Surgical Outcomes Following Peri-procedural TAVR Failures: A Report from the STS National Database

M. Engoren¹, A. Abbas², M. F.L.. Gaudino³, D. Engelman⁴, S. Saadat⁵, A. Kugelmass⁶, R. Habib⁷, T. A.. Schwann^8
1University of Michigan, Ann Arbor, Michigan ²Willam Beaumont University Hospital, Royal Oak, Michigan ³Weill Cornell Medicine, New York, New York ⁴UMASS Chan Medical School-Baystate, Longmeadow, Massachusetts ⁵Baystate Medical Center, West Simsbury, Connecticut ⁶Deborah Heart Institute, Browns Mills, New Jersey ⁷The Society of Thoracic Surgeons, CHICAGO, Illinois ⁸University of Massachusetts-Baystate, Royal Oak, Michigan

Purpose: Outcomes of emergent/urgent surgical interventions performed during the same hospitalization for complications following transcatheter aortic valve replacement (TAVR) procedures are not well defined. This study leverages data from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) to analyze the results of same-admission surgery following failed TAVR.

Methods: SAVR procedures during same hospitalization and following a failed TAVR procedure were identified in the STS ACSD between 2014 and 2023 spanning three ACSD data versions: v2.81 (Era 1: July 2014-June 2017), v2.9 (Era 2: July 2017 – June 2020), and v4.20.2 (Era 3: July 2020 – present). Surgical outcomes including all major complications were analyzed for the entire cohort as well as stratified based on i) surgical priority (Urgent, emergent, or salvage) and ii) chronologically across three sub-eras within the study period (Eras 1, 2 and 3). Patient demographics, comorbidity, cardiac disease, operative details were summarized and parameterized for multivariable risk modeling. Hierarchic multivariable logistic regression was utilized to identify independent predictors of the primary outcome or operative, 30-day mortality.

Results: 465 (0.1% of the 431,826 total TAVR 2014-2023 cohort) patients (mean age 75 ± 9 yrs, 59% male) required urgent (33%), emergent (52%) and salvage (15%) surgery during the index TAVR hospitalization. Prosthetic malposition (43.9%), annular disruption (28%) and failed trans-catheter device (15.9%) were the most common indications for surgery. Cardiogenic shock was present in 29% of the overall study cohort and was significantly higher in non-survivors versus survivors (50% vs 20%, p< 0.001). Circulatory arrest was required in 11% of patients. IABP was used in 11%, VAD in 13%, ECMO in 3%, and catheter support devices in 4% of the study cohort. The overall mortality rate was 27%(12%, 27% and 63% in urgent, emergent and salvage cases, respectively) and did not appreciably change across the study period: 23%, 27%, and 29%, p = 0.593, for data versions 2.81(Era1), 2.9(Era2), and 4.20.2(Era3), respectively. Mortality for annular disruption, acute device malposition and subacute device malfunction was 43%, 22% and 16%, respectively. Morbidities were high: stroke (11%), acute renal failure (17%), dialysis (12%) prolonged ventilation (41%) and re-exploration for bleeding (9%)(Table 1). Independent predictors for mortality were [HR(95CI)]: pre-op dialysis [17.85(4.51-70.70)], female gender [2.04(1.16-3.57)], age [1.07(1.03-1.10)], emergent [2.71(1.10-4.28)] or salvage status [9.09(3.85-21.46)].

Conclusion: Immediate surgical procedures due to TAVR misadventures are rare and are associated with substantial morbidity and mortality. The mortality rate did not change over the course of the study period.

Identify the source of the funding for this research project: Institutional funds.