Skip to main content
Log in

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device

  • Original Paper
  • Published:
Clinical Research in Cardiology Aims and scope Submit manuscript

Abstract

Aims

To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system.

Methods and results

Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III–IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement.

Conclusion

MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Graphic abstract

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Robbins JD, Maniar PB, Cotts W, Parker MA, Bonow RO, Gheorghiade M (2003) Prevalence and severity of mitral regurgitation in chronic systolic heart failure. Am J Cardiol 91:360–362

    Article  Google Scholar 

  2. Trichon BH, Felker GM, Shaw LK, Cabell CH, O’Connor CM (2003) Relation of frequency and severity of mitral regurgitation to survival among patients with left ventricular systolic dysfunction and heart failure. Am J Cardiol 91:538–543

    Article  Google Scholar 

  3. Patel JB, Borgeson DD, Barnes ME, Rihal CS, Daly RC, Redfield MM (2004) Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail 10:285–291

    Article  Google Scholar 

  4. 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

    Article  Google Scholar 

  5. Braunberger E, Deloche A, Berrebi A, Abdallah F, Celestin JA, Meimoun P, Chatellier G, Chauvaud S, Fabiani JN, Carpentier A (2001) Very long term results (more than 20 years) of valve repair with carpentier’s technique in nonrheumatic mitral valve insufficiency. Circulation 104(12 Suppl 1):I8–I11

    Article  CAS  Google Scholar 

  6. Seeburger J, Borger MA, Falk V, Kuntze T, Czesla M, Walther T, Doll N, Mohr FW (2008) Minimal invasive mitral valve repair for mitral regurgitation: results of 1339 consecutive patients. Eur J Cardiothorac Surg 34:760–765

    Article  Google Scholar 

  7. Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL, CTSN (2014) Mitral-valve repair versus replacement for severe ischemic mitral regurgitation. N Engl J Med 370(1):23–32

    Article  CAS  Google Scholar 

  8. Van Mieghem NM, Piazza N, Anderson RH, Tzikas A, Nieman K, De Laat LE, McGhie JS, Geleijnse ML, Feldman T, Serruys PW, de Jaegere PP (2010) Anatomy of the mitral valvular complex and its implications for transcatheter interventions for mitral regurgitation. J Am Coll Cardiol 56:617–626

    Article  Google Scholar 

  9. Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jäckle A, Schlüter M, Reichenspurner H, Meinertz T (2010) Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J 31:1373–1381

    Article  Google Scholar 

  10. Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D, Investigators EVEREST (2009) 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 54(8):686–694

    Article  Google Scholar 

  11. 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

    Article  Google Scholar 

  12. 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

    Article  Google Scholar 

  13. Kriechbaum SD, Boeder NF, Gaede L, Arnold M, Vigelius-Rauch U, Roth P, Sander M, Böning A, Bayer M, Elsässer A, Möllmann H, Hamm CW, Nef HM (2020) Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. Clin Res Cardiol 109(5):549–559

    Article  CAS  Google Scholar 

  14. 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, Schäfer 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 12(14):1369–1378

    Article  Google Scholar 

  15. Besler C, Noack T, von Roeder M, Kitamura M, Kresoja KP, Flo Forner A, Bevilacqua C, Desch S, Ender J, Borger M, Thiele H, Lurz P (2020) Transcatheter edge-to-edge mitral valve repair with the PASCAL system: early results from a real-world series. EuroIntervention. https://doi.org/10.4244/EIJ-D-20-00216

    Article  PubMed  Google Scholar 

  16. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL (2017) ESC scientific document group. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 38:2739–2791

    Article  Google Scholar 

  17. Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS, Mitral Valve Academic Research Consortium (MVARC) (2015) 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 66:308–321

    Article  Google Scholar 

  18. Kuss O (2013) The z-difference can be used to measure covariate balance in matched propensity score analyses. J Clin Epidemiol 66:1302–1307

    Article  Google Scholar 

  19. Austin PC (2007) Propensity-score matching in the cardiovascular surgery literature from 2004 to 2006: a systematic review and suggestions for improvement. J Thorac Cardiovasc Surg 134:1128–1135

    Article  Google Scholar 

  20. Bertsekas DP, Tseng P (1998) Relaxation methods for minimum cost ordinary and generalized network flow problems. Oper Res 36:93–114

    Article  Google Scholar 

  21. Praz F, Spargias K, Chrissoheris M, Büllesfeld L, Nickenig G, Deuschl F, Schueler R, Fam NP, Moss R, Makar M, Boone R, Edwards J, Moschovitis A, Kar S, Webb J, Schäfer 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 390:773–780

    Article  Google Scholar 

  22. Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D, Investigators EVEREST (2009) Percutaneousmitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (endo-vascular valve edge-to-edge repair study) cohort. J Am Coll Cardiol 54:686–694

    Article  Google Scholar 

  23. 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, EVERESTII Investigators (2011) Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 364(15):1395–1406

    Article  CAS  Google Scholar 

  24. Nozohoor S, Hyllén S, Meurling C, Wierup P, Sjögren J (2012) Prognostic value of pulmonary hypertension in patients undergoing surgery for degenerative mitral valve disease with leaflet prolapse. J Card Surg 27:668–675

    Article  Google Scholar 

  25. Kainuma S, Taniguchi K, Toda K, Funatsu T, Kondoh H, Nishino M, Daimon T, Sawa Y (2011) Pulmonary hypertension predicts adverse cardiac events after restrictive mitral annuloplasty for severe functional mitral regurgitation. J Thorac Cardiovasc Surg 142(4):783–792

    Article  Google Scholar 

  26. Damy T, Goode KM, Kallvikbacka-Bennett A, Lewinter C, Hobkirk J, Nikitin NP, Dubois-Randé JL, Hittinger L, Clark AL, Cleland GF (2010) Determinants and prognostic value of pulmonary arterial pressure in patients with chronic heart failure. Eur Heart J 31:2280–2290

    Article  CAS  Google Scholar 

  27. Ghio S, Gavazzi A, Campana C, Inserra C, Klersy C, Sebastiani R, Arbustini E, Recusani F, Tavazzi L (2001) Independent and additive prognostic value of right ventricular function and pulmonary artery pressure in patients with chronic heart failure. J Am Coll Cardiol 37:183–188

    Article  CAS  Google Scholar 

  28. Barth S, Hautmann MB, Kerber S, Gietzen F, Reents W, Zacher M, Halbfass P, Griese DP, Schieffer B, Hamm K (2017) Left ventricular ejection fraction of < 20%: too bad for MitraClip©? Catheter Cardiovasc Interv 90(6):1038–1045

    Article  Google Scholar 

  29. Barth S, Hautmann MB, Kerber S, Gietzen F, Zacher M, Halbfass P, Müller P, Schade A, Deneke T, Diegeler A, Schieffer B, Hamm K (2016) Hemodynamic improvement at three months after MitraClip® treatment in end-stage heart failure patients with functional mitral regurgitation. J Heart Valve Dis 25(4):475–482

    PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Sebastian Barth.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committees of the participating center 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

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Barth, S., Hautmann, M.B., Arvaniti, E. et al. Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device. Clin Res Cardiol 110, 628–639 (2021). https://doi.org/10.1007/s00392-020-01733-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00392-020-01733-7

Keywords

Navigation