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Background: Transfemoral (TF) access is the preferred approach for transcatheter aortic valve replacement (TAVR). Limited data exist regarding the outcomes of intravascular lithotripsy (IVL)-assisted TF TAVR in patients with peripheral artery disease., Objectives: This study sought to examine contemporary characteristics, trends, and outcomes of IVL TAVR in the United States., Methods: The Vizient Clinical Database was queried for patients who underwent percutaneous TAVR between October 1, 2020, and November 30, 2023. Outcomes with IVL TAVR vs non-IVL TAVR were examined after propensity score matching. The primary outcome was a composite of in-hospital death, stroke, vascular complications, surgical vascular intervention, and major bleeding., Results: Over the study period, 129,655 patients (mean age of 78.4 years, 42.2% women, 87.1% White) underwent percutaneous TAVR at 361 hospitals, 1,242 (0.96%) of whom underwent IVL TAVR. There was an uptrend in IVL TAVR, but the frequency remained low. IVL TAVR patients had a higher median Elixhauser comorbidity score (5 [Q1-Q3: 4-7] vs 4 [Q1-Q3: 3-6]) compared to non-IVL TAVR. TAVR was completed via the TF approach in 1,238 (99.7%) IVL TAVR patients. In a 3:1 propensity score matching analysis, IVL TAVR was associated with a higher rate of the primary composite outcome (21.9% vs 13.7%; P < 0.001) driven by higher rates of vascular complications, surgical vascular intervention, and major bleeding. In-hospital death and stroke were similar in both groups., Conclusions: In the United States, IVL is increasingly adopted to facilitate TF TAVR. IVL TAVR patients exhibited a higher burden of comorbidities and experienced more complications compared to non-IVL TAVR patients. Further studies are needed to identify appropriate anatomical and clinical use criteria for IVL TAVR and to compare its outcomes vs alternative non-TF TAVR., Competing Interests: Funding Support and Author Disclosures Dr Soukas has received institutional research grants from Shockwave Medical. Dr Abbott has received personal fees for consulting from Abbott, Medtronic, and Penumbra Inc; and has received institutional research grants from Boston Scientific, Recor Medical, Med Alliance, and Shockwave Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Aortic arch disease is a major cause of acute dissections. Surgical replacement is the current curative treatment for aortic arch disease. While traditional aortic cannulation ensures lower body perfusion, axillary cannulation offers optimum cerebral perfusion., Aim: To evaluate the outcomes of aortic and axillary cannulation methods in hemiarch replacements, focusing on postoperative perfusion and survival., Materials and Methods: A retrospective analysis was conducted on 91 patients who underwent hemiarch replacement surgery between February 2007 and October 2016. Patients were divided into two groups based on the cannulation method: aortic cannulation (54 patients) and axillary cannulation (37 patients). Data regarding preoperative, intraoperative, and postoperative parameters were analyzed, including demographics, surgical outcomes, and complications., Results: Demographic analysis showed comparable characteristics between the two groups, with notable differences in aortic disease severity and classification. Patients in the axillary group had a larger ascending aorta diameter (57.7 ± 10.8 mm vs. 51.8 ± 5.7 mm, p = 0.002) and a higher prevalence of acute dissections (27.0% (n = 10) vs. 3.7% (n = 2), p = 0.001). Cerebral protection methods varied significantly between the two groups (p < 0.001). Antegrade cerebral perfusion was used in 37.8% (n = 14) of the axillary group compared to 3.7% (n = 2) of the central group. The central cannulation group had a higher proportion of patients with temperatures under 20 °C (98.1% (n = 53) vs. 21.6% (n = 8), p < 0.001), whereas the axillary group maintained higher temperatures (24 -28 °C) in 68.6% (n = 23) of cases. AV repair/replacement was more frequent in the aortic cannulation group (48.2% (n = 26) vs. 18.9% (n = 7), p = 0.013). No significant disparities were observed in operative mortality or intraoperative complications. Statistical analysis showed no significant differences between the two groups in the in-hospital outcomes, but renal complications were more prevalent in the axillary cannulation group with 21.6% (n = 8) experiencing acute kidney injury compared to 9.3% (n = 5) in the central group (p = 0.098). The overall survival rate was slightly higher in the aortic cannulation group at various follow-up periods, yet no statistically significant difference was found between the two groups., Conclusion: We found no significant differences in safety and efficacy between axillary cannulation and aortic cannulation in hemiarch replacement procedures., (© 2024. The Author(s).)

Background: Catheterization of target vessels (TV) represented by renal visceral vessels are the crucial aspect during fenestrated and branched endovascular repair. This study aims to assess the efficacy and complications associated with upper limb catheterization during complex aneurysm endovascular surgery repair., Methods: A systematic review was conducted after Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) guidelines, involving a search across PubMed, Cochrane CENTRAL, and Web of Science. Primary endpoint was represented by 30-day stroke. Secondary endpoints were target vessels' (TVs) technical success, 30-day mortality, and local access-related complications. Meta-analyses were performed using a random-effects model., Results: Sixteen observational studies encompassing 4,137 patients were included. The 30-day stroke incidence for upper limb access was 1.4% (95% CI 1.0-1.8%), which was slightly higher than lower limb, despite not statistically significant. Mortality varied between 0 and 6.8%, and local access-related complications occurred in 3.2% (95% CI 1.9-4.4%). Technical success in TV catheterization was 99.2% (95% CI 98.4-100.0%)., Conclusions: This systematic review and meta-analysis demonstrate the safety and efficacy of upper limb access for Fenestrated and Branched Endovascular Aortic Repair (f/b-EVAR), with low stroke risk, mortality rates, and minimal local complications. Despite the risk of bias, the findings suggest that upper limb access may be beneficial, especially in bailout situations when femoral access fails, offering valuable insights for clinical decision-making., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Thromboembolic events, particularly strokes, remain a major complication of transcatheter aortic valve replacement (TAVR). Embolic protection devices have failed to show significant clinical benefit in large randomized clinical trials. Aortic wall thrombus (AWT) is often observed on multidetector computed tomography during TAVR work-up, but its prognostic significance is uncertain., Objectives: This study sought to evaluate the association between the presence of AWT and the incidence of thromboembolic outcomes in patients undergoing transfemoral (TF) TAVR for severe aortic stenosis., Methods: This was a prospective cohort study of consecutive patients who underwent TF TAVR for severe aortic stenosis between January 2011 and April 2022. A dedicated scale (range: 0-10) was qualitatively used to assess AWT. The primary outcome was a composite of procedural thromboembolic events defined as ischemic stroke, blue toe syndrome, bowel ischemia, or other solid organ infarction. The secondary endpoints were ischemic strokes and procedural death., Results: Of the 641 patients included, severe AWT (score ≥8) was identified in 73 (11.4%). The presence of severe AWT was strongly associated with an increase in the primary outcome (OR: 8.48; 95% CI: 3.36-21.40; P < 0.001). This relationship persisted following multivariable analysis, which adjusted for comorbidities and procedural characteristics. The presence of severe AWT was also found to be associated with an increased incidence of stroke and procedural death (OR: 5.66; 95% CI: 2.00-15.30; P = 0.002 and OR: 4.66; 95% CI: 1.80-11.30; P = 0.002, respectively)., Conclusions: The presence of severe AWT on preprocedural multidetector computed tomography is strongly associated with thromboembolic complications including stroke and mortality after TF TAVR., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data., Methods: We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians., Results: We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures., Conclusions: In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications., Competing Interests: Disclosures None., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: Kidney Disease Outcomes Quality Initiative clinical practice guidelines recommend avoiding placement of peripherally inserted vascular access devices in patients with an estimated glomerular filtration rate (eGFR) <45 ml/min. On the other hand, many patients with severe chronic kidney disease (CKD) have poor prognosis.This study carried out a global assessment of mortality at 2 years through Charlson Comorbidity Index (CCI) and Beclap score in patients with PICCs or Midlines, assuming that in those with an estimated high mortality rate at 2 years, it could be acceptable to implant a peripheral vascular access device (PVAD) despite the presence of CKD., Methods: We analyzed data on patients with PICCs or Midlines inserted from October 2018 to November 2019. CCI, Beclap score, and eGFR were calculated for each patient at the time of the catheter insertion. We then followed patients for 2 years to assess 2-year mortality for each., Results: One hundred and thirty-one patients were enrolled, 49 (37.4%) had eGFR<45 ml. The 2-year mortality rate was 57.3%. The cut off derived from ROC curve analysis of 15 for Beclap score and 5 for CCI, showed good sensitivity and specificity in predicting mortality of the total population, patients without an oncological disease and patients with eGFR<45 ml/min., Conclusion: CCI and Beclap score are good predictors of mortality at 2 years.Physicians and nurses can use these tools in the evaluation of patients at risk for future dialysis, instead of relying exclusively on renal function to decide whether implanting PICCs, Midlines, or other vascular access devices., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: The right axillary artery is currently recommended for arterial cannulation in surgery for acute type A aortic dissection. However, the feasibility of cannulation on a dissected right axillary artery remains undetermined. The objective was to examine the feasibility of cannulation on a dissected right axillary artery., Methods: From 2016 to 2020, 835 patients who underwent acute type A aortic dissection repair were included in this study. Cannulation strategy and perioperative outcomes of patients who did and did not have right axillary artery dissection were compared. Propensity score matching and logistic regression were applied., Results: A total of 124 patients had right axillary artery dissection, and 711 patients did not. Direct right axillary artery cannulation was used for cardiopulmonary bypass in the majority of patients, but with a lower rate in patients with right axillary artery dissection (n = 88 [71.0%] vs n = 579 [81.4%], P = .007). Right axillary artery cannulation failure (n = 3 [2.4%] vs n = 5 [0.7%], P = .102) and related complications (n = 1 [0.8%] vs n = 6 [0.8%], P = 1.000) were rare in both groups. In-hospital mortality (n = 18 [14.5%] vs n = 59 [8.3%], P = .027) and stroke (n = 14 [11.3%] vs n = 42 [5.9%], P = .027) were significantly higher in the right axillary artery dissection group, but after propensity score matching, in-hospital outcomes were comparable. Right axillary artery dissection was not a risk factor for mortality, stroke, right axillary artery cannulation not performed, or right axillary artery cannulation failure., Conclusions: Direct right axillary artery cannulation is feasible for most patients with acute type A aortic dissection with right axillary artery dissection., (Copyright © 2022. Published by Elsevier Inc.)

Background: Transthoracic approaches may be contraindicated in some patients and may be associated with poorer outcomes. Therefore other alternative access routes are increasingly being performed. We conducted a systematic review of the literature on Transcarotid transcatheter aortic valve replacement (TC-TAVR) and meta-analysis comparing outcomes of TC-TAVR and other access routes., Methods: We comprehensively searched for controlled randomized and non-randomized studies from 4 online databases. We presented data using risk ratios (95 % confidence intervals) and measured heterogeneity using Higgins' I 2 ., Results: Sixteen observational studies on Transcarotid TAVR were included in the analysis; 4 studies compared 180 TC-TAVR patients vs 524 TT-TAVR patients. The mean age and STS score for patients undergoing TC-TAVR were 80 years and 7.6 respectively. For TT-TAVR patients, the mean age and STS score were 79.7 years and 8.7 respectively. TC-TAVR patients had lower 30-day MACE [7.8 % vs 13.7 %; OR 0.54 (95 % CI 0.29-0.99, P = 0.05)] and major or life-threatening bleeding [4.0 % vs 14.2 %; OR 0.25 (95 % CI 0.09-0.67, P = 0.006)]. There was no significant difference in 30-day: mortality [5.0 % vs 8.6 %; OR 0.61 (95 % CI 0.29-1.30, P = 0.20)], stroke or transient ischemic attack [2.8 % vs 4.0 %; OR 0.65 (95 % CI 0.25-1.73, P = 0.39)] and moderate or severe aortic valve regurgitation [5.0 % vs 4.6 %; OR 1.14. (95 % CI 0.52-2.52, P = 0.75)]. There was a trend towards fewer major vascular complications in TC-TAVR [3.0 % vs 7.8 %; OR 0.42 (95 % CI 0.16-1.12, P = 0.08)]., Conclusion: Compared with transthoracic TAVR, TC-TAVR patients had lower odds of 30-day MACE and life-threatening bleeding and no differences in 30-day mortality, stroke or TIA, aortic valve regurgitation., Competing Interests: Declaration of competing interest All the authors have no declarations to make., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Research comparing the effectiveness of central aortic cannulation to axillary artery cannulation in repairing acute type A aortic dissection is limited and controversial. This meta-analysis aimed to compare early outcomes of central aortic cannulation versus axillary artery cannulation for surgery for acute aortic dissection type A., Methods: A comprehensive systematic search was conducted across PubMed/MEDLINE, Scopus, and the Cochrane Central Register of Controlled Trials up to September 1, 2023. The primary endpoints were operative mortality and incidence of postoperative stroke. Secondary endpoints encompassed cardiopulmonary bypass time, myocardial ischemic time, hypothermic circulatory arrest time, postoperative temporary neurological dysfunction, combination of stroke and temporary neurological dysfunction, as well as the need for reexploration for bleeding, renal replacement therapy, and tracheotomy. A random-effect model was utilized to calculate the pooled effect size., Results: Eleven studies met our eligibility criteria, enrolling a total of 7204 patients (2760 underwent aortic cannulation and 4444 underwent axillary cannulation). The operative mortality and incidence of postoperative stroke did not show statistical differences between the two groups, with a pooled odds ratio of 1.07 (95% confidence interval: 0.73-1.55) and 1.17 (0.95-1.42), respectively. Similarly, none of the secondary endpoints exhibited significant statistical differences between the two groups., Conclusions: Aortic cannulation can be a viable alternative to axillary artery cannulation for repair of acute aortic dissection type A, as both approaches present similar early clinical outcomes., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Basel Ramlawi is a consultant for Medtronic, Boston Scientific, AtriCure, and Corcym.

Purpose: This study aimed to compare the clinical outcomes of isolated surgical aortic valve replacement (SAVR) and transfemoral (TF)-transcatheter aortic valve replacement (TAVR) in low-risk aortic stenosis (AS) patients., Methods: A total of 696 low-risk (Society of Thoracic Surgeons score <4%) AS patients underwent isolated SAVR or TF-TAVR at five centers. After 1:1 propensity score matching, 159 pairs were identified. Early and follow-up events, including cardiac mortality and major adverse cardiac and cerebrovascular events (MACCE: all-cause mortality, heart failure admission, reoperation, prosthetic valve endocarditis, and stroke), were compared., Results: Baseline characteristics are similar between the matched groups. There were no 30-day cardiac mortalities in either group. All-cause mortality and MACCE at 30 days did not differ. During 5-year follow-up (median 3.1 [range 0-7.2] years), the incidence of cardiac mortality (1.3% vs. 18.9%; adjusted hazard ratio [aHR], 8.89; 95% confidence interval [CI], 2.68-29.53; P <0.001), all-cause mortality (4.2% vs. 33.9%; aHR, 8.56; 95% CI, 3.41-21.45; P <0.001), and MACCE (25.1% vs. 47.0%; aHR, 2.36; 95% CI, 1.54-3.63; P <0.001) were lower in the SAVR group than in the TAVR group., Conclusions: Isolated SAVR demonstrated better outcomes in low-risk AS patients. TAVR in this subset should be chosen carefully.

Objective: Upper extremity (UE) access is frequently used for fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR), particularly for complex repairs. Traditionally, left-side UE access has been used to avoid crossing the arch and the origin of the supra-aortic vessels, which could potentially result in cerebral embolization and an increased risk of perioperative cerebrovascular events. More recently, right UE has been more frequently used as it is more convenient and ergonomic. The purpose of this study was to assess the outcomes and cerebrovascular events after F-BEVAR with the use of right- vs left-side UE access., Methods: During an 8-year period, 453 patients (71% male) underwent F-BEVAR at a single institution. UE access was used in more complex repairs. Left UE access was favored in the past, whereas right UE access is currently the preferred UE access side. Brachial artery cutdown was used in all patients for the placement of a 12F sheath. Outcomes were compared between patients undergoing right vs left UE access. End points included cerebrovascular events, perioperative mortality, technical success, and local access-related complications., Results: UE access was used in 361 (80%) patients. The right side was used in 232 (64%) and the left side in 129 (36%) patients for the treatment of 88 (25%) juxtarenal, 135 (38%) suprarenal, and 137 (38%) thoracoabdominal aortic aneurysms. Most procedures were elective (94%). Technical success was achieved in 354 patients (98%). In-patient or 30-day mortality was 3.3%. Five (1%) perioperative strokes occurred in patients undergoing right UE access, of which three were ischemic and two were hemorrhagic. No transient ischemic attacks occurred perioperatively. Two hemorrhagic strokes were associated with permissive hypertension to prevent spinal cord ischemia. No perioperative strokes occurred in patients undergoing left UE access (P = .16). Overall, perioperative strokes occurred with similar frequency in patients undergoing UE (5, 1%) and femoral access only (1, 1%) (P = .99). Arm access-related complications occurred in 15 (5%) patients, 11 (4.8%) on the right side and 4 (6%) on the left side (P = .74)., Conclusions: Right UE access can be used for F-BEVAR with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks. In general, UE access is not associated with an increased risk of perioperative stroke compared with femoral access only. Tight blood pressure control is, however, critical to avoid intracranial bleeding related to uncontrolled hypertension., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Limited data are available to guide the choice of intervention for patients with radiation-induced carotid stenosis (RICS), either transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (TFCAS), or carotid endarterectomy (CEA). The purpose of the present study was to evaluate patients who had undergone these carotid artery interventions for RICS and the associated outcomes., Methods: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) carotid artery stenting surveillance project registry and the SVS VQI CEA modules who had undergone carotid artery intervention (TCAR, TFCAS, or CEA) for RICS were included. Those aged >90 years and those with concomitant interventions (eg, coronary bypass) were excluded. A composite of death, myocardial infarction (MI), and stroke was the primary outcome. The secondary outcomes included death, MI, stroke, cranial nerve injury (CNI), and other local and systemic complications. Multivariable logistic regression controlling for presenting symptomatic status and comorbid medical conditions was conducted for the outcome variables, except for death, which was analyzed using Cox regression modeling., Results: A total of 1927 patients with RICS had undergone CEA (n = 1172), TCAR (n = 253), or TFCAS (n = 502). The CEA group had a higher rate of diabetes (31% vs 25% for TCAR and 25% for TFCAS; P = .01), hypertension (85% vs 82% for TCAR and 79% for TFCAS; P < .01), and peripheral vascular disease (8% vs 4% for TCAR and 4% for TFCAS; P < .01). The TCAR and TFCAS groups had higher rates of coronary artery disease (21% for CEA vs 30% for TCAR and 29% for TFCAS; P < .01). The patients who had undergone TFCAS were more likely to have had symptomatic lesions (57% for TFCAS vs 47% for CEA and 41% for TCAR; P < .01) and prior stroke (55% for TFCAS vs 47% for CEA and 40% for TCAR; P < .001). The composite outcome occurred in 3.2% of TCAR patients, 11.2% of TFCAS patients, and 11.1% of CEA patients (P < .01) with an odds ratio of 0.27 for TCAR, 0.91 for TFCAS, and 1.00 for CEA. However, no differences in the individual outcomes were noted for any procedure. TCAR exhibited the lowest odds ratio for CNI (0.15) compared with TFCAS at 0.9, both relative to CEA (P = .03)., Conclusions: RICS patients treated by TCAR in the SVS VQI had the lowest risk of the composite of stroke, death, and MI and CNI. Therefore, TCAR might be the preferred treatment modality. Further comparative studies are needed to evaluate the long-term outcomes in this population and to elucidate the relationship of these procedures to the individual outcomes of stroke, MI, and death., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background Suprasternal access is an alternative access strategy for transcatheter aortic valve replacement (TAVR) where the innominate artery is cannulated from an incision above the sternal notch. To date, suprasternal access has never been compared with transfemoral TAVR. Thus, we sought to assess safety, feasibility, and early clinical outcomes between suprasternal and transfemoral access for patients undergoing TAVR. Methods and Results We evaluated patients from 2 institutional prospective, observational registries containing 1348 patients. Patients were selected in a 2:1 ratio (transfemoral:suprasternal) on the basis of propensity score matching. The primary outcome was in-hospital mortality, and secondary outcomes included the incidence of ischemic stroke, major bleeding, vascular injury, left bundle-branch block, and permanent pacemaker implantation at 30-day follow-up. Propensity score matching identified 89 patients undergoing suprasternal TAVR and 159 patients undergoing transfemoral TAVR suitable for analysis. There was no significant difference between suprasternal TAVR and transfemoral TAVR with respect to in-hospital mortality (1.1% versus 0.6%; odds ratio [OR], 1.80; 95% CI, 0.11-29.06; P =0.680). No patients in either cohort suffered an ischemic stroke. The incidence of major bleeding (2.2% versus 2.5%; OR, 0.89; 95% CI, 0.16-4.96; P =0.895) and vascular injury (1.1% versus 1.9%; OR, 0.59; 95% CI, 0.06-5.77; P =0.651) did not differ significantly. The frequency of left bundle-branch block (9.4% versus 15.8%; OR, 0.56; 95% CI, 0.24-1.30; P =0.177) and permanent pacemaker implantation (11.2% versus 5.9%; OR, 2.01; 95% CI, 0.75-5.45; P =0.169) were not statistically significantly different. Conclusions Suprasternal TAVR was safe and achieved promising short-term clinical outcomes when compared with transfemoral TAVR. Future studies seeking to identify the optimal alternative access site should evaluate suprasternal TAVR access alongside other substitutes for transfemoral TAVR.

Background:  Numerous studies have documented the safety of alternatives access (AA) transcatheter aortic valve replacement (TAVR) for patients who are not candidates for transfemoral or surgical approach. There is a scarcity of studies relating use of AA TAVR in nonagenarian patients, a high-risk, frail group. Our study sought to investigate the clinical outcomes of nonagenarians who underwent AA TAVR for aortic stenosis, with comparison of nonagenarians age ≥90 years with patients age <90 years., Methods:  A cohort study of 171 consecutive patients undergoing AA TAVR (transapical [TA, n  = 101, 59%], transaxillary [TAX, n  = 56, 33%], transaortic [TAO, n  = 11, 6%], and transcarotid [TC, n  = 3, 2%]) from 2012 to 2019 was analyzed. Baseline, operative, and postoperative characteristics, as well as actuarial survival outcomes, were compared., Results:  AA TAVR patients had decreased aortic valve gradients with no difference detected in nonagenarians and younger patients. Operative mortality was 8% ( n  = 14; nine TA, three TAO, and two TAX). Compared to younger patients, significantly more nonagenarians were recorded to have new onset atrial fibrillation (7 vs. 5%, p  < 0.01*). No significant difference in mortality or postoperative complications, such as stroke, pacemaker requirements, was detected. Actuarial survival at 1 and 5 years was 86 versus 87% (nonagenarians vs younger patients) and 36 versus 22%, respectively, with log-rank = 0.97., Conclusion:  AA TAVR in nonagenarian patients who are not candidates for transfemoral approach can be efficaciously performed with comparable clinical outcomes to younger patients, age <90 years. Furthermore, some access sites should be avoided when possible; notably TA was associated with increased mortality, stroke, and new onset atrial fibrillation., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has gained increasing acceptance for patients with aortic disease. Both transfemoral (TF-TAVR) and transapical (TA-TAVR) approach were widely adopted while their performances are limited to a few studies with controversial results. This meta-analysis aimed to compare the mortality and morbidity of complications between TF- versus TA-TAVR based on the latest data., Methods: Electronic databases were searched until April 2021. RCTs and observational studies comparing the outcomes between TF-TAVR versus TA-TAVR patients were included. Heterogeneity assumption was assessed by an I 2 test. The pooled odds ratios(OR) or mean differences with corresponding 95% confidence intervals (CI) were used to evaluate the difference for each end point using a fixed-effect model or random-effect model based on I 2 test., Results: The meta-analysis included 1 RCT and 20 observational studies, enrolling 19,520 patients (TF-TAVR, n = 11,986 and TA-TAVR, n = 7,534). Compared with TA-TAVR, TF-TAVR patients showed significantly lower rate of postoperative in-hospital death (OR = 0.67, 95% CI 0.59-0.77, P < 0.001) and 1-year death (OR = 0.53, 95% CI 0.41-0.69, P < 0.001). Incidence of major bleeding and acute kidney injury were lower and length of hospital stay was shorter, whereas those of permanent pacemaker and major vascular complication were higher in TF-TAVR patients. There were no significant differences between TF-TAVR versus TA-TAVR for stroke and mid-term mortality., Conclusions: There were fewer early deaths in patients with transfemoral approach, whereas the number of mid-term deaths and stroke was not significantly different between two approaches. TF-TAVR was associated with lower risk of bleeding, acute kidney injury as well as shorter in-hospital stay, but higher incidence of vascular complication and permanent pacemaker implantation., (© 2021. The Author(s).)

Objectives: Refractory postcardiotomy cardiogenic shock complicating cardiac surgery yields nearly 100% mortality when untreated. Use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock has increased worldwide recently. The aim of the current analysis was to outline the trends in use, changing patient profiles, and in-hospital outcomes including complications in patients undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock., Design: Analysis of extracorporeal life support organization registry from January 2010 to December 2018., Setting: Multicenter worldwide registry., Patients: Seven-thousand one-hundred eighty-five patients supported with venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock., Interventions: Venoarterial extracorporeal membrane oxygenation., Measurements and Main Results: Hospital death, weaning from extracorporeal membrane oxygenation, hospital complications. Mortality predictors were assessed by multivariable logistic regression. Propensity score matching was performed for comparison of peripheral and central cannulation for extracorporeal membrane oxygenation. A significant trend toward more extracorporeal membrane oxygenation use in recent years (coefficient, 0.009; p < 0.001) was found. Mean age was 56.3 ± 14.9 years and significantly increased over time (coefficient, 0.513; p < 0.001). Most commonly, venoarterial extracorporeal membrane oxygenation was instituted after coronary artery bypass surgery (26.8%) and valvular surgery (25.6%), followed by heart transplantation (20.7%). Overall, successful extracorporeal membrane oxygenation weaning was possible in 4,520 cases (56.4%), and survival to hospital discharge was achieved in 41.7% of cases. In-hospital mortality rates remained constant over time (coefficient, -8.775; p = 0.682), whereas complication rates were significantly reduced (coefficient, -0.009; p = 0.003). Higher mortality was observed after coronary artery bypass surgery (65.4%), combined coronary artery bypass surgery with valve (68.4%), and aortic (69.6%) procedures than other indications. Lower mortality rates were observed in heart transplantation recipients (46.0%). Age (p < 0.001), central cannulation (p < 0.001), and occurrence of complications while on extracorporeal membrane oxygenation were independently associated with poorer prognosis., Conclusions: The analysis confirmed increased use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. Mortality rates remained relatively constant over time despite a decrease in complications, in the setting of supporting older patients., Competing Interests: Dr. Brodie’s institution received funding from ALung Technologies; he received funding from Baxter, Xenios, Hemovent, and Abiomed; he receives research support from ALung Technologies; he was previously on their medical advisory board; and he has been on the medical advisory boards for Baxter, BREETHE, Xenios, and Hemovent. Dr. MacLaren disclosed that he serves on the Board of Directors for the Extracorporeal Life Support Organization (ELSO). Dr. D’Alessandro received funding from Abiomed. Dr. Alexander’s institution received funding from Novartis and Tenax Therapeutics; she received funding from Instrumentation Laboratory; she disclosed the off-label product use of extracorporeal membrane oxygenation (ECMO). Dr. Barbaro’s institution received funding from Training to Advance Care Through Implementation science in Cardiac And Lung illnesses National Heart, Lung, and Blood Institute, National Institutes of Health (NIH) K12 HL138039; he disclosed that he serves on the ELSO Registry Chair; he received support for article research from the NIH; and he disclosed the off-label product use of ECMO. Dr. Lorusso is consultant and conducts clinical trial for LivaNova (London, United Kingdom), is consultant for Medtronic (Minneapolis, MN), and an Advisory Board member of PulseCath (Arnhem, The Netherlands), and Eurosets (Medolla, Italy). The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2021 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Objective: The available data on outcomes after transfemoral carotid artery stenting (TFCAS) originate from the early experience with TFCAS. Although most previous studies stratified outcomes according to a symptomatic or asymptomatic presentation, they often did not specify the degree of presenting neurologic injury. We previously reported that the outcomes after carotid endarterectomy differed according to neurologic injury severity, the contemporary perioperative outcomes of TFCAS stratified by the specific presenting symptom status are unknown., Methods: Patients with data in the Vascular Quality Initiative database who had undergone TFCAS from 2016 to 2020 were included. We stratified patients according to their preprocedural symptom status as asymptomatic, formerly symptomatic (last symptoms >180 days before the procedure), or recently symptomatic (symptoms <180 days before the procedure). The symptoms included stroke, hemispheric transient ischemic attack (TIA), and ocular TIA. We compared the occurrence of in-hospital stroke or death (stroke/death) among the asymptomatic, formerly symptomatic, and specific subtypes of recently symptomatic patients. Multivariable logistic regression models were constructed to adjust for the baseline differences among the groups., Results: Of the 9807 included patients, 2650 (27%) had had recent stroke, 842 (9%), recent hemispheric TIA, and 360 (4%), recent ocular TIA. In addition, 795 patients (8%) were formerly symptomatic and 5160 (53%) were asymptomatic. The patients with recent stroke had a perioperative stroke/death rate of 5.5%, higher than that of patients with recent hemispheric TIA (2.4%; P < .001) or recent ocular TIA (2.8%; P = .03) and asymptomatic patients (1.4%; P < .001). The stroke/death rate was greater for patients with recent ocular TIA than for asymptomatic patients (2.8% vs 1.4%; P = .04). Formerly symptomatic patients had higher stroke/death rates compared with asymptomatic patients (3.5% vs 1.4%; P < .001). On multivariable-adjusted analysis, recent stroke was associated with higher stroke/death compared with recent hemispheric TIA (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.6-4.3; P < .001) and asymptomatic status (OR, 4.1; 95% CI, 3.0-5.6; P < .001) and demonstrated a trend toward higher stroke/death compared with recent ocular TIA (OR, 2.0; 95% CI, 1.0-3.9; P = .06). Furthermore, asymptomatic status was associated with lower stroke/death compared with formerly symptomatic status (OR, 0.4; 95% CI, 0.2-0.6; P < .001)., Conclusions: For patients undergoing TFCAS, recent stroke was associated with greater odds of in-hospital stroke/death after TFCAS compared with recent hemispheric TIA. Also, formerly symptomatic status was associated with greater odds of stroke/death compared with asymptomatic status. These findings support further symptom stratification by the degree of the presenting neurologic injury in the preoperative risk assessment., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The safety and efficacy of right axillary cannulation during complex aortic aneurysm repair for the deployment of chimney grafts is controversial; however, there are few studies that compare right and left upper extremity access. We favor the right axillary approach because of the relative ease of access to the visceral branches and the ability of surgeons and nursing staff to work on the same side of the patient, while avoiding the left sided image intensifier. We aim to demonstrate that right-sided access is equivalent or safer than left-sided access in terms of technical success and complication rates, with a focus on neurologic outcomes., Methods: This is a single-institution retrospective study with a review of patients who underwent aortic intervention from January 2012 through December 2018. A total of 398 aortic interventions were performed, and 97 of these required brachial, axillary, or subclavian arterial access for attempted ChEVAR or thoracic endovascular aortic repair with parallel chimney grafts. Primary end points that were analyzed were site or sites of upper extremity access, technical success, 30-day mortality, cerebrovascular events, and subclavian/axillary artery injury. The number of parallel grafts, age, mean hospital length of stay, prior aortic intervention, emergent or elective status were also analyzed., Results: Ninety-seven endovascular aortic operations required upper extremity access, with 67 using access from the right upper extremity, 26 using access from the left upper extremity, and 4 using bilateral upper extremity access. A total of 68.0% of patients had undergone prior aortic surgery. Technical success was achieved in 85 cases (87.6%). Five total patients suffered cerebrovascular accidents, with 2 occurring in left-sided access (7.7%), 2 in right-sided access (3.0%), and 1 in bilateral access (25%)., Conclusions: Right upper extremity access for patients undergoing parallel graft placement during endovascular aortic aneurysm repair is a safe and feasible approach that is not associated with an increased risk of stroke or neurological events as compared with left upper extremity access., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, P < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; P = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint ( P = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], P < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.

Objective: An exponential increase in number of office-based laboratories (OBLs) has occurred in the United States, since the Center for Medicare and Medicaid Services increased reimbursement for outpatient vascular interventions in 2008. This dramatic shift to office-based procedures directed to the objective to assess safety of vascular procedures in OBLs., Methods: A retrospective analysis was performed to include all procedures performed over a 4-year period at an accredited OBL. The procedures were categorized into groups for analysis; group I, venous procedures; group II, arterial; group III, arteriovenous; and group IV, inferior vena cava filter placement procedures. Local anesthesia, analgesics, and conscious sedation were used in all interventions, individualized to the patient and procedure performed. Arterial closures devices were used in all arterial interventions. Patient selection for procedure at OBL was highly selective to include only patients with low/moderate procedural risk., Results: Nearly 6201 procedures were performed in 2779 patients from 2011 to 2015. The mean age of the study population was 66.5 ± 13.31 years. There were 1852 females (67%) and 928 males (33%). In group I, 5783 venous procedures were performed (3491 vein ablation, 2292 iliac vein stenting); with group II, 238 arterial procedures (125 femoral/popliteal, 71 infrapopliteal, iliac 42); group III, 129 arteriovenous accesses; and group IV, 51 inferior vena cava filter placements. The majority of procedures belonged to American Society of Anesthesiology class II with venous (61%) and arterial (74%) disease. A total of 5% patients were deemed American Society of Anesthesiology class IV (all on hemodialysis). There was no OBL mortality, major bleed, acute limb ischemia, myocardial infarction, stroke, or hospital transfer within 72 hours. Minor complications occurred in 14 patients (0.5%). Thirty-day mortality, unrelated to the procedure, was noted in 9 patients (0.32%). No statistically significant differences were noted in outcomes between the four groups., Conclusions: Our data suggest that it is safe to use OBL for minimally invasive, noncomplex vascular interventions in patients with a low to moderate cardiovascular procedural risk., (Published by Elsevier Inc.)

Background: Access issues are one of the most common complications of endovascular aneurysm repair (EVAR). However, contemporary rates as well as risk factors for complications and the subsequent impact of access complications on mortality are poorly described., Methods: We studied all EVAR for intact abdominal aortic aneurysms without prior aortic surgery in the Vascular Quality Initiative between 2011 and 2018. We studied factors associated with access complications (thrombosis, embolus, wound infection, hematoma, and conversion to cutdown), as well as the interaction with female sex and the impact on survival using multilevel logistic regression and propensity weighting. Multiple imputation was used for missing data., Results: There were 33,951 EVAR during the study period (91% elective, 9% symptomatic); most cases (70%) involved an attempt at percutaneous access on at least one side, with 30% bilateral cutdowns and 0.1% iliac conduits. There were 1553 patients (4.6%) who experienced at least one access complication. Access complications were almost twice as common in female patients (7.5% vs 3.9%; P < .001). The factors associated with access complications included female sex (odds ratio [OR], 2.7; 95% confidence interval [CI], 2.0-3.6; P < .001), age (OR, 1.05 per 5 years; 95% CI, 1.02-1.1; P < .01), aortouni-iliac device (OR, 1.6; 95% CI, 1.1-2.3; P < .01), smoking (OR, 1.4; 95% CI, 1.1-1.7; P < .01), body mass index of less than 16 (OR, 1.8; 95% CI, 1.3-2.5; P = .001), dual antiplatelet therapy (1.3; 95% CI, 1.02-1.6 P = .03), prior infrainguinal bypass (OR, 1.8; 95% CI, 1.3-2.7; P < .01), and beta blocker use (OR, 1.2; 95% CI, 1.03-1.4; P = .02). Conversion from percutaneous access to open cutdown was associated with higher rates of complications than planned open cutdown (8.6% vs 2.9%; P < .001). In propensity-weighted analysis, percutaneous access was associated with significantly lower odds of access complications in women (OR, 0.6; 95% CI, 0.4-0.96; P = .03). Patients who experienced an access complication had more than four times the odds of perioperative death (OR, 4.2; 95% CI, 2.5-7.1; P < .001), and a 60% higher risk of long-term mortality (hazard ratio, 1.6; 95% CI, 1.2-2.1; P = .001). In addition to death, patients with access site complications had higher rates of other major complications, including reoperation during the index hospitalization (19% vs 1.2%; P < .001), myocardial infarction (3.5% vs 0.7%; P < .001), stroke (0.8% vs 0.2%; P < .001), acute kidney injury (12% vs 3%; P < .001), and reintubation (5.7% vs 0.8%)., Conclusions: Although access complications are infrequent in the current era, they are associated with both perioperative and long-term morbidity and mortality. Female patients in particular are at high risk of access complications, but may benefit from percutaneous access., (Copyright © 2020. Published by Elsevier Inc.)

The differential impact of young age and female gender on transradial access (TRA) outcomes remains to be confirmed. The primary objective was to assess the impact of young age and female gender on in-hospital net adverse cardiovascular events (NACE). Among 12 346 patients from the Coronary Angiogram Database of South Australia (CADOSA) Registry, the impact of gender; men (transfemoral access [TFA] 1995, TRA 6168) and women (TFA 1249, TRA 2934), and a median split of age, ≤63 years (TFA 1617, TRA 4727) and >63 years (TFA 1627, TRA 4375) were analyzed on in-hospital outcomes by creating 5 separate propensity-matched cohorts (entire cohort, men, women, ≤63 and > 63 years). Net adverse cardiovascular event reduction with TRA was limited to the >63 years old cohort (odds ratio [OR] = 0.56, 95% CI: 0.34-0.93, P = .02) and women (OR = 0.37, 95% CI: 0.18-0.76, P = .007). In both the age groups and genders, TRA was associated with a lower risk of bleeding and all-cause mortality. On multivariate logistic regression, TRA was associated with a significant reduction in NACE, major bleeding, and mortality in the overall cohort. In conclusion, a reduction in bleeding and mortality was noted with TRA in all the subgroups in this observational study.

Background: Short-term peripheral venous catheter-associated bloodstream infection rates have not been systematically studied in Asian countries, and data on peripheral venous catheter-associated bloodstream infections incidence by number of short-term peripheral venous catheter days are not available., Methods: Prospective, surveillance study on peripheral venous catheter-associated bloodstream infections conducted from 1 September 2013 to 31 May 2019 in 262 intensive care units, members of the International Nosocomial Infection Control Consortium, from 78 hospitals in 32 cities of 8 countries in the South-East Asia Region: China, India, Malaysia, Mongolia, Nepal, Philippines, Thailand, and Vietnam. For this research, we applied definition and criteria of the CDC NHSN, methodology of the INICC, and software named INICC Surveillance Online System., Results: We followed 83,295 intensive care unit patients for 369,371 bed-days and 376,492 peripheral venous catheter-days. We identified 999 peripheral venous catheter-associated bloodstream infections, amounting to a rate of 2.65/1000 peripheral venous catheter-days. Mortality in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.53% and 12.21% in patients with peripheral venous catheter-associated bloodstream infections. The mean length of stay in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.40 days and 7.11 days in patients with peripheral venous catheter and peripheral venous catheter-associated bloodstream infections. The microorganism profile showed 67.1% were Gram-negative bacteria: Escherichia coli (22.9%), Klebsiella spp (10.7%), Pseudomonas aeruginosa (5.3%), Enterobacter spp. (4.5%), and others (23.7%). The predominant Gram-positive bacteria were Staphylococcus aureus (11.4%)., Conclusions: Infection prevention programs must be implemented to reduce the incidence of peripheral venous catheter-associated bloodstream infections.

Objectives: To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches., Background: In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach., Methods: Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding., Results: One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant)., Conclusions: Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results., (© 2020 Wiley Periodicals LLC.)

Objective: Vascular complications (VCs) occurring in transcatheter aortic valve implantation (TAVI) procedures have frequently been reported in the past. Considering significant technical improvements in delivery systems and vascular closure devices, the goal of this study was to determine the incidence, impact, and prognostic factors of VCs in a recent real-world cohort., Methods: We report a bicentric prospective analysis of 479 consecutive patients who underwent TAVI between January 2017 and December 2017. VCs were defined according to criteria set out by the Valve Academic Research Consortium (VARC)-2., Results: The incidence of VCs was 26.1% (n = 125 patients), of which 2.9% were major (n = 14) and 23.2% were minor (n = 111). VCs were related to the primary puncture point in 69% of cases compared with 31% at the secondary puncture site. Treatments implemented were medical in 76% of cases and surgical in 24% of cases. The risk factors for VCs were as follows: iliac morphology score, sheath to iliofemoral artery ratio (SIFAR), and moderate-severe iliofemoral calcifications or tortuosity. In the case of major VCs, only sheath to iliofemoral artery ratio was a risk factor. Major VCs significantly increased intrahospital mortality (30.7% vs 1.1% for minor VCs and 1.3% for no VCs; log-rank, P < .0001) and 1-year mortality (40.6% vs 5.6% for minor VCs and 5.6% for no VCs; log-rank, P < .0001)., Conclusions: Using strictly VARC-2 end point definitions, more than one-quarter of TAVI procedures were associated with VCs, primarily minor ones. Secondary puncture points were responsible for one-third of VCs and should therefore also be actively monitored. Major VCs have a significant impact on short-term and midterm survival., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI)., Background: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results., Methods: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding., Results: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y 12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03)., Conclusions: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin., (© 2020 Wiley Periodicals, Inc.)

Background: We have aimed to analyze early and mid-term outcomes of patients undergoing transapical/transfemoral transcatheter aortic valve implantation (TA-/TF-TAVI) for aortic stenosis and porcelain aorta (PAo) in our institution. Additionally, we postulated that the TA approach may be associated with a more favorable neurological outcome than the TF approach; hence, a systematic literature review was conducted., Methods: Between 2011 and 2017, 15 patients with PAo underwent TA-TAVI and 4 patients with PAo TF-TAVI at our institution. The assessment of PAo was done either intraoperatively after aborted sternotomy or via computed tomography for elective TAVI. We conducted mid-term follow-up. Furthermore, a systematic review was performed to compare the mortality and neurological outcomes of TF and TA-TAVI approaches., Results: TA/TF-TAVIs were performed with 100% device success, without paravalvular leakage ≥ 2 and without procedural death. The 30-day mortality/stroke rates were 6.6%/0% in TA-TAVI and 0%/25% in TF-TAVI, respectively. The 6-month, 1-year, and 2-year survival rates were in TA/TF-TAVI 93%/75%, 82%/66.6%, and 50%/0%, respectively.The pooled results derived from the literature review were as follows: The prevalence of PAo in the TAVI population is 9.74%; the mean logistic EuroSCORE is 41.9% in TA-TAVI versus 16.2% in TF-TAVI; the mean 30-day mortality is 5.9% in TA-TAVI versus 6.3% in TF-TAVI, and the mean stroke is 0.8% in TA-TAVI versus 9% in TF-TAVI., Conclusion: TA-TAVI shows promising early and mid-term outcomes in patients with PAo. TF-TAVI performed in patients with PAo is likely to be associated with higher rates of stroke than TA-TAVI., Competing Interests: Authors have nothing to disclose with regard to commercial support., (Thieme. All rights reserved.)

Background: Intrathoracic complications (ITC) requiring emergency surgical intervention occur during transcatheter aortic valve replacement (TAVR)., Objectives: Characterize the incidence, outcomes and predictors of ITC in a large cohort of transfemoral (TF) TAVR cases over a 5 year period., Methods: Retrospective registry and chart review of all nonclinical trial TF-TAVR patients from seven centers within one hospital system from 2012-2016. ITC were defined as cardiac perforation, new or worsening pericardial effusion/tamponade, annular rupture, thoracic aortic injury, aortic valve dislodgement, and coronary artery occlusion. Procedural and 30-day outcomes and 1-year mortality were compared between ITC and no ITC patients. Multivariable logistic regression was used to identify predictors of ITC., Results: Over the study period, 1,581 patients had TF-TAVR and 68 ITC occurred in 46 patients (2.9%). The most common ITCs were pericardial effusion/tamponade (59%), cardiac perforation (33%), and valve dislodgement (33%). ITC rate did not decline over time (rate (95% confidence interval) for 2012 = 0% (0-8.8%), 2013 = 1.3% (0-7.2%), 2014 = 4.4% (2.2-8.0%), 2015 = 3.5% (2.0-5.6%), and 2016 = 2.4% (1.5-3.8%)). ITC patients had worse 1-year survival (ITC: 60.7% (45.1-73.1%), no ITC: 88.7% (87.0-90.3%); p < .001). The majority of ITC patient deaths occurred within the first 30 days. Multivariable models to predict ITC were not successful., Conclusions: ITC did not decline over time in our cohort. Predictors of ITC could not be identified. While these events are rare, they are associated with worse procedural outcomes and mortality. Heart teams should continue to be prepared for emergency intervention., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO-3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH)., Background: PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH., Methods: BRAVO-3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30-day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE., Results: The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in-hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days., Conclusions: Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Background: Atherosclerosis affects various vascular beds, such as the coronary and carotid arteries and peripheral vessels, of the lower limbs. Current recommendations for treating multiple vascular beds include targeted catheterization at different intervals and are mainly intended to avoid kidney injury. We examined the efficacy and safety of simultaneous coronary and lower limb catheterization., Methods: This retrospective cohort study included 121 patients who underwent catheterization between January 2008 and December 2016. Patients were divided into four groups: 20 (16.5%) simultaneously underwent coronary and peripheral vascular bed catheterization; 32 (26%) underwent separate procedures (time interval between procedures >2 months); 50 (41%) underwent staged procedure (time interval ≤2 months); and 19 (16%) underwent only peripheral catheterization (single procedure)., Results: No significant between-group differences were observed regarding demographic variables except for sex and diabetes and congestive heart failure incidences. Almost half of all the patients who underwent a single procedure were symptomatic. The successful peripheral catheterization rate was significantly higher in the single procedure group, with no significant difference among the other groups. There were no significant between-group differences with respect to major cardiovascular events, 30-day mortality, mortality within 1 year, and 24-hr vascular complication rate/acute renal failure incidences., Conclusion: Our study demonstrates the efficacy and safety of concurrent catheterization of coronary arteries and lower limb arteries, regardless of the time interval between these two procedures. Simultaneous catheterization of different vascular beds is an effective, timesaving, and safe option. Our findings should be verified in a large-scale prospective study involving additional vascular beds., (© 2020 Wiley Periodicals, Inc.)

Objective: Previous data showed superior outcomes of carotid endarterectomy (CEA) compared with transfemoral carotid artery stenting (TFCAS) in elderly patients because of an increased stroke risk in TFCAS-treated patients. Transcarotid artery revascularization (TCAR) with flow reversal was developed to mitigate the maneuvers at highest risk for causing stroke during TFCAS, such as manipulation of a diseased aortic arch and crossing of the carotid lesion before deployment of an embolic protection device. This study aimed to compare the association between age and outcomes after TCAR, TFCAS, and CEA., Methods: All patients undergoing carotid procedures in the Society for Vascular Surgery Vascular Quality Initiative database between 2015 and November 2018 were included. Patients were divided into three different age groups (≤70 years, 71-79 years, and ≥80 years). In-hospital outcomes after TCAR vs TFCAS and after TCAR vs CEA were compared in each age group by introducing an interaction term between treatment type and age in the logistic regression analysis after adjustment for patients' preoperative characteristics., Results: The study cohort included 3152 TCAR, 10,381 TFCAS, and 61,650 CEA cases. The absolute and adjusted in-hospital outcomes after TCAR did not change across the different age groups. The rates of in-hospital stroke/death after TCAR were 1.4% in patients ≤70 years vs 1.9% in patients 71 to 79 years and 1.5% in patients ≥80 years (P = .55). Comparison of TCAR to CEA across different age groups showed no significant differences in outcomes, and no interaction was noted between treatment and age in predicting in-hospital stroke/death (P = .80). In contrast, TCAR was associated with a 72% reduction in stroke risk (4.7% vs 1%; odds ratio [OR], 0.28; 95% confidence interval [CI], 0.12-0.65; P < .01), 65% reduction in risk of stroke/death (4.6% vs 1.5%; OR, 0.35; 95% CI, 0.20-0.62; P < .001), and 76% reduction in the risk of stroke/death/myocardial infarction (5.3% vs 2.5%; OR, 0.24; 95% CI, 0.12-0.47; P < .001) compared with TFCAS in patients ≥80 years. Moreover, compared with TCAR, the odds of stroke/death after TFCAS doubled at 77 years (OR, 2.0; 95% CI, 1.4-3.0; P < .01) and tripled at 90 years (OR, 3.0; 95% CI, 1.6-5.8; P < .01; P value for the interaction = .08)., Conclusions: TCAR is a relatively safe procedure regardless of the patient's age. The advantages of TCAR become more pronounced in elderly patients, with significant reductions in in-hospital stroke compared with TFCAS in patients ≥77 years old, independent of symptomatic status and other medical comorbidities. These findings suggest that TCAR should be preferred to TFCAS in elderly patients who are at high surgical risk., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To describe and report the results of an original technique for trans-femoral (TF) transcatheter-aortic-valve-replacement (TAVR)., Background: TF approach represents the commonest TAVR technique. The best technique for TF-TAVR is not recognized., Methods: We developed a less-invasive totally-endovascular (LITE) technique for TF-TAVR. The key aspects are: precise TAVR access puncture using angiographic-guidewire-ultrasound guidance radial approach as the "secondary access" (to guide valve positioning, to check femoral-access hemostasis and to manage eventual access-site complications) non-invasive pacing (by retrograde left ventricle stimulation or by definitive pace-maker external programmer) The LITE technique has been systematically adopted at our Institution. Procedure details, complications and clinical events occurring during hospitalization were prospectively recorded. Major vascular complications and life-threatening or major bleedings were the primary study end-points., Results: A total of 153 consecutive patients referred for TF-TAVR were approached using the LITE technique. Mean predicted surgical operative mortality was 4.9% and mean TAVR predicted mortality was 3.9%. In 132 (86.3%) patients, TAVR was completed without the need for additional femoral artery access or transvenous temporary pace-maker implantation. Major vascular complications occurred in 2 (1.3%), life-threatening or major bleedings occurred in 4 (2.6%) patients. All-cause death occurred in 3 patients (2.0%)., Conclusions: TF-TAVR according to LITE technique is feasible and is associated with very low rates of vascular or bleeding complications., (© 2020 Wiley Periodicals, Inc.)

Background: Transcarotid artery revascularization (TCAR) has been shown to have half the rates of transient ischemic attack (TIA), stroke, and death compared with transfemoral carotid artery stenting (TFCAS). Successful outcomes of TFCAS require careful patient selection. The aim of this study was to determine the outcomes of TFCAS versus TCAR in both simple (type I) and complex (type II and III) aortic arches., Methods: A retrospective cohort study was performed comparing the outcomes of patients undergoing TFCAS versus TCAR with simple and complex aortic arches using the Vascular Quality Initiative registry from August 2011 to May 2019. The primary outcome was a composite of in-hospital TIA/stroke/death., Results: About 6,108 carotid artery interventions were analyzed, including 3,536 (57.9%) patients with type I, 2,013 (33.0%) with type II, and 559 (9.2%) with type III aortic arch. In 3,535 patients with a simple arch, 1,917 underwent TFCAS and 1,619 had TCAR. Mean age was 70.6 (±9.5) years, and 2,382 (67.4%) patients were males. The primary outcome of postoperative TIA/stroke/death was seen significantly less frequently in those undergoing TCAR compared with TFCAS in simple arches (odds ratio [OR], 0.63; 95% confidence interval [95% CI], 0.43-0.94; P = 0.0236). Although the individual outcome of death occurred less often in TCAR (P = 0.0025), there was no difference in the occurrence of in-hospital stroke (P = 0.8836) or TIA (P = 0.4608). On multivariable analysis, TCAR was associated with improved outcomes (P = 0.0062). A worse outcome was associated with increasing age (P < 0.001), a prior stroke (P < 0.0001), and increasing number of stents (P = 0.0483). In 2,572 patients with a complex arch, 1,416 underwent TFCAS and 1,156 had TCAR. Mean age was 73.0 (±9.1) years, and 1,655 (64.4%) were males. In complex arch anatomy, the primary outcome of in-hospital TIA/stroke/death was seen significantly less frequently in TCAR compared with TFCAS (OR, 0.49; 95% CI, 0.31-0.77; P = 0.0022). Again noted was a significant difference in death, with better outcomes in TCAR (P = 0.0133). Although the occurrence of in-hospital TIA was no different between the 2 approaches (P = 0.6158), there were significantly fewer strokes in those treated with TCAR (P = 0.0132). TCAR (P = 0.0146) was associated with improved outcomes. A worse outcome was seen with advancing age (P = 0.0003), prior strokes (P = 0.01), and a left-sided lesion (P = 0.0176)., Conclusions: TCAR has improved outcomes of TIA/stroke/death compared with TFCAS in both simple and complex aortic arch anatomy. In simple aortic arches, there is no difference in neurologic outcomes between both approaches. In complex arch anatomy, TCAR has fewer strokes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: We sought to compare outcomes between intravascular ultrasound- (IVUS) versus angiography (AO)-guided peripheral vascular interventions (PVIs). Introduction: Intravascular ultrasound facilitates plaque visualization and angioplasty during PVIs for peripheral arterial disease. It is unclear whether IVUS may improve the durability of PVIs and lead to improved clinical outcomes., Methods: This is a study-level meta-analysis of observational studies. The primary end points of this study were rates of primary patency and reintervention. Secondary end points included rates of vascular complications, periprocedural adverse events, amputations, technical success, all-cause mortality, and myocardial infarction., Results: Eight observational studies were included in this analysis with 93 551 patients. Mean follow-up was 24.2 ± 15 months. Intravascular ultrasound-guided PVIs had similar patency rates when compared with AO-guided PVIs (relative risk [RR]: 1.30, 95% confidence interval [CI]: 0.99-1.71, P = .062). There was no difference in rates of reintervention in IVUS-guided PVIs when compared to non-IVUS-guided PVIs (RR: 0.41, 95% CI: 0.15-1.13, P = .085). There is a lower risk of periprocedural adverse events (RR: 0.81, 95% CI: 0.70-0.94, P = .006) and vascular complications (RR: 0.81, 95% CI: 0.68-0.96, P = .013) in the IVUS group. All-cause mortality (RR: 0.76, 95% CI: 0.56-1.04, P = .084), amputation rates (RR 0.83, 95% CI: 0.32-2.15, P = .705), myocardial infarctions (RR: 1.19, 95% CI: 0.58-2.41, P = .637), and technical success (RR: 1.01, 95% CI: 0.86-1.19, P = .886) were similar between the groups. Conclusions: Intravascular ultrasound-guided PVIs had similar primary patency and reintervention when compared with AO-guided PVIs with significantly lower rates of periprocedural adverse events and vascular complications in the IVUS-guided group.

Background: In patients who are not suitable for traditional access routes for transcatheter aortic valve replacement (TAVR) due to severe peripheral vascular disease (PVD) or prohibitive surgical risk, carotid artery (CA) access is an emerging route for TAVR. This study represents the most up to date on outcomes of carotid access TAVR., Methods: A systematic review was conducted as per the Preferred Reporting Instructions for Systematic Reviews and Meta-analysis (PRISMA). We performed a thorough electronic search through Pubmed, SCOPUS and Embase databases. Statistical analyses were performed using SPSS version 24 (IBM Corporation, Armonk, New York, USA)., Results: A total of 15 non-randomized studies were included in this systematic review comprising of patients that received TAVR via 4 vascular access sites, transcarotid (TC) (N = 1035), transfemoral (TF) (N = 1116), transapical (TAP) (N = 307), transaortic (TAO) (N = 176) and transaxillary (TAX) (N = 90). In the Transcarotid cases, device success was achieved in 95.6% of patients (n = 748). The 30-day and 1-yr mortality was 4.2% and 10.5% respectively. 15.3% of patients required new pacemaker implantation. In-hospital stroke or TIA occurred in 4% of cases. 30-day stroke or TIA occurred in 5% of cases. There were no hemorrhagic strokes. 30-day Mortality was significantly higher in the Transaortic group (12.1%) compared to the Transcarotid group (2.6%) [RR = 2.93 95% CI = 1.15-7.58; p = 0.027]. There were no differences in outcomes between the Transcarotid group and the Transapical or Transaxillary groups., Conclusion: The most contemporary data on Carotid access TAVR shows impressive device success, low rates of stroke and pacemaker implantation and an acceptable 30-day and 1-year mortality. 30-day mortality was significantly lower in TC compared to TAO patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Ultrasound-enhanced catheter-directed thrombolysis (UET) using the Ekosonic® Endovascular System device for acute, peripheral arterial ischemia has been purported in clinical trials to accelerate the fibrinolytic process to reduce treatment time and lytic dosage. We aim to describe outcomes of UET in a real-world clinical setting., Methods: We performed a retrospective review of all patients undergoing UET for acute limb ischemia at a single institution. Data collected included patient demographics, procedural details, and 30-day and 1-year outcomes. The primary endpoints for analysis were major adverse limb events (MALEs; reintervention and/or amputation) and mortality within 30-days and 1-year. Secondary endpoints included technical success, use of adjunctive therapies, and postoperative complications., Results: A total of 32 patients (mean age 67.4 ± 14.9 years; 25% women) underwent UET for acute limb ischemia between 2014 and 2018. The Rutherford Acute Limb Ischemia Classification was Rutherford (R) 1 in 56.3%, R2a in 31.3%, and R2b in 12.5%. Etiology was thrombosis of native artery in 12.5% of patients, prosthetic bypass in 31.3%, autogenous bypass in 6.3%, and stented native vessel in 50.0%. Mean duration of thrombolytic therapy was 22.2 ± 11.3 hr, and mean tissue plasminogen activator dose was 24.5 ± 15.3 mg. MALEs occurred in 16.7% of patients within the first 30 days and 38.9% experienced a MALE by 1 year. Limb salvage at 30 days and 1 year was 93.8% and 87.5%, respectively. Ipsilateral reintervention was required in 12.5% of patients within 30 days and 37.5% of patients within 1 year. Overall mortality was 6.2% at 30 days and 13.5% at 1 year. In-line flow to the foot was re-established in 90.6% of patients, with a significant improvement in preoperative to postoperative ankle-brachial index (0.31 ± 0.29 vs. 0.78 ± 0.34, P < 0.001) and number of patent tibial runoff vessels (1.31 ± 1.20 vs. 1.96 ± 0.86, P < 0.001). There was no significant difference in revascularization success between occluded vessel types. All but one patient required adjunctive therapy such as further thromboaspiration, stenting, or balloon angioplasty. Major bleeding complications occurred in 3 patients (9.4%), including 1 intracranial hemorrhage (3.1%)., Conclusions: UET with the EKOS device demonstrates acceptable real-world outcomes in the treatment of acute limb ischemia. UET is generally safe and effective at re-establishing in-line flow to yield high limb salvage rates. However, UET is associated with a high rate of reintervention. Further investigation is needed into specific predictors of limb salvage and need for reintervention, as well as cost-efficacy of this technology compared with that of traditional methods., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The percutaneous access site of transfemoral transcatheter aortic valve implantation (TAVI) procedures is commonly closed using a preclosure technique with suture-type closure devices. We sought to evaluate the predictors and outcomes of percutaneous closure device (PCD) failure during transfemoral TAVI., Methods and Results: This single-center retrospective analysis included 184 patients who underwent transfemoral TAVI using 2 ProGlide sutures for severe aortic stenosis between July 2011 and September 2018. PCD failure was observed in 11.4%. The causes of PCD failure included 5 cases of insufficient hemostasis, 13 cases of arterial stenosis or occlusion, and 3 cases of dissection. Closure failures were managed by surgical repair in 10 patients and endovascular treatment in 11 patients. In a multivariate binary logistic model, a minimum lumen diameter of the common femoral artery (CFA) (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.15-0.83, P = 0.017) and left femoral access (OR 2.89, 95% CI 1.01-8.30, P = 0.048) was identified as a predictor of PCD failure. PCD failure was not associated with increased mortality (0% vs. 2.5%, P = 1.000) or a major adverse cardiovascular event (MACE; 4.8% vs. 4.3%, P = 1.000) at 30 days., Conclusions: PCD failures were not uncommon in patients undergoing percutaneous transfemoral TAVI. Small CFA diameter and left femoral access are predictors of PCD failure. However, PCD failures were not associated with increased mortality or MACE., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes., Background: Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality., Methods: This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients., Results: The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint., Conclusions: Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Debate still occurs of the benefits of transradial access (TRA) versus transfemoral access (TFA), especially for complex percutaneous coronary interventions. Recent data has shown equivalent efficacy and improved safety outcomes with TRA., Objectives: To systematically review and perform a meta-analysis comparing procedural characteristics and clinical outcomes of TRA versus TFA in patients who underwent percutaneous coronary intervention (PCI) for left main (LM) disease., Methods: We conducted an electronic database search of all published data for studies that compared TRA with TFA in patients undergoing PCI of LM disease. Event rates were compared using the odds ratio (OR) as a measure of effect size. Random-effects models were used to account for interstudy heterogeneity., Results: A total of 12 observational studies including 17,258 patients (TRA n = 7,971; TFA n = 9,287) were included. Compared to TFA, TRA was associated with a significant reduction in access site bleeding (OR = 0.11; 95% confidence interval [CI] = 0.04-0.26; I 2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I 2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I 2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I 2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I 2 = 11%; p = .004) were also lower in the TRA group. There were no significant differences in procedural outcomes between TRA and TFA except for a significant reduction in the rate of long-term target vessel revascularization (TVR) in the TRA group (OR = 0.62; 95% CI = 0.41-0.94: I 2 = 0%: p = .02). We further performed a subgroup analysis for unprotected left main PCI only, which showed a significant reduction in rates of any bleeding episode, lower access site or vascular complications, and in-hospital mortality with TRA as compared to TFA., Conclusion: Patients undergoing PCI for LM disease via TRA have with less bleeding, reduced access site or vascular complications, reduced in-hospital mortality, comparable procedural success, and possibly better long-term clinical efficacy when compared to those undergoing the procedure via TFA., (© 2019 Wiley Periodicals, Inc.)

The femoral approach with the Needle's Eye Snare (NES) is often used for bailout after failure of the superior approach for transvenous lead extraction (TLE). The safety and efficacy of the NES as a first-line tool for TLE remain unclear. The medical records of patients who underwent TLE via the femoral approach utilizing the NES from May 2014 to June 2019 in Peking University People's Hospital were retrospectively reviewed. Nine hundred and eighty-five leads were extracted in 492 patients (369 men; mean age 72.8 ± 29.0 years). The median (range) number of leads extracted per patient was 2 (1-6). The mean indwelling time of all extracted leads was 112.6 ± 52.0 months. The complete procedure success rate, clinical success rate, and failure rate were 94.1% (463/492), 97.8% (481/492), and 1.1% (11/492), respectively. Major complications including death occurred in nine patients (1.9%), of whom eight developed cardiac tamponade. Among these eight patients, emergency pericardiocentesis followed by rescue surgical repair if necessary was successful in 6 (75.0%) and failed in 2 (25.0%). No significant differences were found in the clinical success rate or major complications rate between patients with pacemakers and implantable cardioverter defibrillators, or between patients with infected and uninfected leads. A femoral approach with the NES is safe and effective for TLE of both pacing and defibrillator leads and could be considered a first-line approach. Cardiac tamponade was the most frequent cardiovascular complication. A strategy of emergency pericardiocentesis followed by a rescue surgical approach seems to be reasonable technique to treat a cardiac tamponade.

Background: There is a paucity of data regarding outcomes with transfemoral (TF) versus transapical (TA) access for transcatheter aortic valve replacement (TAVR) in patients with peripheral artery disease (PAD)., Methods: We queried the national inpatient sample database (NIS) (2012-2013) to identify patients with PAD who underwent TAVR. We conducted a propensity matching analysis using 25 clinical variables to compare TF-TAVR versus TA-TAVR. The main outcome was in-hospital mortality., Results: The analysis included 22,349 patients who underwent TAVR, among those 6692 (29.9%) had PAD. In the matched cohort, in-hospital mortality was similar between TF-TAVR and TA-TAVR groups (4.8% vs. 5.1%, OR 0.95; 95%CI 0.74-1.21). TF-TAVR was associated with lower rates of cardiogenic shock (OR 0.64; 95%CI 0.50-0.82), use of mechanical circulatory support (OR 0.56; 95%CI 0.42-0.75), acute kidney injury (OR 0.76; 95%CI 0.67-0.86), hemodialysis (OR 0.51; 95%CI 0.36-0.71), major bleeding (OR 0.72; 95%CI 0.64-0.80), blood transfusion (OR 0.65; 95%CI 0.58-0.73), discharge to a skilled nursing facility (OR 0.61; 95%CI 0.54-0.68) as well as shorter length of hospital stay (8.13 ± 6.76 vs. 10.11 ± 7.80 days) compared with TA-TAVR. However, TF-TAVR was associated with higher rate of vascular complications (11.7% vs. 3.7%, OR 3.40; 95%CI 2.63-4.38), complete heart block (OR 1.52; 95%CI 1.23-1.87), and pacemaker insertion (OR = 1.58; 95%CI: 1.28-1.94). There was no difference between both groups in the rate of cerebrovascular accidents (OR 1.26; 95%CI 0.93-1.72)., Conclusion: In this observational analysis from a large national database, there was no difference in in-hospital mortality between TF-TAVR and TA-TAVR among patients with PAD. Further studies are encouraged to identify the optimal access for TAVR in patients with PAD., Competing Interests: Declaration of competing interest None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background/purpose: General Anesthesia (GA) and conscious sedation (CS) are anesthetics for transfemoral transcatheter aortic valve replacement (TF-TAVR). We compared TF-TAVR outcomes using a novel anesthetic approach with fascia iliaca block (FIB) plus minimal CS (MCS) versus GA., Methods: This retrospective propensity-matched study included consecutive TF-TAVR patients from January 2013 to December 2017 and dichotomized into FIB-MCS vs. GA. Data were collected from electronic records, Society of Thoracic Surgery (STS) database, and the Transcatheter Valve Therapies (TVT) Registry. Primary endpoints were operating room (OR) time, intensive care unit (ICU) and hospital length of stay (LOS). Secondary endpoints were 30-day, 1-year mortality, quality of life, 30-day re-hospitalization rate, failure of FIB-MCS, and hospital safety outcomes., Results: A total of 304 TF-TAVR patients; FIB-MCS (n = 219) vs. GA (n = 85). Propensity matched 162 patients; FIB-MCS (n = 108) vs. GA (n = 54). FIB-MCS had shorter OR time (197.6 ± 56.3 vs. 248.2 ± 46.3 min, p < 0.001), ICU (67.8 ± 71.7 vs. 84.9 ± 72.1 h, p = 0.004) and hospital LOS (3.2 ± 3.7 vs. 5.9 ± 3.5 d, p < 0.001). FIB-MCS had lower rate of blood transfusion. FIB-MCA vs. GA 30-day and 1-year mortality were similar in the entire (2.3 vs. 2.4%, p = 1.0; and 8.2 vs. 5.9%, p = 0.49) and matched cohorts (0 vs. 3.7%, p = 0.11 and 7.4 vs. 5.6%, p = 0.75). FIB-MCS were less likely to be re-hospitalized [Odd Ratio: 0.32, CI:0.13-0.76] and 2% to 3% higher KCCQ-12 score., Conclusion: TF-TAVR using FIB-MCS is feasible and safe with shorter OR time, ICU and hospital LOS, lower risk of 30-day re-hospitalization, similar 30-day and 1-year mortality with better quality of life at 1-year follow-up., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The transradial approach is reportedly associated with reduced bleeding complications and mortality after percutaneous coronary intervention (PCI). It is unknown whether the clinical benefits of transradial vs. transfemoral PCI differ between high bleeding risk (HBR) and non-HBR patients., Methods and results: After excluding patients with acute myocardial infarction, dialysis, and a transbrachial approach from the 13,087 patients undergoing first PCI in the CREDO-Kyoto Registry Cohort-2, 6,828 patients were eligible for this study. Patients were divided into 2 groups according to bleeding risk based on Academic Research Consortium HBR criteria, and then divided into a further 2 groups according to access site, radial or femoral: HBR-radial, n=1,054 (38.3%); HBR-femoral, n=1,699 (61.7%); non-HBR-radial, n=1,682 (41.3%); and non-HBR-femoral, n=2,393 (58.7%). In the HBR group, the 30-day incidence and adjusted risk for major bleeding (1.9% vs. 4.7% [P<0.001]; adjusted hazard ratio [aHR] 0.44, 95% confidence interval [CI] 0.26-0.71 [P<0.001]) and all-cause death (0.3% vs. 0.9% [P=0.04]; aHR 0.30, 95% CI 0.07-0.93 [P=0.04]) were significantly lower in the radial than femoral group. There were no significant differences in the 30-day incidence and adjusted risk for major bleeding (0.5% vs. 1.0% [P=0.09]; aHR 0.68, 95% CI 0.30-1.45 [P=0.33]) or all-cause death (0.1% vs. 0.1% [P=0.96]; aHR 1.51, 95% CI 0.19-9.54 [P=0.67]) between the radial and femoral approaches in the non-HBR group., Conclusions: Compared with transfemoral PCI, transradial PCI was associated with lower risk for 30-day major bleeding and mortality in HBR but not non-HBR patients.

Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; P =0.023); life-threatening or major bleeding (22.1% versus 6%; P =0.004); and VC related to vascular access (12.6% versus 4.2%; P =0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk ( P =0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.

Background: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR., Methods: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3-7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients., Results: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P <0.001; major VC, 1.6% versus 0%, P <0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P <0.001; major VC, 1.8% versus 0%, P <0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P <0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P =0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P <0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P =0.047)., Conclusions: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

Objective: The study compared transradial access (TRA) and transfemoral access (TFA) for splenic angio-embolisation (SAE), with a focus on technical success, intra-operative adjuncts, and complications., Methods: This was a retrospective comparative study of all trauma patients undergoing SAE by TRA or TFA between February 2015 and February 2019 at a single institution. The medical records were queried for procedural and post-operative data, with comparisons made based on access site. Continuous variables were compared using a two tailed t test and categorical variables were compared using a chi square test., Results: Over a four year period, there were 47 cases of SAE via TRA and 127 via TFA. Technical success was 95.7% during TRA and 98.4% during TFA (p = .30). Technical failures were a result of failed splenic artery cannulation after successful radial or femoral access. Time to splenic cannulation was shorter in the TRA group (19 min vs. 30 min; p = .008). Two or fewer catheters were used during TRA, whereas more than two catheters were needed during TFA (p < .001). There were no statistically significant differences in procedure length, fluoroscopy time, radiation dose, or contrast volume between groups. Nine patients (5.2%) developed access related complications, all in the TFA group (p = .12). Mortality rate was 2.3% (n = 4), with no statistical significance between groups (p = .71)., Conclusion: While TFA is the conventional strategy for SAE, TRA is a safe and efficacious modality for SAE in trauma patients. Although larger studies are needed to establish the full efficacy of TRA for SAE at the multi-institutional level, this single centre study demonstrates the legitimacy of an alternative means for SAE in the trauma population., (Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: The purpose of this study was to assess the efficacy of echocardiography-guided ascending aortic central cannulation using the Seldinger technique during surgery for type A acute aortic dissection complicated by stroke due to cerebral malperfusion., Methods: Between April 2007 and December 2017, 208 patients with type A acute aortic dissection underwent echocardiography-guided ascending aortic central cannulation using the Seldinger technique. We analyzed 16 of these patients (7.7%; median age, 63 years; 8 men) with stroke due to cerebral malperfusion, including 10 in a comatose state (Glasgow Coma Scale ≤8) and 6 with hemiplegia (manual muscle test ≤1) on hospital arrival. The Modified Rankin Scale was used to evaluate activities of daily living., Results: The median time from onset of symptoms to establishment of cardiopulmonary bypass was 327 (176-561) minutes. The median time from the start of surgery to establishment of cardiopulmonary bypass was 34 (30-44) minutes. The mortality rate was 6.3% (1/16). In patients with preoperative coma, the Glasgow Coma Scale improved significantly after surgery from 4.5 to 15 at 30 days (P < .001). In patients with preoperative hemiplegia, 4 showed improved motor function on the manual muscle test score at 90 days. In all patients, Modified Rankin Scale scores improved significantly from 5.0 preoperatively to 1.0 after follow-up (P < .001)., Conclusions: Echocardiography-guided ascending aortic central cannulation using the Seldinger technique has potential as a rapid and reliable perfusion route during surgery for type A acute aortic dissection complicated by stroke due to cerebral malperfusion., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Transcarotid and trans-subclavian access routes are increasingly used as alternative approaches for transcatheter aortic valve implantation (TAVI) when transfemoral access is not suitable. However, concerns remain about the risk of periprocedural stroke and long-term outcomes following transcarotid/trans-subclavian TAVI., Aims: The present study sought to compare early and long-term outcomes of transcarotid/trans-subclavian TAVI versus transfemoral TAVI after propensity-score matching., Methods: The 260 patients who underwent TAVI through a transfemoral (n=220), transcarotid (n=32) or trans-subclavian (n=8) approach at our institution over a 4-year period were identified. A 1:1 matching based on propensity score was performed, and led to a study population of 80 patients (40 transfemoral and 40 transcarotid/trans-subclavian). Primary endpoints were early complications; secondary endpoints were long-term outcomes., Results: There were no differences in the baseline characteristics of the two groups. At 30 days after TAVI there were no significant differences between transfemoral and transcarotid/trans-subclavian TAVI in terms of death rates (5% vs 5%, respectively; P=1.00) and stroke rates (5% vs 2.5%, respectively; P=1.00). After a median follow-up of 21 months, the risk of death (P=0.95), stroke (P=0.82) and myocardial infarction (P=0.16) did not differ between the two groups., Conclusions: After propensity-score matching, no significant differences in early and long-term outcomes were observed between transfemoral and transcarotid/trans-subclavian TAVI. These findings should encourage heart teams to consider a transcarotid or trans-subclavian approach when transfemoral access is unavailable., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Objective: To evaluate the efficacy of axillary artery cannulation for early embolic stroke and operative mortality, we retrospectively compared the outcomes between patients with or without axillary artery cannulation during open aortic arch repair with circulatory arrest., Methods: Between January 2004 and December 2017, 468 patients underwent open aortic arch repair with circulatory arrest using antegrade cerebral perfusion and were divided into 2 groups according to the site of arterial cannulation: the axillary artery (axillary group, n = 352) or another site (nonaxillary group, n = 116) groups. Embolic stroke was defined as a physician-diagnosed new postoperative neurologic deficit lasting more than 72 hours, generally confirmed by computed tomography or magnetic resonance imaging., Results: After propensity score matching, the patients' characteristics were comparable between the groups (n = 116 in each). The incidences of acute type A dissection, aortic rupture, shock, or emergency operation were similar between groups. The incidence of early embolic stroke was significantly lower in axillary group (n = 3 [2.6%] vs n = 10 [8.6%]; P = .046). Also, 30-day mortality (n = 3 [2.6%] vs n = 10 [8.6%]; P = .046) and in-hospital mortality (n = 3 [2.6%] vs n = 11 [9.5%]; P = .027) occurred significantly lower in the axillary group., Conclusions: Axillary artery cannulation reduced the early embolic stroke and early mortality after open arch repair with circulatory arrest. Axillary artery cannulation as the arterial cannulation site during open arch repair with circulatory arrest may be helpful in preventing embolic stroke and reducing early mortality., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: This study was performed to summarize our experience in treating acute superior mesenteric artery embolism (SMAE) by percutaneous mechanical thrombectomy (PMT)., Methods: The clinical data of five patients with acute SMAE treated by PMT in our center from October 2015 to May 2018 were retrospectively analyzed. PMT was performed under local anesthesia. Access was established via the femoral artery or brachial artery. Thrombectomy was performed on the superior mesenteric artery using a 6F Rotarex catheter (Straub Medical, Wangs, Switzerland)., Results: Technical success of PMT was achieved in all five patients; emboli were completely removed in three patients and partially removed in two patients. No PMT-related complications were noted after surgery. Four patients were smoothly discharged from the hospital after their symptoms were relieved. One patient still had symptoms of intestinal ischemia after the operation, and massive small intestinal necrosis was found by exploratory laparotomy. Intestinal resection was performed, and the patient died 4 months later., Conclusions: PMT by the Rotarex system is a minimally invasive, safe, and effective technique in removing SMAE. Early application of PMT can avoid intestinal necrosis., (Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.)