Faculty Bibliography

IMPORTANCE/UNASSIGNED:Transcatheter tricuspid valve replacement (TTVR) demonstrated superior outcomes over medical therapy in patients with severe tricuspid regurgitation (TR) in the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device II (TRISCEND II) randomized clinical trial, and received regulatory approval in the US in 2024. Contemporary real-world data on its effectiveness and safety remain limited. OBJECTIVE/UNASSIGNED:To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. DESIGN, SETTING, AND POPULATION/UNASSIGNED:Retrospective cohort study of all consecutive patients who underwent TTVR in the US from February 2024 through March 2025 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients had symptomatic, severe TR despite optimal medical therapy and TTVR was deemed appropriate by a heart team. Statistical analysis was conducted from September 2025 to February 2026. EXPOSURE/UNASSIGNED:Device-enabled TTVR. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Thirty-day event rates (all-cause death, stroke, bleeding, new cardiac implantable electronic device [CIED] implantation, heart failure hospitalizations), TR reduction, and changes in health status (New York Heart Association [NYHA] functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS] score) are reported. Subgroup analyses examined the impact of baseline CIED status on outcomes. RESULTS/UNASSIGNED:Among 1034 attempted procedures at 82 centers (mean [SD] age, 77.1 [10.6] years; 69.1% female; 73.2% NYHA functional class III/IV), a valve was successfully implanted in 1017 patients (98.4%). Mild or less TR was achieved in 98.4% of patients post procedure and in 97.7% at 30 days. At 30 days, all-cause mortality was 3.1%; stroke, 0.2%; bleeding, 7.9%; new CIED, 15.9% in CIED-naive patients; and heart failure hospitalization, 3.1%. There were significant improvements in NYHA functional class (class I/II, 82.7%; P < .001) and mean KCCQ-OS score (22.4 points; P < .001) from baseline to 30 days. There were no significant differences in 30-day mortality (P = .47), heart failure hospitalization (P > .99), and functional outcomes (P = .55) when patients were stratified by baseline CIED status. CONCLUSIONS AND RELEVANCE/UNASSIGNED:Early US real-world experience with TTVR confirms safety and effectiveness in patients with severe TR. Thirty-day outcomes are consistent with the TRISCEND II pivotal trial, demonstrating acceptable safety, near-complete TR elimination, and significant health status improvements in an older, comorbid population. Rates of new CIED implantation and bleeding were lower than randomized clinical trial experience.

BACKGROUND AND AIMS/OBJECTIVE:The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy versus medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity. METHODS:The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR and randomised 2:1 to TTVR (n=267) or control (n=133). In a post-hoc analysis, patients were stratified into severe TR (n=172) and massive/torrential TR (n=220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalisation assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board. RESULTS:One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe (1.64 [95% CI: 1.11, 2.43]) and massive/torrential (2.20 [1.55, 3.14]). At 18 months, TTVR patients had similar mortality to controls (rate difference: severe 0.2% [-11.6, 11.9], massive/torrential -5.8% [-17.6, 6.0], whereas HF hospitalisation rates favoured TTVR in the massive/torrential cohort (vs. control, severe 9.8% [-3.0, 22.7], massive/torrential -15.2% [-28.9, -1.5]). CONCLUSIONS:Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.

BACKGROUND:A novel intra-annular, self-expanding transcatheter heart valve was introduced in the U.S. market in 2023 for treating native aortic stenosis in high- or extreme-risk patients. OBJECTIVES/OBJECTIVE:The authors sought to report early real-world experience with the Navitor valve (Abbott Structural Heart) from the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry). METHODS:Baseline, procedural, and follow-up data were prospectively collected and retrospectively analyzed. The primary outcome was a composite of all-cause mortality or stroke at 30 days. Additional safety and effectiveness outcomes were reported per registry definitions. RESULTS:; moderate or greater PVL occurred in 1.8%. Analysis of case volume showed reduced PPI rate with site experience beyond 20 cases for Navitor Classic (19.4% vs 13.5%; P = 0.0039) and Vision (19.1% vs 10.6%; P = 0.047). Kansas City Cardiomyopathy Questionnaire Overall Summary score improved by 23.8 points from 52.1 ± 24.8 at baseline to 75.9 ± 22.6 at 30 days (P < 0.0001). CONCLUSIONS:Early U.S. experience with the Navitor valve demonstrates favorable early clinical and hemodynamic outcomes, with improved PPI rate associated with procedural experience.

BACKGROUND/UNASSIGNED:Although infective endocarditis during pregnancy is rare, it carries significant morbidity and mortality for both mother and foetus. While professional societies provide recommendations for the treatment of infective endocarditis, there are no specific guidelines for the management of pregnancy-associated infective endocarditis. In this report, we present two cases of infective endocarditis presenting during the second trimester of pregnancy that required surgical intervention, focusing on the unique considerations when caring for pregnant individuals. CASE SUMMARIES/UNASSIGNED:Two patients in the second trimester of pregnancy presented with fevers and malaise. Both were found to have positive blood cultures and mitral valve vegetations, leading to diagnoses of mitral valve endocarditis. Their hospital courses were complicated by embolic strokes, and one patient required transcatheter embolization of a mycotic aneurysm. Both patients underwent surgical valve replacements with bioprosthetic valves. Ultimately, both patients delivered at term without complication. DISCUSSION/UNASSIGNED:In addition to the standard management of infective endocarditis, pregnancy-associated infective endocarditis requires multidisciplinary collaboration regarding the relative timing of cardiac surgery and delivery, the use of intraoperative foetal monitoring, and the choice of valve replacement and anticoagulation. Each of these decisions requires balancing the risk of morbidity and mortality to the patient, the risk of neonatal prematurity and associated complications and disability, and the risk of foetal death during cardiopulmonary bypass. We discuss our teams' decision-making processes with a focus on the relevant considerations for each of these challenging decisions.

OBJECTIVE/UNASSIGNED:Prolonged intubation is associated with worse outcomes and longer intensive care unit (ICU) and hospital length of stay (LOS). Extubation in the operating room for patients undergoing isolated coronary artery bypass grafting is feasible, safe, and decreases ICU and hospital LOS. Aortic root and arch procedures are lengthy and often require circulatory arrest. Here, we present our experience with the safety and feasibility of operating room extubation following simple and complex aortic surgery. METHODS/UNASSIGNED:All consecutive patients who underwent aortic surgery from August 2023 to April 2025 were included in this descriptive study. We evaluated 30-day postoperative outcomes for patients who were extubated in the operating room and those in the ICU. Outcomes of interest were time to chair, ICU and hospital LOS, as well as reintubation and reoperation rates. RESULTS/UNASSIGNED:< .001). Thirty-day outcomes were excellent and comparable in both groups with no deaths or myocardial infarctions for operating room extubation compared with ICU extubation, respectively: atrial fibrillation (n = 49 [21.9%] vs n = 9 [60%]), stroke (n = 1 [0.4%]) vs n = 0), reoperation for bleeding (n = 1 vs n = 0), reintubation for respiratory failure (n = 0 vs n = 1), and 30-day readmission (n = 11 [4.9%] vs n = 2 [11.8%]). CONCLUSIONS/UNASSIGNED:Routine extubation in the operating room is safe and feasible for a wide variety of patients undergoing both simple and complex aortic surgery, even when most of them undergo circulatory arrest. Operating room extubation may accelerate recovery and early ICU and hospital discharge, without increasing readmission or morbidity.

BACKGROUND/UNASSIGNED:Mitral transcatheter edge-to-edge repair (M-TEER) is a treatment option for patients with severe mitral regurgitation (MR) at a high surgical risk. Although most MR involves central A2P2 jets, a subset present with noncentral jets, which may introduce procedural complexity and influence outcomes. The objective of the study was to evaluate the impact of main MR jet location (central [A2P2] versus noncentral [A1/P1 or A3/P3]) on procedural success and clinical outcomes following M-TEER. METHODS/UNASSIGNED:This analysis used the EXPANDed data set, which included patients undergoing M-TEER with MitraClip G3/G4 systems and echocardiographic core laboratory-assessed main MR jet location. One-year clinical, echocardiographic, and functional outcomes were assessed. RESULTS/UNASSIGNED:= 0.47). CONCLUSIONS/UNASSIGNED:In this largest analysis to date of patients with severe MR, main MR jet location did not affect the safety or effectiveness of the MitraClip system. These findings support the use of M-TEER across a range of anatomical presentations, including non-A2P2 MR jets.

BACKGROUND:For patients with asymptomatic, severe aortic stenosis (AS), the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) with respect to the primary endpoint in the intention-to-treat population. OBJECTIVES/OBJECTIVE:The aim of this study was to compare postprocedural outcomes in the valve implant population. METHODS:The valve implant population comprised patients randomized to early TAVR who underwent the procedure and those randomized to CS who underwent delayed aortic valve replacement (AVR). The impact of the clinical presentation at time of delayed AVR was also assessed as progressive valve syndrome (eg, NYHA functional class II) vs acute valve syndrome (AVS; eg, NYHA functional class III or IV, syncope). The primary outcome was the composite of death, stroke, or heart failure hospitalization 2 years postprocedure. RESULTS:Across 75 sites, 97.6% of early TAVR patients (444 of 455) underwent the index procedure, and 87.0% of CS patients (388 of 446) underwent delayed AVR through 5 years; 39.2% presented with AVS and 58.5% with progressive valve syndrome (median time to delayed AVR 11.1 months). Early TAVR demonstrated a benefit compared with delayed AVR for the primary composite (adjusted HR [aHR]: 0.61; 95% CI: 0.38-0.99; P = 0.045). When examined by clinical presentation, delayed AVR with AVS was significantly associated with worse outcomes compared with early TAVR (aHR: 2.12; 95% CI: 1.19-3.78; P = 0.01), driven largely by stroke (aHR: 2.92; 95% CI: 1.26-6.76; P = 0.01). CONCLUSIONS:Among patients with asymptomatic, severe AS, delayed AVR with AVS is associated with higher rates of death, stroke, or heart failure hospitalization compared with early TAVR, highlighting a benefit for early TAVR before symptoms develop given the unpredictability of AS progression. (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).

BACKGROUND:The PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis) trial compared SAPIEN 3 transcatheter aortic valve replacement (TAVR) to surgery in low-risk patients with symptomatic, severe aortic stenosis. Echocardiographic outcomes at 5 years are unknown. OBJECTIVES/OBJECTIVE:This study sought to compare 5-year echocardiographic results of TAVR and surgery in the PARTNER 3 trial. METHODS:Echocardiograms for 1,000 randomized patients were obtained at baseline, 30 days, 1 year, and annually through 5 years and were analyzed by a core lab consortium. The composite primary endpoint of death, stroke, or rehospitalization was adjudicated by a clinical events committee. RESULTS:At 5 years, ≥ mild aortic regurgitation was higher following TAVR vs surgery (24.5% vs 6.3%; P < 0.001), with low ≥ moderate aortic regurgitation in both groups. TAVR patients had higher mean transaortic gradient (12.8 ± 6.5 vs 11.7 ± 5.6 mm Hg; P < 0.001), stroke volume index (44.6 ± 9.7 vs 41.1 ± 9.2; P < 0.0001), and aortic valve area (1.87 ± 0.46 vs 1.82 ± 0.46; P = 0.895). Fewer TAVR patients had low-flow stroke volume index (P < 0.001) and left ventricular hemodynamic burden (valvulo-arterial impedance; P < 0.01). Tricuspid annular plane systolic excursion was also higher with TAVR (P < 0.001), as was right ventricular-to-pulmonary artery coupling (P < 0.0001). In the combined cohorts, 30-day moderate to severe prosthesis-patient mismatch, mild to severe aortic regurgitation, or low stroke volume index were not predictive of clinical outcomes; only low right ventricular-to-pulmonary artery coupling and high valvulo-arterial impedance at 30 days were associated with increased risk of the 5-year composite primary endpoint. CONCLUSIONS:In low-risk patients with severe aortic stenosis, TAVR, compared to surgery, was associated with similar, stable valve hemodynamics at 5 years with less frequent low-flow state, lower valvulo-arterial impedance, and better right ventricular function. (PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis [P3]; NCT02675114).

BACKGROUND:The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated. METHODS:Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system. RESULTS:There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %). CONCLUSION/CONCLUSIONS:Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.

BACKGROUND/UNASSIGNED:Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS/UNASSIGNED:This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS/UNASSIGNED:A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS/UNASSIGNED:Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.