Three-Year Outcomes With the Multilayer Flow Modulator for Repair of Thoracoabdominal Aneurysms: A Follow-up Report From the STRATO Trial.

PURPOSE: To evaluate midterm outcomes of endovascular repair of types II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients unsuitable for open surgery or fenestrated stent-grafts. METHODS: In the prospective, multicenter, nonrandomized STRATO trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (mean age 75.8 years; 19 men) with Crawford type II and III TAAA (mean diameter 6.5 cm) were implanted between April 2010 and February 2011. Outcomes included all-cause mortality and stable aneurysm thrombosis with associated branch vessel patency. RESULTS: Through 36 months, there were 7 deaths (none confirmed as aneurysm-related), and no cases of spinal cord injury, device migration or fracture, or respiratory, renal, or peripheral complications. Three patients were lost to follow-up and 2 devices were explanted. The device was patent in the 11 remaining patients at 3 years. Stable aneurysm thrombosis was achieved for 15 of 20 patients at 12 months, 12 of 13 at 24 months, and 10 of 11 at 36 months. The rate of branch patency was 96% at 12 months (primary patency), 100% at 24 months, and 97% at 36 months. Nine patients suffered from endoleaks (attachment site or device overlap); 9 patients underwent 11 reinterventions (3 surgical). Maximum aneurysm diameter was stable for 18 of 20 patients at 12 months, 11 of 13 at 24 months, and 9 of 11 at 36 months. For 10 patients with computed tomography at 36 months, the mean ratio of aneurysm flow volume to total volume had decreased by 83%; the mean ratio of thrombus volume to total volume increased by 159%. CONCLUSION: Through 3 years, endovascular repair with the MFM appears to be safe and effective while successfully maintaining branch vessel patency.

One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial.

PURPOSE: To evaluate endovascular repair of type II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients with contraindications for open surgery and fenestrated stent-grafts. METHODS: In this prospective, multicenter, nonrandomized trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (19 men; mean age 75.8 years) with Crawford type II (43.5%) and III (56.5%) TAAA (mean diameter 6.5 cm) were treated with the MFM between April 2010 and February 2011. The primary efficacy outcome measure was stable aneurysm thrombosis with associated branch vessel patency at 12 months; the primary safety endpoint was 30-day and 12-month all-cause mortality. RESULTS: The rate of technical success was 100%. In 20 patients with computed tomography scans at 12 months, the primary efficacy outcome was met in 15 patients. The rate of primary patency of covered branch vessels was 96% (53/55); 1 patient with 2 occluded visceral branches underwent successful surgical reintervention. Endoleaks were identified in 5 patients (3 attachment site and 2 at device overlap), 4 of whom underwent reintervention (3 additional MFMs and 1 stent-graft implanted). At 12 months, aneurysm diameter was stable in 18 of 20 patients; the mean ratio of residual aneurysm flow volume to total volume had decreased by 28.9%, and the mean ratio of thrombus volume to total lumen volume had increased by 21.3% (n=17). There were no cases of device migration, loss of device integrity, spinal cord ischemia, or aneurysm rupture. CONCLUSION: At 1 year, endovascular repair with the MFM appears to be safe and effective while successfully maintaining branch vessel patency. Follow-up is ongoing.

Off-pump axillo-coronary artery bypass: a simple approach for high-risk myocardial revascularization.

We report the case of a 66-year-old male with increasing angina occurring after two previous coronary artery surgery procedures. The second operation had been complicated by severe mediastinitis necessitating surgical drainage, and sternal stabilization. Angiography revealed an occlusion of the LAD bypass with a patent LAD associated with a stenotic circumflex coronary artery. The ascending aorta was severely calcified. An off-pump axillo-LAD coronary artery bypass was safely performed in conjunction with stenting of the circumflex artery. This approach dramatically simplified the procedure and reduced the operative risk. At the 52-month follow-up, the patient is free of any angina symptoms.

Cardiac surgery in cirrhotic patients: results and evaluation of risk factors.

OBJECTIVES: Liver cirrhosis increases mortality and morbidity following cardiac surgery. This study evaluated the results of cardiac surgery in cirrhotic patients and the relevance of EuroSCORE, Child-Turcotte-Pugh (CTP) class and model for end-stage liver disease (MELD) score in terms of prediction of surgical mortality and survival. METHODS: The study involved 34 patients with hepatic cirrhosis who underwent cardiac surgery between January 1996 and January 2010. RESULTS: The in-hospital mortality was 26%. Postoperative mortality of patients with CTP class A, B or C was 18, 40 and 100%, respectively. In univariate analysis, a history of cerebrovascular disease and hypoalbuminaemia was predictive of operative mortality. Multivariate exact logistic regression revealed that hypoalbuminaemia was an independent factor. Long-term survival was 63 ± 0.08% at 1 year and 40.2 ± 0.12% at 5 years. The 1-year survival for CTP A, B and C was 76.7 ± 0.09, 60 ± 15.4 and 0%, respectively, and the 5-year survival was 60 ± 15.4, 25 ± 0.19 and 0%, respectively. The EuroSCORE was not a discriminant [area under the curve (AUC): 0.57 ± 0.15]. The performance of CTP class and MELD score was better, but neither provided optimal discrimination: AUC was 0.691 ± 0.110 for MELD and 0.658 ± 0.10 for CTP class. CONCLUSIONS: Cardiac surgery can be performed safely in CTP class A patients. In CTP C patients, surgery is hazardous, and an alternative treatment must be considered. In CTP B, the MELD score could be helpful in deciding whether surgical intervention is a reasonable option.

An aortic ring: from physiologic reconstruction of the root to a standardized approach for aortic valve repair.

OBJECTIVE: We suggest standardizing aortic valve repair using a physiologic approach by associating root remodeling with resuspension of the cusp effective height and external subvalvular aortic ring annuloplasty. METHODS: A total of 187 patients underwent remodeling associated with subvalvular aortic ring annuloplasty (14 centers, 24 surgeons). Three strategies for cusp repair were evaluated: group 1, gross visual estimation (74 patients); group 2, alignment of cusp free edges (62 patients); and group 3, 2-step approach, alignment of the cusp free edges and effective height resuspension (51 patients). The composite outcome was defined as recurrence of aortic insufficiency of grade 2 or greater and/or reoperation. RESULTS: The operative mortality rate was 3.2% (n = 6). Treatment of a cusp lesion was most frequently performed in group 3 (70.6% vs 20.3% in group 1 and 30.6% in group 2, P < .001). Nine patients required reoperation during a follow-up period of 24 months (range, 12-45), 6 patients in group 1 and 3 patients in group 2. At 1 year, no patients in group 3 presented with composite outcome events compared with 28.1% in group 1 and 15% in group 2 (P < .001). Residual aortic insufficiency and tricuspid anatomy were independent risk factors for the composite outcome in groups 1 and 2. The annulus diameter, the presence of Marfan syndrome, and cusp repair had no effect on aortic insufficiency recurrence or reoperation. CONCLUSIONS: A standardized and physiologic approach to aortic valve repair, considering both the aorta (root remodeling) and the valve (resuspension of the cusp effective height and subvalvular ring annuloplasty) improved the preliminary results and might affect their long-term durability. The ongoing Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysm of the Aortic Root (CAVIAAR) trial will compare this strategy to mechanical valve replacement.