Initiation of hemodialysis at one month following fistulogram in patients with advanced kidney disease.

OBJECTIVE: Previous studies have demonstrated that low contrast volume used in access-related interventions had limited effects on the progression of chronic kidney disease (CKD) after fistulography, but studies are limited and heterogeneous. We sought to evaluate the rate of and factors associated with progression to dialysis (HD) within 1 month after fistulography for patients with advanced CKD. METHODS: A single-institution retrospective cohort analysis of patients with CKD stage IV and V, not yet on HD, undergoing fistulography from 1 January 2014 to 31 December 2018 was performed. The primary outcome was progression to HD within 1 month. Additional variables and the association with the primary outcome such as medical comorbidities, contrast type or volume were assessed. RESULTS: A total of 34 patients underwent 41 fistulograms prior to HD initiation. Progression to HD within 1 month of fistulogram occurred in seven patients (all CKD V). The mean time between fistulogram and HD was 271 days for 31 of 34 patients who ultimately progressed to HD. Those with CKD IV began HD in 549 days on average, while those with CKD V began HD in 190 days on average. Three patients had not initiated HD at a mean of 539 days of follow-up. The only factors associated with progression to HD within 1 month included use of isovue (p = .005) and elevated contrast volume, with a mean of 40 mL (p = .027). CONCLUSION: Although none of the patients with CKD IV required HD within 1 month after fistulogram, the use of larger iodinated contrast volume was associated with progression to HD within 1 month of fistulography for patients with CKD V. Further studies should investigate the safety of iodinated and alternative (e.g., carbon dioxide) contrast media in fistulography or duplex-based HD access procedures for CKD patients, especially CKD V, not yet on HD.

Outcomes of the V-Healthy education and awareness program that empowers high school students to understand and diagnose vascular disease risk factors.

INTRODUCTION: V-Healthy (Center for Vascular Awareness Inc, Latham NY) is a grassroots vascular health education and awareness campaign that educates high school students about the importance of the vascular disease risks they face today and its impact decades later, and empowers health care professionals and schoolteachers to lead vascular health education in their communities. This study evaluates the impact of the V-Healthy initiative in empowering and educating adolescents about the implications of vascular disease risk factors and in creating a blueprint for a community outreach program that focuses on vascular health and disease education and awareness. METHODS: The V-Healthy program is an initiative that connects community vascular health care professionals and educators with high school students, for a day of vascular health education. The V-Healthy program curriculum is provided in two distinct stages. Stage I consists of didactic vascular health education and takes place in the classroom for the duration of one class period (40-50 minutes). The class period is divided into four sessions including a PowerPoint presentation to teach the impact of vascular disease risk factors (hypertension, diabetes, hyperlipidemia, smoking/vaping, and genetics) on the development of peripheral arterial disease, venous disease, aortic disease, and stroke, and three hands-on sessions that introduce students to vascular innovation and technology, vascular patients, and the diagnosis of a vascular disease risk factor such as hypertension. Stage I concludes with a student questionnaire aimed to gauge students' retention of the material and attitude toward the program. Stage II offers students (with parental consent) the opportunity to participate in the "Diagnosing Hypertension" study. Students were provided automated blood pressure monitors and taught to measure blood pressure in their parents daily for 1 week. Findings are recorded in designated blood pressure logs, which are then categorized using the 2018 American Heart Association blood pressure categorization system: normal (<120/<80), elevated (120-129/<80), stage I (130-139/80-89), or stage II (≥140/≥90). No identifiable student or guardian information is collected. RESULTS: Over 3 years, more than 12,000 students participated in the V-Healthy program and 5120 students completed student surveys, which indicated that 97% improved their understanding of vascular health, >93% could identify vascular disease risk factors, 84% wanted to educate their families, and 76% wanted more vascular health education. A total of 1064 students participated in the "Diagnosing Hypertension" study and diagnosed hypertension in 73% of their parents: 34% for stage I hypertension and 39% for stage II hypertension. Over a 3-year period of this study, the number of schools participating increased 20-fold (from 1 to 20), the number of volunteer vascular health professionals and schoolteachers increased 13-fold (from 16 to 210), and our ability to connect with and impact high school students grew 15-fold (from 800 to over 12,000). CONCLUSIONS: V-Healthy is the first program to connect over 12,000 students to vascular health professionals in their communities to empower them to diagnose and understand vascular disease risk factors and their implications on the development of vascular disease. Furthermore, the V-Healthy program has displayed substantial growth over a 3-year period in impacting high school students and vascular health care professionals, and has the potential to be used as a blueprint for community-based vascular health education and awareness initiatives.

Anticoagulation Therapy is Associated with Increased Access-related Wound Infections after Hemodialysis Access Creation.

BACKGROUND: The effect of anticoagulation therapy (AC) on hemodialysis access patency and related complications is not well defined. Patients on long-term or chronic AC due to their underlying comorbid conditions may be particularly susceptible to access-related bleeding and complications from repetitive cannulation. Our goal is to assess the effect of anticoagulation therapy on outcomes after access creation. METHODS: The Vascular Quality Initiative (VQI) database was queried for patients undergoing arteriovenous fistula (AVF) or graft (AVG) placement, from 2011 to 2019. Only patients with data on post-procedural AC status were included. Anticoagulation use was defined as patients on warfarin, dabigatran, or rivaroxaban after access creation at postoperative follow up. Demographic and procedural details were analyzed. Wound infection and patency rates at six months were assessed. Binomial logistic regression analysis was performed to assess the association of anticoagulation use with these outcomes. RESULTS: A total of 27,757 patients underwent access creation, with the majority undergoing AVF creation (78.8%). The average age was 61.4 years and 55.3% were male. 12.9% of patients were on postoperative AC. The wound infection rate was 2.3- 3.8% in the no AC and AC cohorts, respectively (P < 0.001). At six months follow-up, patency was 85.7- 84.3% in the no AC and AC cohorts, respectively (P = 0.044). Expectedly, grafts had lower patency rates compared to AVF; those within the no AC cohort had a patency of 83.0% compared to 81.2 % in those on AC (P = 0.106). On multivariable analysis, anticoagulation use was associated with a higher risk of wound infections (odds ratio [OR] 1.513, 95% confidence interval [CI] 1.160-1.973, P = 0.002). AC use did not significantly affect access patency. CONCLUSION: Anticoagulation therapy was associated with a higher rate of wound infections but did not affect short-term access patency within six-months. These patients warrant close surveillance of their access for signs of infection. Furthermore, long-term implications of anticoagulation needs further evaluation.

A Propensity-Matched Analysis of Endovascular Intervention versus Open Nonautologous Bypass as Initial Therapy in Patients with Chronic Limb-Threatening Ischemia.

OBJECTIVES: Endovascular therapies are increasingly used in patients with complex multilevel disease and chronic limb-threatening ischemia (CLTI). Infrageniculate bypass with autologous vein conduit is considered the gold standard in these patients. However, many patients often lack optimal saphenous vein, leading to the use of nonautologous prosthetic conduit. We compared limb salvage and survival rates for patients with CLTI undergoing first time revascularization with either open nonautologous conduit or endovascular intervention. METHODS: We retrospectively reviewed consecutive patients undergoing first time endovascular or open surgical revascularization at our institution between 2009 and 2016. Patients were divided into endovascular intervention or open bypass with nonautologous conduit (NAC) cohorts. Primary endpoints were amputation-free survival (AFS), freedom from reintervention, primary patency, and overall survival. Propensity scoring was used to construct matched cohorts. Outcomes were evaluated using Kaplan-Meier and Cox Proportional Hazards models. RESULTS: A total of 125 revascularizations were identified. There were 65 endovascular interventions and 60 NAC bypasses. In unmatched analysis, there was an elevated risk of perioperative MI (7% vs. 0%, P = 0.05) and amputation (10% vs. 2%, P = 0.04) for the NAC groups compared to the endovascular group. In matched analysis, endovascular patients had a lower incidence of 30-day amputation (1.5% vs. 10% P = 0.04) and length of stay (median days, 1 vs. 9, P < 0.01) compared to the open cohort. While not statistically significant, the endovascular group trended towards increased rates of two-year AFS (76% vs. 65%, P = 0.07) compared to the NAC group. There was no significant difference in overall survival when the endovascular cohort was compared to NAC (85% vs. 77%, P = 0.29) patients. In matched Cox analysis, nonautologous conduit use was associated with an increased risk of limb loss (HR 2.03, 95% CI 0.94-4.38, P = 0.07) compared to endovascular revascularization. CONCLUSIONS: An "endovascular first" approach offers favorable perioperative outcomes and comparable AFS compared to NAC and may be preferable when autologous conduit is unavailable.

Perioperative Opioid and Nonopioid Prescribing Patterns in AVF/AVG Creation.

BACKGROUND: To evaluate postoperative opioid prescribing patterns in patients undergoing hemodialysis access creation. METHODS: Operative logs were reviewed to identify patients undergoing creation of arteriovenous fistula (AVF) or graft (AVG) from September 2016 to January 2018. Immediate postoperative opioid prescriptions were compared for ambulatory patients versus inpatients. Opioid prescriptions at the time of discharge for inpatients were recorded. Rates of opioid prescribing were standardized by conversion to morphine milligram equivalents (MMEs). Opioid use postoperatively and at the time of discharge based on anesthetic technique, general anesthesia versus regional or local anesthesia with sedation were compared. Alternative pain medications administered and pain scores were recorded. Comparisons were made between the percentage of opioid use and doses administered between AVF and AVG patient groups, ambulatory and inpatients, and type of anesthetic technique used. Statistical analysis was performed with chi-square and t-tests. RESULTS: We identified 164 patients undergoing AV access creation but not receiving chronic opioid therapy. A significantly higher percentage of inpatients received opioids in the immediate postoperative period than ambulatory patients (AVF: 72% vs. 19%, P < 0.001; AVG: 62% vs. 25%, P = 0.001). Overall, all AVG patients were more likely to be discharged with an opioid prescription than all AVF patients (37% vs. 8%, P < 0.001). Of AVG patients managed in the ambulatory setting, 48% were discharged with an opioid prescription. The mean total opioid postoperative dose prescribed to inpatients was significantly higher than that prescribed to ambulatory patients for both fistulas (28.73 MMEs vs. 1.27 MMEs, P < 0.001) and grafts (22.11 MMEs vs. 2.16 MMEs, P = 0.005). General anesthesia patient groups were more likely to receive opioids postoperatively than local anesthesia with sedation patients for both AVF (54% vs. 24%, P = 0.027) and AVG creation (61% vs. 17% P < 0.001). Postoperative alternative medication use in the hospital was low with 18% acetaminophen and 1% nonsteroidal anti-inflammatory drug use for AVF patient groups and 24% acetaminophen and 0% nonsteroidal anti-inflammatory drug use for AVG patient groups. The percentage of patients reporting postoperative pain in the recovery room and on the inpatient units was comparable between ambulatory and inpatient settings (AVF: 21% vs. 28%, P = 0.534; AVG: 23% vs. 44%, P = 0.061). CONCLUSIONS: A higher percentage of inpatients undergoing hemodialysis access received opioids when compared with ambulatory patients in the immediate postoperative period. Inpatients were prescribed higher mean doses than ambulatory patients. AVG patient groups were prescribed more opioids than AVF patient groups. Alternative analgesic agent use was low, suggesting an opportunity for improved pain control and opioid reduction. Dialysis access creation represents an opportunity to improve on opioid prescribing patterns.

Ambulatory Status following Major Lower Extremity Amputation.

BACKGROUND: The ability to ambulate following major lower extremity amputation, either below (BKA) or above knee (AKA), is a major concern for all prospective patients. This study analyzed ambulatory rates and risk factors for nonambulation in patients undergoing a major lower extremity amputation. METHODS: A retrospective review of 811 patients who underwent BKA or AKA at our institution between January 2009 and December 2014 was conducted. Demographic information and co-morbid conditions, including the patients' functional status prior to surgery, at 6 months, and at latest follow up were recorded. Following exclusion criteria, 538 patients were included. Patients who were either independent or used an assistive device were considered ambulatory, while those who were completely wheelchair-dependent or bed-bound were considered nonambulatory. RESULTS: Pre-operatively, 83.1% of BKA patients were ambulatory, significantly more so than those undergoing AKA (44.9%, P < 0.0001). At 6-month follow-up these percentages dropped to 58.0% and 25.2%, respectively, for all patients. For patients who were ambulatory pre-operatively, 182/246 (73.9%) of BKA and 32/51 (62.7%) of AKA remained so post-amputation. Of those patients with both 6-month and greater than 1-year follow-up, there was no change in ambulatory status between the 2 time periods. On multivariable logistic regression, age greater than 70 years and female sex were associated with nonambulation post-operatively (P = 0.001, P = 0.015, respectively). None of the co-morbid conditions recorded (diabetes, renal insufficiency, end-stage renal disease, peripheral vascular disease, or body mass index > 35) was found to have a statistically significant correlation with post-operative ambulation using multivariable analysis. CONCLUSIONS: The majority of ambulatory patients undergoing a major amputation were able to remain ambulatory. Patients who failed to ambulate 6 months after their amputation, failed to resume ambulating. Age greater than 70 and female sex were found to have a statistically significant association with becoming nonambulatory following surgery.

Underutilization of Nonopioid Pain Medication in Patients Undergoing Abdominal Aortic Aneurysm Repair.

BACKGROUND: With increased focus on the opioid crisis, it was our goal to describe rates and risk factors for postoperative use of opioids in patients undergoing abdominal aortic aneurysm (AAA) repair as well as identify pain modalities that are underutilized. METHODS: We retrospectively analyzed perioperative analgesic prescriptions for endovascular (EVAR) and open AAA repair between January 1, 2010 and January 1, 2018. Patients' baseline opioid use, demographics, and medical comorbidities were obtained. The EVAR group was further subdivided into percutaneous (pEVAR) and cutdown (cEVAR) groups. Primary outcomes were postoperative and discharge pain medication prescriptions. Relative rates of opioid prescribing were obtained through the electronic medical record and normalized into morphine milligram equivalents (MMEs). RESULTS: Of the 128 patients analyzed in the entire cohort, 21.8% (n = 28) underwent open repair and 78.12% (n = 100) underwent EVAR (46 pEVAR, 54 cEVAR). As expected, open repair had increased postoperative pain reported compared to EVAR (2.67 ± 0.75 vs. 0.96 ± 0.19, P < 0.01). Adjunctive epidural reduced postoperative pain for open repair (0.77 ± 0.48 vs. 3.50 ± 0.96, P < 0.01). EVAR had less postoperative opioid prescriptions compared to open repair (35.0% vs. 77.3%, P < 0.01). In the endovascular group, there was no difference between postoperative opioid prescription based on access, pEVAR versus cEVAR (65.8% vs. 80.1%, P = 0.11). When stratifying patients by number of cutdowns, patients with bilateral cutdown as opposed to a single cutdown received more opioid prescriptions than pEVAR patients (84.44% vs. 65.8%, P = 0.036). Of those receiving opioids, the average MME for open repair was 320.94 mg compared to 28.82 mg for EVAR (P < 0.01). Those undergoing percutaneous repair had significantly less MME use during hospitalization compared to femoral cutdown (17 ± 3.52 vs. 31.90 ± 5.43 mg, P < 0.01). Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and ketorolac, were rarely used in the postoperative period for open or EVAR (8.3% vs 1.1%). Percutaneous EVAR patients reported less pain at discharge compared to cEVAR patients (0.18 ± 0.12 vs. 0.88 ± 0.29, P = 0.036). Open and EVAR had comparable low rates of NSAID and acetaminophen prescriptions at discharge. Open patients had longer postoperative length of stay compared to EVAR patients (9.82 ± 1.27 vs. 3.86 ± 0.47, P < 0.01). pEVAR had a shorter length of postoperative course compared to cEVAR (3.2 ± 0.26 vs. 4.12 ± 0.30, P < 0.01). Patients undergoing EVAR with use of pain medications amounting to <20 MME had a significantly shorter length of stay. CONCLUSIONS: This single institutional retrospective study evaluated pain prescription patterns for patients undergoing AAA repair. AAA patients are predominantly treated with opioid pain medications with few adjunctive therapies. Intraoperative epidural and pEVAR may aid in decreasing the total MME used; however, the total number of opioids prescribed is similar for pEVAR and cEVAR despite the difference in approach. Clinicians must consider alternative nonopioid based pain management strategies.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

Amputation-free Survival in Patients with Critical Limb Ischemia Treated with Paclitaxel-eluting Stents and Paclitaxel-coated Balloons.

OBJECTIVE: The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PESs) and paclitaxel-coated balloons (PCBs) on amputation-free survival in patients with critical limb ischemia (CLI). METHODS: A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel-related technology, both PES and PCB, was carried out over a 4-year period. Clinical grading was determined by Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation-free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization, and patency of target vessels at 12 months. Follow-up occurred at 3, 6, and 12 months postoperatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Postoperative ankle-brachial index (ABI) and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox proportional-hazards models. RESULTS: A total of 88 limbs were revascularized in 88 patients. Drug-eluting stent (DES) was used as the sole drug technology in 56 patients (60.7% men, median age 70.5 years) and drug-coated balloon (DCB) was used as the sole drug technology in 32 patients (46.9% men, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; P = 0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of DCBs. After 12 months of follow-up, amputation-free survival was significantly higher in the DES group than in the DCB group (88.5% vs. 71.1%; P = 0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; P = 0.0198). Freedom from target lesion revascularization was no different between patients treated with DESs and patients treated with DCBs (90.6% vs. 85.7%; P = 0.518). Primary patency at 12 months in patients treated with DESs was significantly higher than in patients treated with PCBs (80.4% vs. 58.1%; P = 0.0255). CONCLUSIONS: Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DESs have higher primary patency rates than those treated with DCBs. This was found to support higher amputation-free survival rates in patients treated with paclitaxel DESs than those treated with paclitaxel DCB. The use of paclitaxel DESs for CLI was also associated with significantly improved wound healing compared with DCBs. Our data suggest improved outcomes with DESs compared with DCBs; however, these patients represent a nonrandomized, heterogenous group that were treated with the operator's best judgment.

Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology.

BACKGROUND: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. METHODS: Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). RESULTS: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. CONCLUSIONS: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.

Repair of Isolated Innominate Artery Pathology with a Modified Endovascular Graft.

Innominate artery pathology is traditionally treated with open surgical repair and is associated with significant morbidity. No dedicated endovascular solution exists for this anatomic location. We report a series of 3 cases of successful management of innominate artery injuries using an off-label, modified Zenith ESLE stent graft (Cook Medical, Bloomington, IN). Two patients presented with pseudoaneurysms after attempted central venous catheterization, and 1 patient developed a tracheo-innominate fistula. Access was obtained in a retrograde fashion via the right common carotid artery in 2 cases, and via the right axillary artery in the other. Additional anatomic considerations included a prior sternotomy in 2 cases and a bovine arch in 2 cases. Due to the emergent nature of the cases, no cerebral protection maneuvers were taken. The ESLE limbs are of uniform diameter with 3 Z-stent wireforms and measure 55 mm in length. Removal of the distal stent reduces the length to 38 mm. Fourteen- to 18-mm diameter grafts were used. All 3 cases resulted in technical success with complete exclusion of the defect. There were no new neurologic deficits and all patients recovered uneventfully. This approach represents an effective off-label solution for what frequently presents as an emergent problem. In 2 cases, it obviated the need for a complicated redo sternotomy and facilitated endovascular repair in a vessel for which there was no indicated off-the-shelf conduit. Modification of existing devices successfully addressed the need for a nontapered graft of short length and moderate vessel diameter and allowed for minimally invasive treatment of anatomically complex pathology.

Factors Associated with Ipsilateral Limb Ischemia in Patients Undergoing Femoral Cannulation Extracorporeal Membrane Oxygenation.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is an important life-saving modality for patients with cardiopulmonary failure. Vascular complications, including clinically significant limb ischemia, may occur as a result of femoral artery cannulation for venoarterial (VA) ECMO. This study examines our institutional experience with femoral VA ECMO and the development of ipsilateral limb ischemia. METHODS: We performed a retrospective review of all consecutive patients undergoing femoral VA ECMO between 2011 and 2016. The primary endpoint was clinical evidence of limb-threatening ischemia. Multivariate logistic regression analysis was used to identify predictors for limb ischemia after cannulation. RESULTS: Between March 2011 and September 2016, 154 patients underwent femoral cannulation for VA ECMO. Overall in-hospital mortality was 59.7%. Clinically significant ipsilateral limb ischemia occurred in 34 (22%) patients; 7 required four-compartment fasciotomy, and 3 of these patients required amputation. On univariate analysis, a history of pulmonary disease, peripheral arterial disease, and stroke or transient ischemic attack was significantly associated with clinical limb ischemia. On multivariate analysis, younger age (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.93-0.99), diabetes (OR, 2.77; 95% CI, 1.08-7.12), pulmonary disease (OR, 3.86; 95% CI, 1.38-10.78), and peripheral arterial disease (OR, 13.68; CI, 2.75-68.01) were associated with limb ischemia. Lack of prophylactic distal perfusion catheter and arterial cannula size were not independently associated with limb ischemia. CONCLUSIONS: Femoral ECMO cannulation can be associated with significant limb ischemia necessitating surgical intervention. Younger patients, as well as those with a history of diabetes, pulmonary disease, and peripheral arterial disease, may be at increased risk for this complication.

Why Do Vascular Surgeons Get Sued? Analysis of Claims and Outcomes in Malpractice Litigation.

BACKGROUND: The objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. METHODS: Cases entered into the Westlaw database from January 1, 1999 to December 31, 2014 were reviewed. Search terms "vascular" and "surgeon" were used. Data were compiled on the allegation, subject matter, and outcome of each case. Additional data including demographics of the defendant were obtained from the U.S. News Health reports on practicing physicians. RESULTS: Of a total of 785 cases identified from the Westlaw database using the search terms "vascular" and "surgeon", 485 (61.8%) were identified where a vascular surgeon was the defendant or expert witness. Of these, 135 (27.8%) had a vascular surgeon identified as a defendant. Among these 135 cases, 88 (65.2%) were found for the defendant with 31 (23%) and 15 (11.1%) being found for the plaintiff or settled, respectively. Of the 31 cases found for the plaintiff, the median award was $750,000 and mean award was $1,830,000. Mean time from incident to verdict was 4.8 years. The most common procedures which led to litigation were open or endovascular peripheral revascularization (PR) (14.8%), carotid interventions (CIs) (11.85%), aortic interventions (AI) (11.1%), vascular trauma (9.63%), dialysis access (8.15%), and venous surgery (5.93%). The most common allegation was "failure to diagnose and treat" (48.9%), followed by complication of open surgery (31.85%) and negligent procedure (25.19%). The most common injuries reported were death (31.85%), major amputation (23.7%), neurovascular injury (14.8%), and bleeding (5.9%). CONCLUSIONS: Analysis of vascular surgery malpractice litigation in the Westlaw database revealed details regarding the subject matter and outcomes of these cases. Through this closed claims analysis, the most common procedures leading to litigation were found to be PR, CI, and AI and not thoracic outlet syndrome procedures as commonly believed. Furthermore, the most common allegations were a "failure to diagnose and treat" and "open surgical complication". Analysis of the salient features and outcomes in these cases can provide a framework for heightened awareness of issues which lead to malpractice claims and can ultimately improve patient care and safety.

Inferior Vena Cava Filter Malpractice Litigation: Damned if You Do, Damned if You Don't.

BACKGROUND: The aim of this study was to analyze malpractice litigation trends and to better understand the causes and outcomes of suits involving inferior vena cava filters (IVCF) to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2000, to December 31, 2015, were reviewed. The search term "inferior vena cava filter" was used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: A total of 156 cases were identified. Duplicates and cases in which the IVCF was incidentally included were excluded from the analysis. Forty-nine cases involving either failure to place or a complication of IVCF placement were identified. Throughout the last 15 years, there has been increased number of jury verdicts toward IVCF. The most frequent defendants were internal medicine physicians (38%), vascular surgeons (19%), and cardiothoracic surgeons (12%). The most frequent claims were denied treatment or delay in treatment (in 35% of cases), negligent surgery (in 24% of cases), and failure to diagnose and treat complications (in 24% of cases). Of these, the most frequent specific claims were failure to place IVC filter (41%), implantation failure such as misplacement and/or misaligned implant (24%), erosion of IVC/retroperitoneal bleed (6%), and discontinuation of anticoagulation prematurely (6%). Seventeen cases (35%) were found for the plaintiff, with median awards worth of $1,092,500. In the 21 cases where pulmonary embolism (PE) was involved (43% of cases), 19 were fatal (90%). Of the fatal PE cases, 8 cases ended with verdicts in favor of the plaintiff (42%). Both nonfatal PE cases were won by the defense. CONCLUSIONS: IVCF placement with subsequent PE and death results in verdicts that favor the plaintiffs. This study emphasizes that adequate and transparent communication regarding preoperative planning, decision for IVCF placement, and informed consent may reduce the frequency of litigation. Public awareness of complications related to the placement of IVCF is increasing largely and spurned by aggressive advertising and marketing by plaintiff attorneys. Conditions for which IVCF placement is contemplated carry significant risk of malpractice litigation.

Fifty years of hemodialysis access literature: The fifty most cited publications in the medical literature.

Objectives The modern era of hemodialysis access surgery began with the publication in 1966 by Brescia et al. describing the use of a surgically created arteriovenous fistula. Since then, the number of patients on chronic hemodialysis and the number of publications dealing with hemodialysis access have steadily increased. We have chronicled the increase in publications in the medical literature dealing with hemodialysis access by evaluating the characteristics of the 50 most cited articles. Methods We queried the Science Citation Index from the years 1960-2014. Articles were selected based on a subject search and were ranked according to the number of times they were cited in the medical literature. Results The 50 most frequently cited articles were selected for further analysis and the number of annual publications was tracked. The landmark publication by Dr Brescia et al. was unequivocally the most cited article dealing with hemodialysis access (1109 citations). The subject matter of the papers included AV fistula and graft (9), hemodialysis catheter (9), complications and outcomes (24), and other topics (8). Most articles were published in nephrology journals (33), with fewer in surgery (7), medicine (7), and radiology (3) journals. Of the 17 journals represented, Kidney International was the clear leader, publishing 18 articles. There has been an exponential rise in the frequency of publications regarding dialysis access with 42 of 50 analyzed papers being authored after 1990. Conclusion As the number of patients on hemodialysis has increased dramatically over the past five decades, there has been a commensurate increase in the overall number of publications related to hemodialysis access.

Risk factors for unplanned readmission and stump complications after major lower extremity amputation.

OBJECTIVE: The unplanned 30-day readmission rate is a marker of quality of patient care across many disciplines. Data regarding risk factors for unplanned readmission after major lower extremity amputation (LEA) are limited. We evaluated predictors of readmission at our institution after major LEA. METHODS: We conducted a retrospective review of all patients undergoing above-knee amputation (AKA) or below-knee amputation (BKA) between November 2009 and November 2014. Patient demographic variables were collected. Predictors of unplanned 30-day readmission and stump complications were determined by multivariable logistic regression. RESULTS: A total of 811 patients were identified (AKA, 325; BKA, 486). Of these, 739 patients were included in the final analysis after excluding 30-day decedents without readmission. The overall 30-day readmission rate was 28.8% (AKA 27.9%; BKA 29.4%; P = .730). Stump complications accounted for 28.6% of readmissions (16.5% of AKA; 35.8% of BKA; P = .004). Other common diagnoses included nonsurgical site infection (33.8%), exacerbation of congestive heart failure (7.0%), and diabetes-related complications (6.1%). Surgical intervention was performed on 61% of stump complications (35.9% of AKA readmitted with stump complications; 68.7% of BKA readmitted with stump complications). BKA stump complications were converted to AKAs in 34.1% of cases (3.2% of the total BKA). None of the AKA stump complications required a higher level of amputation (ie, hip disarticulation). Independent predictors of all 30-day readmission included coronary artery disease and end-stage renal disease. American Society of Anesthesiologists class 3 as compared with class 4 was protective. Independent predictors of 30-day readmission for stump complications included rest pain and BKA. Patients who underwent BKA, rest pain as an indication for amputation, and having an occluded bypass graft were predictors of having a stump complication requiring surgery. CONCLUSIONS: The 30-day readmission rate after major LEA is high, with wound infections accounting for a significant proportion of these readmissions. There was no difference in readmission rates based on level of amputation. Those undergoing BKA were more likely to present with stump complications requiring a surgical intervention, and often a higher level of amputation. Identification of high-risk patients may play a role in reducing postoperative readmissions and stump complications.

Statin use and other factors associated with mortality after major lower extremity amputation.

OBJECTIVE: Above-knee amputations (AKAs) and below-knee amputations (BKAs) are associated with high postoperative mortality rates. In this study, we examined factors associated with 30-day, 90-day, and 1-year mortality in patients who underwent a major lower extremity amputation. METHODS: We queried a prospectively collected institutional database for all patients who underwent AKA or BKA with primary or secondary closure, during a 5-year period, between November 2009 and November 2014. Predictors of 30- and 90-day mortality were determined by multivariable logistic regression, and risk indexes for 1-year mortality were determined with Cox proportional hazards model. RESULTS: We identified 811 patients who underwent AKA (n = 325) or BKA (n = 486). The 30-day mortality was 8.4% (AKA, 13.5%; BKA, 4.9%; P < .001) and 90-day mortality was 15.4% (AKA, 24.3%; BKA, 9.45%; P < .001). Predictors of 30-day mortality included AKA (odds ratio [OR], 3.09; 95% confidence interval [CI], 1.76-5.53), emergency operation (OR, 2.86; 95% CI, 1.56-5.14), chronic obstructive pulmonary disease (OR, 3.09; 95% CI, 1.07-7.81), end-stage renal disease (ESRD) on hemodialysis (HD; OR, 2.35; 95% CI, 1.24-4.33), and chronic kidney disease stages 3 (OR, 1.84; 95% CI, 1.00-3.37) and 4 (OR, 2.33; 95% CI, 1.01-4.98). Predictors of 90-day mortality included age (OR, 1.02; 95% CI, 1.00-1.04), ESRD on HD (OR, 2.56; 95% CI, 1.55-4.22), AKA (OR, 2.61; 95% CI, 1.70-4.05), history of coronary artery bypass grafting (OR, 2.04; 95% CI, 1.06-3.87), and medium-intensity or high-intensity statin (OR, 0.46; 95% CI, 0.29-0.73). One-year survival for the overall cohort was 73.7% (95% CI, 70.8%-76.8%). Predictors of 1-year mortality included AKA (hazard ratio [HR], 2.07; 95% CI, 1.54-2.77), coronary artery bypass grafting (HR, 1.57; 95% CI, 1.07-2.32), age >70 years (HR, 1.39; 95% CI, 1.02-1.88), gangrene (HR, 1.44; 95% CI, 1.07-1.94), ESRD on HD (HR, 1.96; 95% CI, 1.42-2.70), chronic obstructive pulmonary disease (HR, 2.54; 95% CI, 1.52-4.25), Caucasian race (HR, 1.62; 95% CI, 1.18-2.22), history of open lower extremity revascularization (HR, 0.71; 95% CI, 0.51-1.00) and undergoing bilateral amputations (HR, 2.10; 95% CI, 1.06-4.15). In the year after amputation, medium-intensity statin (HR, 0.64; 95% CI, 0.47-0.87) and high-intensity statin (HR, 0.56; 95% CI, 0.33-0.95) conferred a mortality benefit. Low-intensity statins did not confer protection from mortality. At 1 year after amputation, only 44.7% of patients were receiving appropriate statin therapy. CONCLUSIONS: AKA and BKA have historically been associated with high mortality rates. Medium-intensity and high-intensity statin therapies were associated with a mortality benefit at 1 year. We have identified initiation of statin therapy in this high-risk population as a gap in patient care.

Strategies for Hemodialysis Access: A Vascular Surgeon's Perspective.

Problems related to hemodialysis access are a significant cause of morbidity and mortality in patients with end-stage renal disease. Physicians of all specialties who are involved in the placement and maintenance of vascular access for hemodialysis must have a long-term strategy for sequential placement of autogenous fistulas, transpositions, and prosthetic grafts to preserve access sites and to avoid long-term use of tunneled dialysis catheters. The Fistula First and KDOQI initiatives have provided strategies and algorithms for access placement in patients with chronic kidney disease. Preservation of veins should begin before dialysis access is necessary to achieve the goal of creating a primary arteriovenous (AV) fistula or transposition suitable for cannulation when dialysis is initiated. Prosthetic and biologic grafts offer reasonable alternatives when autogenous access is not feasible. Newer graft materials and conduits are under evaluation to improve long-term outcomes. Use of tunneled dialysis catheters should be discouraged and they should be considered a last resort for long-term access. We present a strategy from the perspective of a vascular surgeon for the sequential placement of AV fistulas, venous transpositions, and AV grafts in these challenging patients. We also discuss specific concerns regarding hemodialysis access in difficult patient populations such as the elderly patient and the morbidly obese patient.

Establishing patient-specific criteria for selecting the optimal upper extremity vascular access procedure.

OBJECTIVE: The Kidney Disease Outcome Quality Initiative and Fistula First Breakthrough Initiative call for the indiscriminate creation of arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) without providing patient-specific criteria for vascular access selection. Although the U.S. AVF rate has increased dramatically, several reports have found that this singular focus on increasing AVFs has resulted in increased AVF nonmaturation/early failure and a high prevalence of catheter dependence. The objective of this study was to determine the appropriateness of vascular access procedures in clinical scenarios constructed with combinations of relevant factors potentially influencing outcomes. METHODS: The RAND/UCLA Appropriateness Method was used. Accordingly, a comprehensive literature search was performed and a synthesis of results compiled. The RAND/UCLA Appropriateness Method was applied to 2088 AVF and 1728 AVG clinical scenarios with varying patient characteristics. Eleven international vascular access experts rated the appropriateness of each scenario in two rounds. On the basis of the distribution of the panelists' scores, each scenario was determined to be appropriate, inappropriate, or indeterminate. RESULTS: Panelists achieved agreement in 2964 (77.7%) scenarios; 860 (41%) AVF and 588 (34%) AVG scenarios were scored appropriate, 686 (33%) AVF and 480 (28%) AVG scenarios were scored inappropriate, and 542 (26%) AVF and 660 (38%) AVG scenarios were indeterminate. Younger age, larger outflow vein diameter, normal or obese body mass index (vs morbidly obese), larger inflow artery diameter, and higher patient functional status were associated with appropriateness of AVF creation. Older age, dialysis dependence, and smaller vein size were associated with appropriateness of AVG creation. Gender, diabetes, and coronary artery disease were not associated with AVF or AVG appropriateness. Dialysis status was not associated with AVF appropriateness. Body mass index and functional status were not associated with AVG appropriateness. To simulate the surgeon's decision-making, scenarios were combined to create situations with the same patient characteristics and both AVF and AVG options for access. Of these 864 clinical situations, 311 (36%) were rated appropriate for AVG but inappropriate or indeterminate for AVF. CONCLUSIONS: The results of this study indicate that patient-specific situations exist wherein AVG is as appropriate as or more appropriate than AVF. These results provide patient-specific recommendations for clinicians to optimize vascular access selection criteria, to standardize care, and to inform payers and policy. Indeterminate scenarios will guide future research.