Distal balloon-expandable aortic valve embolization during a valve-in-valve procedure

Master Universitario di II livello Cardiologia Interventistica Cardiovascolare e Strutturale

Anno Accademico

Autore

Tutor Scientifico

Prof. Claudio Passino

Tutor Aziendale

Dr. Sergio Berti

Distal balloon-expandable aortic valve

embolization during a valve-in-valve

Table of contents

Introduction ... 3

Background ... 3

Clinical case ... 3

Procedure ... 4

Discussion ... 4

Conclusions ... 5

References ... 6

Introduction

Trans-catheter Aortic Valve Implantation (TAVI) was performed for the first time in the 2002 by Cribier et al. 1_{. Afterwards, in the 2004, the first series showed a good}

safety and efficacy profile2.

Whether in the one hand, the procedure, used to replace a native degenerate aortic valve, reaches the non-inferiority versus surgical approach and the medical therapy, in intermediate-risk patients3,4. On the other hand, TAVI was applied to replace surgical bioprosthetic valve failure, in high-risk patient, so as in the 2007 Wenaweser

et al. performed the first valve-in-valve (ViV) in aortic position5.

Background

Surgical valve failure is an event time-related.

In the last ten years, a lower age cut-off for bioprosthetic aortic valve replacement (from 65 to 60 years) and a longer life expectancy, are translated to an increased prosthesis failure rate.

Freedom from reoperation after bioprosthetic valve replacement is around 5% at 5 years, reaching 30% at 15 years. The re-operative heart surgery (redo) is consider the

gold standard therapy6.

In elective patients, the risk of re-operative valve replacement for failed aortic bioprosthesis is around 2 to 7 %. This rate rises to 30% in high-risk and non-elective patient7.

Considering the satisfactory results after the initial cases, many papers have confirmed the useful of the TAVI for ViV procedure, with a favourable safety and efficacy profile8-11.

To perform ViV procedure, several features have to be focused. Starting from valve characteristics (stented or stentless) and its fluoroscopic and radiological features, following with the main failure modes, positioning and deployment aspects12.

Clinical case

A female, 86 years old patient, hypertensive with paroxysmal atrial fibrillation, was admitted to our Hospital for severe aortic regurgitation.

In the 2009, she subjected to SAVR [Mitraflow 23] and myocardial revascularization [left internal mammary artery to left anterior descending and saphenous vein graft (Y) to OM and diagonal].

In October 2017, echography evaluation showed severe para-prosthetic aortic regurgitation. Between January and April 2018, two emergency department admissions for heart failure, and after last admission she was referred for ViV

CT-scan showed suitable peripheral accesses [superficial femoral artery 9X9 mm and common iliac artery 16X17 mm]. The valve area derived from perimeter (73 mm) was 424 mm2. The right coronary artery ostium was 10 mm far away from the valvular plane with an increased risk of occlusion after valve deployment.

The ViV Aortic application has suggested for using a 20 mm or 23 mm S 3 Edwards valve.

Thanks to data integration an Edwards Sapien S3, 23 mm, was chosen.

Procedure

After puncture of both superficial femoral arteries (the second one was angiographic guided), a 0.35’’ super-stiff wire was placed into the ventricle. Trough a radial artery, the right coronary artery was engaged and a stent was located into the coronary for protection.

Pacing started but, during deployment, valve moved firstly to ventricle and, after manipulation, to ascending aorta. A second valve, on same wire, was advanced and successful released in aortic position.

After that, the first valve, now in the aortic arch, was manipulated by a “goose neck” to put the valve in the abdominal aorta, unsuccessful (with a broken “goose neck” frame trapped in the stent valve). A rotation maybe occurred and valve reached the abdominal aorta portion, pushed by blood flow. Arterial blood pressure, instantaneously monitored by radial access, abrupt raised reaching 200/100 mmHg. A CP-Stent, then, was deployed into the valve with blood pressure normalization. Afterwards femoral arteries checking, the procedure was successful concluded.

Discussion

The ViV procedure is clinically effective with favourable acute and mid-term outcomes8-11.

According to the VARC criteria, the embolization is defined as “valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus”13_.

As said by Généreux et al., the embolization rate among TAVI procedure was 1.7% [range 0 - 5.6 %]14. The three main causes of embolization are: first, malapposition; secondly, annulus or aortic valvular complex anatomy; and lastly, pacing failure15. Embolization can occur in the acute phase, where main localization is ascending aorta and in a post-acute phase, where main localization is left ventricle. When it occurs late, the mortality rate rises up to 43%. According to Makkar et al., the embolization is consider an independent factor for death at 30 days and 12 moths, largely because of a higher rate of hemodynamic support and conversion to open-heart surgery. There is also an increased risk for major bleeding and vascular complications15_.

According to Tay et al., after embolization, when the final valve localization is not ventricular, adverse clinical consequences are not observed at late follow-up16. In our case, valve embolization occurs because of pacing failure. Indeed, the deployment of the valve started few seconds before the blood pressure fall down. Moreover, considering the main failure prosthetic mode recognized in regurgitation,

the stroke volume direct from the aorta to the ventricle, moved the valve into the ventricle. After manipulation, the valve has been moved to ascending aorta.

Another important feature is the valve managing in aorta (ascending, arch and descending). We removed the stiff wire inside the valve, to use a “goose neck” for a better manipulation and to haul valve to abdominal aorta. This was a mistake that allowed valvular spin. Following the blood flow, valve reached the abdominal portion with an increasing of systemic blood pressure. After a CP-stent deployment, blood pressure normalized and the valve was locked in abdominal position, without any principal artery scarify.

Conclusions

This is a clinical case, that shows as a properly management of an embolization valve could have a favourable final result, as well as literature affirms. However, some remarkable features have to be underlined.

In high-risk patients, TAVI for bioprosthetic aortic valve failure is associated with relatively low mortality and complication rates, and, improved hemodynamic8-10. Pre-procedural planning by CT-scan is now recognized as critical point, to minimize major and minor complications. Moreover, it is axiomatic that knowledge of the basic construction and dimensions, radiographic identification, and potential failure modes of SAV bio-prosthesis is fundamental in understanding key principles involved in TAV-in-SAV implantation12.

Coaxially, timing of balloon inflation, optimal rapid pacing, positioning into the failed bioprosthetic valve reduce the valve embolization.

Even if embolization occurred, and final aortic positioning is reached, properly managing can be correlated with favourable early and mid-term outcomes.

References    

1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8.

2. Cribier A, Eltchaninoff H, Tron C, et al. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. Journal of the American College of Cardiology 2004;43:698-703.

3. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. The New England journal of medicine 2016;374:1609-20.

4. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. The New England journal of medicine 2017;376:1321-31.

5. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneous aortic valve replacement for severe aortic regurgitation in degenerated bioprosthesis: the first valve in valve procedure using the Corevalve Revalving system. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 2007;70:760-4.

6. Pellerin M, Mihaileanu S, Couetil JP, et al. Carpentier-Edwards pericardial bioprosthesis in aortic position: long-term follow-up 1980 to 1994. The Annals of thoracic surgery 1995;60:S292-5; discussion S5-6.

7. Jaussaud N, Gariboldi V, Giorgi R, et al. Risk of reoperation for aortic bioprosthesis dysfunction. The Journal of heart valve disease 2009;18:256-61. 8. Dvir D, Webb J, Brecker S, et al. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry. Circulation 2012;126:2335-44.

9. Dvir D, Webb JG, Bleiziffer S, et al. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. Jama 2014;312:162-70.

10. Latib A, Ielasi A, Montorfano M, et al. Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 2012;7:1275-84.

11. Webb JG, Mack MJ, White JM, et al. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. Journal of the American College of Cardiology 2017;69:2253-62. 12. Piazza N, Bleiziffer S, Brockmann G, et al. Transcatheter aortic valve

implantation for failing surgical aortic bioprosthetic valve: from concept to clinical application and evaluation (part 1). JACC Cardiovascular interventions 2011;4:721-32.

13. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Journal of the American College of Cardiology 2012;60:1438-54.

14. Genereux P, Head SJ, Van Mieghem NM, et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies. Journal of the American College of Cardiology 2012;59:2317-26.

15. Makkar RR, Jilaihawi H, Chakravarty T, et al. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). Journal of the American College of Cardiology 2013;62:418-30.

16. Tay EL, Gurvitch R, Wijeysinghe N, et al. Outcome of patients after transcatheter aortic valve embolization. JACC Cardiovascular interventions 2011;4:228-34.