Surgical versus transcatheter repair for secondary mitral regurgitation: A propensity score-matched cohorts comparison.
TL;DR: In this article, the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral repair (SMVr), among patients with secondary mitral regurgitation (SMR), were compared and retrospectively analyzed.
About: This article is published in The Journal of Thoracic and Cardiovascular Surgery.The article was published on 2021-07-28. It has received 11 citations till now. The article focuses on the topics: Medicine & Hazard ratio.
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TL;DR: An in-depth review of evidence informing the decision-making process between TAVI and SAVR and key elements for treatment selection and lifetime management strategies of patients with severe AS are proposed.
Abstract: Transcatheter aortic valve implantation (TAVI) has matured into a standard treatment option for patients with severe symptomatic aortic valve stenosis (AS) across the whole spectrum of risk. The advances in the interventional treatment of AS raise the question of which patients with severe AS should be referred to surgery. The myriad of clinical permutations does not allow providing a single, uniform treatment strategy. Rather, the advent of TAVI along with established surgical aortic valve replacement (SAVR) fundamentally enforces the role of the multidisciplinary heart team for decision-making recommending the best individual choice of the two options based on a thorough review of clinical and anatomical factors as well as lifetime management considerations. Involvement of the informed patient expressing treatment preferences is a key for a shared decision-making process. Herein, we provide an in-depth review of evidence informing the decision-making process between TAVI and SAVR and key elements for treatment selection. Special attention is given to the populations that have been excluded from randomized clinical trials, and also lifetime management strategies of patients with severe AS are proposed.
17 citations
TL;DR: In this article , the authors provide an in-depth review of evidence informing the decision-making process between TAVI and surgical aortic valve replacement (SAVR) and key elements for treatment selection.
Abstract: Abstract Transcatheter aortic valve implantation (TAVI) has matured into a standard treatment option for patients with severe symptomatic aortic valve stenosis (AS) across the whole spectrum of risk. The advances in the interventional treatment of AS raise the question of which patients with severe AS should be referred to surgery. The myriad of clinical permutations does not allow providing a single, uniform treatment strategy. Rather, the advent of TAVI along with established surgical aortic valve replacement (SAVR) fundamentally enforces the role of the multidisciplinary heart team for decision-making recommending the best individual choice of the two options based on a thorough review of clinical and anatomical factors as well as lifetime management considerations. Involvement of the informed patient expressing treatment preferences is a key for a shared decision-making process. Herein, we provide an in-depth review of evidence informing the decision-making process between TAVI and SAVR and key elements for treatment selection. Special attention is given to the populations that have been excluded from randomized clinical trials, and also lifetime management strategies of patients with severe AS are proposed.
16 citations
TL;DR: Okuno et al. as mentioned in this paper compared surgical repair with restrictive mitral annuloplasty (RMA) versus transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR).
Abstract: The authors reported no conflicts of interest.The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.Okuno and colleagues1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar reported 2-year outcomes comparing surgical repair with restrictive mitral annuloplasty (RMA) versus transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). It highlights contradictions in the 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the indication for TEER in SMR was Class IIb with level of evidence B-R.2Otto C.M. Nishimura R.A. Bonow R.O. Carabello B.A. Erwin III, J.P. Gentile F. et al.2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.J Am Coll Cardiol. 2021; 77: 450-500Crossref PubMed Scopus (249) Google Scholar In that study of 202 patients, the investigators compared propensity-matched surgical versus transcatheter repair for SMR with a report published immediately after the presentation of new AHA/ACC guidelines. After 2 years’ follow-up, although the investigators found no significant difference in survival (P = .909), they recorded superiority in RMA with coronary revascularization versus TEER for decreasing mitral regurgitation (MR), improving ventricular ejection fraction, and reducing New York Heart Association functional class III or IV.1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google ScholarLeft ventricular remodeling predicts poor prognosis in ischemic myocardial disease and is reversible with recovery of viable myocardium.3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar Cardiothoracic Surgical Trials Network trial subanalyses included 75% of patients receiving concomitant coronary artery bypass grafting surgery, eliminating the possibility of improvement in regional wall motion for 25% of patients.4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar,5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google Scholar Subannular procedure combined with RMA have been superior to RMA alone in both ischemic and nonischemic cardiomyopathy in other studies.3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,6Pausch J. Sequeira Gross T. Müller L. von Stumm M. Kloth B. Reichenspurner H. et al.Subannular repair for functional mitral regurgitation type IIIb in patients with ischaemic versus dilated cardiomyopathy.Eur J Cardiothorac Surg. 2021; 60: 122-130Crossref PubMed Scopus (6) Google Scholar,7Harmel E. Pausch J. Gross T. Petersen J. Sinning C. Kubitz J. et al.Standardized subannular repair improves outcomes in type IIIb functional mitral regurgitation.Ann Thorac Surg. 2019; 108: 1783-1792Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar In a papillary muscle approximation (PMA) randomized trial, 96 patients with severe chronic ischemic mitral regurgitation underwent complete surgical myocardial revascularization associated with either isolated RMA or PMA + RMA over a 5-year follow-up. Left ventricular end-diastolic diameter improved at 5-year follow-up (5.8 ± 4.1 mm and −0.2 ± 2.3 mm, respectively; P < .001), maintaining the benefit achieved immediately postoperatively with freedom from major adverse cardiac and cerebrovascular events (P = .004)3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar (Figure 1). TEER use in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) study did not reveal an improvement of left ventricular remodeling (left ventricular end-diastolic volume/mL, 194.4 ± 69.2 mL vs 192.2 ± 76.5 mL),8Nappi F. Antoniou G.A. Nenna A. Michler R. Benedetto U. Avtaar Singh S.S. et al.Treatment options for ischemic mitral regurgitation: a meta-analysis.J Thorac Cardiovasc Surg. 2022; 163: 607-622.e14Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar,9Stone G.W. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1415) Google Scholar although patients who underwent TEER had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity compared with those who received guideline-directed medical therapy (GDMT) at 3 years’ follow-up.10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google Scholar The benefit of TEER over GDMT was confirmed among 58 patients primarily managed with alone who crossed-over receiving TEER. For the subsequent composite rate of mortality or hospitalization for cardiac failure, hospitalization for cardiac failure was reduced compared with GDMT alone (P = .006).10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google ScholarFigure 1Composite cardiac end point. The composite end point of the rate of major adverse cardiac or cerebrovascular events (MACCEs) included cardiac death, stroke, subsequent mitral valve surgery, rehospitalization, and an increase in New York Heart Association functional class of 1 or more. Vertical marks indicate that a patient's data were censored at that point. At 5 years, there were no significant between = group differences with respect to the composite end point of MACCE, with 45 events in the restrictive annuloplasty (RA) group and 34 events in the papillary muscle approximation (PMA) group (left). However, the incidence of MACCE was significantly reduced in the PMA group during the last year of follow-up (right).View Large Image Figure ViewerDownload Hi-res image Download (PPT)Okuno and colleagues1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar revealed that restrictive mitral annuloplasty was superior to TEER at 2 years as a secondary end point. Evidence from randomized controlled trials (RCTs) proved that RMA had higher MR recurrence rates at 2 and 5 years' follow-up (58.8% and 55.9%, respectively).3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google Scholar Suitability for RMA should include smaller preoperative left ventricular end systolic diameter and reduced apical tethering of the leaflets. Seventy-four patients from the Cardiothoracic Surgical Trials Network trial with severe ischemic mitral regurgitation with no persistent or recurrent MR after RMA recorded significantly smaller left ventricles at 2 years’ follow-up compared with patients with recurrent MR post-RMA alone (43 ± 26 mL/m2 vs 63 ± 27 mL/m2). Left ventricular end systolic volume was significantly lower compared with patients managed with mitral valve replacement (61 ± 39 mL/m2).5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google ScholarIn the PMA trial, double-level repair achieved geometric restitution by normalization of 3 measures: anteroposterior annular dilation, tenting area, and interpapillary muscle distance. The goal is to address both the valvular and ventricular features of secondary MR (Carpentier class IIIb).3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar,6Pausch J. Sequeira Gross T. Müller L. von Stumm M. Kloth B. Reichenspurner H. et al.Subannular repair for functional mitral regurgitation type IIIb in patients with ischaemic versus dilated cardiomyopathy.Eur J Cardiothorac Surg. 2021; 60: 122-130Crossref PubMed Scopus (6) Google Scholar,7Harmel E. Pausch J. Gross T. Petersen J. Sinning C. Kubitz J. et al.Standardized subannular repair improves outcomes in type IIIb functional mitral regurgitation.Ann Thorac Surg. 2019; 108: 1783-1792Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar The fundamental role of papillary muscles is also focused on by Kainuma and colleagues.11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar Kainuma and colleagues11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar recorded that the use of restrictive mitral annuloplasty alone only partially alleviated the tethering of leaflet, which instead significantly favored a reduction in tethering and interpapillary muscles distance. The latter was the main determinant of MR recurrence. These beneficial effects could be mainly attributed to post-RMA reverse left ventricular remodeling leading to a reduction in interpapillary muscle distance (31 ± 6 mm to 25 ± 5 mm), potentially offsetting the negative effect of increasing posterior leaflet angle.11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google ScholarPMA is more suitable than TEER in patients with SMR due to nonischemic cardiomyopathy (Carpentier class I) where annular dilation, lateral displacement of anterior and posterior papillary muscle, symmetrical tethering with apical tenting of anterior leaflet, and central jet were prevalent. Patients with severe left ventricular dilation and moderate-to-severe MR had poorer outcomes both in the small group of patients in the COAPT8Nappi F. Antoniou G.A. Nenna A. Michler R. Benedetto U. Avtaar Singh S.S. et al.Treatment options for ischemic mitral regurgitation: a meta-analysis.J Thorac Cardiovasc Surg. 2022; 163: 607-622.e14Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar and in Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation12Iung B. Armoiry X. Vahanian A. Boutitie F. Mewton N. Trochu J.-N. et al.Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.Eur J Heart Fail. 2019; 21: 1619-1627Crossref PubMed Scopus (124) Google Scholar trials. These patients had similar features of proportionate MR and did not respond favorably to TEER (Table 1).13Packer M. Grayburn P.A. New evidence supporting a novel conceptual framework for distinguishing proportionate and disproportionate functional mitral regurgitation.JAMA Cardiol. 2020; 5: 469-475Crossref PubMed Scopus (58) Google ScholarTable 1Randomized clinical trial (RCT) reporting secondary mitral regurgitation (SMR)First author or Study acronymType of studyNo. of patientsTreatmentMean follow-up (y)Criteria for SMRFindingsHarmel, 20197Harmel E. Pausch J. Gross T. Petersen J. Sinning C. Kubitz J. et al.Standardized subannular repair improves outcomes in type IIIb functional mitral regurgitation.Ann Thorac Surg. 2019; 108: 1783-1792Abstract Full Text Full Text PDF PubMed Scopus (19) Google ScholarProspective101RMA (50)RMA + PMR (51)1•Ischemic cardiomyopathy 100%•Average LVEDD >60 mm; LVEF <40%•EROA >0.2 cm2Better improvement of left ventricular remodeling in PMR groupMR > 2+ more common among patients with RMABetter survival in RMA + PMRStone, 20189Stone G.W. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1415) Google ScholarCOAPTRCT614TEER (302)GDMT (312)2•Ischemic cardiomyopathy 62.5%•Average LVEDV 192 mL; LVEF 31% ± 9% (18% LVEF >40%)•MR grade 3 or 4•EROA mean value 0.41 cm2; 14% EROA <0.3 cm2; 41% ≥ 0.4 cm2Lower rate of unplanned hospitalization in TEER with disproportionate SMR. Slight improvement of LVEDV/mL/min (from 194.4 ± 37.4-192.2 ± 76.5)Iung, 201912Iung B. Armoiry X. Vahanian A. Boutitie F. Mewton N. Trochu J.-N. et al.Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.Eur J Heart Fail. 2019; 21: 1619-1627Crossref PubMed Scopus (124) Google ScholarMITRA FrRCT306TEER (152)GDMT (154)1•Ischemic cardiomyopathy 62.5%•Average LVEDV 252 mL 33% ± 7% (all LVEF ≤40%)•EROA mean value 0.31 cm2•50% EROA <0.3 cm2; 16% ≥ 0.4 cm2No difference in unplanned hospitalization rate and death between TEER vs GDMT. Slight improvement of LVEDV/mL/min (from 136.2 ± 37.4-134.2 ± 37)Nappi, 20168Nappi F. Antoniou G.A. Nenna A. Michler R. Benedetto U. Avtaar Singh S.S. et al.Treatment options for ischemic mitral regurgitation: a meta-analysis.J Thorac Cardiovasc Surg. 2022; 163: 607-622.e14Abstract Full Text Full Text PDF PubMed Scopus (13) Google ScholarPMA trialRCT96RMA (48)RMA plus PMA (48)5•Ischemic cardiomyopathy 100%•Coronary artery disease with or without the need for coronary revascularization•Average value LVEDD 62 mm LVEF 42%•MR grade 3 or 4•EROA> 0.2 cm2 or regurgitant volume >30 mL∗European Society of Cardiology guidelines.•EROA mean value 0.34 cm2Lower rate of unplanned hospitalization in PMA group. Better improvement of LVEDD in PMA (62.7 ± 3.4-56.5 ± 5.7) vs RMA (61.4 ± 3.7-60.6 ± 4.6). Lower incidence of recurrent MR in the PMA group (27% vs 55.9%)Goldstein, 20165Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google ScholarCTSNRCT251MVR (125)RMA (126)2•Ischemic cardiomyopathy 100%•Average value LVESV 63.4 mL; LVEF 40%•MR grade 4•EROA ≥0.4 cm2 with tethering•Eligible for surgical repair and replacement of mitral valve•Coronary artery disease with or without the need for coronary revascularizationBetter improvement of LVESVI in MVR (52.6 ± 27.7 mL vs 60.6 ± 39.0 mL). Better improvement of LVESVI in RMA with smaller LV (43 ± 26 mL/m2 vs 63 ± 27 mL/m2). Higher incidence of recurrent MR in the RMA (58.8% vs 3.8%)RMA, Restrictive mitral annuloplasty; PMR, papillary muscle relocation; LVEDD, left ventricular end-diastolic diameter LVEF, left ventricular ejection fraction; EROA, effective regurgitant orifice area; MR, mitral regurgitation; COAPT, Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation; TEER, transcatheter edge-to-edge repair; GDMT, guide-direct medical therapy; LVEDV, left end-diastolic volume; MITRA Fr, Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation; PMA trial, papillary muscle approximation trial; CTSN, Cardiothoracic Surgical Trials Network; MVR, mitral valve replacement; LVESI, left end-systolic volume index.∗ European Society of Cardiology guidelines. Open table in a new tab All 5 AHA/ACC recommendations were classified as level of evidence B-R or B-NR, indicating moderate quality of studies. The available literature lacks RCTs designed with a large number of enrolled patients that include candidates receiving TEER, mitral valve replacement, or mitral valve repair with or without a subvalvular procedure. ACC/AHA guidelines reference 2 TEER-based RCTs with 3-year outcomes that are reported only for the COAPT trial,9Stone G.W. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1415) Google Scholar and the analysis of the new pathophysiological framework of the pathomechanism for SMR.10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google Scholar None of these recommendations are based on reports with 5 years’ follow-up.2Otto C.M. Nishimura R.A. Bonow R.O. Carabello B.A. Erwin III, J.P. Gentile F. et al.2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.J Am Coll Cardiol. 2021; 77: 450-500Crossref PubMed Scopus (249) Google Scholar For double-level repair, there currently is no solid evidence supported by more than 1 RCT, or meta-analysis of moderate-quality RCTs, that allows recommending this procedure.Although the results of the Multicenter Randomized, Controlled Study to Assess Mitral Valve Reconstruction for Advanced Insufficiency of Functional or Ischemic Origin14A Multicenter, randomized, controlled study to assess mitral vAlve reconsTrucTion for advancEd insufficiency of functional or iscHemic ORigiN (MATTERHORN). ClinicalTrials.gov identifier: NCT02371512.https://clinicaltrials.gov/ct2/show/NCT02371512Date accessed: March 8, 2022Google Scholar randomized study are awaited, other RCTs have demonstrated the efficacy of using novel devices. None of these are directed toward manipulating the papillary muscles by either an approximation or a relocation procedure.In the Edwards Pascal Transcatheter Mitral Valve Repair System Study RCT (N = 124), the Pascal system (Edwards Lifesciences) was implanted in patients enrolled for treatment of functional, degenerative, and mixed etiology. The Pascal transcatheter valve repair system and the MitraClip system (Abbott, Abbott Park, Ill) were compared in patients with both functional and degenerative MR. Evidence from the Edwards Pascal Transcatheter Mitral Valve Repair System Study recorded a high rate of survival, with a significant rate of reduction in heart failure-related hospitalization with reverse positive left ventricular remodeling at 1 and 2 years’ follow-up.15Praz F. Spargias K. Chrissoheris M. Büllesfeld L. Nickenig G. Deuschl F. et al.Compassionate use of the PASCAL 536 transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, 537 observational, first-in-man study.Lancet. 2017; 390: 773-780Abstract Full Text Full Text PDF PubMed Scopus (149) Google Scholar, 16Lim D.S. Kar S. Spargias K. Kipperman R.M. O’Neill W.W. Ng M.K.C. et al.Transcatheter valve repair for patients with mitral regurgitation: 30-day results of 539 the CLASP study.JACC Cardiovasc Interv. 2019; 12: 1369-1378Crossref PubMed Scopus (91) Google Scholar, 17Webb J.G. Hensey M. Szerlip M. Schafer U. Cohen G.N. Kar S. et al.1-year outcomes for transcatheter repair in patients with mitral regurgitation 541 from the clasp study.JACC Cardiovasc Interv. 2020; 13: 2344-2357Crossref PubMed Scopus (31) Google Scholar, 18Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF). ClinicalTrials.gov identifier: NCT03706833.https://clinicaltrials.gov/ct2/show/NCT03706833Date accessed: March 8, 2022Google ScholarAdditional multicenter RCTs designed with a minimum of 5-year follow-up enrolling patients to undergo either TEER or double-level repair should be encouraged. The authors reported no conflicts of interest.The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest. Okuno and colleagues1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar reported 2-year outcomes comparing surgical repair with restrictive mitral annuloplasty (RMA) versus transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). It highlights contradictions in the 2020 American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the indication for TEER in SMR was Class IIb with level of evidence B-R.2Otto C.M. Nishimura R.A. Bonow R.O. Carabello B.A. Erwin III, J.P. Gentile F. et al.2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.J Am Coll Cardiol. 2021; 77: 450-500Crossref PubMed Scopus (249) Google Scholar In that study of 202 patients, the investigators compared propensity-matched surgical versus transcatheter repair for SMR with a report published immediately after the presentation of new AHA/ACC guidelines. After 2 years’ follow-up, although the investigators found no significant difference in survival (P = .909), they recorded superiority in RMA with coronary revascularization versus TEER for decreasing mitral regurgitation (MR), improving ventricular ejection fraction, and reducing New York Heart Association functional class III or IV.1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Left ventricular remodeling predicts poor prognosis in ischemic myocardial disease and is reversible with recovery of viable myocardium.3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar Cardiothoracic Surgical Trials Network trial subanalyses included 75% of patients receiving concomitant coronary artery bypass grafting surgery, eliminating the possibility of improvement in regional wall motion for 25% of patients.4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar,5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google Scholar Subannular procedure combined with RMA have been superior to RMA alone in both ischemic and nonischemic cardiomyopathy in other studies.3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,6Pausch J. Sequeira Gross T. Müller L. von Stumm M. Kloth B. Reichenspurner H. et al.Subannular repair for functional mitral regurgitation type IIIb in patients with ischaemic versus dilated cardiomyopathy.Eur J Cardiothorac Surg. 2021; 60: 122-130Crossref PubMed Scopus (6) Google Scholar,7Harmel E. Pausch J. Gross T. Petersen J. Sinning C. Kubitz J. et al.Standardized subannular repair improves outcomes in type IIIb functional mitral regurgitation.Ann Thorac Surg. 2019; 108: 1783-1792Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar In a papillary muscle approximation (PMA) randomized trial, 96 patients with severe chronic ischemic mitral regurgitation underwent complete surgical myocardial revascularization associated with either isolated RMA or PMA + RMA over a 5-year follow-up. Left ventricular end-diastolic diameter improved at 5-year follow-up (5.8 ± 4.1 mm and −0.2 ± 2.3 mm, respectively; P < .001), maintaining the benefit achieved immediately postoperatively with freedom from major adverse cardiac and cerebrovascular events (P = .004)3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar (Figure 1). TEER use in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) study did not reveal an improvement of left ventricular remodeling (left ventricular end-diastolic volume/mL, 194.4 ± 69.2 mL vs 192.2 ± 76.5 mL),8Nappi F. Antoniou G.A. Nenna A. Michler R. Benedetto U. Avtaar Singh S.S. et al.Treatment options for ischemic mitral regurgitation: a meta-analysis.J Thorac Cardiovasc Surg. 2022; 163: 607-622.e14Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar,9Stone G.W. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1415) Google Scholar although patients who underwent TEER had sustained 3-year improvements in MR severity, quality-of-life measures, and functional capacity compared with those who received guideline-directed medical therapy (GDMT) at 3 years’ follow-up.10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google Scholar The benefit of TEER over GDMT was confirmed among 58 patients primarily managed with alone who crossed-over receiving TEER. For the subsequent composite rate of mortality or hospitalization for cardiac failure, hospitalization for cardiac failure was reduced compared with GDMT alone (P = .006).10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google Scholar Okuno and colleagues1Okuno T. Praz F. Kassar M. Biaggi P. Mihalj M. Killing M. et al.Surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score matched cohorts comparison.J Thorac Cardiovasc Surg. July 27, 2021; ([Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.07.029)Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar revealed that restrictive mitral annuloplasty was superior to TEER at 2 years as a secondary end point. Evidence from randomized controlled trials (RCTs) proved that RMA had higher MR recurrence rates at 2 and 5 years' follow-up (58.8% and 55.9%, respectively).3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google Scholar Suitability for RMA should include smaller preoperative left ventricular end systolic diameter and reduced apical tethering of the leaflets. Seventy-four patients from the Cardiothoracic Surgical Trials Network trial with severe ischemic mitral regurgitation with no persistent or recurrent MR after RMA recorded significantly smaller left ventricles at 2 years’ follow-up compared with patients with recurrent MR post-RMA alone (43 ± 26 mL/m2 vs 63 ± 27 mL/m2). Left ventricular end systolic volume was significantly lower compared with patients managed with mitral valve replacement (61 ± 39 mL/m2).5Goldstein D. Moskowitz A.J. Gelijns A.C. Ailawadi G. Parides M.K. Perrault L.P. et al.Two-year outcomes of surgical treatment of severe ischemic mitral regurgitation.N Engl J Med. 2016; 374: 344-353Crossref PubMed Scopus (538) Google Scholar In the PMA trial, double-level repair achieved geometric restitution by normalization of 3 measures: anteroposterior annular dilation, tenting area, and interpapillary muscle distance. The goal is to address both the valvular and ventricular features of secondary MR (Carpentier class IIIb).3Nappi F. Lusini M. Spadaccio C. Nenna A. Covino E. Acar C. et al.Papillary muscle approximation versus restrictive annuloplasty alone for severe ischemic mitral regurgitation.J Am Coll Cardiol. 2016; 67: 2334-2346Crossref PubMed Scopus (127) Google Scholar,4Nappi F. Spadaccio C. Nenna A. Lusini M. Fraldi M. Acar C. et al.Is subvalvular repair worthwhile in severe ischemic mitral regurgitation? Subanalysis of the papillary muscle approximation trial.J Thorac Cardiovasc Surg. 2017; 153: 286-295Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar,6Pausch J. Sequeira Gross T. Müller L. von Stumm M. Kloth B. Reichenspurner H. et al.Subannular repair for functional mitral regurgitation type IIIb in patients with ischaemic versus dilated cardiomyopathy.Eur J Cardiothorac Surg. 2021; 60: 122-130Crossref PubMed Scopus (6) Google Scholar,7Harmel E. Pausch J. Gross T. Petersen J. Sinning C. Kubitz J. et al.Standardized subannular repair improves outcomes in type IIIb functional mitral regurgitation.Ann Thorac Surg. 2019; 108: 1783-1792Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar The fundamental role of papillary muscles is also focused on by Kainuma and colleagues.11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar Kainuma and colleagues11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar recorded that the use of restrictive mitral annuloplasty alone only partially alleviated the tethering of leaflet, which instead significantly favored a reduction in tethering and interpapillary muscles distance. The latter was the main determinant of MR recurrence. These beneficial effects could be mainly attributed to post-RMA reverse left ventricular remodeling leading to a reduction in interpapillary muscle distance (31 ± 6 mm to 25 ± 5 mm), potentially offsetting the negative effect of increasing posterior leaflet angle.11Kainuma S. Funatsu T. Kondoh H. Yokota T. Maeda S. Shudo Y. et al.Beneficial effects of restrictive annuloplasty on subvalvular geometry in patients with functional mitral regurgitation and advanced cardiomyopathy.J Thorac Cardiovasc Surg. 2018; 156: 630-638.e1Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar PMA is more suitable than TEER in patients with SMR due to nonischemic cardiomyopathy (Carpentier class I) where annular dilation, lateral displacement of anterior and posterior papillary muscle, symmetrical tethering with apical tenting of anterior leaflet, and central jet were prevalent. Patients with severe left ventricular dilation and moderate-to-severe MR had poorer outcomes both in the small group of patients in the COAPT8Nappi F. Antoniou G.A. Nenna A. Michler R. Benedetto U. Avtaar Singh S.S. et al.Treatment options for ischemic mitral regurgitation: a meta-analysis.J Thorac Cardiovasc Surg. 2022; 163: 607-622.e14Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar and in Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation12Iung B. Armoiry X. Vahanian A. Boutitie F. Mewton N. Trochu J.-N. et al.Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.Eur J Heart Fail. 2019; 21: 1619-1627Crossref PubMed Scopus (124) Google Scholar trials. These patients had similar features of proportionate MR and did not respond favorably to TEER (Table 1).13Packer M. Grayburn P.A. New evidence supporting a novel conceptual framework for distinguishing proportionate and disproportionate functional mitral regurgitation.JAMA Cardiol. 2020; 5: 469-475Crossref PubMed Scopus (58) Google Scholar RMA, Restrictive mitral annuloplasty; PMR, papillary muscle relocation; LVEDD, left ventricular end-diastolic diameter LVEF, left ventricular ejection fraction; EROA, effective regurgitant orifice area; MR, mitral regurgitation; COAPT, Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation; TEER, transcatheter edge-to-edge repair; GDMT, guide-direct medical therapy; LVEDV, left end-diastolic volume; MITRA Fr, Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation; PMA trial, papillary muscle approximation trial; CTSN, Cardiothoracic Surgical Trials Network; MVR, mitral valve replacement; LVESI, left end-systolic volume index. All 5 AHA/ACC recommendations were classified as level of evidence B-R or B-NR, indicating moderate quality of studies. The available literature lacks RCTs designed with a large number of enrolled patients that include candidates receiving TEER, mitral valve replacement, or mitral valve repair with or without a subvalvular procedure. ACC/AHA guidelines reference 2 TEER-based RCTs with 3-year outcomes that are reported only for the COAPT trial,9Stone G.W. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.Transcatheter mitral-valve repair in patients with heart failure.N Engl J Med. 2018; 379: 2307-2318Crossref PubMed Scopus (1415) Google Scholar and the analysis of the new pathophysiological framework of the pathomechanism for SMR.10Mack M.J. Lindenfeld J. Abraham W.T. Kar S. Lim D.S. Mishell J.M. et al.3-year outcomes of transcatheter mitral valve repair in patients with heart failure.J Am Coll Cardiol. 2021; 77: 1029-1040Crossref PubMed Scopus (57) Google Scholar None of these recommendations are based on reports with 5 years’ follow-up.2Otto C.M. Nishimura R.A. Bonow R.O. Carabello B.A. Erwin III, J.P. Gentile F. et al.2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines.J Am Coll Cardiol. 2021; 77: 450-500Crossref PubMed Scopus (249) Google Scholar For double-level repair, there currently is no solid evidence supported by more than 1 RCT, or meta-analysis of moderate-quality RCTs, that allows recommending this procedure. Although the results of the Multicenter Randomized, Controlled Study to Assess Mitral Valve Reconstruction for Advanced Insufficiency of Functional or Ischemic Origin14A Multicenter, randomized, controlled study to assess mitral vAlve reconsTrucTion for advancEd insufficiency of functional or iscHemic ORigiN (MATTERHORN). ClinicalTrials.gov identifier: NCT02371512.https://clinicaltrials.gov/ct2/show/NCT02371512Date accessed: March 8, 2022Google Scholar randomized study are awaited, other RCTs have demonstrated the efficacy of using novel devices. None of these are directed toward manipulating the papillary muscles by either an approximation or a relocation procedure. In the Edwards Pascal Transcatheter Mitral Valve Repair System Study RCT (N = 124), the Pascal system (Edwards Lifesciences) was implanted in patients enrolled for treatment of functional, degenerative, and mixed etiology. The Pascal transcatheter valve repair system and the MitraClip system (Abbott, Abbott Park, Ill) were compared in patients with both functional and degenerative MR. Evidence from the Edwards Pascal Transcatheter Mitral Valve Repair System Study recorded a high rate of survival, with a significant rate of reduction in heart failure-related hospitalization with reverse positive left ventricular remodeling at 1 and 2 years’ follow-up.15Praz F. Spargias K. Chrissoheris M. Büllesfeld L. Nickenig G. Deuschl F. et al.Compassionate use of the PASCAL 536 transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, 537 observational, first-in-man study.Lancet. 2017; 390: 773-780Abstract Full Text Full Text PDF PubMed Scopus (149) Google Scholar, 16Lim D.S. Kar S. Spargias K. Kipperman R.M. O’Neill W.W. Ng M.K.C. et al.Transcatheter valve repair for patients with mitral regurgitation: 30-day results of 539 the CLASP study.JACC Cardiovasc Interv. 2019; 12: 1369-1378Crossref PubMed Scopus (91) Google Scholar, 17Webb J.G. Hensey M. Szerlip M. Schafer U. Cohen G.N. Kar S. et al.1-year outcomes for transcatheter repair in patients with mitral regurgitation 541 from the clasp study.JACC Cardiovasc Interv. 2020; 13: 2344-2357Crossref PubMed Scopus (31) Google Scholar, 18Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF). ClinicalTrials.gov identifier: NCT03706833.https://clinicaltrials.gov/ct2/show/NCT03706833Date accessed: March 8, 2022Google Scholar Additional multicenter RCTs designed with a minimum of 5-year follow-up enrolling patients to undergo either TEER or double-level repair should be encouraged. Surgical versus transcatheter repair for secondary mitral regurgitation: A propensity score–matched cohorts comparisonThe Journal of Thoracic and Cardiovascular SurgeryPreviewTo compare the efficacy and clinical outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) and surgical mitral valve repair (SMVr) among patients with secondary mitral regurgitation (SMR). Full-Text PDF Reply: The perfect decision with imperfect information: Pitfalls of generalizing to many what we know of few?JTCVS OpenVol. 10PreviewSecondary mitral regurgitation (SMR) remains a problem that affects many. The publication of 2 randomized controlled trials ontranscatheter edge-to-edge repair (TEER) for SMR with conflicting outcomes were followed with the designation of TEER as a IIa indication in the treatment of SMR alongside surgical mitral valve repair with reductive annuloplasty (RMA) plus revascularization in the American Heart Association/American College of Cardiology guidelines.1-3 The final word on the best management of SMR is far from written. Full-Text PDF Open Access
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TL;DR: In this article , the authors compared surgical versus transcatheter repair for secondary mitral regurgitation: a propensity score-matched cohorts comparison, and found surgical restrictive annuloplasty (RA) plus coronary revascularization to be superior to TEER in reducing MR, improving ventricular ejection fraction, and reducing New York Heart Association class III-IV without a survival difference.
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TL;DR: Guidelines and Expert Consensus Documents aim to present management recommendations based on all of the relevant evidence on a particular subject in order to help physicians select the best possible management strategies for the individual patient suffering from a specific condition, taking into account the impact on outcome and also the risk–benefit ratio of a particular diagnostic or therapeutic procedure.
Abstract: Guidelines and Expert Consensus Documents aim to present management recommendations based on all of the relevant evidence on a particular subject in order to help physicians select the best possible management strategies for the individual patient suffering from a specific condition, taking into account the impact on outcome and also the risk–benefit ratio of a particular diagnostic or therapeutic procedure. Numerous studies have demonstrated that patient outcomes improve when guideline recommendations, based on the rigorous assessment of evidence-based research, are applied in clinical practice.
A great number of Guidelines and Expert Consensus Documents have been issued in recent years by the European Society of Cardiology (ESC) and also by other organizations or related societies. The profusion of documents can put at stake the authority and credibility of guidelines, particularly if discrepancies appear between different documents on the same issue, as this can lead to confusion in the minds of physicians. In order to avoid these pitfalls, the ESC and other organizations have issued recommendations for formulating and issuing Guidelines and Expert Consensus Documents. The ESC recommendations for guidelines production can be found on the ESC website.1 It is beyond the scope of this preamble to recall all but the basic rules.
In brief, the ESC appoints experts in the field to carry out a comprehensive review of the literature, with a view to making a critical evaluation of the use of diagnostic and therapeutic procedures and assessing the risk–benefit ratio of the therapies recommended for management and/or prevention of a given condition. Estimates of expected health outcomes are included, where data exist. The strength of evidence for or against particular procedures or treatments is weighed according to predefined scales for grading recommendations and levels of evidence, as outlined in what follows.
The Task Force members of the writing panels, …
3,707 citations
TL;DR: Guidelines summarize and evaluate all evidence available on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome.
Abstract: ACE
: angiotensin-converting enzyme
AF
: atrial fibrillation
aPTT
: activated partial thromboplastin time
AR
: aortic regurgitation
ARB
: angiotensin receptor blockers
AS
: aortic stenosis
AVR
: aortic valve replacement
BNP
: B-type natriuretic peptide
BSA
: body surface area
CABG
: coronary artery bypass grafting
CAD
: coronary artery disease
CMR
: cardiac magnetic resonance
CPG
: Committee for Practice Guidelines
CRT
: cardiac resynchronization therapy
CT
: computed tomography
EACTS
: European Association for Cardio-Thoracic Surgery
ECG
: electrocardiogram
EF
: ejection fraction
EROA
: effective regurgitant orifice area
ESC
: European Society of Cardiology
EVEREST
: (Endovascular Valve Edge-to-Edge REpair STudy)
HF
: heart failure
INR
: international normalized ratio
LA
: left atrial
LMWH
: low molecular weight heparin
LV
: left ventricular
LVEF
: left ventricular ejection fraction
LVEDD
: left ventricular end-diastolic diameter
LVESD
: left ventricular end-systolic diameter
MR
: mitral regurgitation
MS
: mitral stenosis
MSCT
: multi-slice computed tomography
NYHA
: New York Heart Association
PISA
: proximal isovelocity surface area
PMC
: percutaneous mitral commissurotomy
PVL
: paravalvular leak
RV
: right ventricular
rtPA
: recombinant tissue plasminogen activator
SVD
: structural valve deterioration
STS
: Society of Thoracic Surgeons
TAPSE
: tricuspid annular plane systolic excursion
TAVI
: transcatheter aortic valve implantation
TOE
: transoesophageal echocardiography
TR
: tricuspid regurgitation
TS
: tricuspid stenosis
TTE
: transthoracic echocardiography
UFH
: unfractionated heparin
VHD
: valvular heart disease
3DE
: three-dimensional echocardiography
Guidelines summarize and evaluate all evidence available, at the time of the writing process, on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well …
3,608 citations
Columbia University Medical Center1, Vanderbilt University2, Ohio State University3, Cedars-Sinai Medical Center4, University of Virginia5, Intermountain Medical Center6, Baylor University Medical Center7, Carolinas Medical Center8, Piedmont Hospital9, University of Colorado Hospital10, University of Missouri–Kansas City11, MedStar Health12, Scott & White Hospital13
TL;DR: Among patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy, transcatheter mitral‐valve repair resulted in a lower rate of hospitalization forHeart failure and lower all‐cause mortality within 24 months of follow‐up than medical therapy alone.
Abstract: Background Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor Transcatheter mitral-valve repair may improve their clinical outcomes Methods At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group) The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 880% Results Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 t
1,758 citations