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Letters to the Editor
prescribed, efficient and well tolerated would give the best answer to these issues, but we are not aware of such ongoing study. Alternatively, the data of warfarin-treated patients randomized in trials who had excellent TTR control versus poor TTR control would be of high interest. The purpose of this meta-analysis was not to inform decision making at the patient level but our findings obtained in randomized trials indicate that switching from VKA to NOACs may support consideration because it might be associated with lower rates of stroke/systemic embolism, intracerebral bleeding and death. All authors conceived and designed the study, collected or analyzed or interpreted the data, drafted the article or revised it critically for important intellectual content, and gave final approval of the version to be published. Dr Angoulvant has been on the speakers bureau for AstraZeneca, Bayer, MSD, and Servier. Dr Clementy has received travel grants from Biotronik, Boston Scientific and Saint Jude Medical. Dr Fauchier has served as a consultant for Bayer, Medtronic, Novartis and Sanofi Aventis and has been on the speakers bureau for Boehringher
Ingelheim, Bayer, BMS Pfizer, Medtronic, and Sanofi Aventis. Dr Bernard-Brunet, Dr Saint Etienne and Dr Simeon have no conflict of interest.
References [1] Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264–9. [2] Ezekowitz MD, Wallentin L, Connolly SJ, et al. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation 2010;122:2246–53. [3] Mahaffey KW, Wojdyla D, Hankey GJ, et al. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med 2013;158:861–8. [4] Garcia DA, Wallentin L, Lopes RD, et al. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Am Heart J 2013;166:549–58. [5] Sørensen R, Gislason G, Torp-Pedersen C, et al. Dabigatran use in Danish atrial fibrillation patients in 2011: a nationwide study. BMJ Open May 3 2013;3(5), doi:10.1136/bmjopen-2013-002758.
0167-5273/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2014.02.027
“Radial era,” 5F femoral access coronary angiography using a novel closure device: Preliminary data M. Anastasius, H.C. Lowe ⁎ Cardiology Department, Concord Repatriation General Hospital, University of Sydney, NSW, Australia
a r t i c l e
i n f o
Article history: Received 1 January 2014 Received in revised form 25 January 2014 Accepted 13 February 2014 Available online 22 February 2014 Keywords: Femoral access Vascular closure Angiography Ultrasound
To the Editor: Radial artery access has been shown in a number of recent studies to be associated with lower bleeding rates compared to femoral access, and in many centers has become the preferred vascular access option [1]. For selected patients however, radial access remains relatively or absolutely contraindicated, and debate continues as to the relative benefit of the radial approach [2], such that lowering femoral access site bleeding is therefore of increasing importance.
⁎ Corresponding author at: Cardiology Department, Concord Repatriation General Hospital, Hospital Rd, Concord, Sydney, NSW 2139, Australia. Tel.: +61 2 9767 5000; fax: +61 2 9767 6994. E-mail address: [email protected] (H.C. Lowe).
We hypothesized that retrograde femoral access coronary angiography could be performed safely using a 5F system, without the use of heparin, and using a novel 5F vascular closure device (VCD) (Exoseal, Cordis Corp, USA). This device deploys a polyglycolic acid plug immediately superficial and external to the femoral artery superficial puncture site, thus assisting closure entirely extravascularly, and has been associated with low rates of hematoma formation (Fig. 1A, B) [3]. In 10 selected patients undergoing femoral access coronary angiography, a 5F sheath (Terumo Corp, Japan) was inserted and angiography performed in the standard manner, without heparin. Vascular closure was achieved using the Exoseal VCD. Femoral artery ultrasound (12L, GE Healthcare, USA) was performed in the first 5 patients, pre and post Exoseal deployment at between 2 and 4 h. Patients were ambulated at 2 h. Ten selected patients underwent the procedure in a 16 week period, with a mean age of 67.7 years. Five were male. Angiography indications included chest pain (n = 7), dyspnea (n = 2) and syncope (n = 1). Antiplatelet or anticoagulant medications included aspirin alone (n = 2), aspirin and clopidogrel (n = 4), dabigatran alone (n = 1) and nil (n = 3). Though no patients had documented peripheral vascular disease, all had at least 2 other risk factors for cardiovascular disease. A mean of 63 (20) ml contrast was used, with a screening time of 1.1 (0.9) min, except one patient with prior bypass grafts requiring 16 min screening time. There were no sheath hematomas and no intrasheath thromi noted. The VCD was deployed successfully in all cases. No visible hematoma was evident clinically or on ultrasound (Fig. 1C, D). Page 2, para.
Letters to the Editor
125
B
A
Ex Ex D
C
D
CFA
CFA SFA
SFA PF
PF
Fig. 1. A. Diagrammatic representation of the Exoseal vascular closure device (indicated as Ex D) after deployment. Patient's distal limb to left of image. Inset B, marked by black box.B. Enlarged image of Exoseal device, showing polyglycolic plug (indicated as Ex), located just superficial to superficial layer of femoral artery, after deployment (A and B from Cordis.com).C. Femoral ultrasound pre-procedure. CFA = common femoral artery, SFA = superficial femoral artery, PF = profunda femoris.D. Femoral ultrasound post-procedure. No hematoma or other vascular changes are observed. The area marked (white arrow) may represent the Exoseal device plug. CFA = common femoral artery, SFA = superficial femoral artery, PF =profunda femoris.
Radial artery access has become the preferred access choice for angiography and coronary intervention in many centers, but in some patients, femoral access remains preferred or required [1,2]. The data presented here have a number of limitations. They represent a small, select patient cohort, with uncomplicated and generally short procedures, by a single operator. There is no control group, either with manual compression or radial access. This short series is also not the first published series using this device [3,4]. A randomized trial demonstrated safety and efficacy of the 6F Exoseal compared to manual compression in 401 patients, though importantly no 5F devices were used in this study [3]. A large (n = 682 devices) retrospective evaluation of the device has also recently been performed [4]. This patient group was quite different however, with largely trans-arterial hepatic procedures (69.7%) with predominantly repeated procedures (60.5%), using a mix of 5F, 6F and 7F devices, with no procedures evaluating coronary anatomy [4]. Importantly, therefore while these data have important limitations, and are preliminary and without control group only, they do indicate
feasibility and safety of a novel 5F compatible extravascular VCD, such that further evaluation of this device is suggested.
References [1] Byrne RA, Cassese S, Linhardt M, Kastrati A. Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol 2013;10:27–40. [2] Rao SV, Bernat I, Bertrand OF. Clinical update: remaining challenges and opportunities for improvement in percutaneous transradial coronary procedures. Eur Heart J 2012;33:2521–6. [3] Wong SC, Bachinsky W, Cambier P, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of haemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv 2009;2:785–93. [4] Boschewitz JM, Andersson M, Haehle CP, et al. Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure after repeat puncture in diagnostic and interventional radiology: single center experience. J Vasc Interv Radiol 2013;24:698–702.
0167-5273/$ – see front matter. Crown Copyright © 2014 Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2014.02.024
Letters to the Editor
prescribed, efficient and well tolerated would give the best answer to these issues, but we are not aware of such ongoing study. Alternatively, the data of warfarin-treated patients randomized in trials who had excellent TTR control versus poor TTR control would be of high interest. The purpose of this meta-analysis was not to inform decision making at the patient level but our findings obtained in randomized trials indicate that switching from VKA to NOACs may support consideration because it might be associated with lower rates of stroke/systemic embolism, intracerebral bleeding and death. All authors conceived and designed the study, collected or analyzed or interpreted the data, drafted the article or revised it critically for important intellectual content, and gave final approval of the version to be published. Dr Angoulvant has been on the speakers bureau for AstraZeneca, Bayer, MSD, and Servier. Dr Clementy has received travel grants from Biotronik, Boston Scientific and Saint Jude Medical. Dr Fauchier has served as a consultant for Bayer, Medtronic, Novartis and Sanofi Aventis and has been on the speakers bureau for Boehringher
Ingelheim, Bayer, BMS Pfizer, Medtronic, and Sanofi Aventis. Dr Bernard-Brunet, Dr Saint Etienne and Dr Simeon have no conflict of interest.
References [1] Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264–9. [2] Ezekowitz MD, Wallentin L, Connolly SJ, et al. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation 2010;122:2246–53. [3] Mahaffey KW, Wojdyla D, Hankey GJ, et al. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med 2013;158:861–8. [4] Garcia DA, Wallentin L, Lopes RD, et al. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Am Heart J 2013;166:549–58. [5] Sørensen R, Gislason G, Torp-Pedersen C, et al. Dabigatran use in Danish atrial fibrillation patients in 2011: a nationwide study. BMJ Open May 3 2013;3(5), doi:10.1136/bmjopen-2013-002758.
0167-5273/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2014.02.027
“Radial era,” 5F femoral access coronary angiography using a novel closure device: Preliminary data M. Anastasius, H.C. Lowe ⁎ Cardiology Department, Concord Repatriation General Hospital, University of Sydney, NSW, Australia
a r t i c l e
i n f o
Article history: Received 1 January 2014 Received in revised form 25 January 2014 Accepted 13 February 2014 Available online 22 February 2014 Keywords: Femoral access Vascular closure Angiography Ultrasound
To the Editor: Radial artery access has been shown in a number of recent studies to be associated with lower bleeding rates compared to femoral access, and in many centers has become the preferred vascular access option [1]. For selected patients however, radial access remains relatively or absolutely contraindicated, and debate continues as to the relative benefit of the radial approach [2], such that lowering femoral access site bleeding is therefore of increasing importance.
⁎ Corresponding author at: Cardiology Department, Concord Repatriation General Hospital, Hospital Rd, Concord, Sydney, NSW 2139, Australia. Tel.: +61 2 9767 5000; fax: +61 2 9767 6994. E-mail address: [email protected] (H.C. Lowe).
We hypothesized that retrograde femoral access coronary angiography could be performed safely using a 5F system, without the use of heparin, and using a novel 5F vascular closure device (VCD) (Exoseal, Cordis Corp, USA). This device deploys a polyglycolic acid plug immediately superficial and external to the femoral artery superficial puncture site, thus assisting closure entirely extravascularly, and has been associated with low rates of hematoma formation (Fig. 1A, B) [3]. In 10 selected patients undergoing femoral access coronary angiography, a 5F sheath (Terumo Corp, Japan) was inserted and angiography performed in the standard manner, without heparin. Vascular closure was achieved using the Exoseal VCD. Femoral artery ultrasound (12L, GE Healthcare, USA) was performed in the first 5 patients, pre and post Exoseal deployment at between 2 and 4 h. Patients were ambulated at 2 h. Ten selected patients underwent the procedure in a 16 week period, with a mean age of 67.7 years. Five were male. Angiography indications included chest pain (n = 7), dyspnea (n = 2) and syncope (n = 1). Antiplatelet or anticoagulant medications included aspirin alone (n = 2), aspirin and clopidogrel (n = 4), dabigatran alone (n = 1) and nil (n = 3). Though no patients had documented peripheral vascular disease, all had at least 2 other risk factors for cardiovascular disease. A mean of 63 (20) ml contrast was used, with a screening time of 1.1 (0.9) min, except one patient with prior bypass grafts requiring 16 min screening time. There were no sheath hematomas and no intrasheath thromi noted. The VCD was deployed successfully in all cases. No visible hematoma was evident clinically or on ultrasound (Fig. 1C, D). Page 2, para.
Letters to the Editor
125
B
A
Ex Ex D
C
D
CFA
CFA SFA
SFA PF
PF
Fig. 1. A. Diagrammatic representation of the Exoseal vascular closure device (indicated as Ex D) after deployment. Patient's distal limb to left of image. Inset B, marked by black box.B. Enlarged image of Exoseal device, showing polyglycolic plug (indicated as Ex), located just superficial to superficial layer of femoral artery, after deployment (A and B from Cordis.com).C. Femoral ultrasound pre-procedure. CFA = common femoral artery, SFA = superficial femoral artery, PF = profunda femoris.D. Femoral ultrasound post-procedure. No hematoma or other vascular changes are observed. The area marked (white arrow) may represent the Exoseal device plug. CFA = common femoral artery, SFA = superficial femoral artery, PF =profunda femoris.
Radial artery access has become the preferred access choice for angiography and coronary intervention in many centers, but in some patients, femoral access remains preferred or required [1,2]. The data presented here have a number of limitations. They represent a small, select patient cohort, with uncomplicated and generally short procedures, by a single operator. There is no control group, either with manual compression or radial access. This short series is also not the first published series using this device [3,4]. A randomized trial demonstrated safety and efficacy of the 6F Exoseal compared to manual compression in 401 patients, though importantly no 5F devices were used in this study [3]. A large (n = 682 devices) retrospective evaluation of the device has also recently been performed [4]. This patient group was quite different however, with largely trans-arterial hepatic procedures (69.7%) with predominantly repeated procedures (60.5%), using a mix of 5F, 6F and 7F devices, with no procedures evaluating coronary anatomy [4]. Importantly, therefore while these data have important limitations, and are preliminary and without control group only, they do indicate
feasibility and safety of a novel 5F compatible extravascular VCD, such that further evaluation of this device is suggested.
References [1] Byrne RA, Cassese S, Linhardt M, Kastrati A. Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol 2013;10:27–40. [2] Rao SV, Bernat I, Bertrand OF. Clinical update: remaining challenges and opportunities for improvement in percutaneous transradial coronary procedures. Eur Heart J 2012;33:2521–6. [3] Wong SC, Bachinsky W, Cambier P, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of haemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv 2009;2:785–93. [4] Boschewitz JM, Andersson M, Haehle CP, et al. Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure after repeat puncture in diagnostic and interventional radiology: single center experience. J Vasc Interv Radiol 2013;24:698–702.
0167-5273/$ – see front matter. Crown Copyright © 2014 Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2014.02.024
