Abstract： Objective To evaluate early clinical outcomes and short-term follow-up results of CL-V bileaflet prosthesis. Methods From April 2004 to May 2010， 38 patients with valvular heart diseases underwent mechanical heart valve replacement. Eighteen patients received CL-V bileaflet valve replacement （CL group） including 8 males and 10 females with their mean age of （47.4±6.2）years and mean body weight of （64.7±11.9） kg. Preoperatively，15 patients were in New York Heart Association （NYHA） classⅢ， and 2 patients were in NYHA classⅣ. Mitral valve replacement （MVR） was performed in 16 patients， mitral and aortic valve replacement（DVR） in 2 patients. A total of 20 CL-V bileaflet prostheses were implanted. Twenty patients received St. Jude bileaflet valve replacement （SJM group）including 9 males and 11 females with their mean age of （49.7±7.6） years and mean body weight of （66.1±11.1） kg. Preoperatively， 15 patients were in NYHA classⅢ， and 3 patients were in NYHA classⅣ. MVR was performed in 17 patients，aortic valve replacement （AVR） in 1 patient， and DVR in 2 patients. A total of 22 St. Jude bileaflet prostheses were implanted. Clinical outcomes， hear function， hemodynamics and blood compatibility were measured on the 7th postoperative day and 6 months during follow-up and compared between the two groups. Results There was no early mortality （＜30 d） or postoperative complication in either group. Follow-up rate was 100% and the mean follow-up duration was 19.8 （6-61）months. At 6 months after surgery， those patients who were preoperatively in NYHA classⅢ orⅣall improved to classⅠ orⅡ. In CL group， cardiothoracic ratio was 0.51±0.05， left atrium diameter （44.5±7.8） mm， left ventricular end diastolic diameter （LVEDD，46.6±4.1） mm， LVEF 65.3%±7.7%，and LVFS 35.0%±7.1%. In SJM group， cardiothoracic ratio was 0.51±0.06， left atrium diameter （45.8±9.6） mm， LVEDD （46.2±9.8） mm， LVEF 64.1%±9.0%，and LVFS 34.9%±4.7%， which were not statistically different from those parameters of CL group respectively （P＞0.05）. At 6 months after surgery， transthoracic echocardiography was used to compare hemodynamics of bileaflet prostheses with same size 27 mm in the two groups. Prosthetic transvalvular gradient was （5.1±0.9）mm Hg in CL group and （5.8±0.8） mm Hg in SJM group， and effective orifice area was （2.3±0.3）cm2 in CL group and（2.5±0.2）cm2 in SJM group，which were not statistically significant between the two groups （P＞0.05） respectively. In both groups， the level ofhemoglobin， lactate dehydrogenase and platelet at 6 months postoperatively were all within normal range and not statistically from those respective preoperative parameters（P＞0.05）. Hemolytic reaction and hemolytic anemia were not found. During early and short-term follow-up， there was no thromboembolic complications or anticoagulation-related severe bleeding events in the two groups with same anticoagulation intensity target （target INR value 1.5 to 2.5）. Conclusion Early clinical outcomes and short-term follow-up results of CL-V bileaflet prostheses are similar to those of St. Jude bileaflet prostheses. Postoperative patients have good clinical outcomes， hemodynamics and blood compatibility. Patients’ heart function significantly improve during short-term follow-up without valve-related complication. Mid-term and Long-term follow-up are further needed to demonstrate its good performance.
ObjectiveTo systematically review the efficacy and safety of prostacyclin for patients with pulmonary arterial hypertension (PAH).MethodsWe searched PubMed, EMbase, The Cochrane Library, WanFang Data, CBM and CNKI databases for randomized controlled trials (RCTs) compared prostacyclin with placebo from inception to April 2018. Two reviewers independently screened literature, extracted the data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software.ResultsEleven RCTs including 2 549 participants were included. The results of meta-analysis showed that, compared with placebo group, prostacyclin group was superior to the placebo group in 6-min walk distance (MD=31.10, 95%CI 16.89 to 45.30, P<0.001), mortality (RR=0.62, 95%CI 0.41 to 0.94,P=0.03), Brog score (MD=–0.88, 95%CI –1.28 to –0.49, P<0.001), mean pulmonary arterial pressure (MD=–3.31, 95%CI –4.34 to –2.29,P<0.001) and cardiac index (MD=0.32, 95%CI 0.14 to 0.51,P<0.001). However, there were no differences between two groups in reducing delaying time to clinical deterioration (RR=1.27, 95%CI 0.99 to 1.63,P=0.06), tolerability (RR=0.74, 95%CI 0.42 to 1.31, P=0.30) and pulmonary vascular resistance (MD=–4.35, 95%CI –8.85 to 0.15, P=0.06).ConclusionsCurrent evidence reveals that prostacyclin therapy appears to be superior to the placebo in reducing the mortality, improving excise capacity, respiratory and cardiac function, and ameliorating mean pulmonary arterial pressure for pulmonary arterial hypertension. However, the efficacy of prostacyclin in delaying time to clinical deterioration, tolerability and pulmonary vascular resistance for PAH is not clear. Due to the limited quality and quantity of included studies, more high quality RCTs are required for further verification.