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month angiographic follow-up in 709 patients. J Am Coll Cardiol 1994;24:641–648.5. Piana RN, Paik GY, Moscucci M, Cohen DJ, Gibson MC, Kugeimass AD,Carrozza JP, Jr, Kuntz RE, Baim DS. Incidence and treatment of ‘‘no-reflow’’after percutaneous coronary intervention. Circulation 1994;89:2514–2518.6. Kahn JK. Slow coronary flow complicating elective balloon angioplasty inpostthrombolytic patients. Cor Art Dis 1993;4:61–65.7. Hetterich FS, McEniery PT. Right ventricular infarction following percuta-neous coronary rotational atherectomy. Cathet Cardiovasc Diagn 1995;34:321–324.8. Ling FS, Brennan JJ, Cleman MW, Cabin HS. Physiologic assessment ofostial left circumflex coronary artery disease using a Doppler guidewire beforeand after rotational atherectomy facilitated angioplasty. Cathet CardiovascDiagn 1994;32:53–57.9. Alvarez LG, Jackson SA, Berry JA, Eichhorn EJ. Evaluation of a personalcomputer-based quantitative coronary analysis system for rapid assessment ofcoronary stenosis. Am Heart J 1992;123:1500–1510.10. Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U,Topol EJ, Bulle TM and the Multivessel Angioplasty Prognosis StudyGroup. Coronary morphologic and clinical determinants of procedural out-

come with angioplasty for multivessel coronary disease. Circulation1990;82:1193–1202.11. O’Murchu B, Foreman RD, Shaw RE, Brown DL, Peterson KL, BuchbinderM. Role of intraaortic balloon pump counterpulsation in high risk coronaryrotational atherectomy. J Am Coll Cardiol 1995;26:1270–1275.12. Ellis SG, Popma JJ, Buchbinder M, Franco I, Leon MB, Kent KM, PichardAD, Satler LF, Topol EJ, Whitlow PL. Relation of clinical presentation, stenosismorphology, and operator technique to the procedural results of rotationalatherectomy and rotational atherectomy facilitated angioplasty. Circulation1994;89:882–892.13. de Feyter. PJ, de Jaegere PP, Serrruys PW. Incidence, predictors, and man-agement of acute coronary occlusion after coronary angioplasty. Am Heart J1994;127:643–651.14. Mizuno K, Satomura K, Miyamoto A, Arakawa K, Shibuya T, Arai T,Kurita A, Nakamura H, Ambrose JA. Angioscopic evaluation of coronaryartery thrombi in acute coronary syndromes. N Engl J Med 1992;326:287 –291.15. Dangas G, Mehran R, Wallenstein S, Courcoutsakis NA, Kakarala V, Hol-lywood J, Ambrose JA. Correlation between angiographic morphology and clin-ical presentation in unstable angina. J Am Coll Cardiol 1997;29:519–525.

Femoral Complications and Bed Rest Duration AfterCoronary Arteriography

Richard Lim, MD, MPhil, Hilary Anderson, RN, Mark I. Walters, MBChB, Gerald C. Kaye, MD,Michael S. Norell, MD, and John L. Caplin, MD

Hospitals vary in the length of bed rest after cor-onary arteriography via the femoral artery ap-

proach. Before this study, our department observeda policy of 6 hours of bed rest. A shorter durationcould be advantageous if there were no increase inthe incidence of femoral bleeding complications; pa-tients would have less discomfort, ambulate, and bedischarged home earlier, and staff would be de-ployed more efficiently, and throughput would beenhanced. We therefore performed a randomizedstudy, using the FemoStopy pneumatic compressiondevice, to determine whether there is any differencein the femoral bleeding complication rate between 4and 6 hours of bed rest after elective coronary arte-riography.

j j j

At this tertiary referral center, 200 consecutivepatients (mean age 59 years, range 29 to 79) wererandomized to either 4 hours (n Å 100) or 6 hours(n Å 100) of bed rest after elective coronary arteri-ography for the investigation of chest pain. Patientswith peripheral vascular grafts were excluded. Allpatients were taking aspirin regularly. Three patientswith atrial fibrillation were taking warfarin, whichwas discontinued for 4 days before the procedure;the international normalized ratio did not exceed 1.3.Left-sided cardiac catheterization by the Judkin’smethod was performed using 6Fr sheaths and cath-eters by 7 experienced fellows and staff (who hadeach performed ú600 procedures) blinded to thepreprocedure block randomization sequence adopted

From the Department of Cardiology, Hull Royal Infirmary, Universityof Hull Postgraduate Medical School, Kingston Upon Hull, UnitedKingdom. Dr. Lim’s address is: Interventional Cardiology, Universityof Maryland Hospital, 22 South Greene Street, Baltimore, Maryland21201. Manuscript received November 14, 1996; revised manu-script received and accepted March 24, 1997.

by the ward nursing staff. A modified Seldinger tech-nique was used in which only the anterior wall ofthe common femoral artery was punctured.1 Heparinwas not administered. There were no proceduralcomplications.

At the end of the procedure, the FemoStop pneu-matic compression hemostatic device (Radi MedicalSystems, Uppsala, Sweden)2—in routine use at ourcenter—was applied directly over the femoral artery(not skin) puncture site. No patient was too obese forproper positioning of the device. During inflationnear to systolic blood pressure, the femoral sheathwas removed. Inflation pressure was maintained for30 minutes at a level sufficient to achieve hemostasiswithout compromising the foot pulses; this was thecrucial period for nursing observation. Once hemo-stasis was secured, pressure was gradually reducedto and maintained at 40 mm Hg by the nursing staff.The device was usually removed after a total of 60minutes and a dry strip dressing applied. If hema-toma was obvious at this stage, the device would bereapplied at 40 mm Hg for another 30 minutes. Pa-tients would then continue with bed rest in a semi-recumbent (307 to 457) position to complete the du-ration to which they had been randomized. Afterpreliminary ambulation, patients were examined bycardiology residents blinded to their randomized al-location. Bruising was simply classified as ‘‘none’’or ‘‘obvious.’’ Hematoma was graded ‘‘small’’ ifthere was a firm fullness that was just palpable, and‘‘big’’ if there was an obvious swelling that was bothpalpable and visible. If the swelling was pulsatile orvery large, a Doppler ultrasound scan would be per-formed to exclude a femoral pseudoaneurysm. Theneed for blood transfusion, development of pseudo-aneurysm, and ultrasound or surgical interventionwere hard end points.

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The incidence of obvious bruising was 49% inboth groups. Hematoma was observed in 47% of the4-hour group (in which only 4 were graded big) and44% of the 6-hour group (in which only 2 weregraded big) (p Å NS). Thus, the overall incidence ofbig hematomas was only 3%, none of which oc-curred in patients taking warfarin. Patients with bighematomas were advised to avoid excessive hip flex-ion, but did not have their discharge delayed. Nonerequired blood transfusion. The only pseudoaneu-rysm occurred in the 6-hour group; it was treatedsuccessfully by ultrasound-guided compression. Nopatient developed late complications (up to 6 weeks).

A study power of 80% was assumed to show thatcomplication rates were equivalent, i.e., that this wasa truly negative study.3 Based on the 4% incidenceof big hematoma in the 4-hour group and the 2%incidence of pseudoaneurysm or big hematoma inthe 6-hour group, the absolute increase in the hardend-point rate was not significant at 2% (95% con-fidence interval /6.7% to 02.7%). After analysis ofthese results, departmental policy on bed rest dura-tion was altered from 6 to 4 hours. In 500 subsequentconsecutive patients undergoing elective coronaryarteriography, there were no cases of pseudoaneu-rysm formation or major hemorrhage requiringblood transfusion. With use of a Poisson distribution,this observation reduces the upper 95% confidenceinterval to õ1%.

j j j

A telephone survey of cardiac wards showed thatthe duration of bed rest imposed after Judkin’s cor-onary arteriography ranged from 4 to 24 hours (un-published data). Prolonged bed rest may have beenrequired when large catheters (8Fr or greater) wereused and heparinization was performed. Recently,however, there has been a shift to smaller sheathsand catheters (6Fr or less). Shorter bed rest offersadvantages compatible with the demand for efficientthroughput and a shift toward day case procedures.In our diagnostic laboratory, 12 elective left heartcases are routinely scheduled each day; °80% ofthese will be outpatient day cases. The need for rapidturnover and same-day discharge means that groinmanagement is devolved from the catheterizationlaboratory to the cardiac ward, freeing up operatorsto proceed rapidly to the next case.

The efficiency of the traditional model wherebythe operator applies manual compression for 20 to35 minutes to achieve hemostasis followed by 6hours of bed rest may now be questionable, giventhe increasing pressures on catheterization labora-tory time and bed availability, the drive toward cost-effective downsizing of personnel, and the need toeliminate unnecessary hospital stays. Although there

is a cost consideration in our routine use of theFemoStop device (at $70 each), this appears to beoffset by our ability to safely enhance throughput,reduce waiting times to coronary arteriography andmeet contractual demands. We have not needed toinvest in additional trained nurses because of theirefficient deployment around the geographic concen-tration of day-case beds. Ultimately, only a formalcost-effectiveness analysis can confirm that it is fi-nancially advantageous to shorten bed rest durationby 2 hours using our approach.

In this era of routine treatment with aspirin, nearlyhalf of the patients had some degree of bruising andhematoma, but this was an expected transient self-limiting cosmetic effect about which patients wereforewarned. In only 3% was hematoma consideredbig. There was only 1 major complication: a pseu-doaneurysm in the 6-hour group which was treatedsuccessfully by ultrasound-guided compression.4

The results may not be as favorable for simultane-ous right and left-sided cardiac catheterization orwhen other hemostatic methods are used. The lowrisk of serious vascular complications in diagnosticcardiac catheterization is in keeping with publisheddata,1,5–7 but to our knowledge, this is the first re-ported randomized study using 6Fr sheaths and theFemoStop device to show that 4 hours of bed rest issufficient for patient safety.

In conclusion, clean anterior wall puncture ofthe common femoral artery, precise application ofthe FemoStop device, and meticulous nursing bymotivated cardiac staff accustomed to groin careand rapid turnover, contribute to the ability toshorten the duration of bed rest after arteriographywithout compromising patient comfort, conve-nience, and safety. This undoubtedly has positiveimplications for the organization of an efficient ser-vice in busy cardiac centers.

1. Rapaport S, Sniderman KW, Morse SS, Proto MH, Ross GR. Pseudoaneu-rysm: a complication of faulty technique in femoral arterial puncture. Radiology1985;154:529–530.2. Spokojny AM, Sanborn TA. Management of the arterial puncture site. JIntervent Cardiol 1994;7:187–193.3. Detsky AS, Sackett DL. When was a ‘‘negative’’ clinical trial big enough?How many patients you needed depends on what you found. Arch Intern Med1985;145:709–712.4. Agrawal SK, Pinheiro L, Roubin GS, Hearn JA, Cannon AD, Macander PJ,Barnes JL, Dean LS, Nanda NC. Nonsurgical closure of femoral pseudoaneu-rysms complicating cardiac catheterization and percutaneous transluminal cor-onary angioplasty. J Am Coll Cardiol 1992;20:610–615.5. Kern MJ, Cohen M, Talley JD, Litvack F, Serota H, Aguirre F, DeligonulU, Bashore TM. Early ambulation after 5 French diagnostic cardiac catheter-ization: results of a multicenter trial. J Am Coll Cardiol 1990;15:1475–1483.6. Kennedy JW. Complications associated with cardiac catheterization and an-giography. Cathet Cardiovasc Diagn 1982;8:5–11.7. de Bono D. Complications of diagnostic cardiac catheterisation: results from34041 patients in the United Kingdom confidential enquiry into cardiac cathetercomplications. Br Heart J 1993;70:297–300.