Anticoagulation Medications, Monitoring, and Outcomes in Patients with Cardiogenic Shock Requiring Temporary Mechanical Circulatory Support.

Cardiogenic shock (CS) is a syndrome of low cardiac output resulting in critical end-organ hypoperfusion and hypoxia. The mainstay of management involves optimizing preload, afterload and contractility. In medically refractory cases, temporary percutaneous mechanical support (MCS) is used as a bridge to recovery, surgical ventricular assist device, or transplant. Anticoagulation is recommended to prevent device-related thromboembolism. However, MCS can be fraught with hemorrhagic complications, compounded by incident multisystem organ failure often complicating CS. Currently, there are limited data on optimal anticoagulation strategies that balance the risk of bleeding and thrombosis, with most centers adopting local antithrombotic stewardship practices. In this review, we detail anticoagulation protocols, including anticoagulation agents, therapeutic monitoring, and complication mitigation in CS requiring MCS. This review is intended to provide an evidence-based framework in this population at high risk for in-hospital bleeding and mortality.

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.

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.

Thirty-Day Readmissions After Endovascular or Surgical Therapy for Critical Limb Ischemia: Analysis of the 2013 to 2014 Nationwide Readmissions Databases.

BACKGROUND: Thirty-day readmission rates have gained increasing importance as a key quality metric. A significant number of patients are hospitalized for the management of critical limb ischemia (CLI), but limited data are available on the incidence, predictors, and causes of 30-day readmission after hospitalization for CLI. METHODS: Hospitalizations for a primary diagnosis of CLI during which patients underwent endovascular or surgical therapy (revascularization and/or amputation) and were discharged alive were identified in the 2013 to 2014 Nationwide Readmissions Databases. Incidence, reasons, and costs of 30-day unplanned readmissions were determined. Hierarchical logistic regression models were used to identify independent predictors of 30-day readmissions. RESULTS: We included 60 998 (national estimate, 135 110) index CLI hospitalizations (mean age, 68.9±11.9 years; 40.8% women; 24.6% for rest pain, 37.2% for ulcer, and 38.2% for gangrene). The 30-day readmission rate was 20.4%. Presentation with ulcer or gangrene, age ≥65 years, female sex, large hospital size, teaching hospital status, known coronary artery disease, heart failure, diabetes mellitus, chronic kidney disease, anemia, coagulopathy, obesity, major bleeding, acute myocardial infarction, vascular complications, and sepsis were identified as independent predictors of 30-day readmission. Mode of revascularization was not independently associated with readmissions. Infections (23.5%), persistent or recurrent manifestations of peripheral artery disease (22.2%), cardiac conditions (11.4%), procedural complications (11.0%), and endocrine issues (5.7%) were the most common reasons for readmission. The inflation-adjusted aggregate costs of 30-day readmissions for CLI during the study period were $624 million. CONCLUSIONS: Approximately 1 in 5 patients hospitalized for CLI and undergoing revascularization is readmitted within 30 days. Risk of readmission is influenced by CLI presentation, patient demographics, comorbidities, and in-hospital complications, but not by the mode of revascularization.

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.

Characteristics, Trends, and Outcomes of Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Replacement in United States.

BACKGROUND: Transfemoral (TF) access is the preferred approach for transcatheter aortic valve replacement (TAVR). Limited data exist regarding the outcomes of intravascular lithotripsy (IVL)-assisted TF TAVR in patients with peripheral artery disease. OBJECTIVES: This study sought to examine contemporary characteristics, trends, and outcomes of IVL TAVR in the United States. METHODS: The Vizient Clinical Database was queried for patients who underwent percutaneous TAVR between October 1, 2020, and November 30, 2023. Outcomes with IVL TAVR vs non-IVL TAVR were examined after propensity score matching. The primary outcome was a composite of in-hospital death, stroke, vascular complications, surgical vascular intervention, and major bleeding. RESULTS: Over the study period, 129,655 patients (mean age of 78.4 years, 42.2% women, 87.1% White) underwent percutaneous TAVR at 361 hospitals, 1,242 (0.96%) of whom underwent IVL TAVR. There was an uptrend in IVL TAVR, but the frequency remained low. IVL TAVR patients had a higher median Elixhauser comorbidity score (5 [Q1-Q3: 4-7] vs 4 [Q1-Q3: 3-6]) compared to non-IVL TAVR. TAVR was completed via the TF approach in 1,238 (99.7%) IVL TAVR patients. In a 3:1 propensity score matching analysis, IVL TAVR was associated with a higher rate of the primary composite outcome (21.9% vs 13.7%; P < 0.001) driven by higher rates of vascular complications, surgical vascular intervention, and major bleeding. In-hospital death and stroke were similar in both groups. CONCLUSIONS: In the United States, IVL is increasingly adopted to facilitate TF TAVR. IVL TAVR patients exhibited a higher burden of comorbidities and experienced more complications compared to non-IVL TAVR patients. Further studies are needed to identify appropriate anatomical and clinical use criteria for IVL TAVR and to compare its outcomes vs alternative non-TF TAVR.

Meta-Analysis Assessing Efficacy and Safety of Vitamin K Antagonists Versus Direct Oral Anticoagulants for Atrial Fibrillation After Transcatheter Aortic Valve Implantation.

Patients who underwent transcatheter aortic valve implantation (TAVI) with concomitant atrial fibrillation (AF) are at a higher risk for thromboembolic and bleeding events. The optimal antithrombotic strategy for patients with AF after TAVI remains unclear. We sought to determine the comparative efficacy and safety of direct oral anticoagulants (DOAC) versus oral vitamin K antagonists (VKAs) in these patients. Electronic databases such as PubMed, Cochrane, and Embase databases were searched till January 31, 2023, for relevant studies evaluating clinical outcomes of VKA versus DOAC in patients with AF after TAVI. Outcomes assessed were (1) all-cause mortality, (2) stroke, (3) major/life-threatening bleeding, and (4) any bleeding. Hazard ratios (HRs) were pooled in meta-analysis using random effect model. Nine studies (2 randomized and 7 observational) were included in systematic review, and 8 studies with 25,769 patients were eligible to be included in the meta-analysis. The mean age of the patients was 82.1 years, and 48.3% were male. Pooled analysis using random-effects model showed no statistically significant difference in all-cause mortality (HR 0.91, 95% confidence interval [CI] 0.76 to 1.10, p = 0.33), stroke (HR 0.96, 95% CI 0.80 to 1.16, p = 0.70), and major/life-threatening bleeding (HR 1.05, 95% CI 0.82 to 1.35, p = 0.70) in patients that received DOAC compared with oral VKA. Risk of any bleeding was lower in the DOAC group compared with oral VKA (HR 0.83, 95% CI 0.76 to 0.91, p = 0.0001). In patients with AF, DOACs appear to be a safe alternative oral anticoagulation strategy to oral VKA after TAVI. Further randomized studies are required to confirm the role of DOACs in those patients.

Mitral Valve Transcatheter Edge-to-Edge Repair After TAVR: A Nationwide Analysis.

Patients with persistent severe mitral regurgitation after transcatheter aortic valve replacement (TAVR) may benefit from mitral transcatheter edge-to-edge repair (M-TEER). Using the Nationwide Readmission Database, we identified patients who had M-TEER within 6 months after TAVR and compared their outcomes with patients who had M-TEER without previous recent TAVR during the same calendar year between 2014 and 2020. Because Nationwide Readmission Database data do not cross years, analysis was restricted to the last half of each calendar year. End points included in-hospital mortality and 30-day and 90-day postdischarge rehospitalization rates. In 23,885 M-TEER patients, 396 (1.7%) had a previous recent TAVR. The number of post-TAVR M-TEER procedures increased progressively over time from 16 in 2014 to 92 in 2020. Patients who had M-TEER after a recent TAVR versus those without previous TAVR had similar in-hospital mortality (adjusted odds ratio 0.38, 95% confidence interval [CI] 0.12 to 1.23, p = 0.11), but higher rates of 30-day all-cause hospitalization and heart failure hospitalization (adjusted odds ratios 1.34, 95% CI 1.11 to 1.79, p = 0.04 and 1.63, 95% CI 1.13 to 2.36, p = 0.009, respectively). Nonetheless, in patients who underwent M-TEER post-TAVR, the cumulative 90-day all-cause hospitalization and heart failure hospitalization rates were less after M-TEER compared with before M-TEER (from 45.7% to 31.5%, p = 0.007, and from 29.0% to 16.6%, respectively, both p = 0.005). In conclusion, M-TEER procedures after TAVR in the United States are increasing. Patients with M-TEER after TAVR had similar in-hospital mortality as those who underwent M-TEER without recent TAVR, but higher 30-day hospitalization rates. Nonetheless, 90-day hospitalization rates were decreased after M-TEER in patients with previous TAVR.

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.

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.

Intravascular Lithotripsy vs Atherectomy in the Treatment of Calcified Common Femoral Artery Disease.

Background: Common femoral artery (CFA) disease is often heavily calcified and prone to low patency rates with endovascular treatment compared with surgical endarterectomy. Recent data suggest promising short-term outcomes with the adjunct use of intravascular lithotripsy; however, data on its midterm effectiveness are lacking. We compared clinically driven target lesion revascularization (CD-TLR) between patients receiving drug-coated balloon angioplasty with adjunct intravascular lithotripsy (IVL-DCB) vs adjunct atherectomy (Ath-DCB) for treatment of CFA disease. Methods: In a single-center retrospective cohort study, patients receiving IVL-DCB vs Ath-DCB for symptomatic CFA disease from January 2015 to March 2020 were included. The primary outcome was cumulative CD-TLR with angiographic restenosis ≥50%, estimated by Kaplan-Meier analysis during 18-month follow-up and compared by log-rank test. Results: Total of 68 CFA lesions (Ath-DCB, 35; IVL-DCB, 33) were included. Patients had a mean age (standard deviation) of 72 (8) years and were predominantly male (63.3%) and White (92%). Mean baseline angiographic stenosis was 78% (11) in the Ath-DCB group and 70% (10) in the IVL-DCB group (P = .002). Technical success was 100% in both groups. One flow-limiting dissection occurred in IVL-DCB requiring stent placement, whereas 2 bailout stentings were performed in the Ath-DCB group. Cumulative Kaplan-Meier freedom from CD-TLR was 91.2% (95% CI, 81.6%-100%) in the Ath-DCB group vs 79.4% (95% CI, 64.6%-94.2%) in the IVL-DCB group (Log-rank P = .167). Conclusions: The safety and effectiveness of IVL-DCB were comparable to those of Ath-DCB in the treatment of calcified CFA disease during the 18-month follow-up. Further studies are required to verify these findings.

Predictors of In-Hospital De-Escalation of P2Y12 Inhibitors to Clopidogrel in Patients With Acute Myocardial Infarction Treated With Percutaneous Coronary Intervention.

BACKGROUND: Ticagrelor or prasugrel are recommended to reduce ischemic events in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). However, in clinical practice, patients are often switched from a potent P2Y12 inhibitor to clopidogrel prior to or at discharge ('de-escalation'). We sought to assess the incidence and predictors of de-escalation. METHODS: Consecutive patients who received either a ticagrelor or prasugrel loading dose for AMI PCI at two tertiary centers between Jan 2015-Mar 2019 who survived to discharge were included. Data were obtained from the electronic health record and institutional NCDR CathPCI data. Patients who were de-escalated to clopidogrel were compared with those who remained on potent P2Y12 inhibitors through the time of discharge. RESULTS: Of the1818 patients in the cohort, 1146 (63%) were de-escalated. Patients in the de-escalation group were older, more often Black, had lower prevalence of co-morbidities, less often had private insurance, and had less complex PCI. After adjustment, older age remained positively associated (OR 1.2, CI 1.08-1.34, p = .001) and Caucasian race (OR 0.5, CI 0.33-0.77, p = .002), prior MI (OR 0.7, CI 0.5-0.97, p = .032), bifurcation lesion (OR 0.71, CI 0.53-0.95, p = .019), and greater number of stents (OR 0.82, CI 0.75-0.91, p = .0001) were negatively associated with de-escalation. In de-escalated patients, the rationale was not documented in 75.9% of cases. CONCLUSIONS: De-escalation occurred frequently in patients with AMI and was associated with both non-clinical and clinical factors. Medical decision making was poorly documented and represent an area for improvement.

Endovascular Revascularization of Superficial Femoral Artery Stent Occlusion by Combined Retrograde Access With Catheter-Directed Thrombolysis and Pharmaco-Mechanical Thrombectomy.

We report a case of a patient with history of peripheral arterial disease who presented to the hospital with critical limb ischemia. We performed endovascular revascularization of stent thrombosis in superficial femoral artery (SFA), by retrograde pedal access with wire exteriorization. This case highlights the utility of retrograde pedal access in failed antegrade approach of culprit lesion in SFA and the effectiveness of multimodal endovascular thrombectomy to restore blood flow in patients who are otherwise not suitable for surgical interventions.

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.).

Meta-Analysis Comparing Endovascular Treatment Modalities for Femoropopliteal Peripheral Artery Disease.

Endovascular interventions are commonly utilized for treatment of femoropopliteal peripheral artery disease. The relative efficacy of these interventions remains unclear. A Bayesian network meta-analysis was performed comparing 5 endovascular treatment modalities: balloon angioplasty (BA), bare metal stent (BMS), covered stent (CS), drug-coated balloon (DCB), drug-eluting stent (DES) for femoropopliteal peripheral artery disease. The primary efficacy end points were freedom from target lesion revascularization (TLR) and primary patency at 12 months. BA was the reference treatment. Twenty-two trials including 4,381 participants provided data on TLR. Sixteen trials including 3,691 participants provided data on primary patency. Point estimates for DCB suggested that it was the most efficacious treatment for freedom from TLR (odds ratio [OR] 4.23; 95% credible intervals [CrI] 2.43 to 7.66) followed by CS (OR 3.65; 95% CrI 1.11 to 12.55), DES (OR 2.64; 95% CrI 0.72 to 9.77), and BMS (OR 2.3; 95% CrI 1.11 to 4.76). Similarly, point estimates for primary patency were highest with DES (OR 8.93; 95% CrI 3.04, 27.14) followed by CS (OR 3.91; 95% CrI 1.18, 13.84), DCB (OR 3.32; 95% CrI 1.8, 6.25), and BMS (OR 3.5; 95% CrI 1.58, 7.99). In conclusion, DCB has the lowest need for TLR whereas DES has the highest primary patency rate. DCB, CS, and BMS were associated with significant reductions in TLR compared with BA, whereas DCB, DES, CS, and BMS were associated with significantly improved primary patency compared with BA.

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.

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.

Strength of Evidence Underlying the American Heart Association/American College of Cardiology Guidelines on Endovascular and Surgical Treatment of Peripheral Vascular Disease.

BACKGROUND: The objective of this study was to evaluate the evidence-base supporting the American Heart Association and American College of Cardiology guidelines on peripheral vascular interventions. METHODS AND RESULTS: American Heart Association/American College of Cardiology guideline documents available as of May 2018 were abstracted for both endovascular and surgical peripheral vascular intervention. The number of recommendations, class of recommendations (I, II, and III) and the distribution of their respective level of evidence (LOE; A, B, and C) were determined for each procedure. Guidelines were also evaluated for changes in recommendations over time. Of 5 current guidelines reporting 134 recommendations, only 13% were supported by LOE A and 39% were supported by LOE C. Overall, most recommendations were class II (54%), while 35% were class I. Lower LOEs were observed for interventions for pulmonary embolism/deep vein thrombosis (A 0%, B 24%, C 76%), inferior vena cava filter (A 0%, B 31%, C 69%), and renal artery stenosis (A 0%, B 67%, C 33%). Comparatively higher LOE A was observed for endovascular stroke therapy (24%). Compared with previous versions, total number of recommendations for lower extremity peripheral artery disease in the current guideline, decreased from 49 to 26, without an improvement in high-quality evidence. CONCLUSIONS: There is significant variation in the LOE supporting various peripheral vascular intervention in the current American Heart Association/American College of Cardiology guidelines. Overall, the availability of high-quality evidence remains low and the LOE appears insufficient to support many guideline recommendations for peripheral vascular intervention. These findings highlight the need for more objective and comparative evidence to support the use of endovascular and surgical therapy and in some areas, for updated guidelines.

Chronic Venous Insufficiency: Novel Management Strategies for an Under-diagnosed Disease Process.

Chronic venous insufficiency is an often-missed diagnosis that results in a variety of clinical manifestations that may severely compromise quality of life. Prompt recognition is important to provide symptomatic relief and prevent disease progression. Most patients can be treated with a comprehensive plan of conservative measures. However, it is important for providers to recognize those patients who require referral to a vascular specialist for more invasive therapies. Over the past 2 decades, a variety of endovenous strategies have demonstrated effective and lasting results in treatment of severe symptomatic venous insufficiency. [Full article available at http://rimed.org/rimedicaljournal-2017-05.asp].

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.