The Experts below are selected from a list of 7677 Experts worldwide ranked by ideXlab platform

Mahmoud B Malas - One of the best experts on this subject based on the ideXlab platform.

  • association of transCarotid Artery revascularization vs transfemoral Carotid Artery Stenting with stroke or death among patients with Carotid Artery stenosis
    JAMA, 2019
    Co-Authors: Marc L Schermerhorn, Patric Liang, Jens Eldrupjorgensen, Jack L Cronenwett, Brian W Nolan, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Mahmoud B Malas
    Abstract:

    Importance Several trials have observed higher rates of perioperative stroke following transfemoral Carotid Artery Stenting compared with Carotid endarterectomy. TransCarotid Artery revascularization with flow reversal was recently introduced for Carotid Stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral Carotid Artery Stenting, are not well characterized. Objective To compare outcomes associated with transCarotid Artery revascularization and transfemoral Carotid Artery Stenting. Design, Setting, and Participants Exploratory propensity score–matched analysis of prospectively collected data from the Vascular Quality Initiative TransCarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transCarotid Artery revascularization and transfemoral Carotid Artery Stenting for Carotid Artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures TransCarotid Artery revascularization vs transfemoral Carotid Artery Stenting. Main Outcomes and Measures Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results During the study period, 5251 patients underwent transCarotid Artery revascularization and 6640 patients underwent transfemoral Carotid Artery Stenting. After matching, 3286 pairs of patients who underwent transCarotid Artery revascularization or transfemoral Carotid Artery Stenting were identified (transCarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). TransCarotid Artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, −1.52% [95% CI, −2.29% to −0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72];P  Conclusions and Relevance Among patients undergoing treatment for Carotid stenosis, transCarotid Artery revascularization, compared with transfemoral Carotid Artery Stenting, was significantly associated with a lower risk of stroke or death.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P  Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P  = .04] and 3.8% vs 2.2% [ P  = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P  = .06]; TFCAS, 5.3% vs 2.7% [ P P  = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P  = .03), independent of symptom status. Coarsened exact matching showed similar results. Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • restenosis after Carotid Artery Stenting and endarterectomy a secondary analysis of crest a randomised controlled trial
    Lancet Neurology, 2012
    Co-Authors: Kirk W Beach, Helmi L Lutsep, Mahmoud B Malas, Gary S Roubin, Wesley S Moore, David Chiu, Nicole R Gonzales, Lee J Burke, Michael Rinaldi, James R Elmore
    Abstract:

    Summary Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between Carotid Artery Stenting and Carotid endarterectomy for symptomatic or asymptomatic Carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Methods Patients with stenosis of the Carotid Artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target Artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. Findings 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had Carotid Artery Stenting, 1105 who had Carotid endarterectomy). In 2 years, 58 patients who underwent Carotid Artery Stenting (Kaplan-Meier rate 6·0%) and 62 who had Carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63–1·29; p=0·58). Female sex (1·79, 1·25–2·56), diabetes (2·31, 1·61–3·31), and dyslipidaemia (2·07, 1·01–4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after Carotid endarterectomy (2·26, 1·34–3·77) but not after Carotid Artery Stenting (0·77, 0·41–1·42). Interpretation Restenosis and occlusion were infrequent and rates were similar up to 2 years after Carotid endarterectomy and Carotid Artery Stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. Funding National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.

  • restenosis after Carotid Artery Stenting and endarterectomy a secondary analysis of crest a randomised controlled trial
    Lancet Neurology, 2012
    Co-Authors: Brajesh K Lal, Helmi L Lutsep, Mahmoud B Malas, Kirk W Beach, Gary S Roubin, Wesley S Moore, David Chiu, Nicole R Gonzales, Lee J Burke, Michael Rinaldi
    Abstract:

    Summary Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between Carotid Artery Stenting and Carotid endarterectomy for symptomatic or asymptomatic Carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Methods Patients with stenosis of the Carotid Artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target Artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. Findings 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had Carotid Artery Stenting, 1105 who had Carotid endarterectomy). In 2 years, 58 patients who underwent Carotid Artery Stenting (Kaplan-Meier rate 6·0%) and 62 who had Carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63–1·29; p=0·58). Female sex (1·79, 1·25–2·56), diabetes (2·31, 1·61–3·31), and dyslipidaemia (2·07, 1·01–4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after Carotid endarterectomy (2·26, 1·34–3·77) but not after Carotid Artery Stenting (0·77, 0·41–1·42). Interpretation Restenosis and occlusion were infrequent and rates were similar up to 2 years after Carotid endarterectomy and Carotid Artery Stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. Funding National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.

Marc L Schermerhorn - One of the best experts on this subject based on the ideXlab platform.

  • association of transCarotid Artery revascularization vs transfemoral Carotid Artery Stenting with stroke or death among patients with Carotid Artery stenosis
    JAMA, 2019
    Co-Authors: Marc L Schermerhorn, Patric Liang, Jens Eldrupjorgensen, Jack L Cronenwett, Brian W Nolan, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Mahmoud B Malas
    Abstract:

    Importance Several trials have observed higher rates of perioperative stroke following transfemoral Carotid Artery Stenting compared with Carotid endarterectomy. TransCarotid Artery revascularization with flow reversal was recently introduced for Carotid Stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral Carotid Artery Stenting, are not well characterized. Objective To compare outcomes associated with transCarotid Artery revascularization and transfemoral Carotid Artery Stenting. Design, Setting, and Participants Exploratory propensity score–matched analysis of prospectively collected data from the Vascular Quality Initiative TransCarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transCarotid Artery revascularization and transfemoral Carotid Artery Stenting for Carotid Artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures TransCarotid Artery revascularization vs transfemoral Carotid Artery Stenting. Main Outcomes and Measures Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results During the study period, 5251 patients underwent transCarotid Artery revascularization and 6640 patients underwent transfemoral Carotid Artery Stenting. After matching, 3286 pairs of patients who underwent transCarotid Artery revascularization or transfemoral Carotid Artery Stenting were identified (transCarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). TransCarotid Artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, −1.52% [95% CI, −2.29% to −0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72];P  Conclusions and Relevance Among patients undergoing treatment for Carotid stenosis, transCarotid Artery revascularization, compared with transfemoral Carotid Artery Stenting, was significantly associated with a lower risk of stroke or death.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P  Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P  = .04] and 3.8% vs 2.2% [ P  = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P  = .06]; TFCAS, 5.3% vs 2.7% [ P P  = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P  = .03), independent of symptom status. Coarsened exact matching showed similar results. Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

Jack L Cronenwett - One of the best experts on this subject based on the ideXlab platform.

  • association of transCarotid Artery revascularization vs transfemoral Carotid Artery Stenting with stroke or death among patients with Carotid Artery stenosis
    JAMA, 2019
    Co-Authors: Marc L Schermerhorn, Patric Liang, Jens Eldrupjorgensen, Jack L Cronenwett, Brian W Nolan, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Mahmoud B Malas
    Abstract:

    Importance Several trials have observed higher rates of perioperative stroke following transfemoral Carotid Artery Stenting compared with Carotid endarterectomy. TransCarotid Artery revascularization with flow reversal was recently introduced for Carotid Stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral Carotid Artery Stenting, are not well characterized. Objective To compare outcomes associated with transCarotid Artery revascularization and transfemoral Carotid Artery Stenting. Design, Setting, and Participants Exploratory propensity score–matched analysis of prospectively collected data from the Vascular Quality Initiative TransCarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transCarotid Artery revascularization and transfemoral Carotid Artery Stenting for Carotid Artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures TransCarotid Artery revascularization vs transfemoral Carotid Artery Stenting. Main Outcomes and Measures Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results During the study period, 5251 patients underwent transCarotid Artery revascularization and 6640 patients underwent transfemoral Carotid Artery Stenting. After matching, 3286 pairs of patients who underwent transCarotid Artery revascularization or transfemoral Carotid Artery Stenting were identified (transCarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). TransCarotid Artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, −1.52% [95% CI, −2.29% to −0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72];P  Conclusions and Relevance Among patients undergoing treatment for Carotid stenosis, transCarotid Artery revascularization, compared with transfemoral Carotid Artery Stenting, was significantly associated with a lower risk of stroke or death.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P  Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P  = .04] and 3.8% vs 2.2% [ P  = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P  = .06]; TFCAS, 5.3% vs 2.7% [ P P  = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P  = .03), independent of symptom status. Coarsened exact matching showed similar results. Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • regional variation in Carotid Artery Stenting and endarterectomy in the medicare population
    Circulation-cardiovascular Quality and Outcomes, 2010
    Co-Authors: Philip P Goodney, Jack L Cronenwett, Lori L Travis, David J Malenka, Kristen K Bronner, Lee F Lucas, David Goodman, Elliott S Fisher
    Abstract:

    Background— To describe geographic variation in population-based rates of Carotid Artery Stenting (CAS) and Carotid endarterectomy (CEA) performed in Medicare beneficiaries. Methods and Results— Medicare claims and enrollment data were used to calculate age, sex, and race-adjusted rates of CAS and CEA for Medicare beneficiaries in each of 306 hospital referral regions between 1998 and 2007. Procedures were identified using a combination of Current Procedural Terminology codes as well as diagnostic and procedural ICD-9 codes. Overall, the rate of Carotid revascularization has fallen slightly over the last decade (3.8 procedures per 1000 in 1998, 3.1 procedures per 1000 in 2007; P 4-fold between 1998 and 2007, growing from 0.1 to 0.6 CAS procedures per 1000 beneficiaries (P<0.0001). Further, CAS rapidly disseminated across the country over the last decade. In 1998, ...

Vikram S Kashyap - One of the best experts on this subject based on the ideXlab platform.

  • association of transCarotid Artery revascularization vs transfemoral Carotid Artery Stenting with stroke or death among patients with Carotid Artery stenosis
    JAMA, 2019
    Co-Authors: Marc L Schermerhorn, Patric Liang, Jens Eldrupjorgensen, Jack L Cronenwett, Brian W Nolan, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Mahmoud B Malas
    Abstract:

    Importance Several trials have observed higher rates of perioperative stroke following transfemoral Carotid Artery Stenting compared with Carotid endarterectomy. TransCarotid Artery revascularization with flow reversal was recently introduced for Carotid Stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral Carotid Artery Stenting, are not well characterized. Objective To compare outcomes associated with transCarotid Artery revascularization and transfemoral Carotid Artery Stenting. Design, Setting, and Participants Exploratory propensity score–matched analysis of prospectively collected data from the Vascular Quality Initiative TransCarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transCarotid Artery revascularization and transfemoral Carotid Artery Stenting for Carotid Artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures TransCarotid Artery revascularization vs transfemoral Carotid Artery Stenting. Main Outcomes and Measures Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results During the study period, 5251 patients underwent transCarotid Artery revascularization and 6640 patients underwent transfemoral Carotid Artery Stenting. After matching, 3286 pairs of patients who underwent transCarotid Artery revascularization or transfemoral Carotid Artery Stenting were identified (transCarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). TransCarotid Artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, −1.52% [95% CI, −2.29% to −0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72];P  Conclusions and Relevance Among patients undergoing treatment for Carotid stenosis, transCarotid Artery revascularization, compared with transfemoral Carotid Artery Stenting, was significantly associated with a lower risk of stroke or death.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P  Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P  = .04] and 3.8% vs 2.2% [ P  = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P  = .06]; TFCAS, 5.3% vs 2.7% [ P P  = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P  = .03), independent of symptom status. Coarsened exact matching showed similar results. Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

Grace J Wang - One of the best experts on this subject based on the ideXlab platform.

  • association of transCarotid Artery revascularization vs transfemoral Carotid Artery Stenting with stroke or death among patients with Carotid Artery stenosis
    JAMA, 2019
    Co-Authors: Marc L Schermerhorn, Patric Liang, Jens Eldrupjorgensen, Jack L Cronenwett, Brian W Nolan, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Mahmoud B Malas
    Abstract:

    Importance Several trials have observed higher rates of perioperative stroke following transfemoral Carotid Artery Stenting compared with Carotid endarterectomy. TransCarotid Artery revascularization with flow reversal was recently introduced for Carotid Stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral Carotid Artery Stenting, are not well characterized. Objective To compare outcomes associated with transCarotid Artery revascularization and transfemoral Carotid Artery Stenting. Design, Setting, and Participants Exploratory propensity score–matched analysis of prospectively collected data from the Vascular Quality Initiative TransCarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transCarotid Artery revascularization and transfemoral Carotid Artery Stenting for Carotid Artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures TransCarotid Artery revascularization vs transfemoral Carotid Artery Stenting. Main Outcomes and Measures Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results During the study period, 5251 patients underwent transCarotid Artery revascularization and 6640 patients underwent transfemoral Carotid Artery Stenting. After matching, 3286 pairs of patients who underwent transCarotid Artery revascularization or transfemoral Carotid Artery Stenting were identified (transCarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). TransCarotid Artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, −1.52% [95% CI, −2.29% to −0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72];P  Conclusions and Relevance Among patients undergoing treatment for Carotid stenosis, transCarotid Artery revascularization, compared with transfemoral Carotid Artery Stenting, was significantly associated with a lower risk of stroke or death.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P  Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

  • transCarotid Artery revascularization versus transfemoral Carotid Artery Stenting in the society for vascular surgery vascular quality initiative
    Journal of Vascular Surgery, 2018
    Co-Authors: Mahmoud B Malas, Jens Eldrupjorgensen, Jack L Cronenwett, Vikram S Kashyap, Grace J Wang, Raghu L Motaganahalli, Hanaa Dakouraridi, Marc L Schermerhorn
    Abstract:

    Abstract Background Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transCarotid Artery Stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of Carotid Artery Stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transCarotid Artery revascularization (TCAR) and transfemoral Carotid Artery Stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). Methods The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary Artery disease, congestive heart failure, prior coronary Artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. Results Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [ P  = .04] and 3.8% vs 2.2% [ P  = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [ P  = .06]; TFCAS, 5.3% vs 2.7% [ P P  = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P  = .03), independent of symptom status. Coarsened exact matching showed similar results. Conclusions Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.