Case Report: Sapien 3 Transcatheter Heart Valve Embolization: Cause, Management, and Redo
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SUBMITTER: Chen M
PROVIDER: S-EPMC8593098 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Little is known about the presentation of structural valve degeneration complicating transcatheter heart valves (THVs). We report a case of acute heart failure, secondary to leaflet prolapse, in a previously well 77-year-old man, 7.5 years after successful transcatheter aortic valve replacement with a 26-mm balloon-expandable Sapien XT (Edwards Lifesciences, Irvine, CA) THV. This case highlights that structural valve degeneration complicating THVs might lead to acute presentation with little warning from previous echocardiograms. Calcification might be absent on imaging. Redo transcatheter aortic valve replacement is feasible and appears safe. Post deployment optimization with a highly noncompliant balloon might improve full expansion of the newly implanted THV and improve valve performance.
| S-EPMC7984999 | biostudies-literature
Project description:Transcatheter aortic valve implantation (TAVI) is increasingly performed in patients with severe aortic stenosis. The efficacy and safety have been demonstrated in large randomized trials in patients with high- or intermediate operative risk. With latest-generation transcatheter heart valve (THV) systems, growing operator experience and improved patient selection, clinical outcome has significantly improved with a decline of TAVI-related complications. In this review, the Edwards SAPIEN 3 THV is discussed in terms of technology, procedural advances and complication trends and future developments.
| S-EPMC6171512 | biostudies-literature
Project description:BackgroundAortic stenosis (AS) is one of the most common valvular disorders worldwide. An increasing number of transcatheter aortic valve implantation (TAVI) procedures are being performed yearly for managing AS. This, along with the occurrence of common complications, makes timely diagnosis essential to manage rare complications and improve patient outcomes.Case summaryWe present a case of a 77-year-old Caucasian male with severe AS with a dysfunctional bioprosthetic valve following previous surgical valve replacement. During valve-in-valve TAVI, we noted bioprosthetic valve leaflet avulsion and embolization causing a major vascular occlusion that resulted in vascular insufficiency of the left lower extremity. This condition was managed successfully via immediate diagnosis using transoesophageal echocardiogram, angiogram, and vascular surgical intervention for retrieving the embolized valve to re-establish circulation.DiscussionTo our knowledge, this is the first case of aortic valve leaflet embolization during TAVI resulting in significant vascular insufficiency. Vascular complications are common during TAVI. However, not all vascular complications are the same. Our case highlights an embolic vascular complication from an avulsed prosthetic material during a challenging valve-in-valve TAVI procedure.
| S-EPMC7047047 | biostudies-literature
Project description:Abstract Background Transcatheter mitral valve-in-valve (TMVIV) using the Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) transcatheter heart valve is associated with high technical success and sustained valve performance. However, complications may occur or be detected during or after the procedure. Case summary We herein describe a rare case of a 59-year-old female who underwent TMVIV for a failed surgical mitral bioprosthesis. During the procedure, the device was embolized twice into the left ventricle and left atrium, respectively, resulting from the crimped transcatheter valve partially detaching from the balloon of the Certitude delivery system during passage through a tight transapical sheath. Fortunately, we were able to catch the dislodged valve and anchor it by the partially inflated device balloon, followed by successful repositioning and deployment. Discussion In cases where the valve has already detached, as in the present case, the sheath may be advanced against the proximal end of the valve as a pusher, providing good support to push the entire system to cross the bioprosthesis. Then, the delivery catheter should be withdrawn with the counteraction of the sheath in order to correct the interrelated positions of the valve and the balloon. Finally, the valve can be positioned and deployed after the sheath is withdrawn.
| S-EPMC10456212 | biostudies-literature
Project description:BackgroundAortic valve disease is the most prevalent valvular abnormality in the developed world and carries a high risk of morbidity and mortality. Transcatheter aortic valve replacement (TAVR) is favoured over open-heart surgery in high-risk patient categories and is increasingly used in lower-risk groups. End stage kidney disease (ESKD) is associated with premature calcific degeneration of bioprosthetic heart valves. Redo-TAVR requires meticulous pre-procedural planning to avoid the important risks of sinus sequestration and impaired coronary access. Transcatheter aortic valve replacement with the Acurate Neo transcatheter heart valve (THV) has been clinically available for a short time only and there are limited reports describing redo-TAVR in the Acurate Neo.Case summaryWe present a case of early, rapid onset, structural valve degeneration in a Acurate Neo, supra-annular, self-expanding THV in a dialysis patient. The patient presented with chest pain and breathlessness 4 years after TAVR with a Acurate Neo for severe stenosis of a bicuspid aortic valve. Echocardiogram now showed severe stenosis of the THV and computed tomography revealed severe THV leaflet calcification but no pannus or leaflet thrombus. After careful pre-procedural planning a S3 Ultra balloon-expandable valve was selected and positioned relatively high to pin the first THV leaflets in a fully open position without compromising coronary artery flow or coronary access.DiscussionEnd stage kidney disease may cause rapid, calcific degeneration of TAVR valves leading to presentation with severe aortic stenosis. Redo-TAVR in the Acurate Neo THV with a Sapien 3 Ultra is feasible with careful pre-procedural planning to mitigate the risks of sinus sequestration and impaired coronary access.
| S-EPMC9290620 | biostudies-literature
Project description:BackgroundThere are limited commercial valve sizes available for transcatheter aortic valve implantation (TAVI). This makes it challenging or even prohibitive to perform TAVI on large aortic annuli.Case summaryA 78-year-old male with known low-flow, low-gradient severe aortic stenosis presented with progressive dyspnoea, chest pressure, and decompensated heart failure. Successful off-label TAVI was performed for tricuspid aortic valve stenosis with an aortic annulus of >900 mm2. An Edwards S3 29 mm valve was overexpanded with an extra 7 mL of volume at valve deployment. No complications occurred, and only trivial paravalvular leak was seen following implantation. The patient died from a non-cardiovascular cause 8 months following the procedure.DiscussionPatients that require aortic valve replacement with prohibitive surgical risk and have very large aortic valve annuli pose significant technical challenges. This case shows the feasibility of TAVI by overexpanding an Edwards S3 valve.
| S-EPMC9991066 | biostudies-literature
Project description: Not available
| S-EPMC6064864 | biostudies-literature
Project description:ImportanceBioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients.ObjectiveTo assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.Design, setting, and participantsIn this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.ExposuresMitral valve-in-valve for degenerated bioprosthetic mitral valves.Main outcomes and measuresThe primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance.ResultsA total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.Conclusions and relevanceTranscatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.
| S-EPMC7391176 | biostudies-literature
Project description:We describe the case of a 57-year-old man who had severe mitral valve stenosis and regurgitation without significant annular calcification. He was not a candidate for surgical valve replacement or repair because of his substantial comorbid conditions, overall frailty, and elevated surgical risk. He underwent successful transcatheter mitral valve replacement of his native mitral valve with compassionate, off-label use of an Edwards Sapien 3 valve. A search of the literature produced no other cases like ours, which represents a further evolution of the transcatheter valve implantation concept. Further studies are needed to help define accurate valve sizing, intraprocedural positioning, and long-term device stability, as well as to determine which patients might benefit from this commercially available valve. In the meantime, our findings could present a means of treating patients who have no other options.
| S-EPMC5577954 | biostudies-literature
Project description:Background: The outcome of redo transcatheter aortic valve (TAV) implantation (TAVI) is unknown for TAV structural valve degeneration (SVD). This paper reports the initial results of redo TAVI for TAV-SVD in Japanese patients. Methods and Results: Of 630 consecutive patients, 6 (1.0%) underwent redo TAVI for TAV-SVD (689-1,932 days after the first TAVI). The first TAV were 23-mm balloon-expandable valves (BEV, n=5) and a 26-mm self-expandable valve (SEV, n=1). All patients underwent multidetector computed tomography (MDCT) before redo TAVI, which showed first-TAV under-expansion (range, 19.1-21.0 mm) compared with the label size. Two BEV and 4 SEV were successfully implanted as second TAV, without moderate/severe regurgitation or 30-day mortality. One of 2 patients with a BEV-inside-BEV implantation had a high transvalvular mean pressure gradient post-procedurally (34 mmHg) and required surgical valve replacement 248 days after the redo TAVI. This, however, was unnoted in patients with SEV implantation during redo TAVI. Planned coronary artery bypass grafting was concomitantly performed in 1 patient with a small sino-tubular junction and SEV-inside-SEV implantation because of the risk of coronary malperfusion caused by the first TAV leaflets. Five of the 6 patients survived during the follow-up period (range, 285-1,503 days). Conclusions: Redo TAVI for TAV-SVD appears safe and feasible, while specific strategies based on MDCT and device selection seem important for better outcomes.
| S-EPMC7890286 | biostudies-literature