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BACKGROUND: SAPIEN3 (S3) is a ubiquitous redo-transcatheter aortic valve (TAV) replacement alternative for degenerated Evolut valves, but S3 sizing for S3-in-Evolut remains unclear. We sought to compare the impact of in vivo computed tomography (CT)-sizing on redo-TAV feasibility for S3-in-Evolut with traditional bench-sizing. METHODS: CT scans of 290 patients treated using Evolut R/PRO/PRO+ between July 2015 and December 2021 were analyzed. S3-in-Evolut was simulated using S3 outflow/neoskirt plane (NSP) at node-6, -5, and -4. CT-sizing for S3 was determined by averaging 4 areas of the Evolut stent frame at NSP level and 3 nodes below. Redo-TAV was deemed feasible if the NSP was below the coronaries, or the narrowest valve (virtual S3)-to-aorta distance was >4 mm. Risk of prosthesis-patient mismatch was estimated using predicted indexed-effective orifice area. RESULTS: Compared with bench-sizing, CT-sizing yielded smaller S3 size in 82% at node-6, 81% at node-5, and 84% at node-4. Factors associated with CT-sizing less than bench-sizing were larger index Evolut size, underexpansion of index Evolut, and shallower implant depth (all P<0.05). CT-sizing increased redo-TAV feasibility by +8% at node-6, +10% at node-5, and +4% at node-4. Redo-TAV feasibility increased with annulus size, sinotubular junction dimensions, coronary heights, index Evolut size, deeper Evolut implant depth, and lower NSP levels (all P<0.05). CT-sizing had a slightly higher estimated risk of severe prosthesis-patient mismatch (9% at node-6, 7% at node-5, and 6% at node-4), which could be mitigated by changing the NSP. CONCLUSIONS: CT-sizing for S3-in-Evolut is associated with higher feasibility of redo-TAV compared with bench-sizing, potentially reducing the risk of excessive oversizing and S3 underexpansion. Further validation using real-world clinical data is necessary. [ABSTRACT FROM AUTHOR]

BACKGROUND: Our aim was to assess the feasibility of repeat transcatheter aortic valve (TAV) replacement for degenerated Sapien3 (S3) prostheses by simulating subsequent implantation of S3 or Evolut, using in vivo computed tomography--based sizing and the impact on coronary and patient-prosthesis mismatch risks. METHODS: Computed tomography scans from 356 patients with prior S3 TAV replacement implantation were analyzed. The in vivo sizing for second TAV based on averaged area of 3 levels of outflow, mid (narrowest) and inflow, was compared with in vitro recommendations, that is, same size as index S3 for second S3 and 1 size larger for Evolut. Risks of coronary obstruction and patient-prosthesis mismatch were determined by valve-to-aorta distance and estimated effective orifice area, respectively. RESULTS: Overall, the majority of patients (n=328; 92.1%) had underexpanded index S3 with an expansion area of 94% (91%-97%), leading to significant differences in size selection of the second TAV between in vivo and in vitro sizing strategies. Expansion area <89% served as a threshold, resulting in 1 size smaller than the in vitro recommendations were selected in 45 patients (13%) for S3-in-S3 and 13 (4%) for Evolut-in-S3, while the remaining patients followed in vitro recommendations (P<0.01, in vivo versus in vitro sizing). Overall, 57% of total patients for S3-in-S3 simulation and 60% for Evolut-in-S3 were considered low risk for coronary complications. Deep index S3 implantation (odds ratio, 0.76 [interquartile range, 0.67-0.87]; P<0.001) and selecting Evolut as the second TAV (11% risk reduction in intermediate- or high-risk patients) reduced coronary risk. Estimated moderate or severe patient-prosthesis mismatch risk was 21% for S3-in-S3 and 1% for Evolut-in-S3, assuming optimal expansion of the second TAV. CONCLUSIONS: Redo-TAV replacement with S3-in-S3 and Evolut-in-S3 could be feasible with low risk to coronaries in ≈60% of patients, while the remaining 40% will be at intermediate or high risk. The feasibility of redo-TAV replacement is influenced by sizing strategy, type of second TAV, native annular anatomy, and implant depth. [ABSTRACT FROM AUTHOR]

BACKGROUND: Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR. METHODS: The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR. RESULTS: At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% (P<0.0001). CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients. [ABSTRACT FROM AUTHOR]

Background: Consensus-driven criteria have recently been proposed for prediction of mitral transcatheter edge-to-edge repair outcomes, yet validation for response to therapy is needed. We examined the relation between contemporary criteria and outcomes with mitral transcatheter edge-to-edge repair therapy. Methods: Mitral transcatheter edge-to-edge repair patients were classified according to anatomic and clinical criteria (1) Heart Valve Collaboratory criteria for nonsuitability; (2) commercial indications (suitable); and (3) neither (ie, intermediate). Analyses for Mitral Valve Academic Research Consortium–defined outcomes of reduction in mitral regurgitation and survival were performed. Results: Among 386 patients (median age, 82 years; 48% women), the most common classification was intermediate (46%), with 138 patients (36%) and 70 patients (18%) in the suitable and nonsuitable categories, respectively. Nonsuitable classification was related to prior valve surgery, smaller mitral valve area, type IIIa morphology, larger coaptation depth, and shorter posterior leaflet. Nonsuitable classification was associated with less technical success (P <0.001) and survival free of mortality, heart failure hospitalization, and mitral surgery (P <0.001). Among the nonsuitable patients, technical failure or any 30-day major adverse cardiac event occurred in 25.7%. Nevertheless, in these patients, acceptable mitral regurgitation reduction without adverse events still occurred in 69%, and their 1-year survival with mild or no symptoms was 52%. Conclusions: Contemporary classification criteria identify patients less suitable for mitral transcatheter edge-to-edge repair with respect to acute procedural success and survival, though patients most commonly fit an intermediate category. In experienced centers, sufficient mitral regurgitation reduction can be achieved safely in the selected patients even with challenging anatomy. [ABSTRACT FROM AUTHOR]

Background: Although transcatheter edge-to-edge repair (TEER) is effective and safe, there is a need for better prediction of optimal outcomes. We aimed to determine predictors of optimal reduction in mitral regurgitation (MR) and survival with TEER. Methods: We examined mitral anatomy and its change with TEER on outcomes in 183 patients (age, 82 [77–87] years; 53% women). Coaptation reserve was measured as the distance of continuous apposition of the A2 and P2 leaflet segments in 2-dimensional apical long-axis imaging at the site of the predominant jet of MR. Augmentation in coaptation was measured as the total amount of leaflet insertion. Addressable coaptation area was calculated using the physical boundaries of the TEER device. Results: Coaptation reserve, its augmentation, and addressable coaptation area were strong predictors of MR reduction (all P <0.001), as well as heart failure hospitalization and death. For patients with either mild or no residual MR, median values for coaptation reserve, its augmentation, and addressable coaptation area were 3.7 (2.8–4.5) mm, 7.3 (5.2–9.5) mm, and 59.0 (48.0–71.8) mm2, respectively. Receiver operating characteristic analyses determined the best values for optimal MR reduction as a coaptation reserve of >3.0 mm (P <0.001), addressable coaptation area of ≥52 mm2 (P <0.001), and coaptation augmentation of ≥4.7 mm (P <0.001). These values were associated with greater 2-year survival free of all-cause mortality and persisting even in analyses restricted to those with mild or no residual MR after TEER. Conclusions: Coaptation reserve and its augmentation are simple, independent parameters that predict optimal MR reduction and better survival in patients undergoing TEER. These findings may have implications for patient selection and expanded use of the therapy. [ABSTRACT FROM AUTHOR]

Background: Hypoattenuated leaflet thickening (HALT), identified on functional cardiac computed tomography (CTA), can affect valve function and clinical outcomes. The objective of this study was to assess the impact of HALT on clinical outcomes in patients treated with transcatheter aortic valve replacement (TAVR). Methods: In July 2015, Minneapolis Heart Institute implemented prospective screening of HALT at 30-day post-TAVR with CTA. Patients with evidence of HALT were recommended to initiate anticoagulation for 3 to 6 months with warfarin. Echocardiographic, ischemic, and bleeding outcomes were compared between HALT+ and HALT− patients. Survival rates were compared between HALT+ and HALT− patients using log-rank test, with Cox regression analysis used to identify variables independently associated with long-term death landmarked at time of CTA. This analysis included patients treated from July 1, 2015 to October 31, 2019. Results: Of 856 patients undergoing TAVR during the study period, 638 (75%) underwent CTA post-TAVR (median time 31 [30–37] days). HALT+ was evident in 79 (12.3%). HALT+ patients were more likely prescribed warfarin at 1, 3, and 12 months (all P <0.001) and had similar gradients compared with HALT− patients. After a median follow-up of 2.2 years (1.5-3.2), HALT+ patients had increased mortality (30% versus 20%; P =0.001). In Cox regression analysis, presence of HALT (hazard ratio, 1.83 [95% CI, 1.13–2.97]; P =0.014) remained independently associated with long-term mortality. Conclusions: In a large, real-world cohort of patients receiving TAVR followed by systematic screening with CTA 30-days post-procedure, HALT was found in 12% of patients and independently associated with long-term mortality. Findings of this nonrandomized, observational cohort study require independent validation. [ABSTRACT FROM AUTHOR]