Samuel R. Money

Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease

PURPOSE This study evaluated the effects of cilostazol on walking distances in patients with intermittent claudication (IC) caused by peripheral arterial occlusive disease. METHODS The study was a multicenter, randomized, double-blind, placebo-controlled trial. Two hundred thirty-nine patients with IC were randomly assigned to receive cilostazol (100 mg b.i.d.) or a placebo for 16 weeks. All patients underwent serial, variable-grade, constant-speed treadmill testing. Absolute claudication distance (ACD), assessed at the end of the 12-hour dosing interval (trough), was the primary end point. Secondary end points included ACD assessed 3 to 4 hours after dosing (peak) and initial claudication distances (trough and peak). Functional status measures, including the Medical Outcomes Scale (SF-36) and Walking Impairment Questionnaire, were used to assess subjective changes over the 16-week treatment period. Ankle-brachial indexes were calculated from Doppler-measured systolic pressures at every visit with treadmill testing. RESULTS Patients treated with cilostazol demonstrated significant improvements over the placebo patients in ACD at all three time points tested after baseline (weeks 8, 12, and 16). Peak treadmill testing at weeks 8 and 12 also showed significant improvement in walking distances for cilostazol-treated patients over placebo-treated patients. At week 16, patients in the cilostazol group had a 96.4-meter (47%) increase in ACD compared with 31.4 meters (12.9%) for the placebo group (p < 0.001). In the SF-36, significant improvement was observed in the physical component subscale and the composite physical component score. In the Walking Impairment Questionnaire, improvements were significant in patient reports of walking speed and specific measures of walking difficulty. Ankle-brachial indexes improved in the cilostazol group (0.64 +/- 0.02 to 0.70 +/- 0.02) compared with the placebo group (0.68 +/- 0.02 to 0.69 +/- 0.02) (p < 0.0125). The most frequent adverse events were headache, abnormal stools (e.g. loose stools), diarrhea, and dizziness. CONCLUSIONS Cilostazol significantly increased ACD at all measured time points and initial claudication distances at most time points. This agent may represent a new treatment option for patients with intermittent claudication.

Risk of spinal cord dysfunction in patientsundergoing thoracoabdominal aortic replacement

The records of 150 consecutive patients underoingthoracoabdominal aortic replacement from 1980 to 1991 were retrospectively reviewed. There were 89 men and 61 women; mean age was 67.8 years (range: 33 to 88 years). Since June 1989, a multimodality prospective perioperative protocol was used to reduce the risk of spinal cord dysfunction. Ischemia is minimized by complete intercostal reimplantation whenever possible, cerebrospinal fluid drainage, and maintenance of proximal hypertension during cross-clamping. Spinal cord metabolism is reduced by moderate hypothermia, high-dose barbiturates, and avoidance of hyperglycemia. Reperfusion injury is minimized by the use of mannitol, steroids, and calcium channel blockers. Ninety-seven percent of patients survived long enough for evaluation of their neurologic function. Spinal cord dysfunction was reduced from 6 of 108 (6%) in the preprotocol group to 0 of 42 in the protocol group (0%) (p A multimodality protocol appears to be effective in reducing the risk of spinal cord injury during thoracoabdominal aortic replacement.

Hospital cost of endovascular versus open repair of abdominal aortic aneurysms: A multicenter study

BACKGROUND Technology-driven innovation in medicine is frequently associated with higher costs than conventional therapy. A significantly higher cost for endovascular (

Comparison of operative reconstruction and percutaneous balloon dilatation for central venous obstruction

21,250, n = 190) versus open abdominal aortic aneurysm (AAA) repair (

The minimally invasive management of visceral artery aneurysms and pseudoaneurysms

12,342, n = 60) was suggested by a direct cost analysis of patients in a multicenter trial. Estimated inpatient costs (not charges) incurred nationwide by hospitals for endovascular and open repair of AAA were studied to validate these observed trends. METHODS A retrospective analysis of 131 patients undergoing endovascular AAA repair was compared with 49 patients undergoing open repair as part of a Food and Drug Administration phase II prospective multicenter clinical investigation (AneuRx-Medtronic). A model to estimate costs was constructed using important clinical descriptors of these patients. These clinical characteristics where then matched with those from 22, 460 patients undergoing AAA repair obtained from a large national database (Medicare Provider Analysis and Review). Estimated hospital cost was then assigned to each study patient according to the national average of the total hospital costs for the respective matched patients in Medicare Provider Analysis and Review. RESULTS Total inpatient hospital costs of endovascular repair were significantly higher than that of open repair (

Risk of respiratory failure after repair of thoracoabdominal aortic aneurysms

19,985 +/- 7396 versus

Direct replacement of mycotic thoracoabdominal aneurysms

12,546 +/- 5944, respectively, P =.0001). Endograft device cost (

Comparison of Surgical Bypass and Percutaneous Balloon Dilatation With Primary Stent Placement in the Treatment of Central Venous Obstruction in the Dialysis Patient: One-Year Follow-up

10,400) accounted for 52% of the total cost of endovascular repair. The 1999 mean blended Medicare reimbursement for AAA repair was

Complications associated with percutaneous closure devices

18,989. CONCLUSION In this early development stage, hospital cost for endovascular AAA repair is significantly greater than open repair when device cost greatly exceeds

Stroke Prevention by Cilostazol in Patients with Atherothrombosis: Meta-analysis of Placebo-controlled Randomized Trials

5000. Although incremental reductions in cost of endovascular repair may be anticipated if use of diagnostic studies, operating time, and length of stay decrease, device cost has the single greatest impact on the expense of endovascular AAA repair. At current device pricing, mean blended Medicare reimbursement does not cover the cost of endovascular AAA repair.