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.

Feasibility of sutureless valve implantation in reoperation for degenerated 19 mm aortic valvular bioprostheses.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) is a promising option to treat degenerated aortic valve bioprostheses, and may involve Valve-in-Valve (ViV) procedures. Unfortunately, the ViV technique may provide an inadequate relief of stenosis in small-diameter degenerated bioprostheses, especially in the 19 mm valve subgroup. The study aim was to determine the feasibility and reliability of reoperating 19 mm degenerated bioprostheses, using a minimally invasive sutureless valve implantation. METHODS: Between March and December 2012, three reoperative procedures for degenerated 19 mm conventional aortic bioprostheses were performed at the authors' unit. Stenosis was the main modality of structural deterioration. A partial upper ministernotomy approach was used, whereby part of the sewing ring of the previous bioprosthesis was left in place and a 19 mm Medtronic Enable sutureless valve was implanted in all cases. RESULTS: The average valve implantation time was 10.3 min. There were no cases of operative mortality or major morbidity. One permanent pacemaker was required. At discharge, transthoracic echocardiography showed no paravalvular leakages; the average transvalvular gradient was 16 mmHg. The one-year follow up showed no paravalvular leakages and unchanged gradients. CONCLUSION: The use of a surgical sutureless valve after explanting a 19 mm degenerated bioprosthesis is feasible and effective for relieving stenosis However, larger series are needed to confirm these preliminary results.

Endovascular treatment of a tuberculous thoracoabdominal aneurysm with the Multilayer stent.

PURPOSE: To describe a case of multiple thoracoabdominal aneurysms of tuberculous origin treated in an endovascular procedure with the Multilayer stent. CASE REPORT: A 16-year-old girl had been treated 4 years previously for a ruptured abdominal aortic aneurysm of tuberculous origin. Due to the presence of 4 rapidly evolving saccular aneurysms of the descending thoracic aorta and a fusiform aneurysm of the suprarenal aorta, an endovascular solution was chosen after the patient refused open surgery. Three uncovered Multilayer stents (16×40, 16×80, and 16×80 mm) were successively implanted with a 1-cm overlap from the left subclavian artery to cover the entire aneurysmal segment of the thoracoabdominal aorta to above the renal arteries. At 18 months, serial imaging studies have shown disappearance of some aneurysms and regression of others. CONCLUSION: In this young patient, the endovascular treatment of a thoracoabdominal aneurysm with an uncovered stent made it possible to stabilize the aneurysm process without exposing the patient to the high morbidity and mortality of open surgery.

Totally minimized extracorporeal circulation: an important benefit for coronary artery bypass grafting in Jehovah's witnesses.

BACKGROUND: Jehovah's Witnesses who require cardiac surgery represent a challenge to the physician because of their refusal to accept blood transfusions. Because coronary artery bypass grafting (CABG) is performed by most surgeons under cardiopulmonary bypass (CPB), which has potentially deleterious effects on hemostasis, we used a new concept called minimal extracorporeal circulation (MECC). MECC includes heparin-coated tubing, a centrifugal pump, and an oxygenator. There is no venous reservoir or vent, and suction is used through the cell saver. We assessed the hypothesis that MECC in combination with low-volume blood cardioplegia preserves more hemoglobin than conventional CPB in standard CABG. METHODS: In 40 patients of the Jehovah's Witnesses faith undergoing CABG with the use of MECC and intermittent warm blood cardioplegia, clinical and biological data as well as values for parameters of hemolysis (plasma hemoglobin) and myocardial damage (troponin T) were determined. The results were compared with those of a control group of 40 patients who underwent operations with standard CPB. RESULTS: Demographics, hemodynamics, the number of anastomoses, and CPB and cross-clamp times were comparable between the groups. MECC patients demonstrated significantly lower peak levels of plasma hemoglobin (21.8 +/- 114 mg/dL versus 35.4 +/- 15 mg/dL) and troponin T (0.12 +/- 0.4 ng/mL versus 0.65 +/- 0.7 ng/mL), a higher minimum hematocrit level during CPB (30% +/- 7% versus 23% +/- 6%), and a higher hemoglobin level 2 days after surgery (13 +/- 3 g/100 mL versus 9.4 +/- 0.98 g/100 mL). Preoperative values were not significantly different. CONCLUSION: The use of MECC instead of conventional CPB reduces hemolysis, hemodilution, blood loss, and myocardial damage.

Economic Impacts of Treatment for Type II or III Thoracoabdominal Aortic Aneurysm in the United States.

BACKGROUND: Current treatment for extensive thoracoabdominal aortic aneurysms (TAAAs) involves high-risk surgical and endovascular repairs, with a hospital mortality exceeding 20%, and a postoperative paraplegia rate beyond 10.5%. OBJECTIVES: The aim of this study was to present an estimation of the economic impacts of surgical and endovascular treatments of types II and III TAAAs in the US as well as the economic consequences of the elimination of spinal cord injury and mortality via an endovascular repair of extensive TAAAs (1). MATERIALS AND METHODS: We compared the current hospital charges of endovascular and surgical repair of extensive TAAAs, also provided a cost analysis of health care charges resulting from paraplegia in the United States, and determined the prevalence of extensive TAAAs found yearly during autopsies in the U.S. Based on the figures gathered and the frequency of Thoracic Aortic Aneurysms per year, we were able to calculate the nationwide inpatient hospital charges, the total average expenses affected by paraplegia during the first 12 months after the repair, the total average expenses after paraplegia for each subsequent year, mortality rate at 30 days and one year, and the number of extensive TAAAs ruptures. RESULTS: The current nationwide inpatient hospital charges for type II or III TAAA repair cost $12484324 and $37612665 for endovascular repair and surgical repair respectively, and the total average expenses for patients affected by paraplegia during the first 12-month were $4882291 and $23179110 after endovascular repair and surgical repair respectively. The nationwide average expense after 10 years for patients undergoing surgical repair and affected by paraplegia is $33421910 and $6,316,183 for patients undergoing endovascular repair. Moreover, 55 patients with a type II or type III TAAA died after 30 days, and 100 after 1 year. The potential risk of type II or III TAAA ruptures is totally 1637 in a year. CONCLUSIONS: Major economic impacts of type II or III TAAA repairs in the United States have been identified. An endovascular repair excluding spinal cord injury and mortality with the same average costs as present endovascular treatments makes it possible to save at least $53189742 after one year, 100 lives of operated patients would be saved after one year, and 1637 type II and III TAAA ruptures would be avoided yearly.

Aortic valve replacement and repair of left ventricular pseudoaneurysm in a Jehovah's Witness.

The preoperative and surgical management of a giant left ventricular pseudoaneurysm(LVP) associated with aortic valve replacement in a 76 year old male Jehovah's Witness patient is reported. The satisfactory recovery observed in this patient demonstrates the feasibility of this complex surgical procedure even in this particular patient population.

Outcomes in cardiac surgery in 500 consecutive Jehovah's Witness patients: 21 year experience.

BACKGROUND: Refusal of heterogenic blood products can be for religious reasons as in Jehovah's Witnesses or otherwise or as requested by an increasing number of patients. Furthermore blood reserves are under continuous demand with increasing costs. Therefore, transfusion avoidance strategies are desirable. We describe a historic comparison and current results of blood saving protocols in Jehovah's Witnesses patients. METHODS: Data on 250 Jehovah's Witness patients operated upon between 1991 and 2003 (group A) were reviewed and compared with a second population of 250 patients treated from 2003 to 2012 (group B). RESULTS: In group A, mean age was 51 years of age compared to 68 years in group B. An iterative procedure was performed in 13% of patients in group B. Thirty days mortality was 3% in group A and 1% in group B despite greater operative risk factors, with more redo, and lower ejection fraction in group B. Several factors contributed to the low morbidity-mortality in group B, namely: preoperative erythropoietin to attain a minimal hemoglobin value of 14 g/dl, warm blood cardioplegia, the implementation of the Cornell University protocol and fast track extubation. CONCLUSIONS: Cardiac surgery without transfusion in high-risk patients such as Jehovah Witnesses can be carried out with results equivalent to those of low risk patients. Recent advances in surgical techniques and blood conservation protocols are main contributing factors.

Multilayer stents in the treatment of thoraco-abdominal residual type B dissection.

Multilayer stents are already being used for the treatment of peripheral aneurysms. In France, they are currently under evaluation in the treatment of thoraco-abdominal aneurysms. We have used multilayer stents to treat aneurysmal evolution of thoraco-abdominal residual type B dissection. Third month computed tomography (CT)-scan showed a false channel no longer patent. Multilayer stents are promising but it is too soon to draw conclusions on the use of this device in the treatment of patent false channels.