Advertisements
Feeds:
Posts
Comments

Archive for the ‘Rare heart rhythm disorders and Long QT syndrome (LQTS)’ Category


Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Reporter: Aviva Lev-Ari, PhD, RN

 

BackBeat’s CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS).  Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.

For more information: www.orchestrabiomed.com

October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.

Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).

“The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.

The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:

  • Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.
    • 14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months
    • 23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years
  • High responder rate in a population where 78 percent of patients had isolated systolic hypertension.
    • 85 percent AMB BP reduced >5mmHg
    • 74 percent AMB BP reduced >10 mmHg
  • Safety Outcomes: The study met the safety endpoint.
    • Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function
    • Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity

“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”

To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control.  The company is expecting results on the first cohort of patients in 2019.

SOURCE

https://www.dicardiology.com/content/backbeat-cardiac-neuromodulation-therapy-reduces-blood-pressure-two-years?eid=333021707&bid=2258792

Advertisements

Read Full Post »


Renowned Electrophysiologist Dr. Arthur Moss Died on February 14, 2018 at 86

Reporter: Aviva Lev-Ari, PhD, RN

 

— Stephen

Dr. Moss never lost the opportunity to get to know who an individual is by name, to complement one, to greet one, to teach one, to be available, and to show respect. His contributions to clinical medicine, patient care and physician education, along with pivotal research, is among the ver most notable of our era. I will miss him greatly and extend my most heartfelt gratitude to him and his family.

Stephen Winters, MD
Morristown Medical Center

Comments Section

 

Renowned Cardiologist Arthur J. Moss, Pioneer of Research and Treatment in Sudden Death, Passes Away

Friday, February 16, 2018

Arthur J. Moss, M.D.

Arthur J. Moss, M.D.

Cardiologist Arthur J. Moss, whose research saved hundreds of thousands of lives and improved the standard of care for legions of people with heart disease, died on February 14, 2018. He was 86.

During a career spanning six decades, Moss made some of the most significant and long-lasting discoveries in the prevention and treatment of sudden cardiac death. His astounding accomplishments in scientific research and clinical care stemmed especially from his special devotion to patients; he understood the importance of listening, building trust and working together to bring about change. He was also a skilled leader, able to foster meaningful collaborations that led to some of the most productive clinical trials in all of cardiology.

“Arthur was a man of absolute integrity, both of science and of character, and an amazing visionary who could see where the field of electrophysiology was headed long before others,” said Wojciech Zareba, M.D., Ph.D.,director of the Heart Research Follow-up Program at the University of Rochester Medical Center, who worked closely with Moss for the past 26 years. “He was eternally optimistic in all aspects of his life; he brought a positive attitude to everything he did and didn’t worry about the small stuff, which helped him accomplish great things.”

In 1958, as an intern at Massachusetts General Hospital, Moss planned to pursue a career in hematology. That summer he was called to serve in the United States Navy. When he arrived in Pensacola, Fla., his commanding officers thought he was a cardiologist, for reasons unbeknownst to him. They asked Moss to teach flight surgeons electrocardiography, a test known as an EKG that checks the electrical activity of the heart. Undaunted, he read multiple books on the topic and taught them. The intricacy of the heart’s electrical activity captured Moss’ interest and he never looked back.

Moss spent the first half of his career figuring out which patients were at high risk of sudden cardiac death and the second half finding the best ways to treat them. He became an eminent authority on common arrhythmias that afflict hundreds of thousands of adults with heart disease and often lead to sudden death, as well as rare heart rhythm disorders that are smaller in number but no less deadly.

An unexpected patient visit in 1970 started what Moss called the most rewarding part of his career: his life-long quest to help individuals with Long QT syndrome (LQTS). Doctors could not understand why this patient – a woman in her 30s – would suddenly fall unconscious when she got excited while bowling. An unusual EKG led Moss, then a young cardiologist at URMC, to diagnose LQTS. An uncommon genetic condition caused by a glitch in the heart’s electrical system, LQTS puts patients at high risk of arrhythmias, fainting spells and sudden death.

Moss devised the first effective surgical treatment for the disorder and had the foresight to create the International Long QT Syndrome Registry in 1979, one of the first rare disease registries in the world. The registry allowed Moss and colleagues to identify risk factors that enable early diagnosis; develop multiple treatment options that have achieved an 80 percent reduction in life-threatening events; and contribute to the discovery of multiple genes associated with the disorder. The National Institutes of Health has supported the registry since its creation, and in 2014 Moss received a NIH grant to fund the registry and associated research projects through 2019.

“Not only was Arthur extraordinary in understanding the immediate problem, but he was also visionary in that long before we knew how to analyze genes he started the registry and preserved blood samples that could be used in the future,” said Mark B. Taubman, M.D., CEO of URMC and dean of the School of Medicine and Dentistry. “The registry has become one of the most important repositories in the world, helping prevent thousands of untimely deaths from Long QT and enabling the in-depth investigation of how genetics influence a form of heart disease. The impact of his work is unparalleled.”

Beginning in the 1990s, Moss led the MADIT (Multicenter Automatic Defibrillator Implantation Trial) series of clinical trials, which showed that the implantable cardioverter defibrillator or ICD – a device that detects arrhythmias and shocks the heart back into a normal rhythm – significantly reduces the risk of sudden death in patients who’ve experienced a heart attack. In the early 2000s these findings changed medical guidelines worldwide and led to the use of life-saving ICD therapy in hundreds of thousands of patients.

Later, in 2009, Moss completed the MADIT-CRT trial, which found that cardiac resynchronization therapy plus defibrillator – CRT-D therapy – prevents the progression of heart failure in patients living with mild forms of the disease. The device, which improves the mechanical pumping action of the heart and corrects fatal rhythms, was originally approved to treat patients with severe heart failure. Moss’ work opened the door for multitudes more patients to benefit and live longer, better lives.

“Arthur’s research was so successful and powerful because the results of his studies were usually strikingly positive or negative. This came from his rare ability to ask a simple question, and use a simple clinical trial design,” said Bradford C. Berk, M.D., Ph.D., professor of Medicine and Cardiology at URMC. “He did this so well because he was a superb clinician who had a remarkable insight into the underlying pathologic mechanisms of heart disease.”

Colleagues also credit Moss’ research success to his unique ability to bring people together, trigger discussion, and make all involved – from the highest-ranking physician to the newest graduate student or fellow – feel welcome and valued.

“I first met Art in 1976 and was at least three academic ranks lower than anyone else at the meeting,” said Henry (Hank) Greenberg, M.D., special lecturer of Epidemiology and Medicine at the Columbia University Medical Center. “Art sensed this and stated that everyone at the table contributed. This carried forward for four decades and was a reason why his trials were always superbly done. His ego did not get in the way.”

Moss was founding director of URMCs Heart Research Follow-up Program, a worldwide hub of international studies on medical interventions for sudden death, cardiac arrhythmias, heart attack and heart failure. He published more than 750 scientific papers, including a 1962 article – his first of many in the New England Journal of Medicine – highlighting the first three published cases of cardiopulmonary resuscitation (CPR), which included external chest massage followed by external defibrillation.

Charles J. Lowenstein, M.D., chief of Cardiology at URMC, said, “Arthur’s contributions to cardiac electrophysiology were vast and he was extremely well respected as a clinician and researcher. He also trained hundreds of medical students, residents, and fellows, and inspired many of us to dedicate our lives to medicine. This is his greatest legacy.”

Moss attended Yale as an undergraduate then Harvard Medical School. He interned at Massachusetts General Hospital and finished his residency in Rochester, where he also did a fellowship in cardiology. Moss joined the faculty at URMC in 1966 and stayed for the rest of his career, ultimately becoming  the Bradford C. Berk, M.D., Ph.D. Distinguished Professor in Cardiology. A valued member of the faculty, Moss received the Eastman Medal in 2012, the University of Rochester’s highest honor that recognizes individuals who, through their outstanding achievement and dedicated service, embody the high ideals for which the University stands.

On numerous other occasions, Moss was recognized locally, nationally and internationally for his tenacity and advancement of medical and cardiologic science. In 2008 he received the Glorney-Raisbeck Award in Cardiology, the highest honor of the New York Academy of Medicine. A year later he was awarded the prestigious Golden Lionel Award at the Venice International Cardiac Arrhythmias Meeting. The Heart Rhythm Society, the major international electrophysiology society, bestowed its top honor, the Distinguished Scientist Award, to Moss in 2011 and its Pioneer in Cardiac Pacing and EP Award to Moss in 2017.  

On November 11, 2017, just four months before his death, Moss was given the 2017 James B. Herrick Award at the American Heart Association’s Scientific Sessions. The award is given annually to a physician whose scientific achievements have contributed profoundly to the advancement and practice of clinical cardiology.

“Arthur’s passing is very sad news for the world of cardiology and clinical trials,” said David Cannom, director of Cardiology at Good Samaritan Hospital in Los Angeles. “There was no one quite like Arthur in terms of intelligence, judgement, leadership skills and thoughtful friendship. Plus good humor. An era is closing and he will be sorely missed.”  Other colleagues from around the world described him as a “true giant” in the field, a “role model,” and a “pioneer.”

Moss’s daughter Deborah, herself a physician, was always inspired by her dad’s curiosity, creativity and perseverance. “He paid close attention to his patients, their stories and their situations, and generated research questions that would make a difference not just for one patient, but for many patients. He was bold, never afraid to try something new, and wouldn’t stop until he solved a problem. Looking back on the entirety of his career, it was really incredible.”

Moss is survived by his wife Joy F. Moss, three children – Katherine M. Lowengrub, M.D., instructor in Psychiatry at the Sackler School of Medicine in Tel Aviv, Israel; Deborah R. Moss, M.D., M.P.H., associate professor of Pediatrics at the University of Pittsburgh Medical Center; and David A. Moss, Ph.D., professor at Harvard Business School – and nine grandchildren and two great-grandchildren. A memorial service will take place at Temple B’rith Kodesh on Elmwood Ave at 11 a.m. on Sunday, February 18. In lieu of flowers, donations may be sent to:

UR Heart Research Follow-Up Program

Alumni & Advancement Center

300 East River Rd. P.O. Box 270032

Rochester, NY 14627

SOURCE

https://www.urmc.rochester.edu/news/story/5273/renowned-cardiologist-arthur-j.-moss-pioneer-of-research-and-treatment-in-sudden-death-passes-away.aspx

His legacy is a career spanning more than 60 years that was marked by major contributions to cardiac electrophysiology, including the first surgical treatment for long QT syndrome and his leadership in the MADIT trials showing that an implantable cardioverter defibrillator could reduce the risk of sudden cardiac death.

Moss started his career in risk stratification studies and evaluating the potential of ventricular arrhythmias, according to longtime colleague Sanjeev Saksena, MD, past president of the North American Society of Pacing and Electrophysiology. Sakesna said that in 1983 Moss published “pivotal studies on risk stratification after myocardial infarction that led to his recognition as a leader in this field and was famously covered by TIME magazine for these contributions.”

Saksena also noted his early support of Michel Mirowski’s concept of an implanted standby defibrillator. This support, Saksena said “made him a lone voice arguing against the medical establishment more than 40 years ago for development of a therapy that is now a cornerstone of cardiovascular medicine.”

Douglas Zipes, MD, Past President, American College of Cardiology: “Wonderful man, scientist. He was the gold standard role model for the clinician investigator: he took care of patients and advanced the science of cardiology. A great loss, but his observations will live on.”

Robert Myerberg, MD, Professor of Medicine, University of Miami: “Art Moss had had an incredibly productive career. His dominant characteristic was a lack of fear of stepping into areas where there were gaps in our knowledge or untested hypotheses, and find a way to get us on to a path that would ultimately answer important and practical questions … His impact will continue to be felt long into the future. And on a personal level, his warmth and collegiality will be missed by his friends and colleagues.”

Bernard Gersh, MD, Professor of Medicine, Mayo Clinic: “Major contributions to our understanding of the long QT syndrome and the PI [principal investigator] of the major trials that established the clinical role of the ICD.”

Richard L. Page, MD, Chair, Department of Medicine, University of Wisconsin, School of Medicine & Public Health: “Arthur Moss was a consummate professional, gentleman, scholar, and physician. He was a role model for me and for a generation of cardiologists.”

Jagmeet P. Singh MD, Roman W. DeSanctis Endowed Chair in Cardiology, Massachusetts General Hospital Heart Center: “A huge loss for our community. He was my mentor.”

SOURCE

Eminent Cardiologist Arthur Moss Dies

Tributes to a giant in electrophysiology

https://www.medpagetoday.com/cardiology/arrhythmias/71227?xid=nl_mpt_cardiodaily_2018-02-20&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CDnews_022018&utm_term=AHA%20Cardiovascular%20Daily%20-%20Active%20Users%20180%20days

Read Full Post »