Outcomes After TAVR in High- and Intermediate-Risk Patients With Aortic Stenosis

Study Questions:

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)?

Methods:

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.

Results:

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.

Conclusions:

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.

Perspective:

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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