Abstract
Objective
This study aims to demonstrate a bailout strategy for balloon rupture of the SAPIEN 3 Ultra RESILIA valve during redo transcatheter aortic valve replacement in a calcified, failed Evolut R valve.
Key Steps
(1) Prompt en bloc removal of the Commander delivery system with the ruptured balloon and 14-F eSheath. (2) Sheath upsizing to 16 F to tamponade potential iliac injury, followed by iliac angiography to confirm the absence of active bleeding. (3) Immediate postdilation of the underexpanded valve to prevent device migration. (4) Endovascular repair of injured iliofemoral arteries using covered stents.
Potential Pitfalls
Abrupt iliofemoral artery rupture may cause hemorrhagic shock. If significant resistance is encountered during removal, en bloc extraction is aborted and the system is repositioned in the aorta for alternative retrieval (eg, contralateral snaring). If hemorrhagic shock occurs after en bloc removal, covered stents were deployed from the abdominal aorta to the femoral access site. If it occurs before removal is complete, emergent surgical repair is required.
Take-Home Messages
Severe supra-annular leaflet calcification in prior Evolut R valves may predispose to SAPIEN 3 Ultra RESILIA balloon rupture. A successful bailout strategy includes en bloc removal, sheath upsizing, immediate postdilation, and timely endovascular repair.
Key words: aortic valve, complication, valve replacement
Visual Summary
Visual Summary.
Balloon Rupture of Sapien 3 Ultra Resiliia in Failed Evolut R
(Left) An 84-year-old woman underwent redo TAVR with a 23-mm SAPIEN 3 Ultra RESILIA (S3UR) valve for severely calcified supra-annular leaflets of a previously implanted Evolut R valve (lower, white arrows), which had been placed for calcified type 1 bicuspid aortic valve (upper, white arrows). (Middle) During valve deployment, the balloon ruptured proximally, creating an umbrella-like configuration of the distal balloon segment (left lower, white arrowheads). The rupture corresponded to the area of severe supra-annular leaflet calcification (right and left, white arrows). (Right) The umbrella-shaped distal portion of the torn balloon could not be withdrawn through the 14-F eSheath (left). Therefore, the delivery catheter and sheath were removed en bloc, the sheath was upsized to 16-F, postdilation was performed to secure the incompletely expanded valve, and the endovascular covered stent was placed to treat injured iliofemoral arteries (right). TAVR = transcatheter aortic valve replacement.
Balloon rupture during deployment of the SAPIEN 3 Ultra RESILIA (S3UR) valve (Edwards Lifesciences) is a rare complication. However, when it occurs, it can lead to catastrophic outcomes. Operators must be familiar with prompt recognition and management strategies to ensure procedural success and patient safety.
Take-Home Messages
-
•
Severe calcification on the supra-annular leaflets of the Evolut valve can directly impinge on the SAPIEN 3 Ultra RESILIA balloon, increasing the risk of balloon rupture.
-
•
En bloc removal of the ruptured balloon system, sheath upsizing, immediate postdilation, and timely endovascular intervention constitute an effective bailout strategy.
Case Summary
An 84-year-old woman with a history of severe aortic stenosis status after transcatheter aortic valve replacement (TAVR) using a 26-mm Evolut R valve (Medtronic) 9 years prior presented with worsening dyspnea, fatigue, and bilateral leg weakness for 1 week. She had been hospitalized for heart failure 1 month earlier.
Transesophageal echocardiography (TEE) at that time demonstrated severe degeneration of the bioprosthetic aortic valve and a large thrombus in the left atrial appendage. Redo TAVR was deferred because of the left atrial appendage thrombus, and oral anticoagulation was initiated.
The initial TAVR had been complicated by complete atrioventricular block, necessitating biventricular pacemaker implantation because of a low left ventricular ejection fraction of 29%. Her medical history was also notable for hypertension.
Transthoracic echocardiography (TTE) showed thickened and calcified supra-annular leaflets of the Evolut R valve (Figure 1, Video 1) with a peak velocity of 3.9 m/s, a mean pressure gradient of 33 mm Hg, and an effective orifice area (EOA) by velocity-time integral (VTI) of 0.67 cm2. TEE revealed severe bioprosthetic stenosis, severe transvalvular regurgitation, and mild paravalvular leak (PVL) (Figure 2, Video 2). The left atrial appendage thrombus remained unchanged, measuring 2.9 × 1.0 cm. Additional findings included minimal mitral regurgitation, mild tricuspid regurgitation, and an estimated pulmonary artery systolic pressure of 32 mm Hg.
Figure 1.
Transthoracic Echocardiography Showing Long-Axis View of the Evolut R Valve
The supra-annular leaflets of the Evolut R demonstrate restricted motion with severe thickening and calcification (white arrows). The ventricular side of the Evolut R valve frame is also visible (white arrowheads).
Figure 2.
Transesophageal Echocardiography Showing the Left Ventricular Outflow Tract View
Severe transvalvular regurgitation is visible (white arrows), along with mild paravalvular regurgitation (white arrowheads).
Given her advanced age, worsening frailty after recent heart failure hospitalization, and a Society of Thoracic Surgeons–Predicted Risk of Mortality score of 12%, the patient was deemed to be at extreme surgical risk. Therefore, the heart team elected to proceed with redo TAVR.
Before TAVR, percutaneous suction of the left atrial appendage thrombus was performed, followed by successful left atrial appendage closure using a Watchman FLX device (Boston Scientific).
Pre–index TAVR computed tomography revealed a type 1 bicuspid aortic valve with fusion of the left and right coronary cusps and a calcified raphe (Figure 3, left). Severe calcification of the noncoronary cusp leaflet was also noted (Figure 3, left). Key measurements were as follows:
-
•
Annulus: 24.9 × 18.9 mm, area 373.8 mm2, perimeter 69.7 mm.
-
•
Left ventricular outflow tract: 26.8 × 18.5 mm, area 373.9 mm2, perimeter 70.8 mm.
-
•
Sinotubular junction: 25.2 × 23.0 mm.
-
•
Sinus of Valsalva: 25.0 mm (left), 23.6 mm (right), 26.4 mm (noncoronary).
-
•
Coronary heights: 14.4 mm (left), 13.2 mm (right).
Figure 3.
CT Imaging
(Left) Pre–index TAVR CT demonstrating a type 1 bicuspid aortic valve with fusion of the left and right coronary cusps and a calcified raphe (white arrow), along with severe calcification of the noncoronary cusp leaflet (white arrowheads). (Middle) pre–redo TAVR CT at node 4 of the Evolut R showing elliptical expansion of the index valve frame due to calcified leaflet (white arrowheads) and calcified raphe (white arrow). (Right) Pre–redo TAVR CT at node 5 of the Evolut R demonstrating severe calcification on the leaflets of the index valve (white arrows). CT = computed tomography; TAVR = transcatheter aortic valve replacement.
To minimize the risk of aortic root rupture due to the extensive leaflet and raphe calcification associated with type 1 bicuspid aortic stenosis, a 26-mm self-expanding Evolut R valve was implanted during the index TAVR procedure.
Pre–redo TAVR computed tomography demonstrated elliptical expansion of the prior Evolut R valve due to severe leaflet and raphe calcification (Figure 3, middle). In addition, heavy calcification was noted on the leaflets of the index Evolut valve (Figure 3, right).
The coronary risk plane was determined to be node 5 for the left coronary artery and node 4.5 for the right coronary artery (RCA). The average annular area from node 1 to node 4 was 364.5 mm2, with a perimeter of 68.0 mm. Iliofemoral arteries were suitable for transfemoral access, with a minimal luminal diameter of 6.2 mm.
To minimize the risk of coronary obstruction, transfemoral redo TAVR was planned using a 23-mm balloon-expandable S3UR valve, with the outflow positioned at node 4 of the prior Evolut R frame.
Procedural Steps
The procedure was performed under general anesthesia with TEE guidance (Table 1). A 14-F eSheath (Edwards Lifesciences) was inserted via the left femoral artery.
Table 1.
Step-by-Step Sequence for Managing SAPIEN 3 Ultra RESILIA Balloon Rupture in a Failed Evolut R
| Step | Procedural Event | Key Finding | Management/Consideration |
|---|---|---|---|
| 1 | Predilation using a 21-mm TRUE balloon | A balloon waist at the level of the calcified Evolut R leaflet | Confirms severe leaflet calcification |
| 2 | Deployment of a 23-mm SAPIEN 3 Ultra RESILIA | Sudden loss of inflator pressure | Recognize rupture immediately |
| Contrast pooling in the distal balloon with umbrella-like configuration | Suggests horizontal tear, balloon unlikely to re-enter sheath | ||
| Incomplete valve expansion | Anticipate need for prompt postdilation to prevent embolization | ||
| 3 | Attempted withdrawal of the Commander system | Balloon could not be advanced into 14-F eSheath | Prepare for en bloc removal |
| 4 | Preparation | Call vascular surgery | |
| Have covered stent ready | |||
| Upsize sheath to 16-F eSheath | |||
| 5 | En bloc removal of the delivery system and sheath | Risk of vascular injury, monitor hemodynamics | Slowly withdraw en bloc |
| 6 | Insertion of 16-F eSheath | Provides tamponade, prepare for endovascular repair | |
| 7 | Contralateral iliac angiography | Left common iliac artery dissection without extravasation | Proceed with valve postdilation under sheath protection |
| 8 | Postdilation with a 23-mm TRUE balloon | Improved valve expansion, no PVL | Confirms secure valve position |
| 9 | Withdrawal of 16-F sheath to the external iliac artery | Watch for blood pressure drop | Prepare covered stent |
| 10 | Covered stent placement in the common iliac artery | 8 × 59-mm VBX deployed, stable hemodynamics | Successful bailout of iliac injury |
| 11 | Iliac angiography | No extravasation | Confirms complete stenting |
| 12 | Removal of 16-F eSheath | Closure failure with Perclose due to prior injury | Required covered stent |
| 13 | Covered stent placement in the common femoral artery | 7 × 50-mm Viabahn graft deployed contralaterally | Successful bailout of major access site |
PVL = paravalvular leak.
Aortography was performed to obtain a left anterior oblique view for optimal frame alignment, which revealed severe calcification between node 4 and node 5—corresponding to the supra-annular leaflets of the prior Evolut R valve (Figure 4, Video 3).
Figure 4.
Left Anterior Oblique Frame Alignment View
Severe calcification is visible between node 4 and node 5 (white arrows), corresponding to the supra-annular leaflets of the Evolut R valve.
Selective coronary angiography was performed using a 6-F IR1.5 catheter for the left coronary artery and a 3DRC catheter for the RCA, confirming coronary risk planes of node 5.5 and node 4.5, respectively (Figure 5, Videos 4 and 5).
Figure 5.
Coronary Angiography
Coronary angiography demonstrated a coronary risk plane (CRP) of node 5.5 for the left coronary artery (LCA) and node 4.5 for the right coronary artery (RCA).
Prophylactic coronary protection was performed by wiring the RCA and positioning a stent in the mid RCA.
Predilation with balloon aortic valvuloplasty was performed using a 21-mm TRUE balloon (BD). A balloon waist was observed at the level of the calcified Evolut R leaflets (Figure 6A, Video 6), confirming resistance due to heavy leaflet calcification.
Figure 6.
Step-by-Step Sequence
(A) Pre–balloon aortic valvuloplasty using a 21-mm TRUE balloon. A balloon waist was observed at the level of the calcified Evolut R leaflets (white arrows), indicating resistance during inflation. (B) Balloon rupture of the 23-mm SAPIEN 3 Ultra RESILIA (S3UR) during deployment. Contrast pooling in the distal portion of the balloon (white arrowheads) produced an umbrella-like appearance, indicating a horizontal tear. The 23-mm valve was incompletely deployed (white arrow). (C) Iliac angiogram from the contralateral side. Dissection of the left common iliac artery is seen without active extravasation (white arrow). (D) Postdilation of the incompletely expanded S3UR valve using a 23-mm TRUE balloon. (E) Iliac angiography after endovascular intervention. The 16-F eSheath was withdrawn to the left external iliac artery, and an 8 × 59 mm VBX covered stent was deployed in the dissected common iliac artery (white bidirectional arrow). (F) Femoral angiography after endovascular intervention. The left common femoral access site was sealed using a 7 × 50 mm Viabahn stent graft (white bidirectional arrow). Final angiography showed no extravasation and preserved flow.
At that time, the coronary protection system in the RCA obstructed advancement of the aortic valvuloplasty catheter. Therefore, the system was temporarily removed, and a pigtail catheter was placed in the ascending aorta.
Subsequently, a 23-mm S3UR valve was deployed with the outflow aligned at node 4.5 of the index valve frame. During balloon inflation, rupture occurred, resulting in incomplete valve expansion. Contrast pooling in the distal portion of the balloon suggested a horizontal tear, producing an umbrella-like configuration that prevented withdrawal of the system through the 14-F eSheath (Figure 6B, Video 7).
The delivery system and sheath were removed en bloc from the left femoral access site, and the sheath was upsized to a 16-F eSheath to tamponade a suspected vascular injury. Iliac angiography via the contralateral side revealed a dissection of the left common iliac artery without active extravasation (Figure 6C, Video 8). Hemodynamics remained stable throughout the procedure.
Postdilation of the incompletely expanded S3UR valve was then performed using a 23-mm TRUE balloon (Figure 6D, Video 9). Subsequent TEE confirmed appropriate valve positioning with no evidence of PVL.
The 16-F eSheath was withdrawn to the level of the left external iliac artery, and an 8 × 59-mm VBX covered stent (Gore Medical) was deployed to treat the dissected left common iliac artery (Figure 6E, left; Videos 10 and 11). The left femoral access site was sealed with a 7 × 50-mm Viabahn stent graft (Gore Medical) (Figure 6F, right; Video 12). Final angiography demonstrated no contrast extravasation and preserved flow (Video 13).
TTE on postoperative day 1 showed a left ventricular ejection fraction of 40%, no transvalvular regurgitation, minimal PVL, a mean gradient of 6 mm Hg, and an EOA by VTI of 1.78 cm2. The postoperative course was uneventful, and the patient was discharged home on postoperative day 11.
At 30-day follow-up, the patient remained stable in NYHA functional class II. TTE demonstrated a peak transvalvular velocity of 1.5 m/s, a mean pressure gradient of 6 mm Hg, and an EOA by VTI of 1.43 cm2. There was no transvalvular regurgitation, and only mild PVL was observed.
Potential Pitfalls
This case highlights 2 key points: 1) the risk of balloon rupture of the S3UR valve during redo TAVR for a heavily calcified supra-annular Evolut R valve, and 2) an effective bailout strategy for managing balloon rupture.
Failure to recognize the severity of balloon rupture may lead to forceful retrieval without precautionary measures, potentially resulting in catastrophic vascular complications. When the balloon ruptures horizontally, contrast may remain trapped in the distal balloon segment due to the inability of the indeflator to evacuate it, creating an umbrella-like configuration (Figure 6B). On fluoroscopy, this appearance should alert operators to the likelihood that the distal portion of the ruptured balloon may not re-enter even a large-bore sheath.1, 2, 3, 4
In addition, failure to postdilate an incompletely expanded SAPIEN 3 valve may result in valve migration or embolization. Once the ruptured balloon system is removed and vascular access is re-established, immediate postdilation is essential to secure valve fixation. Prompt recognition and decisive action are critical to avoid serious procedural complications.
If we try the en bloc removal with planned endovascular repair, abrupt rupture of iliofemoral arteries causing hemorrhagic shock could occur. If strong resistance is felt during retrieval, it is necessary to stop pulling the whole system and to bring it back to the aorta and to take another measure such as contralateral snaring5 or reverse umbrella technique.6 If hemorrhagic shock occurs after the en bloc removal, it is required to place covered stents from the abdominal aorta to the femoral access site. If hemorrhagic shock occurs before completing the removal, emergent surgical repair is needed. In addition, an aortic occlusion balloon is also used in cases of aortoiliac rupture.
Conclusions
This case highlights a rare but serious complication of S3UR balloon rupture during redo TAVR in a heavily calcified Evolut R valve. A systematic bailout strategy—including en bloc device removal, sheath upsizing, postdilation, and endovascular repair—facilitated successful procedural completion and patient recovery.
Funding Support and Author Disclosures
Dr Khera is a consultant and proctor for Medtronic and Abbott Structural Heart, consultant for Terumo and W. L. Gore & Associates, consultant and advisory board member of EastEnd Medical, and serves on the Speakers Bureau for Zoll Medical and Edwards Lifesciences. Dr Safi serves on the speakers’ bureau for Abbott Structural Heart and Medtronic. Dr Tang has received speaker honoraria from and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria from and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific, a consultant and physician screening committee member for Shockwave Medical, a consultant for Philips and Edwards Lifesciences, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Footnotes
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.
Appendix
For supplemental videos, please see the online version of this paper.
Appendix
Transthoracic Echocardiography Showing Long-Axis View of the Evolut R Valve
The 16-F eSheath Was Withdrawn to the Left External Iliac Artery, and an 8 × 59 mm VBX Covered Stent Was Deployed in the Dissected Common Iliac Artery
Transesophageal Echocardiography Showing the Left Ventricular Outflow Tract View
Severe transvalvular regurgitation is visible, along with mild paravalvular regurgitation.
Left Anterior Oblique Frame Alignment View
Severe calcification is visible between node 4 and node 5, corresponding to the supra-annular leaflets of the Evolut R valve.
Left Coronary Angiography
Left coronary angiography demonstrated a coronary risk plane of 5.5 for the left coronary artery.
Right Coronary Angiography
Right coronary angiography demonstrated a coronary risk plane of 4.5 for the right coronary artery.
Pre–Balloon Aortic Valvuloplasty Using a 21-mm TRUE Balloon
A balloon waist was observed at the level of the calcified Evolut R leaflets, indicating resistance during inflation.
Balloon Rupture of the 23-mm SAPIEN 3 Ultra RESILIA During Deployment
Contrast pooling in the distal portion of the balloon produced an umbrella-like appearance, indicating a horizontal tear. The 23-mm valve was incompletely deployed.
Iliac Angiogram From the Contralateral Side
Dissection of the left common iliac artery is seen without active extravasation.
Postdilation of the Incompletely Expanded SAPIEN 3 Ultra RESILIA Valve Using a 23-mm TRUE Balloon
Final Angiography Demonstrating no Contrast Extravasation and Preserved Flow
The 16-F eSheath Was Withdrawn to the Left External Iliac Artery, and an 8 × 59 mm VBX Covered Stent Was Deployed in the Dissected Common Iliac Artery
Iliac Angiography After Endovascular Intervention
Femoral Angiography After Endovascular InterventionThe left common femoral access site was sealed using a 7 × 50 mm Viabahn stent graft.
References
- 1.Buono A., Bettari L., Pero G., et al. Fully percutaneous retrieval of delivery system after balloon rupture during trans-catheter aortic valve-in-valve implantation. Cardiovasc Revasc Med. 2023;48:43–44. doi: 10.1016/j.carrev.2022.06.253. [DOI] [PubMed] [Google Scholar]
- 2.Sawaya F.J., Roy A., Neylon A., et al. An unusual complication after rupture of the SAPIEN 3 valve balloon during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016;9:e79–e81. doi: 10.1016/j.jcin.2016.01.040. [DOI] [PubMed] [Google Scholar]
- 3.Takamura T., Inoue R., Seko T., et al. Successful bailout of Sapien 3 valve balloon rupture during transcatheter valve implantation via transaortic approach. Cardiovasc Interv Ther. 2020;35:415–416. doi: 10.1007/s12928-019-00630-9. [DOI] [PubMed] [Google Scholar]
- 4.Basman C., Landers D., Kliger C., et al. Balloon rupture during transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2024;103:1035–1041. doi: 10.1002/ccd.31029. [DOI] [PubMed] [Google Scholar]
- 5.Bruno A.G., Taglieri N., Saia F., et al. Recapture of the Sapien-3 delivery system after transversal balloon rupture using a whole percutaneous femoral approach. JACC Cardiovasc Interv. 2021;14:e183–e187. doi: 10.1016/j.jcin.2021.04.032. [DOI] [PubMed] [Google Scholar]
- 6.Basman C., Kodra A., Mustafa A., et al. Percutaneous retrieval of a ruptured SAPIEN ultra balloon: the reverse umbrella technique. JACC Cardiovasc Interv. 2022;15:e17–e19. doi: 10.1016/j.jcin.2021.10.028. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Transthoracic Echocardiography Showing Long-Axis View of the Evolut R Valve
The 16-F eSheath Was Withdrawn to the Left External Iliac Artery, and an 8 × 59 mm VBX Covered Stent Was Deployed in the Dissected Common Iliac Artery
Transesophageal Echocardiography Showing the Left Ventricular Outflow Tract View
Severe transvalvular regurgitation is visible, along with mild paravalvular regurgitation.
Left Anterior Oblique Frame Alignment View
Severe calcification is visible between node 4 and node 5, corresponding to the supra-annular leaflets of the Evolut R valve.
Left Coronary Angiography
Left coronary angiography demonstrated a coronary risk plane of 5.5 for the left coronary artery.
Right Coronary Angiography
Right coronary angiography demonstrated a coronary risk plane of 4.5 for the right coronary artery.
Pre–Balloon Aortic Valvuloplasty Using a 21-mm TRUE Balloon
A balloon waist was observed at the level of the calcified Evolut R leaflets, indicating resistance during inflation.
Balloon Rupture of the 23-mm SAPIEN 3 Ultra RESILIA During Deployment
Contrast pooling in the distal portion of the balloon produced an umbrella-like appearance, indicating a horizontal tear. The 23-mm valve was incompletely deployed.
Iliac Angiogram From the Contralateral Side
Dissection of the left common iliac artery is seen without active extravasation.
Postdilation of the Incompletely Expanded SAPIEN 3 Ultra RESILIA Valve Using a 23-mm TRUE Balloon
Final Angiography Demonstrating no Contrast Extravasation and Preserved Flow
The 16-F eSheath Was Withdrawn to the Left External Iliac Artery, and an 8 × 59 mm VBX Covered Stent Was Deployed in the Dissected Common Iliac Artery
Iliac Angiography After Endovascular Intervention
Femoral Angiography After Endovascular InterventionThe left common femoral access site was sealed using a 7 × 50 mm Viabahn stent graft.