A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention

J. B. Pracyk, T. C. Wall, J. P. Longabaugh, F. D. Tice, J. Hochrein, C. Green, G. Cox, K. Lee, R. S. Stack, J. E. Tcheng

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63% (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65% of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound- defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound- defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice.

Original languageEnglish
Pages (from-to)970-976
Number of pages7
JournalAmerican Journal of Cardiology
Volume81
Issue number8
DOIs
StatePublished - Apr 15 1998
Externally publishedYes

Fingerprint

Thigh
Hemostasis
Blood Vessels
Physical Examination
Hematoma
Ecchymosis
Ultrasonography
Hand
Pathology
Pressure
False Aneurysm
Arteriovenous Fistula
Percutaneous Coronary Intervention
Femoral Artery
Cosmetics
Length of Stay
Thrombosis
Randomized Controlled Trials
Color
Logistic Models

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pracyk, J. B., Wall, T. C., Longabaugh, J. P., Tice, F. D., Hochrein, J., Green, C., ... Tcheng, J. E. (1998). A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. American Journal of Cardiology, 81(8), 970-976. https://doi.org/10.1016/S0002-9149(98)00074-5

A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. / Pracyk, J. B.; Wall, T. C.; Longabaugh, J. P.; Tice, F. D.; Hochrein, J.; Green, C.; Cox, G.; Lee, K.; Stack, R. S.; Tcheng, J. E.

In: American Journal of Cardiology, Vol. 81, No. 8, 15.04.1998, p. 970-976.

Research output: Contribution to journalArticle

Pracyk, JB, Wall, TC, Longabaugh, JP, Tice, FD, Hochrein, J, Green, C, Cox, G, Lee, K, Stack, RS & Tcheng, JE 1998, 'A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention', American Journal of Cardiology, vol. 81, no. 8, pp. 970-976. https://doi.org/10.1016/S0002-9149(98)00074-5
Pracyk, J. B. ; Wall, T. C. ; Longabaugh, J. P. ; Tice, F. D. ; Hochrein, J. ; Green, C. ; Cox, G. ; Lee, K. ; Stack, R. S. ; Tcheng, J. E. / A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. In: American Journal of Cardiology. 1998 ; Vol. 81, No. 8. pp. 970-976.
@article{cca2c82747f341fbae704ef5977fdc75,
title = "A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention",
abstract = "This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63{\%} (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65{\%} of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound- defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound- defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice.",
author = "Pracyk, {J. B.} and Wall, {T. C.} and Longabaugh, {J. P.} and Tice, {F. D.} and J. Hochrein and C. Green and G. Cox and K. Lee and Stack, {R. S.} and Tcheng, {J. E.}",
year = "1998",
month = "4",
day = "15",
doi = "10.1016/S0002-9149(98)00074-5",
language = "English",
volume = "81",
pages = "970--976",
journal = "American Journal of Cardiology",
issn = "0002-9149",
publisher = "Elsevier Inc.",
number = "8",

}

TY - JOUR

T1 - A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention

AU - Pracyk, J. B.

AU - Wall, T. C.

AU - Longabaugh, J. P.

AU - Tice, F. D.

AU - Hochrein, J.

AU - Green, C.

AU - Cox, G.

AU - Lee, K.

AU - Stack, R. S.

AU - Tcheng, J. E.

PY - 1998/4/15

Y1 - 1998/4/15

N2 - This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63% (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65% of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound- defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound- defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice.

AB - This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63% (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65% of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound- defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound- defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice.

UR - http://www.scopus.com/inward/record.url?scp=0032522410&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032522410&partnerID=8YFLogxK

U2 - 10.1016/S0002-9149(98)00074-5

DO - 10.1016/S0002-9149(98)00074-5

M3 - Article

C2 - 9576155

AN - SCOPUS:0032522410

VL - 81

SP - 970

EP - 976

JO - American Journal of Cardiology

JF - American Journal of Cardiology

SN - 0002-9149

IS - 8

ER -