GUIDELINES IN ASYMPTOMATIC MR DECISION MAKING DEL CARDIOCHIRURGO NELL’ NELL’INSUFFICIENZA MITRALICA: ISTRUZIONI D’ D’USO PER IL CARDIOLOGO ACC/AHA ESC Antonio Miceli Heart Hospital – Monasterio Foundation NATURAL/ MEDICAL MR HISTORY Organic MR is a condition with adverse events • • Under medical management MR due to flail leaflets display excess mortality compared with the genaral population Sudden death 0.8% per year Sarano. Lancet 2009;373:1382-94 3% 9% 6% 12% In patients with organic MR, surgery is almost unavoidable • High likelihood of developing symptoms or LV dysfunction in 6-10 years. • Patients in their 50s, rate of surgical indication is 7-10% per year • Patients in their 60s, rate of death or cardiac surgery is 20% per year; @ 10 years after diagnosis, 90% of patients either are dead or surgery • Mortality rate in patients with severe MR with flail leaflets is 6-7% per year. THE QUESTION IS NOT “IF” BUT “WHEN” SURGERY SHOULD BE PERFORMED RATIONALE FOR EARLY SURGERY Class I indications are associated with worse outcomes EARLY SURGERY VS WATCHFUL WAITING Tribouilloy C et al. Circulation 1999;99:400-405 RATIONALE FOR EARLY SURGERY RATIONALE FOR EARLY SURGERY Class I indications are associated with worse outcomes Class I indications are associated with worse outcomes Tribouilloy C et al. Circulation 1999;99:400-405 Tribouilloy C et al. JACC 2009;54:1961-8 RATIONALE FOR EARLY SURGERY ATRIAL FIBRILLATION RATIONALE FOR EARLY SURGERY ERO ERO>40mm is associated with : - doubling of the mortality risk - quadrupling of the risk of cardiac events Sarano et al. Circulation 2010;121:804-812 RATIONAL FOR EARLY SURGERY Sarano et al. Circulation 2010;121:804-812 Survival in asymptomatic severe MR: the MIDA registry B-TYPE NATRIURETIC PEPTIDE Sarano et al. Circulation 2010;121:804-812 Suri et al., The JAMA (2013) 310:609310:609-616 Study design Design Initial medical management Echo - Flail leaflet Murmur detected • MIDA Registry: 2097 consecutive patients with flail mitral valve regurgitation (1980-2004). Mean follow-up is 10.3 year and is 98% complete. • Routine cardiac practice at six tertiary centers (France, Italy, Belgium and USA) Mitral surgery within 3 Months Suri et al., The JAMA (2013) 310:609-616 MIDA Registry International Sites Suri et al., The JAMA (2013) 310:609310:609-616 Participants • One-thousand-and-twenty-one patients with mitral regurgitation and without class I triggers - 446 pt underwent mitral valve surgery within 3 months following detection Rochester, MN, USA - 575 pt initially medically managed Brussels, Belgium Amiens, France Bologna, Italy Marseille, France Modena, Italy Suri et al., The JAMA (2013) 310:609310:609-616 • Association between treatment strategy and survival, heart failure, and new-onset atrial fibrillation. Suri et al., The JAMA (2013) 310:609310:609-616 Exclusion criteria Baseline Characteristics Overall • Ischemic mitral regurgitation • Significant concomitant aortic valve disease, congenital heart disease, mitral stenosis, and previous valve surgery • Current heart failure symptoms due to mitral regurgitation as defined per Framingham criteria • Overt left ventricular dysfunction defined as either ejection fraction<60 % or end-systolic diameter ≥40 mm • Contraindication to surgery due to comorbidity Characteristic (%) Medical management n=575 Early surgery n=446 Total n=1,021 P Age, mean (SD) (yr) Men 67 (13) 72.1 62 (13) 73.0 65 (13) 72.8 <0.001 0.56 Charlson index, mean (SD) Minimal subjective manifestation 0.9 (1.2) 32.5 0.8 (1.1) 52.2 0.8 (1.2) 41.1 0.05 0.001 Ejection fraction, mean (SD) (%) Hypertension 68.6 (6) 37.4 68.7 (6) 36.5 68.7 (6) 37.0 0.65 0.78 10.0 11.8 12.4 16.8 11.0 14.0 0.21 0.02 19.1 75 (14) 27.1 74 (16) 22.6 74 (15) 0.002 0.28 LVEDD, mean (SD) (mm) 56.0 (6.1) 57.7 (5.9) 56.7 (6.1) <0.001 LVESD, mean (SD) (mm) 32.2 (4) 33.5 (4) 32.8 (4) <0.001 LVESD/BSA mean (SD) (mm/m2) 17.6 (2.5) 17.9 (2.6) 17.7 (2.6) 0.04 LA diameter, mean (SD) (mm) 48.0 (8.0) 49.2 (7.6) 48.5 (7.9) 0.03 86.0 87.4 86.6 0.52 Atrial fibrillation Pulmonary hypertension Class II indication Heart rate, mean (SD) (bpm) Flail posterior Suri et al., The JAMA (2013) 310:609310:609-616 Characteristic (%) Age, mean (SD) (yr) Men Charlson index, mean (SD) Minimal subjective manifestation Ejection fraction, mean (SD) (%) Hypertension Atrial fibrillation Pulmonary hypertension Class II indication Heart rate, mean (SD) (bpm) LVEDD, mean (SD) (mm) LVESD, mean (SD) (mm) LVESD/BSA mean (SD) (mm/m2) Propensity score-matched cohort Medical management Early surgery Total n=324 n=324 n=648 64 (12) 64 (12) 64 (12) 76.2 76.2 76.2 0.8 (1.2) 0.8 (1.2) 0.8 (1.2) 10.1 44.1 42.1 68.5 (6) 68.2 (6) 68.3 (6) 40.1 36.4 38.3 9.9 13.7 11.8 10.8 17.0 13.9 18.2 28.7 23.52 74 (14) 74 (16) 74 (15) 56.1 (6) 57.6 (6) 56.9 (6) 32.6 (4) 33.7 (4) 33.1 (4) 17.5 (2.5) 18.0 (2.4) 17.8 (2.5) P 0.75 >0.99 0.79 0.30 0.46 0.33 0.14 0.02 0.002 0.48 0.004 0.001 0.03 Unmatched survival in the MIDA registry 100 94.6 80 84.2 85.7 Survival (%) Baseline Characteristics: Propensity scorematched cohort Suri et al., The JAMA (2013) 310:609-616 60 Flail posterior 48.0 (7.4) 49.3 (7.7) 48.7 (7.6) 0.04 86.2 88.5 87.3 0.38 Suri et al., The JAMA (2013) 310:609-616 63.2 53.7 40 40.9 20 Medical Early surgery Log rank p < 0.001 0 0 LA diameter, mean (SD) (mm) 74.1 69.4 2 4 6 8 10 12 14 16 18 20 Time (years) Suri et al., The JAMA (2013) 310:609-616 Matched survival in the MIDA registry 100 Unmatched chronic heart failure in the MIDA registry 50 94 Medical Early surgery 84 87 72 76 60 40 60 63 52 40 20 Log rank p = 0.002 0 2 6 4 8 35 28 30 23 20 16 10 Medical Early surgery 0 Heart failure (%) Survival (%) 80 7 4 0 2 6 4 Time (years) 8 10 12 14 16 18 20 Time (years) Suri et al., The JAMA (2013) 310:609-616 Matched chronic heart failure in the MIDA registry 50 Unmatched atrial fibrillation in the MIDA registry 50 30 24 15 18 11 11 11 8 10 Atrial fibrillation (%) 40 Heart failure (%) Suri et al., The JAMA (2013) 310:609-616 Medical Early surgery 20 10 Log rank p < 0.001 0 10 12 14 16 18 20 10 Medical Early surgery 43 40 36 30 26 31 27 20 15 10 14 23 4 Log rank p < 0.001 0 0 2 4 6 8 10 12 14 16 18 20 Time (years) Log rank p = 0.33 0 0 2 4 6 8 10 12 14 16 18 20 Time (years) Suri et al., The JAMA (2013) 310:609-616 Suri et al., The JAMA (2013) 310:609-616 Matched atrial fibrillation in the MIDA registry Atrial fibrillation (%) 50 Medical Early surgery 40 32 30 35 31 25 Summary • Early-surgery was not associated with excess short term (3 months) mortality or heart failure, but does carry a small increased risk of early atrial fibrillation • Long-term results are coherent regardless of the statistical methods employed (direct comparison, adjusted comparison, propensity-matching, Inverse-probability weighting) and demonstrate : 26 20 – a net survival benefit (total mortality decrement of approximately 40%) 24 16 14 10 Log rank p = 0.33 0 0 2 4 6 8 10 12 14 16 18 20 – A diminished risk of heart failure (reduction of approximately 60%) Time (years) Suri et al., The JAMA (2013) 310:609-616 What is new in Mitral Surgery? Suri et al., The JAMA (2013) 310:609-616 Heart Hospital 10year Experience in MIMVS Baseline Characteristics October 2003 - April 2013 1392 Patients underwent MIMVS through right thoracotomy Overall Logistic EuroSCORE (%) Results 7 (4-15) Baseline Characteristics of 978 repair Central Aortic Cannulation 1108 pts (80%) Femoral Artery Cannulation 287 pts (20%) Direct Aortic Cross-Clamp 1189 pts Endoaortic Ballon 148 pts Ventricular Fibrillation / Beating Heart 55 pts Conversion to sternotomy 49 patients (3.5%) Principles of Reconstruction Results • Preserve or restore full leaflet motion • Create a large surface of coaptation • Remodel and stabilize the annulus Results Freedom from Reoperation 98% ±5% Median Follow-up 3 (1-5 years) TAKE HOME MESSAGES 1.EARLY SURGICAL INDICATIONS 1.ADVANTAGES OF MIMVS