Valve Academic Research Consortium Criteria Research Articles

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Determining risk factors for vascular and bleeding complications after TAVR using CT angiography

Abstract Funding Acknowledgements None. Introduction The use of pre-procedural computed tomography angiography (CTA) of the iliofemoral sector in the planning of transaortic valve replacement (TAVR) has demonstrated a reduction in the risk of vascular complications in patients undergoing TAVR. In this study, we aimed to characterise the clinical and radiological factors associated with bleeding and vascular complications after TAVR. Methods Patients undergoing transfemoral TAVR in a tertiary centre between 2017 and 2019 were included in this analysis. All patients underwent iliofemoral CTA before the procedure and classical CTA-derived data as well as iliofemoral calcium volume were collected. Clinical data and outcomes regarding bleeding events, as well as vascular complications according to Valve Academic Research Consortium 2 (VARC-2) criteria, were also collected. 207 patients were included in this analysis, of whom 53% were women. The median age was 82 years (IQR 76-86) and the median STS mortality risk score was 3.9% (IQR 2.59-5.99). In this population, vascular complications according to the VARC-2 criteria occurred in 33% of patients (19% with major complications). Patients with lower body mass index (BMI) were more likely to suffer vascular complications. Vascular access with fluoroscopy was associated with a higher prevalence of complications compared to ultrasound-guided vascular access (62% vs. 38%, p=0.037). When considering radiological criteria, smaller minimum luminal diameter and area of the common femoral and external iliac arteries were associated with a greater risk of vascular complications, as were increased sheath to external iliac artery ratios and luminal attenuation values (p<0.05 for all). Bleeding complications occurred in 20 patients, with a greater prevalence of bleeding events in female patients (77% vs. 23%, p=0.001). Patients with a lower BMI, a history of obstructive pulmonary disease or coronary artery disease, aortic insufficiency and fluoroscopic valvular access were more likely to have bleeding complications. Regarding radiological criteria, decreased maximal luminal diameter of the common femoral artery and smaller minimal luminal diameters and areas of the external iliac artery were associated with bleeding complications. Increased sheath-to-femoral artery ratios and luminal attenuation values were associated with an increased risk of vascular complications (p<0.05 for all). Conclusion Our study underscores the importance of pre-procedural CTA in TAVR planning and identifies separate risk factors for vascular and bleeding complications.

Simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction: initial experience.

Simultaneous transcatheter mitral valve in valve (VIV) replacement and aortic valve replacement experience is limited. We report our initial experience with simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction. A total of 8 patients had simultaneous transcatheter heart valve implants for severe mitral bioprosthesis failure (VIV), with a second valve procedure that included native aortic regurgitation (n = 3) or degenerated bioprostheses in the aortic position (n = 5). All patients were treated with a self-expandable J-valve transcatheter valve, using the transapical approach. The mean age of the patients was 73.1 ± 6.2years. The mean Society of Thoracic Surgeons score was 13.8 ± 6.3%. Device success was 100% according to Valve Academic Research Consortium-2 criteria. No other procedure-associated complications occurred, including left ventricular outflow tract obstruction and valve migration. The mean hospital lengths of stay after the procedure were 11.5 ± 8.0days. No deaths occurred at 30days. At a median follow-up period of 28.7 ± 22.3months, no patients died. All patients were in New York Heart Association functional classes I-II. Echocardiographic parameters at follow-up showed a normofunctioning J valve in the mitral position and a mean max mitral flow velocity of 2.0 ± 0.5m/s; the J valve in the aortic position was also normofunctioning, and the mean max aortic flow velocity was 2.3 ± 0.5m/s. Simultaneous transapical transcatheter aortic and mitral valve replacement using the self-expandable J valve appears to be a feasible and effective alternative to redo surgery.

Transcatheter Aortic Valve Replacement in Patients ≥80 and <80 Years of Age with Aortic Valve Stenosis at Moderate Surgical Risk: Findings from an Observational Study in the Vietnamese Population

Objectives: The increasing number of elderly patients with severe aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR) has prompted concerns regarding their clinical outcomes compared with the younger population. This study evaluated the outcomes of TAVR on the basis of age group (<80 or ≥80 years) among Vietnamese patients with severe aortic valve stenosis at intermediate surgical risk. Methods: From March 2017 to December 2022, 21 patients ≥80 years of age and 69 patients <80 years of age underwent TAVI at a single center. Clinical characteristics, procedures, and outcomes at 30 days and 1 year were compared with the Valve Academic Research Consortium (VARC-2) criteria. Results: Patients ≥80 years of age had a higher prevalence of comorbidities but no significant differences in other clinical characteristics and procedures. No statistically significant differences were observed in procedural mortality (4.8% vs. 0.0%, P = 0.233), 30-day mortality (5.0% vs. 1.5%, P = 0.405), and 1-year mortality (11.8% vs. 3.7%, P = 0.241) between age groups. Major endpoints at specified time points also showed no significant differences. Conclusions: TAVR in patients with aortic stenosis at intermediate surgical risk has similar clinical outcomes at 30 days and 1 year, according to VARC-2 criteria, with no statistically significant age-associated differences (≥80 vs. <80 years). However, further studies with larger patient populations are needed to better understand the effects of age on TAVI outcomes in patients with similar characteristics.

Myocardial Injury After Transcatheter Mitral Valve Replacement Versus Surgical Reoperation

This study aimed to evaluate the incidence and clinical implications of myocardial injury, as determined by cardiac biomarker increase, in patients who underwent mitral bioprosthesis dysfunction treatment with transcatheter mitral valve replacement (TMVR) versus surgical mitral valve replacement reoperation (SMVR-REDO). Between 2014 and 2023, 310 patients with mitral bioprosthesis failure were included (90 and 220 patients for TMVR and SMVR-REDO, respectively). Multivariable analysis and propensity score matching were performed to adjust for the intergroup differences in baseline characteristics. Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTn) were collected at baseline and 6 to 12, 24, 48, and 72 hours after intervention. The cardiac biomarkers values were evaluated in relation to their reference values. The outcomes were determined according to the Mitral Valve Academic Research Consortium criteria. CK-MB and cTn increased above the reference level in almost all patients after SMVR-REDO and TMVR (100% vs 94%, respectively), with the peak occurring within 6 to 12 hours. SMVR-REDO was associated with a two- to threefold higher increase in cardiac biomarkers. After 30 days, the mortality rates were 13.3% in the TMVR and 16.8% in the SMVR-REDO groups. At a median follow-up of 19 months, the mortality rates were 21.1% in the TMVR and 17.7% in the SMVR-REDO groups. Left ventricular ejection fraction, estimated glomerular filtration rate, CK-MB, and cTn were predictors of mortality. In conclusion, some degree of myocardial injury occurred systematically after the treatment of mitral bioprosthetic degeneration, especially after SMVR, and higher CK-MB and cTn levels were associated with increased cumulative late mortality, regardless of the approach.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Myocardial injury after transcatheter aortic valve replacement according to VARC-3 criteria

Abstract Background Periprocedural myocardial injury (PPMI) is frequent in patients undergoing transcatheter aortic valve replacement (TAVR). PPMI after TAVR as defined by Valve Academic Research Consortium-2 (VARC-2) criteria occurs in >50% of the patients and had inconsistent results regarding prognostic significance. However, recent VARC-3 definition is more specific, having increased the troponin threshold from 15-times to 70-times the upper reference limit (URL) to define PPMI. This recent definition of PPMI following TAVR lacks the clinical validation. Objective To determine the incidence, predictors and clinical impact of PPMI following TAVR as defined by recent VARC-3 criteria. Methods We included 1,394 consecutive patients who underwent TAVR with a new generation transcatheter heart valve in two tertiary centers in Canada and Italy, from 2015 to 2022. Patients undergoing a trans-aortic or a trans-apical approach were excluded. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs. ≥15 times according to VARC-2 definition). Baseline, procedural and follow-up data were prospectively collected in a dedicated database. Results PPMI was diagnosed in 193 patients (14%) according to the VARC-3 criteria. Female sex and peripheral artery disease were found independent predictors of PPMI in the multivariable analysis (p<0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.76, 95% CI: 1.54-4.95, p=0.001 for all-cause mortality; HR: 9.54, 95%CI: 2.69 to 33.80, p<0.001 for cardiovascular mortality) and 1-year-follow-up (HR: 1.52, 95%CI: 1.02-2.27, p=0.037 for all-cause mortality; HR: 3.04, 95%CI: 1.68-5.50, p<0.001 for cardiovascular mortality). PPMI according to VARC-2 criteria had no impact on mortality (Figure 1). According to restricted cubic splines analysis, the minimal threshold at which high-sensitivity troponin elevation is significantly associated with 1-year all-cause mortality is an 82-fold increase above URL (Figure 2). Conclusions About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria and it had a negative impact on early and late survival. Baseline factors as female gender and peripheral disease increased the risk. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.Kaplan-Meier estimates of mortalityRestricted cubic splines analysis

Up to 6-year performance and clinical outcomes of balloon expandable transcatheter aortic valve according to the implantation strategy: insight from the DIRECTAVI trial

Abstract Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. Purpose To evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVI versus BAV) with the SAPIEN 3 balloon-expandable device in patients included in the DIRECTAVI trial. Methods All patients included in the DIRECTAVI trial since 2016 were offered a clinical and echocardiographic follow-up until January 2023. We applied Valve Academic Research Consortium (VARC-3) criteria to define moderate/severe hemodynamic valve deterioration (HVD) as an increase in mean gradient ≥10 mm Hg resulting with a final mean gradient ≥20 mm Hg, or new/worsening aortic regurgitation (AR) of 1 grade resulting in ≥moderate AR. Survival until moderate/severe HVD between the 2 groups was the primary end-point and overall survival between direct TAVI and BAV were compared using logrank tests. Major clinical outcomes at latest follow-up were also assessed using Chi² or Fisher’s tests. Results Among 250 patients included in DIRECTAVI, 228 patients were followed-up during 4.5 ± 1.1 years. Mean age at follow-up was 87 ± 6.7 years. Incidence rates of moderate/severe HVD were similar in the 2 groups (1.45 versus 1.97 per 100 person-years, p=0.6) (Figure). Incidence rates for death were similar between groups (9.19 and 7.34 events per 100 persons-years for BAV and direct TAVI, respectively, p=0.4). No clinically significant differences in outcomes were observed at the latest follow-up, including major stroke (4.4% for BAV versus 2.6% for direct TAVI, p=0.7), hospitalizations for heart failure (15.8% for BAV group and 11.4% for direct TAVI group, p=0.3), permanent pacemaker implantation (37.7% for BAV and 31.6% for direct TAVI, p=0.3). Moderate/severe patient-prosthesis mismatch was also similar between groups (p=0.6). Conclusion Compared to systematic BAV, direct implantation of the SAPIEN 3 device was not associated with an increased risk of moderate/severe valve deterioration or adverse clinical events up to 6-year follow-up. These results encourage wide use of this simplified strategy with balloon-expandable devices, when possible.Survival without valve deterioration

Early safety and mid-term clinical outcomes of technology transfer of transcatheter aortic valve implantation in patients with severe aortic valve stenosis in Vietnam: a single-center experience of 90 patients

This study investigated the early safety and mid-term outcomes of stepwise implementation of transcatheter aortic valve implantation (TAVI) in Vietnamese patients with severe aortic stenosis (AS) at a single center, following the process of technical transfer. From 2017 to 2022, 90 patients with symptomatic severe AS underwent TAVI at a tertiary hospital in Vietnam. The first 30 cases received support for technology transfer from international proctors. One-year outcomes were evaluated using the Valve Academic Research Consortium-2 (VARC-2) criteria. Forty patients (45.5%) had bicuspid aortic valve (BAV). The Medtronic Evolut R/Pro self-expanding valve system was used in 98.9% of all cases, with a 29-mm valve being the most common. Device success was achieved in 95.6% of cases, whereas one procedural death occurred. At one year, four deaths (5.3%) occurred and all were in the BAV group. Other complications included stroke (2.8%), hospital readmission due to the valve or worsening heart failure (2.8%), permanent pacemaker implantation (9.9%), and moderate paravalvular leak (3.0%). The left ventricular ejection fraction and mean transvalvular gradient significantly improved after TAVI. There were no significant differences in procedural success and mortality when the proctor support period and the subsequent solo operator period were compared. TAVI procedure is safe for treating severe AS in Vietnamese patients, despite the high prevalence of BAV. The procedural complication rate was low, with promising outcomes at one year. These results also highlight the effectiveness of the TAVI technical transfer model in Vietnam. No funding was provided for this study.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

BackgroundThe CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. MethodsThis was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. ResultsWe enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). ConclusionsThe Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov IdentifierNCT03752866.

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.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR

BackgroundIn patients undergoing percutaneous coronary intervention (PCI) in the work-up pre–transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. ObjectivesThis study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. MethodsThis was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. ResultsLBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). ConclusionsIn TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Safety and feasibility of zero-contrast transcatheter aortic valve implantation using balloon-expandable valves in patients with aortic stenosis and severe renal impairment: A single-center study

BackgroundAortic stenosis (AS) and chronic kidney disease (CKD) can coexist. Repeat exposure to contrast media in patients undergoing transcatheter aortic valve implantation (TAVI) has latent mortality risks and increased risk for acute kidney injury. We aimed to assess our “zero-contrast TAVI” protocol for patients with advanced CKD. MethodsConsecutive patients with severe AS who underwent TAVI at a single center registry were enrolled. Zero-contrast TAVI group included patients who underwent TAVI without contrast and who had an estimated glomerular filtration rate <30 mL/min/1.73 m2. Conventional TAVI group included patients who underwent the regular TAVI procedure. Patients using balloon-expandable valves via transfemoral approach were analyzed. Baseline clinical and procedural characteristics and clinical outcomes were compared between two groups. The primary outcome was early safety as defined by Valve Academic Research Consortium Criteria. Secondary outcomes included the presence of severe prosthesis-patient mismatch, moderate or greater perivalvular leakage, and requirement for new dialysis (within 3 months). ResultsA total of 520 patients were analyzed. Among these, 32 (6 %) underwent zero-contrast TAVI and 488 (94 %) conventional TAVI. In the zero-contrast TAVI group, 12 patients (37.5 %) had to use 20.7 (11.0–31.2) mL of contrast media. There were no significant differences in the primary and secondary outcomes between zero-contrast TAVI and conventional TAVI groups (78.1 % vs. 86.8 %, P = 0.184 and 9.4 % vs. 8.1 %, P = 0.738 for the primary and secondary outcomes, respectively). ConclusionsZero-contrast TAVI is feasible, safe, and effective in patients with AS and stage 4 CKD.

The relationship between the serum uric acid/creatinine ratio and prognosis in patients with transcatheter aortic valve implantation.

Aortic valve stenosis is a common valve disease in developed countries where the elderly population is high. Aortic valve stenosis is not a simple calcification; it is a dynamic process in which uric acid plays a serious role. We investigated the role of the serum uric acid/creatinine (SUA/Cr) ratio, which is an indicator of uric acid level independent of renal function, in determining the prognosis in patients who had undergone transcatheter aortic valve implantation (TAVI).In this retrospective cohort study, 357 patients who underwent TAVI for symptomatic severe aortic stenosis between March 2019 and March 2022 were retrospectively analyzed. After applying exclusion criteria, the remaining 269 patients were included in the study. According to the Valve Academic Research Consortium criteria, major adverse cardiac and cerebrovascular events (MACCE) defined the endpoint of the study. Therefore, patients were divided into two groups: the MACCE group and the no MACCE group.Serum uric acid level was significantly higher in the MACCE group (7.0 ± 2.6) than in the no MACCE group (6.0 ± 1.7) (p = 0.008). SUA/Cr ratio was significantly higher in the MACCE group (6.7 ± 2.3) than in the no MACCE group (5.9 ± 1.1) (p = 0.007).The serum UA/creatinine ratio is important in determining the prognosis of patients undergoing TAVI.

Newer versus Early Generation of the MitraClip for Primary Mitral Regurgitation: A Japanese Single-Center Experience

Background: The MitraClip G4 system is the latest version of the transcatheter edge-to-edge repair (TEER) system for mitral regurgitation (MR). We aimed to investigate the impact of the new system on routine clinical practice and patient outcomes in the treatment of primary MR. Methods: Consecutive patients with primary MR who underwent TEER with either the MitraClip G2 or G4 between 2018 and 2021 were enrolled from a single center registry. Baseline clinical and echocardiographic characteristics as well as procedural and clinical outcomes up to 1 year were compared between groups. Technical and device success were defined in accordance with the Mitral Valve Academic Research Consortium criteria. Results: Among 71 patients with primary MR, 34 were treated with G2 and 37 were treated with G4. Patients treated with G4 had lower surgical risk (7.74 [5.04, 14.97] vs. 5.26 [3.98, 6.40]; p &lt; 0.01) than those with G2. There were no significant differences in other baseline clinical variables between groups. On baseline echocardiography, MR volume and flail gap were significantly greater in the G4 group than in the G2 group (regurgitant volume: 63 [41–76] mL vs. 68 [62–84] mL; p = 0.04, flail gap: 4.5 [3.5–5.5] mm vs. 5.4 [4.5–7.1] mm; p = 0.04). Technical success was achieved in over 95% of both groups with no significant difference (p &gt; 0.99). Device success was achieved in 61.8% of the G2 group, while in 70.3% of the G4 group (p = 0.47). Post-procedural MR severity was comparable (p = 0.42) and there was no significant difference in the occurrence of mitral stenosis (p = 0.61) between groups. Among patients who reached 1-year follow-up (n = 54), there was no significant difference between groups in a composite endpoint of death or heart failure rehospitalization (10.5% vs. 20.2%; HR 0.61; 95% CI 0.17–2.22; p = 0.45). Residual heart failure symptoms (NYHA ≥3) at 1 year were observed in 3.7% of the G2 group, while no patient in the G4 group (p &gt; 0.99). Conclusions: The MitraClip G4 system achieved comparable device outcomes to the early-generation device (G2), despite treating more severe primary MR with a larger flail gap.

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve.

The ACURATE neo transcatheter aortic valve is a self-expanding device. Several studies have investigated safety and efficacy, but meta-analysis and pooled data are lacking. We aimed to provide a comprehensive systematic review and meta-analysis on the clinical outcomes of transcatheter aortic valve implantation with the ACURATE neo valve. A systematic literature search for eligible records was conducted. The primary endpoint was device success as designated by Valve Academic Research Consortium-2 criteria. The secondary endpoints (time frame: 30 days) were all-cause mortality, stroke, myocardial infarction, need for new permanent pacemaker, major vascular complications, major bleeding, acute kidney injury stage II or III, and paravalvular regurgitation grade moderate or severe (II or III). Our search yielded a total of 355 records, 20 of those (n = 5858 ACURATE neo receivers) were included in our meta-analysis. Device success was achieved in 94.5% (95% confidence interval [CI], 91.4-96.5%) of the patients. The 30-day all-cause mortality incidence proportion was 1.8% (95% CI, 1.3-2.4%). New pacemaker implantation was required in 7.7% (95% CI, 6.4-9.2%) of the patients, stroke occurred in 1.9% (95% CI, 1.6-2.3%), myocardial infarction in 0.5% (95% CI, 0.3-0.7%), major bleeding in 5.0% (95% CI, 3.9-6.5%), major vascular complication in 5.6% (95% CI, 4.0-7.8%), acute kidney injury stage ≥2 in 2.5% (95% CI, 1.8-3.4%), and paravalvular leak grade ≥moderate was observed in 4.3% (95% CI, 3.0-6.2%). Balloon predilatation and postdilatation incidence was 93.9% (95% CI, 87.0-97.3%) and 43.2% (95% CI, 37.9-48.6%), respectively. ACURATE neo appears to be safe and effective in our analysis with high device success incidence, low mortality, and low new pacemaker implantations.

Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.

Transcatheter aortic-valve implantation. A ten years clinical experience

Transcatheter aortic-valve implantation (TAVI) was introduced in 2002 and the first implants in our country were performed in 2010. To review the TAVI experience in our hospital, considering the technology improvements and gained experience throughout this period. All patients undergoing TAVI in our center were included. Results and complications were adjudicated according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Patients were divided in 3 groups, according to procedural year: Period 1: 2010-2015 (n = 35); Period 2: 2016-2018 (n = 35); Period 3: 2019-2021 (n = 41). Mortality up to one year after the procedure was recorded. Between 2010 and 2021, 111 TAVI procedures were performed. The mean age of patients was 82 years and 47% were women. Risk scores for in-hospital mortality were STS 6.7%, EUROSCORE II 8.0% and ACC/STS TAVR Score 4.9%. The trans-femoral route was used in 88% and a balloon-expandable valve was chosen in 82% of patients. A successful implant was achieved in 96%, with an in-hospital mortality of 1.8%. Mortality at 30 days and 1-year were 2.7 and 9.0%, respectively. During period 3, 100% of implants were successful, with no in-hospital mortality, less vascular complications (p < 0.01), less stroke (p = 0.04), less severe paravalvular leak (p = 0.01) and significantly lower rate of acute complications (p < 0.01). TAVI achieves excellent results. With greater experience and better available technologies, these results are even more favorable.

Echocardiographic predictors of operative outcome for transapical off-pump mitral valve repair with neochord implantation

Abstract Introduction Transapical off-pump mitral valve repair with artificial neochord implantation (TOP-MINI) is safe and effective for the treatment of primary mitral regurgitation12, however, the current literature regarding echocardiographic criteria prior to the procedure is scarce. Objective To identify preoperative echocardiographic predictors of technical success after TOP-MINI for severe primary mitral regurgitation. Methods All consecutive patients who underwent TOP-MINI for severe primary mitral regurgitation from 2017 to 2022 were included. Preoperative echocardiographic evaluation included transthoracic and transesophageal echocardiography. Transesophageal evaluation included 2D measurements of mitral valve annulus, mitral leaflets, flail gap, and 3D mitral valve reconstruction among others, the leaflet-to-annulus index was estimated in all patients. Mitral valve morphology was classified as: Type A (Central posterior leaflet prolapse/flail) or non-Type A (Type B: posterior multisegment involvement; type C: anterior leaflet prolapse; type D: paracommissural or calcified leaflet). Technical success was defined according to the Mitral Valve Academic Research Consortium criteria. Independent echocardiographic predictors for the primary outcome were identified using a multivariate logistic regression model. Results Fifty-five patients were included. Mean age was 66.7 years (SD 12.9). Technical success with MR &amp;lt;2+ was achieved in 48 (87.27%) patients. Significant predictors for technical success were the leaflet-to-annulus index (OR 1.09; p=0.012; 95% CI: 1.02–1.15), with an optimal cutoff value of 1.26 (sensitivity 73.3%, specificity 85.7%); and a non-type A valve morphology (OR 0.04; p=0.024; 95% CI: 0.01–0.65). The model showed good discrimination (AUC = 0.92) and calibration (Hosmer-Lemeshov p=0.21). Conclusion A thorough preoperative echocardiographic evaluation is key to improve outcomes in TOP-MINI. In this study, a leaflet-to-annulus index &amp;gt;1.26 was associated with technical success, whether a non-type A valve morphology was associated with technical failure. These parameters could help to identify proper candidates for this technique. Funding Acknowledgement Type of funding sources: None.

Combination Use of Inoue-Balloon and Self-Expandable Transcatheter Valves in Managing Aortic Stenosis Not Amenable to Balloon-Expandable Valves.

Data on the combined use of aortic Inoue-Balloon catheter and self-expandable transcatheter valve for patients undergoing transcatheter aortic valve replacement (TAVR) are lacking. This study aimed to assess the feasibility and safety of this combination, particularly in patients who cannot be safely managed with balloon-expandable valves.Between 2018 and 2021, 140 consecutive patients who had Inoue-Balloon catheters with self-expandable valves were retrospectively examined. Self-expandable transcatheter valves were deployed using the heart team approach in patients with calcification on the left ventricular outflow tract, which could not be safely addressed with the current-generation balloon-expandable valves.The 20- and 22 mm Inoue-Balloon catheters were used with the 26- and 29 mm Evolut valves, respectively. According to the Valve Academic Research Consortium-2 criteria, the procedural success rate was 95.0%, with an early safety at 30 days rate of 6.5%. A total of 27 patients required post-dilation with the same Inoue-Balloon catheter used for pre-dilation after adjustment to appropriate sizes. Post-dilation, with balloon size adjusted to be 1.4 ± 0.9 mm larger than that in pre-dilation, was effective in 19 out of 27 patients (70.3%) for decreasing paravalvular leak after transcatheter valve deployment. The procedural complication rates between patients with and without post-dilation were not different.The combined use of the size-adjustable Inoue-Balloon catheter and self-expandable valve is safe, particularly in patients who cannot be safely managed with balloon-expandable valves. However, further studies are warranted to elucidate concerns regarding the durability of self-expandable transcatheter valves after post-dilation using the Inoue-Balloon catheter.