Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR

Abstract

Objectives: The authors aimed to investigate the rates, predictors, and prognostic impact of technical success in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: The Valve Academic Research Consortium-3 (VARC-3) has introduced a composite endpoint to assess the immediate technical success of TAVR.

Methods: In the prospective Bern TAVR registry, patients were stratified according to VARC-3 technical success. Technical failure differentiated between vascular and cardiac complications.

Results: In a total of 1,624 patients undergoing TAVR between March 2012 and December 2019, 1,435 (88.4%) patients had technical success. Among 189 patients with technical failure, 140 (8.6%) had vascular and 49 (3.0%) had cardiac technical failure. Female, larger device landing zone calcium volume, and the early term of the study period were associated with an increased risk for cardiac technical failure, whereas higher body mass index and the use of the Prostar (Abbott Vascular Inc) MANTA (Teleflex) (compared with the ProGlide [Abbott Vascular Inc]) were predictors of vascular technical failure. In multivariable analysis, technical failure conferred an increased risk for cardiovascular death or stroke (HR: 2.01; 95% CI: 1.37-2.95). The adverse effect remained when stratified to cardiac (HR: 2.62; 95% CI: 1.38-4.97) or vascular technical failure (HR: 1.95; 95% CI: 1.28-2.95) and limited to the periprocedural period (0-30 days: HR: 3.42 [95% CI: 2.05-5.69]; 30-360 days: HR: 1.36 [95% CI: 0.79-2.35]; P for interaction = 0.002).

Conclusions: Technical failure according to VARC-3 was observed in 1 of 10 patients undergoing TAVR and was associated with a 2-fold increased risk of the composite outcome at 1 year after TAVR. (Swiss TAVI Registry; NCT01368250).

Keywords: Valve Academic Research Consortium; aortic stenosis; technical success; transcatheter aortic valve replacement.

Conflict of interest statement

Funding Support and Author Disclosures Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, Med Alliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration; is an unpaid member of the Pfizer Research Award selection committee in Switzerland and the Women as One Awards Committee; is a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and the Advisory Board of the Australian Victorian Heart Institute; and is the chairperson of the ESC Congress Program Committee and Deputy Editor of JACC: Cardiovascular Interventions. Dr Pilgrim has received research grants to the institution from Edwards Lifesciences, Boston Scientifc, and Biotronik; has received personal fees from Biotronik and Boston Scientific; and has received travel reimbursement from Medira and HighLife SAS (Clinical Event Adjudication Committee). Dr Stortecky has received research grants to the institution from Edwards Lifesciences and Medtronic; and has received personal fees from Boston Scientific, Teleflex, and BTG. Dr Praz has received travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr Okuno has received speaker fees from Abbott. Dr Heg has no personal conflicts; his employer, CTU Bern, University of Bern, has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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