Abstract
Objectives
Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR).
Background
Access site–related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary.
Methods
We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015.
Results
Included were 25 patients at a mean (±SD) age of 82 ± 9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11 mm and a length of 50 mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6 ± 1.3 g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9 ± 5 days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site.
Conclusions
The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site–related VC following TAVR.
Summary
The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR.
1
Introduction
Vascular complications (VC) during transcatheter aortic valve replacement (TAVR) are common, and treatment options may vary . Advent of newer generation valves with the concerted effort to reduce the sheath size of their accompanying delivery systems may reduce the rate of VC following TAVR . The current mainstay procedural step before the insertion of the large bore access sheath is to perform pre-closure of the arterial puncture site with suture-mediated vascular closure devices . Pre-closure device failure occurring at the point of the large caliber sheath removal, usually results in access site related bleeding with a need for immediate treatment. Beyond restoring hemodynamic stabilization, with or without the use of blood products, treatment options may include manual compression, balloon occlusion, covered stent deployment or surgical intervention .
Although stent deployment across the inguinal ligament has been traditionally considered to be contraindicated because of concerns of device kinking, fracture or occlusion, and possible obliteration of the artery , this technique has been more frequently used in the present cohorts referred to TAVR . The safety and efficacy of the polytetrafluoroethylene (ePTFE) covered Nitinol self-expanding stent-graft (Gore® Viabahn® Endoprosthesis; Gore Medical; USA) for VC following TAVR was recently reported . That study however did not differentiate the type of VC and the indication for stenting. We describe our experience in a series of consecutive patients who underwent TAVR, for whom the indication for common femoral artery stenting with the Viabahn stent-graft was failure of the pre-closure device to achieve complete hemostasis.
2
Methods
2.1
Study population
Data on consecutive patients with severe, symptomatic AS treated with TAVR at the MedStar Washington Hospital Center are entered in a computerized data base since 2007. We have previously described our database . In brief, severe, symptomatic AS was confirmed by transthoracic echocardiography and hemodynamic evaluation during cardiac catheterization. The eligibility for TAVR was determined based on clinical trial inclusion/exclusion criteria and using a heart team approach. Patients had an echocardiography, coronary angiography, and chest and peripheral computed tomography angiography as part of the routine screening process. The final decision for TAVR eligibility was based on the consensus of the heart team. Follow-up at 30 days included both clinical information and echocardiography details. Data collection was approved by the local institutional review board.
In the present analysis we have included all patients that had vascular access site related bleeding as a result of pre-closure devices failure, and have been treated with the implantation of the Viabahn stent-graft in the period of January 2013 to December 2015. For those patients all catheterization laboratory reports and angiography films were reviewed. One patient was excluded due to the presence of concomitant iliac perforation that was also successfully treated with the deployment of a Viabahn stent across the avulsed segment.
2.2
TAVR procedure
The technical aspects of TAVR in our center were previously described .
The valves used were first and second generation valves and included: 3 SAPIEN 3 (Edwards Lifesciences, USA); 4 SAPIEN XT (Edwards Lifesciences, USA); 9 CoreValve (Medtronic, USA); 1 Evolut R (Medtronic, USA); 4 Lotus (Boston Scientific ); and 1 Portico (St. Jude Medical, USA). The valve diameter sizes ranged between 23 and 31 mm and the sheath sizes ranged between 14 and 20 Fr.
Puncture site of the access artery was performed following ‘road map’ vessel angiography achieved by a puncture of the contralateral common femoral artery (CFA). This was followed by ipsilateral CFA injection through a 4 Fr micro-puncture sheath (Cook medical, USA). If the access site was too low or too high the micro-puncture catheter was pulled out after manual compression and a second puncture was done, followed by repeat angiography through the micro-catheter sheath. The puncture site was then upsized by a standard 8 Fr access sheath. Subsequently, the pre-closure devices used were the suture-mediated Perclose ProGlide and the Prostar devices (both by Abbott Vascular, USA). Using a stiffer wire, larger dilators were then advanced under fluoroscopic imaging. After the conclusion of the TAVR procedure, the introducer sheath was slowly removed with a guidewire left in the femoral artery to maintain access. Immediately thereafter the pre-closure device sutures were tightened around the wire. At this point, if there was no residual bleeding or leak (complete hemostasis) the wire was removed, sutures were further tightened, the knots were locked and residual extraneous suture strings were cut under the skin.
2.3
Management of Pre-Closure Device Failure
Failure of the suture-mediated vascular pre-closure device was suspected with either an obstructive iatrogenic occlusion of the femoral artery or relevant bleeding with or without hemodynamic compromise. The latter is clearly diagnosed by active bleeding from the puncture site and by the angiographic visualization of free contrast extravasation from the vessel wall at the arteriotomy site ( Fig. 1 ). In the event of incomplete hemostasis with significant bleeding and with the ipsilateral access side guidewire in situ, an 8F Angio-Seal vascular closure device (St. Jude Medical, St. Paul, MN, USA) sheath was inserted into the arteriotomy site as a “test.” If the bleeding was controlled with the Angioseal sheath, the vascular closure device was deployed to create a final immediate seal of the arteriotomy site. If bleeding continued, temporizing hemostasis was immediately applied and the following maneuvers were applied: 1) Manual compression of the bleeding arteriotomy site. 2) Crossover balloon occlusion to temporarily occlude the inflow to the bleeding access site using guidewire access from the contralateral femoral artery. 3) Reinsertion of the large bore access sheath over the in situ ipsilateral access side guidewire across the arteriotomy site. The latter was the preferred method due to its ease of use and the immediate and complete hemostasis achieved. No protamine reversal was administered and the activated clotting time (ACT) was kept at >250 s, as the temporary hemostasis that was being applied may have compromised antegrade flow to the distal vessels of the lower extremity leading to an increased risk of thromboembolic complications.
For definitive therapy, our de facto management strategy was the deployment of an ePTFE covered stent across the bleeding arteriotomy site. The currently available ePTFE-covered Nitinol self-expanding stent graft in the US include the Fluency Plus endovascular stent-graft (Bard Peripheral Vascular, Tempe AZ, USA), and the Viabahn Endoprosthesis (W.L. Gore & Associates, Flagstaff AZ, USA) which we used in all our patients. Following successful temporary hemostasis, cross-over access from the contralateral ilio-femoral artery was immediately established. This allowed selective angiography to localize the arteriotomy site and more importantly, to pinpoint the superficial femoral artery (SFA) and deep femoral artery (profunda femoris) bifurcation. Angiography was performed at a 30–40 degree angle ipsilateral to the access site for optimal visualization of the CFA bifurcation. A 0.035″ stiff guidewire was advanced across the arteriotomy site and positioned as distally in the distal SFA or popliteal artery segment to provide the most support during the delivery of the bulky ePTFE-covered stent-graft. To deliver the stent-graft, an appropriate sized cross-over sheath was inserted dependent on the diameter-size of the ePTFE-covered Nitinol self-expanding stent. Thus, a 10-mm diameter Fluency stent will require a 9F sheath while a 10-mm diameter Viabahn stent will need an 11F sheath to deliver the stent-graft. The diameter-size of the implanted Viabahn stent-graft was estimated by a 20% oversizing of the pre-procedural computerized tomography measurement of the target CFA diameter. In some cases delivery of the Viabahn stent-graft to the bleeding arteriotomy site was advanced sheathless, i.e. in a ‘bare-back’ technique. This obviates the need to upsize the contralateral sheath. A 7F or 8F sheath usually sufficed in achieving complete hemostasis of the contralateral access site after delivery of the Viabahn stent-graft. Meticulous preparation of the access track with thorough blunt dissection of the tissue around the guidewire to avoid any impediment to the advancement of the ‘bare-back’ Viabahn stent-graft into the vessel was performed. Secondly, a stiff guidewire (0.035″ Supra Core guidewire, Abbott Vascular, Santa Clara, CA, USA) was utilized to rail in the stent-graft. Advancement of the Viabahn device was done under direct fluoroscopic guidance to ensure its proper entry into the contralateral femoral artery and across the iliac bifurcation. If difficulty is encountered in advancing the Viabahn stent-graft due to the presence of severe calcification and resultant loss of vessel compliance, the ‘bare-back’ technique was abandoned and an appropriate sized sheath was inserted into the contralateral femoral access site for delivery. The target site for the deployment of the ePTFE-covered stent, was immediately proximal the CFA bifurcation so as not to compromise blood flow to one of the bifurcating vessel. The Viabahn stent-graft was then positioned across the arteriotomy site followed by the removal of the large bore access sheath. Removal of the latter was followed by immediate deployment of the ePTFE-covered Nitinol self-expanding stent. Prior to withdrawal of the large bore sheath, the guidewire of the former sheath was exchanged out for a Terumo 0.035″ stiff Glidewire (Terumo Medical Corporation, Somerset NJ, USA). The Glidewire was left in-situ during the removal of the large bore sheath and the Viabahn stent-graft was deployed over the guidewire. The Glidewire was only pulled out when hemostasis was achieved with the deployment of the Viabahn stent-graft. Post-stenting angiography was performed following deployment to confirm complete hemostasis and brisk flow through the ipsilateral distal vessels.
2.4
Statistical methods
Continuous variables are presented as mean ± SD and categorical variables are presented as number and percentage. All analyses were performed using SPSS version 20 (IBM, USA).
2
Methods
2.1
Study population
Data on consecutive patients with severe, symptomatic AS treated with TAVR at the MedStar Washington Hospital Center are entered in a computerized data base since 2007. We have previously described our database . In brief, severe, symptomatic AS was confirmed by transthoracic echocardiography and hemodynamic evaluation during cardiac catheterization. The eligibility for TAVR was determined based on clinical trial inclusion/exclusion criteria and using a heart team approach. Patients had an echocardiography, coronary angiography, and chest and peripheral computed tomography angiography as part of the routine screening process. The final decision for TAVR eligibility was based on the consensus of the heart team. Follow-up at 30 days included both clinical information and echocardiography details. Data collection was approved by the local institutional review board.
In the present analysis we have included all patients that had vascular access site related bleeding as a result of pre-closure devices failure, and have been treated with the implantation of the Viabahn stent-graft in the period of January 2013 to December 2015. For those patients all catheterization laboratory reports and angiography films were reviewed. One patient was excluded due to the presence of concomitant iliac perforation that was also successfully treated with the deployment of a Viabahn stent across the avulsed segment.
2.2
TAVR procedure
The technical aspects of TAVR in our center were previously described .
The valves used were first and second generation valves and included: 3 SAPIEN 3 (Edwards Lifesciences, USA); 4 SAPIEN XT (Edwards Lifesciences, USA); 9 CoreValve (Medtronic, USA); 1 Evolut R (Medtronic, USA); 4 Lotus (Boston Scientific ); and 1 Portico (St. Jude Medical, USA). The valve diameter sizes ranged between 23 and 31 mm and the sheath sizes ranged between 14 and 20 Fr.
Puncture site of the access artery was performed following ‘road map’ vessel angiography achieved by a puncture of the contralateral common femoral artery (CFA). This was followed by ipsilateral CFA injection through a 4 Fr micro-puncture sheath (Cook medical, USA). If the access site was too low or too high the micro-puncture catheter was pulled out after manual compression and a second puncture was done, followed by repeat angiography through the micro-catheter sheath. The puncture site was then upsized by a standard 8 Fr access sheath. Subsequently, the pre-closure devices used were the suture-mediated Perclose ProGlide and the Prostar devices (both by Abbott Vascular, USA). Using a stiffer wire, larger dilators were then advanced under fluoroscopic imaging. After the conclusion of the TAVR procedure, the introducer sheath was slowly removed with a guidewire left in the femoral artery to maintain access. Immediately thereafter the pre-closure device sutures were tightened around the wire. At this point, if there was no residual bleeding or leak (complete hemostasis) the wire was removed, sutures were further tightened, the knots were locked and residual extraneous suture strings were cut under the skin.
2.3
Management of Pre-Closure Device Failure
Failure of the suture-mediated vascular pre-closure device was suspected with either an obstructive iatrogenic occlusion of the femoral artery or relevant bleeding with or without hemodynamic compromise. The latter is clearly diagnosed by active bleeding from the puncture site and by the angiographic visualization of free contrast extravasation from the vessel wall at the arteriotomy site ( Fig. 1 ). In the event of incomplete hemostasis with significant bleeding and with the ipsilateral access side guidewire in situ, an 8F Angio-Seal vascular closure device (St. Jude Medical, St. Paul, MN, USA) sheath was inserted into the arteriotomy site as a “test.” If the bleeding was controlled with the Angioseal sheath, the vascular closure device was deployed to create a final immediate seal of the arteriotomy site. If bleeding continued, temporizing hemostasis was immediately applied and the following maneuvers were applied: 1) Manual compression of the bleeding arteriotomy site. 2) Crossover balloon occlusion to temporarily occlude the inflow to the bleeding access site using guidewire access from the contralateral femoral artery. 3) Reinsertion of the large bore access sheath over the in situ ipsilateral access side guidewire across the arteriotomy site. The latter was the preferred method due to its ease of use and the immediate and complete hemostasis achieved. No protamine reversal was administered and the activated clotting time (ACT) was kept at >250 s, as the temporary hemostasis that was being applied may have compromised antegrade flow to the distal vessels of the lower extremity leading to an increased risk of thromboembolic complications.
