Sabine Bleiziffer1, Johan Bosmans2, Stephen Brecker3, Ulrich Gerckens4, Peter Wenaweser5, Corrado Tamburino6, Axel Linke7. 1. Clinic for Cardiovascular Surgery, Department of Cardiovascular Surgery, German Heart Center, Technical University Munich, Lazarettstr. 36, 80636, Munich, Germany. bleiziffer@dhm.mhn.de. 2. Cardiovascular Diseases Department, Antwerp University Hospital, Edegem, Belgium. 3. Cardiology Clinical Academic Group, St. George's Hospital, London, UK. 4. Cardiology Department, Gemeinschaftskrankenhaus, Bonn, Germany. 5. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 6. Cardiology Unit, Ferrarotto Hospital, University of Catania, Catania, Italy. 7. Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Leipzig, Germany.
Abstract
BACKGROUND: Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. OBJECTIVE: To report clinical and echocardiographic 3-year results from the ADVANCE study. METHODS: ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years. RESULTS: Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration. CONCLUSIONS: Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.
BACKGROUND: Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. OBJECTIVE: To report clinical and echocardiographic 3-year results from the ADVANCE study. METHODS: ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years. RESULTS: Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; VARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration. CONCLUSIONS: Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered, since postprocedural valve-related events were identified as independent predictors of mid-term mortality. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01074658.
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