Dataset Information

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

ABSTRACT:

Background

Physician-modified endografts and custom-manufactured devices use branched and fenestrated techniques (F/BEVAR) to repair complex aneurysms. Traditionally, many of these are deployed through a combination of upper and lower extremity access. However, with newer steerable sheaths, you can now simulate upper extremity (UEM) access from a transfemoral approach. Single-institution studies have demonstrated increased risks of access site complications and stroke when UEM access is used. This study compares outcomes after F/BEVAR in a national database between total transfemoral (TTF) access and mixed UEM access.

Methods

This study is an analysis of the Vascular Quality Initiative for all patients who underwent F/BEVAR from 2014 to 2021. Patients were stratified based on a TTF delivery of all devices versus any UEM access for deployment of target vessel stents. Primary outcomes included stroke, myocardial infarction (MI), and perioperative death. Secondary outcomes included access site hematoma, occlusion or embolization, operative time, fluoroscopy time, and technical success. Multivariable linear and logistic regression analyses were performed.

Results

Three thousand one hundred forty six patients underwent an F/BEVAR: 2,309 (73.4%) TTF and 837 (26.6%) UEM. Logistic regression analysis indicated a two-fold increased risk of death and MI and a three-fold increased risk of stroke in the UEM group. Furthermore, there is decreased operative time (221 vs. 297 min, P < 0.001) and fluoroscopy time (62 vs. 80 min, P < 0.001) in the TTF group and no difference in technical success between groups (96% vs. 97%, P = 0.159). Finally, there was a decrease in access site hematoma 2.54% vs. 4.31% (P = 0.013), access site occlusion 0.61% vs. 1.91% (P = 0.001), and extremity embolization 2.17% vs. 3.58% (P = 0.026) in the TTF versus UEM group.

Conclusions

This study using Vascular Quality Initiative data demonstrates that patients who undergo an F/BEVAR using UEM access have an increased risk of perioperative MI, death, and stroke compared to TTF access.

SUBMITTER: Patel RJ

PROVIDER: S-EPMC10841218 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

Patel Rohini J RJ Sibona Agustin A Malas Mahmoud B MB Lane John S JS Al-Nouri Omar O Barleben Andrew R AR

Annals of vascular surgery 20230811

<h4>Background</h4>Physician-modified endografts and custom-manufactured devices use branched and fenestrated techniques (F/BEVAR) to repair complex aneurysms. Traditionally, many of these are deployed through a combination of upper and lower extremity access. However, with newer steerable sheaths, you can now simulate upper extremity (UEM) access from a transfemoral approach. Single-institution studies have demonstrated increased risks of access site complications and stroke when UEM access is ...[more]

PMID: 37574045

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Project description:ObjectiveCarotid artery stenting (CAS) is frequently used for patients at high risk for carotid endarterectomy. However, there are limited data comparing transradial or transbrachial (tr/tbCAS) access with more established CAS approaches. Therefore, we examined the effect of a tr/tbCAS approach versus a transfemoral (tfCAS) or transcarotid (TCAR) approach on outcomes after CAS.MethodsWe identified all patients undergoing CAS in the Vascular Quality Initiative registry from January 2016 to December 2021. We compared outcomes across 1:3 propensity score-matched cohorts of patients who underwent tr/tbCAS versus tfCAS or tr/tbCAS versus TCAR. As a secondary analysis, we assessed outcomes stratified by carotid symptom status. Our primary outcome was a composite end point of in-hospital stroke/death.ResultsAmong 40,835 CAS patients, 962 (2.4%) underwent tr/tbCAS, 18,840 (46%) underwent tfCAS, and 21,033 (52%) underwent TCAR. Among matched patients who underwent tr/tbCAS versus tfCAS, there was no significant difference in the risk of stroke/death (4.1% vs 2.9%; relative risk [RR] 1.4; 95% confidence interval [CI], 0.95-2.1), but tr/tbCAS was associated with a higher risk of death (2.4% vs 1.3%; RR, 1.8; 95% CI, 1.1-3.1). In the symptomatic subgroup, tr/tbCAS was associated with a higher risk of stroke/death (6.1% vs 3.9%; RR, 1.6; 95% CI, 1.0-2.4) and death (3.6% vs 1.7%; RR, 2.1; 95% CI, 1.2-3.7), but there were no differences in asymptomatic patients. After adjustment for mRS in patients with preoperative stroke, there were no significant differences in stroke/death (RR, 1.1; 95% CI, 0.66-1.9) or death (RR, 1.6; 95% CI, 0.81-3.3) between groups. In matched patients who underwent tr/tbCAS versus TCAR, tr/tbCAS was associated with a higher risk of stroke/death (4.2% vs 2.3%; RR, 1.8; 95% CI, 1.2-2.7) and death (2.4% vs 0.5%; RR, 4.8; 95% CI, 2.4-9.5). In the symptomatic subgroup, tr/tbCAS remained associated with a higher risk of stroke/death (6.2% vs 2.4%; RR, 2.6; 95% CI, 1.6-4.2) and death (3.7% vs 0.7%; RR, 5.6; 95% CI, 2.6-12), but there were no differences in asymptomatic patients. After adjustment for Modified Rankin Scale in patients with preoperative stroke, there were no significant differences in stroke/death (RR, 1.4; 95% CI, 0.79-2.6) or death (RR, 2.3; 95% CI, 0.95-5.7) between groups.ConclusionsCompared with tfCAS or TCAR, tr/tbCAS was associated with a higher risk of in-hospital stroke/death in symptomatic patients, which was driven primarily by a higher risk of death. These inferior outcomes were partly attributable to more severe preoperative neurologic disability in tr/tbCAS patients. In contrast, there were no differences in outcomes in asymptomatic patients. Overall, our findings highlight the importance of guideline-directed patient selection in tr/tbCAS.

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Project description:ImportanceAn upper-extremity approach for secondary access during transfemoral transcatheter aortic valve implantation (TAVI) may reduce clinically relevant secondary access site-related bleeding.ObjectiveTo investigate the safety and efficacy of an upper-extremity approach compared with a lower-extremity approach in patients undergoing TAVI.Design, setting, and participantsThe TAVI XS trial was a randomized clinical trial performed between November 28, 2022, and November 15, 2023, with a 30-day follow-up, in 4 TAVI centers in the Netherlands. Eligibility was determined first, and only those patients with severe aortic stenosis and no contraindication for upper- or lower-extremity secondary access were informed about the study and asked to participate.InterventionParticipants were randomized 1:1 between the upper-extremity approach (radial artery diagnostic access and upper-arm vein for temporary pacing lead placement) and lower-extremity approach (femoral artery diagnostic access and femoral vein for temporary pacing lead placement) for secondary access during TAVI.Main outcomes and measuresPrimary end point was clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) of the randomized secondary access. Secondary end points included any clinically relevant bleeding, time to mobilization, duration of hospitalization, secondary access failure, and procedural time.ResultsOf a total of 324 eligible patients, 238 patients undergoing transfemoral TAVI (mean [SD] age, 79.4 [6.5] years; 150 male [63.0%]; median European System for Cardiac Operative Risk Evaluation II score, 2.2% [IQR, 1.5%-3.5%]) were included. The primary end point occurred in 5 of 119 patients (4.2%) in the upper-extremity group and 16 of 119 (13.4%) in the lower-extremity group (odds ratio [OR], 0.28 [95% CI, 0.10-0.80]; P = .01). Incidence of any clinically relevant bleeding was decreased in the upper-extremity group (25 of 119 [21.0%] vs 41 of 119 [34.5%] patients; OR, 0.51 [95% CI, 0.28-0.91]; P = .02). There was no difference in time to mobilization or duration of hospitalization. Secondary access failure (14 of 119 [11.8%] vs 1 of 119 [0.8%] patients; OR, 15.73 [95% CI, 2.03-121.69]; P = .001) and procedural time (60.0 [IQR, 39.0-88.0; 95% CI, 53.0-70.0] vs 48.0 [IQR, 34.0-64.0; 95% CI, 40.0-55.0] minutes; P = .002) were higher in the upper-extremity cohort.Conclusion and relevanceIn this randomized clinical trial of patients undergoing transfemoral TAVI, the upper-extremity approach for secondary access was associated with less clinically relevant access site-related bleeding compared with the conventional lower-extremity approach and should be considered to reduce periprocedural bleeding complications.Trial registrationClinicalTrials.gov Identifier: NCT05672823.

Dataset Information

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

Background

Methods

Results

Conclusions

Publications

Upper Extremity Access Has Worse Outcomes in F/BEVAR Using the VQI Dataset.

Similar Datasets

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