Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

BACKGROUND: Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. METHODS: We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. FINDINGS: Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. INTERPRETATION: Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. FUNDING: UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Survival comparison of the Ross procedure and mechanical valve replacement with optimal self-management anticoagulation therapy: propensity-matched cohort study.

BACKGROUND: It is suggested that in young adults the Ross procedure results in better late patient survival compared with mechanical prosthesis implantation. We performed a propensity score-matched study that assessed late survival in young adult patients after a Ross procedure versus that after mechanical aortic valve replacement with optimal self-management anticoagulation therapy. METHODS AND RESULTS: We selected 918 Ross patients and 406 mechanical valve patients 18 to 60 years of age without dissection, aneurysm, or mitral valve replacement who survived an elective procedure (1994 to 2008). With the use of propensity score matching, late survival was compared between the 2 groups. Two hundred fifty-three patients with a mechanical valve (mean follow-up, 6.3 years) could be propensity matched to a Ross patient (mean follow-up, 5.1 years). Mean age of the matched cohort was 47.3 years in the Ross procedure group and 48.0 years in the mechanical valve group (P=0.17); the ratio of male to female patients was 3.2 in the Ross procedure group and 2.7 in the mechanical valve group (P=0.46). Linearized all-cause mortality rate was 0.53% per patient-year in the Ross procedure group compared with 0.30% per patient-year in the mechanical valve group (matched hazard ratio, 1.86; 95% confidence interval, 0.58 to 5.91; P=0.32). Late survival was comparable to that of the general German population. CONCLUSIONS: In comparable patients, there is no late survival difference in the first postoperative decade between the Ross procedure and mechanical aortic valve implantation with optimal anticoagulation self-management. Survival in these selected young adult patients closely resembles that of the general population, possibly as a result of highly specialized anticoagulation self-management, better timing of surgery, and improved patient selection in recent years.

A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program.

BACKGROUND: We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program. METHODS: Two hundred overweight subjects were randomly assigned to a conventional low-fat diet and a low-carbohydrate diet group (target carbohydrate content: >55% energy and <40% energy, respectively). Both groups attended a weekly nutrition education program and dietary counselling by telephone, and had to transfer actual body weight data to our clinic weekly with added Bluetooth technology by mobile phone. Various fatness and fat distribution parameters, energy and macronutrient intake, and various biochemical risk markers were measured at baseline and after 6, and 12 months. RESULTS: In both groups, energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months. Macronutrient composition differed significantly between the groups from the beginning to month 12. At study termination, weight loss was 5.8 kg (SD: 6.1 kg) in the low-carbohydrate group and 4.3 kg (SD: 5.1 kg) in the low-fat group (p = 0.065). In the low-carbohydrate group, triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group (P = 0.005-0.037). Other risk markers improved to a similar extent in both groups. CONCLUSION: Despite favourable effects of both diets on weight loss, the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet. Nevertheless, compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet. TRIAL REGISTRATION: Clinicaltrials.gov as NCT00868387.

[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.

Relationship between pulse transit time and blood pressure is impaired in patients with chronic heart failure.

AIMS: Pulse transit time (PTT), the interval between ventricular electrical activity and arrival of the peripheral pulse wave, has been used to detect changes in autonomic tone during sleep and anesthesia. The purpose of this study was to evaluate PTT in patients with chronic heart failure (HF). METHODS AND RESULTS: Pulse transit time was measured with R-wave gated photoplethysmography in 24 healthy volunteers and in 112 patients with chronic HF and ejection fraction (EF) <40%. PTT was mildly elevated in patients with HF (468 ± 12 vs. 430 ± 23 ms, p = 0.001). In healthy volunteers, PTT was directly proportional to blood pressure (BP): when BP increased, PTT shortened, and vice versa. This relationship between PTT and BP (PTTi) was altered in patients with HF and particularly in the 26 patients with decompensated HF (3.6 ± 0.4 vs. 4.2 ± 0.9, p = 0.04). PTTi did not correlate with functional NYHA class and levels of pro-BNP, epinephrine or norepinephrine. There was a modest correlation between PTTi and EF (p = 0.01, r = -0.48) and PTTi tended to correlate with microvascular flow measured with Laser Doppler (p = 0.08). However, there was an excellent correlation between PTTi and systolic time intervals, left ventricular ejection time (LVET) (p = 0.0014, r = -0.75) and pre-ejection time/LVET (p = 0.006, r = 0.80). The latter ratio reflects ventricular-arterial coupling. CONCLUSION: The relationship between PTT and BP is altered in severe HF and may indicate impaired ventricular-arterial coupling. It merits further investigation as both parameters can be easily determined and used for serial monitoring in HF.

[Structural valve deterioration of aortic bioprostheses and reoperation in octogenarians. Results and risk factors for survival]. / Degeneration biologischer Aortenklappenprothesen im Senium. Ergebnisse und Risikofaktoren der operativen Therapie.

BACKGROUND: Due to increasing life expectancy of patients with heart valve replacement and a limited durability of heart valve bioprostheses, replacement of aortic valve prosthesis becomes necessary in a significant percentage of patients. However, reliable data on mortality and its risk factors in octogenarians after replacement of aortic bioprostheses are limited. PATIENTS AND METHODS: 56 patients aged > or = 80 years who underwent cardiac reoperation of a bioprosthesis due to structural valve deterioration at the authors' heart center between 1991 and 2004 were analyzed retrospectively. To assess predictors of 30-day and 3-year survival, uni- and multivariate Cox regression analyses were performed. RESULTS: 30-day, 1-year, 3-year, and 5-year survival rates were 81.1%, 71.3%, 67.5%, and 50.8%, respectively. Patients with reoperation had an estimated median survival of 5.0 years. Patients who survived their in-hospital stay had a very similar life expectancy compared with the general German population. Postoperative complications such as low cardiac output syndrome and intestinal failure were the only independent predictors of 30-day and 3-year survival (p < 0.001). Postoperative New York Heart Association functional class improved markedly in the study cohort and the majority of survivors was able to live at home. As we cannot offer these patients an alternative effective medical therapy, octogenarians who need their aortic valve prosthesis to be replaced are left in a miserable condition with a poor prognosis, if surgery is denied. Therefore, considering that almost the same criteria are used for younger patients with the emphasis that surgery should not be delayed until they are highly symptomatic, reoperation of the aortic valve in this age group is justified. CONCLUSION: The data demonstrate that it is possible to achieve an acceptable outcome in octogenarians who are in need of a replacement of their aortic valve prosthesis. Early as well as mid-term survival are predominantly influenced by unexpected postoperative complications.

New East-Westfalian Postoperative Therapy Concept: a telemedicine guide for the study of ambulatory rehabilitation of patients after cardiac surgery.

In-hospital rehabilitation can improve recovery of patients after surgery, but also contributes to the high costs of the German health system. A telemedicine-based rehabilitation used in the home as an alternative to in-hospital rehabilitation was evaluated in a pilot study. In an open trial, 170 patients performed a 3-month ambulatory rehabilitation after cardiac surgery. There were two groups (group 1 [n = 70] and group 2 [n = 100]). Group 1 participated in conventional in-hospital rehabilitation. Group 2 received ambulant rehabilitation using telemedicine. Physical performance, quality of life, (measured with a questionnaire), complications and costs were assessed and compared between the two groups. Maximal physical performance (MPP) was assessed at 6 and at 12 months after cardiac surgery. It was significantly increased by 46-54 watts 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, group 2 was the only group to show statistical significance in all categories. Fewer incidents of angina pectoris were reported within the study interval in group 2 compared to group 1 (p < 0.01). The total cost of rehabilitation was 58% lower in group 2 compared to group 1. Ambulatory rehabilitation using telemedicine improves physical performance, quality of life, is safe, and is inexpensive. Our data indicate that home-based rehabilitation is more effective than in-hospital rehabilitation for patients after cardiac surgery.

Self management of oral anticoagulation with the IN Ratio system: impact of a structured teaching program on patient's knowledge of medical background and procedures.

BACKGROUND: Self management of oral anticoagulation (OAC) decreases complication rates and improves quality of life. Manual and cognitive abilities of patients and patient training in a structured format are a precondition for this concept. Up to now, there is no evidence about knowledge increase from teaching programs. METHODS: Seventy-six patients (mean age, 57.4 years, 71% male) who started long-term OAC were included in the prospective multi-center study at three teaching centers representing different populations of anticoagulation patients: a department of cardiovascular surgery, an inpatient rehabilitation center and an anticoagulation clinic. The patients were trained in a structured education program for two days. For the evaluation, the patients performed standardized tests including 16 questions prior to start (T0), after each training unit (T1/T2) and 6 weeks later (T3). The primary endpoint was the percentage of > or =75% of patients who could answer > or =50% of questions correctly at T3. Secondary endpoints were the overall and item-specific percentages of correct answers at the end of each training unit (T1, T2) and at T3. In addition, the teaching program was rated by the patients on a six-point rating scale. RESULTS: Seventy-four out of 76 patients gave at least 50% correct answers at T3 (97.4%; 95% confidence interval, 90.8-99.7%). The average rates of correct answers developed from 40% (T0), 86% (T1), 94% (T2) to 96% (T3). The greatest increase of knowledge was observed with blood components, interpretation of International Normalized Ratio (INR) value, and the interaction of anticoagulation with other variables (e.g. drugs or infection). Patients rated the teaching program between 1 (best rating) and 2 at all time points. At T3, the patients reported less fear of complications and less limitations in their daily life than in earlier evaluations. CONCLUSION: The structured training program INRatio appears to be an appropriate instrument for instruction of INR self management. In comparison with baseline knowledge, the percentage of correctly answered questions was twice as high directly after the end of training and remained at a high level of >90% for at least 6 weeks.