News | January 18, 2012

Multi-Disciplinary Convergent EP Procedure Shows Promise in Treating Persistent AF

January 18, 2011  – Epicardial ablation device vendor nContact Inc. said data presented by physicians in two posters at the 17th Annual International Boston Atrial Fibrillation Symposium may change how physicians think about treating atrial fibrillation (AF) patients with enlarged atria.

These posters included outcomes from a single European site at the University Medical Center in Ljubljana, Slovenia as presented by Prof. Borut Gersak, M.D., Ph.D., chief of Department of Cardiac Surgery at University Medical Center Ljubljana, and a multi-center U.S. data collection led by Eric Prystowsky, M.D., FACC, of St. Vincent Hospital in Indianapolis and presented by Keith Golden, M.D., also of St. Vincent Hospital.  Physicians performed the interdisciplinary Convergent procedure in a challenging patient population with persistent and longstanding persistent AF, utilizing high monitoring standards to document procedural outcomes.

Below is information from each poster presentation.

Prospective Reveal XT Outcomes for the Convergent Atrial Fibrillation Ablation Procedure; Gersak et al.

“Historically, surgical approaches have proven too invasive to attract cardiology referrals for standalone AF treatment. Surgeons are not the recognized experts in electrophysiology (EP), and do not have the EP diagnostic and ablation technologies to assure a comprehensive and predictive approach to treatment,” said Gersak.

Gersak said, “With the support of our EP team, Medtronic’s Reveal 24-hour loop recorders were implanted in fifty patients undergoing the Convergent procedure to determine the long term success of the procedure by continuously recording rhythm status.  The surgical portion of the procedure requires no chest incisions or ports, no lung deflation or heart incisions, and takes about 1 ½ hours to perform. Access to the posterior of the atrium is through the diaphragm and a small incision in the abdomen. This access is named SUBTLE, or ‘sub-thoracic total endoscopic’ and provides direct visibility to place the ablation device and assure lesion connectivity. Of the fifty patients treated, 94 percent had persistent or longstanding persistent AF.  At six-, twelve- and twenty-four-month follow-up, 95 percent, 91 percent, and 87 percent of patients, respectively, were in sinus rhythm, with only one patient requiring a repeat catheter ablation procedure.  AF burden of less than or equal to 3 percent was recorded in 81 percent, 84 percent and 87 percent of patients over six, twelve and twenty-four months respectively.  The outcomes, as recorded by the Reveal technology, may set a new monitoring standard for comparative ablation approaches.”


Multicenter Retrospective Outcomes for the Treatment of Atrial Fibrillation Using the Multidisciplinary Convergent Procedure; Golden et al.

The poster reported by Golden indicated that 115 patients underwent the Convergent Procedure across four U.S. centers and of these, 97 were followed for an average of 11.4 months using a 72-hour Holter monitor. Eighty-four percent of the patients were in sinus rhythm and 77 percent were in sinus rhythm off anti-arrhythmic dugs (ADDs) or had no change in AAD prophylaxis almost one year post procedure. 

Jeff Olson, an EP cardiologist who has been a primary contributor to the Convergent procedure experience at St. Vincent Hospital, said, “It is hoped that by standardizing the evolving Convergent procedure and patient selection, future sites may expect the same results. The Convergent procedure is an important ablation option for persistent and longstanding persistent patients in our practice. We believe the multi-disciplinary procedure offers a comprehensive approach that neither discipline can attain individually. It has substantially reduced EP procedure times, complexity and the amount of ablation required.”

nContact’s Numeris Coagulation System with VisiTrax and next generation EPi-Sense Coagulation System technology integrate suction, perfusion and radiofrequency energy to ensure consistent cardiac tissue contact and create visible, continuous lesions on the epicardium of a beating heart. 

For more information:

Related Content

FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
Overlay Init