Impact of Percutaneous Mitral Valve Repair Using the Mitraclip System on Tricuspid Regurgitation
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CLINICAL RESEARCH INTERVENTIONS FOR VALVULAR DISEASE AND HEART FAILURE Euro Intervention 2016;11: e 1680- e 1686 published online online published Impact of percutaneous mitral valve repair using the MitraClip system on tricuspid regurgitation e Antonio H. Frangieh1, MD, MPH; Christiane Gruner2, MD; Fran Mikulicic2, MD; -edition April 2016 Adrian Attinger-Toller1, MD; Felix C. Tanner2, MD; Maurizio Taramasso3, MD; Roberto Corti1,4, MD; Jürg Grünenfelder3,4, MD; Thomas F. Lüscher1, MD; Frank Ruschitzka5, MD; Dominique Bettex6, MD; Francesco Maisano3, MD; Oliver Gaemperli1*, MD 1. Andreas Grüntzig Cardiac Catheterization Laboratories, University Heart Center, Zurich, Switzerland; 2. Echocardiography, University Heart Center, Zurich, Switzerland; 3. Cardiac Surgery, University Heart Center, Zurich, Switzerland; 4. Heart Clinic Hirslanden, Zurich, Switzerland; 5. Heart Failure Clinic, University Heart Center, Zurich, Switzerland; 6. Cardiac Anesthesiology, University Hospital Zurich, Zurich, Switzerland KEYWORDS Abstract Aims: Tricuspid regurgitation (TR) severity and right ventricular (RV) dysfunction have been identified as • MitraClip significant predictors of outcome after mitral valve surgery. The aim of the present study was to investigate • mitral regurgitation the impact of percutaneous mitral valve repair (PMVR) with the MitraClip system on functional TR sever- • percutaneous ity and RV function. mitral valve repair Methods and results: • right ventricle Among 119 consecutive patients with severe mitral regurgitation who under- • tricuspid went PMVR, 67 had complete baseline and follow-up transthoracic echocardiography after 3-12 months regurgitation (6.8±2.9 months). TR severity was graded as mild, moderate, and severe. RV systolic function was assessed by fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE). Clinical end- points at follow-up included mortality, reoperation of the mitral valve, hospitalisation for congestive heart failure and New York Heart Association (NYHA) functional class. After PMVR, a significant decrease in TR severity (by at least one grade) was observed in 22 (33%) patients, while an increase occurred in only seven (10%) patients (p=0.02). Overall, systolic RV function (FAC and TAPSE), RV dimensions, and tri- cuspid annular diameter did not change significantly. Baseline SPAP was significantly higher (57±15 vs. 43±14 mmHg, p=0.002) and SPAP reduction significantly larger (-14±13 versus 1±15 mmHg, p=0.012) in patients who improved their TR. Multivariate logistic regression analysis identified the change in SPAP as the only significant predictor of changes in TR (odds ratio [OR] [for every change in SPAP by 10 mmHg] DOI: 1.90, 95% CI: 1.02±3.54; p=0.044). Patients with mild/moderate TR at follow-up after PMVR had lower 10.4244/EIJV11I14A320 event rates compared to those with severe TR (35% vs. 78%, respectively, p=0.025). Conclusions: PMVR using the MitraClip device improves functional TR severity in approximately one third of patients, particularly in those who experience a significant SPAP reduction after the procedure. *Corresponding author: Andreas Gruntzig Laboratories and Cardiac Imaging, University Heart Center, Rämistrasse 100, 8091 Zurich, Switzerland. E-mail: [email protected] © Europa Digital & Publishing 2016. All rights reserved. SUBMITTED ON 02/03/2015 - REVISION RECEIVED ON 1st 24/04/2015 / 2 nd 16/05/2015 - ACCEPTED ON 29/05/2015 e1680 MitraClip and tricuspid regurgitation Euro Intervention Introduction PERCUTANEOUS MITRAL VALVE REPAIR (PMVR) Severe mitral regurgitation (MR) is associated with progressive left PROCEDURE ventricular dysfunction and congestive heart failure, leading to high PMVR with the MitraClip device was performed according rates of morbidity and mortality1. In Europe, MR is the second most to standard technique described elsewhere16 with echocardio- 2016;11: frequent valve disease requiring surgery2. Recently, percutaneous graphic (three-dimensional transoesophageal echocardiography) mitral valve repair (PMVR) with the MitraClip® system (Abbott and fluoroscopic guidance, and under general anaesthesia. Acute e Vascular, Santa Clara, CA, USA) has emerged as a safe, less inva- procedural success (APS) was defined as successful MitraClip 1680- sive, alternative therapeutic option to surgery, in patients with implantation with immediate MR reduction to grade 2+ or less by e moderate to severe MR and high surgical risk. Based on the favour- echocardiography. 1686 able results of several multicentric investigator-driven registries3-6 and the results of one randomised trial7, the technique has gained ECHOCARDIOGRAPHY wide acceptance with more than 16,000 patients treated so far. On Transthoracic echocardiography was performed at baseline (shortly 24 October 2013 the MitraClip received FDA approval for use in prior to the PMVR procedure) and at follow-up three to 12 months patients with degenerative MR and at prohibitive surgical risk8. after PMVR. All echocardiographic films were stored in our clini- Functional tricuspid regurgitation (TR), which occurs on struc- cal image database and independently reviewed by an experienced turally normal tricuspid valves, is frequently observed in patients reader, blinded to the clinical history of the patient. A second with MR9. Paradoxically, TR tends to worsen after mitral valve reader re-evaluated TR severity (baseline and follow-up) to assess surgery10 (particularly in patients with ischaemic or dilative car- inter-observer variability. TR quantification, as well as evaluation diomyopathy), with close to 50% of patients having postoperative of RV dimensions and function, were performed according to the TR despite successful surgery with lowering of pulmonary pres- recommendations of the American Society of Echocardiography sure9. The severity of TR may increase even further in the years (ASE), the European Association of Echocardiography and the following surgery, and is associated with worse outcomes11. Some Canadian Society of Echocardiography15,17. have proposed impaired right ventricular function6 and/or geo- In brief, TR severity was graded as mild, moderate or severe metrical distortion of the tricuspid annulus after MV surgery as based on integration of various Doppler parameters (central the underlying mechanism for postoperative TR9,12. PMVR with jet area, density and contour, vena contracta width and hepatic the MitraClip has only a slight impact on mitral annular geom- vein flow) and the dimensions of the right-sided chambers. End- etry and has been shown to induce reverse left ventricular (LV) systolic and end-diastolic RV dimensions were measured by remodelling13, but its effect on RV dimensions and function, tri- planimetry from the RV-focused apical 4-chamber (4CH) view17. cuspid annular geometry and TR has not been extensively inves- RV function was assessed through fractional area change (FAC) tigated as yet14. defined as ([4CH end-diastolic area–4CH end-systolic area]/4CH The purpose of this study was therefore to explore changes end-diastolic area×100) as well as the tricuspid annular plane sys- in TR severity and RV function after PMVR, and to relate these tolic excursion (TAPSE) acquired on M-mode tracings through findings to acute and long-term procedural success and patient the tricuspid annulus17. MR severity was graded from 1+ to 4+ outcome. according to ASE recommendations15. Systolic pulmonary artery pressure (SPAP) was calculated from peak tricuspid regurgitant jet Methods velocity using the simplified Bernoulli’s equation and adding an PATIENT POPULATION AND STUDY DESIGN estimate of right atrial pressure estimated from the inferior vena We included consecutive patients who underwent PMVR using the cava diameter17. MitraClip system at the University Hospital Zurich and had base- line and follow-up transthoracic echocardiography (TTE) availa- CLINICAL FOLLOW-UP ble. Exclusion criteria included a recent myocardial infarction or Clinical outcome was obtained from hospital records or by direct revascularisation, any cardiac surgery, repeat PMVR, or cardiac interrogation of the patient or his/her general practitioner. Clinical resynchronisation therapy (CRT) device implantation <6 weeks endpoints included death, recurrent hospitalisation for congestive prior to the index PMVR or during follow-up, or degenerative TR heart failure (CHF), mitral valve surgery, and New York Heart aetiology. Indications for PMVR included symptomatic moderate Association (NYHA) functional class. CHF was defined by the to severe (3+) or severe (4+) MR15, with a high risk for surgery. classic Framingham criteria, with two major or one major and two An interdisciplinary Heart Team, which included an interventional minor criteria required to diagnose CHF18. cardiologist, a cardiac surgeon, an echocardiographer, and a car- diac anaesthetist, discussed each subject’s eligibility for PMVR. STATISTICAL ANALYSIS All patients gave written informed consent to be included in a pro- Statistical analysis was performed with SPSS, Version 20 (IBM spective MitraClip registry (KEK-ZH-Nr. 2010-0466). The proto- Corp., Armonk, NY, USA). Quantitative data are expressed col of the registry was approved by the cantonal ethical committee as mean±SD or median with interquartile range (IQR) where of Zurich. appropriate and were compared using the Student’s t-test or the e1681 Euro Intervention Mann-Whitney U test, respectively. Categorical data are given in Table 1. Baseline characteristics. Comparison between