Haemodynamic and clinical outcomes at 5 years according to predicted prosthesis-patient mismatch after transcatheter aortic valve replacement.

BACKGROUND/PURPOSE: Although the impact of predicted prosthesis-patient mismatch (PPMP) on outcomes after surgical aortic valve replacement is well established, studies on PPMP in transcatheter aortic valve replacement (TAVR) are limited. This study investigated the effects of PPMp on haemodynamic and 5-year clinical outcomes after TAVR. METHODS/MATERIALS: We analysed 1733 patients who underwent TAVR. PPMp was defined using two different methods: 1) normal reference values of the effective orifice area for each valve type and size indexed to body surface area (PPMp1; n = 1733) and 2) reference values for aortic annulus area or perimeter assessed with pre-procedural computed tomography indexed to body surface area (PPMp2; n = 1227). The primary endpoint was the composite of all-cause death and/or rehospitalisation for heart failure at 5 years. RESULTS: The incidence of PPMp1 was 11.7 % and 0.8 % in moderate and severe cases, respectively. PPMp2 was classified as either moderate (3.8 %) or severe (0 %). Rates of residual mean aortic gradient ≥20 mmHg significantly increased depending on PPMp1 severity (no PPMp1: 3.1 % vs. moderate PPMp1: 26.8 % vs. severe PPMp1: 53.9 %, p < 0.0001) and PPMp2 (no PPMp2: 4.1 % vs. moderate PPMp2: 12.8 %, p = 0.0049). Neither of PPMP methods were associated with the composite outcome in total cohort; however, PPMP1 was significantly related to worse clinical outcomes at 5 years among patients with reduced left ventricular ejection fraction (LVEF) in multivariate analysis (HR: 1.87; 95 % CI: 1.02-3.43). CONCLUSIONS: The impact of PPMP on TAVR clinical outcomes may not be negligible in patients with low LVEF.

Sodium-Glucose Cotransporter-2 Inhibitors Stabilize Coronary Plaques in Acute Coronary Syndrome With Diabetes Mellitus.

Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are widely used in cardiology and are effective in treating acute coronary syndrome (ACS). Their effects on unstable plaque in patients with ACS remains unclear. This study aimed to examine the effectiveness of SGLT2is in coronary plaque based on optical coherence tomography (OCT) images and the prognosis of ACS with type 2 diabetes mellitus. This retrospective study included 109 patients in the total cohort and 29 patients in the OCT cohort. Based on SGLT2i administration after ACS, the total cohort was categorized into non-SGLT2i (n = 69) and SGLT2i (n = 40) groups. The OCT cohort had 15 and 14 patients in the non-SGLT2i and SGLT2i groups, respectively. The OCT images of unstable plaque were analyzed in nonstented lesions during ACS catheterization and at the 6-month follow-up. The total cohort was assessed after 1 year for major adverse cardiovascular events, including all-cause mortality, revascularization, cerebrovascular disease, and heart failure hospitalization. SGLT2is improved unstable lesions with a significantly thicker fibrous cap (48 ± 15 µm vs 26 ± 24 µm, p = 0.005), reduced lipid arc (-29 ± 12° vs -18 ± 14°, p = 0.028), higher % decrease in total lipid arc (-35 ± 13% vs -19 ± 18%, p = 0.01), and lower major adverse cardiovascular event incidence (log-rank p = 0.023, hazard ratio 4.72 [1.08 to 20.63]) and revascularization rate (adjusted hazard ratio 6.77 [1.08 to 42.52]) than the non-SGLT2i group. In conclusion, SGLT2is can improve the markers of plaque stability and may improve the prognosis in patients with type 2 diabetes mellitus.

Long-Term Assessment of Survival After Transcatheter Aortic Valve Implantation　- Insights From the International Transcatheter Aortic Valve Implantation Registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS), but despite estimates of life expectancy after TAVI being essential in heart team discussion, these data are scarce. Therefore, the current study sought to assess long-term survival and its trends in relation to chronological age, surgical risk, and treatment period.Methods and Results: We included 2,414 consecutive patients who underwent TAVI for severe symptomatic AS between 2008 and 2021 at 2 international centers. For the analysis, long-term survival was evaluated according to age, surgical risk, and treatment period categorized into 3 groups, respectively. The longest follow-up was 13.5 years. Overall survival was 67.6% at 5 years and 26.9% at 10 years. Younger patients, lower surgical risk, and later treatment period showed better survival (log-rank P<0.001, respectively). In the multivariate analysis, age <75years, lower surgical risk, and later time period were significantly associated with better survival. The incidence of paravalvular leakage ≥moderate, red blood cell transfusion, and acute kidney injury were independently associated with increasing risk of 5-year death. CONCLUSIONS: In a real-world registry, survival was substantial following TAVI, especially in younger and lower surgical-risk patients, with improving outcomes over time. This should be considered in heart team discussions of life-long management for AS patients after TAVI.

Risk Assessment of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation in Patients With Preexisting Right Bundle Branch Block.

Preexisting right bundle branch block (RBBB) is the strongest predictor for permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). However, the risk assessment for new PPI and effective procedural strategy for preventing new PPI in patients with preexisting RBBB are still unclear. This study stratified the new PPI risk after TAVI and investigated the impact of implantation strategy in a preexisting RBBB cohort. We analyzed 237 patients with preexisting RBBB who underwent TAVI. The primary endpoint was the incidence of new PPI. Multivariate analyses investigating predictors for new PPI were performed. The overall PPI rate was 33.3%. Significant baseline predictors for new PPI were combination of RBBB, left anterior or posterior fascicular block, and first-degree atrioventricular block (odds ratio [OR] 2.55, 95% confidence interval [CI] 1.09 to 5.04), high calcium volume of noncoronary cusp (OR 2.08, 95% CI 1.05 to 4.10), and membranous septum (MS) length <2 mm (OR 2.02, 95% CI 1.09 to 3.75) in the univariate analysis and MS length <2 mm (OR 2.25, 95% CI 1.06 to 4.82) in the multivariate analysis. On the multivariate analysis including procedural variables, predilatation (OR 2.41, 95% CI 1.01 to 5.83), self-expanding valves (Corevalve, Evolut R, and Evolut Pro/Pro+; Medtronic Inc., Minneapolis, Minnesota) or mechanical expanding valves (Lotus/Lotus Edge; Boston Scientifics, Marlborough, Massachusetts) (OR 3.00, 95% CI 1.31 to 6.91), and implantation depth > MS length (OR 4.27, 95% CI 1.81 to 10.08) were significantly associated with new PPI. The incidence of new PPI increased according to the number of baseline predictors (0: 20.9%, 1: 34.3%, and ≥2: 52.0%) and procedural predictors (0: 3.7%, 1: 20.9%, 2: 40.5%, and 3: 60.0%). New PPI risk in a preexisting RBBB subset could be stratified by baseline factors. Device selection and implantation strategy considering MS length could prevent new PPI even in these high-risk population.

Hemodynamics and Conduction Disturbance After Transcatheter Aortic Valve Implantation With SAPIEN3 Ultra Versus SAPIEN3: The HomoSAPIEN 2 Study.

The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p = 0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD. Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115.

Conduction Disturbance After Transcatheter Aortic Valve Implantation With Self- or Balloon-Expandable Valve According to the Implantation Depth.

Membranous septum (MS) length, in conjunction with implantation depth (ID), is known as a determinant of conduction disturbance (CD) after transcatheter aortic valve implantation (TAVI). However, its impact might be dissimilar among valve types because each valve has a different platform. This study sought to investigate the different impacts of ID and MS length on the new-onset CD between ACURATE neo and SAPIEN 3. This study included patients without a previous permanent pacemaker implantation who underwent TAVI with ACURATE neo and SAPIEN 3 and divided them into 2 groups based on the ID according to MS length (deep and shallow implantation group). Deep implantation was defined as transcatheter heart valve implantation deeper than MS length. The primary endpoint was new-onset CD (new permanent pacemaker implantation or new-onset complete left bundle branch block). A total of 688 patients (deep implantation: n = 373, shallow implantation: n = 315) were identified as a study cohort. New-onset CD developed more frequently in the deep implantation group (16.6% vs 7.0%; p = 0.0001). Deep implantation was revealed as a predictor of new-onset CD. Moreover, deep implantation was significantly associated with new-onset CD after SAPIEN 3 implantation but not after ACURATE neo. Among patients with MS shorter than 2 mm, ACURATE neo was superior in terms of avoiding new-onset CD. In conclusion, the deep implantation was associated with new-onset CD after TAVI with SAPIEN 3 but not with ACURATE neo. These results may impact device selection in patients with a preexisting high risk of CD.

Transseptal snaring technique as a bailout from valvuloplasty balloon entrapment within a self-expanding valve: a case report.

Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment strategy for severe aortic stenosis in patients with high and intermediate surgical risk. Although complications are significant cause of increasing mortality after TAVR and bailout techniques have been well established, we still encounter a rare complication without widely accepted bailout option. We present a rare complication of valvuloplasty balloon entrapment to a self-expanding valve strut with successful bailout. Case summary: A 71-year-old man complaining of dyspnoea underwent valve-in-valve TAVR for failed surgical aortic valve. However, he developed acute decompensated heart failure due to high residual aortic gradient (peak aortic velocity of 4.0 m/s and mean aortic gradient of 37 mmHg) on the 3rd day after TAVR. Computed tomography demonstrated underexpansion of transcatheter heart valve (THV) within the surgical valve. Therefore, urgent balloon valvuloplasty was performed. The balloon entrapment in the THV stent frame happened during the procedure. Percutaneous removal through transseptal approach using snaring technique was successfully performed. Discussion: Balloon entrapment within a THV is a rare complication and potentially requires urgent surgical removal. To our knowledge, this is the first report utilizing the snaring technique through transseptal approach for balloon entrapment within a THV. Through the current report, we highlight the utility and effectiveness of the transseptal snaring technique with using a steerable transseptal sheath. Moreover, this case shows the importance of the multiprofessional approach to resolve unexpected complications.

Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access.

BACKGROUND: Data regarding the impact of high transcatheter heart valve (THV) implantation on coronary access after transcatheter aortic valve replacement (TAVR) as assessed by postimplantation computed tomography (CT) are scarce. OBJECTIVES: The authors sought to assess the impact of high THV implantation on coronary access after TAVR. METHODS: We included 160 and 258 patients treated with Evolut R/PRO/PRO+ and SAPIEN 3 THVs, respectively. In the Evolut R/PRO/PRO+ group, the target implantation depth was 1 to 3 mm using the cusp overlap view with commissural alignment technique for the high implantation technique (HIT), whereas it was 3 to 5 mm using 3-cusp coplanar view for the conventional implantation technique (CIT). In the SAPIEN 3 group, the HIT employed the radiolucent line-guided implantation, whereas the central balloon marker-guided implantation was used for the CIT. Post-TAVR CT was performed to analyze coronary accessibility. RESULTS: HIT reduced the incidence of new conduction disturbances after TAVR for both THVs. In the Evolut R/PRO/PRO+ group, post-TAVR CT showed that the HIT group had a higher incidence of the interference of THV skirt (22.0% vs 9.1%; P = 0.03) and a lower incidence of the interference of THV commissural posts (26.0% vs 42.7%; P = 0.04) with access to 1 or both coronary ostia compared with the CIT group. These incidences were similar between the HIT and CIT groups in the SAPIEN 3 group (THV skirt: 0.9% vs 0.7%; P = 1.00; THV commissural tabs: 15.7% vs 15.3%; P = 0.93). In both THVs, CT-identified risk of sinus sequestration in TAVR-in-TAVR was significantly higher in the HIT group compared with the CIT group (Evolut R/PRO/PRO+ group: 64.0% vs 41.8%; P = 0.009; SAPIEN 3 group: 17.6% vs 5.3%; P = 0.002). CONCLUSIONS: High THV implantation substantially reduced conduction disturbances after TAVR. However, post-TAVR CT revealed that there is a risk for unfavorable future coronary access after TAVR and sinus sequestration in TAVR-in-TAVR. (Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access; UMIN000048336).

Impact of Mild Paravalvular Regurgitation on Long-Term Clinical Outcomes After Transcatheter Aortic Valve Implantation.

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 [95% confidence interval: 1.04 to 1.91]). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes.

Discordance between fractional flow reserve and instantaneous wave-free ratio in patients with severe aortic stenosis: A retrospective cohort study.

BACKGROUND: Discordance between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) occurs in approximately 20 % of cases. However, no studies have reported the discordance in patients with severe aortic stenosis (AS). We aimed to evaluate the diagnostic discordance between FFR and iFR in patients with severe AS. METHODS: We examined 140 consecutive patients with severe AS (164 intermediate coronary artery stenosis vessels). FFR and iFR were calculated in four quadrants based on threshold FFR and iFR values of ≤0.8 and ≤0.89, respectively (Group 1: iFR >0.89, FFR >0.80; Group 2: iFR ≤0.89, FFR >0.80; Group 3: iFR >0.89, FFR ≤0.80; and Group 4: iFR ≤0.89, FFR ≤0.80). Concordant groups were Groups 1 and 4, and discordant groups were Groups 2 and 3. Positive and negative discordant groups were Groups 3 and 2, respectively. RESULTS: The median (Q1, Q3) FFR and iFR were 0.84 (0.76, 0.88) and 0.85 (0.76, 0.91), respectively. Discordance was observed in 48 vessels (29.3 %). In the discordant group, negative discordance (Group 2: iFR ≤0.89 and FFR >0.80) was predominant (45 cases, 93.6 %). Multivariate analysis showed that the left anterior descending artery [odds ratio (OR), 3.88; 95 % confidence interval (CI): 1.54-9.79, p = 0.004] and peak velocity ≥5.0 m/s (OR, 3.21; 95%CI: 1.36-7.57, p = 0.008) were independently associated with negative discordance (FFR >0.8 and iFR ≤0.89). CONCLUSIONS: In patients with severe AS, discordance between FFR and iFR was predominantly negative and observed in 29.3 % of vessels. The left anterior descending artery and peak velocity ≥5.0 m/s were independently associated with negative discordance.

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

BACKGROUND: One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC). AIMS: We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective.  Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days. RESULTS: In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results. CONCLUSIONS: Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

Early Hemodynamic Outcomes in Self-Expandable Valves: Comparison of ACURATE Neo Versus ACURATE Neo2.

BACKGROUND: Comparisons of hemodynamic results between ACURATE Neo and ACURATE Neo 2, which have updated outer sealing skirts, are limited. This retrospective study aimed to demonstrate the differences in hemodynamic outcomes between the two transcatheter heart valves (THVs). METHODS: We included 449 patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with either ACURATE Neo2 (n = 100) or ACURATE Neo (n = 348) between January 2016 and November 2021. The primary endpoint was the incidence of moderate or severe paravalvular leakage (PVL). The mean aortic pressure gradient (APG), peak aortic velocity (AV), and early clinical outcomes were assessed as secondary outcomes. RESULTS: In the propensity-score matching comparison (94 pairs), there were no significant differences in the incidence of moderate or severe PVL (4.3 % in Neo2 group vs. 8.5 % in Neo group, p = 0.233), and peak AV and mean APG were significantly higher in Neo2 group (Peak AV: 2.1 ± 0.4 vs. 1.9 ± 0.5 m/s, p = 0.003; mean APG: 10.6 ± 4.8 vs. 9.0 ± 6.1 mmHg, p = 0.045). In the multivariate logistic regression analysis, the THV type (ACURATE Neo2) was not an independent predictor of moderate or severe PVL. CONCLUSION: The incidence of moderate or severe PVL did not significantly differ between TAVR with ACURATE Neo2 and ACURATE Neo; however, it was numerically lower in ACURATE Neo2. In contrast, the Neo2 group had a higher residual mean APG and peak AV. A larger study with long-term follow-up is warranted to assess the clinical relevance of these findings.

Effects of Zinc Acetate Hydrate Supplementation on Renal Anemia with Hypozincemia in Hemodialysis Patients.

INTRODUCTION AND AIMS: This study examined whether zinc supplementation with zinc acetate hydrate improved renal anemia with hypozincemia in patients undergoing hemodialysis. METHODS: The study participants included 21 patients undergoing hemodialysis who presented with a serum zinc level < 60 mg/dL and who were administered zinc acetate hydrate at 50 mg (reduced to 25 mg, as appropriate) for 6 months. Patients with a hemorrhagic lesion, acute-phase disease (pneumonia or cardiac failure), or hematologic disease and those whose treatment was switched from peritoneal dialysis to hemodialysis were excluded. The changes in the erythropoietin resistance index (ERI) before and after zinc acetate hydrate administration were examined. ERI was defined as the dose (IU) of erythropoiesis-stimulating agent (ESA)/week/body weight (kg)/hemoglobin content (g/dL). The differences between the two groups were analyzed using the Wilcoxon signed rank sum test, and p < 0.05 was considered statistically significant. RESULTS: The study participants included 19 men and 2 women aged 41-95 years (mean ± standard deviation (SD): 67.1 ± 13.6). The changes in the values of parameters measured before and after zinc acetate hydrate administration were as follows: Blood Hb did not change significantly, from 10.0-13.6 g/dL (11.5 ± 1.0 g/dL) to 10.2-12.4 g/dL (11.4 ± 0.7 g/dL); serum zinc concentration significantly increased, from 33.0-59.0 mg/dL µg/dL (52.4 ± 7.6 mg/dL µg/dL) to 57.0-124.0 mg/dL µg/dL (84.1 ± 16.3 mg/dL µg/dL; p < 0.01); the ESA dose significantly decreased, from 0-12,000 IU/week (5630 ± 3351 IU/week) to 0-9000 IU/week (4428 ± 2779; p = 0.04); and ERI significantly decreased, from 0.0-18.2 (8.1 ± 5.1) to 0.0-16.0 (6.3 ± 4.3; p = 0.04). CONCLUSIONS: Zinc supplementation increased the serum zinc concentration and significantly reduced the ESA dose and ERI, suggesting that a correction of hypozincemia contributes to lessening renal anemia in these patients.

Percutaneous transvenous mitral commissurotomy and transcatheter aortic valve replacement for rheumatic mitral and aortic stenosis.

The indications for transfemoral transcatheter aortic valve replacement (TAVR) have been expanding; however, treatment protocol for patients with severe aortic stenosis with other significant valve disease is still controversial. Furthermore, there are few randomized data to guide therapy in multivalvular disease. We describe a successful percutaneous transvenous mitral commissurotomy and TAVR simultaneously. A 3-year follow-up echocardiography showed preserved valve function. Learning objective: A combination of percutaneous transvenous mitral commissurotomy and transcatheter aortic valve replacement for multivalvular disease with severe mitral stenosis and aortic stenosis may be a treatment option. For multivalvular disease, heart team decisions can be valuable for an optimal management strategy.

Distal Transradial Access For Cardiac Catheterization in Patients Undergoing Hemodialysis.

OBJECTIVES: Although a distal radial artery (DRA) approach has recently been used in patients undergoing cardiac catheterization, no studies have so far investigated the safety and feasibility of DRA in patients undergoing hemodialysis (HD). We aimed to investigate the incidence of conventional radial artery (CRA) occlusion and puncture site complications after DRA puncture in patients undergoing HD. METHODS: We retrospectively analyzed the data of 117 consecutive patients with HD who underwent coronary angiography or percutaneous coronary intervention via a DRA approach at our institution from September 2017 to December 2019. The primary endpoint was the incidence of CRA occlusion after DRA puncture, as assessed via vascular ultrasonography. Secondary endpoints included difficulty achieving hemostasis, DRA occlusion, aneurysm, arteriovenous shunt, and acute ischemia. RESULTS: The DRA puncture was successful in 106 patients (success rate: 90.5%). Because 21 patients lacked postprocedural vascular ultrasonography data, the primary endpoint was evaluated in 85 patients. CRA occlusion occurred in three patients (3.5%) following DRA puncture. DRA occlusion and aneurysm occurred in five patients (5.9%) and one patient (1.2%), respectively. CONCLUSIONS: Catheterization through DRA is feasible in patients undergoing HD, with a clinically acceptable incidence of CRA and complications.

Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation.

Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p = 0.001). VCD failure rate were 7.5% and 3.9%, respectively (p = 0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p = 0.023; minor: 8.1% vs 4.4%, p = 0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p = 0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (Pinteraction = 0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA.

Device Failure in Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Implantation.

Recent studies showed the favorable outcomes of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BAV) stenosis. However, data on the relation between BAV morphology and optimal transcatheter heart valve (THV) selection are limited. This study sought to evaluate the determinants of device performance in patients with BAV who underwent TAVI. Consecutive patients with BAV who underwent TAVI with the SAPIEN 3 from multicenters were evaluated. Outcomes were the incidence and predictors of device failure. Device failure was defined as peak aortic velocity >3.0 m/s, mean pressure gradient >20 mm Hg, moderate or severe paravalvular leakage and/or procedure mortality. A total of 187 patients with BAV were identified, aged 77 years, and 38.0% were women. A total of 37 patients (19.8%) were treated with 23-mm valve, 58 (31.0%) with 26-mm valve, and 92 (49.2%) with 29-mm valve. Predischarge echocardiogram demonstrated 37 patients (19.8%) with device failure. BAV with excessive leaflet calcification plus calcified raphe (EC-BAV) (OR 16.7, 95% CI 1.99 to 39.6) and smaller THV (OR 4.41, 95% CI 1.43 to 13.6) were independently associated with increased risk of device failure. In addition, 4.0%, 5.1%, and 11.1% of device failures were observed in patients without EC-BAV who underwent TAVI with 23-, 26- and 29-mm THV (p = 0.47), respectively, and 91.7%, 31.6% and 23.2% in those with EC-BAV, respectively (p <0.001). In conclusion, EC-BAV morphology was the major determinant of a device failure after TAVI. Moreover, TAVI in patients with EC-BAV requiring small SAPIEN 3 could be challenging. Further data on device and treatment selection in patients with BAV are still warranted.