the online version of this article ( doi:10.1007/s40119 - 014 - 0034 - 7 ) contains supplementary material , which is available to authorized users .
patients undergoing structural and congenital heart interventions usually require large - sized sheath insertion into the femoral arteries .
hence , active management of the femoral access site can potentially reduce the risk of vascular complications and allow early mobilization and discharge .
the use of arterial closure devices is well established in patients undergoing diagnostic and percutaneous coronary interventions , percutaneous aortic balloon valvuloplasty ( pabv ) , and endovascular aortic procedures .
the use of the perclose ( abbott vascular devices , santa clara , ca , usa ) device in venous access sites has also been described [ 47 ] . here
, we describe the use of the perclose suture - mediated device using the pre - closure technique in a series of 101 femoral arterial access site closures in patients undergoing congenital and structural heart interventions .
data from 100 consecutive patients who underwent large femoral arterial access ( 8  fr ) site closures for congenital and structural interventions were analyzed retrospectively .
time to hemostasis , mobilization , and need for further intervention at the access site were analyzed .
patients had clinical follow - up reviews at 3  months and at 912  months . at follow - up ,
vascular assessment included checking for the femoral pulses , presence of hematoma , or signs of arterial occlusion .
all the procedures were performed in a tertiary cardiac center , where there were vascular interventional and surgical services available .
patients with previous multiple vascular access , who had difficult arterial access due to extensive scarring , did not receive the perclose device .
major complications related to device were defined as the need for peri - procedural surgical or radiological intervention or bleeding requiring blood transfusion .
the perclose device efficacy was defined as achievement of hemostasis at the femoral arterial access site in  2  min following sheath removal and deployment of the pre - deployed sutures without the need for further manual compression .
subsequently , a 6  fr perclose ( a - t or proglide ; abbott vascular devices ) device was inserted and the wire was removed .
the footplate of the device was deployed and the device pulled back and sutures set as usual . the footplates were released and the device partially retrieved until the port for the guide wire was visible ( figs .  1 , 2 ) .
the sutures were tightened at the end of the procedure upon removal of the sheath(s ) from the vessel.fig . 
2rewiring of the vessel following pre - deployment of the perclose ( abbott vascular devices , santa clara , ca , usa ) device insertion of 6 fr dilator over the wire following femoral vessel access rewiring of the vessel following pre - deployment of the perclose ( abbott vascular devices , santa clara , ca , usa ) device a single perclose device was deployed for each arterial access up to 12  fr and two devices were pre - deployed at right angles to each other when sheath size was expected to be greater than 12 fr .
fourteen patients who underwent transcatheter aortic valve implantation ( tavi ) had two devices used per procedure .
all procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation ( institutional and national ) and with the helsinki declaration of 1975 , as revised in 2000 and 2008 . informed written consent for the procedure was obtained from all patients .
subsequently , a 6  fr perclose ( a - t or proglide ; abbott vascular devices ) device was inserted and the wire was removed . spontaneous blood flow through the side port was observed .
the footplate of the device was deployed and the device pulled back and sutures set as usual .
the footplates were released and the device partially retrieved until the port for the guide wire was visible ( figs .  1 , 2 ) .
the sutures were tightened at the end of the procedure upon removal of the sheath(s ) from the vessel.fig . 
2rewiring of the vessel following pre - deployment of the perclose ( abbott vascular devices , santa clara , ca , usa ) device insertion of 6 fr dilator over the wire following femoral vessel access rewiring of the vessel following pre - deployment of the perclose ( abbott vascular devices , santa clara , ca , usa ) device a single perclose device was deployed for each arterial access up to 12  fr and two devices were pre - deployed at right angles to each other when sheath size was expected to be greater than 12 fr .
fourteen patients who underwent transcatheter aortic valve implantation ( tavi ) had two devices used per procedure .
all procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation ( institutional and national ) and with the helsinki declaration of 1975 , as revised in 2000 and 2008 . informed written consent for the procedure was obtained from all patients .
a total of 101 femoral arterial sites closures were performed in 100 consecutive patients over a period of 4  years . of these , 14 underwent tavi , 39 had pabv , and 47 underwent coarctation of the aorta ( coa ) stenting .
sixty - two percent of the patients were male and their mean ( sd ) age was 52 ( 26 )  years ( range 1695  years ) .
all received anticoagulation with heparin during the procedure with a standard dose of 5,000  iu .
the size of the sheaths used during the procedure ranged from 8 to 18  fr with a mean ( sd ) arterial sheath diameter of 13 ( 2 )  fr .
final sheath sizes were 12  fr in 86 patients and 14  fr in 14 patients .
all patients were mobilized in 2  h except for patients requiring general anesthesia who were mobilized after 4  h. major complications in the form of pseudoaneurysm were seen in two patients ( 2% ) .
one required open vascular repair 2  weeks following the procedure , while the second was treated with thrombin injection .
five patients had mild access site oozing requiring manual compression for less than 30  min on the arterial access site . in five cases , the device failed to deploy on pre - closure initially , necessitating the use of a further device .
both procedures were done as emergency procedures after presenting with cardiogenic shock in the setting of severe aortic stenosis .
none of the deaths were related to vascular access site complications and there was no significant drop in hemoglobin levels requiring a blood transfusion .
ninety - six percent had clinical follow - up available with a mean ( sd ) follow - up of 24 ( 12 )  months and median follow - up of 8.5  months .
all patients were mobilized in 2  h except for patients requiring general anesthesia who were mobilized after 4  h. major complications in the form of pseudoaneurysm were seen in two patients ( 2% ) .
one required open vascular repair 2  weeks following the procedure , while the second was treated with thrombin injection .
five patients had mild access site oozing requiring manual compression for less than 30  min on the arterial access site . in five cases , the device failed to deploy on pre - closure initially , necessitating the use of a further device .
both procedures were done as emergency procedures after presenting with cardiogenic shock in the setting of severe aortic stenosis .
none of the deaths were related to vascular access site complications and there was no significant drop in hemoglobin levels requiring a blood transfusion .
ninety - six percent had clinical follow - up available with a mean ( sd ) follow - up of 24 ( 12 )  months and median follow - up of 8.5  months .
the perclose device has been used for femoral arterial and venous closure in small - sized sheaths following percutaneous coronary intervention procedures [ 1 , 3 ] .
the use of perclose device leads to early hemostasis , early sheath removal , and early patient mobilization . a meta - analysis of 30 studies by nikolsky et al
paul , mn , usa ) were comparable to mechanical compression in obtaining arterial hemostasis in the setting of diagnostic coronary angiography and the risk of access site complications was similar .
as all these studies were on coronary interventions , they generally used smaller arterial sheath sizes ( 6  fr ) .
bangalore et al .   have shown lower deployment success and higher risk of vascular complications with perclose compared with the angioseal device . in our study , we had 39 patients , who underwent pabv , in whom we used 12  fr sheaths with no vascular access site complications .
forty - seven patients underwent successful perclose device deployment to achieve complete homeostasis in patients who underwent stenting for coa . to the best of our knowledge , no previous
literature exists on pre - closure of the access site with the perclose device for patients undergoing stenting for coa .
the american heart association currently recommends the use of femoral artery closure devices to achieve faster hemostasis , shorter duration of bed rest , and possibly improved patient comfort .
this study demonstrates that optimal results can be obtained with pre - closure using a perclose device for large - sized femoral arterial access in a wide range of congenital and structural heart interventions , including tavi where large caliber arterial sheaths are required for valve implantation .
the use of the perclose device in securing hemostasis in the venous access sites has also been described more recently .
have reported the use of perclose for femoral venous closure and maintenance of venous patency as assessed by doppler following such closure . a recent study by hamid et al
.   described the successful use of the device in 310 large femoral venous access sites ( 8  fr ) in 243 patients undergoing structural heart interventions .
reported use of perclose closure device for access site management after using 14  fr femoral venous sheaths for antegrade pabv .
this study demonstrates that perclose device can be used safely and effectively for large - sized femoral arterial access in a wide range of congenital and structural heart interventions .
similarly , we used perclose devices in tavi where large caliber arterial sheaths are required for valve implantation .
this is a retrospective series with no control group that underwent manual compression or other form of repair to compare efficacy in a more objective manner .
there may also be the possibility of operator bias in choosing cases for pre - closure .
this is a retrospective series with no control group that underwent manual compression or other form of repair to compare efficacy in a more objective manner .
there may also be the possibility of operator bias in choosing cases for pre - closure .
pre - closure with the perclose suture technique for femoral arterial sites following the insertion of large - sized sheaths ( 8  fr or above ) for cardiac interventions is safe and effective , with a low risk of vascular access site complications .
tahir hamid , tawfiq r. choudhury , bernard clarke , and vaikom s. mahadevan declare no conflicts of interest .
all procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation ( institutional and national ) and with the helsinki declaration of 1975 , as revised in 2000 and 2008 . informed written consent for the procedure was obtained from all patients .
this article is distributed under the terms of the creative commons attribution noncommercial license which permits any noncommercial use , distribution , and reproduction in any medium , provided the original author(s ) and the source are credited .
 introductionpatients undergoing structural heart interventions often require large - sized sheath insertion into femoral arteries and veins . clinical outcome data on the use of suture - mediated devices for large femoral arterial access in structural heart interventions is limited . 
 we assessed the efficacy of the perclose ( abbott vascular devices , santa clara , ca , usa ) suture - mediated device using the pre - closure technique in achieving hemostasis in femoral arterial access sites following large sheath insertion ( 8  fr).methodsone hundred consecutive patients underwent 101 femoral artery access sites closures with the perclose device using the pre - closure technique . sixty - two percent of the patients were male and their mean ( sd ) age was 52 ( 26 )  years . 
 all patients received heparin.resultsmean arterial access site sheath diameter was 13    2  fr . 
 immediate hemostasis was achieved in 96/101 ( 96% ) procedures ( 2  min ) . 
 two patients ( 2% ) had access site - related complications requiring further interventions . on clinical follow up [ mean ( sd ) follow - up of 24 ( 12 )  months and median follow - up of 8.5  months ] , 
 no complications were seen in the arterial access sites.conclusionpre-closure of large - size femoral arterial access sheath sites using the suture - mediated perclose device is efficacious in achieving rapid hemostasis in patients undergoing structural interventions . 
 on 1-year follow - up , there were no arterial access site complications requiring further investigations or interventions.electronic supplementary materialthe online version of this article ( doi:10.1007/s40119 - 014 - 0034 - 7 ) contains supplementary material , which is available to authorized users . 
Electronic supplementary material
Introduction
Methods
Pre-closure Technique
Compliance with Ethics Guidelines
Results
Post-procedural Outcomes
Follow-up
Discussion
Limitations
Conclusion
Electronic supplementary material
Conflict of interest
Compliance with ethics guidelines
Open Access