Abstract
Aims
To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results.
Methods and results
A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications.
Conclusion
PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.
Graphic abstract
Similar content being viewed by others
References
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M (2006) Burden of valvular heart diseases: a population-based study. Lancet 368(9540):1005–1011. https://doi.org/10.1016/s0140-6736(06)69208-8
Dziadzko V, Clavel MA, Dziadzko M, Medina-Inojosa JR, Michelena H, Maalouf J, Nkomo V, Thapa P, Enriquez-Sarano M (2018) Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet 391(10124):960–969. https://doi.org/10.1016/s0140-6736(18)30473-2
Rossi A, Dini FL, Faggiano P, Agricola E, Cicoira M, Frattini S, Simioniuc A, Gullace M, Ghio S, Enriquez-Sarano M, Temporelli PL (2011) Independent prognostic value of functional mitral regurgitation in patients with heart failure. A quantitative analysis of 1256 patients with ischaemic and non-ischaemic dilated cardiomyopathy. Heart 97(20):1675–1680. https://doi.org/10.1136/hrt.2011.225789
Nishimura RA, Vahanian A, Eleid MF, Mack MJ (2016) Mitral valve disease–current management and future challenges. Lancet 387(10025):1324–1334. https://doi.org/10.1016/s0140-6736(16)00558-4
Mirabel M, Iung B, Baron G, Messika-Zeitoun D, Detaint D, Vanoverschelde JL, Butchart EG, Ravaud P, Vahanian A (2007) What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 28(11):1358–1365. https://doi.org/10.1093/eurheartj/ehm001
Andalib A, Mamane S, Schiller I, Zakem A, Mylotte D, Martucci G, Lauzier P, Alharbi W, Cecere R, Dorfmeister M, Lange R, Brophy J, Piazza N (2014) A systematic review and meta-analysis of surgical outcomes following mitral valve surgery in octogenarians: implications for transcatheter mitral valve interventions. EuroIntervention 9(10):1225–1234. https://doi.org/10.4244/eijv9i10a205
Vahanian A, Iung B, Hamm C, Rodriguez Muñoz D, Lansac E, Bax JJ, Sjögren J, Zamorano JL, De Bonis M, Wendler O, Lancellotti P, Holm PJ, Tornos Mas P, Rosenhek R, Windecker S, Walther T, Falk V, Baumgartner H (2017) 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 38(36):2739–2791. https://doi.org/10.1093/eurheartj/ehx391
Iliadis C, Lee S, Kuhr K, Metze C, Matzik AS, Michels G, Rudolph V, Baldus S, Pfister R (2017) Functional status and quality of life after transcatheter mitral valve repair: a prospective cohort study and systematic review. Clin Res Cardiol 106(12):1005–1017. https://doi.org/10.1007/s00392-017-1150-x
Pfister R, Baldus S (2018) Atrioventricular valve disease: challenges and achievements in percutaneous treatment. Clin Res Cardiol 107(Suppl 2):88–93. https://doi.org/10.1007/s00392-018-1303-6
Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L (2015) Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVEREST II. J Am Coll Cardiol 66(25):2844–2854. https://doi.org/10.1016/j.jacc.2015.10.018
Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L (2011) percutaneous repair or surgery for mitral regurgitation. N Engl J Med 364(15):1395–1406. https://doi.org/10.1056/NEJMoa1009355
Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T (2013) 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol 62(4):317–328. https://doi.org/10.1016/j.jacc.2013.04.030
Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ (2018) Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med 379(24):2307–2318. https://doi.org/10.1056/NEJMoa1806640
Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N (2018) Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 379(24):2297–2306. https://doi.org/10.1056/NEJMoa1805374
Pfister R, Hausleiter J, Boekstegers P, Mollmann H, Nef H, Rudolph V (2019) Role of percutaneous edge-to-edge repair in secondary mitral regurgitation after MITRA-FR and COAPT: a comment by the section of AV-valve treatment of the Working Group of Interventional Cardiology (AGIK) of the German Society of Cardiology (DGK). Clin Res Cardiol. doi:10.1007/s00392-019-01457-3.
Desai MY, Grigioni F, Di Eusanio M, Saccocci M, Taramasso M, Maisano F, Suri RM, Gillinov AM (2017) Outcomes in degenerative mitral regurgitation: current state-of-the art and future directions. Prog Cardiovasc Dis 60(3):370–385. https://doi.org/10.1016/j.pcad.2017.10.005
Asgar AW, Mack MJ, Stone GW (2015) Secondary mitral regurgitation in heart failure: pathophysiology, prognosis, and therapeutic considerations. J Am Coll Cardiol 65(12):1231–1248. https://doi.org/10.1016/j.jacc.2015.02.009
Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, St Goar F, Rodriguez L, Silvestry F, Schwartz A, Sanborn TA, Condado JA, Foster E (2005) Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol 46(11):2134–2140. https://doi.org/10.1016/j.jacc.2005.07.065
Grasso C, Popolo Rubbio A (2017) The PASCAL transcatheter mitral valve repair system for the treatment of mitral regurgitation: another piece to the puzzle of edge-to-edge technique. J Thorac Dis 9(12):4856–4859. https://doi.org/10.21037/jtd.2017.10.156
Attizzani GF, Ohno Y, Capodanno D, Cannata S, Dipasqua F, Imme S, Mangiafico S, Barbanti M, Ministeri M, Cageggi A, Pistritto AM, Giaquinta S, Farruggio S, Chiaranda M, Ronsivalle G, Schnell A, Scandura S, Tamburino C, Capranzano P, Grasso C (2015) Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry. JACC Cardiovasc Interv 8(1 Pt A):74–82. https://doi.org/10.1016/j.jcin.2014.07.024
Lesevic H, Karl M, Braun D, Barthel P, Orban M, Pache J, Hadamitzky M, Mehilli J, Stecher L, Massberg S, Ott I, Schunkert H, Kastrati A, Sonne C, Hausleiter J (2017) Long-term outcomes after MitraClip Implantation according to the presence or absence of EVEREST inclusion criteria. Am J Cardiol 119(8):1255–1261. https://doi.org/10.1016/j.amjcard.2016.12.027
Lancellotti P, Tribouilloy C, Hagendorff A, Popescu BA, Edvardsen T, Pierard LA, Badano L, Zamorano JL (2013) Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 14(7):611–644. https://doi.org/10.1093/ehjci/jet105
Kitamura M, Kaneko H, Schluter M, Schewel D, Schmidt T, Alessandrini H, Kreidel F, Neuss M, Butter C, Kuck KH, Frerker C (2019) Predictors of mortality in ischaemic versus non-ischaemic functional mitral regurgitation after successful transcatheter mitral valve repair using MitraClip: results from two high-volume centres. Clin Res Cardiol 108(3):264–272. https://doi.org/10.1007/s00392-018-1352-x
Doenst T, Kirov H, Moschovas A, Gonzalez-Lopez D, Safarov R, Diab M, Bargenda S, Faerber G (2018) Cardiac surgery 2017 reviewed. Clin Res Cardiol 107(12):1087–1102. https://doi.org/10.1007/s00392-018-1280-9
Wengenmayer T, Reinohl J, Steinfurt J, Mittag A, Bode C, Biermann J (2017) Implantation of CARILLON((R)) mitral contour system with transvenous left ventricular lead in place. Clin Res Cardiol 106(10):796–801. https://doi.org/10.1007/s00392-017-1121-2
Praz F, Spargias K, Chrissoheris M, Bullesfeld L, Nickenig G, Deuschl F, Schueler R, Fam NP, Moss R, Makar M, Boone R, Edwards J, Moschovitis A, Kar S, Webb J, Schafer U, Feldman T, Windecker S (2017) Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Lancet 390(10096):773–780. https://doi.org/10.1016/s0140-6736(17)31600-8
Kreusser MM, Geis NA, Berlin N, Greiner S, Pleger ST, Bekeredjian R, Katus HA, Raake PW (2019) Invasive hemodynamics and cardiac biomarkers to predict outcomes after percutaneous edge-to-edge mitral valve repair in patients with severe heart failure. Clin Res Cardiol 108(4):375–387. https://doi.org/10.1007/s00392-018-1365-5
Ledwoch J, Franke J, Lubos E, Boekstegers P, Puls M, Ouarrak T, von Bardeleben S, Butter C, Schofer J, Zahn R, Ince H, Senges J, Sievert H (2018) Prognostic value of preprocedural 6-min walk test in patients undergoing transcatheter mitral valve repair-insights from the German transcatheter mitral valve interventions registry. Clin Res Cardiol 107(3):241–248. https://doi.org/10.1007/s00392-017-1177-z
Schwencke C, Bijuklic K, Ouarrak T, Lubos E, Schillinger W, Plicht B, Eggebrecht H, Baldus S, Schymik G, Boekstegers P, Hoffmann R, Senges J, Schofer J (2017) Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry. Clin Res Cardiol 106(4):249–258. https://doi.org/10.1007/s00392-016-1044-3
Schueler R, Ozturk C, Sinning JM, Werner N, Welz A, Hammerstingl C, Nickenig G (2017) Impact of baseline tricuspid regurgitation on long-term clinical outcomes and survival after interventional edge-to-edge repair for mitral regurgitation. Clin Res Cardiol 106(5):350–358. https://doi.org/10.1007/s00392-016-1062-1
Möllmann H, Bayer M, Blumenstein J, Dörr O, Marks M, Dyckmanns N, Dohmen G, Sydow M, Al-Terki H, Husser O, Hamm CW, Nef H, Gaede L (2019) First experience with the new MitraClip NTR/XTR device. Struct Heart 1–8. doi:10.1080/24748706.2019.1618512
Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE (2019) Transcatheter valve repair for patients with mitral regurgitation: 30-day results of the CLASP study. JACC Cardiovasc Interv. doi:10.1016/j.jcin.2019.04.034
Stolfo D, De Luca A, Morea G, Merlo M, Vitrella G, Caiffa T, Barbati G, Rakar S, Korcova R, Perkan A, Pinamonti B, Pappalardo A, Berardini A, Biagini E, Saia F, Grigioni F, Rapezzi C, Sinagra G (2018) Predicting device failure after percutaneous repair of functional mitral regurgitation in advanced heart failure: Implications for patient selection. Int J Cardiol 257:182–187. https://doi.org/10.1016/j.ijcard.2018.01.009
Taramasso M, Denti P, Latib A, Guidotti A, Buzzatti N, Pozzoli A, Di Giannuario G, La Canna G, Colombo A, Alfieri O, Maisano F (2015) Clinical and anatomical predictors of MitraClip therapy failure for functional mitral regurgitation: single central clip strategy in asymmetric tethering. Int J Cardiol 186:286–288. https://doi.org/10.1016/j.ijcard.2015.03.236
Neuss M, Schau T, Isotani A, Pilz M, Schöpp M, Butter C (2017) Elevated mitral valve pressure gradient after MitraClip implantation deteriorates long-term outcome in patients with severe mitral regurgitation and severe heart failure. JACC: Cardiovasc Intervent 10(9), 931–939. https://doi.org/10.1016/j.jcin.2016.12.280
Acknowledgements
We thank Elizabeth Martinson, Ph.D., of the KHFI Editorial Office for her editorial assistance.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
HM and LG received speaker honoraria from Abbott Vascular and Edwards Lifesciences. HN received speaker honoraria from Abbott Vascular; none of the other authors have any potential conflict of interest regarding this topic.
Ethical standards
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committees of the participating centers and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Rights and permissions
About this article
Cite this article
Kriechbaum, S.D., Boeder, N.F., Gaede, L. et al. Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. Clin Res Cardiol 109, 549–559 (2020). https://doi.org/10.1007/s00392-019-01538-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00392-019-01538-3