Author + information
- S0735109716347994-f7c32351c86476c8a02eef35fa96808dMarina Urena, MD, PhD,
- S0735109716347994-5b545bfc1c6b73795f7ce93fd6d8de6eDominique Himbert, MD∗ (, )
- S0735109716347994-13d19f4978c89c0fdbd8c720fe416a5bPatrick Ohlmann, MD, PhD,
- S0735109716347994-71bf1c2a3dc0bcf8b97d0a9cd1f77937Giuliana Capretti, MD,
- S0735109716347994-e8e09c472f39184f11f754a3eba92d97Coppelia Goublaire, MD,
- S0735109716347994-dcd939c5834de3ef5e1c9cabbd74e49cMichel Kindo, MD,
- S0735109716347994-8249988753c96bd62dd44cf0fb401d86Olivier Morel, MD,
- S0735109716347994-cf380371eaeca6223bf1fdd9b7d63ef6Walid Ghodbane, MD,
- S0735109716347994-ae6bd0a7b9e844a19025abd4cbfe1151Bernard Iung, MD, PhD and
- S0735109716347994-3d7c9066562843c38b23cbbf033c7d8fAlec Vahanian, MD
- ↵∗Bichat Claude Bernard Hospital, 46 Henri Huchard, 75018 Paris, France
No evidence exists on the feasibility of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves to treat pure aortic regurgitation (AR) on noncalcified native valves (NCNV). We report the first experience of TAVR with SAPIEN 3 prostheses (Edwards Lifesciences, Irvine, California) in patients with pure AR on NCNV.
From September 2015 to March 2016, 3 inoperable patients as judged by the local heart team with severe AR on NCNV were treated with TAVR using these valves. Patient #1 was a 75-year-old woman with previous renal transplantation and severe recurrent renal failure, psychiatric disorders, and leukemia. Patient #2 was an 87-year-old man with severe peripheral vascular disease and low left ventricular ejection fraction (20%). Patient #3 was a 63-year-old woman with advanced liver cirrhosis and previous severe gastrointestinal bleeding. The mechanism of AR was a lack of central coaptation in Patient #1 and prolapsus of the noncoronary cusp in Patients #2 and #3. All patients were in New York Heart Association functional classes III or IV with congestive heart failure and had been discussed by a Heart Team and formally declined for surgery.
On multidetector computed tomography, aortic annulus mean diameters comprised between 21.0 mm (Patient #3) and 26.7 mm (Patient #2), and surfaces between 334 mm2 and 559 mm2. The size of the SAPIEN 3 valve used was 29 mm for Patients #1 and #2 and 26 mm for Patient #3, with oversizing ratios of 23%, 16%, and 27%, respectively. In addition, an extra contrast volume of 4 ml for Patient #1, 3 ml for Patient #2, and 3 ml for Patient #3 was placed in the inflation syringe to assure a flower shape of the prosthesis.
The procedures were performed transfemorally with conscious sedation and local anesthesia under fluoroscopy guidance. A pigtail catheter was positioned on the noncoronary cusp of the aortic valve. The intended position was more ventricular than that recommended for aortic stenosis: ∼5 mm below the aortic annulus. The prosthesis was implanted with simultaneous angiography using the slow inflation technique in order to allow for final adjustment of the position. A rapid ventricular pacing with a heart rate between 180 and 220 beats/min was used to achieve a systolic pressure ≤50 mm Hg during the implantation. Immediate transthoracic echocardiographic (TTE) and fluoroscopic controls confirmed the good position of the prosthesis and the absence of any significant residual AR in Patients #2 and #3. Mild paravalvular AR was observed in Patient #1, which was reduced to trivial after post-dilation with no complications. Post-operative course was uneventful and TTE findings before discharge were unchanged. At 1 month, all 3 patients were in New York Heart Association functional classes I or II and TTE confirmed the absence of any valve displacement or paravalvular AR. No other cases with unsuccessful procedure or valve embolization were performed.
A few isolated cases of patients with post–left ventricular assist device AR (1) treated with TAVR using these balloon-expandable transcatheter heart valves (SAPIEN XT or 3) have been reported. However, mechanisms of AR in these patients are different than those of chronic AR. The 2 largest series performed so far in the latter used the CoreValve system (Medtronic Inc., Dublin, Ireland) and the JenaValve (JenaValve Technology GmbH, Munich, Germany). Although feasibility was confirmed, they emphasized difficulties and mixed outcomes in this population (2,3). In addition, the JenaValve is implanted through the transapical route, which has been associated with increased morbidity and mortality.
This case series is the first experience of TAVR using this valve for chronic pure AR on NCNV. Despite the absence of calcification, native aortic valves with severe AR may offer enough support to allow stable anchoring of balloon-expandable prostheses with no residual AR. Of note, the prosthesis and annulus oversizing ratio was >15% and prostheses were overexpanded using some additional contrast volume inflation. An algorithm showing imaging criteria is shown in Figure 1.
Balloon-expandable valves have been considered not suitable for native AR because of the lack of calcification to anchor the prosthesis. This preliminary experience suggests that TAVR using the SAPIEN 3 prostheses may be safely performed in selected patients with severe AR on NCNV and provide hemodynamic and clinical improvement. A feasibility study is currently underway. If confirmed, these results may contribute to expand the use of TAVR in patients with severe aortic valve diseases.
Please note: Dr. Himbert has served as a consultant and proctor for Edwards Lifesciences. Dr. Iung has served as a consultant for Boehringer Ingelheim; and has received speaker fees from Edwards Lifesciences. Dr. Vahanian has received speaker fees from Edwards Lifesciences, Abbott Vascular, and Valtech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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