Outcomes After TAVR in High- and Intermediate-Risk Patients With Aortic Stenosis
What are the early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement (TAVR) in inoperable, high-risk (HR), and intermediate-risk (IR) patients with aortic stenosis (AS)?
Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1,078 IR) were enrolled in a multicenter, nonrandomized registry at 57 sites in the United States and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1,443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. Time-to-event variables are presented as Kaplan–Meier estimates, using all available follow-up.
The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, p < 0.0001) and 54.7 to 74.0 (IR, p < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mm Hg at baseline to 11.4 mm Hg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm2.
The authors concluded that the SAPIEN 3 transcatheter heart valve (THV) system was associated with low rates of 30-day mortality and major/disabling stroke, as well as low rates of moderate or severe paravalvular regurgitation.
This prospective cohort study reports that treatment of HR/inoperable and IR AS patients with the new SAPIEN 3 THV was associated with low rates of 30-day mortality, stroke, and repeat hospitalization; significant improvements in symptoms, quality of life, and functional status; low rates of procedural complications including aortic/annulus rupture, coronary occlusion, valve embolization, or valve-in-valve implants; low rates of significant aortic regurgitation but higher than previously observed rate of new permanent pacemakers; and shorter duration length of hospital stay. These and other contemporary data would suggest that TAVR should be a preferable modality in HR/inoperable patients with AS and may be considered an alternative to surgery in many elderly IR patients as well. Longer-term follow-up and future prospective studies in even lower risk patients will help determine the role of TAVR and surgical AVR in the treatment strategy of all patients with severe AS.
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