Bioprosthetic valve fracture (BVF) as an adjunct to valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding, with modest improvements in echocardiography-derived hemodynamic status, and the timing of BVF is a key factor in the procedure’s safety and efficacy, new study results show.
Adnan K. Chhatriwalla, MD, Keith B. Allen, MD, from St. Luke’s Mid America Heart Institute and the University of Missouri, Kansas City, and colleagues, reported these findings in a manuscript published Monday online and in the March 13 issue of JACC: Cardiovascular Interventions.
The authors assessed the safety and efficacy of VIV TAVR using the SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry.
VIV TAVR)has emerged as an important alternative to reoperation for the treatment of failed bioprosthetic valves, which is associated with significant operative risks. Despite the safety of VIV TAVR, patient-prosthesis mismatch (PPM) after VIV TAVR is a potential limitation and is associated with worse clinical outcomes, especially in patients with smaller surgical valves. BVF is a technique that intentionally disrupts the stent frame of the surgical heart valve (SHV) to optimize expansion of the transcatheter heart valve (THV). BVF has been shown in the past to reduce residual gradients and increase the effective orifice area after VIV TAVR.
A total of 2,975 patients underwent VIV TAVR from Dec. 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (odds ratio [OR]: 2.51; 95% confidence interval [CI]: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after THV implantation), BVF after THV implantation was associated with improved hemodynamic status and similar mortality.
This study represents the largest cohort of patients to date who underwent BVF as an adjunct to VIV TAVR. The authors noted several important findings.
First, BVF is commonly performed as an adjunct to VIV TAVR in the United States, particularly in patients with small surgical valves (30% frequency). Second, institutional volumes of attempted BVF are relatively low, with fewer than 35 hospitals performing five or more BVF procedures per year. Third, in adjusted analyses, in-hospital and 30-day mortality, cardiac death, all-cause death or stroke, and life-threatening bleeding were higher in patients who underwent VIV TAVR with attempted BVF compared with those who underwent VIV TAVR without BVF. However, these differences were numerically smaller and not statistically significant in patients who underwent BVF after THV implantation, compared with patients in whom BVF was not attempted, suggesting that procedural technique plays an important role in the safety of the procedure. Last, although significant differences in valve area and valve gradient were observed in patients who underwent BVF following THV implantation compared with patients in whom BVF was not attempted, no differences were seen in patients in whom BVF was attempted prior to THV implantation. This suggests that procedural technique plays a key role in the efficacy of BVF as well.
The study concludes that the use of BVF as an adjunct to VIV TAVR with SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality, excess bleeding, modest reduction in echocardiographic valve gradient, and gain in valve area.
The authors suggest that when clinically indicated, BVF should be performed after, rather than before, THV implantation.
An editorial comment by Didier Tchetche, MD and Chiara de Biase, MD, from Clinique Pasteur, Toulouse, France, was published in the same issue.
The editorial comment congratulates the investigators for the key information provided.
However, the editorialists emphasized that the study has several limitations, the most important being the focus on balloon-expandable valves and a specific type of surgical bioprosthesis. Also, longer-term follow-up is required to understand any effect of BVF on TAVR durability, they added.
The editorial comment suggests that BVF, after a new TAVR device is placed, may abrade or tear the leaflets or sutures of the device, with a potential impact on durability, and that BVF carries the risk for coronary obstruction. New leaflet modification devices such as the ShortCut leaflet splitting device, aimed at preventing coronary obstruction, will likely be part of future VIV procedures, according to Tchetche and de Biase.
Chhatriwalla AK, Allen KB, Depta JP, et al. Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR. JACC Cardiovasc Interv. 2023;16:530–539.
Tchetche D, de Biase C. Bioprosthetic Valve Fracture: Timing Matters. JACC Cardiovasc Interv. 2023;16:540–541.
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