Retrospective Multicenter Study Comparing Infectious and Noninfectious Aortitis.

BACKGROUND: Determining the etiology of aortitis is often challenging, in particular to distinguish infectious aortitis (IA) and noninfectious aortitis (NIA). This study aims to describe and compare the clinical, biological, and radiological characteristics of IA and NIA and their outcomes. METHODS: A multicenter retrospective study was performed in 10 French centers, including patients with aortitis between 1 January 2014 and 31 December 2019. RESULTS: One hundred eighty-three patients were included. Of these, 66 had IA (36.1%); the causative organism was Enterobacterales and streptococci in 18.2% each, Staphylococcus aureus in 13.6%, and Coxiella burnetii in 10.6%. NIA was diagnosed in 117 patients (63.9%), mainly due to vasculitides (49.6%), followed by idiopathic aortitis (39.3%). IA was more frequently associated with aortic aneurysms compared with NIA (78.8% vs 17.6%, P < .001), especially located in the abdominal aorta (69.7% vs 23.1%, P < .001). Crude and adjusted survival were significantly lower in IA compared to NIA (P < .001 and P = .006, respectively). In the IA cohort, high American Society of Anesthesiologists score (hazard ratio [HR], 2.47 [95% confidence interval {CI}, 1.08-5.66]; P = .033) and free aneurysm rupture (HR, 9.54 [95% CI, 1.04-87.11]; P = .046) were significantly associated with mortality after adjusting for age, sex, and Charlson comorbidity score. Effective empiric antimicrobial therapy, initiated before any microbial documentation, was associated with a decreased mortality (HR, 0.23, 95% CI, .08-.71]; P = .01). CONCLUSIONS: IA was complicated by significantly higher mortality rates compared with NIA. An appropriate initial antibiotic therapy appeared as a protective factor in IA.

Referral Centre Experience with Infected Abdominal Aortic Endograft Explantation.

OBJECTIVE: The increasing use of endovascular aneurysm repair (EVAR) appears to be associated with the burden of vascular endograft infections. Complete stent graft explantation is recommended but leads to significant mortality. This study aimed to assess the technical challenges, complications, and mortality rate following infected endograft explantation. METHODS: Patients who underwent abdominal aortic endograft explantation for infection at the Bordeaux University Hospital from July 2008 to December 2020 were included retrospectively in this single centre observational study. The diagnosis was established based on the MAGIC criteria. The primary endpoint was 30 day mortality. Secondary endpoints were 90 day and in hospital mortality, survival, and re-infection. RESULTS: Thirty-four patients were included, median age 69 years (interquartile range [IQR] 65, 76), with four (12%) treated as an emergency. The median time from EVAR to explantation was 17.5 months (4.5 - 36.3). In situ reconstruction was carried out with prosthetic grafts in 24 patients (71%, including 23 antimicrobial grafts combining silver and triclosan), and biological grafts in 10 (five femoral veins, four arterial allografts, three bovine patches, one biosynthetic graft). Seventeen aorto-enteric fistulae (AEnF) were addressed with direct repair of the intestinal tract (n = 10/17; 59%) or resection and anastomosis (n = 7/17; 41%). The culture was polymicrobial in 12 patients (35%) and remained sterile in four (12%). The 30 day and in hospital mortality rates were 21% (n = 7) and 27% (n = 9). Twenty-five patients (73%) presented with early post-operative complications, requiring 16 revision procedures (47%). Over a median follow up of 16.2 months (IQR 8.3, 33.6), the mortality rate was 35% (n = 12; 11 aortic related; 32%), with two re-infections (6%), both after biological reconstruction (one for an AEnF). CONCLUSION: Early morbidity and mortality remain high after complete infected endograft explantation, even in a high volume centre. Comparison with other treatment modalities in large multicentre cohorts might be of interest.

EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease.

BACKGROUND: Endovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD. METHODS: Our consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded. RESULTS: Between March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters. CONCLUSIONS: The results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Fifteen-year, single-center experience with in situ reconstruction for infected native aortic aneurysms.

OBJECTIVE: The purpose of the present study was to evaluate the survival and freedom from reinfection for patients with infected native aortic aneurysms (INAAs) treated with in situ revascularization (ISR), using either open surgical repair (OSR) or endovascular aneurysm repair (EVAR), and to identify the predictors of outcome. METHODS: Patients with INAAs who had undergone ISR from January 2005 to December 2020 were included in the present retrospective single-center study. The diagnosis of INAAs required a combination of two or more of the following criteria: (1) clinical presentation, (2) laboratory results, (3) imaging findings, and (4) intraoperative findings. The primary endpoint was 30-day mortality. The secondary endpoints were in-hospital mortality, estimated survival, patency, and freedom from reinfection using the Kaplan-Meier method. The predictive factors for adverse outcomes were evaluated using the Mann-Whitney U test or the Fisher exact test and multivariate regression analysis. RESULTS: A total of 65 patients (53 men [81.5%]; median age, 69.0 years; interquartile range, 61.5-75.0 years) were included, 31 (47.7%) were immunocompromised, 60 were symptomatic (92.3%), and 32 (49.2%) had presented with rupture, including 3 aortocaval fistulas (4.6%) and 12 aortoenteric fistulas (18.5%). The most common location was infrarenal (n = 39; 60.0%). Of the 65 patients, 55 (84.6%) had undergone primary OSR with ISR, 3 (4.6%) had required EVAR as a bridge to OSR, and 8 (12.3%) had undergone EVAR as definitive treatment. The approach was a midline laparotomy for 44 patients (67.7%), mostly followed by reconstruction and aortic-aortic bypass (n = 28; 40.6%) and the use of a silver and triclosan Dacron graft (n = 30; 43.5%). Causative organisms were identified in 55 patients (84.6%). The 30-day and in-hospital mortality rates were 6.2% (n = 4) and 10.8% (n = 7). The median follow-up was 33.5 months (interquartile range, 13.6-62.3 months). The estimated 1- and 5-year survival rates were 79.7% (95% confidence interval [CI], 67.6%-87.7%) and 67.4% (95% CI, 51.2%-79.3%). The corresponding freedom from reinfection rates were 92.5% (95% CI, 81.1%-97.1%) and 79.4% (95% CI, 59.1%-90.3%). On multivariate analysis, in-hospital mortality increased with uncontrolled sepsis (P < .0001), rapidly expanding aneurysms (P = .008), and fusiform aneurysms (P = .03). The incidence of reinfection increased with longer operating times (P = .009). CONCLUSIONS: The selective use of ISR and OSR combined with targeted antimicrobial therapy functioned reasonably well in the treatment of INAAs, although larger, prospective, multicenter studies with appropriately powered comparative cohorts are necessary to confirm our findings and to determine the best vascular substitute and precise role of EVAR as a bridge to OSR or definitive treatment.

Contemporary Results with the Biosynthetic Glutaraldehyde Denatured Ovine Collagen Graft (Omniflow II) in Lower Extremity Arterial Revascularization in a Septic Context.

BACKGROUND: Peripheral vascular graft infections are poorly-evaluated, despite high mortality and amputation rates. The vascular substitute of choice remains controversial when veins are unavailable. This study aims to evaluate the results of a biosynthetic collagen graft (Omniflow II®) in an infected field when autologous veins are unavailable. METHODS: This retrospective, multicentric study included all consecutive patients in whom an Omniflow II graft was used for infra-inguinal revascularization in a septic context from January 2015 to January 2020. The primary end-point was freedom from major amputation; secondary end-points were 30-day mortality, survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method. RESULTS: Twenty-nine patients (27 men, median age of 69 years interquartile range IQR:60; 76) were included. Fever was present in 58.6%, a septic rupture in 17.9%, a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4%. Median follow-up reached 49 months. At 1 and 3 years, estimated freedom from major amputation was 88.4% and 83.9%, survival: 96%, primary patency: 74.6% and 65.8%, and reinfection free-survival: 85.6%. There were 7 occlusions (1 iliofemoral, 1 below-knee, and 5 above-knee bypasses), 3 explantations for persistent sepsis, 4 reinfections (all within 6 months which led to 1 death and 3 out of 4 major amputations). The risk of major amputation increased with bypass reinfection (P = 0.004), occlusion (P = 0.005), and polymicrobial infection (P = 0.05). CONCLUSIONS: In a septic context, the Omniflow II graft shows acceptable freedom from major amputation and reinfection. This usage remains outside the instructions of use, it is, therefore, is essential to pursue longer-term studies in larger cohorts.

Quantifying Donor Deficits Following Nerve Transfer Surgery in Tetraplegia.

PURPOSE: Nerve transfer (NT) surgery can improve function in people with cervical spinal cord injury (SCI). However, the impact of donor nerve deficits remains unclear. The purpose of this study was to quantify donor deficits experienced by individuals with cervical SCI following NT. METHODS: This prospective single-arm, comparative study included people with SCI undergoing upper extremity NTs. Myometry was used to assess muscle strength at baseline and follow-up. The Spinal Cord Independence Measure was used to measure the ability to perform activities of daily living. RESULTS: Ten individuals underwent 20 NTs to restore elbow extension (donor, posterior deltoid; n = 2), hand opening (donor, supinator; n = 7), and hand closing (donor, brachialis; n = 11). Shoulder abduction strength decreased (-5.6% at early and -4.5% late follow-up) in the elbow extension NT. Wrist extension strength decreased at early (-46.9% ± 30.3) and increased by late (76.4% ± 154.0) follow-up in the hand opening NT. No statistically significant change in elbow flexion strength was noted in the hand closing NT. Spinal Cord Independence Measure scores did not change significantly between baseline and early postoperative follow-up; they improved at late follow-up. CONCLUSIONS: Use of expendable donor nerves with redundant function to perform NT surgery has relatively little impact on strength or capacity to perform activities of daily living, even in the unique and highly vulnerable SCI population. Early, temporary loss in wrist extension strength can be seen after the supinator to posterior interosseous nerve transfer. This study offers quantitative data about possible diminution of donor function after NT, enabling hand surgeons to better counsel individuals contemplating upper extremity reconstruction. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic I.

Adjuncts to the Management of Graft Aorto-Enteric Erosion and Fistula with in situ Reconstruction.

OBJECTIVE: The objective of this retrospective single centre study was to determine whether different enteric reconstruction methods and adjuncts confer a benefit after in situ reconstructions (ISRs) of graft aorto-enteric erosion (AEnE) and fistula (AEnF). METHODS: Primary endpoints were in hospital mortality and AEnE/F recurrence. Survival was estimated using the Kaplan-Meier method and explanatory factors were searched for using uni- ± multivariable Cox regression analysis. In 2013, a multidisciplinary team meeting was convened and since then the primary operator has always been a senior surgeon. RESULTS: Sixty-six patients were treated for AEnE (n = 38) and AEnF (n = 28, 42%) from 2004 to 2020. All patients with AEnF presented with gastrointestinal bleeding (vs. 0 for AEnE; p < .001). Signs of infection were seen in 50 patients (76% [37 for AEnE vs. 13 for AEnF]; p < .001). Referrals for endograft infection increased over time (n = 15, 23%; one before 2013 vs. 14 after; p = .002). Most patients underwent complete graft excision (n = 52, 79%) with increasing suprarenal cross clamping (n = 21, 32%; four before 2013 vs. 17 after; p = .015). Complex visceral reconstructions decreased over time (n = 31, 47%; 17 before 2013 vs. 14 after; p = .055), while "open abdomens" (OAs) increased (one before 2013 vs. 22 after; p < .001), reducing operating time (p = .012). In hospital mortality reached 42% (n = 28). Estimated survival reached 47.6% (95% confidence interval [CI] 35.0 - 59.1) at one year and 45.6% (95% CI 33.0 - 57.3) at three years and was higher for AEnE than for AEnF (log rank p = .029). AEnE/F recurrence was noted in 12 patients (18%). Older age predicted in hospital mortality in multivariable analysis (p = .034). AEnE/F recurrence decreased with the presence of a primary senior surgeon (vs. junior; p = .003) and OA (1 [4.4%] vs. 11 [26%] for primary fascial closure; p = .045) in univariable analysis. CONCLUSION: Mortality and recurrence rates remain high after ISR of AEnE/F. Older age predicted in hospital mortality. Primary closure of enteric defects ≤ 2 cm in diameter reduced operating time without increasing the recurrence of AEnF.

Migration and sac expansion as modes of midterm therapeutic failure after endovascular aneurysm sealing.

BACKGROUND: Endovascular aneurysm sealing (EVAS) is a disruptive technology to treat abdominal aortic aneurysm (AAA). The use of sac filling rather than endograft fixation was designed to treat aortic aneurysms in a wide range of morphologic appearances and to reduce endoleaks. There are few data reporting outcomes beyond postoperative follow-up. This study reports outcomes up to 5 years for Nellix (Endologix, Irvine, Calif) EVAS. METHODS: Data were prospectively collected for EVAS patients from the time of adoption of EVAS in 2013. All patients treated with the Nellix device are included in this study, and as such, it reports on infrarenal, ruptured, and iliac aneurysms as well as the Nellix-in-Nellix application. Juxtarenal and suprarenal aneurysms were treated using the EVAS system with parallel grafts into the visceral vessels and are included. Therapeutic failure, a composite outcome of migration, sac expansion >5 mm, type Ia and type Ib endoleak, and secondary aortic rupture, was the primary outcome along with all-cause mortality, aneurysm-related mortality, and reintervention rates. RESULTS: There were 295 EVAS cases undertaken between March 2013 and July 2018. Indications for treatment were infrarenal (n = 185), juxtarenal and suprarenal (n = 73), ruptured (n = 18), and iliac (n = 13) aneurysms. There were 15 reinterventions using the Nellix-in-Nellix application. In some cases, EVAS was used to salvage failing endovascular or open aneurysm repairs. Median follow-up was 2.42 years (interquartile range, 1.07-3.57 years). Therapeutic failure was observed in 98 of the 295 cases (33.2%) overall and exceeded 50% in some subgroups. In 71 cases (24.1%), reintervention was performed, with reasons for no reintervention being mainly physiologic. Complications leading to therapeutic failure were most commonly seen beyond 2 years of follow-up. There were 15 secondary ruptures (5.36%), and 9 EVAS devices required explantation either electively or for aortic rupture. CONCLUSIONS: EVAS with the Nellix device has not met expectations, and early encouraging results have been eroded. The incidence of therapeutic failure has been high, occurring 2 years and beyond after implantation. The Nellix system has been voluntarily recalled by Endologix, and the CE mark has subsequently been suspended. The adoption of EVAS as a disruptive technology highlights the need for cautious adoption of novel technologies and the strict governance around such arrangements.

Early results of endovascular aneurysm sealing with chimney grafts to treat juxtarenal and suprarenal abdominal aortic aneurysms.

BACKGROUND: The treatment of juxtarenal abdominal aortic aneurysms is challenging. Open surgical repair is not a viable option for many patients. The use of endovascular aneurysm sealing (EVAS) with chimney grafts (Ch-EVAS) has been proposed as an immediately available, off-the-shelf option for individuals with juxtarenal aneurysms who require urgent treatment or are unsuitable for fenestrated or branched devices. This study reports the outcomes from our first patients to undergo this procedure. METHODS: Data were collected prospectively for 62 consecutive patients undergoing Ch-EVAS at our institution. The procedures were undertaken for intact juxtarenal or suprarenal aneurysms in patients who were unfit for open repair or needed urgent treatment or when the aneurysm morphology was unsuitable for treatment with fenestrated or branched endografts. RESULTS: Between July 2013 and June 2016, there were 62 patients who were treated with Ch-EVAS; 77.4% were male, and the mean age was 73.9 years. Median aneurysm diameter was 64.5 mm. Eight suprarenal aneurysms were treated, with three chimney grafts. Of 54 juxtarenal aneurysms treated, 21 cases used two chimney grafts and 33 cases used one chimney graft. Median follow-up was 407 days. Eleven patients underwent reintervention. There were five type IA endoleaks, all successfully treated. One type IB and one type II endoleak occurred, neither requiring treatment. There were four minor strokes. Chimney patency is 97%. CONCLUSIONS: These results in a group of high-risk patients suggest that Ch-EVAS is a viable alternative to custom-made devices in patients who are unfit for open surgery. Longer term follow-up and data from the international registry will determine the widespread applicability and durability of this technique.

Midterm results of endovascular aneurysm sealing to treat abdominal aortic aneurysm.

BACKGROUND: Endovascular aneurysm sealing (EVAS) represents a novel approach to the treatment of abdominal aortic aneurysms. It uses polymer technology to achieve an anatomic seal within the sac of the aneurysm. This cohort study reports the early clinical outcomes, technical refinements, and learning curve during the initial EVAS experience at a single institution. METHODS: Results from 150 consecutive EVAS cases for intact, infrarenal abdominal aortic aneurysms are reported here. These cases were undertaken between March 2013 and July 2015. Preoperative, perioperative, and postoperative data were collected for each patient prospectively. RESULTS: The median age of the cohort was 76.6 years (interquartile range, 70.2-80.9 years), and 87.3% were male. Median aneurysm diameter was 62.0 mm (IQR, 58.0-69.0 mm). Adverse neck morphology was seen in 69 (46.0%) patients, including aneurysm neck length <10 mm (17.3%), neck diameter >32 mm or <18 mm (8.7%), and neck angulation >60 degrees (15.3%). Median follow-up was 687 days (IQR, 463-897 days); 37 patients (24.7%) underwent reintervention. The rates of unresolved endoleak are 1.3% type IA, 0.7% type IB, and 2.7% type I. There were no type III endoleaks. There have been seven secondary ruptures in this cohort; all but one of these patients survived after reintervention. Only one rupture occurred in an aneurysm that had been treated within the manufacturer's instructions for use (IFU). CONCLUSIONS: The rate of unresolved endoleaks is satisfactorily low. The incidence of secondary rupture is of concern; however, when the IFU are adhered to, the rate is very low. The results of this study suggest that working within the IFU yields better clinical results.

Short Stay EVAR is Safe and Cost Effective.

OBJECTIVE: Reducing length of stay (LOS) following surgery offers the potential to improve resource utilisation. Endovascular aneurysm repair (EVAR) is now delivered with a low level of morbidity and as such may be deliverable as a "23 hour stay" intervention. This systematic review aims to assess safety, feasibility and cost effectiveness of a short stay EVAR pathway. METHODS: A database search of Ovid MEDLINE (1996 - April 2018) and Embase (1974 - April 2018) was completed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. A Newcastle-Ottawa Scale was applied to assess study bias. RESULTS: In total, 570 papers were identified through the literature search, of which 32 abstracts were screened. This led to nine papers being assessed for eligibility. From five suitable studies, 450 (75%) patients were successfully discharged the same or next day after EVAR. Complications most often occurred within 3 hours of surgery, and major complications requiring intensive treatment unit admission occurred within 6 hours. Readmission rates were 0-5% for those discharged early, with no difference in 30 day readmission. Early discharge led to a statistically significant cost saving of £13,360 (LOS four days) to £9844 (LOS one day). CONCLUSION: Selected patients can safely undergo EVAR using a short stay pathway. A period of monitoring 6 h post-operatively for low risk patients would be sufficient. Reducing length of stay after EVAR in the UK from the current median of three days to 1.5 days would free 4361 bed days and lead to a saving of approximately £1,800,000 annually.

Comparing surgeries to restore upper extremity function in tetraplegia: Impact on function during the perioperative period.

CONTEXT/OBJECTIVE: To assess short-term changes in health outcomes in people with cervical-level spinal cord injury (SCI) who underwent upper extremity (UE) reconstruction via either novel nerve transfer (NT) or traditional tendon transfer (TT) surgery with individuals who did not undergo UE surgical reconstruction. DESIGN: Prospective, comparative cohort pilot study. PARTICIPANTS: 34 participants with cervical SCI met the following inclusion criteria: age 18 or older, greater than 6 months post-injury, and mid-cervical level SCI American Spinal Injury Association Impairment Scale (AIS) A, B or C. SETTING: Two tertiary academic hospitals and their affiliated veterans' hospitals. METHODS: Health outcomes were assessed using two previously validated measures, the Spinal Cord Independence Measure (SCIM) and Short-Form Health Survey (SF-36). Demographic, surgical, and survey data were collected at the initial evaluation and one month postoperatively/post-baseline. RESULTS: 34 participants with cervical SCI were recruited across three cohorts: no surgery (n = 16), NT (n = 10), and TT (n = 8). The TT group had a decline in SCIM and SF-36 scores whereas the NT and no surgery groups experienced little change in independence or health status in the immediate perioperative period. CONCLUSIONS: Surgeons and rehabilitation providers must recognize differences in the perioperative needs of people with cervical SCI who chose to have restorative UE surgery. Future work should focus on further investigation of health outcomes, change in function, and improving preoperative counseling and cross-disciplinary management.

Upper Extremity Surgery in Cervical Spinal Cord Injury: A Prospective Comparative Mixed Methods Study.

BACKGROUND: Cervical spinal cord injury (SCI) is a devastating injury. Restoring upper extremity function is a top priority, which can be accomplished by tendon transfer (TT) and nerve transfer (NT) surgeries. The purpose of this prospective comparative study was to assess long-term changes in UE function between surgical (TT or NT) and non-surgical groups through a comprehensive mixed methods approach. METHODS: This multicenter, cohort study compared data among three groups: those undergoing 1) no surgery 2) TT surgery, or 3) NT surgery. Quantitative data, the Spinal Cord Independence Measure (SCIM) and Short Form Health Survey (SF-36), was collected at baseline and long-term follow-up (6-24 months). Qualitative semi-structured interview data was also obtained from these participants and their identified caregivers at baseline, early follow-up (1 month), and long-term follow-up (6-24 months). RESULTS: Thirty-one participants had quantitative data across all timepoints: no surgery (n=14), TT (n=7), and NT (n=10). SCIM scores improved in TT and NT groups compared to the no surgery group (p<0.05). SF-36 scores did not differ among groups. Qualitative data analysis (n=168 interviews) corroborated SCIM findings: surgical participants and their caregivers reported improvement in transfers and ability to perform activities of daily living, including grooming and self-catheterization. Improved use of electronics and ability to operate a motor vehicle were also reported. Post-operative therapy was identified as a critical component of achieving gains. CONCLUSION: Both TT and NT surgery leads to quantitative and qualitative functional gains as compared to the no surgery group. This comparative information should be used to help surgeons discuss treatment options.

Surgery to restore upper extremity function in tetraplegia-Preferences for early and frequent access to information.

INTRODUCTION: People with cervical spinal cord injury (SCI) identify improving upper extremity (UE) function as a top priority. In addition to comprehensive rehabilitation, UE surgeries, including nerve and tendon transfers, enhance function. However, barriers exist to disseminating information about surgical options to enhance UE function. OBJECTIVE: To assess the experiences and preferences of people with cervical SCI and their caregivers in accessing information about surgery to enhance UE function. DESIGN: Prospective cohort study. Participants were followed up for 24 months and completed up to three interviews. SETTING: Tertiary care at academic and affiliated Veterans Administration Health Care Centers. PARTICIPANTS: Adults with cervical SCI (n = 35) ages 18 to 80 years with mid-cervical SCI American Spinal Injury Association Impairment Scale A, B, or C (at least 6 months post-injury) and their caregivers (n = 23) were eligible to participate. Participants were enrolled in three groups: nerve transfer, tendon transfer, or no UE reconstructive surgery. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Semi-structured interviews about surgical knowledge and experiences. RESULTS: Data were analyzed and three themes were identified. First, providing information about UE surgical options early post-injury was recommended. The acute or inpatient rehabilitation phases of recovery were the preferred times to receive surgical information. Second, challenges with information dissemination were identified. Participants learned about UE surgery through independent research, medical provider interactions, or peers. Third, peers were identified as valuable resources for SCI needs and surgical information. CONCLUSIONS: Following cervical SCI, information about UE reconstructive surgeries should be a standard component of education during rehabilitation. An increased understanding of the reconstructive options available to improve UE function is necessary to educate stakeholders. Future research is needed to support the development of strategies to effectively present surgical information to individuals with SCI and health care providers.

Caregiving for People With Spinal Cord Injury Undergoing Upper Extremity Reconstructive Surgery: A Prospective Exploration of Lived Experiences, Perioperative Care, and Change Across Time.

Background: Nerve transfer (NT) and tendon transfer (TT) surgeries can enhance upper extremity (UE) function and independence in individuals with cervical spinal cord injury (SCI). Caregivers are needed to make this surgery possible, yet caregivers experience their own set of challenges. Objectives: This comparative study explored the perioperative and nonoperative experiences of caregivers of individuals with cervical SCI, focusing on daily life activities, burden, and mental health. Methods: Caregivers of individuals with cervical SCI were recruited and grouped by treatment plan for the person with SCI: (1) no surgery (NS), (2) TT surgery, and (3) NT surgery. Semistructured interviews were conducted at baseline/preoperative, early follow-up/postoperative, and late follow-up/postoperative. Caregivers were asked about their daily life, mental health, and challenges related to caregiving. Interviews were audio recorded, transcribed verbatim, and analyzed using thematic analysis. Quantitative, single-item standardized burden score (0-100) data were collected at each timepoint. Results: Participants included 23 caregivers (18 family members, 4 friends, 1 hired professional). The surgeries often brought hope and motivation for caregivers. Caregivers reported increased burden immediately following surgery (less for the NT compared to TT subgroup) yet no long-term changes in the amount and type of care they provided. NS caregivers discussed social isolation, relationship dysfunction, and everyday challenges. Conclusion: Health care providers should consider the changing needs of SCI caregivers during perioperative rehabilitation. As part of the shared surgical decision-making approach, providers should educate caregivers about the postoperative process and the extent and potential variability of short- and long-term care needs.

A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat®, for the Management of Bleeding in Elective Carotid Artery Surgery.

Anastomotic bleeding in vascular surgery can be difficult to control. Patients, in particular those undergoing carotid surgery, have often been started on treatment with dual antiplatelet agents and receive systemic heparinization intraoperatively. The use of local hemostatic agents as an adjunct to conventional methods is widely reported. 3-D Matrix's absorbable hemostatic material RADA16 (PuraStat®), is a fully synthetic resorbable hemostatic agent. The aim of this study is to confirm the safety and performance of this agent when used to control intraoperative anastomotic bleeding during carotid endarterectomy (CEA). A prospective, single-arm, multicenter study involving 65 patients, undergoing CEA, in whom the hemostatic agent was applied to the suture line after removal of arterial clamps. Patients were followed up at 24 h, discharge, and one month after surgery. Time to hemostasis was measured as the primary endpoint. Secondary endpoints included hemostasis efficacy and safety outcomes, blood loss, intraoperative and postoperative administration of blood products, and incidence of reoperation for bleeding. A total of 65 cases (51 male and 14 female) undergoing CEA, utilizing patch reconstruction (90. 8%), eversion technique (6.1%), and direct closure (3.1%) were analyzed. All patients received dual antiplatelet therapy preoperatively and were administered systemic intravenous heparin intraoperatively, as per local protocol. The mean time to hemostasis was 83 s ± 105 s (95% CI: 55-110 s). Primary hemostatic efficacy was 90.8%. The mean volume of product used was 1.7 mL ± 1.1 mL. Hemostasis was achieved with a single application of the product in 49 patients (75.3%). Two patients required a transfusion of blood products intraoperatively. There were no blood product transfusions during the postoperative period. The intraoperative mean blood loss was 127 mL ± 111.4 mL and postoperatively, the total mean drainage volume was 49.0 mL ± 51.2 mL. The mean duration of surgery was 119 ± 35 min, and the mean clamp time was 35 min 12 s ± 19 min 59 s. In 90.8% of patients, there was no presence of hematoma at 24 h postoperatively. Three returned to theatre due to bleeding (2 in the first 24 h), however, none of these cases were considered product related. Overall, there were no device-related serious adverse events (SAE) or unanticipated device-related SAEs reported. Use of the hemostatic agent PuraStat® is associated with a high rate of hemostatic efficacy (90.8%) and a short time to hemostasis. The safety of the product for use on vascular anastomoses has been demonstrated.

Obesity and inpatient rehabilitation outcomes for patients with a traumatic spinal cord injury.

OBJECTIVE: To examine the effect of obesity on change in FIM self-care and mobility ratings and community discharge for patients with traumatic spinal cord injury (SCI). DESIGN: Retrospective cohort study analyzing National Model Systems SCI Database data. SETTING: Fourteen Model Systems SCI programs. PARTICIPANTS: Patients (N=1524) with a new traumatic SCI discharged from Model Systems rehabilitation centers between October 2006 and October 2009. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Change in FIM self-care and mobility ratings, discharge destination. Separate analyses were conducted by neurologic category: paraplegia incomplete, paraplegia complete, tetraplegia incomplete, and tetraplegia complete. RESULTS: Of all patients with traumatic SCI, approximately 25% were obese at admission. Patients who were obese were more likely to be married and slightly older than nonobese patients. In patients with paraplegia incomplete, obese patients had lower FIM self-care (-1.9; 95% confidence interval [CI], -3.4 to -.4) and mobility score gains (-1.5; 95% CI, -2.9 to -.1) than normal-weight patients. For patients with paraplegia complete, obese patients had significantly lower self-care (-2.2; 95% CI, -3.5 to -.8) and mobility score gains (-2.7; 95% CI, -3.9 to -1.5). For patients with tetraplegia incomplete and tetraplegia complete, FIM self-care and mobility ratings for obese patients were not significantly different from ratings for normal-weight patients. Within each neurologic category, the percentage of patients discharged to the community was not significantly different for nonobese and obese patients. CONCLUSIONS: Obesity appears to be a barrier to meeting self-care and mobility functional goals for patients with paraplegia in inpatient SCI rehabilitation.