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Successful Bail-Out for a Migrated Self-Expandable Transcatheter Heart Valve Stuck in the Sinus of Valsalva

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This work is licensed under a Creative Commons Attribution-NonCommercial- NoDerivatives International License. ©2021 Japan Transcatheter Valve Therapies

Case Report

Successful Bail-Out for a Migrated Self-Expandable

Transcatheter

Heart Valve Stuck in the Sinus of Valsalva

Joji Ito,1 Kotaro Obunai,2 Hiroyuki Watanabe,2 and Minoru Tabata1

1Department of Cardiovascular Surgery, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Chiba, Japan 2Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Chiba, Japan

Received: June 19, 2020; Accepted: November 27, 2020

Corresponding author: Joji Ito. Department of Cardiovascular surgery, Tokyo Bay Urayasu Ichikawa Medical Center, 3-4-32, Todaijima, Urayasu, Chiba 279-0001, Japan

Email orejouji2@gmail.com

Objective: The embolization of the transcatheter heart valve (THV) is one of the complications of transcatheter aortic valve

replacement (TAVR). A migrated THV in the sinus of Valsalva (SOV) needs to be withdrawn to a supra-coronary position. In this case, we successfully pulled the valve with a novel technique using a snare catheter and balloon for coronary intervention.

Case Presentation: A 90-year-old woman with critical aortic stenosis was presented with extremely small aortic valve

annu-lus, heavily calcified left ventricular outflow tract (LVOT), and stenosis in the left anterior descending artery (LAD). Follow-ing percutaneous coronary intervention (PCI) to the LAD, a self-expandable THV was deployed. The THV was not fully expanded because of the heavy calcification of the LVOT. The THV was retracted by the nose cone, then migrated to the zero position. Post balloon dilation for the paravalvular leak (PVL) resulted in further migration into the SOV. We could not mobi-lize the THV by grasping the top frame of the THV. Instead, we grasped the bottom of the stent frame, and we could pull the THV to the supra-coronary position. We passed the previously used coronary balloon through the stent frame and kept pull-ing the THV with a dilated balloon durpull-ing the second THV implantation. The second valve was successfully implanted.

Conclusion: We experienced THV embolization and difficulty in withdrawing the THV in the case with the small annulus

and heavily calcified LVOT. A combination of snaring the bottom stent frame and balloon retraction technique is a useful alternative method for withdrawing the migrated THV.

Keywords: aortic stenosis, transcatheter aortic valve replacement, self-expandable valve, device embolization

the migrated valve that was stuck in the sinus of Valsalva (SOV), and we successfully pulled the valve with a novel technique using a snare catheter and balloon for coro-nary intervention.

Case Presentation

A 90-year-old woman presented with symptomatic severe aortic stenosis. She was frail and small (height: 138 cm, weight: 31 kg, body surface area: 1.1). The Society of Thoracic Surgery (STS) score was 4.0%

Echocardiography showed that the aortic valve area was 0.54 cm2, the maximum aortic valve velocity was

5.4 m/s, and the peak and the mean aortic valve pressure gradients were 118 mmHg and 72 mmHg, respectively. The grade of aortic insufficiency was moderate. Computed tomography scan showed that the aortic valve annulus

Introduction

The embolization of the transcatheter heart valve (THV) is one of the complications of transcatheter aortic valve replacement (TAVR). A migrated self-expandable THV needs to be withdrawn to supra-coronary position to avoid interfering with the coronary arteries and the sec-ond valve. Using a snare catheter is known as a standard method to pull the THV. In this case, we could not pull

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area was 259 mm2, the perimeter of the aortic annulus was

59 mm, the diameter of the SOV of 26 mm, and the SOV height of 15 mm. There was severe calcification in the left ventricular outflow tract (LVOT) under the left coronary cusp. The distance from the annulus to the right coronary artery was 12.5 mm and the distance from the annulus to the left coronary artery was 9.7 mm (Fig. 1). The anterior

surface of the common femoral artery was calcified. Cor-onary angiography showed 90% stenosis in the middle of the left anterior descending artery (LAD).

Following our heart team discussion, she was planned to undergo simultaneous percutaneous coronary inter-vention (PCI) and TAVI. We chose general anesthesia instead of local anesthesia because of the procedural complexity. We also chose a self-expandable THV due to heavily calcification of the native valve and LVOT.

Interventions

After induction of general anesthesia, the right side femoral artery was cut down and a 20-Fr DrySeal Sheath (W. L. Gore

& Associates, Inc., Newark, DE, USA) was inserted. We used transesophageal echocardiography during the procedure.

First, we performed PCI to the LAD with a 3.5 mm × 18 mm BioFreedom stent (Biosensors International Ltd., Singapore) and 3.0 mm × 15 mm Lacrosse LAXA (Goodman Co., Ltd, Aichi, Japan) coronary balloon catheter. After successful PCI, the guiding wire was kept in the LAD to protect the low left coronary artery

Balloon aortic valvuloplasty was performed under short rapid pacing using a 20 mm Z-MED balloon (B. Braun Interventional Systems Inc., Bethlehem, PA, USA). A 23-mm Evolut PRO valve (Medtronic, Minneapolis, MN, USA) was delivered to the aortic valve and deployed under control pacing. The valve was positioned at 2 mm below the non-coronary annulus and 4mm below the left coronary Annulus. The lower part of the THV was not fully expanded because of the heavy calcification of the LVOT. When we carefully pulled the nose cone out of the left ventricle, the THV was retracted by the nose cone, then migrated to the zero position of the non-coronary annulus. TEE showed severe paravalvular leak (PVL).

Fig. 1 (A) Computed tomography showed left coronary height was 9.7 mm. (B and C) Heavily and

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We performed balloon dilation with the previously used 20 mm balloon and expanded the lower part of the THV. However, the THV was further migrated above the annu-lus when we pulled the balloon out of the left ventricle.

We decided to pull up the THV to supracoronary posi-tion and implant a second THV. Since the stent frame was completely attached to the greater curvature of the

ascending aorta, we could not grasp it with an EN Snare (MeritMedical, Salt Lake City, UT, USA) endovascular snare system. Instead, we grasped the stent frame on the lesser curvature of the aorta; however, we could not mobilize the THV. Then, we grasped the bottom of the stent frame (Fig. 2A), and we could pull the THV to

supra-coronary position. However, the THV was not stabilized

Fig. 2 (A) After crossing the stent flame, grasping the stent frame on the bottom of the THV using

endovascular snare system, the THV was pulled up toward ascending aorta. (B) The coronary

balloon was passed through the stent frame, then dilated and hooked. This balloon was kept pulling back while the second valve was passing through the first valve and deployed. THV: transcatheter heart valve

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and was likely to dive back into the SOV at the time of second THV implantation.

We passed the previously used 3.5 mm coronary bal-loon through the stent frame and kept pulling the THV with a dilated balloon during the second THV implanta-tion (Fig. 2B). The second valve was successfully

implanted at 8mm below the aortic annulus without interfering with the mitral valve. TEE showed a moder-ate PVL again. Then, we performed balloon dilation using a new 20mm Z-MED balloon that reduced PVL to a mild degree. This balloon did not retract the second valve when it was pulled out of the left ventricle. Aortog-raphy showed localized aortic dissection at the aortic root without extravasation. TEE showed no pericardial effusion. (Fig. 3) We decided to observe the aortic

dis-section carefully with anti-hypertensive medications.

Outcome

The postoperative course was uneventful. She was dis-charged home on day 6. Postoperative TTE before discharge showed good left ventricular function, mild PVL, the peak pressure gradient of 21 mmHg, and mean pressure gradient of 10 mmHg. Postoperative CT showed no progression of the aortic dissection. She was in good condition at the out-patient clinic a year from the TAVI procedure.

One-year follow-up TTE showed good left ventricular function, mild PVL, the peak pressure gradient of 36mmHg, and mean pressure gradient of 16 mmHg. One year follow-up CT showed no progression of the aortic dissection.

Discussion

The incidence of THV embolization has been reported 0–1%.1,2) The mechanism of THV embolization includes

anatomical factors such as undersized prosthesis, bulky calcified leaflet, paucity of annular calcifications, large aortic annulus and horizontal aorta, procedural factors such as poor coplanar angle, malpositioning, incomplete balloon inflation, pacing failure, premature pacing ter-mination, failure to manage the distal tip of the delivery catheter (i.e., nose cone), post-dilatation, stored wire tension, and device-related factors such as failure of tabs’ detachment.3–6)

In addition to the findings of previous literature, a small aortic annulus and heavily calcified LVOT that were seen in our case can also be an anatomical risk fac-tor for THV embolization. The small annulus can cause insufficient valve expansion, which increases the risk of being retracted by the distal tip of the delivery catheter. Our case had an extremely narrow annulus and heavily calcified LVOT. This small anatomy caused under- expansion of THV, which resulted in retraction by the nose cone. Regarding procedural factors, we think that poor management of the nose cone and insufficient deflation of the post-dilation balloon caused THV embolization in our case. Although we carefully retrieved the nose cone at an anterior–posterior view, the left anterior oblique projection may be better to confirm the positional rela-tionship between the THV and delivery catheter. The bal-loon was not completely deflated even after fully aspirating diluted contrast medium from the balloon probably because it had been used for pre-dilation. We learned the following things regarding THV emboliza-tion from this case. (1) A small annulus and heavily calcified LVOT can be a risk factor of THV embolization. (2) Especially when the THV is under-expanded, the balloon should be retrieved at multiple view angles. (3) A new balloon should be used for post-dilation when a risk of THV embolization is high.

Regarding the selection of the THV, we chose a self-expandable THV because a balloon-expandable valve is known to have a higher risk of annulus rupture in the context of heavily calcified LVOT than a self-expandable THV.7) Even with a self-expandable THV, however, there

was still a high possibility of post-balloon dilatation for under-expanded self-expandable THV and a risk of annulus rupture at the time of post-balloon dilatation in this case. A balloon-expandable THV with slow and underfilling deployment might have been an option as

Fig. 3 Aortography showed localized aortic dissection at

the aortic root without extravasation or pericardial effusion.

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well. A mechanically expandable THV might have been useful in preventing annulus rupture and controlling PVL in highly calcified annulus cases. However, it was not commercially available in Japan at that time.

In this case, we failed to withdraw the first valve by snaring the tab on the stent top that has been reported as a standard bail-out method.3) We were able to snare the

lesser curvature side; however, it was not enough to bring the THV valve up. Instead, we used an alternative novel method, which included snaring the bottom stent frame on the greater curvature side and balloon retraction.

The balloon retraction technique was very useful to pull the THV up, and it has not been published before to the best of our knowledge. Although we used the 3.5-mm coronary balloon since we used it for simultaneous PCI in this case, other small balloons may work as well.

Conclusion

We experienced THV embolization and difficulty in withdrawing the THV in the case with the small annulus and heavily calcified LVOT. When it is difficult to snare the stent tab, a combination of snaring the bottom stent frame and balloon retraction technique is a useful alter-native method for withdrawing the migrated THV.

Authors’ contributions

Research concept and design: Joji Ito and Minoru Tabata. Collection and analysis of research data: Joji Ito and Minoru Tabata.

Interpretations of research data and critical recommenda-tions on important intellectual content of manuscript: Joji Ito, Minoru Tabata, Kotaro Obunai, and Hiroyuki Watanabe. Final approval of submitted papers and published manuscripts: all authors.

Consent to accountability for research: all authors

Disclosure Statement

Joji Ito, Kotaro Obunai, and Hiroyuki Watanabe have no conflicts of interest to declare.

Minoru Tabata has a following financial relationship to disclose.

Honoraria (lecture fee) from: Medtronic

References

1) Chieffo A, Petronio AS, Mehilli J, et al: Acute and 30-day outcomes in women after TAVR: results from the WIN-TAVI (Women’s INternational Transcathe-ter Aortic Valve Implantation) Real-World Registry. JACC Cardiovasc Interv 2016; 9: 1589–1600.

2) Adams DH, Popma JJ, Reardon MJ, et al: Tran-scatheter aortic-valve replacement with a self- expanding prosthesis. N Engl J Med 2014; 370: 1790–1798.

3) Alkhouli M, Sievert H, Rihal CS: Device emboliza-tion in structural heart intervenemboliza-tions: incidence, out-comes, and retrieval techniques. JACC Cardiovasc Interv 2019; 12: 113–126.

4) Ibebuogu UN, Giri S, Bolorunduro O, et al: Review of reported causes of device embolization following trans-catheter aortic valve implantation. Am J Cardiol 2015; 115: 1767–1772.

5) Makkar RR, Jilaihawi H, Chakravarty T, et al: Deter-minants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Place-ment of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am Coll Car-diol 2013; 62: 418–430.

6) Laborde JC, Brecker SJ, Roy D, et al: Complications at the time of transcatheter aortic valve implan-tation. Methodist Debakey Cardiovasc J 2012; 8: 38–41.

7) Coughlan JJ, Kiernan T, Mylotte D, et al: Annular rupture during transcatheter aortic valve implantation: predictors, management and outcomes. Interv Cardiol 2018; 13: 140–144.

Fig. 1   (A) Computed tomography showed left coronary height was 9.7 mm. (B and C) Heavily and  eccentric calcification in the LVOT (arrow)

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