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Coming to a Consensus on TAVR

Coming to a Consensus on TAVR

In 2011, the FDA approved transcatheter aortic valve replacement (TAVR) for transfemoral use in symptomatic patients with severe aortic stenosis who are not considered candidates for surgery. On behalf of the Society for Cardiovascular Angiography and Interventions, the American College of Cardiology Foundation, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, my colleagues and I collaborated to develop an expert consensus document on TAVR. The document, published in a 2012 issue of Journal of the American College of Cardiology, is intended to inform physicians on the most appropriate use of TAVR based on available evidence. The consensus document does not recommend universal use of TAVR because the technology is still being investigated. Instead, we recommend that hospitals eligible to perform TAVR should initially be limited to those that are currently performing an average of at least one aortic valve replacement per week. This means that the 400 busiest cardiac surgery programs would be able to access this technology in the first 2 years following FDA approval. After monitoring outcomes, use of TAVR could be expanded or restricted depending on success and failure rates. A Team Approach to TAVR It’s recommended that territorial and specialty-based decisions on treatment with TAVR be avoided by utilizing a heart team approach. This team should include a surgeon, interventional cardiologist, cardiac anesthesiologist, and an imaging specialist. Allied health professionals—including social workers, nutritionists, and physician assistants— should also be involved. Data from the PARTNER trial, which was the initial regulatory trial for TAVR conducted in the United States, indicate that use of heart team approaches may enhance outcomes. “It’s recommended that...

The Emergence of Transcatheter Aortic Valve Replacement

Aortic valve stenosis (AVS) involves thickening and progressive immobility of the aortic valve. This restricts blood flow from the left ventricle to the aorta. AVS most frequently involves an anatomically normal three-leaflet aortic valve and is less frequently due to either a congenitally abnormal bicuspid aortic valve or to the late consequence of rheumatic fever. Since AVS predominantly afflicts the elderly, its prevalence is increasing. In fact, AVS currently ranks among the top five Medicare cardiac diagnoses. AVS is slowly progressive and has a long asymptomatic period. However, the prognosis turns grim once the cardinal triad of symptoms occur, including: Progressive shortness of breath. Anginal-like chest discomfort. Lightheaded or fainting spells. In such cases, the average survival without aortic valve replacement (AVR) is between 1 and 2 years. Improved Surgical Treatments for AVS Until recently, the only treatment for AVS has been surgical AVR. Unfortunately, the morbidity and mortality related to this open-heart surgery in elderly patients can be prohibitive and has prompted the development of less invasive non-surgical, catheter-based technologies to replace the aortic valve. Recently, the FDA has approved a new balloon-expandable stent-mounted bovine pericardial valve (SAPIEN, Edwards Life Sciences) for the treatment of symptomatic severe AVS in patients who are considered to be at either high or prohibitive risk for surgical AVR. The valve represents a significant advance in that it’s delivered via femoral arterial access and does not require cardiopulmonary bypass. “There is hope that TAVR will continue to emerge as a viable alternative to surgical AVR in patients at high surgical risk.” In the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter AVR (TAVR)...

TAVR Beneficial for Inoperable Severe Aortic Stenosis

Transcatheter aortic-valve replacement (TAVR) appears to reduce rates of death and hospitalization in patients with severe aortic stenosis who are not suitable candidates for surgery, according to findings from a 2-year investigation. The mortality rate at 2 years was 43.3% among those who underwent TAVR, compared with a 68.0% rate for those who received standard therapy. Rates of rehospitalization were 35.0% for TAVR and 72.5% for standard therapy. At 2 years, TAVR was associated with sustained decreases in symptoms and improved valve hemodynamics. Abstract: New England Journal of Medicine, May 3,...

Transcatheter Cardiovascular Therapeutics Annual Scientific Symposium

The 22nd Transcatheter Cardiovascular Therapeutics, or TCT, Annual Scientific Symposium was held from September 21 to 25 in Washington, DC, showcasing the latest advances in current therapies and clinical research in interventional cardiovascular medicine. The features below highlight just some of the studies that emerged from the symposium. Transcatheter Valves for Aortic Stenosis The Particulars: Patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. The Placement of AoRTic TraNscathetER Valve Trial (PARTNER) was a randomized controlled trial that compared transcatheter aortic-valve implantation (TAVI) with standard therapy in people with severe aortic disease who were unable to undergo surgery. Data Breakdown: At 1 year in the PARTNER study, the rate of death from any cause was significantly lower with TAVI when compared with standard therapy (30.7% vs 50.7%, respectively). The rate of the composite endpoint of death from any cause or repeat hospitalization was also significantly lower with TAVI when compared with standard therapy (42.5% vs 71.6%, comparatively). Among survivors at 1 year, the rate of cardiac symptoms was lower among patients who had undergone TAVI than among those who had received standard therapy. Take Home Pearls: Patients with severe aortic stenosis who are not suitable candidates for surgery appear to benefit significantly from TAVI. The procedure reduces the rates of death from any cause, death from any cause or repeat hospitalization, and cardiac symptoms. Robotically-Assisted PCI Safe & Feasible The Particulars: Concerns of interventional cardiology include occupational injuries for clinicians, including sore backs, shoulders, hips and knees, as well as cumulative risks of long-term radiation exposure. A robotically-assisted PCI (CorPath...
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