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Titolo:
A MULTICENTER RANDOMIZED TRIAL COMPARING A PERCUTANEOUS COLLAGEN HEMOSTASIS DEVICE WITH CONVENTIONAL MANUAL COMPRESSION AFTER DIAGNOSTIC ANGIOGRAPHY AND ANGIOPLASTY
Autore:
SANBORN TA; GIBBS HH; BRINKER JA; KNOPF WD; KOSINSKI EJ; ROUBIN GS;
Indirizzi:
CORNELL UNIV,MED CTR,NEW YORK HOSP,DEPT MED,DIV CARDIOL,STARR 445,525E 68 ST NEW YORK NY 10021 JOHNS HOPKINS UNIV HOSP BALTIMORE MD 00000 ST JOSEPHS HOSP ATLANTA ATLANTA GA 00000 ST VINCENTS HOSP BRIDGEPORT CT 00000 UNIV ALABAMA BIRMINGHAM AL 00000
Titolo Testata:
Journal of the American College of Cardiology
fascicolo: 5, volume: 22, anno: 1993,
pagine: 1273 - 1279
SICI:
0735-1097(1993)22:5<1273:AMRTCA>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
CARDIAC-CATHETERIZATION; VASCULAR COMPLICATIONS; INTERVENTIONAL PROCEDURES; CORONARY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
17
Recensione:
Indirizzi per estratti:
Citazione:
T.A. Sanborn et al., "A MULTICENTER RANDOMIZED TRIAL COMPARING A PERCUTANEOUS COLLAGEN HEMOSTASIS DEVICE WITH CONVENTIONAL MANUAL COMPRESSION AFTER DIAGNOSTIC ANGIOGRAPHY AND ANGIOPLASTY", Journal of the American College of Cardiology, 22(5), 1993, pp. 1273-1279

Abstract

Objectives. A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. Background. peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bedrest, represent significant morbidity for invasive cardiac procedures. Methods. A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascularcomplications in patients receiving a vascular hemostasis device withthose undergoing conventional compression techniques. Results. After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75],p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, withoutheparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p =NS). After angioplasty, there was a trend toward fewer hematomas whenthe device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). Conclusions. A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to he determined.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/11/20 alle ore 08:57:06