Did you miss the Heart Rhythm sessions in Denver? The Heart Rhythm Society’s 34th Annual Scientific Sessions were held in Denver from May 8-11, 2013. Enclosed below is a compilation of clinical news highlights from the meeting.
St. Jude Medical Announces Results from Independent Analysis of Optim-Insulated Defibrillation Leads in Late-Breaking Clinical Trial Session at Heart Rhythm 2013
St. Jude Medical, Inc., a global medical device company, announced the Population Health Research Institute (PHRI), an academic health science research institute, has conducted a further independent analysis of data received from ongoing prospective registries that monitor the performance of the Durata™ and Riata™ ST Optim implantable cardioverter defibrillator (ICD) leads. The analysis was performed by PHRI and the results were presented during the late-breaking clinical trial presentations at Heart Rhythm 2013.
PHRI analyzed data from three actively monitored registries: the OPTIMUM, SCORE and SJ4 Post-Approval registries, all sponsored by St. Jude Medical. The combined data from these registries currently represents more than 11,000 leads implanted at 293 sites.
The findings from PHRI’s initial analysis of the combined Optim-insulated lead registries, for data collected through Feb. 28, 2013, include:
- 99.9 percent rate of freedom from all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage) at five years
- 99.4 percent rate of freedom from all-cause mechanical failure (includes any insulation abrasion, conductor fracture, failure of a crimp, weld, or bond, or other mechanical failure) at five years
“Data from St. Jude Medical’s prospective, actively-monitored Optim lead registries have been thoroughly analyzed by PHRI and continue to demonstrate very low rates of insulation abrasion and mechanical failure,” said Dr. John Cairns, professor of Medicine and former dean of Medicine at University of British Columbia in Vancouver. “These prospective registries are well designed with pre-specified definitions for adverse events and a centralized reporting structure. They have now been independently adjudicated by PHRI.”
PHRI convened a committee of independent physicians chaired by Dr. John Cairns, an internationally recognized expert in cardiology clinical trials who has no affiliations with the cardiac rhythm management device industry, to perform the analysis. Additional committee members include Dr. Stuart Connolly, professor and director of the Division of Cardiology at McMaster University, Dr. Jeff Healey, associate professor of Cardiology at McMaster University, Dr. Andrew Epstein, professor of Medicine at the University of Pennsylvania and chief of Cardiology at the Philadelphia Veterans Administration Medical Center, and Dr. Christopher Buller, professor of Medicine at The University of Toronto and director of Cardiac Catheterization and Intervention at St. Michael’s Hospital.
“St. Jude Medical is proud to sponsor the largest actively monitored lead performance evaluation ever conducted for an ICD lead family,” said Dr. Mark Carlson, chief medical officer and senior vice president of Research and Clinical Affairs for St. Jude Medical’s Implantable Electronic Systems Division. “We are pleased that PHRI’s independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads.”
The results are published beginning on page 257 of the first edition of the 2013 St. Jude Medical Product Performance Report (PPR), which will be released on sjmprofessional.com. The committee will continue to meet on an ongoing basis to review data as it is collected, which will be reported in future PPRs.
The Population Health Research Institute (PHRI) was founded in 1999 as a joint Institute of Hamilton Health Sciences Corporation (HHS) and McMaster University; it is now one of the largest and most cited academic cardiovascular research groups worldwide. The institute’s vision is to conduct large simple studies to address questions of international importance and relevance. Its research programs explore the causes and prevention of cardiovascular disease, diabetes, obesity and societal influences on health, perioperative vascular complications, and stroke.
PHRI has conducted more than 50 global trials and epidemiological studies in more than 1,500 centers in 83 countries, involving over 500,000 patients, leading to more than 800 publications in the last 10 years in prestigious medical journals such as the New England Journal of Medicine, The Lancet, the Journal of the American Medical Association, the British Medical Journal, Circulation, the Journal of the American College of Cardiology and the European Heart Journal. Several of the discoveries made by scientists at the PHRI have influenced prevention and treatment practices worldwide.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, MN, and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please click here.
Biosense Webster Reports Compelling Results from Ground-Breaking SMART-AF IDE Study on the Safety and Effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheter
Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the 12-month safety and effectiveness results of the ThermoCool® SmartTouch™ Catheter and Software Module in the treatment of symptomatic, drug refractory, paroxysmal atrial fibrillation from the ground-breaking SMART-AF Investigational Device Exemption (IDE) clinical trial. The results of the trial were presented at the Heart Rhythm Society’s 34th Annual Scientific Sessions in Denver, CO, by Dr. Andrea Natale, a member of the study Advisory Committee and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX.
“The ThermoCool® SmartTouch™ Catheter represents a major advance in RF catheter ablation technology,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. “It enables physicians to directly measure contact force, rather than having to rely on surrogate measures, as is required for all currently marketed ablation catheters in the U.S. today.” The ThermoCool® SmartTouch™ Catheter measures in real time the catheter tip contact force and direction inside the heart during cardiac ablation procedures. The ThermoCool® SmartTouch™ Catheter is approved for investigational use only (IDE) and is not for sale in the United States. The results from this study will be submitted later this month for the ThermoCool® SmartTouch™ Catheter Premarket Approval application to the FDA.
The 12-month study enrolled 172 subjects (72 percent male and 28 percent female) at 21 leading centers across the United States. To date, the study met its prospective safety and effectiveness endpoints with no unanticipated device-related adverse events and 72 percent of subjects were free from AF recurrence at the end of the 12-month follow-up period. Eighty percent of subjects who were off AADs at 12 months were free from AF recurrence.
The ThermoCool® SmartTouch™ Catheter represents the industry-leading catheter technology coming from Biosense Webster, Inc. The data it produces are graphically displayed on the Carto® 3 System mapping and navigation system with Software Version 2 or higher, the market’s technological leader in 3D mapping systems, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities.
In discussing the study results, Dr. Natale said, “SMART-AF showed a 12-month success rate of 72 percent with comparable safety to previous studies. Furthermore, increased percent of time within physician-targeted contact force range correlated with increased freedom from arrhythmia recurrence, with 84.4% of subjects arrhythmia-free at 12 months when the force was within the targeted range >82% of the time. This is exciting data for the EP community, which has been working tirelessly to provide better treatments for AF. This will provide an important new tool for treating paroxysmal AF patients.”
About AF and Cardiac Ablation
Atrial fibrillation is the most prevalent arrhythmia, and is a leading cause of stroke among people 65 years and older. Worldwide, it is estimated that 20 million people have AF, yet only ~130,000 are treated with ablation every year. The public health implications of AF are a growing concern because those with AF are at an increased risk of morbidity and mortality as well as a reduced quality of life.
Most patients with AF today are treated with anti-arrhythmic drugs (AADs), even though about half of them are refractory to these drugs. During cardiac ablation, energy is delivered through the catheter to those areas of the heart muscle causing the abnormal heart rhythm. This energy “disconnects” the pathway of the abnormal rhythm. Cardiac ablation is commonly used for “simple” arrhythmias, like Wolff-Parkison-White Syndrome and atrioventricular nodal re-entry tachycardia (AVNRT), and is increasingly being used for more complex arrhythmias like ventricular tachycardia and atrial fibrillation. ThermoCool® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with Carto® Systems (excluding NaviStar® RMT ThermoCool Catheter).
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP diagnostic catheters more than 20 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and mapping tools. As the leader in EP navigation systems and ablation therapy, Biosense Webster, Inc. has technology that includes the largest installed base of cardiac mapping navigation systems worldwide in leading hospitals and teaching institutions. For more information about Biosense Webster and its products, please click here.
Dr. Natale is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.
Always verify catheter tip location using fluoroscopy or IC signals and consult the Carto® System User Guide regarding recommendations for fluoroscopy use.
New Four-Year Data From Boston Scientific Demonstrated WATCHMAN® Device Was Superior To Warfarin For Mortality And Primary Efficacy In Patients With Atrial Fibrillation In Long Term Follow-Up Of The PROTECT AF Trial
Boston Scientific Corporation reports that the four-year follow-up data from the PROTECT AF clinical trial demonstrated the WATCHMAN® Left Atrial Appendage (LAA) Closure device was statistically superior to warfarin for preventing cardiovascular death, all-cause stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin. The data were presented as a late-breaking clinical trial at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions in Denver, by Vivek Reddy, MD, a principal investigator of the PROTECT AF trial, and Professor of Medicine and Director of the Cardiac Arrhythmia Services at Mount Sinai School of Medicine in New York. The abstract is titled, “Long Term Results of PROTECT AF: The Mortality Effects of Left Atrial Appendage Closure versus Warfarin for Stroke Prophylaxis in AF.”
Atrial fibrillation (AF) is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. The condition affects approximately 2.7 million Americans and 15 million people worldwide, and is the most common cause of disabling stroke. A primary treatment goal for AF patients is to reduce the risk of blood clots causing stroke. Patients with AF and additional risk factors for stroke are commonly prescribed blood-thinning medications, also known as anticoagulants, like warfarin, to prevent blood clots from forming in the heart. However, due to blood monitoring requirements, dietary restrictions, side effects and an increased risk of serious bleeding, many patients are unable or unwilling to take these medications for long periods of time. In contrast, the WATCHMAN device is designed to close off the LAA, a major source of clots in patients with AF, and reduce the risk of stroke, potentially eliminating the need for long-term use of blood-thinning medications.
“This is a significant development because for the first time we were able to demonstrate that the WATCHMAN device was superior to warfarin for both primary efficacy and also mortality,” said Dr. Reddy. “This has tremendous upside potential for patients. In the PROTECT AF trial, LAA closure with the WATCHMAN device demonstrated the potential for a device-based approach to reduce the risk of stroke in AF patients. As clinicians, we often feel uncomfortable with life-long systemic anticoagulation therapy in patients because of an increased risk of falls and bleeding. The four-year data provide additional support for LAA closure as a potential viable long-term alternative to chronic warfarin therapy for patients to reduce the risk of stroke.”
The PROTECT AF clinical trial is a multicenter, prospective randomized clinical trial designed to demonstrate the safety and effectiveness of the Boston Scientific WATCHMAN device in patients with non-valvular AF who are eligible for warfarin therapy and meet certain stroke risk factors. A total of 707 patients from 59 centers were randomized 2:1 to device or warfarin control.
The PROTECT AF trial achieved superiority for the combined endpoint of all stroke, cardiovascular or unexplained death and systemic embolism.1
- The observed primary efficacy event rate was 2.3 percent and 3.8 percent in the WATCHMAN and control groups, respectively, demonstrating a 40 percent relative risk reduction in primary efficacy in the WATCHMAN group (RR = 0.60, posterior probability of superiority = 96 percent).
Secondary analysis also showed a relative risk reduction and superiority to control for all-cause mortality and cardiovascular mortality.
- All-Cause Mortality: the WATCHMAN group was superior to the control group, 3.2 percent to 4.8 percent respectively, representing a 34 percent relative risk reduction in all-cause mortality in the WATCHMAN group (HR = 0.66, p=0.0379).
- Cardiovascular Mortality: the WATCHMAN group was superior to the control group, 1.0 percent and 2.4 percent respectively, representing a 60 percent relative risk reduction in cardiovascular death in the WATCHMAN group (HR = 0.40, p=0.0045).
“This is exciting news for patients with non-valvular AF and a high risk of stroke,” said Kenneth Stein, MD, chief medical officer, Cardiac Rhythm Management, Boston Scientific. “These data convincingly show that the WATCHMAN device was superior to the current standard of care in these patients and demonstrated its potential to prevent stroke and save lives. The WATCHMAN device underscores the Boston Scientific commitment to meaningful innovation and to providing the medical community with the tools it needs to improve patients’ lives.”
PROTECT AF long-term data add to the growing body of evidence for the WATCHMAN device as the most studied LAA closure device and the only LAA closure device with long-term follow-up. Data from the PROTECT AF trial, PREVAIL study, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data will form the basis for the full and final clinical module to support device regulatory approval in the United States. To date, more than 2,000 patients with 4,800 patient-years of follow-up have been studied in clinical trials of the WATCHMAN device.
The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009. It is already commercially available in 55 countries worldwide. In the United States, the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011. Please click here for more information.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, click here.
1 For Bayesian analysis, posterior probabilities are used to determine superiority; >95% represents superiority
Endosense Underscores Significance of Contact Force Parameters with New Study Data at Heart Rhythm 2013
Endosense, a pioneer and leader in contact force (CF) technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, further advanced its leadership position in the field with new study data validating the importance of several proprietary contact force parameters, including its most recently developed Lesion Index (LSI™). Unveiled in abstracts at the Heart Rhythm 2013 held in Denver, the data also demonstrated the ability of the company’s TactiCath® ablation catheter to detect excessive contact force during robotic catheter navigation.
A key Endosense abstract at the society’s 34th annual congress was presented by Dr. Moussa Mansour, director of the Cardiac Electrophysiology Laboratory as well as the Atrial Fibrillation Program at Massachusetts General Hospital. “Application of Contact Force Guidelines Increases Durable Isolation after Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation” provided evidence of the value of combining three contact force parameters to improve durability of pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF). These include Endosense’s contact force (CF); Force Time Integral (FTI™); and Lesion Index (LSI). Featured in Endosense’s new TactiCath Quartz device, LSI is a sophisticated algorithm that combines radiofrequency power, ablation time and contact force applied to the cardiac tissue in order to estimate lesion formation in real time.
Contact force guidelines were developed from Endosense’s TOCCATA study, a 12-month study completed in 2010 which found that clinical outcomes improve with CF > 20g; and its later EFFICAS I post-market clinical trial, which not only revealed the value of FTI, but established the clinical practice guideline of an absolute minimum FTI of 400 gs per individual ablation lesion. Early results of the TOCCASTAR IDE study presented by Dr. Mansour underscored this guidance and showed that, in a subgroup that underwent a redo procedure, subjects treated with the combined CF guidelines of CF > 20g, FTI > 400gs and LSI > 5.0 showed the strongest improvement in pulmonary vein isolation rate: 80 percent when all criteria were fulfilled versus 46 percent when not all criteria were fulfilled.
“The data has clearly demonstrated the importance of contact force in achieving durable pulmonary vein isolation following the catheter ablation treatment of PAF,” said Dr. Dipen Shah, Professor of Cardiology at the University Hospital Geneva and co-author of the paper. “I believe these new CF guidelines have great potential to improve clinical practice and, ultimately, lead to better patient outcomes.”
Endosense CEO Jan Keltjens added, “Endosense has made significant strides since demonstrating the correlation between contact force and the durability of PVI for the treatment of PAF. In addition to establishing contact force guidelines, we have found that the long-term success of PVI is greatest when minimum CF is combined with minimum FTI and LSI parameters.”
In “Quantitative Magnetic Resonance Imaging Analysis of the Relationship between Contact Force and Left Atrial Scar Formation after Catheter Ablation of Atrial Fibrillation,” Dr. Christian Sohns of Kings College London examined the relationship between contact force achieved during catheter ablation for PAF and late gadolinium enhancement MRI (LGE-MRI) signal intensity as a measure for durable isolation following PVI. He found that increased LGE-MRI signal intensity correlates with increased FTI values, hence an important guidance for long-term isolation.
While low contact force can lead to ineffective lesions, excessive contact force may cause safety concerns. In the third Heart Rhythm 2013 abstract, “Complementary Techniques and Location of Excessive Contact Force Detection in the Left Atrium with Robotic Catheter Navigation,” Dr. Sarah K. Hussain of The University of Virginia, Charlottesville, concluded that in a simulated bench experiment, Endosense’s TactiCath ablation catheter could enhance the capabilities of current robotic catheter systems in detecting excessive contact force wherever it occurs in the left atrium.
Endosense’s leadership in the field of contact force dates back to the first abstract on TactiCath at Heart Rhythm 2006. Since that time, the company has conducted a number of clinical studies demonstrating the safety, efficiency and effectiveness of contact-force sensing over traditional ablation technologies, and has also nearly completed enrollment and follow-up in the pivotal TOCCASTAR investigational device exemption clinical trial.
Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of Contact Force measurement in catheter ablation with the development of the TactiCath, the first force-sensing ablation catheter to give physicians a real-time, objective measure of Contact Force during the catheter ablation procedure. Endosense is backed by Edmond de Rothschild Investment Partners, Neomed, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners, Initiative Capital Romandie and NGN Capital. For more information, click here.
Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.
Landmark Study Demonstrates Lower Rate of Inappropriate Shocks in Patients with Sorin Dual Chamber ICD Devices
Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announced findings from the landmark OPTION study1 demonstrating that patients with Sorin dual-chamber implantable cardioverter defibrillators (ICDs) experienced a significantly lower incidence of inappropriate shocks compared with patients with standard single-chamber devices (4.3% vs.10.3%, p=0.015). The study also found that there was no difference in all-cause mortality between the two groups.
The OPTION study results were presented as a late-breaking clinical trial at the Heart Rhythm Society’s 2013 Annual Scientific Meeting in Denver.
A total of 462 patients at 54 centers in Europe and North America were enrolled in the study. Patients were randomized to either dual-chamber or standard single-chamber ICD therapy. Study endpoints were the occurrence of appropriate and inappropriate shocks and all-cause mortality. Median follow-up was over two years.
The OPTION study demonstrates the benefits of dual-chamber ICD therapy with Sorin. Sorin dual-chamber ICDs feature the PARAD+™ arrhythmia discrimination algorithm which reduces the number of inappropriate shocks,2 and the SafeR™ pacing mode which minimizes unnecessary ventricular pacing.3 Excessive right ventricular pacing has been associated with dual-chamber pacing and has been shown to increase heart failure and atrial fibrillation.4,5
“This is very good news for patients. We have known for a long time that inappropriate shocks were associated with poor quality of life and adverse outcomes,” said, Dr. Christof Kolb of the Deutsches Herzzentrum Munich, Germany, and principal study investigator. “The findings demonstrate that patients can rest assured that their Sorin ICD is correctly monitoring their heart and delivering only the therapy that is needed.”
While ICDs deliver lifesaving therapy to patients at risk of sudden cardiac arrest, inappropriate shocks still occur too frequently and negatively impact patients’ quality of life. ICDs are available in single and dual-chamber models and use differing methods to detect a patient’s arrhythmias and treat them with antitachycardia therapies; both types of ICDs can provide rescue shocks. Many physicians consider that dual-chamber ICDs provide superior antitachycardia therapy compared with single-chamber devices, but long-term data were lacking.
“The results of the OPTION study fill an evidence gap,” said Dr. Dan Dan, Piedmont Heart Institute, Atlanta, GA. “We always thought that dual-chamber ICDs which preserve the natural cardiac conduction were a better choice for our patients. This has been proven in this well-designed study,” he said.
“Sorin is committed to developing technologically advanced devices that provide smart therapies that are both lifesaving and beneficial to physicians and patients alike. We continue to invest in advancing knowledge about cardiac rhythm disorders and will support clinical trials that provide the strongest possible evidence supporting our therapies,” said Stefano Di Lullo, President, CRM Business Unit, Sorin Group.
About Sorin Group
Sorin Group is a global, medical device company and a leader in the treatment of cardiovascular diseases. The company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, the company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 80 countries. For more information, please clicl here.
- Kolb C, Babuty D, Sick P, et al. Lower occurrence of inappropriate shock in dual chamber ICD therapy reached with optimized discrimination and minimized Vp. Presented at: 34th Annual Scientific Sessions of the Heart Rhythm Society, May 8-11, 2013, Denver, CO, USA.
- Anselme F, Mletzko R, Bowes R, et al. Prevention of inappropriate shocks in ICD recipients: a review of 10,000 tachycardia episodes. PACE. 2007;30S128-S133. Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms.
- Davy JM, Hoffmann E, Frey A, et al. Near elimination of ventricular paving in SafeR mode compared to DDD modes: a randomized study of 422 patients. Pacing Clin Electrophysiol. 2012;35(4):392-402.
- Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003;107:2932-2937.
- Wilkoff BL, Cook JR, Epstein AE, et al. Dual chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the dual chamber and VVI implantable defibrillator (DAVID) trial. JAMA. 2002; 288:3115-23.
Nanostim Announces Preliminary Results from LEADLESS Study in Late-Breaking Clinical Trial at Heart Rhythm 2013
Nanostim, Inc., a privately-owned developer of miniaturized, leadless cardiac pacemakers (LCP), announced preliminary results from its LEADLESS study during the late-breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions in Denver. Early findings from the study of the world’s first self-contained, leadless cardiac pacemaker demonstrated overall device performance comparable to conventional pacemakers.
The LEADLESS study is a prospective, single-arm, multicenter study evaluating more than 30 patients. Initial findings from the study, which follow device performance and assess patient outcomes through 90 days of follow-up, demonstrate pacing thresholds (0.51 volts) and sensing thresholds (10.6 mV), which measure the minimum level that must be reached for an effect to be produced, are equivalent to those found in conventional pacemakers. Total procedural times averaged 28 minutes.
“These initial findings give us significant insight into the feasibility of this pioneering technology,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, NY. “The device’s ease of delivery, coupled with its ability to be acutely repositioned and later retrieved if necessary, gives physicians a less invasive option that may ultimately revolutionize the delivery of pacemaker therapy.”
There were no significant device-related adverse events and one significant procedure-related adverse event (perforation). This event rate is comparable with adverse event rates associated with conventional pacemakers. Because this minimally invasive approach eliminates the surgical pocket and lead, the device has the potential to reduce overall complications, specifically infection and lead failure. There was no failure to sense, pace or communicate with the pacemaker and no infections in these early data.
The small size of the device, less than 10 percent the size of a conventional pacemaker, allows for percutaneous placement through the femoral vein with a steerable catheter. Even with miniaturization, initial results indicate battery longevity is comparable to conventional pacemakers, with an average lifespan of 8.5 years at 100 percent pacing.
The study is being conducted in Europe to gather data in support of CE Mark approval. Devices were implanted at Homolka Hospital, Prague, Czech Republic; Academic Medical Center (AMC) Hospital in Amsterdam, the Netherlands; and Institute for Clinical and Experimental Medicine (IKEM) Hospital in Prague, Czech Republic. The study’s principal investigator is Dr. Johannes Sperzel, at the Kerckhoff Klinic in Bad Nauheim, Germany.
“We are looking forward to the potential benefits this technology will be able to offer our patients,” said Dr. Petr Neuzil, head of cardiology at Homolka Hospital in Prague, Czech Republic. “The elimination of the surgical pocket and lead has the potential to reduce long-term patient complications.”
In a conventional pacemaker procedure, an incision is made in the upper chest and one or more leads are guided through a vein into the heart. The pacemaker is then connected to the lead(s) and inserted beneath the skin and the incision closed. Nanostim’s leadless pacemakers are implanted via a percutaneous, catheter-based procedure. The devices are placed directly into the heart and are designed without the requirement for a lead or surgical pocket.
The Nanostim approach is designed to improve patient comfort by giving the physician a less invasive option, permitting implantation as an outpatient and eliminating the visible lump and scar at a conventional pacemaker’s pectoral implant site. Because of the elimination of the lead, the device is inherently MRI compatible and also removes the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.
“We’re excited with these outstanding preliminary results,” said Drew Hoffmann, chief executive officer of Nanostim, Inc. “We remain confident that the LEADLESS study will further our understanding of the benefits of this innovative, minimally invasive technology, and look forward to making this important technology available to patients and physicians worldwide.”
Nanostim is an emerging medical device manufacturer that is developing a self-contained leadless cardiac pacemaker system. The company is backed by InterWest Partners, US Venture Partners, Emergent Medical Partners, Life Science Angels and St. Jude Medical, which has an exclusive option to purchase Nanostim upon the completion of certain development milestones.
Use of TYRX Antibacterial Envelope Associated with Extremely Low 90-Day Cardiac Device Infection Rates
Use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope reduced major infection rates by more than 90% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to similar high-risk cohorts, according to the CITADEL & CENTURION clinical study results presented at the Late-Breaking Clinical Trials session at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions.
CITADEL / CENTURION is a prospective, multicenter clinical study to evaluate the major device infection and mechanical complication rates in the 12 months after implantation, in patients at high risk for CIED infection who have their CIED implanted with an AIGISRx Antibacterial Envelope. Study patients were enrolled at 55 U.S. centers, and were at high risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (CITADEL), or a cardiac resynchronization therapy (CRT) device (CENTURION).
The results from a planned interim analysis of the primary endpoints for the first 1,000 eligible patients after 90 days of follow-up were presented by Dr. Charles A. Henrikson, the Chief of Electrophysiology at the Oregon Health Sciences University.
Key study findings include:
The CITADEL / CENTURION cohort at 90 days of follow-up had 95% fewer major CIED infections than the pre-defined published control cohort of 533 ICD and CRT replacement procedures (Gould et al. JAMA. 2006;295(16):1907-1911.) which had a major CIED infection rate of 1.88% at a mean follow-up of 81 days (0.1% vs. 1.88%; P<0.001).
The CITADEL / CENTURION cohort at 90 days of follow-up had 94% fewer major infections than the 45-day major infection rate of 1.7% reported for the cohort of 1,081 ICD/CRT replacement procedures in the Ontario ICD Database (Krahn et al. Circulation Arrhythmia and Electrophysiology. 2011;4(2):136-42.) (0.1% vs. 1.7%; P<0.001).
There was 1 major infection (0.1%), the primary efficacy endpoint of the study, after 90 days of follow-up. There were 11 minor infections (limited to the incision and skin) (1.1%).
- The incidence of the most common mechanical complication, major hematomas (1.5%), was not significantly different than the pre-defined control cohort (2.3%; P = NS).
- There were no unanticipated serious AIGISRx-related adverse events. There were 20 (2%) deaths, none related to the AIGISRx.
“CIED infections are increasing in frequency, are associated with substantial morbidity, mortality, and cost, and present significant challenges to patients and for the physicians who provide care for them,” stated Charles A. Henrikson, MD, FHRS, Oregon Health Sciences University, Portland, Oregon. “The CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers which will provide us with useful clinical information on the use of the AIGISRx Envelope in a variety of patients who are at high risk for CIED infection.”
The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the US and around the world.
This study was funded by TYRX, Inc.
About Heart Rhythm Society
Heart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by pathogens responsible for the majority of CIED infections, including “superbugs” such as methicillin-resistant S. aureus (MRSA).*
Biventricular Pacing Reduces Symptoms and Improves Quality-of-Life in AV Block Patients with Heart Failure and Reduced Pumping Function
Medtronic, Inc. announced new data demonstrating that simultaneously pacing the lower chambers of the heart, or biventricular (BiV) pacing with a cardiac resynchronization therapy (CRT) device, significantly improves heart failure symptoms and quality of life in a subset of heart failure patients.
Findings from the BLOCK HF clinical trial, presented as late-breaking data at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions, showed a marked reduction in heart failure-related symptoms for patients with atrioventricular (AV) block and left ventricular (LV) systolic dysfunction at six, 12, 18 and 24 months treated with BiV pacing as opposed to conventional right-ventricular (RV) pacing. Additionally, the data revealed a considerable improvement in quality of life among BiV-paced patients at six and 12 months. Primary results from BLOCK HF were recently published in the New England Journal of Medicine. Medtronic CRT devices are not currently approved in the United States for patients with AV block with left ventricular dysfunction; the results from BLOCK HF will serve as the basis for an application to the FDA seeking an expanded indication for this patient population.
“These new data add to the growing body of evidence supporting the use of BiV pacing for treating patients who have AV block and left ventricular dysfunction who are indicated under current clinical guidelines for permanent RV pacing with a pacemaker,” said Anne B. Curtis, MD, lead investigator and Chair of the Department of Medicine at the University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY. “The BLOCK HF findings have previously demonstrated that BiV pacing delays disease progression, prevents heart failure-related events and preserves cardiac function in this patient population. The findings presented confirm two additional, yet equally important clinical benefits associated with this innovative therapy — symptom and quality-of-life improvement.”
At six months, 14 percent more patients randomized to BiV pacing improved compared to patients in the RV arm. Similar positive findings comparing improvement between arms were reported at later points and sustained over a two-year period in the patients who received BiV pacing. These results were measured using the Packer Clinical Composite Score (CCS), which analyzes a patient’s condition as improved, unchanged or worsened using variables including death, heart failure hospitalization, a patient global assessment questionnaire, and change in symptoms as measured by New York Heart Association (NYHA) heart failure class. Additionally, increased improvement in NYHA heart failure classification with BiV pacing was seen at 12 months post-randomization.
BiV patients also experienced an average improvement of five points in quality-of-life (QoL) score at six months post-randomization. These QoL findings, measured by the Minnesota Living with Heart Failure Questionnaire, are based on a more subjective analysis of the ways heart failure affects the physical, emotional, and social dimensions of a patient’s quality-of-life.
“RV pacing has been considered the gold standard for decades in treating patients with AV block; however, findings from the BLOCK HF trial continue to exhibit better overall outcomes with BiV pacing via CRT devices for these patients,” said David Steinhaus, MD, vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic.
More than 800,000 Americans have AV block. While RV pacing via a single or dual chamber pacemaker helps restore heart function in patients with AV block (in which the electrical signals do not travel between the top and bottom chambers of the heart), smaller studies suggest that in patients with both AV block and LV dysfunction, RV pacing may escalate the progression of heart failure.1,2
About BLOCK HF
BLOCK HF (Biventricular versus Right Ventricular Pacing in Patients with Left Ventricular Dysfunction and Atrioventricular Block) is a prospective, multi-center, randomized, double-blind, controlled trial that evaluated patients with AV block and LV dysfunction (ejection fraction less than or equal to 50 percent), New York Heart Association (NYHA) Class I, II or III and who met standard indications for ventricular pacing. It enrolled 918 patients from 60 centers in the United States and Canada; of these, 691 patients were randomized to receive either BiV (349) or RV (342) pacing. The primary results, published in the April 25, 2013, edition of the New England Journal of Medicine, showed a 26 percent relative risk reduction in the composite of death, healthcare utilization visits requiring IV heart failure therapy, and significant increase in left ventricular end systolic volume (LVESVi, a measure of cardiac function) among patients receiving BiV pacing.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
- Kindermann M, et al. Biventricular Versus Conventional Right Ventricular Stimulation for Patients With Standard Pacing Indication and Left Ventricular Dysfunction: The Homburg Biventricular Pacing Evaluation (HOBIPACE). J Am Coll Cardiol. 2006;47(10):1927-1937. Available at http://content.onlinejacc.org/article.aspx?articleid=1137582.
- Martinelli Filho M, et al. Conventional versus biventricular pacing in heart failure and bradyarrhythmia: the COMBAT study. J Card Fail. 2010;16(4):293-300. Available at http://www.onlinejcf.com/article/S1071-9164(09)01228-7/abstract.
Three Scientific Societies Collaborate to Release Expert Consensus Statement on Diagnosis and Management of Patients with Inherited Primary Arrhythmias Symptoms
The Heart Rhythm Society (HRS), the European Heart Rhythm Association (EHRA) and Asia Pacific Heart Rhythm Society (APHRS), have released the HRS/EHRA/APHRS Expert Consensus Statement on the Diagnosis and Management of Patients with Inherited Primary Arrhythmia Syndromes. The expert consensus statement, presented at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions, provides the first comprehensive statement of recommendations on the proper diagnosis and management of patients with inherited primary arrhythmia syndromes.
The document addresses inherited conditions that can increase the risk of sudden cardiac death (SCD), especially in young individuals, as SCD is one of the leading causes of non-traumatic mortality in young individuals within Western Countries. Long QT Syndrome (LQTS), a common inherited arrhythmia, causes about 3,000 to 4,000 sudden deaths in children and young adults each year in the United States, according to the National Heart, Lung, and Blood Institute.
The consensus statement provides a state-of-the-art review of the field and reports the recommendations of a writing group comprised of international experts. The recommendations summarize the opinions of the expert writing group, based on an extensive literature review as well as their own clinical experience. The consensus statement is for all healthcare professionals who manage the patient care of individuals who have survived cardiac arrest at a young age, family members of individuals who have died suddenly at a young age with a negative autopsy, patients in whom the diagnosis of an inherited arrhythmia is clinically possible, or young patients with unexplained syncope.
The statement provides the diagnostic risk stratification and management of patients, among others, affected by LQTS and Brugada Syndrome (BrS). Documented for the first time, the statement also includes a consensus of recommendations on the diagnosis, risk stratification, and management of the following arrhythmic diseases and unexplained causes of sudden death/cardiac arrest:
- Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
- Short QT Syndrome (SQTS)
- Early Repolarization (ER)
- Progressive Cardiac Conduction Disease (PCCD)
- Unexplained cardiac arrest including Idiopathic Ventricular Fibrillation (VF), Sudden Unexplained Death Syndrome (SUDS), and Sudden Unexplained Death in Infancy (SUDI)
“This document is a great advancement for electrophysiology because it provides one, comprehensive and uniform recommendation on all rare arrhythmia syndromes,” said Arthur A. Wilde, MD, PhD, University of Amsterdam, Amsterdam, Netherlands, EHRA Chairperson. “As new data emerges and our understanding of the role of genetics improves, collaboration like this will help ensure the best quality of care is delivered.”
An additional primary recommendation from the expert consensus writing committee is that patients and first-degree relatives with a diagnosed or suspected inherited cardiovascular disease should be evaluated in a dedicated clinic with appropriately trained clinical staff and the resources to provide support to the patient and family members.
The consensus statement has representatives on the writing committee from the American College of Cardiology Foundation (ACCF), the Association for European Pediatric and Congenital Cardiology (AEPC), the American Heart Association (AHA), and the Pediatric and Congenital Electrophysiology Society (PACES). At the time of the release of this document, endorsement by these organizations is pending. The document will be published simultaneously in HeartRhythm and in EP Europace in fall 2013.
Heart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 8,000 attendees, 250 educational sections and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society’s Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.
About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of more than 5,800 heart rhythm professionals in more than 72 countries around the world. For more information, visit HRSonline, voted 2012’s “Best in Class” website for a nonprofit by the Interactive Media Council.
About the European Society of Cardiology (ESC)
The European Society of Cardiology (ESC) represents 80,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
The European Heart Rhythm Association (EHRA) is a registered branch of the European Society of Cardiology. Its aim is to improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reduce sudden cardiac death. For more information, click here.
About EHRA EUROPACE
EHRA EUROPACE is an established, international conference attracting key opinion leaders, well-recognized scientists, physicians, allied professionals and industry, who all enjoy scientific exchange of the highest level in an informal atmosphere. This year, EHRA EUROPACE will take place from 23 to 26 June in Athens.