Off-Pump Debranching and Thoracic Endovascular Aortic Repair for Aortic Arch Pathology.

OBJECTIVE: This study aimed to simplify an until-now complex procedure for the treatment of proximal aortic arch pathology (zones 0 and 1), where a deep hypothermic circulatory arrest even with selective cerebral perfusion is still a high-risk procedure with accompanying splanchnic and spinal cord ischemia. METHODS: From June 2012 until March 2013, 106 patients underwent aortic surgery in our institution, of whom, 20 patients underwent aortic arch surgery. Of the 20 patients, 7 with multiple comorbidities and a high operative risk and no other indication for a cardiopulmonary bypass were selected to undergo an off-pump aortic arch debranching and thoracic endovascular aortic repair: 4 patients had chronic dissections, and 3 patients had arch aneurysms. The procedure was performed through median sternotomy. The supraaortic branches were rerouted to the ascending aorta, and this process was followed by thoracic endovascular aortic repair of the aortic arch and proximal descending aorta. Transaortic antegrade stenting was performed in 5 cases. Cerebral protection and perfusion monitoring were achieved by biradial pressure monitoring, electroencephalogram, and online transcranial duplex sonography. The preoperative, operative, and postoperative data were collected and analyzed retrospectively. RESULTS: All procedures were successful. There were no conversions to cardiopulmonary bypass support. The mean operative time was 184 ± 24 minutes. Postoperatively, there was 1 rethoracotomy for bleeding and 1 cerebrovascular insult. The 30-day mortality was 1 patient. CONCLUSIONS: Off-pump aortic debranching with arch stenting is a reproducible procedure that could be favorable in certain situations, such as in patients with a higher operative risk profile, thereby reducing the risks associated with deep hypothermic circulatory arrest and also yielding favorable outcomes, even in an older patient cohort with more comorbidities.

Results from a First-in-Human Trial of a Novel Vascular Sealant.

BACKGROUND: Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX ((®)) ) is a polyaldehyde-bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study. MATERIALS AND METHODS: A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance. RESULTS: Fifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10 min of observation. The three most common adverse events were graft or bypass occlusion (n = 5 patients), infection (n = 4), and seroma (n = 3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts. CONCLUSION: PreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial.

Noninvasive management of the diabetic foot with critical limb ischemia: current options and future perspectives.

Foot ulcers are a major complication in patients with diabetes mellitus and involve dramatic restrictions to quality of life and also lead to enormous socio-economical loss due to the high amputation rate. The poor and slow wound healing is often aggravated by the frequent comorbidity of foot ulcers with peripheral arterial disease, making the treatment of this condition even more complicated. While the local treatment of foot ulcers is mainly based on mechanical relief and prevention or treatment of infection, improving perfusion of the impaired tissue remains the major challenge in peripheral arterial disease. While focal arterial stenosis is the domain of interventional angioplasty or vascular surgery, patients with critical limb ischemia and lacking options for revascularization have a much worse prognosis, because current treatment options avoiding amputation are scarce. However, based on recent research efforts, there is rising hope for promising and more-effective therapeutic approaches for these patients. Here, we discuss the current improvements of established therapies aimed at an improvement of limb perfusion, as well as the development of novel cutting-edge therapies based on stem-cell technology. The experiences of a 'high-volume center' for treatment of diabetic foot syndrome with a current major amputation rate of 4% are discussed.

Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver.

The purpose of this study was to assess the safety of a novel vascular prosthesis in 50 patients who underwent inguinal and infrainguinal vascular reconstructions. The safety data were based on ultrasound Doppler data at 2 and 18 months to quantify the graft-tissue integration in this patient cohort. Between August 9, 2005, and January 25, 2006, 50 patients underwent inguinal or infrainguinal reconstructions with the Silver Graft (SG; B. Braun Melsungen AG, B. Braun Aesculap AG, Tuttlingen, Germany) in six vascular centers. All participating centers received the metallic silver-coated polyester graft (SG) with a diameter of 8 mm and a total length of 60 cm, which was length adjusted to fit the patient's anatomy and the planned vascular reconstruction. The mean patient age was 69.1 +/- 9.0 years, the male inclusion rate was 72.0%, and the Fontaine classifications were stage IV (16%), stage III (14%), stage IIb (66%), and stage IIa (4%), whereas aneurysm repairs amounted to 4%. In-hospital results revealed the presence of minimal perigraft fluid in 14.0% of all cases (7 of 50). At the 2-month follow-up, perigraft fluid was detected in one patient (1 of 50). At 18 months, a single case of minimal perigraft fluid was detected in an asymptomatic patient. Wound healing was accomplished at discharge in 96% of all patients, whereas at the 2-month follow-up, no signs of wound infection or irritation could be detected. The accumulated primary patency rates were 94% at 2 months and 88% at 18 months. The available clinical data on perigraft fluid as a marker for graft-tissue incorporation at 2 and 18 months, patency, and wound healing are comparable to those of other relevant clinical results with polyester grafts and support the safety of the metallic SG in the studied patient population with inguinal and infrainguinal reconstructions. However, it cannot be guaranteed that all graft infections can be avoided with the SGs.

Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: a multicenter retrospective study.

BACKGROUND: The development of newer-generation endografts for the endovascular treatment of abdominal aortic aneurysms has resulted in considerable improvements in clinical performance. However, long-term outcome data are still scarce. To assess long-term clinical and radiographic outcomes after use of the Talent stent graft, a retrospective analysis was performed that was based on 165 patients treated with this endograft in Germany between October 1996 and December 1998. METHODS: Data were collected according to the recommendation of the ad hoc committee for standardized reporting practices in vascular surgery and were evaluated statistically by using univariate and multivariate analyses. RESULTS: A total of 165 patients were treated with a Talent endograft in 9 German centers before December 31, 1998. Most were asymptomatic (94.5%), male (97.6%), and treated with a bifurcated graft (86.7%). Two patients (1.2%) died within 30 days, and 28 (17%) died during the follow-up period. The cause of death was aneurysm rupture in one case. Survival was 95.4% +/- 1.7% at 1 year, 89% +/- 2.6% at 2 years, 78.1% +/- 3.6% at 5 years, and 76.2% +/- 4.1% at 7 years. Patients classified as American Society of Anesthesiologists grade IV had a significantly lower survival rate (24.9%) than those classified as American Society of Anesthesiologists grade II and III (91.9% and 77.3%). During a mean follow-up period of 53.2 +/- 20.1 months (range, 1-84 months), 47 secondary procedures were performed in 31 patients (18.8%). Kaplan-Meier estimates showed a freedom from secondary intervention of 94.7% +/- 1.8%, 81.7% +/- 3.3%, and 77.4% +/- 3.6% at 1, 3, and 7 years, respectively. The reason for secondary treatment was endograft thrombosis in 10 patients (6.1%), persisting primary endoleak in 9 (5.5%), late secondary endoleak in 6 (3.6%), graft migration in 3 (1.8%), aneurysm rupture in 2 (1.2%), and graft infection in 1 (0.6%). Device migration (> or =10 mm) occurred in seven patients (4.2%). Other graft changes, such as graft kinking (n = 4; 2.4%), fracture of metallic stents (n = 2; 1.2%), erosion of the longitudinal bar (n = 2; 1.2%), or modular component separation (n = 1; 0.6%), were rare. Follow-up computed tomographic imaging revealed a decrease of the maximum aneurysm sac diameter (>5 mm) in 106 (64.2%) patients and an increase in 14 (8.5%) patients. The mean aneurysm diameter significantly decreased (P < .001). Of the factors recorded at baseline, only endoleaks showed a significant correlation with the risk of aneurysm increase during follow-up (P < .001). Adverse anatomy (neck diameter >28 mm, neck length <15 mm, and '5 patent aortic branches) did not adversely influence the aneurysm shrinkage rate, the risk for a secondary procedure, or the clinical success rate. A significantly higher rate of clinical success (P < .05) was observed in patients older than 65 years of age. CONCLUSIONS: Implantation of the Talent endograft device is a safe and effective alternative to open surgery for exclusion of abdominal aortic aneurysm. In comparison with first-generation grafts, the device showed superior durability for as long as 5 to 7 years after implantation. Even if prototypes of the Talent device were implanted in this study, the graft was also successfully used in most patients, even in those with adverse anatomy. Because improvements of the endograft have been made to address connecting bar breaks, a lower incidence of graft limb occlusion can be expected in the future.