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News Article | December 13, 2016
Site: www.marketwired.com

New Study to Evaluate Transcatheter Aortic Valve Replacement in Low Risk Patients BALTIMORE, MD--(Marketwired - December 13, 2016) - MedStar Heart & Vascular Institute at MedStar Union Memorial Hospital is one of only 80 cardiac centers in the world, selected by the industry to participate in a study of an alternative treatment option for surgical aortic valve replacement. The study will evaluate the safety and effectiveness of the transcatheter approach to replacing the aortic valve, known as TAVR, in treating low risk patients with severe aortic stenosis. An estimated 2.5 million people over the age of 75, suffer with aortic stenosis, caused by calcium build-up in the aortic valve. The result is a narrowing in the valve which prevents it from opening and closing properly, forcing the heart to work harder to pump blood throughout the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. "Replacing the aortic valve during open heart surgery has been a gold standard in treating aortic stenosis," said Dr. John Wang, chief of the cardiac catheterization laboratory at MedStar Union Memorial and scientific director for Baltimore Cardiovascular Research. "However, during a TAVR procedure, we can replace the diseased aortic valve using a catheter, through a small incision in the groin. The heart remains beating and the results have been excellent. The study will allow us to examine if this option is best for patients who are at a lower risk -- who could safely undergo the surgical replacement." MedStar Union Memorial Hospital is a regional leader in performing TAVR procedure, having done over 300 of these with stellar outcomes since it was first introduced in 2012. Presently, the technology is approved only for patients who are high or intermediate risk for the surgical replacement of their aortic valve. The study, which is supported by the MedStar Health Research Institute, will include up to 1256 patients and follow up for 5 years. Learn more about aortic stenosis and the trial, by visiting www.MedStarUnionMemorial.org.


PubMed | MedStar Heart & Vascular Institute
Type: Journal Article | Journal: The American journal of cardiology | Year: 2016

This analysis was designed to (1) examine the impact of heparin-induced thrombocytopenia (HIT) on contemporary cardiac surgical practice and (2) describe the results of a protocol designed for early identification of the presence of the immune mechanisms involved. Consecutive patients who underwent cardiac surgery were screened postoperatively for thrombocytopenia. Patients with thrombocytopenia were tested for antiplatelet factor 4 (PF4)/heparin antibodies by ELISA and clinical evidence of thrombosis sought. Demographics, co-morbidities, operative details, and outcomes were abstracted from the departmental registry. Of 14,415 consecutive patients undergoing cardiac surgery, 1,849 patients (13%) had thrombocytopenia. Of them, 277 patients (15%) had PF4/heparin antibodies and 76 patients (4%) had both antibodies and clinical thrombosis. Antibodies were more frequent: (1) in women (p = 0.01), (2) in patients with an increased body mass index (p <0.01), and (3) in patients with clinical heart failure before surgery (p <0.01). Thirty-day mortality was greatest among the 76 patients with the triad of thrombocytopenia, antibodies, and clinical thrombosis (30%). Of the 1,849 patients with thrombocytopenia, the presence of PF4/heparin antibodies was an independent predictor of 30-day mortality (odds ratio 2.09, 95% CI 1.46 to 2.49; p <0.001). HIT remains an infrequent but very serious complication of heparin therapy in contemporary cardiac surgical practice. The possibility that the presence of HIT antibodies in patients with thrombocytopenia independently increases operative mortality deserves further study.

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