Single-center five-year outcomes after interventional edge-to-edge repair of the mitral valve
Abstract
Background: The MitraClip procedure was established as a therapeutic alternative to mitral valve surgery for symptomatic patients with severe mitral regurgitation (MR) at prohibitive surgical risk. In this study, the aim was to evaluate 5-year outcomes after MitraClip.
Methods: Consecutive patients undergoing the MitraClip system were prospectively included. All patients underwent clinical follow-up and transthoracic echocardiography.
Results: Two hundred sixty-five patients (age: 81.4 ± 8.1 years, 46.7% female, logistic EuroSCORE: 19.7 ± 16.7%) with symptomatic MR (60.5% secondary MR [sMR]). Although high procedural success of 91.3% was found, patients with primary MR (pMR) had a higher rate of procedural failure (sMR: 3.1%, pMR: 8.6%; p = 0.04). Five years after the MitraClip procedure, the majority of patients presented with reduced symptoms and improved functional capacity (functional NYHA class: p = 0.0001; 6 minutes walking test: p = 0.04). Sustained MR reduction (≤ grade 2) was found in 74% of patients, and right ventricular (RV) function was significantly increased (p = 0.03). Systolic pulmonary artery pressure (sPAP) was significantly reduced during follow-up only in sMR patients (p = 0.05, p = 0.3). Despite a pronounced clinical and echocardiographical amelioration and low interventional failure, 5-year mortality was significantly higher in patients with sMR (p = 0.05). The baseline level of creatinine (HR: 0.695), sPAP (HR: 0.96) and mean mitral valve gradient (MVG) (HR: 0.82) were found to be independent predictors for poor functional outcome and mortality.
Conclusions: Transcatheter mitral valve repair with the MitraClip system showed low complication rates and sustained MR reduction with improved RV function and sPAP 5 years after the procedure was found in all patients, predominantly in patients with sMR. Despite pronounced functional amelioration with low procedure failure, sMR patients had higher 5-year mortality and worse outcomes. Baseline creatinine, MVG, and sPAP were found to be independent predictors of poor functional outcomes and 5-year mortality.
Keywords: MitraCliptranscatheter mitral valve repairlong-term outcomesmitral regurgitation
References
- Baldus S, Schillinger W, Franzen O, et al. MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail. 2012; 14(9): 1050–1055.
- Franzen O, van der Heyden J, Baldus S, et al. MitraClip® therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011; 13(5): 569–576.
- Garatti A, Castelvecchio S, Bandera F, et al. Mitraclip procedure as a bridge therapy in a patient with heart failure listed for heart transplantation. Ann Thorac Surg. 2015; 99(5): 1796–1799.
- Silvestry FE, Rodriguez LL, Herrmann HC, et al. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007; 20(10): 1131–1140.
- Feldman T, Kar S, Rinaldi M, et al. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009; 54(8): 686–694.
- Mauri L, Garg P, Massaro JM, et al. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010; 160(1): 23–29.
- Mauri L, Foster E, Glower DD, et al. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013; 62(4): 317–328.
- Puls M, Lubos E, Boekstegers P, et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J. 2016; 37(8): 703–712.
- Neuss M, Schau T, Isotani A, et al. Elevated mitral valve pressure gradient after mitraclip implantation deteriorates long-term outcome in patients with severe mitral regurgitation and severe heart failure. JACC Cardiovasc Interv. 2017; 10(9): 931–939.
- Matsumoto T, Nakamura M, Yeow WL, et al. Impact of pulmonary hypertension on outcomes in patients with functional mitral regurgitation undergoing percutaneous edge-to-edge repair. Am J Cardiol. 2014; 114(11): 1735–1739.
- Stone GW, Adams DH, Abraham WT, et al. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015; 66(3): 278–307.
- Zoghbi WA, Enriquez-Sarano M, Foster E, et al. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003; 16(7): 777–802.
- Ashikhmina E, Shook D, Cobey F, et al. Three-dimensional versus two-dimensional echocardiographic assessment of functional mitral regurgitation proximal isovelocity surface area. Anesth Analg. 2015; 120(3): 534–542.
- Sherif MA, Paranskaya L, Yuecel S, et al. MitraClip step by step; how to simplify the procedure. Neth Heart J. 2017; 25(2): 125–130.
- Thornton T, McDermott L. MitraClip® system design and history of development. Percutaneous Mitral Leaflet Repair. 2013: 36–44.
- Armstrong EJ, Foster E. Echocardiographic evaluation for mitral regurgitation grading and patient selection. Percutaneous Mitral Leaflet Repair: MitraClip Therapy for Mitral Regurgitation, vol. 17. First Informa Healthcare. 2012: 73–79.
- Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013; 14(10): 935–949.
- Toggweiler S, Zuber M, Sürder D, 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.
- Capodanno D, Adamo M, Barbanti M, et al. Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair. Am Heart J. 2015; 170(1): 187–195.
- Feldman T, Kar S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol. 2015; 66(25): 2844–2854.
- Stone G, Lindenfeld J, Abraham W, et al. Transcatheter mitral-valve repair in patients with heart failure. New Engl J Med. 2018; 379(24): 2307–2318.
- Buzzatti N, Denti P, Scarfò IS, et al. Mid-term outcomes (up to 5 years) of percutaneous edge-to-edge mitral repair in the real-world according to regurgitation mechanism: A single-center experience. Catheter Cardiovasc Interv. 2018 [Epub ahead of print].
- Azzalini L, Millán X, Khan R, et al. Impact of left ventricular function on clinical outcomes of functional mitral regurgitation patients undergoing transcatheter mitral valve repair. Catheter Cardiovasc Interv. 2016; 88(7): 1124–1133.
- Ohno Y, Attizzani GF, Capodanno D, et al. Impact of chronic kidney disease on outcomes after percutaneous mitral valve repair with the MitraClip system: insights from the GRASP registry. EuroIntervention. 2016; 11(14): e1649–e1657.
