Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

BACKGROUND: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. METHODS: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. RESULTS: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. CONCLUSION: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. CLINICAL IMPACT: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease.

OBJECTIVE: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. METHODS: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. RESULTS: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. CONCLUSIONS: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Treatment Variability Among Patients Hospitalized for Chronic Limb-Threatening Ischemia: An Analysis of the 2016 to 2018 US National Inpatient Sample.

BACKGROUND: Little is known about treatment variability across US hospitals for patients with chronic limb-threatening ischemia (CLTI). METHODS AND RESULTS: Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient- and hospital-related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19-1.38), 1.86 (1.77-1.95), 1.65 (1.55-1.74), 1.37 (1.28-1.45), and 1.42 (1.27-1.55), respectively. CONCLUSIONS: Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study.

OBJECTIVE: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up.

BACKGROUND: Intravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. METHODS: In a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. RESULTS: Among 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). CONCLUSION: IVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.

One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease.

BACKGROUND: Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients' preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking. METHODS: In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status. RESULTS: In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P<0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively (P<0.001). CONCLUSIONS: Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01419080.

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

BACKGROUND: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. METHODS: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. RESULTS: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. CONCLUSIONS: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Intravascular Lithotripsy in Calcified Subclavian and Innominate Peripheral Artery Disease: A Single-Centre Experience.

BACKGROUND: Intravascular lithotripsy (IVL) is a novel tool for the treatment of calcified vascular stenosis. Recently, IVL has been successfully used for modification of calcified plaque in coronary and lower extremity peripheral arteries with promising results. However, experience in subclavian and innominate peripheral arterial disease is limited. This study aims to report our initial experience of IVL use in calcified subclavian and innominate vasculature. METHODS: This was a retrospective review of all the cases of IVL performed in subclavian and innominate arteries at the Miriam Hospital, Providence, between January 2019 and May 2020. Data on the baseline and procedural characteristics were collected. The primary endpoint was procedural success defined as residual stenosis of <20% after stenting. Other endpoints of interest were; 1) procedural complications, including dissections, perforations, abrupt closure, slow or no-reflow, thrombosis, and distal embolization; 2) in-hospital major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, or stroke/transient ischemic attack. RESULTS: A total of 7 patients with 13 lesions undergoing IVL were included. Of these, 5 (71%) were women, the mean age was 74.6 ± 12.9, and the mean BMI was 25.1 ± 6.7. IVL was successfully delivered to all the target lesions with a mean 252.9 ± 54.4 pulses delivered per patient. Procedural success was achieved in 100% of the treated lesions. No procedure-related complications or in-hospital MACE occurred in any of the patients. CONCLUSIONS: In this single-center retrospective analysis, IVL facilitated acute procedural success without any procedural complications in severely calcified stenoses of the subclavian and innominate vasculature. Larger studies with an active comparator and longer follow-up are needed to establish the relative efficacy and safety of IVL use in this vascular bed.

Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study.

PURPOSE: To evaluate the safety and effectiveness of the Shockwave S4 intravascular lithotripsy (IVL) catheter in an "all-comers" cohort of patients with calcified infrapopliteal lesions. MATERIALS AND METHODS: The Disrupt PAD III Observational Study (NCT02923193) is a prospective, nonrandomized, multicenter single-arm study designed to assess the "real-world" acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified, stenotic peripheral arteries. Patients were eligible for enrollment if they had claudication or critical limb ischemia (CLI) and at least moderate calcification as assessed by angiography. This subanalysis includes consecutive patients enrolled with angiographic core lab-assessed treatment of infrapopliteal arteries using the Shockwave S4 IVL catheter. RESULTS: From July 2018 to August 2020, 101 patients with 114 calcified infrapopliteal arteries treated with the S4 IVL catheter were enrolled at 15 sites in 3 countries. CLI was present in 69.3% of patients. The anterior tibial and tiboperoneal trunk were the most commonly treated vessels with an overall mean reference vessel diameter (RVD) of 3.1±0.8 mm, minimum lumen diameter (MLD) of 0.5±0.6 mm, and a corresponding diameter stenosis of 83.4%±15.8% by core lab assessment. Mean lesion length was 64.7±54.7 mm with moderate to severe calcification in 69.3% of lesions by the Peripheral Academic Research Consortium (PARC) criteria. Adjunctive calcium-modifying technology, defined as scoring or cutting balloon and/or atherectomy, was used in 22.7% of procedures. The average acute gain at the end of the procedure was 2.0±0.7 mm with a residual stenosis <50% achieved in 99.0% of lesions and a mean residual stenosis of 23.3±12.5%. There were no flow-limiting dissection, embolization, slow flow/no-reflow, or abrupt closure events at the end of the procedure. CONCLUSION: This subanalysis of the PAD III Observational Study represents the largest report to-date of IVL treatment of heavily calcified below-the-knee (BTK) lesions in a "real-world" patient cohort. The use of S4 IVL demonstrated consistent acute safety and effectiveness outcomes consistent with prior IVL peripheral studies. These consistent outcomes were achieved with the initial use of the S4 IVL catheter for treatment of complex BTK lesions.

Acoustic Shock Waves to Modify Calcific Plaques - Intravascular Lithotripsy in the Peripheral Circulation.

Intravascular lithotripsy (IVL) is a new technique for treatment of severely calcified lesions that uses acoustic shockwaves in a balloon-based system to induce fracture in calcific plaque, facilitating luminal gain and vessel expansion. In this review, we provide a concise summary of the available data and clinical experience of IVL in various peripheral vascular beds, including facilitating vascular access for large-bore devices. We discuss the physics and mode of action of IVL in modifying calcified plaques, include several illustrative examples of utility of IVL in peripheral interventions, and discuss the future directions for adoption of the technique in peripheral interventions.

Considerations for Potential Global Expansion of Serum Institute of India.

In a time of global vaccine shortages, especially for COVID-19 products, Serum Institute of India (SII) is straining to meet demand for vaccines in India. While this organization is not known worldwide, they entered into a recent alliance with AstraZeneca, who is partnered with Oxford University for COVID-19 vaccine, to manufacture their supply of vaccines for distribution in India. Several other such partnerships are also underway. And, SII is considering plans to become a much larger player, not only in India, but globally. This commentary is focused on if, when, where, why, and how global expansion could proceed. Our work was carried out as a class project to identify options and strategies appropriate for expansion and has been expanded subsequently as events continued to develop.

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic's impact on vascular procedural volumes and outcomes has not been fully characterized. METHODS: Volume and outcome data before (1/2019 - 2/2020), during (3/2020 - 4/2020), and following (5/2020 - 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative (VQI). Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. RESULTS: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. CONCLUSION: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.

Intravascular Lithotripsy for Treatment of Calcified Lesions During Carotid Artery Stenting.

PURPOSE: To report the use of intravascular lithotripsy (IVL) in the treatment of calcified carotid artery lesions. MATERIALS AND METHODS: The records of 21 high-surgical-risk patients (mean age 75.1±8.1 years; 17 men) who were treated at 8 centers for carotid artery stenosis ≥70% were retrospectively reviewed. Twelve patients had a history of cerebrovascular disease. All patients had heavily calcified carotid artery lesions: 19 de novo and 2 in-stent restenoses (ISR). The mean baseline stenosis was 82.3%±9.7%. IVL was utilized at the discretion of the operator, followed by balloon angioplasty. Embolic protection devices were used in all cases. RESULTS: In 19 patients, IVL was followed by stent implantation; the 2 ISR lesions were dilated only. The mean IVL balloon diameter was 4.64±1.13 mm, and the mean number of IVL pulses applied was 67.2±61.4 (range 10-180). All procedures were technically successful (<30% residual stenosis). No patients developed symptomatic bradycardia or hypotension due to IVL, and there were no adverse events associated with IVL delivery. All patients were discharged on dual antiplatelet therapy. Seventeen days after the procedure, 1 patient experienced an ischemic stroke that was deemed due to aortic arch manipulation during transfemoral access. Carotid duplex ultrasound examination identified significant restenosis (>70%) in 1 asymptomatic patient at 12 months after the index procedure. No patients required reintervention during a median follow-up of 6 months (range 1-12). CONCLUSION: This preliminary experience demonstrates that IVL can be a safe and effective approach for the management of severely calcified carotid lesions. Further research is warranted to determine the longer-term safety and efficacy of IVL for dilation of calcified carotid artery lesions as an adjunct to carotid artery stenting.

Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial.

OBJECTIVES: To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires. BACKGROUND: CTO crossing remains a challenge during peripheral artery interventions. METHODS: In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%. RESULTS: A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%. CONCLUSIONS: Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.

Predictors of Treatment Response Following Ultrasound-Facilitated Catheter-Directed Thrombolysis for Submassive and Massive Pulmonary Embolism: A SEATTLE II Substudy.

BACKGROUND: Little is known about which factors predict improvement in clinical and imaging parameters among patients undergoing catheter-directed thrombolysis for submassive or massive pulmonary embolism. The identification of such predictors may allow for more appropriate patient selection for ultrasound-facilitated catheter-directed thrombolysis. METHODS: We conducted a retrospective cohort analysis of patients from the SEATTLE II trial (Prospective, Single-Arm, Multi-Center Trial of EkoSonic Endovascular System and Activase for Treatment of Acute Pulmonary Embolism) to identify clinical characteristics that independently predict pulmonary artery pressures, right ventricular-to-left ventricular (RV/LV) diameter ratio, and modified Miller angiographic index following ultrasound-assisted catheter-directed thrombolysis. Eligible patients had submassive or massive pulmonary embolism and an RV/LV diameter ratio ≥0.9 on chest computed tomography. Multivariable linear regression was used to identify independent clinical predictors of each outcome. RESULTS: One hundred fifty patients with massive (n=31) or submassive (n=119) pulmonary embolism were enrolled. Mean (±SD) baseline and postprocedure RV/LV diameter ratio, pulmonary artery systolic pressure, and modified Miller Score were 1.59 (±0.39) and 1.14 (±0.2), 51.45 (±16.0), and 37.47 (±11.9), and 23.0 (±5.7) and 15.7 (±5.9), respectively. The multivariable model adjusted R2 for absolute change in RV/LV ratio, pulmonary artery systolic pressure, modified Miller Score was 0.71, 0.57, and 0.43, respectively. After adjusting for age, gender, and baseline RV/LV ratio, pulmonary artery systolic pressure, and modified Miller Score, patients with higher body mass index, renal or hepatic dysfunction, active smoking, or a higher baseline heart rate showed less improvement. CONCLUSIONS: Patients with more life-threatening pulmonary embolism may derive the greatest benefit from ultrasound-assisted, catheter-directed thrombolysis.

Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study.

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study (ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.

Thirty-Day Readmissions After Carotid Artery Stenting Versus Endarterectomy: Analysis of the 2013-2014 Nationwide Readmissions Database.

BACKGROUND: Contemporary, nationally representative 30-day readmissions data after carotid artery stenting (CAS) and carotid endarterectomy (CEA) are lacking. METHODS: Patients undergoing CAS or CEA were identified from the 2013 to 2014 Nationwide Readmissions Databases. Propensity matching was used to balance baseline clinical characteristics. Thirty-day nonelective readmission rates, length of stay, and causes of readmission were compared. RESULTS: Overall, 85 337 (national estimate of 194 332) patients were identified before propensity score matching, 11 490 (13.4%) of whom underwent CAS and 73 847 (86.6%) of whom underwent CEA. Crude 30-day readmission rates were higher for patients treated with CAS than CEA (8.3% versus 6.8%; P<0.001), but these differences were negated in the propensity-matched cohort (n=22 214; 8.4% versus 7.9%, P=0.20), and readmission length of stay was longer for CEA than CAS (2 versus 1 day, respectively; P=0.002). The most common reasons for readmission were neurological and cardiac events; readmission reasons varied by revascularization modality. Readmission due to a stroke or transient ischemic attack was more common among patients treated with CAS than CEA (1.2% versus 0.9%; P=0.042), while readmission for procedural or medical complications occurred more often following CEA than CAS (1.1% versus 0.5%; P<0.001); readmission rates for cardiac causes were similar between groups. CONCLUSIONS: Less than 8% of patients are readmitted within 30 days of a carotid revascularization procedure. After adjusting for baseline differences, readmission rates are similar for CAS and CEA although readmission length of stay is longer after the latter. Readmission for neurological causes was more common following CAS while readmission for procedural or medical complications occurred more often following CEA. Higher annual institutional CEA volumes were associated with lower risk for 30-day readmission; in contrast, institutional CAS volumes were not related to readmission risk. These data provide important insights into the short-term, outcomes of patients following carotid artery revascularization.

Intravascular Lithotripsy for Treatment of Calcified, Stenotic Iliac Arteries: A Cohort Analysis From the Disrupt PAD III Study.

PURPOSE: The presence of calcification in the iliac arteries is associated with decreased procedural success and increased complication risk during endovascular intervention. The objective of this study was to evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) during endovascular treatment of iliac arterial peripheral artery disease (PAD). METHODS: The Disrupt PAD III Observational Study is a prospective, non-randomized, multi-center single-arm study to assess the 'real-world' safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified lesions in the peripheral arteries, with a goal of treating 1500 patients. This is an analysis of consecutive patients enrolled for treatment of an iliac artery, a specified sub-group, with at least moderate calcification and a minimum length of 20 mm. RESULTS: Between December 2017 and July 2019, 118 patients with a total of 200 lesions were enrolled across 20 sites. 101 patients were treated primarily for claudication or critical limb ischemia, while 17 patients were treated to optimize the iliac vasculature for large-bore access. All 118 patients had successful IVL catheter delivery. The average reference vessel diameter was 7.3 mm ± 1.9 mm, with an average diameter stenosis of 83.1% ± 13.4% and an average lesion length of 58.3 mm ± 57.6 mm. Severe calcification was present in 82.0% of overall cases. Stent placement was performed in 72.9% of the overall cases. As expected, the access group received less adjunctive therapies including stents (41.2%, p < 0.001). Angiographic complications were minimal with no flow-limiting dissections and a final mean residual stenosis of 12.0% ± 12.1% with no differences between the groups. CONCLUSIONS: Acute results with IVL in calcified iliac lesions suggest that it is a safe and effective option for calcified, stenotic iliac disease. IVL can be used successfully both for treatment of PAD symptoms and to optimize access for large-bore procedures.

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

BACKGROUND: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking. METHODS: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs. RESULTS: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; P=0.002), myocardial infarction (1.9% versus 2.7%; P=0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; P<0.001), acute kidney injury (10.5% versus 11.9%; P=0.043), fasciotomy (1.9% versus 8.9%; P<0.001), major bleeding (16.7% versus 21.0%; P<0.001), and transfusion (10.3% versus 18.5%; P<0.001), but higher vascular complications (1.4% versus 0.7%; P=0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; P=0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization. CONCLUSIONS: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.