Catheterization and Cardiovascular Interventions 83:154–155 (2014)
Editorial Comment Closure for Arterial Access in Balloon Aortic Valvuloplasty Curtiss T. Stinis,1 MD and Marvin H. Eng,2* MD 1 Division of Interventional Cardiology, Scripps Clinic and Research Foundation, La Jolla, California 2 Department of Medicine/Division of Cardiology, University of Texas Health Sciences Center, San Antonio, Texas
In this issue, O’Neil et al. present retrospective data analyzing the outcomes of the “pre-closure” technique using two Proglide suture-mediated devices (Abbott Laboratories, Redwood City, CA) to achieve hemostasis in patients undergoing balloon aortic valvuloplasty (BAV). Their data show that utilization of the “pre-closure” technique (in the setting of bivalirudin anticoagulation for the majority of patients) appears to decrease acute vascular complications and bleeding. Moreover, use of the “preclosure” technique was associated with lower rates of death and myocardial infarction, which translated into lower rates of major adverse cardiac events and lower net adverse cardiovascular events. When examining the data in greater depth, however, several important points must be considered. First, this was not a randomized study, and the decision to use the “pre-closure” technique was entirely up to the discretion of the operators. Second, there are important statistically significant differences between the groups. As compared with patients who underwent arterial closure with the “pre-closure” technique, patients who were treated with manual compression of the arteriotomy site were more likely to have been treated with bivalirudin as opposed to heparin (60.6% vs. 37.7%), had more underlying peripheral arterial disease (30.8% vs. 20.1%), had undergone more previous BAV procedures (10.7% vs. 3.9%), underwent BAV with larger balloon sizes (possibly requiring larger sheaths) (22 mm vs. 21.6 mm), and underwent more rapid ventricular pacing (which could potentially contribute to myocardial ischemia and worse clinical outcomes). Despite these important considerations, however, the data suggest a potential benefit to the “pre-closure” technique in the setting of BAV, and clearly further studies designed to specifically compare the use of the “pre-closure” technique to manual compression in a more controlled way are in order. The “pre-closure” technique using two Proglide devices, the Prostar suture-mediated closure device C 2013 Wiley Periodicals, Inc. V
(Abbott Laboratories), and the Angioseal collagenbased closure device (St. Jude Medical, Minneapolis, MN) are the current vascular closure devices used for hemostasis in BAV. A recent analysis of bleeding comparing manual compression to the Angioseal and “preclosure” techniques demonstrated fewer complications when using vascular closure devices [1]. The “preclosure” technique had the greatest number of technical failures (12%) in this analysis, but the rate of major vascular complications remained similar across all three treatment groups (5.5–6.7%). Those who have experience using the Proglide device and with performing the “pre-closure” technique will appreciate that there is a definite technical learning curve in becoming proficient at using the device, and this needs to be considered when designing future studies and analyzing the resultant data. Individual analysis and meta-analysis have shown no difference with respect to bleeding or cardiovascular outcomes when examining vascular closure device data in the context of coronary interventions [2]. Although the series presented here by O’Neil et al. demonstrated less bleeding with closure device usage, the fact that most of the “pre-closure” cases utilized bivalirudin cannot be discounted because bivalirudin was associated with a 36% reduction in major bleeding when used during acute myocardial infarction [3]. Moreover, post hoc analysis of the Acute Catheterization and Urgent Intervention Triage Strategy trial showed an association between vascular closure devices, bivalirudin use, and decreased bleeding—similar to the outcomes described in this manuscript [4]. Perhaps, the retrospective data shown here may lay a roadmap to using more bivalirudin in structural interventions, especially those with large-bore arterial access. Anatomic selection for vessel access plays a significant role in avoiding complications. Technical success of the Proglide suture-mediated device is predicted to have an adequate vessel lumen, uncomplicated single anterior puncture technique, and uncalcified vessel *Correspondence to: Marvin H. Eng, Scripps Clinic and Research Foundation, La Jolla, CA. E-mail: [email protected] Received 6 November 2013; Revision accepted 10 November 2013 DOI: 10.1002/ccd.25285 Published online 18 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
Closure for Arterial Access
walls. Incidentally, these same important key factors to successful Proglide deployment are independent predictors of vascular complication. Variables associated with vascular complication in transcatheter aortic valve replacement include degree of vessel calcification, operator experience, and vessel/sheath diameter ratio [5]. As operator discretion was the determining factor for performing the “pre-closure” technique in the current study, those not undergoing the “pre-closure” technique may have had small or calcified vessels or other anatomic attributes not conducive to successful performance of the “pre-closure” technique and, thus, were intrinsically more susceptible to vascular complications. The keys to successful closure device-mediated hemostasis are appropriate anatomic screening and selection, proper vessel access techniques, technical proficiency and experience with the vascular closure device of choice, and possibly the use of bivalirudin as an anticoagulant. While the manuscript presented by O’Neil et al. is retrospective and, therefore, most appropriate only for hypothesis gathering, the authors have made a case for further exploring the use of the “pre-closure” technique for large-bore arterial access
155
closure in conjunction with bivalirudin in a prospective manner. REFERENCES 1. Ben-dor I, Looser P, Bernardo N, et al. Comparison of closure strategies after balloon aortic valvuloplasty: Suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv 2011;78:119–124. 2. Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. J Am Med Assoc 2004;291:350–357. 3. Stone GW, Witzenbickler B, Gualiumi G, et al. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): Final 3-year results from a multicentre, randomised controlled trial. Lancet 2011;377:2193– 2204. 4. Sanborn TA, Ebrahimi R, Manoukian SV, et al. Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circ Cardiovasc Interv 2010;3:57–62. 5. Hayashida K, Lefevre T, Chevalier B, et al. Transfemoral aortic valve implantation: New criteria to predict vascular complications. JACC Cardiovasc Interv 2011;4:851–858.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Closure for Arterial Access in Balloon Aortic Valvuloplasty Curtiss T. Stinis,1 MD and Marvin H. Eng,2* MD 1 Division of Interventional Cardiology, Scripps Clinic and Research Foundation, La Jolla, California 2 Department of Medicine/Division of Cardiology, University of Texas Health Sciences Center, San Antonio, Texas
In this issue, O’Neil et al. present retrospective data analyzing the outcomes of the “pre-closure” technique using two Proglide suture-mediated devices (Abbott Laboratories, Redwood City, CA) to achieve hemostasis in patients undergoing balloon aortic valvuloplasty (BAV). Their data show that utilization of the “pre-closure” technique (in the setting of bivalirudin anticoagulation for the majority of patients) appears to decrease acute vascular complications and bleeding. Moreover, use of the “preclosure” technique was associated with lower rates of death and myocardial infarction, which translated into lower rates of major adverse cardiac events and lower net adverse cardiovascular events. When examining the data in greater depth, however, several important points must be considered. First, this was not a randomized study, and the decision to use the “pre-closure” technique was entirely up to the discretion of the operators. Second, there are important statistically significant differences between the groups. As compared with patients who underwent arterial closure with the “pre-closure” technique, patients who were treated with manual compression of the arteriotomy site were more likely to have been treated with bivalirudin as opposed to heparin (60.6% vs. 37.7%), had more underlying peripheral arterial disease (30.8% vs. 20.1%), had undergone more previous BAV procedures (10.7% vs. 3.9%), underwent BAV with larger balloon sizes (possibly requiring larger sheaths) (22 mm vs. 21.6 mm), and underwent more rapid ventricular pacing (which could potentially contribute to myocardial ischemia and worse clinical outcomes). Despite these important considerations, however, the data suggest a potential benefit to the “pre-closure” technique in the setting of BAV, and clearly further studies designed to specifically compare the use of the “pre-closure” technique to manual compression in a more controlled way are in order. The “pre-closure” technique using two Proglide devices, the Prostar suture-mediated closure device C 2013 Wiley Periodicals, Inc. V
(Abbott Laboratories), and the Angioseal collagenbased closure device (St. Jude Medical, Minneapolis, MN) are the current vascular closure devices used for hemostasis in BAV. A recent analysis of bleeding comparing manual compression to the Angioseal and “preclosure” techniques demonstrated fewer complications when using vascular closure devices [1]. The “preclosure” technique had the greatest number of technical failures (12%) in this analysis, but the rate of major vascular complications remained similar across all three treatment groups (5.5–6.7%). Those who have experience using the Proglide device and with performing the “pre-closure” technique will appreciate that there is a definite technical learning curve in becoming proficient at using the device, and this needs to be considered when designing future studies and analyzing the resultant data. Individual analysis and meta-analysis have shown no difference with respect to bleeding or cardiovascular outcomes when examining vascular closure device data in the context of coronary interventions [2]. Although the series presented here by O’Neil et al. demonstrated less bleeding with closure device usage, the fact that most of the “pre-closure” cases utilized bivalirudin cannot be discounted because bivalirudin was associated with a 36% reduction in major bleeding when used during acute myocardial infarction [3]. Moreover, post hoc analysis of the Acute Catheterization and Urgent Intervention Triage Strategy trial showed an association between vascular closure devices, bivalirudin use, and decreased bleeding—similar to the outcomes described in this manuscript [4]. Perhaps, the retrospective data shown here may lay a roadmap to using more bivalirudin in structural interventions, especially those with large-bore arterial access. Anatomic selection for vessel access plays a significant role in avoiding complications. Technical success of the Proglide suture-mediated device is predicted to have an adequate vessel lumen, uncomplicated single anterior puncture technique, and uncalcified vessel *Correspondence to: Marvin H. Eng, Scripps Clinic and Research Foundation, La Jolla, CA. E-mail: [email protected] Received 6 November 2013; Revision accepted 10 November 2013 DOI: 10.1002/ccd.25285 Published online 18 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
Closure for Arterial Access
walls. Incidentally, these same important key factors to successful Proglide deployment are independent predictors of vascular complication. Variables associated with vascular complication in transcatheter aortic valve replacement include degree of vessel calcification, operator experience, and vessel/sheath diameter ratio [5]. As operator discretion was the determining factor for performing the “pre-closure” technique in the current study, those not undergoing the “pre-closure” technique may have had small or calcified vessels or other anatomic attributes not conducive to successful performance of the “pre-closure” technique and, thus, were intrinsically more susceptible to vascular complications. The keys to successful closure device-mediated hemostasis are appropriate anatomic screening and selection, proper vessel access techniques, technical proficiency and experience with the vascular closure device of choice, and possibly the use of bivalirudin as an anticoagulant. While the manuscript presented by O’Neil et al. is retrospective and, therefore, most appropriate only for hypothesis gathering, the authors have made a case for further exploring the use of the “pre-closure” technique for large-bore arterial access
155
closure in conjunction with bivalirudin in a prospective manner. REFERENCES 1. Ben-dor I, Looser P, Bernardo N, et al. Comparison of closure strategies after balloon aortic valvuloplasty: Suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv 2011;78:119–124. 2. Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: Systematic review and meta-analysis. J Am Med Assoc 2004;291:350–357. 3. Stone GW, Witzenbickler B, Gualiumi G, et al. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): Final 3-year results from a multicentre, randomised controlled trial. Lancet 2011;377:2193– 2204. 4. Sanborn TA, Ebrahimi R, Manoukian SV, et al. Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. Circ Cardiovasc Interv 2010;3:57–62. 5. Hayashida K, Lefevre T, Chevalier B, et al. Transfemoral aortic valve implantation: New criteria to predict vascular complications. JACC Cardiovasc Interv 2011;4:851–858.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
