Propensity-score-matched analysis of dual antiplatelet treatment and alternative antiplatelet regimens after transcarotid revascularizations.

OBJECTIVE: Dual antiplatelet therapy (DAPT) continues to be the preferred medication regimen after the placement of a carotid stent using the transcarotid revascularization (TCAR) technique despite a dearth of quality data. Therefore, this investigation was performed to define the risks associated with antiplatelet choice. METHODS: We queried all patients who underwent TCAR captured by the Vascular Quality Initiative from September 2016 to June 2022, to determine the association between antiplatelet choice and outcomes. Patients maintained on DAPT were compared with those receiving alternative regimens consisting of single antiplatelet, anticoagulation, or a combination of the two. A 1:1 propensity-score match was performed with respect to baseline comorbidities, functional status, anatomic/physiologic risk, medications, and intraoperative characteristics. In-hospital and 1-year outcomes were compared between the groups. RESULTS: During the study period, 29,802 procedures were included in our study population, with 24,651 (82.7%) receiving DAPT and 5151 (17.3%) receiving an alternative antiplatelet regimen. A propensity-score match with respect to 29 variables generated 4876 unique pairs. Compared with patients on DAPT, in-hospital ipsilateral stroke was significantly higher in patients receiving alternative antiplatelet regimens (1.7% vs 1.1%, odds ratio [95% confidence interval]: 1.54 [1.10-2.16], P = .01), whereas no statistically significant difference was noted with respect to mortality (0.6% vs 0.5%, 1.35 [0.72-2.54], P = .35). A composite of stroke/death was also more likely in patients receiving an alternative regimen (2.4% vs 1.7%, 1.47 [1.12-1.93], P = .01). Immediate stent thrombosis (2.75 [1.16-6.51]) and a nonsignificant trend toward increased return to the operating room were more common in the alternative patients. Conversely, the incidence of perioperative myocardial infarction was lower in the alternative regimen group (0.4% vs 0.7%, 0.53 [0.31-0.90], P = .02). At 1 year after the procedure, we observed an increased risk of mortality (hazard ratio [95% confidence interval]: 1.34 [1.11-1.63], P < .01) but not stroke (0.52 [0.27-0.99], P = .06) in patients treated with an alternative medication regimen. CONCLUSIONS: This propensity-score-matched analysis demonstrates an increased risk of in-hospital stroke and 1-year mortality after TCAR in patients treated with an alternative medication regimen instead of DAPT. Further studies are needed to elucidate the drivers of DAPT failure in patients undergoing TCAR to improve outcomes for carotid stenting patients.

Results associated with the health system-wide adoption of transcarotid revascularization.

BACKGROUND: In the present report, we have detailed the results derived from the adoption of transcarotid artery revascularization (TCAR) at a large health system based in the United States. METHODS: A retrospective review was performed of a prospectively maintained database capturing all carotid stents deployed using the ENROUTE neuroprotection device (Silk Road Medical, Sunnyvale, CA) and cerebral flow reversal. The demographics, intraoperative findings, and postoperative results were tabulated and reported. RESULTS: From September 2017 to December 2021, 429 TCAR procedures were attempted within the Memorial Hermann Health System. Preoperatively, all the patients were either asymptomatic with >70% stenosis (66.9%) or symptomatic with >50% stenosis (33.1%). The degree of stenosis was determined using computed tomography angiography and/or duplex ultrasound. We achieved a technical success rate of 99.1%, with the failures attributed to an inability to cross the lesion, an inability to track the stent, visualization of a flow-limiting dissection, and stent maldeployment for one patient each. During the 30-day perioperative period, nine strokes (2.3%) had occurred, three of which had occurred after discharge from the index operation and before the end of the 30-day period. No patient had experienced myocardial infarction. Five patients had died in the perioperative period. Three of the deaths were related to stroke, and two were attributed to cardiopulmonary events secondary to aspiration and likely pulmonary embolus. The mean follow-up after TCAR was 14.5 ± 12.0 months. During the follow-up period, two patients had required reintervention for in-stent stenosis. Ipsilateral to the implanted carotid stent, the overall (including perioperative) stroke incidence was 2.5%. Contralateral to the stent, the stroke incidence was 0.8%. The myocardial infarction rate was 0.8% during follow-up. Mortality in our study population was 5.1% during the follow-up period. CONCLUSIONS: After adoption of TCAR across the Memorial Hermann Health System, we found this procedure to be safe and efficacious with minimal perioperative risks comparable to the historically reported results associated with alternative carotid interventions.

One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial.

PURPOSE: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. METHODS: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound-defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. RESULTS: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. CONCLUSION: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial.

PURPOSE: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). METHODS: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed. RESULTS: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001). CONCLUSION: The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries.

A Novel Anesthetic Technique for PEVAR.

BACKGROUND: Percutaneous endovascular aneurysm repair (PEVAR) continues to evolve. Device profiles continue to decline, further reducing the physiological insult of the procedure. Anesthesia, however, has not evolved with a large proportion of patients continuing to receive general anesthesia for their increasingly less invasive procedures. We report on a novel anesthetic technique providing outstanding anesthesia in patients undergoing PEVAR in an outpatient setting. The total anesthesia used was remarkably cost effective. METHODS: Six patients underwent PEVAR in an outpatient setting. The patients received moderate intravenous (IV) access sedation using versed and fentanyl in combination with bilateral ilioinguinal nerve blocks. Patients received 25 mL bilaterally of 0.5% bupivicaine with epinephrine. All patients were American Society of Anesthesiologists class III. None received central venous access, arterial, or urinary catheters. Standard noninvasive monitoring was used. A board-certified anesthesiologist was present at all times during the procedures. RESULTS: All patients underwent successful repair. Average cost per case for anesthetic supplies averaged around $7.00. The fentanyl dose ranged from 100 to 200 µg with an average dose of 130 µg. Versed dose ranged from 2 to 3 mg with an average dose of 2.4 mg. No patient required conversion to general anesthesia. Postoperative pain relief was excellent. Two patients required pain medication before discharge. Two patients required oral narcotic analgesic the night of discharge. No patients required narcotics after that time. CONCLUSIONS: Bilateral ilioinguinal nerve block, when combined with moderate IV sedation allows outstanding anesthesia for patients undergoing PEVAR. This novel combination has not been reported previously. The technique provides safe, effective, care for of a subset of patients not requiring general anesthesia. It offers a greatly reduced cost when compared with general anesthesia. Additional benefits include prolonged pain relief perioperatively as well as potentially decreasing the physiologic and cognitive effects seen with general anesthesia.

Transcarotid stenting of extracranial carotid artery aneurysm with covered stents and flow reversal.

Introduction: An extracranial carotid artery aneurysm (ECAA) is a rare pathology comprising <1% of all arterial aneurysms. The etiology includes trauma, previous surgery, radiation, and infection. Treatment of ECAAs has evolved from open repair to endovascular repair with stenting. Reports of endovascular repair describe the transfemoral approach; however, little more than case reports are available describing the transcarotid approach for ECAAs. In this study, we describe a cohort of patients who safely underwent transcarotid repair of ECAAs. Methods: We performed a retrospective medical record review of all cases of transcarotid stenting using covered stents for a carotid aneurysm within 11 different hospitals within the Memorial Hermann Health System from December 2019 through December 2022. Technical success is defined as coverage of the aneurysm with no endoleak. We report the patient demographics, clinical presentation, intraoperative metrics, and outcomes. Results: Seven patients underwent transcarotid covered stent placement using flow reversal for neurologic protection. Their average age was 65 years, and four of the seven patients were men. Three patients presented with pain, two with transient ischemic attack, one with stroke, and one with a pulsatile mass. Technical success was 100%. All the patients were treated with transcarotid stenting, and the average aneurysm size was 13 mm. The average operative time was 69 minutes, and the flow reversal time was 9 minutes. No postoperative stroke, myocardial infarction, or death occurred. The average length of hospital stay was 2.7 days. Conclusions: A transcarotid approach for endovascular treatment of ECAAs was safe for this cohort of patients, with no postoperative death, stroke, or myocardial infarction. Also, the technical success was 100%.

VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers.

OBJECTIVE: Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates. METHODS: The VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months. RESULTS: We enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points. CONCLUSIONS: Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.

Association between cardiac conditions with venous leg ulcers in patients with chronic venous insufficiency.

INTRODUCTION: Venous leg ulcers (VLUs) are the final stage of chronic venous insufficiency. This study aims to characterize the association between cardiovascular diseases and VLU. METHODS: A multicentric case-control study analyzed 17,788 patients between 2015 and 2020. Cases were matched (1:2) by age and sex, and odds ratios (OR) were analyzed with conditional logistic regressions adjusted by risk factors. RESULTS: The prevalence of VLU was 15.2%. 2390 cases were analyzed. Diseases found to be associated with VLU were atrial fibrillation (OR, 1.21; 95% CI: 1.03-1.42), pulmonary hypertension (OR, 1.45; 95% CI: 1.06-2.00), right heart failure (OR, 1.27; 95% CI: 1.13-1.43), peripheral artery disease (OR, 2.21; 95% CI: 1.90-2.56), and history of pulmonary embolism (OR, 1.45; 95% CI: 1.06-2.00). CONCLUSIONS: Certain cardiovascular conditions showed an association with VLU. Further studies are warranted to evaluate the effect that treating concomitant cardiovascular diseases might exert on the natural history of venous leg ulcers.

Initial experience and early outcomes of the management of acute pulmonary embolism using the FlowTriever mechanical thrombectomy device.

BACKGROUND: Submassive and massive pulmonary embolism is associated with a high risk of complications. We aimed to evaluate our initial experience with a mechanical thrombectomy device in the management of these patients. METHODS: A single-center, retrospective study was performed in patients with acute submassive and massive pulmonary embolism treated with the FlowTriever device (Inari Medical, Irvine, CA, USA) between June 2019 and November 2020. Clinical and technical parameters were analyzed during the hospitalization and at 30- and 180-days after the procedure. RESULTS: Fourteen patients were evaluated with a median (IQR) age of 60 (50-69) years and 64% were male. All had right heart strain as the main indication for thrombectomy. The procedure duration and fluoroscopic time was 52 (37-89) and 13 (9-24) minutes, respectively. There was 100% technical success, and the pulmonary arterial pressure went from 60 (48-65) mmHg to 40 (34-47) mmHg. Thrombolysis was used in two patients and nine patients required intensive care. 100% experienced improvement in symptoms at the time of discharge. There were no device-related complications, major bleeding events, myocardial infarctions, or deaths. Preprocedural hemoglobin was 13 (12-15) g/dL, and predischarge was 12 (10-13) g/dL. Overall postprocedural length of stay was three (2-6) days. All the patients were discharged with oral anticoagulation. There were no device-related complications or recurrence of embolism at 30 and 180 days. CONCLUSIONS: The mechanical thrombectomy device for submassive and massive pulmonary embolism is promising and appears a safe and effective procedure with 100% technical success, no complications, short intensive care requirement/stay, and good early clinical outcomes.

Degradation of lymphatic anatomy and function in early venous insufficiency.

OBJECTIVE: We used near-infrared fluorescence lymphatic imaging in a pilot study to assess the lymphatics in preulcerative (C2-C4) venous insufficiency and determine whether involvement and/or degradation of lymphatic anatomy or function could play a role in the progression of chronic venous insufficiency. We also explored the role of lymphatics in early peripheral arterial disease. METHODS: After informed consent and intradermal injections of indocyanine green for rapid lymphatic uptake, near-infrared fluorescence lymphatic imaging was used to assess the lymphatic anatomic structure and quantify the lymphatic propulsion rates in subjects with early venous insufficiency. The anatomic observations included interstitial backflow, characterized by the abnormal spreading of indocyanine green from the injection site primarily into the surrounding interstitial tissues; dermal backflow, characterized by the retrograde movement of dye-laden lymph from collecting lymphatics into the lymphatic capillaries; and lymphatic vessel segmentation and dilation. RESULTS: Ten subjects with venous insufficiency were enrolled, resulting in two legs with C2 disease, nine legs with C3 disease, eight legs with C4 disease, and one leg with C5 disease. Interstitial and/or dermal backflow were observed in 25%, 33%, and 41% of the injection sites in each limb with C2, C3, and C4 disease, respectively. Distinct vessel segmentation and dilation were observed in limbs with a C3 and higher classification, and dermal backflow proximal to the injection sites was observed in two legs with C4 disease and in the inguinal region of the C5 study subject. The overall average lymph propulsion rates were 1.3 ± 0.4, 1.2 ± 0.7, and 0.8 ± 0.5 contractile events/min for limbs with C2, C3, and C4 disease, respectively. One subject with peripheral arterial disease, who had previously undergone bypass surgery, presented with extensive dermal backflow and lymphatic reflux. CONCLUSIONS: Near-infrared fluorescence lymphatic imaging demonstrated that, compared with normal health subjects, the lymphatic anatomy and contractile function generally degrade with the severity of venous insufficiency. Lymphatic abnormalities mimic those in early cancer-acquired lymphedema subjects, as previously observed by us and others. Additional studies are needed to decipher the relationship, including any causality, between lymphatic dysfunction and peripheral vascular disease and venous insufficiency.

Contemporary results of endovascular repair of abdominal aortic aneurysms: effect of anatomical fixation on outcomes.

PURPOSE: To report the contemporary controlled trial experience with the fully supported unibody Powerlink stent-graft for endovascular treatment of abdominal aortic aneurysm (AAA). METHODS: Between 2000 and 2008, 3 prospective multicenter trials of the Powerlink system evaluated 157 AAA patients (141 men; mean age 72.0+/-9.1 years) with mean AAA sac diameter of 5.6+/-0.9 cm who received a bifurcated stent-graft featuring anatomical fixation at the aortoiliac bifurcation and proximal sealing with extension stent-grafts as needed. Challenging infrarenal aortic neck anatomy was present in 83% of patients. Postoperative follow-up occurred at defined intervals to 5 years. RESULTS: Technical success was achieved in 99% of patients. Aneurysm exclusion was achieved in all patients over a mean procedure time of 132+/-58 minutes. No aneurysm-related deaths, ruptures, conversions, or migrations have been observed to current follow-up as these aneurysms have continued to remodel, with > or =92% of patients free from sac growth. CONCLUSION: The implant technique of placing a fully-supported unibody stent-graft at the aortoiliac bifurcation with proximal sealing appears to safely and effectively reline the aorta and exclude aneurysms. Results from controlled clinical trial experience suggest this algorithm can provide stable, secure fixation for patients with challenging infrarenal aortic neck anatomy.

Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial.

BACKGROUND: Endovascular repair of abdominal aortic aneurysms with the Endologix Powerlink System has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. We report the mid-term outcomes of an endovascular repair approach wherein the infrarenal bifurcated stent graft was placed at the aortoiliac bifurcation, with concomitant placement of a proximal extension having suprarenal orientation for proximal sealing. METHODS: Between 2006 and 2008, eight US sites enrolled 44 consecutive eligible patients presenting with abdominal aortic aneurysm in a prospective, single arm pivotal trial approved by the Food and Drug Administration. Each patient received a Powerlink infrarenal bifurcated stent graft through anatomical fixation at the aortoiliac bifurcation and a suprarenal extension to achieve proximal sealing. Analysis of the primary endpoint (proximal type I endoleak) was evaluated using contrast-enhanced computed tomography scans at 30 days, with on-going long-term follow-up for safety and treatment effectiveness. RESULTS: Patients (89% male) presented at a mean age of 70 ± 10 years with mean maximal aneurysm sac diameter of 5.5 cm. Challenging infrarenal aortic neck anatomy was present in 93% of patients. Technical success was 100% over a mean procedure time of 129 minutes. No aneurysm-related deaths, conversions, ruptures, migrations, or type III or IV endoleaks have been observed. The majority of endoleaks (80%) observed to date are type II. Currently, the primary clinical success rate is 93%. Two endovascular secondary procedures have been performed for resolution of type IA or type IB endoleak, and one surgical intervention was performed for resolution of limb occlusion. Significant reduction in sac diameter is observed to up to 2 years. CONCLUSIONS: The combination of an anatomically-fixed Powerlink infrarenal bifurcated stent graft and a suprarenal proximal extension safely and effectively excludes aneurysms in eligible patients. Longer term follow-up will determine the durability of these findings.

The effects of intraoperative fenoldopam on renal blood flow and tubular function following suprarenal aortic cross-clamping.

This study evaluated the effect of fenoldopam, a selective dopamine (DA1) agonist, on renal blood flow and renal tubular function following renal ischemia induced by suprarenal aortic cross-clamping. Twenty anesthetized research pigs received either fenoldopam (10 micro g/kg/min; n = 10) or saline ( n = 10) beginning 20 min before suprarenal aortic cross-clamping and continuing for 20 min after clamp release, for a total infusion time of 160 min (120-min cross-clamp). Recordings of renal blood flow, mean arterial pressure, and heart rate were taken at baseline, during cross-clamping, and immediately postclamp. Ischemic renal injury was evaluated by serum creatinine and by histologic grading of acute tubular necrosis. Treatment with fenoldopam increased renal blood flow in comparison to that in the control group ( p = 0.03). The mean creatinine increase from baseline at 6 hr and 18 hr after cross-clamp removal for the fenoldopam-treated group was significantly less than that in the control group ( p < 0.001). On histologic evaluation, the mean score for the degree of tubular necrosis was significantly higher in the control group ( p = 0.02), indicating less derangement of tubular morphology in the fenoldopam group. This study demonstrated that the intraoperative use of a continuous infusion of fenoldopam during suprarenal aortic cross-clamping results in increased renal blood flow, less postoperative rise in creatinine, and better preservation of tubular histology in the pig model.