Safety, success, and restenosis after elective coronary implantation of the Palmaz-Schatz stent in 100 patients at a single center.

We report the immediate safety, efficacy, and 6-month angiographic follow-up after elective implantation of the Palmaz-Schatz stent (Johnson & Johnson Interventional Systems, Warren, N.J.) in the first 100 consecutive patients at a single center. Patients with suitable cardiac anatomy and no contraindications to anticoagulation were prospectively entered into the study. One hundred two stents were successfully implanted in 99 patients. The mean diameter stenosis was 70% +/- 11% before implantation and was reduced to 20% +/- 11% after stent implantation. There were no deaths, Q-wave myocardial infarcts, urgent bypass operations, or strokes during the procedure or follow-up period. Stent thrombosis occurred in two patients; in both vessel patency was successfully accomplished by balloon angioplasty. There were three gastrointestinal hemorrhages, two of which required transfusion. Angiographic follow-up was performed in 98% of patients at 6.3 +/- 2.6 months after the procedure. Restenosis (> or = 50% stenosis within or immediately adjacent to the stent) occurred in 32%. Stent restenosis was associated with male sex (36% vs 7% for female subjects; p = 0.03) and stent implantation in a restenosis lesion (47% vs 25% for de novo lesions; p = 0.03); it was inversely associated with current cigarette smoking (0% vs 36% for nonsmokers; p = 0.02). In conclusion, the Palmaz-Schatz stent can be electively implanted with high success and low complication rates. The restenosis rate appears to be similar to that of balloon angioplasty.

Subcutaneous narcotic infusions for cancer pain: treatment outcome and guidelines for use.

OBJECTIVE: To provide guidelines for the institution and maintenance of a continuous subcutaneous narcotic infusion program for cancer patients with chronic pain through an analysis of the narcotic requirements and treatment outcomes of patients who underwent such therapy and a comparison of the costs of two commonly used infusion systems. DESIGN: Retrospective study. SETTING: Tertiary care facilities and patients' homes. PATIENTS: Of 481 patients seen in consultation for cancer pain between July 1987 and April 1990, 60 (12%) met the eligibility criteria (i.e., standard medical management had failed, and they had adequate supervision at home). INTERVENTION: Continuous subcutaneous infusion with hydromorphone hydrochloride or morphine started on an inpatient basis and continued at home whenever possible. OUTCOME MEASURES: Patient selectivity, narcotic dosing requirements, discharge rate, patient preference for analgesic regimen, side effects, complications and cost-effectiveness. RESULTS: The mean initial maintenance infusion dose after dose titration was almost three times higher than the dose required before infusion (hydromorphone or equivalent 6.2 v. 2.1 mg/h). Eighteen patients died, and the remaining 42 were discharged home for a mean of 94.4 (standard deviation 128.3) days (extremes 12 and 741 days). The mean maximum infusion rate was 24.1 mg/h (extremes 0.5 and 180 mg/h). All but one of the patients preferred the infusion system to their previous oral analgesic regimen. Despite major dose escalations nausea and vomiting were well controlled in all cases. Twelve patients (20%) experienced serious systemic toxic effects or complications; six became encephalopathic, which necessitated dose reduction, five had a subcutaneous infection necessitating antibiotic treatment, and one had respiratory depression. The programmable computerized infusion pump was found to be more cost-effective than the disposable infusion device after a break-even point of 8 months. CONCLUSIONS: Continuous subcutaneous infusion of opioid drugs with the use of a portable programmable pump is safe and effective in selected patients who have failed to respond to standard medical treatment of their cancer pain. Dose titration may require rapid dose escalation, but this is usually well tolerated. For most communities embarking on such a program a programmable infusion system will be more cost-effective than a disposable system.

Comparison of continuous subcutaneous and intravenous hydromorphone infusions for management of cancer pain.

To compare the safety and efficacy of subcutaneous and intravenous infusion of opioid analgesics, a randomised, double-blind, crossover trial was carried out in inpatients. 15 patients with severe cancer pain received two 48 h infusions of hydromorphone--one subcutaneously and one intravenously in randomly allocated order. The study was made double-blind by the use of two infusion pumps throughout; during the active subcutaneous infusion the intravenous pump delivered saline and vice versa. Serial measurements of pain intensity, pain relief, mood, and sedation by means of visual analogue scales showed no clinically or statistically significant difference between the two infusion routes. Side-effects were slight, and the mean number of morphine injections for breakthrough pain did not differ significantly between the routes (4.8 [SD 4.5] for intravenous vs 5.3 [5.6] for subcutaneous). Plasma hydromorphone concentrations measured at 24 h and 48 h of infusion showed stable steady-state pharmacokinetics; the mean bioavailability from subcutaneous infusion was 78% of that with intravenous infusion. Because of the simplicity, technical advantages, and cost-effectiveness of continuous subcutaneous opioid infusion into the chest wall or trunk, intravenous opioid infusion for the management of severe cancer pain should be abandoned.