Minor Access Site Research Articles

Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Advanced practice nurse-coordinated same-day-discharge after atrial fibrillation ablation

Abstract Background Catheter ablation is an effective atrial fibrillation (AF) therapy, but a complex, resource-intensive procedure. Same-day discharge (SDD) reduces utilization of health care resources including personell and hospital beds, and may help to accommodate the increasing demand for AF ablation. However, besides structural adaptations, SDD requires more efficient logistics and coordination. Purpose Against this background, we established and validated a streamlined SDD program fully coordinated by an advanced practice nurse. Methods As dedicated SDD coordinator the advanced practice nurse was in charge of the full SDD protocol, including patient eligibility, patient flow, in-hospital logistics, patient education, discharge and short-term follow-up. For inclusion, basic home support and accessibility of the hospital within 60 minutes had to be warranted. Patients with LVEF &amp;lt;35% were excluded. Ablation was performed at the operator’s discretion. Ultrasound-guided femoral puncture was at the operator’s discretion for the first 150 SDD patients but became mandatory per protocol for all subsequent patients. Discharge by the SDD coordinator followed a standardized protocol including supervised ambulation, patient education, femoral inspection and echo. On post-ablation days 1 and 3, patients were called by the SDD coordinator to ensure well-being and good aspect of the femoral access site (smartphone foto control). In addition, patients could consult the SDD coordinator via mobile phone any time during working hours. In-person follow-up visits were scheduled at 2 weeks and 3, 6 and 12 months post-ablation. Results 420 consecutive patients were evaluated by the SDD coordinator of whom 331 were eligible for SDD. Reasons for exclusion were lack of home support (4.5%), living remotely (6.9%), or LVEF &amp;lt;35% (4.0%). 300 of the eligible patients (91%) were successfully discharged the same day (Fig. 1). Rates of unplanned medical attention (4.0%) and 30d-readmission (1.6%) were extremely low. Importantly, there was no major post-SDD complication. Unplanned medical attention and hospital readmissions were largely driven by minor femoral access site complications. Of note, those were significantly reduced upon introduction of mandatory ultrasound-guided puncture after the first 150 SDD patients (p=0.0145, Fig. 2). SDD coordination by the advanced practice nurse streamlined patient flow and in-hospital logistics and significantly reduced the total workload of nursing and medical staff. This resulted in great acceptance of the SDD program and satisfaction both among staff and patients. Conclusions Advanced practice nurse-coordinated SDD after AF ablation is safe and efficient. In fact, the position of a dedicated coordinator may be a key in the forthcoming transition of hospitals to SDD. Importantly, ultrasound-guided femoral puncture virtually eliminated relevant femoral access site complications and should be a prerequisite for SDD.Figure 1Figure 2

Abstract 250: Radial vs femoral access for neuroendovascular diagnostic and therapeutic procedures. A systematic review and Meta‐analysis

Introduction Transradial access (TRA) has become increasingly utilized among neurointerventionalists. There is evidence of reduced complications and higher patient satisfaction compared to transfemoral access (TFA), but more data directly comparing the safety and efficacy of the two approaches is needed. To assess the proportion of technical success and complications with TRA versus TFA in patients who underwent neuroendovascular diagnostic and therapeutic procedures. Methods PRISMA guidelines were used to conduct a systematic review of the literature with PubMed/Medline, Scopus, Embase, and Cochrane databases up to February 2023. Randomized clinical trials (RCT) and observational studies that compared TRA and TFA were included. Studies reporting results of patients who underwent diagnostic angiograms, endovascular management of acute stroke, aneurysm repair, and carotid or vertebral stenting were included. Our primary outcome was technical success, defined as successful arterial access and completion of the intended procedure without crossover. Secondary safety outcomes were rate of complications including access site and non‐access site related, and other efficacy measures such as procedure duration, fluoroscopy time, and radiation exposure. Random effects model was used to perform a meta‐analysis. The Mantel‐Haenszel method was used to calculate risk ratio (RR) and 95% confidence intervals (CI) for each outcome. Heterogeneity was evaluated using I2 and considered high if over 70%. Results Twenty‐nine studies comprising 14,523 patients met inclusion criteria. TRA was attempted in 5,865 (40.38%) patients and TFA in 8,658 (59.62%). Baseline characteristics were similar between groups. The rate of technical success was 95.46% (95% CI: 93.59 – 96.81; p &lt; 0.01) in the TRA group compared with 98.43% (95% CI: 97.60 – 98.97; p = 0.02) in the TFA group. Patients who underwent a diagnostic or therapeutic angiogram via TRA had a slightly lower chance of achieving technical success (RR = 0.98; 95% CI: 0.96 – 0.99; p &lt; 0.01) compared to TFA, with substantial heterogeneity (I2 = 68%). Major access site complications were non‐significantly lower in the TRA group (RR = 0.64; 95% CI: 0.29 – 1.41; p = 0.81) with null heterogenicity (I2 = 0%) between groups. Minor access site complications were significantly lower in the TRA group (RR = 0.43; 95% CI 0.28 – 0.67; p &lt; 0.01), with moderate heterogeneity (I2 = 57%). Non‐access site related complications (including mortality) were lower in the TRA group (RR = 0.69; 95% CI 0.51 – 0.94; p = 0.14) with low heterogeneity (I2 = 26%) between groups; for this outcome, the TRA approach shows a protective but not statistically significant result. Conclusion Our study suggests TRA is feasible and safe for diagnostic and therapeutic neuroendovascular procedures with low certainty of evidence. Minor complications were lower in the TRA group. RCTs directly comparing TRA vs TFA for these procedures are needed to confirm these results.

Impact of Valve Academic Research Consortium 3 (VARC-3) minor access site vascular complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation.

The aim of this study was to investigate the impact of Valve Academic Research Consortium 3 minor access site vascular complications (VCs) in patients who underwent percutaneous transfemoral (TF) transcatheter aortic valve implantation (TAVI). This single-centre retrospective study included consecutive patients who underwent percutaneous TF-TAVI from 2009 to 2021. A propensity score-matched analysis was performed to compare early and long-term clinical results between patients with VC and without VC (nVC). A total of 2161 patients were included, of whom 284 (13.1%) experienced access site VC. Propensity score analysis allowed to match 270 patients from the VC group with 727 patients from the nVC group. In the matched cohorts, the VC group showed longer operative times (63.5 vs 50.0 min, P < 0.001), higher operative and in-hospital mortality (2.6% vs 0.7%, P = 0.022; and 6.3% vs 3.2%, P = 0.040, respectively), longer hospital length of stay (8 vs 7 days, P = 0.001) and higher rates of blood transfusion (20.4% vs 4.3%, P < 0.001) and infectious complications (8.9% vs 3.8%, P = 0.003). Overall survival during follow-up was significantly lower in the VC group (hazard ratio 1.37, 95% CI 1.03-1.82, P = 0.031) with 5-year survival rates being 58.0% (95% CI 49.5-68.0%) and 70.7% (95% CI 66.2-75.5%) for the VC and nVC groups, respectively. This retrospective study observed that minor access site VCs during percutaneous TF-TAVI can be serious events affecting early and long-term outcomes.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up

BackgroundPercutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). MethodsConsecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. ResultsOverall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. ConclusionsFigulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

Early Experience With the Bentley BeGraft Aortic Stent for the Management of Aortic Arch Pathology in the Paediatric Population.

Aortic arch pathology in older children is often treated preferentially with stenting. Both bare metal and covered stents have been utilised, with potential advantages of covered stents. The search for the ideal covered stent continues. Retrospective review of all paediatric patients undergoing treatment of aortic arch pathology utilising the Bentley BeGraft Aortic stent (BeGraft Aortic, Bentley InnoMed, Hechingen, Germany) from June 2017 to May 2021. Outcome measures were procedural success, complications, medium-term patency and need for re-intervention. Fourteen (14) stents were placed in 12 children (seven males). Indications were coarctation of the aorta in 10 and aneurysm in two. Median age was 11.8 years (8.7-16.6 years) and median weight 42.5 kg (24.8-84 kg). Median coarctation narrowing of 4 mm (range 1-9 mm), improved to 11 mm (range 9-15 mm). The median coarctation gradient improved from 32 mmHg (range 11-42 mmHg) to 7 mmHg (range 0-14 mmHg). Both aneurysms were successfully occluded. There was no mortality or major morbidity. In one patient balloon rupture occurred requiring a second balloon for full inflation and one patient had a minor access site bleed. Follow-up median was 28 months (range 13-65 months). One patient underwent repeat balloon dilation for increased blood pressure gradient at 47 months post implant and a second patient additional stent insertion for a mid-stent aneurysm at 65 months. The Bentley BeGraft Aortic stent can be safely deployed in children for the treatment of aortic arch pathology. Medium-term patency is acceptable. Longer term follow-up in larger series will be required to assess stent performance.

Gender Differences in High-risk CAS through Radial Access

AIMS: Transradial (TR) carotid artery stenting (CAS) has been established as an acceptable alternative to carotid endarterectomy, especially in patients with a high risk for surgery. The purpose of this study was to evaluate the gender differences of radial access CAS in high-risk patients. MATERIALS AND METHODS: This was a prospective analysis which included 54 consecutive patients in the period from December 2020 to January 2022. According to the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy study for high-risk CAS, patients with at least one anatomic or comorbid factor associated with increased surgical risk were included in the study. Subjects were divided into two groups according to sex. Follow-up assessments included neurological exams, 12-lead electrocardiogram, and duplex ultrasound (DUS). The primary endpoint was 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications according to Early Discharge after TR Stenting of Coronary Arteries (EASY) score classification, target lesion revascularization, and in-stent restenosis evaluated with DUS. RESULTS: The study population was predominantly male 37 (61.1%) and females were 17 (38.9%). Mean age in the women group was 64.4 ± 7.43 years, and in men, it was 69.1 ± 8.01 years (p = 0.0223). From risk factors for coronary artery disease, hypertension and smoking were more frequent in the male group and hyperlipidemia and diabetes in the female group. Most of the male patients were symptomatic compared to the female group (p = 0.0151). Procedural success was obtained in all cases. Transient vasospasm induced by the distal protection device was present in one male patient. No 30-day major adverse events were recorded between the two groups. Minor access site bleeding complications according to EASY score (Easy type 1) were recorded in 4 patients (3 males vs. 1 female). There were no cases of hand ischemia after procedure or follow-up. None of the patients had in-stent restenosis &gt;70% on DUS during 1-year follow-up. CONCLUSION: Results from this study demonstrate no gender-related differences in radial access CAS for high-risk patients.

Therapeutic efficacy and complications of radial versus femoral access in endovascular treatment of unruptured intracranial aneurysms.

The transradial approach (TRA) in neuroendovascular treatment is known to have a lower risk of complications than the transfemoral approach (TFA). However, little research has focused on assessments of efficacy and risk of complications in the treatment of intracranial aneurysms. This study aimed to compare the efficacy and complications of TRA and TFA in coil embolization of unruptured intracranial aneurysms (UIAs) at our institution. Consecutive patients who underwent endovascular surgery via TRA or TFA at a single institution from 1 April 2019, to 28 February 2022, were retrospectively analyzed. Patients were classified into TRA and TFA groups and assessed using propensity-adjusted analysis for outcomes including fluoroscopy time, volume embolization ratio (VER), and complications. A total of 163 consecutive UIAs were treated with coil embolization during the 35-months study period. The incidence of minor access site complications (ASCs) was significantly higher with TFA (20%, 25/126) than with TRA (2.7%, 1/37; p = 0.01). Propensity-adjusted analysis (matched for age, sex, aneurysm volume, embolization technique, and sheath size) revealed that TRA was associated with a lower risk of minor ASCs (odds ratio, 0.085; 95% confidence interval 0.0094-0.78; p = 0.029). However, TRA did not differ significantly from TFA with respect to fluoroscopy time, VER, major ASCs, and non-ASCs. Coil embolization for UIAs via TRA can reduce risk of minor ASCs without increasing the risk of non-ASCs compared with conventional TFA, and can achieve comparable results in term of efficacy and fluoroscopy time.

Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis.

Background: Transcatheter aortic valve replacement (TAVR) improves the survival and life quality of nonagenarian patients with aortic stenosis. Stroke remains one of the most worrisome complications following TAVR. Cerebral embolic protection devices (CEPDs) may reduce neurological complications after TAVR. This study evaluated the safety and efficacy of CEPDs during TAVR in nonagenarian patients. Methods: Between January 2018 and October 2021, 869 patients underwent transfemoral TAVR (TF-TAVR) at our center. Of these, 51 (5.9%) patients were older than ninety years. In 33 consecutive nonagenarian patients, TF-TAVR was implanted without CEPDs using balloon-expandable valves (BEVs) and self-expandable valves (SEVs). Eighteen consecutive nonagenarians underwent TF-TAVR using a CEPD (CP group). Follow up period was in-hospital or 30 days after the procedure, respectively. Results: Minor access site complications occurred in two patients (3.9%) and were not CEPD-associated. Postinterventional delirium occurred in nine patients (17.6%). Periprocedural minor non-disabling stroke and delirium occurred in ten patients (19.6%). Periprocedural major fatal stroke occurred in two patients in the BEV group (3.9%). Two patients in the BEV group died due to postinterventional pneumonia with sepsis. The mortality rate was 7.8%. The results did not differ between the groups. Conclusions: Age alone is no longer a contraindication for TAVR. CEPD using the Triguard 3 system in nonagenarian TAVR patients was feasible and safe and did not increase access site complications.

Percutaneous proximal axillary artery versus femoral artery access for endovascular interventions

ObjectiveThe primary objective of this study is to describe and illustrate the technique of ultrasound-guided percutaneous proximal axillary artery (PAA) access, and secondarily to evaluate the versatility and safety of this approach in peripheral, visceral, and aortic endovascular interventions. MethodsThis is a single-center retrospective review of all peripheral, visceral, and aortic endovascular cases using percutaneous PAA access from February 2019 to March 2021 compared with a sample of an equivalent number of consecutive cases completed via percutaneous common femoral artery (CFA) access during the same time period. Access entry success, minor and major access site complications within 30 days, major adverse events within 30 days, demographics, and procedural details were analyzed using standard statistical analyses. ResultsA total of 115 accesses—59 PAA and 56 CFA—were reviewed during the study period. Group demographics were not significantly different. Access entry success was achieved in 58 (98.3%) and 56 (100%) of PAA and CFA accesses, respectively, with no statistically significant difference. There were no significant differences in minor access-site complications (13.6% vs 5.4%; P = .21) major access site complications (3.4% vs 7.1%; P = .43), or major adverse events (6.8% vs 5.4%). between the PAA and CFA groups. With respect to versatility, PAA cases had a significantly greater mean number of vessels intervened on per procedure compared with CFA access (2.59 ± 1.31 vs 1.95 ± 0.98; P < .01). A wide range of target vessels were intervened on in both groups. PAA cases had significantly more bilateral lower leg interventions (28.8% vs 12.5%; P = .04). PAA access had a significantly longer mean procedure time (103.2 minutes vs 58.63 minutes; P < .001) and fluoroscopy time (18.21 minutes vs 12.87 minutes; P = .02). ConclusionsThe PAA is a feasible, versatile, and safe percutaneous access option for endovascular intervention. The in-line trajectory from this site facilitates visceral, renal, aortic, and bilateral lower extremity interventions with ease. Outcomes, complications, and major adverse events are similar to those of conventional CFA access in the short term.

Ultrasound- Versus Fluoroscopy-Guided Strategy for Transfemoral Transcatheter Aortic Valve Replacement Access: A Systematic Review and Meta-Analysis.

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Comparison of anticoagulated versus non-anticoagulated patients with intra-aortic balloon pumps

BackgroundThere is limited guidance regarding the use of anticoagulation in patients on intra-aortic balloon pumps (IABP). The purpose of this study is to compare the safety outcomes in anticoagulated versus non-anticoagulated patients with an IABP.MethodsThis was a single center, retrospective chart review of patients admitted to the coronary care unit or cardiac surgery unit who received an IABP from May 2015 to July 2018. Patients who were anticoagulated with heparin while on an IABP were compared to those who were not anticoagulated. Major endpoints included a composite of thrombotic events and a composite of bleeding events. The major composite endpoint of thrombotic events included the incidence of ischemic stroke, any venous thromboembolism, device thrombosis, and limb ischemia. The major composite endpoint of bleeding events included major access site bleeding, minor access site bleeding, major non-access site bleeding, and minor non-access site bleeding. Minor endpoints included any major endpoint events occurring within 24 and 48 h of IABP insertion, hospital length of stay, intensive care unit length of stay, and in-hospital mortality.ResultsA total of 185 patients were evaluated for inclusion and 147 were included in the final analysis. There were 82 and 65 patients in the heparin and non-heparin groups, respectively. The composite endpoint of thrombotic events occurred in 7.3 and 7.7% in the heparin and non-heparin groups, respectively (p = 1). The composite bleeding endpoint occurred in 20.7 and 20.0% in the heparin and non-heparin groups, respectively (p = 0.91). There were no differences found in minor endpoints between groups.ConclusionThere were no significant differences found in major endpoints of bleeding and thrombotic events in patients who received anticoagulation while on an IABP versus those who did not receive anticoagulation.

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

ObjectivesTo study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.BackgroundThe MANTA is a novel plug‐based device for large bore arteriotomy closure.MethodsWe included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC‐2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.ResultsBetween February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS‐score of 2.7 [IQR 2.0–4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20–120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.ConclusionIn this study, MANTA appeared to be a safe and effective device for large bore access closure under real‐world conditions.

Comparison of different access sites (radial, brachial and femoral) for subclavian artery intervention

Abstract Introduction The primary purpose of this multicenter prospective register was to evaluate the success and complication rate of different access sites for subclavian artery intervention. Secondary purpose was to investigate the safety of the distal radial artery access for subclavian artery intervention. Methods The clinical and angiographic data of 223 consecutive patients with symptomatic subclavian and anonym artery stenosis treated via transradial (TR), transbrachial (TB) and transfemoral (TF) access between 2015 and 2019 were evaluated in a multicenter registry. The exclusion criteria of the intervention was the acute proximal subclavian artery thrombosis. Primary endpoint: angiographic outcome of the subclavian and anonym artery intervention, rate of major and minor access site complications. Secondary endpoints: procedural complications, consumption of the angioplasty equipment, cross over rate to another puncture site and hospitalization in days. Results The procedure was successful in 182/184 in TR, in 5/5 in TB and in 32/32 patients in TF group. The cross over rate in the TR, TB and TF group was 0%. Chronic total occlusion recanalization was successful in 75/77 cases in TR, and 15/15 cases in the TF group. Contrast consumption was 152±106 ml in TR, 99±22.5 ml in TB and 152±95 in TF group, respectively (p=ns). Cummulativ dose was 602±1205 mGray in RA, 455±210 mGray in BA and 1089±1674 mGray in FA group (p&amp;lt;0.05). Procedural complications occurred in 1/184 (0.5%) case in RA group, in 0 case (0%) in BA group and in 4/32 cases (12.5%) in the FA group (p&amp;lt;0.05). Major access site complication were detected in 3 patients (1.6%) in RA, in 1 patient in BA (20%) and in 1 patient in FA group (3.1%) (p&amp;lt;0.05). Minor access site complication were encountered in 9 patients in the RA (4.8%), in 1 patient in the BA (20%) and in 8 patients in the FA group (25%) (p&amp;lt;0.05). Distal radial access was used in 29 cases and proximal radial access in 155 patients. The rate of radial artery occlusion in proximal and distal radial group was 5.1% and 0% (p&amp;lt;0.05). Conclusions Subclavian artery intervention can be safely and effectively performed using radial access with acceptable morbidity and high technical success. Femoral and brachial access is associated with more access site complications than radial artery access. Distal radial access is associated with less radial artery occlusion than proximal radial artery access. Funding Acknowledgement Type of funding source: None

TRIACCESS study: randomized comparison between radial, femoral and transpedal access for for percutanous supertfitial femoral artery angioplasty

Abstract Background Traditional access for the treatment of femoral artery lesions is the femoral artery (FA) approach, but radial (RA) and pedal access (PA) is an alternative access site. The aim of the study was to compare the success rate, complication rate of different access sites for the treatment of superfitial artery stenosis in a randomized study Methods 180 consecutive patients were randomized in a prospective study to treat symptomatic superficial femoral stenosis, via RA, FA and PA. Primary endpoint: technical success, rate of major and minor access site complications. Secondary endpoints: major adverse events (MAE), procedural factors, cross-over rate, and duration of hospitalization. Results Technical success was achieved in 96.6%, 100% and 100% patients in RA, FA and PA group (p=ns). Secondary access site was used in 30%, 3.3% and 30% in the RA, FA and PA access group (p&amp;lt;0.01). Stent implantation was done in the femoral artery in 26.6%, 58.3% and 71.6% cases in RA, FA and PA group (p&amp;lt;0.01). CTO recanalization was performed in 34/36 (100%), 30/30 (100%) and 45/45 (100%) cases successfully in RA, FA and PA group (p=ns). Contrast consumption, fluoroscopy and procedure time was not statistically different, but the X Ray dose was significantly lower in PA than in the RA and FA access group (63.1 vs 162 vs 153 Dyn). The cumulative rate of access site complications in the RA, FA and PA group was 3.3% (0% major and 3.3% minor), 15% (3.3% major and 11.6% minor) and 3.3% (0% major and 3.3% minor) (p&amp;lt;0.01), respectively. The cumulative incidence of MAE's at 6 months in the RA, FA and PA group was 8.3% vs 13.3% and 18.3%. (p&amp;lt;0.05) Conclusion Femoral artery intervention can be safely and effectively performed using radial, femoral and pedal access, but radial and pedal access is associated with less access site complication rate. Pedal access is associated with less X Ray dose than radial and femoral access. Funding Acknowledgement Type of funding source: None

Perioperative and long-term outcomes after percutaneous thrombectomy of arteriovenous dialysis access grafts

ObjectiveMaintenance of functional arteriovenous grafts (AVGs) for dialysis is difficult secondary to low primary patency, need for reinterventions, and limited alternative dialysis access options. We assessed our experience with percutaneous thrombectomy for treatment of occluded AVGs. MethodsWe performed a retrospective analysis of all percutaneous thrombectomies for AVGs from 2015 to 2017. These were generally performed using mechanical thrombectomy and occasional chemical tissue plasminogen activator thrombolysis, over-the-wire balloon embolectomy for inflow, and adjunctive inflow and outflow interventions as necessary. Perioperative outcomes, long-term patency, reinterventions, and need for new permanent access placement were analyzed. ResultsThere were 218 percutaneous thrombectomies performed on 86 AVGs in 77 patients. Approximately half (53.2%) of the patients were male and 68.8% were black. Mean age was 61.1 ± 13.0 years. At the time of thrombectomy, 73.8% underwent venous outflow interventions and 4.5% underwent arterial inflow interventions. Within 30 days, 24.8% of declotted grafts underwent repeated percutaneous thrombectomy, 14.3% required tunneled dialysis catheter placement, 4% developed minor access site or graft infections, and one patient underwent surgical arterial thrombectomy for arm ischemia. There were no venous thromboembolic, cardiopulmonary, or cerebrovascular complications or clinically significant pulmonary embolism. At 1 year and 3 years after percutaneous thrombectomy, freedom from repeated thrombosis was 37% and 18%, respectively, and freedom from new dialysis access placement was 66% and 51%, respectively. Overall patient survival was 82% at 3 years. ConclusionsPercutaneous thrombectomy of AVGs is safe and is associated with acceptable patency rates. This minimally invasive method extends AVG use for these high-risk patients with limited dialysis access options.

Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience

BackgroundReal world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known. MethodsAll consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention. ResultsA total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed. ConclusionIn this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.

P4703Distal radial artery access using slender technique for superfitial femoral artery intervention

Abstract Purpose The purpose of this pilot study was to evaluate the acute success and complication rate of the distal radial artery access for femoral artery intervention. Methods and results The clinical and angiographic data of 195 consecutive cases with symptomatic superficial femoral stenosis, treated via distal radial (DR) or proximal radial (PR) access using 6F sheathless guiding between 2014 and 2018, were evaluated in a pilot study. Secondary access was achieved through the pedal artery. Primary endpoint: major adverse events (MAE), rate of major and minor access site complications. Secondary endpoints: angiographic outcome, procedural factors, cross-over rate to femoral access site, and duration of hospitalization. Overall technical success was achieved in 186 patients (95.4%) with 25/26 (96.1%) success in DR and 161/169 (95.2%) success in PR group (ns). The cross over rate to femoral access site was 3.8% in DR and 4.7% in PR group (ns), while dual (transradial and transpedal) access was used in 9/26 (34.6%) patients in DR and 39/169 (23%) patients in PR group (p&lt;0.05). Stent implantation was necessary in 8/26 (30.7%) cases in DR and in 42/169 (24.8%) cases in PR group (ns). CTO recanalization was performed in the DR and PR group with 94.1% (16/17) and 92.6% (79/81) technical success rate. The mean contrast consumption, fluoroscopy time and procedure time was in the DR and PR group was: 93.4 [78–108]ml vs 120 [108–131]ml, 662 [501–822]vs 769 [671–866]min, and 33.4 [27–39]vs 36.5 [32–40]min (ns), respectively. The rate of access site complications in the DR and PR group was 0% and 4.7% (0% major, 4.7% minor) (p p&lt;0.001), respectively. The cumulative incidence of MAE at 3 months in the DR and PR group was 3.8% vs 10.6% (p&lt;0.05). Conclusion Femoral artery intervention can be safely and effectively performed using distal transradial access and distal radial access is associated with lower access site complications.

P4709Subclavian CTO stenting using bilateral retrograde wrist approach

Abstract Aims To assess the procedural safety and results of subclavian artery stenting using bilateral retrograde radial (TRA) and/or ulnar approach (TUA). Methods We report 40 consecutive patients that underwent retrograde opening and stenting of the subclavian artery using wrist approach with contralateral control from the opposite TRA or TUA. Primary outcome was procedural success rate. Secondary outcomes were: presence of procedural complications, restenosis, MI, stroke or death and presence of any type of access site bleeding hemathoma. One year clinical follow up and duplex ultrasonography was done in all patients. Results The same technique was used in all patients: 6F guiding catheter Judkins right 4.0 was most frequently used (n=37) for coronary hydrophilic wire retrograde crossing of the occlusion and ballon predilatation. Exchange of wire was made with 0,035 guide wire. Balloon expandable stents were implanted solely through the short hydrophilic sheath, with contralateral contrast check. Contralateral injection strategy was used to confirm proper wire advancement within the lesion and optimal stent positioning. Most frequently used guide wire for CTO opening was CROSS IT 400. The average stent diameter was 7 mm (range 5.0–9.0 mm), and the average stent length was 29, 1 mm (range 15–80 mm). 38 procedures were successfully done using bilateral retrograde radial approach. Only two patients required transfer to transfemoral approach to open the subclavian chronic total occlusion. Minor access site bleeding complications were recorded in 4 patients. There were no other complications. Seven patients were discharged the same day, the others one day after admission. At follow up only one patient had symptomatic in stent restenosis and a balloon angioplasty was done inside the stent 3 years after the primary intervention, the patient was a smoker. One other patient had asymptomatic in stent restenosis documented 6 months after the intervention with duplex follow up. Conclusions Bilateral wrist access can be a successful and safe strategy in opening subclavian artery occlusions with a low rate of complications.

P6519Transulnar approach vs. left radial access in STEMI patients: experiences from a single high volume center

Abstract Background Transulnar and left radial artery approach are alternative wrist access sites from right TRA for coronary diagnostic and interventional procedures. Using wrist approach in all STEMI patients can decrease access site bleeding and vascular complications, improve patient outcomes and reduce MACCE, allowing rapid ambulation. Purpose To compare the results of the two most common wrist access crossover sites from right TRA in a large single center registry of consecutive STEMI PPCI patients. Methods From March 2011 until December 2017, 5048 consecutive STEMI patients that underwent catheterization were included in a single center prospective registry. Right radial access was used in 97% (4891) of patients. From the total number of STEMI patients, Transulnar approach was used in 95 (1.9%) patients. LRA was used in 43 (0.8%), TFA in 8 (0.1%) and TBA in 11 (0.2%). We compared two groups of patients with TUA and LRA by analyzing access site complications, procedural characteristics, procedural and fluoroscopy time. Results All procedures were successfully performed through TUA and LRA. Procedural time was slightly longer in STEMI patients with LRA transfer (41±16 vs. 38±16 min), but there was no significant difference between patients with TUA and LRA transfer in terms of fluoroscopy time (10±9.3 vs. 10±6.8 min), procedural success and vascular complications. Patients with TUA had significantly smaller number of anomalies 1% vs. 14% in LRA and were less prone to high degree spasm 1% vs. 4,6%. Both access sites had similar number of patients with multiple access site punctures 7.3% vs. 6.9%. Hand ischemia was not observed in any patient on day 1 after procedure and on 1 month follow-up. None of the patients showed nerve injury. Minor access site hematomas were similar with 2% EASY type 1 hematoma present in both groups. TUA vs. LRA STEMI STEMI (n=5048) LRA TUA P value ACCESS 43 (0,8%) 95 (1,9%) Anomalies 7 (14%) 1 (1%) P&lt;0,0001 Multiple punctures &gt;3 3 (6,9%) 7 (7,3%) NA High grade spasm 2 (4.6%) 1 (1%) P&lt;0.0001 Procedure time 41±16 min 38±16.4 min 0.0250 Fluoroscopy time 10±6.8 10±9.3 NA STEMI = ST segment elevation myocardial infarction; LRA = Left Radial Access; TUA = Transulnar Access. TUA vs.LRA STEMI Conclusion Both transulnar and left radial access are safe and feasible alternatives to the default right radial approach, decreasing the need of TFA crossover in STEMI patients.