Study Finds Balloon-Expandable Valves Used After TAVR Procedures Linked to Valve Dysfunction and Mortality Risks

Researchers warn that individuals who received balloon-expandable valves were more than four times more likely to suffer valve dysfunction that could lead to blood leaks or valve failure.

Amid rising concerns over complications from heart implants, new research has identified that patients receiving balloon-expandable valves after Transcatheter Aortic Valve Replacement (TAVR) surgery may face increased health risks when compared to those receiving self-expanding valves.

TAVR is a minimally invasive surgical technique aimed at replacing a poorly functioning aortic valve, typically narrowed by aortic stenosis. This procedure avoids the need for open-heart surgery by inserting the replacement valve through a small incision in the leg, using a catheter that guides it to the heart. There are two principal types of valves used in TAVR: balloon-expandable and self-expanding.

Balloon-expandable valves are positioned within the heart and then inflated with a balloon to ensure they fit securely in place. Self-expanding valves, on the other hand, are crafted from a material that naturally expands to fit the valve space once deployed. Each type of valve offers distinct advantages and considerations in terms of how well they adapt to the heart’s anatomy and function, which in turn influences the risks and overall success of the procedure.

In a recent study published in the New England Medical Journal, Howard C. Hammermann, M.D. and colleagues found that individuals who received a balloon-expandable valve following TAVR surgery face higher risks of valve dysfunction, along with increased incidences of stroke, hospitalization and mortality.

Hammermann, from the Perelman School of Medicine at the University of Pennsylvania, and a team of researchers evaluated the efficacy of self-expanding valves compared to balloon-expandable valves in patients with severe aortic stenosis and a small aortic annulus.

The study included 716 patients from 83 medical centers across 13 countries, predominantly involving elderly women with an average age of 80. Participants were randomly assigned to receive one of the two types of valves and were monitored over 12 months for major health events such as death, disabling strokes, or heart failure requiring hospitalization.

Additionally, the study assessed the incidence of valve dysfunction, which includes any issues with the artificial valve that could impair its performance.

Balloon-Expandable Valves Increased Health Risks

The findings revealed that self-expanding valves not only led to slightly better clinical outcomes, but also significantly reduced valve-related complications. The overall rates of major adverse events, including death, stroke, or hospitalization, were lower with self-expanding valves at 9.4%, compared to 10.6% with balloon-expandable valves. Though the difference is modest, it underscores a slight safety advantage for the self-expanding option, the researchers determined.

The most statistically significant difference identified between the two devices was related to valve dysfunction. The study revealed that the rate of valve dysfunction was significantly lower in the group with self-expanding valves, only 9.4%, as opposed to 41.6% in those with balloon-expandable valves.

Hammermann and colleagues’ findings suggest that self-expanding valves are more reliable and less likely to experience issues that could impede their function, such as improper sealing or alignment, which can lead to blood leaks or valve failure.

Furthermore, the study found that patients with self-expanding valves experienced better blood flow through the heart to minimize the heart’s workload and improves overall cardiovascular health following the TAVR procedure.

TAVR Surgery Side Effect Risks

Previous medical research has found that individuals undergoing aortic valve replacement face an increased risk of serious side effects and a greater risk of death, especially if the patient must undergo additional heart surgery later on.

Dr. Michael Bowdish, of Cedars-Sinai Medical Center in Los Angeles, told attendees at a meeting of the Society of Thoracic Surgeons earlier this year that patients who underwent TAVR procedures and needed cardiac surgery later on often faced complications requiring additional surgeries. They also often required the TAVR to be completely removed, and face an increased risk of death.

Other medical research has linked TAVR surgery to an increased risk of endocarditis, a serious inflammation of the lining of the heart and heart valves, while other data has shown TAVR may increase the risk of death and inflammation of the heart’s inner lining, even among low-risk patients.

Late last year, the U.S. Food and Drug Administration (FDA) announced an Impella Blood Pump device correction as a Class I recall, warning that the Impella’s Instructions for Use (IFU) fail to warn doctors to be careful when treating patients who have undergone a TAVR procedure, because the Impella motor housing may contact the implanted heart valves, resulting in damage or destruction of the motor’s blades.

As a result of design defects with the heart pump, a number of families are now considering Impella lawsuits against the manufacturer, alleging that severe and often fatal complications could have been avoided with a safer alternative design.