Author + information
- Randall C. Starling, MD, MPH⁎ ( and )
- David J. Farrar, PhD
- ↵⁎Department of Cardiovascular Medicine, Cleveland Clinic, Heart and Vascular Institute, Cleveland, Ohio 44195
On behalf of the authors, we thank Drs. Dhruva and Redberg for their letter in reference to our paper (1). We strongly acknowledge the importance that women are well represented in clinical trials and that sex-specific outcomes are reported. Indeed, the newer axial flow pumps have now enabled a wider dissemination of left ventricular assist devices (LVADs), because prior devices were limited to patients with body surface areas >1.5 m2. We reported a consecutive group of patients implanted with the HeartMate II (HMII) (Thoratec Corporation, Pleasanton, California) device and the previously-approved Federal Drug Administration devices as per a stipulated post-market approval study.
Of the 169 HMII patients, there were 131 men (78%) and 48 women (22%). The percentage of patients who were transplanted, recovered, or received ongoing support at 180 days was 90% for men and 92% for women. A smaller percentage of women (24%) received transplants by 12 months of support compared with men (39%), and a larger percentage were still on LVAD support (63% women vs. 47% males) at 12 months. However, there was no difference in overall survival (log rank p = 0.4038), and the 1-year survival estimate for patients remaining on LVAD support was 83.8 ± 6.7% (women) versus 88.3 ± 3.0% (men). There were no statistically significant differences in any adverse event between women and men. The control group had a smaller percentage of women (17% vs. 22%), but this was not statistically significant (p = 0.217). In comparison with results in the clinical trial for bridge to transplantation for the HeartMate II LVAD in 465 patients as reported by Bogaev et al. (2), the distribution of women (22%) and 361 men (78%) was the same. In addition, similar to the post-approval study, there was a smaller percentage of women receiving heart transplants over the first 18 months of support and a greater percentage with ongoing support compared with men, and also with no difference in overall survival. In contrast to the post-approval study, in the clinical trial, hemorrhagic stroke occurred more frequently in women versus men, and device-related infections occurred less frequently than in men.
Finally, it should be noted that historically, the percentage of women undergoing cardiac transplantation has been significantly lower than men. The latest international heart transplant registry report shows: men, 80.1% from 1992 to 2001 and 77.1% from 2002 to 2006/2009; p < 0.0001 (3). We fully agree with Drs. Dhruva and Redberg of the importance to collect and report “gender-specific outcomes,” and we appreciate the opportunity to respond and provide additional information.
- American College of Cardiology Foundation
- Starling R.C.,
- Naka Y.,
- Boyle A.J.,
- et al.