First Reported Successful Femoral Valve-in-Valve Transcatheter Aortic Valve Replacement Using the Edwards Sapien 3 Valve

Abstract: Objectives. Management of degenerated aortic valve bioprosthesis classically requires redo surgery, but transcatheter aortic valve-in-valve implantation is becoming a valid alternative in selected cases. In the case of a degenerated Mitroflow bioprosthesis, TAVR is associated with an additional challenge due to a specific risk of coronary occlusion. We aimed to assess the safety and feasibility of transfemoral valve-in-valve implantation of the new Edwards Sapien 3 (Edwards Lifesciences) in a degenerated Mitroflow bioprosthesis (Sorin Group, Inc). Methods. We report here the safety and feasibility of transfemoral valve-in-valve implantation of a 23 mm Edwards Sapien 3 in a degenerated 25 mm Mitroflow valve and describe the specific assessment of the risk of coronary obstruction using a multi-imaging modality. Results. The final result showed an absence of aortic regurgitation and a mean transvalvular gradient of 14 mm Hg. The patient had no major adverse cardiovascular events at 30-day follow-up. Conclusion. Transcatheter valve-in-valve implantation of an Edwards Sapien 3 in a degenerated Mitroflow is feasible and safe, considering a careful assessment of the risk of coronary obstruction with Mitroflow bioprosthesis due to leaflets mounted externally to the stent.

J INVASIVE CARDIOL 2015;27(10):E220-E223

Key words: transcatheter aortic valve replacement, aortic stenosis, valve disease

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According to the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, bioprosthesis is the prosthesis of choice for aortic valve replacement in patients aged >65 years.¹ Even if their durability seems to have improved with third-generation prostheses, degeneration is still an issue that often requires redo cardiac surgery (8% freedom from reoperation at 15 years in patients aged 61-70 years).^2-4 Nonetheless, these patients may present with a high surgical risk, and transcatheter valve procedures are becoming valid alternatives in such situations.⁵ 

The Mitroflow bioprosthesis (Sorin Group, Inc) is a stented biological surgical valve with a unique design characterized by long leaflets (15 mm) mounted externally to the stent. As a consequence, the distance between the leaflets and the coronary ostia is reduced when the valve is in an open position, increasing the risk of coronary artery obstruction after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedures.⁶ 

Several cases reports of successful transfemoral ViV procedures have been published to treat Mitroflow bioprosthesis degeneration using different types of transcatheter heart valves, but to the best of our knowledge, the Edwards Sapien 3 valve has never been reported for such an indication. We report here a case of transfemoral ViV-TAVR using a 23 mm Edwards Sapien 3 valve in an 82-year-old woman with severe aortic insufficiency due to a degenerated 25 mm Mitroflow bioprosthesis.

Case Report

An 82-year-old female patient was referred to our hospital for a severe and symptomatic bioprosthetic aortic valve regurgitation. She had past medical history of aortic valve (25 mm Mitroflow bioprosthesis) and ascending aorta replacement with a Vascutek Gelweave (Terumo Corporation) for an ascending aortic aneurysm with aortic regurgitation in 2009. Transthoracic echocardiography showed a broad eccentric jet of aortic regurgitation; the severity of the insufficiency was confirmed by a short pressure half-time of 197 ms and the detection of a holodiastolic regurgitant flow in the abdominal aorta (Figure 1). The left ventricular systolic function was normal, with an ejection fraction of 65%. The patient refused any surgical intervention. Our Heart Team considered the patient for a ViV-TAVR. Computed tomography scan (Figure 2) was performed to assess the distance from the sinotubular junction (Figure 2-1) to the aortic valve annulus (Figure 2-2), which was 23 mm, and the distance from the left coronary ostia (Figure 2-3) and the right coronary ostia (Figure 2-4) to the aortic valve annulus (14.4 mm and 9.7 mm, respectively).

The patient was scheduled for TAVR under general anesthesia and transesophageal echocardiography (TEE) guidance. Preintervention TEE identified a tear of the leaflet in non-coronary position as the mechanism of the severe aortic valve regurgitation. It also confirmed the presence of a dilated left coronary sinus of Valsalva with a distance of 1.2 cm between the left main stem ostium and the leaflets of the Mitroflow bioprosthesis in systole (Figures 3A and 3B). After access to the right common femoral artery and vein, a temporal pacing wire was introduced in the apex of the right ventricle. Because of the risk of lateral displacement of the bioprosthesis leaflets toward the coronary ostia, a guiding catheter was placed via left radial access into the left main coronary artery with a deflated 4 x 15 mm Sapphire II balloon (OrbusNeich) in case of coronary obstruction during valve deployment.  A 10 Fr arterial introducer was used. Under TEE guidance and short rapid cardiac pacing (180 beats/minute), a 23 mm Edwards Sapien 3 valve was successfully implanted (Figure 4). Under fluoroscopic guidance, the metallic ring of the bioprosthesis was employed as a key landmark, allowing us to position the marker of the Edwards Sapien 3 just above, with the bottom row of small cells below the sewing ring. The final angiogram showed a well-seated prosthesis with the leaflets of the Mitroflow valve almost completely covered by the transcatheter heart valve stent. TEE confirmed normal leaflet function, with a mean transvalvular gradient of 14 mm Hg and no significant paravalvular leak. Diastolic flow in the aortic root and the left main stem was preserved (Figure 5). 

At follow-up, the patient had no major adverse cardiovascular events at 30 days and remained asymptomatic with a New York Heart Association class-1 functional status.

Discussion

We report the first Edwards Sapien 3 valve implantation in a ViV procedure. Evidence of the feasibility of transfemoral ViV-TAVR is growing for both stented and stentless heart valves. Several recent reports have shown safety and feasibility of ViV-TAVR with second-generation transcatheter aortic valves, such as the CoreValve,⁷ the Direct flow,⁸ the Lotus valve,⁹ the Portico,¹⁰ and the Jena Valve,¹¹ but the new Edwards Sapien 3 has not been reported in a ViV procedure with a Mitroflow valve. Indeed, the latter valve has been shown to have >8x higher incidence of ostial coronary obstruction when compared with other stented bioprostheses due to its particular design with leaflets mounted on the outside of the valve stent.

In the published data from the Global Valve-in-Valve Registry,an ostial coronary obstruction was reported in 3.5% of cases.⁶ Of note, this adverse event was associated with a high mortality rate (57.1%) and observed in 7.7% of the Mitroflow cases. This proportion was significantly higher than for the other stented valves (P=.049). In a 25 mm Mitroflow valve, leaflets in their open position are at a distance of 15 mm from the sewing ring. In our case, the left coronary ostium was measured at 9.7 mm above the aortic annulus and was accordingly at risk of coronary obstruction. Nevertheless, the distance from the aortic annulus to sinotubular junction was 23 mm, and therefore longer than the leaflet length (15 mm). 

Regarding the positioning of the Edwards Sapien 3 for ViV procedures, the only available recommendations come from the ViV Aortic app¹² supported by the Paris Course in Revacularization. According to this app, we placed the Edwards Sapien 3 20% below the sewing ring of the bioprosthesis before expansion. It must be mentioned that the design of the cobalt-chromium alloy frame of the Edwards Sapien 3 is made of four rows and four columns of cells between each commissure in order to improve its radial strength. As the cells at the bottom are smaller than the upper cells, after deployment, we typically observe with this valve a device shortening from the crimped to open configuration, as illustrated in our case. 

Compared with other transcatheter valves implanted in the setting of a ViV procedure, the Sapien 3 has the advantage of an outer skirt that seals paravalvular leak, which is not the case with other transcatheter valves. In addition, the Commander delivery system (transfemoral) has an ultra-low profile and is compatible with the 14 Fr eSheath for the 23 and 26 mm valves. Whenever the transfemoral route is not possible, the Sapien 3 also has the advantage of implantation via the transapical route, which is not the case with other valves such as the CoreValve. The main disadvantage of the Sapien 3 is the inability to reposition the device post implantation, which is possible with most of the recent self-expanding transcatheter valves.

Conclusion

A transcatheter ViV procedure using the new Edwards Sapien 3 is a feasible alternative to repeat cardiac surgery in high-risk patients with degenerated Mitroflow bioprostheses. As the Mitroflow bioprosthesis is associated with a specific risk of coronary obstruction during ViV procedures, the careful anatomical evaluation of the aortic root with computed tomography and/or TEE is mandatory in order to better assess the procedural risks.

Impact on daily practice. This first case report of a transfemoral aortic ViV implantation using an Edwards Sapien 3 in a degenerated Mitroflow bioprosthesis demonstrates the feasibility of the procedure. Given the specific challenges associated with this procedure, it also underlines the importance of a careful risk assessment using advanced non-invasive imaging of the aortic root. Due to its performance and its characteristics (notably its outer skirt), the Edwards Sapien 3 valve can be added to the armamentarium of physicians when dealing with an aortic bioprosthetic degeneration in a patient with contraindications to surgery.

References

1. Vahanian A, Alfieri O, Andreotti F, et al; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology, European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33:2451-2496.
2. Chikwe J, Filsoufi F. Durability of tissue valves. Semin Thorac Cardiovasc Surg. 2011;23:18-23.
3. Brown JM, O’Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009;137:82-90.
4. Chan V, Jamieson WR, Germann E, et al. Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after aortic valve replacement. J Thorac Cardiovasc Surg. 2006;131:1267-1273.
5. Walther T, Falk V, Dewey T, et al. Valve-in-a-valve concept for transcatheter minimally invasive repeat xenograft implantation. J Am Coll Cardiol. 2007;50:56-60.
6. 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;126:2335-2344.
7. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneous aortic valve replacement for severe aortic regurgitation in degenerated bioprosthesis: the first valve procedure using the CoreValve revalving system. Catheter Cardiovasc Interv. 2007;70:760-764.
8. Bruschi G, Cannata A, Barosi A, et al. Direct flow valve-in-valve implantation in a degenerated mitral bioprosthesis. EuroIntervention. 2015 July 9 (Epub ahead of print).
9. Castriota F, Cavazza C, Secco GG, Micari A, Cremonesi A. First Lotus aortic valve-in-valve implantation to treat degenerated Mitroflow bioprostheses. EuroIntervention. 2015 July 8 (Epub ahead of print).
10. Jeger RV, Manoharan G, Kaiser CA. First-in-man Portico transcatheter aortic valve-in-valve implantation in a degenerated 19 mm Mitroflow aortic pericardial heart valve. EuroIntervention. 2014;9:1368.
11. Conradi L, Kloth B, Seiffert M, et al. The challenge of valve-in-valve procedures in degenerated Mitroflow bioprostheses and the advantage of using the JenaValve transcatheter heart valve. EuroIntervention. 2014;10:990-994.
12. Vinayak B. ViV aortic app. Apple Store. 2012.

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From the Departments of ¹Cardiology, ²Radiology, and ³Anesthesiology, University Hospital Center Vaudois (CHUV), Lausanne, Switzerland.

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 August 3, 2015, provisional acceptance given August 21, 2015, final version accepted September 8, 2015.

Address for correspondence: Olivier Muller, MD, PhD, Service de cardiologie, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland. Email: Olivier.Muller@chuv.ch