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.

Transcarotid versus transthoracic transcatheter aortic valve replacement: A systematic review and meta-analysis.

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' I2. 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.

Aortic versus axillary cannulation in acute type A aortic dissection repair: A meta-analysis.

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.

Association Between Aortic Wall Thrombus and Thromboembolic Events After Transfemoral Transcatheter Aortic Valve Replacement.

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.