounted for in previous studies include patients undergoing chest and cardiac MRI exams and patients with abandoned or fractured leads, or wires that connect the device to the heart.

To develop a more comprehensive picture of risk, Gupta and colleagues established the Patient Registry of Magnetic Resonance Imaging in Non-Approved Devices (PROMeNADe). They enrolled more than 500 participants who had undergone a total of 608 MRI exams, including 61 cardiac MRI exams. Participants included people from groups not accounted for in previous research.

Patients had their devices checked before and after each MRI and had their vital signs monitored closely by a nurse during their time in the scanner. Devices were turned to asynchronous mode in pacemaker-dependent patients before they went in the scanner. ICD patients had tachycardia therapies disabled during the MRI.

The results demonstrated that MRI exams—including chest MRI exams—can be performed safely in pacemaker-dependent ICD patients and in patients with non-MR conditional devices or abandoned leads.   

“There were no adverse events,” Gupta explained. “The protocol worked amazingly well. We had no issues with any of the patients and no harm to the devices.”

The registry is now the largest series of MRI scans that has ever been put together in patients with pacemaker-dependent ICDs. It is also the second largest in patients with abandoned or fractured leads and the third largest in non-compatible devices.

Results from a survey of the physicians who had referred the patients for MRI underscored the importance of the exams. According to responses from 150 physicians, MRI results changed the suspected diagnosis 25% of the time and changed suspected prognosis in 26% of participants, with planned medical or surgical treatment being changed 42% of the time.

“We’re hopeful that our work will add support to expand the FDA’s indications for devices that are considered MRI-compatible,” Gupta said.

The study was inspired, in part, by the case of a patient with a brain tumor who was unable to get sorely needed MRI examinations because her pacemaker was not MR conditional. Without MRI results to precisely localize the tumor, the patient had to undergo several risky surgeries.

“A lot of work went into this study but it’s worth it when you consider all the lives impacted,” Gupta said. “I feel like it makes a difference to a lot of people.”

Related Content with Dr. Sanjaya Gupta:

VIDEO: Artificial Intelligence to Automatically Risk Stratify Atrial Fibrillation Patients— Interview with Sanjaya Gupta, M.D.

Artificial Intelligence Applications in Cardiology
 

 
Reference:

1. Sanjaya K. Gupta , Lina Ya’qoub, Alan P. Wimmer, Stanley Fisher, Ibrahim M. Saeed. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiology: Cardiothoracic Imaging. Published Online: Oct 22 2020. https://doi.org/10.1148/ryct.2020200086.

February 2, 2021 – Optimize EP, a digital health company focused on transforming cardiac care by improving the current state of cardiac data management, recently emerged from stealth mode to announce the launch of CaRM, the company’s unique cloud-based software that streamlines patient data from multiple electrophysiology (EP) cardiac devices onto one accessible and easy-to-use platform. 

Founded by Maninder Bedi, M.D., who also serves as the company’s chief medical officer, Optimize EP incorporates both enterprise performance management (EPM) and electronic medical record (EMR) systems effortlessly into the CaRM software. It features data algorithms designed specifically to help physicians, clinical teams and administrators overcome the challenges associated with codifying and simplifying the immense amount of remote monitoring data transmitted each day so care teams can deliver improved and differentiated patient care. 

“Remote monitoring has the potential to dramatically improve patient care, but the reality of managing cardiac device data is daunting; it can be chaotic and time-consuming,” Bedi said, who is a practicing electrophysiologist with Regional Cardiac Arrhythmia in Steubenville, Ohio. “CaRM can streamline data from both implantable and external devices and features a number of automated processes that simplify day-to-day workflow, making it possible for clinical teams to devote more time to treating more patients.” 

CaRM integrates a variety of hospital and clinic billing software programs, ensuring the accuracy of reimbursement codes and the essential capture of associated revenue. The platform can be customized to create unique alerts and notifications, increasing the functionality and simplicity of the interface. CaRM also syncs directly with the FDA’s product recall page, automatically and immediately alerting physicians to any FDA recall announcements impacting their patients’ devices, giving them the opportunity to adjust treatment strategies and alter care quickly. 

“On the clinical side of things, CaRM can make patient care easier, but for hospitals and clinics, it can also strengthen their operational margins,” said Ravi Kartan, president and CEO of Optimize EP. “CaRM is an invaluable tool for those EPs and cardiologists who own their practices and rely on intuitive technologies like ours to keep things up and running. It’s a practical digital tool for sustainability and profitability.” 

CaRM is commercially available in the United States.

Founded in 2018, Optimize EP is a digital health company focused on transforming cardiology care by improving cardiac data management to create sustainable, profitable practices that deliver optimal patient care. CaRM, the company’s proprietary software developed by a practicing electrophysiologist, is a cloud-based platform that improves efficiency and streamlines the clinical and administrative operations necessary for efficient cardiac device remote monitoring, reimbursement and billing.

For more information: https://www.optimizeep.com

A few weeks ago, a patient of mine experienced a cardiac event — his heart stopped. Completely. However, his implantable cardioverter defibrillator (ICD) did exactly what it was designed to do — it shocked him and it saved his life. There was just one problem, my patient had no idea that his heart had stopped or that he had been shocked because he was asleep. 

Luckily, his device was being monitored remotely. An actionable alert was sent to us, and we were able to call him the next morning to schedule an appointment. As it turns out, he was having mild heart attack symptoms and needed a stent, which he was able to get in a matter of days. None of this would have been possible without remote monitoring. But while many of the advantages of the technology are clear, it is only one side of a story that is fast increasing in complexity.  

EP Remote monitoring is Now Common and Reduces Response Time

Remote monitoring technology is becoming commonplace in cardiac electrophysiology. Over the last decade, we have seen a steady rise in adoption of remote monitoring technologies for cardiac devices, due in large part to the publication of a couple of groundbreaking clinical studies, including the TRUST trial in 2010, which demonstrated that remote monitoring could reduce the average time between the onset of an arrhythmia and a physician evaluation by almost 90%, from 40 days down to just 5.5 days.[1]

Reducing response times to these actionable events is ultimately what saves lives, including my patient’s, and while compliance rates are not yet perfect, they are improving, and more actionable events are being addressed in a timely manner as the technology becomes more sophisticated. Remote monitoring has undoubtedly created never-before-seen advantages for cardiac device patients. Its rapidly growing prevalence, a byproduct accelerated by both technological innovations and the COVID-19 pandemic, has also illuminated some of its shortcomings. 

With current remote monitoring practices, patients come into the office every 90 days to have their devices checked (about four times per year), provided there have not been any device interrogations that have been deemed actionable and required immediate attention. Even then, the process to obtain the cardiac data that is being transmitted involves the following:
   • Contacting the specific device company representative in the event of an emergent actionable event or consulting the alert directly as it is streamed to the device’s remote monitor
   • Downloading the cardiac data from the device company’s secure server
• Printing the data
• Reading the data 
• Signing off on the data
• Initiating any follow-up appointments or actions based on the data
• Scanning the data into EMR
• Billing for the time spent with the data

It is a cumbersome and time-consuming process, and each cardiac device manufacturer must be consulted separately. Our practice includes nearly 4,000 patients. This equates to roughly 16,000 total office visits each year, and each office visit involves 6-10 pages of patient device data plus all of the previous steps listed above. My fellow physicians and I were spending four to five hours per week reading through and signing off on our patients’ remote monitoring data. And our care teams were spending just as much time printing, scanning and billing. 

And by 2018, the cardiac device patients at our practice were nearly 100% remote monitored. However, the amount of work required to obtain the cardiac data, to examine the data, to keep accurate record of the data and to accurately account for the time spent with the data for precise reimbursements was putting a massive strain on our practice operationally and financially. 

Something had to change. 

Integrating Remote Monitoring From Various EP Vendors Into One Interface

We sought out companies designing software that could integrate remote monitoring technology from the four largest cardiac device manufacturers — Abbott, Medtronic, Boston Scientific, and Biotronik — into one automated, customizable and completely digitized user interface. This would effectively streamline and simplify the tedious data management processes that are currently standard practice. Unfortunately, it quickly became apparent that while much of the software being developed included elements of what we needed, none of them included exactly what we were envisioning. 

A question arose: What if we designed our own software that could address the most pressing issues EPs and their care teams were facing in managing remote monitoring data? So, that is what we did. 

We created the company Optimize EP and our proprietary software, CaRM (pronounced See-Arm), came into existence, but before we could begin the process of potentially helping other EPs enhance the management of their own remote monitoring data, we had to make sure we were addressing definitive needs in a way that would increase efficiency across all aspects of the remote monitoring landscape.  

We worked out deals with the four primary cardiac device companies, as well as iRhythm, which deals in external monitors, to facilitate access to the data being transmitted by their respective devices so that our software could house cardiac data from all five companies on a single user interface and online platform. 

Automated, Digitized and Customizable Processes and Billing Integration in Remote EP Device Monitoring

We designed the infrastructure of the software so that all device interrogations were automated, instantaneous and entirely digital. There was no more printing thousands of pages each week. 

We also made the user interface customizable so that specific alerts could be tailored to specific device patients. Now, barring any actionable alerts or interrogations, our patients only come into the office once per year. Remote monitoring in combination with CaRM takes care of the rest.  

Automated EMR and billing integration were also the keys to streamlining remote EP monitoring operations. We are now able to upload any patient’s cardiac device data and chart notes automatically from a mobile device and into EMR while simultaneously having that time billed accurately and with the proper codes. 

Over the last year, we have reduced our workload in this area by 90% and increased our reimbursement efficiency by 47%. This has created more chances for us to spend more significant, meaningful time with even more patients, while keeping our practice sustainable and efficient. 

Launching Optimize EP and CaRM at the beginning of 2021 has presented a number of unique opportunities to explore, both for us and for the EPs and hospitals that it can benefit, but more importantly, the years-long process in bringing everything full circle is a compelling reminder that physicians can be powerful agents for change in healthcare when there is a gap to be filled, and that we should embrace that role as often as we can, even if it means filling the gap ourselves.

Remote monitoring is a young, agile, and rapidly evolving technology that has been proven to save lives and help patients live longer, and because the pandemic has altered the way we practice medicine, probably for good, we are only just beginning to discover what’s possible in terms of improving patient outcomes and considering how impactful the improvement of remote monitoring technology can be.

About the author: Maninder Bedi, M.D., is the founder and chief medical officer of Optimize EP. He also is a board-certified electrophysiologist at Wheeling Hospital in Wheeling, W.Va.

Related EP Remote Monitoring Content:

VIDEO: Rising Interest in Remote Monitoring of EP Devices in the COVID-19 Era— Interview with Robert Kowal, M.D.

EP Trials Show Positive Results for Advanced Remote Monitoring and Micra Transcatheter Pacing

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

Patient Data From Several Cardiac Devices Streamlined Into One Platform With New Cloud-based Software

Find more EP Lab news and video
 

Reference: 

1. Niraj Varma, Andrew E. Epstein, Anand Irimpen, et al. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST). Circulation. 2010;122:325-332.

April 2, 2021 — Today, the American College of Cardiology (ACC) launched the Electrophysiology (EP) Device Implant Registry as part of its National Cardiovascular Data Registry (NCDR). The NCDR is the ACC’s suite of cardiovascular data registries helping hospitals and private practices measure and improve the quality of care they provide based on data comparisons.

This new registry will include data on implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) procedures previously captured in the NCDR ICD Registry, as well as provide the flexibility to capture novel pacemaker procedures. The registry is aligned with the ACC’s Electrophysiology Accreditation program, fully supporting the program’s data requirements.

“The expanded scope of the EP Device Implant Registry will allow hospitals to track new and existing procedures, giving them the ability to optimize patient care and outcomes,” said NCDR Management Board Chair Frederick A. Masoudi, M.D., MSPH, FACC. “The registry is well-positioned to support continuous quality assessment and improvement in the growing EP procedure service line.”

On April 1, 2021, the ICD Registry name changed to reflect a minor update to Version 2.3 that now offers the opportunity to include select novel pacemaker procedures in addition to the current procedure types. Participants can submit data for select novel pacemaker procedures or submit data for ICD/CRT-D procedures or submit data for both. The registry captures data on shared decision-making, a requirement for the CMS National Coverage Determination for ICD/CRT-D primary prevention device implants, ACC said.

In addition, the EP Device Implant Registry now allows participants to capture data on shared decision-making, a compliance requirement for the CMS National Coverage Determination for ICD/CRT-D primary prevention device implants. 

Since its inception in 2005, the ICD Registry has been the national standard for understanding patient selection, care and outcomes in patients receiving ICD therapy. The new EP Device Implant Registry will continue to empower the patient care team in their decision making by providing nationally benchmarked data on patient care and outcomes for broader range of devices. Over 800 U.S. based hospitals currently participate in the EP Device Implant Registry. 

For a complete list of participating facilities, visit Find Your Heart a Home.

NCDR is the ACC’s suite of cardiovascular data registries helping hospitals and private practices measure and improve the quality of the care they provide. The EP Device Implant Registry is one of 10 NCDR hospital and outpatient registries.

For more information about the EP Device Implant Registry, visit ACC.org/EPDeviceRegistry.

Related ACC NCDR Content:

VIDEO: The Role of the NCDR in Boosting Cardiology Quality Improvement — Interview with Fred Masoudi, M.D.

American College of Cardiology Registries Collect COVID-19 Data

New Report Highlights National Trends in Heart Disease Treatments

Study Finds High Survival Rate for Elderly Patients with Implantable Defibrillator

April 19, 2021 — Former Vice President Mike Pence is recovering after having a pacemaker successfully implanted to improve a slow heart rate, according to statement from his office released to media outlets April 15. A full recovery is expected. The statement says Pence was diagnosed with asymptomatic left bundle branch block (LBBB).

Pence had the procedure done at Inova Fairfax Medical Campus in Falls Church, Virginia. Near where he lives in Virgina. Pence said previously he plans to move back to his home state of Indiana this summer.

Pence disclosed his medical history in 2016 when he was nominated vice president that he had been diagnosed with asymptomatic left bundle branch block. However, over the past two weeks, Pence experienced symptoms with a slow heart beat. After consulting with his doctors, he underwent the pacemaker implant. 

"I am grateful for the swift professionalism and care of the outstanding doctors, nurses and staff at Inova Heart and vascular Institute, including Dr. Brett Atwater and Dr. Behnam Tehrani," Pence said in a statement following the procedure. 

Pence said he appreciated his cardiologists at Inova consulted with his doctors back in Indiana, including pulmonologist Michael Busk, M.D., and cardiologist Charles Taliercio, M.D., at Ascension St. Vincent. 

What is Left Bundle Branch Block

The American Heart Association (AHA) sent out a statement on the vice president and used it as an opportunity to educate the public on LBBB.

"Left bundle branch block indicates that that one of the electrical pathways regulating the normal rhythm of the heart is not functioning. Because the heart has another conduction pathway called the right bundle, patients with left bundle branch block are generally asymptomatic. They are monitored on a regular basis by their cardiologist. If patient with a left bundle branch block develops a slow heart rate and symptoms such as fatigue or lightheadedness, a pacemaker is sometimes needed,"Mark A. Estes, M.D., FACC, FHRS, is an American Heart Association (AHA) volunteer medical expert and a professor of medicine in the University of Pittsburgh Medical Center (UPMC) cardiac electrophysiology program in Pittsburgh, Pa. "After pacemaker placement patients commonly are discharged from the hospital within 24 hours. They commonly recover sufficiently to return to work within a week."

A left bundle branch block (LBBB) is a common conduction disorder. Normally, electrical impulses travel down the right and left branches of the ventricles at the same speed. This allows both ventricles to contract simultaneously. But when there’s a “block” in one of the branches, electrical signals have to take a different path through the ventricle. This detour means that one ventricle contracts a fraction of a second slower than the other, causing an arrhythmia.

Symptoms and Diagnosis of LBBB

A person with bundle branch block may experience no symptoms, especially in the absence of any other problems. In such cases, bundle branch block is usually first identified by testing for some other reason, such as a routine physical. An electrocardiogram (ECG) reveals bundle branch block when it measures the heart’s electrical impulses.

Treatment for Bundle Branch Block

The AHA said often, no treatment is required for bundle branch block, but regular monitoring is recommended. If a pacemaker is needed to help the heart beat in a regular rhythm, the small battery-operated device may be implanted. This includes the generator, a small battery-powered unit that produces the electrical impulses that stimulate your heart to beat. The generator is implanted under the patient's skin through a small incision.

The generator is connected to the heart through tiny lead wires that are implanted at the same time in the veins leading to the heart. The impulses flow through these leads to the heart and are timed to flow at regular intervals just as impulses from the heart's natural pacemaker would. Some pacemakers are external and temporary, not surgically implanted.

How a Pacemaker Works

A pacemaker is an electrophysiology (EP) device that replaces the heart's defective natural pacemaker functions.

The sinoatrial (SA) node or sinus node is the heart's natural pacemaker. It is a small mass of specialized cells in the top of the right atrium (upper chamber of the heart). It produces the electrical impulses that cause your heart to beat.

A chamber of the heart contracts when an electrical impulse or signal moves across it. For the heart to beat properly, the signal must travel down a specific path to reach the ventricles (the heart's lower chambers).

When the heart's natural pacemaker is defective, the heartbeat may be too fast, too slow or irregular.

Rhythm problems also can occur because of a blockage of your heart's electrical pathways. The pacemaker's pulse generator sends electrical impulses to the heart to help it pump properly. An electrode is placed next to the heart wall and small electrical charges travel through the wire to the heart.

Most pacemakers have a sensing mode that inhibits the pacemaker from sending impulses when the heartbeat is above a certain level. It allows the pacemaker to fire when the heartbeat is too slow. These are called demand pacemakers.
 

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May 14, 2021 — Abbott is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment distributed from April 2015 to February 2019, because a small number of devices from that time frame have experienced problems when moisture is able to get inside the device.

There have been 135 complaints and 135 injuries, but no deaths reported for this issue, according to the FDA. 

The company issued a letter March 15, 2021 to customers informing them of the issue and providing patient management guidelines. The FDA issued a public notice on this recall May 13. 

Read the letter Abbott recall letter

Abbott said moisture can cause an electrical short, that may lead to:
   • A loss of device pacing.
   • Telemetry failure or errors in information
   • Early and fast battery drain
   • Less time between the first battery depletion warning (elective replacement indicator or ERI) and the device’s end of service (EOS)

If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness or discomfort. Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment.

Abbott's patient management guidelines including:

   • No recommendation for replacing the device if there is no evidence of the issue, due to a low rate of occurrence and low potential for patient harm as long as a replacement is completed if the device issues an unexpected ERI/EOS alert.
   • Routine follow-up per standard of care and clinical protocol, to include:
   • A review of any device function impacts such as battery voltage or any unexpected change in battery consumption.
   • Evaluating the potential risk for patients who are pacemaker dependent and unable to be reliably followed using remote monitoring.
   • Prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
   • If possible, use Abbott’s Merlin.net patience management system for patient monitoring to receive alerts between routine device checks. Remind patients of the importance of using remote monitoring.
   • Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Assurity and Endurity are implantable pacemakers that detect when the heart is beating too slowly (bradycardia) and then send signals to the heart to make it beat at the correct pace. These pacemakers can be used to provide pacing for one chamber of the heart or both chambers, based on the patient’s condition.

Read the full FDA recall notice.

May 14, 2021 — The U.S. Food and Drug Administration (FDA) is advising patients and caregivers to keep any consumer electronic devices, such as cell phones and smart watches, at least 6 inches away from implanted electrophysiology (EP) medical devices, such as pacemakers and implantable cardioverter defibrillators (ICD).

The FDA is aware that some newer consumer electronic devices, including cell phones and smart watches, have magnets that may cause some implanted medical devices to go into a magnetic safe mode and temporarily suspend normal operation. The magnetic safe mode allows for safe operation during certain medical procedures such as undergoing an MRI imaging scan.

The FDA believes the risk to patients is low, and the agency is not aware of any adverse events associated with this issue at this time. The FDA continues to monitor all relevant scientific information (including adverse event reports) about this ongoing issue and will continue to inform the public and healthcare providers, if the need arises based on risk analysis.

Some consumer electronic devices, such as certain cell phones and smart watches, use high-field strength magnets. Recent studies have shown that consumer electronic devices with high-field strength magnets may cause certain implanted medical devices to switch to “magnet mode” and suspend normal operations until the magnet is moved away from the medical device.

These safety features are typically engaged by physicians with the use of a high field strength magnet that is placed near the implanted device placing it into a “magnet mode” for MRI scans. Removal of the magnetic field causes the device to return to normal operation.

Precautions for Patients With Pacemakers, ICDs and CRT Devices to Prevent Interference from Cell Phones and Smart Watches

The FDA recommends patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least 6 inches away from implanted medical devices, in particular cardiac defibrillators. Many implanted medical devices have FDA-approved information written for patients (patient labeling), which cautions patients to keep all cell phones and smart watches at least six inches from the implanted medical device.

People with implanted medical devices may want to take some simple precautions, including:
   • Keep the consumer electronics, such as certain cell phones and smart watches, six inches away from implanted medical devices.
   • Do not carry consumer electronics in a pocket over the medical device, such as a chest pocket in a coat or shirt.
   • Check your device using your home monitoring system, if you have one.
   • Talk to your health careprovider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

When near high strength magnets, devices with a magnetic safe mode could stop working or change how the device works. For example, an implantable cardioverter cardiac defibrillator (ICD) may be unable to detect tachycardia events. Or it may change the operational mode of the devices such as turning on asynchronous mode in a pacemaker.

Cardiac implanted electronic devices are intended to support heart rhythm disorders, such as slow or fast heart rates. When the device stops working, a patient may experience dizziness, loss of consciousness or even death if therapy is not delivered when lifesaving shocks are required.

The FDA emphasized it is important to avoid interference between cell phones and smart watches and a patient's heart device by keeping them at least 6 inches (15 centimeters) away from implanted medical devices. Also, do not place cell phones, smart watches, and other consumer electronics close to your implanted medical device.

The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact. The FDA also conducted its own testing on some products that use the high field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question. The FDA believes the risk to patients is low, and the agency is not aware of any adverse events associated with this issue at this time.

The FDA continues to monitor all relevant scientific information about this ongoing issue and will continue to take appropriate action, including informing the public and providing additional information, if the need arises based on its risk analysis.

Read the full FDA warning.

Related article from January 2021: iPhone 12 May Cause Implantable Cardioverter Defibrillators to Malfunction.

Find more EP technology news

The FDA includes a list of recent articles from peer review journals that raise concerns over the cell phone magnet issue:

• Letter to the Editor: Lifesaving Therapy Inhibition by Phones Containing Magnets
• Letter to the Editor: Phone Interaction with CIEDs: Problem or Not External Link Disclaimer
• To the Editor: New phones, old problem? Interference with cardiovascular implantable electronic devices by phones containing magnets External Link Disclaimer
• Study: iPhone 12 Magnets Can Deactivate Cardiac Devices External Link Disclaimer
• Henry Ford Cardiologists Find Apple iPhone 12 Magnet Deactivates Implantable Cardiac Devices External Link Disclaimer
• About the magnets inside iPhone 12, iPhone 12 mini, iPhone 12 Pro, iPhone 12 Pro Max, and MagSafe accessories - Apple Support