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.

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.

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.

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.

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.

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.

Intravascular Lithotripsy for Treatment of Severely Calcified Mesenteric Stenosis.

Intravascular lithotripsy (IVL) is an emerging approach for modification of calcified atherosclerotic plaque. We report 2 cases of IVL used for calcific mesenteric stenosis, one in de novo superior mesenteric artery stenosis and another in celiac artery in-stent restenosis. In both cases, IVL was used successfully, reducing stenosis without any complications. (Level of Difficulty: Intermediate.).

Sham-Controlled Randomized Trials of Catheter-Based Renal Denervation in Patients With Hypertension.

BACKGROUND: There are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension. OBJECTIVES: The purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials. METHODS: Databases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis. RESULTS: The analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD -3.65 mm Hg, 95% CI: -5.33 to -1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD -4.07 mm Hg, 95% CI: -6.46 to -1.68; p < 0.001), office systolic BP (WMD -5.53 mm Hg, 95% CI: -8.18 to -2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD -1.71 mm Hg, 95% CI: -3.06 to -0.35; p = 0.01), daytime ambulatory diastolic BP (WMD -1.57 mm Hg, 95% CI: -2.73 to -0.42; p = 0.008), and office diastolic BP (WMD -3.37 mm Hg, 95% CI: -4.86 to -1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13). CONCLUSIONS: RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.

Thirty-day readmission after endovascular or surgical revascularization for chronic mesenteric ischemia: Insights from the Nationwide Readmissions Database.

There are limited contemporary data on readmission after revascularization for chronic mesenteric ischemia (CMI). This study aimed to determine the rates, reasons, predictors, and costs of 30-day readmission after endovascular or surgical revascularization for CMI. Patients with CMI discharged after endovascular or surgical revascularization during 2013 to 2014 were identified from the Nationwide Readmissions Database. The rates, reasons, length of stay, and costs of 30-day all-cause, non-elective, readmission were determined using weighted national estimates. Independent predictors of 30-day readmission were determined using hierarchical logistic regression. Among 4671 patients with CMI who underwent mesenteric revascularization, 19.5% were readmitted within 30 days after discharge at a median time of 10 days. More than 25% of readmissions were for cardiovascular or cerebrovascular conditions, most of which were for peripheral or visceral atherosclerosis and congestive heart failure. Independent predictors of 30-day readmission included non-elective index admission, chronic kidney disease (CKD), and discharge to home healthcare or to a skilled nursing facility. Revascularization modality did not independently predict readmission. In a nationwide, retrospective analysis of patients with CMI undergoing revascularization, approximately one in five were readmitted within 30 days. Predictors were largely non-modifiable and included non-elective index admission, CKD, and discharge disposition.

Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease.

BACKGROUND: Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success. OBJECTIVE: To evaluate the additive efficacy of drug coated balloon in treating CFA disease. METHODS: Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound. RESULTS: Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. CONCLUSION: Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment.

Use of a novel embolic filter in carotid artery stenting: 30-Day results from the EMBOLDEN Clinical Study.

OBJECTIVES: The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA). BACKGROUND: General considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GORE® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction. METHODS: Patients at high risk for CEA (N = 250) were treated with CAS using the GEF study device paired with an FDA-approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre-determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab. RESULTS: The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30-day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre-defined performance goal (P < 0.001). The 30-day rate for death and major stroke was 1.2% and for death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among non-octogenarians. CONCLUSION: In patients at high risk for CEA undergoing CAS, the GEF not only showed high rates of successful deployment but also met the primary endpoint of low death, stroke, and MI rates, thus demonstrating safety and effectiveness.

Endovascular Versus Surgical Revascularization for Chronic Mesenteric Ischemia: Insights From the National Inpatient Sample Database.

OBJECTIVES: This study sought to compare in-hospital major adverse cardiac and cerebrovascular events (MACCE) following endovascular therapy with open surgery for chronic mesenteric ischemia (CMI). BACKGROUND: There are limited contemporary data on in-hospital cardiovascular outcomes among patients with CMI undergoing revascularization via endovascular therapy versus open surgery in the United States. METHODS: Patients with CMI undergoing endovascular or surgical (mesenteric bypass or endarterectomy) revascularization between 2007 and 2014 were identified from the National Inpatient Sample. Weighted national estimates were obtained. Primary and secondary endpoints were MACCE (death, myocardial infarction, stroke, cardiac post-operative complications) and composite in-hospital complications (MACCE + post-operative peripheral vascular complications, gastrointestinal hemorrhage, major bleeding, and bowel resection), respectively. Propensity score matching was used to obtain a balanced cohort of 880 unweighted patients in each group. RESULTS: Of 4,150 patients with CMI, 3,206 (77.2%) underwent endovascular therapy and 944 (22.8%) underwent surgery (weighted national estimates of 15,850 and 4,687, respectively). In the propensity-matched cohort, MACCE and composite in-hospital complications occurred significantly less often after endovascular therapy than surgery (8.6% vs. 15.9%; p < 0.001; and 15.3% vs. 20.3%; p < 0.006). Endovascular therapy was also associated with lower median hospital costs ($20,807.00 [interquartile range: $13,640.20 to $32.754.50] vs. $31,137.00 [interquartile range: $21,680.40 to $52,152.20]; p < 0.001, respectively) and shorter length of stay (5 [interquartile range: 2 to 10] vs. 10 [interquartile range: 7 to 17] days, respectively; p < 0.001) compared with open surgery. CONCLUSIONS: In a large, retrospective analysis of patients with CMI, endovascular therapy remained the dominant revascularization modality, and was associated with lower rates of MACCE, composite in-hospital complications, lower costs, and shorter length of stay compared with surgery.

Pulmonary Embolism in 2017: Increasing Options for Increasing Incidence.

Scope of the problem - An increasing burden of disease Acute pulmonary embolism (PE) is a problem encountered by a majority of medical and surgical specialties in their scope of practice. Acute PE is currently the 3rd leading cause of cardiovascular death in the United States, resulting in 100,000 deaths annually as estimated by the Centers for Disease Control (CDC (1). There is a paucity of data and a broad range of estimates for both incidence and morbidity due to acute PE. The mortality of all patients presenting with acute PE is estimated between 10-30% at 90 days utilizing current treatment regimens (2). The incidence of acute symptomatic PE seems to be increasing from 3/100 to more than 6.5/100 in the past 15 years (2). The increasing burden of disease has led to a period of intense investigation into new therapies and strategies to treat acute PE. [Full article available at http://rimed.org/rimedicaljournal-2017-05.asp].