The Transaxillary Approach via Prosthetic Conduit for Transcatheter Aortic Valve Replacement With the New-Generation Balloon-Expandable Valves in Patients With Severe Peripheral Artery Disease

Background: The left subclavian artery (LSA) is an infrequently used alternative access route for patients with severe peripheral artery disease (PAD) in patients who underwent transcatheter aortic valve replacement (TAVR). We report a new endovascular approach for TAVR combining an axillary prosthetic conduit-based access technique with new-generation balloon-expandable TAVR prostheses.Methods and Results: Between January 2020 and December 2020, 251 patients underwent TAVR at the West German Heart and Vascular Center. Of these, 10 patients (3.9%) were deemed to be treated optimally by direct surgical exposure of the left or right axillary artery via a surgically adapted prosthetic conduit. All procedures were performed under general anesthesia. One procedural stroke occurred due to severe calcification of the aortic arch. No specific complications of the subclavian access site (vessel rupture, vertebral, or internal mammary ischemia) were reported. Two minor bleedings from the access site could be treated conservatively. No surgical revision was necessary.Conclusion: The axillary prosthetic conduit-based access technique using new-generation balloon-expandable valves allows safe and successful TAVR in a subgroup of patients with a high risk of procedural complications due to severe peripheral vascular disease. Considering the increasing number of patients referred for TAVR, this approach could represent an alternative for patients with limited access sites.

Extremity Dysfunction After Large‐Bore Radial and Femoral Arterial Access

Background The use of large‐bore (LB) arterial access and guiding catheters has been advocated for complex percutaneous coronary intervention. However, the impact of LB transradial access (TRA) and transfemoral access (TFA) on extremity dysfunction is currently unknown. Methods and Results The predefined substudy of the COLOR (Complex Large‐Bore Radial PCI) trial aimed to assess upper and lower‐extremity dysfunction after LB radial and femoral access. Upper‐extremity function was assessed in LB TRA‐treated patients by the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire and lower‐extremity function in LB TFA‐treated patients by the Lower Extremity Functional Scale questionnaire. Extremity pain and effect of access site complications and risk factors on extremity dysfunction was also analyzed. There were 343 patients who completed analyzable questionnaires. Overall, upper and lower‐extremity function did not decrease over time when LB TRA and TFA were used for complex percutaneous coronary intervention, as represented by the median Quick Disabilities of the Arm, Shoulder, and Hand score (6.8 at baseline and 2.1 at follow‐up, higher is worse) and Lower Extremity Functional Scale score (56 at baseline and 58 at follow‐up, lower is worse). Clinically relevant extremity dysfunction occurred in 6% after TRA and 9% after TFA. A trend for more pronounced upper‐limb dysfunction was present in female patients after LB TRA ( P =0.05). Lower‐extremity pain at discharge was significantly higher in patients with femoral access site complications ( P =0.02). Conclusions Following LB TRA and TFA, self‐reported upper and lower‐limb function did not decrease over time in the majority of patients. Clinically relevant limb dysfunction occurs in a small minority of patients regardless of radial or femoral access. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03846752.

Acceptance and safety of femoral versus radial access for percutaneous coronary intervention (PCI): results from a large monitor-controlled German registry (QuIK)

Background In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry. Methods The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization. Results From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009). Conclusion Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention.

Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices

Background: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) are associated with morbidity and mortality. However, consistent predictors have not been identified yet. The size of the implantation sheath seems to play a role, though especially with new generation TAVI devices and their improved sheaths and delivery systems this remains uncertain.Objectives: This study aimed to determine the incidence and predictors of access site-related vascular complications (VC) in the era of new generation TAVI devices.Methods and Results: Four hundred consecutive patients receiving TAVI in an experienced tertiary care center were analyzed. VC occurred in 89 patients (22.25%) with the majority being minor VC (21%) and only 1.25% major VC. Possible predictors for VC were tested, and only peri-interventional dual antiplatelet therapy (DAPT) showed to be predictive for VC [OR 2.11 (95% CI 1.10–4.06, p = 0.025)]. The female gender [OR 0.75 (95% CI 0.44–1.3), p = 0.31], sheath to femoral artery ratio &gt;1.05 [OR 1.18 (95% CI 0.66–2.08, p = 0.58)], calcification of the access site vessel [OR 0.83 (95% CI 0.48–1.42, p = 0.48)], known peripheral artery disease [OR 0.95 (95% CI 0.4–2.25, p = 0.9)], and BMI ≥ 25 kg/m2 [OR 0.69 (95% CI 0.41–1.19, p = 0–19)] were not predictive of VC. The larger sheath with 20 French even showed less VC than the smaller sheath with 16 French [OR 0.43 (95% CI 0.25–0.74, p = 0.002)].Conclusions: Overall, the rate of major and minor VC was low in this study population (for major VC: rate of 1.25%). Predefined risk factors were not associated with the occurrence of VC, except for peri-interventional treatment with DAPT. Especially, larger sheath size could not be identified as a predictor for VC in the setting of TAVI procedures performed with contemporary devices.

Incidence and Predictors of Access Site Vascular Complications Following Ultrasound-Guided MANTA Closure Deployment

Purpose: There is no report on the reproducibility of the ultrasound-navigated MANTA deployment (US-MANTA) technique and little is known about predictors for US-MANTA-related vascular complication (VC). This study aimed to assess the incidence and predictors of access-site VC using the US-MANTA technique and report insights of MANTA-related VC from consecutive cases following large-bore arteriotomy. Materials and Methods: Consecutive patients who underwent transfemoral transcatheter aortic valve replacement with the US-MANTA technique from November 2018 to February 2020 were evaluated. MANTA-related VC was defined as access-site complications leading to major or minor VCs based on Valve Academic Research Consortium-2 criteria. Results: Among 378 patients, 23 cases (6.1%) of MANTA-related VC (major VC: n=7 [1.9%], minor VC: n=16 [4.2%]) were identified. No significant difference was observed in the incidence of MANTA-related VC over the observational period (first quartile: 5.3%, second: 5.4%, third: 7.4%, and fourth: 6.3%, p>.50). In 7 patients with MANTA-related major VC, 4 (57.1%) of complications resulted from incomplete apposition of the toggle due to anterior wall calcification of the common femoral artery (CFA). Anterior calcification of the CFA determined by computed tomography was identified as an independent predictor of MANTA-related VCs. Conclusions: The US-MANTA technique sustainably provides a low rate of access-site VCs following large-bore arteriotomy. Incomplete apposition of the toggle due to anterior calcification of the CFA may lead to ongoing vascular and bleeding complications.

470 Percutaneous arterial closure devices and ultrasound-guided trans-femoral puncture observational investigation: insights from the PETRONIO registry

Aims To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. Methods and results All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (i) control period with F and M mainly performed; (ii) phase out period where U and P were introduced; and (iii) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, and U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). 418 procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; P = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; P = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. Conclusions The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleeding with a progressive improvement after the first 6 months learning period.