Cortical infarction following cardiosurgical procedures - air embolism as a probable cause.

BACKGROUND: Focal neurological deficits following cardiopulmonary bypass surgery are usually thought to be the result of embolic stroke. Computed tomography (CT) is sometimes negative although severe deficits persist. OBJECTIVES: To describe a syndrome consisting of reduced postoperative vigilance, frequent epileptic seizures and focal neurological deficits in the presence of an apparently normal CT scan and often isolated cortical infarction on magnetic resonance imaging (MRI). METHODS: We retrospectively collected data on all patients fulfilling the above-mentioned criteria, seen for neurological examination by the consultant between 2002 and 2006 in our heart center. RESULTS: We found 39 patients, nearly all of whom had cortical hyperintense lesions on diffusion-weighted MRI in the right hemisphere with corresponding left-sided hemiparesis. Early seizures occurred in 31 patients. Clinical outcome was heterogeneous. CONCLUSIONS: Predominance of right hemisphere involvement and lesion pattern in MRI make air embolism the most probable cause for this postoperative syndrome.

Heparin-coated extracorporeal circulation in combination with low dose systemic heparinization reduces early postoperative blood loss in cardiac surgery.

AIM: According to a recently performed meta-analysis, heparin-bonded circuits do not reduce blood loss in cardiac surgery patients compared to nonheparin-bonded circuits within the first 24 h postoperatively. We investigated the effects of heparin-coated circuits in combination with a reduced systemic heparin dose on early postoperative blood loss (first 12 h), platelet function, and postoperative complications. METHODS: Patients who underwent their first coronary artery bypass graft surgery were included in a randomized prospective study. Group A (n=149) was perfused with an uncoated extracorporeal circulation (ECC)-set and groups B (n=152) and C (n=149) with heparin-coated ECC-sets. In groups A and B, conventional dose systemic heparin was given, whereas group C received low dose systemic heparin. Blood loss was assessed within the first 12 h postoperatively. Moreover, biochemical parameters of pro-coagulant activity and immunological function were measured. RESULTS: None of the pro-coagulant activity markers and immunological parameters measured differed preoperatively or postoperatively between study groups. However, intraoperative platelet counts and maximal intraoperative concentrations of platelet factor 4, ss-thromboglobulin, and poly-morpho-nuclear (PMN)-elastase were lowest in group C, whereas group C also had the highest concentrations of thrombin-antithrombin complex (P<0.018-0.001). Blood loss within the first 12 h postoperatively was 457 +/- 204 mL in group A, 431 +/- 178 mL in group B, and 382 +/- 188 mL in group C (P<0.01). Complication rates and 30-day mortality did not differ between study groups. CONCLUSION: The combined use of heparin-coated circuits and low dose systemic heparinization is able to reduce early postoperative blood loss without enhancing the risk of complications.

Combined calcium and vitamin D supplementation is not superior to calcium supplementation alone in improving disturbed bone metabolism in patients with congestive heart failure.

OBJECTIVES: To clarify the potential role of vitamin D supplementation on bone metabolism in congestive heart failure (CHF) patients with low vitamin D status and insufficient dietary calcium intake. SUBJECTS/METHODS: One hundred and two ambulatory male CHF patients were recruited, of whom the majority was treated with loop diuretics. Nine patients died during follow-up. Additional 14 participants dropped out prematurely because their health status worsened markedly. Five patients had to be excluded due to lack of compliance. A daily vitamin D3 supplement plus 500 mg calcium (CaD group) or a placebo plus 500 mg calcium (Ca group) was given for 9 months. Biochemical parameters of vitamin D and bone metabolism were analyzed at baseline and after 9 months. RESULTS: Median 25-hydroxyvitamin D concentrations increased from 41.7 to 103.0 nmol/l (P < 0.001) in the CaD group and remained constant in the Ca group, while median calcium intake increased above 1200 mg/day in both groups. The percentage of patients with elevated parathyroid hormone levels (> 60 pg/ml), as well as the serum concentration of undercarboxylated osteocalcin, an indicator of osteoporotic fracture risk and the bone resorption marker C-telopeptide fell significantly in both study groups (P < 0.025-0.001). At the end of the study period, biomarkers of bone turnover did not differ between groups. CONCLUSIONS: A vitamin D3 supplement of 50 microg/day has no additional beneficial effects on markers of bone metabolism in CHF patients with low initial 25-hydroxyvitamin D concentrations if an adequate daily calcium intake is guaranteed.

Cardiac surgery after heart transplantation: coronary artery bypass grafting and heart valve replacement.

INTRODUCTION: Due to increasing need for and a shortage of donor organs, therapeutic procedures such as heart valve replacement for valve insufficiency and coronary artery bypass grafting (CABG) for graft vasculopathy (GVP) must be performed to improve allograft function to avoid retransplantation. METHODS: We performed a retrospective analysis of patients who underwent surgical procedures after orthotopic heart transplantation. Since 1989, we have performed more than 1400 heart transplantation procedures. Valve replacement was necessary in 8 patients and CABG was necessary in 3 patients. Five patients received valve prostheses (3 bioprostheses and 2 mechanical valves) at the tricuspid position. Three patients received a Hancock bioprosthesis at the mitral position. One of the 3 received the valve 3 years after heart transplantation while suffering from mitral regurgitation grade IV, and another patient received the valve 1 year following heart transplantation while suffering from mitral insufficiency grade III due to infective endocarditis. Three patients underwent coronary artery revascularization, 2 patients underwent the procedure 1 and 7 years after heart transplantation because of GVP, 1 patient underwent the procedure simultaneously with heart transplantation because of donor coronary artery disease. One patient received concomitant CABG with heart transplantation because of 75% left anterior descending stenoses in the donor organ, and one patient received CABG 1 year after heart transplantation because of rapidly progressive GVP in the left anterior descending artery. The third patient had 3-vessel disease with 95% left stem and 75% ramus circumflex, ramus marginalis, and ramus diagonalis. RESULTS: Two patients who underwent CABG and 4 patients who underwent valve replacement are still alive and maintain good clinical performance. One patient with a graft at the mitral position died 9 years after heart transplantation and 6 years after mitral valve replacement. Two patients with a graft at the tricuspid position died 17 and 4 years after heart transplantation (6 and 3 years after valve replacement, respectively). One patient with a bioprostheses at the tricuspid position had to be retransplanted 2 years following valve replacement while suffering from a paravalvular leakage grade III. CONCLUSION: Cardiac surgical procedures can be safely performed after heart transplantation. To improve graft and patient survival, such procedures must be carefully performed after heart transplantation to avoid retransplantation. The shortage of donor organs will and must lead to an increase in the number of conventional procedures performed to improve allograft function in transplanted hearts.

No evidence for an improvement of long-term survival by HLA matching in heart transplant recipients.

It has been assumed that better HLA matching improves midterm survival in cardiac transplantation. However, statistically reliable data on long-term survival according to HLA matching are scanty. We performed a retrospective analysis of all patients who underwent orthotopic heart transplantation at our heart center between 1989 and 2005. HLA typing data (major histocompatability complex [MHC] class I and II) were available in 923 patients and their heart donors. Univariate and multivariate analyses were performed to assess the impact of HLA matching on long-term survival. The average follow-up period was 6.1 +/- 4.3 years (range, 0.0 to 15.0 years). In total, the 923 patients accrued 5625 patient-years of observation. Zero, one, and two mismatches occurred at each locus in between 0.3% (HLA-B) to 6.6% (HLA-C), 16.6% (HLA-B) to 39.4% (HLA-DQ), and 55.4% (HLA-DQ) to 83.3% (HLA-B), respectively. Two hundred eleven patients died during follow-up (22.9%). Survival at 1, 2, 5, and 10 years was 87.7%, 86.2%, 78.4%, and 63.9%, respectively. In the multivariate analysis, age, transplant era, presence of MHC class I and II antibodies, and high urgency status but not HLA mismatches were independent predictors of long-term survival. Moreover, diagnoses other than dilated cardiomyopathy increased long-term mortality risk. In summary, our data demonstrate that HLA matching is not an independent risk factor for longterm survival in heart transplant recipients. However, several pretransplant factors and transplant era were independently associated with mortality risk.

Initial experience with the medtronic ADVANTAGE valve prosthesis in the mitral position--clinical outcome and analysis of complications.

OBJECTIVE: The Medtronic ADVANTAGE prosthetic heart valve is a bileaflet mechanical heart valve which has two main design modifications. The prosthesis has an enlarged central orifice to improve blood flow characteristics and an asymmetric butterfly pivot recess with expanded outflow component designed to enhance the blood flow washing through the pivot region. This report summarizes the initial experience with 55 patients who underwent isolated mitral valve replacement. METHODS: We prospectively followed 55 patients undergoing mitral valve replacement with the Medtronic ADVANTAGE prosthesis in a single center study. All patients were operated on via a median sternotomy and a left atrial approach. RESULTS: The age of the patients at implant ranged from 42 years to 77 years with a mean of 61.8 years. Forty-five percent of the patients were male. Seventy-five percent of the patients were in NYHA functional class III or IV prior to valve replacement. The diameters of the implanted prostheses were as follows: 25 mm in 2 patients, 27 mm in 12 patients, 29 mm in 20 patients, and 31 mm in 21 patients. Coronary artery bypass grafting was performed with valve replacement in 16.4 % of patients and additional tricuspid repair in 10.9 %. After one year, 97.6 % and after two years 100 % of the included patients were in NYHA functional class I or II. All patients had Coumadin (warfarin) therapy postoperatively with a target INR range of 2.5 to 3.5, or 3.0 to 4.0. There were 4 thromboembolic events (7.3 %) in the early period and 2 late events (2.6 %). Episodes of valve thrombosis were not seen during the follow-up, which consisted of 76.5 patient years. The hemodynamic performance was favorable and within clinically acceptable ranges. The incidence of valve-related mortality and morbidity in this preliminary study was extremely low, indicating good clinical results comparable to those reported for other bileaflet valves. CONCLUSION: The ADVANTAGE valve is a safe and effective option for mitral valve replacement with a very low incidence of valve-related complications.

A risk score to predict 30-day mortality in patients with intra-aortic balloon pump implantation.

BACKGROUND: Several risk factors for early mortality after intra-aortic balloon pump (IABP) implantation have been described. METHODS: We performed a retrospective analysis in 120 patients receiving peri- or postoperative IABP support. Univariate and multivariate analyses were carried out to assess variables potentially influencing 30-day mortality in order to develop a risk score for the prognosis of survival and for the decision on optimal patient-specific treatment. RESULTS: The 4 parameters (mean arterial pressure, adrenaline dose, central venous pressure, and blood lactate concentrations) at 6 hours of IABP use were independently related to 30-day mortality. They were used to develop a risk score (0 - 4 points). With this score, patients who scored 3 or 4 points had no probability of surviving, whereas patients with a score of zero had a probability of 84.4 %. A prospectively screened cohort of 145 patients confirmed the reliability of our risk score. CONCLUSIONS: Our data demonstrate that a score can predict 30-day mortality in patients with IABP implantation. Such a score can be useful to find out whether or not ECMO/VAD implantation is necessary.

IgG classification of anti-PF4/heparin antibodies to identify patients with heparin-induced thrombocytopenia during mechanical circulatory support.

Commercial immunoassays frequently detect anti-PF4/heparin antibodies during mechanical circulatory support (MCS), but only a small minority of patients develops heparin-induced thrombocytopenia (HIT). Whereas platelet functional tests can distinguish between platelet-activating and non-platelet-activating antibodies, commercial PF4-dependent immunoassays do not. Between 2003 and 2004, 113 patients were placed on MCS. Blood samples were obtained on postimplant day 5-7 for analyses by antibody assays and the functional heparin-induced platelet activation (HIPA) assay. Three distinct groups of patient sera were identified: platelet-activating anti-PF4/heparin antibodies (n = 10), non-platelet-activating anti-PF4/heparin antibodies (n = 53), and anti-PF4/heparin antibody negative (n = 50). Patients with platelet-activating antibodies had the highest risk for thromboembolic events (P < 0.005), whereas those with non-platelet-activating antibodies did not differ from antibody negative patients (P = 0.369). The enzyme-immunoassay and column agglutination assays, which cover all immunoglobulin classes, demonstrated adequate sensitivity and negative predictive value; yet, both lacked specificity with respect to the platelet-activating antibodies. If all antibody positive patients were further classified by an IgG-specific anti-PF4/heparin enzyme-immuno assay, specificity for platelet-activating antibodies increased. Whereas IgG-specific optical density (OD) values below 1.0 were likely for non-platelet-activating anti-PF4/heparin antibodies, higher values were progressively predictive for pathogenic platelet activation. The probability of the development of clinical HIT also increased steeply. In conclusion, platelet-activating anti-PF4/heparin antibodies are relatively common (about 9%) in patients on MCS and are associated with significantly higher thrombotic event rates. Low IgG-specific OD values (< 1.0) in the enzyme-immunoassay indicate low likelihood for the presence of platelet-activating antibodies. These results justify further validation so that anticoagulation during MCS becomes safer and adequate.

Aortico-left ventricular tunnel, an unusual congenital cardiac anomaly in adult: application of a new operative technique.

Aortico-left ventricular tunnel is a rare congenital cardiac anomaly. A 45-year-old man was referred to our clinic with unstable angina pectoris. The patient had an aortico-left ventricular tunnel that had been operated on 15 years before and that now showed a recurrence. We performed a new surgical technique, including closure of orifices of the tunnel by resection of the aorta at the left coronary ostium, reconstruction of the aorta with patch plasty, and formation of a neo-left main branch by applying a saphenous magna vein patch at the noncoronary cusp. In this technique, the possibility of aortic regurgitation caused by stretching and distortion of the aortic ring and leaflets by primary suture closure of tunnel is eliminated. The postoperative 2-D colored Doppler echocardiography and cardiac MRI showed an excellent result of the procedure. Coronary flow could be restored, and thus anginal symptoms disappeared.

Pediatric patients with Kawasaki disease and a case report of Kitamura operation.

Kawasaki disease (KD), also called mucocutaneous lymph node syndrome, is an acute, self-limiting, small-vessel vasculitis with an unknown cause that affects children between the ages of 6 months and 5 years. It is the most common cause of acquired coronary artery disease in childhood. Acute myocardial infarction and coronary artery aneurysm are major complications. We present a cohort of patients with KD who were followed up and treated in the Heart Center, North Rhine-Westphalia. Included is a review of important relevant items common to cases of KD, such as clinical data and management, including medical management of the acute condition and the diagnosis and management of coronary vasculitis and aneurysms as well as the application of coronary artery bypass grafting (CABG) in those conditions. Between January 2002 and January 2006, we evaluated the findings and characteristics of 18 pediatric patients with a history of KD and their long-term outcome. The acute illness occurred between the ages of 4 months and 14 years of age. Anomalies of the coronary arteries were found in 6 patients ranging in age from 5 months to 10 years. One patient had acute myocardial infarction; another underwent CABG after 5 years from disease onset at the age of 15 years. Kitamura operation was performed successfully. The other patients are still under observation.Coronary artery aneurysms and stenosis requiring surgery are rare in KD; nevertheless, CABG is the standard therapy when myocardial ischemia is detected. Kitamura operation provides good growth potential and long-term graft patency.

Unusual pacemaker implantation through a left sided superior vena cava via anonymous vein after heart transplantion.

We report the case of a 56-year-old male heart transplant recipient, who underwent postoperative pacemaker implantation through a left sided superior vena cava (LSVC) via anonymous vein. We describe our successful management of this case. We suggest that the specific anatomic conditions should be considered in all heart transplant recipients with LSVC if pacemaker implantation is necessary postoperatively.

The controversy of donor serum sodium levels in heart transplantation--a multicenter experience.

BACKGROUND: Elevated donor serum sodium is a phenomenon often encountered in the management of brain dead donors. The clinical relevance on recipient outcome is less examined. We investigated the impact of elevated donor serum sodium levels (DSL) on outcome after heart transplantation in 1800 heart transplantations. METHODS: Data was conducted in a retrospective analysis from 1989 until 2005. The transplantations were performed at three German heart transplant centers. The joined database included DSL at the time of organ procurement, recipient and donor age, ischemia time, primary graft failure and survival data. RESULTS: Mean DSL was 147.7 +/- 10.3 l/l (range 111 - 208 l/l). Recipients were divided into 4 groups with percentiles of 141, 147, and 154 l/l resulting in DSL of A: 135.8 +/- 4.4, B: 143.6 +/- 1.7, C: 149.7 +/- 1.9, and D: 161.3 +/- 7.7 l/l for the four quartiles. Primary graft failure occurred in 2.6 % of the patients with A: 2.8 %, B: 2.8 %, C: 3.7% and D: 1.4 % ( P = n.s.). Mean 5- and 10-year-survival rates were 70.9 % (57.6 %) with A: 71.1 % (53.86 %), B: 69.3 % (53.9 %), C: 72.7 % (61.0 %), D: 71.2 % (62.4 %), respectively ( P = n. s.). In a multivariate analysis a significant impact on postoperative results could be revealed for recipient age ( P = 0.002), ischemia time ( P = 0.002) and donor age ( P = 0.009). DSL were no individual risk factor in the multivariate analysis. CONCLUSION: There was no impact of donor serum sodium levels neither on early postoperative results, nor on long-term outcome indicating that cardiac allografts from donors with elevated sodium levels might be transplanted successfully, achieving favourable results.

[Left ventricular pacing and CRT. What CV lead fits into which vein?]. / Linksventrikuläre Stimulation und CRT -- Welche Elektrode passt zu welcher Vene?

The experience of 579 patients with left ventricular pacing specific characteristics of various leads and lead types for left ventricular stimulation are reported. After describing the advantages of coronary vein (CV) leads versus epicardial lead usage for left ventricular stimulation, commercially available CV leads are introduced and discussed. Since there is no universally applicable CV lead, the individual optimal lead choice and the sequelae of erroneous lead choice are described in typical clinical examples.

Anterolateral right thoracotomy for mitral valve procedure after previous coronary artery bypass grafting with functioning internal mammary artery grafts.

AIM: Mitral valve procedure after previous coronary artery bypass grafting (CABG) with functioning internal mammary artery (IMA) grafts has high risk. Especially, internal mammary artery grafts injury may be fatal. The anterolateral right thoracotomy affords easy access to the right atrium with minimal dissection, and minimizes the risk of injury to the IMA grafts. We reviewed our operative technique and outcome after mitral valve procedure after previous CABG with functioning IMA grafts. METHODS: Thirteen patients (11 male and 2 female, mean age of 67.7+/-8.5 years, range 54 to 80 years) underwent mitral valve replacement after previous CABG with functioning IMA grafts from march 1993 to september 2002. The mean interval between the previous CABG and the mitral valve procedure was 3.8 years (range 9 months to 8 years). Four patients had simultaneous mitral valve procedures at initial CABG (2 repairs and 2 replacements). The operation has performed through the anterolateral right thoracotomy, under ventricular fibrillation with moderate hypothermia and without cardioplesia. RESULTS: Mitral valve repair was performed in 3 patients, mitral valve replacement in 10 patients. The mean coronary bypass time was 69.1+/-16.2 min (range 45 to 98 min). The operation time was 159.3+/-29.4 min (range 120 to 219 min). Intensive care unit stay days was 1.9+/-1.6 days (range 1 to 5 days). Peak CK/CK-MB values were 555.1+/-290.4 IU/16.6+/-10.7 IU (range 176 to 924 IU/7 to 44 IU). Peak troponin I value was 9.5+/-5.2 pg/mL (range 4 to 17.8 pg/mL). There was no IMA injury and no early death. Other complications were newly arrhythmia in 3 patients, renal insufficiency in 1 patient, reoperation for bleeding in 1 patient. CONCLUSIONS: Anterolateral right thoracotomy approach, ventricular fibrillation with moderate hypothermia without cardioplesia were a safe and good method for mitral valve operation after previous CABG with functioning IMA graft.

Frequent detection of hepatitis B core antibodies in heart transplant recipients without preceding hepatitis B infection.

It is unclear whether heart donors positive for hepatitis B core antibodies (anti-HBc) can transfer hepatitis B virus (HBV) infection to immunosuppressed heart recipients, or whether passive transfer of anti-HBc simulates a hepatitis B infection. Therefore, we performed a case-controlled study in 46 heart recipients who all tested negative for hepatitis B antigen (HbsAg), antiHBc, and hepatitis B surface antibodies before heart transplantation. Twenty-three patients (group 1) received hearts from anti-HBc-positive donors, while 23 other patients (group 2) received hearts from anti-HBc-negative donors. After heart transplantation, anti-HBc were present in 65.0% of blood samples among group 1 and 47.8% of the blood samples among group 2 (P > .05). HbsAg was undetectable in blood samples of all patients of both study groups. The immunoglobulin preparation that we regularly use for immune suppression immediately after heart transplantation contained a relatively high concentration of anti-Hbc antibodies. The nearly identical presence of anti-HBc in both study groups indicated that passive transfer via immunoglobulin preparations rather than HBV infection is the cause for the anti-HBc detected in heart recipients. Since only a small volume of blood is transferred with the donor heart, it seems to be rather unlikely that the donor heart might be the source of anti-HBc. In summary, we observed no evidence for HBV infection in those heart recipients who received organs from anti-HBc-positive donors. Moreover, our data demonstrated that the presence of anti-HBc in heart recipients frequently occurs but does not necessarily indicate a preceding HBV infection.

First use of the Molecular Adsorbent Recirculating System technique on patients with hypoxic liver failure after cardiogenic shock.

The Molecular Adsorbent Recirculating System (MARS) has been proven to prolong survival in patients with hepatorenal syndrome. MARS is a modified dialysis that uses an albumin containing dialysate, which is recirculated and perfused online through charcoal and anion exchanger columns. It allows the selective removal of albumin bound substances. Despite advances in medical therapy and technology, the prognosis of patients with cardiogenic shock remains poor. Mortality rates are as high as 80%, often because of persistent multiple organ failure. To determine whether patients with hypoxic liver failure after cardiogenic shock after cardiac surgery might benefit from MARS, we performed a prospective, randomized, controlled, single center study. The primary objective was to prove that MARS improves survival. This article is a report on the interim analysis of the first 27 patients included between August 2000 and December 2001; 14 patients were in the MARS group, and 13 patients were in the non-MARS group. All had bilirubin levels greater than 8 mg/ml. Both groups had a similar risk profile. The MARS group received MARS for 3 consecutive days-if bilirubin was still greater than 6 mg/dl afterward, MARS was continued. The non-MARS group received conventional therapy. We had seven survivors in the MARS group (50%) compared with four (32%; p = ns) in the non-MARS group. We conclude that despite the limited number of patients included in this analysis, MARS can be recommended for patients with acute, hypoxic liver failure because it might prolong survival. Further studies in similar patient cohorts are needed to verify our results.

Intermittent aortic cross-clamping for isolated CABG can save lives and money: experience with 15307 patients.

BACKGROUND: The ideal myocardial protection during isolated CABG is still a matter of debate. Cardioplegia versus intermittent aortic cross-clamping (IACC) are the main opponents; the following article shows that IACC can be safe, efficient and might be cheaper than cardioplegia. METHODS: Demographics and co-morbidities of 15307 CABG only patients consecutively operated on between January 1993 and October 2001 in the Heart Center in Bad Oeynhausen were assessed by the German Quality Assurance data set and risk-stratified using the EuroSCORE. Outcome (30-day or in-hospital mortality) was compared to the expected EuroSCORE estimation. RESULTS: Expected mortality was 3.25 %, observed mortality was 1.3 %, being significantly lower in the low, medium as well as high risk patients subgroup. Complication rates increased steadily with expected mortality rates. Stroke and myocardial infarction rates for patients with peripheral vessel disease were not higher than in comparable studies. More than 1000000 EUR were saved by lower cardioplegia bills. CONCLUSION: Myocardial protection with intermittent aortic cross-clamping for isolated CABG can be safe, effective, and economically advantageous when compared to cardioplegic solutions.

Organs from donors with primary brain malignancy: the fate of cardiac allograft recipients.

BACKGROUND: The phenomenon of malignancy transmission from donors with primary brain malignancy (PBM) which is relatively well documented in renal or liver transplant recipients, has not been analyzed in cardiac allograft recipients. METHODS: We reviewed the medical records of 32 cardiac allograft recipients who were transplanted with organs from donors suffering from primary brain malignancies from 1989 to 2003. RESULTS: No case of donor-transmitted malignancy has been reported with a mean follow-up of 80.6 months. CONCLUSIONS: In our experience as well as according to a review of the literature, the risk of tumor transmission from donors with primary brain malignancy to cardiac allograft recipients seems to be extremely low. In the context of the increased donor shortage, we recommend to accept all suitable cardiac allografts harvested from donors with primary brain malignancy provided there are no detectable remote metastases.

INR self-management permits lower anticoagulation levels after mechanical heart valve replacement.

BACKGROUND: The Early Self Controlled Anticoagulation Trial (ESCAT I) showed that anticoagulation self-management after mechanical heart valve replacement decreased complication rates by maintaining INR levels closer to the target range than International Normalized Ratio (INR) home doctor management. The therapeutic range for the INR in that study was between 2.5 and 4.5 for all positions of prosthetic valves. ESCAT II should find out whether lowering the target range for INR self-management would further reduce complication rates. METHODS: ESCAT II is a prospective controlled randomized (valves: St. Jude Medical Standard or Medtronic Hall, treatment: conventional/low-dose) multicenter study with 3,300 patients. We present interim results of 1,818 patients. 908 were categorized as having a low-dose target range, which was INR 1.8 to 2.8 for prostheses in aortic position and 2.5 to 3.5 for prostheses in mitral position or in combined valve replacement. The control group (conventional group) with 910 patients aimed at an INR of 2.5 to 4.5 for all valve positions. RESULTS: In the conventional group, 74% of INR values measured were within the therapeutic range. In the low-dose group, 72% of the values were within that range. The linearized thromboembolism rate (% per patient year) was 0.21% for both groups. The bleeding complication rate was 0.56% in the low-dose regimen group versus 0.91% in the conventional group. CONCLUSIONS: Early onset INR self-management under oral anticoagulation after mechanical heart valve replacement enables patients to keep within a lower and smaller INR target range. The reduced anticoagulation level resulted in fewer grade III bleeding complications without increasing thromboembolic event rates.