Assessment of Frailty Criteria For Invasive Procedures in 2016 Open - PowerPoint PPT Presentation

Assessment of Frailty Criteria For Invasive Procedures in 2016 – Open Surgical Intervention, Transcatheter Interventions or Conservative Care? James L Velianou MD, FRCPC Interventional Cardiology Hamilton Health Sciences Associate Professor of Medicine McMaster University ACC Rockies 2016 velianj@mcmaster.ca

Objectives 1) TAVI can help Patients with AS! 2) TAVI may not be Appropriate for All Patients 3) Frailty is Important in Deciding Best Care

Potential Conflicts of Interest As noted in Course Manual

Dismal Prognosis of Untreated Patients Culmulative Survival : No AVR vs AVR Congestive Heart Failure Pts Cumulative Survival % 100% 80% 60% No AVR 40% AVR 20% 0% 1 5 10 Time in Years

Large Untreated Patient Population 31.8% did not undergo intervention, most frequently because of comorbidities!!!!!

TAVI in “Elderly” 98 yo Patient

PARTNER All-Cause Mortality (ITT) 5 Years NON SURGICAL Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 93.6% 87.5% 80.9% All-Cause Mortality (%) 68.0% 71.8% 50.8% 64.1% 53.9% 43.0% 30.7% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.

All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) PARTNER I and II Trials Overall and TF Patients Restricted – not for external distribution 175 344 240 271 282 583 491 1072 947 SAPIEN SXT SAPIEN 3 8 Presented at ACC 2015 on March Sunday 15 during the LBT session by S. Kodali on behalf of The PARTNER Trial Investigators

Results of AVR, AVR+CABG in Ontario Table 40 - Prevalence of Risk Factors by Hospital for Isolated AVR Surgery Risk Factor Total HHSC HSN KGH LHSC SHSC SM Table 38 - Provincial distribution of risk factors by mortality for isolated CABG surgery, isolated AVR surgery 68.37 68.96 69.14 66.62 67.87 69.13 Mean ± 12.27 ± 12.54 ± 10.13 ± 12.23 ± 12.78 ± 13.02 ± ± ± ± ± ± and combined CABG/AVR surgery for 2008/09 to 2010/11 † Age <65 32.8 34.7 30 39.1 32.3 26.9 Isolated CABG Isolated AVR Combined CABG/AVR 65-74 30.7 25.4 35.7 27.2 33.9 32.8 Surgery Surgery Surgery ฀ 75 † 36.5 39.9 34.3 33.7 33.9 40.3 In-Hospital 30-Day In-Hospital 30-Day In-Hospital 30-Day Sex Female 43.2 43.9 39.1 Risk Factor 34.8 39.4 43.5 Mortality Mortality Mortality Mortality Mortality Mortality 16.1 † † † <25% 26.1 22.8 27.2 23.9 29 <65 0.8 0.7 1.2 1.1 2.8 2.2 25 † † 25-30% 35.5 39.3 33.5 37.3 38.7 BMI Age 65-74 1.7 1.7 2.2 1.9 3.9 3.4 † >30% 35 38 39.1 35.9 38.8 31.2 Disease 0 † 11.3 † 12 † Yes >75 0 † <5 3.8 2.3 † † 3.7 2.3 † 3.5 3 † 6.6 6 4.9 5.2 Unknown 3.4 ฀ 50% 18.7 † 16.3 † Male 1.5 1.1 1.4 1.1 † 1.8 1.9 † 1.4 1.5 † 4.1 3.3 3.3 2.9 CHF 27 26.7 29.9 28 17.4 † † COPD 13.3 14.9 11.3 35-49% 16.5 11.3 1.7 1.8 3.6 3.9 7.4 5.2 15.5 † LVEF 7.8 † 15.2 † CVD 11.9 10.5 12.4 20-34% 3.6 3.4 6.5 5.7 9.9 8.9 Diabetes 28.2 29.7 28.3 31.5 26.2 26.3 <5 <5 <5 <5 <20% 5.5 5.7 Hypertension 69.3 74.6 70.4 57.6 69.8 72 <5 <5 <5 Unknown 3.9 3.7 12.2 1 81.1 83.5 75.7 80.4 81.9 74.7 <5 13.4 † † † 2 10.7 13.2 9.1 11.5 LV 3.3 † 6.5 † 8.6 † † † † † 3 4.7 4.3 5 Function 0 † <5 0 † <5 <5 † † † 4 1.1 0 † 10.4 † 9.8 † <5 <5 † † † Unknown 2.4 12.9 † 5.2 † 7 † † † † PVD 8.8 7.6 7.3 † † † % † † † † † † † † † Age <75 63.5 † † † † † † † † † † † † † † † † † LVEF Grade 1 81.1 † † † † † † † Source: CCN. Report On Adult Cardiac Surgery in Ontario, 2008 - 2011

Should Every AS Patient be considered for TAVI? NOTION: Nordic Aortic Valve Intervention Prospective, multicentre, randomized trial AVR vs TAVI  All comers ≥ 70 years old  3 participating centres in Denmark (2) and Sweden (1)  280 patients being enrolled from Dec. 2009 to Apr. 2013  Restricted – not for external distribution 10 Presented at ACC 2015 on March Sunday 15 by H. Thyregod – Copenhagen University hospital, Denmark

NOTION Study TAVI Corevalve vs. SAVR Primary endpoint Death SAVR TAVI 30 3.7% 7.6% Restricted – not for external distribution days 1 year 2.1% 4.9% Stroke SAVR TAVI 30 3.0% 4.6% days 1 year 1.4% 2.9% MI SAVR TAVI 30 6.0% 6.0% days 1 year 2.8% 3.5% 11 Presented at ACC 2015 on March Sunday 15 by H. Thyregod – Copenhagen University hospital, Denmark

Does this apply to all?

48-month Follow-Up Survival Curves Canadian Multicenter Experience 100 No Frailty (n=254) 90 Frailty (n=85) 80% Frailty +STS (n=36) 80 71% 70 78% Free of death (%) 58% 74% 68% 58% 60 59% 50 37% 41% 40 Log-Rank (Frailty vs. No Frailty : 0.04 40% 30 30% Log-Rank (Frailty+STS<8% vs. No Frailty: 0.31 20 10 0 0 6 12 18 24 30 36 42 48 Months follow-up Patients at risk: 254 200 186 166 143 99 61 32 10 85 65 57 49 36 26 13 7 3 36 27 26 22 19 13 5 2 1

Canadian Long-term Registry TIMING OF DEATH AT FOLLOW-UP – Time for Reboot? Number of patients 20 19 10 7 8 8 8 8 4 2 1 Months follow-up

Canadian Long-term Registry Predictive factors of cumulative late mortality Cumulative Late Mortality Yes No Hazard Ratio 95%CI P value (n=136) (n=203) Chronic obstructive pulmonary disease 50 (37%) 50 (25%) 1.78 1.24-2.57 0.002 Chronic kidney disease 86 (63%) 104 (51%) 1.67 1.16-2.41 0.006 Chronic atrial fibrillation 58 (43%) 57 (28%) 1.58 1.12-2.24 0.009 Frailty !Eyeball Test! 42 (31%) 43 (21%) 1.53 1.06-2.22 0.02

PARTNER All-Cause Mortality NON SURGICAL Stratified by STS Score (ITT) – Low Risk Better? STS < 5 STS 5-15 STS > 15 p (log rank) = 0.0012 p (log rank) = 0.0002 p (log rank) = 0.0749 100% 93.4% 93.3% 75.2% 73.7% Mortality (%) 55.9% Months Months Months Standard Rx (n = 12) Standard Rx (n = 123) Standard Rx (n = 43) TAVR (n = 28) TAVR (n = 113) TAVR (n = 38)

PARTNER High Risk AS All-Cause Mortality (ITT) – 3 Years HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 44.8% 34.6% 44.2% 26.8% 33.7% 24.3% No. at Risk TAVR 348 298 261 239 222 187 149 AVR 351 252 236 223 202 174 142

PARTNER High Risk Impact of STS Score on Mortality (ITT) TAVR Patients 49.1% 36.1% 39.6% 28.8% 31.4% 19.9% No. at Risk STS ≤11 177 155 141 128 117 106 87 STS >11 171 143 120 111 105 81 62

Correlates for Conventional Aortic Valve Replacement Surgeons are actually Smart!! Variable Multivariable Cox Analysis HR 95% CI P-value Age 1.02 0.95 -1.11 0.56 Chronic obstructive 0.30 0.09-0.98 <0.05 pulmonary disease Previous coronary 0.51 0.17-1.54 0.23 artery bypass grafting Porcelain aorta 0.00 0.00-0.00 0.998 Frailty 0.19 0.07-0.56 <0.01 Pulmonary 0.62 0.23-1.64 0.33 hypertension Bainey et al. Am J Cardiol. 2013 Apr 2

TAVI and Risk…..Is Tide Changing???

TAVI Decision Schematic Not high risk for AVR High Risk for AVR or TAVR Futility (Very Old) (Very Low BMI) Severe Frailty status Severe (fixed)LV dysfunction – EF<20% Low Flow AS Young age Severe MR with MAC Bicuspid aortic valve Pulm HTN – PAP > 60 mmHg No CAD Severe COPD – O2 dependent Good LV CAD with no revasc options No Prior CABG End Stage - Renal Dysfunction Severe Liver disease Cancer with “limited lifespan” Severe cognitive dysfunction Malnutrition Technical considerations**

PURE Study (>100,000 Patients) Low Grip Strength, High Mortality? PURE Study, Lancet 2015 386:266-73

How do we Measure Frailty?

Dalhousie Scale

Frailty and other Factors Affecting QoL

FRIED Criteria for Frailty

FRAIL Questionnaire

Approach to Complex Elderly and Others

Possible Framework for Decision Making JACC:Cardiovascular Interventions.2014:7(7);707-716

Jimmy V’s 5 A • Age (chronologic / physiologic) • Activity (prior normal activity) • Attitude / Courage (includes realistic understanding) • Associated diseases • Ability to tolerate medical therapy

Points to Consider in Selection of Patients for TAVI, SAVR or Conservative Therapy  Will patient be better off with TAVI or SAVR?  Can Patient Benefit from TAVI or Medical?  Does Patient want SAVR or TAVI? Family Pressure?  Does Patient and Family Understand Intervention?  Does TAVI Team Understand Patient Wishes?  Does End Result justify Emotional, Economic Costs?

How Do We Improve Selection of Patients?  Heart Team – Check Egos at Door!  Involve other Specialties – Neuro, Geriatrics, Resp , OT/PT  Frailty Assessment (Formalized)  Efficient, Rapid Assessment to ensure SAVR if Appropriate  Courage to Decline Patients ….End of Life Discussions  More Research to Facilitate the Above!!!

Teamwork!!!!!