2Department Cardiology, University Heart Center Zurich, Zurich, Switzerland
3Heart Clinic Hirslanden, Zurich, Switzerland
4Department Cardiovascular Surgery, University Heart Center Zurich, Zurich, Switzerland
Methods: Seventeen consecutive surgical intermediate to highrisk patients with recurrent MV disease not considered suitable for redo surgery were analyzed. Percutaneous MitraClip repair (n=11), valve-in-ring (n=3) or valve-in-valve (n=3) replacement were performed.
Results: Median age was 76.0 years (53.6 to 89.4 years). Median EuroSCORE II and STS mortality score were 4.5% (0.5 to 14.4%) and 4.9% (1.5 to 20.9%), respectively. Pre-operative MR grade was moderate-severe (n=4, 24%) or severe (n=13, 76%). Interventional success was obtained in all but three cases (82%). 30 day survival rate was 100%. At last follow-up (mean 270 days, range 31 to 1559 days), the overall survival rate was 76%. MR grade was none-mild in 76% and moderate in 24% of patients. Reduction of dyspnea was achieved in all but 2 patients (88%).
Conclusion: Percutaneous MV treatments after failed MV surgery are feasible and associated with a lower than expected periinterventional mortality in carefully selected patients not suitable for redo MV surgery. The interventions proved effective regarding reduction in MR and symptoms as well as lowering of pulmonary pressure.
Keywords: Percutaneous mitral valve interventions; Transcatheter mitral valve replacement; MitraClip; Valve-in-ring; Valve-in-valve; Redo mitral valve surgery
Nevertheless, the initial surgical treatment may fail over time, resulting in recurrent mitral valve disease. If the patient is old or otherwise at high-risk for redo-surgery, the management of recurrent mitral valve disease can be challenging. For such patients, percutaneous treatment approaches are commonly preferred and are associated with good peri-interventional success [9,10]. Percutaneous mitral valve repair with a MC has been described as a valid option to surgery [11]. However, MC insertion is not always technically feasible, so that other interventions like percutaneous valve-in-ring (VIR) and valve-invalve (VIV) replacement have been described [12].
The aim of this study was to analyze the outcome of the three percutaneous therapy options (MC in repaired mitral valve, VIR and VIV replacement) in a cohort of selected high-risk and symptomatic patients with a recurrent mitral valve disease not suitable for redo surgery.
Legend: Examples of the three performed interventions are shown before (A, C, E) and after (B, D, F) the procedure. A) Patient with a recurrent flail of the P2 segment after mitral valve repair with ring annuloplasty ring and B) after MitraClip implantation. C) Patient with restrictive posterior mitral leaflet after ring annuloplasty, resulting in severe recurrent mitral regurgitation and D) after transapical valve-in-ring implantation of a 26mm Sapien XT prosthesis. E) Patient with a degenerated mitral valve prosthesis with flail of the posterolateral cusp, and F) after transapical valve-in-valve implantation of a 26mm Sapien XT prosthesis.
Legend: Image demonstrating important steps for valve-in-ring replacement. Before the intervention, details of the implanted annuloplasty system, in this case a 28mm Edwards Physio II ring, are studied in vivo using 3D TEE and specialized software for post-processing. The height of the ring is estimated at 4mm, and the landing zone (skirt zone) of the chosen prosthesis (in this case a 26mm Sapien XT prosthesis) measures 8.7mm. During the intervention, precise positioning is guaranteed using fluoroscopy. Post implantation, the position of the prosthesis within the ring is re-analysed. In this case, optimal position could be achieved, leaving no paravalvular regurgitation at all.
|
Population (n=17) |
- male, n (%) |
11 (65%) |
- age at redo intervention, years (range) |
76.0 (53.6/89.4) |
Clinical Data |
1.9 (1.2/2.5) |
Comorbidities |
8 (47%) |
Drugs |
14 (82%) |
BMI: body mass index; NYHA: New York Heart Association; STS: Society of thoracic surgeons; COPD: chronic obstructive pulmonary disease.
|
Population (n=17) |
Echocardiography |
63 (40/72) |
Invasive hemodynamic (n = 8) |
58 (48/75) |
Labor |
130 (95/157) |
Patient |
Reason for 1. intervention |
1. intervention |
time to failure (y) |
Mode of failure |
Age at 2. Intervention (y) |
2. Intervention |
MR Grade at FU |
Outcome |
1 |
Mixed primary & secondary |
MV repair without ring |
11.4 |
Recurrent prolapse |
86 |
MitraClip |
Mild |
Death at 31d |
2 |
Prolapse |
MV repair without ring |
7.9 |
Recurrent prolapse & Flail leaflet |
76 |
MitraClip |
Moderate |
Alive |
3 |
Unknown |
MV repair without ring |
7.7 |
Degeneration |
84 |
MitraClip |
Mild |
Death at 1093d |
4 |
Unknown |
MV repair without ring |
11.1 |
Flail leaflet |
76 |
MitraClip (3x) |
Moderate |
Alive |
5 |
Prolapse |
MV repair without ring |
7.0 |
Flail leaflet |
69 |
MitraClip |
Mild |
Alive |
6 |
Prolapse |
MV repair without ring |
10.5 |
Recurrent prolapse |
73 |
MitraClip |
Mild |
Alive |
7 |
Prolapse |
MV repair with ring |
18.6 |
Recurrent prolapse |
69 |
MitraClip in ring |
Mild |
Alive |
8 |
Unknown |
MV repair with ring |
15.2 |
Flail leaflet |
88 |
MitraClip in ring |
Mild |
Death at 427d |
9 |
Flail leaflet |
MV repair with ring |
1.4 |
Flail leaflet |
62 |
MitraClip in ring (2x) |
Moderate |
Alive |
10 |
Functional MR |
MV repair with ring |
3.2 |
Dehiscence |
54 |
MitraClip in ring (3x) |
None |
Alive |
11 |
Prolapse |
MV repair with ring |
1.2 |
Recurrent prolapse |
58 |
MitraClip in ring (2x) |
Moderate |
Alive |
12 |
Anulusdilatation & Tethering |
MV repair with ring |
2.3 |
Restrictive posterior leaflet |
79 |
Valve-in-ring, |
Mild |
Alive |
13 |
Infectious endocarditis |
MV repair with ring |
1.0 |
Degenerative/Stenotic |
73 |
Valve-in-ring, |
None* |
Alive |
14 |
Unknown |
MV repair with ring |
7.0 |
Flail leaflet |
77 |
Valve-in-ring, |
Mild |
Alive |
15 |
Infectious endocarditis |
MV replacement |
13.3 |
Flail leaflet |
89 |
Valve-in-valve, |
None |
Death at 394d |
16 |
Unknown |
MV replacement |
9.8 |
Flail leaflet |
80 |
Valve-in-valve, |
None |
Alive |
17 |
Post-rheumatic |
MV replacement |
8.2 |
Degeneration |
85 |
Valve-in-valve, Sapien 3 26mm (transseptal) |
None* |
Alive |
Technical success was obtained in 15 cases (88%). The intra-procedural TEE in patient #13 showed a left ventricular outflow tract obstruction after VIR procedure. A CoreValve Evolut R 29 mm prosthesis (Medtronic, Minneapolis, Minnesota) was successfully implanted in aortic position and effectively reduced outflow tract obstruction. Furthermore, trace of a paravalvular leak in mitral position was detected after the procedure but did not required treatment. At last examination (3 months), good clinical condition (NYHA I) and no signs of LVOT obstruction or worsening of paravalvular leak were observed [22]. For patient #14 the first intended procedure was a MC repair. However, after initial MC placement, significant MR remained, and the insertion of a second MC would not have been possible due to a too small MV area. The MC intervention was thus aborted and successfully converted to a VIR (Sapien 3, 29mm) after removal of the clip. Patient #17 developed a minimal paravalvular leak, which did not needed treatment. Patient #15 required a pacemaker implantation for symptomatic sick sinus syndrome on the first post-operative day.
Abbreviations: RV: Right ventricle; RA: Right atrium.
The valve prosthesis and access route of choice for redo transcatheter mitral valve replacement is a matter of debate. At this time, balloon-expandable aortic Sapien XT or Sapien 3 valves (Edwards Life sciences, Irvine, California) are predominantly reported in series describing percutaneous mitral VIR or VIV replacement [9,12,23,25]. Other types of valves are either under investigation, anatomically not suitable or described only in few number of studies. Based on the experiences of transcatheter aortic valve implantations, the initial access route for percutaneous mitral valve replacement was transapical, enabling good alignment with the ring/prosthesis in mitral position [10]. The development of third and fourth generation percutaneous valves with advanced steering capabilities of the catheter has promoted the transseptal approach in recent publications [23,25,27]. The use of the recently developed real time fusion imaging techniques like EchoNavigator (Phillips Healthcare, Amsterdam, Netherlands) further facilitates such interventions [30,31]. The rate of mild paravalvular MR of 33% in our cohort reflects the results of others [26]. Considering an occurrence rate of paravalvular MR after surgical MV replacement in native valves between 5-17% [32], these initial studies may suggest that paravalvular MR are more likely to occur during VIR and VIV. Access route might play a role in this regard as optimal axonal orientation of the prosthetic valve within the annuloplasty ring is more easily reached using an apical compared to a transseptal approach.
- Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11. doi:10.1016/S0140-6736(06)69208-8
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014;148(1):e1-e132. doi:10.1016/j.jtcvs.2014.05.014
- Thourani VH, Weintraub WS, Guyton RA, Jones EL, Williams WH, Elkabbani S, et al. Outcomes and long-term survival for patients undergoing mitral valve repair versus replacement: effect of age and concomitant coronary artery bypass grafting. Circulation. 2003;108(3):298-304. doi:10.1161/01.CIR.0000079169.15862.13
- Enriquez-Sarano M, Schaff HV, Orszulak TA, Tajik AJ, Bailey KR, Frye RL. Valve repair improves the outcome of surgery for mitral regurgitation. A multivariate analysis. Circulation. 1995;91(4):1022-8
- Goldstein D, Gelijns AC, Moskowitz AJ. Surgery for Severe Ischemic Mitral Regurgitation. N Engl J Med. 2016;374(20):1992-3. doi:10.1056/NEJMc1602607
- Feldman T, Young A. Percutaneous approaches to valve repair for mitral regurgitation. J Am Coll Cardiol. 2014;63(20):2057-68 doi:10.1016/j.jacc.2014.01.039
- Surder D, Pedrazzini G, Gaemperli O, Biaggi P, Felix C, Rufibach K, et al. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart. 2013;99(14):1034-40. doi:10.1136/heartjnl-2012-303105
- Nishimura RA, Vahanian A, Eleid MF, Mack MJ. Mitral valve disease--current management and future challenges. Lancet. 2016;387(10025):1324-34. doi:10.1016/S0140-6736(16)00558-4
- Descoutures F, Himbert D, Maisano F, Casselman F, de Weger A, Bodea O, et al. Transcatheter valve-in-ring implantation after failure of surgical mitral repair. Eur J Cardiothorac Surg. 2013;44(1):e8-15. doi:10.1093/ejcts/ezt155
- Webb JG, Wood DA, Ye J, Gurvitch R, Masson JB, Rodés-Cabau J, et al. Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves. Circulation. 2010;121(16):1848-57. doi:10.1161/CIRCULATIONAHA.109.924613
- Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010;76(3):455-9. doi:10.1002/ccd.22547
- Wilbring M, Alexiou K, Tugtekin SM, Arzt S, Ibrahim K, Matschke K, et al. Pushing the limits-further evolutions of transcatheter valve procedures in the mitral position, including valve-in-valve, valve-in-ring, and valve-in-native-ring. J Thorac Cardiovasc Surg. 2014;147(1):210-9. doi:10.1016/j.jtcvs.2013.09.021
- Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. EuroSCORE II. Eur J Cardiothorac Surg. 2012;41(4):734-44. doi:10.1093/ejcts/ezs043
- Puskas JD, Kilgo PD, Thourani VH, Lattouf OM, Chen E, Vega JD, et al. The society of thoracic surgeons 30-day predicted risk of mortality score also predicts long-term survival. Ann Thorac Surg. 2012;93(1):26-33; discussion -5. doi:10.1016/j.athoracsur.2011.07.086
- Chikwe J, Goldstone AB, Passage J, Anyanwu AC, Seeburger J, Castillo JG et al. A propensity score-adjusted retrospective comparison of early and mid-term results of mitral valve repair versus replacement in octogenarians. Eur Heart J. 2011;32(5):618-26. doi:10.1093/eurheartj/ehq331
- Gaemperli O, Moccetti M, Surder D, Biaggi P, Hurlimann D, Kretschmar O, et al. Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes. Heart. 2012;98(2):126-32. doi:10.1136/heartjnl-2011-300705
- Gruner C, Herzog B, Bettex D, Felix C, Datta S, Greutmann M, et al. Quantification of mitral regurgitation by real time three-dimensional color Doppler flow echocardiography pre- and post-percutaneous mitral valve repair. Echocardiography. 2015;32(7):1140-6. doi:10.1111/echo.12809
- Biaggi P, Felix C, Gruner C, Herzog BA, Hohlfeld S, Gaemperli O, et al. Assessment of mitral valve area during percutaneous mitral valve repair using the MitraClip system: comparison of different echocardiographic methods. Circ Cardiovasc Imaging. 2013;6(6):1032-40. doi:10.1161/CIRCIMAGING.113.000620
- Frank M, Ganzoni G, Starck C, Grünenfelder J, Corti R, Gruner C, et al. Lack of Accessible Data on Prosthetic Heart Valves. Int J Cardiovasc Imaging. 2016;32(3):439-47. doi:10.1007/s10554-015-0805-9
- Frank M, Ganzoni G, Starck C, Grünenfelder J, Corti R, Gruner C, et al. Lack of Accessible Data on Prosthetic Heart Valves. Int J Cardiovasc Imaging. 2016;32(3):439-47. doi:10.1007/s10554-015-0805-9
- Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, et al. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015;66(3):308-21. doi:10.1016/j.jacc.2015.05.049
- Taramasso M, Nietlispach F, Schmid M, Maisano F. Corevalve Evolut R implantation to treat severe left ventricle outflow tract obstruction following mitral valve-in-ring: first-in-man report. Eur Heart J. 2016;37(3):317. doi:10.1093/eurheartj/ehv617
- Taramasso M, Nietlispach F, Schmid M, Maisano F. Corevalve Evolut R implantation to treat severe left ventricle outflow tract obstruction following mitral valve-in-ring: first-in-man report. Eur Heart J. 2016;37(3):317. doi:10.1093/eurheartj/ehv617
- Cheung A, Webb JG, Barbanti M, Freeman M, Binder RK, Thompson C et al. 5-year experience with transcatheter transapical mitral valve-in-valve implantation for bioprosthetic valve dysfunction. J Am Coll Cardiol. 2013;61(17):1759-66. doi:10.1016/j.jacc.2013.01.058
- Bouleti C, Fassa AA, Himbert D, Brochet E, Ducrocq G, Nejjari M, et al. Transfemoral implantation of transcatheter heart valves after deterioration of mitral bioprosthesis or previous ring annuloplasty. JACC Cardiovasc Interv. 2015;8(1 Pt A):83-91. doi:10.1016/j.jcin.2014.07.026
- Seiffert M, Conradi L, Baldus S, Schirmer J, Knap M, Blankenberg S, et al. Transcatheter mitral valve-in-valve implantation in patients with degenerated bioprostheses. JACC Cardiovasc Interv. 2012;5(3):341-9. doi:10.1016/j.jcin.2011.12.008
- Coylewright M, Cabalka AK, Malouf JA, Geske JB, Pollak PM, Suri RM, et al. Percutaneous mitral valve replacement using a transvenous, transseptal approach: transvenous mitral valve replacement. JACC Cardiovasc Interv. 2015;8(6):850-7. doi:10.1016/j.jcin.2015.01.028
- Grasso C, Ohno Y, Attizzani GF, Cannata S, Immè S, Barbanti M, et al. Percutaneous mitral valve repair with the MitraClip system for severe mitral regurgitation in patients with surgical mitral valve repair failure. J Am Coll Cardiol. 2014;63(8):836-8. doi:10.1016/j.jacc.2013.09.045
- Toggweiler S, Zuber M, Surder D, Biaggi P, Gstrein C, Moccetti T, et al. Two-year outcomes after percutaneous mitral valve repair with the MitraClip system: durability of the procedure and predictors of outcome. Open Heart. 2014;1(1):e000056. doi:10.1136/openhrt-2014-000056
- Sundermann SH, Biaggi P, Grunenfelder J, Gessat M, Felix C, Bettex D, et al. Safety and feasibility of novel technology fusing echocardiography and fluoroscopy images during MitraClip interventions. EuroIntervention. 2014;9(10):1210-6. doi:10.4244/EIJV9I10A203
- Biaggi P, Fernandez-Golfin C, Hahn R, Corti R. Hybrid Imaging During Transcatheter Structural Heart Interventions. Curr Cardiovasc Imaging Rep. 2015;8(9):33. doi:10.1007/s12410-015-9349-6
- Rihal CS, Sorajja P, Booker JD, Hagler DJ, Cabalka AK. Principles of percutaneous paravalvular leak closure. JACC Cardiovasc Interv. 2012;5(2):121-30. doi:10.1016/j.jcin.2011.11.007
- Bail DH, Doebler K. The MitraClip System: a systematic review of indications, procedural requirements, and guidelines. Thorac Cardiovasc Surg. 2014;62(1):18-25. doi:10.1055/s-0033-1360509