Extracorporeal life support in pediatric cardiac dysfunction.

BACKGROUND: Low cardiac output (LCO) after corrective surgery remains a serious complication in pediatric congenital heart diseases (CHD). In the case of refractory LCO, extra corporeal life support (ECLS) extra corporeal membrane oxygenation (ECMO) or ventricle assist devices (VAD) is the final therapeutic option. In the present study we have reviewed the outcomes of pediatric patients after corrective surgery necessitating ECLS and compared outcomes with pediatric patients necessitating ECLS because of dilatated cardiomyopathy (DCM). METHODS: A retrospective single-centre cohort study was evaluated in pediatric patients, between 1991 and 2008, that required ECLS. A total of 48 patients received ECLS, of which 23 were male and 25 female. The indications for ECLS included CHD in 32 patients and DCM in 16 patients. RESULTS: The mean age was 1.2 ± 3.9 years for CHD patients and 10.4 ± 5.8 years for DCM patients. Twenty-six patients received ECMO and 22 patients received VAD. A total of 15 patients out of 48 survived, 8 were discharged after myocardial recovery and 7 were discharged after successful heart transplantation. The overall mortality in patients with extracorporeal life support was 68%. CONCLUSION: Although the use of ECLS shows a significantly high mortality rate it remains the ultimate chance for children. For better results, ECLS should be initiated in the operating room or shortly thereafter. Bridge to heart transplantation should be considered if there is no improvement in cardiac function to avoid irreversible multiorgan failure (MFO).

Low-dose oral anticoagulation in patients with mechanical heart valve prostheses: final report from the early self-management anticoagulation trial II.

AIMS: In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR self-management. METHODS AND RESULTS: In a prospective, randomized multi-centre trial, 1346 patients with a target INR range of 2.5-4.5 and 1327 patients with a target INR range of 1.8-2.8 for aortic valve recipients and an INR range of 2.5-3.5 for mitral or double valve recipients were followed up for 24 months. The incidence of thrombo-embolic events that required hospital admission was 0.37 and 0.19% per patient year in the conventional and low-dose groups, respectively (P = 0.79). No thrombo-embolic events occurred in the subgroups of patients with mitral or double valve replacement. The incidence of bleeding events that required hospital admission was 1.52 and 1.42%, respectively (P = 0.69). In the majority of patients with bleeding events, INR values were < 3.0. Mortality rate did not differ between the study groups. CONCLUSION: Data demonstrate that low-dose INR self-management does not increase the risk of thrombo-embolic events compared with conventional dose INR self-management. Even in patients with low INR target range, the risk of bleeding events is still higher than the risk of thrombo-embolism.

[New Eastern Westfalian Postoperative Therapeutic Concept (NOPT). A telemedically guided study for ambulatory rehabilitation of patients after cardiac surgery]. / Neues Ostwestfälisches Postoperatives Therapiekonzept (NOPT) Eine telemedizinisch betreute Studie zur ambulanten Rehabilitation von Patienten nach kardiochirurgischen Operationen.

BACKGROUND AND PURPOSE: In-hospital rehabilitation can improve recovery of patients after surgery, but also contributes to the high costs of the German health system. Therefore, the possibility of a telemedically monitored rehabilitation at home as an alternative to an in-hospital rehabilitation was evaluated in a pilot study. PATIENTS AND METHODS: In an open trial, 100 patients performed an ambulatory rehabilitation after heart surgery under coverage of telemedical monitoring for 3 months. 70 patients performed a regular conventional in-hospital rehabilitation for 3 weeks. Physical performance, quality of life (questionnaire), complications, and costs were assessed and compared between the two groups. RESULTS: 6 and also 12 months after surgery, maximal physical performance was significantly increased by 46-54 W in both study groups compared to their baseline value. Moreover, physical and psychological quality of life had increased in both study groups compared to baseline values. However, only in the ambulatory group all items had increased with statistical significance. Fewer insults of angina pectoris were reported during follow-up in the ambulatory group compared to the in-hospital group (p < 0.01). Total costs of the rehabilitation were 59% lower in the ambulatory group compared to the in-hospital group. CONCLUSION: An ambulatory rehabilitation improves physical performance, quality of life, and is safe and cheap. The data of this study indicate that rehabilitation at home can be established instead of an in-hospital rehabilitation for patients after heart surgery.

The Bad Oeynhausen concept of INR self-management.

BACKGROUND: A significant number of patients depend on the intake of vitamin K antagonists for prevention and treatment of thromboembolic events. The development of portable anticoagulation monitors has enabled self-testing and self-adjustment of anticoagulation therapy. OBJECTIVE: To describe the principles of a training course to learn INR self-management and to illustrate reliability of our concept. DESCRIPTION: The training is divided into an early postoperative training, an ambulatory training six months later, and a 24 hours care and consultation. According to our concept, each patient who depends on long-term anticoagulation therapy is able to learn INR self-management. Reliability of our concept has been proved in two prospective, randomized clinical trials. STUDY RESULTS: A study with 1,155 patients has demonstrated that INR values lie more often in the predetermined target range in the INR self-management group if compared to the conventional group (79.2% vs. 64.9%; P < 0.001). Moreover, this study has demonstrated that self-management can lead to a reduction of thromboembolism (1.5% vs. 2.8%; P < 0.05), and to a lower lethality if compared to conventional INR management (3.5% vs 6.0%; P < 0.025). A second study with 1,816 patients has confirmed that INR self-management results in a high percentage of INR values in the target range (76%), even though target INR-range is reduced and narrowed. Thus, low dose INR self-management did not increase the risk of thromboembolism while avoiding the zone of higher risk for bleeding, beginning from INR > 3.5. CONCLUSIONS: The Bad Oeynhausen concept of INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. It can thus be successfully applied to patients with an indication for permanent anticoagulation therapy.

Low-dose international normalized ratio self-management: a promising tool to achieve low complication rates after mechanical heart valve replacement.

BACKGROUND: International normalized ratio (INR) self-management can significantly reduce INR fluctuations, bleeding, and thromboembolic events compared with INR control managed by general practitioners. However, even patients with INR self-management may have an increased risk of bleeding if their INR value is above 3.5. This study evaluated the compliance, clinical complications, and survival of patients after mechanical heart valve replacement with low-dose INR self-management compared with conventional-dose anticoagulation. METHODS: Group 1 (n = 908) received low-dose anticoagulation with a target INR range of 1.8 to 2.8 for aortic valve replacement and 2.5 to 3.5 for mitral or double valve replacement. Group 2 (n = 910) received conventional-dose anticoagulation with a target INR range of 2.5 to 4.5 for all heart valve prostheses. RESULTS: In groups 1 and 2, 76% and 75% of INR values, respectively, were in the target range. Results did not differ according to schooling and age. The rate of thromboembolic events per patient year was 0.18% in group 1 and 0.40% in group 2 (p = 0.210). The rate of bleeding complications was 0.74% for group 1 and 1.20% for group 2 (p = 0.502). In most patients with clinically relevant bleeding, these complications occurred although their measured INR values were below 3.5. The survival rate did not differ between the study groups (p = 0.495). CONCLUSIONS: Low-dose INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. INR self-management is applicable for all patients in whom permanent anticoagulation therapy is indicated. Even INR values below 3.5 can bear the risk of bleeding complications.

Does the noise of mechanical heart valve prostheses affect quality of life as measured by the SF-36 questionnaire?

OBJECTIVE: The closure clicks of mechanical heart valve prostheses' leaflets are quite often clearly audible. The study describes the effects of subjective valve sound perception on the patients' quality of life and analyses factors that might contribute to valve noise-related discomfort. METHODS: We included 556 patients who received a mechanical valve prosthesis and participated in the study in our institution from 1994 to 1998. All compiled the standardised questionnaire Short-Form-36 Health Survey (SF-36) and indicated their subjective disturbance grade pre- and postoperatively, then every 6 months up to 2 years. A series of factors was scanned for correlation with unpleasant noise perception. RESULTS: Two years after the operation, only 5.8% classified their valve sounds as 'quite' or 'very much' disturbing. Age <60 years and being female were statistically significant factors for persisting unease caused by valve sounds. Without one of these factors, severe disturbance chance was 1.5%. As expected, quality of life improved after surgery. Patients disturbed seriously by valve noise showed significantly lower mean life quality values on each SF-36 scale. CONCLUSION: Patients (94.2%) with mechanical heart valve replacement have no persistent complaints about the valve noise. The grade of annoyance by valve noise is paralleled by lower average quality of life. Age under 60 years or being female increases the probability of severe disturbance due to mechanical valve sounds. It remains unclear whether the disturbing noise is reason or consequence of lower quality of life.