Quality Outcomes Mitral Valve Repair

Transcription

1 Quality Outcomes Mitral Valve Repair Moving Beyond Reoperation Rakesh M. Suri, D.Phil. Professor of Surgery 2015 MFMER

2 Disclosure Mayo Clinic Division of Cardiovascular Surgery Research funding Edwards Lifesciences St. Jude Medical Sorin Group Current technology licensing agreements Sorin Group and St. Jude Principle Investigator FDA Perceval Trial Sorin Group Co-Investigator PARTNER II, COAPT, SURTAVI, PORTICO No personal relationships with Industry 2015 MFMER

3 Outcomes Degenerative Mitral Repair Quality Left Ventricular Dysfunction MR Recurrence Quality of Life Heart Failure / Survival 2015 MFMER

4 2014 ACC/AHA Guideline Summary Stages of Progression of VHD A. At risk B. Progressive C. Asymptomatic severe C1: Asymptomatic ventricle compensated C2: Asymptomatic decompensated ventricle D. Symptomatic severe 2015 MFMER

5 2014 ACC/AHA Guideline Summary Mitral Valve Surgery in Patients with Nonischemic Severe Mitral Regurgitation Class IIa The weight of evidence favors MV repair: perform early mitral repair before these triggers are reached avoids intensive surveillance and lost preserved to follow-up LV function until (LVEF advanced >60% and LVESD <40 dysfunction has already ensued... Asymptomatic pt with chronic severe primary MR and mm) (stage C1) in the following situations: New onset AFib or pulmonary HTN or Expected repair>95% and mortality <1% experienced teams lower risk a) heart failure and b) mortality with when pt with flail leaflets undergo early operation vs. watchful waiting... Nishimura: Circulation. Online March 3, MFMER

6 What is important to the patient with MR? I want a normal heart and valve I want to feel well, have good quality of life, be alive and not need reintervention 2015 MFMER

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8 Left Ventricular Dysfunction 2015 MFMER

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10 Open questions regarding the LV in MR: In patients with normal EF (>60%) prior to mitral valve repair who develop early LV dysfunction (EF<50%): Incidence? Predictors? Short and long-term consequences? 2015 MFMER

11 How we answered this question: (n=5,258) mitral valve repair for MR 1,705 pt w/o sxs, preop EF >60% Divided into pt with and without early LV dysfunction (EF<50%) Studied early and late outcomes Determined predictors of LV dysfunction and late survival Follow-up 93% complete, mean 5.9 yr 2015 MFMER

12 How Many Had Triggers for Operation? 1,705 Preop EF >60% AATS ,391 (82%) Post EF 50% No Dysfx 314 (18%) Post EF <50% Dysfx 37% No class I/IIa trigger 22% No class I/IIa trigger 63% 78% 2015 MFMER

13 Baseline Characteristics Surgical Variable All patients n=1,705 Pre-dismissal EF 50% n=1,391 <50% n=314 P Artificial chordae implant 261 (15.2) 211 (15.2) 50 (15.9) 0.73 ECC (min) 60±30 61±31 59± Interatrial communication 267 (15.6) 222 (16.3) 45 (14.3) 0.38 Leaflet plication 331 (19.4) 259 (18.6) 72 (22.9) 0.08 Maze procedure 178 (10.4) 145 (10.4) 33 (10.5) 0.96 Robotic MV 262 (15.4) 213 (15.3) 49 (15.6) 0.81 Surgical Era: (62.9) 884 (63.5) 189 (60.2) 0.26 Triangular resection 1116 (65.5) 902 (64.8) 214 (68.2) 0.26 TV repair 77 (4.5) 64 (4.6) 13 (4.1) 0.72 XClamp (min) 43±22 43±22 42± MFMER

14 Postoperative Clinical Course Variable 50% n=1,391 <50% n=314 P Hospital LOS, median (IQR) days 5 (4-7) 5 (4-7) 0.37 IABP 10 (0.7) 3 (0.9) 0.66 ICU stay median (IQR) (hours) 22.5 ( ) 23 ( ) 0.11 Infection (all) 47 (3.4) 6 (1.9) 0.17 Need for inotropic support 136 (28) 50 (37.3) 0.04 Renal failure 7 (0.5) 4 (1.2) 0.12 Reoperation for bleeding 32 (2.3) 12 (3.8) 0.12 Residual moderate MR 33 (2.4) 5 (1.5) 0.35 Stroke 6 (0.4) 1 (0.3) MFMER

15 EF (%) Post-Repair Changes in EF * * -11%* %* Preop EF Postop EF No Dysfunction Dysfunction *P< MFMER

16 Mean EF Long Term Echocardiographic Follow-Up 70 No Dysfunction Dysfunction P<0.001 P<0.001 P= <5 years 5-10 years >10 years Years 2015 MFMER

17 Long Term Normalization EF(>60%) Early EF 50% Early EF <50% EF 60 EF >60 34% 32% 66% EF >60 EF 60 68% 2/3 rds never recover EF >60% 2015 MFMER

18 Hazard of late death Early Post Mitral Repair EF Hazard of Late Death Post mitral repair EF (%) 2015 MFMER

19 Survival (%) Late Survival by Postoperative EF % 60 <40% P= Follow-up time (year) Postop EF<40 No Yes MFMER

20 Predictors of Early Postoperative EF<40% Univariate analysis Multivariate model Preoperative data HR (95% CI) P HR (95% CI) P Higher LV mass 1.01 <0.001 Higher LAD 1.07 <0.001 Higher LVEDD 1.19 <0.001 NYHA III/IV Atrial fibrillation RVSP >49 mm Hg 4.57 < <0.001 Higher ERO (PISA) 5.00 <0.001 LVESD >36 mm 5.93 < < MFMER

21 Remember long term impact LV dysfunction (EF <50%) following mitral valve repair with normal preoperative EF (>60%) Occurs in 20% of pt Of whom 20% lack classical triggers 68% fail to normalize EF >60% Early EF<40% increase late mortality 70% Predictors RVSP >49 mm Hg and LVESD >36 mm 2015 MFMER

22 2015 MFMER

23 MR Recurrence 2015 MFMER

24 : 840 pt MV repair for degenerative MR Biennial evaluations median 10.4 yr 2015 MFMER

25 Freedom from MV reoperation (%) Mitral Valve Reoperation <0.5% per year n Years since initial MV surgery David et al: Circulation 127:1485, MFMER

26 Freedom MR (%) Freedom From Recurrent MR 100 Severe 100 Moderate - Severe % 0.5%/yr % 1.6%/yr n n Years since initial MV surgery Years since initial MV surgery David et al: Circulation 127:1485, MFMER

27 Multivariable Predictors Adverse Events All-cause mortality Age by 5-yr increments COPD (FEV 1 <1 L/s) Lower LV ejection fraction (per level) Hypertension Valve-related mortality Age by 5-yr increments Higher NYHA class (per level) Cardiac-related mortality Age by 5-yr increments Higher NYHA class (per level) Lower LV ejection fraction (per level) HR (95% CI) 1.55 ( ) 2.38 ( ) 1.55 ( ) 1.46 ( ) 1.64 ( ) 1.98 ( ) 1.40 ( ) 2.76 ( ) 2.00 ( ) P < < < Thromboembolism Age by 5-yr increments 1.12 ( ) 0.01 Reoperation on the mitral valve Isolated anterior leaflet prolapse Myxomatous degeneration (per level) Duran ring annuloplasty Recurrent moderate/severe mitral valve regurgitation Age Isolated anterior leaflet prolapse Myxomatous degeneration No annuloplasty ring Cardiopulmonary bypass time 5.04 ( ) 1.54 ( ) 3.23 ( ) 1.33 ( ) 2.86 ( ) 1.57 ( ) 2.13 ( ) 1.11 ( ) < <0.001 < David et al: Circulation 127:1485, MFMER

28 Quality of Life 2015 MFMER

29 How Will I Feel Prospectively quantified MR and administered questionnaires Stress and Health related-qol: 131 Pt (60 yr; 75% men) before and 6 months after operation for organic MR 62 Pt with mitral disease without operation 36 Normal controls: similar age 2015 MFMER

30 Stress, median Delta, mean Anxiety, median Delta, mean Psychoemotional Status at Diagnosis and Follow-Up P=0.01 Baseline P=0.7 Mitral operated Mitral unoperated Normal control * Follow-up * 22 P= P= * Baseline Follow-up -2.0 * *P<0.05 baseline vs follow-up Bayer-Topilsky et al: Ann Thorac Surg 99:847, MFMER

31 Conclusions: Patients with severe organic MR present with frequent psychoemotional alterations and HR-QOL deterioration, in contrast to prolapse patients who do not require mitral operation and normal controls. After surgery, notable improvement Quantification of emotional and physical well-being provides important outcome measures in patients with organic MR and uncovers important benefits provided by surgical correction of MR MFMER

32 Survival/CHF 2015 MFMER

33 2015 MFMER

34 MIDA Multinational Registry Flail Mitral Leaflets, n=2097 Rochester, MN, USA Amiens, France Brussels, Belgium Marseille, France Bologna, Italy Modena, Italy 2015 MFMER

35 Study Design Initial Medical Management Murmur detected Echo Flail Leaflet Mitral Surgery Within 3 Months 2015 MFMER

36 Survival (%) Cumulative risk of CHF (%) Six tertiary valve practices Early Surgery Improves Survival Surgery 3 months Conclusion 94 and Relevance: pts 50 Medicalwith flail 84 Early surgery P=0.003 mitral 87 leaflets performance 40 of early mitral Medical Early surgery P= Follow-up (years) Early Surgery >1000 Pt flail MV Decreases Heart Failure surgery was associated with greater long % term survival and a lower risk of heart failure Medical Follow-up (years) management % Follow-up 10.3 yr 93% Complete JAMA 310 (6), MFMER

37 The Latest: Long Term Outcome Mitral Repair Think: quality Intervene upon Class IIa patients >95% repair rate and <0.5% mortality Detect and monitor: LV dysfunction MR recurrence <0.5-1% / year Improvement QOL Early operation decreases late death / heart failure risk 2015 MFMER

38 Questions? 2015 MFMER

39 Baseline Characteristics Clinical Variable All patients n=1,705 Pre-dismissal EF 50% n=1,391 <50% n=314 P Age 58.8± ± ± Atrial fibrillation 105 (6.2) 80 (5.7) 25 (7.9) 0.14 BMI 25.9±4.3 26± ± BSA 1.93± ± ± COPD 108 (6.3) 84 (6.1) 24 (7.7) 0.29 Diabetes 45 (2.6) 38 (2.7) 7 (2.2) 0.61 Female 575 (34) 487 (35) 88 (28) Hypertension 693 (40.7) 589 (42.4) 104 (33.2) NYHA III/IV 496 (29.2) 393 (26.3) 103 (32.9) 0.11 Peripheral vascular disease 68 (3.9) 52 (3.7) 14 (4.4) 0.54 Renal failure (creat >1.4 mg/dl) 10 (0.9) 8 (0.9) 2 (1) 0.88 Stroke 29 (2.5) 23 (2.4) 6 (2.9) MFMER

40 Predictors of Long-Term Mortality Univariate analysis Multivariate model Preoperative data HR (95% CI) P HR (95% CI) P Age 1.10 < <0.001 Gender (female) Diabetes Hypertension 1.78 < NYHA < Preop atrial fibrillation 4.88 < ECC (min) XClamp (min) TV repair 3.75 <0.001 Maze procedure Preop RVSP (mm Hg) 1.03 <0.001 LAD (mm) Preop LVSED Preop LVDED Preop MR ERO Preop LV mass Postop EF <40% MFMER

41 Clinical Characteristics of All Patients Age at surgery, yr, median (IQR) <45 yr, no. (%) yr, no. (%) yr, no. (%) >75 yr, no. (%) 60 (50-68) 125 (14.8) 300 (35.4) 374 (44.2) 48 (5.7) Sex (male), no. (%) 606 (71.6) Year of surgery, no. (%) < Previous cardiac operations, no. (%) Coronary artery bypass graft Aortic valve surgery Mitral valve repair Congenital heart surgery Timing of surgery, no. (%) Elective Semiurgent (<7 days from a cardiac event) Urgent/emergent (<72 hr from a cardiac event) 87 (10.3) 149 (17.6) 261 (30.8) 252 (29.8) 23 (2.7) 4 (0.5) 4 (0.5) 13 (1.5) 9 (1.1) 734 (90.2) 41 (5.1) 39 (4.8) Angina pectoris, no. (%) 93 (11.0) Myocardial infarction within 30 days, no. (%) 5 (0.6) New York Heart Association functional class, no. (%) I II III IV 128 (15.1) 311 (36.7) 312 (36.8) 96 (11.3) History of congestive heart failure, no. (%) 418 (49.4) Infective endocarditis, no. (%) Active Healed Associated diseases, no. (%) Diabetes mellitus Hypertension Hyperlipidemia Chronic obstructive pulmonary disease (FEV 1 <1 L/s) Previous stroke or transient ischemic attack Peripheral vascular disease Renal failure Marfan syndrome Clinical investigation, no. (%) Atrial fibrillation or flutter Complete heart block/pacemaker Left ventricular ejection fraction 60% 40-59% 20-39% <20% 87 (10.3) 6 (0.7) 81 (9.5) 34 (4.0) 227 (26.8) 167 (19.7) 29 (3.4) 53 (6.3) 8 (0.9) 3 (0.4) 16 (3.3) 181 (21.4) 8 (1.0) 509 (60.1) 294 (34.7) 43 (5.1) 1 (0.1) Coronary artery disease 121 (14.3) Mitral regurgitation Moderate Severe 42 (5.0) 805 (95.0) Tricuspid regurgitation (moderate/severe) 31 (3.7) Ventricular and atrial septal defect 17 (2.0) David et al: Circulation 127:1485, MFMER

42 Operative Data Mitral valve prolapse, no. (%) None (isolated annular dilatation) Isolated posterior leaflet prolapse Isolated anterior leaflet prolapse Bi-leaflet prolapse Degree of myxomatous changes, no. (%) None or mild (eg, fibroelastic deficiency) Moderate Severe 6 (0.7) 431 (51.0) 93 (11.0) 316 (37.4) 341 (40.3) 326 (38.5) 180 (21.3) Extensive calcification of the mitral annulus 20 (2.4) Mitral annuloplasty ring, no. (%) No annuloplasty ring Carpentier ring Duran ring Cosgrove band 78 (9.2) 101 (11.9) 152 (18.0) 516 (60.9) Chordal replacement with Gore-Tex sutures 542 (63.9) Reconstruction of the mitral annulus 20 (2.4) Other procedures, no. (%) Tricuspid valve surgery Replacement of ascending aorta Repair of ventricular and septal defects Coronary artery bypass graft Maze procedure 31 (3.7) 5 (0.6) 17 (2.0) 123 (14.5) 67 (7.9) Cardiopulmonary bypass time, min, median (IQR) 77 (61-93) Aortic clamping time, min, median (IQR) 61 (46-75) David et al: Circulation 127:1485, MFMER

43 Proportion of patients (%) Patients Survival and Competing Risk for Mortality and Reoperation n Alive and free from MV reoperation Noncardiac death Cardiac/valve death MV reoperation Years since initial MV surgery David et al: Circulation 127:1485, MFMER

44 Patient survival (%) Patient survival (%) Patient Survival Stratified by Preoperative NYHA Class and Including Expected Population Survival NYHA I 80 NYHA I 60 NYHA II 60 NYHA II 40 NYHA III 40 NYHA III 20 NYHA IV 20 NYHA IV 0 P< P< Years since initial MV surgery Years since initial MV surgery David et al: Circulation 127:1485, MFMER

45 Patient survival (%) Hazard of thromboembolic event Freedom From Thromboembolic Events and Competing Risk n Years since initial MV surgery Years since initial MV surgery David et al: Circulation 127:1485, MFMER

46 Survival Estimates and Freedom From Adverse Events at Various Time Intervals From Competing Risk Models and From Parametric Survival Regression Models 1 yr (95% CI) 5 yr (95% CI) 10 yr (95% CI) 15 yr (95% CI) 20 yr (95% CI) Competing risk* Valve-related death Cardiac death (nonvalve) Noncardiac death Reoperation Alive and reoperation-free 100% 0.3 ( ) 0.3 ( ) 0.4 ( ) 0.9 ( ) 98.1 ( ) 100% 1.7 ( ) 1.3 ( ) 2.6 ( ) 2.7 ( ) 91.7 ( ) 100% 3.7 ( ) 2.8 ( ) 7.4 ( ) 4.1 ( ) 82.1 ( ) 100% 6.7 ( ) 5.0 ( ) 14.8 ( ) 5.1 ( ) 68.5 ( ) 100% 11.3 ( ) 7.8 ( ) 23.7 ( ) 5.9 ( ) 51.9 ( ) Freedom from other outcomes All-cause mortality Mitral reoperation Mitral regurgitation Severe Moderate/severe Endocarditis Thromboembolism 98.9 ( ) 99.1 ( ) 99.6 ( ) 99.3 ( ) No event 97.9 ( ) 94.1 ( ) 97.3 ( ) 97.9 ( ) 96.3 ( ) 99.4 ( ) 94.0 ( ) 85.8 ( ) 95.9 ( ) 95.5 ( ) 90.4 ( ) 99.0 ( ) 90.8 ( ) 72.5 ( ) 94.9 ( ) 93.1 ( ) 81.3 ( ) 98.5 ( ) 88.1 ( ) 54.8 ( ) 94.1 ( ) 90.7 ( ) 69.2 ( ) 98.5 ( ) 85.7 ( ) * These are proportion of patients, freedom = 100 (proportion of patients) Reoperation on the mitral valve David et al: Circulation 127:1485, MFMER

47 Conclusions: De novo postoperative LV dysfunction is not uncommon in patients with normal preoperative EF undergoing mitral valve repair. LV dysfunction can persist, impairing recovery of LV size, function, and survival. The consideration of mitral repair before the onset of excessive LV dilation or pulmonary hypertension, even in those with preserved EF, seems warranted MFMER

48 LVESD (mm) Post-Repair Changes in LVESD * * 11%* -2%* Preop LVESD Postop LVESD No Dysfunction Dysfunction *P< MFMER

49 Results 2015 MFMER

50 RVSP (mm Hg) Post-Repair Changes in RVSP * Preop RVSP Postop RVSP %* %* No Dysfunction Dysfunction *P< MFMER