Percutaneous Vascular Closure Device Research Articles

Comparison of percutaneous decannulation and open surgical repair for large-bore arterial access sites of extracorporeal membrane oxygenation.

Following weaning of peripheral venoarterial extracorporeal membrane oxygenation (ECMO) support, removal of cannulas and repair of large-bore arterial sites is traditionally by open surgical repair (OSR). The use of a percutaneous vascular closure device (VCD) offers a minimally invasive alternative to OSR with potential for reduced operative complications, reduced hospital length of stay and in-hospital mortality. A systematic review of Medline and Embase databases was conducted for studies comparing VCD-assisted decannulation with OSR following decannulation of peripheral ECMO. The primary endpoint was rate of post-procedural complications, namely wound infection and limb ischaemia. The secondary endpoint was in-hospital mortality. Eight studies, with a total of 685 patients, met inclusion criteria. Forty-eight percent (n = 328) of patients underwent VCD-assisted decannulation with the remainder decannulated by OSR. Pooled analysis demonstrated that patients undergoing VCD-assisted decannulation are at significantly lower risk of overall complications than surgical repair (OR 4.34; 95% CI 2.19-8.57; p < .001). Specifically, there was a substantial decrease in groin infections (OR 6.77; 95% CI 3.07-14.97; p < .001) without notable differences in limb ischaemia or pseudoaneurysm occurrence between the VCD and OSR cohorts. There was a lower incidence of intra-operative bleeding and haematoma in the VCD cohort (p < .001 and p = .002, respectively). Vascular closure device-assisted decannulation of peripheral ECMO offers a significantly reduced risk of complications, particularly groin infections and bleeding. Future research should encompass larger cohorts, randomised controlled trials, cost-benefit analyses, and the training of surgeons, cardiologists and intensivists in VCD-assisted decannulation, potentially through the integration of simulation-based training.

Feasibility and Safety of Percutaneous Axillary Artery Access in a Prospective Series of 100 Complex Aortic and Aortoiliac Interventions

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50-10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.

Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation.

Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited. We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI. We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria. Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08). A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Percutaneous Cannulation of Femoral Vessels in Minimally Invasive Cardiac Surgery.

Despite the recent trend of access miniaturization in minimally invasive cardiac surgery (MICS) surgical "cut down (CD)" for femoral cannulation remains the standard at many centers. Percutaneous vascular closure (PVC) devices have recently been introduced for minimizing invasiveness during interventional diagnostic and therapy. This report summarizes the initial experience with this new approach in the setting of MICS, with a special focus on safety and advantages. Percutaneous cannulation with a standard protocol including preoperative computer tomography imaging and intraoperative point-of-care ultrasound guidance was performed in 93 consecutive patients from September 2018 until February 2020, while conventional "CD" procedure performed in 218 patients in the previous period. We analyzed patients' characteristics and compared access site complications of PVC group versus conventional "CD" group. As far as operative/postoperative outcome, the duration of intensive care unit stay as well as hospital stay was statistically shorter in PVC compared with CD (CD vs. PVC: 2.74 ± 3.83 vs. 2.16 ± 2.01 days, p < 0.01, 16.7 ± 8.75 vs. 13.0 ± 4.96 days, p < 0.001, respectively). Further, we found no femoral infection or lymphocele in the PVC group, whereas 4 cases of wound complications were observed in the CD group. According to our results, percutaneous closure system for femoral vessels in MICS seems to be beneficial with the assist of preoperative computed tomography and intraoperative Doppler guidance.

Percutaneous Plug-Based Vascular Closure Device in 1000 Consecutive Transfemoral Transcatheter Aortic Valve Implantations

Percutaneous Plug-Based Vascular Closure Device in 1000 Consecutive Transfemoral Transcatheter Aortic Valve Implantations

Control of Femoral Cannulation with a ProGlide Pre-Closure Device during Cardiac Surgery: Is It Reliable?

BackgroundThe use of ProGlide as a percutaneous vascular closure device in cardiac surgery remains inconclusive. This study investigated the clinical outcomes of using ProGlide in the percutaneous cannulation of femoral vessels in adult cardiac surgery.MethodsFrom September 2017 to July 2018, 131 consecutive patients underwent femoral vessel cannulation during cardiac surgery. The ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA) with percutaneous cannulation was used in 118 patients (mean age, 55.7±15.5 years). The accessibility of femoral cannulation was evaluated through preoperative computed tomography. For cannulation, sonography was routinely used. The postoperative ankle-brachial index (ABI) was used to evaluate femoral artery stenosis.ResultsOf the 118 patients, 112 (94.9%) and 6 (5.1%) underwent minimally invasive cardiac surgery and median sternotomy, respectively. Most femoral cannulations were performed on the right side (98.3%) using 15F to 19F arterial cannulas. The technical success rate of cannulation with ProGlide was 99.2%, with no delayed bleeding or cannulation site-related complications during hospitalization. During follow-up, only 1 patient showed femoral artery stenosis with claudication and was treated with interventional balloon angioplasty. The postoperative ABI revealed no significant difference in functional stenosis between the cannulation and non-cannulation sides (n=86; cannulation vs. non-cannulation, 1.2±0.1 vs. 1.1±0).ConclusionPercutaneous femoral cannulation with ProGlide was safe and feasible in adult cardiac surgery. This technique may be a good alternative option in patients requiring femoral vessel cannulation for cardiac surgery.

TCT CONNECT-296 Use of Endovascular Percutaneous Vascular Closure Device as Compared to Surgical Cutdown for Decannulation in Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO)

TCT CONNECT-296 Use of Endovascular Percutaneous Vascular Closure Device as Compared to Surgical Cutdown for Decannulation in Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO)

Perclose Proglide™ for vascular closure.

In the past 20years, numerous percutaneous vascular closure devices have been tested and compared with manual compression and to surgical cut-down. The suture-mediated closure device Perclose ProGlide™ system (Abbott Vascular, CA, USA) emerged as a safe and effective alternative for many procedures requiring either small or large bore vascular accesses. In this review, we will discuss the characteristics of this vascular closure device and the main studies that proved its potential to reduce vascular complications, time to deambulation, time to discharge and patient discomfort.

Percutaneous treatment of vascular access-site complications: a ten years\u2019 experience in two centres

BackgroundThe spread of percutaneous arterial catheterization in diagnostic and therapeutic procedures has led to a parallel increase of vascular access site complications. The incidence of these events is between 0.2–1%. A detailed analysis of injuries by type of procedure shows a higher incidence of injuries after therapeutic procedures (3%) than those observed for diagnostic ones (1%), due to the greater size of the vascular devices used and the necessity to frequently administer anticoagulant and antiplatelet therapy during procedures. The iatrogenic arterial injuries requiring treatment are the pseudoaneurysm, arteriovenous fistula, arterial rupture and dissection. Less frequent complications include distal embolization of the limbs, nerve damage, abscess and lymphocele.Moreover, the use of percutaneous vascular closure devices (VCD) has further expanded the types of complications, with an increased risk of stenosis, thrombosis, distal embolism and infection. Our work aims to bring the personal 10 years’ experience in the percutaneous treatment of vascular access-site complications.ResultsNinety-two pseudoaneurysms (PSA), 12 arteriovenous fistulas (AVF), 15 retrograde dissections (RD) and 11 retroperitoneal bleedings (RB) have been selected and treated. In 120/130 cases there were no periprocedural complications with immediate technical success (92.3%). Nine femoral PSA, treated with percutaneous ultrasound-guided thrombin injection, showed a failure to close the sac and therefore they were treated by PTA balloon inflation with a contralateral approach and cross-over technique. Only one case of brachial dissection, in which the prolonged inflation of the balloon has not led to a full reimbursement of the dissection flap, was then surgically repaired. At the 7 days follow-up, complications were two abscesses in retroperitoneal bleedings, treated by percutaneous drainage. At 3 months, acute occlusion of 3 covered femoral stents occurred, then treated by loco-regional thrombolysis and PTA. A total of 18 major complications was recorded at 2 years, with a complication rate at 2 years of 13.8%.ConclusionsThe percutaneous treatment of vascular access-site complications is the first-choice treatment. It represents a safe and effective option, validated by a high technical success rate and a low long-term complication rate, that allows avoiding the surgical approach in most cases.

Off-label use of Proglide percutaneous closure device in iatrogenic arterial catheterizations: Our experience.

Incidental arterial puncture is one of the main complications associated with central venous catheter placement. Manual compression to achieve hemostasis in subclavian and carotid artery punctures is often ineffective because of the anatomical arterial position. Accidental cannulation has traditionally been treated with open surgery or endovascular treatment, but such procedures are not exempt from complications. Report our experience with ultrasound-guided off-label use of Perclose ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA) in patients with iatrogenic arterial cannulation. Six unstable patients with accidental arterial catheterization during placement of a central venous catheter: five of them in the subclavian artery and one in the right common carotid artery. Ultrasound-guided percutaneous closure was performed at bedside using a Perclose ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA). All patients underwent duplex ultrasound 6, 12, 24, and 48 h postprocedure, and no complications associated with percutaneous closure (embolism, ischemia, stenosis, or arterial occlusion, bleeding, pseudoaneurysm, etc.) were described. Accidental artery puncture during central venous catheterization is an uncommon situation but can be effectively managed by using percutaneous vascular closure device. It is a reliable alternative that should be considered as a first-line approach before endovascular or open surgery, specially in patients with unstable conditions in which it is possible to be performed without transfer to an operation room.

Simulation training on bedside veno-arterial extracorporeal membrane oxygenation decannulation.

Veno-arterial extracorporeal membrane oxygenation is a form of mechanical circulatory support for patients with refractory decompensated heart failure. Blood is drawn from a large vein and pumped back to a large artery, usually a femoral artery through large bore catheters. When the heart recovers, the extracorporeal membrane oxygenation support can be terminated and the catheters are decannulated. The bleeding at the venous side can be controlled by prolonged compression; however, the arteriotomy wound needs to be repaired. Conventionally, the arteriotomy wounds require open vascular repair in the operating theater. The novel application of percutaneous vascular closure devices, which have been commonly used in vascular operations and percutaneous structural heart interventions, could be applied for closure of arteriotomy wounds at the bedside after extracorporeal membrane oxygenation support. The post-close ProGlide (Abbott Vascular) technique was shown to be safe and could potentially save time and manpower. The wounds are much smaller as compared with the conventional open repair and potentially, the chance of wound infection can be reduced. However, the success of percutaneous bedside closure requires careful prior planning and technique training. Backup plans with vascular surgeons' standby are essential in case of failure of closure. Staffs in the extracorporeal membrane oxygenation centers need to be familiar with the preparation, the procedure as well as the device application technique for successful percutaneous closure. The long learning curve and the limited case load mean that such skills are best trained by simulation scenarios. This article described how this new technique and the team logistics can be trained by simulation.

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.

Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesTo determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR). BackgroundLimited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14–16 French (F) sheaths. MethodsWe recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively. ResultsThe final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1–9.2) and presence of CAD (OR 8.2; 95% CI 1.8–37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84–14; p = 0.086). There were no independent predictors of PCDF. ConclusionContemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.

Percutaneous Vascular Closure Device in Minimally Invasive Mitral Valve Surgery

Minimally invasive mitral valve surgery requires femoral artery cannulation for extracorporeal circulation, predominantly performed through surgical cutdown. Surgical groin incision is frequently associated with complications such as seroma and infection. We evaluated the safety and efficacy of a percutaneous plug-based large-bore vascular closure device (VCD) for femoral artery closure in minimally invasive mitral valve surgery. This was a single-center prospective study comparing patients undergoing minimally invasive mitral valve surgery with femoral cannulation performed either through surgical cutdown or percutaneously with access site closure using a plug-based VCD (MANTA; Teleflex/Essential Medical, Malvern, PA). From 2016 to 2018, a total of 268 (147 surgical cutdown, 121 VCD) patients underwent minimally invasive mitral valve surgery with femoral arterial cannulation of catheters sized 19-F or 21-F. Propensity score matching resulted in 109 matched pairs. In both the overall series and the propensity-matched cohort, VCD patients had a significantly higher incidence of Valve Academic Research Consortium-2 major access site vascular complications (overall cohort: 0% vs 4.1%; P= .013; propensity score-matched cohort: 0% vs 4.6%; P= .024). Bleeding did not occur in any group. In the overall series, surgical cutdown patients had a higher incidence of seroma (10.9% vs 0%; P < .001). Infection and seroma did not occur in the VCD group. Percutaneous femoral artery cannulation using a novel plug-based VCD in minimally invasive mitral valve surgery eliminates traditional complications frequently seen with surgical cutdown with no femoral access site seroma and infection though at the expense of an increased risk for vascular complications.

Treatment of inadvertent subclavian artery cannulation with a percutaneous vascular closure device

Inadvertent puncture of the subclavian artery is an uncommon but potentially fatal complication of the commonly performed internal jugular vein catheterization. We report a case of accidental subclavian artery catheterization close to the vertebral artery during internal jugular venous cannulation, which was successfully managed in the interventional suite with catheter removal and use of a vascular closure device.

TCT-802 A Novel Ultrasound-Navigated Versus Conventional Vascular Closing Technique Using MANTA Following Transfemoral Transcatheter Aortic Valve Replacement

The incidence of major vascular complications (MVCs) using the MANTA percutaneous vascular closure device (Teleflex, Carrington, North Carolina) following transfemoral transcatheter aortic valve replacement (TF-TAVR) in the real-world clinical setting is still unacceptable. Therefore, the MANTA

Highlights From the Circulation Family of Journals.

Highlights From the Circulation Family of Journals.

Propensity-matched comparison of vascular closure devices after transcatheter aortic valve replacement using MANTA versus ProGlide.

Vascular and bleeding complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). However, data regarding the efficacy and safety of the MANTA percutaneous vascular closure device (VCD) are scarce. The present study sought to compare VARC-2 complications between collagen plug-based closure using "MANTA" and suture-based closure using "ProGlide" to evaluate the efficacy of the novel MANTA VCD. We performed a retrospective, propensity score-matched study to compare vascular and bleeding complications in 325 consecutive patients who underwent TAVR using MANTA and ProGlide. The 1:1 propensity score matching resulted in 111 matched pairs. For MANTA- versus ProGlide-treated patients, all-cause mortality (0% vs. 4%, p=0.02), vascular complications (14% vs. 21%, p=0.21), and bleeding complications (18% vs. 33%, p=0.01) were observed. Access-site vascular injury was significantly less frequent in patients who received MANTA versus ProGlide (8% vs. 17%, p=0.04). MANTA resulted in a significantly lower haemoglobin decrease (16.4 vs. 20.0 g/l, p=0.04) and shorter hospital stay after TAVR (3.3 vs. 5.8 days, p=0.02). It was also associated with fewer bleeding complications (OR 0.44, 95% CI: 0.23-0.83; p=0.01). Moreover, significant decreases of all endpoints were not seen across the procedure date tertiles in the MANTA group. MANTA resulted in a significantly lower complication rate, especially for bleeding, than did ProGlide, despite the operators' inexperience in the use of MANTA.

The utility of Prostar XL percutaneous vascular closure device after stent-graft implantation for infrarenal abdominal aortic aneurysms

Introduction. Over time, endovascular techniques of abdominal aortic aneurysm repair became the principal methods of treatment of this potentially fatal disease. Currently, endovascular aneurysm repair (EVAR) constitutes an effective alternative to open surgery, also in cases of aneurysm rupture. Low degree of invasiveness is the main advantage of this method. Introduction of a system enabling percutaneous stent-graft implantation appears to be the next step in the development of endovascular AAA surgery. Aim of the study is to evaluate the Prostar XL® closure device with regard to clinical effectiveness, safety, cost-effectiveness. Material and methods. The study included 100 patients (from January 2013 to December 2015) subject to endovascular abdominal aortic aneurysm repair in the infrarenal region of the aorta with the application of the Prostar Xl® closure device. Most patients were operated under epidural anaesthesia. Local anaesthesia (1% Lidocaine) was used in 36 patients due to comorbidities. A possible application of the closure system depended on a preoperative assessment of common femoral arteries using ultrasonography. Presence of atherosclerotic plaque on the anterior wall of the vessel disqualified the patient from percutaneous endovascular aneurysm repair (PEVAR). The main part of the procedure consisted of stent-graft implantation into the abdominal aortic aneurysm. In the final stage, puncture site on the anterior wall of common femoral arteries was closed using previously placed sutures of the Prostar XL system. The wound in the inguinal region was closed with a skin suture. Results. The analysis of obtained results demonstrated significantly shorter mean hospitalization times in patients treated with PEVAR compared to EVAR. Low rates and types of observed complications in the study group (PEVAR) compared to the control group (EVAR) are strongly in favour the percutaneous technique (PEVAR) of endovascular aortic abdominal aneurysm repair in the infrarenal region of the aorta, confirming its minimally invasive character.

Successful percutaneous treatment of late-onset femoral pseudoaneurysm after transcatheter aortic valve implantation procedure

Transcatheter aortic valve implantation (TAVI) is usually done via the transfemoral route and often a percutaneous vascular closure device is mostly used to achieve the haemostasis of the femoral artery access site. Nonetheless, vascular access site complications pose a major concern after TAVI. Failure of these devices may lead to undesirable events such as bleeding events, transfusions, acute kidney injury, and increased mortality, especially in the early period. However, late-onset complication of vascular closure device after TAVI procedure is not a very expected complication.