ProGlide Devices Research Articles

P302 SIMULTANEOUS CORRECTION OF SEVERE LOW–FLOW LOW–GRADIENT AORTIC STENOSIS AND ABDOMINAL AORTIC ANEURYSM BY TAVI + EVAR

Abstract We report the case of a 72–year–old man with arterial hypertension, dyslipidemia, type 2 diabetes mellitus, and severe chronic obstructive pulmonary disease. The patient had a previous stroke with occlusion of both internal carotid arteries about 7 years ago. He presented to the emergency department with dyspnea on exertion (NYHA class III), and the echocardiogram revealed a dilated left ventricle with severe reduction of global systolic function (EF 35%), severe low–flow low–gradient aortic stenosis (AVA on VTI 0.526 cmq/mq, SVi 29.7 ml/mq, Gmax 25.6 mmHg, Gmed 16 mmHg), and abdominal aortic aneurysm. Subsequently, he underwent an angio–CT scan that showed an almost completely thrombosed abdominal aortic aneurysm with a maximum diameter of 65 mm and a longitudinal extension of about 11 cm. The patient also underwent coronary angiography, which showed diffuse calcified atherosclerosis, and he was recommended for medical therapy. After a joint Heart Team consultation with cardio–anesthesiologists, cardiac surgeons, and vascular surgeons, it was decided to perform transfemoral transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (EVAR) in the same procedure (EUROSCORE II > 4%). The patient underwent TAVI followed by EVAR of the aorto–bisiliac arteries through a main access site in the left femoral artery guided by ultrasound, a secondary access site in the right femoral artery for placement of a pigtail catheter on the aortic plane, and a venous access site in the right femoral vein for placement of a temporary pacing catheter at the apex of the right ventricle. First, an Edwards Sapien 3 Ultra 26mm valve was implanted, and then the 14Fr sheath in the left femoral artery was exchanged for an 18Fr sheath for the EVAR, which was placed in the aorto–bisiliac region. Hemostasis was achieved using the Manta system on the left femoral artery and two Proglide devices on the right femoral artery. The procedure was completed without complications, and the patient was discharged 10 days later, asymptomatic and in stable clinical condition, with a recommendation for dual antiplatelet therapy with aspirin and clopidogrel. At the 6–week follow–up, the patient remained asymptomatic with an EF of 40%. Conclusion In selected cases, the simultaneous correction of severe low–flow low–gradient aortic stenosis using TAVI and abdominal aortic aneurysm using EVAR can be considered after appropriate discussion and consultation within the Heart Team."

Feasibility and clinical benefits of the double-ProGlide technique for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants.

To access the efficacy and safety of the double-ProGlide technique for the femoral vein access-site closure in cryoballoon ablation with uninterrupted oral anticoagulants (OAC), and its impact on the electrophysiology laboratory time as well as hospital stay after the procedure in this observational study. Patients with atrial fibrillation undergoing cryoballoon ablation with uninterrupted OAC at Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China from May 2019 to May 2021 were enrolled in this study. From October 2020, double-ProGlide technique was consistently used for hemostasis (ProGlide group), and before that conventional manual compression was utilized (manual compression group). The occurrence of vascular and groin complications was accessed during the hospital stay and until the three-month follow-up. A total of 140 participants (69.30% of male, mean age: 59.21 ± 10.29 years) were evaluated, 70 participants being in each group. Immediate hemostasis was achieved in all the patients with ProGlide closure. No major vascular complications were found in the ProGlide group while two major vascular complications were occurred in the manual compression group. The incidence of any groin complication was obviously higher in subjects with manual compression than patients with ProGlide devices (15.71% vs. 2.86%, P = 0.009). In addition, compared with the manual compression group, the ProGlide group was associated with significantly shorter total time in the electrophysiology laboratory [112.0 (93.3-128.8) min vs. 123.5 (107.3-158.3) min, P = 0.006], time from sheath removal until venous site hemostasis [3.8 (3.4-4.2) min vs. 8.0 (7.6-8.5) min, P < 0.001], bed rest time [8.0 (7.6-8.0) h vs. 14.1 (12.0-17.6) h, P < 0.001] and hospital stay after the procedure [13.8 (12.5-17.8) h vs. 38.0 (21.5-41.0) h, P < 0.001]. Utilization of the double-ProGlide technique for hemostasis after cryoballoon ablation with uninterrupted OAC is feasible and safe, which has the clinical benefit in reducing the total electrophysiology laboratory time and the hospital stay length after the procedure.

Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.

The “Pro-Seal” Large-Bore Arterial Access Closure Technique: Making the Best of What Is Available

The number of patients undergoing transcatheter aortic valve replacement (TAVR) and other percutaneous procedures for structural heart disease has risen in recent years and will likely continue to increase. Despite iterative improvements in delivery systems resulting in smaller sizes and entry profiles, large-bore vascular access will continue to be needed. Cardiovascular interventionalists are tasked with performing TAVR procedures as safely as possible while maintaining a low incidence of bleeding and ischemic access site complications—all while using commercially available vascular closure equipment.Multiple large-bore vascular closure devices are currently used in clinical practice; one of the most commonly employed is the suture-based Perclose ProGlide system (Abbott Vascular, Inc). Even though its versatility and effectiveness are acceptable, the Perclose ProGlide device does occasionally fail. How best to achieve complete hemostasis when a failure occurs remains to be determined.In this issue of the Journal, Cakal et al1 report their experience using an ANGIOSEAL device (Terumo Medical Corporation) in patients for whom Perclose ProGlide device deployment did not result in complete hemostasis. The authors performed a retrospective review of 185 patients who underwent TAVR in their center. In all individuals, vascular closure was performed using 2 Perclose ProGlide devices; in 46 of these patients, an 8F ANGIO-SEAL device was added as a “bailout” when the Per-close ProGlide device failed and persistent vascular bleeding was noted. The auxiliary ANGIO-SEAL device was deemed successful in all cases. No statistically significant differences in vascular complications were noted, although a higher incidence of hematoma formation was found in the ANGIO-SEAL bailout group.The findings from Cakal et al1 support the safety and feasibility of using an ANGIO-SEAL device as bailout when use of 2 Perclose ProGlide devices fails to achieve hemostasis in large-bore arterial closure—an approach that has come to be referred to as the “Pro-Seal” technique. These are welcome data because they inform current practice and broaden the operators' options in complex patients. Nonetheless, it is worth noting a particular limitation of this study and its proposed approach (beyond its limited number of patients and retrospective nature). Deciding when hemostasis is suboptimal remains a significantly subjective endeavor. It is unclear whether manual compression after Perclose ProGlide closure might have successfully controlled bleeding in some of these patients, thereby avoiding the use of an additional device that could cause further complications. Clarifying this point is especially important because the operators suggest a Perclose ProGlide failure rate exceeding 20%, which is significantly higher than expected. Fortunately, given the authors' experience, the downside of adding an ANGIO-SEAL device appears to be minimal.Even though a surgeon with experience in open vascular repair may be profoundly dissatisfied with the macroscopic and microscopic appearance of 2 Perclose ProGlide devices and 1 ANGIO-SEAL device in the arteriotomy site, the Pro-Seal technique appears to be an acceptable solution for completing the procedure safely and efficiently. This strategy is effective not only as bailout in case of bleeding but also as a planned strategy from the outset, as demonstrated in a large retrospective study.2 As expected, additional data confirming the utility, safety, and effectiveness of the Pro-Seal approach are needed, as is the development of newer and better closure devices designed from inception to be used specifically for large-bore access closure.

SINGLE ARTERIAL ACCESS FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE ACURATE NEO SELF-EXPANDING AORTIC BIOPROSTHESIS: INSIGHTS FROM THE LONDON HEALTH SCIENCES CENTRE HEART TEAM

SINGLE ARTERIAL ACCESS FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE ACURATE NEO SELF-EXPANDING AORTIC BIOPROSTHESIS: INSIGHTS FROM THE LONDON HEALTH SCIENCES CENTRE HEART TEAM

D-52 | Comparison of Outcomes after MANTA or Perclose ProGlide Devices following Transcatheter Aortic Valve Replacement: A Meta-Analysis

D-52 | Comparison of Outcomes after MANTA or Perclose ProGlide Devices following Transcatheter Aortic Valve Replacement: A Meta-Analysis

Perclose ProGlide devices simplified the removal of the femoral venous cannulas for the transcatheter closure of atrial septal defect

OBJECTIVE: This study aimed to assess the effectiveness, feasibility, and security of the Perclose ProGlide device that was used to remove the femoral venous cannulas for the transcatheter closure of atrial septal defect (ASD). METHODS: A total of 145 cases were analyzed retrospectively, who performed transcatheter closure of ASD in our center from March 2019 to March 2021. Based on whether the Perclose ProGlide device was placed or not in the femoral vein, 48 patients were assigned to the Perclose group and 97 ones to the non-Perclose group. The data of general characteristics, femoral venous cannulas, and related puncture complications were compared between the two groups. RESULTS: The data of general characteristics or femoral venous cannulas were not significantly different between the two groups, but the procedure duration of removing venous cannulas was shorter in the Perclose group (0.5 min [0.35, 0.70] vs. 5 min [3.6, 7.4], P &lt; 0.001). The puncture procedure-related blood lose was not significantly different between the two groups (Hemoglobin reduction value: 0.10 [−0.47, 0.30] g/dL vs. 0.10 [−0.50, 0.30] g/dL, P = 0.905). In addition, other complications caused by the removal of venous cannulas, length of stay in the ward, puncture infection, reintervention, and so on were not significantly different between the groups. CONCLUSIONS: The Perclose ProGlide device could simplify the removal of femoral venous cannulas for ASD transcatheter closure by decreasing procedure duration and time in bed. The efficiency, feasibility, and safety of Perclose ProGlide devices, which were used to remove venous cannulas, are good enough for their clinical application.

Comparing the outcomes of bedside percutaneous VA-ECMO decannulation by ProGlide and Manta in a high-ECMO-volume center in Hong Kong.

The use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) decannulation with different percutaneous closure devices has been increasing. At our center, ProGlide devices have been used since November 2018, and Manta devices became an alternative since March 2020. This study aimed to compare the success and complication rates and the clinical outcomes of ProGlide and Manta devices for VA-ECMO decannulation after arteriotomy wound closure. We retrospectively reviewed the results of bedside VA-ECMO decannulation between November 2018 and June 2021. Patients with VA-ECMO who could be bridged to recovery were recruited and divided into the ProGlide or Manta group based on the closure device used. Procedure time, amount of blood loss, amount of blood products transfused, and use of vasoactive medications during the procedure were documented. Clinical examination and Doppler ultrasound were performed to detect any complications. After the closure technique, ProGlide was used in 44 patients and Manta was used in 13. There was no significant difference in the success rate between the ProGlide and Manta groups (86.4% vs. 100%). Amount of blood loss was greater in the ProGlide group than in the Manta group (290 [100-400] ml vs. 50 [50-100] ml), and more patients in the ProGlide group required an increased dose of inotropes during the procedure (59.1% vs. 15.4%), but the transfusion requirement was similar between the two groups. The success rate of hemostasis using arteriotomy wound closure during VA-ECMO decannulation was similar between the two devices.

Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker.

The miniaturized transcatheter pacing system (TPS) implant is performed using a 27 Fr sheath. Achieving femoral vein access hemostasis after sheath removal is of utmost importance. Feasibility and clinical effectiveness of double device-based suture-mediated closure technique (DualPerclose) were evaluated. Patients undergoing TPS positioning and treated with DualPerclose technique at our institution were considered. Feasibility of the DualPerclose technique included the rates of effective initial device suture fixation and effective hemostasis after sheath removal. Clinical efficacy considered intraprocedural and periprocedural bleeding events as well as midterm access site vascular injury assessed at 3months using lower limb vascular ultrasonography. Data on all follow-up major adverse events were also collected. All patients (n = 83 patients; mean age 82.3 ± 7.1years, 67.5% male gender, 85.5%, with structural heart disease, mean left ventricular ejection fraction 54.0 ± 9.6%, renal impairment in 31.3%) who underwent TPS positioning between November 2015 and February 2020 were considered. TPS positioning was successful in all patients. In 82 patients, the DualPerclose approach was utilized: 13 patients (15.8%) required > 2 devices to obtain effective fixing of 2 sutures; complete immediate hemostasis was achieved in 80 patients (97.6%). One (1.2%) severe groin-related bleeding event occurred. At midterm, 1 (1.2%) mildly symptomatic arteriovenous fistula was diagnosed (conservative treatment). Over a median follow-up of 22 (IQR 10-35.5) months, 14 (17.1%) major adverse events were recorded, including 1 loss of capture requiring TPS replacement and 5 deaths. Femoral vein access closure using dual Perclose Proglide devices during TPS is feasible and clinically effective.

Comparison of Success Rate and Complications of Totally Percutaneous Decannulation in Patients With Veno-Arterial Extracorporeal Membrane Oxygenation and Endovascular Aneurysm Repair.

Background: Total percutaneous closure for the site of femoral arterial puncture using Perclose ProGlide (PP) has become prevalent post-percutaneous endovascular aortic repair (EVAR) and veno-arterial extracorporeal membrane oxygenation (VA-ECMO).Objective: To evaluate the safety and efficacy of total percutaneous closure of the femoral artery access site post-EVAR compared with VA-ECMO.Methods: This was a retrospective observational study conducted over 4 years, including 88 patients who underwent EVAR (64 patients) and VA-ECMO (24 patients). Perclose ProGlide devices were used in the femoral artery puncture sites closed percutaneously. In this study, technical success was defined as successful arterial closure of the common femoral artery (CFA) without additional surgical or endovascular procedures to prevent vessel leaking. Access site complications, including overt bleeding requiring transfusion or surgical intervention, minor bleeding, tinea cruris, pseudoaneurysm, and lymphocele, were recorded 24 h and 30 days after arterial closure.Results: Each group's technical success rates were 95.8% (VA-ECMO) and 92.2% EVAR, respectively. There were no differences in the periprocedural complications of major bleeding, pseudoaneurysm, minor bleeding, acute limb ischemia, and groin infection. Furthermore, we did not observe any complications such as arterial thrombosis, dissection, stenosis, arteriovenous fistula, hematoma, groin infection, or lymphocele at the access site by following-up an ultrasound examination. There was no significant difference in the technical success rate of percutaneous closure by the PP device in the EVAR and VA-ECMO oxygenation groups. Also, no periprocedural or 30-day complications were observed at the access site of the EVAR and VA-ECMO patients.

Percutaneous Transgastric Duodenal Stenting and Gastrostomy Repair Using a Vascular Closure Device: Proof of Concept in a Porcine Model.

Introduction. Gastroduodenal stenting is efficacious and safe in both benign and malignant foregut diseases. Transgastric duodenal stenting has been described and however requires a gastrostomy tube to remain in situ for 4 to 6 weeks post-procedure which can lead to complications. We present a technique for immediate gastric repair using a suture-mediated vascular closure device, without the need for a gastrostomy tube in porcine models. Methods. Percutaneous access into the stomach was achieved using fluoroscopy. Two or 3 Perclose Proglide devices were pre-deployed. The tract was dilated and a wire advanced into the distal duodenum. A 15.5 cm covered enteric stent was delivered through the gastrostomy, deployed and position confirmed. The gastrostomy was closed using Perclose Proglide sutures. Necropsy leak pressure measurement was performed to assess integrity of gastrostomy closure in the porcine models. Results. Two (n = 8) or 3 (n = 2) Perclose Proglide devices were deployed in ten porcine models, with 1 misfire (4.5%). Percutaneous transgastric access and stent delivery was successful in all porcine models. Mean leak pressure in the animals with adequately deployed devices was 219 mmHg (range 172 mmHg–270 mmHg). Conclusion. This study demonstrates percutaneous transgastric duodenal stenting with immediate gastric repair using suture-mediated vascular closure devices is a feasible procedure.

Dry Field Closure of Large-Bore Access With Iliac Artery Angioplasty Through the Ipsilateral Sheath: The Single-Access Dry-Closure Technique.

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Meanwhile, the interventional community has gradually shifted from an open surgical to endovascular closure. However, vascular access complications and bleeding still remain a significant risk. Various techniques involving an additional access site have been described to allow for endovascular bailout of potential complications. However, these by themselves create an additional burden to procedural morbidity. Furthermore, the weight of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the "second arterial access" strategy. For that reason, we propose an alternative strategy, the "single-access dry-closure" technique, which provides vascular access control without the additional burden and risk of a second arterial access. This involves the use of low-pressure iliac artery occlusive angioplasty, delivered through the ipsilateral sheath during the endovascular closure. We hereby describe the steps, advantages and disadvantages of this novel technique. We also include the description of multiple technical variations depending on the use of one or two preclosed Proglide devices. This novel approach seems to be a safe, effective, simple, fast and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. It also lowers contrast volume and radiation exposure while improving the overall set-up and operator ergonomics.

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.

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

Single versus double use of a suture-based closure device for transfemoral aortic valve implantation

BackgroundThe most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. MethodsBetween March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. ResultsThe mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). ConclusionThe single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach.

One-year experience of bedside percutaneous VA-ECMO decannulation in a high-ECMO-volume center in Hong Kong.

When veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support can be terminated, open repair of arteriotomy wounds in operating theaters is the standard of practice. Comparable outcomes by percutaneous decannulation using different closure devices have been reported. However, transport of the critically- ill, man-power and timeslots of operating theaters could be saved if decannulation was performed at bedside. Bedside percutaneous arteriotomy wound closure became our default method of decannulation since November 2018. We reviewed our 1-year data to evaluate if such practice could be safely adopted in a local high-ECMO-volume center. Between November 2018 and October 2019, 25 patients had their VA-ECMO terminated at the bedside. Twenty-one patients (84%) had successful decannulation. For those who failed, emergency open repair resulted in no additional complications. Two ProGlide devices were used in 15 (71.4%) patients and three were used in 6 (28.6%) patients. The procedure time was 27 (15-45) min. The median blood loss was 300 mL (250-400). Minor complications were found in 4 (19.1%) patients, including two arterial clot formation, one pseudoaneurysm and one wound infection. There were no other major complications. Our 1-year experience showed that percutaneous bedside VA-ECMO decannulation was feasible to commence in a local large-ECMO-volume center.

A novel technique for postclosure of large-bore sheaths using two Perclose devices.

This study aimed to assess the feasibility, efficacy, and safety of a novel percutaneous postprocedure closure technique for large arterial sheath removal with the use of two Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA) devices. Postprocedural closing of large-bore arteriotomies using the Perclose system can be difficult given the subsequent inability of the device to capture sufficient wall tissue. Our study was a single-center retrospective analysis of 22 consecutive patients who underwent large arteriotomy closure via the postclosure technique with a 12-16-Fr sheath. Efficacy endpoints included successful deployment of the system and hemostasis. Safety endpoints included the incidence of major or minor vascular complications as defined by the Vascular Academic Research Consortium-2 (VARC-2) definitions at 30-day follow-up. The postclosure technique resulted in 100% technical success rate and no postprocedural bleeding or vascular complications. Postclosure technique is a safe, highly effective, and feasible percutaneous method to achieve large-bore arteriotomy hemostasis with low rates of major bleeding or vascular complications and favorable early outcome.

Percutaneous Closure of Gastrostomy Using a Suture-Mediated Vascular Closure Device in a Swine Model.

After any procedure through the percutaneous gastrostomy (PG), a PG tube should be kept in place until a mature tract develops. For this period of maturation which takes about 2 to 4weeks, tube dislodgement, leakage, or peritonitis can occur. Complications from PG tube maintenance can be prevented by closing the PG immediately after the procedure. The purpose of this study was to evaluate the feasibility and safety of immediate PG closure using Perclose ProGlide. A 2-week survival study was performed in a swine model. We applied one Perclose ProGlide device for closing a 13-Fr PG (n = 3) and two devices for closing a 20-Fr PG (n = 3). Body weight, temperature and laboratory findings were observed. Autopsy and microscopic examination were performed after 2weeks. All the swine subjects did not demonstrate any sign of systemic inflammatory responses in terms of fever and laboratory findings. From autopsy results, five pigs showed complete healing of the PG. One pig that underwent 20-Fr gastrostomy site closure with double Perclose ProGlide had scanty semitransparent fluid in the peritoneal cavity but that was not indicative of inflammation. En bloc tissue samples from all the pigs demonstrated complete wound healing of the PG sites. Percutaneous application of single or double Perclose ProGlide devices is feasible and safe for the PG closure in a swine model. No level of evidence, Animal study.

Percutaneous Access Downsizing to Achieve Early Limb Reperfusion in Fenestrated/Branched TAAA Repair

Introduction - Large-bore introducer sheaths required during complex fenestrated and branched endovascular TAAA repair (F/B-EVAR) can determine non-negligible malperfusion to the pelvis and lower limbs. Early pelvic and limb reperfusion has been linked to improved neurological outcomes secondary to a reduction in spinal cord ischemia during such procedures1. The technique presented hereby allows percutaneous downsizing of the large femoral access required for fenestrated/branched grafts delivery, while maintaining an introducer sheath in place, in order to reduce pelvic and limb ischemia while preserving the femoral access to complete the procedure. Methods - Twenty-one patients were treated between 2015 and 2017 by means of F/B-EVAR and as part of standard procedure received bilateral percutaneous femoral access with two Perclose Proglide vessel closure devices per each side. Once allowed by procedural restraints, the main introducer sheath was removed and replaced by a smaller 10Fr x 11cm sheath, and hemostasis achieved by gently pulling on the Proglide thread. A cohort of 468 patients treated by means of percutaneous TEVAR was analyzed and matched 2:1 to the previous 21 patients according to main introducer sheath size (Fr), common femoral artery diameter (mm) and presence of previous surgical femoral access. The downsizing maneuvers success was evaluated as well as the technical success of percutaneous vessel closure at procedure completion in both the matched and downsizing group. Results - Downsizing technical success was 100% (21/21), with no access requiring premature complete closure or re-introduction of sheaths >10Fr to achieve hemostasis. Technical success at procedure completion was not different: 90% (19/21) in the downsizing group and 93% (39/42) in the matched group. Conclusion - Percutaneous downsizing of a femoral access with partial closure of the Perclose Proglide devices is feasible and safe and does not impair overall technical success of percutaneous vessel closure. Early limb reperfusion during complex aortic procedure can be performed also with percutaneous approach. References1The Impact of Early Pelvic and Lower Limb Reperfusion and Attentive Peri-operative Management on the Incidence of Spinal Cord Ischemia During Thoracoabdominal Aortic Aneurysm Endovascular RepairMaurel, B. et al.European Journal of Vascular and Endovascular Surgery , Volume 49 , Issue 3 , 248 - 254

Feasibility and safety of total percutaneous closure of femoral arterial access sites after veno-arterial extracorporeal membrane oxygenation.

To evaluate the safety and efficacy of total percutaneous closure of the femoral artery access site after veno-arterial extracorporeal membrane oxygenation (VA-ECMO) with the Perclose ProGlide device.This retrospective observational study during an almost 2-year period included 21 patients who underwent VA-ECMO in whom the femoral artery puncture site was closed percutaneously with Perclose ProGlide devices. Technical success was defined as successful arterial closure of the common femoral artery, without the need for additional surgical or endovascular procedures. Access site complications were recorded at 24 hours and 30 days after arterial closure, such as major bleeding requiring transfusion or surgical intervention, minor bleeding, groin infection, pseudoaneurysm, and lymphocele.Technical success was achieved in 20 patients (95.2%). One patient required surgical repair for an access site pseudoaneurysm. Eighteen femoral arteries were closed with 2 devices each, while 3 patients required the use of a third device for femoral artery access site closure to achieve adequate hemostasis. No arterial thrombosis, arterial dissection, arterial stenosis, groin infection, or arteriovenous fistula occurred during the periprocedural period (within 24 hours of arterial closure) or during 30-day follow-up.Percutaneous closure with the Perclose ProGlide device is a feasible procedure for closing femoral arterial access sites after VA-ECMO, with a low incidence of access site complications.