A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Outcomes Following Urgent Fenestrated-Branched Endovascular Repair for Pararenal and Thoracoabdominal Aortic Aneurysms.

BACKGROUND: To evaluate outcomes following urgent or emergent fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAA) in patients who are considered high-risk for open repair. METHODS: A retrospective, single institution evaluation of outcomes following F-BEVAR of symptomatic, rapidly enlarging, or ruptured PRA or TAAA treated with physician modified endograft (PMEG) and company manufactured devices (CMD). Outcomes were technical success, 30-day morbidity and mortality, and 1 year aortic related outcomes. RESULTS: Thirty-two patients (23 male, mean age, 74 ± 9 years) underwent F-BEVAR using PMEG or CMD over a 12-year period. Fourteen patients underwent emergent repair for contained rupture and 18 patients underwent urgent repair for symptomatic, mycotic, or rapidly growing aneurysms. Aneurysm classification was PRA in 10 patients and TAAA in 22 (9 extent IV and 13 extent I-III). Twenty-three patients (72%) were repaired with PMEG and 8 patients (26%) with CMD. Technical success was 97% with a total of 98 renal-mesenteric arteries incorporated using 67 fenestrations (68%), 29 directional branches (29%), and 2 double-wide scallops (2%). A 30-day mortality was 6%, with 1 patient expiring from unclear causes after hospital discharge and the other from mesenteric ischemia. Mortality and major adverse events MAEs otherwise occurred in 16 patients (50%), including minor stroke in 3 patients, transient paraparesis and heart failure in 1 patient each, and early return to the operating room in 6 patients. Mean follow-up was 24 ± 22 months. At 1-year, overall survival, freedom from aortic-related mortality and freedom from secondary intervention were 70% ± 8%, 94% ± 3 and 83% ± 7, respectively. CONCLUSIONS: Urgent F-BEVAR of selected patients with PRA and TAAA is a feasible and potentially safe treatment in patients with suitable anatomy, with low rates of early mortality and spinal cord complications. Long-term follow-up is needed to assess the durability of repair and device-related complications.

Adventitial cystic disease of the common femoral vein: an unusual cause of lower extremity swelling and review of the literature.

We report the case of a 61-year-old man who had presented with acute unilateral limb swelling. Computed tomography venography and duplex ultrasound demonstrated compression of the right common femoral vein by a common femoral vein adventitial cyst. Before intervention, the patient had developed an acute deep vein thrombosis of the right common femoral vein and great saphenous vein. Preoperative magnetic resonance imaging demonstrated concern for synovial connection. After 6 months of anticoagulation therapy, the patient underwent adventitial cyst excision with ligation of the hip joint articular connection. At 4 months postoperatively, the patient was symptom free without cyst recurrence. The findings from the present case support the synovial theory for adventitial cystic disease.

Development of quantitative structure-activity relationships for explanatory modeling of fast reacting (meth)acrylate monomers bearing novel functionality.

The photoinitiated polymerization of (meth)acrylate monomers bearing novel carbamate functionality exhibits significantly greater reaction rate when compared to more traditional acrylate monomers undergoing similar polymerization. This unusually fast reactivity has been the subject of much investigation. In order to suggest an explanatory mechanism for the enhanced polymerization rates we have conducted quantitative structure-activity relationship investigations of these novel monomers. These studies have resulted in statistically sound models with coefficients of multiple determination of R(2)>0.93. Principal component and k nearest neighbor similarity analysis were also conducted on the multiple regression models. These results are discussed in light of published experimental investigations of the photopolymerization reactivity of the novel monomers.