New Valve Replacement Roll Out Seems Stable

Transcatheter aortic valve replacement or TAVR shows steady results since FDA approval

/ Author:  / Reviewed by: Robert Carlson, M.D Beth Bolt, RPh

(RxWiki News) New treatments can offer exciting new options to patients, but their rollout can also be marked by unknowns. A recent study took a close look at a new method for heart surgery as it became available to patients.

The study focused on transcatheter aortic valve replacement, a relatively new procedure available to patients in the US.

The researchers found results similar to those of pre-approval trials for the procedure: high levels of success in completing the procedure and low levels of complications.

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According to the authors of this study, who were led by Michael J. Mack, MD, of the Baylor Heart Hospital in Plano, Texas, transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration in 2011 for treating patients with severe aortic stenosis — a condition in which the main artery responsible for blood flow out of the heart doesn't open fully.

The TAVR procedure aims to increase the blood flow out of the heart by replacing the aortic valve.

Dr. Mack and colleagues wanted to examine the early effectiveness and safety of TAVR since the procedure's approval. To do so, they looked at 7,710 TAVR cases in the US from 224 American hospitals.

The procedures took place between November 2011 and May 2013. The average age of patients was 84 years old, and 49 percent of patients were female.

Dr. Mack and colleagues measured instances of death and complications like stroke after TAVR. They also looked at the success of the procedure in terms of factors like correct placement of the valve and proper function of the device. Outcomes 30 days out from TAVR were available for 3,133 of the cases (40.6 percent).

Successful implantation of the device occurred in 7,069 of the patients (92 percent).

Complications after TAVR included stroke in 2.0 percent of patients, dialysis-dependent renal failure (kidney failure requiring additional treatment to help filter the blood) in 1.9 percent of patients and major vascular injury in 6.4 percent of patients. In addition, 5.5 percent of patients died in the hospital.

The average hospital stay was six days, with 4,613 patients (63 percent) discharged to their homes at this time.

Of the 3,133 patients with 30-day follow up information, 7.6 percent had died 30 days later.

Dr. Mack and colleagues noted that their findings were consistent with those of trial data for TAVR. However, they reported that long-term follow-up and further research is needed to continue to assess the safety and effectiveness of the procedure.

This study was published November 17 in the Journal of the American Medical Association (JAMA).

Several study authors reported receiving travel assistance to meetings from the Society of Thoracic Surgeons and the American College of Cardiology, groups involved in tracking and reporting these TAVR cases. An additional author reported consultancy work for several pharmaceutical companies.

Review Date: 
November 16, 2013
Last Updated:
November 25, 2013