article from the hfsa conf.

Smaller Pump Implants Benefit Heart-Failure Patients Awaiting Cardiac Transplantation: Presented at HFSA
By Crina Frincu-Mallos, PhD

WASHINGTON, DC -- September 20, 2007 -- A new, smaller, bearingless third-generation rotary left-ventricular assist device (LVAD) offers low operative mortality, low stroke rate, and no device malfunctions/failures for patients awaiting cardiac transplantation, researchers reported here at the 11th Annual Scientific Meeting of the Heart Failure Society of America (HFSA).

Adverse events have been a concern with LVADs in the past.

Jeffrey Teuteberg, MD, Assistant Professor of Medicine, Cardiovascular Institute, Heart Failure/Transplantation, University of Pittsburgh, Pittsburgh, Pennsylvania, United States, one of the authors of the VentrAssistTM LVAD Bridge to Transplant (BTT) feasibility trial, presented the results of this single arm, multi-centre trial.

The authors sought to look at 30-day clinical outcomes, including survival, adverse events (AE), and hospital discharge of the use of the VentrAssist TM device in 28 patients.

After the approval of the United States Food and Drug Administration (FDA) for hospital discharge, 21 (66.7%) patients left the hospital within 30 days of the implant.

"The new pump expands the patient population, since there is less of a size exclusion, which was the case with the old pulsatile pumps. It offers ease of implantation, more flexibility, and ease for the patient as well. Due to its smaller size, in general, the adverse-events profiles are probably different than with the old pulsatile devices," explained Dr. Teuteberg.

All but one patient included in the study were New York Heart Association (NYHA) class IV, with 24 patients (85.7%) receiving inotropic medication.

Serious adverse events included right-heart failure in seven (25%) of the patients, perioperative bleeding, and respiratory dysfunction in 5 patients.

The 30-days assessment showed that one patient had expired, while the surviving patients are still on support.

As for future plans, "based on this data, the new BTT trial was approved by the FDA, and now we are beginning to enrol patients," said Dr. Teuteberg.

"We have been very pleased with our experience; our patients have been doing well, we have implanted seven. We are seeing, in general, fewer strokes and maybe less right-ventricular dysfunction, but these results are preliminary," Dr. Teuteberg added. "We just completed the BTT prospective clinical trial, so these are data on the first patients looking at safety, efficacy, and survival."

The trials have been sponsored through Ventracor, Ltd, Chatswood, New South Wales, Australia.