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Outcomes of TAVR in Patients With Bicuspid Aortic Valve
Study Questions:
How do the short-term outcomes differ for transcatheter aortic valve replacement (TAVR) in patients with bicuspid versus tricuspid aortic valve?
Methods:
This is a retrospective review of the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry comparing TAVR performed in patients with tricuspid versus bicuspid aortic valves (BAVs). Patients with aborted procedures, prior aortic valve replacement, and other valve morphologies (unicuspid, quadricuspid, uncertain) were excluded. Valve prostheses were stratified by early and current generation devices. Outcomes analyzed were: success of device implantation; valve performance; in-hospital mortality, stroke, and major bleeding; and length of stay. STS/ACC TVT Registry data were linked to Medicare data to determine incidence of mortality and stroke out to 1 year. Kaplan-Meier method and multivariable Cox proportional hazards modeling were used to assess the association between valve morphology and mortality. For stroke, death was treated as a competing risk. The models were heavily adjusted for baseline characteristics that differed significantly between the two groups.
Results:
Of 198,436 patients who underwent TAVR from November 2011-November 2018, 170,959 patients were included in the analysis after exclusions. Valve morphology was assessed by computed tomographic angiography (70.2%), transesophageal echocardiography (11.7%), transthoracic echocardiography (11.0%), or angiography (0.34%). A total of 5,412 were determined to have BAV. Compared to patients with tricuspid aortic valve, patients with BAV were younger (74 vs. 82 years), had lower STS Predicted Risk of Mortality (3.8% vs. 5.6%), and had slightly larger annular size (25 mm vs. 24 mm) (p < 0.001 for all). Eighty-one percent of procedures were performed with current generation devices (Sapien 3 and Evolut R), with the Sapien 3 valve used in the majority of procedures for both tricuspid (73.4%) and bicuspid (68.9%) aortic valves. Device success was slightly lower in the BAV group (96.0% vs. 96.7%, p = 0.004), with more BAV patients requiring deployment of a second device (1.7% vs. 1.2%, p = 0.002). BAV patients had a slightly higher mean valve gradient post-procedure (10 mm Hg vs. 9 mm Hg, p < 0.001), but valve area was not significantly different. For all generation devices, more patients with BAV had residual moderate or worse aortic insufficiency (4.7% vs. 3.5%, p < 0.001). With current generation devices, the incidence of paravalvular aortic insufficiency decreased, with slightly higher incidence in BAV patients compared to patients with tricuspid aortic valve (2.7% vs. 2.1%, p = 0.006). There were no differences in in-hospital mortality, stroke, or major bleeding or in length of stay between the two groups. At 1 year, the adjusted hazard radio (HR) for death was slightly lower in patients with BAV (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.78-0.99), while the adjusted HR for stroke was no different (HR, 1.14; 95% CI, 0.94-1.39).
Conclusions:
In the STS/ACC TVT Registry, patients with BAV who underwent TAVR had comparable outcomes to those of patients with tricuspid aortic valve, especially with current generation devices.
Perspective:
First, this is an analysis of patients with BAV who were deemed by a Heart Team to be at higher risk for mortality from surgical aortic valve replacement and were therefore eligible to undergo commercial TAVR. Patients with BAV who were not high-risk surgical candidates and were enrolled in a clinical trial registry are not included in the STS/ACC TVT database, so the results of this analysis cannot be broadly applied to all patients with BAV, and especially not for those BAV patients with aortic root and/or ascending aortic dilation for whom concomitant aortic replacement might be recommended. Second, Medicare claims data were used to help determine 1-year outcomes for the patients, so these results would not apply to younger patients with BAV who are not enrolled in Medicare.
There has certainly been an evolution in the application of TAVR to patients with BAV with regard to device sizing, selection, and positioning/deployment as well as advancements in the devices themselves. With current generation devices, the results in this cohort of patients were quite good, which means that higher-risk patients with BAV need not necessarily be excluded, just because of valvular morphology, from the benefits of TAVR. For lower-risk patients with BAV, long-term valve durability and ramifications of a higher incidence of permanent pacemaker placement with TAVR still need to be determined.
The authors mention several limitations of the study that are important to note: BAV morphology was determined by transthoracic echo in about 12% of patients and overall, morphology was not centrally adjudicated; information regarding specific Sievers type was not available, and post-TAVR echocardiogram data were missing in 12% of patients in the analysis. Also, type of TAVR valve used was missing in about 20% of patients.
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, Angiography, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Angiography, Aortic Valve Insufficiency, Bicuspid, Cardiac Surgical Procedures, Echocardiography, Echocardiography, Transesophageal, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Hospital Mortality, Pacemaker, Artificial, Stroke, STS/ACC TVT Registry, Tomography, X-Ray Computed, Transcatheter Aortic Valve Replacement, Tricuspid Valve, Tricuspid Valve Insufficiency
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