Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache.

BACKGROUND: Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in approximately 80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial. METHODS AND RESULTS: Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed > or = 2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; P=0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (P=0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. CONCLUSIONS: This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe.

A vector-based, 5-electrode, 12-lead monitoring ECG (EASI) is equivalent to conventional 12-lead ECG for diagnosis of acute coronary syndromes.

AIMS: The conventional 12-lead electrocardiogram (cECG) derived from 10 electrodes using a cardiograph is the gold standard for diagnosing myocardial ischemia. This study tested the hypothesis that a new 5-electrode 12-lead vector-based ECG (EASI; Philips Medical Systems, formerly Hewlett Packard Co, Boeblingen, Germany) patient monitoring system is equivalent to cECG in diagnosing acute coronary syndromes (ACSs). METHODS: Electrocardiograms (EASI and cECG) were obtained in 203 patients with chest pain on admission and 4 to 8 hours later. Both types of ECGs were graded as ST-elevation myocardial infarction if at least 1 of the 2 consecutive recordings showed ST elevation more than 0.2 mV, as ACS if one or both showed ST elevation less than 0.2 mV, T-wave inversion, or ST depression. Otherwise, the ECG was graded negative. RESULTS: Final diagnosis was identical in 177 patients (87%; 95% confidence interval [CI], 82%-91%; kappa = 0.81; SE = 0.035). ST-elevation myocardial infarction was correctly identified or excluded by EASI with a specificity of 94% (95% CI, 89%-97%) and a sensitivity of 93% (95% CI, 86%-97%; using cECG as the gold standard). Of 118 patients with enzyme elevations, an almost identical number (72 [61% by EASI] and 73 [62% by cECG]) had ST elevations. Both techniques were equivalent in predicting subsequent enzyme elevation (identical, 108/143; 75% of ACS and ST-elevation myocardial infarction ECGs by EASI and cECG). Thus, both ECG methods had exactly the same specificity of 59% (95% CI, 48%-69%) and sensitivity of 91% (95% CI, 85%-96%) for detecting myocardial injury. CONCLUSION: EASI is equivalent to cECG for the diagnosis of myocardial ischemia.

Survival after surgery or therapeutic catheterisation for congenital heart disease in children in the United Kingdom: analysis of the central cardiac audit database for 2000-1.

OBJECTIVES: To analyse simple national statistics and survival data collected in the central cardiac audit database after treatment for congenital heart disease and to provide long term comparative statistics for each contributing centre. DESIGN: Prospective, longitudinal, observational, national cohort survival study. SETTING: UK central cardiac audit database. MAIN OUTCOME MEASURES: Survival at 30 days and one year after treatment in the year April 2000-March 2001, assessed by using both volunteered life status and independently validated life status through the Office for National Statistics, using the patient's unique NHS number, or the general register offices of Scotland and Northern Ireland. Institutional results following a group of six benchmark operations and three benchmark catheterisation procedures. RESULTS: Since April 2000 data have been received from all 13 UK tertiary centres performing cardiac surgery or therapeutic cardiac catheterisation in children with congenital heart disease. Altogether 3666 surgical procedures and 1828 therapeutic catheterisations were performed. Central tracking of mortality identified 469 deaths, 194 occurring within 30 days and 275 later. Forty two of the 194 deaths within 30 days were detected by central tracking but not by volunteered data. For surgery overall, survival at 30 days was 94.9%, falling to 91.2% at one year; this effect was most marked for infants. For therapeutic catheterisation survival at 30 days was 99.1%, falling to 98.1% at one year. Survival of individual centres or individual operators did not differ from the national average after benchmark procedures. CONCLUSIONS: Independent data validation is essential for accurate survival analysis. One year survival gives a more realistic view of outcome than traditional perioperative mortality. Currently no detectable difference exists in survival between any of the 13 UK tertiary congenital heart disease centres, but confidence intervals for small centres are wide, limiting our power to detect underperformance from analysis of a single year's data. Appropriately resourced, focused national audit is capable of accurate data collection on which nationwide, long term quality control can be based.