TAVR Found Safe and Effective in Patients With Cardiogenic Shock: An NCDR Analysis

Patients with cardiogenic shock who survived the first 30 days following TAVR had similar mortality rates to those without cardiogenic shock and reported improved symptoms and quality of life, demonstrating the safety and efficacy of the procedure in this patient population, according to a recent study published in the European Heart Journal.

Kashish Goel, MD, FACC, et al., used data from the STS/ACC TVT Registry to look at a total of 309,505 patients undergoing TAVR with balloon-expandable valves (SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis) between June 2015 and September 2022, 5,006 (1.6%) of which presented with cardiogenic shock prior to TAVR. Researchers defined cardiogenic shock as at least one of the following conditions: coding of cardiogenic shock within 24 hours on registry form, preprocedural use of inotropes or mechanical circulatory support devices or cardiac arrest within 24 hours prior to TAVR.

Successful valve implantation was reported in 97.9% of patients, with technical success according to Valve Academic Research Consortium-3 criteria achieved in 94.5% of cases. Cardiogenic shock was associated with higher mortality rates compared to patients undergoing TAVR without cardiogenic shock in-hospital (9.9% vs. 2.7%), at 30 days (12.9% vs. 4.9%) and one-year postprocedure (29.7% vs. 22.6%). However, the study’s landmark analysis with propensity-matched cardiogenic shock and noncardiogenic shock groups revealed similar risk of one-year mortality after 30 days following TAVR (hazard ratio [HR], 1.07, 95% CI, 0.95-1.21). At one-year follow-up, patients reported significant improvements in functional class (Class I/II 89%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire [KCCQ] score +50).

Multivariable analysis found several factors independently associated with one-year mortality including: older age (HR, 1.02, 95% CI, 1.02-1.03), peripheral artery disease (HR, 1.25, 95%, CI 1.06-1.47), prior ICD implantation (HR, 1.37, 95% CI, 1.07-1.77), patients on dialysis (HR, 2.07, 95% CI, 1.69-2.53), immunocompromised status (HR, 1.33, 95% CI, 1.05-1.69), NYHA Class III/IV symptoms (HR, 1.50, 95% CI, 1.06-2.12), lower aortic valve mean gradient, lower albumin levels, lower hemoglobin levels, and lower KCCQ scores.

“One-year mortality in the present study was 29%, which is lower than the previously reported mortality rate of 35%-50% after TAVR in [cardiogenic shock],” write the authors. “Overall, this study confirms the safety and efficacy of TAVR in patients with [cardiogenic shock] and suggests that TAVR with new generation balloon-expandable valves may be offered to most patients who are anatomically suitable candidates, as long as active medical conditions such as sepsis, pneumonia, hemorrhage, cancer or other issues preclude them from recovery or deriving any benefit.”

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and Vascular Medicine

Keywords: Peripheral Arterial Disease, Shock, Cardiogenic, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement, STS/ACC TVT Registry, National Cardiovascular Data Registries


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