Mean Society Of Thoracic Surgeons Research Articles

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve

Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Science, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Long-term outcomes after transcatheter aortic valve replacement: Meta-analysis of Kaplan-Meier-derived data.

Transcatheter aortic valve replacement (TAVR) is as an alternative treatment to surgical AVR, but the long-term outcomes of TAVR remain unclear. This study aimed to analyze long-term outcomes following TAVR using meta-analysis. A literature search was performed with MEDLINE, EMBASE, Cochrane Library, Web of Science, and Google Scholar through November 2022; studies reporting clinical outcomes of TAVR with follow-up periods of ≥8 years were included. The outcomes of interest were overall survival and/or freedom from structural valve deterioration (SVD). Surgical risk was assessed with the Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) score. A subgroup analysis was conducted for intermediate-/high-surgical risk patients only. Eleven studies including 5458 patients were identified and analyzed. The mean age was 82.0 ± 6.5 years, and mean STS PROM score ranged from 2.9to 10.6%. Survival rate at 5 and 10 years was 47.7% ± 1.4% and 12.1 ± 2.0%. Five studies including 1509 patients were analyzed for SVD. Freedom from SVD at 5 and 8 years was 95.5 ± 0.7% and 85.1 ± 3.1%. Similar results for survival and SVD were noted in the subgroup analysis of intermediate-/high-risk patients. Following TAVR, approximately 88% of patients died within 10 years, whereas 85% were free from SVD at 8 years. These date suggest that baseline patient demographic have the greatest impact on survival, and SVD does not seem to have a prognostic impact in this population. Further investigations on longer-term outcomes of younger and lower-risk patients are warranted.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results

BackgroundHigh surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. ObjectivesThis analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. MethodsThe Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. ResultsA total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. ConclusionsThe early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark

BackgroundThe use of transcatheter aortic valve replacement for severe aortic stenosis in low-risk patients necessitates an evaluation of contemporary long-term, real-world outcomes of similar patients undergoing surgical aortic valve replacement (SAVR) in a national cohort. MethodsAll patients undergoing primary, isolated SAVR in The Society of Thoracic Surgeons (STS) database between 2011 and 2019 were examined. The study population of 42,586 adhered to the inclusion/exclusion criteria of the Placement of Aortic Transcatheter Valves (PARTNER) 3 and Evolut Low Risk randomized trials. Patients were further stratified by STS predicted risk of mortality (PROM), age, and left ventricular ejection fraction. The primary end-point was all-cause National Death Index mortality. Unadjusted survival to 8 years was estimated using the Kaplan-Meier method. ResultsMean age was 74.3 ± 5.7 years and mean STS PROM was 1.9% ± 0.8%. The overall Kaplan-Meier time to event analysis for all-cause mortality at 1, 3, 5, and 8 years was 2.6%, 4.5%, 7.1%, and 12.4%, respectively. In subset analyses, survival was significantly better for (1) lower STS PROM (P < .001), (2) younger vs older age (P < .001), and (3) higher vs lower left ventricular ejection fraction (P < .001). When STS PROM was below 1% or the patient age was below age 75 years, the 8-year survival after SAVR was 95%. ConclusionsThe results of this national study confirm that long-term survival after SAVR remains excellent, at 92.9% at 5 years. These contemporary longitudinal data serve to aid in the balanced interpretation of current and future trials comparing SAVR and transcatheter aortic valve replacement and may assist in the clinical decision-making process for patients of lower surgical risk.

Mid-term outcomes and hemodynamic performance of transcatheter aortic valve implantation in bicuspid aortic valve stenosis: Insights from the bicuSpid TAvi duraBILITY (STABILITY) registry.

Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure[BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.

Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.

Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.

Transcatheter Aortic Valve Replacement Prognostication with Augmented Mean Arterial Pressure.

Post-transcatheter aortic valve replacement (TAVR) patient outcome is an important research topic. To accurately assess post-TAVR mortality, we examined a family of new echo parameters (augmented systolic blood pressure (AugSBP) and arterial mean pressure (AugMAP)) derived from blood pressure and aortic valve gradients. Patients in the Mayo Clinic National Cardiovascular Diseases Registry-TAVR database who underwent TAVR between 1 January 2012 and 30 June 2017 were identified to retrieve baseline clinical, echocardiographic and mortality data. AugSBP, AugMAP and valvulo-arterial impedance (Zva) (Zva) were evaluated using Cox regression. Receiver operating characteristic curve analysis and the c-index were used to assess the model performance against the Society of Thoracic Surgeons (STS) risk score. The final cohort contained 974 patients with a mean age of 81.4 ± 8.3 years old, and 56.6% were male. The mean STS risk score was 8.2 ± 5.2. The median follow-up duration was 354 days, and the one-year all-cause mortality rate was 14.2%. Both univariate and multivariate Cox regression showed that AugSBP and AugMAP parameters were independent predictors for intermediate-term post-TAVR mortality (all p < 0.0001). AugMAP1 < 102.5 mmHg was associated with a 3-fold-increased risk of all-cause mortality 1-year post-TAVR (hazard ratio 3.0, 95%confidence interval 2.0-4.5, p < 0.0001). A univariate model of AugMAP1 surpassed the STS score model in predicting intermediate-term post-TAVR mortality (area under the curve: 0.700 vs. 0.587, p = 0.005; c-index: 0.681 vs. 0.585, p = 0.001). Augmented mean arterial pressure provides clinicians with a simple but effective approach to quickly identify patients at risk and potentially improve post-TAVR prognosis.

Pulmonary Hypertension and Operative Risk in Mitral Valve and Coronary Surgery

IntroductionPulmonary hypertension (PHT) is a known risk factor for coronary artery bypass grafting (CABG), though less well understood for valve operations. We hypothesized PHT is associated with lower risk during mitral valve operations compared to CABG. MethodsPatients undergoing isolated mitral valve or CABG operations (2011-2019) in a regional Society of Thoracic Surgeons (STS) database were stratified by pulmonary artery systolic pressure (PASP). The association of PASP by procedure type was assessed by hierarchical regression modeling, adjusting for STS predicted risk scores. ResultsOf the 2542 mitral and 11,059 CABG patients, the mitral population had higher mean STS risk of mortality (3.6% versus 2.4%, P < 0.0001) and median PASP (42 mmHg versus 32 mmHg, P < 0.0001). PASP was independently associated with operative mortality and major morbidity in both mitral and CABG patients. However, for mitral patients a 10-mmHg increase in PASP was associated with lower odds of morbidity (odds ratio: 1.06 versus 1.13), mortality (odds ratio: 1.11 versus 1.18) and intensive care unit time (4.3 versus 7.6 h) compared with CABG patients (interaction terms P < 0.0001). Among mitral patients, median PASP was higher in stenotic versus regurgitant disease (57 mmHg versus 40 mmHg, P < 0.0001). However, there was no differential association of PASP on morbidity or mortality (interaction terms P > 0.05). ConclusionsAlthough mitral surgery patients tend to have higher preoperative pulmonary artery pressures, PHT was associated with a lower risk for mitral outcomes compared with CABG. Further research on the management and optimization of patients with PHT perioperatively is needed to improve care for these patients.

Robotic advanced hybrid coronary revascularization: Outcomes with two internal thoracic artery grafts and stents.

Advanced hybrid coronary revascularization is the integration of sternal-sparing multivessel coronary artery bypass grafting and percutaneous coronary intervention in patients with multivessel coronary artery disease. We sought to review our advanced hybrid coronary revascularization experience over an 8.5-year period using robotic totally endoscopic coronary artery bypass with bilateral internal thoracic artery grafts and percutaneous coronary intervention. From August 2013 to February 2022, 664 patients underwent robotic totally endoscopic coronary artery bypass at our institution. Of the 293 patients who underwent totally endoscopic coronary artery bypass assigned to a hybrid revascularization strategy, 156 patients received bilateral internal thoracic artery grafts and are the subject of this review. Patients underwent percutaneous coronary intervention with drug-eluting stents before or after totally endoscopic coronary artery bypass. We reviewed early and midterm outcomes (up to 8years) in this cohort of patients with intent-to-treat advanced hybrid coronary revascularization. The mean age of patients was 65±10years. The mean Society of Thoracic Surgeons predicted risk of mortality was 1.26±1.56. Triple-vessel disease occurred in 94% of patients, and 17% of patients had 70% or more left-main disease. The mean operative time was 311±54minutes, and the mean hospital length of stay was 2.7±1.1days. All patients had bilateral internal thoracic artery grafts; the total number of grafts was 334. Eight seven percentage of patients had totally endoscopic coronary artery bypass ×2, and 13% of patients had totally endoscopic coronary artery bypass ×3. One patient received totally endoscopic coronary artery bypass ×4. The mean number of grafts per patient was 2.14±0.4, and the mean number of vessels stented was 1.23±0.5. There were no conversions, perioperative stroke, or myocardial infarction. Early mortality occurred in 2 patients. Early graft patency was 98% (209/214 grafts); left internal thoracic artery to left anterior descending patency was 100% (66/66 grafts). At 8-year follow-up in 155 patients (mean 39±26months), all-cause and cardiac-related mortality were 11.6% and 3.9%, respectively. Freedom from major adverse cardiac/cerebrovascular events including repeat revascularization was 94%. In patients with multivessel coronary artery disease, integrating robotic totally endoscopic coronary artery bypass with bilateral internal thoracic artery and percutaneous coronary intervention resulted in excellent early and midterm outcomes. Further studies are warranted.

Transcatheter Tricuspid Valve Repair in Prohibitive Risk Patients: Impact on Quality of Life and Major Organ Systems.

Percutaneous repair for severe tricuspid regurgitation (TR) is emerging as a viable option, but patient selection is challenging and predetermined by comorbidities. This study evaluated mid-term outcomes of transcatheter tricuspid valve repair (TTVR) in very sick inoperable patients and explored the concept of risk-based therapeutic futility. TTVR patients treated in our centre were prospectively assigned to prohibitive-risk (PR) and high-risk (HR) subgroups, based on Society of Thoracic Surgeons (STS) Score, frailty indices, and major organ system compromise. Efficacy and safety outcomes were compared at baseline, 30 days, and 6 months. Thirty-three patients (mean age 81.9 ± 5.1 years) completed follow-up from May 2021 to March 2022: 18 PR (mean STS Score 15.5 ± 7%) and 15 HR (mean STS Score 6.4 ± 1.7%). The primary efficacy end point of at least 1 grade of TR reduction by 30 days was recorded in 93.9% of all patients, with no device-related adverse events. Improvement in initial New York Heart Association functional class III/IV occurred in 74% of PR and 93% of HR patients. Six-minute walk test increased by 81 ± 43.6 metres (P < 0.001) and 85.8 ± 47.9 metres (P < 0.001), respectively. Renal function tests improved by 15% (P= 0.048) and 7% (P= 0.050), while liver enzymes decreased by 18% (P= 0.020) and 28% (P= 0.052). Right ventricular systolic function increased in both subgroups by at least 24% (P < 0.001). Six-month mortality was 12.1%, with 6 hospitalisations for acute heart failure. TR reduction significantly affected quality of life, functional capacity, cardiac remodelling, and multiorgan involvement similarly in PR and HR patients. TTVR is feasible in very sick symptomatic patients, regardless of predicted risk.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Low-risk Patients: A Meta-Analysis Based on a 2-Year Follow-Up.

Previous studies have shown that transcatheter aortic valve implantation is the best alternative therapy to surgical aortic valve replacement in high-risk surgical patients with aortic stenosis. However, it is not clear whether transcatheter aortic valve implantation can be utilized in low-risk surgical patients with aortic stenosis. This studyaimed to evaluate the safety and efficacy of transcatheter aortic valve implantation in low-risk patients. From the outset of our initiative until April 2022, PubMed, EMBASE, and the Cochrane database were thoroughly searched, yielding the selection of 3 randomized controlled trials including 2644 patients with aortic stenosis, to assess outcome measures at distinct follow-up time. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score of patients was 2.2. At the 30-day and 1-year follow-up, transcatheter aortic valve implan- tation was associated with a lower incidence of all-cause mortality, cardiovascular mor- tality, acute kidney injury (stage 2 or 3), life-threatening or significant bleeding, and new atrial fibrillation but an increased risk of permanent pacemaker implantation. At the 2-year follow-up, transcatheter aortic valve implantation only had an advantage in new atrial fibrillation (relative risk, 0.27; 95% CI, 0.14-0.51; P &lt; .0001), with no significant differ- ence in all-cause mortality or cardiovascular mortality. For low-risk surgical patients with aortic stenosis, compared to surgical aortic valve replacement, transcatheter aortic valve implantation was associated with lower all-cause mortality at 30-day follow-up and lower cardiovascular mortality at 1-year follow-up. Except for the advantages in new atrial fibrillation, transcatheter aor- tic valve implantation had no significant impact on mortality at 2-year follow-up.

Hybrid Coronary Revascularization: Early Outcomes and Midterm Follow-Up in Patients Undergoing Single or Multivessel Robotic TECAB and PCI.

Hybrid coronary revascularization (HCR) is the integration of sternal-sparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD). It is traditionally performed with single-vessel bypass (left internal mammary artery [LIMA] to left anterior descending artery [LAD]) and PCI but can also be accomplished with multiple arterial grafts using bilateral IMA conduits. We sought to review our HCR experience over an 8-year period with robotic totally endoscopic coronary artery bypass (TECAB) and PCI. Of 694 patients undergoing beating-heart TECAB from August 2013 to June 2022, 306 patients were designated as intention-to-treat HCR candidates. Patients underwent PCI prior to, the same day as, or following TECAB, performed using single or bilateral IMA grafts. We retrospectively reviewed early and midterm outcomes up to 8 years in this cohort of patients. The mean Society of Thoracic Surgeons predicted risk of mortality was 1.5% ± 2.5%. There were 44 patients (14%) who had ≥70% left main disease and 218 patients (71%) who had triple-vessel disease. A total of 193 patients (63%) underwent multivessel grafting (advanced HCR), with 83% bilateral IMA use. Mean operative time was 263 ± 80 min, and mean length of stay was 2.6 days. The mean number of vessels bypassed per patient was 1.7 ± 0.6. The mean number of vessels stented was 1.2 ± 0.5. Of the patients, 84% underwent TECAB first, 14% PCI first, and 2% same-day TECAB/PCI. Mortality was 0.6% (observed to expected ratio: 0.42). Early graft patency was 97% (328 of 339 grafts); LIMA-LAD patency was 98%. At 8-year follow-up (mean 37 ± 26 months), all-cause and cardiac-related mortality were 13% and 2.6%, respectively. Freedom from major adverse cardiac and cerebrovascular events was 92%. In patients with multivessel CAD, integrating robotic single and multivessel TECAB with PCI resulted in excellent early and midterm outcomes. In experienced hands, the robotic endoscopic approach allows the routine use of multiple arterial grafting during HCR.

Similar clinical outcomes with transcatheter aortic valve implantation and surgical aortic valve replacement in octogenarians with aortic stenosis.

Transcatheter aortic valve implantation (TAVI) is the preferred treatment option for severe aortic stenosis in the elderly and in patients with comorbidities. We sought to compare outcomes after TAVI and surgical aortic valve replacement (SAVR) in octogenarians. In this retrospective cohort study conducted at our tertiary center, clinical data were gathered before and after TAVI and SAVR procedures performed from January 2013 to May 2019; follow-up completed in March 2021. The primary outcome was 1-year mortality. Patients were stratified according to Society of Thoracic Surgeons (STS) score and procedure type. Propensity score-based matching was also performed. Of 542 patients who matched the inclusion criteria, 273 underwent TAVI and 269 SAVR. TAVI patients were older (85.8 ± 3.0 vs. 82.2 ± 2.2 years; P < 0.001) and had a higher mean STS score (5.0 ± 4.0 vs. 2.8 ± 1.3; P < 0.001) and EuroSCORE II (5.3 ± 4.1 vs. 2.8 ± 6.0; P < 0.001). Rates of postoperative permanent pacemaker insertion (15.0% vs. 9.3%; P = 0.040) and paravalvular leak (9.9% vs. 0.8%; P < 0.001) were higher and acute kidney injury lower (8.8% vs. 32.7%; P < 0.001) after TAVI, with no difference between treatment groups for major bleeding (11.0% vs. 6.7%; P = 0.130) or 30-day mortality (5.5% vs. 3.7%; P = 0.315). A statistically significant difference was found between TAVI and SAVR in low- and intermediate-risk groups when it came to occurrence of paravalvular leak, acute kidney injury, and new onset AF (all P < 0.001). This analysis of an octogenarian "real-life" population undergoing TAVI or SAVR (with a biological valve) showed similar outcomes regarding clinical endpoints in low- and medium-risk (STS score) groups.

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

Although transcatheter aortic valve replacement (TAVR) has demonstrated favorable outcomes in randomized studies, there remains a sizable group of patients in whom TAVR may be futile. Characterizing the survival rate in a wide array of patients undergoing TAVR can help develop effective strategies for improving the allocation of medial resources. The aim of this study was to develop a risk model to estimate 1-year mortality after TAVR from a representative nationwide registry in Japan. The J-TVT (Japan Transcatheter Valve Therapies) registry contains complete data, including 1-year outcomes, on patients undergoing TAVR in Japan. A total of 17,655 patients underwent TAVR between 2013 and 2018. They were randomly divided into 2 groups in a 7:3 ratio to form a derivation cohort of 12,316 patients and a validation cohort of 5,339 patients. A risk model was constructed for 1-year mortality in the derivation cohort, and its discrimination and calibration were assessed in the validation cohort. The mean age of all registered patients was 84.4 years, and 68.8% were women. The mean body size area was 1.43m2, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.3%. The estimated 1-year survival was 91.8%; 202 and 1,316 deaths were observed at 30days and 1 year, respectively; The estimated C index for the developed model was 0.733 (95%CI: 0.709-0.757) in the validation cohort, with good calibration. A prediction model for 1-year survival following TAVR derived from a national clinical database performed well and should aid physicians managing TAVR patients.

Multicenter Experience With the Transcatheter Leaflet Repair System for Symptomatic Tricuspid Regurgitation.

Transcatheter treatment techniques for tricuspid regurgitation (TR) have evolved in recent years, with leaflet repair being the most commonly used, but thus far evidence on the PASCAL and PASCAL Ace system is based mainly on compassionate use data. This is the first report on commercial use in a multicenter study with a large patient cohort investigating the safety and efficacy of the PASCAL and PASCAL Ace system in the treatment of TR. In a retrospective, multicenter, observational setting, data from all consecutive patients undergoing leaflet repair for TR at 8 centers was collected, including a centralized analysis of echocardiographic data. A total of 235 high-risk patients (mean age 78 ± 8 years, 49% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality score 8.6% ± 6.8%) were included. TR was functional in 87% of patients and graded severe or higher in 91%. TR was successfully reduced to moderate or less in 78% of patients (P< 0.001). Procedural success was 78% (n=153). At the latest available follow-up (median 173days), TR reduction was sustained (78% with TR moderate orless; P< 0.001), and echocardiography showed indications of right ventricular remodeling (mean right ventricular end-diastolic diameter 56 ± 9mm vs 53 ± 9mm; P< 0.001). Patients' symptoms diminished significantly (63% were inNew York Heart Association functional class I or II at follow-up; P< 0.001). In a device-specific analysis, the PASCAL andPASCAL Ace showed no difference in TR reduction (postprocedural TR moderate or less in 77% vs 78%; P=0.82). In early clinical experience, the PASCAL (Ace) leaflet repair system has high technical and procedural success rates with efficient TR reduction and significant clinical and echocardiographic improvement at follow-up.

A study on correlation between preprocedural CT indexes and procedural success rate of transfemoral transcatheter aortic valve replacement with different self-expanding valves (VitaFlow or VenusA-Valve) in patients with pure native aortic regurgitation.

BackgroundThe rate of procedural success of transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valves in patients with pure native aortic regurgitation (PNAR) is quite low. Which anatomy evaluated by computed tomography (CT) as well as which kind of self-expanding valve is associated with higher success rate remain unknown. The aims of this study were to evaluate the relationship between preprocedural CT indexes and procedural success rate and to compare the procedural success rates between 2 kinds of self-expanding valves with different shaped frameworks.MethodsThis was a retrospective comparative study. The study enrolled the symptomatic patients with severe PNAR, who were treated by transfemoral TAVR using a VenusA-Valve (Venus Medtech, Hangzhou, China) or a VitaFlow valve (Microport, Shanghai, China) at Zhongshan Hospital, Fudan University from October 2018 to December 2020. The procedural success rate (VARC-2 standard) was recorded. Preprocedural CT data were collected, including the perimeters of the aortic annulus (AA), left ventricular outflow tract (LVOT), sinotubular junction (STJ), and ascending aorta (AAO) and the angle of the aortic root. Leaflet thickening was evaluated qualitatively.ResultsA total of 77 patients with a mean Society of Thoracic Surgeons (STS) score of 7.7±5.9 underwent TAVR. The total rate of procedural success was 80.5%. In the successful procedure group, the circumferences of the AA, LVOT, and STJ measured by CT were significant smaller than those in the failed procedure group (P=0.02, P=0.002 and P=0.045, respectively). Meanwhile, there were more patients with leaflet thickening in the successful procedure group (58.1% vs. 20.0%; P=0.02). The VenusA-Valve and the Vita-Flow valve were used in 47 patients and 30 patients, respectively. The procedural success rate was significantly higher in the VitaFlow group than in the VenusA-Valve group (93.3% vs. 72.3%; P=0.048), which was mainly due to the lower incidence of second transcatheter heart valves implantations in the VitaFlow group (6.7% vs. 27.7%; P=0.048).ConclusionsSevere PNAR patients with a smaller AA, LVOT, and STJ and leaflet thickening might have a higher success rate in transfemoral TAVR using a self-expanding valve. The self-expanding valve with a non-A-shaped framework might be a better choice for improved procedural outcomes.

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair

BackgroundContinued development of transcatheter mitral repair technologies is needed to address the large and diverse population of high-risk patients with symptomatic mitral regurgitation (MR). The new PASCAL Ace implant system, with its narrower profile, complements the original PASCAL transcatheter valve repair system. The aim of this study is to report 1-year outcomes from the early, compassionate-use observational experience with the novel PASCAL Ace implant system. MethodsAfter heart team assessment, adults with symptomatic moderate-to-severe (3+) or severe (4+) MR despite optimal medical therapy were treated under compassionate use at 3 hospitals internationally. Data were prospectively collected, and outcomes were assessed over a 12-month follow-up period. ResultsSeventeen patients (mean age 76 years, 65% male, mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score 9.6) were treated. MR etiology was degenerative in 29%, functional in 65%, and mixed in 6%; 59% were in New York Heart Association (NYHA) class III-IV. Technical success was achieved in 100%, and procedural success in 94%. At 1 year, MR grade ≤2+ was achieved in 93% (p < 0.001) with 88% survival rate and 94% free from heart failure hospitalization. The composite major adverse event rate was 6% and 100% of patients had ≤NYHA class II symptoms (p < 0.001). ConclusionsAt 1 year, the PASCAL Ace implant system demonstrated feasibility in this early, compassionate use experience in a small group of symptomatic patients with anatomically complex MR. The unique features of the PASCAL Ace implant may expand the treatable MR population.

Abstract 66: Predictors And Long-term Outcomes Of Skilled Nursing Facility Use After Cardiac Surgery: Insights From Michigan

Background: Payment reform efforts have sought to minimize the use of skilled nursing facilities (SNF) after coronary artery bypass grafting (CABG). Little is known about the characteristics and long-term consequences of CABG patients that are discharged to SNF. The purpose of this study was to identify clinical predictors and long-term outcomes associated with SNF use after isolated CABG. Methods and Results: Clinical data from the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative were linked to Medicare fee-for-service claims for 8280 Michigan residents undergoing isolated CABG that had no prior SNF use and were discharged alive between 7/1/2012-12/31/2018. A total of 1876 patients (22.7%) had any SNF use identified in claims within one year of discharge with a mean of 27.1 SNF days (SD=30.2). Mean Society of Thoracic Surgeons calculated preoperative risk of mortality was higher for SNF users compared to non-users (3.6% vs 2.0%, p&lt;0.001). Among the 2471 patients with a five-meter walk test, SNF users had a significantly longer five-meter walk time (7.4 vs 6.0 seconds, p&lt;0.001). Multivariable logistic regression identified several factors associated with SNF use, including female sex, older age, non-white race, urgent admission, and the presence of comorbid conditions and major operative morbidity. Long-term survival was significantly worse for SNF users (log-rank test p&lt;0.001) with Kaplan-Meier estimated 5-year survival at 66% versus 86% for non-SNF users (Figure). Even after risk adjustment, hazard ratio of mortality associated with SNF use was 2.04 (95% CI: 1.81-2.29, p&lt;0.001). Conclusions: One in five isolated CABG patients in Michigan used SNF within a year of discharge and represented a demographically and clinically distinct population of patients with worse long-term survival. Efforts to reduce SNF use following CABG could result in serious unintended effects on outcomes in this at-risk population.

Risk stratification using growth differentiation factor 15 in patients undergoing transcatheter aortic valve implantation.

Growth differentiation factor 15 (GDF15) shows potential predictive value in various cardiac conditions. We investigated relationships between GDF15 and clinical or procedural outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) in order to propose clinically useful predictive risk stratification model. This prospective single-center registry enrolled 88 consecutive patients with severe symptomatic aortic stenosis treated with TAVI. Clinical parameters were collected and biomarkers including GDF-15 were measured within 24 h before TAVI. All relevant clinical outcomes according to the Valve Academic Research Consortium-2 were collected over the follow-up period. The cohort included 52.3% of females. The mean age of study participants was 81 years; the mean Society of Thoracic Surgeons (STS) score and logistic EuroSCORE were 3.6% and 15.4%, respectively. The mortality over the entire follow-up period was 10.2%; no death was observed within the first 30 days following TAVI. Univariate analysis showed significant associations between GDF15 and mortality (P=0.0006), bleeding (P=0.0416) and acute kidney injury (P=0.0399). A standard multivariate logistic regression model showed GDF-15 as the only significant predictor of mortality (P=0.003); the odds ratio corresponding to an increase in GDF15 of 1000 pg/mL was 1.22. However, incremental predictive value was not observed when the STS score was combined with GDF15 in this predictive model. Based on our observations, preprocedural elevated GDF15 levels are associated with increased mortality and demonstrate their additional value in predicting adverse clinical outcomes in a TAVI population.