Randomized comparison of flexible versus nonflexible femoral sheaths on patient comfort after angioplasty Ron Waksman, MD, Neal A. Scott, MD, PhD, Ziyad M.B. Ghazzal, MD, Rachel Mays, RN, Frances A. Frerichs, RN, Jackie Y. Petersen, RN, and Spencer B. King III, MD Atlanta, Ga. Patients who undergo percutaneous transluminal coronary angioplasty (PTCA) by the femoral approach are usually re- quired to lie flat in bed for 6 to 24 hours, which may result in significant discomfort. This study was performed to eval- uate the safety and benefit of a flexible sheath that enables patients to sit at a 60-degree angle while the sheath is in place in the femoral artery. Sixty patients were randomly as- signed to receive either flexible or nonflexible sheaths before PTCA. Patients w..=th flexible sheaths were allowed to sit at an angle of 60 degrees after the procedure. Heparin management was the same in both groups. Frequency of calls to nurses for back pain was recorded for both groups. For analgesia, nalbuphine was administered in 2-mg incre- ments. All sheaths were removed the day after the proce- dure. Femoral ultrasound was used to detect groin compli- cations (hematoma, pseudoaneurysm, or arteriovenous fistula) and was performed in all patients. Baseline charac, teristics were similar in both groups. There were no differ- ences in ease of sheath insertion or guide catheter move- ment through the sheaths. The arterial pressure waveform was not dampened in any of the flexible sheath patients while in the sitting position. Patients with flexible sheaths had fewer calls for back pain and required less nalbuphine than patients with nonflexible sheaths. Groin complications were similar in both groups. In conclusion, by allowing pa- tients to sit up to an angle of 60 degrees, flexible sheaths have a beneficial effect in reducing back pain and the need for analgesics after PTCA. (Am Heart J 1996;131:1076-8.) Percutaneous transluminal coronary angioplasty (PTCA) is a procedure that is frequently used to treat patients with unstable angina and myocardial in- farction.Z, 2 The femoral artery is the site of vascular access in the majority of these procedures. Catheters used during PTCA are deployed through an intro- ducer sheath, which is inserted in the femoral artery. Because of relatively large heparin requirement for PTCA and, in selected cases, the need for uninter- From the Andreas Gruentzig Cardiovascular Center, Emory University School of Medicine. Received for publication Sept. 25, 1995; accepted Nov. 3, 1995. Reprint requests: Ron Waksman, MD, Andreas Gruentzig Cardiovascular Center, F606, Emory University Hospital, 1364 Clifton Road NE, Atlanta, GA 30022. Copyright © 1996 by Mosby-Year Book, Inc. 0002-8703/96/$5.00 + 0 4/1//1365 rupted anticoagulant therapy, the sheaths usually remain in place for 6 to 24 hours after the procedure. As a result, patients are required to lie flat in bed throughout this period. The prolonged immobiliza- tion frequently causes significant discomfort, usu- ally requiring analgesics. Recently a flexible sheath has been developed that permits patients to sit at a 60-degree angle with the sheath in place. 3 The pur- pose of this study was to compare the safety and benefit of flexible and nonflexible sheaths in patients after PTCA. METHODS After signing an informed consent, 60 patients were randomly assigned to receive either arterial and venous stainless-steel flexible sheaths (Arrow International Inc., Reading, Penn.) or standard, nonflexible sheaths (Daig Corp., Minnetonka, Minn.) before PTCA. Sheaths were in- serted by the Seldinger technique.4 Sheath sizes ranging from 6F to 10F were used in both groups. At the end of the procedure, the obturator was introduced and the sheath was sutured to the skin. In patients who received flexible sheaths, the side port of the sheath was connected to a pressure transducer to evaluate pressure waveform in both the sitting (60-degree) and the supine positions. Be- fore the patient left the catheterization suite, the opera- tor's impression of the ease of sheath insertion and guide catheter movement through the sheath were recorded. In addition, patients who received flexible sheaths were also evaluated for the quality of the arterial pressure waveform while sitting at an angle of 60 degrees. Patients with flex- ible sheaths were allowed to sit at a 60-degree angle immediately after the procedure, and patients with non- flexible sheaths were required to lay flat for the entire time the sheath was in place. Intravenous heparin after PTCA was adjusted for a therapeutic partial thromboplastin time. For analgesia after PTCA, patients were instructed to call for their nurse for administration of nalbuphine. Nalbuphine was administered in 2-mg increments. Fre- quency of calls to nurses for back and groin pain was recorded on the patient flow sheet. All sheaths were removed the day after the procedure. Heparin was discon- tinued, and the sheath was removed after the activated clotting time was <150 seconds. Manual pressure or pres- sure applied with the Femostop (USCI Inc., Billerica, 1076