Prognostic Effects of Pulmonary Valve Replacement in Repaired Tetralogy of Fallot: Results From a Large Multicenter Study

Introduction: The prognostic impact and optimal timing of pulmonary valve replacement (PVR) in repaired tetralogy of Fallot (rTOF) remains a subject of debate. The objective of this study was to determine whether PVR was associated with beneficial outcome. Methods: In this multicenter, case-controlled study, clinical, ECG, cardiac magnetic resonance (CMR) and outcome data of rTOF patients were collected. A propensity score for PVR was created to adjust for baseline differences between PVR and non-PVR patients. A frailty failure time model was used to determine the association of PVR, with matching on propensity score and adjustment for other risk factors, on time to the composite of death/sustained ventricular tachycardia (VT). In addition, differential association between impact of PVR and outcome according to predefined ‘proactive’ and ‘conservative’ (see figure) criteria was studied. Results: A total of 440 PVR patients (age 24±13 years at baseline CMR, 58% male, RV ejection fraction (EF) 47±8%, QRS duration 148±27ms) and 537 non-PVR patients (age 29±15 years, 53% male, RV EF 51±8%, QRS duration 140±27ms) were included. During follow-up of 5.3±3.1 years, 41 events occurred (30 death, 11 sustained VT). The adjusted hazard ratio (HR) for death/sustained VT for patients with versus without PVR was 0.65 (95% CI: 0.31, 1.36, p=0.25). There was an increasing hazard of event across prespecified ordered PVR x criteria subgroups (Figure; P=0.044 for proactive, P=0.002 for conservative). There was a two-fold risk (hazard ratio=2.15, 95% CI: 1.34, 3.46) comparing each adjacent subgroup, suggesting benefit of PVR when conservative criteria were met, and lack of benefit of PVR when criteria were not met. A roughly similar pattern was seen according to proactive criteria. Conclusions: In this multicenter, 5-year follow-up study in patients with rTOF, conservative guidelines seemed useful in selecting patients for PVR. Longer follow-up is necessary to confirm these findings

Early revascularization in acute myocardial infarction complicated by cardiogenic shock

Background The leading cause of death in patients hospitalized for acute myocardial infarction is cardiogenic shock. We conducted a randomized trial to evaluate early revascularization in patients with cardiogenic shock. Methods Patients with shock due to left ventricular failure complicating myocardial infarction were randomly assigned to emergency revascularization (152 patients) or initial medical stabilization (150 patients). Revascularization was accomplished by either coronary-artery bypass grafting or angioplasty. Intraaortic balloon counterpulsation was performed in 86 percent of the patients in both groups. The primary end point was mortality from all causes at 30 days. Six-month survival was a secondary end point. Results The mean (+/-SD) age of the patients was 66+/-10 years, 32 percent were women, and 55 percent had been transferred from other hospitals. The median time to the onset of shock was 5.6 hours after infarction, and most infarcts were anterior in location. Ninety-seven percent of the patients assigned to revascularization underwent early coronary angiography, and 87 percent underwent revascularization; only 2.7 percent of the patients assigned to medical therapy crossed over to early revascularization without clinical indication. Overall mortality at 30 days did not differ significantly between the revascularization and medical-therapy groups (46.7 percent and 56.0 percent, respectively; difference, -9.3 percent; 95 percent confidence interval for the difference, -20.5 to 1.9 percent; P = 0.11). Six-month mortality was lower in the revascularization group than in the medical-therapy group (50.3 percent vs. 63.1 percent, P=0.027). Conclusions In patients with cardiogenic shock, emergency revascularization did not significantly reduce overall mortality at 30 days. However, after six months there was a significant survival benefit. Early revascularization should be strongly considered for patients with acute myocardial infarction complicated by cardiogenic shock. (N Engl J Med 1999;341:625-34.) (C) 1999, Massachusetts Medical Society

A propensity score-adjusted analysis of clinical outcomes after pulmonary valve replacement in tetralogy of Fallot

OBJECTIVE: To determine the association of pulmonary valve replacement (PVR) with death and sustained ventricular tachycardia (VT) in patients with repaired tetralogy of Fallot (rTOF). METHODS: Subjects with rTOF and cardiac magnetic resonance from an international registry were included. A PVR propensity score was created to adjust for baseline differences. PVR consensus criteria were predefined as pulmonary regurgitation >25% and ≥2 of the following criteria: right ventricular (RV) end-diastolic volume >160 mL/m2, RV end-systolic volume >80 mL/m2, RV ejection fraction (EF) 160 ms. The primary outcome included (aborted) death and sustained VT. The secondary outcome included heart failure, non-sustained VT and sustained supraventricular tachycardia. RESULTS: In 977 rTOF subjects (age 26±15 years, 45% PVR, follow-up 5.3±3.1 years), the primary and secondary outcomes occurred in 41 and 88 subjects, respectively. The HR for subjects with versus without PVR (time-varying covariate) was 0.65 (95% CI 0.31 to 1.36; P=0.25) for the primary outcome and 1.43 (95% CI 0.83 to 2.46; P=0.19) for the secondary outcome after adjusting for propensity and other factors. In subjects (n=426) not meeting consensus criteria, the HR for subjects with (n=132) versus without (n=294) PVR was 2.53 (95% CI 0.79 to 8.06; P=0.12) for the primary outcome and 2.31 (95% CI 1.07 to 4.97; P=0.03) for the secondary outcome. CONCLUSION: In this large multicentre rTOF cohort, PVR was not associated with a reduced rate of death and sustained VT at an average follow-up of 5.3 years. Additionally, there were more events after PVR compared with no PVR in subjects not meeting consensus criteria