Although valve failure is rare, patients who had to undergo re-operation were at risk of negative outcomes.
Although early transcatheter aortic valve malfunction or failure is rare, patients who do experience early valve failure and require surgical valve aortic valve replacement often experience worse outcomes than patients who received the surgical treatment option from the outset.
These findings were detailed in a paper recently published in Journal of the American College of Cardiology: Cardiovascular Interventions and led by DCRI fellow Oliver Jawitz, MD, MHS.
The study team examined a group of 123 patients from the Society of Thoracic Surgeons Adult Cardiac Surgery Database to identify patients who had received transcatheter aortic valve replacement (TAVR) prior to surgical aortic valve replacement (SAVR).
Common reasons for re-operation included TAVR device failures such as paravalvular leak, structural prosthetic deterioration, failed repair, sizing/position issues, and prosthetic valve endocarditis. Seventy-six percent of the patients had symptoms of heart failure within two weeks prior to the SAVR procedure.
The study team stratified patients based on their pre-operative risk of mortality, with 17 percent at low risk, 24 percent at intermediate risk, and 59 percent at high risk. Low and intermediate risk patients were more likely to undergo SAVR as an elective procedure rather than an emergency procedure.
Seventeen percent of the study cohort died within 30 days of receiving SAVR, including 14 percent of the low-risk group, 10 percent of the intermediate risk group, and 21 percent of the patients with high risk. Postoperative morbidity was also common, with 10 percent experiencing new renal failure, 15 percent requiring new permanent pacemaker or ICD placement, and 41 percent requiring prolonged (longer than 24 hours) ventilation.
Although the introduction of transcatheter aortic valves in 2002 gave patients with aortic valve stenosis a non-surgical option to manage their condition, Jawitz said these results indicate there is still much to learn about these relatively novel devices, especially as their use becomes more prevalent and expands to lower-risk patients.
Further, SAVR after TAVR is a complex, highly technical procedure requiring long operative times with increased perioperative morbidity and much higher than expected operative mortality. “These mortality rates were higher than we expected to see across the spectrum of pre-operative risk,” Jawitz said. “Although valve failure is relatively rare, there is more work to be done to gain a more complete understanding of the mechanisms of device failures and to refine re-operation techniques.”
Additional DCRI and Duke contributors to this study include Maria Grau-Sepulveda, MD, MPH; Roland Matsouaka, PhD; and J. Matthew Brennan, MD, MPH.
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