Eleid, Mackram F.

Background Transcatheter edge‐to‐edge repair (TEER) and replacement (TTVR) have emerged as new modalities to treat patients with symptomatic significant tricuspid regurgitation. This study aimed to compare invasive hemodynamic and right ventricular (RV) changes and symptom improvement over 1 year. Methods Patients who underwent TEER/TTVR at Mayo Clinic (Rochester, MN, 2017–2024) were included. Hemodynamic profiles were described before and immediately after intervention, in addition to RV enlargement/dysfunction ≥moderate at 30 days and change in symptoms over time. Results Of 100 patients included (50 per group, median age 81 versus 80 years and female 62% versus 42%, in TTVR and TEER, respectively), all had ≥ moderate–severe symptomatic tricuspid regurgitation. Post intervention, mean right atrial pressure decreased in TEER (16 to 14 mm Hg, P <0.001), V wave decreased in both groups (to 16 mm Hg, P <0.001). RV enlargement was less prevalent in both cohorts at 30 days (60%–40% in TEER, P =0.01, and 72 to 58% in TTVR, P =0.07), yet prevalence of RV dysfunction decreased only in TEER (26 to 15%, P =0.17) as opposed to TTVR (31 to 44%, P =0.13). TTVR resulted in a higher stroke volume index and more complete tricuspid regurgitation elimination at 30 days. Both groups resulted in similar improvements in New York Heart Association class, with overall similar survival. Conclusions TEER was associated with a greater reduction in right atrial pressure and more favorable RV remodeling at 30 days, as opposed to TTVR, which achieved more complete and sustained elimination of tricuspid regurgitation with higher forward stroke volume.

Importance 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 To evaluate 30-day clinical, echocardiographic, and health status outcomes of TTVR in real-world use. Design, Setting, and Population 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 Device-enabled TTVR. Main Outcomes and Measures 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 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 &amp;lt; .001) and mean KCCQ-OS score (22.4 points; P &amp;lt; .001) from baseline to 30 days. There were no significant differences in 30-day mortality ( P = .47), heart failure hospitalization ( P &amp;gt; .99), and functional outcomes ( P = .55) when patients were stratified by baseline CIED status. Conclusions and Relevance 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: Transcatheter mitral valve-in-valve replacement is an established therapy for intermediate and high-risk patients with degenerated bioprostheses, but restricted transcatheter valve (THV) expansion within rigid surgical frames and elevated gradients have raised durability concerns. This study aimed to evaluate midterm outcomes of mitral valve-in-valve patients according to THV expansion and sizing strategy. METHODS: Patients who underwent mitral valve-in-valve with balloon-expandable valves at Mayo Clinic Rochester between 2014 and 2023 were retrospectively analyzed. THV expansion (inflow, waist, outflow) was measured from procedural fluoroscopy and indexed to nominal size, with zero indicating expansion to nominal dimensions. Median index values were used as subgroup cutoffs to compare the incidence of the primary composite outcome of all-cause mortality, heart failure readmission, and valve reintervention. RESULTS: The analysis included 80 patients with a median follow-up of 2.5 years. A total of 53 (66%) valves were underexpanded across all 3 sizes, with median inflow, waist, and outflow expansion indices of −10.2, −16.2, and −3.2, respectively. Across all indices, THV expansion closer to nominal size was associated with lower rates of the primary outcome ( P <0.05). Greater expansion correlated with a larger mitral valve area and lower transvalvular mean gradient. Oversized THVs were significantly less expanded and had a higher incidence of the primary composite outcome compared with recommended-size THVs ( P =0.02). CONCLUSIONS: THV underexpansion in degenerated mitral bioprostheses is common and associated with elevated gradients and worse midterm outcomes. Further research is warranted to define THV expansion targets and improve outcomes following mitral valve-in-valve intervention.

Background Bileaflet aortic valve prevalence in transcatheter aortic valve replacement (TAVR) patients is poorly defined. We evaluated a TAVR cohort to determine the bileaflet aortic valve prevalence and understand features which may improve detection. In addition, we related valvar morphology to the occurrence of permanent pacemaker implantation (PPI) following TAVR. Methods Aortic valvar morphology diagnosis was recorded from the pre-procedural cardiac CTA reports prior to TAVR. Commissural angles, comparison of commissural heights, and dynamic visual inspection of the aortic valve were subsequently evaluated on pre-procedural cardiac CTA by an expert cardiac anatomist and imager, methods previously validated in a surgical cohort, to determine aortic valvar morphology and compared to the historical diagnosis. Relationships between valvar morphological characteristics with the need for PPM within 30-days post-TAVR were determined. Results Four-hundred and thirty-three (mean age 81.3 ± 6.6 years, 53.8% female) underwent TAVR [corrected diagnosis: 393 (90.8%) trileaflet vs. 40 (9.2%) bileaflet valves]. Bileaflet valves were historically misdiagnosed in 80% of pre-procedural cardiac CTA reports. Thirty-four (85.0%) had intercoronary leaflet fusion [mean commissural angle = 148.1 (18.3) degrees]. A commissural angle threshold of 141.1 degrees had a sensitivity of 0.73 and specificity of 0.86 for identifying a bileaflet valve. PPI post-TAVR occurred in 38% bileaflet vs. 19% trileaflet patients ( p = 0.0114 ) [unadjusted OR for bileaflet valve requiring PPI = 2.54, 95% CI (1.25–5.01)]. Conclusions Bileaflet aortic valves are commonly misdiagnosed. Assessment of the commissural angle and comparison of commissural heights may improve CTA-based diagnostic accuracy prior to TAVR. Improved detection may guide improved outcomes in this higher risk population.

Abstract Aims We aimed to assess regression and development rates of ≥moderate secondary mitral regurgitation (MR) and tricuspid regurgitation (TR) in patients with heart failure and reduced ejection fraction (HFrEF) receiving contemporary guideline-directed medical therapy (GDMT). Methods Patients with a &lt;1 year diagnosis of HFrEF with mildly (40% ≤ EF &lt; 50%) or moderately (&lt;40%) reduced EF enrolled in GDMT titration programme 2019–2024 were identified. Regression rates of ≥moderate MR/TR to ≤mild and development rates of incident ≥moderate MR/TR were calculated. Results Among 844 patients [median age 64; 68% men; 26% mildly reduced EF; 24% New York Heart Association (NYHA) Class III/IV], 28% had ≥moderate MR and 14% had ≥moderate TR. Over median 7.1 months, 171 (75%) patients with ≥moderate MR and 87 (75%) of patients with ≥moderate TR experienced regression to no/mild MR and TR, respectively. Conversely, over median 13 months, incident ≥moderate MR and TR developed in 5% and 6%, respectively, of patients with no/mild baseline MR and TR. Number of GDMT medications at follow-up was less in patients who did not have MR/TR regression (vs who did) and in patients who developed MR/TR (vs who did not). Patients with NYHA Class I/II received a similar number of GDMT and had a similar rate of MR and TR regression and development vs patients with NYHA Class III/IV. However, patients with mildly reduced EF received less GDMT medications vs patients with moderately reduced EF and experienced less MR regression. Conclusion In patients with a recent diagnosis of HFrEF receiving contemporary GDMT, the majority with ≥moderate secondary MR and TR achieved regression of MR/TR, and the minority without significant baseline MR/TR developed ≥moderate regurgitation at follow-up.

Background Artificial intelligence (AI)–enabled electrocardiography has emerged as a tool for detecting cardiac dysfunction. The prognostic relevance of AI‐enabled electrocardiography–derived diastolic dysfunction (DD) in patients undergoing transcatheter aortic valve replacement had not been assessed. Methods We analyzed 3197 patients undergoing transcatheter aortic valve replacement for severe aortic stenosis between 2010 and 2023 with baseline 12‐lead ECGs processed by a validated AI model to classify diastolic function (grades 0–3). Multivariable Cox models and nested model comparisons assessed associations with all‐cause mortality, including a prespecified analysis in patients with indeterminate echocardiographic grading. Trajectories were defined by change in AI‐enabled electrocardiography DD grade (<2 versus ≥2) from baseline to 30‐day or 1‐year follow‐up. Results At baseline, 21% had grade 3, 57% had grade 2, 8% had grade 1, and 14% had grade 0 AI‐enabled electrocardiography DD. Higher grades were associated with adverse cardiac remodeling and comorbidities. Over a median follow‐up of 3.4 years, grade 3 AI‐enabled electrocardiography DD independently predicted mortality (hazard ratio [HR], 1.80 [95% CI, 1.47–2.20]; P <0.001). AI‐enabled electrocardiography DD improved prognostic discrimination beyond clinical and echocardiographic measures (ΔHarrell concordance statistic, 0.016; Δ χ 2 =57; P <0.001). Among 1259 patients with indeterminate echocardiographic grading, AI‐enabled electrocardiography added prognostic value (ΔHarrell concordance statistic, 0.02; Δ χ 2 =13; P =0.006). Worsening or persistently high‐risk trajectories were associated with increased mortality (HRs, 1.45–1.80; all P <0.05). Conclusions AI‐enabled electrocardiography–derived DD independently predicts mortality after transcatheter aortic valve replacement, adds value beyond echocardiographic grading, and enables dynamic risk stratification through longitudinal tracking.

BACKGROUND: The current study aims to describe outcomes after transcatheter valve replacement in adults with congenital heart disease. METHODS: Retrospective study of adults with congenital heart disease who underwent transcatheter valve replacement and had a 1-year follow-up postintervention at Mayo Clinic (2010–2024). The study period was divided into early (2010–2014), mid (2015–2019), and late (2020–2024) eras. The primary outcome was valve reintervention. The secondary outcomes were all-cause mortality and temporal change in prosthetic valve gradient and clinical indices of disease severity. RESULTS: Overall, 341 patients (age 38±17 years; 175 [51%] men) received 346 prostheses (pulmonary [N=236, 68%], tricuspid [N=75, 22%], aortic [N=22, 8%], and mitral [N=7, 2%]). The prostheses were Sapien (N=181, 52%), Melody (N=142, 41%), and Harmony prostheses (N=23, 7%). The number of transcatheter valve implantations increased from the early era (N=75), mid era (N=109), to the late era (N=162). The 10-year incidence of valve reintervention was 35%, and was similar between Sapien versus Melody prosthesis (41% versus 33%; P =0.11). The 10-year incidence of all-cause mortality was 13%. There was a temporal increase in prosthetic valve Doppler mean gradient (baseline versus 10 years) for pulmonary (12±5 versus 28±11 mmHg; P <0.001), tricuspid (3±1 versus 8±3 mmHg; P <0.001), and aortic prosthesis (13±5 versus 26±12 mmHg; P <0.001). There was a temporal increase in predicted peak oxygen consumption (absolute ∆, 9% [95% CI, 4–13]; P =0.006) and a decrease in NT-proBNP (N-terminal pro-B-type natriuretic peptide) level (absolute ∆, −138 pg/mL [95% CI, −209 to −64]; P <0.001) at 1-year postintervention. CONCLUSIONS: There has been a temporal increase in the number of transcatheter valve implantations over time. Transcatheter valve replacement was associated with clinical improvement across multiple domains. However, there was a significant increase in prosthetic valve gradient within 10 years of follow-up, suggesting limited prosthesis longevity. There is a need for strategies to improve prosthetic valve longevity, which in turn may improve outcomes in this population.

Abstract Aims The increasing adoption of transcatheter tricuspid valve replacement (TTVR) offers a promising therapeutic option for patients with severe tricuspid regurgitation. However, many of these patients have pre-existing cardiac implantable electronic devices (CIEDs), raising concerns about potential lead-related complications. Despite these concerns, limited data exist on the impact of TTVR on CIED integrity and function. This study aimed to evaluate the impact of TTVR on CIED lead function, including pacing thresholds, sensing, and impedance, in patients undergoing TTVR with the EVOQUE valve system. Methods and results A retrospective observational study was conducted at Mayo Clinic Rochester, including 32 consecutive patients who underwent TTVR with pre-existing CIEDs. A total of 32 patients were included, with a mean age of 79.2 ± 8.4 years; 59% were female. A total of 62.5% had a permanent pacemaker, 12.5% had an implantable cardioverter-defibrillator, 15.6% had a cardiac resynchronization therapy pacemaker, and 9.4% had a cardiac resynchronization therapy defibrillator. Following TTVR, 10 (31%) of patients developed lead function changes during a median device follow-up of 210 days (IQR: 43–307 days). The right ventricular lead was primarily affected, with only one case involving an atrial lead. Neither the Ottawa score nor the anatomical lead position reliably predicted lead abnormality (P = 0.86 and P = 0.53, respectively). R-wave sensing changes were the most common lead change observed, affecting 55% of cases. In 67% of these cases, R-wave sensing alterations occurred as an isolated finding, with no significant change in impedance or thresholds, and were managed conservatively without any need for device reprogramming. Four patients (13%) had findings concerning for a lead insulation breach, in which one (3%) required a lead revision. Among five patients with follow-up exceeding 600 days, two patients exhibited a statistically significant gradual decline in impedance without other lead dysfunction, suggesting potential subclinical lead degradation. Conclusion Transcatheter tricuspid valve replacement with the EVOQUE system in the setting of cardiac device leads is associated with lead function changes in 31%. The majority of lead-related changes were managed conservatively, but 13% of patients had findings concerning for an insulation breach. Future studies should focus on refining implantation techniques and defining optimal strategies for managing device-lead interactions in this population.

Abstract Aims The pathophysiology of tricuspid regurgitation (TR) during exercise in heart failure with preserved ejection fraction (HFpEF) is not well understood. Methods and results We investigated dynamic changes in TR severity during exercise in patients with HFpEF and associated relationships with haemodynamics, cardiopulmonary reserve, and prognosis using invasive haemodynamic exercise testing with simultaneous echocardiography and expired gas analysis. Among 169 patients with HFpEF (91 no TR, 44 mild TR, 34 ≥ moderate TR), older age and atrial fibrillation were more common in patients with greater TR severity. Right heart remodelling and dysfunction were more frequently observed with greater TR severity, particularly in the right atrium, along with stepwise increases in right atrial (RA) pressure and interventricular septal flattening, and decreases in cardiac output (CO). During exercise, TR severity frequently worsened, and over half of the patients with moderate TR at rest displayed severe TR during exercise, accompanied by profound RA dilatation, reduced RA reservoir strain, increased septal flattening, and more severely impaired CO reserve. Abnormalities in tricuspid annular motion and ventricular interaction were amplified by exercise with greater TR, but exercise pulmonary vascular pressures did not differ across groups. Patients with ≥ moderate TR during exercise displayed higher event rates (hazard ratio 2.85, 95% confidence interval 1.18–6.85), but patients with mild TR had similar prognosis as those without TR in adjusted models. Conclusions Tricuspid regurgitation in HFpEF is related to advanced RA myopathy and often worsens during exercise leading to dynamic right-sided heart failure, exaggerated ventricular interaction, impaired CO reserve, and increased risk for adverse outcomes. These data emphasize the clinical importance of exercise evaluation and call for further study of novel treatments in those with significant resting and provocable TR.

Abstract Background and Aims 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 vs 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 randomized 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) hospitalization 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% confidence interval (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 hospitalization 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.