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 .