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Published on: May 21, 2017
Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock
Kashish Goel1, Pinak Shah2, Brandon M Jones3
1Division of Cardiovascular Diseases, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Insights
Transcatheter aortic valve replacement (TAVR) is safe and effective for patients with cardiogenic shock (CS), with similar long-term mortality to non-CS patients after 30 days. Survivors show improved quality of life.
Area of Science:
- Cardiology
- Interventional Cardiology
- Heart Valve Disease
Background:
- Transcatheter aortic valve replacement (TAVR) is a common treatment for aortic stenosis.
- The safety and efficacy of TAVR in patients with cardiogenic shock (CS) are not well-established.
- CS is a critical condition characterized by the heart's inability to pump enough blood to meet the body's needs.
Purpose of the Study:
- To evaluate the safety and efficacy of TAVR using balloon-expandable valves in patients with CS.
- To compare outcomes of TAVR in patients with and without CS.
- To identify predictors of mortality in CS patients undergoing TAVR.
Main Methods:
- Analysis of TAVR procedures performed between June 2015 and September 2022 using SAPIEN 3/SAPIEN 3 Ultra valves from the STS/ACC TAVR Registry.
- Definition of CS based on registry coding, pre-procedural support, or cardiac arrest.
- Propensity-matched and landmark analyses comparing outcomes (mortality, complications) at 30 days and 1 year between CS and non-CS groups.
Main Results:
- Of 309,505 TAVR patients, 5006 (1.6%) had CS.
- CS patients had higher in-hospital, 30-day, and 1-year mortality in propensity-matched analysis.
- After 30 days, 1-year mortality was similar between CS and non-CS groups (HR 1.07).
- Survivors at 1 year showed significant improvements in functional class and quality of life.
Conclusions:
- TAVR is a safe and effective treatment for patients with aortic stenosis and CS.
- Patients surviving the initial 30 days post-TAVR have comparable long-term mortality to those without CS.
- Older age, comorbidities like PAD and dialysis, and NYHA class III/IV symptoms are predictors of 1-year mortality in CS patients.
Aims:
The safety and efficacy of transcatheter aortic valve replacement (TAVR) with contemporary balloon expandable transcatheter valves in patients with cardiogenic shock (CS) remain largely unknown. In this study, the TAVRs performed for CS 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 Registry were analysed.
Methods And Results:
CS was defined as: (i) coding of CS within 24 h on Transcatheter Valve Therapy Registry form; and/or (ii) pre-procedural use of inotropes or mechanical circulatory support devices and/or (iii) cardiac arrest within 24 h 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. A total of 309 505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5006 patients presented with CS prior to TAVR (1.6%). The mean Society of Thoracic Surgeons 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 (ΔKCCQ 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 haemoglobin levels, and lower Kansas City Cardiomyopathy Questionnaire scores were independently associated with 1-year mortality.
Conclusion:
This large observational real-world study demonstrates that the 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.
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