A study released Nov. 10 at the 23rd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco reports that patients receiving an innovative new heart valve benefit from a marked increase in quality of life.

Researchers at Saint Luke’s Mid America Heart Institute, one of the only hospitals in the country to participate in the trial, prepared a report showing that the transcatheter aortic heart valve had marked benefits, not least because it can be installed without major surgery.

The transcatheter aortic heart valve is a collapsible valve that can be introduced into the body through a catheter-based delivery system via one of two approaches:

  • Through a small incision through the groin (similar to coronary angioplasty or stenting)s
  • Between the ribs.

The valve replaces a patient’s diseased “native” valve without traditional open-heart surgery, and while the patient’s heart continues to beat.

On 2nd November this year the FDA approved the device for transfemoral (TF) delivery of the valve for the treatment of inoperable patients with severe aortic stenosis (a narrowing of the valve that severely restricts blood flow).

Over the past ten years the device has been primarily used for the kinds of patients in poorer condition that might not withstand or recover from full open heart surgery.

There has not been a study previously to assess the effectiveness of the device. It now appears that it at least matches the more traditional surgical aortic valve replacement and more specifically, the one year mortality rate for high risk patients is similar.

Patients were assessed on a broad range of factors :

  • Their symptoms
  • Physical limitations
  • Social limitations
  • Overall quality of life upon enrollment in the trial
  • Quality of life follow-up intervals of one month, six months, and 12 months

A total of 699 patients were randomized to either TAVR (N=348) or SAVR (N=351).

The study population was then divided into groups of who were eligible for TF valve implantation and a separate group of patients for whom only a transapical (TA) approach through a small incision in the chest was possible.

At the one-year follow-up, patients who underwent either surgical or transcatheter AVR experienced substantial improvement in disease-specific and generic health quality of life measures.

For TF patients, TAVR resulted in substantial quality of life benefits compared with surgical AVR at one month with similar benefits at later time points.

For patients eligible only for the TA approach, there was no benefit of TAVR over AVR at any time point, and quality of life measures tended to be better with surgical AVR at both one and six months.

David J. Cohen, M.D., principal investigator for the quality of life sub-study and director of Cardiovascular Research at Saint Luke’s Mid America Heart Institute confirmed :

“Taken together with previous data, these findings demonstrate that for patients suitable for a transfemoral approach, transcatheter aortic valve replacement provides important benefits compared with surgical aortic valve replacement from the patient’s perspective … The lack of benefit and suggestion of worse quality of life among patients ineligible for the transfemoral approach suggest that the transapical approach may not be preferable to surgical aortic valve replacement in such patients …

Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation.”

The trial was funded by a research grant from Edwards Lifesciences. The symposium was sponsored by the Cardiovascular Research Foundation.

Written by Rupert Shepherd