The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

False Lumen Intercostal Artery Embolization to Halt Type R Entry Flow in Chronic Type B Aortic Dissection.

BACKGROUND: Treatment of aneurysmal type B aortic dissection often involves thoracic endovascular aortic repair (TEVAR). However, persistent patency of the false lumen from type R entry flow is common and is associated with late complications including rupture. We describe 9 patients with aneurysmal chronic type B aortic dissections and patent false lumens and 7 despite prior thoracic endovascular aortic repair. The goal of the false lumen intercostal embolization in these patients was to achieve propagation of false lumen thrombosis (FLT) and to prevent spinal cord ischemia (SCI) using a staged approach in the overall treatment of their complex aortic aneurysm. METHODS: A multicenter retrospective review was performed of all consecutive false lumen intercostal embolization procedures; 9 were identified. Preoperative and postoperative computed tomographic angiograms were compared. We hypothesized that embolization was a safe and feasible treatment option. The primary outcome was procedural characteristics and SCI to establish safety and feasibility. Secondary outcomes included a change in supraceliac patent false lumen length and other perioperative clinical outcomes. RESULTS: In total, 30 of 31 (97%) targeted false lumen intercostal arteries were successfully coiled. Median procedural time was 57 min (interquartile range [IQR] 23-99), median air kerma was 585 mGy (IQR 398-1,644), and median contrast dose was 141 mL (IQR 74-240). After embolization, all patients demonstrated propagation of FLT, with mean false lumen length decreasing by 48% from 13.8 cm to 6.6 cm. There was no mortality associated with this procedure; 2 patients suffered a lumbar drain-related complication; 1 with cerebrospinal fluid leak and 1 with a spinal hematoma that was managed conservatively with no neurological deficit. No other complications occurred. CONCLUSIONS: In this review, false lumen intercostal coil embolization was technically feasible and did not result in any cases of SCI. The procedures required acceptable amounts of operative time, fluoroscopic dose, and contrast. All patients experienced propagation of FLT and no long-term procedure-related morbidity was noted. More data will be required to ascertain whether this procedure is effective at halting type R entry flow, preventing future type II entry flow, and promoting aortic remodeling over time.

Procedure-Associated Costs and Mid-Term Outcomes of Endovascular Zone 0 and Zone 1 Aortic Arch Repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch pathology provides a less-invasive treatment option for high-risk patients ineligible for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the mid-term outcomes after Zone 0 and Zone 1 TEVAR and describe the associated technical costs, revenues, and net margins at a single tertiary medical center. METHODS: We examined all patients who underwent TEVAR between April 2011 and August 2019 via retrospective chart review. Patients were categorized by proximal endograft extent to identify Zone 0 or Zone 1 repairs. Procedural characteristics and outcomes were described. Technical costs, revenues, and margins were obtained from the hospital finance department. RESULTS: We identified 10 patients (6 Zone 0, 4 Zone 1) who were denied open arch reconstruction. Patients were predominantly female (n = 8; 80%) and the mean age was 72.8 ± 5.5 years. TEVAR was performed in 5 asymptomatic patients, urgently in 3 symptomatic patients, and emergently in 2 ruptured patients. TEVAR plus extra-anatomic bypass was performed in 4 patients. Another 4 patients also received parallel stent-grafting while 1 patient received a branched thoracic endograft and yet another an in-situ laser fenestration followed by branch stent grafting. Within the 30-day postoperative period, 1 patient experienced stroke and 1 patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean 19.3 months). Mean total technical cost associated with all procedures or repair stages was $105,164 ± $59,338 while mean net technical margin was -$25,055 ± $18,746. The net technical margin was negative for 9 patients. CONCLUSIONS: Endovascular repair of the proximal aortic arch is associated with good mid-term outcomes in patients considered too high-risk for open repair. However, reimbursement does not adequately cover treatment cost, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to both optimize aortic arch TEVAR delivery as well as advocate for reimbursement commensurate with associated costs.

Surgical Needs of Internally Displaced Persons in Kerenik, West Darfur, Sudan.

BACKGROUND: The burden of surgical disease in refugee and internally displaced person (IDP) populations has not been well defined. Populations fleeing conflict are mobile, limiting the effectiveness of traditional sampling methods. We employed novel sampling and survey techniques to conduct a population-based surgical needs assessment amongst IDPs in Kerenik, West Darfur, Sudan, over 4 weeks in 2008. METHODS: Satellite imagery was used to identify man-made structures. Ground teams were guided by GPS to randomly selected households. A newly created surgical needs survey was administered by surgeons to household members. One randomly selected individual answered demographic and medical history questions pertaining to themselves and first-degree blood relatives. All household members were offered a physical examination looking for surgical disease. FINDINGS: There were 780 study participants; 82% were IDPs. A history since displacement of surgical and potentially surgical conditions was reported in 38% of respondents and by 73% of respondents in first-degree blood relatives. Surgical histories included trauma (gunshots, stabbings, assaults) (5% respondents; 27% relatives), burns (6% respondents; 14% relatives), and obstetrical problems (5% female respondents; 11% relatives). 1485 individuals agreed to physical examinations. Untreated surgical and potentially surgical disease was identified in 25% of participants. INTERPRETATION: We identified and characterized a high burden of surgical and potentially surgical disease in an IDP population in West Darfur. Our study is unique in its direct assessment of a traumatized, mobile, vulnerable population. Health officials and agencies charged with the care of IDP and refugee populations should be aware of the high prevalence of surgical and potentially surgical conditions in these communities. This study adds to the growing body of evidence that investment in surgical resources may address a significant portion of the overall burden of disease in marginalized populations.

Are American Surgical Residents Prepared for Humanitarian Deployment?: A Comparative Analysis of Resident and Humanitarian Case Logs.

BACKGROUND: Effective humanitarian surgeons require skills in general surgery, OB/GYN, orthopedics, and urology. With increasing specialization, it is unclear whether US general surgery residents are receiving exposure to these disparate fields. We sought to assess the preparedness of graduating American surgical residents for humanitarian deployment. METHODS: We retrospectively analyzed cases performed by American College of Graduate Medical Education general surgery graduates from 2009 to 2015 and cases performed at select Médecins Sans Frontières (MSF) facilities from 2008 to 2012. Cases were categorized by specialty (general surgery, orthopedics, OB/GYN, urology) and compared with Chi-squared testing. Non-operative care including basic wound and drain care was excluded from both data sets. RESULTS: US general surgery residents performed 41.3% MSF relevant general surgery cases, 1.9% orthopedic cases, 0.1% OB/GYN cases, and 0.3% urology cases; the remaining 56.4% of cases exceeded the standard MSF scope of care. In comparison, MSF cases were 30.1% general surgery, 21.2% orthopedics, 46.8% OB/GYN, and 1.9% urology. US residents performed fewer OB/GYN cases (p < 0.01) and fewer orthopedic cases (p < 0.01). Differences in general surgery and urology caseloads were not statistically significant. Key procedures in which residents lacked experience included cesarean sections, hysterectomies, and external bony fixation. CONCLUSION: Current US surgical training is poorly aligned with typical MSF surgical caseloads, particularly in OB/GYN and orthopedics. New mechanisms for obtaining relevant surgical skills should be developed to better prepare American surgical trainees interested in humanitarian work.

Laser assisted trans-endograft coil embolization of a type II endoleak.

A type II endoleak after endovascular aneurysm repair can be challenging to stop. Numerous methods have been described, including trans-arterial, trans-lumbar, trans-caval, trans-endograft, peri-endograft, and open and laparoscopic surgical techniques. We present our experience with a laser-assisted trans-endograft approach, including technical variations of previous descriptions that might improve efficacy. In select cases, the laser-assisted trans-endograft approach might provide the most direct method of accessing and occluding the vessels feeding type II endoleaks.

Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.

Objective: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). Design: Multicentre retrospective cohort study. Setting: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres. Participants: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other. Main outcome measures: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality. Results: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1-2). Median total LOS was 1 day (IQR: 1-2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths. Conclusions: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.

Balloon guidance for superior mesenteric artery scallop alignment during Cook Zenith Fenestrated AAA Endovascular Graft deployment.

To achieve seal, aortic endografts may require coverage of the aorta adjacent to or involving critical branch vessels. One technique for maintaining branch vessel patency at the leading edge of an endograft is use of a scallop. However, it may be difficult to ensure proper scallop alignment both before and after endograft deployment. We describe a technique for improving superior mesenteric artery scallop alignment of the Cook Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) using scallop precannulation and ostial superior mesenteric artery balloon inflation during both diameter expansion and top cap release.

Intercostal artery embolization to induce false lumen thrombosis in type B aortic dissection.

Persistent false lumen flow is common after thoracic endovascular aortic repair of type B aortic dissection and may contribute to continued aortic aneurysmal degeneration. We report an innovative technique of intercostal artery embolization within the false lumen for a patient who had incomplete false lumen thrombosis and progressive aortic enlargement after thoracic endovascular aortic repair of chronic type B aortic dissection. Technical success was facilitated by use of on-table cone beam computed tomography angiography, virtual vessel marking, and modern endovascular tools. The patient had no complications from the procedure. Postoperative imaging demonstrated complete thoracic false lumen thrombosis and favorable aortic remodeling with reduction in maximal aortic diameter.

Novel use of the ENROUTE transcarotid arterial sheath for antegrade cerebral perfusion during retrograde innominate stenting.

Femoral-carotid bypass has been described to preserve antegrade cerebral perfusion during aortic arch and great vessel interventions. We describe a novel use of the ENROUTE transcarotid arterial sheath (Silk Road Medical, Sunnyvale, Calif) as the outflow component of a femoral-carotid shunt for maintenance of antegrade cerebral perfusion during a retrograde innominate stenting procedure. We discuss the unique advantages of this sheath for use in this application.

Atypical May-Thurner syndrome caused by endovascular aortic aneurysm repair.

May-Thurner syndrome is characterized by unilateral lower extremity venous hypertension and stasis due to compression of an iliac vein between an iliac artery and the lumbar spine. In almost all cases, the left common iliac vein is compressed by the right common iliac artery; however, other patterns have been described. Rarely, May-Thurner syndrome may be created iatrogenically as a result of iliac artery stenting. We present an unusual case of new left common iliac vein thrombosis caused by ipsilateral left iliac artery compression after aortobi-iliac endovascular aneurysm repair.

Fenestrated aortic endograft branching with Gore VBX poses failure risk from delayed-onset branch kinking.

The Gore VBX stent graft (Gore Medical, Flagstaff, Ariz) provides a new option for branching of fenestrated aortic endografts. However, its modular stent structure has raised concerns about potential kinking at the interspace between stent rings if lateralizing force exists between the fenestration and target vessel orifice. We present a case of near-occlusion of a VBX celiac branch due to narrowing of this interspace identified at postoperative month 3. Although the Gore VBX offers several potential advantages as a branch endoprosthesis, its design poses the risk of unpredictable, delayed-onset kinking and raises concern for its use as a fenestrated endograft branch.

Spontaneous splenic rupture caused by Babesia microti infection.

Babesiosis has not been previously associated with spontaneous splenic rupture. We describe an otherwise healthy 61-year-old man with symptomatic babesiosis whose spleen ruptured during hospitalization. Although this complication is rare, practitioners who commonly treat patients with babesiosis should be aware of its potential occurrence.

The Colorado Humanitarian Surgical Skills Workshop: A Cadaver-Based Workshop to Prepare Residents for Surgery in Austere Settings.

OBJECTIVE: Interest in humanitarian surgery is high among surgical and obstetric residents. The Colorado Humanitarian Surgical Skills Workshop is an annual 2-day course exposing senior residents to surgical techniques essential in low- and middle-income countries but not traditionally taught in US residencies. We evaluated the course's ability to foster resident comfort, knowledge, and competence in these skills. DESIGN: The cohort of course participants was studied prospectively. Participants attended didactic sessions followed by skills sessions using cadavers. Sample areas of focus included general surgery (mesh-free hernia repair), orthopedics (powerless external fixation), and neurosurgery (powerless craniotomy). Before and after the course, participants answered a questionnaire assessing confidence with taught skills; took a knowledge-based test composed of multiple choice and open-ended questions; and participated in a manual skills test of tibial external fixation. SETTING: The Center for Surgical Innovation, University of Colorado School of Medicine. PARTICIPANTS: A total of 12 residents (11 general surgical and 1 obstetric) from ten US institutions. RESULTS: After the course, participants perceived increased confidence in performing all 27 taught procedures and ability to practice in low- and middle-income countries. In knowledge-based testing, 10 of 12 residents demonstrated improvement on multiple choice questioning and 9 of 12 residents demonstrated improvement on open-ended questioning with structured scoring. In manual skills testing, all external fixator constructs demonstrated objective improvement on structured scoring and subjective improvement on stability assessment. CONCLUSIONS: For senior residents interested in humanitarian surgery, a combination of skills-focused teaching and manual practice led to self-perceived and objective improvement in relevant surgical knowledge and skills. The Colorado Humanitarian Surgical Skills Workshop represents an effective model for transmitting essential surgical principles and techniques of value in low-resource settings.

Successful use of continuous vasodilator infusion to treat critical vasospasm threatening a distal bypass.

Vasospasm immediately after lower extremity arterial bypass may represent an uncommon cause of early graft failure. We report a successful case of catheter-directed, intra-arterial continuous vasodilator infusion to salvage a bypass graft threatened by severe, refractory vasospasm after incomplete response to nicardipine, verapamil, and nitroglycerin boluses. A continuous nitroglycerin infusion was administered for 24 hours, by which time the vasospasm resolved. At 12 months postoperatively, the graft remained patent with normal results of vascular laboratory studies. This report demonstrates that in cases of refractory vasospasm after peripheral bypass, continuous vasodilator infusion can be an effective treatment to prevent early graft failure.

Choosing Surgery for Neurogenic TOS: The Roles of Physical Exam, Physical Therapy, and Imaging.

Neurogenic thoracic outlet syndrome (nTOS) is characterized by arm and hand pain, paresthesias, and sometimes weakness resulting from compression of the brachial plexus within the thoracic outlet. While it is the most common subtype of TOS, nTOS can be difficult to diagnose. Furthermore, patient selection for surgical treatment can be challenging as symptoms may be vague and ambiguous, and diagnostic studies may be equivocal. Herein, we describe some approaches to aid in identifying patients who would be expected to benefit from surgical intervention for nTOS. We describe the role of physical examination, physical therapy, and imaging in the evaluation and diagnosis of nTOS.

Case report: treatment of severe subcutaneous emphysema with a negative pressure wound therapy dressing.

OBJECTIVE: This article describes a patient who developed severe subcutaneous emphysema and a persistent air leak after several attempts at needle thoracostomy for what was thought to be a tension pneumothorax. Subcutaneous emphysema was effectively treated with a topical negative pressure wound therapy dressing applied to a typical subfacial "blowhole" incision. This article aims to describe and contextualize the use of negative pressure wound therapy within the existing treatment options for subcutaneous emphysema. METHODS: A case report of the clinical course and technique was drafted, and the relevant literature in PubMed was reviewed. RESULTS: The level of subcutaneous emphysema decreased significantly within 48 hours of negative pressure wound therapy as confirmed with physical examination and computed tomography scans. Negative pressure wound therapy for subcutaneous emphysema has not been previously described in the literature. CONCLUSIONS: Negative pressure wound therapy applied over subfascial incisions is a novel technique that effectively and rapidly controlled massive subcutaneous emphysema and persistent air leak. This technique may be efficacious in other cases of subcutaneous emphysema.