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Outcomes of TAVR in Patients With Cardiogenic Shock
Study Questions:
What is the safety and efficacy of transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter valves in patients with cardiogenic shock (CS)?
Methods:
All patients undergoing TAVR between June 2015 and September 2022 using SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry were analyzed. CS was defined as: 1) coding of CS within 24 hours on TVT registry form, and/or 2) preprocedural use of inotropes or mechanical circulatory support devices, and/or 3) cardiac arrest within 24 hours prior to TAVR. The control group was comprised of all the other patients undergoing TAVR. Baseline characteristics, all-cause mortality, and major complications at 30-day and 1-year outcomes were reported. Landmark analysis was performed at 30 days post-TAVR. Cox-proportional multivariable analysis was performed to determine the predictors of all-cause mortality at 1 year.
Results:
A total of 309,505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5,006 patients presented with CS prior to TAVR (1.6%). The mean STS score was 10.76 ± 10.4. The valve was successfully implanted in 97.9% of patients. Technical success according to Valve Academic Research Consortium-3 criteria was 94.5%. In a propensity-matched analysis, CS was associated with higher in-hospital (9.9% vs. 2.7%), 30-day (12.9% vs. 4.9%), and 1-year (29.7% vs. 22.6%) mortality compared to the patients undergoing TAVR without CS.
In the landmark analysis after 30 days, the risk of 1-year mortality was similar between the two groups (hazard ratio [HR], 1.07; 95% confidence interval [CI], 0.95-1.21). Patients who were alive at 1 year noted significant improvements in functional class (Class I/II 89%) and quality of life (Δ Kansas City Cardiomyopathy Questionnaire [KCCQ] score +50). In the multivariable analysis, older age (HR, 1.02; 95% CI, 1.02–1.03), peripheral artery disease (HR, 1.25; 95% CI, 1.06–1.47), prior implantation of an implantable cardioverter-defibrillator (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), New York Heart Association 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 were independently associated with 1-year mortality.
Conclusions:
This large observational real-world study demonstrates that TAVR is a safe and effective treatment for aortic stenosis patients presenting with CS. Patients who survived the first 30 days after TAVR had similar mortality rates to those who were not in CS.
Perspective:
The current analysis from the STS/ACC TVT registry evaluated outcomes among patients presenting with CS and undergoing TAVR in contemporary practice. Findings showed a high success rate (95% technical success rates) and as expected higher in-hospital, 30-day, and 1-year mortality compared to patients undergoing TAVR without CS. For patients surviving to 30 days, 1-year mortality was similar among those with and without CS. Although these findings provide reassurance that TAVR can be performed successfully among patients with CS, identifying patients who will derive long-term benefit still needs to be considered carefully among this cohort of high-risk patients.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Aortic Valve Stenosis, Heart Failure, Shock, Cardiogenic, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement
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