Primary TAVR may be best strategy for aortic stenosis causing cardiogenic shock
Key takeaways:
- Transcatheter aortic valve replacement is safe and effective in people with aortic stenosis and cardiogenic shock.
- Early definitive treatment of aortic stenosis can prevent cardiogenic shock.
Data suggest transcatheter aortic valve replacement with a balloon-expandable valve is an acceptable and safe treatment for patients with aortic stenosis and cardiogenic shock, researchers reported.
Compared with patients with aortic stenosis who underwent TAVR and had no cardiogenic shock, those with aortic stenosis and cardiogenic shock who underwent TAVR had worse outcomes in-hospital and at 30 days, which was expected given the nature of cardiogenic shock, but similar outcomes between 30 days and 1 year, according to the researchers.
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Patients in cardiogenic shock are an extremely high-risk population, with upward of 70% mortality unless the obstruction across the aortic valve is resolved, Abhijeet Dhoble, MD, associate professor at McGovern Medical School at The University of Texas Health Science Center at Houston, said during a late-breaking clinical trial presentation at EuroPCR. Patients in cardiogenic shock are not typically considered candidates for TAVR; the safety and efficacy of TAVR with contemporary transcatheter heart valves in this population remains largely unknown.
“With that in mind, our objective for the study was to assess the outcomes of TAVR with balloon-expandable Sapien 3 and Sapien 3 Ultra [Edwards Lifesciences] bioprosthetic valves in patients with cardiogenic shock,” Dhoble said during a presentation.
Real-world outcomes
Dhoble and colleagues analyzed data from patients who underwent TAVR between June 2015 and September 2022, using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry (n = 309,505). Researchers defined cardiogenic shock as the coding of cardiogenic shock; preprocedural use of mechanical circulatory support; and cardiac arrest within 24 hours before TAVR. A control group comprised patients undergoing TAVR without cardiogenic shock, who then were propensity score-matched with the cardiogenic shock group to adjust for baseline characteristics (n = 4,952 patients in each arm). The mean age of patients was 76 years; 65% were men; mean STS Predicted Risk of Mortality score was 10.3 and half of all patients had atrial fibrillation.
The primary outcomes were all-cause mortality and major complications in-hospital, at 30 days and at 1 year.
Few patients experienced procedural complications in both arms, Dhoble said; however, rates of coronary occlusion (0.2% vs. 0.4%; P = .04), and conversion to open surgery (0.4% vs. 0.7%; P = .02) were higher in the cardiogenic shock than in the control arm. Rates of other adverse events were similar in both groups.
For in-hospital outcomes, mortality was higher among patients with cardiogenic shock vs. controls (9.9% vs. 2.7%; P < .0001), as were rates of stroke, major vascular complications, life-threatening bleeding and new-onset AF. Similarly, median length of hospital stay and mean ICU length of stay were longer for patients with cardiogenic shock vs. those without shock, whereas fewer patients with cardiogenic shock were discharged to home, which was expected, Dhoble said.
For outcomes at 30 days and 1 year, trends were similar, Dhoble said. There was higher incidence of 30-day all-cause mortality (12.9% vs. 4.9%; P < .0001) and 1-year all-cause mortality (29.7% vs. 22.6%; P < .0001) among patients with cardiogenic shock who underwent TAVR vs. controls, as well as higher rates of stroke. However, readmission for any cause at 30 days and 1 year were similar for both arms.
Longer-term data show safety
Independent predictors of all-cause mortality at 30 days were dialysis at baseline, having a preexisting pacemaker or mechanical assist device before TAVR, peripheral artery disease, older age, lower aortic valve mean gradient, lower Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and lower albumin level.
In landmark analyses beyond 30 days, all-cause mortality was similar in the cardiogenic shock and control arms after 30 days up to 1 year (19.3% vs. 18.5%; HR = 1.07; 95% CI, 0.95-1.21; log rank P = .264).
“Beyond 30 days, the mortality rates were similar in both groups up to 1 year, suggesting that if these patients survived the initial impact of shock, they do remarkably well and as well as the patients undergoing TAVR without cardiogenic shock,” Dhoble said.
Patients with cardiogenic shock also experienced functional improvement similar to controls at 1 year, with more than 90% of patients in both groups improving to NYHA class I or II, as well as improvements in quality of life as reflected in improved KCCQ scores, Dhoble said.
“We have come a long way from the first TAVR that was performed by Dr. [Alain] Cribier in 2002, [a patient] who also had cardiogenic shock at that time,” Dhoble said. “Now, we can at least suggest that the results of this study indicate that the primary TAVR may be an appropriate strategy in select patients with aortic stenosis causing obstructive cardiogenic shock. Efforts should be made not only to avoid delaying TAVR in such patients, but also to prevent cardiogenic shock by earlier recognition of aortic stenosis before the patient progresses to cardiogenic shock.”
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Dhoble A, et al. Late-breaking clinical data: TAVI. Presented at: EuroPCR; May 16-19, 2023; Paris (hybrid meeting).