Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management

IntroductionThe comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs.MethodsPubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3.ResultsFour observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31–2.84; I² = 0%).ConclusionIn conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.     

Postcardiac inflammatory syndrome following leadless pacemaker implantation

Journal of Interventional Cardiac Electrophysiology -     

Improved hybrid technique for vascular access and closure

PURPOSE: To present a technique for vascular access that features minimal surgical visualization of the target vessel, fast and safe access using an open Seldinger technique under tactile and visual control, and suture closure. TECHNIQUE: After minimal surgical access to the target vessel, exposing only the anterior wall, 4 preliminary 5-0 polypropylene transmural single sutures are placed in the horizontal plane, 2 on either side of the proposed entry point. If the anterior wall is calcified, the sutures are placed more laterally or medially in a suitable plaque-free area. The vessel is then accessed via an open Seldinger technique in the midline between the 4 sutures, and the corresponding sheaths are inserted over the wire. At the end of the procedure, the sheath and wire are removed, and with digital pressure on the vessel distally, the access site is washed out in antegrade fashion. All 4 sutures are then pulled tight by an assistant, and the surgeon ties all the sutures sequentially. Over a 4-year period, this technique has been used in 536 accesses involving the common femoral (n = 500) and iliac (n = 32) arteries and the abdominal aorta (n = 4). Up to 24-F sheaths were introduced. Mean time for vascular access was 9.0+/-3.3 minutes. There were no access-related early complications detected in routine postprocedural imaging and clinical evaluation. CONCLUSION: The "Surgiclose" technique, which is easy to learn and applicable to all vessels, provides a fast, easy, and reliable remote vascular access. It combines the best of both surgical and interventional access techniques, affording minimal surgical access and maximal safety.     

无导线起搏器植入术后股静脉血栓的发生及其临床特征

目的探讨无导线起搏器术后股静脉血栓的发生及其临床特征。 方法连续入选2020年4月到2022年1月在复旦大学附属中山医院接受无导线起搏器植入的患者。所有患者均符合缓慢性心律失常植入单腔起搏器适应证。术后第1天复查股静脉穿刺处彩超,观察股静脉血栓的发生情况及其临床特征,并分析其相关因素。 结果研究纳入146例无导线起搏器植入术后患者,共4例（2.74%,4/146）患者出现股静脉血栓,年龄（75.75±19.14）岁,其中男3例,均无相关症状。经抗凝治疗后3例患者血栓在1个月后消失,1例在2个月后消失,未出现血栓栓塞等不良后果。股静脉血栓者D-二聚体水平（>0.5 mg/L）术前1例升高,术后3例升高,但术前和术后比较差异无统计学意义［0.33（0.26,0.94）mg/L对1.49（0.67,2.17）mg/L,P=0.057］。Spearman相关分析发现无导线起搏器术后股静脉血栓与术后D-二聚体升高呈显著正相关（r=0.239,P=0.037）,而与年龄、性别、体重、合并症（心房颤动、高血压、糖尿病）、基线超声心动图参数、术前D-二聚体升高、X线曝光时间、伤口闭合方式等均无显著相关性（P均>0.05）。 结论无导线起搏器术后股静脉血栓发生率较低,无导线起搏器术后复查D-二聚体和穿刺点血管超声有助于及时发现股静脉血栓并及时开启抗凝治疗。     

Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center

BackgroundVascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites.ObjectiveWe aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD.MethodsFrom February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition.ResultsOverall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32–0.91, p = 0.022).ConclusionsThe M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.     

Outcomes of primary leadless pacemaker implantation: A systematic review

Background

During the last decade, leadless pacemakers (LPMs) have turned into a prevalent alternative to traditional transvenous (TV) pacemakers; however, there is no consolidated data on LPM implantation in emergencies.

Methods

Digital databases were searched for this review and four relevant studies, including 1276 patients were included in this review with procedure duration, fluoroscopic time, major complications, and mortality as primary outcomes and pacing threshold, impedance, sensing of LPM, and hospital stay as secondary outcomes.

Results

Gonzales et al. and Marschall et al. showed the duration of the procedure to be 180 ± 45 versus 324.6 ± 92 and 39.9 ± 8.7 versus 54.9 ± 9.8, respectively. Zhang et al. demonstrated the duration of the procedure and fluoroscopy time to be 36 ± 13.4 and 11.1 ± 3.1, respectively. Similarly, Schiavone et al. exhibited intermediate times of implantation at 60 (45–80) versus 50 (40–65) and fluoroscopic times at 6.5 (5–9.7) versus 5.1 (3.1–9). Hospital stay was more with a temp-perm pacemaker as compared to LPM and pacing parameters were not significantly different in all the studies.

Conclusion

For underlying arrhythmias, whenever appropriate, our review shows that LPMs may be a better option than temporary pacemakers, even as an urgent treatment.     

The learning curve associated with the implantation of the Nanostim leadless pacemaker

Purpose

Use of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators’ experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency.

Methods

Patients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e., LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (>?10 implants) and patients in quartiles 1 through 3 (1–10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts.

Results

Nanostim LP implant was performed in 1439 patients by 171 implanters at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4 to 4.5% (p =?0.038) after more than 10 implants per operator. Total procedure duration decreased from 30.9?± 19.1 min in quartile 1 to 21.6?± 13.2 min (p <?0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p <?0.001), 2 (26.6%; p <?0.001), and 3 (20.4%; p =?0.03).

Conclusions

Learning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.

     

A new technique for vascular access management in transcatheter aortic valve implantation

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty‐two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards‐Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards‐Sapien) or one (CoreValve). There were serious “on‐table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites. © 2009 Wiley‐Liss, Inc.