Saphenous vein graft patency is frequently limited by degeneration. Experimental studies have indicated that rigid external support of venous grafts by a flexible, tubular nitinol mesh may improve graft patency. The study presented was part of a prospective, randomized, multicenter first-in-man trial investigating the safety and effectiveness of nitinol-supported venous grafts in coronary artery bypass graft (CABG) surgery. From our clinic, 25 subjects with multivessel coronary artery disease requiring saphenous vein graft CABG of the right coronary artery (RCA) and the circumflex artery were entered into the trial. Subjects were randomized to receive a mesh-supported graft on one of these arteries; the other vessel received an untreated vein graft. Graft patency was assessed by coronary angiography nine months after surgery. The implantation of mesh grafts was simple and safe. In 10 cases, a nitinol mesh-supported venous graft was anastomosed to the circumflex artery and in 15 cases to the RCA. All patients survived the observation period. A total of 72% of the patients underwent control coronary angiography. The patency rate of mesh-supported grafts was 27.8% nine months postoperatively. Conventional vein grafts showed an 85.7% patency, and arterial grafts had a 100% patency. No complications directly related to the implantation of mesh-supported grafts were observed. The promising experimental results of mesh-supported venous grafts could not be reproduced in the study presented. A critical item seems to be correct selection of nitinol mesh diameter, the anastomotic method and fixation of the mesh tube to the venous graft.
BackgroundThe optimal timing of coronary artery bypass grafting (CABG) in clinically stable patients with acute myocardial infarction who are unsuitable for percutaneous coronary intervention is unclear. We report our experience with early CABG in these patients.Methods and ResultsBetween January 2001 and May 2015, 766 patients with ST‐segment–elevation myocardial infarction (STEMI, n=305) or non‐STEMI (NSTEMI, n=461) not including cardiogenic shock underwent CABG within 48 hours at our department. STEMI patients were younger than non‐STEMI patients (age 65 years [range: 58–72] versus 70 years [range: 62–75], P<0.001) with a lower EuroSCORE II (4.12 [range: 2.75–5.81] versus 4.58 [range: 2.80–7.74], P=0.009). STEMI patients had undergone preoperative percutaneous coronary intervention more often (20.3% versus 7.8%, P<0.001). Time to surgery was shorter in STEMI compared with non‐STEMI patients (5.0 hours [range: 3.2–8.8] versus 11.7 hours [range: 6.4–22.0], P<0.001). No significant differences concerning arterial graft use (93.8% versus 94.8%, P=0.540) or complete revascularization (87.5% versus 83.4%, P=0.121) were observed. The rate of strokes did not differ between the groups (2.0% versus 3.9%, P=0.134). Thirty‐day mortality was lower in STEMI patients (2.7% versus 6.6% P=0.018), especially when CABG was performed within 6 hours (1.8% versus 7.1%, P=0.041). Survival of STEMI and non‐STEMI patients was 94% versus 88% after 1 year (P<0.001), 87% versus 73% after 5 years (P<0.001), and 74% versus 57% after 10 years (P<0.001). Independent predictors of 30‐day and long‐term mortality included preoperatively increased lactate values, age, atrial fibrillation, and reduced left ventricular function.ConclusionsStable STEMI patients showed a lower rate of perioperative complications and better survival compared with non‐STEMI patients when CABG was performed within 48 hours.
The study was approved by the institutional review board (IRB) at the University Medical Center Campus Kiel, Kiel, Germany (reference number: AZ D 559/18) and registered at the German Clinical Trials Register (reference number: DRKS00022222). Objective. Unilateral pulmonary edema (UPE) is a complication after minimally invasive mitral valve surgery (MIMVS). We analyzed the impact of this complication on the short- and long-term outcome over a 10-year period. Methods. We retrospectively observed 393 MIMVS patients between 01/2009 and 12/2019. The primary endpoint was a radiographically and clinically defined UPE within the first postoperative 24 h, secondary endpoints were 30-day and long-term mortality and the percentage of patients requiring ECLS. Risk factors for UPE incidence were evaluated by logistic regression, and risk factors for mortality in the follow-up period were assessed by Cox regression. Results. Median EuroSCORE II reached 0.98% in the complete MIMVS group. Combined 30-day and in-hospital mortality after MIMVS was 2.0% with a 95, 93 and 77% survival rate after 1, 3 and 10 years. Seventy-two (18.3%) of 393 patients developed a UPE 24 h after surgery. Six patients (8.3%) with UPE required an extracorporeal life-support system. Logistic regression analysis identified a higher creatinine level, a worse LV function, pulmonary hypertension, intraoperative transfusion and a longer aortic clamp time as predictors for UPE. Combined in hospital mortality and 30-day mortality was slightly but not significantly higher in the UPE group (4.2 vs. 1.6%; p = 0.17). Predictors for mortality during follow-up were age ≥ 70 years, impaired RVF, COPD, drainage loss ≥ 800 mL and length of ventilation ≥ 48 h. During a median follow-up of 4.6 years, comparable survival between UPE and non-UPE patients was seen in our analysis after 5 years (89 vs. 88%; p = 0.98). Conclusions. In-hospital outcome with UPE after MIMVS was not significantly worse compared to non-UPE patients, and no differences were observed in the long-term follow-up. However, prolonged aortic clamp time, worse renal and left ventricular function, pulmonary hypertension and transfusion are associated with UPE.
This study demonstrates adequate deployment and anchorage of a unique, repositionable mitral valved stent. A good valve function was revealed in animals observed for 4 weeks and in one pig after 8 weeks.
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