Learning curve of transfemoral carotid artery stenting in the Vascular Quality Initiative registry.

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.

Aortic versus axillary artery cannulation for hemiarch replacement: single-centre real-world experience.

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.

Complications and Technical Success on Upper Limb Vascular Access for Endovascular Repair of Complex Abdominal and Thoraco-abdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis.

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.

Perioperative neurologic outcomes of right versus left upper extremity access for fenestrated-branched endovascular aortic aneurysm repair.

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.

Perioperative outcomes of carotid endarterectomy and transfemoral and transcervical carotid artery stenting in radiation-induced carotid lesions.

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.

Venoarterial Extracorporeal Membrane Oxygenation for Postcardiotomy Shock-Analysis of the Extracorporeal Life Support Organization Registry.

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.

Safety of vascular interventions performed in an office-based laboratory in patients with low/moderate procedural risk.

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.

The long-term implications of access complications during endovascular aneurysm repair.

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.

Outcomes after transfemoral carotid artery stenting stratified by preprocedural symptom status.

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.

Dose approach matter? A meta-analysis of outcomes following transfemoral versus transapical transcatheter aortic valve replacement.

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 I2 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 I2 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.

Right-sided Upper Extremity Access for Patients Undergoing Parallel Graft Placement during Endovascular Aortic Repair is Not Associated with Increased Neurologic Events When Compared with Left Upper Extremity Access.

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.

Alternative Access Transcatheter Aortic Valve Replacement in Nonagenarians versus Younger Patients.

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.

Incidence, predictors, impact, and treatment of vascular complications after transcatheter aortic valve implantation in a modern prospective cohort under real conditions.

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.

The impact of age on in-hospital outcomes after transcarotid artery revascularization, transfemoral carotid artery stenting, and carotid endarterectomy.

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.

Efficacy of intra-arterial catheter-directed thrombolysis for popliteal and infrapopliteal acute limb ischemia.

OBJECTIVE: The purpose of this study was to examine the efficacy and safety of catheter-directed thrombolysis (CDT) for first-line treatment of popliteal and infrapopliteal acute limb ischemia. METHODS: A total of 28 consecutive patients (30 limbs) who underwent CDT for treatment of popliteal and infrapopliteal acute limb ischemia of thromboembolic origin between March 2012 and December 2017 were enrolled in this study. Per the Society for Vascular Surgery, limbs were classified into three runoff score groups: <5, good; 5 to 10, compromised; and >10, poor. The primary end points were primary patency and limb salvage assessed by Kaplan-Meier survival analysis. Secondary end points were technical success and clinical success. The Society for Vascular Surgery-recommended scale for gauging changes in clinical status was used to assess clinical success. Safety of the procedure was evaluated on the basis of periprocedural complications according to the Society of Interventional Radiology classification system. RESULTS: Technical success was achieved in 25 (83.33%) treated limbs. Improved clinical status (grade +3/+2) was achieved in 93.33% of limbs. Primary patency and limb salvage for the entire cohort were 76.67% and 90% at 6 months and 60.0% and 76.67% at 12 months, respectively. The patency rate at 6 months and 12 months was 91.67% and 83.33% for the good runoff group, 80% and 60% for the compromised runoff group, and 50% and 25% for the poor runoff group, respectively. The patency rate of the good runoff group was significantly higher compared with that of the poor runoff group (P = .004). Major amputation rate and mortality rate were 16.67% and 7.14%, respectively, at 12 months. The reintervention rate was 3.57% at 6 months and 21.42% at 12 months. CONCLUSIONS: CDT is safe and effective for revascularization of smaller vessel acute arterial thromboembolism as a primary therapy. However, more studies with a larger sample are warranted.

Left main percutaneous coronary intervention-Radial versus femoral access: A systematic analysis.

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; I2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I2 = 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: I2 = 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.

Intrathoracic complications associated with trans-femoral transcatheter aortic valve replacement: Implications for emergency surgical preparedness.

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.

Outcomes and safety of concurrent coronary and peripheral catheterization (REVascularization in concomitant PERIpheral artery disease and coronary artery disease REV-PERICAD Study).

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.

Aortic valve replacement in patients with preexisting liver disease: Transfemoral approach with favorable survival.

INTRODUCTION: The treatment of aortic stenosis has been revolutionized by transcatheter aortic valve replacement (TAVR), but the experience in patients with liver disease is limited. To address this open question, we report the outcome of patients with liver disease undergoing surgical aortic valve replacement (SAVR), transapical (TA), and transfemoral (TF) TAVR. METHODS AND RESULTS: Between January 2004 and August 2016, 4,394 patients received aortic valve replacement at our institution. We identified 85 patients (mean follow-up 504 ± 733 days, age 73.4 ± 9.2 years, 44.7% female) with preexisting liver disease (median model of end-stage liver disease score 11, MELD-Na), who underwent TF-TAVR (n = 30), TA-TAVR (n = 13), or SAVR (n = 42). Baseline Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) and of Mortality and Morbidity (STS-PROMM) were the lowest in SAVR patients (related to TF- and TA-TAVR, both p < 0.01). Operative mortality (18.8%) was high, but no procedure showed superior short-term outcome. Need for renal replacement therapy (31.5% vs. 10.3%, p = 0.046) and reoperation occurred more frequently after SAVR than after TF-TAVR (26.6% vs. 6.7%, p = 0.021). Moreover, TF-TAVR patients had superior long-term survival compared to SAVR (log-rank test p = 0.048 and Cox regression adjusted for MELD and STS-PROM, p = 0.01, HR 0.25, CI95 0.09-0.71). Baseline MELD-Na (p = 0.013) and STS PROMM (p = 0.01) were predictors for operative mortality (ROC-analysis). CONCLUSIONS: Our results indicate increased perioperative risks for patients with liver disease undergoing AVR, but favorable long-term survival after TF-TAVR compared to SAVR. For baseline risk, stratification in patients with liver disease undergoing AVR, MELD-Na and STS-PROMM are valuable predictors.

Clinical outcomes after TAVR with heparin or bivalirudin as periprocedural anticoagulation in patients with and without peripheral arterial disease: Results from the BRAVO-3 randomized trial.

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.