Closure Device Research Articles

Transcatheter closure of a right pulmonary artery to left atrium fistula using multi-modality image fusion guidance.

We present the case of 53-year-old woman with a late diagnosis of an right pulmonary artery-left atrium fistula who underwent transcatheter device closure using multi-modality imaging for pre-procedural planning and procedural guidance.

New generation endoscopic closure devices for full-thickness defects: a comparative pre-clinical study (with videos).

Endoscopic closure techniques are effective and safe in the management of transmural gastrointestinal defects. However, there is a paucity of data regarding their comparative effectiveness. This study aimed to compare the efficacy and safety of several new-generation, endoscopic closure devices in a pre-clinical model. We evaluated five commercially available devices: a through-the-scope clip (TTSC), an anchor-pronged TTSC, a suturing device, helical tacking system, and over-the-scope clip. We tested closure strength using an ex-vivo porcine model. Next, live animals underwent 15mm gastric and colonic perforations followed by immediate endoscopic closure with one of the devices. We assessed technical success, 7-day survival, time to complete closure, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) task load index. A total of 60 ex-vivo closures were conducted (12 per device). The suturing device achieved a higher closure strength than all other devices (P < 0.05 for all comparisons). Technical success was achieved in 80% of cases, and 9 of 10 animals (90%) survived to 7days post-closure. The mean procedure time for the suturing device was longer than all other devices (P < 0.05 for all comparisons). The mean procedure time for the anchor-pronged TTSC was also faster than over-the-scope clip (P = 0.04). The total endoscopist NASA-TLX score for the suturing device and helical system were greater than all other devices (P < 0.05 for all comparisons). Each closure device varies significantly in closure strength, closure time, and ease of use. Optimal device selection will depend on defect size, anatomic location, the viability of the surrounding tissue, and endoscopist/technician expertise.

Transcatheter closure of patent ductus arteriosus with mitral regurgitation in children: Clinical outcome and improvement of mitral regurgitation after procedure with echocardiogram follow-up

Background: Patent ductus arteriosus (PDA) is a prevalent pediatric heart condition, often causing heart failure and pulmonary hypertension. Mitral regurgitation, a common occurrence, may be improved by CMRI after PDA closure, suggesting improved follow-up. Objectives: The purpose of this retrospective study is to evaluate the clinical outcomes and follow-up echocardiogram results following transcatheter PDA closure in these patients, with the view of proposing an effective treatment strategy. On other words, the goal is to improve the follow-up of children with PDA and mitral regurgitation five years after PDA closure in which the issue of long-term follow-up of these children still needs to be assessed. Methods: The Queen Alia Heart Institute conducted retrospective study that examined the outcomes and follow-up of children with open PDA with only mitral regurgitation (MR) who underwent closure, outcomes, and follow-up by echocardiography from January 2018 to March 2022. The patient cohort included 46 children who were discussed in heart team meetings and were candidates for catheterization for device closure due to no resolution of the shunts proposed for transcatheter closure of PDA with color Doppler echocardiography. Transcatheter closure was performed with general anesthesia or conscious sedation, and continuous hemodynamic monitoring was performed for at least 30 minutes to ensure stabilization. The study also reviewed the management and outcomes of children with isolated MR and no intervention for PDA. Current intervention techniques for transcatheter closure in patients diagnosed with PDA and MR are divided into four main strategies: Lesson-Severn wire-controlled occlusion, Sideris muscular device implantation, inter-procedural MR availability assessment before device deployment, and secondary transcatheter or interventional strategy due to remaining MR. Advances in treatment have allowed patients to receive intervention at younger ages and benefit from a reduced dose of radiation. Results: A study comparing children with and without PDA and MDI showed significant improvements in post-intervention EROA, RV volume, RVEF, LVEDVi, and LVFS compared to pre-intervention values. The subgroup analysis revealed that after PDA closure, MR drainage volume decreased, while ventricular volume and function were compensated. The study also found that the improvement and EROA reduction might be related to sex rather than age. The results showed no statistical difference in hospitalization rates between the two groups, but the DuctAngio group had a higher proportion of patients with symptoms and poor health. The study also found that patients with MR showed better patient experience, highlighting the potential improvements in pediatric cardiology. Conclusions: The study found that transcatheter closure of significant PDA with MR improved MR in most patients rapidly and at midterm follow-up, with immediate symptomatic improvement and cardiac remodeling, without long-term MR progression.

Percutaneous Carotid Access in Endovascular Aortic Arch Repair: Initial Experience.

Direct percutaneous access to the carotid artery (diPerCa) during endovascular aortic arch repair (EVAAR) can potentially present a minimally invasive access with lesser local adverse events. A retrospective review of consecutive EVAAR between January 2018 and January 2024, in a tertiary referral center, was performed to identify cases, in which diPerCa was used. Patients who were planned for EVAAR with no previous carotid intervention were included. A standardized technique was employed where an ultrasound-guided retrograde puncture of the carotid artery was performed with a micro-puncture set and a suture-mediated closure device (pre-closure technique). Of the 13 included patients, technical success was achieved in 12 (92.3%), with one intraoperative death unrelated to diPerCa. Major complications included one case of carotid pseudoaneurysm and one case of non-flow-limiting carotid dissection. Minor complications were unilateral recurrent laryngeal nerve palsy in one case and new-onset dizziness in one case. All carotid arteries remained patent without stenosis, with one case of non-progressing dissection noted at the conclusion of the mean follow-up of 22.5±2.4 months. Direct percutaneous carotid access with suture-mediated closure devices during EVAAR is feasible with acceptable results and low incidence of clinically relevant neurological and local complications. Further studies are needed to confirm these findings and evaluate long-term outcomes. Direct percutaneous carotid access (diPerCa) during endovascular aortic arch repair (EVAAR) offers a minimally invasive alternative to retrograde access via open surgical exposure. This technique, supported by suture-based closure devices, demonstrates no stroke and low rates of local complications. Overall outcomes are promising, suggesting diPerCa as a feasible option for select patients. Further research is warranted to validate these findings and assess long-term outcomes.

Percutaneous Device Closure of Perimembranous Ventricular Septal Defects Associated with Aortic Valve Prolapse and Aortic Regurgitation.

The progression of aortic regurgitation (AR) in perimembranous ventricular septal defects (pVSD) remains uncertain; research indicates that the accompanying AR tends to worsen over time. There is controversy surrounding the percutaneous closure of defects in patients with pVSD associated with aortic valve prolapse (AVP) and AR. Our research focused on transcatheter closure for pVSD accompanied by AVP, AR, and septal aneurysm, with the aim of addressing challenges through device placement in aneurysmal tissue to eliminate the Venturi effect. We studied 44 patients with AVP, AR, and septal aneurysm who underwent transcatheter device closure. The mean age and weight were 10.5 ± 4.0years and 36.0 ± 15.1kg, respectively. Transcatheter closure was attempted in 44 patients. One case (2.3%) was referred to surgery, while the procedure was successfully completed in 43 out of 44 patients (97.7%). Early complications were minimal. Embolization of the device to the pulmonary artery was observed in one patient; upon re-evaluation, significant aneurysm tissue damage was detected, leading to a referral for surgery. Additionally, three patients (6.9%) developed permanent incomplete right bundle branch block (iRBBB). The median follow-up time was 43months. During the follow-up period, AR progressed in only 1(2.3%) patient, while AR in 7(16.3%) patients regressed markedly. Follow-up assessments demonstrated high rates of complete occlusion; the rates at immediate, 24h, 6months, and 1year were assessed as 72, 83.7, 93, and 95.3%, respectively. Transcatheter device closure of pVSD offers a minimally invasive, safe, effective, and alternative treatment option for patients with pVSD associated with AVP and AR.

Closure of Post-infarct Basal Ventricular Septal Defect by Using an Atrial Septal Defect Closure Device: A Case Report

Ventricular Septal Defect, also known as VSD is a rare and life-threatening complication associated with MI. Therefore, it should be immediately diagnosed and treated. Transcatheter closure of the ventricular septal defect is a new alternative treatment approach compared to surgery. In this case, we presented a patient with post-infarct basal ventricular septal defect whose ventricular septal defect was closed using an atrial septal defect closure device. The ability to successfully close such a large defect via catheter is promising for the treatment of patients with VSD.

Assessment of percutaneous closure for decannulation of veno-arterial extracorporeal membrane oxygenation: A retrospective study.

Despite the evidence supporting the use of Perclose Proglide® (PP) suture-mediated vascular closure devices in various clinical scenarios, limited evidence exists regarding its role in percutaneous arterial closure of the femoral artery after venoarterial extracorporeal membrane oxygenation (VA-ECMO). Compared to conventional methods, this study evaluates the effectiveness and complications of bedside percutaneous femoral artery closure using Perclose ProGlide (PP) for VA-ECMO decannulation. Retrospective cohort of consecutive patients managed with mechanical circulatory support VA-ECMO for refractory cardiogenic shock, who survived decannulation between January 2017 and August 2023. A comparison between PP and other decannulation strategies was established to evaluate the effectiveness and procedure-related complications of bedside percutaneous femoral artery closure using a PP with a post-closure technique compared to conventional approaches of surgical and manual decannulation. Among 122 patients decannulated from VA-ECMO with a mean age of 48.6 ± 13.1 and 78 (63.9) males, 49.2% comprised the PP group. Despite the older age (p = 0.021) and higher prevalence of arterial hypertension (p = 0.045), the PP group had a larger number of patients free from decannulation-related adverse events. Additionally, a higher haemoglobin level 24 h post decannulation (p = 0.047), with no difference in terms of transfusion of red blood cells between groups (p = 0.263) was found. The pseudoaneurysm was the most frequently reported complication, while the arterial cannulation surgical wound site infection was only documented in the open repair subgroup. A trend towards reduced Intensive Care (ICU) and hospital length of stay after decannulation was noted, although it did not reach statistical significance. There was no difference in mortality between both groups and no procedure-related deaths occurred. A mean of 2.7 PP devices were required to achieve complete haemostasis in the PP cohort, where technical failure was documented in four cases (6.7%). Bedside Percutaneous decannulation of VA-ECMO using a PP device with a post-closure technique is safe and reliable for achieving effective haemostasis, with fewer vascular complications than conventional approaches and a low device failure rate.

Feasibility and safety of endovascular interventions via percutaneous access to the axillary artery

Endovascular treatment of peripheral arterial disease requires safe and reliable arterial access. This study evaluates the feasibility and safety of percutaneous axillary artery access for endovascular therapy. A variety of anatomic and logistic obstacles can be overcome with upper extremity access. In this retrospective case review, we describe our experience with percutaneous trans-axillary access for lower extremity peripheral arterial disease intervention. Medical records of all patients undergoing axillary artery percutaneous access from December 2021 to August 2024 were reviewed. Demographic data, procedural details, and complications such as pseudoaneurysm, hematoma, nerve injury, and closure device success were analyzed. Technical success and perioperative complications, including bruising, edema, hematoma, nerve injury, infection, thrombosis, and pseudoaneurysm, were assessed. Clinical outcomes were analyzed via follow-up clinic records. During the study period, seventy-nine axillary artery accesses were performed on sixty-four patients. The patients were 55% male and had typical vascular comorbidities: hypertension (87%), hyperlipidemia (68%), coronary artery disease (27%), stroke (19%), and diabetes (16%); 58% were active tobacco users, and 80% were former tobacco users. Axillary access facilitated peripheral endovascular procedures, including iliac intervention (55), femoral (44), mesenteric (16), tibial (11), and embolization or visceral aneurysm treatments. A 6F sheath and ultrasound guided Angio-Seal closure device were uniformly employed, with no major complications, perioperative deaths, or reoperations required. Minor complications of bruising and edema were present in eleven patients (14%). Other minor complications such as hematoma, nerve injury, thrombosis, dissection, pseudoaneurysm, or limb ischemia were absent. Percutaneous axillary artery access demonstrates promise for complex endovascular interventions with a favorable safety profile. Advantages include avoidance of unfavorable femoral anatomy, improved working length compared with radial access, and enhanced control of visceral therapy. Bilateral iliac and lower extremity therapy is feasible in a single treatment as well. Percutaneous axillary artery access is a safe, reliable adjunct for enhancing endovascular arterial intervention capabilities.

Atrial Arrhythmias After PFO Device Closure: Common, Clinically Important, and Preventable?

Atrial Arrhythmias After PFO Device Closure: Common, Clinically Important, and Preventable?

Left Atrial Appendage Closure after Ablation for Atrial Fibrillation.

Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking. We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated score (≥2 in men and ≥3 in women) on the CHA2DS2-VASc scale (range, 0 to 9, with higher scores indicating a greater risk of stroke) and who underwent catheter ablation. Patients were randomly assigned in a 1:1 ratio to undergo left atrial appendage closure or receive oral anticoagulation. The primary safety end point, tested for superiority, was non-procedure-related major bleeding or clinically relevant nonmajor bleeding. The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months. The secondary end point, tested for noninferiority, was major bleeding, including procedure-related bleeding, through 36 months. A total of 803 patients were assigned to undergo left atrial appendage closure, and 797 to receive anticoagulant therapy. The mean (±SD) age of the patients was 69.6±7.7 years, 34.1% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 36 months, a primary safety end-point event had occurred in 65 patients (8.5%) in the left atrial appendage closure group (device group) and in 137 patients (18.1%) in the anticoagulation group (P<0.001 for superiority); a primary efficacy end-point event had occurred in 41 patients (5.3%) and 44 patients (5.8%), respectively (P<0.001 for noninferiority); and a secondary end-point event had occurred in 3.9% and 5.0% (P<0.001 for noninferiority). Complications related to the appendage closure device or procedure occurred in 23 patients. Among patients who underwent catheter-based atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to a composite of death from any cause, stroke, or systemic embolism at 36 months. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.).

Abstract 4120246: PFO Device Complications: Literature Review and Possible Implications for Echocardiographic Follow-up

Introduction: Transthoracic (TTE) guidelines after PFO device closure are vague. Goal: To perform a literature search to characterize the type, frequency, and timing of complications that occur after PFO device placement to determine the utility of routine TTE in post-device patients. Methods: A search was performed in Medline (PubMed) with English language and publication date (2000-2023) filters applied. Studies were included if they reported on PFO device closures. If a study included both PFO and ASD device closures with no distinction between the groups, it was included. Studies were excluded if it only reported on ASD device closures, were meta-analysis/review papers, or did not report any outcomes for the PFO device procedure. Results: Total of 305 articles met criteria. Incidence of complications was 6.9% (3358/48348). Maximum range of follow-up was 0 – 17 years. Types and timing of complications presented in Tables 1 and 2. Majority of complications occurred &lt; 6 months (57.8%, 1941/3358) with only 0.8% (27/3358) occurring &gt; 5 years post-device. All patients with complications &gt; 5 years device placement presented with clinical symptoms related to their complications. Conclusion: Incidence of complications after PFO device placement appeared to significantly decrease 5 years post-procedure. Late complications were all preceded by clinical symptoms. Routine use of TTE &lt; 5 years post-device may be reasonable, but &gt; 5 years, TTE may only be needed if clinical symptoms occur.

Abstract 4137278: Efficacy and Safety of Left Atrial Appendage Closure Devices in Patients Aged Above 80 Years: A Systematic Review and Meta-Analysis

Background: Limited single-center and observational studies suggest that left atrial appendage occlusion (LAAO) may be a safe alternative in selected elderly patients with AFib. Hypothesis: We hypothesize that patients aged over 80 will have similar rates of complications and the same level of efficacy in stroke prevention as young patients. Aims: This review aims to establish the safety and efficacy of LAAO in octogenarians and nonagenarian patients with AFib. Methods: A systematic search of PubMed, Science Direct, and CENTRAL was performed for studies that reported outcomes comparing octogenarian and nonagenarian patients who underwent LAAo with their younger counterparts. The Review Manager 5.4 software was utilized to conduct a meta-analysis of the outcomes. Results: Seven observational studies consisting of 6,126 patients were included, of whom 1,879 (31%) were ≥80 years old and 4247 (69%) &lt;80 years old. The mean age of the octogenarian and older cohort ranged from 82.3 to 84.5 years, while that of the younger cohort ranged from 68.2 to 75.9 years. The mean follow-up across the studies ranged from one month to five years post-LAAO. Our pooled analysis showed no significant difference in the odds of mortality (OR 1.30; 95% CI [0.49, 3.47]; p = 0.60), all causes of stroke (OR 1.22; 95% CI [0.61, 2.43]; p= 0.57), vascular complications (OR 1.70; 95% CI [0.61,4.73]; p=0.31), and pericardial complications (OR 1.45; 95% CI [0.69, 3.05]; p = 0.33) but a significant difference in the odds of major bleeding events (OR 1.88; 95% CI [1.51, 2.34]; p&lt;0.00001)occurred in patients aged &gt;80 compared to their younger counterparts. Conclusion: This meta-analysis suggests that LAAO in patients aged 80 years and above demonstrates comparable mortality rates, post-procedural complications, and efficacy to those seen in younger patients. The findings support the safety and effectiveness of LAAO as a viable alternative for stroke prevention in very elderly patients, with additional consideration needed for those with increased susceptibility to bleeding events.

Bogota Bag as Temporary Abdominal Closure

The Bogotá bag, a sterile plastic device for temporary abdominal closure, has become integral in managing open abdomen cases due to trauma, intra-abdominal infections, and abdominal compartment syndrome (ACS). This review outlines its indications, advantages, disadvantages, and technique. Known for its cost-effectiveness and simplicity, the Bogotá bag allows for reoperations and drainage, making it valuable in resource-limited settings. However, limitations include infection risk, evisceration, inadequate fascial traction, and entero atmospheric fistulas. Proper patient assessment, secure placement, and close monitoring are essential for minimizing complications. While effective, the device's drawbacks highlight the need for further research to refine its use in surgical care.

Percutaneous Closure of Postmyocardial Infarction Ventricular Septal Rupture – A Single Center Experience from the Eastern Part of India

Abstract Background: Postinfarction ventricular septal rupture (VSR) is a rare but lethal mechanical complication of an acute myocardial infarction (AMI). It results in 90%–95% mortality within 2 months of diagnosis without any kind of intervention. Given high surgical mortality, transcatheter closure has emerged as a potential strategy and as an alternative to high-risk surgical closure. Indian data on percutaneous device closure of post-AMI VSR are limited; hence, we report our resource-limited single-center experience with different kinds of occluder devices for closure of post-AMI VSR. Methods and Results: In this single-center, retrospective cohort study, patients who underwent transcatheter closure of postmyocardial infarction (MI) VSR between 2018 and 2024 at Health World Hospitals in Durgapur, West Bengal, were included. The primary outcome was a mortality rate of 30 days. The study population was eleven primary cases of post-MI VSR. The mean age of the population was 61 years. The majority of the patients had anterior wall MI (54.5%), and the remaining had inferior wall MI. Different kinds of devices (Amplatzer atrial septal occlude, post-MI VSD device, and Konar-Multifunctional Occluder) were used to close VSR. Successful closure was performed in 9 patients (81%) with minimal residual shunt in 2 patients. Of 9 cases, 3 patients expired; one was lost to follow-up, and the rest are doing well at 30-day follow-up. Conclusion: Transcatheter closure of PMI VSRs can be performed with different kinds of devices with high technical success, relatively low procedural complication rates, and a good 30-day survival even in a setup outside the metropolis with limited availability of devices, as an alternative to very high-risk surgical closure.

Successful Transcatheter Closure of an Iatrogenic Axillary Arteriovenous Fistula in a Young Girl: A Delayed Complication of Intervention in a Resource-limited Setup

Abstract Arteriovenous fistula (AVF) is a well-known complication in the adult population following cardiac interventions. Data on the pediatric age group are lacking. Furthermore, there are no guidelines for the management of the pediatric population. We present a case of successful endovascular device closure of iatrogenic axillary AVF in a limited resource setup. A 9-year-old girl had palliative ductal stenting through the left axillary artery for complex congenital cyanotic heart disease 6 months back. She presented with an iatrogenic axillary AVF. We planned to close the defect in catheterization laboratory. After successful device deployment, there was a complete occlusion of the arterial system. To maintain arterial patency stenting was performed subsequently. Successful device closure of complicated axillary AVF in the pediatric population can be achieved even in a recourse-limited setup.

A novel reopenable clip with sharp claw for complete closure of mucosal defects after colorectal endoscopic submucosal dissection.

The MANTIS Closure Device (MCD; Boston Scientific, Marlborough, Massachusetts, USA) is a reopenable clip with a sharp claw used for closure after endoscopic submucosal dissection (ESD). We evaluated the effectiveness of the MCD for fast and complete closure after colorectal ESD. Cases involving closure with the MCD after ESD of 20-60-mm colorectal lesions between April 2023 and January 2024 were reviewed. The primary end point was complete closure of the ESD defect with the MCD. Secondary end points included closure time, delayed bleeding, delayed perforation, and post-ESD coagulation syndrome (PECS). MCD application involved: 1) grasping the mucosa on the anal-side of the defect; 2) pushing the clip toward the oral-side mucosa and deploying it; 3) adding other reopenable clips for complete closure. 61 cases involving MCD were analyzed. Mean tumor size was 32.3 (SD 9.2) mm. Complete closure rate was 98.4% and mean closure time was 6.9 (SD 2.6) minutes. The mean number of MCDs and other clips used was 1.0 (SD 0.1) and 4.7 (SD 1.4), respectively. Rates of delayed bleeding, delayed perforation, and PECS were 0%, 0%, and 9.8%, respectively. Fast and complete closure after colorectal ESD was successfully achieved using the MCD.

Endoscopic resection for colorectal tumors.

Endoscopic resection techniques for colorectal tumors are constantly evolving with improvements. Over the past decade, there has been a paradigm shift towards cold polypectomy for the removal of small lesions (<10 mm), known as the «Cold Revolution». In recent years, underwater endoscopic mucosal resection (EMR) has emerged as an alternative to conventional EMR and has been gaining popularity for resection of intermediate and large-sized lesions (≥10 mm). Although colorectal endoscopic submucosal dissection (ESD) requires a high level of advanced skills, improvements in dissection techniques and devices have facilitated the procedure. In Japan, the safety and efficacy of ESD for resecting large lesions (≥20 mm) has been demonstrated in a large-scale, multicenter, prospective cohort study (CREATE-J). ESD is being increasingly adopted in Western countries. As endoscopic resection continues to advance and include large and more complex defects, a variety of closure techniques and new devices are also being developed. Meanwhile, the number of endoscopic resections for T1-colorectal cancer (T1-CRC), including those intended for total excisional biopsy, has been increasing owing to the aging population and improvements in endoscopic technique. This review provides a broad summary of endoscopic resection for colorectal tumors including advancements in closure techniques and devices for mucosal defects, as well as the potential role of endoscopic resection for patients with T1-CRC.

Device closure via minimally invasive left intercostal incision in children with perimembranous ventricular septal defect

When treating perimembranous ventricular septal defect, median sternotomy leads to unsightly scar, right subaxillary thoracotomy requires cardiopulmonary bypass, and transcatheter device closure constrained by vascular condition. Using small left intercostal incision, we employed transthoracic device closure to get around these issues. During this study, right subaxillary thoracotomy was used for surgical repair in 117 patients (Surgical group), whereas small left intercostal incision was used for transthoracic device closure in 131 patients (Device group). Retrospective data collection and analysis were conducted. The success rate was comparable (117/117 vs. 130/131, P = 1.000). The device group experienced notably reduced operating time, mechanical ventilation duration, ICU stay, and postoperative hospital stay (All P < 0.001). Given that the device group’s incision was much smaller than the surgical group’s (1.1 ± 0.3 vs. 6.8 ± 1.6 cm, P < 0.001), blood transfusion or drainage tube was not needed. The device group observed a lower frequency of complications, with the exception of small residual shunt. It is feasible and safe to perform transthoracic device closure in children with perimembranous ventricular septal defects via small left intercostal incision. It can be a good minimally invasive substitute for surgical closure when utilized properly.

A real-world, prospective, observational, investigator initiated trial to evaluate early discharge following Angio-Seal™ vascular closure device in patients undergoing percutaneous coronary intervention

BackgroundCardiac catheterization procedures such as percutaneous coronary intervention (PCI) are widely used but with complications of access site bleeding. Manual compression (MC)is the well accepted technique to control bleeding but time consuming (15-20 min); vascular closure devices (VCDs) are used increasingly as an alternative to MC and require <5 min for deployment.We aimed to document the real-world experience with a bioabsorbable collagen closure device (Angio-Seal™) with absorbable traction suture in patients undergoing PCI. ObjectiveThe primary objective was time (hours) to discharge from hospital after the procedure; to document the incidence of vascular access site complications, time to ambulation and time to hemostasis were the secondary objectives. MethodThis was a prospective, observational, investigator-initiated clinical trial wherein adult patients who underwent PCI procedure through femoral access route, with deployment of Angio-Seal™ femoral closure device were included. ResultsAmongst the 100 patients enrolled, 68 % were males. systemic hypertension (63 %), and type-2 diabetes mellitus (37 %) were the major comorbidities reported. Mean overall time from the end of procedure to hemostasis was 2.32 ± 0.99min. Time to ambulation was 156.08 ± 36.81min and to hospital discharge was 25.21 ± 4.49 h, One subject experienced hematoma. No other complications particularly pertaining to vascular access site were observed. ConclusionAngio-Seal™ is an effective and safe VCD and results in early ambulation, rapid hemostasis, and discharge in patients undergoing PCI.

Safety and effectiveness of ultrasound-guided percutaneous versus open brachial artery access: results of the multicenter prospective ARCHIBAL study Percutaneous/open brachial artery access

Although brachial access has become increasingly used in percutaneous endovascular procedures, results from head-to-head comparisons between open (OBA) and ultrasound-guided percutaneous (PBA) brachial accesses are limited in the literature. The objective of our multicenter, prospective, non-interventional ARCHIBAL study was to compare the safety and efficacy of OBA and PBA to perform peripheral arterial interventions. From July 2019 to January 2021, all patients needing peripheral endovascular procedures with brachial artery access were consecutively included in the study by 15 surgeons in 14 centers. Procedures were done with 4F-8F introducer sheaths. Arterial closure was done by conventional arterial sutures for OBA and compression or vascular closure devices for PBA. The primary endpoint was the rate of access site complications occurring up to 30 days post-operatively. Secondary endpoints were the occurrence of adverse events and the overall rates of clinical success of brachial access cannulation and technical success. Among the 251 included patients (mean age, 69.9 years; males 70.5%), 122 (48.6%) had an OBA and 129 (51.4%) a PBA, without significant differences in baseline demographic and clinical characteristics. 38.6% of the patients had the procedure for more than one indication. Clinical success was achieved in all patients and technical success in 244 patients (97.2%). No death, cerebral, cardiac, or embolic complications were reported. Access site complications (primarily hematomas) were significantly (P=0.02) more frequent in the PBA (8/1296.2%) than the OBA group (1/125, (0.8%) or when using introducer sheaths >6F for OBA or vascular closure devices for PBA. Our prospective study confirmed the safety and effectiveness of brachial access and showed the benefit in terms of safety of OBA vs PBA even when PBA was ultrasound-guided and performed by trained surgeons. It encourages the use of OBA and ultrasound guidance when using PBA. Large and/or randomized studies should be performed to support these results.