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TAVR Outcomes With a 20 mm Balloon-Expanding Device
Study Questions:
What are the outcomes of a balloon-expandable transcatheter aortic valve replacement (TAVR) device in patients with native aortic stenosis (AS) and a small annulus or prior small bioprosthetic valve?
Methods:
This study examined outcomes in a subset of 55 patients from a multicenter registry treated with a small 20 mm balloon-expandable TAVR device. This included patients treated with TAVR for native AS (n = 30) and for degeneration of a prior bioprosthetic aortic valve replacement (n = 25).
Results:
Median Society of Thoracic Surgeons score was 7.8%. For patients with native AS, mean annular diameter was 19 ± 1 mm, while mean internal diameter for bioprosthetic valves was 17 ± 1 mm. Successful TAVR implantation was observed in 96% of cases, with no early mortality events. Overall 30-day death, stroke, and major bleeding events were observed in 3%, 3%, and 7% of patients with native AS; and in 8%, 0%, and 12% of patients treated with valve-in-valve procedures, respectively. A postprocedural mean gradient >20 mm Hg was observed in 10% with native AS and 60% with valve-in-valve procedures (p < 0.001). Change in mean transaortic gradient was -40 ± 18 mm Hg for native AS and -21 ± 16 mm Hg for valve-in-valve procedures, and severe patient-prosthesis mismatch was observed in 10% of patients with native AS and 48% of patients with valve-in-valve procedures (p = 0.03). Postprocedural rates of at least moderate aortic regurgitation were 7% and 0% for native AS and valve-in-valve procedures, respectively.
Conclusions:
TAVR using a 20 mm device has high rates of procedural success, low rates of significant aortic regurgitation, and low rates of adverse events at 30 days. Rates of patient-prosthesis mismatch were low for patients with native AS, although this was observed in nearly half of patients undergoing valve-in-valve procedures.
Perspective:
This really represents two separate studies, one examining the outcomes of patients with native AS and a small annulus treated with a new 20 mm TAVR device, and one examining the outcomes of patients with degenerated small bioprosthetic valves treated with valve-in-valve implantation. In patients with native AS, the outcomes were acceptable, with low rates of adverse 30-day events, patient-prosthesis mismatch, and significant aortic regurgitation, and a significant improvement in valve hemodynamics. In contrast, patients with degenerated bioprosthetic valves treated with valve-in-valve procedures had smaller improvements in valve hemodynamics, and nearly half had patient-prosthesis mismatch. While 30-day outcomes were acceptable, long-term outcomes may be worse based on these findings, and will be important to report. These findings suggest caution in the use of these small devices for valve-in-valve procedures.
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Hemorrhage, Stroke, Transcatheter Aortic Valve Replacement
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