Redo TAVR may be reasonable option for failed transcatheter heart valves
Key takeaways:
- Patients who underwent a second transcatheter aortic valve replacement had outcomes similar to those with a first TAVR.
- Outcomes were similar whether redo TAVR was performed early or late after the first TAVR.
Patients who underwent a second transcatheter aortic valve replacement were no more likely to experience adverse in-hospital, 30-day and 1-year outcomes than those after a first TAVR, according to an analysis of real-world registry data.
With the expansion of TAVR indications to younger populations, more patients will need a repeat aortic valve replacement in their lifetime, Raj R. Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai, said during a late-breaking clinical trial presentation at EuroPCR. Understanding the performance of redo TAVR procedures can inform decision-making for the initial aortic valve replacement in addition to the redo procedure, Makkar said; however, there are limited data evaluating the safety and efficacy of redo TAVR.
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“Our objective was an analyze real-world experience with redo TAVR using Sapien balloon-expandable valves [Edwards Lifesciences], compare the safety and efficacy of redo TAVR to native TAVR, and determine if outcomes associated with redo TAVR are dependent on the index transcatheter heart valve,” Makkar said during the presentation.
Data show redo TAVR rare
Makkar and colleagues analyzed data from 1,216 patients who underwent redo TAVR, defined as a second TAVR procedure performed at a different date from the index TAVR procedure, using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry of more than 348,000 patients. The median time to redo TAVR for registry patients was 26.25 months. Within the cohort, 475 patients underwent redo TAVR of an Edwards index transcatheter heart valve and 741 patients underwent redo TAVR of a non-Edwards valve.
The researchers used propensity score matching to compare outcomes among redo TAVR and 1,216 native TAVR patients (mean age, 79 years; 57.4% men). The primary endpoint was death and stroke at 30 days and 1 year; secondary endpoints included procedural, in-hospital, echocardiographic and health status outcomes.
Patients who underwent redo TAVR were sicker, with a higher STS risk score compared with native TAVR patients (mean, 8.3 vs. 5.2; P < .01), as well as a higher prevalence of atrial fibrillation, stroke, decreased renal function and frailty, Makkar said.
Implant success was similar in both groups and procedural complications for patients in both groups were low, with less than 0.5% of patients in either group experiencing annulus rupture, need for cardiopulmonary bypass, conversion to open heart surgery, need for a second valve or aortic dissection.
Death, stroke rates similar
For in-hospital outcomes, all-cause death for redo TAVR vs. native TAVR patients was 3.4% vs. 2.3% (P = .11), stroke incidence was 1.7% vs. 1.8% (P = .88) and all-cause death or stroke incidence was 4.7% vs. 3.9% (P = .32).
For 30-day outcomes, all-cause death for redo TAVR vs. native TAVR patients was 4.8% vs. 4.1% (P = .36), stroke incidence was 2% vs. 2.1% (P = .93) and all-cause death or stroke incidence was 6.1% vs. 5.9% (P = .77).
At 1 year, rates of death were 17.7% and 17.2% for the redo TAVR and native TAVR groups, respectively (HR = 0.99; 95% CI, 0.8-1.24; P = .961). Rates of stroke were also similar at 3.5% and 3.3% for redo TAVR and native TAVR, respectively (HR = 0.99; 95% CI, 0.62-1.6; P = .982).
Addressing secondary endpoints, Makkar noted that aortic valve reintervention was more common among patients with redo TAVR vs. native TAVR, but incidence remained rare at 0.6% vs. 0.09% for redo TAVR vs. native TAVR at 30 days (P = .03) and 1.09% vs. 0.21% for redo TAVR vs. native TAVR at 1 year (P = .01), Makkar said. Other secondary outcomes were similar between groups.
Aortic valve mean gradients were higher among patients who underwent redo TAVR compared with native TAVR (mean gradient at discharge, 14 mm Hg vs. 11 mm Hg); however, valve gradients were stable for both groups at 1 year (mean, 15 mm Hg vs. 11.7 mm Hg).
In secondary analyses, Makkar said there were no significant differences in death or stroke among redo TAVR and native TAVR patients regardless of whether the redo TAVR was performed early or late after the first TAVR. Additionally, redo TAVR with balloon-expandable valves resulted in comparable procedural, echocardiographic and clinical outcomes regardless of whether the index valve type was balloon-expandable or non-balloon-expandable, Makkar said.
Makkar noted that the reason for redo TAVR was not available in the TVT registry and that there may be selection bias for higher-risk patients for redo TAVR, who may have been unable to undergo surgical explant. Additionally, when the index valve was not Edwards, the valve type was not known.
“Redo TAVR with balloon-expandable transcatheter heart valves may be a reasonable treatment option for failed transcatheter heart valves,” Makkar said. “Of course, we need further data on long-term outcomes and outcomes stratified according to the initial and subsequent valve types are needed.”
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Makkar RR, et al. Late-breaking clinical data: TAVI. Presented at: EuroPCR; May 16-19, 2023; Paris (hybrid meeting).
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