加拿大心脏学会心力衰竭指南.pdf

Society GuidelinesCCS/CHFS Heart Failure Guidelines: Clinical Trial Update onFunctional Mitral Regurgitation, SGLT2 Inhibitors, ARNI inHFpEF, and Tafamidis in AmyloidosisPrimary Panel and Secondary Panel Writing Members: Eileen OMeara, MD,a,*Michael McDonald, MD,b,* Michael Chan, MBBS,cAnique Ducharme, MD,aJustin A. Ezekowitz, MBBCh,dNadia Giannetti, MD,eAdam Grzeslo, MD,fGeorge A. Heckman, MD,gJonathan G. Howlett, MD,hSheri L. Koshman, PharmD,dSerge Lepage, MD,iLisa M. Mielniczuk, MD,jGordon W. Moe, MD,kElizabeth Swiggum, MD,lMustafa Toma, MD,mSean A. Virani, MD,mShelley Zieroth, MD,nSabe De, MD,oSylvain Matteau, MD,i,pMarie-Claude Parent, MD,aExternal Reviewers and Co-authors:Anita W. Asgar, MD,aGideon Cohen, MD,qNowell Fine, MD,rMargot Davis, MD,mSubodh Verma, MD,sDavid Cherney, MD,tSecondary Panel: Howard Abrams, MD,uAbdulAl-Hesayen,MD,kAlainCohen-Solal,MD,vMichelDAstous,MD,wDiegoH.Delgado,MD,uOlivier Desplantie, MD,xEstrellita Estrella-Holder, RN,yLee Green, MD,dHaissam Haddad, MD,zKaren Harkness, RN,aaAdrian F. Hernandez, MD,bbSimon Kouz, MD,ccMarie-H? elne LeBlanc, MD,ddDouglas Lee, MD,uFrederick A. Masoudi, MD,eeRobert S. McKelvie, MD,ffMiroslaw Rajda, MD,ggHeather J. Ross, MD,band Bruce Sussex, MBBShhaInstitut de Cardiologie de Montr? eal, Universit? e de Montr? eal, Montr? eal, Qu? ebec, Canada;bPeter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada;cUniversity of Alberta, Royal Alexandra Hospital, Edmonton, Alberta, Canada;dUniversity of Alberta, Edmonton, Alberta, Canada;eMcGill University, Montr? eal, Qu? ebec,Canada;fHamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada;gSchlegel-University of Waterloo Research Institute for Aging, University of Waterloo,Waterloo, Ontario, Canada;hCumming School of Medicine, University of Calgary, Libin Cardiovascular Institute, Calgary, Alberta, Canada;iUniversit? e de Sherbrooke,Sherbrooke, Qu? ebec, Canada;jUniversity of Ottawa Heart Institute, Ottawa, Ontario, Canada;kSt Michaels Hospital, Toronto, Ontario, Canada;lRoyal Jubilee Hospital,University of British Columbia, Victoria, British Columbia, Canada;mUniversity of British Columbia, Vancouver, British Columbia, Canada;nUniversity of Manitoba,Winnipeg, Manitoba, Canada;oLondon Health Sciences, Western University, London, Ontario, Canada;pChaleur Regional Hospital, Bathurst, New Brunswick, Canada;qSunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada;rUniversity of Calgary, Calgary, Alberta, Canada;sSt Michaels Hospital, University ofToronto, Toronto, Ontario, Canada;tDivision of Nephrology, Department of Medicine, University Health Network, University of Toronto, Toronto, Ontario, Canada;uUniversityHealth Network, Toronto, Ontario, Canada;vParis University, UMR-S 942, Hpital Lariboisire, Paris, France;wCHU Dumont UHC, Moncton, New Brunswick, Canada;xRoyal Jubilee Hospital, Victoria, British Columbia, Canada;ySt Boniface General Hospital, Winnipeg, Manitoba, Canada;zUniversity of Saskatchewan, Saskatoon,Saskatchewan, Canada;aaHamilton Health Sciences, Hamilton, Ontario, Canada;bbDuke Clinical Research Institute, Durham, North Carolina, USA;ccCentre Int? egr? e de Sant? eet de Services Sociaux de Lanaudire - Centre Hospitalier de Lanaudire, Joliette, Qu? ebec, Canada;ddInstitut universitaire de cardiologie et de pneumologie de Qu? ebec (IUCPQ),Universit? e Laval, Qu? ebec, Qu? ebec, Canada;eeUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado, USA;ffSt Josephs Health Care, Western University, London,Ontario, Canada;ggQEII Health Sciences Centre, Halifax, Nova Scotia, Canada;hhMemorial University, St Johns, Newfoundland and Labrador, CanadaCanadian Journal of Cardiology 36 (2020) 159e169Received for publication November 3, 2019. Accepted November 26, 2019.*Co-primary authors.Corresponding author: Dr Eileen OMeara, Universit? e de Montr? eal,Institut de Cardiologie de Montr? eal, 5000 B? elanger, Montreal, Quebec H1T1C8, Canada. Tel.: 1-514-376-3330 ?3947; fax: 1-514-593-2575.E-mail: The disclosure information of the authors and reviewers is available fromthe CCS on their guidelines library at www.ccs.ca.This statement was developed following a thorough consideration ofmedical literature and the best available evidence and clinical experience. Itrepresents the consensus of a Canadian panel comprised of multidisciplinaryexperts on this topic with a mandate to formulate disease-specific recom-mendations. These recommendations are aimed to provide a reasonable andpractical approach to care for specialists and allied health professionals obligedwith the duty of bestowing optimal care to patients and families, and can besubject to change as scientific knowledge and technology advance and aspractice patterns evolve. The statement is not intended to be a substitute forphysicians using their individual judgement in managing clinical care inconsultation with the patient, with appropriate regard to all the individualcircumstances of the patient, diagnostic and treatment options available andavailable resources. Adherence to these recommendations will not necessarilyproduce successful outcomes in every case.https:/doi.org/10.1016/j.cjca.2019.11.0360828-282X/? 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.ABSTRACTIn this update, we focus on selected topics of high clinical relevance forhealth care providers who treat patients with heart failure (HF), on thebasis of clinical trials published after 2017. Our objective was to reviewthe evidence, and provide recommendations and practical tipsregarding the management of candidates for the following HF thera-pies: (1) transcatheter mitral valve repair in HF with reduced ejectionfraction; (2) a novel treatment for transthyretin amyloidosis or trans-thyretin cardiac amyloidosis; (3) angiotensin receptor-neprilysin inhi-bition in patients with HF and preserved ejection fraction (HFpEF); and(4) sodium glucose cotransport inhibitors for the prevention andtreatment of HF in patients with and without type 2 diabetes. Weemphasize the roles of optimal guideline-directed medical therapy andof multidisciplinary teams when considering transcatheter mitral valverepair, to ensure excellent evaluation and care of those patients. In thepresence of suggestive clinical indices, health care providers shouldconsider the possibility of cardiac amyloidosis and proceed with properinvestigation. Tafamidis is the first agent shown in a prospective studyto alter outcomes in patients with transthyretin cardiac amyloidosis.Patient subgroups with HFpEF might benefit from use of sacubitril/valsartan, however, further data are needed to clarify the effect of thistherapy in patients with HFpEF. Sodium glucose cotransport inhibitorsreduce the risk of incident HF, HF-related hospitalizations, and car-diovascular death in patients with type 2 diabetes and cardiovasculardisease. A large clinical trial recently showed that dapagliflozin pro-vides significant outcome benefits in well treated patients with HF withreduced ejection fraction (left ventricular ejection fraction ? 40%), withor without type 2 diabetes.R?ESUM?EDans cette mise jour, nous nous int? eressons des th? ematiquespr? ecises ayant une pertinence clinique dimportance pour les four-nisseurs de soins de sant? e qui traitent des patients atteints dinsuf-fisance cardiaque (IC), sur la base dessais cliniques publi? es aprs2017. Notre objectif ? etait dexaminer les donn? ees probantes et defournir des recommandations et des conseils pratiques concernant laprise en charge des candidats aux diff? erents traitements dIC suivants :(1) la r? eparation de la valve mitrale par cath? eter dans le cadre dune ICavec une fraction d? ejection r? eduite; (2) un nouveau traitement pourlamylose de la transthyr? etine ou lamylodose cardiaque la trans-thyr? etine; (3) linhibition du r? ecepteur de langiotensine et de lan? evrilysine chez les patients atteints dIC avec une fraction d? ejectionpr? eserv? ee (ICFEP); et (4) les inhibiteurs du cotransporteur sodium-glucose pour la pr? evention et le traitement de lIC chez les patientsavec et sans diabte de type 2. Nous mettons lemphase sur le rledune th? erapie m? edicale optimale encadr? ee par les lignes directriceset sur le rle des ? equipes multidisciplinaires lorsquune r? eparation dela valve mitrale par cath? eter est envisag? ee, ceci afin de garantirlexcellence dans l? evaluation et les soins port? es ces patients. Enpr? esence de signes cliniques manifestes, les fournisseurs de soins desant? e devraient envisager l? eventualit? e dune amylose cardiaque etproc? eder un examen appropri? e. Le tafamidis est le premier agentdont une ? etude prospective a d? emontr? e quil remanie les effets duneamylose cardiaque transthyr? etine chez les patients. Lutilisation dusacubitril/valsartan pourrait tre b? en? efique pour les sous-groupes depatients atteints dICFEP; toutefois, des donn? ees compl? ementairessont n? ecessaires pour clarifier leffet de ce traitement chez les patientsatteints dICFEP. Les inhibiteurs du cotransporteur sodium-glucoser? eduisent le risque dincidence de lIC, les hospitalisations li? ees lICet les d? ecs dorigine cardiovasculaire chez les patients atteints dediabte de type 2 et de maladie cardiovasculaire. Un vaste essaiclinique a r? ecemment montr? e que la dapagliflozine procure desb? en? efices importants sur le plan des r? epercussions chez les patientscorrectement trait? es atteints dIC avec une fraction d? ejection r? eduite(fraction d? ejection du ventricule gauche ? 40 %), avec ou sans di-abte de type 2.The Canadian Cardiovascular Society (CCS) heart failure(HF) guidelines program provides guidance to clinicians,policy makers, and health systems as to the evidence sup-porting existing and emerging management of patients withHF. The 2019 update on clinical trial data is a brief set ofguidelines incorporating new evidence from randomizedcontrolled trials published after the 2017 update on topics ofimportance for health care providers in HF management. Itupdates the last version of the CCS HF guidelines on thosespecific topics.The constitution and roles of the primary and secondarypanels, systematic review strategy, and methods for formu-lating the recommendations are described at www.ccs.ca. Therecommendations were developed using the Grading of Rec-ommendations Assessment, Development, and Evaluation(GRADE) standards.1,2Primary panelists were responsible forwriting and reviewing the document, with writing participa-tion of 3 secondary panelists and 6 external content experts.The objective of this update was to highlight new clinicaltrial evidence on 4 topics of high importance in terms ofchanges and evolution in the care of patients with HF: (1)transcatheter mitral valve repair; (2) potential treatments fortransthyretin amyloidosis (ATTR) or transthyretin cardiacamyloidosis (CA); (3) the role of angiotensin receptor-neprilysin inhibition in patients with HF and preservedejection fraction (HFpEF); and (4) prevention of HF out-comes with sodium glucose cotransport (SGLT2) inhibitors.We collaborated with content experts on each topic whoprovided critical external input and perspective.1. Percutaneous Mitral Valve Repair forPatients With HF and Reduced Ejection Fractionand Severe Functional Mitral RegurgitationFunctional mitral regurgitation (FMR) secondary to leftventricular (LV) dysfunction and dilatation is an importantcontributor to the high mortality3observed in patients withHF and reduced ejection fraction (HFrEF). Observationalstudies and 1 previous randomized trial4showed the potentialbenefits of surgical correction or percutaneous mitral valverepair (PMVR) for improving symptoms and promotingreverse remodelling. However, this has not been routinelyrecommended to date.4-7Such data have raised awarenessregarding the importance of FMR on progression of HF and160Canadian Journal of CardiologyVolume 36 2020the potential for treatment of FMR to improve outcomes.Although a number of technologies are in clinical develop-ment, edge-to-edge leaflet repair with the MitraClip system(Abbott Structural Heart) is currently the only HealthCanada-approved device for PMVR.In a previous retrospective observational study mitral in-terventions (either transcatheter or surgical) were comparedwith conservative management.8Conservative management inpatients with FMR was associated with a higher mortalitycompared with PMVR (hazard ratio HR, 1.79; 95% con-fidence interval CI, 1.34-2.39), with no significant mortalitydifference identified between the PMVR and surgical arms(HR, 0.86; 95% CI, 0.54-1.38). Of note, the death rate wasnumerically higher for patients treated with PMVR vs surgery(33% vs 23%), in keeping with the higher mean EuropeanSystem for Cardiac Operative Risk Evaluation (EuroSCORE)II observed in this group of patients (8.9 vs 4.7; P 0.001).Because of the nonrandomized observational study design,these findings are not conclusive with respect to the role ofPMVR in patients with HF and severe FMR.In 2018, 2 randomized controlled trials were publishedthat compared the efficacy of PMVR using the MitraClipdevice (Abbott Structural Heart) in addition to guideline-directed medical therapy (GDMT) with GDMT alone inpatients with FMR for whom mitral valve surgery was notdeemed appropriate.7,8These trials differed with respect topatient characteristics and outcome definitions. The Percuta-neous Repair with the MitraClip device for Severe Func-tional/Secondary Mitral Regurgitation (MITRA-FR) 9 trialenrolled 304 patients with at least moderate-severe FMR(mean effective regurgitant orifice area of 31 mm2) and severeLV dilatation (indexed left ventricular end-diastolic volume of135 ? 37 mL/m2). PMVR did not provide a benefit in sur-vival over GDMT alone (24.3% vs 22.4%; HR, 1.11; 95%CI, 0.69-1.77) or in the rate of unplanned hospitalization forHF (HHF; 48.7% vs 47.4%; HR, 1.13; 95% CI, 0.81-1.56)during the 1-year follow-up period.Incontrast, theCardiovascularOutcomesAssessmentoftheMitraClip Percutaneous Therapy for Heart Failure PatientsWith Functional Mitral Regurgitation (COAPT)10trialenrolled 614 patients after optimization of GDMT (only one-third of the screened patients were eventually randomized;Table 1) with longer (2-year) follow-up. Trial participants hadhigher brain natriuretic peptide (BNP) concentrations (mean,1043 vs 800 ng/L), smaller indexed LV end-diastolic volume(101 ? 34 mL/m2), and more severe FMR (mean effectiveregurgitant orifice area, effective regurgitant orifice area of 40.5mm2comparedwiththeMITRA-FRpopulation).11,12Patientswho received PMVR had lower all-cause mortality at 2 yearscompared with GDMT alone (29.1% vs 46.1%; HR, 0.62;95%CI,0.46-0.82;P0.001).PMVRalsoreducedtheriskofHF hospitalizations (35.8% vs 67.9% per patient-year; HR,0.53; 95% CI, 0.4-0.7; P 70 mm) and less than severe mitral regurgitationmight be poor candidates for MitraClip (Abbott StructuralHeart).Practic