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Title: Reduced-Size Pump Benefits Patients With Smaller Body Size: Presented at AHA
URL: http://www.pslgroup.com/dg/216C32.htm
Doctor's Guide
November 6, 2007


By Emma Hitt, PhD

ORLANDO, FL -- November 6, 2007 -- Smaller patients may benefit from a new, reduced-size (25% weight of the pulsatile pump) continuous-flow left ventricular assist device (LVAD), a technology that is not typically feasible in this patient group.

The HeartMate II (HM II) bridge is a mechanical circulatory support used to bridge patients to cardiac transplantation. It is one of the first of a new generation of pumps called axial continuous-flow pumps.

The results of a study comparing changes in functional capacity and outcomes between the male and female patients were reported here on November 4 at the American Heart Association (AHA) 2007 Scientific Sessions.

A total of 231 patients (23% women) with New York Heart Association (NYHA) class IV heart failure received the HM II as a bridge to cardiac transplantation at 40 centers in the United States.

Lead author Roberta C. Bogaev, MD, Medical Director, Heart Failure and Transplant, Texas Heart Institute, Houston, Texas, presented results of an analysis that included a small-body cohort in which 90% of the patients were women.

Out of 194 patients who underwent 6 months of follow-up, the percentage of patients who lived to undergo transplant, who had the device removed after therapy, or who were still using the device at 180 days of support was similar between men and women (79.5% women vs 80.6% men).

In addition, right ventricular dysfunction requiring a temporary right ventricular assist device was reported in 10 patients. Stroke within 2 days of placement occurred in six patients and stroke after day 2 occurred in 12 patients.

After 3 months of support, 76% of the women and 57% of the men had increased their 6-minute walk distance to more than 200 m, and symptoms were reduced to NYHA functional class I or II in 84% of both the men and women. Median duration of support, up to 693 days, was similar among men and women.

The 11 smallest patients were all women with a body surface area (BSA) of less than 1.5 m2, and 100% were survivors at 180 days. The smallest woman was 40 kg, with a BSA of 1.33 m2.

"We were very pleased that men and women both benefited equally well in terms of survival and had an acceptable adverse event risk profile," Dr. Bogaev said in an interview. "This device will allow many women who have previously been denied mechanical support as a bridge to transplantation to receive this technology."

According to Dr. Bogaev, the HM II is going before a US Food and Drug Administration panel for consideration of approval in November.


[Presentation title: An Emerging Option for Women With Advanced Heart Failure: Results of the HeartMate II Continuous Flow Left Ventricular Assist Device Bridge to Transplant Trial. Abstract 1762]

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