Sex Difference in Patients With Ischemic Heart Failure Undergoing Surgical Revascularization: Results From the STICH Trial (Surgical Treatment for Ischemic Heart Failure).

BACKGROUND: Female sex is conventionally considered a risk factor for coronary artery bypass grafting (CABG) and has been included as a poor prognostic factor in multiple cardiac operative risk evaluation scores. We aimed to investigate the association of sex and the long-term benefit of CABG in patients with ischemic left ventricular dysfunction enrolled in the prospective STICH trial (Surgical Treatment for Ischemic Heart Failure Study). METHODS: The STICH trial randomized 1212 patients (148 [12%] women and 1064 [88%] men) with coronary artery disease and left ventricular ejection fraction ≤35% to CABG+medical therapy (MED) versus MED alone. Long-term (10-year) outcomes with each treatment were compared according to sex. RESULTS: At baseline, women were older (63.4 versus 59.3 years; P=0.016) with higher body mass index (27.9 versus 26.7 kg/m2; P=0.001). Women had more coronary artery disease risk factors (diabetes mellitus, 55.4% versus 37.2%; hypertension, 70.9% versus 58.6%; hyperlipidemia, 70.3% versus 58.9%) except for smoking (13.5% versus 21.8%) and had lower rates of prior CABG (0% versus 3.4%; all P<0.05) than men. Moreover, women had higher New York Heart Association class (class III/IV, 66.2% versus 57.0%), lower 6-minute walk capacity (300 versus 350 m), and lower Kansas City Cardiomyopathy Questionnaire overall summary scores (51 versus 63; all P<0.05). Over 10 years of follow-up, all-cause mortality (49.0% versus 65.8%; adjusted hazard ratio, 0.67; 95% confidence interval, 0.52-0.86; P=0.002) and cardiovascular mortality (34.3% versus 52.3%; adjusted hazard ratio, 0.65; 95% confidence interval, 0.48-0.89; P=0.006) were significantly lower in women compared with men. With randomization to CABG+MED versus MED treatment, there was no significant interaction between sex and treatment group in all-cause mortality, cardiovascular mortality, or the composite of all-cause mortality or cardiovascular hospitalization (all P>0.05). In addition, surgical deaths were not statistically different (1.5% versus 5.1%; P=0.187) between sexes among patients randomized to CABG per protocol as initial treatment. CONCLUSIONS: Sex is not associated with the effect of CABG+MED versus MED on all-cause mortality, cardiovascular mortality, the composite of death or cardiovascular hospitalization, or surgical deaths in patients with ischemic left ventricular dysfunction. Thus, sex should not influence treatment decisions about CABG in these patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00023595.

Transcatheter valve-in-ring implantation of a repositionable valve system for treatment of severe mitral regurgitation.

INTRODUCTION: Years after mitral valve surgery, progressive degeneration of reconstructed mitral valves or bioprostheses might lead to severe mitral valve regurgitation. Patients with significant comorbidity, or impaired left ventricular function are poor candidates for redo surgery at an acceptable risk at that later time point. METHODS AND RESULTS: This study reports the first-in-man transapical valve-in-ring implantations in the mitral position of the fully repositionable Lotus valve system approved for transcatheter aortic valve replacement in Europe. Transapical valve-in-ring implantations with this valve system were successfully performed in a 64-year-old female, and a 53-year-old male patient. Both patients were NHYA class IV, and carried an unacceptably high risk of cardiac surgery due to clinical condition and comorbidity. The first patient was successfully implanted a 25 mm valve, improved to NYHA class II, and was discharged 2 weeks after the procedure. The second patient required a short episode of cardiopulmonary resuscitation after valve implantation (27 mm), and was placed on veno-venous ECMO for 24 hr to improve oxygenation. He developed stroke on day 7, and deceased from fatal, toxic rhabdomyolysis 13 days after the procedure. CONCLUSION: Transapical valve-in-ring implantation of the repositionable Lotus valve system in the mitral position is a feasible and promising option that merits further evaluation. © 2015 Wiley Periodicals, Inc.

[Case report: extracorporeal life support for treatment of fulminant pulmonary embolism in a young woman during pregnancy]. / Kasuistik: Fulminante Lungenembolie bei Schwangerer in der 19. SSW - Behandlung mittels extrakorporalem Unterstützungssystem (ECLS).

During pregnancy, prothrombotic changes of the coagulation system are associated with an increased risk for thrombotic events such as deep vein thrombosis and/or pulmonary embolism. We report the case of a thirty-one year old woman, who suffered severe pulmonary embolism with cardiogenic shock during pregnancy. Systemic fibrinolysis failed to improve hemodynamic deterioration. Finally, insertion of an extracorporeal life support system with subsequent pulmonary thromboendarterectomysaved the life of the patient.

Topical Vancomycin Reduces the Incidence of Deep Sternal Wound Complications After Sternotomy.

BACKGROUND: Deep sternal wound infection remains a significant hazard for cardiosurgical patients undergoing median sternotomy. Although the prophylactic use of topical vancomycin to reduce the incidence of deep sternal wound complications (DSWC) has been repeatedly examined, the method remains controversial. METHODS: We report here on a continuous experience that encompassed a total of 1251 cardiosurgical patients who underwent various procedures via median sternotomy. Beginning in October 2015 and in response to a surge of DSWC (4.4%), 3 surgeons on our team began to apply 2.5 g vancomycin paste to the sternal edges just prior to closure, while the remaining 2 surgeons did not. An interim analysis comparing the 2 groups suggested that vancomycin was indeed effective, and from February 2016 on, all surgeons adopted the routine use of vancomycin in all patients. RESULTS: Retrospective analysis of 496 surgical patients from January to September 2015 had revealed a baseline incidence of DSWC of 4.4%. In the divided-use period between October 2015 and February 2016, DSWC was seen in 8.6% (8 of 93) of the no-vancomycin group. In the vancomycin group, the incidence fell to 0.8% (1 of 129). In March 2016, all surgeons began using vancomycin and the overall rate of DSWC for all surgeons and all patients subsequently declined to 1.1%. No adverse effects were observed. CONCLUSIONS: Topical vancomycin application is highly effective in the prevention of DSWC after median sternotomy.

Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery.

OBJECTIVES: To define the prognostic contribution of global and regional left ventricular (LV) function measurements in patients with ischaemic cardiomyopathy randomised to coronary artery bypass graft surgery (CABG) with (n=501) or without (n=499) surgical ventricular reconstruction (SVR). METHODS: Novel multivariable methods to analyse global and regional LV systolic function were used to better formulate prediction models for long-term mortality following CABG with or without SVR in the entire cohort of 1000 randomised SVR hypothesis patients. Key clinical variables were included in the analysis. Regional function was classified according to the discreteness of anteroapical hypokinesia and akinesia into those most likely to benefit from SVR, those least likely and those felt to have intermediate likelihood of benefit from SVR. RESULTS: The most prognostic clinical variables identified in multivariable models include creatinine, LV end-systolic volume index (ESVI), age and NYHA (New York Heart Association) class. Addition of LV ejection fraction, LV end-diastolic volume index and regional function assessment did not contribute additional power to the model. Subgroup analysis based on regional function did not identify a cohort in which SVR improved mortality. CONCLUSIONS: ESVI is the single parameter of LV function most predictive of mortality in patients with LV systolic dysfunction following CABG with or without SVR in multivariable models that include all key clinical and LV systolic function parameters. Assessment of regional cardiac function does not enhance prediction of mortality nor identify a subgroup for which SVR improves mortality. These results do not support elective addition of LV reconstruction surgery in patients undergoing CABG. TRIAL REGISTRATION NUMBER: NCT00023595.

Effective and rapid sealing of coronary, aortic and atrial suture lines †.

OBJECTIVES: Cardiac surgical procedures carry a high risk of perioperative bleeding. Surgical sealants are often used to prevent suture line bleeding. PreveLeak™ is a surgical sealant composed of bovine serum albumin, a polyaldehyde cross-linker, and other components that forms a soft, flexible, water-tight, mechanical seal that is biocompatible and bioresorbable. METHODS: A prospective, multicentre study evaluated PreveLeak use in 44 subjects undergoing 63 cardiac procedures, primarily coronary artery bypass grafting (n = 23/63, 36.5%) and aortic valve replacement (n = 19/63, 30.2%). PreveLeak was applied to 127 suture lines and the time to sealing evaluated upon clamp release. The primary safety endpoint was the incidence of significant bleeding, infections, neurological deficits and immune/inflammatory allergic responses within 6 weeks post-treatment; subjects were followed for 3 months. RESULTS: Immediate sealing was achieved at all sites in 42 of 44 subjects (95.5%) and 125 of 127 treatment sites (98.4%). There were nine primary safety events: eight infections and one transient neurological deficit. Most adverse events were mild (n = 46/71, 64.8%) or moderate (n = 18/71, 25.4%) in severity. One adverse event (transient vasospasm) was considered possibly sealant-related. One death occurred due to a cardiac arrest. CONCLUSIONS: PreveLeak prevented bleeding at 98.4% of treated sites and was well tolerated; adverse events were consistent with those commonly observed in subjects undergoing surgical procedures. These results compared favourably with published studies of other sealants. The observed prevention of bleeding is clinically important in cardiac surgical patients. A randomized, comparative study is justified to further evaluate PreveLeak and confirm the findings from this study.