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Balloon-Expanding vs. Self-Expanding Valve-in-Valve TAVR
Quick Takes
- In a relatively small prospective, randomized, multicenter trial among patients undergoing ViV TAVR for a failed small (≤23 mm; ≤21 mm inner diameter) surgical stented bioprosthesis, intervention with a self-expanding device was associated with better 30-day echo/Doppler valve hemodynamics compared to a balloon-expanding device.
- There were no differences between groups in intraprocedural invasive valve hemodynamics or 30-day clinical outcomes.
- The discrepant findings between invasive hemodynamics during TAVR compared to echo/Doppler results at 30 days could be attributable to echo/Doppler measurements affected by pressure recovery and/or invasive measurements confounded by nonrepresentative hemodynamics during and immediately after intervention.
Study Questions:
What are the comparative hemodynamic results after balloon-expandable (BE) versus self-expanding (SE) valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) among patients with a failed small surgical stented bioprosthetic aortic valve?
Methods:
In a prospective, randomized trial conducted at 11 centers in the United States, Canada, and Europe (European Union) between 2017–2022, patients with a failed small (≤23 mm; ≤21 mm inner diameter) surgical stented bioprosthesis were randomized to receive a BE (Sapien [3/Ultra]; Edwards Lifesciences) or an SE (Evolut [R/Pro/Pro+]; Medtronic) ViV TAVR. Patients with a failed stentless or sutureless valve were excluded. The primary endpoint was echocardiography/Doppler valve hemodynamics (maximal and mean gradient, severe prosthesis-patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days. The protocol was amended to add a hemodynamic invasive substudy at the time of ViV TAVR; secondary outcomes included invasive hemodynamic measurements during TAVR and clinical endpoints (death, stroke, major or life-threatening bleeding, pacemaker implantation, myocardial infarction) at 30 days.
Results:
A total of 102 patients were randomized, of which 98 underwent ViV TAVR (n = 46 BE, n = 52 SE). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SE-TAVR group had lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs. 23 ± 8 mm Hg, p ˂ 0.001; 28 ± 16 mm Hg vs. 40 ± 13 mm Hg, p ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs. 64%, p = 0.07). There were no cases of moderate-severe aortic regurgitation. Of 55 consecutive patients (n = 27 SE, n = 28 BE) who underwent invasive valve hemodynamic evaluation during the TAVR procedure, there were no differences in mean and peak transvalvular gradients between groups (p = 0.41 and p = 0.70, respectively).
Conclusions:
Among patients with small failed aortic bioprostheses, ViV TAVR with an SE (vs. a BE) device was associated with improved valve hemodynamics and a tendency towards a lower incidence of severe PPM as evaluated by echocardiography at 30 days. There were no differences between groups in intraprocedural invasive valve hemodynamics or 30-day clinical outcomes.
Perspective:
This relatively small, multicenter, randomized, prospective study among patients with a small (inner diameter ≤21 mm) aortic valve bioprosthesis found that ViV TAVR with an SE device was associated with better 30-day echo/Doppler valve hemodynamics compared to a BE device. Invasive hemodynamics acquired in a subset of patients during the ViV TAVR procedures revealed lower gradients compared to echo/Doppler measurements, with differences that tended to be higher after BE TAVR compared to SE TAVR; and did not show differences in gradients between the SE and BE groups. Previous studies among patients with native valve aortic stenosis have shown superior valve hemodynamics after SE compared to BE TAVR, especially among patients with a small aortic annulus; this study suggests that the same may be true among patients undergoing ViV TAVR in the setting of a small surgical aortic valve bioprosthesis. The discrepant findings in this study between invasive hemodynamics during TAVR compared to echo/Doppler results at 30 days could be attributable to echo/Doppler measurements affected by pressure recovery and/or invasive measurements confounded by nonrepresentative hemodynamics during and immediately after intervention.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Valve Diseases, Hemodynamics, Hemorrhage, Myocardial Infarction, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement
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