the road ahead
TRANSCRIPT
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The conundrum of mitral regurgitation
in heart failure
Piotr Ponikowski, MD, PhD, FESC Medical University, Centre for Heart Disease
Clinical Military HospitalWroclaw, Poland
The road ahead
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Disclosure
Consultancy fees and speaker’s honoraria from: ABBOTT VASCULAR
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Primary vs functional MR: key question for the current management
n Primary MRMR→LV volume overload→remodeling with subsequent consequences „correction of primary MR in a timely fashion reverses these consequences”
n Functional MR – damaged LV causes MR„primarily a ventricular problem it is less obvious that correcting the MR by itself will be curative or even beneficial”
Carabello BA, JACC 2008;52:319-26
• Secondary MR„because MR is only 1 component of the disease (severe LV dysfunction, CAD or idiopathic myocardial disease are the others), restoration of mitral valve competence is not by itself curative;
2014 AHA/ACC Valvular Heart Disease Guideline
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Primary vs functional MR: key question for the current management
Marwick TH, Zoghbi WA, Narula J. JACC CV Imaging 2014
Potential confounders in the causal pathway linking FMR and adverse events
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MR in Heart FailureManagement options: how / when to intervene ?
• Optimal medical therapy• CRT
• Surgery MV surgery Surgical treatment of LV
• Percutaneous techniques
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Functional Mitral Regurgitation – management options
Acute effect of CRT on FMR in HF patients (EF<30%) with LBBB
Breithardt OA et al. JACC 2003;41,765-770
…increase in TMP mediated by a rise in maximal rate of LV systolic pressure rise due to more coordinated LV contraction, may facilitate effective MV closure…
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Functional Mitral Regurgitation – management options
Impact of CRT on the severity of FMR
Di Biase L et al. Europace 2011;13, 829–838The distribution of MR in CRT population
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Functional Mitral Regurgitation – management options
CRT in Patients with Moderate-Severe FMR
van Bommel et al. Circulation 2011;124:912-9
100
200
300
BL F-UP BL F-UP
LVEDV (mL)
LVESV (mL)
BL F-UP BL F-UP
LVEDV (mL)
LVESV (mL)
MR improvers MR non-improvers
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MR in Heart FailureManagement options: how / when to intervene ?
• Optimal medical therapy• CRT
• Surgery MV surgery Surgical treatment of LV
• Percutaneous techniques
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ESC Guidelines on the Management of VHD 2012
Indications for mitral valve surgery in chronic secondary MR
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Euro Heart Survey: why surgery is denied in clinical practice ?
Mirabel et al., Eur Heart J 2007;28:1358-65
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Cardiac surgeon
Cardiologist
Anaesthetists
Other specialists:geriatrician, GP, etc Imaging specialist (ECHO, CT, MRI)
Decision-makingin VHD patient
HEART TEAM
‘heart team’ approach is particularly advisable in the management of high-risk patients and is also important for other subsets, such as asymptomatic patients, where the evaluation of valve repairability is a key component in decision-making…
ESC Guidelines on the Management of VHD 2012
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MR in Heart FailureManagement options: how / when to intervene ?
• Optimal medical therapy• CRT
• Surgery MV surgery Surgical treatment of LV
• Percutaneous techniques
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Percutaneous Mitral Valve RepairMitraClip® System
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WHY to recommend „new procedure” for HF patient ?
Therapy footprint
Economic impact
Patient
Durability
Procedural success
Safety profile
Survival & QoL
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MitraClip therapy“The most established PMVR therapy”
n More than 20000 patients treated worldwide n Used in more than 420 centers and 35 countriesn More than 560 clinical papers published to date*n Included in:
– 2012 ESC/HFA/EACTS Guidelines² – 2014 ACC/AHA Guidelines3
– 2012/2013 German Guidelines4,5
– 2014 Italian Guidelines6
• H. Hermann & F. Maisano – Transcatheter therapy of Mitral Regurgitation – Circulation 2014; 130:1712-1722• ESC/EACTS 2012 Guidelines on the management of valvular heart disease. Eur Heart J (2012) 33, 2451–2496.• Nishimura RA, et al. - 2014 ACC/AHA valve guidelines: earlier intervention for chronic mitral regurgitation - Heart June 2014 Vol 100 No 12• Boekstegers P. et.al. Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system Clin. Res. Cardiol. 2013• Nickenig G. et al. - Consensus of the German Cardiac Society and the German Society for Thoracic and Cardiovascular Surgery on treatment of mitral valve insufficiency -
Kardiologe 2013 · 7:76–90• Maisano et al. - Transcatheter treatment of chronic mitral regurgitation with the MitraClip system: an Italian consensus statement - J Cardiovasc Med 2014, 15:173–188
Therapy footprint
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EVEREST II: 279 patients with moderately severe or severe (grade 3+ or 4+) MR randomized in a 2:1 ratio to percutaneous repair or conventional surgeryLVEF – 60%, functional MR – 27%
12 months
Surgery better Percutaneous repair better
Feldman T et al., N Engl J Med 2011
MitraClip therapy“The most established PMVR therapy”
Therapy footprint
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MitraClip therapySafety profile
• T. Feldman, et al., The New England journal of medicine 364, 1395 (2011)/ 2. P. L. Whitlow, et al., Journal of the American College of Cardiology 59, 130 (2012)/ 3. F. Maisano, et al., Journal of the American College of Cardiology 62, 1052 (2013)/ 4. S. Kar, Presented at TCT, 2013, San Francisco, CA (2013)/ 5. W. Schillinger, et al., EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 9, 84 (2013)/4. C. Grasso, et al., The American journal of cardiology 111, 1482 (2013)
Safety profile
• Low Major Adverse Events (MAEs) • Low post-procedural mortalityLow Major Adverse Events (MAEs) Low post-procedural mortality
SMC
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MitraClip as therapeutic option for MRfirst (and strong) evidence
EVEREST II: 4-year results
Sustained clinical benefits comparable to those after surgeryImprovement in MR durable through 4 years
Mauri et al., JACC 2013
Survival & QoL
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MitraClip as therapeutic option for MRfirst (and strong) evidence
EVEREST II: 4-year results
Mauri et al., JACC 2013
Differences in rates of the efficacy endpoints: freedom from death, MV surgery and from +3/+4 MR
Survival & QoL
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MitraClip as therapeutic option for MRReal World Experience
ACCESS-EU: 567 pts with significant MR who underwent MitraClip therapy at 14 European sites; 69% functional MR, 85% NYHA III-IV, 53% LVEF <40%Implant rate – 99.6%; mortality: 30-day – 3.4%,1-year – 81.8%
Maisano F et al., JACC 2013;62:1052–61
Severity of MR at baseline and during follow-up Changes in 6MWT in patients with MitraClip
Survival & QoL
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MitraClip as therapeutic option for MRReal World Experience
TCVT – ESC : 628 consecutive pts with significant MR who underwent MitraClip therapy at 25 European sites; 72% functional MR: 88% NYHA III-IV, 42% LVEF <30%, EuroScore - 22
Nickenig G al., JACC 2014;64:875–84
Survival & QoL
Composite of death and HF rehospitalisation
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MitraClip as therapeutic option for MRReal World Experience
139 consecutive pts with MitraClip therapy vs 53 treated surgically vs 59 treated conservativelyMitraClip: EuroScore: 24±16%NYHA II-III: 77%; LVEF: 37±15%FMR: 77%
Swaans et al., JACC Interv 2014;7:875-81
Conclusion: high-surgical-risk
patients treated with TMVR displayed
survival benefit vs those treated
conservatively.
Survival & QoL
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Grades A & BAt risk of MR → Progressive MR•Primary myocardial disease with LV dilation and systolic dysfunction•Symptoms due to CAD/HF •OMT/devices/revascularization
Grade CAsymptomatic severe MR•Abnormal valve hemodynamics – ERO, RF•Symptoms due to CAD/HF•OMT/devices/revascularization
Grade DSymptomatic severe MR•Abnormal valve hemodynamics – ERO, RF•Symptoms due to MR, persist even after OMT/devices/revascularization
Modified from 2014 AHA/ACC Valvular Heart Disease Guideline
strategy:1.Treat HF optimally2.MR - watch and see
strategy:1.Treat HF optimally2.MR – consider intervention
Ready to challenge this paradigm ?
Is there enough evidence ?
FMR in Heart Failurehow / when / WHY to intervene ?