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Post-Dilatation and Outcomes in PARTNER 2 SAPIEN 3
Study Questions:
Does post-dilating SAPIEN 3 transcatheter aortic valves affect procedural and clinical outcomes?
Methods:
Data were analyzed for 1,661 intermediate- and high-risk patients enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) II SAPIEN 3 observational study. Patients who underwent balloon post-dilatation (BPD) were compared to patients who did not receive BPD. Procedural and clinical outcomes were compared at 30 days and 1 year and included mortality, rehospitalization, and stroke.
Results:
12.5% of all patients had BPD (208/1,661). Patients with BPD had higher Society of Thoracic Surgeons (STS) risk scores, had significantly less oversizing, and had higher left ventricular outflow tract and annular calcification. There was no difference in need for permanent pacemaker placement, annular rupture, or valve embolization. There was significantly more paravalvular regurgitation among patients with BPD. There were no significant differences in 30-day or 1-year mortality, rehospitalization, or stroke.
Conclusions:
BPD is associated with a larger valve area and greater degree of paravalvular regurgitation; however, it is not associated with adverse procedural or clinical outcomes at 1 year.
Perspective:
This analysis highlights the use and safety of PBD. Although there was a signal for increased minor stroke in BPD patients, this finding did not differ between the groups after adjusting for baseline clinical differences. It is reassuring to know that BPD is not associated with procedure-related complications or adverse clinical outcomes at 1 year. Of note, a higher number of patients did receive a second transcatheter valve in the PBD group, most likely reflecting an unacceptable amount of paravalvular regurgitation. It remains to be determined what the longer-term impact of larger aortic valve area with higher paravalvular regurgitation is on clinical outcomes.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine
Keywords: Aortic Rupture, Aortic Valve Insufficiency, Aortic Valve Stenosis, Calcinosis, Dilatation, Heart Valve Diseases, Outcome Assessment, Health Care, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement, Vascular Calcification, Vascular Diseases
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