Atrial Fibrillation (AFib) Support Group
Atrial fibrillation (AF or afib) is an abnormal heart rhythm (cardiac arrhythmia) which involves the two small, upper heart chambers (the atria). Heart beats in a normal heart begin after electricity generated in the atria by the sinoatrial node spread through the heart and cause contraction of the heart muscle and pumping of blood.
I thought I would start a thread for any new research or innovations in the wonderful world of afib.
Here's a news release that was sent to me today:
MARLBOROUGH, Mass., Feb. 21, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces the first patient has been enrolled and treated in the HeartLight EAS U.S. pivotal trial, designed to evaluate the safety and efficacy of the technology in treating symptomatic AF. The 48-year-old patient, one of the nearly three million Americans with AF,[i] had suffered with paroxysmal AF for three years and underwent successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York, NY. All four PVs were isolated on the very first attempt using only visual guidance during the approximately two hour procedure.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation. The Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.
"The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory atrial fibrillation. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes," said Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, and Principal Investigator of the trial. "The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial."
The prospective trial will randomize the HeartLight EAS against the NaviStar THERMOCOOL Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the THERMOCOOL system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the U.S. and follow them for one year post procedure.
The primary outcome measures will assess both safety and freedom from documented, symptomatic atrial fibrillation. The results will be used as the basis for CardioFocus's Premarket Approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, TX is also currently enrolling patients.
"Catheter ablation offers a minimally invasive, interventional treatment option for millions of people with drug-refractory AF. However, traditional systems have demonstrated limited durable pulmonary vein isolation and compromised long-term efficacy after only a single procedure," said Andrea Natale, MD, of Texas Cardiac Arrhythmia Research Foundation and trial Co-Principal Investigator. "We are excited to be involved in evaluating this ground-breaking catheter ablation option that has the potential to improve upon the current standard of care."
"Beginning this pivotal trial is a key milestone for CardioFocus and our technology, as it brings us one step closer to offering the HeartLight EAS treatment option to patients in the U.S.," said Stephen Sagon, President and CEO of CardioFocus. "We look forward to working with the prominent medical centers involved in this trial, and expect their experiences to demonstrate the clinical advantages of the HeartLight EAS' visualization capabilities, compliant balloon and unique energy source."
The HeartLight EAS technology is currently available at sites throughout Europe for the treatment of AF. For more information on the trial, please visit http://clinicaltrials.gov/show/NCT01456000.
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel HeartLight Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.
The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
[i] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics2010 Update: a report from the American Heart Association. Circulation. 2010;121:e91, via CDC "Atrial Fibrillation Fact Sheet."
Read more here: http://www.bradenton.com/2012/02/21/3889547/first-patient-treated-in-cardiofocus.html#storylink=cpy
Here's a news release that was sent to me today:
MARLBOROUGH, Mass., Feb. 21, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces the first patient has been enrolled and treated in the HeartLight EAS U.S. pivotal trial, designed to evaluate the safety and efficacy of the technology in treating symptomatic AF. The 48-year-old patient, one of the nearly three million Americans with AF,[i] had suffered with paroxysmal AF for three years and underwent successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York, NY. All four PVs were isolated on the very first attempt using only visual guidance during the approximately two hour procedure.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation. The Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.
"The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory atrial fibrillation. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes," said Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, and Principal Investigator of the trial. "The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial."
The prospective trial will randomize the HeartLight EAS against the NaviStar THERMOCOOL Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the THERMOCOOL system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the U.S. and follow them for one year post procedure.
The primary outcome measures will assess both safety and freedom from documented, symptomatic atrial fibrillation. The results will be used as the basis for CardioFocus's Premarket Approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, TX is also currently enrolling patients.
"Catheter ablation offers a minimally invasive, interventional treatment option for millions of people with drug-refractory AF. However, traditional systems have demonstrated limited durable pulmonary vein isolation and compromised long-term efficacy after only a single procedure," said Andrea Natale, MD, of Texas Cardiac Arrhythmia Research Foundation and trial Co-Principal Investigator. "We are excited to be involved in evaluating this ground-breaking catheter ablation option that has the potential to improve upon the current standard of care."
"Beginning this pivotal trial is a key milestone for CardioFocus and our technology, as it brings us one step closer to offering the HeartLight EAS treatment option to patients in the U.S.," said Stephen Sagon, President and CEO of CardioFocus. "We look forward to working with the prominent medical centers involved in this trial, and expect their experiences to demonstrate the clinical advantages of the HeartLight EAS' visualization capabilities, compliant balloon and unique energy source."
The HeartLight EAS technology is currently available at sites throughout Europe for the treatment of AF. For more information on the trial, please visit http://clinicaltrials.gov/show/NCT01456000.
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel HeartLight Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.
The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
[i] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics2010 Update: a report from the American Heart Association. Circulation. 2010;121:e91, via CDC "Atrial Fibrillation Fact Sheet."
Read more here: http://www.bradenton.com/2012/02/21/3889547/first-patient-treated-in-cardiofocus.html#storylink=cpy
First use of HeartLight Endoscopic Ablation System to treat atrial fibrillation
Published on February 22, 2012 at 8:31 AM
For the first time in a new U.S. clinical trial, researchers at Mount Sinai School of Medicine have used the HeartLight Endoscopic Ablation System (EAS) to correct abnormal electrical signals inside the heart of a patient affected by atrial fibrillation (AFib), one of the nation's most common heart ailments. The device is the first catheter ablation system to incorporate a camera that allows doctors to see a direct, real-time image of the patient's heart tissue during ablation.
The HeartLight EAS national clinical trial is headed by Vivek Y. Reddy, MD, Professor of Cardiology, Mount Sinai School of Medicine, and Director of the Cardiac Arrhythmia Service at Mount Sinai Heart. Along with colleagues, he performed the successful procedure on the first patient on Valentine's Day last week. His colleagues include Srinivas R. Dukkipati, MD, Director of Mount Sinai's Experimental Electrophysiology Laboratory, and Andre d'Avila, MD, Co- Director of the Cardiac Arrhythmia Service.
"This new device has the potential to make AFib ablation more reliable, more reproducible, and more consistent for patients with paroxysmal [intermittent] atrial fibrillation," said Dr. Reddy. "The technology which is currently available leads to widely variable success rates, depending largely on physician skill and experience with the procedure. This visually-guided system with a rotating laser design has the potential to simplify AFib ablation and make it available to more patients than ever, before their paroxysmal AFib becomes chronic [continuous] AFib."
Estimates are that there are as many as six million U.S. adults with atrial fibrillation (AFib), a condition characterized by a rapid and irregular heart beat that can cause serious complications, including stroke, palpitations, fainting and early death. AFib diagnosis has increased over the past two decades and the condition now accounts for one-quarter of all strokes in the elderly.
Paroxysmal (intermittent) AFib is caused by irregular electrical signals that come from pulmonary veins that drain blood from the lungs to the heart. During a standard AFib ablation procedure, physicians use spot catheters to cauterize heart tissue in a point-by-point manner to encircle these pulmonary veins, creating a ring of scar tissue that electrically isolates the pulmonary veins, preventing the irregular electrical signals from causing AFib. But this is a technically complicated procedure since, unlike open heart surgery, physicians cannot directly see the tissue that is being cauterized. Despite using various cardiac mapping systems, problems often arise because the scar tissue that is created is not continuous, allowing the abnormal electrical signals to continue to pass into the heart and cause recurrence of AFib.
The new balloon catheter device used by the Mount Sinai Heart team features a built-in camera that allows the physicians to directly see the heart tissue that needs to be ablated. They can then guide an internal laser in a continuous arc around the origin of the vein, creating more uniform scar tissue. "By directly seeing the tissue that we are ablating, there is less chance of a gap in the encircling ablation line," said Dr. Dukkipati.
The trial is expected to eventually enroll an estimated 450 patients at up to 25 sites in the U.S. and follow them for up to 5 years post procedure. The Food and Drug Administration (FDA) granted Investigational Device Exemption approval for HeartLight EAS in December, and the device is already in use in Europe.
Released: 2/21/2012 1:00 PM EST
Source: Mount Sinai Medical Center
Newswise (February 21, 2012 New York) For the first time in a new U.S. clinical trial, researchers at Mount Sinai School of Medicine have used the HeartLight Endoscopic Ablation System (EAS) to correct abnormal electrical signals inside the heart of a patient affected by atrial fibrillation (AFib), one of the nations most common heart ailments. The device is the first catheter ablation system to incorporate a camera that allows doctors to see a direct, real-time image of the patients heart tissue during ablation.
The HeartLight EAS national clinical trial is headed by Vivek Y. Reddy, MD, Professor of Cardiology, Mount Sinai School of Medicine, and Director of the Cardiac Arrhythmia Service at Mount Sinai Heart. Along with colleagues, he performed the successful procedure on the first patient on Valentines Day last week. His colleagues include Srinivas R. Dukkipati, MD, Director of Mount Sinais Experimental Electrophysiology Laboratory, and Andre dAvila, MD, Co- Director of the Cardiac Arrhythmia Service.
This new device has the potential to make AFib ablation more reliable, more reproducible, and more consistent for patients with paroxysmal [intermittent] atrial fibrillation, said Dr. Reddy. "The technology which is currently available leads to widely variable success rates, depending largely on physician skill and experience with the procedure. This visually-guided system with a rotating laser design has the potential to simplify AFib ablation and make it available to more patients than ever, before their paroxysmal AFib becomes chronic [continuous] AFib."
Estimates are that there are as many as six million U.S. adults with atrial fibrillation (AFib), a condition characterized by a rapid and irregular heart beat that can cause serious complications, including stroke, palpitations, fainting and early death. AFib diagnosis has increased over the past two decades and the condition now accounts for one-quarter of all strokes in the elderly.
Paroxysmal (intermittent) AFib is caused by irregular electrical signals that come from pulmonary veins that drain blood from the lungs to the heart. During a standard AFib ablation procedure, physicians use spot catheters to cauterize heart tissue in a point-by-point manner to encircle these pulmonary veins, creating a ring of scar tissue that electrically isolates the pulmonary veins, preventing the irregular electrical signals from causing AFib. But this is a technically complicated procedure since, unlike open heart surgery, physicians cannot directly see the tissue that is being cauterized. Despite using various cardiac mapping systems, problems often arise because the scar tissue that is created is not continuous, allowing the abnormal electrical signals to continue to pass into the heart and cause recurrence of AFib.
The new balloon catheter device used by the Mount Sinai Heart team features a built-in camera that allows the physicians to directly see the heart tissue that needs to be ablated. They can then guide an internal laser in a continuous arc around the origin of the vein, creating more uniform scar tissue. "By directly seeing the tissue that we are ablating, there is less chance of a gap in the encircling ablation line," said Dr. Dukkipati.
The trial is expected to eventually enroll an estimated 450 patients at up to 25 sites in the U.S. and follow them for up to 5 years post procedure. The Food and Drug Administration (FDA) granted Investigational Device Exemption approval for HeartLight EAS in December, and the device is already in use in Europe.
More information about the clinical trial can be found at http://clinicaltrials.gov/show/NCT01456000.
Dr. Vivek Reddy is the national PI and a Co-Investigator of this study at Mount Sinai School of Medicine. Dr. Reddy receives financial compensation as a consultant for CardioFocus, Inc., the study sponsor and manufacturer of the endoscopic ablation system evaluated in the study.
About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of the leading medical schools in the United States. The Medical School is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nations oldest, largest and most-respected voluntary hospitals. In 2011, U.S. News & World Report ranked The Mount Sinai Hospital 16th on its elite Honor Roll of the nations top hospitals based on reputation, safety, and other patient-care factors. Of the top 20 hospitals in the United States, Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.
For more information, visit http://www.mountsinai.org/.
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The endoscope only refers to a camera. The ablation is still done in the usual fashion, it is just done with the assistance of a "scope" or "camera." It is not done through the esophagus.