Prevention of sudden cardiac death: rationale and design of the Implantable Cardioverter Defibrillators in Dialysis patients (ICD2) Trial--a prospective pilot study.

OBJECTIVE: Sudden cardiac (arrhythmic) death (SCD) is the single largest cause of death in dialysis patients. Prophylactic Implantable Cardioverter Defibrillator (ICD) therapy reduces SCD and reduces all-cause mortality in several groups of patients at high risk for arrhythmic death. Whether this also applies to dialysis patients is unknown. RESEARCH DESIGN AND METHODS: The Implantable Cardioverter Defibrillator in Dialysis patients (ICD2) trial is a prospective randomised controlled study. It has been designed to evaluate the efficacy and safety of prophylactic ICD therapy in reducing sudden cardiac death rates in dialysis patients aged 55-80 years. A total of 200 patients will be included. The primary endpoint of the study is sudden cardiac (arrhythmic) death. The mean follow-up time will be 4 years. TRIAL REGISTRATION: 'The Netherlands Trial Register'--ISRCTN20479861 CONCLUSION: The ICD2 trial--a pilot study--will be the first study to evaluate the possible benefit of ICD therapy for the primary prevention of sudden cardiac death in dialysis patients.

Comparison of surgical repair with balloon angioplasty for native coarctation in patients from 3 months to 16 years of age.

OBJECTIVE: Surgery and balloon angioplasty (BA) for coarctation of the aorta have shown comparable short-term results, but long-term follow-up remains unclear. Comparison of surgical repair and balloon coarctation for native coarctation of the localised membranous form is performed retrospectively. To allow a valid comparison between both techniques, identical inclusion criteria were applied. METHODS: Results of surgery (group A, 18 patients, age 0.30-14 years, median 0.63 years) and BA (group B, 28 patients, age 0.25-15 years, median 5.8 years) for isolated, native coarctation in children >3 months, performed in a 10-year-period, were compared. Kaplan-Meier analysis was performed in both groups. Mean follow-up ranged from 2.5 to 11 years (mean 7.2+/-2.4 years) in group A and from 1.4 to 10 years (mean 5.4+/-2.8 years) in group B. RESULTS: Immediate success was obtained in all patients following surgery and 27/28 patients (96%) following BA. No statistical difference between surgery and angioplasty with respect to resultant pressure gradient decreases were found. Mortality was not encountered. Hospital stay varied from 6 to 20 days in group A and was 48 h for all patients in group B. Recoarctation occurred in one patient (5.6%) in group A and in two patients (7%) in group B. Log-rank test reveals no statistical difference in freedom from reintervention probabilities between surgery and angioplasty. Aneurysm formation was not encountered. CONCLUSIONS: Both surgical repair and BA for native coarctation yield low reintervention probabilities in comparable patients. Aneurysm formation was not encountered following different treatment types.

Comparison of polytetrafluoroethylene patch aortoplasty and end-to-end anastomosis for coarctation of the aorta.

OBJECTIVES: Although aneurysm formation and recoarctation after Dacron patch aortoplasty have been reported on extensively, less is known about these outcomes after polytetrafluoroethylene patch repair, which was compared with resection and end-to-end anastomosis in this study. METHODS: Two hundred sixty-two children had surgical repair of coarctation of the aorta by means of either resection and end-to-end anastomosis (n = 137; mean age, 1.85 +/- 3.1 years) or polytetrafluoroethylene patch aortoplasty (n = 118; mean age, 1.09 +/- 1.9 years) during a 28-year period. Coarctation was isolated in 109 (41.6%), associated with ventricular septal defect in 77 (29.4%), and associated with complex intracardiac anomalies in 76 (29.0%) patients. Follow-up ranged from 2 days to 29.3 years (median, 11.9 years). Seven patients were lost to follow-up. Kaplan-Meier survival curves were estimated, and multivariable Cox regression analysis was performed for several outcome variables. RESULTS: Mortality was 8.2% and was associated with intracardiac pathology in all cases. Recoarctation occurred in 53 patients, 23 after resection and anastomosis and 30 after patch repair, not differing statistically (P =.4, log-rank test). Aneurysm formation occurred in 8 patients after patch repair that included ridge resection in 7 of the 8 patients. Late hypertension occurred in less patients (n = 3) after resection and anastomosis than after patch repair (n = 8) (P <.03). Arch hypoplasia (P <.01) and age less than 1 month (P <.001) were found to be independent risk factors for recoarctation. CONCLUSIONS: Polytetrafluoroethylene patch repair including coarctation ridge resection was found to be a risk factor for aneurysm formation and late hypertension. Arch hypoplasia and young age must be considered to predispose to recoarctation.

Angioplasty for coarctation in different aged patients.

BACKGROUND: Differences in the indication and outcome of balloon angioplasty for coarctation in children and adults have not been elucidated sufficiently. The results of balloon angioplasty for coarctation are compared between pediatric and adult age groups. METHODS: Balloon angioplasty for coarctation of the aorta was performed in 85 patients who were classified according to age and native coarctation/recoarctation. Groups A (patients aged <16 years, n = 32) and B (patients aged > or =16 years, n = 17) included patients with native coarctations. Groups rCoA A (patients aged <16 years, n = 33) and rCoA B (patients aged > or =16 years, n = 3) included patients with recoarctations. Follow-up included 2-dimensional Doppler scanning echocardiography and additional angiography or magnetic resonance imaging. Gradient reductions in groups were compared by use of the independent-samples t test. Kaplan-Meier and log-rank analyses were performed as a means of comparing long-term outcome. RESULTS: No mortality occurred. Immediate success was equal in groups A, B, and rCoA A (94%). Dilatation was unsuccessful in 2 patients in group rCoA B. Pressure gradients decreased 23 mm Hg in group A, 31 mm Hg in group B, 18 mm Hg in group rCoA A, and 11 mm Hg in group rCoA B. Pressure gradient drops, compared between groups A and B, showed a significant difference (P <.001). The length of hospital stay ranged from 12 to 48 hours. The period of follow-up ranged from 6 months to 12 years (mean, 4.9 years). Kaplan-Meier curves of groups A and B are not different, as determined by means of log-rank analysis. No aneurysm formation was encountered. CONCLUSIONS: The results of balloon angioplasty for native coarctation in both selected children and adults are excellent. In recoarctation, we recommend balloon angioplasty in the pediatric patients.