Heart Failure

Heart failure occurs when the heart cannot pump as much blood as the body requires. This ineffective pumping can lead to enlargement of the heart as the myocardium works harder pump the same amount of blood. Heart failure may be caused by defects in the myocardium, such as an a heart attack infarct, or due to structural issues such as severe heart valve regurgitation. Heart failure can be divided into HF with preserved ejection fraction (HFpEF), and HF with reduced ejection fraction (HFrEF). The disease is further divided into four New York Heart Association (NYHA) classes. Stage IV heart failure is when the heart is completely failing and requires a heart transplant or hemodynamic support from a left ventricular assist device (LVAD).

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Stephen Browning, FDA assistant director for hemodynamic and heart failure diagnostics, explains the FDA perspectives and regulatory pathways for AI-enabled cardiovascular devices at TCT 2024.

FDA regulator examines AI's growing influence in cardiology

Stephen Browning, the FDA's assistant director of hemodynamics and heart failure diagnostics, spoke with Cardiovascular Business about the agency's perspective on AI-enabled cardiovascular devices and many other topics.

Video of Clyde Yancy, MD, explaining new directions in treating heart failure with preserved ejection fraction.

Exploring the 'new era' of HFpEF treatment: More options exist, but challenges remain

Clyde Yancy, MD, spoke with Cardiovascular Business about how the treatment of heart failure with preserved ejection fraction (HFpEF) has evolved in recent years.

The Vanderbilt Transplant Center, part of Vanderbilt University Medical Center (VUMC), has set a world record by performing 174 adult and pediatric heart transplants in a single year.

‘A team effort’: VUMC sets world record for heart transplants in a single year

The center's 2024 total of 174 heart transplants represents an increase of 36% compared to 2023, and 10 of the patients receiving a new heart were young children. 

Alleviant Medical, a Texas-based medical device company, has received the FDA’s breakthrough device designation and an investigational device exemption (IDE) for its new atrial shunt that treats heart failure without leaving a permanent implant in the body.

FDA sees value in no-implant heart failure device

The new atrial shunt from Alleviant Medical was designed to treat heart failure without leaving a permanent implant behind. The FDA granted the technology its breakthrough device designation and approved additional research. 

artificial intelligence pharmaceutical industry

FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

Surgeons in Houston have performed the world’s first successful human implant of BiVACOR’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023.

‘Incredibly rewarding’: FDA expands total artificial heart study after early success

An additional 15 patients will now receive BiVacor's titanium total artificial heart technology as they wait for a permanent transplant.

Left: Petr Neužil, MD, PhD, head of the department of cardiology at Na Homolce Hospital in Prague, Czech Republic / Right: Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital in New York City

Cardiologists perform world’s first leadless LBBAP procedures with Abbott pacemaker

The first-in-human procedures were performed in Prague with the investigational Aveir CSP leadless pacemaker system.

cardiologists evaluating the human heart to provide a treatment strategy

Cardiologists work to standardize the diagnosis and management of acute myocarditis

New expert recommendations from the American College of Cardiology were designed to help cardiologists, primary care physicians, emergency physicians, rheumatologists and other clinicians deliver the best care possible when managing suspected myocarditis. 

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