Clinical outcomes of venoarterial extracorporeal life support in 462 patients: Single-center experience.

This study aims to investigate the outcomes of venoarterial extracorporeal life support (VA-ECLS) in a large single-center patient cohort regarding survival and adverse events. Between June 2009 and March 2019, 462 consecutive patients received VA-ECLS. The mean age was 66.2 ± 11.9 years. Two patient groups were identified: Group 1-patients with ECLS due to postcardiotomy shock (PCS) after cardiac surgery (PCS, n = 357); Group 2-patients with ECLS due to cardiogenic shock (CS) without previous surgery (nonPCS, n = 105). The primary end point was overall in-hospital survival, while secondary end points were adverse events during the study period. Overall, the in-hospital survival rate was 26%. There was no statistically significant difference between the groups: 26.3% for PCS and 24.8% for nonPCS, respectively (P > .05). Weaning from VA-ECLS was possible in 44.3% for PCS and in 29.5% for nonPCS (P = .004). The strong predictors of overall mortality were postoperative hepatic dysfunction (OR = 14.362, 95%CI = 1.948-105.858), cardiopulmonary resuscitation > 30 minutes (OR = 6.301, 95%CI = 1.488-26.673), bleeding with a need for revision (OR = 2.123, 95%CI = 1.343-3.355), and previous sternotomy (OR = 2.077, 95%CI = 1.021-4.223). Despite its low survival rates, VA-ECLS therapy is the last resort and the only lifesaving option for patients in refractory CS. In contrast, there is still a lack of evidence for VA-ECLS in PCS patients. Future studies are warranted to evaluate the outcomes of VA-ECLS therapy after cardiac surgery.

Impact of Previous Sternotomy on Outcome after Left Ventricular Assist Device Implantation.

BACKGROUND: The main purpose of this article is to investigate the impact of previous sternotomy (PS) on the outcome of three different left ventricular assist devices (LVAD). METHODS: Between June 2007 and February 2018, a total of 121 patients received HeartMate II (60.3%), HeartWare (12.4%), or HeartMate III (27.3%), with or without previous sternotomy (PS and non-PS groups, respectively). Propensity matching resulted in 44 patient pairs. The primary end point was overall survival at 30 days, 1 year, 2, and 5 years, postoperatively. Secondary end points were adverse events. RESULTS: The overall cumulative survival rates for the two study groups were significantly different (77, 63, 54, and 38% for non-PS group vs 64, 39, 27, and 24% for PS group, p = 0.036). In the PS group, there was a higher need for intraoperative implantation of short-term right ventricular assist device (22.7 vs 6.8%, p = 0.034) and a higher incidence of hepatic dysfunction (20.5 vs 4.5%, p = 0.025) and acute kidney dysfunction (40.9 vs 20.5%, p = 0.032). CONCLUSION: PS is a reliable predictor of mortality and morbidity after LVAD implantation.

Clinical Outcome and Comparison of Three Different Left Ventricular Assist Devices in a High-Risk Cohort.

We present a comparison between three left ventricular assist devices (LVADs): HeartWare (HVAD) (HeartWare International Inc., Framingham, MA, USA), HeartMate II (HMII) and HeartMate III (HMIII) (Thoratec Corp., Pleasanton, CA, USA). To our knowledge, no study to date has aimed at placing these three devices in juxtaposition. Between June 2007 and June 2017, 108 consecutive patients received HMII, n = 77 (71.3%), HVAD, n = 14 (13%), or HM III, n = 17 (15.7%), for end-stage heart failure. Mean age was 63.8 ± 11.2 years (range 24-84 years), with median INTERMACS profile of 3. Preoperatively, 26 patients (24.1%) were ventilated, 17 patients (15.7%) had an intraaortic balloon pump, and 27 patients (25%) were on extracorporeal life support. Overall survival at 30 days was 70.4%, at 1 year 51.9%, and at 5 years 38% with no significant difference in survival between HMII, HVAD, and HMIII. Median cardiopulmonary bypass time was 113 min (range 50-371 min). Two patients received a minimally-invasive procedure. Most common adverse events were revision for bleeding (42.6%), tracheotomy (33.3%), acute kidney failure with new-onset dialysis (25%), sepsis (17.6%), and gastrointestinal bleeding (10.2%). The average duration of follow-up was 1.52 ± 2.11 years (range 0-7.95 years). The median number of readmissions was 2 (range 0-23), the median length of hospital stay as readmission was 17 days (range 0-158 days). Strong predictors of overall mortality (P < 0.05) were postoperative sepsis (OR = 5.729, 95%CI = 3.001-10.937), intraoperative/postoperative need for right ventricular mechanical support (OR = 5.232, 95%CI = 3.008-9.102), preoperative extracorporeal life support (OR = 2.980, 95%CI = 1.615-5.500), readmission because of suboptimal INR value (OR = 2.748, 95%CI = 1.045-7.226), need of inotropes over 7 days postoperatively (OR = 2.556, 95%CI = 1.432-4.562), new onset of temporary hemodialysis postoperatively (OR = 1.986, 95%CI = 1.084-3.635), and female gender (OR = 1.955, 95%CI = 1.062-3.598). No significant difference in mortality between HMII, HVAD, and HMIII was observed. The following predictors of overall mortality were identified (P < 0.05): postoperative sepsis, need for perioperative mechanical support, readmission because of suboptimal INR value, new onset of temporary hemodialysis postoperatively and female gender.

Stentless Bioprostheses for Aortic Valve Replacement in Octogenarians: The Influence of Coronary Artery Disease.

BACKGROUND: We sought to determine the long-term results of stentless biological heart valve replacement in octogenarians to find out whether coronary artery disease or the coronary artery bypass grafting (CABG) procedure itself influences survival in these aged patients. METHODS: From 4,012 patients undergoing aortic valve replacement (AVR) with a stentless prosthesis (Freestyle, Medtronic) at a single center, 721 patients were older than 80 years. They had a mean age of 83 ± 2 (2,320 patient years), the male/female ratio was 42:58, NYHA (New York Heart Association) class I and II was prevalent in 22.8%, preoperative atrial fibrillation (AF) in 20.6%, coronary artery disease in 56.1%, mitral valve disease in 12.5%, and aortic disease in 3.5%. Follow-up included a total of 11,546 patient years (mean follow-up time: 74 ± 53 months); follow-up mortality data were 96.3% complete. RESULTS: In these aged patients, 30-day mortality in the isolated AVR group (10.3%) was similar to that in the AVR + CABG group (13.4%). Although long-term survival (15 years) in the octogenarian population is low (9% in the AVR group and 6% in the AVR + CABG group), it was not different (p = 0.191) between patients with and without coronary artery disease. The stroke rate and the myocardial infarction rate, respectively, in the AVR + CABG group (0.43%/100 patient years and 0.17%/100 patient years) were only insignificantly higher than that in the isolated AVR group (each 0.01%/100 patient years). The actuarial freedom from reoperation was 99% in both the groups. CONCLUSION: Use of the Freestyle stentless valve prosthesis for AVR is feasible also in octogenarians. The existence of coronary artery disease leads to concomitant bypass surgery, but not a higher level of perioperative or long-term mortality.

Prediction and Perception of Technical Difficulties in Adult Cardiac Surgery.

BACKGROUND: Unexpected intra-operative technical difficulties are not uncommon in cardiac surgery. Our objective is to study the incidence, predictors, and consequences of unexpected difficulties in adult cardiac operations. METHODS: A total of 500 consecutive elective operations were included in the study. Before every operation, the surgeon and the assistant were asked to study the case and give a score (one to ten) for the expected technical difficulty of the operation. After every operation, the surgeon and the assistant were asked to give a score for the observed technical difficulty. The scores and perioperative data were collected and statistically analyzed. RESULTS: In relation to different interventions and consultant/trainee predictions, unexpected technical difficulties were encountered in 7% to 16% of cases. There was a significant difference between surgeons and trainees in the perception of level of increased difficulty, represented by the mean of differences between expected and observed score (0.084 ± 0.54 versus 0.016 ± 0.5, P = .0002). In multivariable analysis, only female gender (P < .0001) was identified as a factor associated with unexpected technical difficulties. There was no correlation between the incidence of complications and unexpected surgical difficulty. However, there was a weak positive correlation between operative times and observed difficulty score. CONCLUSION: Unexpected technical difficulties are not uncommon in adult cardiac operations. Trainees tend to underestimate the difficulties perceived by the surgeon. This study can be a first step towards developing a technical difficulty score, which could be a helpful tool for medical quality management, as well as in training programs.

The Use of Bilateral Internal Mammary Arteries for Coronary Revascularization in Patients with COPD: Is It a Good Idea?

BACKGROUND: The use of bilateral internal mammary arteries (BIMA) is limited worldwide, especially in patients with chronic obstructive pulmonary disease (COPD). Thus, we assessed the safety of the use of BIMA in COPD patients. METHODS: From cohorts of 8846 patients operated on at our center for primary isolated multi-vessel coronary bypass operations between 2002 and 2012, we studied two propensity-matched groups of patients with COPD who received either single internal mammary artery and saphenous vein grafts (SIMA group: 137 patients) or exclusively BIMA (BIMA group: 137 patients). Preoperative data were similar regarding age (63.59 ± 10.62 versus 65.55 ± 9.61 years; P = .10), body mass index (BMI) (28.6 ± 4.71 versus 28.42 ± 3.86 kg/m2; P = .72), diabetes mellitus (32% versus 27%; P = .08), EuroSCORE (4.34 ± 2.23 versus 4.8 ± 2.52; P = .09) and ejection fraction (58.7 ± 13.08% versus 60.29 ± 14.13%; P = .32). RESULTS: No significant differences were noticed between the two groups regarding the number of peripheral anastomoses (3.07 ± 0.77 versus 3.06 ± 0.85; P = .90), total operation time (192.17 ± 43.06 versus 200.63 ± 39.24 min; P = .08), postoperative stroke (0.7% versus 0%; P = .29), myocardial infarction (2.92% versus 3.6%; P = .81), reintubation (2.9% versus 4.4%; P = .66), reexploration (0.7% versus 2.2%; P = .32), deep sternal wound infection (2.9% versus 3.6%; P = .81) and 30-day mortality (2.2% versus 2.9%; P = .77). However, postoperative blood loss (726.1 ± 468.35  versus 907 ± 890.58 mL; P = .03) was higher in the BIMA group. CONCLUSION: COPD patients can benefit from coronary artery revascularization with BIMA; however, postoperative blood loss can be higher using this technique.

Left ventricular assist device implantation with concomitant tricuspid valve repair: is there really a benefit?

BACKGROUND: The objectives of this study was to investigate if concomitant tricuspid valve repair in patients undergoing continuous flow left ventricular assist device (LVAD) implantation has an impact on the outcome regarding survival and adverse events. METHODS: Between June 2007 and February 2018, 124 consecutive patients received HeartMate II (HMII) [74 (59.7%)] HeartWare (HVAD) [16 (12.9%)], or HeartMate III (HM III) [34 (27.4%)] for end-stage heart failure. Mean age was 63.5±10.9 years. Two 18-patient groups were identified; with [tricuspid valve reconstruction (TVR)] group and without (non-TVR group) accompanying TVR. The primary endpoint was overall survival after device implantation. Secondary endpoints were adverse events during the follow-up period. RESULTS: Survival was not significantly different between the groups (P>0.05). In TVR group, there was a higher need for open chest after surgery and a prolonged inotrope use because of right heart failure (RHF), a higher incidence of acute kidney dysfunction requiring dialysis, as well as a higher need for packed red blood cells due to postoperative bleeding (P<0.05). CONCLUSIONS: In this cohort of patients, LVAD implantation with a concurrent tricuspid valve repair appears to have a worse outcome regarding RHF, bleeding tendency and renal dysfunction (P<0.05). However, the survival was comparable in both TVR and Non-TVR groups (P>0.05).

Impact of preoperative extracorporeal life support on left ventricular assist device outcomes: A comparative study.

BACKGROUND: To investigate whether preoperative short-term extracorporeal life support therapy in patients undergoing continuous-flow left ventricular assist device implantation has an impact on the outcome regarding survival and adverse events. METHODS: Between January 2011 and May 2018, 100 consecutive patients received HeartMate II, HeartWare, or HeartMate III for end-stage heart failure. Mean age was 64.2 ± 10.3 years. Three patient groups were identified: without preoperative extracorporeal life support (non-extracorporeal life support group, n = 80), with preoperative extracorporeal life support due to postcardiotomy shock after conventional cardiac surgery (postcardiotomy shock group, n = 9), and with preoperative extracorporeal life support without previous surgery (non-postcardiotomy shock group, n = 11). The primary endpoint was overall survival after device implantation. Secondary endpoints were adverse events during the follow-up period. RESULTS: Survival was significantly different between the groups (p < 0.05): 30-day, 6-month, and 1-year survival rates were 85%, 68%, and 61% for non-extracorporeal life support group; 44%, 22%, and 22% for postcardiotomy shock group; and 45%, 27%, and 24% for non-postcardiotomy shock group, respectively. Furthermore, in both extracorporeal life support groups (postcardiotomy shock and non-postcardiotomy shock), there were a higher incidence (p < 0.05) of postoperative right heart failure (30% vs 66.7% vs 54.5%), acute renal failure requiring dialysis (20% vs 77.8% vs 54.5%), and respiratory failure (31.3% vs 88.9% vs 81.8%). CONCLUSION: Continuous-flow left ventricular assist device implantation with prior extracorporeal life support appears to have a worse outcome regarding survival, right heart failure, renal and respiratory dysfunction (p < 0.05). Future studies have to be done to evaluate the outcome after extracorporeal life support bridge pre-left ventricular assist device, especially as ultima ratio in postcardiotomy shock patients.

Concomitant aortic valve replacement and coronary bypass: the effect of valve type on the blood flow in bypass grafts.

OBJECTIVE: In cases of aortic valve replacement, the downstream flow profile and turbulence in the ascending aorta differ according to the prosthetic aortic valve implanted. The objective of this work is to study the influence of prosthetic valve type on the flow in the bypass grafts implanted to the ascending aorta in cases of concomitant aortic valve replacement and coronary artery bypass. METHODS: The study is conducted on 456 patients receiving concomitant aortic valve replacement and coronary bypass vein grafts anastomosed to the ascending aorta. The patients included in the study received a total number of 725 vein grafts, 249 biological aortic valves and 207 mechanical aortic valves. Intraoperative transit time flow measurement was done for all bypass grafts and a multiple regression model was calculated for the factors influencing the flow in the bypass grafts. RESULTS: The mean flow in vein grafts in patients receiving biological valves was 49.79+/-26.88 ml/min, while in patients receiving mechanical valves it was 46.54+/-26.68 ml/min. The multiple regression model revealed that receiving a mechanical valve is an independent risk factor for lower flow in the vein grafts. CONCLUSIONS: The type of the aortic valve implanted and consequently the downstream flow profile in the ascending aorta do affect the flow in the vein grafts in cases of concomitant aortic valve replacement and coronary bypass. Receiving a mechanical aortic valve is an independent risk factor for lower flow in the vein grafts.

Body mass index: a risk factor for 30-day or six-month mortality in patients undergoing aortic valve replacement?

BACKGROUND AND AIM OF THE STUDY: In recent studies, the impact of a low or high body mass index (BMI) on outcome after cardiac surgery has been the subject of controversy. A retrospective study was conducted to determine the influence of BMI on 30-day and six-month mortality after aortic valve replacement (AVR). METHODS: A multivariable logistic regression was performed on data from 1,241 consecutive patients (mean age 69 +/- 11 years) who underwent AVR either with (n = 514; 41%) or without coronary artery bypass grafting CABG between 2000 and 2003. A wide spectrum of periprocedural variables was collected, including laboratory data as markers for nutritional status and comorbidity. Patients were followed up for six months after AVR (99% complete). RESULTS: Mortality rates after 30 days and after six months were 3.9% (n = 49) and 7.6% (n = 94), respectively. A low BMI was identified as an independent risk factor for 30-day (OR (odds ratio) 0.87; CI (confidence interval) 0.8-0.94) and six-month mortality (OR 0.91; CI 0.86-0.96). The relationship between the logit function and BMI was linear; however, a BMI value of 24 was considered an appropriate cut-off point. Both models containing the BMI linearly or dichotomic were equivalent. As patients with a lower BMI differ in their preoperative risk profile compared to those with a higher BMI, a saturated propensity score estimating the propensity towards having a BMI < 24 was calculated. The propensity score was not significant in the final models for 30-day and six-month mortality (0.24 and 0.73, respectively), and the OR for BMI remained largely unaltered (0.89 and 0.91, respectively). CONCLUSION: A BMI < 24 is predictive of an increased risk of mortality after AVR, independently of malnutrition, advanced heart disease, or valve size. Further studies are required to investigate the role of adipose tissue in extreme situations and chronic disease. It is mandatory to include BMI in outcome studies after AVR.

Freestyle stentless bioprosthesis for aortic valve therapy: 17-year clinical results.

BACKGROUND: Aortic valve replacement with stentless bioprostheses has been shown to produce lower aortic gradients than stented bioprostheses, thus facilitating left ventricular mass regression and preventing heart failure. We sought to determine the long-term results of stentless biological aortic valve replacement over a 17-year follow-up. METHODS: Between 1996 and 2012, 2551 patients underwent isolated aortic valve replacement with a stentless prosthesis (Medtronic Freestyle) at a single center. The mean patient age was 72 ± 10 years, 55% were male, 24.1% were in New York Heart Association class I and II, 9.6% had undergone previous surgery, 18.1% had coronary artery disease, and 23.1% had diabetes. For the long-term follow-up, patients were contacted in writing and by telephone; follow-up was 96.3% complete, resulting in 11,546 patient-years. RESULTS: At 30 days, mortality (5.4%), renal failure (3.9%), myocardial infarction (0.7%), and stroke (1.4%) rates were acceptable. During long-term follow-up of 1-17 years, the bleeding rate (2.9%) was higher than the thromboembolic event rate (0.7%) despite 18.1% of patients being on oral anticoagulants. New pacemaker implantation (4.5%; 0.87 events/100 patient-years), neurological disorders (5%; 0.52 events/100 patient-years), valve insufficiency (0.7%; 0.16 events/100 patient-years), paravalvular leakage (0.4%; 0.09 events/100 patient-years) and reoperation due to valvular complications (0.7%; 0.38 events/100 patient-years) were rare. Long-term survival was 41.8% ± 1.6 after 10 years, 21.3% ± 2.3 after 15 years, and 12.1% ± 3.9 after 17 years. CONCLUSION: Long-term results after aortic valve replacement with stentless biological prostheses compare favorably with those obtained with stented bioprostheses.

Current determinants of operative mortality in 1400 patients requiring aortic valve replacement.

BACKGROUND: Determinants of operative mortality after aortic valve replacement vary with a changing patient population due to advances in operative management and increasing life expectancy. In order to predict current groups of high risk patients, a statistically valid large study population base recruited over a short period of time is required. METHODS: Between January 1996 and June 2001, 1408 aortic valves were replaced in 1400 patients (572 of them with simultaneous coronary artery bypass grafting). The data were analyzed by multivariate logistic regression to evaluate the operative risk. Mean age of the study population was 68 +/- 11 years (range 19 to 90 years old, 44% female). RESULTS: Overall operative mortality (within 30 days) was 3.8%. Independent predictive factors for operative mortality were previous bypass surgery, emergency operation, simultaneous mitral valve replacement, renal dysfunction, more than 80 years old, simultaneous bypass surgery in female patients with a body mass index greater than 29 kg/m(2), and height smaller than 1.57 m for patients more than 71 years old. Simultaneous coronary artery bypass grafting in general (p = 0.6), previous aortic valve replacement (p = 0.59), and implantation of stented bioprostheses (p = 0.39) or stentless bioprostheses (p = 0.7) were not identified as independent risk factors. CONCLUSIONS: Certain groups of patients with a high operative risk were identified: patients more than 80 years old, women with a body mass index greater 29 kg/m(2) undergoing simultaneous coronary artery bypass surgery, and "small" patients more than 71 years old.

Midterm outcome after aortic root replacement with stentless porcine bioprostheses.

OBJECTIVE: Midterm clinical outcome was evaluated after aortic root replacement with Freestyle® stentless aortic root bioprostheses. METHODS: Between April 1996 and December 2007, 301 patients underwent aortic valve replacement with stentless Medtronic Freestyle® bioprostheses in full-root technique at a single center. Concomitant coronary artery bypass grafting (CABG) was required in 96 patients (32%). In 94 patients (31%), the ascending aorta was replaced. The mean age was 71.6 ± 9.1 (range: 36-89) years. Follow-up was closed in October 2008, 99% complete and encompassed 916 patient-years. RESULTS: Overall mortality within 30 days was 5%. A total of 62 patients died during the follow-up period. Overall survival at 5 and 9 years was 74 ± 4% and 53 ± 6%, respectively. Re-operations were required in three patients: in one patient due to structural valve deterioration, and in two patients due to prosthetic valve endocarditis. Non-structural dysfunctions were not observed. In eight patients, prosthetic valve endocarditis occurred, in most of them (N = 6) during the first year after surgery. Rate of freedom from re-operation, structural valve deterioration, prosthetic valve endocarditis, thrombo-embolic and major bleeding events at 9 years was 94 ± 6%, 94 ± 6%, 94 ± 3%, 87 ± 5%, and 95 ± 2%, respectively. The linearized rates of late adverse events in percent per patient-year were 0.35, 0.12, 0.83, 1.7, and 0.7, respectively, for re-operation, structural valve deterioration, prosthetic valve endocarditis, thrombo-embolic and major bleeding events. A little less than a quarter (22%) of the patients required anticoagulation therapy. CONCLUSIONS: Aortic root replacement with the stentless Freestyle® bioprosthesis provided a respectable short-term mortality, optimal valve durability and acceptable rates of valve-related complications within 9 years.

Aortic valve replacement in octogenarians: identification of high-risk patients.

OBJECTIVE: This study identifies high-risk octogenarians for surgical aortic valve replacement (AVR) because with the current advances in transcatheter valve therapy, a definition of patient selection criteria is essential. METHODS: Between 1996 and 2006, 493 consecutive octogenarians with symptomatic aortic stenosis underwent AVR with and without (51%) concomitant coronary artery bypass grafting (CABG). To identify high-risk patient groups, risk factors of 6-month mortality were determined using multivariable logistic regression. RESULTS: The 30-day mortality rate was 8.4% and it increased up to 15.2% until 6 months after AVR. Independent risk factors of 6-month mortality were patients older than 84 years (odds ratio (OR): 2.2 (1.29-3.61)), left ventricular ejection fraction <60% (OR: 2.5 (1.35-4.61)), body mass index (BMI) <24 (OR: 2.0 (1.22-3.36)), creatinine (OR: 1.6 (1.04-2.53)) and blood glucose (OR: 1.01 (1.001-1.009)). High-risk groups were patients older than 84 years with an ejection fraction <60% (6-month mortality 28%) and patients younger than 84 years with an ejection fraction <60% and a BMI <24 (6-month mortality 23.2%). These high-risk groups comprised 37% of the patient population. After isolated AVR, the 30-day mortality and survival at 1 and 5 years was 11.6%, 69% and 35% in this high-risk group, respectively. In octogenarians with an STS score >10 and an EuroScore >20, the 30-day mortality and survival at 1 year was 10.5% and 80%, 11.6% and 77%, respectively. CONCLUSIONS: In most octogenarians, AVR is a safe and beneficial procedure. In high-risk octogenarians, identified by STS score >10, EuroScore >20 and by simple three risk factors (age >84 years, ejection fraction <60% and BMI <24), the mortality after surgical AVR was no different from the currently reported outcome after transcatheter AVI.

Short term outcomes of total arterial coronary revascularization in patients above 65 years: a propensity score analysis.

BACKGROUND: Despite the advantages of bilateral mammary coronary revascularization, many surgeons are still restricting this technique to the young patients. The objective of this study is to demonstrate the safety and potential advantages of bilateral mammary coronary revascularization in patients older than 65 years. METHODS: Group I included 415 patients older than 65 years with exclusively bilateral mammary revascularization. Using a propensity score we selected 389 patients (group II) in whom coronary bypass operations were performed using the left internal mammary artery and the great saphenous vein. RESULTS: The incidence of postoperative stroke was higher in group II (1.5% vs. 0%, P = 0.0111). The amount of postoperative blood loss was higher in group I (908 +/- 757 ml vs. 800 +/- 713 ml, P = 0.0405). There were no other postoperative differences between both groups. CONCLUSION: Bilateral internal mammary artery revascularization can be safely performed in patients older than 65 years. T-graft configuration without aortic anastomosis is particularly beneficial in this age group since it avoids aortic manipulation, which is an important risk factor for postoperative stroke.

Efficacy and safety of very low-dose self-management of oral anticoagulation in patients with mechanical heart valve replacement.

BACKGROUND: Self-management improves oral anticoagulation control. Here we provide data of a preplanned interim analysis of very low-dose early self-controlled anticoagulation. METHODS: In a prospective, randomized, multicenter trial, 1,137 patients performed low-dose international normalized ratio (INR) self-management with a target INR range of 1.8. to 2.8 for aortic valve replacement recipients and 2.5 to 3.5 for mitral or double valve replacement recipients for the first six postoperative months. Thereafter, 379 patients continued to achieve the aforementioned INR target range (LOW group), whereas the INR target value was set at 2.0 (range, 1.6 to 2.1) for the remaining patients with aortic valve replacement and 2.3 (range, 2.0 to 2.5) for the remaining patients with mitral valve or double valve replacement. One half of this latter group had to check their INR values once a week (VL1 group) the other half twice a week (VL2 group). Patients were followed up for 24 months. RESULTS: Beyond study month six, the incidence of thromboembolic events that required hospital admission was 0.58%, 0.0%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.368). The incidence of bleeding events per patient-year was 1.16%, 1.07%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.665). Mortality rate did not differ among study groups. CONCLUSIONS: Data demonstrate the efficacy and safety of very low-dose INR self-management.

The concept of negative pressure wound therapy (NPWT) after poststernotomy mediastinitis--a single center experience with 54 patients.

Deep sternal infections, also known as poststernotomy mediastinitis, are a rare but often fatal complication in cardiac surgery. They are a cause of increased morbidity and mortality and have a significant socioeconomic aspect concerning the health system. Negative pressure wound therapy (NPWT) followed by muscular pectoralis plasty is a quite new technique for the treatment of mediastinitis after sternotomy. Although it could be demonstrated that this technique is at least as safe and reliable as other techniques for the therapy of deep sternal infections, complications are not absent. We report about our experiences and complications using this therapy in a set of 54 patients out of 3668 patients undergoing cardiac surgery in our institution between January 2005 and April 2007.