Faculty Bibliography

OBJECTIVES/OBJECTIVE:The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND:Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm. METHODS:Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS:, and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS:Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Background: The SURTAVI trial is a prospective, multicenter, randomized clinical trial (RCT) that confirmed the noninferiority of transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Following completion of enrollment in the randomized trial, eligible patients were enrolled in the SURTAVI continued access study (CAS) in order to obtain additional data on the use of the second generation Evolut-R bioprosthesis. Our aim was to compare clinical outcomes and hemodynamics of patients in the CAS versus TAVR arm of the RCT (TAVR-RCT).
Method(s): Eligible patients were required to have a predicted risk for 30-day surgical mortality of >=3% and <15%. The SURTAVI RCT predominantly used the first-generation CoreValve (n = 724) and less frequently next-generation Evolut R device (n = 139) whereas the SURTAVI CAS treated 255 of 275 patients with Evolut R and only 20 patients with a 31-mm CoreValve device.
Result(s): Baseline characteristics of the CAS and RCT patients included mean age (79.0 +/- 6.1 vs. 79.9 +/- 6.2 years), sex (male: 46.2% vs. 57.6%), and mean Society of Thoracic Surgeons score (4.1 +/- 1.5 vs. 4.4 +/- 1.5). When compared with the RCT results without any adjustments, the 30-d and 2-y rates of all-cause mortality, disabling stroke, aortic valve hospitalization, and permanent pacemaker implantation were numerically lower in the CAS population (Table). Hemodynamic performance was comparable between RCT and CAS patients at 2 years. [Formula presented]
Conclusion(s): TAVR with the supra-annular, self-expandable Evolut R prosthesis compared with first-generation CoreValve in intermediate-risk patients resulted in numerically improved 30-days and 2-years clinical outcomes, lower rates of permanent pacemaker implantation and excellent hemodynamic performance. Categories: STRUCTURAL: Valvular Disease: Aortic
Copyright

PURPOSE OF REVIEW/OBJECTIVE:We review the prevalence; natural history; impact of subclinical clinical thrombosis on valve hemodynamics, clinical outcomes, and valve durability; and the role of anticoagulation after transcatheter aortic valve replacement (TAVR). RECENT FINDINGS/RESULTS:Subclinical leaflet thrombosis is a dynamic finding present in both transcatheter and surgical bioprosthetic aortic valves. This finding is less prevalent in patients on anticoagulation and resolves following initiation of anticoagulation. Routine anticoagulation after TAVR in high-surgical-risk patients was associated with increased mortality and thromboembolic complications. In the absence of a clinical indication for anticoagulation, there is no reason to initiate anticoagulation after TAVR for the prevention of subclinical leaflet thrombosis. In patients with an established indication for anticoagulation, for instance, atrial fibrillation, clinical or symptomatic valve thrombosis, or a clinical event related to valve thrombosis, anticoagulation should be initiated or continued after TAVR to treat the clinical indication.

BACKGROUND:Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS:In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS/RESULTS:=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION/CONCLUSIONS:The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING/BACKGROUND:Abbott.

BACKGROUND:Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES/OBJECTIVE:This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS:Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS:A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS:Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).

OBJECTIVES/OBJECTIVE:This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND:TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves. METHODS:The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves. Clinical and echocardiographic outcomes were analyzed through 1-year follow-up. RESULTS:Between July 2015 and September 2018 a total of 932 patients with bicuspid aortic valve stenosis underwent elective TAVR with the self-expanding Evolut R or Evolut PRO valve. These patients were compared with a group of 26,154 patients with tricuspid aortic stenosis who underwent TAVR during that same time period. At baseline, patients with bicuspid valves were younger, had fewer cardiac comorbidities, and had lower Society of Thoracic Surgeons Predicted Risk of Mortality scores (5.3 ± 4.2% vs. 6.9 ± 4.8%; p < 0.001). To account for these differences, propensity matching was performed, which resulted in 929 matched pairs. Within these match groups, the rates of all-cause mortality at 30 days (2.6% vs. 1.7%; p = 0.18) and 1 year (10.4% vs. 12.1%; p = 0.63), as well the rate of stroke at 30 days (3.4% vs. 2.7%; p = 0.41) and 1 year (3.9% vs. 4.4%; p = 0.93), were comparable. CONCLUSIONS:All-cause mortality, stroke, and valve hemodynamics did not differ at 30 days or 1 year between patient groups. In patients at increased surgical risk, TAVR for bicuspid aortic valve stenosis indicates acceptable safety outcomes with low complications rates.

BACKGROUND:Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES/OBJECTIVE:The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS:The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS:The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS:Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.