Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study.

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.