Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial.

BACKGROUND: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. METHODS: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint. RESULTS: At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling). CONCLUSION: SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.

Diastolic Dysfunction and Health Status Outcomes After Transcatheter Aortic Valve Replacement.

Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. Results: Of 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). Conclusions: Change in LVDD grade was associated with change in health status 1 year following TAVR.

Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure: Placement of Aortic Transcatheter Valves 3 Aortic Valve-in-Valve Study.

Background: Transcatheter aortic valve implantation is safe and effective for high-risk patients with bioprosthetic valve failure (BVF) but has not been studied in low- and intermediate-risk patients. One year outcomes of the PARTNER 3 Aortic Valve-in-valve (AViV) Study were evaluated. Methods: This prospective, single-arm, multicenter study enrolled 100 patients from 29 sites with surgical BVF. The primary endpoint was a composite of all-cause mortality and stroke at 1 year. The key secondary outcomes included mean gradient, functional capacity, and rehospitalization (valve-related, procedure-related, or heart failure related). Results: A total of 97 patients underwent AViV with a balloon-expandable valve from 2017 to 2019. Patients were 79.4% male with a mean age of 67.1 years and Society of Thoracic Surgeons score of 2.9%. The primary endpoint occurred in 2 patients (2.1%) who had strokes; there was no mortality at 1 year. Five patients (5.2%) had valve thrombosis events, and 9 patients (9.3%) had rehospitalizations, including 2 (2.1%) for strokes, 1 (1.0%) for heart failure, and 6 (6.2%) for aortic valve reinterventions (3 explants, 3 balloon dilations, and 1 percutaneous paravalvular regurgitation closure). From baseline to 1 year, New York Heart Association class III/IV decreased from 43.3% to 4.5%, mean gradient from 39.1 ± 18.2 mm Hg to 19.7 ± 7.6 mm Hg, and ≥moderate aortic regurgitation from 41.1% to 1.1%. Conclusions: AViV with a balloon-expandable valve improved hemodynamic and functional status at 1 year and can provide an additional therapeutic option in selected low- or intermediate-risk patients with surgical BVF, although longer term follow-up is necessary.

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The population structure, regeneration ways and spatial relationships of six relict deci-duous broadleaved trees were examined based on community investigation on Mount Tianmu, East China. The results showed that relict deciduous broadleaved trees had a strong ability of vegetative reproduction and their population structure was generally belonged to intermittent type. Some relict species such as Cyclocarya paliurus and Liquidamb aracalycina regenerated discontinuously at appropriate sites via long-distance diffusion. Some species such as Emmenoptery henryi and Euptelea pleiospermum regenerated discontinuously around mature trees due to habitat limitation and frequent disturbance. After occupying forest gaps by seedling regeneration, C. paliurus, L. acalycina, Nyssasinensis and Liquidambar formosana could recruit and form multi-stemmed individuals by their inherent sprouting ability at relatively stable sites such as crest slope and side slope. At riverbed, valley slope and head hollow, recognized as unstable habitats, Emmenopterys henryi, E. pleiospermum, and L. formosana could also recruit by strong sprouting ability due to sparse seedlings and individual loss incurred by disturbance. Therefore, the relict deciduous broadleaved trees could be classified into two ecological species groups (repairment species for forest gap and supplement species for special habitat) based on spatial distribution and strategy of regeneration and competition. We suggested that the protection of special habitats of their communities should be strengthened.