Faculty Bibliography

Background: Ventricular tachycardia (VT) and ventricular fibrillation (VF) remain a challenging problem in patients with implantable cardioverter-defibrillators (ICDs). Objectives: This study aimed to determine whether ranolazine administration decreases the likelihood of VT, VF, or death in patients with an ICD. Methods: This was double-blind, placebo-controlled clinical trial in which high-risk ICD patients with ischemic or nonischemic cardiomyopathy were randomized to 1,000 mg ranolazine twice a day or placebo. The primary endpoint was VT or VF requiring appropriate ICD therapy or death, whichever occurred first. Pre-specified secondary endpoints included ICD shock for VT, VF, or death and recurrent VT or VF requiring ICD therapy. Results: Among 1,012 ICD patients (510 randomized to ranolazine and 502 to placebo) the mean age was 64 +/- 10 years and 18% were women. During 28 +/- 16 months of follow-up there were 372 (37%) patients with primary endpoint, 270 (27%) patients with VT or VF, and 148 (15%) deaths. The blinded study drug was discontinued in 199 (39.6%) patients receiving placebo and in 253 (49.6%) patients receiving ranolazine (p = 0.001). The hazard ratio for ranolazine versus placebo was 0.84 (95% confidence interval: 0.67 to 1.05; p = 0.117) for VT, VF, or death. In a pre-specified secondary analysis, patients randomized to ranolazine had a marginally significant lower risk of ICD therapies for recurrent VT or VF (hazard ratio: 0.70; 95% confidence interval: 0.51 to 0.96; p = 0.028). There were no other significant treatment effects in other pre-specified secondary analyses, which included individual components of the primary endpoint, inappropriate shocks, cardiac hospitalizations, and quality of life. Conclusions: In high-risk ICD patients, treatment with ranolazine did not significantly reduce the incidence of the first VT or VF, or death. However, the study was underpowered to detect a difference in the primary endpoint. In prespecified secondary endpoint analyses, ranolazine administration was associated with a significant reduction in recurrent VT or VF requiring ICD therapy without evidence for increased mortality. (Ranolazine Implantable Cardioverter-Defibrillator Trial [RAID]; NCT01215253)

INTRODUCTION: Successful antiemesis contributes significantly to quality, safety, and patient satisfaction. Patients undergoing general anesthesia often experience postoperative nausea and vomiting (PONV). Acupressure offers a side effect-free alternative to common first-line antiemetics. Because the patient may perceive needle acupuncture as uncomfortable, acupressure is a desirable alternative for the prevention of PONV. METHODS: This study was a randomized, prospective, double-blinded clinical trial investigating the effect of acupressure in patients with a history of PONV and motion sickness. The three auricular acupressure points chosen were shen men, point zero, and the subcortex point. Rescue treatment for PONV with 4 mg intravenous ondansetron was used if the patient reported persistent nausea. A blinded observer recorded antiemetic rescue data, and postoperative analgesic use was recorded over 24 hours. Nausea, vomiting, and retching were assessed in the post-anesthesia care unit (PACU). RESULTS: Using univariate analysis, we ruled out the null hypothesis of equal means as a function of intervention group (p = 0.001). Pair-wise comparisons revealed a difference between placebo and test groups (p = 0.000) and also sham and test groups (p = 0.033) where age (p = 0.048) and gender (p = 0.003) were significant covariates. DISCUSSION: Our data reveal that auricular acupressure significantly decreases nausea during the PACU stay and within the 24 hours postoperatively. It is not clear whether the intervention decreases nausea as a primary effect or as a secondary result by decreasing narcotic requirements. Also, perception of nausea may be in part subjective. This is evidenced by our results in which subjects who received sham points fared better than the placebo subjects.