Background Bleeding remains among the most common complications following catheter-based structural heart procedures. Its clinical implications following transcatheter tricuspid valve interventions have yet to be systematically evaluated. Objectives The aim of this study was to evaluate the incidence of bleeding and its predictors and prognostic implications following transcatheter tricuspid valve repair. Methods TriValve (International Multisite Transcatheter Tricuspid Valve Therapies Registry; NCT03416166) is an international multicenter registry capturing a range of transcatheter tricuspid valve interventions. Bleeding events were classified according to the Bleeding Academic Research Consortium (BARC). For this analysis, BARC bleeding events type 2, 3, and 5 occurring within 1 year of transcatheter tricuspid valve repair were retrospectively evaluated. Results A total of 440 patients (mean age 76.6 ± 8.9 years, 57.7% women) were included. The BARC major bleeding incidence was 11.4% (50 patients). Postprocedural tricuspid regurgitation severity (adjusted ORl]: 1.83; 95% CI: 1.12-3.01; P = 0.02), higher systolic pulmonary artery pressures (adjusted OR: 1.61; 95% CI: 1.16-2.24; P = 0.0048), and increasing procedure duration (adjusted OR: 1.49; 95% CI: 1.00-2.22; P = 0.049) were associated with bleeding, whereas concomitant oral anticoagulation was not (adjusted OR: 1.51; 95% CI: 0.74-3.10; P = 0.30). Major bleeding was associated with a markedly increased risk for in-hospital death (adjusted OR: 106; 95% CI: 1.31-8,553; P = 0.04). Likewise, bleeding was significantly associated with a 1-year composite of death or all-cause hospital readmission (adjusted HR: 2.41; 95% CI: 1.39-4.19; P = 0.002), all-cause death (adjusted HR: 3.55; 95% CI: 1.75-7.21; P = 0.0004), and cardiovascular death (adjusted HR: 3.72; 95% CI: 1.62-8.52; P = 0.002). Conclusions BARC major bleeding occurs in about 11% of patients following transcatheter tricuspid valve repair and is a major determinant of in-hospital and 1-year death. Enhanced patient selection and procedural optimization (with shorter procedural times) may help curb bleeding risk.
IntroductionCerebral Embolic Protection Devices (CEPs) have been designed to minimize the risk of periprocedural stroke. The clinical significance of these devices, however, is still under debate. We aimed to compare periprocedural neurological outcomes and mortality in patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR) with vs. without CEP.MethodsA single-center retrospective analysis of 1,101 patients undergoing transfemoral TAVR from August 2017 to May 2025 was performed. CEPs were used routinely at our institution whenever anatomically feasible beginning with October 2019. The primary outcome was defined as the incidence of ischemic stroke occurring within 3 days postoperatively. Secondary endpoints included transient ischemic attack (TIA) and delirium within 3 days and short-term all-cause mortality.ResultsOverall, 809 underwent TF-TAVR with CEP, while 292 were treated without. The primary endpoint of clinical ischemic stroke occurred less frequently in the CEP group (1.4% vs. 4.1%), and the group difference revealed a significant result in a univariable Cox regression analysis (p = 0.007). No clinically relevant differences were observed in the incidence of TIA (0.5% vs. 0.7%, p = 0.71) and postprocedural delirium (1.6% vs. 2.4%, p = 0.39). The 30-day mortality rate was numerically higher in the control group, but the difference did not reach statistical significance (1.9% vs. 3.9%, p = 0.06).ConclusionThe use of neuroprotection during TAVR was associated with a lower observed hazard of early periprocedural ischemic stroke in this unadjusted retrospective cohort.
Tricuspid regurgitation (TR) frequently coincides with severe mitral regurgitation (MR). Transcatheter mitral valve replacement (TMVR) effectively eliminates MR and may secondarily affect TR severity. This study aimed to assess incidence and prognostic value of TR improvement after TMVR using data from an international multicentre registry. Patients with symptomatic MR and baseline TR undergoing TMVR from the CHOICE-MI international multicentre registry were analysed. TR improvement was defined as a ≥1-grade TR reduction at discharge. The primary endpoint was all-cause mortality or heart failure (HF) hospitalization at 1 year. Stepwise Cox regression was performed to assess the adjusted prognostic impact of TR improvement. Among 309 patients (median age 77 years), TR improvement occurred in 33.0% after TMVR. Patients with TR improvement were younger, had higher EuroSCORE II, less coronary artery disease, and lower baseline TAPSE. MR was durably eliminated in most patients, irrespective of TR evolution. At 1 year, there was no statistically significant difference in all-cause mortality or HF hospitalization between patients with and without TR improvement (27.0% vs. 36.9%; p=0.14). Following stepwise Cox regression, TR improvement was an independent predictor of all-cause mortality or HF hospitalization 1 year after TMVR (HR 0.45, 95% CI 0.23–0.88; p=0.02). TR improvement occurs frequently following TMVR and is associated with favourable 1-year outcomes. These results support the clinical relevance of concomitant TR and the systematic assessment of TR after TMVR.
OBJECTIVES:This study evaluates intermediate-term survival and valve-related complications in patients undergoing minimally invasive surgical aortic valve replacement (MI-SAVR) using rapid-deployment (RD) valves compared with those receiving transfemoral transcatheter aortic valve replacement (TF-TAVR) after propensity-matched analysis. METHODS:All consecutive patients treated with either isolated MI-SAVR with an RD valve or TF-TAVR at a single cardiac-surgery centre were retrospectively reviewed. A propensity score was created, and exact matching was applied after the maximum propensity score difference. Nearest-neighbour matching was conducted with a caliper of 0.2 standard deviations of the logit of the propensity score, without replacement and with a 1:1 matching ratio. RESULTS:From April 2011 to June 2022, 926 patients underwent either isolated MI-SAVR with an RD valve (n = 400) or TF-TAVR (n = 526). After propensity score matching, the final cohort (n = 366) included 183 matched pairs. Operative mortality was 0% after MI-SAVR compared with 3.3% (n = 6) following TF-TAVR (P = .03). Perioperative stroke occurred in 2.7% (n = 5, MI-SAVR) vs 2.2% (n = 4, TF-TAVR, P = 1). At 3 years, MI-SAVR was associated with significantly lower rates of paravalvular leakage (2.2% vs 13.8%, P < .001), new pacemaker implantations (6.6% vs 14.8%, P = .01) and a composite end-point of thromboembolic and major bleeding events (7.2% vs 12.7%, P = .025). No difference between aortic valve re-interventions and stroke was identified between groups. Survival at 1- and 3-year follow-up was 98% and 88% (MI-SAVR) and 88% and 67% (TF-TAVR) respectively (P < .001). EuroScore II emerged as an independent predictor of mortality (HR 1.12 [1.02, 1.23], P = .014). CONCLUSIONS:Minimally invasive SAVR with RD-valves could represent a treatment modality to TF-TAVR for severe AS in an older, low-risk patient cohort. In our retrospective cohort study, MI-SAVR was linked to improved survival and lower rates of permanent pacemaker implantation and paravalvular leakage.
Objectives: This study aims to review short- to intermediate-term outcomes after transapical transcatheter mitral valve replacement (TMVR) using the Tendyne valve system in patients with mitral annular calcification (MAC), including off-label use in severe MAC. Methods: This retrospective sub-analysis of the multicenter Tendyne European Experience (TENDER) registry included fifty-three MAC patients who underwent commercial Tendyne-TMVR in 15 European heart centers between 01/2020 and 06/2022. Patients were assigned to the mild (n = 16), moderate (n = 17), and severe MAC (n = 20) cohorts according to Guerrero's MAC score. Additionally, the predictive value of detailed computed tomography-derived, quantitative, and qualitative MAC characteristics on clinical outcome was tested. Results: In this overall multimorbid patient population, predominantly treated for severe mitral regurgitation (MR), technical success rates were comparable among cohorts (mild MAC: 93.8% vs. moderate MAC: 88.2%vs. severe MAC: 95%, p = 0.720). Complete MR abolishment was achieved in 88.7% of patients, with no significant difference between cohorts in the incidence of residual MR >1+ (n = 1 in moderate MAC; p = 0.350) or paravalvular leakage >1+ (PVL; n = 2 in moderate MAC, p = 0.118) at discharge. All three in-hospital deaths occurred in patients with moderate MAC (p = 0.034). There were no significant differences in 1-year cardiovascular mortality (mild MAC: 23.1% vs. moderate MAC: 6.3% vs. severe MAC: 0%, p = 0.085) and overall mortality (mild MAC: 38.5% vs. moderate MAC: 43.8% vs. severe MAC: 18.8%, p = 0.291) between the cohorts, including in patients with off-label severe MAC. The rate of heart failure hospitalization at 1 year was significantly higher in the moderate MAC cohort (mild MAC: 10% vs. moderate MAC: 61.5%, severe MAC: 21.4%, p = 0.017). Further quantitative and qualitative MAC parameters showed no significant impact on 1-year survival or hemodynamic prosthetic performance. Conclusions: This MAC-focused analysis suggests that Valve-in-MAC using the Tendyne valve system is safe, technically feasible, and associated with satisfying hemodynamic and clinical outcomes, irrespective of MAC morphology.
BACKGROUND:Transcatheter mitral valve replacement (TMVR) is an alternative for patients with mitral regurgitation (MR), but data on transfemoral (TF) devices are limited. OBJECTIVES:The aim of this study was to evaluate clinical, echocardiographic, and functional outcomes following TF TMVR in an international registry. METHODS:The CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) Registry included patients undergoing TMVR with dedicated devices at 41 international centers. This analysis included only TF TMVR. Outcomes were assessed per Mitral Valve Academic Research Consortium criteria. Echocardiographic, functional, and clinical outcomes up to 2 years were reported. The primary endpoint was a composite of all-cause mortality or heart failure hospitalization at 2 years. Predictors were identified using multivariable Cox regression. RESULTS:A total of 124 patients (median age 79 years [Q1-Q3: 75-83 years], 50% women, median European System for Cardiac Operative Risk Evaluation II score 5.0% [Q1-Q3: 3.3-8.5]) underwent TF TMVR with 9 different devices. The leading MR etiology was primary MR (n = 49 [39.5%]), with mitral annular calcification in 12.9%. Technical success was achieved in 113 of 124 patients (91.1%), and procedural mortality was low (1 of 124 [0.8%]). Residual MR ≤1+ was achieved in 94.9% at discharge, with stable results at follow-up. The rates of cardiovascular mortality were 14.7% (95% CI: 7.9%-21.5%) and 20.3% (95% CI: 11.4%-29.1%) and of the primary endpoint 44.1% (95% CI: 30.6%-50.0%) and 52.4% (95% CI: 40.2%-62.1%) at 1 and 2 years, respectively, and NYHA functional class had significantly improved at 1- and 2-year follow-up. Atrial fibrillation was an independent predictor of the primary endpoint, whereas technical success was associated with survival. CONCLUSIONS:TMVR using dedicated TF devices demonstrates favorable safety, durable MR reduction, and sustained functional improvement in high-risk patients. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI Registry]; NCT04688190).
OBJECTIVES:This study aimed to assess long-term outcomes of automated titanium fasteners versus hand-tied knots in mitral valve surgery. METHODS:In this retrospective, single-centre analysis, 2678 adult patients who underwent mitral valve repair or replacement between November 2008 and November 2024 at the Medical University of Vienna were included. Patients were grouped according to the suture-securing technique used: automated titanium fasteners versus hand-tied knots. The primary endpoint was prosthetic dehiscence (either mitral annuloplasty ring or valve replacement prosthesis) requiring reintervention. Secondary endpoints comprised ischaemic stroke, intracranial bleeding, and all-cause mortality during the follow-up period. RESULTS:Among the study population, 1072 (40%) underwent mitral valve surgery using an automated titanium fastener device, and 1606 (60%) with conventional hand-tied sutures. A total of 31 patients (1.2%) had prosthetic dehiscence during the follow-up period. The risk of prosthetic dehiscence was significantly lower in the automated titanium fastener group in both univariable (crude sub-hazard ratio [sHR] 0.32; 95% confidence interval [CI], 0.12-0.86, P = .023) and multivariable competing risk regression analysis (adjusted sHR 0.34; 95% CI, 0.12-0.91, P = .033). Automated titanium fastener group was not associated with an increased risk of ischaemic stroke (adjusted sHR 0.92; 95% CI, 0.67-1.27, P = .600), intracranial bleeding (adjusted sHR 0.89; 95% CI, 0.52-1.52, P = .675), or all-cause mortality (adjusted hazard ratio 0.93; 95% CI, 0.74-1.18, P = .559). CONCLUSIONS:The use of an automated titanium fastener device seems to be associated with a lower risk of prosthetic dehiscence in mitral valve surgery. Due to the limited number of prosthetic dehiscence events and the potential for residual confounding, the results should be interpreted with caution.
BackgroundGlutaraldehyde (GA) fixation of pericardial tissue is widely used in bioprosthetic heart valves. However, how GA concentration and incubation time jointly influence structure-function relationships remains incompletely understood. This study systematically evaluates the effects of GA concentration and incubation time on collagen architecture and mechanical behavior in human pericardial tissue.ResultsHuman pericardium was treated with GA concentrations of 0%–2.5% for 5–90 min. Collagen structure was quantified using Picrosirius red imaging and image analysis, while mechanical behavior was assessed via strain-controlled uniaxial tensile testing. Increasing incubation time was associated with reduced collagen waviness and evidence of fiber bundling. Mechanical analysis revealed a significant interaction between GA concentration and incubation time for maximum strain and transition strain (p < 0.05), indicating a non-linear, non-additive treatment effect. Repeated-measures correlation analysis showed strong internal consistency among mechanical parameters (e.g., maximum stress vs. high-strain modulus, rrm = 0.92), whereas structural descriptors such as waviness and fiber orientation exhibited minimal association with mechanical outcomes (rrm = 0.06).ConclusionGA treatment effects arise from a coupled, non-additive interaction between concentration and incubation time rather than a simple dose-response relationship. Importantly, commonly used structural metrics do not directly predict mechanical performance, underscoring the need for integrated structure-function assessment. These findings provide a framework for future evaluation of GA-treated pericardium in bioprosthetic applications.
OBJECTIVES:We report three-year safety and clinical outcomes in patients younger than 60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS:The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, multicentre registry to assess clinical outcomes of patients under 60 years. Patients with planned surgical aortic valve replacement with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance, and quality-of-life (QoL) at three years were assessed. RESULTS:The study cohort included 415 patients with a mean age of 53.5 years, 76.9% being male and 27.1% in New York Health Association (NYHA) class III/IV. Outcomes after three years included cardiovascular-related mortality (0.4%), thromboembolic events (0.6%), valve-related bleeding (0.0%) and new permanent pacemaker implantation (0.4%). QoL increased over the time course of the study from baseline to three-year follow-up. Three-year freedom from all-cause mortality was 95.4% (95% CI 93.3-97.6), and 84.5% were NYHA I versus 22.0% at baseline. No patient developed haemodynamic valve deterioration stage 3. The mean aortic pressure gradient was 13.7 mmHg at three years, and the mean effective orifice area was 1.8 cm. CONCLUSIONS:The three-year data from the INSPIRIS RESILIA valve demonstrate reassuring safety findings and stable haemodynamic performance as well as a high QoL.
Objective: The Bentall procedure is a well-established surgical technique for managing aortic root disease involving the ascending aorta and aortic valve. The use of automated suturing technology may facilitate ergonomic, reliable suture placement, especially in minimally invasive approaches. Here we present the results of a study to evaluate the feasibility of using automated suturing technology for Bentall procedures in an ex vivo porcine model using a passive beating heart simulator.Methods: This study included 20 ex vivo porcine hearts, divided into an automated suturing cohort (n = 10) and a manual suturing cohort (n = 10). A Bentall procedure was performed on each heart, with the subject automated suturing technology used in place of manual suturing in the first cohort. After the procedure, each heart was tested in a passive beating heart testing simulator under increasingly challenging hemodynamic conditions (80, 100, and 120 mm Hg); any fluid leakage at the proximal anastomosis was quantified. Data were analyzed using nonparametric statistical tests.Results: Overall, leakage from the proximal anastomosis increased with higher pressure and longer duration in both groups (P < 0.001). There was no statistically significant difference in leakage between the automated and manual suture cohorts (P > 0.05), indicating that the study technology appears to be feasible and effective for placing sutures in Bentall procedures. Correlation analysis indicated a moderate positive relationship between aortic pressure and leakage in both groups.Conclusions: The subject automated suturing technology demonstrated comparable performance to manual suturing in ex vivo Bentall procedures, with no significantly different leakage across a range of increasing aortic pressures.
BACKGROUND:Transcatheter mitral valve replacement (TMVR) is a preferred interventional option for high-risk patients with severe mitral regurgitation who are ineligible for transcatheter edge-to-edge repair. However, the role of annular dimensions in risk stratification has been marginally explored in this distinct anatomical setting with preserved native leaflets in patients with varying degree of myocardial damage. METHODS:This subanalysis of the multicenter TENDER registry (NCT04898335) included 145 TMVR patients. Preprocedural 4D-computed tomography-derived annular dimensions were evaluated for associations with cardiac and all-cause mortality. RESULTS:At 1 year, all-cause mortality was 24.8% (n = 36 of 145) and cardiac mortality was 5.5% (n = 8 of 145). Cardiac deaths were associated with significantly larger annular parameters, including systolic and diastolic anteroposterior diameter (32.8 ± 2.3 mm vs 29.9 ± 3.5 mm, P = .023; 33.2 ± 2.5 mm vs 30.3 ± 3.4 mm, P = .018), systolic and diastolic annular perimeter (126.1 ± 9.5 mm vs 115.8 ± 10.5 mm, P = .008; 125.6 ± 10.4 mm vs 115.8 ± 12.7 mm, P = .034), and annular area (1271.7 ± 193.2 mm2 vs 1076.2 ± 193.6 mm2, P = .006; 1262.7 ± 209.9 mm2 vs 1087.2 ± 194.7 mm2, P = .015). Annular area loss, calculated as the difference between native diastolic mitral annular area and the geometric effective orifice area of the implanted valve, was significantly greater in patients who died for cardiac reasons (999.72 ± 225.72 mm2) compared with survivors (826.68 ± 189.45 mm2; P = .022; odds ratio, 1.005, P = .030). CONCLUSIONS:Larger annular dimensions and greater annular area loss may predict 1-year cardiac death. Possible mechanisms include impaired left ventricle filling, artificial inflow-related outflow tract obstruction, and limited reverse remodeling. Comprehensive annular assessment may also enhance patient selection for future transseptal TMVR systems.
BACKGROUND:Mitral regurgitation (MR) and tricuspid regurgitation (TR) commonly coexist in patients with heart failure (HF). Their concomitant occurrence carries a much poorer prognosis than isolated valve disease. Transcatheter edge-to-edge repair (TEER) of MR and TR is safe and effective, but there is limited data on combined MR/TR TEER. OBJECTIVE:The study evaluates the safety and efficacy of combined TEER for MR and TR in a real-world cohort. METHODS:This retrospective safety and efficacy analysis included the first 40 patients treated with combined MR/TR TEER between 2019 and 2021 at our single tertiary care referral centre. RESULTS:Combined procedural success (MR reduction ≥2° and TR reduction ≥1°) was achieved in 80% of the cases. Simultaneous TEER was safe, with no intraprocedural death, myocardial infarction (MI), stroke, or major bleeding. At 1-year follow-up, the median New York Heart Association functional (NYHA) class improved by one grade; twelve patients (30%) died, and fourteen patients (35%) were hospitalized for HF. Procedural success and postprocedural residual MR ≤ 1° were associated with reduced 1-year mortality rates but not HF hospitalizations. CONCLUSION:Combined MR/TR TEER is safe and reduces MR and TR in most patients, conferring a potential benefit regarding symptoms and prognosis. Randomized controlled trials (RCTs) are needed to rigorously evaluate combination therapy in this setting.
BACKGROUND:The best management of coronary artery disease in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) is debated. We investigated the clinical impact of the residual extent of myocardium at risk in patients undergoing TAVI. METHODS:Patients enrolled in the REVASC-TAVI (Management of Myocardial Revascularization in Patients Undergoing TAVI With Coronary Artery Disease) international multicenter registry were stratified according to the myocardium jeopardized by coronary artery disease using the British Cardiovascular Intervention Society Jeopardy Score (BCIS-JS) after a planned coronary revascularization. A planned revascularization included percutaneous coronary interventions performed before TAVI, during TAVI, or within 1 month after TAVI. The study population was divided according to the residual BCIS-JS (rBCIS-JS): patients with extensive residual myocardial at risk (rBCIS-JS >4 group) and patients without extensive residual myocardial at risk (rBCIS-JS ≤4 group). The primary study end point was the composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 2 years. RESULTS:Among the 2407 patients enrolled, 294 pairs of patients were selected by propensity matching and compared. At 2-year follow-up, the incidence of the primary end point was higher in patients with rBCIS-JS >4 compared with patients with rBCIS-JS ≤4 (37.5% versus 23.0%, P=0.004). A significantly lower rate of myocardial infarction was reported in patients with BCIS-JS ≤4 (8.2% versus 2.6%, P=0.011). At multivariate analysis, rBCIS-JS >4 (hazard ratio, 1.43 [95% CI, 1.11-1.84]; P=0.005) independently predicted 2-year major adverse cardiac and cerebrovascular events. CONCLUSIONS:In patients with concomitant coronary artery disease and severe aortic stenosis, the residual myocardial risk significantly affects TAVI outcomes. In particular, a rBCIS-JS >4 is associated with higher rates of major adverse cardiac and cerebrovascular events at 2 years.
IntroductionTranssubclavian (TS) access has emerged as a rapidly growing alternative to the traditional transfemoral (TF) approach in patients with hostile iliofemoral access undergoing transcatheter aortic valve replacement (TAVR). The aim of this study was to investigate clinical outcomes following TS-TAVR and TF-TAVR in severe aortic valve stenosis treated with self-expanding devices.MethodsWe conducted a single-center retrospective analysis of consecutive patients undergoing TS- or TF-TAVR between August 2017 and May 2025 at our department. Clinical endpoints were reported according to the Valve Academic Research Consortium-3 (VARC 3) criteria.ResultsA total of 817 patients underwent TF-TAVR, while 75 patients underwent TS-TAVR. Patients undergoing TS-TAVR were more frequently men, presented with a higher Euro Score II, and carried a greater burden of atherosclerotic disease. Unadjusted data analysis showed a significant association between TS access and 30-day mortality [HR 2.64, 95% CI: 1.00–6.97, p = 0.05], stroke [HR 2.44, 95% CI: 1.19–5.01, p = 0.01], myocardial infarction [HR 4.31, 95% CI: 1.16–15.96, p = 0.03], major bleeding [HR 1.79, 95% CI: 1.17–2.73, p = 0.007], and cardiovascular hospitalization [HR 1.65, 95% CI: 1.02–2.65, p = 0.01]. After risk adjustment, the access site remained independently associated with stroke and major bleeding, while 30-day mortality and cardiovascular hospitalization lost statistical significance.ConclusionOverall, TS-TAVR appears to be a feasible approach when TF-TAVR is not possible. Adjusted data revealed no statistically significant association with early mortality. However, the access site was significantly associated with stroke and major bleeding, findings likely attributable to the higher baseline risk of the subclavian cohort in our study.
Coronary artery bypass grafting is frequently performed in combination with valve surgery; however, minimally invasive approaches for such combined procedures remain limited due to challenges in exposure and access. While bilateral minimally invasive strategies have been described in selected cases, standardized access concepts for concomitant procedures are not well defined. This study aimed to assess the anatomical accessibility and procedural workflow of a minimally invasive biaxillary access strategy for combined coronary and valve surgery in a human cadaver model. Combined coronary artery bypass grafting and valve procedures were performed in nine Thiel/ethanol-fixed human cadavers using a biaxillary access approach. Anatomical exposure, conduit length, graft harvesting and anastomosis times, and valve positioning were evaluated by macroscopic inspection and postprocedural three-dimensional computed tomography imaging. All planned procedural steps were completed in all nine cadavers. The mean left and right internal thoracic artery lengths were 18.1 ± 1.8 cm and 18.9 ± 1.9 cm, respectively. The average bilateral internal thoracic artery harvest and anastomosis times were 52.0 ± 17.6 min and 46.6 ± 12.6 min, respectively. Postprocedural three-dimensional computed tomography imaging and macroscopic inspection demonstrated consistent graft positioning and anatomical valve seating across all specimens. This cadaveric study demonstrates that a minimally invasive biaxillary access strategy allows anatomical exposure and supports a conceptual procedural workflow for combined coronary and valve interventions. These findings represent an early-stage technical proof-of-concept and require further validation before clinical application can be considered.
Objectives: Transcatheter mitral valve replacement (TMVR) is an emerging therapy for patients with severe mitral regurgitation (MR) who are not suitable for surgery or edge-to-edge repair. The impact of TMVR on right ventricular (RV) function and RV-pulmonary artery (PA) coupling remains poorly understood. We aimed to investigate the prognostic significance of right heart function and RV-PA coupling in TMVR recipients. Methods: This study evaluated patients from the multicentre TENDER registry entailing transapical TMVR with the Tendyne valve. We assessed RV systolic function, tricuspid regurgitation (TR), systolic PA pressure (sPAP), and the tricuspid annulus plane systolic excursion (TAPSE)/sPAP ratio as a marker of RV-PA coupling before and 1 year after TMVR. Results: Among 195 patients, 57.4% had impaired RV-PA coupling (TAPSE/sPAP < 0.4) at baseline. One year after TMVR, sPAP and TR severity significantly improved, while TAPSE slightly declined. The TAPSE/sPAP ratio increased modestly. Patients with preserved baseline RV-PA coupling experienced numerically lower rates of mortality and heart failure hospitalization at 1 year, although the differences did not reach the statistical significance. Reversal of pulmonary hypertension was associated with lower mortality or rehospitalization risk. Conclusions: RV dysfunction and impaired RV-PA coupling are frequent among TMVR candidates. They may inform risk stratification and carry prognostic significance. TMVR is associated with haemodynamic improvements that could benefit RV-PA coupling. Patients with secondary MR, with baseline association of impaired coupling and severe TR, or failed reversal of pulmonary hypertension may require closer clinical follow-up. Further studies are warranted to validate these findings.
Objective: Determining the appropriate expanded polytetrafluoroethylene (ePTFE) chord length remains a critical step in mitral valve repair. Freehand ePTFE suturing and premeasured loops are widely used but present technical challenges. A novel chordal holder device was developed to temporarily secure the ePTFE suture during pressurized saline infusion testing, enabling precise subsequent adjustment of chordal length. This feasibility study evaluated this technology in an ex vivo porcine heart model. Methods: In 20 ex vivo porcine hearts, Carpentier type II mitral regurgitation was induced by cutting chordae tendineae in the A2 and/or P2 segments. An LS-5 ePTFE suture was placed using the Mi-STITCH Device. The study technology temporarily held the ePTFE suture at a desired length during infusion testing. Once optimal coaptation was achieved, the chord was permanently secured with a customized Mi-KNOT titanium fastener. Times for suture placement, length adjustment, knot fixation, and total implantation were recorded. Results: A total of 37 ePTFE sutures were implanted. The chordal holder provided reliable temporary fixation and facilitated readjustment with no suture damage. Median time for valve repair was 3 minutes, 20 seconds (02:21; 5:14), with 1 to 4 ePTFE suture placements required to achieve adequate repair. Procedural times did not differ between isolated and nonisolated P2 prolapse (P = .8265). Final infusion testing showed no residual mitral regurgitation greater than trace in all specimens. Conclusions: Setting appropriate replacement chordal length with the evaluated technology is fast, feasible, and intuitive. The chordal holder enabled precise length adjustment and competent repairs. These encouraging results support further evaluation in clinical settings.
BACKGROUND:The impact of proportionality to heart valve regurgitation has been widely investigated in mitral regurgitation, helping to better characterize the best candidates for therapies. However, it has never been studied in tricuspid regurgitation (TR). The aim of the present study is to investigate the impact of the proportionality of TR on outcomes. METHODS:Patients undergoing tricuspid transcatheter edge-to-edge repair were selected from the TRIVALVE registry (International Multisite Transcatheter Tricuspid Valve Therapies Registry). Patients were divided according to the ratio between effective regurgitant orifice area (EROA) and right ventricular (RV) end diastolic diameter (RVEDD) into tertiles: patients with low EROA/RVEDD (RV, dominant); intermediate EROA/RVEDD (RV and TR, RV-TR, codominant), and high EROA/RVEDD (TR, dominant). The primary outcome was all-cause mortality. Median follow-up was 9.7 months (4.2-12.0). RESULTS:A total of 204 patients were included in the present study: 67 for the RV dominant, 68 for the RV-TR codominant, and 69 for the TR dominant group. The 3 groups presented different baseline characteristics. Survival analysis among the 3 groups showed a trend towards worse prognosis for the RV-dominant group, as compared with the RV-TR codominant and TR dominant groups. CONCLUSIONS:The conceptual framework of proportionality is applicable to TR with EROA/RVEDD, defining a higher risk RV-dominant phenotype with a trend towards worse survival after tricuspid transcatheter edge-to-edge repair.