Valve Reintervention Research Articles

Efficacy of transcatheter edge-to-edge repair for cardiac implantable electronic device-associated tricuspid regurgitation: insights from the TRI-SPA registry.

This study aimed to assess the effectiveness and clinical outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with cardiac implantable electronic devices (CIEDs). This subanalysis of the Transcatheter Tricuspid Valve Repair in Spain (TRI-SPA) registry included patients with at least severe tricuspid regurgitation (TR) who were treated with T-TEER between June 2020 and May 2023 in Spain. Patients with CIEDs and no or mild tricuspid lead-leaflet interaction were compared with those without CIEDs. The primary composite endpoint was all-cause mortality, heart failure-related hospitalization, and tricuspid valve reintervention at 12 months. Among 310 patients (mean age 75.5 ± 9.1 years, 70% female) with significant TR treated with T-TEER, 35 (11%) had CIEDs. Device implantation success was high in both groups (97.1% in the CIED group vs 96.4% in the non-CIED group, P = .81), with a similar rate of ≤ 2+ residual TR (84.9% in the CIED group vs 91.0% in the non-CIED group, P = .26). Patients with CIEDs experienced comparable rates of the primary composite endpoint to the non-CIED group (23.8% vs 19.1%, respectively, HR, 1.40; 95%CI, 0.60-3.31; P = .44), sustained successful TR reduction (≤ 2+ in 55.0% vs 73.8%, P = .07), and functional improvement (NYHA class I/II 81.8% vs 79.9%, P = .79). In a real-world setting, T-TEER seems to be an effective therapeutic option for selected patients with more than moderate TR and CIEDs with no or mild lead-leaflet interaction, offering comparable cardiovascular outcomes and clinical improvement to those without leads. However, the presence of CIEDs may represent an independent risk factor for TR recurrence.

Early and Late Outcomes of Transcatheter Aortic Valve Replacement in Patients With Prior Chest Radiation: A Systematic Review and Meta-Analysis.

Patients with prior history of chest or mediastinal radiation are deemed high risk for surgical AVR. Transcatheter aortic valve replacement (TAVR) has emerged as a promising alternative for these patients, however, this patient population was underrepresented in prior TAVR trials. To compare the outcomes of TAVR in patients with versus without a history of prior chest or mediastinal radiation. This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Systematic search of electronic databases was conducted up to September 2023. We compared early and late mortality as well as complications. A meta-analysis was conducted with the use of a random effects model. The I-square statistic was used to assess heterogeneity. Seven studies comprising 6358 patients were included in this meta-analysis. Patients undergoing TAVR in the radiation group had a higher risk for heart failure exacerbation (OR: 2.06; 95% CI: 1.18-3.59) and aortic valve reintervention (OR: 5.68; 95% CI: 1.83-17.67) in the early postoperative period compared to the nonradiation group. Analysis revealed similar short-term (in-hospital or 30-day) all-cause-mortality (OR: 1.63; 95% CI: 0.89-2.98) between the two groups. Other perioperative complications including myocardial infarction (MI), stroke, pacemaker insertion requirement, major bleeding as well as access-related complications were not significantly different between the two groups. TAVR in the radiation group was not associated with increased all-cause mortality compared to the nonradiation group (OR: 1.40; 95% CI: 0.93-2.11) after a mean follow-up of 17.6 months. Other endpoints including MI, stroke, need for pacemaker insertion, heart failure readmission rate, and need for aortic valve reintervention were similar in the mid-term follow-up between the two groups. TAVR in patients with a history of prior chest or mediastinal radiation was associated with similar short-term and mid-term mortality compared to patients without radiation. The history of chest or mediastinal radiation was associated with more frequent heart failure hospitalizations and aortic valve reintervention in the postoperative period. No difference was found in mid-term complications. Future studies are warranted to validate our findings.

Impact of Anticoagulation Therapy after Bioprosthetic and Homograft Pulmonary Valve Replacement.

The effect of anticoagulation on early postoperative outcomes following pulmonary valve replacement (PVR) with bioprosthetic valves and homografts is not yet defined. We hypothesized that short-term anticoagulation would be associated with improved valve durability. Patients undergoing PVR or right ventricle-pulmonary artery conduits with a bioprosthetic or homograft valve >15 mm in diameter between 1/2015 and 4/2021 at Boston Children's Hospital were retrospectively compared by anticoagulation status. Survival, postoperative echocardiographic data, and the incidence of pulmonary valve reintervention and prosthetic valve dysfunction were compared using multivariable Cox and logistic regression analyses adjusted for a propensity score based on anticoagulation therapy. Among a total of 531 patients with a median follow-up of 1.16 years, 130 received anticoagulation therapy. Freedom from reintervention was 99%, 92%, and 86% at 1, 3, and 5 years, respectively. Adjusted for propensity score, there was no association between reintervention and anticoagulation (hazard ratio 0.78 [95% CI: 0.18-3.47], p=0.75). The propensity-score-adjusted rates of valve dysfunction were 9% in anticoagulated patients and 15% in nonanticoagulated patients (odds ratio 0.54 [95% CI 0.18-1.56], p=0.25). There was no difference in early major bleeding rates between groups (3.4% vs. 2.4%, p=0.59) nor other postoperative outcomes. Only 1/18 (6%) of all bleeding events in the anticoagulated group occurred after starting anticoagulation. Anticoagulation therapy appeared safe with no association with major postoperative bleeding. However, additional follow-up is necessary to assess its impact on mid- to long-term valve durability following PVR.

Real-World Experience in Tricuspid Transcatheter Edge-to-Edge Repair: Transcatheter Tricuspid Valve Repair in Spain Registry.

Significant tricuspid regurgitation (TR) is associated with increased morbidity and mortality. The development of transcatheter valve repair therapies has opened a wide range of opportunities for treatment of patients with high surgical risk. Real-world data might improve patient selection and outcome. The authors sought to investigate acute and short-term cardiovascular outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with dedicated devices in a real-world setting. This is a retrospective, single-arm, multicenter registry conducted at 15 sites in Spain. The primary end point was a composite of all-cause death, rehospitalization for heart failure, and tricuspid valve re-intervention. Patients included (n=283) were older (76±9 years, 70% female), and showed significant comorbidities. Massive or torrential TR was present in 55% of subjects, with secondary cause being the main mechanism of regurgitation in ≈80% of individuals. Intraprocedural success was achieved in 79% of patients. At 1-year follow-up, significant improvements in TR grade (≥3+, 100% to 25%, P <0.001) and New York Heart Association functional class (I/II, 33%-86%, P <0.001) were observed. Lead-induced cause and single leaflet device attachment emerged as independent predictors of at least severe predischarge residual TR. In-hospital mortality occurred in 4 (1.4%) patients, whereas the Kaplan-Meier estimated 1-year primary end point occurrence rate was 21%. Intraprocedural success (hazard ratio, 0.353 [95% CI, 0.156-0.798]; P=0.012), was found to be an independent predictor of primary end point. In a real-world contemporary setting, tricuspid transcatheter edge-to-edge repair with dedicated devices emerged as effective therapeutic option for patients with severe TR.

Valve Sparing Aortic Root Replacement in the Resternotomy Setting.

While valve-sparing aortic root replacement (VSRR) has demonstrated satisfactory outcomes, its utility in a reoperative sternotomy setting remains uncertain. This study evaluates the perioperative safety and long-term durability of reoperative sternotomy VSRR. All consecutive VSRR at two centers from 2005-2020 were included. Reoperative VSRR was defined as prior sternotomy for any reason. Time-dependent outcomes were compared between groups after balancing of covariates with inverse probability of treatment weighting. Multivariable Cox regression and Fine-Gray sub-distribution hazard model were used to identify factors associated with 10-year survival and aortic valve (AV) reintervention, respectively. Of 778 VSRR, 69 (8.9%) were reoperative sternotomies. Compared to primary, reoperative VSRR patients were younger (43 [34-54] vs 51 [39-61] years, p<0.001) and had less aortic insufficiency (33.3% vs 48.5%, p=0.02). Cardiopulmonary bypass times were longer in reoperative VSRR with similar rates of circulatory arrest. Reoperative VSRR had a higher incidence of postoperative acute kidney injury (10.1% vs 3.2%, p=0.01) and prolonged ventilation (24.6% vs 9.9%, p<0.001); operative mortality was higher in reoperative VSRR (2.9% (2/69) vs 1.4% (10/709)) although not significantly (p=0.66). Ten-year survival was 82.0% [70.0-96.0] and AV reintervention rate was 11.8% [2.3-19.4] after reoperative VSRR. After IPTW adjustment, survival and AV reintervention rates were not different. Reoperative sternotomy was not associated with long-term mortality (p=0.13) or AV reintervention (p=0.77) on multivariable analysis. Although complex, reoperative sternotomy VSRR can be performed with low operative mortality in carefully selected patients. Ten-year survival and AV reintervention rates were acceptable and comparable to primary VSRR.

Transcatheter vs Surgical Aortic Valve Replacement in Medicare Beneficiaries with Aortic Stenosis and Coronary Artery Disease.

As percutaneous therapeutic options expand, the optimal management of severe aortic stenosis (AS) and concomitant coronary artery disease (CAD) is being questioned between coronary artery bypass grafting and surgical aortic valve replacement (CABG+SAVR) versus percutaneous coronary intervention and transcatheter aortic valve replacement (PCI+TAVR). We sought to compare perioperative and longitudinal risk-adjusted outcomes between patients undergoing CABG+SAVR versus PCI+TAVR. Using the United States Centers for Medicare and Medicaid Services inpatient claims database, we evaluated all patient age 65 and older with AS and CAD undergoing CABG+SAVR or PCI+TAVR (2018-2022). Comorbidities and frailty were accounted for using validated metrics with doubly robust risk-adjustment using inverse probability weighting, multilevel regression, and competing-risk time to event analyses. The primary endpoint was 5-year composite of stroke, myocardial infarction (MI), valve reintervention and/or death. A total of 37,822 patients formed the study cohort (PCI+TAVR, n=17,413; CABG+AVR, n=20,409). Accounting for age, comorbidities, frailty, and number of vessels revascularized, PCI+TAVR was associated with lower procedural mortality (1.1% vs 3.6%, OR 0.29, p < 0.001), but higher vascular complications (OR 6.02, p < 0.001) and new permanent pacemaker (OR 1.92, p < 0.001). However, the longitudinal 5-year primary endpoint favored CABG+SAVR (20.4% vs 14.2%, OR 1.44, p < 0.001). Subgroup analyses demonstrated a benefit in the use of arterial conduit in CABG+SAVR in patients with single vessel CAD. Among Medicare beneficiaries with severe AS and CAD, CABG+SAVR was associated with higher procedural mortality than PCI+TAVR but lower 5-year risk-adjusted stroke, MI, valve reintervention, and death.

Redo Surgical Aortic Valve Replacement versus Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprosthetic Valves.

Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is associated with improved perioperative safety compared to redo surgical aortic valve replacement (redo-SAVR), but long-term outcomes remain uncertain. We therefore compare long-term outcomes of ViV-TAVR and redo-SAVR. The study included 1:1 propensity-matched Medicare beneficiaries with degenerated bioprosthetic valves admitted between 09/29/2011 and 12/30/2020 undergoing either redo-SAVR or ViV-TAVR. Exclusion criteria included endocarditis, other concomitant cardiac surgery, or aortic valve re-intervention during the same admission. The primary outcome was 5-year survival. Composite secondary outcomes included major adverse cardiovascular events (MACE; 30-day operative mortality, stroke, or acute myocardial infarction) and major valve event-free survival (congestive heart failure readmission, endocarditis, or aortic valve reintervention). Time-to-event analyses utilized Kaplan-Meier analysis and multivariable Cox proportional hazard modeling. Overall, 4,699 patients were identified including 1,775 redo-SAVR and 2,924 ViV-TAVR patients. Redo-SAVR patients were younger (median[IQR] 72[68,77] vs 79[73,84]) with less CHF(39.6% vs. 68.8%) and prior CABG (17.9% vs. 32.0%) (all p<0.05). In the propensity-matched cohorts of 1,256 patients each, redo-SAVR had higher MACE (17.4% vs 13.2%, p=0.003), but better major valve event-free (71[62,79] vs 43[38,47] months, p<0.001) and 5-year (62.3% vs 46.7%, p<0.001) survival. After stratification by Charlson Comorbidity Index, the long-term survival benefit persisted in patients of lower (67.6% vs 54.9%, p=0.001) and medium or higher-risk (55.1% vs 36.7%, p<0.001). Redo-SAVR may have better long-term survival than ViV-TAVR despite greater perioperative morbidity. Clinical trial data is needed to fully inform clinical decision-making regarding degenerated bioprosthetic valve reintervention, particularly for patients with reasonable life expectancy.

Hemodynamic Valve Deterioration After Transcatheter Aortic Valve Replacement: Incidence, Predictors, and Clinical Outcomes.

Reports on the durability of transcatheter aortic valve replacement (TAVR) prostheses are scarce and confounded by varying definitions and competing risks of death. The authors sought to determine the incidence, predictors, and clinical outcomes of hemodynamic valve deterioration (HVD) according to the Valve Academic Research Consortium 3 definition after TAVR. We analyzed consecutive patients undergoing TAVR in the prospective Bern TAVI (Transcatheter Aortic Valve Implantation) registry between August 2007 and June 2022 for the incidence and predictors of HVD and performed case control-matching to compare outcomes according to HVD. A total of 2,403 eligible patients (mean age 81.8 ± 6.2 years, median Society of Thoracic Surgeons Predicted Risk of Mortality score 3.8% [Q1-Q3: 2.4%-6.0%]) were included and had a median duration of follow-up of 376days (Q1-Q3: 365-1,825days). The cumulative incidence of moderate or severe HVD was 2.2% (95%CI: 1.6%-3.1%), 10.8% (95%CI: 9.2%-12.7%), and 25.6% (95%CI: 17.5%-36.5%) at 1, 5, and 10 years, respectively. Aortic valve complex calcium volume (HR: 1.81; 95%CI: 1.11-2.97; P=0.018), residual aortic regurgitation at discharge (HR: 1.87; 95%CI: 1.34-2.60; P<0.001), and treatment with oral anticoagulants (HR: 1.78; 95%CI: 1.00-3.15; P=0.048) were independent predictors of HVD. In the case control-matched cohort (HVD, n=155, no-HVD, n=600), patients with HVD had similar yearly rates of all-cause and cardiovascular mortality, and infective endocarditis, but higher rates of repeat aortic valve intervention (rate ratio [RR]: 4.81 [95%CI: 1.74-13.26]; P=0.001). HVD occurred in up to 1 in 4 patients throughout 10-year post-TAVR and was associated with a 5-fold increase in the risk of aortic valve reintervention.

Comparison of short- and long-term outcomes between isolated and concomitant tricuspid valve surgery

BackgroundAccurate reflections of long-term outcomes of isolated tricuspid valve surgery are underreported in the literature. Most published cohort studies consisted of patients receiving tricuspid valve surgery concomitant with left-sided procedures. Patients who undergo isolated tricuspid valve surgery usually present late for surgery, with deteriorating risk factors leading to increased surgical risk. Thus, this study aimed to compare the short- and long-term outcomes of isolated tricuspid valve surgery with those of tricuspid surgery concomitant with left-sided valve procedures. This retrospective cohort study included 617 patients who underwent isolated and left-sided concomitant tricuspid valve surgery from 2009 to 2020. We grouped the patients into isolated (n = 63) vs. concomitant tricuspid surgery (n = 554).ResultsIsolated tricuspid surgery was associated with significantly greater rates of operative mortality (19% vs. 5.2%, P < 0.001), renal failure requiring dialysis (12.7% vs. 2.71%, P < 0.001), and need for ventilation > 24 h (22.22% vs. 12.27%, P = 0.028). ICU (3 days vs. 2 days, P = 0.005) and hospital stays (13 days vs. 11 days, P = 0.042) were significantly longer in isolated tricuspid surgery patients. Isolated tricuspid surgery independently predicted hospital mortality (OR: 4.00 (95% CI: 1.59–10.05), P = 0.003). The risk of follow-up mortality was higher in patients with isolated surgery (HR: 1.95 (95% CI: 0.98–3.86); P = 0.055). However, isolated tricuspid surgery was not associated with heart failure rehospitalization (HR: 1.11 (95% CI: 0.51–2.41); P = 0.798) or increased tricuspid valve reinterventions (HR: 1.42 (95% CI: 0.51– 3.92); P = 0.499).ConclusionsIsolated tricuspid surgery independently predicted hospital mortality and was associated with nonsignificantly higher long-term mortality. This finding highlights the importance of timely referral and intervention for patients with isolated tricuspid valve disease to optimize short- and long-term outcomes.

The Clinical Impact of Mitral Gradient Post Transcatheter Edge-To-Edge Repair: A Systematic Review and Meta-Analysis.

Mitral transcatheter edge-to-edge repair (TEER) is a minimally invasive therapy for severe mitral regurgitation (MR) in patients with high surgical risk. TEER results in a tissue bridge that decreases mitral valve area, potentially leading to elevated mean gradient. The clinical impact of elevated gradient on outcomes is unclear. This systematic review and meta-analysis was based on a comprehensive search of five databases. We included studies that evaluated post mitral TEER gradient on one of the following outcomes: all-cause mortality, combined endpoints, symptoms, hospitalizations, and mitral valve re-intervention. Meta-analysis was conducted using the random-effects model. Out of 6458 citations, 17 studies were included (2017-2024) reporting on 7748 patients. There was significant heterogeneity between studies related to the cutoff used to define elevated gradient, etiology of MR, and outcomes. Elevated mitral gradient post TEER (4, 4.5, 5 mmHg) was associated with worse combined endpoint (HR = 1.35, 95% CI 1.07-1.71; I2 64%), but not all-cause mortality (HR = 1.25, 95% CI 0.97-1.59; I2 45%) or risk of hospitalization. For the combined endpoint, this association was mainly significant in patients who had mitral gradient assessed using discharge echocardiogram (HR = 1.39, 95% CI 1.07-1.81; I2 62%) for all patients and for those with degenerative MR. Despite the heterogeneity between studies, the current analysis suggests that patients with elevated mitral gradient post TEER are at risk of worse clinical outcomes, particularly in patients who had mitral gradient assessed using discharge transthoracic echocardiogram.

Transcatheter vs Surgical Aortic Valve Replacement in Bicuspid Aortic Valves.

Recent approval of transcatheter aortic valve replacement (TAVR) in patients at lower risk profiles has resulted in a real-world expansion in patients with bicuspid aortic valves (BAV), otherwise excluded from trials comparing TAVR with surgical aortic valve replacement (SAVR). This study compared perioperative and longitudinal outcomes between BAV patients undergoing TAVR vs SAVR. Using the United States Centers for Medicare and Medicaid Services inpatient claims database, we evaluated all beneficiaries with BAV undergoing isolated SAVR or TAVR (2018-2022). Comorbidities and frailty were accounted for using validated metrics with doubly robust risk adjustment using inverse probability weighting, multilevel regression models, and competing-risk time to event analysis. Subgroup analysis evaluated patients <75 years with low surgical risk (<4%). The study included 11,289 BAV patients (8123 SAVR and 3166 TAVR). Accounting for age, comorbidities, and frailty, TAVR was associated with lower procedural mortality (odds ratio, 0.40; P < .001) but higher pacemaker (12.4% vs 2.3%; odds ratio, 5.4; P < .001), longitudinal stroke (2.4% vs 1.5%; hazard ratio [HR], 1.35; P < .001), and all-cause mortality (8.8% vs 5.7%; HR, 1.49; P < .001) compared with SAVR. The young low-risk subgroup (5393 SAVR and 1731 TAVR) highlighted similar findings, with TAVR associated with higher longitudinal stroke (2.1% vs 1.7%; HR, 1.22; P= .017) and composite stroke, valve reintervention, or death (8.1% vs 5.9%; HR, 1.37; P < .001) compared with SAVR. Among Medicare beneficiaries with BAV, TAVR was associated with lower index in-hospital mortality but also lower 5-year risk-adjusted freedom from longitudinal stroke compared with SAVR, even in the youngest low-risk patients.

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial

Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. Isala Heart Centre and Medtronic.

Optimizing Percutaneous Mitral Valvuloplasty for Rheumatic Mitral Stenosis ― Clinical Significance of Changes in Mitral Valve Area ―

Percutaneous mitral valvuloplasty (PMV) is a standard treatment for severe rheumatic mitral stenosis (RMS). However, the prognostic significance of the change in mitral valve area (∆MVA) during PMV is not fully understood.Methods and Results: This study analyzed data from the Multicenter mitrAl STEnosis with Rheumatic etiology (MASTER) registry, which included 3,140 patients with severe RMS. We focused on patients with severe RMS undergoing their first PMV. Changes in echocardiographic parameters, including MVA quantified before and after PMV, and composite outcomes, including mitral valve reintervention, heart failure admission, stroke, and all-cause death, were evaluated. An optimal result was defined as a postprocedural MVA ≥1.5 cm2without mitral regurgitation greater than Grade II. Of the 308 patients included in the study, those with optimal results and ∆MVA >0.5 cm² had a better prognosis (log-rank P<0.001). Patients who achieved optimal results but with ∆MVA ≤0.5 cm² had a greater risk of composite outcomes than those with optimal outcomes and ∆MVA >0.5 cm² (nested Cox regression analysis, hazard ratio 2.27; 95% confidence interval 1.09-4.73; P=0.028). Achieving an increase in ∆MVA of >0.5 cm2was found to be correlated with improved outcomes. This suggests that, in addition to achieving traditional optimal results, targeting an increase in ∆MVA of >0.5 cm2could be a beneficial objective in PMV treatment for RMS.

Abstract 4135270: Clinical and Procedural Outcomes after Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement in Severe Aortic Stenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: A growing body of evidence from randomized controlled trials (RCTs) has demonstrated the superiority of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR) irrespective of surgical risk in patients with severe aortic stenosis (SAS). Given the rise in TAVR procedures, analyzing trends in outcomes over time is critical to aid clinical decision-making. Hence, we pooled RCT data for a robust assessment of clinical and procedural outcomes in SAS patients undergoing TAVR and SAVR. Methods: PUBMED and SCOPUS were queried until April 2024. Trials were classified into high and low-risk groups based on surgical risk. The outcomes were analyzed at 30 days (short-term), 1 year (mid-term), and 5 years (long-term). Estimates were calculated as random effects risk ratios (RRs) with 95% confidence intervals (CI). Results: 10 RCTs with a total of 10,252 patients were included. There was no significant association between TAVR and SAVR in reducing all-cause mortality at 30 days (RR: 0.84 [0.64, 1.10]; Figure 1a). While TAVR was associated with a significantly lower all-cause mortality at 1 year (RR: 0.82 [0.68-0.97]; Figure 1b), it was linked with a significantly higher all-cause mortality at 5 years (RR: 1.14 [1.07-1.21]; Figure 1c). Myocardial infarction and stroke were similar in both groups up to 5 years. TAVR was associated with a lower risk of acute kidney injury for up to 1 year and atrial fibrillation for up to 5 years but a higher risk of new permanent pacemaker implantation and aortic valve re-intervention for up to 5 years. In low-risk patients, TAVR showed no significant differences from SAVR for all-cause mortality at 30 days and 5 years, but it was significant at 1 year. In high-surgical-risk patients, all-cause mortality was comparable between TAVR AND SAVR at 30 days and 1 year, with a higher rate observed with TAVR at 5 years. Conclusion: Compared with SAVR, TAVR was superior in reducing all-cause mortality at 1 year in low-risk patients and inferior in reducing all-cause mortality at 5 years in high-risk patients. A thorough evaluation of anatomical, clinical, and procedural factors is crucial to tailor the optimal intervention for each patient.

Abstract 4138782: A Meta-Analysis Comparing Same-Day Discharge to Later-Day Discharge in Transcatheter Aortic Valve Replacement

Background: One of the benefits of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR) is the possibility of same-day discharge, allowing for early mobilization and reduced total hospital stay. However, there is limited evidence comparing same-day discharge to later-day post-TAVR discharge. This meta-analysis aimed to compare the outcomes of same-day and later-day discharge post-TAVR in patients with aortic stenosis. Methods: A systematic bibliographic search was conducted using electronic databases, including PubMed, Embase, and the Cochrane Library, from inception to May 23, 2024. We pooled the risk ratios (RR) with 95% confidence intervals (CI) using the inverse-variance random-effects model. Statistical significance was set at p &lt;0.05. Results: Six studies were included with 71,550 patients undergoing TAVR (2215: same-day discharge; 69335: later-day discharge). The mean age for the same-day and later-day discharge groups was 77.3 ± 8.3 and 78.3 ± 8.5, respectively. Same-day discharge for patients post-TAVR was associated with a higher risk of 30-day stroke [RR: 1.93; 95% CI: 1.14, 3.27] and 30-day major vascular complications [RR: 1.82; 95% CI: 1.02, 3.24] as compared to later-day discharge post-TAVR. However, no significant differences in the risks of 30-day mortality [RR: 0.30; 95% CI: 0.06, 1.57], 30-day readmission [RR: 0.93; 95% CI: 0.66, 1.32], 30-day major bleeding [RR: 0.86; 95% CI: 0.52, 1.42], 30-day new permanent pacemaker [RR: 1.00; 95% CI: 0.81, 1.22], 30-day acute kidney injury [RR: 1.04; 95% CI: 0.73, 1.49], and 30-day valve reintervention [RR: 5.77; 95% CI: 0.60, 55.39] were noted between the two groups. Conclusion: This meta-analysis concluded that same-day discharge post-TAVR is associated with a higher risk of 30-day stroke and 30-day major vascular complications than later-day discharge after TAVR. Same-day discharge was comparable to later-day discharge post-TAVR in terms of 30-day mortality, 30-day readmission, 30-day major bleeding, 30-day new permanent pacemaker, 30-day acute kidney injury, and 30-day valve reintervention. This study underscores the possibility of same-day discharge after uncomplicated TAVR in select patients. Further randomized studies are required to evaluate the safety and feasibility of the same-day discharge protocols.

One-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States

BackgroundLonger term outcomes of transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA (S3UR) valve over its predecessors have not been reported in a national registry. ObjectivesThe aim of this study was to compare the 1-year clinical and echocardiographic outcomes of the S3UR with those of the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. MethodsFrom September 2022 to March 2023, patients who underwent native TAVR with the S3UR or the S3 or S3U valve were propensity matched and compared. Predictors of 1-year outcomes were identified. The median follow-up time was 358 days (Q1-Q3: 47-365 days) for the S3UR and 364 days (Q1-Q3: 80-365 days) for the S3 and S3U. ResultsA total of 4,598 S3UR patients were propensity matched with 4,598 and 32,536 S3 and S3U patients. At discharge, effective orifice areas were larger in the S3UR group (P < 0.0001). The lower discharge mean gradient in the S3UR group was maintained at 30 days and 1 year (P < 0.0001 for all). At 1 year, all-cause mortality (7.6% vs 9.7%; HR: 0.8; 95% CI: 0.67-0.93; P = 0.004), mild or greater paravalvular leak (PVL) (15.6% vs 18.5%; HR: 0.82; 95% CI: 0.69-0.97; P = 0.02), and life-threatening bleeding (2.0% vs 2.7%; HR: 0.7; 95% CI: 0.54-0.94; P = 0.03) were lower in the S3UR group. S3UR and mild or greater PVL were predictive of 1-year mortality in the overall cohort and in low-risk patients. Valve reintervention remained rare at 1 year (0.6% vs 0.4%; HR: 1.46; 95% CI: 0.77-2.78; P = 0.25). ConclusionsTAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention. Longer follow-up will determine the durability of the RESILIA technology in the SAPIEN valve platform.

Incidence of aortic valve reintervention in patients with aortic stenosis undergoing TAVI vs SAVR: A systematic review and meta-analysis of randomised controlled trials

Abstract Introduction Transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) are two established treatments for severe aortic stenosis (AS). The relative comparison between TAVI and SAVR for recurrent aortic valve interventions is not well defined. Purpose We aimed to perform a systematic review and meta-analysis comparing the incidence of aortic valve reintervention in patients undergoing TAVI versus SAVR. Methods MEDLINE, Embase and Cochrane databases were searched for randomised controlled trials (RCT) that compared TAVI with SAVR for the treatment of AS reporting the occurrence of aortic valve reinterventions. We also performed a subgroup analysis of different types of TAVI prosthesis. We performed a meta-regression to evaluate the effect of age and Society of Thoracic Surgeons (STS) risk score in the outcome of interest. Statistical analysis was performed using RevMan 5.4.1 and RStudio 2023.12.1. Heterogeneity was assessed with I2 statistics. Results We included 8 RCTs with 8,698 patients, of whom 4,443 (51%) underwent TAVI. Mean follow-up ranged from 1 to 10 years. Aortic valve reintervention was significantly more common in patients treated with TAVI compared with SAVR (RR 1.89; 95%CI 1.24-2.88; p = 0.003). In a subgroup analysis stratified by balloon-expandable or self-expandable valves, there were no significant subgroup differences in their respective comparisons with TAVR (p = 0.20). In meta-regression analysis, older age (p = 0.008) and higher STS score (p = 0.009) were significantly associated with a higher incidence of aortic valve reinterventions with TAVI relative to SAVR. Conclusion In patients who undergo aortic valve replacement, TAVI is associated with a significantly higher incidence of aortic valve reinterventions relative to SAVR, particularly in populations with older age or higher STS score.

Prosthesis-patient mismatch is associated with long-term mortality following surgical aortic valve replacement

Abstract Background Prosthesis-patient mismatch (PPM) refers to a situation where the indexed effective orifice area (iEOA) of an implanted prosthetic valve is too small relative to the patient's body size, resulting in hemodynamic compromise. Studies examining the long-term consequences of PPM after surgical aortic valve replacement (SAVR) have yielded conflicting results. Purpose To evaluate the impact of PPM on long-term outcomes in patients undergoing primary isolated SAVR. Methods All patients who underwent isolated first-time SAVR from 1990-2014 were included in this observational, single-center study. PPM was defined as a predicted iEOA &amp;lt;0.85 cm2/m2 and severe PPM was defined as an iEOA &amp;lt;0.65 cm2/m2. Patient demographics, surgical details, and in-hospital outcomes were prospectively collected in our institutional database. Cases were linked to provincial administrative databases at an independent, non-profit research institute whose legal status allows it to collect and analyze health care and demographic data. The primary outcome of interest was all-cause mortality. Secondary outcomes were aortic valve reoperation (surgical or transcatheter) and post-operative hospitalization for heart failure. Multivariable Cox regression analysis identified risk factors for long-term mortality. Kaplan-Meier curves were generated for long-term survival and cumulative incidence functions for aortic valve reoperation and heart failure hospitalization. Results A total of 1,798 patients were included (no PPM: 770 [43%]; moderate PPM: 943 [52%]; and severe PPM: 85 [5%]). Mean age was 64±13 years, and 750 (42%) were female. 451 (25%) patients received a mechanical valve, and 1347 (75%) received a stented bioprosthetic valve. Concomitant aortic root enlargement was performed in 492 (27%) patients. At 20 years, survival was 47.8% (95% CI: 43.2%–52.2%) in the "no PPM group" compared with 29.5% (95% CI: 25.6%–33.5%) and 24.7% (95% CI: 12.7%–38.8%) in the moderate and severe PPM groups, respectively (p&amp;lt;0.001) (Figure 1). On multivariable analysis, iEOA was independently associated with long-term mortality (HR 0.95 per 0.10 increase in iEOA, 95% CI [0.91–0.98]; p=0.007). In a pre-specified subgroup analysis, iEOA was found to be associated with late mortality in patients younger than 65 years (p&amp;lt;0.001) but not in patients 65 years and older (p=0.23). Readmission for heart failure was more frequent among patients who had PPM than those who did not (Figure 2). There was no difference in aortic valve reintervention in patients with or without PPM (p=0.654). Conclusions Prosthesis-patient mismatch is common after SAVR and is associated with late mortality and hospitalization for heart failure. The deleterious impact of PPM on survival appears more pronounced in young patients. These findings may have important implications for the lifetime management of patients with aortic valve disease.Survival post SAVRHeart failure hospitalization post SAVR

Transcatheter versus surgical aortic valve replacement in lower-risk patients: an updated meta-analysis of randomised controlled trials

Abstract Background Long-term clinical outcomes after transcatheter [TAVI] and surgical [SAVR] aortic valve replacement are of utmost importance in lower-risk patients. Event rates are diminished in lower-risk patients, therefore individual trials may be separately underpowered to assess low-frequency outcomes. New randomised data has emerged, including 4, 5 and 10-year follow-up from the Evolut Low Risk, PARTNER-3 and NOTION trials, respectively. Purpose To perform a systematic review and meta-analysis of randomised trials studying long-term outcomes in patients with severe aortic stenosis at low-surgical risk undergoing TAVI versus SAVR. Methods Trials randomising patients at lower surgical risk in trials comparing TAVI with SAVR were systematically identified. The prespecified primary endpoint was all-cause death. Key secondary endpoints included stroke, death or disabling stroke, cardiac death, new permanent pacemaker, aortic valve reintervention, and new-onset atrial fibrillation. Reconstructed individual patient data [IPD] was obtained via digitisation of Kaplan-Meier survival curves. Using these data, Cox proportional hazards regression was performed using frailty models on the primary outcome of all-cause death. To assess total lifetime lost, the restricted mean survival time [RMST] was calculated. Conventional pairwise random effects meta-analyses were also performed. This analysis was prospectively registered [CRD42023484976]. Results 4 eligible trials contributed data from 3557 patients with a weighted mean follow-up duration of approximately 4 years (47.6 months). In the reconstructed IPD pooled analyses, there was no significant difference in the hazard of death [hazard ratio 1.15, 95% CI 0.93 to 1.41, p=0.20] or RMST [Δ-0.8 months, p=0.09] (Figure 1). In pairwise meta-analyses, there was no difference between TAVI and SAVR in all-cause death [relative risk (RR) 0.94, 95% confidence interval (CI) 0.78 to 1.13, p=0.51] (Figure 2). There was also no significant difference for stroke [RR 0.94, 95% CI 0.59 to 1.50, p=0.80], or a composite of death or disabling stroke [RR 0.92, 95% CI 0.70 to 1.22, p=0.57]. There was an increase in new pacemaker implantation with TAVI [RR 2.15, 95% CI 1.50 to 3.07, p&amp;lt;0.001], and a reduction in new AF with TAVI [RR 0.43, 95% CI 0.26 to 0.70, p&amp;lt;0.001]; there was no significant difference in any other endpoint (Figure 2). Conclusions The present analysis demonstrates no difference in major clinical outcomes with TAVI or SAVR in lower-risk patients at 4-years follow-up. These results were consistent when analysed using pooled reconstructed IPD or conventional meta-analyses and there were no differences in RMST. These data are informative for lower-risk patients and clinicians, but longer-term follow-up is required to confirm whether equivalence is maintained.Kaplan-Meier plot comparing TAVI vs SAVRForest plot for key clinical endpoints

Trends in Transcatheter Versus Surgical Aortic Valve Replacement Outcomes in Patients With Low-Surgical Risk: A Systematic Review and Meta-Analysis of Randomized Trials.

Limited data exist on long-term outcomes after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). This meta-analysis aims to elucidate outcome trends following TAVR versus SAVR in patients with severe aortic stenosis and low-surgical risk. A systematic search was conducted in PubMed, Embase, Scopus, and the Cochrane Library databases from inception until May 2024, to identify studies comparing TAVR versus SAVR in patients with low-surgical risk (Society of Thoracic Surgeons predicted risk of mortality score <4%). The primary outcome was all-cause mortality. Secondary outcomes included cardiovascular mortality, stroke, disabling stroke, rehospitalization, myocardial infarction, aortic valve reintervention, permanent pacemaker implantation, and new-onset atrial fibrillation. Binary random-effects models were used to compare the risk of each outcome across various follow-up intervals and the risk of bias was assessed using the Cochrane Collaboration's Risk of Bias-2 tool. The meta-analysis included 6 randomized trials including 4682 patients. TAVR was associated with a lower risk of all-cause mortality than SAVR in the 30-day (hazard ratio [HR: 0.45] [95% CI: 0.26-0.77], I2: 0%) and 30-day to 1-year (HR: 0.55 [95% CI: 0.37-0.81], I2: 16%) follow-ups. However, the risk of all-cause mortality was similar during >1-year follow-ups. TAVR was associated with a significantly lower risk of cardiovascular mortality, disabling stroke, rehospitalization, new-onset atrial fibrillation, and a higher risk of permanent pacemaker implantation compared with SAVR during the 30-day follow-up. TAVR was associated with a lower risk of all-cause mortality within the first year of post-procedural follow-up compared with SAVR. However, the risk of all-cause mortality was similar in >1-year follow-ups.