Transcatheter Edge-to-Edge Repair (TEER) of Mitral Valve

Transcatheter Edge-to-Edge Repair (TEER) of Mitral Valve

Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is done for treatment of mitral regurgitation [1]. Anterior and posterior leaflets of mitral valve are approximated using a clipping device and is similar to the corresponding surgical procedure known as Alfieri stitch [2].

Earlier porcine study had used left thoracotomy for placing the flexible delivery catheter with a clip in the left atrium. The clip grasped and approximated the mid portion of the anterior and posterior mitral leaflets with echocardiographic and fluoroscopic guidance. Clip was detached from the system and the catheter withdrawn after confirmation of creation of double orifice [3].

EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort was a prospective multicenter single arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system [1]. Among the 107 patients treated, 10 had a major adverse event including one nonprocedural death. There was no embolization of the clip in the study. Partial clip detachment occurred in 10 patients. Acute procedural success was achieved in 74% and 64% were discharged with 1+ or lesser mitral regurgitation.

30% had mitral valve surgery 3.2 years after the clip procedures. Surgical repair was successful in 21 of the 25 cases planned. Two thirds of the successfully treated patients were free from death, mitral valve surgery or mitral regurgitation more than 2+ at 12 months. There were 23 patients with functional mitral regurgitation, who had similar acute results and durability.

The MitraClip device (Evalve, Inc., Menlo Park, California) is delivered to the mitral valve through a percutaneous femoral venous transseptal access. The clip is aligned above the mitral valve and advanced across the mitral orifice before grasping and coapting the leaflets.

EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II study [4] was a randomized trial which compared MitraClip vs conventional surgery for degenerative mitral regurgitation. One year result of EVEREST II showed that mitral valve edge-to-edge repair was less effective than surgery for reducing mitral regurgitation, but had superior safety and similar improvements in clinical outcome. Major adverse events in percutaneous repair group was 15% while it was 48% in the surgical group, at 30 days (P<0.001). Death rate was 6% in both groups.

5-Year Results of EVEREST II showed that even though surgery for residual mitral regurgitation was more often in percutaneous repair at one year, the need for surgery between one to five years was comparable in the two groups [5].

The MitraClip grasps the mitral leaflet edges and reduces the regurgitation volume and the preload of the left ventricle. In the long run, it reverses adverse left ventricular remodeling and improves clinical outcome. But the results may be poor in those who have long standing left ventricular volume overload due to severe mitral regurgitation. These persons may have irreversible left ventricular dysfunction and poor prognosis [6].

Mid-term outcomes from the CUTTING-EDGE International Registry were reported in 2021. 332 patients across 34 centres underwent mitral valve surgery after TEER from 2009 to 2020. Median follow up was 9.0 months after mitral valve surgery.  Follow up was 96.1% complete at 30 days and 81.1% complete at 1 year [7].

The median interval from TEER to surgery was 3.5 months, with overall median Society of Thoracic Surgeons risk of 4.8% for mitral valve replacement. Recurrent mitral regurgitation was the primary indication for surgery. Mitral valve replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients respectively. 30 day and 1 year mortality rates were 16.6% and 31.3% respectively.

Authors mentioned that at the time of their report, over 100,000 mitral TEER procedures had been performed worldwide. They also added that the mortality and morbidity risks of mitral valve surgery after TEER were not negligible and only less than 10% of patients underwent mitral valve repair.

References

1. 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; EVEREST Investigators. 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 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077. PMID: 19679246.
2. Maisano F, Torracca L, Oppizzi M, Stefano PL, D’Addario G, La Canna G, Zogno M, Alfieri O. The edge-to-edge technique: a simplified method to correct mitral insufficiency. Eur J Cardiothorac Surg. 1998 Mar;13(3):240-5; discussion 245-6. doi: 10.1016/s1010-7940(98)00014-1. PMID: 9628372.
3. Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9. PMID: 15302782.
4. Feldman T, Foster E, Glower DD, Glower DG, 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; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011; 364:1395–1406.
5. 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; EVEREST II Investigators. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854.
6. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM, 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 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 Clinical Practice Guidelines. Circulation 2017; 135:e1159-e1195.
7. Kaneko T, Hirji S, Zaid S, Lange R, Kempfert J, Conradi L, Hagl C, Borger MA, Taramasso M, Nguyen TC, Ailawadi G, Shah AS, Smith RL, Anselmi A, Romano MA, Ben Ali W, Ramlawi B, Grubb KJ, Robinson NB, Pirelli L, Chu MWA, Andreas M, Obadia JF, Gennari M, Garatti A, Tchetche D, Nazif TM, Bapat VN, Modine T, Denti P, Tang GHL; CUTTING-EDGE Investigators. Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2010-2021. doi: 10.1016/j.jcin.2021.07.029. PMID: 34556275.