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Valvular heart disease
Original research
Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole
  1. Jonas Pausch1,
  2. Eva Harmel2,
  3. Hermann Reichenspurner1,3,
  4. Jörg Kempfert4,5,
  5. Thomas Kuntze6,
  6. Tamer Owais7,
  7. Tomas Holubec8,
  8. Thomas Walther8,9,
  9. Markus Krane10,11,
  10. Keti Vitanova10,
  11. Michael Andrew Borger12,
  12. Matthias Eden13,
  13. Violetta Hachaturyan14,
  14. Peter Bramlage14,
  15. Volkmar Falk4,5,15,16,
  16. Evaldas Girdauskas1,3,7
  1. 1 Department of Cardiovascular Surgery, University Medical Center Hamburg-Eppendorf University Heart & Vascular Center, Hamburg, Germany
  2. 2 I. Medical Clinic, University Hospital Augsburg, Augsburg, Germany
  3. 3 German Center for Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel, Hamburg, Germany
  4. 4 Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany
  5. 5 German Center for Cardiovascular Research, Partner Site Berlin, Berlin, Germany
  6. 6 Department of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany
  7. 7 Department of Cardiovascular and Thoracic Surgery, University Hospital Augsburg, Augsburg, Germany
  8. 8 Department of Cardiovascular Surgery, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany
  9. 9 German Center for Cardiovascular Research, Partner Site Rhine-Main, Frankfurt, Germany
  10. 10 Department of Cardiac Surgery, German Heart Center Munich, München, Germany
  11. 11 Department of Surgery, Yale School of Medicine, New Haven, Connecticut, USA
  12. 12 University Clinic of Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany
  13. 13 Department for Internal Medicine, University Hospital Heidelberg, Heidelberg, Germany
  14. 14 Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
  15. 15 Department of Cardiovascular Surgery, Charité - Universitätsmedizin Berlin, Berlin, Germany
  16. 16 Department of Health Sciences and Technology, ETH Zurich, Zurich, Switzerland
  1. Correspondence to Dr Jonas Pausch, Department of Cardiovascular Surgery, University Medical Center Hamburg-Eppendorf University Heart & Vascular Center, Hamburg 20246, Germany; j.pausch{at}uke.de

Abstract

Objective Ventricular secondary mitral regurgitation (SMR) (Carpentier type IIIb) results from left ventricular (LV) remodelling, displacement of papillary muscles and tethering of mitral leaflets. The most appropriate treatment approach remains controversial. We aimed to assess the safety and efficacy of standardised relocation of both papillary muscles (subannular repair) at 1-year follow-up (FU).

Methods REFORM-MR (Reform-Mitral Regurgitation) is a prospective, multicentre registry that enrolled consecutive patients with ventricular SMR (Carpentier type IIIb) undergoing standardised subannular mitral valve (MV) repair in combination with annuloplasty at five sites in Germany. Here, we report survival, freedom from recurrence of MR >2+, freedom from major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death, myocardial infarction, stroke, MV reintervention and echocardiographic parameters of residual leaflet tethering at 1-year FU.

Results A total of 94 patients (69.1% male) with a mean age of 65.1±9.7 years met the inclusion criteria. Advanced LV dysfunction (mean left ventricular ejection fraction 36.4±10.5%) and severe LV dilatation (mean left ventricular end-diastolic diameter 61.0±9.3 mm) resulted in severe mitral leaflet tethering (mean tenting height 10.6±3.0 mm) and an elevated mean EURO Score II of 4.8±4.6 prior to surgery. Subannular repair was successfully performed in all patients, without operative mortality or complications. One-year survival was 95.5%. At 12 months, a durable reduction of mitral leaflet tethering resulted in a low rate (4.2%) of recurrent MR >2+. In addition to a significant improvement in New York Heart Association (NYHA) class (22.4% patients in NYHA III/IV vs 64.5% patients at baseline, p<0.001), freedom from MACCE was observed in 91.1% of patients.

Conclusions Our study demonstrates the safety and feasibility of standardised subannular repair to treat ventricular SMR (Carpentier type IIIb) in a multicentre setting. By addressing mitral leaflet tethering, papillary muscle relocation results in very satisfactory 1-year outcomes and has the potential to durably restore MV geometry; nevertheless, long-term FU is mandatory.

Trial registration number NCT03470155.

  • mitral valve insufficiency
  • heart failure, systolic
  • cardiomyopathies

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/heartjnl-2022-322239

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Presented at Data were presented at the EACTS 36th Annual Meeting 2022 in Milano, Italy.

    • Contributors All named authors have contributed significantly to the content of the manuscript and approved the final version for submission. EG acted as guarantor.

    • Funding This work (IIT – Investigator-Initiated-Trial) was supported by Edwards Lifesciences, (Nyon, Switzerland) and conducted by IPPMed – Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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