valvular heart disease

David L. Rutlen, M.D.10 July 2014

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Natural History of Aortic Stenosis

Outcome of 622 Adults with Asymptomatic Hemodynamically Significant Aortic Stenosis

During Prolonged Follow Up

622 PatientsAge 72 ± 11 yearsPeak systolic velocity ≥ 4 m/sAt 5 years only 25% alive and without surgery11 patients died suddenly without surgery or symptoms ~ 1 % per yearalthough no follow up for ≥ 1 year in 5 of 11

2005; 111; 3290-3295 3

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Copyright ©2007 American Heart Association

Operative Risk Stratification and Predictors for Long-Term Outcome: A Multicenter Study using

Dobutamine Stress Hemodynamics

6 centers, 136 patientsAortic valve area 0.7 cm² (0.6 – 0.8)Transaortic gradient 29 mm Hg (23 – 34)Cardiac index 2.11 L/min/m² (1.75 – 2.55)Contractile reserve assessed during dobutamine

group 1: 92 patients, present stroke volume increased 33%

(26-46%) group 2: 44 patients, absent stroke volume increased 10% (2

– 13%)

2003: 108: 319-3245

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Outcome after Aortic Valve Replacement for Low-Flow/Low-Gradient Aortic Stenosis without

Contractile Reserve on Dobutamine Stress Echocardiography

81 symptomatic patientsAVA ≤ 1 cm ², LV EF ≤ 40%

No increase stroke volume ≥ 20% with dobutamine

J Am Coll Cardiol 2009; 53: 1865-1873

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Prognostic Impact of AVR in LGAS Patients Without CR on DSE: Matched Population

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Transcatheter Aortic-Valve Implantation for Inoperable Aortic Stenosis

•358 Patients with severe aortic stenosis• Aortic valve area <0.8 cm²• Mean aortic valve gradient ≥ 40 mm Hg• Peak aortic jet velocity ≥ 4.0 m/sec

•≥50% Predicted probability• 30 day death or serious irreversible

condition

•Randomized: 179/179• Standard therapy including aortic

valvuloplasty• Transfemoral transcatheter implantation

balloon – expandable bovine pericardial valve

N. Engl J. Med 2012; 366: 1696-1704

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Two-Year Mortality, Stratified According to the Society of Thoracic Surgeons (STS) Risk Score.

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Two-Year Mortality, Stratified According to the Society of Thoracic Surgeons (STS) Risk Score.

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Two-Year Mortality, Stratified According to the Society of Thoracic Surgeons (STS) Risk Score.

Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement

699 patients with severe aortic stenosis > 15% predicted probability 30 day death randomized:

TAVR: 244 transfemoral

104 transapicalSurgical replacement: 351

42 did not receive assigned therapy4 in TAVR group38 in surgery group

N. Engl J. Med 2012: 366: 1686-9518

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Transcatheter Aortic – Valve Replacement with a Self-Expanding Prosthesis

•795 Patients with severe aortic stenosis

• aortic valve area ≤ 0.8 cm²

• mean aortic valve gradient > 40 mm Hg

• peak aortic jet velocity ≥ 4.0 m/sec

•risk of death within 30 days after surgery ≥ 15%

•risk of death or irreversible complications within 30 days < 50%

•Randomized• 394 TAVR• 401 surgical AVR

N. Engl. J. Med. 2014; 370: 1790-1798

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Kaplan-Meier Cumulative Frequency of Death from Any Cause.

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Intervene Aortic Stenosis

Class I1.Severe AS (Vmax > 4 m/s) with symptoms2.Severe AS, LVEF < 50%3.Severe AS, undergoing other cardiac surgeryClass II (a)1.Very severe AS (Vmax > 5 m/s), low surgical risk2.Severe AS, decreased exercise tolerance or exercise fall in BP3.Symptomatic patients with low flow/low gradient severe AS4.Moderate AS (Vmax 3.0-3.9 m/s) undergoing other cardiac surgeryClass II (b)1.Severe AS, rapid progression, low surgical risk

AHA/ACC Guidelines March 2014

Copyright ©2007 American Heart Association

Natural History of Asymptomatic Patients with Aortic Regurgitation and Normal

Left Ventricular Function77 asymptomatic patientsNormal LVEF63 patients : 3-4 + AR14 patients : pulse pressure > 70 mm HgFollow-up 49 months (6-114)Events : development sxs LVEF ≤ 0.50No patients died12 patients underwent aortic valve replacement

Onset sxs: 11 patients Onset LV dysfunction: 1 patient

1983; 68; 509-517 23

Copyright ©2007 American Heart Association

1983; 68; 509-517 (cont) 24

Copyright ©2007 American Heart Association

1983; 68; 509-517 (cont) 25

Copyright ©2007 American Heart Association

1983; 68; 509-517 (cont) 26

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Intervene Aortic Regurgitation

Class I1.Severe AR with symptoms2.Severe AR with LVEF < 50%3.Severe AR, undergoing other cardiac surgeryClass II (a)1.Severe AR with LVESD > 50 mm2.Moderate AR, undergoing other cardiac surgeryClass II (b)1. Severe AR with LVEDD > 65mm if surgical risk low

AHA/ACC Guidelines March 2014

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Late Results of Percutaneous Mitral Commissurotomy

Bichat University Hospital and Pitie-Sulpetriere Hospital 1986-1995

1024 patients

Good functional resultsno cv deathno interventionNYHA I or II

Circulation 2012; 125:2119-2127

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Intervene Mitral Stenosis

Class I1.Percutaneous commissurotomy for severe MS (MVA ≤ 1.5 cm2) with symptoms2.Mitral surgery for severe MS if symptoms severe and not candidate for commissurotomy3.Severe MS, undergoing other cardiac surgeryClass II (b) Percutaneous commissurotomy for severe MS with new AF

AHH/ACC Guidelines March 2014

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Survival Implication of Left Ventricular End-Systolic Diameter in Mitral Regurgitation dueto Flail Leaflets

registry: 4 European & 1 U.S.Center 739 patients1980-2004medical management: 187medical and surgical management 552

J am coll cardiol 2009; 54: 1961-1968

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Overall survival according to left ventricular end-systolic diameter (LVESD) in patients with organic mitral regurgitation (MR): (A) conservative management

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Overall survival according to left ventricular end-systolic diameter (LVESD) in patients with organic mitral regurgitation (MR): (B) medical and surgical treatment

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Adjusted post-operative overall survival according to LVESD in operated patients with organic MR.

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Recovery of Left Ventricular Function after Surgical Correction of Mitral Regurgitation caused by Leaflet Prolapse

Mayo Clinic1063 patients underwent mitral surgery

924 repair139 replacement

1980-2000

J. Thorac Cardiovascular Surgery 2009; 137:1071-1076

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Pulmonary hypertension adversely affects short- and long-term survival after mitral valve operation for mitral regurgitation

University of Maryland Medical Center 873 consecutive patients underwent mitral surgery2002-2010Pulmonary hypertension: systolic pulmonary artery pressure none: sPAP< 40 mm Hg mild: 40 ≤ sPAP < 50 mm Hg moderate: 50 ≤ sPAP < 60 mm Hg severe: sPAP ≥ 60 mm Hg

J Thorac Cardiovasc Surg 2011; 142: 1439-1452

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Hospital mortality according to opreoperative PH grade (P< .0001). PH, Pulmonary hypertension.

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Long-term survival according to preoperative PH. B, Survival according to preoperative PH grade.

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Comparison of Early Surgery versus Conventional Treatment in Asymptomatic Severe Mitral Regurgitation

Asan Medical Center, Seoul, Korea447 Consecutive Asymptomatic Patients Observed preserved LVEF, Severe MR enrolled 1996-2005 early surgery 161, conventional 286 similar age, gender, euro SCORE, LVEF end point: operative mortality, cardiac death,

repeat mitral valve surgery, CHF admission

Circulation 2009; 119:797-804

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Comparison of event-free survival rates between the operated (OP) and conventional treatment (CONV) groups in propensity-matched pairs.

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Should Patients with Severe Degenerative Mitral Regurgitation Delay Surgery Until Symptoms Develop

Cleveland Clinic registry4,586 patientsPrimary mitral valve repair or replacement1985-2008

Ann Thorac Surg 2010; 90:481-488

unadjusted

Survival According to NYHA Class

propensity matched

Survival According to NYHA Class

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Association Between Early Surgical Intervention vs Watchful Waiting and Outcomes for Mitral Regurgitation due to Flail Mitral Leaflets

6 centers Europe and U.S.1980 – 20041021 patients

575 initial medical management446 mitral valve surgery within 3 months

enrollment

JAMA 2013:310(6): 609-616

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Overall

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Propensity Matched

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Overall

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Propensity matched

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Valve Repair Versus Valve Replacement for Denegerative Mitral Valve Disease

Cleveland Clinic3286 Patients Undergo Primary Mitral Surgery1985-2005

J Thorac Cardiovasc Surg 2008; 135: 885-893

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UNADJUSTED SURVIVAL

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PROPENSITY MATCHED SURVIVALBlue=repairRed=replacementGreen=age, gender matched US population

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REOPERATION IN PROPENSITY MATCHED Blue=repair

Red=replacement with bioprosthesis Black=replacement with mechanical valve

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Long-Term Survival of Patients Undergoing Mitral Valve Repair and Replacement: A Longitudinal Analysis of Medicare Fee-for-Service Beneficiaries

47,279 fee for service beneficiaries Primary isolated mitral valve repair or replacement2000-2009Annual mitral procedure volume determined >40 cases per year ≤ 40 cases per year

Circulation 2013:1870-1876

Ten-year survival for Medicare fee-for-service beneficiaries undergoing mitral valve repair and replacement from 2000 through 2009 compared with expected survival in the age- and sex-matched

US population.

Vassileva C M et al. Circulation. 2013;127:1870-1876

Copyright © American Heart Association, Inc. All rights reserved.

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Longitudinal Outcome of Isolated Mitral Repair in Older Patients

Linked Society of Thoracic Surgeons and Centers for Medicare and Medicaid Services databases14,604 isolated non-emergent primary mitral repairs1991-2007Mean age 73 years

Ann Thorac Surg 2012; 94:1870-1879

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Operative Mortality

Avoidance of mitral reoperation

Ten-year survival after isolated primary mitral valve (MV) repair in patients aged 65 years or more.

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Percutaneous Repair or Surgery for Mitral Regurgitation

37 Centers in U.S. and Canada2005-2008279 patients 3+ or 4+ chronic mitral regurgitation

symptomatic: LVEF > 25% and LVESD < 55 mmasymptomatic: LVEF 25-60%, LVESD 40-55, new

AF or PAH malcoaptation middle scallops anterior and

posterior leafletsrandomized 2:1 percutaneous repair or conventional surgery

N Engl J Med 2011; 364: 1395 - 1406

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Percutoneous Repair vs Standard Surgery

12 months

Efficacy 55% 73% P=0.007 death 6% 6% surgery 20% 2% P< 0.001 3+ or 4+ MR 21% 20%

30 days

Major adverse events 15% 48% P < 0.001

difference due to mechanical ventillation > 48 hourstransfusion ≥ 2 units blood

percutaneous standard

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Intervene Primary Mitral RegurgitationClass I1.Severe MR with symptoms and LVEF > 30%2.Severe MR and LVEF 30-60% or LVESD ≥ 40 mm3.Repair in preference to replacement when severe MR limited to posterior leaflet4.Repair in preference to replacement when severe MR involves just anterior leaflet or both leaflets if durable repair can be accomplished5.Severe MR undergoing other cardiac surgeryClass II a1.Repair for severe MR

a. new onset AFb. PA systolic pressure > 50 mm Hg

Class II b1.transcatheter repair NYHA Class III – IV, severe MR, prohibitive surgical risk

AHA/ACC Guidelines March, 2014

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Independent Prognostic Value of Functional Mitral Regurgitation in Patients with Heart Failure: 1256 Patients with Ischaemic and non-ischaemic Cardioneyopathy

Retrospective review 4 Italian centersQuantitative assessment MREnd-point: mortality & hospitalization for CHFEnd-point correlated with degree of MR

independent of LVEF and restrictive mitral filling

Heart 2011; 97: 1675 - 1680

66years

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Impact of Mitral Valve AnnuloplastyCombined with Revascularization in Patients with Functional Mitral Regurgitation

Cleveland Clinic, 390 patients, 1991-20033 - 4+ ischemic MR undergoing CABG290 mitral annuloplasty100 no mitral annuloplastyAnnuloplasty improved early symptoms

J am coll cardiol 2007; 49: 2191 - 2201

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Survival Ater CABG Either Alone or With Concomitant MV Annuloplasty for Functional Ischemic MR

Unadjusted

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Survival Ater CABG Either Alone or With Concomitant MV Annuloplasty for Functional Ischemic MR

Propensity matched

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Influence of Mitral Regurgitation Repair on Survival in the Surgical Treatment for Ischemic Heart Failure Trial

99 world wide sites, LVEF ≤ 35%1212 patients randomized: medicine vs CABG18% moderate or severe MR

Circulation 2012; 125: 2639-2648

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Years Following Randomization

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Coronary Artery Bypass Surgery with or without Mitral Valve Annuloplasty in moderate Functional Ischemic Mitral Regurgitation

6 centers in U.K., 1 in Poland73 patients referred for CABG

moderate ischemic MRLVEF > 30%

Randomized: CABG + annuloplasty (34) CABG (39)

1 year follow up

Circulation 2012; 126:2502-2510

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Surgical Revascularization is Associated with Maximal Survival in Patients with Ischemic Mitral Regurgitation

Duke University Medical Center1990-2009, 4989 patients, retrospective significant coronary artery disease moderate or severe mitral regurgitation

Circulation 2014; 1229: 2547-2556

Adjusted survival curves by treatment category

Castleberry A W et al. Circulation. 2014;129:2547-2556

Copyright © American Heart Association, Inc. All rights reserved.

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Intervene Chronic Severe Secondary Mitral Regurgitation

Class II (a)Undergoing CABG or AVRSeverely symptomatic (NYHA Class III or IV)Class II (b)Repair for moderate MR undergoing other cardiac surgery

AHA/ACC Guidelines, March 2014

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END