February 14, 2017 — Biotronik has developed an online tool that streamlines the workflow for physicians selecting the right magnetic resonance (MR)-conditional heart monitor or pacing or implantable cardioverter defibrillator (ICD) system for their patients.

The ProMRI Configurator is an intuitive, user-friendly tool that allows physicians to select the desired MRI conditions, subsequently generating a selection of all suitable MR-conditional cardiac devices and leads approved and available in their country. In this way, physicians can ensure that patients receive the most appropriate MR-conditional cardiac system for access to MRI in case of a new implantation or a replacement.

Biotronik manufactures a broad range of MR-conditional devices, along with a wide assortment of leads, offering a variety of options and combinations for different MR conditions. The ProMRI Configurator brings ease and convenience to the physician trying to find the most suitable setup for the individual patients’ MRI needs.

The online tool marks the second offering of the ProMRI Check online platform. The first tool — the ProMRI SystemCheck — allows physicians and patients to retrospectively check whether an implanted cardiac system is MR-conditional. The ProMRI Configurator enhances the platform with its focus on the proactive selection of an MR-conditional system.

Last year, Biotronik won the Cardiostim Innovation Award in the category “Best Practice Improvement” for its MRI AutoDetect feature in implantable cardioverter defibrillators, cardiac resynchronization devices and pacemakers. MRI AutoDetect recognizes an MRI environment and automatically switches to and from MRI mode without the cardiologist’s intervention. This not only eases the workflow for patients, physicians and radiologists, but also adds to patients’ safety.

For more information: www.promricheck.com

March, 10, 2017 - Medtronic announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved coverage for the Micra Transcatheter Pacing System (TPS). This decision, effective immediately, follows the approval of two studies required to enable reimbursement through Medicare's policy of Coverage with Evidence Development (CED).
 
In January 2017, CMS issued a final National Coverage Determination (NCD) that covered leadless pacemakers under CED when used in accordance with U.S. Food and Drug Administration (FDA)-approved labeling in FDA-approved studies that have been approved by CMS, or under prospective, longitudinal studies approved by CMS. The two Micra studies approved by CMS are the Micra Post-Approval Study (PAS), which was required by the FDA as a condition of approval of the device in April 2016, and a new Micra CED Study, the "Longitudinal Coverage with Evidence Development Study on Micra Leadless Pacemakers," which was developed by Medtronic to address research questions identified by CMS in the NCD.
 
The Micra PAS Study will enroll a subset of Medicare Micra patients through a traditional clinical research design, while the Micra CED Study will encompass all Medicare beneficiaries who receive Micra under an innovative new approach to CED, linking information from Medtronic's device registration system to Medicare health insurance claims and enrollment data.
 
"Since the Medicare coverage decision was announced earlier this year, we have been working closely with CMS to secure study approvals which will provide additional evidence supporting the Micra TPS," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the cardiac rhythm and heart failure division. "We are pleased that all Medicare beneficiaries indicated for Micra according to the FDA label are now covered by the NCD and, as a result, have access to this innovative pacing technology."
 
Approved by the FDA in April 2016 for patients who need a single-chamber pacemaker, the Micra TPS is the first and only leadless pacemaker approved for use in the United States. The miniaturized device was recently named at the top of U.S. News & World Report's list of "2016's Biggest Achievements in Medicine."
 
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 leads or pockets are eliminated.
 
The Micra design incorporates a retrieval feature which can be enabled, if possible; 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. It is designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network. Remote monitoring of Micra devices is expected to be available later this year.
 
Primary results from the Medtronic Micra TPS Global Clinical Trial, published November 2015 in the New England Journal of Medicine, showed the Micra TPS was successfully implanted in 99.2 percent of patients by 94 physicians around the world and that the system met its safety and effectiveness endpoints at 6 months follow-up with wide margins. Long-term results from the Micra Trial, published November 2016 in Heart Rhythm, reinforced these data, showing the risk of major complications at 12 months for Micra patients was low at 4 percent, 48 percent lower than for patients with traditional pacemakers (hazard ratio: 0.52, 95% CI: 0.35-0.77, P=0.001).

Read the article "One-Year Results for Micra TPS Pacemaker Trial Presented at ESC 2016."

For more information: www.medtronic.com

March 22, 2017 — Patients with recurrent fainting episodes (syncope) who received a pacemaker delivering a pacing program designed to detect and stop the abnormal heart rhythms that precede syncope, had a seven-fold reduction in syncope compared with patients in a placebo pacing group. These were the findings of the SPAIN trial, presented at the American College of Cardiology (ACC) 2017 Annual Scientific Session. 

The study is the first prospective double-blind, placebo-controlled trial to show robustly positive results for the pacing program known as closed loop stimulation (DDD-CLS). It was used in patients with recurrent syncope. The trial met its primary endpoint of a significant reduction in fainting episodes with DDD-CLS compared to placebo pacing. 

“Our study showed up to a seven-fold reduction in recurrences of syncope” in patients who used the DDD-CLS program, said Gonzalo Baron-Esquivias, M.D., Ph.D., FESC, associate professor, chief of the clinical cardiology section and head of studies in the cardiology department at Virgen del Rocio University Hospital in Seville, Spain, and the study’s lead author. 

This study is important, he said, because of the lack of available treatments for recurrent syncope. 

“Now a door is open and we have a new possible treatment for these patients,” he said. 

Syncope is triggered by a sudden drop in blood pressure and heart rate, which in turn reduces blood flow to the brain. While episodes of syncope are not fatal, they can be very dangerous due to loss of consciousness and can severely affect patients’ quality of life. About half of all women and one-third of men will experience syncope in their lifetime. The real concern, Baron-Esquivias said, is that for many, these episodes will recur and they aren’t predictable. 

Pacemakers are widely used to treat other heart-rhythm disorders, particularly an abnormally slow heart beat (bradycardia). In DDD-CLS pacing for recurrent syncope, the pacemaker detects contractions or spasms in the heart muscle that typically occur before an episode of syncope and releases an electrical signal that calms the heart down, preventing sudden dips in heart rate and blood pressure. Earlier small trials of DDD-CLS had shown mixed results in preventing fainting episodes. 

In the SPAIN trial, Baron-Esquivias and his colleagues recruited 54 patients aged 40 or older from 12 medical centers in Spain and Canada. All had experienced more than five episodes of syncope in their lifetimes, with more than two in the past year. To be eligible, participants had to have normal results on an electrocardiogram, echocardiogram, 24-hour Holter test, carotid sinus massage and orthostatic test. They also had to show a drop in blood pressure and heart rate on a test in which the head rapidly changes position. 

All participants were implanted with a pacemaker. The researchers randomly assigned half to receive DDD-CLS pacing for 12 months and the other half to a pacing program called DDI, which does not respond to the contractions in the heart that precede syncope and, therefore, functioned in the SPAIN trial as a placebo program. After 12 months, the two programs were switched so that the patients who had received DDD-CLS during the first year received DDI for the next 12 months, and vice versa. If a patient in either group had more than three episodes of syncope in one month, their pacing assignment was switched. Patients and their doctors were blinded at all times to their group assignment. 

Forty-six patients completed the trial, which lasted two years. The patients’ average age was 56, and 48 percent of them were men. During the trial, four patients experienced syncope while receiving DDD-CLS pacing, compared with 21 patients who fainted during DDI pacing, a statistically significant difference. 

Among patients initially assigned to DDD-CLS, 72.2 percent saw a reduction of more than 50 percent in syncope episodes within the first year, but fainting recurred after they crossed over to the DDI group. Patients who crossed over to DDD-CLS after a year of placebo pacing saw a reduction of more than 50 percent in syncope episodes during the second year. Nine patients who initially received DDI pacing met the criterion for early crossover to DDD-CLS during the first year. The estimated time to a first syncope episode was longer among patients receiving DDD-CLS –– 29 months compared with just over nine months for patients receiving DDI, a statistically significant difference. 

Limitations of the study are its small size and short duration of follow-up (two years), Baron-Esquivias said. 

Baron-Esquivias, who currently uses DDD-CLS pacing to treat patients with recurrent syncope in his own practice, said that if these findings are confirmed by larger, ongoing studies, such as the ongoing BioSync CLS trial sponsored by Biotronic, he expects that international guidelines will be changed to recommend DDD-CLS pacing in these patients. 

The trial was funded by the Investigation Agency of the Spanish Society of Cardiology, which received an unrestricted grant from Biotronik Spain. Biotronik is the developer of the DDD-CLS program.

Find out more information on CLS programing. 

March 23, 2017 — Biotronik announced the launch of the Edora series, its smallest series of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The new devices are equipped with features geared towards improving patient safety, therapy and comfort. Moreover, Edora pacemakers are significantly smaller and lighter than preceding models, achieving compactness and full functionality without compromising battery life.

“Biotronik’s new series of pacemakers fits well in the current age of smart technologies, with devices that are smaller, lighter and shorter while retaining longevity,” stated Saravanan AL Krishinan, M.D., Hospital Sultanah Bahiyah, Alor Setar, Malaysia. "What's more, the devices offer simplified MRI [magnetic resonance imaging] access, which is often crucial for better patient care.”

To facilitate patient access to MRI, Edora pacemakers and CRT-Ps are MR-conditional and feature Biotronik’s MRI AutoDetect functionality. This means that within a programmable window of up to 14 days, the device’s built-in sensor can detect an MRI environment and automatically switch the system to MRI mode; the device then automatically switch back to its standard mode once the scan is complete. Since the device is only in MRI mode for the duration of the scan, the patient receives optimal therapy for the maximum amount of time.

Devices in the Edora series also support Biotronik Home Monitoring for remote long-term patient care with a streamlined workflow. Biotronik Home Monitoring automatically collects cardiovascular data from the patient’s device on a daily basis and transmits it remotely to the physician without the need for any patient interaction. This facilitates the early detection of arrhythmias, with clinical trial results demonstrating that the monitoring system significantly reduces hospitalization for atrial arrhythmia and related stroke in pacemaker patients.

Edora CRT-Ps are specifically tailored for individualized therapy through quadripolar technology for flexible pacing in the left ventricle (LV). This is complemented by a comprehensive LV lead portfolio, which caters for diverse patient anatomies.

For more information: www.biotronik.com

A discussion with Heart Rhythm Society (HRS) President Michael Gold, M.D., Ph.D., director of cardiology and associate dean at the Medical University of South Carolina (MUSC), at the American College of Cardiology 2017 annual meeting. Read more about EP advances over the past couple years. 

This video, provided by Medtronic, demonstrates the implantation of Micra transcatheter pacing system (TPS). The device is a leadless pacemaker for single chamber pacing and eliminated the need for a surgical pocket or transvenous leads. The design concept is to simplify pacemaker implantation and eliminate the need for leads, which open the patient up to additional device and infection complications. Read the article “Safety, Performance of the World's Smallest Pacemaker Reinforced in Real-world Patients.”
 

May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Registry showed a 99.6 percent implant success rate and a low rate of major complications (1.51 percent) at 30 days in a diverse, real-world patient population. The study was presented in a late-breaking clinical trial session at Heart Rhythm 2017, the Heart Rhythm Society's 38th Annual Scientific Sessions, and simultaneously published in Heart Rhythm.

"It is encouraging to see these strong outcomes with such a novel technology in the hands of new implanting physicians," said Mikhael El-Chami, M.D., director of electrophysiology at Emory Midtown and associate professor of medicine at Emory University School of Medicine in Atlanta. "The high implant success and low major complication rates in a real-world patient population reinforce the positive results seen in the investigational Micra clinical trial."

The global Micra Post-Approval Registry is an ongoing, prospective single-arm observational study designed to assess the safety and effectiveness of the Micra TPS in the post-approval setting. Data presented at HRS were from an interim analysis of 795 patients treated by 149 physicians at 97 centers across 20 countries worldwide, which assessed system or procedure-related major complications through 30 days following implant. These rates were then compared to the major complication rates of the Micra Investigational Device Exemption study (IDE).

More than 20 percent of patients in the Micra Post-Approval Registry study had at least one condition that did not allow the use of a transvenous pacemaker including history of infection or compromised venous access. Nearly 87 percent of the physicians in the analysis were new implanters with no previous experience with Micra.

Major complications were low, with 1.51 percent of patients experiencing a major complication at 30 days post-implant (95 percent CI: 0.78 percent to 2.62 percent). There were low rates of cardiac perforation or prefusion (0.13 percent), device dislodgement (0.13 percent), and infection (0.13 percent), and no (0 percent) major complications related to battery or telemetry issues. When compared to the IDE study, the rate of major complications in this real-world registry trended lower after adjusting for differences in baseline patient characteristics (1.51 vs. 2.89 percent; odds ratio = 0.59, 95 percent CI: 0.27, 1.27; P=0.18).

As operators gain more experience with the Micra, they found it may be safer to implant the system on the septal side of the right ventricle. Medtronic said 53 percent of the implants in the post-market study were septal side implants. Some operators at Heart Rhythm expressed concerns of implanting the device in the apex due to the thinner tissue in that area of the heart. 

Watch a VIDEO showing how to implant the Micra pacemaker.

About the Micra Pacemaker

Approved by the U.S. Food and Drug Administration in April 2016 for patients who need a single-chamber pacemaker, the Micra TPS is the first and 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 possible; 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. It is designed to allow patients to be followed by their physicians and send data remotely via the Medtronic CareLink Network. Remote monitoring of Micra devices is expected to be available in the U.S. later this year.

Primary results from the Medtronic Micra TPS Global Clinical Trial, published in November 2015 in the New England Journal of Medicine, showed the Micra TPS was successfully implanted in 99.2 percent of patients by 94 physicians around the world and that the system met its safety and effectiveness endpoints at six months follow-up with wide margins. Long-term results from the Micra Trial, published in November 2016 in Heart Rhythm, reinforced these data, showing the risk of major complications at 12 months for Micra patients was low at four percent, 48 percent lower than for patients with traditional pacemakers (hazard ratio: 0.52, 95 percent CI: 0.35-0.77, P=0.001).

Medtronic said the goal of the Micra was to remove the need for leads and a surgical pocket, which could reduce complications for pacemaker implantation and management by 50 percent. 

As of May 2017m there are more than 6,000 patients implanted with the Micra system world-wide, Medtronic said. 

Single-chamber Pacemaker Market

The Micra is a single-chamber pacemaker. These devices only account for about 15 percent of the U.S. pacemaker market. Medtronic said they see the 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. 

Read the article “Leadless Pacemaker Gains Medicare Reimbursement.”

Read the article "One-Year Results for Micra TPS Pacemaker Trial Presented at ESC 2016."

For more information: www.medtronic.com

Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospital, N.Y., discusses advancements in leadless pacemaker technology at the 2017 Heart Rhythm Society (HRS) annual meeting. Read the articles “Leadless Endocardial CRT Pacing Effective for Heart Failure Patients,” and “New Data Showcases Long-term Benefits of Nanostim Leadless Pacemaker.”

Bruce Wilkoff, M.D., director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, discusses advancements in lead management technology at the 2017 Heart Rhythm Society (HRS) annual meeting.

DAIC Editor Dave Fornell takes a tour of some of the most innovative new electrophysiology (EP) technology at the 2017 Heart Rhythm Society (HRS) annual meeting.

June 20 2017 — Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European Heart Rhythm Association (EHRA) EUROPACE - CARDIOSTIM 2017 conference, June 18-21 in Vienna, Austria. Devices revealed the time and cause of death in some cases where autopsy failed to do so.

“In forensic medicine around 30 percent of cases remain unsolved because the cause or time of death after autopsy remains unclear,” said lead author Philipp Lacour, M.D., a cardiologist at Charité - Medical University of Berlin, Germany.

“The number of implanted cardiac devices with sophisticated diagnostic functions is increasing and we thought interrogating them might help to shed light on these unclear deaths,” he added. “Currently, device interrogation is not routinely performed after autopsy.”

The study was conducted in cooperation with the Department of Forensic Medicine at Charité - Medical University of Berlin where more than 5,000 autopsies were performed in a five-year period. Of these, 150 cases had an implantable cardiac device that was removed from the body during the autopsy.

The explanted devices included 107 pacemakers, 22 implantable cardioverter defibrillators (ICDs), 14 cardiac resynchronization therapy (CRT) systems and six implantable loop recorders. The devices were interrogated by two electrophysiologists to determine time and cause of death, and device failure.

Time of death could be determined in 76 percent of cases using data from the device. It could be identified precisely (to the minute) when the patient had tachycardia  at the end of life. In other cases, changes in seven parameters were used to assign the time of death. These included lead impedance and pacing threshold.

Lacour said, “At the end of life, lead impedance rises because of changes in the heart muscle and pacing climbs to 100 percent because the device doesn’t detect any heart rhythm.”

Cause of death was determined in 24 percent of cases. This included bradycardia, tachycardia, ventricular fibrillation and device malfunctions.

“The cause of death was most easily determined when the patient had a lethal arrhythmia such as tachycardia which was documented by the device,” said Lacour. “For example a ventricular fibrillation was recorded by a pacemaker, which did not intervene because it was not a defibrillator, and showed us that this arrhythmia caused the death.”

Device malfunction occurred in 7 percent of cases. This included hardware failure such as a broken lead, algorithm issues meaning the device did not recognize an arrhythmia or deliver a shock when it occurred, or a programming issue where the shock setting was insufficient to terminate an arrhythmia.

Lacour said, “In our study, the time or cause of death was unclear in about 30 percent of cases after autopsy alone. This dropped to around 10–20 percent using device interrogation. The two procedures provide complementary information and with the combination we can solve around 85 percent of all unclear deaths.”

“We think device interrogation should be routinely performed after autopsy in all forensic cases,” continued Lacour. “It helps determine the time and cause of death and identifies device malfunctions that might otherwise have gone unnoticed and should be highlighted to manufacturers and health departments.”

He concluded, “To ensure that accurate data is extracted from cardiac devices, the time between autopsy and device interrogation should be kept as short as possible and we try to do it within two weeks. This avoids the memory of the device filling up with artifacts that can be generated after the leads are cut.”

For more information: www.escardio.org

Electrophysiology (EP) technology has been advancing rapidly the past few years with new ablation tools to improve arrival fibrillation (AF) treatments, miniaturized diagnostic monitoring systems, and new implantable rhythm management devices that are making procedures much less invasive.

To see examples of some of the technologies explained below, watch the VIDEO “Editor's Choice of Most Innovative New Technology at HRS 2017.”

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 headless, 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.
 

Wireless CRT 

CRT systems typically use an epicardial coronary sinus pacing lead for the left ventricle (LV), but placement of the lead on the outside of the heart is not ideal because of issues with the coronary sinus anatomy or scar tissue. This may be the cause of about 30 percent of patients not responding well to CRT therapy. Placing the lead inside the LV is ideal, but not practical with current technology.

EBR Systems is developing the WiSE CRT system, the first endocardial, leadless CRT pacing system. It uses an electrode about the size of a large grain of rice that is implanted inside the wall of the LV using transcatheter delivery. A wireless ultrasound transducer is surgically implanted between the ribs to send ultrasound energy to the electrode, which converts the waves into electrical energy for pacing, eliminating the need for a battery or lead wire, allowing the device to be very small. This works as an adjunct device to work in combination with an existing connected pacemaker, ICD or CRT device. The conventional system senses the RV pacing and can work with the WiSE system to synchronize the LV.

“There is a study we did in Europe using this where we showed the technology does work. It improves heart failure in patients who failed biventricular pacing, it improved ejection fraction, functional class and everything else we looked at,” Reddy said. “This technology is going to be studied very soon in a large multi-center randomized trial here in the United States.” 

EBR Systems has CE mark approval for the system in Europe, where there are about 100 patients implanted with the WiSE system. The company is working to initiate an FDA investigational device exemption (IDE) trial in the U.S.

Improved Ablation Technologies 

Intracardiac ablation systems can cure or improve cardiac function due to arrhythmias by killing tracts of heart tissue to block the pathways of faulty electrical signals. This is most often done using pulmonary vein isolation (PVI). However, this technology requires EPs to literally connect the dots if using traditional point-by-point ablation catheters. This can be difficult, even for the most experienced operators, inside the moving heart using the surrogate visualization provided by electro-mapping systems. The difficulty is illustrated in the fact that atrial fibrillation (AF) ablations are unsuccessful in about 40 percent of patients. Ablation procedures are also very lengthy, often lasting several hours. 

“Ablation therapy is growing at an extremely rapid rate, but it is still not a perfect procedure,” said Hugh Calkins, M.D., FACC, FAHA, FHRS, director of cardiac arrhythmia services and professor of medicine at Johns Hopkins Hospital. “Part of that is because we don’t have a perfect understanding of the mechanisms of atrial fibrillation, and part of that is because we don’t have perfect tools to accomplish what we want to accomplish.”

Calkins said about 70-80 percent of AF patients who go back for a repeat ablation procedure have at least one PVI that failed and reconnected to continue the arrhythmia. He said there is a lot of room for improvement with the technology and there are several new techniques being developed.

He said Medtronic’s cryoballoon ablation system has seen rapid, widespread adoption in the past year since the release of positive data from the FIRE AND ICE trial. The study showed better outcomes with the cryoballoon compared to radiofrequency (RF) ablation. An economic analysis from that trial also savings from fewer rehospitalizations and repeat ablations.

HeartLight was granted FDA clearance in 2016 for its laser ablation balloon technology indicated for pulmonary vein isolation to treat AF. The system consists of a compliant balloon that seats in the ostia of the pulmonary veins and a laser inside the catheter can be rotated around to ablate the tissue. It also has a camera inside the catheter to offer direct visualization of the ablation and location of the laser, eliminating the need for electro-mapping systems and cutting procedural time. The lesions are created with 20-30 second ablations. About 25 ablations are needed to isolate a pulmonary vein with lesion overlap. The combination of the balloon, camera and variable-energy, steerable ablation is believed to be able to eliminate the interoperator variability in ablation procedures. Another advantage of the system is that it can deliver variable energy, so the energy of the laser can be dialed down when ablating near the esophagus or other neighboring critical structures. 

A late-breaking HRS trial highlighted a first-in-human study for the Biosense Webster RF balloon catheter in treating patients with AF.  The 39-patient RADIANCE study showed it could uniformly achieve pulmonary vein isolation (PVI) in all patients without the need for “touch-up” with a focal ablation catheter. The system uses a balloon that is lined with several electrodes. The energy level for each electrode can be tailored to prevent damage to neighboring nerves or the esophagus.  

Calkins said another technology to watch is the development of noninvasive focused ultrasound to perform PVI ablations without the need for catheterization.

Watch the VIDEO “Current State of Atrial Fibrillation Ablation Technologies,“ an interview with Hugh Calkins, M.D., at HRS 2017.

Increasing Safety in Lead Extractions

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. However, Spectranetics Bridge Occlusion Balloon, introduced in 2016, offers a new 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 is credited with saving about 20 lives in the past year since gaining market clearance. 

EP lead management expert Bruce Wilkoff, M.D., Cleveland Clinic, said the device is one of the most important new developments in lead extraction technology and has become part of Cleveland Clinic’s lead extraction protocol. He said the balloon offers a safety net to minimize the effect of a potentially catastrophic SVC tear. While rare, he said this complication has made some physicians shy away from referring patients for lead extractions in the past.

Watch the VIDEO "EP Lead Extraction Strategies," an interview with Bruce Wilkoff, M.D., at HRS 2017.

Subcutaneous ICDs

Boston Scientific introduced the first subcutaneous implantable cardioverter defibrillator (S-ICD) system in 2009. Since then, there have been many studies published showing the system delivers very effective therapy and reduces the invasiveness of traditional ICD implants by eliminating the leads to the heart. Instead, the system uses a lead placed under the skin of the chest over the heart, eliminating transvenous leads or the need for lead management later on. 

“The leads are the Achilles heel of both pacemakers and ICDs, so these new platforms take the leads out of the vasculature,” said Lucas Boersma, M.D., Ph.D., FESC, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands, who was heavily involved in the S-ICD trials. However, he said one drawback of the S-ICD is it cannot deliver pacing, so it limits its patient population. “Many patients still need pacing, and right now it is still not available, so the future direction is to come up with hardware solutions that can pace.”

He said this may include incorporating a separate pacemaker device in combination with the S-ICD. Boersma explained Medtronic is developing substernal ICD leads below the ribs so they are closer to the heart, but not inside vessels. This will include a pacing electrode. He also mentioned the EBR WiSE wireless CRT technology as another future direction.

About 40 percent of the ICD market today is composed of cardiac resynchronization therapy (CRT) systems with pacing. Of the remaining 60 percent, Boersma said between 30-50 percent would benefit from S-ICD therapy if they do not have any need for pacing. 

A new technology in development is the “string ICD,” which replaces the can and cardiac leads with a long, thin cable-like device that is implanted subcutaneously in the patient's chest. The first-of-its-kind NewPace Ltd. ISSD string ICD was developed to eliminate the need for an active generator and places only a small, flexible device including coils below and over the ribs and totally subcutaneously. It only requires two very small incisions with no need to create a pulse generator pocket. This results in minimal anatomical protrusion, for improved patient comfort and aesthetic appearance. First-in-man data for 22 patients implanted with the ISSD was presented at HRS showed an average implant time of 20 minutes.

Watch the VIDEO “Overview of Subcutaneous ICD Technology,” an interview with Lucas Boersma, M.D., at HRS 2017. 

Replacing Holters With Wearable and Implantable Devices

Both the American College of Cardiology (ACC) and HRS meetings have seen an explosion of vendors with simple, small, wearable, stick-on Holter monitoring systems that eliminate the need for a bulky, belt-worn device and the placement of multiple wire leads on the patients. These new devices offer a less expensive, even disposable option to traditional, durable Holter monitoring systems. Some vendors offer the devices themselves, others offer the devices in connection with monitoring services. 

Another monitoring technology that is seeing increasing usage are implantable cardiac monitors (ICMs). Biotronik, Medtronic and St. Jude Medical offer different iterations of these monitors, which are placed subcutaneously in the chest using a simple, fast, in-office procedure. The Medtronic Linq device is credited by many with pushing the technology to the next level, because of its small size (about a quarter of the size of a USB thumb drive) which can easily be inserted under the patient’s skin.

Abbott/St. Jude Medical received CE mark in May 2017 for its latest version, the Confirm RX. It pushes remote electrocardiogram (ECG) monitoring to the next level as the first implantable EP device to interface with the patient’s smartphone. The phone, usually carried on the patient, acts as the wireless monitoring base unit to receive data from the device and enable transmission to a monitoring service or a physician’s office. 

Data from the HRS 2017 late-breaking REVEAL AF study showed ICMs used for long-term, 24-hour-a-day monitoring, detected a high incidence of AF in patients previously undiagnosed but suspected to be at high-risk for AF and stroke. The study found that at 18 months, continuous monitoring with either the Medtronic Reveal XT or the Reveal Linq resulted in an AF detection rate of 29.3 percent among previously undiagnosed high-risk patients. The data showed continuous monitoring with an ICM detected AF beyond 18 months with a detection rate of 40 percent at 30 months. Additionally, 6.2 percent of patients were diagnosed with AF at 30 days, indicating that more than three-quarters of high-risk patients with AF would have gone undetected with only 30 days of cardiac monitoring. The median time from device insertion to the first AF episode was 123 days, which is outside the range of conventional external monitoring. 

New Electro-mapping Systems

For years the EP mapping system market was dominated by Biosense Webster and St. Jude Medical, but there were complaints from EPs that there was little progress in advancing the technology to overcome some of its limitations. This changed in 2014, when Boston Scientific launched  the Rhythmia mapping system. At HRS 2017, the updated Rhythmia HDx was launched. The system can show lower voltages than on previous-generation mapping systems. It uses a 64-electrode basket catheter to create very detailed, high-density electro-maps with as many as 50,000 to 60,000 points.

“All the mapping systems are getting better, and the introduction of the Rhythmia super-high density mapping system has really put pressure on the other companies to come up with their own really-high-density mapping systems,” Calkins said. “Clearly, the whole field is moving toward more accurate mapping, more points, clearer electrograms, and hopefully this will translate into better efficacy with outpatients.”

Biosense Webster is now developing a new mapping system. In December 2016, Abbott/St. Jude Medical received FDA clearance for the Ensite Precision system. It was designed to improve the reliability and accuracy for AF ablation procedures. It includes the launch of the Advisor mapping catheter, which incorporates magnetic sensing technology. This works with a magnetic sensor placed under the patient to more accurately locate mapping points and the tip of the catheter inside the anatomy. It also helps increase the accuracy of the anatomical model of the heart the system creates to guide procedures. St. Jude said this has eliminate distortion of the model that was a drawback of the previous-generation system. 

A new technology that may offer a big reduction in mapping/procedural times is the Acutus Medical AcQMap High Resolution Imaging and Mapping System. It uses a basket catheter with 48 electrodes combined with 48 tiny ultrasound transducers. The basket can be manually rotated around inside the atrium to rapidly “paint” a very accurate combined electro- and anatomical map simultaneously in about five minutes. Conventional EP mapping systems can take 20 minutes or longer to complete the mapping process. The electrodes do not need to contact the walls of the heart because the vendor said they can detect the electrical field created by cardiac contractions. The system was approved in Europe in 2016 and the company said it will soon be submitting for FDA 510(k) approval. 

MRI To Guide Ablation Procedures

iMRIcore is redesigning devices to make them safe for use in a magnetic resonance imaging (MRI) environment to perform MRI-guided ablation procedures. MRI offers many advantages over X-ray angiography and traditional mapping systems. It can image without any radiation, eliminating the need to wear heavy protective aprons. Second, unlike angiography, it can image soft tissue and visualize the tissue response to ablations and when a scar forms, allowing EPs to see the pattern and effectiveness of their ablation points and patterns. 

The catheters iMRIcore developed have MRI receiver coils near the tip so they clearly show up on live MR imaging. 

The company has European CE mark approval for its EP recorder/stimulator system, but its catheters are still pending market clearance and they hope for approval by the end of 2017 so they can start a commercial launch in 2018. The company has seven EP lab installs in Europe that were used for the CE mark trials. It is working with a U.S. university medical center to begin early feasibility studies for an eventual launch in the U.S. market. The vendor says it has been approached by a handful of luminary U.S. heart centers that are looking at building out new EP labs using MRI instead of angiography. 

New Leads Introduced

The FDA recently granted market approval for the Biotronik Ilivia CRT system and two new CRT and ICD leads. The Plexa ProMRI shocking lead utilizes a unique spiral-wound segment of wire to help reinforce the segment of the lead where it beds as it enters the heart and tends to be a fatigue point with leads due to constant flexing from cardiac motion. The Sentus ProMRI lead is the first quadripole lead introduced by Biotronik and is the thinnest quadripolar left ventricular lead available in the United States.

Ultrasound Guidance in the EP Lab

Two vendors have developed lightweight, compact, cart-based ultrasound systems that allow high-quality intracardiac echocardiography (ICE) and transesophageal echo (TEE) in the EP or cath lab. Both systems offer many of the features of premium echocardiography systems.

Siemens Healthineers released its new Acuson P500 ICE Edition compact ultrasound system at HRS 2017. It offers ICE to help guide transeptal punctures and has a transducer to aid in needle guidance or vascular access. The system also has an interface with BioSense Webster’s mapping system. It does not have TEE capability, but does offer transthoracic echo (TTE). It offers color and spectral Doppler capabilities as well. 

GE Healthcare displayed its Vivid iq compact system, which weighs 4.5 kg and is built for tough conditions and for mobile use in the cath and EP lab. It matches the high image quality and high-end functionality of GE's premium systems, including 3-D/4-D TEE. It is intuitive to use with a touchscreen and requiring fewer keystrokes.

Watch the VIDEO “Advances in Electrophysiology Technology,” a discussion with Heart Rhythm Society (HRS) President Michael Gold, M.D., Ph.D., director of cardiology and associate dean at the Medical University of South Carolina (MUSC), at the American College of Cardiology 2017 annual meeting.

July 3, 2017 — Medtronic recently announced that its Reactive ATP therapy slows the progression of atrial fibrillation (AF) in patients with implanted cardiac devices. A robust, real-world analysis of nearly 8,800 patients was presented as a late breaking clinical trial at EHRA EUROPACE-CARDIOSTIM 2017, June 18-21 in Vienna, Austria.

An unusually fast or quivering rhythm in the heart's upper chambers (atria), AF is a progressive disease that afflicts more than 33 million people worldwide. Common among patients with cardiac devices, AF impairs quality of life and increases the risk of hospitalization, stroke and death. Reactive ATP (atrial-based antitachycardia pacing) is an advanced, painless pacing therapy found exclusively on Medtronic pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. It repeatedly sends pacing pulses to the atria during abnormally fast rhythms to restore the heart's normal rhythm, thereby slowing the progression of AF.

The retrospective analysis assessed pacemaker, ICD and CRT device data from 8,798 patients followed by the Medtronic CareLink remote monitoring system. Reactive ATP therapy was associated with a statistically significant decrease in AF events compared to a matched control group. Most notably, the Reactive ATP patient group experienced a 38 percent reduction in persistent AF events (lasting greater than seven days) (p<0.0001). This benefit was observed across patient age, sex, and device type.

"Atrial fibrillation can be a debilitating disease that imposes a significant burden upon the entire healthcare community — impacting patients, caregivers, providers and costs of care — especially as the disease progresses," said Giuseppe Boriani, M.D., Ph.D., full professor of cardiology at the University of Modena and Reggio Emilia, Italy. "These are the first real-world data on the clinical impact of Reactive ATP therapy and the first in patients with ICDs and CRT devices. These data have important implications for all device patients because of the high prevalence of AF and the correlation of disease progression to worsened patient outcomes."

This study builds upon the MINERVA trial, the first randomized, controlled study of Reactive ATP. It found that Reactive ATP therapy significantly slowed AF disease progression in patients with pacemakers with the therapy, compared to those without it. Furthermore, Reactive ATP significantly reduced AF-related hospitalizations, emergency department visits and cardioversions, resulting in payer cost savings.

For more information: www.medtronic.com

July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural pacemaker. Scientists at The Ohio State University Wexner Medical Center have shown the human SAN is hardwired with a backup system — three diverse regions of pacemakers acting as batteries and up to five conduction pathways that act as wires to connect the signal to the atria. This built-in redundancy maintains consistent heart rhythm, even under trying conditions.

The research is published online by the journal Science Translational Medicine.

Like a battery, the SAN generates electrical impulses to initiate heartbeats. Until now, scientists didn’t know for sure how the SAN protected the heart’s rhythm and how the system failed.

“It’s been challenging because our human SAN differs greatly from well-studied animal models, and clinical electrode recordings only capture what’s on the surface,” said Vadim Fedorov, an associate professor in Ohio State’s Department of Physiology and Cell Biology.

So Fedorov and his team applied optical mapping, 3-D structural imaging and molecular mapping to 21 explanted human hearts to define the internal function of the SAN. The hearts, which are not viable for human transplant, were donated by heart transplant recipients and Lifeline of Ohio.  

To resuscitate the hearts, researchers placed them in a glass chamber filled with an oxygenated solution at body temperature and perfused the coronary arteries with warm, oxygenated solution that simulates blood flow, allowing the SAN to beat again with the same rhythm as when it was inside the body for at least 12 hours.

Then the chamber with live heart tissue is surrounded by four highly-sensitive infrared cameras, and a fluorescent dye is injected. This dye can visualize spontaneous electrical activity moving within the human SAN in 3-D.

“We observed that all three intranodal pacemakers are used, depending on the heart’s needs at rest, or during normal or high exertion,” Fedorov said.

To study how the SAN functions under stress, Fedorov’s team applied adenosine, a heart rhythm regulator that is overproduced when there is heart failure and inadequate blood supply.

“The central pacemaker was most affected, as it is highly sensitive to adenosine. The head and tail pacemakers were able to maintain a slower rhythm and prevent complete cardiac arrest. We saw similar shifts in the preferred conduction pathways,” Fedorov said. Total cardiac arrest occurs only when all pacemakers or conduction pathways fail, whether due to disease or age.”

When there is a problem with SAN pacing or conduction, doctors implant an electronic pacemaker to prevent cardiac arrest. Approximately 225,000 Americans get a pacemaker every year, according to the World Society of Arrhythmia.

“Patients are at high risk of cardiac arrest if the SAN gets down to one pacemaker, or one conduction pathway,” Fedorov said. “Knowing this, our next quest is to work with electrophysiologists to more precisely identify who needs a pacemaker implant, and who still has backups and can get along without one.”

Clinicians are excited by this discovery.

“It’s groundbreaking. This is the first step in explaining why the SAN can be ‘sluggish’ for years before a total failure, allowing the clinician to detect the problem before a catastrophic event,” said Raul Weiss, M.D., a cardiologist and clinical researcher at Ohio State.

“I think this work can fundamentally change the way we diagnose disease of the heart’s natural pacemaker,” said John Hummel, M.D., a cardiologist and clinical researcher at Ohio State. “In some patients, it can be incredibly challenging, and these insights may allow us to diagnose those challenging patients more effectively.”

Because a pacemaker is merely a crutch and cannot fix the underlying problem, Fedorov’s team is also seeking out ways to improve or restore the impaired portions of the SAN. Their hope is that someday, pacemaker implants could be obsolete.

This research was funded by the National Institutes of Health, the American Heart Association, the C.R. Webb Fund in Cardiovascular Research and the TriFit Challenge Discovery Fund.

Other Ohio State researchers include: Ning Li, Brian Hansen, Thomas Csepe, Anthony Ignozzi, Lidiya Sul, Stanislav Zakharkin, Anuradha Kalyanasundaram, Jonathan Davis, Brandon Biesiadecki, Ahmet Kilic, Paul Janssen and Peter Mohler.

For more information: www.stm.sciencemag.org

August 21, 2017 — Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI (magnetic resonance imaging) AutoDetect technology.

With a volume of 15 cc, Edora HF-T QP is the smallest MR conditional CRT-P available in the U.S., according to Biotronik, with longevity of nearly 10 years, reducing the frequency of device replacements for heart failure patients. Edora HF-T QP features MRI AutoDetect, Closed Loop Stimulation (CLS) and Biotronik Home Monitoring with automatic, daily transmission verification.

In recent studies, Biotronik Home Monitoring was associated with a greater than 50 percent reduction in mortality due to heart failure2 and a 36 percent reduction in hospitalization for worsening heart failure.3

“Patient care is a constant journey. It doesn’t end when the patient leaves my office or recovers from a procedure. As healthcare providers, we must think beyond today and help ensure patients are appropriately cared for throughout their lifetime,” said Roderick Tung, M.D., a cardiac electrophysiologist in Chicago. “MR conditional CRT-Ps that can be programmed to automatically switch to MRI mode when they enter the MRI environment are another significant step in delivering the best possible care throughout the patient journey. This technology eliminates an office visit for patients and decreases administrative burden for providers. The impact is significant, especially in institutions that perform cardiac MRI for advanced ventricular care."

Biotronik’s MRI AutoDetect technology is designed to improve patient safety by minimizing the time the pacemaker device is in MRI mode and remedying logistical programming challenges for physicians and health systems. Once activated by a clinician, MRI AutoDetect automatically recognizes when a patient enters an MRI field and changes the device programming to MRI mode.

The Biotronik Home Monitoring system includes the Heart Failure Monitor Online, a summary of nine long-term heart failure statistics including thoracic impedance. When combined with daily updates, this allows physicians to continuously monitor and evaluate patients’ heart failure status. Equipped with comprehensive patient monitoring and easily accessible statistical trends, physicians can review individual patient data quicker, leading to early intervention and better outcomes.

For more information: www.biotronik.com

August 29, 2017 — The U.S. Food and Drug Administration (FDA) approved a firmware update that is now available to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities involving certain Abbott (formerly St. Jude Medical) pacemakers and defibrillators. This updated software is intended to address a recall of these devices and an FDA corrective action involving these devices.   

The firmware update will be available beginning Aug. 29, 2017. Pacemakers manufactured beginning Aug. 28, 2017, will have this update pre-loaded in the device. The firmware update requires an in-person patient visit with a healthcare provider; it cannot be done from home via the Merlin.net patient monitoring device. The update process will take approximately three minutes to complete. The firmware update process is described in Abbott's Dear Doctor Letter issued on Aug. 28, 2017.

“As we’ve said previously, Abbott is resolving all old St. Jude Medical issues.” said Jonathon Hamilton, Abbott public affairs. “These planned updates further strengthen the security and device management tools for our connected cardiac rhythm management devices.”

The new device updates include a battery performance alert for the company’s implantable cardioverter defibrillators (ICDs) that provides physicians with earlier warning of the potential for the low risk of premature battery depletion. They also include a planned update to pacemaker firmware to add additional security protections designed to reduce the risk of unauthorized access to patients' pacemakers.

"Connected devices are having a significant positive impact for patients and their health," said Robert Ford, executive vice president, medical devices, Abbott. "To further protect our patients, Abbott has developed new firmware with additional security measures that can be installed on our pacemakers."

There have been no reports of unauthorized access to any patient's implanted device, according to an advisory issued by the U.S. Department of Homeland Security. Abbott said compromising the security of these devices would require a highly complex set of circumstances. The FDA said it reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment. This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.

Abbott said it is communicating with regulatory authorities worldwide to implement the new updates to the implantable devices. Abbott's recommendation, and that of its Cyber Security Medical Advisory Board, is that a patient have a conversation with their physician to determine if the update is right for them. Abbott will continue to make updates and product enhancements across its devices as part of the company's ongoing commitment to provide safe, effective and secure products for patients.

The FDA said many medical devices — including St. Jude Medical's implantable cardiac pacemakers — contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.

"All industries need to be constantly vigilant against unauthorized access," continued Ford.  "This isn't a static process, which is why we're working with others in the healthcare sector to ensure we're proactively addressing common topics to further advance the security of devices and systems."

Read an overview of medical device cybersecurity and the issues with Abbott's devices leading up to this firmware update in the article Raising the Bar for Medical Device Cyber Security.

No Reason to Explant SJM Pacemakers

The FDA and Abbott do not recommend prophylactic removal and replacement of affected devices. 

The FDA recommends doctors discussing the risks and benefits of the cybersecurity vulnerabilities and associated firmware update with patients at the next regularly scheduled visit. As part of this discussion, the FDA said it is important to consider each patient's circumstances, such as pacemaker dependence, age of the device, and patient preference and provide them with Abbott's Patient Communication.

The agency said physicians should determine if the update is appropriate for the given patient based on the potential benefits and risks. If deemed appropriate, install the firmware update following the instructions on the programmer. For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator can be readily provided. Also, providers should print or digitally store the programmed device settings and the diagnostic data in case of loss during the update. After the update, confirm that the device maintains its functionality, is not in backup mode and that the programmed parameters have not changed.

Abbott Addresses ICD Battery Performance Problems 

In October 2016, Abbott notified physicians and patients that a subset of ICD and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured between January 2010 and May 2015 could potentially experience premature battery depletion due to short circuits from lithium clusters.

The potential for premature battery depletion in the affected devices is low. The new battery performance alert can be used as a tool to further assist in identifying the potential for these devices to experience premature battery depletion.

More detailed information on the battery performance alert algorithm testing methods and performance can be found on the website www.sjm.com/batteryupdate.

Updated Pacemaker Firmware Addresses Cybersecurity Concerns

Abbott said the new pacemaker firmware update is part of Abbott's planned enhancements that began with updates announced in January 2017 to the Merlin@home v8.2.2 software. The new updates provide an additional layer of security against unauthorized access to these devices. The update contains a software release that includes data encryption, operating system patches and the ability to disable network connectively features, in addition to the firmware update.

The pacemaker devices to which this update applies include the RF telemetry versions of the following devices in the U.S.: Accent SR RF, Accent MRI, Assurity, Assurity MRI, Accent DR RF, Anthem RF, Allure RF, Allure Quadra RF and Quadra Allure MP RF. 

This update will be released outside the U.S. following local regulatory approvals. Outside of the U.S., the pacemaker devices to which this update applies include the RF telemetry versions of the following devices: Accent SR RF, Accent ST, Accent MRI, Accent ST MRI, Assurity, Assurity+, Assurity MRI, Accent DR RF, Anthem RF, Allure RF, Allure Quadra RF, Quadra Allure MP RF, Quadra Allure and Quadra Allure MP.

Every pacemaker manufactured beginning Aug. 28, 2017, will have this update pre-loaded in the device and those devices will not need to be updated. Based on Abbott's consultation with the FDA, this update is being treated as a field action. However, Abbott and the FDA have both said the devices should continue to function as intended and replacement of implanted pacemaker devices is not recommended.

Abbott said it is communicating with the FDA, the U.S. Department of Homeland Security and global regulators, and works with leading independent security experts, to strengthen protections against unauthorized access to its devices. 

In part due to the cybersecurity issues of St. Jude Medical's electrophysiology (EP) devices revealed last year, the FDA has announced it plans to regulate medical device cyber security in the future. Read the article FDA Seeks Management of Cybersecurity in Medical Devices. 

Where to Find Information on the Abbott/St. Jude Medical Cybersecerity Updates

For more information about the pacemaker firmware update, please contact the dedicated hotline at (800) 722-3774 (U.S.). Abbott created has additional resources available to address questions from physicians and patients about these updates at www.sjm.com/cyberupdate and www.sjm.com/batteryupdate.

DAIC has created a cybersecurity channel that will include related news as it becomes available. 

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm573854.htm

Here is a list of aggregated DAIC content about cybersecurity relating to cardiology — “The State of Healthcare Cyber Security.”

September 11, 2017 — According to the latest market study released by Technavio, the global electrophysiology therapeutic devices market is expected to grow at a compound annual growth rate (CAGR) of more than 9 percent between 2017 and 2021.

This research report titled ‘Global Electrophysiology Therapeutic Devices Market 2017-2021’ provides an in-depth analysis of the market in terms of revenue and emerging market trends. This report also includes an up-to-date analysis, and forecasts for various market segments and all geographical regions.

The market research analysis categorizes the global electrophysiology therapeutic devices market into four major product segments. They are:

• Implantable cardioverter defibrillators (ICDs);
• Cardiac pacemakers;
• Cardiac resynchronization therapy (CRT) devices; and
• Ablation catheters.

Global ICD Market

In the global ICD market, the key vendors are Boston Scientific, Imricor, Medtronic, MicroPort Scientific and St. Jude Medical.

According to Srinivas Sashidhar, a lead analyst at Technavio for orthopedics and medical devices research, “The global ICD market is expected to rise during the forecast period due to the growing incidence rate of CVD [cardiovascular disease]. The market is also witnessing an increase in the demand for ICDs in emerging regions like APAC [Asia-Pacific] and the Middle-East. Several healthcare awareness programs have been organized across the world for increasing the adoption rate of ICDs. Subcutaneous ICDs are one of the widely used ICDs, which are popular due to fewer complications during implantation.”

Global Cardiac Pacemakers Market

Several investments in research and development (R&D) have been made to create technologically advanced pacemakers that are more compact and cause minimum discomfort. Such advancements have encouraged the use of cardiac pacemakers in cardiac rhythm management. The demand for implantable cardiac pacemakers is expected to witness rapid growth during the forecast period.

Global CRT Devices Market

CRT devices are one of the main revenue contributors to the global EP therapeutic market. The key vendors of the global CRT devices market are Medtronic, Boston Scientific, St. Jude Medical and GE Healthcare. According to the report, Claria MRI CRT-D by Medtronic is one of the most magnetic resonance imaging (MRI)-friendly CRT devices used for cardiac rhythm management.

“The adoption rate of CRT devices is likely to rise due to the complications associated with the other implantable devices such as ICDs and cardiac pacemakers. The procedure cost of CRT devices is comparatively low. The use of MRI-friendly devices helps in better management of cardiac diseases,” said Srinivas.

Global Ablation Catheters Market

The rise in atrial fibrillation is expected to propel the market growth during the forecast period. The leading players in the market include Medtronic, Boston Scientific and St. Jude Medical. The launch of new products and expected new regulatory approvals is likely to boost the global electrophysiology therapeutic devices market, according to Technavio.

For more information: www.technavio.com

October 18, 2017 — The U.S. Food and Drug Administration (FDA) recently approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea (CSA). The  Respicardia Remedē System is an implantable pacemaker-like device that stimulates the phrenic nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.

Watch a VIDEO showing a demonstration of how the Remede System works.

“This implantable device offers patients another treatment option for central sleep apnea,” said Tina Kiang, Ph.D., acting director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices in the FDA’s Center for Devices and Radiological Health. “Patients should speak with their healthcare providers about the benefits and risks of this new treatment compared to other available treatments.”

Sleep apnea is a disorder that causes individuals to have one or more pauses in breathing or shallow breaths during sleep. Breathing pauses can last from a few seconds to minutes. Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe, causing an individual to stop breathing during sleep for a period of 10 seconds or more before restarting again. According to the National Institute of Health’s National Center on Sleep Disorders Research, central sleep apnea can lead to poor sleep quality and may result in serious health issues, including an increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes. Common treatment options for moderate to severe sleep apnea include medication, positive airway pressure devices, or surgery.

The Remedē System is comprised of a battery pack surgically placed under the skin in the upper chest area and small, thin wires that are inserted into the blood vessels in the chest near the nerve (phrenic) that stimulates breathing. The system monitors the patient’s respiratory signals during sleep and stimulates the nerve to move the diaphragm and restore normal breathing.

The FDA evaluated data from 141 patients to assess the effectiveness of the Remedē System in reducing apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes. After six months, AHI was reduced by 50 percent or more in 51 percent of patients with an active Remedē System implanted. AHI was reduced by 11 percent in patients without an active Remedē System implanted.

The FDA said the most common adverse events reported included concomitant device interaction, implant site infection and swelling, and local tissue damage or pocket erosion. The Remedē System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging. This device is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.

Use of the Remede Device in Heart Failure Patients

The Remede device is being investigated in trials for possible use to treat heart failure patients with CSA. In September, the Lancet published results from an international, randomized study showing how the device significantly improves symptoms in patents with CSA, without causing serious side effects. William Abraham, M.D., co-lead author and director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, presented findings from the study at the 2017 European Society of Cardiology (ESC) congress. 

Review the study in the Lancet. 

Unlike the more common obstructive sleep apnea, in which the airway partially collapses and causes pauses in breathing, CSA occurs when the brain fails to control breathing during sleep. “CSA is a serious concern because it affects about a third of people with heart failure and it’s known to make the condition worse,” Abraham said. 

“Currently, we don’t have good treatments available. Positive airway pressure devices have been used, but many patients don’t tolerate them well and a recent study showed them to be harmful.”

The study used the Respicardia Remede System, which is a pacemaker-like device designed to improve cardiovascular health by restoring natural breathing during sleep in patients with CSA.

Abraham, along with lead author Maria Rosa Costanzo, M.D., at Advocate Heart Institute in Naperville, Ill., led the study at 31 hospitals in the United States, Germany and Poland. The research team tested the safety and effectiveness of a transvenous phrenic nerve stimulator. Much like a pacemaker, it sends a regular signal telling the diaphragm to breathe during sleep.

In the randomized study, 151 patients were implanted with the device. Ten were excluded due to non-study related medical issues or deaths, exiting the study or missing visits. During the first six months of evaluation, 68 devices were activated for treatment, while 73 were left inactive as the control group. Between six and 12 months of follow-up, all patients received the neurostimulation treatment.

At the six month evaluation, the device reduced CSA events per hour by half or more for 35 of the 68 members (51 percent) of the treatment group. Only eight (11 percent) of those in the control group achieved the same reduction. Other important sleep measures, such as the amount of time spent with a low blood oxygen level, were also significantly improved. About a third of patients in the treatment group reported therapy-related discomfort that was resolved with some reprogramming of the device.

“Not only did we see this reduction in events per hour, the patients also rated themselves better on the Epworth Sleepiness Scale (meaning they were less sleepy during the day) and on a global assessment of their overall quality of life,” Abraham said. “This tells us the effects of neurostimulation are clinically relevant and this could be a promising therapy for those with central sleep apnea.”

Watch a VIDEO showing a demonstration of how the Remede System works.

November 10, 2017 — Mexican doctors have safely reused donated pacemakers after sterilization, shows a study presented at the 30th Mexican Congress of Cardiology, Nov. 2-5 in Guadalajara, Mexico. The findings create the possibility for patients to receive a pacemaker who otherwise could not afford one.

“There is no report of the number of pacemaker implants per year in Mexico, but we implant close to 150 new pacemakers per year in our hospital,” said first author Carlos Gutiérrez, M.D., a cardiologist at the General Hospital of Mexico "Dr. Eduardo Liceaga" in Mexico City.

“According to government reports, more than half of the population in Mexico does not have access to social security or private insurance that covers a pacemaker implant, and 44 percent live in poverty,” he continued.1 “This suggests that many Mexicans cannot afford a pacemaker. Previous studies have shown the safety of reusing pacemakers after sterilization.” 2-5

The current study included 33 patients with a pacing indication who could not afford a new pacemaker or a battery change. Patients received a reused device at the General Hospital of Mexico between 2011 and 2017. Devices had been donated by relatives of deceased patients and had a minimum of six years of battery life.

After confirming that the pacemakers were functioning correctly, they were washed with enzymatic soap and sterilized in an autoclave for 38 minutes. Pacemaker function was rechecked after sterilization.

Patients were 72 years old on average (the age range was 20 to 106 years) and 52 percent were female. The indications for a pacemaker were sinus node dysfunction in ten patients (30 percent) and advanced atrioventricular block in 23 patients (70 percent).

Of the 33 patients, 25 received a reused pacemaker. Eight patients already had a pacemaker and received a reused generator (battery). During the implant procedure there was one hematoma which resolved without further complications. There were no complications during the six month follow-up period.

Gutiérrez said: “This was a small study but it shows that with a thorough and standardised sterilization process, explanted pacemakers with a battery life of more than six years can be reused safely. This provides an effective option for patients who cannot afford a new device or a replacement battery.”

“This practice could be implemented in many other centers that have equipment to sterilize and reprogram pacemakers,” continued Gutiérrez. “We also need to promote the donation of pacemakers with little use from deceased patients.”

Erick Alexanderson, M.D., president of the Mexican Society of Cardiology, said: “This study has encouraging results which open up the possibility of pacemaker treatment for many more Mexicans who need it.”

For more information: www.escardio.org

Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center, explains the new mobile application he developed, which lets users visually model the forces at work during an MRI exam on patients with implanted medical devices, at the 2017 Radiological Society of North America (RSNA) meeting.

Read the related article “The Changing Relationship Between MRIs and Pacemakers.”