July 6, 2017 — Two predictive models may help cardiologists decide which patients would most benefit from an implantable cardioverter defibrillator (ICD), suggests a new study published in the Journal of the American College of Cardiology. According to the researchers, confirming the findings in a larger, randomized trial could lead to new national guidelines for choosing patients who are good candidates for ICD implantation.

An ICD is a small device placed in the chest or abdomen to treat life-threatening arrhythmias. The ICD has a lead that connects to the bottom right chamber of the heart. This wire has coils, which deliver shocks to help treat life-threatening arrhythmias that can cause sudden cardiac arrest. Recent clinical trials have highlighted the need for better models to identify patients at higher risk for death from arrhythmias, known as sudden cardiac death.

“ICDs are very expensive, and there are also additional hospital and physician costs,” said Kenneth Bilchick, M.D., associate professor of medicine at the University of Virginia Health System in Charlottesville, Va., and the study’s lead author. “While implanting an ICD is a very safe procedure, there is a small risk of complications during the procedure, as well as a long-term risk of infection. In addition, about every six to 10 years the device’s generator needs to be replaced.”

ICDs were first used in patients with prior cardiac arrest and arrhythmias. In recent years, they also have been used in patients with heart failure without prior cardiac arrest and arrhythmias.

This study included 98,846 patients with heart failure. Of these patients, 87,914 had ICDs and had not previously experienced sudden cardiac arrest. They were part of the National Cardiovascular Data Registry (NCDR) ICD Registry, the world’s largest registry of ICD patients. The remaining 10,932 patients did not have ICDs.

The researchers evaluated all the patients using two predictive models: the Seattle Heart Failure Model (SHFM), which is widely used to predict overall death from any cause in patients receiving ICDs, and the newer Seattle Proportional Risk Model (SPRM), used to predict patients’ proportional risk of sudden cardiac death. These models consider many factors, including:

• Patients’ age;
• Gender;
• History of heart failure;
• Etiology of heart failure;
• Overall heart function;
• Heart failure class;
• Electrocardiographic findings;
• Blood pressure;
• Diabetes;
• Pulmonary disease;
• Medication use; and
• Laboratory values.

The study found that patients who underwent ICD implantation had a 25 percent lower risk of death over five years, compared with patients without ICDs. The researchers also found the combination of the two models effectively predicted the survival benefit from ICDs.

The researchers identified a subgroup of 25 percent of patients with ICDs who had a 40 percent reduction in mortality during the five years of follow-up. Another 25 percent of ICD patients did not receive a significant survival benefit from the device. The remaining 50 percent of patients with ICDs received survival benefits somewhere in between.

The study found that patients with a 5.7 percent or less predicted annual risk of death and with a predicted proportional risk of sudden death approximately 50 percent or less were the ones least likely to have a survival benefit from an ICD. In contrast, patients whose overall annual predicted risk of death was greater than 5.7 percent and whose predicted proportional risk of sudden death was greater than approximately 50 percent were the ones most likely to have their life saved by having an ICD.

“Patients with a low risk of death overall and a lower proportional risk of sudden death may be the ones who would do well with medical therapy alone rather than medical therapy with an ICD, but this will require further study in a randomized clinical trial,” Bilchick said.

These predictive models could help determine effective use of healthcare resources for the benefit of these patients if future studies confirm the researchers’ findings in the current study.

In an editorial accompanying the study, Scott D. Solomon, M.D., and Neal A. Chatterjee, M.D., of Brigham and Women’s Hospital in Boston, wrote, “By highlighting the need to look beyond absolute risk, Bilchick and colleagues have offered us an important step forward in sudden death prevention.”

They said the current “‘one size fits all’ approach to ICD implantation does not appear to be a clinically or cost-effective strategy in sudden death prevention.” They concluded, “this study leaves us with an important lesson: While you can only die once, there is more than one way to die—understanding the difference is key.”

For more information: www.jacc.org

July 13, 2017 — Experts in heart failure management gathered in June to discuss varying scientific evidence in their field and how to transfer results into clinical practice. The Biotronik symposium “CRT in 2017: Remaining Challenges and New Opportunities in Heart Failure Management” took place at the Europace-Cardiostim 2017 congress, June 18-21 in Vienna, Austria.

One challenge is the limited data on whether to exchange cardiac resynchronization therapy defibrillators (CRT-Ds) for pacemakers (CRT-Ps) during routine device replacements in patients who responded well to therapy with improved hemodynamics. Jacques Mansourati, M.D., University of Western Brittany, Brest, France, is using the BioContinue study to help define the profile of CRT responders who may no longer need an implantable cardioverter defibrillator (ICD).

Between 20 to 40 percent of CRT patients suffer from chronotropic incompetence, representing a potentially high need for rate-adaptive pacing. At the same time, there is a lack of evidence about the effectiveness of accelerometer rate adaption — current guidelines do not include a recommendation. Mattias Roser, M.D., Charité Hospital, Berlin, Germany, is conducting a pilot study to research if rate-adaptive pacing with Closed Loop Stimulation (CLS) improves clinical outcomes. The primary endpoint is ventilatory efficiency – a cardio-pulmonary exercise test’s most reliable prognostic variable.

“Although available for decades, there is still conflicting evidence on whether an accelerometer, which measures patients’ movements, is clinically beneficial,” explained Roser. “We believe that CLS has the potential to significantly improve CRT patient outcomes as it reflects individual metabolic demand and reacts to the heart’s contractility. CLS from Biotronik is the only technology to respond to mental as well as physical stress.”

Physicians also discussed the benefits of Biotronik Home Monitoring for CRT patients. Guidelines recommend remote monitoring since the IN-TIME study demonstrated a significant reduction in mortality with Home Monitoring. Interestingly, when the Biotronik system was excluded from trials, such as REM-HF, More-CARE and Opti-Link HF, no clinical benefits of remote monitoring were found. The differences in study results can be explained by Home Monitoring’s features, according to the company: a multi-parameter analysis of relevant clinical data and highly-reliable daily data transfer. With efficient in-clinic workflow, Home Monitoring can prevent heart failure progression and reduce mortality as demonstrated by Hindricks et. al in the recent TRUECOIN meta-analysis.

For more information: www.biotronik.com

July 21, 2017 — Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica cardiac resynchronization therapy (CRT)-DX implantable cardioverter defibrillator (ICD) systems. The launch of Intica CRT-DX extends the benefits of Biotronik's DX technology to heart failure patients. DX eliminates the need for an atrial lead while still providing physicians with critical diagnostic information based on a true atrial signal.

Biotronik launched DX technology in 2013 with a focus on improving patient care and decreasing the rate of complication. DX minimizes hardware and provides critical diagnostics that allow physicians to better monitor, manage and prevent cardiac events. Intica CRT-DX is the first cardiac rhythm management device for the treatment of heart failure patients that delivers atrial diagnostics without an atrial lead. Atrial diagnostics aid physicians in the early identification of supraventricular tachycardia (SVT), atrial fibrillation (AF) and atrial ventricular synchronization.

"When treating heart failure patients, we are often managing several comorbidities that can increase the likelihood of complications and risk when implanting a CRT-D and in the years that follow," said Larry Chinitz, M.D., a cardiac electrophysiologist in New York City. "Balancing risk and therapeutic needs has historically been a challenge. CRT-DX changes this and creates a higher echelon of patient care. Now there is an ICD for heart failure patients that minimizes hardware and risk while providing optimal diagnostics to help patients feel better and stay out of the hospital. The addition of DX technology to a CRT device is a breakthrough."

Intica CRT-DX also includes Biotronik's recently FDA approved MultiPole Pacing (MPP) technology. MPP enables the left ventricle (LV) to be paced twice per cardiac cycle — sequentially or simultaneously — allowing for even greater customization of heart failure therapy.

Only Biotronik offers MR conditional devices with independent, simultaneous LV paces, according to the company.

The Intica DX device systems also incorporate other technologies including:

• MRI AutoDetect – shortens window of reduced therapy and eliminates the need for post-MRI (magnetic resonance imaging) reprogramming;
• Biotronik Home Monitoring – automatically transmits device data daily; associated with a >50 percent reduction in mortality due to heart failure and a 36 percent reduction in hospitalization for worsening heart failure; and
• Closed Loop Stimulation – equips the device to respond appropriately to physiologic demands and acute mental stress.

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

September 22, 2017 — Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of the company's most widely-used implantable cardioverter defibrillators (ICD) and associated high voltage leads. The approval of MR-conditional labeling for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads adds another patient-centric benefit to the device and will help further improve access for patients suffering from abnormally fast heart rhythms who need an ICD and who may need an MRI scan in the future.

When electrical signals in the lower chamber of the heart fire erratically, the heart can beat abnormally fast – a condition known as ventricular tachycardia or tachyarrhythmia – which in turn leaves the heart unable to pump blood effectively. In addition to symptoms such as light-headedness, chest pains and shortness of breath, over time the condition can lead to a potentially life-threatening arrhythmia, heart failure, stroke or cardiac arrest. Abbott's ICD devices can monitor for and detect abnormally fast heart rhythms and deliver electricity to the heart to restore the heart's natural rhythm.

The new MR-conditional labeling for the Ellipse ICD allows patients to undergo an MRI scan if needed. In addition, patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans.

The smaller shape and size of Ellipse ICD helps improve patient comfort once implanted, and Abbott engineered the device with features designed to optimize ICD therapy and improve patient safety. The features, known as Abbott's TailoredTherapy approach, include:

• DeFT Response Technology: Allows physicians to adapt how therapy is delivered by the Ellipse ICD to ensure each patient receives therapy based on their unique need. The feature also helps ensure successful therapy delivery without the need to deliver an initial shock at the time of implant;
• SecureSense: Abbott's SecureSense algorithm offers an additional level of protection for patients by providing proper sensing within the heart even in the presence of external interference (known as "lead noise") to safeguard against unnecessary therapy being delivered to the patient; and
• DynamicTx: With Abbott's DynamicTx algorithm, physicians can be confident that their patient's devices are consistently evaluating the condition of the lead and adapting the path of the electrical impulse to deliver appropriate therapy.

As a further benefit, all therapy and other data captured by the Ellipse ICD can be directly, securely and wirelessly sent to a patient's physician through the Merlin.net Patient Care Network. This communication allows physicians to remotely monitor their patient's therapy and assess any need for intervention.

The latest labeling follows approval earlier this year of Abbott's Assurity MRI pacemaker and prior MR-conditional labeling approvals in Europe.

For more information: www.sjm.com

September 27, 2017 — Boston Scientific recently launched the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogic Heart Failure Diagnostic to help physicians improve heart failure (HF) management. The new devices, which are approved by the U.S. Food and Drug Administration (FDA) for conditional use in a magnetic resonance imaging (MRI) environment, also combine the company's SmartCRT Technology with EnduraLife Battery Technology to improve patient management through personalized care.

The newly introduced HeartLogic Diagnostic alerts physicians of worsening HF by combining data from sensors evaluating heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity. The alert is the first and only heart failure diagnostic in an implantable device that has been validated to have an observed sensitivity of 70 percent as well as the ability to provide weeks of advance notice – a median of 34 days ahead of an impending HF event – and low burden for detecting indications of worsening HF.1

In addition to the HeartLogic Diagnostic, all CRT-Ds in the Resonate family of devices are enabled with SmartCRT Technology to help physicians customize where, when and how to pace the lower chambers of the heart using the Multisite Pacing capability for multi-electrode pacing. The SmartCRT Technology, coupled with EnduraLife Battery Technology, provides physicians with the ability to tailor device settings according to individual patient needs, without fear of adversely draining the battery and causing unnecessary replacement procedures.

The company recently began enrolling patients in the MANAGE-HF study to evaluate further the HeartLogic Diagnostic and has initiated a series of clinical trials to demonstrate improved response to CRT therapy with the SmartCRT Technology.

"Through the MANAGE-HF study we will be able to realize fully the capabilities of the HeartLogic Diagnostic in clinical practice," said Adrian Hernandez, M.D., principal investigator of the MANAGE-HF study, director of health services and outcomes research at the Duke Clinical Research Institute and vice dean of clinical research at Duke University School of Medicine. "We look forward to collecting additional data on how the alert can enable improved patient outcomes."

The MR-conditional labeling allows patients implanted with specific models of the company's Resonate family of devices to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met. This capability extends beyond the Resonate family and includes those patients who were previously implanted with Autogen, Dynagen, and Inogen ICD and CRT-D devices. MRI approval was based on clinical trial results from the global ENABLE MRI study, which was completed earlier this year.

For more information: www.bostonscientific.com

References

1. Boehmer, J et al., JACC-HF, 2017;5(3),2 1 6 – 2 56.

October 30, 2017 — The American College of Cardiology, along with the American Heart Association and the Heart Rhythm Society, published new guidelines for the treatment of patients with ventricular arrhythmias and the prevention of sudden cardiac death.

Ventricular arrhythmias are an abnormal heartbeat arising from the heart’s lower chambers, or ventricles. This condition can lead to sudden cardiac arrest, which, in turn, results in sudden cardiac death if the abnormal rhythm is not quickly stopped to restore a normal rhythm.

“Sudden cardiac arrest and sudden cardiac death are major public health problems, accounting for approximately half of all cardiovascular deaths, with at least 25 percent being first manifestation of cardiac disease,” said Sana M. Al-Khatib, M.D., MHS, FACC, FAHA, FHRS, professor of medicine at Duke University Medical Center and chair of the writing committee. “The risks of ventricular arrhythmias and sudden cardiac death vary in specific populations with different underlying cardiac conditions, and with specific family history and genetic variants, and this variation has important implications for studying and applying therapies.”

This new guideline, which replaces the 2006 ACC/AHA/ESC Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death, is intended to guide management of adults who have ventricular arrhythmias or who are at risk for sudden cardiac death, including diseases and syndromes associated with a risk of sudden cardiac death from ventricular arrhythmias. Some recommendations from the earlier guidelines have been updated as warranted by new evidence or a better understanding of existing evidence.

This guideline includes indications for implantable cardioverter defibrillators (ICDs) for the treatment of ventricular arrhythmias and prevention of sudden cardiac death. The guideline provides much needed guidance on the use of ICDs in patients with non-ischemic cardiomyopathy, as the role of ICDs in such patients was called into question by the recent publication of the DANISH trial. The guideline also provides recommendations on the use of ICDs in patients with left ventricular assist devices, use of subcutaneous ICDs and the role of catheter ablation of ventricular arrhythmias, and provides several recommendations on genetic counseling and genetic testing to help inform clinical practice. This guideline is the first to include value statements, specifically on the strength of evidence surrounding ICDs and cost-effectiveness. 

The writing committee stresses the importance of shared decision-making between patients and clinicians.

“Treatment decisions should not be based only on the best available evidence, but also on the patients’ health goals, preferences and values,” Al-Khatib said.

Patients considering implantation of a new ICD or replacement of an existing one should be informed of their individual risk of sudden cardiac death and nonsudden death from heart failure or noncardiac conditions, and the effectiveness and potential complications of the ICD. In patients nearing the end of life from other illness, clinicians should discuss ICD shock deactivation as they reassess their patients’ goals and preferences.

The writing committee acknowledges that despite the substantial progress in recognizing individuals at risk for sudden cardiac death and the prevention and treatment of sudden cardiac death and ventricular arrhythmias, many gaps in knowledge remain. More research is needed to better define which patients among all currently ICD-eligible patients are most likely to benefit from an ICD, to define the role of the ICD in patient subgroups not well-represented in the pivotal ICD trials, and to develop approaches to preventing sudden death in the large population of patients who do not meet present indications for an ICD, but account for the majority of cases of sudden death. Increasing funding for research in these areas is critically important.

The 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death are published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm.

For more information: www.acc.org, www.heart.org, www.hrsonline.org

November 25, 2017 — Sitting in, or standing close to the charging port of a Tesla electric vehicle did not trigger a shock or interfere with implantable cardioverter defibrillator (ICD) performance, according to preliminary research presented at the 2017 American Heart Association (AHA) Scientific Sessions 2017.

Researchers examined the potential effect of electromagnetic interference while charging an electric vehicle battery at 220 Volts. The study included 26 men and 8 women from Good Samaritan Hospital in Dayton, Ohio, average age 69, with implanted cardiac defibrillators of various types.

Adjusting the defibrillators to both their least and most sensitive settings, the devices did not sense the electromagnetic signal from the electric vehicle battery when patients sat in the driver’s seat, passenger seat, backseat or at the charging post (where the electromagnetic interference is at its highest).

These findings suggest that electric vehicles may be safe to use for individuals with cardiac defibrillators, according to the principal investigator, Abdul Wase, M.D. and his team.

The study was conducted by Thein Tun Aung, M.D. and Abdul Wase, M.D., at Good Samaritan Hospital, Dayton, Ohio.

Links to other AHA 2017 Late-breaking Trials

For more information: heart.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.”

January 3, 2018 — Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) and Fortify Assura implantable cardioverter defibrillator (ICD). The approvals follow recent MR-conditional labeling approvals for the Assurity MRI pacemaker, Ellipse ICD and associated MRI-compatible leads, and further expand Abbott's portfolio of MRI-ready devices for patients indicated for ICDs and/or CRT-D devices who may need an MRI in the future.

Physicians utilize ICDs to restore normal heart rhythms in patients at risk for experiencing potentially life-threatening heart rhythms; they implant CRT-D devices to help the lower chambers of the heart beat in rhythm in patients battling progressive congestive heart failure and improve blood flow throughout the body. For some patients, the potential need for a future MRI has made MR-conditional labeling important as physicians assess therapies and device options. As a result, Abbott has done extensive testing to demonstrate that these devices are safe in the most commonly-used MRI scanners.

In addition to MRI compatibility, Abbott's Fortify Assura ICD and Quadra Assura MP CRT-D also include the company's suite of TailoredTherapy features, which are designed to provide physicians additional flexibility and control in how they deliver therapy to treat their patient's cardiac arrhythmias and congestive heart failure, even as their patient's therapy needs change over time. With the TailoredTherapy feature set, the Fortify Assura ICD and Quadra Assura MP CRT-D help protect against the delivery of unnecessary therapy and continuously evaluate the condition of a lead to consistently deliver appropriate therapy. Combined with MRI compatibility, these features offer physicians additional options to leverage when managing patient care.

The Quadra Assura MP CRT-D also offers Abbott's proprietary MultiPoint Pacing and SyncAV technology to provide additional options for CRT patients who are not responsive to traditional cardiac resynchronization therapy. With MultiPoint Pacing, Abbott allows physicians to "individualize" cardiac resynchronization therapy and shift their patient's treatment options from a single point of pacing to multiple options to better deliver therapy where needed. Abbott's SynvAV software allows a CRT device to detect real-time changes in a patient's cardiac condition and adjust therapy accordingly.

As with all Abbott cardiac rhythm management devices, all therapy data captured by the Fortify Assura and Quadra Assura MP devices can be directly, securely and wirelessly sent to a patient's doctor through the Merlin.netTM Patient Care Network. This communication allows physicians to remotely monitor their patient's therapy and assess any need for intervention.

For more information: www.sjm.com

Related Content

Abbott Receives FDA Approval for MR-Conditional Labeling of Assurity Pacemaker

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD

St. Jude Medical Announces U.S. Launch, Implants of MultiPoint Pacing

St. Jude Medical Expands Heart Failure Portfolio with SyncAV CRT Technology

February 26, 2018 — The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to a defect in the manufacturing process. The FDA said this defect causes an out-of-specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.

On Jan. 22, 2018, Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to:

• Consider prophylactic device replacement for patients who have been implanted with one of the affected devices;
• Contact their Medtronic sales representative for terms and conditions for device warranties; and
• Review the recall notice and ensure appropriate staff is aware of the notice.

The recall impacts patients with an affected Medtronic ICD or CRT-D device, caregivers of those patients, and healthcare providers treating patients with heart failure or heart rhythm problems using these devices. The recall affects CRT-Ds an ICDs with product codes NIK and LWS, manufactured between July 13, 2013, and Aug. 8, 2017 — a total of 48 units nationwide.

Medtronic will offer a supplemental device warranty for affected devices. Customers who have questions or need additional information or support regarding this recall should contact their local Medtronic sales representative or Medtronic Technical Services at 800-723-4636.

Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).

Healthcare professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.

ICDs and CRT-Ds are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Both types of devices are implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia) or needs coordination to treat heart failure.

The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.

See the complete list of affected serial numbers here.

For more information: www.medtronic.com

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

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

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

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

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

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

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

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

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

For more information: www.onlinejacc.org

Related Cybersecurity Content

Raising the Bar for Medical Device Cyber Security

The State of Healthcare Cyber Security

FDA Seeks Management of Cybersecurity in Medical Devices

Cybersecurity Threats in Medical Imaging

April 12, 2018 — Biotronik U.S. and Aziyo announced a strategic agreement allowing Biotronik to distribute Aziyo's CanGaroo extracellular matrix (ECM) cardiovascular implantable electronic device (CIED) envelopes in the United States. BioEnvelope will be available from Biotronik starting in April 2018.

BioEnvelope reduces scar formation and has been shown to mitigate the risk of device migration and erosion in in vivo studies.1 Its ECM material consists of a flexible bioscaffold that remodels in three to six months while encouraging the body to naturally regrow and restore functional, vascularized tissue. The newly remodeled tissue may enhance patient comfort and facilitate easier CIED removal for future device replacements.

Device dislodgement and pocket infection following implantation are serious complications that are associated with higher mortality and increased healthcare costs.2 Biotronik partners with hospitals and health systems to alleviate the cost burden of long-term care for CIED patients.

With BioEnvelope, physicians can choose how to best treat each individual patient with or without local antibiotic use. This extends the benefits of CIED envelopes to more patients and further customizes care.

"It's an exciting time to embrace the merging fields of regenerative medicine and cardiac rhythm management," said John N. Catanzaro, M.D., FESC, FACC, FHRS, SECURE study investigator, associate medical director and associate program director of electrophysiology in Jacksonville, Fla. "The natural ECM material benefits our patients by promoting a natural healing environment that produces a healthy, vascularized tissue pocket without inflammation, scarring or calcification."

BioEnvelope is indicated for use with the full spectrum of transvenous and subcutaneous CIEDs and has a three-year shelf life. It is also made in five sizes, eliminating the need to manually resize envelopes on a case-by-case basis.

For more information: www.biotronik.com

References

1. Data on file.

2. Polyzos K et al. EP Europace. 2015, 17(5).

April 13, 2018 — Medical advice about implanted cardiac defibrillators obtained via an online message board appears to be accurate only half of the time, according to new preliminary research. The research was presented at the American Heart Association’s (AHA) Quality of Care and Outcomes Research Scientific Sessions 2018, April 6-7 in Arlington, Va.

The study was based on analysis of two years of messages on an anonymous online board about implanted cardiac defibrillators (ICDs). Results showed that about 25 percent of the messages contained inappropriate advice, and 6 percent of advice shared was controversial. Researchers analyzed 127 discussions, 82 of which pertained to medical advice in several topical areas, including cardiovascular disease, device programming and maintenance, physical activity restrictions and management of other health conditions.

The research team said the findings underscore the need to ensure that clinicians follow up with patients about their information sources to ensure they are receiving accurate advice outside of the doctor’s offices. Ensuring appropriate advice is particularly important when it comes to complex decisions about advanced procedures, tests and interventions such as the decision to have an ICD, the study authors added.

“The internet is a critical piece of the vast network of information available to patients, as Americans use the internet to understand their health all the time,” said Christopher Knoepke, Ph.D., study lead investigator and an instructor of cardiology at the University of Colorado Denver. “Our findings indicate that patients should be advised that discussions on these online message boards can provide some good, basic information, but more complicated and in-depth advice may be problematic.”

ICDs are miniature devices surgically implanted in the heart to fire off electric shocks that interrupt potentially lethal arrhythmias and restore normal heart rhythm. Between 1 and 2 million people live with ICDs in the United States, the study authors said, and some 130,000 new devices are implanted in patients each year.  

Given how common patient use of online medical information is, clinicians must be aware of the potential their patients will be exposed to inaccurate or dangerous information, the research team said.

“Clinicians should caution patients it’s impossible for anyone not familiar with his or her case and full medical history to help put information into context for their individual patient needs,” Knoepke said.

Co-authors are Daniel Slack, Daniel Matlock and Lucas Marzec. Author disclosures are on the abstract.

For more information: www.heart.org

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

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

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

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

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

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

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

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

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

May 16, 2018 — Boston Scientific announced results from an analysis of the LATITUDE database evaluating the successful reduction of inappropriate shocks using the Smart Pass sensing filter with the Emblem Subcutaneous Implantable Defibrillator (S-ICD) System. The real-world data were presented during a late-breaking clinical trial at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions, May 9-12 in Boston. The results demonstrated that when the sensing filter was in use, the rate of inappropriate shocks was reduced to 4.3 percent at one year.

The analysis was also published online in the Heart Rhythm Journal.[1]

The Smart Pass sensing filter is an advanced algorithm within the Emblem S-ICD System that filters out certain signals that are the primary reason for inappropriate shocks, while still accurately detecting ventricular tachycardia or ventricular fibrillation and delivering lifesaving therapy. Study authors evaluated the effect of Smart Pass on shocks in ambulatory patients and found that the filter reduced the risk for the first inappropriate shock by 50 percent and the risk for all inappropriate shocks by 68 percent, without a negative impact on delivery of appropriate shocks.

"The study data validate the clinical benefit of this sensing methodology to significantly reduce inappropriate shocks by the S-ICD," said Tom F. Brouwer, M.D., presenting author, Department of Clinical and Experimental Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands. "At one year, the inappropriate shock rate for patients with the Smart Pass filter in use was as low as rates observed in studies with transvenous implantable cardioverter-defibrillators employing modern programming strategies."

The prospective, blinded evaluation reviewed one year of remote monitoring data from 1,984 patients implanted with an Emblem S-ICD System between 2015 and 2016.

The S-ICD was included for the first time in recently updated guidelines from the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS), which recommend the device for the treatment of patients with ventricular arrhythmias and the prevention of sudden cardiac death.1

For more information: www.bostonscientific.com

References

1. Jean-Benoit le Polain de Waroux, Sylvain Ploux, Pierre Mondoly, et al. Defibrillation testing is mandatory in patients with subcutaneous implantable cardioverter–defibrillator to confirm appropriate ventricular fibrillation detection. HeartRhythm. May 2018. Volume 15, Issue 5, Pages 642–650DOI: https://doi.org/10.1016/j.hrthm.2018.02.013

2. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death, Heart Rhythm (2017), doi: 10.1016/j.hrthm.2017.10.036.

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

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

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

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

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

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

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

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

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

Related Cardiovascular Device Cybersecurity Content:

Can Your Cardiac Device Be Hacked?

Raising the Bar for Medical Device Cyber Security

The State of Healthcare Cyber Security

FDA Seeks Management of Cybersecurity in Medical Devices

Cybersecurity Threats in Medical Imaging

FDA Announces New Medical Device Safety Action Plan

Reference:

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

#HRS2018  #HRS18

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

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

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

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

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

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

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

Reference:

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

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

#HRS2018