Abstract
Large bore vascular access is becoming increasingly common for a range of interventional cardiovascular procedures. In the vast majority, percutaneous closure is preplanned and successfully achieved. However, for patients with percutaneous closure failure, or those requiring prolonged hemodynamic support, alternatives to percutaneous closure are required. Currently there are no approved vascular closure devices for delayed removal of large bore sheaths and therefore, manual hemostasis or surgical closure remains the only options. In this case series we present an endovascular approach to achieve delayed large bore vascular hemostasis, using either the contralateral femoral arterial access or radial arterial access.
1
Introduction
The use of percutaneous mechanical circulatory support has recently increased due to the limitations of intra-aortic balloon pump counter-pulsation therapy especially in patients with shock, and the availability of more effective percutaneous ventricular assist devices (pVAD) such as the Impella (Abiomed, Danvers, MA) and Tandem Heart (CardiacAssist Inc. Pittsburg, PA) systems .
The Impella 2.5 and the Impella CP are inserted via femoral access, utilizing 13 and 14 French (F) sheaths, respectively. The Tandem Heart support system requires 15 or 17F arterial cannulas, providing flows between 3.5 and 5 L/min. Given the size of the sheath, the size of femoral arteries and expected duration of use, simultaneous antegrade femoral access is also required to ensure distal flow and reduce ischemic complications . As such the use of these devices is associated with an increased risk of access site complications and bleeding, both during the insertion and maintenance periods. Equally or perhaps more importantly these complications may occur during the removal of the device, with prolonged manual compression (between 40 and 60 min) of the artery or surgical intervention routinely required to ensure hemostasis .
When pVAD devices are utilized for hemodynamic support during complex, high-risk percutaneous interventions, the large bore access site can be closed with the use of orthogonally placed Perclose Proglide sutures (Abbott Vascular, Lake Bluff, IL). However this is not recommended in cases where the pVAD is placed for prolonged hemodynamic support in patients with cardiogenic shock, due to an increased risk of infection. Currently, no appropriate vascular closure devices are available for safe and effective large bore access site closure during removal of a previously placed pVAD device and as such manual compression of the arterial access site or primary surgical closure is required to achieve hemostasis.
We describe an endovascular technique to achieve large bore vascular access site closure at a time point distinctly separate from the index procedure. The success of this technique in six patients utilizing both the femoral and radial approaches is presented. With all procedures prolonged endovascular balloon inflation was performed just proximal to and across the access site after removal of the device. This endovascular approach requires minimal to no manual compression, achieving complete hemostasis in a shorter time period and can be considered in patients who are at higher risk of bleeding complication with device removal.
2
Technique summary
2.1
Femoral crossover technique
Contralateral femoral arterial access is obtained, and using standard peripheral intervention approach the target artery is accessed by crossing over the aorto-iliac bifurcation ( Table 1 ). Once accessed, placement of a stiff peripheral guide wire enables the advancement of an occlusion balloon ( Fig. 1 A ). The placement of a long sheath is essential for imaging purposes. Appropriate balloon sizing and inflation after device removal should be limited to 5–10 min to minimize the risk of thrombosis and distal embolization ( Fig. 1 B). If bleeding persists, this step can be repeated. After large bore access site hemostasis, the contralateral access site can be closed with a closure device or manual compression. The following 4 cases further describe this endovascular approach.
| STEP | IN DETAIL |
|---|---|
| 1. Ensure ACT between 160 and 180 | This is the recommended ACT, to reduce bleeding while ensuring no thrombus forms on the device. |
| 2. Contralateral femoral access | A standard sheath is placed in contralateral common femoral artery |
| 3. Ipsilateral arterial access | Standard peripheral catheters and wires (Omni Flush and Terumo Glidewires) needed to access the ipsilateral arterial system via the contralateral approach across the aorto-iliac bifurcation |
| 4. Insertion of long sheath and stiff wire | Once the ipsilateral artery has been accessed, a long support sheath and stiff wire should be used to aid in delivery of the peripheral balloon |
| 5. Ipsilateral peripheral angiogram | Angiography to identify an appropriately sized peripheral balloon |
| 6. Balloon insertion | Balloon should be advanced to ipsilateral artery spanning the arteriotomy. |
| 7. Impella removal | The Impella should be weaned and removed as per standard manufacturer’s recommendations |
| 8. Hemostasis | Manual pressure required while balloon inflated. The balloon inflation should be maintained between 5 and 10 min before evaluating for hemostasis. The inflation should be repeated if there is visible bleeding and repeated until bleeding ceases. |
| 9. Repeat ipsilateral peripheral angiogram | A repeat angiogram is required to ensure no evidence of contrast extravasation and to confirm the absence of any complications |
| 10. Contralateral arterial access | Once the equipment is removed the contralateral access may be managed via manual compression or standard vascular closure devices. |
2.1.1
Case #1
An 88 year-old man with history of ischemic cardiomyopathy (ejection fraction (EF) 35%) and severe aortic stenosis underwent percutaneous balloon aortic valvuloplasty and Impella placement as a bridge to evaluation for transcatheter aortic valve replacement (TAVR). An Impella CP was placed via the left common femoral artery (CFA). The Impella remained in place for 48-h with improvements in systemic perfusion and the decision to remove the device in the catheterization laboratory using an endovascular approach was made.
In the laboratory, the right CFA was accessed and a 5F sheath was inserted. After crossing over to the left lower extremity using an Omni Flush catheter (Cook, Bloomington, IN) and a soft Terumo Glidewire (Terumo, Somerset, NJ), the soft Glidewire was exchanged for a stiff, angled Terumo Glidewire, which was advanced into the left superficial femoral artery (SFA). At this point the Omni Flush catheter and 5F sheath were exchanged for a 6F, Ansel (Cook) 45 cm sheath, which was advanced to the left external iliac artery. The Terumo wire was then exchanged for a for a long SupraCore (Abbott Vascular) wire, which was advanced into the left SFA. After digital subtraction angiography (DSA), a 6.0 × 40 mm Admiral (Medtronic, Minneapolis, MN) balloon was advanced and positioned at the site of the arteriotomy in the left CFA. The Impella device was weaned and removed along with the 14F sheath. Manual hemostasis was temporarily applied as the balloon was inflated ( Fig. 2 A ). Angiography with the balloon inflated revealed no evidence of active contrast dye extravasation. The balloon was inflated in 5-min increments sequentially with interval contrast injections to assess for ongoing extravasation or thrombus formation. Thereafter, the balloon was deflated under direct visualization after achieving hemostasis. A final DSA was performed demonstrating no evidence of extravasation at the arteriotomy site ( Fig. 2 B), dissection or distal embolization of thrombotic material.
2.1.2
Case #2
A 74-year-old man developed cardiogenic shock following 3-vessel coronary artery bypass surgery (CABG) for ischemic cardiomyopathy (EF 22%) complicated by post operative ventricular fibrillation arrest with successful resuscitation necessitating the placement of an Impella CP for hemodynamic support utilizing the right CFA. Post stabilization he was referred for endovascular removal of the device. Contralateral femoral access was obtained and a 5F sheath placed in the left CFA. We experienced significant resistance advancing a standard 0.035″ J-tipped guide wire through the left iliac system due to a stenosed stent. The J-wire was exchanged for a Terumo Glidewire (Terumo) that was used to navigate through the stenosis. Cross-over required balloon angioplasty of the left iliac stent following which a 6F 45 cm destination sheath (Terumo) was positioned in the proximal right external iliac artery. Over a stiff angled Glidewire wire (Terumo), a 6.0 × 40 mm Admiral (Medtronic) balloon was advanced to the right external iliac artery proximal to the arteriotomy. The Impella device was weaned off and removed; manual pressure was temporarily maintained while the balloon was inflated to 5 atm (low pressure was used due to severe atherosclerosis) ( Fig. 2 C). After 5-min, the balloon was slowly deflated demonstrating no evidence of further bleeding. Final angiography revealed severe R iliofemoral disease with a calcified 90–95% lesion in the right CFA but excellent flow into the SFA ( Fig. 2 D).
2.1.3
Case #3
A 24-year-old man with chemotherapy induced cardiomyopathy (EF 20%) was referred for percutaneous removal of his Impella device, which had been placed through the right CFA at an outside institution. Contralateral access was obtained with a 5-French sheath and access to the right iliofemoral vessel was obtained as described in case 1. Following a peripheral angiogram ( Fig. 2 E), the Glidewire wire was exchanged for a long SupraCore (Abbott Vascular) wire over which a 6.0 × 60 mm EverCross (eV3, Plymouth, MN) balloon was advanced into the right CFA. At this point, the Impella and its sheath were removed. Manual hemostasis was temporarily applied while the balloon was inflated to adequate pressure to achieve hemostasis.
After two 5-min balloon inflations, angiography revealed no evidence of contrast extravasation, however a filling defect was noted extending from the distal right CFA into the mid right SFA ( Fig. 2 F). The balloon was removed and a 0.035 Trailblazer (eV3) catheter was used to exchange the SupraCore wire within the mid SFA for a 300 cm Grand Slam wire (Abbott Vascular). Intravenous unfractionated heparin was administered achieving an ACT of 292. The Trailblazer was then switched out for a Pronto V3 (Vascular Solutions, Minneapolis, MN) aspiration catheter. Multiple runs of aspiration thrombectomy within the right proximal to mid SFA and the R CFA were performed with successful removal of an extensive amount of organized thrombus ( Fig. 2 G). The organized nature of the aspirated material was suggestive of pre-formed thrombus possibly at the arteriotomy site or thrombus adherent to the Impella catheter itself, perhaps dislodged during removal. However, thrombus formation due to stasis of blood flow during the balloon inflation could not be excluded. After thrombectomy, angiography demonstrated excellent flow in the right CFA, profunda femoris artery, the SFA ( Fig. 2 H) and the tibial vessels.
2.1.4
Case #4
A 67-year old man with ischemic cardiomyopathy (EF 25%) with acute decompensated heart failure was transferred from an outside facility with shock requiring an Impella placement via the right CFA. In the catheterization laboratory, left femoral access was obtained and a 5F sheath was inserted. Access to the right iliofemoral vessels was again obtained as described in case 1. Eventually a 45 cm 6F destination sheath (Terumo) was advanced through the left CFA and eventually advanced up to the right common iliac artery and a SupraCore wire (Abbott Vascular) was placed within the right SFA. Following a DSA of the iliac and femoral arteries an 8 X 40 mm EverCross balloon (eV3, Plymouth, MN) was elected and positioned within the CFA, just proximal to the Impella insertion. At this point the balloon was inflated as the Impella was weaned and removed. A total of 15 min of balloon inflation was required to achieve hemostasis, with no evidence of dissection, contrast extravasation or flow compromise on final angiography.
2.2
Radial approach
The radial approach is an alternative technique in patients without contralateral femoral access or in patients with high risk of femoral vascular complications and bleeding — especially those with abdominal obesity or a coagulopathy. Briefly, radial artery access is required with insertion of a radial sheath ( Table 2 ). Either a 6F glide-sheath (Terumo) or a 7F slender sheath (Terumo) is required as 6 or 7F sheath/catheters are required for delivery of appropriate sized peripheral balloons to the arteriotomy site. Next, an exchange length J-tipped wire is used to access the descending aorta. In cases in which significant tortuosity is encountered within the subclavian/aortic arch, a long sheath (90 cm) may be used to optimize guide catheter manipulation. This approach however may limit the operator to a 6F system including 6F guide compatible peripheral balloons, as the radial artery may not easily tolerate a 7F long sheath. Next using a 125 cm (or 135 cm) guide catheter positioned in the distal abdominal aorta, access to the iliac artery of the target limb is obtained. The lack of availability of these length catheters and long shaft balloons may limit use of the radial approach as the standard 100 cm catheters maybe too short for adequate imaging. The patient’s height and arm-span will also limit the use of the radial approach, as these factors may restrict access to the femoral artery for vessel visualization, balloon sizing as well as wire and balloon delivery. Following iliac angiography and balloon selection, a supportive guide wire is advanced through the guide catheter beyond the pVAD insertion site to the distal SFA ( Fig. 3 A ). The selected balloon is then advanced just proximal to the Impella insertion site and inflated as the Impella is removed. Finally, as described for the femoral approach, balloon inflation should be limited to 5 min increments and can be repeated until large bore access site hemostasis is achieved ( Fig. 3 B). Once hemostasis is achieved, a standard radial artery compression device, such as a TR Band (Terumo) maybe applied and the radial sheath removed. The following 2 cases further highlight the radial approach.
| STEP | IN DETAIL |
|---|---|
| 1. Ensure ACT between 160 and 180 | This is the recommended ACT, to reduce bleeding while ensuring no thrombus forms on the device. |
| 2. Ipsilateral radial access | A standard sheath (5 or 6F) is placed in the radial artery |
| 3. Access to the descending aorta | A standard 0.035 in. wire is advanced into the descending thoracic/abdominal aorta (A diagnostic coronary catheter may be needed to assist with directing the wire into the descending aorta) |
| 4. Insertion of long sheath and stiff wire | Once the descending aorta has been accessed, the standard radial sheath can be exchanged for a long support sheath (i.e. 90 cm or longer). This sheath is advanced into the distal aorta under fluoroscopic guidance. |
| 5. Insertion of guide catheter | A long (125 or 135 cm) guide catheter (JR4 or multipurpose) is needed, which is advanced into the distal aorta and directed towards the appropriate iliac vessels. |
| 6. Peripheral angiogram | This is performed through the guiding catheter for selection of appropriate balloon size. |
| 7. Insertion of wire | Once a balloon is selected (The selected balloon must be 6F compatible and should have a long shaft to be able to reach the insertion site), an appropriate wire can be advanced through the catheter into ipsilateral superficial femoral artery |
| 8. Balloon insertion | Balloon should be advanced to ipsilateral artery spanning the arteriotomy. |
| 9. Impella removal | The Impella should be weaned and removed as per standard manufacturer’s recommendations |
| 10. Hemostasis | Manual pressure required while balloon inflated. The balloon inflation should be maintained between 5 and 10 min before evaluating for hemostasis. The inflation should be repeated if there is visible bleeding and repeated until bleeding ceases. |
| 11. Repeat ipsilateral peripheral angiogram | A repeat angiogram is required to ensure no evidence of contrast extravasation and to confirm the absence of any complications |
| 12. Radial arterial access | Once the equipment is removed the radial artery access site may be managed via manual compression or standard compression devices such a TR band. |
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