The Safety and Efficacy of Temporary Distal Aortic Occlusion to Facilitate TAVR Large-Bore Arterial Closure

Abstract: Objectives. To evaluate the safety and efficacy of temporary distal aortic occlusion (TDAO) for facilitated large-bore arterial closure during transcatheter aortic valve replacement (TAVR). Background. Ipsilateral iliac artery occlusion and TDAO have been used to facilitate TAVR delivery sheath access-site closure, but ipsilateral iliac artery occlusion has been associated with arterial complications at the balloon site. Methods. TDAO was performed in 117 consecutive transfemoral TAVR cases from July 2010 to April 2012. The valve delivery access site was preclosed with suture-mediated closure devices (n = 100) or had a planned surgical cutdown performed (n = 17). TDAO was performed using a 22 mm x 5 cm Tyshak II balloon, which was deployed at the minimum pressure to stop antegrade blood flow in the distal abdominal aorta via a contralateral 8 Fr femoral sheath. This served to occlude iliac runoff as the TAVR delivery sheath access site was closed. Final aortogram with bilateral run-off was performed to evaluate for aortic, iliac, or femoral dissection or rupture, or ilio-femoral vascular complications in accordance with Valve Academic Research Consortium (VARC)-2 criteria. Results. TDAO was successfully performed in all patients with no complications related to the TDAO technique itself. There were vascular complications related to the TAVR procedure. 7 patients (6.0%) had VARC-2 major vascular complications and 16 patients (13.7%) had VARC-2 minor vascular complications. Conclusions. TDAO is a safe and effective technique to facilitate large-bore arterial closure by both percutaneous and open surgical closure techniques.

J INVASIVE CARDIOL 2014;26(8):394-396

Key words: aortic stenosis, valve replacement, balloon occlusion

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Transcatheter aortic valve replacement (TAVR) offers a new option for the treatment of high-risk patients with aortic stenosis.^1,2 The transfemoral TAVR approach requires large-bore arterial access, which can lead to vascular complications.^3,4 The transfemoral access can be performed via either femoral artery surgical cutdown or percutaneous approach. Percutaneous access for TAVR most commonly employs a variety of “preclosure” arterial techniques using vascular closure devices,⁵ but the closure of these access sites under arterial pressure can be a clinical challenge.⁶ Temporary proximal arterial occlusion to “depressurize” the sheath access site has been employed to facilitate this closure. 

The two most commonly described techniques for proximal arterial occlusion are ipsilateral iliac artery occlusion⁷ and temporary distal aortic occlusion (TDAO).⁸ Both techniques facilitate large-bore closure by temporarily occluding proximal arterial flow and thereby reduce arterial pressure at the access site and facilitate deployment of previously placed vascular closure devices. Temporary ipsilateral iliac artery occlusion is commonly used but necessitates “crossover” placement of the occlusion balloon. Complications directly related to the balloon deployment in the common iliac artery have been described.⁹ With the TDAO technique, the device is place in the distal aorta below the renal arteries with the balloon just above the aorto-iliac bifurcation (Figure 1A). There is no impact on the renal arteries or kidney function directly related to the TDAO technique. Our early evaluation of the TDAO technique did not result in local arterial complications.⁸ This study extends the initial TDAO results to 117 consecutive cases and evaluates the safety and efficacy of TDAO for facilitated large-bore arterial closure during TAVR. 

Methods

TDAO was performed in 117 consecutive transfemoral TAVR cases from July 2010 through April 2012. All operations were performed in a hybrid operating room with a multidisciplinary heart team including an interventional cardiologist, a cardiothoracic surgeon, and an anesthesiologist. This study includes patients in whom the Sapien valve (Edwards Lifesciences) was implanted as part of the PARTNER I and II trials (n = 95) or in commercial use (n = 22). Fifty-nine patients received a 23 mm valve, delivered through either an 18 Fr sheath (n = 14; 7.2 mm outer diameter) or 22 Fr sheath (n = 45; 7.5 mm outer diameter). The remaining 58 patients received a 26 mm valve via a 19 Fr sheath (n = 16; 8.3 mm outer diameter) or 24 Fr sheath (n = 42; 9.3 mm outer diameter). The valve delivery access site was “preclosed” with two or three Perclose Proglide devices (Abbott Vascular) (n = 100) or had a planned surgical cutdown performed (n = 17). Regardless of the technique used for gaining access for valve sheath delivery, all patients had facilitated sheath access closure by employing TDAO via a contralateral femoral approach. TDAO was performed using a 22 mm x 5 cm Tyshak II balloon (B. Braun Medical, Inc), which was introduced through an 8 Fr contralateral femoral arterial sheath (the same sheath employed for the pigtail catheter during the TAVR procedure). The Tyshak II balloon was deployed at the minimal pressure required in the distal abdominal aorta in order to occlude ilio-femoral run-off. Once the suture closure devices were deployed, the Tyshak II balloon was deflated. The site was evaluated for adequate hemostasis once ilio-femoral run-off was restored. If adequate hemostasis was achieved, the Tyshak II balloon was then removed.

Abdominal aortography under digital subtraction technique was performed after the Tyshak II balloon was removed. We evaluated for aortic, iliac, or femoral dissection or rupture, and ilio-femoral vascular complications and run-off in accordance with the Valve Academic Research Consortium (VARC)-2 criteria.¹⁰ Major vascular complications include any access site or access-related injury leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment. A complication is also considered major if the use of unplanned endovascular or surgical intervention is needed, and is associated with death, major bleeding, visceral ischaemia, or neurological impairment. Minor vascular complications include any access-related injury or unplanned intervention that does not meet the criteria for a major vascular complication. Failed deployment of a percutaneous closure device is reported as neither major nor minor, but as its own category of complication if the failed deployment leads to alternative treatment other than manual compression or adjunctive endovascular ballooning. Vascular complications are reported for: (1) the site of TDAO; (2) the valve delivery sheath side; and (3) the contralateral access side. Baseline characteristics of the patient population are given in Table 1.

Results

TDAO was successfully performed in all patients. Twenty-four patients (20.5%) had VARC-2 vascular complications, with none occurring at the TDAO site. Of these complications, 7 were major vascular complications (6.0% of total) and 16 were minor complications (13.7% of total). There was 1 percutaneous closure device failure requiring surgical repair. Interventions for the major complications included stenting (n = 2), balloon angioplasty (n = 1), and surgical repair (n = 1); additionally, 1 case required both surgical repair and stenting, 1 case required surgical repair and balloon angioplasty, and 1 case required stenting and an end-to-end graft. Three of the major complications (2.6% of total) occurred in the femoral artery of the patient, and 1 complication (0.9% of total) occurred in the iliac artery. The remaining 3 patients (2.6% of total) with major complications had them in the iliac and femoral arteries. Minor complications were treated with stenting (n = 5), balloon angioplasty (n = 5), and surgical repair (n = 3), and 1 case required both stenting and surgical repair. Two cases with minor complications needed no unplanned treatment. 

Three of the major complications occurred on the contralateral access side, all of which were access related. No instances of aortic complications occurred, as all complications were found in the ilio-femoral arteries. The locations of the complications are shown in Figure 1. In cases where balloon angioplasty was needed as an intervention, the Tyshak II occlusion balloon could be easily replaced with a balloon to perform the angioplasty. In cases where surgical repair was performed, the occlusion balloon was left in place to maintain proximal vessel control.

Of this patient population, 80 patients (68.4%) needed blood transfusions during their hospital stay. The average amount of red blood cells received by each patient who required a transfusion was 2.8 units. Seven patients (6.0% of total) with vascular complications required transfusion of 4 or more units, while 9 patients (7.7% of total) received transfusion of 4 or more units but had no vascular complications. The average duration of hospitalization for the population was 8.3 days. There was 1 death (0.9%) at 30 days among patients with vascular complications, which was due to a stroke. Three patients (2.6%) who did not have vascular complications died within 30 days, with 1 death due to renal problems and 2 deaths due to pulmonary complications. All procedural outcomes are reported in Table 2.

Discussion

 This study reports the outcomes of the use of TDAO to assist in the percutaneous or surgical closure of the arterial access site following transfemoral TAVR. A completely percutaneous approach to transfemoral TAVR is an increasingly utilized technique. As sheath delivery sizes continue to become lower profile, the number of transfemoral TAVR cases performed percutaneously is likely to increase. 

Successful closure of the preclosed access site is critical to procedural success. Closure of the large-bore arterial access site can be facilitated by techniques that provide temporary proximal arterial occlusion. Ipsilateral iliac artery occlusion is commonly employed and functions identically to distal aortic occlusion; however, the ipsilateral occlusion involves a more involved positioning of the balloon-tipped catheter by “crossing over” the aortic bifurcation. 

This technique has been described in a series of 56 patients by Genereux and colleagues. Their technique was effective in facilitating large-bore arterial closure. As reported, their technique was not associated with any direct complications.¹¹ Sharp et al, however, reported a thrombosis requiring unplanned Fogarty catheter rescue and surgical repair that was directly related to inflation of the balloon for ipsilateral iliac artery occlusion.⁹ Complications related to ipsilateral occlusion are rare. Our series is the largest to be presented to date, and demonstrates no such complications directly related to the TDAO technique. The crossover technique is a more involved procedural process requiring additional catheters, wires, and balloons. The TDAO approach represents a simpler method with fewer procedural steps that provides equally effective facilitated closure. This may be particularly helpful to less experienced operators who are learning the percutaneous TAVR technique; specifically, those without a depth of peripheral vascular experience. 

The TDAO technique, as we have employed it, has been without associated vascular complication. Aortic occlusion is, however, associated with an increase in systemic afterload. We have not observed any valve dysfunction or hemodynamic instability requiring intervention with TDAO. Our series is limited by the fact that it is from a high-volume, single-center experience. Further investigation and perhaps a randomized control evaluation of ipsilateral balloon occlusion versus the TDAO technique are likely warranted.

Conclusion

Using VARC-2 criteria, our results demonstrated no major vascular complications related to the TDAO technique in 117 consecutive transfemoral TAVR patients. All major complications were access related. TDAO as described is a safe and effective technique to facilitate large-bore arterial closure. This method of proximal arterial occlusion may be preferable to temporary ipsilateral iliac occlusion due to its lack of complications and ease of use.

References

1. Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32(2):198-204.
2. Yan TD, Cao C, Martens-Nielsen J, et al. Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: a systematic review. J Thorac Cardiovasc Surg. 2010;139(6):1519-1528.
3. Alsac JM, Zegdi R, Blanchard D, et al. Complications of the access during aortic valve implantation through transfemoral access. Ann Vasc Surg. 2011;25(6):752-757.
4. Ducrocq G, Francis F, Serfaty JM, et al. Vascular complications of transfemoral aortic valve implantation with the Edwards SAPIEN prosthesis: incidence and impact on outcome. EuroIntervention. 2010;5(6):666-672.
5. Kahlert P, Eggebrecht H, Erbel R, et al. A modified “preclosure” technique after percutaneous aortic valve replacement. Catheter Cardiovasc Interv. 2008;72(6):877-884.
6. Bangalore S, Arora N, Resnic F. Vascular closure device failure: frequency and implications: a propensity-matched analysis. Circ Cardiovasc Interv. 2009;2(6):549-556. Epub 2009 Oct 27.
7. Genereux P, Kodali S, Leon MB, et al. Clinical outcomes using a new crossover balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv. 2011;4(8):861-867.
8. Bowers BS, Head SJ, Brown DL. Temporary aortic occlusion to facilitate large-bore arterial closure. J Invasive Cardiol. 2010;22(10):503-504.
9. Sharp ASP, Michev I, Maisano F, et al. A new technique for vascular access management in transcatheter valve implantation. Catheter Cardiovasc Interv. 2010;75(5):784-793.
10. Kappetein AP, Head SJ, Genereux P. Updated standardized endpoint definitions for transcatheter aortic valve replacement: the VARC-2 consensus document. Eur Heart J. 2012;33(19):2403-2418.
11. Genereux P, Kodali S, Leon, M, et al. Clinical outcomes using a new balloon occlusion technique for percutaneous closure after transfemoral aortic valve implantation. JACC Cardiovasc Interv. 2011;4(8):861-867.

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From ¹Medical City Dallas Hospital, Dallas, Texas; ²Cardiopulmonary Research Science and Technology Institute, Dallas, Texas; and ³The Heart Hospital Baylor Plano, Plano, Texas.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted December 19, 2013, provisional acceptance given January 20, 2014, final version accepted February 14, 2014.

Address for correspondence: Director Tina Worley, RN, CRSTI, 7777 Forest Lane, C-742, Dallas, TX 75230. Email: tworley@crsti.org