Randomized, single-blind, placebo-controlled pilot study of catheter-based myocardial gene transfer for therapeutic angiogenesis using left ventricular electromechanical mapping in patients with chronic myocardial ischemia.

BACKGROUND: Catheter-based myocardial gene transfer (GTx) has not been previously tested in human subjects. Accordingly, we performed a pilot study to investigate the feasibility and safety of catheter-based myocardial GTx of naked plasmid DNA encoding vascular endothelial growth factor-2 (phVEGF-2) in patients with chronic myocardial ischemia. METHODS AND RESULTS: A steerable, deflectable 8F catheter incorporating a 27-guage needle was advanced percutaneously to the left ventricular myocardium of 6 patients with chronic myocardial ischemia. Patients were randomized (1:1) to receive phVEGF-2 (total dose, 200 microgram), which was administered as 6 injections into ischemic myocardium (total, 6.0 mL), or placebo (mock procedure). Injections were guided by NOGA left ventricular electromechanical mapping. Patients initially randomized to placebo became eligible for phVEGF-2 GTx if they had no clinical improvement 90 days after their initial procedure. Catheter injections (n=36) caused no changes in heart rate or blood pressure. No sustained ventricular arrhythmias, ECG evidence of infarction, or ventricular perforations were observed. phVEGF-2-transfected patients experienced reduced angina (before versus after GTx, 36.2+/-2.3 versus 3.5+/-1.2 episodes/week) and reduced nitroglycerin consumption (33.8+/-2.3 versus 4.1+/-1.5 tablets/week) for up to 360 days after GTx; reduced ischemia by electromechanical mapping (mean area of ischemia, 10.2+/-3.5 versus 2.8+/-1.6 cm(2), P=0.04); and improved myocardial perfusion by SPECT-sestamibi scanning for up to 90 days after GTx when compared with images obtained after control procedure. Conclusions-This randomized trial of catheter-based phVEGF-2 myocardial GTx provides preliminary indications regarding the feasibility, safety, and potential efficacy of percutaneous myocardial GTx to human left ventricular myocardium.

Evaluation of pain after arthroscopically assisted anterior cruciate ligament reconstruction.

Pain after arthroscopically assisted anterior cruciate reconstruction was examined during the first 5 postoperative days to evaluate its intensity and duration. One hundred consecutive patients who underwent arthroscopically assisted anterior cruciate ligament reconstruction using a bone-patellar tendon-bone autograft were examined. During surgery, ketorolac (60 mg) was given intravenously and 0.25% bupivicaine (1 ml/kg total) was injected into the joint space and the graft donor site. After surgery, all patients received scheduled doses of oral acetaminophen (650 mg) and ketorolac (10 mg) four times a day, and they were allowed to take oral oxycodone (5 to 10 mg) every 2 hours as needed. Pain scores at rest and with activity reached a maximum on the 2nd postoperative morning. Oxycodone consumption also peaked on the 2nd postoperative day. Eighty-nine (89%) patients reported overall pain as mild or moderate, and 95 patients (95%) reported either excellent or good overall relief of pain. The 5-day cumulative mean of visual analog scale pain scores for attempting straight leg raises was significantly higher for patients unable to successfully perform that activity than for patients who were able to perform it. The association between elevated pain scores and diminished ability to perform straight leg raises suggests that pain may inhibit function and therefore early rehabilitation.

Experience with early postcesarean hospital dismissal.

OBJECTIVE: Our purpose was to assess early postcesarean hospital dismissal. STUDY DESIGN: A retrospective review was performed of all women receiving cesarean delivery over the most recent 6-month period in a busy private obstetrics practice that routinely dismisses its cesarean patients on postoperative day 2. Women who meet certain criteria (uncomplicated pregnancy, Pfannenstiel incision, uncomplicated surgery, no febrile morbidity, stable vital signs, ability to ambulate without assistance, ability to urinate without assistance, and auscultation of active bowel sounds) on postoperative day 2 are dismissed from the hospital. Outcomes were compared against women undergoing cesarean delivery during the 6 months immediately before the institution of the early dismissal program. RESULTS: Among 147 women undergoing cesarean deliveries, 117 (80%) met the criteria for early dismissal. When compared with controls (n = 93), there was no difference in outcomes. No one in the early dismissal group required readmission to the hospital. CONCLUSION: Among properly selected candidates, early postcesarean hospital admission is a reasonable option.