Evidence
In the EVEREST II (Endovascular Valve Edge-to Edge Repair Study) trial, investigators compared the device to open mitral valve repair/replacement in high-risk patients with grade 3 (moderate to severe) or grade 4 (severe) mitral regurgitation.14 279 patients were randomised to percutaneous repair with the device, or open surgical repair/replacement of the valve. The primary end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months.
In the intention-to-treat analysis, rates of death and mitral regurgitation of grade 3+ or 4+ at 12 months were similar in both groups (6% rate of death in both groups, p=1.00, 21% in percutaneous vs. 20% in surgical group had rate of grade 3+ or 4+ mitral regurgitation), but the rate of surgery for mitral-valve dysfunction was more common in the percutaneous group (20% in percutaneous group vs. 2.2% repeat surgery in the surgery group, p<0.001). Other important findings from this trial included no statistically significant difference in rate of adverse events (excluding need for less than two units of blood transfusion which was significantly higher in the surgery group) and a significantly greater improvement of mitral regurgitation in the surgery group.
The results of this trial and other European experiences have pointed to a limited role for the device in select patients. Subgroup analysis in the EVEREST trial showed a significant benefit to patients older than 70 and importantly, in patients with functional rather than degenerative mitral regurgitation. Accordingly, this technology will likely find most use among older, high surgical risk candidates with functional mitral regurgitation.
Transcatheter mitral valve-in-valve (TMVIV) replacement
Percutaneous transcatheter mitral valve replacement (TMVR) has proven to be feasible as valve-in-valve and valve-in-ring procedure in selected high-risk surgical patients.27 TMVIV implantation is an emerging technique for reoperative mitral valve replacement in high-risk patients. Clear guidelines on the use of TMVIV implantation are yet to be determined.31
A few case series have recorded successes in the use of TMVIV technology.31-35 Cheung et al described minimal operative morbidity and mortality and favourable midterm clinical and hemodynamic outcomes in a group of 23 consecutive patients who underwent transapical TMVIV implantation for severe dysfunctional biological mitral prosthesis under transesophageal and fluoroscopic guidance (figures 11 and 12).32 Bioprosthetic dysfunction was secondary to stenosis in 6 (26.1%), regurgitation in 9 (39.1%), and combined in 8 (34.8%) patients. All patients were octogenarians with high risk for surgical redo-operation. Balloon expandable valves (Edwards Lifesciences) were implanted transapically without significant intraoperative events. Post-operatively, a significant reduction in mitral transvalvular gradient and absent mitral regurgitation (figure 13) was reported.32 Thirty-day survival was 100%. Median follow up was 753 days with 90.4% survival (NYHA class I/II). Atrial migration of transcatheter MV was reported in one patient at two months; redo-TMVIV implantation was successful. One stroke and six major bleeding events were reported in-hospital.
Figure 11. Step-by-step transapical mitral valve-in-valve procedure
Positioning (A) and deployment (B to D) of a 26-mm Edwards SAPIEN XT valve (Edwards Lifesciences) into a degenerated 27-mm Carpentier-Edwards prosthesis in mitral position
This image can be viewed as figure 1 in Cheung32
Figure 12. Panel A shows 3D transesophageal echocardiogram pre- and post-transapical mitral valve-in-valve implantation. Panel B shows systolic and diastolic 3D reconstruction of a degenerated 27-mm Carpentier-Edwards (pre) (Edwards Lifesciences) and a 26-mm Edwards SAPIEN XT (Edwards Lifesciences) valve deployed inside (post)
This image can be viewed as figure 2 in Cheung32
Figure 13. Doppler continuous transoesophageal echocardiogram showing transvalvular gradient pre- and post-transcatheter mitral valve-in-vale implantation
This image can be viewed as figure 3 in Cheung32
Similar outcomes have been demonstrated in other case series of TMVIV implantation in select high-risk groups with similar demographics and disease severity. However, some recorded a higher 30-day mortality (~7.4%).31,33-35 A case series of 19 patients even recorded successful outcomes in children as young as 10-years old.34
The available literature supports the use of transcatheter MVIV implantation in selected high-risk patients with favourable results. Although there are no available long-term data on the procedure, the early and mid-term outcomes are excellent with no evidence of structural valve deterioration in the available follow-up period.31
Key points:
- Transcatheter aortic valve implantation aims for patients with severe symptomatic aortic stenosis with predicted surgical mortality ≥15%
- Three main approaches: transfemoral, transapical, and direct aortic
- Two models: balloon-expandable and self-expanding valves
- Complications include strokes, paravalvular leaks, and vascular events
- Mitral techniques include interventions addressing the leaflets, direct annuloplasty, indirect annuloplasty (via the coronary sinus – CS), chordal implantation and left ventricular remodeling.
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References
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Suggested further reading
Ray R, Chambers J. Mitral valve disease. Int J Clin Prac 2014;68:1216–20. http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12321/epdf
Chambers J. Prosthetic valves. Int J Clin Prac 2014;68:1227–30. http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12309/epdf
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