A multicenter randomized trial comparing a percutaneous collagen hemotasis device with conventional manual compression after diagnostic angiography and angioplasty

Sanborn, Timothy A.; Gibbs, Harry; Brinker, Jefrey A.; Knopf, William D.; Kosinski, Edward J.; Roubin, Gary S.

doi:10.1016/0735-1097(93)90529-a

Cited by 182 publications

(106 citation statements)

References 13 publications

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“…[17][18][19][20] The main advantages of VCDs are greater patient comfort and improved cost-effectiveness because of reduced puncture site hemostasis time, bed rest, time to ambulation, and hospital stay compared with manual compression. [17][18][19][20][21][22] Although evidence has accrued that VCDs (compared with manual compression) may be of greater value in higher-risk subjects-such as those receiving anticoagulant agents-in terms of reducing bleeding complications, [23][24][25][26][27][28][29] with 1 population-based study (US CathPCI registry, n=1 819 611) 29 associating the most frequently used VCDs with a substantial reduction in bleeding and vascular complications, this has proven to be controversial, particularly because VCDs in themselves have been associated with life-threatening complications. 21,[30][31][32][33][34][35][36] Consequently, the 2010 American Heart Association guidelines give a class IIa recommendation for VCD (reasonable to perform the procedure) to achieve faster hemostasis and improve patient comfort and a class III recommendation (procedure should not be performed because it is not helpful and may be harmful) when used with the intent to reduce vascular complications.…”

Section: Farooq Et Al Femoral Vascular Closure Devices and 30-day Mormentioning

confidence: 99%

Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

Farooq

Goedhart

Ludman

et al. 2016

Circ: Cardiovascular Interventions

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Background-The impact of vascular closure devices (VCDs) via the femoral arterial access site on short-term mortality in patients undergoing percutaneous coronary intervention is currently unknown. 001).A more pronounced association of VCD with a reduction in 30-day mortality was evident in females (HR, 0.85; 95% CI, 0.77-0.94; P interaction =0.037), presentation with acute coronary syndrome (HR, 0.88; 95% CI, 0.83-0.94; P interaction =0.0027), or recent lysis (HR, 0.63; 95% CI, 0.40-1.01; P interaction =0.0001). Conclusions-When compared with manual pressure, VCD was associated with a minor short-term (30-day) prognostic benefit after propensity score correction in the global population and clinically relevant subgroups. The potential for residual confounding factors impacting on short-term mortality cannot be excluded, despite the study having measured and balanced all recorded confounder factors. (Circ Cardiovasc Interv. 2016;9:e003560.

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Section: Farooq Et Al Femoral Vascular Closure Devices and 30-day Mormentioning

confidence: 99%

Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

Farooq

Goedhart

Ludman

et al. 2016

Circ: Cardiovascular Interventions

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show abstract

“…The unfractionated heparin bolus should be reduced to 50 to 70 IU per kg when GP IIb/IIIa inhibitors are given in order e236 ACC/AHA/SCAI Practice Guidelines ACC -www.acc.org AHA -www.americanheart.org SCAI -www.scai.org degree to which these technologies reduce length of hospital stay and cost remains to be determined (764,(770)(771)(772).…”

Section: Heparin Dosing Guidelinesmentioning

confidence: 99%

ACC/AHA/SCAI Practice Guidelines, February 21, 2006

Wilkins¹

2006

Circulation

350

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“…a percutaneous collagen femoral closure device has been shown to reduce the puncture site hemostasis time and time to ambulation without significantly increasing peripheral vascular complications 5 . yet widespread use of these devices has not occurred due to acute complications related to placement and to the intravascular components required for vascular closure.…”

Section: Introductionmentioning

confidence: 99%

Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

et al. 2013

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This retrospective study evaluated the safety and feasibility of a new arterial femoral access closure device in neurointerventional procedures. The study includes all consecutive adult patients who underwent femoral arteriotomy closure with the MynxGrip™ closure device after Neurointerventional procedures performed between June and December 2012. All patients had a follow-up color Doppler ultrasound (US) within 48 hours after the procedure, which was independently interpreted by two experienced radiologists to evaluate for access site complications. Device success/failure, sheath size, ambulation time, and periprocedural complications were recorded. Fifty-five closure devices were deployed in 53 patients. There were 23 (43%) males and 30 (57%) females; age ranged from 22 to 84 years (mean: 52.1 years). Thirty of the 55 procedures (55%) were therapeutic and 25 were diagnostic interventions (45%). Sheath sizes used were 5F in 35 procedures (64%) and 6F in 20 procedures (36%). The right femoral artery was accessed in 51 procedures (93%) and the left in four procedures (7%). There was only one (1.8%) minor periprocedural complication (small hematoma). Hemostasis was successful in 51 of the 55 procedures (93%) with subsequent early ambulation. No device-induced complications associated with serious clinical sequelae were reported. In our small series, the MynxGrip™ femoral access closure device provided a safe and feasible way of closing the femoral artery puncture site after neurointerventional procedures with low minor complication rates and no major complications. Further large prospective randomized trials are necessary to evaluate the efficacy of the device.

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A multicenter randomized trial comparing a percutaneous collagen hemotasis device with conventional manual compression after diagnostic angiography and angioplasty

Cited by 182 publications

References 13 publications

Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011

ACC/AHA/SCAI Practice Guidelines, February 21, 2006

Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

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