Registry review shows positive results for novel heart surgery procedure

A new report published in the Annals of Thoracic Surgery and the Journal of the American College of Cardiology reveals how, 4 years after its approval in the US, a minimally invasive form of heart surgery has helped improve outcomes for patients with one of the most common and severe heart valve conditions.

[An older lady in hospital]
Researchers say their review should reassure elderly patients with aortic stenosis that they will benefit from TAVR.

Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration (FDA) in November 2011 for the treatment of aortic stenosis – a condition in which the aortic valve opening narrows, restricting blood flow from the heart to the rest of the body.

Aortic stenosis can be life-threatening; the heart has to work harder in an attempt to pump enough blood through the narrowed valve, causing it to weaken, which can lead to chest pain, arrhythmia, heart failure and cardiac arrest.

Open-heart surgery involving aortic valve replacement remains the primary treatment for aortic stenosis, but TAVR offers a less invasive option for individuals who are too high risk to receive the standard procedure.

TAVR involves replacing the aortic valve with a prosthetic one. When the procedure was first approved, it could only be completed by insertion of a catheter through the femoral artery in the groin (transfemoral). It has since expanded so the procedure can be done via the left ventriclular apex of the heart (transcapial), the aorta (transaortic) or the right common carotid artery (transcarotid).

Soon after TAVR was given the green light, the US Centers for Medicare & Medicaid Services (CMS) required that all hospitals performing the procedure report clinical outcomes via The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry) – a requirement for Medicare coverage.

The STS/ACC TVT Registry was set up by the FDA, CMS, the National Institutes of Health and Duke Clinical Research Institute.

Now, Dr. David R. Holmes, from Mayo Clinic in Rochester, MN, and colleagues have reviewed this data for the first time, providing an overview of the evolution of TAVR since its approval and the clinical outcomes from the procedure.

Findings ‘should reassure patients TAVR is safe and effective’

The Registry included 26,414 patients who underwent TAVR between January 1, 2012, and December 31, 2014.

Dr. Holmes and colleagues compared the outcomes of patients who underwent the procedure in 2012-13 with those who had the procedure in 2014, enabling them to determine whether clinical outcomes have changed over time alongside procedural changes.

The team found that the average age of patients who underwent TAVR in 2012-13 and 2014 was 82, and most were frail, had poor self-reported health status and multiple health conditions.

On assessing clinical outcomes, the researchers found that the risks for neurological complications, heart attack, kidney injury and mortality were similarly low for both groups.

Vascular problems and bleeding requiring transfusion were the most common complications from TAVR, though the researchers note the rate of vascular complications fell between 2012-13 and 2014, from 5.6% to 4.2%. In addition, site-reported stroke rates stayed the same, at 2.2%.

Additionally, the team found that the use of moderate sedation rather than general anesthesia is on the rise, which may speed up the procedure and patients’ recovery and, in turn, reduce the length of hospital stays.

Report coauthor Dr. Frederick L. Grover, from the University of Colorado, believes these results should give elderly patients with aortic stenosis the confidence that the TAVR procedure will help them:

“For patients, particularly those who are frail or elderly and have multiple health conditions, the outcomes reported thus far should provide reassurance that TAVR is safe and effective for the relief of symptoms in the short term.

This patient population is more often concerned with quality of life than long-term results, and our report shows that TAVR is a good option for them.”

Patients will continue to benefit from Registry data

The Registry data also enabled the researchers to identify some shortfalls when it comes to the use of TAVR. For example, they found the procedure is underutilized among certain race/ethnic groups, with only 5% of black aortic stenosis patients undergoing TAVR.

“Information like this would have been unknown to us before, but because the Registry data were published, we know about the issue and can more easily address it in clinical practice,” notes Dr. Holmes.

In an editorial linked to the study, Drs. Michael J. Reardon and Neal S. Kleiman, from Houston Methodist DeBakey Heart & Vascular Center in Texas, note the importance of the STS/ACC TVT Registry for providing ongoing data on the use and clinical outcomes of TAVR.

“This multidisciplinary approach has shown tremendous benefit in other areas, such as oncology,” says Dr. Reardon. “I firmly believe that this ‘team’ approach will allow patients to benefit greatly from the best of both specialties.” 

Last year, Medical News Today reported on a study published in the Journal of Thoracic and Cardiovascular Surgery, in which researchers detailed the first completely endoscopic aortic valve replacement conducted on two patients in France.