Comparison of phenobarbital monotherapy to a benzodiazepine-based regimen for management of alcohol withdrawal syndrome in trauma patients.

BACKGROUND: Alcohol withdrawal syndrome (AWS) is associated with increased morbidity and mortality in the trauma population. Benzodiazepines (BZDs) are standard of care for AWS; however, given the risk of delirium with BZDs and reports of BZD-refractory withdrawal, phenobarbital (PHB) has emerged as an alternative therapy for AWS. Safety and efficacy studies of PHB for AWS in trauma patients are lacking. Our aim was to compare a BZD versus PHB protocol in the management of AWS in trauma patients. METHODS: We performed a retrospective cohort study at a level 1 trauma center of patients at risk for AWS managed with either a BZD or a low-dose oral PHB regimen. Patients were excluded if they were taking BZDs or barbiturates before admission, received propofol or dexmedetomidine before initiation of the study drug, presented with delirium tremens or seizures, or died or discharged within 24 hours of presentation. The primary outcome was complicated AWS (seizures or alcohol withdrawal delirium/delirium tremens). Secondary outcomes included uncomplicated AWS; therapy escalation; oversedation; delirium-, intensive care unit-, and ventilator-free days; and length of stay. RESULTS: A total of 411 patients were identified; 118 received BZD, and 293 received PHB. The odds of developing complicated AWS with PHB versus BZD-based therapy were not statistically significant (odds ratio [OR], 0.52; 95% confidence interval [CI], 0.21-1.39); however, patients receiving PHB were less likely to develop uncomplicated AWS (OR, 0.08; 95% CI, 0.04-0.14) and less likely to require escalation of therapy (OR, 0.45; 95% CI, 0.24-0.84). The PHB group had a length of stay 3.1 days shorter than the BZD group ( p = 0.002). There was no difference in intensive care unit-, ventilator-, or delirium-free days. CONCLUSION: A PHB-based protocol for the management of AWS is a safe and effective alternative to BZD-based regimens in trauma patients. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease.

OBJECTIVE: The Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. METHODS: A single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. RESULTS: The mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. CONCLUSIONS: In this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

Results of the North American Complex Abdominal Aortic Debranching (NACAAD) Registry.

BACKGROUND: Hybrid debranching repair of pararenal and thoracoabdominal aortic aneurysms was initially designed as a better alternative to standard open repair, addressing the limitations of endovascular repair involving the visceral aorta. We reviewed the collective outcomes of hybrid debranching repairs using extra-anatomic, open surgical debranching of the renal-mesenteric arteries, followed by endovascular aortic stenting. METHODS: Data from patients who underwent hybrid repair in 14 North American institutions during 10 years were retrospectively reviewed. Society of Vascular Surgery scores were used to assess comorbidity risk. Early and late outcomes, including mortality, morbidity, reintervention, and patency were analyzed. RESULTS: A total of 208 patients (118 male; mean age, 71±8 years old) were treated by hybrid repair with extraanatomic reconstruction of 657 renal and mesenteric arteries (mean 3.2 vessels/patient). Mean aneurysm diameter was 6.6±1.3 cm. Thoracoabdominal aortic aneurysms were identified in 163 (78%) patients and pararenal aneurysms in 45 (22%). A single-stage repair was performed in 92 (44%) patients. The iliac arteries were the most common source of inflow (n=132; 63%), and most (n=150; 72%) had 3 or more bypasses. There were 30 (14%) early deaths, ranging widely across sites (0%-21%). A Society of Vascular Surgery comorbidity score >15 was the primary predictor of early mortality (P<0.01), whereas mortality was 3% in a score ≤9. Early complications occurred in 140 (73%) patients and included respiratory complications in 45 patients (22%) and spinal cord ischemia in 22 (11%), of whom 10 (45%) fully recovered. At 5 years, survival was 61±5%, primary graft patency was 90±2%, and secondary patency was 93±2%. The most significant predictor of late mortality was renal insufficiency (P<0.0001). CONCLUSIONS: Mortality after hybrid repair and visceral debranching is highly variable by center, but strongly affected by preoperative comorbidities and the centers' experience with the technique. With excellent graft patency at 5 years, the outcomes of hybrid repair done at centers of excellence and in carefully selected patients may be comparable (or better) than traditional open or even totally endovascular approaches. However, in patients already considered as high-risk for surgery, it may not offer better outcomes.

Delayed referral of venous ulcers increases resource usage.

OBJECTIVE: Venous insufficiency is often not readily recognized as a contributing etiology to nonhealing wounds by nonvascular surgery specialists, potentially delaying appropriate treatment to achieve wound healing and increasing healthcare costs. The objective of the present study was to understand the time and resources used before the definitive treatment of venous ulcers. METHODS: A single-institution retrospective medical record review of C6 patients undergoing radiofrequency saphenous and perforator vein ablation from May 2016 to January 2018 identified 56 patients with 67 diseased limbs. The numbers of inpatient, emergency department, and wound care visits and the intervals to vein ablation from the initial evaluation of the ulceration by a healthcare provider were collected. The demographics, comorbidities, previous venous interventions, wound characteristics, duplex ultrasound imaging, and available wound healing follow-up through July 2018 were assessed for all patients. RESULTS: For the 67 limbs examined, 588 total healthcare visits were performed for wound assessment before a referral to a vascular surgeon, with 413 visits at a wound care center (70% of all visits). Other specialty visits included emergency medicine (17.9% of limbs) and rheumatology (22.4% of limbs). Six patients (nine limbs) were admitted to inpatient services for treatment of their ulceration. Overall, the patients were seen an average of 8.6 ± 9.7 times for their ulcer with the wound center before determination of a contributing venous etiology and subsequent treatment. These visits translated to a median of 230 days (interquartile range, 86.5-1088 days) between the first identification of the ulcer by healthcare providers and subsequent accurate diagnosis and definitive treatment of their venous disease with radiofrequency saphenous and perforator vein ablation. After intervention, 18.64% of the limbs had healed at 1 month, 33.92% had healed at 3 months, 50% had healed at 6 months, and 82.92% had healed by 12 months. CONCLUSIONS: An earlier and accurate diagnosis of the venous contribution to ulcers and subsequent appropriate treatment of venous etiologies in wound formation by a vascular venous specialist could significantly improve healing and minimize resource usage.

Optimization of factors for the prevention of spinal cord ischemia in thoracic endovascular aortic repair.

OBJECTIVES: Spinal cord ischemia following thoracic endovascular aortic repair (TEVAR) is a devastating complication. This study seeks to demonstrate how a standardized protocol to prevent spinal cord ischemia affects incidence in patients undergoing TEVAR. METHODS: Using CPT codes 33880 and 33881, all TEVAR procedures performed at a single tertiary care center from January 2017 to December 2018 were examined. Patients who had concomitant ascending aortic repairs or a TEVAR for traumatic indications were excluded from analysis, leaving 130 TEVAR procedures. Comorbid conditions, procedural characteristics, extent of coverage, peri-procedural management strategies, and post-operative outcomes were collected and analyzed retrospectively. RESULTS: One hundred thirty patients undergoing TEVAR were examined for four perioperative variables: postoperative hemoglobin greater than 10 g/dL, subclavian revascularization, preoperative spinal drain placement, and somatosensory evoked potential monitoring (SSEP). All conditions were met in 46.2% (60/130) of procedures; 37.8% (28/74) in emergent/urgent cases and 61.5% (32/52) in elective cases. Of patients who required subclavian coverage, 87.1% (54/62) underwent subclavian revascularization; 70.8% (92/130) of patients received spinal drains preoperatively; 68.5% (89/130) of patients had SSEP monitoring; 73.8% (93/130) of patients obtained a postoperative hemoglobin of >10 g/dL. Out of all patients, two (1.5%) developed spinal cord ischemia. CONCLUSION: Incidence of spinal cord ischemia in our cohort was low at 1.5% (2/130). Individual and bundled interventions for the prevention of spinal cord ischemia were unable to demonstrate a statistically significant effect given the low rate. Nonetheless, we advocate for a proactive approach for the prevention of spinal cord ischemia given our experience in this complex population.

Transcarotid Arterial Revascularization Adoption Should not Be Hindered by a Concern for a Long Learning Curve.

BACKGROUND: Transcarotid arterial revascularization (TCAR) offers a novel technique for carotid artery stenting (CAS) that provides flow reversal in the carotid artery and avoids aortic arch manipulation, thus, potentially lowering ipsilateral and contralateral periprocedural stroke rates. As a new technology, adoption may be limited by concern for learning a new technique. This study seeks to examine the number of cases needed for a surgeon to reach technical proficiency. METHODS: Retrospective analysis was performed using a prospectively collected database of all TCAR procedures performed in a tertiary health care system between 2016 and 2020. Patient demographics and anatomic characteristics were collected. Intraoperative variables and perioperative outcomes were examined. These variables were collated into groups for the first 4 procedures, procedures 5-8, and after 8. Independent Samples t test, 1-way ANOVA, and logarithmic regression were used to statistically analyze the data. RESULTS: One-hundred and eighty-seven TCARs were performed by 14 surgeons. One hundred and twenty-two (65%) were male, 59 (32%) were older than 75 years, and 83 (44%) were symptomatic. The most common indications were high-lesions in 87 patients (47%) and recurrent stenosis after CEA in 37 patients (20%). Significant differences were found between the first and second groups of 4 cases when comparing mean operative time (71 vs. 58 min; P = 0.001) and flow reversal time (10.8 vs. 7.9 min; P= 0.004). similar significant differences were found between the first and third groups of 4 cases but not between the second and third groups. There was a reduction in contrast usage and fluoroscopy time after the first 4 cases, however, this did not reach statistical significance. There was no ipsilateral perioperative strokes. One patient had a contralateral stroke on postoperative day 2 due to intracranial atherosclerosis, and there was one perioperative mortality that occurred on postoperative day 3 after discharge. CONCLUSIONS: Procedural and flow reversal times significantly shorten after 4 TCAR procedures are performed. Other metrics, such as fluoroscopy time and contrast usage, are also decreased. Complications, in general, are minimal. Proficiency in TCAR, as measured by these metrics, is met after performing only 4 procedures.

The risks and benefits of early venous thromboembolism prophylaxis after elective spinal surgery: A single-centre experience.

BACKGROUND: There is a wide ranging incidence of venous thromboembolism after surgery and it continues to be a major cause of morbidity after spinal procedures.This study's aim was to investigate the relationship between timing and administration of venous thromboembolism (VTE) pharmacologic chemoprophylaxis after spinal surgery and the resulting VTE and bleeding complications by reviewing current practices and outcomes at a high-volume single institution to better define opportunities for perioperative intervention to prevent VTE without increasing bleeding complications. METHODS: All patients who underwent elective one or two-stage lumbar spinal fusion procedures were identified. A logistic regression was used to evaluate (1) risk of symptomatic VTE within 30 days of surgery and (2) bleeding-related complications. The odds of developing a VTE as well as bleeding-related complications were compared among the three treatment groups: no chemoprophylaxis, chemoprophylaxis < 24h of surgery and chemoprophylaxis given > 24h post-surgery. RESULTS: When adjusted for doses administered, the odds of developing a postoperative VTE within 30 days were 0.189 (95% confidence interval (0.044, 0.808)) in patients who received anticoagulation < 24h postoperatively, compared to those who received no anticoagulation (p = 0.025). There was no difference in bleeding rates. CONCLUSION: Patients undergoing elective spinal surgery who received anticoagulation within 24h of the conclusion of their procedure had an 81% reduction in the odds of developing a deep vein thrombosis within 30 days with no significant difference in bleeding complications.

The need for perforator treatment after VenaSeal and ClosureFast endovenous saphenous vein closure in CEAP 6 patients.

OBJECTIVE: The authors have previously demonstrated that VenaSeal (Medtronic, Inc, Minneapolis, Minn) adhesive, compared with radiofrequency ablation (RFA, ClosureFast; Medtronic, Inc), in treatment of refluxing saphenous veins in CEAP 6 limbs, results in shorter healing times of venous ulcers. The authors hypothesize that the longer treated length possible with VenaSeal's nonthermal modality may affect the number of critical refluxing perforators contributing to the nonhealing wound. This follow-up study compares the need for follow-up treatment of perforator veins after saphenous vein treatment with either radiofrequency ablation (ClosureFast RFA) or adhesive closure (VenaSeal). METHODS: A multi-institutional retrospective review of CEAP 6 patients who had closure of their saphenous veins from 2015 to 2020 was conducted. Patients who underwent follow-up treatment of perforator veins were grouped according to their method of initial management of their saphenous veins. The primary end point was incidence of a perforator procedure after ClosureFast or VenaSeal ablation. Secondary end points included sclerotherapy to facilitate wound healing. Bivariate analysis used the χ2 test, Fisher exact test, t-test, and Wilcoxon rank sum test. A P value of <.05 defined statistical significance. RESULTS: There were 119 CEAP 6 patients with saphenous closure: 51 limbs treated with VenaSeal and 68 with RFA. Median follow-up was 105 days (interquartile range: 44, 208). All limbs achieved wound healing during the study period. Mean time to wound healing post index procedure was shorter for VenaSeal than RFA (72 vs 293.8 days, P > .0009), as was median time (43 vs 104 days, P = .001). More limbs treated with RFA had previous known deep vein thrombosis (29% vs 10%, P = .009), deep venous insufficiency (82% vs 51%, P = .0003), and perforator reflux (57% vs 29%, P = .002). Limbs with identified follow-up perforator reflux treated with RFA had a higher prevalence of initially treated saphenous veins with RFA compared with those treated with VenaSeal (49% vs 27%, P = .003). There was no difference between the methods of vein closure and use of concurrent sclerotherapy. CONCLUSIONS: ClosureFast and VenaSeal are both effective and safe modalities of saphenous ablation, but VenaSeal treatment was associated with less perforator RFA intervention.

Results of Obturator Foramen Bypass in Patients with Groin Infection and Arterial Involvement.

BACKGROUND: Arterial bypass tunneling via the obturator foramen (OFB) can be performed to circumvent groin infections during lower extremity revascularization. The objective of this study is to report safety and efficacy outcomes of OFB in the setting of infected femoral pseudoaneurysms and infected prosthetic femoral bypass grafts. METHODS: A multihospital, single-entity healthcare system retrospective review was conducted for all patients who underwent OFB between January 2014 through June 2020. Any patient >18 years of age who underwent OFB in the setting of groin infection with a minimum of 30 days follow-up was included in the trial. Demographic, operative, and clinical characteristics of patients were gathered during chart review. Statistical analysis was performed using Microsoft Excel and R studio. RESULTS: Seventeen patients underwent OFB during the defined time-period. Demographic data are presented in the first table (Demographic Characteristics). Mean American Society of Anesthesiologists score was 3.25. Mean estimated blood loss was 500 mL. Mean operative time was 307 min. Mean follow-up time was 8.5 months (range 0-35 months). In total, 41.2% patients underwent fluoroscopic-guided tunneling, and, when compared to blind tunneling, showed no difference in intraoperative complications or operative time (P value 0.3). In total, 52.9% of patients required ICU admission resulting in a mean number of 0.8 ICU days. The overall mean length of stay was 16.8 days. Two major amputations were reported during follow-up. Patient mortality within 30 days was 0%. Primary patency within 30 days was 100%. Intravenous drug use was not associated with an increased number of subsequent groin wound procedures (P value 0.3). Intravenous drug use was not associated with concomitant methicillin-resistant Staphylococcus aureus infection (P value 0.3). CONCLUSION: OFB is a safe and effective surgical option in patients who are unable to undergo anatomic tunneling during lower extremity bypass. OFB is associated with favorable rates of primary patency and amputation-free survival at midterm follow-up.

Systematic review and meta-analysis of endovascular interventions for Stanford type A aortic dissection.

OBJECTIVE: The standard surgical approach to Stanford type A aortic dissection is open repair. However, up to one in four patients will be declined surgery because of prohibitive risk. Patients who are treated nonoperatively have an unacceptably high mortality. Endovascular repair of the ascending aorta is emerging as an alternative treatment for a select group of patients. The reported rates of technical success, mortality, stroke, and reintervention have varied. The objective of the study was to systematically report outcomes for acute type A dissections repaired using an endovascular approach. METHODS: The systematic review and meta-analysis was conducted in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. We performed online literature database searches through April 2020. The demographic and procedural characteristics of the individual studies were tabulated. Data on technical success, short-term mortality, stroke, and reintervention were extracted and underwent meta-analysis using a random effects model. RESULTS: Fourteen studies with 80 cases of aortic dissection (55 acute and 25 subacute) were included in the final analysis. A wide variation was found in technique and device design across the studies. The outcomes rates were estimated at 17% (95% confidence interval [CI], 10%-26%) for mortality, 15% (95% CI, 8%-23%) for technical failure, 11% (95% CI, 6%-19%) for stroke and 18% (95% CI, 9%-31%) for reintervention. The mean Downs and Black quality assessment score was 13.9 ± 3.2. CONCLUSIONS: The technique for endovascular repair of type A aortic dissection is feasible and reproducible. The results of our meta-analysis demonstrate an acceptable safety profile for inoperable patients who otherwise would have an extremely poor prognosis. Data from clinical trials are required before the technique can be introduced into routine clinical practice.

Parallel Grafting Should Be Considered as a Viable Alternative to Open Repair in High-Risk Patients With Paravisceral Aortic Aneurysms.

BACKGROUND: Parallel grafting presents a viable method for treating patients with complex aortic aneurysms. The current literature is limited to mostly pararenal configurations. We examined our results in patients with SMA and/or Celiac artery involvement. METHODS: A retrospective analysis was performed for all patients undergoing parallel grafting during the period of 2014 to 2018 at a single institution. All patients had at least SMA with and/or without Celiac artery parallel grafting. RESULTS: Seventy-nine patients (65% male, median age 74) were treated with 208 parallel grafts. Median ASA score is 4. Forty-nine cases were elective, 22 urgent, and 8 emergent. Mean pre-operative aneurysm diameter was 7.1 cm (4.6-15 cm). Self-expanding covered stents were used for the renal arteries (mean 6.3mm), and balloon-expandable covered stents were used for the SMA and Celiac (mean SMA 8.6 mm, mean celiac 8.3 mm). Axillary exposure was the choice of access in 68 patients (86%). Technical success was achieved in all cases. We defined this as aneurysm sac exclusion with patent visceral stent grafts, and absent to mild gutter leaks. Mean aortic graft proximal seal achieved was 48mm. Coverage extended above the celiac artery in 75% (10% stented and 65% covered). Median contrast volume was 145ml, operative duration was 4 hours, fluoroscopy time was 56 min, and EBL was 250 ml. Perioperative mortality was 6.1%. 4.5%, and 25%, for the elective, urgent, and emergent groups, respectively. There was no incidence of spinal cord ischemia. Axillary access was complicated in 4 patients, requiring patch closure of the axillary artery. One patient developed postprocedural ESRD from a rupture and ATN despite patent renal stents. Of those patients with a patent GDA and celiac coverage, 2 required a cholecystectomy. Nine patients had a persistent gutter leak at the conclusion of the procedure. Median follow-up was 12 months. On follow-up imaging, all SMA and Celiac stents were patent. Six renal stents were occluded and 2 patients progressed to ESRD, both solitary renal periscope configurations at the index procedure. Only 4 patients had persistent gutter leaks with 2 requiring reintervention. Ninety-five percent of patients demonstrated sac regression or stabilization with a mean sac size of 6.5 cm. CONCLUSIONS: Parallel grafting presents a safe, efficacious and off the shelf alternative to conventional repair of complex aortic aneurysms involving the visceral aorta.

Reporting standards for endovascular aortic repair of aneurysms involving the renal-mesenteric arteries.

Endovascular aortic aneurysm repair of complex aortic aneurysms requires incorporation of side branches using specially designed aortic stent grafts with fenestrations, directional branches, or parallel stent grafts. These techniques have been increasingly used and reported in the literature. The purpose of this document is to clarify and to update terminology, classification systems, measurement techniques, and end point definitions that are recommended for reports dealing with endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms involving the renal and mesenteric arteries.

Maximizing proximal seal zone in fenestrated endografting: Evolution in the approach to graft configuration.

OBJECTIVE: Fenestrated endografting for juxtarenal and pararenal abdominal aortic aneurysms affords the ability to seal stent grafts in normal aorta at and above the renal arteries. The Zenith fenestrated graft (ZFEN; Cook Medical, Bloomington, Ind) is custom-made to surgeon specifications, subject to certain manufacturing limitations. The most common configuration in the pivotal trial and in commercial use after approval has been as a scallop for the superior mesenteric artery (SMA) and two small fenestrations for the renal arteries (configuration A). An alternative configuration to maximize the seal zone length, consisting of a large fenestration for the SMA and two small fenestrations for the renal arteries (configuration B) has been routinely adopted at our institutions to potentially prevent type IA endoleak. METHODS: The present retrospective cohort study examined 100 consecutive ZFEN grafts designed for patients at two university centers from 2012 through 2019. The proximal seal length, measured from the top of the graft to the beginning of the aneurysm, was determined from the preoperative computed tomography angiograms. Alternative configurations were evaluated to determine whether they would have provided a longer proximal seal length. RESULTS: The two most common configurations were B (n = 45) and A (n = 38). For the cases in which A had been chosen but B could have been built, 5.8 ± 1.9 mm of seal zone length was lost. For the cases in which B was chosen but A could have been built, 5.8 ± 2.8 mm of seal zone length was gained. Owing, in part, to the increased proximal seal length with configuration B, this configuration has been used more frequently in the past 4 years of the present study compared with the first four (53% vs 25%; P = .004). Of 95 patients who had completed surgery and follow-up, type IA endoleaks were observed in 12 (13%) on completion angiography, all of which had resolved on follow-up imaging without intervention. No SMA was compromised by misalignment of the large fenestration in configuration B. CONCLUSIONS: A significantly longer proximal seal length can be obtained using a ZFEN with a large fenestration for the SMA and two small fenestrations for the renal arteries. Whenever possible, surgeons should consider this configuration to maximize the proximal seal length and potentially reduce the risk of proximal endoleak. An additional advantage of this approach is that stenting of the SMA to prevent shuttering will be unnecessary or impossible, making the procedure more technically facile.

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.

Reinstating Elective Surgeries in MedStar Health: A Roadmap for Healthcare Organizations.

Introduction: Coronavirus disease 2019 (COVID-19) infections have strained hospital resources worldwide. As a result, many facilities have suspended elective operations and ambulatory procedures. As the incidence of new cases of COVID-19 decreases, hospitals will need policies and algorithms to facilitate safe and orderly return of normal activities. We describe the recommendations of a task force established in a multi-institutional healthcare system for resumption of elective operative and ambulatory procedures applicable to all hospitals and service lines. Methods: MedStar Health created a multidisciplinary task force to develop guidelines for resumption of elective surgeries/procedures. The primary focus areas included the establishment of a governance structure at each healthcare facility, prioritization of elective cases, preoperative severe acute respiratory syndrome coronavirus 2 testing, and an assessment of the needs and availability of staff, personal protective equipment, and other essential resources. Results: Each hospital president was tasked with establishing a local perioperative leadership team answering directly to them and granted the authority to prioritize elective surgery and ambulatory procedures. An elective surgery algorithm was established using a simplified Medically Necessary Time Sensitive score, with multiple steps requiring a "go/no-go" assessment based on local resources. In addition, mandatory preoperative COVID testing policies were developed and operationalized. Conclusions: Even when the COVID pandemic has passed, hospitals and surgical centers will require COVID screening and testing, case prioritization, and supply chain management to provide care essential to the surgical patient while protecting their safety and that of staff. Our guidelines consider these factors and are applicable to both tertiary academic medical centers and smaller community facilities.

Evaluating the Impact of Auto-Calculation Settings on Opioid Prescribing at an Academic Medical Center.

BACKGROUND: Overprescribing of opioids is a key contributor to the opioid epidemic, which has led to a substantial increase in overdose deaths. The purpose of this study was to evaluate the discontinuation of a dispense quantity automatic calculation function on prescribing of as needed (PRN) opioids. METHODS: During the implementation of a new electronic health record (EHR), Vanderbilt University Medical Center discontinued functionality that autocalculated the maximum needed dispense quantity for PRN outpatient prescription opioids. This study analyzed prescribing trends for immediate-release hydrocodone- and oxycodone-containing prescriptions 90 days before and after implementation of the new EHR. RESULTS: A total of 21,323 prescriptions were analyzed in the preintervention group and 22,730 prescriptions in the postintervention group. Discontinuing the autocalculation functionality resulted in a mean decrease of 1.4 dispense units per prescription (58.5 vs. 57.1; p = 0.006) across all patient care areas. The most significant finding was a 10.5% relative decrease in dispense units from inpatient discharge prescriptions (37.2 vs. 33.3; p < 0.001). In the new EHR, PRN oxycodone products defaulted to a dispense quantity of 30, which resulted in a 142.0% (10.0% vs. 24.2%; p < 0.001) increase in oxycodone prescriptions ordered for 30 dispense units but was a net reduction in the doses dispensed per oxycodone prescription. CONCLUSION: This study suggests that removing the autocalculation functionality reduced the number of opioid units ordered. In addition, using a default dispense quantity for PRN opioid prescriptions may decrease the number of opioid dispense units per prescription.

Multicenter study of retrograde open mesenteric artery stenting through laparotomy for treatment of acute and chronic mesenteric ischemia.

OBJECTIVE: Retrograde open mesenteric stenting (ROMS) through laparotomy was introduced as an alternative to surgical bypass in patients with acute mesenteric ischemia (AMI). The purpose of this study was to evaluate the indications and outcomes of ROMS for treatment of AMI and chronic mesenteric ischemia. METHODS: We reviewed the clinical data and outcomes of all consecutive patients treated by ROMS in seven academic centers from 2001 to 2013. ROMS was performed through laparotomy with retrograde access into the target mesenteric artery and stent placement using a retrograde or antegrade approach. End points were early (<30 days) and late mortality, morbidity, patency rates, and freedom from symptom recurrence and reintervention. RESULTS: There were 54 patients, 13 male and 41 female, with a mean age of 72 ± 11 years. Indications for ROMS were AMI in 44 patients (81%) and subacute-on-chronic mesenteric ischemia with flush mesenteric occlusion in 10 patients (19%). A total of 56 target mesenteric vessels were stented, including 52 superior mesenteric arteries and 4 celiac axis lesions, with a mean treatment length of 42 ± 26 mm. Retrograde mesenteric access was used in all patients, but 16 patients also required a simultaneous antegrade brachial approach. The retrograde puncture was closed primarily in 34 patients and with patch angioplasty in 17 patients; 1 patient had manual compression. Bowel resection was needed in 29 patients (66%) with AMI because of perforation or gangrene. Technical success was achieved in all (98%) except one patient for whom ROMS failed, who was treated by bypass. Early mortality was 45% (20/44) for AMI and 10% (1/10) for subacute-on-chronic mesenteric ischemia (P = .04). Early morbidity was 73% for AMI and 50% for subacute-on-chronic mesenteric ischemia (P = .27). Patient survival for the entire cohort was 43% ± 9% at 2 years. Primary patency and secondary patency at 2 years were 76% ± 8% and 90% ± 8%, respectively. Freedom from symptom recurrence and freedom from reinterventions were 72% ± 8% and 74% ± 8% at the same interval. CONCLUSIONS: ROMS offers an alternative to bypass or percutaneous stenting in patients with AMI who require abdominal exploration and in those who have flush mesenteric occlusions and have failed to respond to or are considered unsuitable for stenting by a percutaneous approach. Despite high technical success, mortality remains elevated in patients with AMI. Patency rates and freedom from symptom recurrence and reinterventions are comparable to the results achieved with stenting using percutaneous technique.

Management of Difficult Access during Endovascular Aneurysm Repair.

BACKGROUND: To describe a large single-institutional experience in managing challenging access situations during endovascular aneurysm repair (EVAR). METHODS: Data from all patients undergoing EVAR at a tertiary academic medical center between 2009 and 2013 were collected retrospectively, including demographics, size of iliac arteries, type of device used, approach to managing difficult access (DA), and outcomes. The median follow-up was 38 months. DA was defined as iliac arteries with a diameter of less than 7 mm bilaterally. Fenestrated and snorkel repairs were excluded. RESULTS: Of 400 EVARs performed during the study period, 191 (48%) were done in patients with DA. Of the DA patients, 35 (18.3%) underwent 42 adjuncts before the introduction of the main body device: including 15 dilators, 11 balloon angioplasties, 9 aortouniiliac devices, 3 SoloPath sheaths, 1 retroperitoneal cutdown, and 3 iliac stents. In another 29 patients, iliac stents were used to correct stenoses or kinks in the limbs after EVAR devices were deployed. The average diameter of the iliac artery used to deliver main body component was 4.6 mm in the group of patients requiring adjuncts and 5.4 mm in the remainder of the patients with small iliac arteries (P = 0.008). The median size of the main body device was 28 mm. Two cases were aborted due to inability to deliver the device. Other complications included 7 (3.6%) iliac ruptures, 3 (1.6%) instances of limb ischemia, and 5 (2.6%) patients needed early reoperation (within 30 days). Two patients (1%) had type I endoleaks at the conclusion of EVAR. During follow-up, 12 (6.3%) patients required EVAR revisions. Seven patients (3.6%) had limb thrombosis which occurred only in patients who did not have adjective procedures during the initial EVAR. Limb thrombosis and rate of revisions in patients with DA were not significantly different from the rates observed in non-DA patients. Perioperative mortality after elective repairs was 1.6% in DA patients and 0% in non-DA patients (P = 0.12). CONCLUSIONS: EVAR can be successfully performed in patients with bilateral small iliac arteries. Adjunctive procedures might increase the technical success rate of EVAR in these patients and should definitely be considered in patients with iliac arteries less than 5 mm in diameter. Next generation and "low-profile" devices might minimize the need for adjunctive procedures and facilitate EVAR in these patients.

Evaluating the venous experience in vascular surgery training.

OBJECTIVE: There is an increasing recognition and treatment of venous disease in the United States; results of the Society for Vascular Surgery 2014 membership survey showed that venous disease represents 18.8% of a vascular surgeon's current practice. Despite this, there are no operative objectives or case requirements specific to venous disease for vascular surgery trainees. The objective of this study was to examine the current venous surgical training experience of graduating vascular surgery trainees. METHODS: Following Institutional Review Board waiver and Association of Program Directors in Vascular Surgery and Residency Review Committee approval, results of the 2014 Association of Program Directors in Vascular Surgery Educational Needs Assessment Survey pertinent to venous training as well as the Vascular Surgery In-Training Examination (VSITE) venous scores were summarized. Using the Residency Review Committee case log database, venous case logs of 0/5 resident and 5/2 fellow vascular surgery graduates from 2012 to 2015 differentiated by Current Procedural Technology code were summarized. Venous case logs of 0/5 vascular surgery residents were compared with those of 5/2 fellows using a Student t-test, with results considered statistically significant at P < .05. RESULTS: Of the recent vascular surgery graduates, 15% thought they encountered training gaps in venous procedures; 54% thought this was due to a gap in vascular surgery training, whereas 43% thought this was due to evolution in technology. Venous VSITE scores were similar between 0/5 residents and 5/2 fellows (69% vs 76% correct answers, respectively), as were overall VSITE scores (70% vs 74% correct answers, respectively). The 0/5 residents completed between 11 and 264 cases and 5/2 fellows completed between 1 and 188 cases during their training. The 0/5 residents' venous cases were 8.1% of overall cases and the 5/2 fellows' cases were 4.3% of overall cases during their training. CONCLUSIONS: Current vascular surgery trainee experience is highly variable and not consistent with future vascular surgery clinical practice. Vascular surgery trainee fund of knowledge does not appear affected. Program directors should consider developing a better-defined venous curriculum that includes venous case minimums in defined categories.