Validation of VARC-3 Technical Success in TAVR

Quick Takes

  • The VARC-3 definition of TAVR technical success includes freedom from death, successful access, delivery of the device, retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location; and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication.
  • The current study assessed VARC-defined technical success among a contemporary cohort of patients undergoing TAVR in the Swiss TAVI Registry. Notable findings include overall 89% rate of technical success with increasing rates in the more recent study period.
  • Technical failure (vascular or cardiac) was associated with a twofold higher risk of cardiovascular death and stroke at 1 year.
  • Women and those with higher landing zone calcium were more likely to have increased cardiac technical failure, while higher BMI and use of MANTA closure device predicted vascular technical failure.

Study Questions:

What are the rates, predictors, and prognostic impact of technical success in patients undergoing transcatheter aortic valve replacement (TAVR)?

Methods:

The Valve Academic Research Consortium 3 (VARC-3) has introduced a composite endpoint to assess the immediate technical success of TAVR. 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–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 sex, larger device landing zone calcium volume, and the early term of the study period were associated with an increased risk for cardiac technical failure, while higher body mass index and the use of the Prostar/MANTA compared with the ProGlide were predictors of vascular technical failure. In multivariable analysis, technical failure conferred an increased risk for cardiovascular death or stroke (hazard ratio [HR], 2.01; 95% confidence interval [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 one out of ten patients undergoing TAVR and was associated with a twofold increased risk of the composite outcome at 1 year after TAVR.

Perspective:

The VARC-3 definition of technical success includes freedom from death, successful access, delivery of the device, retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location; and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication. The current study assessed VARC-defined technical success among a contemporary cohort of patients undergoing TAVR in the Swiss TAVI Registry. Notable findings include overall 89% rate of technical success with increasing rates in a more recent study period. Technical failure (vascular or cardiac), on the other hand, was associated with a twofold higher risk of cardiovascular death and stroke at 1 year. While women and those with higher landing zone calcium were more likely to have increased cardiac technical failure, higher body mass index (BMI) and use of the MANTA closure device predicted vascular technical failure.

Keywords: Aortic Valve Stenosis, Body Mass Index, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Risk, Stroke, Transcatheter Aortic Valve Replacement, Vascular Access Devices, Vascular Diseases


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