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.

Closed incision negative pressure wound therapy may decrease wound complications in major lower extremity amputations.

OBJECTIVE: Wound complications after major lower extremity amputations (LEAs) are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are few data on its use in major LEAs. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would decrease the risk of complications as compared with a standard dressing in patients with peripheral vascular disease undergoing major LEA. METHODS: Fifty-four consecutive patient limbs with a history of peripheral arterial disease underwent below-knee or above-knee amputations. This was a retrospective review of a prospectively maintained database from January 2018 to December 2019, and it included 23 amputations in the NPWT group and 31 amputations in the standard dressing group. NPWT using the PREVENA system was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a nonadherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value of less than .05 was considered statistically significant. RESULTS: For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared with the standard group (44% vs 13%; P = .011), as well as trends toward increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared with the standard group (52% vs 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared with the standard group (13% vs 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI, and one incision line necrosis. In the standard group, there were four wound dehiscences with deep SSI, three superficial SSIs, four incision line necroses, and one stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard groups (3% vs 4% and 4.3% vs 10%, respectively). CONCLUSIONS: Closed incision NPWT may decrease the incidence of wound complications in vascular patients undergoing major LEA. This held true even among a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.

Endovascular treatment of popliteal artery aneurysms has comparable long-term outcomes to open repair with shorter lengths of stay.

OBJECTIVE: During the past two decades, the treatment of popliteal artery aneurysms (PAAs) has undergone a transformation. Although open surgical repair (OR) has remained the reference standard for treatment, endovascular repair (ER) has become an attractive alternative for select patient populations. The objective of the present study was to compare the outcomes of OR vs ER of PAAs at a single institution. METHODS: We performed a retrospective review of the medical records for all patients who had undergone repair for PAAs from 1998 to 2017. The baseline patient, anatomic, and operative characteristics and outcomes were compared between the OR and ER cohorts. Intervention and treatment were at the discretion of the surgeon. RESULTS: From 1998 to 2017, 64 patients had undergone repair of 73 PAAs at our tertiary care center. Of the 69 patients (73 PAAs), 29 (33 PAAs) had undergone OR and 35 (40 PAAs) had undergone ER. When comparing the two cohorts, no statistically significant differences were found in the demographic characteristics such as age, gender, or number of runoff vessels. Significantly more patients in the ER group (n = 21; 53%) than in the OR group (n = 7; 21%) had had hyperlipidemia (P = .008) and a previous carotid intervention (6% vs 0%; P = .029). Overall, the presence of symptoms was similar between the two groups. However, the OR group had a significantly higher number of patients who had presented with acute ischemia (P = .01). The length of stay was significantly shorter for the ER cohort (mean, 1.8 days; range, 1-11 days) than for the OR group (mean, 5.4 days; range, 2-13 days; P < .0001). No significant difference was found in the primary or secondary patency rates between the two groups. In the ER group, good runoff (two or more vessels) was a positive predictor for primary patency at 1 year (odds ratio, 3.36; 95% confidence interval, 1.0-11.25). However, it was not in the OR group. Postoperative single and/or dual antiplatelet therapy did not affect primary patency in either cohort. CONCLUSIONS: The results of our study have demonstrated that ER of PAAs is a safe and durable option with patency rates comparable to those with OR and a decreased length of stay, with good runoff a positive predictor for primary patency in the ER cohort.

Adjunctive false lumen intervention for chronic aortic dissections is safe but offers unclear benefit.

OBJECTIVE: Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, these data are derived from small single-institution experiences and the potential benefit of FLE remains unproven. In this study, we examined perioperative and midterm outcomes of patients with aortic dissection undergoing concomitant TEVAR and FLE.* METHODS: : Patients 18 or older who underwent TEVAR for chronic aortic dissection with known FLE status in the Society for Vascular Surgery Vascular Quality Initiative database between January 2010 and February 2020 were included. Ruptured patients and emergent procedures were excluded. Patient characteristics, operative details and outcomes were analyzed by group: TEVAR with or without FLE. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up mean maximum aortic diameter change, rates of false lumen thrombosis, re-intervention rates, and mortality. RESULTS: 884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, prior aortic interventions, mean maximum pre-operative aortic diameter (5.1cm vs. 5.0cm, P=0.43), presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, P=0.0002), increased contrast use (134mL vs. 113mL, P=0.02), and prolonged fluoroscopy time (34min vs. 21min, P<0.0001). However, FLE was not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, P=0.51), length of stay (6.5 vs. 5.7 days, P=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, P=1). In mid-term follow-up (median 15.5months, IQR 2.2-36.2 months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); and Kaplan-Meier analysis demonstrated no difference in overall survival between groups (P=0.23). By Cox regression analysis, post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, P<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, P=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, P=1) were similar. CONCLUSIONS: Adjunctive FLE, despite increased procedural times, can be performed safely for patients with chronic dissection without significantly higher overall perioperative morbidity or mortality. TEVAR/FLE demonstrates trends for improved survival and increased rates of FL thrombosis in the treated thoracic segment; however, given the lack of evidence to suggest a significant reduction in re-intervention rates or induction of more favorable aortic remodeling compared to TEVAR alone, the overall utility of this technique in practice remains unclear. Further investigation is needed to determine the most appropriate role for FLE in managing chronic aortic dissections.

Intrathoracic subclavian artery aneurysm repair in the thoracic endovascular aortic repair era.

OBJECTIVE: Intrathoracic subclavian artery aneurysms (SAAs) are rare aneurysms that often occur in association with congenital aortic arch anomalies and/or concomitant thoracic aortic pathology. The advent of thoracic endovascular aortic repair (TEVAR) methods may complement or replace conventional open SAA repair. Herein, we describe our experience with SAA repair in the TEVAR era. METHODS: A retrospective review was performed of all intrathoracic SAAs repaired at a single institution since United States Food and Drug Administration approval of TEVAR in 2005. RESULTS: Nineteen patients underwent 20 operations to repair 22 (13 native, nine aberrant) SAAs with an intrathoracic component. Mean SAA diameter was 3.1 cm (range, 1.6-6.0 cm). Mean patient age was 57 years (range, 24-80 years). Twenty-one percent (n = 4) of patients had a connective tissue disorder (two Loeys-Dietz, two Marfan). Thirty-six percent (n = 8) of SAAs were repaired by open techniques and 64% (n = 14) via a TEVAR-based approach. All TEVAR cases required proximal landing zone in the aortic arch (zone 0-2), and revascularization of at least one arch vessel was required in 83% (10/12) of patients. Concomitant repair of associated aortic pathology was performed in 50% (n = 10) of operations. Thirty-day/in-hospital rates of death, stroke, and permanent paraplegia/paraparesis were 5% (n = 1), 5% (n = 1), and 0%, respectively. Over mean (standard deviation) follow-up of 24 (21) months, 16% (n = 3) of patients required reintervention for subclavian artery bypass graft revision (n = 2) or type II endoleak (n = 1). CONCLUSIONS: This is the largest single-institution series to date of TEVAR for SAA repair. Modern endovascular techniques expand SAA repair options with excellent results. The majority of SAAs and nearly all aberrant SAAs (Kommerell's diverticulum) can now be repaired using a TEVAR-based approach without the need for sternotomy or thoracotomy.

Direct oral anticoagulant agents might be safe for patients undergoing endovenous radiofrequency and laser ablation.

OBJECTIVE: Studies assessing the effect of the use of anticoagulant agents on endovenous thermal ablation (ETA) have been limited to patients taking warfarin. Thus, the aim of the present study was to assess the efficacy and safety of ETA for patients taking direct oral anticoagulants (DOACs). We hypothesized that the outcome of ETA for patients taking DOACs would not be superior to the outcomes for patients taking DOACs. METHODS: We performed a retrospective review to identify patients who had undergone radiofrequency ablation or endovenous laser ablation with 1470-nm diode laser fibers for symptomatic great or small saphenous venous reflux from 2018 to 2020. The patients were dichotomized into those who had received a therapeutic dose of DOACs periprocedurally and those who had not (control group). The outcomes of interest included the rates of treated vein closure at 7 days and 9 months and the incidence of deep vein thrombosis (DVT), endothermal heat-induced thrombosis (EHIT), and bleeding periprocedurally. RESULTS: Of the 301 patients (382 procedures), 69 patients (87 procedures) had received DOACs and 232 control patients (295 procedures) had not received DOACs. The patients receiving DOACs were more often older (mean age, 65 years vs 55 years; P < .001) and male (70% vs 37%; P < .001), with a higher prevalence of venous thromboembolism and more severe CEAP (clinical, etiologic, anatomic, pathophysiologic) classification (5 or 6), than were the control patients. Those receiving DOACs were more likely to have had a history of DVT (44% vs 6%; P < .001), pulmonary embolism (13% vs 0%; P < .001), and phlebitis (32% vs 15%; P < .001). Procedurally, radiofrequency ablation had been used more frequently in the control group (92% vs 84%; P = .029), with longer segments of treated veins (mean, 38 mm vs 35 mm, respectively; P = .028). No major or minor bleeding events nor any EHIT had occurred in either group. Two patients in the control group (0.7%) developed DVT; however, no DVT was observed in those in the DOAC group (P = .441). At 9 months, the treated vein had remained ablated after 94.4% of procedures for patients receiving DOACs and 98.4% of the control group (P = .163). On multivariable analysis, DOAC usage was not associated with an increased risk of vein recanalization (hazard ratio, 5.76; 95% confidence interval, 0.57-58.64; P = .139). An increased preprocedural vein diameter and the use of endovenous laser ablation were associated with an increased risk of recanalization. CONCLUSIONS: In our study of patients who had undergone ETA for symptomatic saphenous venous reflux, the periprocedural use of DOACs did not adversely affect the efficacy of endovenous ablation to ≥9 months. Furthermore, DOAC use did not confer an additional risk of bleeding, DVT, or EHIT periprocedurally. DOACs may be safely continued without affecting the efficacy and durability of ETA.

Tumor proximity to the recurrent laryngeal nerve in patients with primary hyperparathyroidism undergoing parathyroidectomy.

BACKGROUND: Recurrent laryngeal nerve (RLN) injury is a rare complication for patients undergoing neck exploration for primary hyperparathyroidism (pHPT). Distances between RLNs and parathyroid adenomas have not been previously published. In this study we used a RLN monitor to identify the RLN and to measure the proximity to parathyroid tumors. METHODS: Patients with pHPT (n = 136) underwent neck exploration and had the clinical data recorded prospectively. Adenomas were recorded in 1 of 4 locations (right upper, right lower, left upper, left lower). Measurement of RLN to adenoma distances were recorded intraoperatively with the gland in situ. The RLN location was confirmed with a RLN monitor. RESULTS: The average RLN to adenoma distance was 0.52 ± 0.52 cm. Adenomas in the right upper position were significantly closer to the nerve (0.25 ± 0.39 cm) compared with adenomas in the left upper (0.48 ± 0.61 cm, p = .03), left lower (0.70 ± 0.53 cm, p < .001), and right lower position (1.02 ± 0.56 cm, p < .001). Left upper adenomas were also significantly closer to the nerve compared with right lower adenomas (p < .001). Adenomas in the right upper position abutted the nerve more often (47 %) compared with adenomas in other positions (p = .001). There were no perioperative characteristics that predicted tumor abutment. There were no permanent RLN injuries. CONCLUSION: In patients with sporadic pHPT, parathyroid adenomas in the right upper location have, on average, greater proximity to the RLN and are more often directly abutting compared with adenomas in other locations.

Staged total abdominal debranching and thoracic endovascular aortic repair for thoracoabdominal aneurysm.

OBJECTIVE: Thoracoabdominal aortic aneurysms (TAAAs) occur most commonly in elderly individuals, who are often suboptimal candidates for open repair because of significant comorbidities. The availability of a hybrid option, including open visceral debranching with endovascular aneurysm exclusion, may have advantages in these patients who are at high-risk for conventional repair. This report details the evolution of our technique and results with complete visceral debranching and endovascular aneurysm exclusion for TAAA repair in high-risk patients. METHODS: Between March 2005 and June 2011, 47 patients (51% women) underwent extra-anatomic debranching of all visceral vessels, followed by aneurysm exclusion by endovascular means at a single institution. A median of four visceral vessels were bypassed. The debranching procedure was initially performed through a partial right medial visceral rotation approach, leaving the left kidney posterior in the first 22 patients, and in the last 25 by a direct anterior approach to the visceral vessels. The debranching and endovascular portions of the procedure were performed in a single operation in the initial 33 patients and as a staged procedure during a single hospital stay in the most recent 14. RESULTS: Median patient age was 71.0 ± 9.8 years. All had significant comorbidity and were considered suboptimal candidates for conventional repair: 55% had undergone previous aortic surgery, 40% were American Society of Anesthesiologists (ASA) class 4, and baseline serum creatinine was 1.5 ± 1.3 mg/dL. The 30-day/in-hospital rates of death, stroke, and permanent paraparesis/plegia were 8.5%, 0%, and 4.3%, respectively, but 0% in the most recent 14 patients undergoing staged repair. These patients had significantly shorter combined operative times (314 vs 373 minutes), decreased intraoperative red blood cell transfusions (350 vs 1400 mL), and were more likely to be extubated in the operating room (50% vs 12%) compared with patients undergoing simultaneous repair. Over a median follow-up of 19.3 ± 18.5 months, visceral graft patency was 97%; all occluded limbs were to renal vessels and clinically silent. There have been no type I or III endoleaks or reinterventions. Kaplan-Meier overall survival is 70.7% at 2 years and 57.9% at 5 years. CONCLUSIONS: Hybrid TAAA repair through complete visceral debranching and endovascular aneurysm exclusion is a good option for elderly high-risk patients less suited to conventional repair in centers with the requisite surgical expertise with visceral revascularization. A staged approach to debranching and endovascular aneurysm exclusion during a single hospitalization appears to yield optimal results.

Histologic assessment of lower extremity deep vein thrombus from patients undergoing percutaneous mechanical thrombectomy.

BACKGROUND: Histologic analyses of deep vein thrombi (DVTs) have used autopsy samples and animal models. To the best of our knowledge, no previous study has reported on thrombus composition after percutaneous mechanical extraction. Because elements of chronicity and organization render thrombus resistant to anticoagulation and thrombolysis, a better understanding of clot evolution could inform therapy. METHODS: We performed a histologic evaluation of DVTs from consecutive patients who had undergone mechanical thrombectomy for extensive iliofemoral DVTs using the Clottriever/Flowtriever device (Inari Medical, Irvine, Calif). The DVTs were scored using a semiquantitative method according to the degree of fibrosis (collagen deposition on trichrome staining) and organization (endothelial growth with capillaries and fibroblastic penetration). RESULTS: Twenty-three specimens were available for analysis, with 20 presenting as acute DVT (≤14 days from symptom onset). Of the 23 patients, 11 (48%) had had >5% fibrosis (ie, collagen deposition) and 14 (61%) had had >5% organization (ie, endothelial growth, capillaries, fibroblasts). Four patients with acute DVT had had ≥25% organized thrombus and two had had ≥25% collagen deposition. Of the 20 patients with acute DVT, 40% had had >5% fibrosis and 55% had had >5% organization. The acuity of DVT did not correlate with the amount of fibrosis or organizing scores. CONCLUSIONS: A large proportion of patients with acute DVT will have histologic elements of chronicity and fibrosis. A better understanding of the relationship between such elements and the response to anticoagulant agents and fibrinolytic drugs could inform our approach to therapy.

Risk of thrombotic events after respiratory infection requiring hospitalization.

Thrombosis is a major concern in respiratory infections. Our aim was to investigate the magnitude and duration of risk for arterial and venous thrombosis following discharge after respiratory infection. Patients with respiratory infections were identified using the United States Nationwide Readmission Database from 2012 to 2014. Patients admitted with asthma or cellulitis served as comparators. Readmissions for acute myocardial infarction (MI) and venous thromboembolism (VTE) were evaluated at 30 to 180 days. The likelihood of a first thrombotic event after discharge was compared with a 30-day period prior to hospitalization. Among 5,271,068 patients discharged after a respiratory infection, 0.56% and 0.78% were readmitted within 30-days with MI and VTE, respectively. Relative to asthma and cellulitis, respiratory infection was associated with a greater age and sex-adjusted hazard of 30-day readmission for MI (adjusted HR [aHR] 1.48 [95% CI 1.42-1.54] vs. asthma; aHR 1.36 [95% CI 1.31-1.41] vs. cellulitis) and VTE (aHR 1.28 [95% CI 1.24-1.33] vs. asthma; aHR 1.26, [95% CI 1.22-1.30] vs. cellulitis). Risks of MI and VTE attenuated over time. In a crossover-cohort analysis, the odds of MI (OR 1.68 [95% CI 1.62-1.73]) and VTE (OR 3.30 [95% 3.19-3.41]) were higher in the 30 days following discharge after respiratory infection than during the 30-day baseline period. Hospitalization for respiratory infection was associated with increased risks of thrombosis that were highest in the first 30-days after discharge and declined over time.

Deep vein thrombosis in hospitalized patients with coronavirus disease 2019.

OBJECTIVE: The pandemic of coronavirus disease 2019 (COVID-19) has caused devastating morbidity and mortality worldwide. In particular, thromboembolic complications have emerged as a key threat for patients with COVID-19. We assessed our experience with deep vein thrombosis (DVT) in patients with COVID-19. METHODS: We performed a retrospective analysis of all patients with COVID-19 who had undergone upper or lower extremity venous duplex ultrasonography at an academic health system in New York City from March 3, 2020 to April 12, 2020 with follow-up through May 12, 2020. A cohort of hospitalized patients without COVID-19 (non-COVID-19) who had undergone venous duplex ultrasonography from December 1, 2019 to December 31, 2019 was used for comparison. The primary outcome was DVT. The secondary outcomes included pulmonary embolism, in-hospital mortality, admission to the intensive care unit, and antithrombotic therapy. Multivariable logistic regression was performed to identify the risk factors for DVT and mortality. RESULTS: Of 443 patients (COVID-19, n = 188; and non-COVID-19, n = 255) who had undergone venous duplex ultrasonography, the COVID-19 cohort had had a greater incidence of DVT (31% vs 19%; P = .005) than had the non-COVID-19 cohort. The incidence of pulmonary embolism was not significantly different statistically between the COVID-19 and non-COVID-19 cohorts (8% vs 4%; P = .105). The DVT location in the COVID-19 group was more often distal (63% vs 29%; P < .001) and bilateral (15% vs 4%; P < .001). The duplex ultrasound findings had a significant impact on the antithrombotic plan; 42 patients (72%) with COVID-19 in the DVT group had their therapy escalated and 49 (38%) and 3 (2%) had their therapy escalated and deescalated in the non-DVT group, respectively (P < .001). Within the COVID-19 cohort, the D-dimer level was significantly greater in the DVT group at admission (2746 ng/mL vs 1481 ng/mL; P = .004) and at the duplex examination (6068 ng/mL vs 3049 ng/mL; P < .01). On multivariable analysis, male sex (odds ratio [OR], 2.27; 95% confidence interval [CI], 1.06-4.87; P = .035), intensive care unit admission (OR, 3.42; 95% CI, 1.02-11.44; P = .046), and extracorporeal membrane oxygenation (OR, 5.5; 95% CI, 1.01-30.13; P = .049) were independently associated with DVT. CONCLUSIONS: Given the high incidence of venous thromboembolic events in this population, we support the decision to empirically initiate therapeutic anticoagulation for patients with a low bleeding risk and severe COVID-19 infection. Duplex ultrasonography should be reserved for patients with a high clinical suspicion of venous thromboembolism for whom anticoagulation therapy could result in life-threatening consequences. Further study of patients with COVID-19 is warranted to elucidate the etiology of vascular thromboembolic events and guide the prophylactic and therapeutic interventions for these patients.

Assessment of quality of life changes in patients with lower extremity lymphedema using an advanced pneumatic compression device at home.

OBJECTIVE: Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy has been limited, with poor surgical salvage options. Preliminary studies have demonstrated that the use of advanced pneumatic compression devices (APCDs) improves clinical outcomes. However, limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS: The present postmarket, multicenter, single-arm, observational clinical trial conducted in the Veterans Affairs Healthcare System evaluated patients with a diagnosis of primary or secondary edema of unilateral or bilateral lower extremities treated with the Flexitouch APCD (Tactile Medical, Minneapolis, Minn) from February 2016 to March 2019. The patients were assessed at baseline and 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (short form-36 and Lymphedema Quality of Life), device compliance, cellulitis episodes, and lymphedema-related healthcare use since the previous visit. The primary endpoints of interest were the QOL at baseline compared with at 12 weeks, unscheduled lymphedema-related clinic visits, and hospital admissions at 52 weeks. The secondary endpoints included the change in limb girth and QOL at 52 weeks compared with baseline. RESULTS: A total of 178 patients with lower extremity lymphedema were prospectively enrolled. The present study reports the interim data for the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean age, 67 years), obese (median body mass index, 32 kg/m2), and most commonly enrolled for the treatment of phlebolymphedema (71.6%) with largely bilateral lower extremity involvement (91.9%). No significant difference was seen in QOL at 12 weeks. However, at 52 weeks, the Lymphedema Quality of Life scores had significantly improved from baseline (6.3 vs 7.4; P < .0001) and the short form-36 had demonstrated significant improvement from baseline in the physical component (38.6 vs 40.8; P = .035), with an effect toward overall improvement in the mental component (49.9 vs 51.3; P = .549). The limb circumference had decreased significantly at 12 weeks compared with baseline (28.5 cm vs 27.7 cm; P = .0005) in the most affected lower extremity, and this reduction had remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitis episodes (24.3% vs 8.1%; P = .005), lymphedema-related clinic visits (2.2 vs 0.7; P = .02), urgent care visits (1.2 vs 0.3; P = .004), and hospital admissions (0.5 vs 0.1; P = .047) per patient. CONCLUSIONS: The Flexitouch APCD resulted in initial significant limb girth reduction as early as 12 weeks and a steady and sustained improvement in health-related QOL for ≤1 year. The latter was likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic and urgent care visits and hospital admissions.

Arterial thromboembolism associated with COVID-19 and elevated D-dimer levels.

The novel coronavirus 2019 (SARS-CoV-2) was first identified in January 2020 and has since evolved into a pandemic affecting >200 countries. The severity of presentation is variable and carries a mortality between 1% and 3%. We continue to learn about the virus and the resulting acute respiratory illness and hypercoagulability; however, much remains unknown. In our early experience in a high-volume center, we report a series of four cases of acute peripheral artery ischemia in patients with COVID-19 in the setting of elevated D-dimer levels.

Minimally invasive radio-guided surgery for primary hyperparathyroidism.

BACKGROUND: Minimally invasive parathyroidectomy can reduce operative morbidity and operative time. Radio-guided parathyroidectomy utilizing Tc-99m Sestamibi is one approach to minimally invasive parathyroidectomy. Here, we report a multimedia case study of minimally invasive radio-guided parathyroidectomy. METHODS: A 60-year-old African American female was found to have total calcium of 11.1 mg/dl, intact parathyroid hormone (iPTH) of 175 pg/ml, and a 24-h urine calcium of 620 mg/24 h. A Tc-99 Sestamibi scan (23.5 mCi of Tc-99 Sestamibi injected i.v.) and ultrasound localized a candidate adenoma to the right upper position. The patient was injected with 5.3 mCi Tc-99m Sestamibi 3 h before incision. RESULTS: A gamma probe (C-Trak Automatic System, Care Wise Medical Products) recorded in vivo counts of the right upper parathyroid (3,465) that were 160% of the background. Background counts were recorded from the resected tumor bed (2,224). A 1.4-g adenoma was identified in this location; ex vivo counts (3,226) were 150% of the background. Intra-operative iPTH baseline values were 176 pg/ml and 148 pg/ml, and 5- and 10-min post-resection levels were 17 pg/ml (90% drop) and 18 pg/ml (90% drop), respectively. The patient's recovery was uncomplicated. At 1 week postoperatively, total calcium was 8.9 mg/dl and iPTH was 16 pg/ml. At 1 year, the calcium and iPTH levels were 8.7 mg/dl and 53 pg/ml, respectively. CONCLUSIONS: Radio-guided minimally invasive parathyroidectomy using Tc-99 Sestamibi localization is an effective approach to hyperparathyroidism. For patients without localization, exposure of all four parathyroid glands is preferable. Surgeons should be familiar with both techniques.

Predictors of electrocerebral inactivity with deep hypothermia.

OBJECTIVE: Cooling to electrocerebral inactivity (ECI) by electroencephalography (EEG) remains the gold standard to maximize cerebral and systemic organ protection during deep hypothermic circulatory arrest (DHCA). We sought to determine predictors of ECI to help guide cooling protocols when EEG monitoring is unavailable. METHODS: Between July 2005 and July 2011, 396 patients underwent thoracic aortic operation with DHCA; EEG monitoring was used in 325 (82%) of these patients to guide the cooling strategy, and constituted the study cohort. Electroencephalographic monitoring was used for all elective cases and, when available, for nonelective cases. Multivariable linear regression was used to assess predictors of the nasopharyngeal temperature and cooling time required to achieve ECI. RESULTS: Cooling to a nasopharyngeal temperature of 12.7°C or for a duration of 97 minutes was required to achieve ECI in >95% of patients. Only 7% and 11% of patients achieved ECI by 18°C or 50 minutes of cooling, respectively. No independent predictors of nasopharyngeal temperature at ECI were identified. Independent predictors of cooling time included body surface area (18 minutes/m(2)), white race (7 minutes), and starting nasopharyngeal temperature (3 minutes/°C). Low complication rates were observed (ischemic stroke, 1.5%; permanent paraparesis/paraplegia, 1.5%; new-onset dialysis, 2.2%; and 30-day/in-hospital mortality, 4.3%). CONCLUSIONS: Cooling to a nasopharyngeal temperature of 12.7°C or for a duration of 97 minutes achieved ECI in >95% of patients in our study population. However, patient-specific factors were poorly predictive of the temperature or cooling time required to achieve ECI, necessitating EEG monitoring for precise ECI detection.

Resident designed intern orientation to address the new ACGME Common Program Requirements for resident supervision.

OBJECTIVE: To design an orientation for surgical interns to meet the new Accreditation Council for Graduate Medical Education Common Program Requirements regarding supervision, to test patient-management competencies, and to assess confidence on skills and tasks pre-orientation and post-orientation. DESIGN: Twenty-seven incoming surgical interns participated in a two-day orientation to clinical duties. Activities included a pre-test, lectures, simulation, oral examination, intern shadowing, and a post-test. Incoming interns were surveyed before and after orientation and two months later for confidence in patient-management and surgical intern skills. Paired t-tests were used to determine if confidence improved pre-orientation and post-orientation, and two months following orientation. SETTING: The study took place at an academic training hospital. PARTICIPANTS: All (n = 27) postgraduate year-1 (PGY-1) surgical residents at our institution, which included the categorical and nondesignated preliminary general surgery, urology, orthopedic surgery, otolaryngology, and neurosurgery programs. RESULTS: All interns passed the oral and written examinations, and were deemed able to be indirectly supervised, with direct supervision immediately available. They reported increased confidence in all areas of patient management addressed during orientation, and this confidence was retained after two months. In surgical and floor-related tasks and skills, interns reported no increase in confidence directly following orientation. However, after two months, they reported a significant increase in confidence, particularly in those tasks that are performed often. CONCLUSIONS: New requirements for resident supervision require creative ways of verifying resident competency in basic skills. This type of orientation is an effective way to address the new requirements of supervision and teach interns the tasks and skills that are necessary for internship.

Outcomes after surgical management of synchronous bilateral primary lung cancers.

BACKGROUND: Distinguishing between synchronous primary lung cancers and metastatic disease in patients with bilateral lung masses is often difficult. The objective of this study is to examine outcomes associated with a strategy of performing staged bilateral resections in patients without N2 disease based on invasive mediastinal staging and without distant metastases. METHODS: Patients undergoing resections of bilateral synchronous primary lung cancer at our institution between 1997 and 2010 were reviewed. Perioperative complications were graded according to National Cancer Institute guidelines. Survival was estimated using the Kaplan-Meier method and compared using a log-rank test. End points included overall survival, disease-free survival, operative death, cancer recurrence, and postoperative complications. RESULTS: Resections of bilateral synchronous primary lung cancers were performed in 47 patients. Forty-five patients (96%) had at least a unilateral thoracoscopic approach; 28 (60%) had bilateral thoracoscopic approaches. The median postresection length of stay was 3 days. Thirteen patients (28%) had a postoperative complication; only 3 (6%) were grade 3 or higher. There was 1 perioperative death (2%). Eleven patients received adjuvant therapy; only 3 patients in whom adjuvant therapy was indicated did not receive the recommended treatment. The overall 3-year survival was 35%. Survival of patients whose bilateral tumors had identical histology did not differ from patients whose histology was different (p = 0.57). Three-year disease-free survival was 24%. CONCLUSIONS: Aggressive surgical treatment of apparent synchronous bilateral primary lung cancer can be performed with low morbidity. Most patients tolerate the bilateral surgeries and adjuvant therapy. Overall survival is sufficiently high to support this aggressive approach.

Results of thoracic endovascular aortic repair 6 years after United States Food and Drug Administration approval.

BACKGROUND: Since United States Food and Drug Administration approval in 2005, the short-term safety and efficacy of thoracic endovascular aortic repair (TEVAR) have been established. However, longer-term follow-up data remain lacking. The objective of this study is to report 6-year outcomes of TEVAR in clinical practice. METHODS: A prospective cohort review was performed of all patients undergoing TEVAR at a single referral institution between March 2005 and May 2011. Rates of reintervention were noted. Overall and aortic-specific survival were determined using Kaplan-Meier methods. Log-rank tests were used to compare survival between groups. RESULTS: During the study interval, 332 TEVAR procedures were performed in 297 patients. Reintervention was required after 12% of procedures at a mean of 8 ± 14 months after initial TEVAR and was higher in the initial tercile of patients (15.0% vs 9.9%). The 6-year freedom from reintervention was 84%. Type I endoleak was the most common cause of reintervention (5%). Six-year overall survival was 54%, and aorta-specific survival was 92%. Long-term survival was significantly lower than that of an age- and sex-matched United States population (p < 0.001). Survival was similar between patients requiring a reintervention vs those not (p = 0.26). Survival was different based on indication for TEVAR (p = 0.007), and patients with degenerative aneurysms had the lowest survival (47% at 6 years). Cardiopulmonary pathologies were the most common cause of death (27 of 93 total deaths). CONCLUSIONS: Long-term aortic-related survival after TEVAR is high, and the need for reintervention is infrequent. However, overall long-term survival is low, particularly for patients with degenerative aneurysms, and additional work is needed to identify patients unlikely to derive a survival benefit from TEVAR.

Handoffs in the era of duty hours reform: a focused review and strategy to address changes in the Accreditation Council for Graduate Medical Education Common Program Requirements.

With changes in the Accreditation Council for Graduate Medical Education (ACGME) Common Program Requirements related to transitions in care effective July 1, 2011, sponsoring institutions and training programs must develop a common structure for transitions in care as well as comprehensive curricula to teach and evaluate patient handoffs. In response to these changes, within the Duke University Health System, the resident-led Graduate Medical Education Patient Safety and Quality Council performed a focused review of the handoffs literature and developed a plan for comprehensive handoff education and evaluation for residents and fellows at Duke. The authors present the results of their focused review, concentrating on the three areas of new ACGME expectations--structure, education, and evaluation--and describe how their findings informed the broader initiative to comprehensively address transitions in care managed by residents and fellows. The process of developing both institution-level and program-level initiatives is reviewed, including the development of an interdisciplinary minimal data set for handoff core content, training and education programs, and an evaluation strategy. The authors believe the final plan fully addresses both Duke's internal goals and the revised ACGME Common Program Requirements and may serve as a model for other institutions to comprehensively address transitions in care and to incorporate resident and fellow leadership into a broad, health-system-level quality improvement initiative.

Impact of 25-hydroxyvitamin D deficiency on perioperative parathyroid hormone kinetics and results in patients with primary hyperparathyroidism.

BACKGROUND: Successful parathyroidectomy for sporadic primary hyperparathyroidism (pHPT) is predicted by a 50% drop in PTH intra-operatively. Vitamin D is a known inhibitor of PTH secretion and is associated with secondary HPT following adenoma resection. This study examined the impact of 25-hydroxyvitamin D (25OHD) deficiency on perioperative PTH kinetics and outcomes following parathyroidectomy. METHODS: Patients undergoing adenoma resection for pHPT (n=93) had PTH levels recorded at six perioperative time points. Preoperative 25OHD levels were examined retrospectively. Patients were considered 25OHD deficient if the level was <25 ng/mL (n=47) and adequate if the level was >or=25 ng/mL (n=46). RESULTS: Patients with 25OHD-deficiency had significantly higher preoperative calcium, alkaline phosphatase, and PTH levels. PTH levels were significantly higher in 25OHD-deficient patients at incision, at 1 week postop and 1-3 months postop. Average drop in PTH level five minutes post resection was 79+/-14% in the deficient group and 72+/-22% in the non-deficient group (P=.03). 25OHD levels inversely correlated with adenoma weight (P=.03) and postoperative PTH measurements (P=.008). CONCLUSIONS: Sporadic pHPT patients with 25OHD deficiency have higher baseline and postoperative PTH levels compared to non-deficient patients but do not have altered intraoperative PTH kinetics. Vitamin D deficiency is associated with postoperative elevation of PTH.