Closure Device In Patients Research Articles

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%) <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<0.00001)occurred in patients aged >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.

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 mins); vascular closure devices (VCDs) are used increasingly as an alternative to MC and require <5 minutes 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 hours, 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.

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed. 107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038). VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. We collected relevant clinical data of patients undergoing TAVI in a large volume centre. main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. Five hundred and seventeen patients undergoing TF-TAVI were included. In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

Abstract TMP39: Paucity of Evidence-Based Patent Foramen Ovale Severity Ratings in Transesophageal Echocardiogram Clinical Reports

Introduction: The presence of a large physiologic shunt, defined as &gt;20 left atrial microbubbles within 3 cardiac cycles on transesophageal echocardiography (TEE), is a key, randomized controlled trial-validated, indication for patent foramen ovale (PFO) with a closure device in patients with otherwise cryptogenic ischemic stroke. The frequency with which this information is available to treating physicians from clinical TEE reports has not been well delineated. Methods: Among consecutive ischemic stroke patients admitted to an academic medical center undergoing TEE between January-June 2023, TEE reports were reviewed to determine frequency with which formal, clinical-trial definition-adherent characterization of PFO shunt size was provided, frequency of informal PFO shunt size descriptions, and correlations with transcranial Doppler (TCD) formal shunt grades (Spencer Grades 1-5). Results: Among the 50 patients, median age was 64 (IQR 58-74.5), and 20 (40%) were female. On TEE, shunt presence was assessed by bubble study in 38 (76%), direct Doppler alone in 6 (12%), and neither in 6 (12%). Among patients with bubble study, a right-to-left shunt (RLS) potentially due to PFO was present 15 (39%). RLS severity was quantified in 27% (4/15) of PFO patients, all with formally small (&lt;20) shunts. For the remaining 11, reports informally characterized shunt severity with various descriptive terms, including “mild” (7 cases), “mild/trace” (1), “moderate” (2), and “large” (1). TCD bubble studies were performed in 67% (10/15) of the TEE RLS PFO patients. Shunt severity correlation between TEE and TCD was 100% (3/3) for the formally quantified TEE shunts, but poor for the 7 informally assessed TEE shunts, with 60% (3/5) of shunts deemed “mild” on TEE quantified as intermediate-large on TCD, 1/1 deemed “moderate” on TEE quantified as intermediate on TCD, and 1/1 deemed “large” on TEE quantified as miniscule on TCD. Conclusions: Quantified, evidence-based ratings of PFO shunt severity were present in less than 3 of every 10 TEE reports, and unquantified, informal size estimates correlated poorly with TCD quantification of shunt severity. Patient management would be aided by inclusion of formal PFO shunt size quantification in all clinical stroke patient TEE reports.

Use of the MynxGrip vascular closure device in patients undergoing interventional diagnosis or treatment: The PANDA multicenter, open-label, randomized controlled trial.

MynxGrip is a non-suture, balloon catheter- and extravascular sealant-based vascular closure device designed to help hemostasis after an arterial puncture. This study evaluated the efficacy and safety of MynxGrip versus manual compression for femoral artery access closure in patients undergoing diagnostic or interventional procedures. The PANDA multicenter, parallel-group, open-label, randomized controlled trial enrolled patients undergoing a diagnostic or interventional procedure through femoral artery access between April 2019 and September 2020 at six centers in China. The participants were randomized 2:1 to the MynxGrip group and the manual compression group. Time to hemostasis and incidence of severe complications were the primary efficacy and safety endpoints, respectively. A total of 304 consecutive participants were included. The baseline characteristics were similarly distributed in the MynxGrip (n = 203) versus manual compression (n = 101) groups. Compared with the manual compression group, the median time to hemostasis and time to ambulation were significantly shorter (3.0 (interquartile range: 2.0, 4.0) vs 18.0 (11.0, 22.0) min, and 479.0 (275.0, 932.0) vs 1410.3 (1121.0, 1476.0) min, respectively; both p = 0.0001) in the MynxGrip group, with similar procedural success rate, and without severe complications in either group. The incidence of device-related adverse events was 11.8% in the MynxGrip group, most possibly or definitely unrelated. Compared with manual compression, the MynxGrip vascular closure device significantly shortens the times to hemostasis and ambulation without severe complications after diagnostic or interventional procedures through the femoral artery access.

Lumbar Discectomy With Bone-Anchored Annular Closure Device in Patients With Large Annular Defects: One-Year Results.

Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone. The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States. In this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life. Fifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life. In this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to theRCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

Sex-specific Long-term Outcomes of Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation.

A recent analysis of a large registry showed differences in periprocedural outcomes of the Watchman left atrial appendage closure device in males compared with females. The objective of our study was to investigate the 5-year event rate in males and females enrolled in the Watchman device premarket clinical studies submitted for US Food and Drug Administration review. We conducted a patient-level meta-analysis of 2256 patients from 4 studies: the PROTECT AF (Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation vs Long-Term Warfarin Therapy) randomized controlled trials and their continued-access registries-CAP1 (Continued Access to PROTECT AF) and CAP2 (Continued Access to PREVAIL). The outcomes evaluated were ischemic stroke (IS), IS/systemic embolism, hemorrhagic stroke (HS), and all-cause mortality. Mixed-effects Cox regression models and statistical testing for treatment-by-sex interaction were used to compare left atrial appendage closure vs warfarin in males and females. Hazard ratios adjusted (aHRs) for CHADS2 scores were generated using the same model with CHADS2 score as a covariate. Time-to-event end points were evaluated using the Kaplan-Meier method and log-rank test. For Watchman vs warfarin in the 2 randomized controlled trials, there was no significant interaction between sex and treatment for IS, IS/systemic embolism, HS, and all-cause mortality (P > .05); both males and females in the Watchman group had a lower aHR for HS than that in the warfarin group, which was statistically significant for males (aHR, 0.163; 95% CI, 0.045-0.593). In addition, there were no differences in outcomes between females and males treated with the Watchman device when pooling all studies. These data suggest that sex does not significantly affect the long-term safety and effectiveness of the Watchman device in patients with nonvalvular atrial fibrillation; however, further studies are needed.

Abstract 14772: Comparing Efficacy of Venous Closure Devices in Patients Undergoing Atrial Fibrillation and Atrial Flutter Ablation: A Retrospective Review

Introduction: Vascular closure devices have shown marked improvement in patient comfort and time to ambulation after undergoing atrial fibrillation (AF) and atrial flutter (AFL) radiofrequency ablation. They have been proven superior to manual closure and Figure of 8 suture in terms of pain control and time to ambulate. However, data comparing different vascular closure devices is sparse. Hypothesis: To compare the efficacy of venous closure devices Methods: We retrospectively reviewed 100 patients at our institution who underwent AF and AFL radiofrequency ablation. We aimed to assess the difference in time to ambulation, device failure, pain control and vascular complication rate between the two commonly used venous closure devices (VASCADE and PERCLOSE). Results: A total of 100 patients (50 in each arm) were included in the study. The mean age was 67.6 + 9.3 years and 73% patients were men. The two groups were well balanced with respect to baseline demographics and clinical characteristics except for coronary artery disease (24% VASCADE vs. 14% PERCLOSE, p &lt;0.001). No significant difference was observed in time to ambulate between PERCLOSE (2 + 0.21 hours) vs VASCADE (2 + 0.23 hours); p=0.74. 8% patients (n=4) in VASCADE arm required additional PERCLOSE to achieve hemostasis. 4% (n=2) patients in PERCLOSE arm required opioids for pain management; compared to none in VASCADE arm. No closure device related complications were observed in either arm. Conclusions: Both venous vascular closure systems offer similar efficacy in terms of time to ambulate. However, PERCLOSE was used in addition to VASCADE in a few instances to achieve hemostasis.

Performing transcatheter left atrial appendage closure: Techniques and challenges.

The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation.1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium (LA), thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients who are at risk for atrial fibrillation–related stroke. Based on the PROTECT AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation)2 and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation [AF] Versus Long Term Warfarin Therapy)3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, Marlborough, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 following the PINNACLE-FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) study.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure

BackgroundIn the U.S. Food and Drug Administration (FDA) clinical trials of left atrial appendage (LAA) closure, a postimplantation peridevice leak (PDL) of ≤5 mm (PDL≤5) was accepted as sufficient LAA “closure.” However, the clinical consequences of these PDLs on subsequent thromboembolism are poorly characterized. ObjectivesWe sought to assess the impact of PDL≤5 on clinical outcomes after implantation of the Watchman device. MethodsUsing combined data from the FDA studies PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation), PREVAIL (Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy), and CAP2 (Continued Access to PREVAIL), we assessed patients with successful device implantation for PDL by means of protocol-mandated transesophageal echocardiograms (TEEs) at 45 days and 1 year. Five-year outcomes were assessed as a function of the absence or presence of PDL≤5. ResultsThe cohort included 1,054 patients: mean age 74 ± 8.3 years, 65% male, and CHA2DS2-VASc 4.1 ± 1.4. TEE imaging at 45 days revealed 634 patients (60.2%) without and 404 (38.3%) with PDL≤5, and 1-year TEE revealed 704 patients (71.6%) without and 272 (27.7%) with PDL≤5. The presence of PDL≤5 at 1 year, but not at 45 days, was associated with an increased 5-year risk of ischemic stroke or systemic embolism (adjusted HR: 1.94; 95% CI: 1.15-3.29; P = 0.014), largely driven by an increase in nondisabling stroke (HR: 1.97; 95% CI: 1.03-3.78; P = 0.04), while disabling or fatal stroke rates were similar (HR: 0.69; 95% CI: 0.19-2.46; P = 0.56). PDL≤5 was not associated with an increased risk of cardiovascular or unexplained death (HR: 1.20; P = 0.45) or all-cause death (HR: 0.87; P = 0.42). ConclusionsPDL≤5 at 1 year after percutaneous LAA closure with the Watchman device are associated with increased thromboembolism, driven by increased nondisabling stroke, but similar mortality. (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation [PROTECT-AF; NCT00129545]; Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation vs Long Term Warfarin Therapy [PREVAIL; NCT01182441]; Continued Access to PREVAIL [CAP2; NCT01760291])

Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials.

The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data. Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants. Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models. A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P< 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P=0.005), and failed device implantation (7.5% vs 3.6%, P< 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P=0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P=0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P=0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P=0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P=0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P=0.44) among trial warfarin (4.48%) and registry (5.86%) patients. In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441).

Double ProGlide preclose technique for vascular access closure after leadless pacemaker implantation.

The use of vascular closure devices in patients receiving the Micra leadless pacemaker may shorten time to ambulation, facilitate same-day discharge, and reduce risk of venous thrombosis associated with manual hemostasis. We sought evaluate the feasibility of double Perclose ProGlide (Abbott, CA) preclosure for access site hemostasis after leadless pacemaker implant. Patients with leadless pacemaker implant and double preclosure for access hemostasis from 2020 to 2021 were reviewed for complications requiring increase of flat time or transfusion, incidence of venous thromboembolism, and hemoglobin decrement. Two ProGlide devices were deployed with a double preclose technique after ultrasound guided wire access. Patients were instructed to lay flat for 2-4h and were allowed to ambulate after. A total of 36 patients (age 74.5 ± 15.1years, BMI 27.9 ± 9.0kg/m2, 30% female gender) were included with 6 having prior venous thromboembolism, 21 with AF, and 15 with chronic kidney disease. Anticoagulation was continued in 14 (8 direct oral anticoagulants, 2 warfarin, 4 intravenous heparin) and interrupted in 5. In one patient, minor rebleeding prompted 10min of manual pressure and extension of flat time by 2h. No patients had other complications, prolongation of flat time, transfusion, delayed re-initiation of anticoagulation, or venous thromboembolism within 30days. The double preclose technique is a safe and feasible method of achieving access site hemostasis and facilitates early ambulation after leadless pacemaker implantation.

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial.

Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations. LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02702271.

Clinical efficacy and safety of the PRO-glide device as a sUture-mediated ClosurE in Thoracic EndoVascular Aortic Repair in patients with previous groin intervention (from the PRODUCE-TEVAR Trial).

While the percutaneous approach is increasingly preferred, suture-mediated closure devices have been put into clinical practice to close the femoral artery during procedures requiring a large-sized introducer. However, scar in the groin is considered a contraindication or an exclusion criterion for percutaneous procedures. The aim of our study was to investigate the outcomes and safety of Pro-Glide device as suture-mediated closure device in patients who underwent thoracic endovascular aortic repair with percutaneous femoral access ≥22 F who had previous groin intervention. A total of 73 patients who underwent endovascular repair with percutaneous femoral access were retrospectively included in the study. Previous groin intervention was defined as history of open surgical access or large sheath insertion (>18 F) to femoral artery because of endovascular or valvular intervention. Patients were divided into two groups as who had previous groin intervention PGI (+) and had not PGI (-). A total of 73 patients [60 male (82.2%)] were included in the study. Seventeen patients had PGI, and 56 did not. When groups were compared in terms of sheath sizes, a significantly higher sheath sizes were used in PGI (+) patients (24.5 ± 1.1 F vs. 23.8 ± 0.9 F, p = 0.005). The overall success rate in the femoral approach with pre-close technique was statistically insignificant between two groups (94.1% vs. 96.4%, p = 0.55). One patient in PGI (+) group and two patients in PGI (-) had technical failure for percutaneous femoral approach. One patient (5.9%) in PGI (+) group and one patient (1.8%) in PGI (-) group had femoral complications after the procedures; however, there was no significant difference between the groups in terms of complications (5.9% vs. 1.8%, p = 0.13). Pro-Glide device may be a safe and less invasive method for femoral access in patients with PGI and might not be considered as a contraindication for patients with history of PGI.

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

Prospective, Real-Life Evaluation of a Low-Angle Arterial Entry Closure Device for Endovascular, Outpatient-Based Interventions Using the Arstasis AXERAandreg; 2 System ( AXCELERATE Trial)

Background: The purpose of the AXCELERATE study was to evaluate the safety and efficacy of the AXERA® 2 vascular closure device in patients undergoing endovascular therapeutic arterial interventions. Methods: A single-center, single-operator, prospective observational study was performed over 15-months in consecutive patients undergoing outpatient-based, endovascular procedures using the AXERA® 2 device. Diagnostic procedures only were excluded. The primary endpoints were hemostasis success, time to hemostasis (TTH), early (< 60 minutes) sit up time (TTS), time to ambulation (TTA), time to discharge (TTD) and access-related complications. Results: A total of 105 arterial consecutive procedures were included. The mean age was 73.8 years (55.2% males). The vast majority of procedures were performed by using 6- and 7-French sheaths (48.6% each) and mostly due to ischemic rest pain (35.2%). Heparin was given in all cases and 85.7% were taking an antiplatelet or anticoagulant agent at procedural time. The median TTH was 14.8 minutes of manual compression. Early sit up was accomplished in 80.2% of patients with no complications. The average TTA was 2.4 hours and the TTD was 3.8 hours. A total of 97.1% of patients were discharged without access-related problems and in good clinical condition upon procedural completion. Fourteen complications were seen (13 patients), all of them hematomas > 6-cm (13.3%). Four patients required hospital admission after their interventions (3.8%), 2 required blood transfusions (1.9%) and 2 developed pseudoaneurysms (1.9%). No infectious, vascular thrombotic or other access-related complications were seen during a median follow-up of 117 days. When complications were analyzed with respect to the quartile of occurrence, no statistical differences where found (p>0.05 for all quartiles). Conclusions: The AXCELERATE trial shows that the use of the AXERA® 2 device reduces TTS, TTA and TTD, while being a safe and effective method of hemostasis for outpatient-based interventions.

Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries

BackgroundLong-term data on the safety and efficacy of left atrial appendage closure (LAAC) for stroke prevention in patients with nonvalvular atrial fibrillation remain limited. ObjectivesThe purpose of this study was to evaluate 4.5- to 5-year data in 2 U.S. Food and Drug Association LAAC mandated registries (CAP [Continued Access to PROTECT-AF] and CAP2 [Continued Access to PREVAIL]) for safety and efficacy. MethodsTwo registries of patients implanted with LAAC devices provide the largest source of follow-up data. Both accompanied their respective randomized clinical trials, PROTECT-AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device In Patients with Atrial Fibrillation versus Long Term Warfarin Therapy), which used the same endpoints (primary efficacy of composite of stroke, systemic embolism, cardiovascular/unexplained death, and safety). ResultsCAP included 566 patients with an average follow-up of 50.1 months (2,293 patient-years), and CAP2 included 578 patients with an average follow-up of 50.3 months (2,227 patient-years). CAP2 patients were significantly older and had higher CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) scores (4.51 vs. 3.88; p < 0.001). Procedural success was similar in both (94%). The primary composite endpoint occurred at a rate of 3.05 per 100 patient-years in CAP and 4.80 per 100 patient-years in CAP2; events contributing to this endpoint were most commonly cardiovascular/unexplained death (1.69 per 100 patient-years for CAP and 2.92 per 100 patient-years for CAP2). Hemorrhagic stroke was significantly less than ischemic stroke (0.17 per 100 patient-years in CAP and 0.09 per 100 patient-years in CAP2), and total stroke rates were significantly less than predicted by CHA2DS2-VASc score (78% reduction with CAP, 69% reduction with CAP2). ConclusionsThese registries, which contain the longest and largest follow-up data of patients with the Watchman device, support LAAC as a safe and effective therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation, and document the lowest rate of hemorrhagic stroke identified in this population.

Cost-Effectiveness of Left Atrial Appendage Closure for Stroke Reduction in Atrial Fibrillation: Analysis of Pooled, 5-Year, Long-Term Data.

BackgroundRecent publications reached conflicting conclusions about the cost‐effectiveness of left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, Marlborough, MA) for stroke risk reduction in nonvalvular atrial fibrillation (AF). This analysis sought to assess the cost‐effectiveness of LAAC relative to both warfarin and nonwarfarin oral anticoagulants (NOACs) using pooled, long‐term data from the randomized PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long‐Term Warfarin) trials.Methods and ResultsA Markov model was constructed from a US payer perspective with a lifetime (20‐year) horizon. LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF and PREVAIL trial 5‐year data. Warfarin and NOAC inputs were derived from published meta‐analyses. The model was populated with a cohort of 10 000 patients, aged 70 years, at moderate stroke and bleeding risk. Sensitivity analyses were performed. LAAC was cost‐effective relative to warfarin by year 7 ($48 674/quality‐adjusted life‐year) and dominant (more effective and less costly) by year 10. LAAC became cost‐effective and dominant compared with NOACs by year 5. Over a lifetime, LAAC provided 0.60 more quality‐adjusted life‐years than warfarin and 0.29 more than NOACs. In sensitivity analyses, LAAC was cost‐effective relative to warfarin and NOACs in 98% and 95% of simulations, respectively.ConclusionsUsing pooled, 5‐year PROTECT AF and PREVAIL trial data, LAAC proved to be not only cost‐effective, but cost saving relative to warfarin and NOACs. LAAC with the Watchman device is an economically viable stroke risk reduction strategy for patients with AF seeking an alternative to lifelong anticoagulation.