Multi-center experience with intravascular lithotripsy for treatment of severe calcification during transcarotid artery revascularization for high-risk patients.

OBJECTIVE: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication in carotid artery stenting. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease. METHODS: All consecutive patients who underwent TCAR+IVL from 2018-2022 at nine institutions were identified. IVL was combined with pre-dilatation angioplasty to treat calcified vessels before stent deployment. The primary outcome was a new ipsilateral stroke within 30 days. Secondary outcomes included any new ipsilateral neurologic event (stroke/transient ischemic attack [TIA]) at 30 days, technical success, and <30% residual stenosis. RESULTS: Fifty-eight patients (62% male; mean age, 78 ± 6.6 years) underwent TCAR+IVL, with 22 (38%) for symptomatic disease. Fifty-seven patients (98%) met high-risk anatomical or physiologic criteria for CEA. Forty-seven patients had severely calcific lesions. Fourteen patients (30%) had isolated eccentric plaque, 20 patients (43%) had isolated circumferential plaque, and 13 (27%) had eccentric and circumferential calcification. Mean procedure and flow reversal times were 87 ± 27 minutes and 25 ± 14 minutes. The median number of lithotripsy pulses per case was 90 (range, 30-330), and mean contrast usage was 29 mL. No patients had electroencephalogram changes or new deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 98% having <30% residual stenosis on completion angiography. One patient had an in-hospital post-procedural stroke (1.72%). Four patients total had any new ipsilateral neurologic event (stroke/TIA) within 30 days for an overall rate of 6.8%. One TIA and one stroke occurred during the index hospitalization, and two TIAs occurred after discharge. Preoperative mean stenosis in patients with any postoperative neurologic event was 93% (vs 86% in non-stroke/TIA patients; P = .32), and chronic renal insufficiency was higher in patients who had a new neurologic event (75% vs 17%; P = .005). No differences were observed in calcium, procedural, or patient characteristics between the two groups. The mean follow-up was 132 days (range, 19-520 days). Three stents developed recurrent stenosis (5%) on follow-up duplex; the remainder were patent without issue. There were no reported interventions for recurrent stenosis during the study period. CONCLUSIONS: IVL sufficiently remodels calcified carotid arteries to facilitate TCAR effectively in patients with traditionally prohibitive calcific disease. One patient (1.7%) suffered a stroke within 30 days, although four patients (6.8%) sustained any new neurological event (stroke/TIA). These results raise concerns about the risks of TCAR+IVL and whether it is an appropriate strategy for patients who could potentially undergo CEA.

Vascular Surgeon Involvement in Pulmonary Embolism Response Teams: Barriers, Challenges, Concerns and the Imperative for Integration.

BACKGROUND: The effective management of pulmonary embolism (PE) necessitates coordinated care among physicians from diverse specialties within a time-sensitive framework. Pulmonary Embolism Response Teams (PERTs) have been developed as a strategic approach to optimize and expedite treatment by integrating and coordinating different specialties. The current survey audit aimed to understand the level of interest among vascular surgeons and the logistical considerations surrounding their participation within the PERT. METHODS: A deidentified Research Electronic Data Capture (REDCap) survey was disseminated to vascular surgeons, with collected data submitted to the Vascular Surgery Collaborative (VASC) database. RESULTS: A total of 139 vascular surgeons with an average of 10.6 years of practice experience responded to the VASC PERT audit. The majority (70.5%) practice in academic settings and only 24.5% currently perform PE interventions in their practice. While nearly half of respondents (52.5%) reported the existence of PERT in their institutions, only a fraction (23.3%) was actively involved in the PERT. Notably, a significant proportion in our cohort (38.1%) expressed dissatisfaction with the representation of vascular surgeons in multidisciplinary teams managing venous thromboembolism (VTE), including deep vein thrombosis (DVT) and PE. Vascular surgery (VS) representation in PERT was only 34.2%, with pulmonology (pulm) (60.3%), interventional radiology (IR) (57.5%), interventional cardiology (IC) (57.5%), and critical care (CC) (50.7%) being the most represented specialties. The primary barriers to VS participation in PERT were competing interests from other specialties and logistical scheduling challenges. CONCLUSIONS: The audit shows a global deficit in the integration of VS expertize within PERT frameworks. Primary barriers include exclusion due to competing interests from other specialties and challenges in the logistical coordination of PERT calls.

Complicated and Uncomplicated Isolated Abdominal Aortic Dissections Demonstrate Different Patient Characteristics and Outcomes.

BACKGROUND: Isolated abdominal aortic dissection (IAAD) is a rare entity with poorly defined risk factors and wide variation in management. We set forth to compare patient characteristics, management, and outcomes of uncomplicated isolated abdominal aortic dissection (uIAAD) versus high risk and complicated isolated abdominal aortic dissection (hrcIAAD) to investigate whether these categories can be utilized to guide IAAD management and provide risk stratification for intervention. METHODS: Retrospective chart review was performed to identify all patients with spontaneous IAAD at a tertiary health care system between 1996 and 2022. Demographics, comorbidities, factors relating to initial presentation including imaging findings, and dissection outcomes including long-term all-cause mortality and aortic-related mortality from time of dissection to final available record were abstracted. IAAD demonstrating rupture or malperfusion were designated as complicated, those with aortic diameter greater than 4 cm on presentation or refractory pain were designated as high risk, and the remainder was designated as uIAAD. All variables were compared between hrcIAAD and uIAAD using Fisher's exact test, unpaired t-test, and Mann-Whitney U-test as appropriate. RESULTS: Over the study period, 74 patients presented with spontaneous IAAD (mean age 60 ± 16 years, 61% male) with postdissection follow-up records to an average of 6.8 ± 5.8 years. Of these, 76% presented with uIAAD versus 24% with hrcIAAD. hrcIAAD was diagnosed at a significantly younger age on average than uIAAD (52 ± 14 vs. 62 ± 16 years, P = 0.02), was less likely to present with concomitant hyperlipidemia (0% vs. 41%, P < 0.01), coronary artery disease (6% vs. 47%, P < 0.01), and prior smoking history (39% vs. 72%). hrcIAAD was more likely to present in patients with a genetic aortopathy (27% vs. 7%, P = 0.03). Hypertension was not significantly different between groups. Patients with hrcIAAD were significantly more likely to present with extension into iliac arteries compared to uIAAD (61% vs. 18%, P < 0.01). A much higher proportion of hrcIAAD required hospitalization compared to uIAAD (83% vs. 30%, P < 0.01) and operative intervention (67% vs. 7%, P < 0.01). While there was no significant difference in all-cause mortality between groups, there was a significant difference between aortic-related mortality which only occurred in those with hrcIAAD (28% vs. 0%, P < 0.01). CONCLUSIONS: Comparison of long-term outcomes suggests that hrcIAAD is associated with increased hospitalization and need for operative intervention compared to uIAAD. Significant differences in atherosclerotic risk factors and proportions of connective tissue disease history between patients who present with hrcIAAD and uIAAD suggest that differences in underlying etiology are largely responsible for whether IAAD progresses towards rupture or has a more benign course and should be considered in risk stratification to guide more specific and targeted management of IAAD.

Impact of COVID-19 on patients undergoing scheduled procedures for chronic venous disease.

OBJECTIVE: The COVID-19 pandemic has drastically altered the medical landscape. Various strategies have been employed to preserve hospital beds, personal protective equipment, and other resources to accommodate the surges of COVID-19 positive patients, hospital overcapacities, and staffing shortages. This has had a dramatic effect on vascular surgical practice. The objective of this study is to analyze the impact of the COVID-19 pandemic on surgical delays and adverse outcomes for patients with chronic venous disease scheduled to undergo elective operations. METHODS: The Vascular Surgery COVID-19 Collaborative (VASCC) was founded in March 2020 to evaluate the outcomes of patients with vascular disease whose operations were delayed. Modules were developed by vascular surgeon working groups and tested before implementation. A data analysis of outcomes of patients with chronic venous disease whose surgeries were postponed during the COVID-19 pandemic from March 2020 through February 2021 was performed for this study. RESULTS: A total of 150 patients from 12 institutions in the United States were included in the study. Indications for venous intervention were: 85.3% varicose veins, 10.7% varicose veins with venous ulceration, and 4.0% lipodermatosclerosis. One hundred two surgeries had successfully been completed at the time of data entry. The average length of the delay was 91 days, with a median of 78 days. Delays for venous ulceration procedures ranged from 38 to 208 days. No patients required an emergent intervention due to their venous disease, and no patients experienced major adverse events following their delayed surgeries. CONCLUSIONS: Interventions may be safely delayed for patients with venous disease requiring elective surgical intervention during the COVID-19 pandemic. This finding supports the American College of Surgeons' recommendations for the management of elective vascular surgical procedures. Office-based labs may be safe locations for continued treatment when resources are limited. Although the interventions can be safely postponed, the negative impact on quality of life warrants further investigation.

Catheter Interventions for Pulmonary Embolism: Mechanical Thrombectomy Versus Thrombolytics.

Pulmonary embolism is a debilitating and potentially life-threatening disease characterized by high mortality and long-term adverse outcomes. Traditional treatment options are fraught with serious bleeding risks and incomplete thrombus removal, necessitating the development of innovative treatment strategies. While new interventional approaches offer promising potential for improved outcomes with fewer serious complications, their rapid development and need for more comparative clinical evidence makes it challenging for physicians to select the optimal treatment for each patient among the many options. This review summarizes the current published clinical data for both traditional treatments and more recent interventional approaches indicated for pulmonary embolism. While published studies thus far suggest that these newer interventional devices offer safe and effective options, more data is needed to understand their impact relative to the standard of care. The studies in progress that are anticipated to provide needed evidence are reviewed here since they will be critical for helping physicians make informed treatment choices and potentially driving necessary guideline changes.

A referral pathway for treating patients with severe venous disease using mechanical thrombectomy.

BACKGROUND: DVT is associated with clinically significant sequelae, and the most widely used therapies for severe venous disease are often ineffective. Mechanical thrombectomy (MT) offers a promising approach, but most patients with a history of DVT are not evaluated for such intervention. OBJECTIVE: To present overall outcomes and the outcome of a single case after use of an MT procedure to manage advanced deep venous disease. MATERIALS AND METHODS: This retrospective, single-center analysis included all patients with a CEAP score of C6 secondary to DVT who were referred from a wound clinic and underwent an MT-based procedure. RESULTS: Eleven patients with 14 affected limbs were referred for treatment from an associated care network and were treated with MT. As necessary, adjunctive venoplasty and stent placement were also used. The endovascular treatment was successful in removing fibrous obstructions from veins and supporting the improvement or resolution of C6 venous disease in all cases, including the 66-year-old male discussed in the current report. CONCLUSION: Collaboration between endovascular interventionists and local postacute wound care specialists to identify and refer patients with severe venous disease for advanced treatment may lead to improved outcomes.

Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.

Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry.

Background: We report in-hospital outcomes from the multicenter, prospective, single-arm ClotTriever Outcomes (CLOUT) registry, which enrolled up to 500 patients with proximal lower extremity deep vein thrombosis (DVT) treated with percutaneous mechanical thrombectomy using the ClotTriever System (Inari Medical). Methods: The CLOUT registry enrolled all-comer patients with DVT, irrespective of symptom duration, thrombus age, prior treatment of the current DVT, or bilateral thrombus. The primary effectiveness end point was defined as complete or near complete (≥75%) reduction in Marder score. Thrombus burden was assessed by an independent core laboratory. Mortality and serious adverse events, including device-relatedness, were adjudicated by an independent medical monitor. Here, safety and outcomes are evaluated through discharge. Results: The median age was 61.9 years (IQR, 48.0-70.8), 50.5% were women, 24.9% had a history of DVT, and 23.2% had previously failed treatment of the current DVT. Nearly all procedures (99.4%) were performed in a single session with negligible procedural blood loss (median 40.0 mL; IQR, 20.0-50.0), and most patients (97.8%) required no subsequent intensive care unit monitoring. The primary effectiveness end point was achieved in 91.2% of limbs. Through discharge, 1 device-related serious adverse event (0.2%) occurred. Health status, as assessed by self-reported pain and circumferential measurements of limb edema, were significantly improved at discharge. Conclusions: Thrombectomy with the ClotTriever System is a safe and effective treatment for proximal lower extremity DVT, while also avoiding the need of intensive care. Early patient improvements are demonstrated, and follow-up is ongoing to 2 years.