Perclose ProGlide Research Articles

The Use of Closure Devices for Aortic Stent-Graft Insertion: Outcomes Following a Paradigm Shift to Percutaneous Access in a Tertiary Vascular Center.

This retrospective case series aims to evaluate the efficacy of the Perclose ProGlide system for postoperative hemostasis following aortic stent-graft insertion. A prospectively maintained database of patients with a minimum follow-up of 12 months following percutaneous aortic procedures was interrogated. Preprocedural computed tomography (CT) scans were reviewed to assess existing stenosis in the common femoral artery (CFA). Arteries with an estimated stenosis of greater than 25% on visual inspection underwent quantification using multiplanar and curved planar reformation. The preoperative and 1-year follow-up CTs of these patients were assessed for change in stenosis. Analysis was performed by 2 independent reviewers, with senior authors reviewing any discrepancies. One hundred forty-two endovascular aortic aneurysm repairs (EVARs) were performed. The ProGlide system was used in 235 arteries, yielding a high success rate in obtaining postprocedural hemostasis (94%). There were 13 postprocedural access-related complications, including 5 patients requiring surgical closure due to inadequate seal. Two patients required thrombectomy due to distal embolization. One patient required CFA endarterectomy at 6 months for the treatment of preexisting short distance claudication. Vessel analysis was performed in 31 arteries. Mean preoperative stenosis was 32% (range: 20%-57%). Mean postoperative stenosis was 32% (21%-57%). No significant change in degree of stenosis was detected (defined as a 5% change). The ProGlide system yielded a high success rate in obtaining postoperative hemostasis with low rate of conversion to surgical closure and low complication rates. There was no evidence of worsening vessel stenosis in arteries with preprocedural stenotic disease. Level 4, Case Series.

Percutaneous Decannulation Instead of Surgical Removal for Weaning After Venoarterial Extracorporeal Membrane Oxygenation-A Crossed Perclose ProGlide Closure Device Technique Using a Hemostasis Valve Y Connector.

Establishment of a highly standardized and safe decannulation technique based on the Perclose ProGlide closure system, which is described in detail with comprehensive instructions for the executive clinician and first application in the context of a pilot study. So far our technique has already been used successfully in seven patients since January 2019 as a standard procedure on our ICU with only one minor complication occurred after the first procedure, that is, a small pseudoaneurysm likely originating from antegrade perfusion puncture site which was sealed by thrombin injection. Our crossed ProGlide technique using a hemostasis valve Y connector ensuring no blood loss seems to be a very promising decannulation technique.

The application of a vascular closure device for closing a gastrostomy opening used for procedural access.

To study the feasibility of applying the Perclose ProGlide vascular closure device (PPVCD) in vitro for closing a gastrostomy opening for procedural access in the swine stomach in order to prevent peritoneal leakage. The study included four experimental groups: one manual suture (n = 10), two manual sutures (n = 10), one PPVCD suture (n = 10), and two PPVCD sutures (n = 5). In the two PPVCD sutures group, the "pre-close" technique was used. The leak pressure was measured, and statistical analysis was conducted to compare the leak pressures among the experimental groups. The gastrostomy openings were successfully closed in all experimental groups. The median (range) values of leak pressure (mmHg) for each experimental group were as follows: one manual suture, 86.0 (75.0-110.0); two manual sutures, 98.5 (44.0-130.0); one PPVCD suture, 96.5 (56.0-119.0); and two PPVCD sutures, 98.0 (66.0-104.0). The Mann-Whitney U test revealed no statistically significant difference in leak pressure between the manual (n = 20) and PPVCD (n = 15) suture groups. The Kruskal-Wallis test revealed no statistically significant difference in leak pressure among the four experimental groups. The Bonferroni post hoc test also revealed no statistically significant difference in the pairwise comparisons among the groups. Application of PPVCD is feasible for the closure of gastrostomy openings in an animal model and is as effective as a manual suture. In our in vitro study, percutaneous closure of gastrostomy opening using PPVCD was possible; animal survival studies and development of specific devices are needed before clinical application.

Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement

BackgroundTo describe and evaluate the intentional combination of Angio-Seal (AS) and Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). MethodsThis study cohort was divided into two groups: dual PP versus one AS with one PP (AS + PP) used for common femoral artery haemostasis. The baseline, procedural characteristics and all outcomes (defined according toVARC-2 criteria) were prospectively collected and retrospectively compared. ResultsOverall, a total of 151 consecutive patients (68 men; 80.9 ± 7.3 years old) were evaluated. Of these, 51 patients (33.8%) underwent TAVR using the dual PP, and 100 (66.2%) using one AS with one PP. There were no significant differences in the baseline characteristics of both patient groups, except higher incidence of chronic pulmonary disease in dual PP group (21.6% vs 7%, P = 0.009). Patients in AS + PP group had lower rate of arterial stricture (21.6% vs 8%, P = 0.017), arterial dissection (13.7% vs 4.0%), requiring endovascular intervention for puncture site issues (21.6% vs 9.0%, P = 0.031). Less procedural time (139.8 ± 36.9vs97.9 ± 31.4 min, P < 0.001) & contrast medium consumption (223.9 ± 88.3vs174.1 ± 49.7 ml, P < 0.001) were also observed in AS+PP group. There were no statistically significant differences between 2 groups in regards of closure device failure, major and minor vascular complications, nor major and minor bleeding. ConclusionsIntentional combination of one PP and one AS for femoral access haemostasis in patients undergoing TAVR is feasible and safe, with low risk of vascular and bleeding complications.

Short-term outcome and mid-term access site complications of the percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) after introduction in a vascular teaching hospital.

The objective is to evaluate our center's experience with the safety and efficacy of the percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) with use of the Perclose Proglide device, in the first period after introduction in our center in 2014. We retrospectively identified all patients that underwent PEVAR or endograft extension with percutaneous approach in our center in the urgent and elective setting. Included were all procedures performed between the introduction of the technique in January 2014 and February 2016 when PEVAR had become the predominant technique in our center. Exclusion progressed from expected difficulty of the procedure as estimated by the operator to total calcification of the ventral wall of the CFA towards the end of the study period. Surgical and clinical reports were used to analyze patient characteristics, procedural success, and short-term outcome after 30days. Follow-up imaging was used to assess mid-term access site complications at 1 and 2 years postoperatively. A univariate regression analysis was conducted to determine significant predictors of access-related complications with the Perlcose Proglide system. Of all 78 patients (mean age 74, SD: 7years, 70 men), 68 (87.2%) underwent PEVAR and 10 (12.8%) underwent endograft extension procedures with percutaneous approach. Sixty-seven (85.9%) patients underwent an elective procedure and 11 (14.1%) patients underwent urgent PEVAR. The total number of vessels that was percutaneously accessed was 142. Direct technical success of the procedure as analyzed per vessel was 98.6% (140/142), with two cases of conversion to the femoral cut-down approach. A total of 274 Perclose Proglide devices were placed. Device failure of the Perclose device occurred in 5.8% (16/274) and was reason for conversion to cut-down procedure in one case. Mean duration of the procedure and median time of hospitalization were 100 (SD: 34) min and 2 (IQR 1, 3) days, respectively. Event-free survival per vessel after 30days was 91.0%, with two minor access-related complication. Fifty-five individual patients (105 vessels) were eligible for inclusion in the 1-year follow-up analysis. Of these patients, 19 (34 vessels) could be included in the 2-year follow-up analysis. No additional access site complications occurred at mid-term follow-up. No significant predictors of device failure were found. The percutaneous approach to EVAR appears to be a safe and effective option with high success rate and low complication rate in a real-world setting. Based on our findings, we conclude that the technique can safely be introduced in a vascular center.

Safety and Effectiveness of Suture-mediated Arterial Closure Device in Hepatocellular Carcinoma Patients Who Underwent Drug-Eluting Beads Transarterial Chemoembolization

The number of transarterial percutaneous procedures has risen over the years, consequently reducing puncture site related complications has become a necessity. To this end, the use of arterial closure devices has been growing progressively and their benefits have become a focus of research. The purpose of this study is to assess the safety and effectiveness of a suture-mediated closure device, Perclose ProGlide® (Abbott Vascular, Redwood City, CA), in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads. A cohort of 253 hepatocellular carcinoma patients who underwent 449 procedures of transarterial liver chemoembolization with drug-eluting beads using the Perclose Proglide device was prospectively studied. The main endpoints evaluated were the technical success of the device, defined as complete hemostasis achieved within 3min after the closure, and the incidence of puncture-site complications. The secondary endpoints evaluated were the correlation between epidemiological factors, coagulation profile and degree of liver disease, and the occurrence of complications. Technical success was achieved in 96% of the cases. Among patients who underwent repeated procedures using the same vascular access, this rate was 95.3%. Puncture-site complications were observed in 7 procedures (1.56%); 4 (0.89%) were due to hemorrhage, 2 (0.44%) hematomas and 2 (0.44%) pseudoaneurysms; 2 (0.44%) due to limb ischemia; and 1 (0.22%) due to arterial dissection. Among them, 3 cases required intervention. The statistical analysis of demographic characteristics, Child-Pugh classification, and coagulation status did not show a significant correlation with the occurrence of complications. Of the 449 procedures, only 4 (0.89%) needed hospitalization due to puncture-site complications. The use of Perclose Proglide is safe and effective in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads.

Comparison of Complication and Success Rates of ProGlide Closure Device in Patients Undergoing TAVI and Endovascular Aneurysm Repair.

Introduction Usage of the Perclose ProGlide® (PP: Abbott Laboratories, Chicago, IL, USA) closure device is becoming increasingly prevalent during percutaneous endovascular aortic repair (EVAR) and transcatheter aortic valve implantation (TAVI). The respective conditions treated via these procedures, abdominal aortic aneurysm and aortic valve stenosis, share risk factors but are two different physiopathological problems. Aim Our aim was to compare the complication and success rates of PP closure device use in patients undergoing EVAR and TAVI. Materials and Methods A total of 74 patients, including 58 undergoing TAVI and 16 undergoing EVAR, were analysed in our study. Results Of the TAVI patients treated using the PP closure device, two (3.4%) had access to site-related bleeding complications and two (3.4%) experienced device failure. Of the EVAR patients who received the PP closure device, three (18.8%) had bleeding complications and three (18.8%) experienced device failure. Conclusion Due to the underlying diffuse aortic wall pathology, the success rate of PP closure device use was lower and the complication rate of PP closure device was higher in the EVAR group versus the TAVI group.

Effect of emergency thoracic endovascular aortic repair in patients with acute traumatic thoracic aortic injury

Objective: To investigate the effect of emergency thoracic endovascular aortic repair (TEVAR) in patients with acute traumatic thoracic aortic injury. Method: From January 2014 to December 2016, a total of 35 patients with acute traumatic thoracic aortic injuries were treated with emergency TEVAR in our hospital, their clinical data were analyzed retrospectively in this study. Results: The patients were 42 (34, 55) years old,and there were 31 males.All cases were diagnosed by emergency aorta computed tomography angiography (CTA),and 5 cases were diagnosed as aortic transaction, 13 cases were diagnosed as aortic pseudoaneurysm, 7 cases were diagnosed as aortic dissection, and 10 cases were diagnosed as aortic intramural hematoma combined hemothorax.The concomitant injuries included cerebral contusion (3 cases, 8.6%), pulmonary contusion with rib fracture (31 cases, 88.5%), long bone fracture (7 cases, 22.5%), contusion of viscera or internal organs (3 cases, 8.6%).Emergency TEVAR were performed with vascular suture system preset under local anesthesia after diagnosis,and combined injury was treated in related departments.CTA was repeated after 1, 3 and 6 months and yearly thereafter. One patient died before transferring to catheter room,and 34 (97.1%) patients underwent TEVAR procedure successfully.Time from door to operating room was (88.6±26.6) minutes,and the procedure time was (52.0±9.4) minutes. A total of 69 Perclose Proglide vascular suture system were used,and 2 cases underwent surgical suture because of hematoma and pseudoaneurysm formation in femoral arteries.The involved length of thoracic aorta was (44.5±7.4)mm. A total of 46 stent-grafts were implanted, the length of stent-graft was (164.3±15.2)mm,and the proximal oversize rate was (22.3±8.6)%. The follow-up time was 24 (12,24) months, and there were no procedure related complication such as endoleak and paraplegia. Complete aortic remodeling was observed in 14 cases. Fully thrombolization at stent segments were observed in 7 cases. Fully thrombalization of pseudoaneurysms were observed in 13 cases. One patient complained mild left upper limb weakness due to left subclavian artery occlusion. Conclusion: Emergency TEVAR is safe and effective procedure for the treatment of patients with acute traumatic thoracic aortic injury.

Safety and Effectiveness of Percutaneous Axillary Artery Access for Complex Aortic Interventions

To evaluate the safety and effectiveness of preclose percutaneous axillary artery access in patients requiring upper extremity large sheath access during complex aortic interventions. Between October 2017 and April 2018, 17 patients undergoing endovascular thoracoabdominal aortic artery aneurysm repair or visceral artery interventions had percutaneous axillary artery access with a 12-Fr sheath using an off-label preclose technique with PerClose Proglide (Abbott Vascular, Santa Clara, Calif) suture-mediated closure system. Percutaneous access to the third portion of the axillary artery was obtained under ultrasound guidance at the lateral border of the pectoralis minor muscle. Two PerClose devices were deployed before introducing a 12-Fr sheath. Completion angiography was performed to assess technical success, which was defined as successful arterial closure without evidence of persistent hemorrhage or axillary artery stenosis or occlusion requiring intervention. Technical success was achieved in 16 of the 17 patients (94%). One patient required endovascular covered stent placement during the index operation to control persistent access site bleeding. Two of the 17 patients (12%) suffered access-related complications. Two patients experienced transient ipsilateral upper extremity paresthesias without motor weakness. There was no incidence of conversion to open repair of the axillary artery and on follow-up computed tomography scan no access site complications (stenosis, occlusion, or dissection) were observed. Percutaneous axillary artery access using PerClose Proglide devices for hemostasis can be used to provide upper extremity arterial access during complex aortic interventions with high rates of technical success and safety. Accessing the lateral axillary artery under ultrasound guidance provides a preferred target where pressure may be applied to assist in achieving hemostasis. Overall complication rates are low; however, neurologic complications in the form of ipsilateral paresthesias can occur.

PCV61 - Inpatient Admission Length Of Stay And Costs Among Vascular Procedure Patients Receiving Perclose Proglide Suture-Mediated Closure Compared To Patients Receiving Surgical Cutdown For Closure Of Large Bore Arterial Access

To compare length of stay (LOS) and costs among patients undergoing procedures requiring closure of large bore arterial access using the Perclose ProGlide® Suture-Mediated Closure System (ProGlide) versus manual surgical cutdown (Cutdown) in a real-world setting. This retrospective study analyzed patients undergoing procedures that require arterial closure (Transcatheter Aortic Valve Replacement/Repair (TAVR), Endovascular Abdominal Aortic Aneurysm Repair (AAA), Thoracic Endovascular Aortic Repair (TAA), or Balloon Aortic Valvuloplasty (BAV)) from 2013 -2017 in the IBM Explorys Research Database. Patients receiving ProGlide during the procedure were directly matched and compared to patients treated by the same providers that were closed via manual surgical cutdown. The LOS for the procedure admission and procedure complications were assessed. Costs per day of admission were estimated using claims data from TAVR, AAA, TAA, or BAV procedure admissions in the Truven Health MarketScan Research Database. A generalized linear model was used to quantify the cost associated with differences in LOS. A total of 839 ProGlide patients and 839 matched Cutdown patients met the inclusion criteria. Proglide patients experienced lower rates of complications, including infection. Average LOS for ProGlide patients was nearly four days shorter than Cutdown patients (mean: 9.0 vs. 5.1 days; median: 7.0 vs. 3.0; p<0.001). While controlling for index procedure, age, and gender, LOS was a significant predictor of costs, with each day associated with a 4% increase in total cost for the hospitalization (p<0.05). Using the difference in median LOS, predicted total costs for the procedure admission were $20,599 lower among ProGlide patients compared to Cutdown. The use of Perclose ProGlide was associated with significantly shorter length of stay for the procedure admission compared to surgical Cutdown. Future analyses should focus on directly quantifying the cost-savings and patient benefit from lower complication rates and shortened LOS.

Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair

ObjectiveThe aim of this study was to assess the safety and effectiveness of upper extremity access (UEA) with percutaneous closure of the axillary artery (AxA) during endovascular treatment of thoracoabdominal aortic aneurysms with fenestrated and branched endografts. MethodsBetween January 2014 and 2017, 34 out of 37 patients (92%) required UEA during a staged branched and fenestrated endovascular approach. A percutaneous AxA (pAxA) approach was used in 14 consecutive patients (41%) with the off-label use of two Perclose ProGlide (Abbott Vascular, Santa Clara, Calif) devices. The results of patients who had received a pAxA access were analyzed; technical success was defined as successful arterial closure with no evidence of persistent bleeding or arterial occlusion requiring secondary interventions. Early (30 days) and short-term (6 months) success rates were recorded. The anatomic characteristics of the AxA of the entire cohort (34 cases) were studied. ResultsPrimary technical success of pAxA was 100%; in one case, an adjunctive Perclose ProGlide device was used to achieve complete closure. No secondary open or endovascular procedures were required. At predischarge computed tomography, no intimal defects, pseudoaneurysms, or signs of bleeding were observed, and all patients were discharged without neurologic deficits related to the AxA puncture site. All 14 patients are alive at follow-up, and 9 of 14 patients completed a 6-month clinical follow-up with computed tomography examination; no late complications were observed at the site of UEA percutaneous repair. With regard to the anatomic characteristics of the AxA, the vessel diameters in the first and third segments were statistically different (P < .001) with a median difference of 1.5 mm (1.0-2.0 mm), with no differences between the right and left sides. The distance between the end of the first segment of the AxA and the origin from the aortic arch was statistically different between the right and left sides, with a median difference of 36 mm (17-50 mm). A positive linear correlation was found between the diameter of the AxA and the height of the patients. ConclusionsAxA is adequate in terms of both caliber and lack of calcifications as an access vessel for large-sheath catheterizations, and it might be considered an alternative UEA for complex aortic endovascular procedures thanks to its proximity to visceral target vessels. In this preliminary experience, percutaneous closure of AxA access with the Perclose ProGlide device is clinically safe and technically feasible with high rates of success.

CRT-200.28 The Use of the Perclose Proglide Suture Mediated Closure (SMC) Device for Vein Artery Access Site Closure Up To 24F Sheaths

Evaluate the safety and performance of ProGlide in closure of venous access site in subjects with a large-caliber femoral vein sheath (24F). This was a prospective analysis of retrospective data from the EVEREST II REALISM (REALISM) MitraClip study population who had received either ProGlide or

An Alternative Technique to Achieve Haemostasis During PEVAR Using Perclose ProGlide.

IntroductionPercutaneous endovascular abdominal aortic aneurysm repair (PEVAR) using the Perclose ProGlide suture mediated closure device is currently performed on a global scale. A safe, effective, and cheap technique for achieving haemostasis during PEVAR is described that allows the reversible downsizing of the arteriotomy, without using any other devices.TechniqueThe procedure consists of pulling the blue thread of the pre-implanted ProGlide, advancing the knot close to the arterial wall by pushing it with the dilator of a small introducer sheath, and maintaining the system under tension by grasping the end of the blue thread with a haemostat until bleeding control is achieved.DiscussionSeventeen PEVAR femoral access downsizing procedures have been performed between February and June 2018 and no complications were observed. The technique could be useful in everyday practice and has now become the author's standard practice.

TCTAP C-281 Double Perclose ProGlide Devices Method with a Balloon for Removal of Arterial Cannula of Extracorporeal Membrane Oxygenation Support

TCTAP C-281 Double Perclose ProGlide Devices Method with a Balloon for Removal of Arterial Cannula of Extracorporeal Membrane Oxygenation Support

CRT-800.20 Safety and Feasibility of Using a Single Perclose ProGlide Device for Large Bore Vascular Closure in Transcatheter Aortic Valve Replacement

Current practices have adopted the use two Perclose ProGlide (P-PG) devices for vascular closure. Despite proven a safe technique, this has been associated with significant residual stenosis/dissections in some instances. We demonstrate the feasibility of using a single P-PG device to safely achieve

The Effectiveness Of Local Hemostasis After Endovascular Interventions

Актуальность. В современной медицине широко используются эндоваскулярные технологии, которые доказали свою эф-фективность в диагностике и лечении различных заболеваний. Но их использование может приводить к развитию гемор-рагических осложнений, процент которых может составлять от 0,2 до 15%.Цель исследования – повышение эффективности лечения больных со злокачественными новообразованиями после эндова-скулярных вмешательств путем применения оптимальных методов локального гемостаза.Материалы исследования. Изучены результаты лечения 82 больных, которым были выполнены 221 эндоваскулярное вме-шательство правым транскутантным феморальным доступом. Пациенты были разделены на 4 группы исследования повиду применяемого метода локального гемостаза. В 1-й группе был выполнен компрессионный гемостаз; во 2-й – компрес-сионный гемостаз с использованием манжеты; в 3-й – применялось устройство ExoSeal; в 4-й – устройство PerCloseProGlide. Всем пациентам проводилось клиническое обследование, применялись общие и биохимические лабораторные,инструментальные методы исследования, визуальная шкала оценки болевого синдрома, статистическая обработка ре-зультатов.Результаты исследования. Остановка кровотечения методом мануальной компрессии занимала в среднем 13,6±4,3 ми-нут; методом компрессии с использованием манжеты – 3,0±1,0 минуты, с применением устройств ExoSeal – 3,8±1,3минут, Perclose – 6,5±2,3 минут. Вероятность развития гематом в месте выполнения пункции при использовании ману-ального гемостаза составила 33,3%, мануального гемостаза с манжетой – 5,6%, устройства ExoSeal – 3,6%, устройстваPerclose – 0%.Вывод. Применение компрессионного гемостаза с использованием манжеты позволило снизить вероятность развитиякровотечения из места пункции в 5 раз, гематом – в 5,9 раза; использование устройства ExoSeal – в 6,5 и в 9,3 раза, соот-ветственно, при проведении сравнения с традиционным компрессионным гемостазом. Применение устройства Percloseполностью исключило вероятность развития локальных геморрагических осложнений.Ключевые слова: локальный гемостаз, эндоваскулярные вмешательства, ExoSeal; PerClose ProGlide, мануальная компрес-сия

Totally Percutaneous Access Using Perclose Proglide for Endovascular Treatment of Aortic Diseases.

ObjectiveTo evaluate our experience following the introduction of a percutaneous program for endovascular treatment of aortic diseases using Perclose Proglide® assessing efficacy, complications and identification of potential risk factors that could predict failure or major access site complications.MethodsA retrospective cohort study during a two-year period was performed. All the patients submitted to totally percutaneous endovascular repair (PEVAR) of aortic diseases and transcatheter aortic valve implantation since we started the total percutaneous approach with the preclosure technique from November 2013 to December 2015 were included in the study. The primary endpoint was major ipsilateral access complication, defined according to PEVAR trial. ResultsIn a cohort of 123 patients, immediate technical success was obtained in 121 (98.37%) patients, with only two (0.82%) cases in 242 vascular access sites that required intervention immediately after the procedure. Pairwise comparisons revealed increased major access complication among patients with >50% common femoral artery (CFA) calcification vs. none (P=0.004) and > 50% CFA calcification vs. < 50% CFA calcification (P=0.002). Small artery diameter (<6.5 mm) also increased major access complication compared to bigger diameters (> 6.5 mm) (P=0.027).ConclusionThe preclosure technique with two Perclose Proglide® for PEVAR is safe and effective. Complications occur more often in patients with unfavorable access site anatomy and the success rate can be improved with proper patient selection.

Single-center experience with vascular closure devices in real-world endovascular peripheral interventions.

The aim of the current study was to evaluate the efficacy and safety of vascular closure devices (VCDs) in non-cardiac endovascular interventions. Retrospective analysis of consecutive patients submitted to endovascular interventions, with deployment of 2327 vascular closure devices. Demographic, clinical/periprocedural, post-operative, complication and reintervention data were reviewed. A total of 2107 patients (1409 [66.9%] men) were included. Perclose ProGlide® (Abbott Vascular) was employed 1683 times (72.3%), Angio-Seal™ (St. Jude Medical Inc.) 463 (19.9%) and 181 (7.8%) Exoseal® (Cordis). Patients were 70.4±11 years old. Of all vascular approaches, 1794 were retrograde (77.1%) and 533 antegrade (22.9%), with sheath size ranging from 5 to 8 French. Overall success rate was 95.2% and did not significantly vary according to the device. Overall failure rate was 4.8%, with high puncture site, morbid obesity, previous total anticoagulation and severe calcification being related to worse efficiency results. Major complications occurred in 15 patients (0.6%). All patients were evaluated before discharge from the hospital, and were scheduled to return for ambulatory follow-up visits at 30 days postoperatively. Control duplex ultrasonography was performed on a regular basis, or within this period in case of clinical complain/signs. Vascular closure devices proved to be safe and effective in this study. Additional prospective randomized studies are recommended.

Incidence, Predictors, and Mid-Term Outcomes of Percutaneous Closure Failure After Transfemoral Aortic Valve Implantation Using an Expandable Sheath (from the Optimized Transcatheter Valvular Intervention [OCEAN-TAVI] Registry)

The aim of this study was to evaluate the incidence, predictors, and outcomes of percutaneous closure device (PCD) failure during transfemoral transcatheter aortic valve implantation (TAVI) with an Edwards Sapien-XT prosthesis using an expandable sheath (eSheath). From October 2013 to April 2016, 1,215 patients who underwent TAVI were prospectively enrolled in the Optimized Transcatheter Valvular Intervention (OCEAN-TAVI) registry. Of these, 478 patients underwent transfemoral TAVI with Sapien-XT prosthesis using an eSheath and percutaneous closure with a Perclose ProGlide system. We evaluated the predictors of PCD failure and whether it affected the clinical outcomes. Patients were aged 85years (interquartile range 82 to 88years). PCD failure occurred in 36 patients (8%). Sheath-to-femoral artery ratio (SFAR) (per 1 increase) (odds ratio 5.40, 95% confidence interval 1.28 to 22.92, p= 0.022) predicted PCD failure in a multivariate model. The sensitivity-specificity curves identified an SFAR threshold of 1.03; the area under the curve for SFAR as a predictor of PCD failure was 0.629. The PCD failure group did not have a higher rate of 30-day mortality (0% vs 1%, p= 0.52) or mid-term (365-day) mortality (log-rank test p= 0.85) compared with the PCD success group in the Kaplan-Meier analysis. In conclusion, PCD failures occurred in 8% of the patients and were not associated with 30-day or mid-term mortality rates after percutaneous transfemoral TAVI. The SFAR threshold of 1.03 was useful for predicting PCD failures.

Single-Center Experience Following the Introduction of a Percutaneous Endovascular Aneurysm Repair First Approach

We evaluated our experience following the introduction of a percutaneous endovascular aneurysm repair (pEVAR) first approach using Perclose Proglide assessing efficacy, complications, and identification of factors that could predict failure. A retrospective cohort study on patients over a 2-year period following the introduction of a pEVAR first approach was performed. The primary end point was defined as successful deployment and access site hemostasis. Percutaneous EVAR was technically successful in 41 (77.4%) of 53 patients and 83 (86.5%) of 96 access sites. Factors associated with failure were smaller common femoral artery (CFA) diameter ( P = .045) and CFA circumferential calcification of greater than 50% ( P = .0001). The incidence of access site infection was significantly higher in the failure group ( P = .008) as was procedure duration ( P = .026). Percutaneous EVAR first approach must be introduced with caution. Percutaneous EVAR failure occurs more often in patients with unfavorable access site anatomy. Success rate can be improved with careful patient selection.