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New Developments in the Management of Aortic and Mitral Valve Disorders

New Developments in the Management of Aortic and Mitral Valve Disorders Patricia A. Pellikka, M.D. Mayo Clinic, Rochester, MN Conflicts of interest: none. Prevalence of Valve Diseases Moderate or severe. Population-NIH Series. Olmsted County. Valve disease. Total. Mitral valve.

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New Developments in the Management of Aortic and Mitral Valve Disorders

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  1. New Developments in the Management of Aortic and Mitral Valve Disorders Patricia A. Pellikka, M.D. Mayo Clinic, Rochester, MN Conflicts of interest: none

  2. Prevalence of Valve DiseasesModerate or severe Population-NIH Series Olmsted County Valve disease Total Mitral valve Aortic valve Prevalence (%) % <45 55-64 75 0-39 50-59 70-79 45-54 65-75 40-49 60-69 80

  3. Burden of Valve Diseases in the U.S. Year 2000 2030 Disease 2.5million 4.6million AS 2.7million 4.8million MR

  4. Overview • Natural history • Assessment of morphology and severity • Guidelines • Surgical and percutaneous intervention

  5. Onset severe symptoms Angina Syncope Failure Latent period (increasing obstruction, myocardial overload) Average survival (yr) Average death age (male) Natural History of Aortic Stenosis 0 40 50 60 70 80 Age (yr) Ross J Jr. and Braunwald E: Circ 38:61, 1968 CP1154825-3

  6. “Early” “Late” Angina Syncope Dyspnea LV failure Initial symptomsin 1/3 Elderly Symptoms in Aortic Stenosis CP1154825-4

  7. Survival Free of Symptoms Censoredat AV Surgery Survivalfree ofsymptoms(%) Years No. at risk 397 265 185 128 80 47 25 15 9 6 Pellikka, Circulation 111:3290-5, 2005 CP1154825-22

  8. Outcome of 622 Adults with Asymptomatic AS Multivariate Analysis – Symptoms HR P Aortic valve area 0.33 0.005(per 1 cm) LVH 1.39 0.04 Pellikka, Circulation 111:3290-5, 2005 CP1154825-53

  9. Outcome of 622 Adults with Asymptomatic AS Multivariate Analysis – Mortality HRP Age (per year) 1.05 <0.0001 Chronic renal failure 2.41 0.004 Inactivity 2.0 0.001 Aortic valve velocity 1.46 0.03 Pellikka, Circulation 111:3290-5, 2005 CP1154825-54

  10. Vmax <3.0 m/s 3.0-4.0 m/s >4.0 m/s Survival in Asymptomatic AS Event-free survival Time from enrollment (months) Otto CM: Circulation 95:2262, 1997 CP1154825-31

  11. AVR/died Asymptomatic AVA for Patients Who Developed Symptoms and Required AVR Compared with Valve Area of Asymptomatic Patients (n=123) Baseline Final Aorticvalvearea (cm2) Clinical outcome Otto: Circulation, 1997 CP1154825-33

  12. Class I-II 67±7% Class III-IV 21±11% MR with flail leaflet: Natural historyNYHA Class 229 pts Survival (%) P<0.0001 Years

  13. MR with flail leaflet: Natural HistoryLeft Ventricular Ejection Fraction EF 60%(61±8%) Survival(%) EF <60%(40±12%) P=0.0001 Years

  14. Asymptomatic MVP Risk Stratification • Secondary risk factors (morb) • Age 50 years • AFib • Slight MR • Flail leaflet • LA 40 mm Primary risk factors (mort) • EF <50% • MR  moderate

  15. Outcome of Asymptomatic MVP Overall Survival Cardiac Survival No or 1 secondary RF P(exp)=0.17 100 95±2 87±4 ³2 secondary RF P(exp)=0.20 Survival (%) 70±5 Primary RF 66±10 P(exp)=0.01 P<0.001 P<0.001 55±9 Years after diagnosis

  16. Asymptomatic MR Natural History ERO mm2 1-19 91±3 Survival(%) 20-39 P=0.03 vs expected 66±6 P<0.01 ³40 58±9 Years

  17. 95 Pt undergoing invasivehemodynamics (%) 54 40 35 29 23 13 13 Year (no.) Early1980s 1990 91 92 93 94(122) (149) (152) (160) (145) 98 99 % of Aortic Stenosis Patients Undergoing Invasive Hemodynamics, After Complete Doppler Exam,Prior to Valve ReplacementMayo Clinic 100 80 60 40 20 0 Roger: Mayo Clinic Proc, 2/96 CP1008395-3

  18. P= 4V2 Simplified Bernoulli Equation CP984907-31

  19. Aortic StenosisCW Doppler CP1009156-1

  20. x A TVI TVI Continuity Equation AVA = CP984907-42

  21. ACC/AHA 2006 Guidelines Severity of Aortic Stenosis AVA Mean (cm2) cm2/m2 grad Mild >1.5 0.9 <25 Moderate 1-1.5 0.6 25-40 Severe <1.0 <0.6 >40 CP1284125-5

  22. Echo/Doppler assessment • Morphology • Severity of obstruction • Associated conditions- LV size, function, hypertrophy, aortic root size, diastolic function, pulmonary artery pressure

  23. Flow Calculation

  24. Mitral RegurgitationGrading of Severity RVol EROASE grade (mL) (mm2) Mild Grade I <30 <20 Moderate Grade II 30-44 20-29 Grade III 45-59 30-39 Severe Grade IV 60 40

  25. Mitral RegurgitationMitral Valve Repair vs Replacement Expected Overallsurvival(%) Repair-195 pts Replacement-214 pts P=0.0004 Years

  26. Type I Normal valve movement Class II Excessive movement Class IIIa Diastolic restric Class IIIb Systolic restric examples annular dilatation leaflet perforation prolapse rheumatic functional Carpentier’s classification

  27. ACC/AHA Guidelines Heart Failure STEMI Unstable angina Valvular Heart Disease Expert opinion Expert opinion Data 5,000-40,000 pts RCTs Data 50-600 pts Observational Studies

  28. ACC/AHA 2006 Guidelines forValvular Heart Disease Indications for AVR Class I • Symptomatic pt with severe AS • Pt with severe AS undergoing CABG or surgery on aorta or other valves • Severe AS and EF < 50% B C C CP1284125-11

  29. ACC/AHA 2006 Guidelines forValvular Heart Disease Indications for AVR Class IIa • Pt with moderate AS undergoing CABG or surgery on aorta or other valves B CP1284125-11

  30. Should CABG Surgery Patients with Mild or Moderate AS Undergo Concomitant AVR? • Markov decision analysis: Long-term, quality-adjusted outcomes of pt with AS – CABG or CABG/AVR CABG/AVR preferred Peak aortic valvegradient by echo 28 mm Hg CABG preferred Age at time of CABG • Outcome influenced by AS rate of progression:<3 mm Hg/yr – CABG if gradient <50; >10 mm Hg/yr, CABG/AVR except if >80 yr and gradient <25 Smith: JACC, 2004 CP1284125-6

  31. ACC/AHA 2006 Guidelines Indications for AVR Class IIb • Extremely severe AS, mean grad>60, operative mortality ≤ 1% • Mild AS undergoing CABG with evidence for rapid progression • Severe AS and likelihood of rapid progression or if surgery would be delayed at symptom onset • Severe AS and abnormal response to exercise C C C C CP1284125-11

  32. MR: Indications for Mitral Valve Operation B Class I • Symptomatic patients with acute severe MR • Patients with chronic severe MR and NYHA class II, III or IV symptoms in absence of severe LV dysfunction (EF <30%) and/or end-sys dimension >55 mm • Asymptomatic patients with chronic severe MR and mild to mod LV dysfunction, EF 30-60% and/or end-sys dimension 40 mm • MV repair recommended over replacement in majority of patients with severe chronic MR who require surgery B B C ACC/AHA 2006 Guidelines for Valvular Heart Disease

  33. MR: Indications for Mitral Valve Operation B Class IIa • MV repair in experienced surgical center for asymptomatic pts with chronic severe MR, preserved LV function if repair likely • MV surgery for asx pts with chronic severe MR, preserved LV function and new atrial fib • Asymptomatic patients with chronic severe MR, preserved LV function and pulmonary hypertension • MV surgery for patients with chronic severe MR due to abnormality of mitral apparatus, class II-IV sx and severe LV dysfunction if repair likely C C C ACC/AHA 2006 Guidelines for Valvular Heart Disease

  34. Transapical Minimally-InvasiveAortic Valve Implantation • 59 patients, 81±6 years • EuroSCORE 9 • Predicted mortality 26.8% • Follow-up 110±77 days, mortality 22% Walther: Circulation, 2007 CP1284125-3

  35. Eligibility met for high-risk symptomatic,critical calcific aortic stenosis Cohort A Cohort B Operableassessment Femoralaccess evalY/N Femoralaccess evalY/N 1:1 randomization 1:1 randomization 1:1 randomization Transfemoral Trans-femoral Trans-femoral Medical mgmt control AVRcontrol AVRcontrol vs vs PARTNER TrialPARTNER Trial Proposal (with Transapical) Yes No Not instudy Yes No No Yes vs Subgroup analyses: TA vs control, TF vs control Primary analyses: TF and TA vs control (combined)

  36. TEE Pre Post 56 mm Hg to 8 mm Hg

  37. Baseline Demographics and Risk Factors TF (n=463) TA (n=575) P Age (yr) 81.7 80.7 NS Female 55% 56% NS Pulmonary disease 25% 29% NS Renal dysfunction 26% 33% 0.024 Logistic EuroSCORE 25.7 29.2 <0.005 Peripheral vascular disease 11% 28% <0.001 Carotid artery stenosis (>50%) 8% 17% <0.001 Incidence of CAD 47% 56% <0.006 Porcelain aorta 5% 12% <0.001 Prior CABG 18% 27% <0.001 Mitral valve disease 16% 33% <0.001

  38. Implantation Success TF (n=463) TA (n=575) Total (n=1,038) No. % No. % No. % Acute procedure 436 95.6 523 92.9 959 94.1success Device success comp* 428 92.4 522 90.8 950 91.5 Conversion to sAVR 8 1.7 20 3.5 28 2.7 AR >+2** 15 3.2 34 5.9 49 4.7 Valve migration 0 0.0 3 0.5 3 0.3 Valve malposition 8 1.7 8 1.4 16 1.5 Coronary obstruction 3 0.7 3 0.5 6 0.6 * Device success is a composite including AR <2+and no valve in valve ** Site reported All procedural X1 to aorta X2 to ventricle

  39. Major Complications (≤30 Days) TFn=463 TAn=575 Totaln=1,038 No. % No. % No. % Death 29 6.3 59 10.3 88 8.5 Stroke 11 2.4 16 2.6 27 2.5 Renal failure 23 5.0 69 11.7 92 8.7requiring dialysis Permanent 31 6.7 42 7.3 73 7.0pacemaker

  40. Causes of Death ≤30 Days – Transfemoral 30-day mortality – transfemoral (29/463) = 6.3% Related to implant* (9/463) Heart failure 4 Bleeding event major 2 Cardiac tamponade 1 Annular dissection 1 Multiple organ failure 1 Related to procedure** (20/463) Multiple organ failure 4 Sudden death (3 unk) 4 Sepsis 3 Heart failure 2 Gastrointestinal 1 Cardiac arrest 1 Bleeding event major 1 Circulatory disorder 1 Hematologic disorder 1 Cardiogenic shock 1 Renal failure 1 * Related to implant: direct result of valve implant ** Related to procedure: result of procedure

  41. Causes of Death ≤30 Days – Transapical 30-day mortality – transapical (59/575) = 10.3% Related to implant* (16/575) Heart failure 9 Hemorrhage 3 Multiple organ failure 1 Bleeding event major 1 Aortic dissection 1 Cardiac arrest 1 Related to procedure** (43/575) Multiple organ failure 14 Gastrointestinal 5 Cardiac arrest 4 Heart failure 4 Sepsis 4 Respiratory failure 2 Bleeding event major 1 Sudden death 1 Circulatory disorder 1 Hematologic disorder 1 Cardiac decompensation 1 Pneumonia 1 Pulmonary embolism 1 Myocardial inarction 1 Stroke 1 Renal failure 1 * Related to implant: direct result of valve implant ** Related to procedure: result of procedure

  42. Steadily Improving Outcomes 94% survivalat 30 days 30 days (%)

  43. Aortic mitral fibrosa Anteriorlateralcommissure Anterior leaflet A1 Posteriormedialcommissure A2 A3 P1 P3 P2 Posterior leaflet Normal Flail posterior leaflet Resection of flail segment Repaired mitral valve CP1023486-1

  44. Percutaneous MV Repair Alfieri Procedure Mitral Annuloplasty D'Gara et al: JACC CV Imaging, 2008

  45. Survival of Patients Censored atSurgery vs Referent Group Referent group Survival(%) Patients P<0.001 Years No. at risk 469 349 263 177 116 74 41 26 16 11 Pellikka, Circulation 111: 3290-5, 2005 CP1154825-24

  46. Mitral Regurgitation Due to Flail LeafletMulticenter European Experience 304 pts with nonsurgical management MV surgery/CVD 88±2% HF 57±9% Incidence (%) AFib 30±7% Follow-up (years) Grigioni F et al: J Am Coll Cardiol Img 1:133, 2008

  47. Summary • Follow-up is needed to understand safety and durability of percutaneous devices • Prospective, randomized clinical trials needed

  48. Summary • Less-invasive alternatives to conventional valve surgery will result in earlier intervention and intervention in a larger number of patients

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