Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines

Aims: There is heterogeneity in the reporting of procedural outcomes and complications following transcatheter aortic valve replacement (TAVR). Recently, new definitions have been proposed by the Valve Academic Research Consortium (VARC) in an effort to standardise these outcomes and improve the quality of future clinical research. The aim of this study is to report the procedural outcomes and complication rates following TAVR in a large sequential patient cohort using a balloon expandable valve according to the new VARC definitions. Methods and results: Three hundred and ten consecutive patients undergoing TAVR were assessed, including patients forming our early historical series at the infancy of TAVR. All complication rates were re-evaluated according to VARC definitions. Mean age was 82.2 +/- 8.1 years and the Society of Thoracic Surgeons score was 9.4 +/- 5.7%. Transfemoral 30-day mortality was 6.8% (3.8% in the second half of the cohort) and transapical 30-day mortality was 13.7% (9.4% in the second half of the cohort). Cardiovascular 30-day mortality was 7.4% and the composite safety endpoint at 30-days was 18.4%. Device success was 80% (post-procedural valve area <1.2 cm(2) in 9.7%). Failure to deliver and deploy a valve occurred in only 3.5%, with 82% (nine cases) occurring in the first half of the experience. Of those who did not meet echocardiographic criteria for device success (valve area <= 1.2 cm(2), transaortic gradient >= 20 mmHg or >= moderate aortic incompetence), 90% achieved a New York Heart Association class I/II. Life threatening bleeding complications occurred in 8.4%. In 7.7% of patients, red blood cell transfusions were given without evidence of overt bleeding. Major strokes occurred in 2.3% and acute kidney injury occurred in 6.5%. Conclusions: The VARC consensus guidelines provide a standardised reporting framework for clinical endpoints and complications post TAVR. We report the first series to our knowledge of 30-day outcomes using these definitions utilising a balloon expandable valve system.