Safety and efficacy of the CELT ACD femoral arteriotomy closure device in the office-based laboratory.

Objective: Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bedrest and 20 to 30 minutes or more of compression for hemostasis. Current arterial closure devices have emerged in recent years, but patients still require prolonged bedrest and time to ambulation and discharge, and these devices are associated with significant access device complications, including hematoma, retroperitoneal bleeding, transfusion requirement, pseudoaneurysm, arteriovenous fistula, and arterial thrombosis. A novel femoral access closure device, the CELT ACD (Vasorum Ltd, Dublin, Ireland), has been previously shown to reduce these complication rates and allow rapid hemostasis, require little or no bedrest, and shortened time to ambulation and discharge. This is especially advantageous in the outpatient setting. We report our initial experience with this device. Methods: A prospective single-center single-arm study was performed in an office-based laboratory setting to assess the safety and efficacy of the CELT ACD closure device. Patients underwent diagnostic and therapeutic peripheral arterial procedures from retrograde or antegrade common femoral artery access. Primary endpoints include device deployment success, time to hemostasis, and major or minor complications. Secondary endpoints include time to ambulation and time to discharge. Major complications were defined as bleeding requiring hospitalization or blood transfusion, device embolization, pseudoaneurysm formation, and limb ischemia. Minor complications were defined as bleeding not requiring hospitalization/blood transfusion, device malfunction, and access site infection. Results: A total of 442 patients were enrolled with common femoral access only. Median age was 78 years (range, 48-91 years), and 64% were male. Heparin was given in all cases, with median heparin dose of 6000 units (range, 3000-10,000 units). Protamine reversal was used in 10 cases due to minor soft tissue bleeding. Average time to hemostasis was 12.1 seconds (±13.2 seconds), time to ambulation was 17.1 minutes (±5.2 minutes), and time to discharge was 31.7 minutes (±8.9 minutes). All devices (100%) were deployed successfully. No major complications occurred (0%). Ten minor complications (2.3%) occurred; all were minor soft tissue bleeding from the access site that resolved with protamine reversal of heparin and manual compression. Conclusions: The CELT ACD closure device is safe and easily deployed with a very low complication rate, and significantly reduces time to hemostasis, ambulation, and discharge in patients undergoing peripheral arterial intervention from a common femoral artery approach in the office-based laboratory setting. This is a promising device that deserves further evaluation.

Clopidogrel versus ticagrelor for antiplatelet therapy in transcarotid artery revascularization in the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Transcarotid artery revascularization (TCAR) with dynamic flow reversal is a hybrid technique for operative management of carotid artery stenosis. Dual antiplatelet therapy is recommended for patients undergoing TCAR; however, nonresponders to these medications may be predisposed to perioperative thromboembolic complications. Prevalent in up to 44% to 66% of patients taking clopidogrel, high on-treatment platelet reactivity may thus be responsible for a portion of adverse cerebrovascular events in TCAR. A previous single-institution study has demonstrated the use of ticagrelor as a viable alternative to clopidogrel for antiplatelet therapy in patients undergoing TCAR; however, large-scale comparisons between clopidogrel and ticagrelor are needed to confirm the safety of ticagrelor outside of highly selected patients and providers. METHODS: Data from patients enrolled in the Society for Vascular Surgery Vascular Quality Initiative undergoing TCAR with a perioperative antiplatelet therapy regimen including either clopidogrel or ticagrelor from January 2015 to March 2021 were analyzed and compared. Multivariable logistic regression and propensity score matching were used to evaluate the primary 30-day outcomes of stroke, major bleeding event, and combined stroke/myocardial infarction (MI)/death rate while adjusting for baseline characteristics of the patients. RESULTS: A total of 11,973 patients underwent TCAR with a dual antiplatelet therapy regimen that included clopidogrel vs 426 patients with ticagrelor. Compared with patients on clopidogrel, patients on ticagrelor were significantly more likely to have coronary artery disease (51% vs 66%; P < .001), particularly unstable angina or MI within 6 months (3% vs 9%; P < .001), and more likely to have insulin-dependent diabetes mellitus (14% vs 19%; P < .001). The unadjusted 30-day rates of stroke, major bleeding, and combined stroke/MI/death were not statistically significant among both groups (1.3% vs 0.5%; P = .14, 2.4% vs 1.4%; P = .18, and 1.9% vs 1.6%; P = .71], respectively). After multivariable adjustment and propensity matching, these remained statistically insignificant. CONCLUSIONS: Despite a substantially higher medical risk in patients undergoing TCAR with ticagrelor, 30-day rates of stroke, major bleeding events, and combined stroke/MI/death were similar between patients on ticagrelor and clopidogrel as part of adjunctive antiplatelet therapy. Randomized prospective trials, and studies with larger sample sizes and longer follow-up will be needed to better examine the outcome differences in TCAR between these two medications.

Outcomes and strategy of tailored antiplatelet therapy with ticagrelor in patients undergoing transcarotid artery revascularization.

OBJECTIVE: Antiplatelet drug resistance is associated with periprocedural ischemic complications in patients undergoing intravascular stent implantation. Nonresponders are subject to increased risk of stent thrombosis and in-stent stenosis, and high on-treatment platelet reactivity (HTPR) is present in up to 44% of patients taking clopidogrel, a widely used component of dual antiplatelet therapy (DAPT). Evidence points to ticagrelor as a viable alternative to overcome HTPR on clopidogrel. Studies have shown fewer thromboembolic events with ticagrelor therapy; however, results on bleeding risk are mixed, and its safety and efficacy in hybrid operative techniques have yet to be established. Transcarotid artery revascularization (TCAR) is a hybrid procedure to treat severe carotid stenosis. The objective of this study was to establish the safety and efficacy of ticagrelor as part of DAPT in patients undergoing TCAR and to develop a protocol to ensure adequate antithrombotic protection throughout the operative course. METHODS: Data were collected retrospectively for patients undergoing TCAR on DAPT of aspirin and ticagrelor for symptomatic (≥50%) or asymptomatic (≥80%) carotid stenosis. Preoperative platelet reactivity was determined using Thromboelastography with Platelet Mapping (Haemonetics Corporation, Braintree, Mass), with adequate platelet reactivity defined as maximal amplitude produced by adenosine diphosphate <50 mm. The primary safety end point was 30-day major bleeding event rate. Primary efficacy end points were 30-day incidence of ipsilateral cerebrovascular ischemic event (stroke or transient ischemic attack), myocardial infarction, and death. Secondary end points were postoperative length of hospital stay, procedure time, and clamp/flow reversal time. RESULTS: Sixty-seven TCAR procedures with patients receiving periprocedural DAPT of ticagrelor and aspirin were performed during the study period. Patients had an average age of 79 years, and 28 (42%) were symptomatic. The mean procedure time was 45.8 ± 9.2 minutes, with a mean clamp/flow reversal time of 4.8 ± 1.5 minutes, and mean postoperative length of hospital stay of 3.1 ± 2.2 days for inpatients and 1.3 ± 0.8 days for outpatients. Technical success was achieved in all cases, with no 30-day major bleeding events and no occurrence of ipsilateral cerebrovascular ischemic event, myocardial infarction, or death. CONCLUSIONS: Initial experience with ticagrelor as part of DAPT in patients undergoing TCAR demonstrated its safety and efficacy in both symptomatic and asymptomatic disease. No bleeding events or thromboembolic complications occurred. Furthermore, a protocol to administer ticagrelor to assay for HTPR on ticagrelor and consequent medication and patient management is proposed. Ticagrelor may represent a safe and effective alternative to overcome clopidogrel nonresponsiveness in DAPT regimens for TCAR.

Outcomes of Transcarotid Artery Revascularization (TCAR) in Octogenarians and Older.

BACKGROUND: Carotid revascularization, both endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS), are associated with an increased risk of adverse outcomes in patients aged ≥80 years. Transcarotid artery revascularization (TCAR) is a technique that combines surgical principles of neuroprotection with less invasive endovascular techniques to treat severe carotid stenosis. Data from a recent registry study comparing TCAR with that of CEA and TFCAS demonstrated no significant difference in outcomes between TCAR and CEA in patients aged ≥80 years, and a significant reduction in stroke and composite outcomes between TCAR and TFCAS in patients aged ≥80 years. To add to these studies, a more in-depth analysis of demographic, procedural, and outcome factors is warranted for elderly patients aged ≥80 years undergoing TCAR. At our center, with a large volume of elderly patients based on local demographics, we expect there will be no significant effect of age on outcome measures between patients aged <80 years and those aged ≥80 years. METHODS: Data were collected retrospectively for patients undergoing TCAR for symptomatic (≥50%) or asymptomatic (≥80%) extracranial carotid artery stenosis. Primary endpoints were the incidence of ipsilateral cerebrovascular ischemic event (stroke or transient ischemic attack), myocardial infarction (MI), cranial nerve injury, and death through 30 days after the procedure. Secondary endpoints were postoperative length of hospital stay (LOS), procedure time, carotid artery clamp/flow reversal time, and fluoroscopy time. Subgroup analyses were performed to examine the effect of inpatient/outpatient status, carotid symptomatology, and type of anesthesia on secondary outcomes. RESULTS: Ninety-seven TCAR procedures were performed at our institution during the study period, of which 43 (44%) were on patients aged ≥80 years. Technical success was achieved in all cases, with no incidence of cerebrovascular ischemic event, MI, cranial nerve injury, or mortality through 30 days after procedure. In patients aged ≥80 years, the mean procedure time was 47 ± 12 min, clamp/flow reversal time was 4.7 ± 1.1 min, fluoroscopy time was 4.1 ± 1.6 min, and median LOS was 2.0 ± 1.0 days. Procedure time, clamp/flow reversal time, and fluoroscopy time were not significantly different between the age groups. However, there was a significant difference in the LOS, with patients aged <80 years demonstrating a median LOS of 1.0 ± 0.0 days (P = <0.001). CONCLUSIONS: Our experience with TCAR confirms that it can be performed successfully in both symptomatic and asymptomatic high-risk elderly patients, with our series finding no incidence of perioperative cerebral ischemic event, MI, or death.