Incidence and Predictors of Access Site Vascular Complications Following Ultrasound-Guided MANTA Closure Deployment

Purpose: There is no report on the reproducibility of the ultrasound-navigated MANTA deployment (US-MANTA) technique and little is known about predictors for US-MANTA-related vascular complication (VC). This study aimed to assess the incidence and predictors of access-site VC using the US-MANTA technique and report insights of MANTA-related VC from consecutive cases following large-bore arteriotomy. Materials and Methods: Consecutive patients who underwent transfemoral transcatheter aortic valve replacement with the US-MANTA technique from November 2018 to February 2020 were evaluated. MANTA-related VC was defined as access-site complications leading to major or minor VCs based on Valve Academic Research Consortium-2 criteria. Results: Among 378 patients, 23 cases (6.1%) of MANTA-related VC (major VC: n=7 [1.9%], minor VC: n=16 [4.2%]) were identified. No significant difference was observed in the incidence of MANTA-related VC over the observational period (first quartile: 5.3%, second: 5.4%, third: 7.4%, and fourth: 6.3%, p>.50). In 7 patients with MANTA-related major VC, 4 (57.1%) of complications resulted from incomplete apposition of the toggle due to anterior wall calcification of the common femoral artery (CFA). Anterior calcification of the CFA determined by computed tomography was identified as an independent predictor of MANTA-related VCs. Conclusions: The US-MANTA technique sustainably provides a low rate of access-site VCs following large-bore arteriotomy. Incomplete apposition of the toggle due to anterior calcification of the CFA may lead to ongoing vascular and bleeding complications.Peer reviewe

Long-term improvement of symptoms of angina pectoris after successful revascularization of coronary artery chronic total occlusions

Objectives. To compare long-term angina pectoris relief of successful versus failed percutaneous coronary intervention of chronic total occlusions (CTO PCI). Background. Previous studies demonstrate better short-term angina pectoris relief of CTO PCI than with optimal medical treatment (OMT), however, data on the long-term effects are lacking. Methods. 295 patients undergoing CTO PCI were analyzed retrospectively, with a follow-up evaluation of symptoms of angina pectoris and all-cause death one to four years after the intervention. The primary outcome was long-term relief of symptoms of angina pectoris. Secondary outcomes included a composite of major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, stroke, and later target vessel revascularization (TVR). At follow-up, patients were interviewed for symptoms of angina pectoris at 1, 6, 12, and 22 to 48 months after the intervention. Results. CTO PCI was successful in 225 (76%) patients and failed in 70 (24%) patients. Short-term (six months) relief of angina pectoris was observed in both groups, but only the successful CTO PCI group showed long-term relief. The Kaplan-Meier curves of all-cause death did not differ between the groups (p = .715). The final follow-up was a mean (range) of 37 (25 to 44) months after the intervention in the successful CTO PCI group, and 33 (28 to 48) months in the failed CTO PCI group. Conclusions. Successful CTO PCI is associated with better long-term relief of symptoms of angina pectoris compared to failed CTO PCI.Peer reviewe

RELATIONSHIPS BETWEEN THE MAXIMUM SHOULDER EXTERNAL ROTATION ANGLE DURING THROWING AND PHYSICAL VARIABLES

To our knowledge, excessive shoulder external rotation may increase elbow valgus stress during throwing (2005). Inhibition of the greater shoulder external rotation angle could prevent elbow injury during throwing. Thus the purpose of this study was to determine physical factors that would increase the maximum shoulder external rotation (MER) angle

Hemodynamic comparison of transcatheter aortic valve replacement with theSAPIEN3 Ultra versusSAPIEN3 : TheHomoSAPIENregistry

Objectives The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR). Background The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited. Methods A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of >= mild PVL after the S3-Ultra and S3 implantation. Results Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 +/- 6.7 years and mean aortic annulus area: 492.5 +/- 91.2 mm(2)). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of >= mild PVL (the total cohort: 7.2 vs. 22.3%,p = mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%,p= .05) in patients with the S3-Ultra. Conclusions In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced >= mild PVL, with comparable safety.Peer reviewe

Hemodynamic comparison of transcatheter aortic valve replacement with theSAPIEN3 Ultra versusSAPIEN3 : TheHomoSAPIENregistry

Objectives The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR). Background The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited. Methods A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of >= mild PVL after the S3-Ultra and S3 implantation. Results Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 +/- 6.7 years and mean aortic annulus area: 492.5 +/- 91.2 mm(2)). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of >= mild PVL (the total cohort: 7.2 vs. 22.3%,p = mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%,p= .05) in patients with the S3-Ultra. Conclusions In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced >= mild PVL, with comparable safety.Peer reviewe

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

Publisher Copyright: © 2022 The AuthorsDespite 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. (c) 2022 The Authors. Published by Elsevier Inc.Peer reviewe

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 rela-tion 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 under-went 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. Predis -charge 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 fail-ures 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 deter-minant of a device failure after TAVI. Moreover, TAVI in patients with EC-BAV requir-ing small SAPIEN 3 could be challenging. Further data on device and treatment selection in patients with BAV are still warranted. (C) 2022 The Author(s). Published by Elsevier Inc.Peer reviewe

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 interna-tional 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.(c) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/) (Am J Cardiol 2023;191:14-22)Peer reviewe

Transplantation of vascular cells derived from human embryonic stem cells contributes to vascular regeneration after stroke in mice

<p>Abstract</p> <p>Background</p> <p>We previously demonstrated that vascular endothelial growth factor receptor type 2 (VEGF-R2)-positive cells induced from mouse embryonic stem (ES) cells can differentiate into both endothelial cells (ECs) and mural cells (MCs) and these vascular cells construct blood vessel structures in vitro. Recently, we have also established a method for the large-scale expansion of ECs and MCs derived from human ES cells. We examined the potential of vascular cells derived from human ES cells to contribute to vascular regeneration and to provide therapeutic benefit for the ischemic brain.</p> <p>Methods</p> <p>Phosphate buffered saline, human peripheral blood mononuclear cells (hMNCs), ECs-, MCs-, or the mixture of ECs and MCs derived from human ES cells were intra-arterially transplanted into mice after transient middle cerebral artery occlusion (MCAo).</p> <p>Results</p> <p>Transplanted ECs were successfully incorporated into host capillaries and MCs were distributed in the areas surrounding endothelial tubes. The cerebral blood flow and the vascular density in the ischemic striatum on day 28 after MCAo had significantly improved in ECs-, MCs- and ECs+MCs-transplanted mice compared to that of mice injected with saline or transplanted with hMNCs. Moreover, compared to saline-injected or hMNC-transplanted mice, significant reduction of the infarct volume and of apoptosis as well as acceleration of neurological recovery were observed on day 28 after MCAo in the cell mixture-transplanted mice.</p> <p>Conclusion</p> <p>Transplantation of ECs and MCs derived from undifferentiated human ES cells have a potential to contribute to therapeutic vascular regeneration and consequently reduction of infarct area after stroke.</p