Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention

Background. The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the proced...

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Main Authors: Birthe Sindberg, Christel Gry Aagren Nielsen, Marianne Hestbjerg Poulsen, Martin Bøhme Rasmussen, Steen Carstensen, Troels Thim, Lars Jakobsen, Jacob Thorsted Sørensen, Benedicte Haastrup, Hanne Maare Søndergaard, Michael Mæng, Christian Juhl Terkelsen
Format: Article
Language:English
Published: Wiley 2019-01-01
Series:Journal of Interventional Cardiology
Online Access:http://dx.doi.org/10.1155/2019/7348167
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author Birthe Sindberg
Christel Gry Aagren Nielsen
Marianne Hestbjerg Poulsen
Martin Bøhme Rasmussen
Steen Carstensen
Troels Thim
Lars Jakobsen
Jacob Thorsted Sørensen
Benedicte Haastrup
Hanne Maare Søndergaard
Michael Mæng
Christian Juhl Terkelsen
author_facet Birthe Sindberg
Christel Gry Aagren Nielsen
Marianne Hestbjerg Poulsen
Martin Bøhme Rasmussen
Steen Carstensen
Troels Thim
Lars Jakobsen
Jacob Thorsted Sørensen
Benedicte Haastrup
Hanne Maare Søndergaard
Michael Mæng
Christian Juhl Terkelsen
author_sort Birthe Sindberg
collection DOAJ
description Background. The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the procedure is also a potential risk. We evaluate whether the design of the sheath has any impact on these variables. Methods. A total of 1,000 patients scheduled for radial CAG or PCI were randomized (1:1) to the use of a Slender or a Standard sheath during the procedure. Randomization was stratified according to chosen sheath size (5, 6, 7 French) and gender. A radial band was used to obtain hemostasis after the procedure, employing a rapid deflation technique. A reverse Barbeau test was performed to evaluate radial artery patency after removal of the radial band, and level of pain was assessed using a numeric rating scale (NRS). Results. Use of the Slender sheath was associated with less pain during sheath insertion (median NRS 1 versus 2, p=0.02), whereas no difference was observed in pain during the procedure, radial procedural success rates, use of analgesics and sedatives during the procedure, and radial artery patency following the procedure. Rate of RAO was 1.5% with no difference between groups. Conclusion. The use of the hydrophilic coated Slender sheath during radial CAG or PCI was associated with less pain during sheath insertion, whereas no difference in other endpoints was observed. A rapid deflation technique was associated with RAO of only 1.5%.
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spelling doaj-art-bf4b653c74784bfcb789854b7de6ff9c2025-02-03T06:47:54ZengWileyJournal of Interventional Cardiology0896-43271540-81832019-01-01201910.1155/2019/73481677348167Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary InterventionBirthe Sindberg0Christel Gry Aagren Nielsen1Marianne Hestbjerg Poulsen2Martin Bøhme Rasmussen3Steen Carstensen4Troels Thim5Lars Jakobsen6Jacob Thorsted Sørensen7Benedicte Haastrup8Hanne Maare Søndergaard9Michael Mæng10Christian Juhl Terkelsen11Department of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkViborg Regional Hospital, Heibergs Alle 4, 8800 Viborg, DenmarkViborg Regional Hospital, Heibergs Alle 4, 8800 Viborg, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Cardiology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkBackground. The transradial approach is generally associated with few complications. However, periprocedural pain is still a common issue, potentially related to sheath insertion and/or arterial spasm, and may result in conversion to femoral access. Radial artery occlusion (RAO) following the procedure is also a potential risk. We evaluate whether the design of the sheath has any impact on these variables. Methods. A total of 1,000 patients scheduled for radial CAG or PCI were randomized (1:1) to the use of a Slender or a Standard sheath during the procedure. Randomization was stratified according to chosen sheath size (5, 6, 7 French) and gender. A radial band was used to obtain hemostasis after the procedure, employing a rapid deflation technique. A reverse Barbeau test was performed to evaluate radial artery patency after removal of the radial band, and level of pain was assessed using a numeric rating scale (NRS). Results. Use of the Slender sheath was associated with less pain during sheath insertion (median NRS 1 versus 2, p=0.02), whereas no difference was observed in pain during the procedure, radial procedural success rates, use of analgesics and sedatives during the procedure, and radial artery patency following the procedure. Rate of RAO was 1.5% with no difference between groups. Conclusion. The use of the hydrophilic coated Slender sheath during radial CAG or PCI was associated with less pain during sheath insertion, whereas no difference in other endpoints was observed. A rapid deflation technique was associated with RAO of only 1.5%.http://dx.doi.org/10.1155/2019/7348167
spellingShingle Birthe Sindberg
Christel Gry Aagren Nielsen
Marianne Hestbjerg Poulsen
Martin Bøhme Rasmussen
Steen Carstensen
Troels Thim
Lars Jakobsen
Jacob Thorsted Sørensen
Benedicte Haastrup
Hanne Maare Søndergaard
Michael Mæng
Christian Juhl Terkelsen
Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
Journal of Interventional Cardiology
title Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
title_full Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
title_fullStr Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
title_full_unstemmed Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
title_short Randomized Comparison of Terumo® Coated Slender™ versus Terumo® Noncoated Traditional Sheath during Radial Angiography or Percutaneous Coronary Intervention
title_sort randomized comparison of terumo r coated slender™ versus terumo r noncoated traditional sheath during radial angiography or percutaneous coronary intervention
url http://dx.doi.org/10.1155/2019/7348167
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