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

velianj@mcmaster.ca ACC Rockies 2016

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

0% 20% 40% 60% 80% 100%

1 5 10 Time in Years Cumulative Survival % No AVR AVR

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

71.8% 93.6%

All-Cause Mortality (%) Months

HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < 0.0001 Standard Rx (n = 179) TAVR (n = 179) 30.7% 50.8% 43.0% 68.0% 64.1% 87.5% 53.9% 80.9% * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.

Restricted – not for external distribution

Presented at ACC 2015 on March Sunday 15 during the LBT session by S. Kodali on behalf of The PARTNER Trial Investigators 8

All-Cause Mortality at 30 Days

Edwards SAPIEN Valves (As Treated Patients)

175 344 240 271 282 583 491 1072 947

SAPIEN SXT SAPIEN 3

PARTNER I and II Trials Overall and TF Patients

Table 40 - Prevalence of Risk Factors by Hospital for Isolated AVR Surgery Risk Factor Total HHSC HSN KGH LHSC SHSC SM

Age Mean 68.37 ± 12.27 68.96 ± 12.54 69.14 ± 10.13 66.62 ± 12.23 67.87 ± 12.78 69.13 ± 13.02 ± ± ± ± ± ± <65 32.8 34.7 30 39.1 32.3 26.9 † 65-74 30.7 25.4 35.7 27.2 33.9 32.8 ฀75 36.5 39.9 34.3 33.7 33.9 40.3 † Sex Female 43.2 43.9 39.1 34.8 39.4 43.5 BMI <25% 26.1 22.8 16.1† 27.2 23.9 29 † † 25-30% 35.5 39.3 33.5 25† 37.3 38.7 † >30% 35 38 39.1 35.9 38.8 31.2 † Unknown 3.4 0† 11.3† 12† 0† <5 † † † † CHF 27 26.7 18.7† 16.3† 29.9 28 † † † COPD 13.3 14.9 11.3 17.4† 16.5 11.3 † CVD 11.9 15.5† 7.8† 15.2† 10.5 12.4 Diabetes 28.2 29.7 28.3 31.5 26.2 26.3 Hypertension 69.3 74.6 70.4 57.6 69.8 72 LV Function 1 81.1 83.5 75.7 80.4 81.9 74.7 2 10.7 13.2 9.1 <5 11.5 13.4† † † 3 4.7 3.3† 4.3 6.5† 5 8.6† † † † † 4 1.1 0† <5 0† <5 <5 † † † Unknown 2.4 0† 10.4† 9.8† <5 <5 † † † PVD 8.8 12.9† 5.2† 7.6 7.3 7† † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † † †

†

Results of AVR, AVR+CABG in Ontario

Disease Yes 2.3 2.3 6.6 5.2 LVEF ฀50% 1.1 1.1 1.9 1.5 3.3 2.9 35-49% 1.7 1.8 3.6 3.9 7.4 5.2 20-34% 3.6 3.4 6.5 5.7 9.9 8.9 <20% 5.5 5.7 <5 <5 <5 <5 Unknown 3.9 3.7 <5 <5 12.2 <5

Table 38 - Provincial distribution of risk factors by mortality for isolated CABG surgery, isolated AVR surgery and combined CABG/AVR surgery for 2008/09 to 2010/11

Isolated CABG Surgery Isolated AVR Surgery Combined CABG/AVR Surgery Risk Factor In-Hospital Mortality 30-Day Mortality In-Hospital Mortality 30-Day Mortality In-Hospital Mortality 30-Day Mortality Age <65 0.8 0.7 1.2 1.1 2.8 2.2 65-74 1.7 1.7 2.2 1.9 3.9 3.4 >75 3.8 3.7 3.5 3 6 4.9 Male 1.5 1.4 1.8 1.4 4.1 3.3

% 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?

Presented at ACC 2015 on March Sunday 15 by H. Thyregod – Copenhagen University hospital, Denmark

Restricted – not for external distribution

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

10

Presented at ACC 2015 on March Sunday 15 by H. Thyregod – Copenhagen University hospital, Denmark

Restricted – not for external distribution

Primary endpoint

Death SAVR TAVI 30 days 3.7% 7.6% 1 year 2.1% 4.9% Stroke SAVR TAVI 30 days 3.0% 4.6% 1 year 1.4% 2.9% MI SAVR TAVI 30 days 6.0% 6.0% 1 year 2.8% 3.5%

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NOTION Study TAVI Corevalve vs. SAVR

Does this apply to all?

100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48

Free of death (%)

78% 71% 58% 58%

Months follow-up

74% 59% 41% 37% 80% 68% 40% 30%

48-month Follow-Up Survival Curves Canadian Multicenter Experience

254 200 186 166 143 99 61 32 10

Patients at risk:

36 27 26 22 19 13 5 2 1 85 65 57 49 36 26 13 7 3

Log-Rank (Frailty+STS<8%

• vs. No Frailty: 0.31

Log-Rank (Frailty vs. No Frailty : 0.04 No Frailty (n=254) Frailty +STS (n=36) Frailty (n=85)

Canadian Long-term Registry TIMING OF DEATH AT FOLLOW-UP – Time for Reboot?

Months follow-up Number of patients

8 19 2 10 8 20 4 1 8 7 8

Canadian Long-term Registry Predictive factors of cumulative late mortality

Hazard Ratio 95%CI P value 1.24-2.57 1.16-2.41 1.12-2.24 1.06-2.22 1.78 1.67 1.58 1.53 0.002 0.006 0.009 0.02 Chronic obstructive pulmonary disease Chronic kidney disease Chronic atrial fibrillation Frailty !Eyeball Test! 50 (37%) 86 (63%) 58 (43%) 42 (31%) Yes (n=136)

Cumulative Late Mortality

No (n=203) 50 (25%) 104 (51%) 57 (28%) 43 (21%)

PARTNER All-Cause Mortality NON SURGICAL Stratified by STS Score (ITT) – Low Risk Better?

Mortality (%)

Months Months Months

STS < 5 STS 5-15 STS > 15

100% 55.9% 93.3% 73.7% 75.2% 93.4% p (log rank) = 0.0012 p (log rank) = 0.0002 p (log rank) = 0.0749 Standard Rx (n = 123) TAVR (n = 113) Standard Rx (n = 12) TAVR (n = 28) Standard Rx (n = 43) TAVR (n = 38)

TAVR 348 298 261 239 222 187 149 AVR 351 252 236 223 202 174 142

PARTNER High Risk AS All-Cause Mortality (ITT) – 3 Years

• No. at Risk

HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483 26.8% 24.3% 34.6% 33.7% 44.8% 44.2%

PARTNER High Risk Impact of STS Score on Mortality (ITT)

TAVR Patients

177 155 141 128 117 106 87 171 143 120 111 105 81 62 STS ≤11 STS >11

• No. at Risk

28.8% 19.9% 36.1% 31.4% 49.1% 39.6%

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 pulmonary disease 0.30 0.09-0.98 <0.05 Previous coronary artery bypass grafting 0.51 0.17-1.54 0.23 Porcelain aorta 0.00 0.00-0.00 0.998 Frailty 0.19 0.07-0.56 <0.01 Pulmonary hypertension 0.62 0.23-1.64 0.33

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 Severe MR with MAC Pulm HTN – PAP > 60 mmHg Severe COPD – O2 dependent CAD with no revasc options End Stage - Renal Dysfunction Severe Liver disease Cancer with “limited lifespan” Severe cognitive dysfunction Malnutrition Technical considerations** Young age Bicuspid aortic valve No CAD Good LV No Prior CABG

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

• Age (chronologic / physiologic)
• Activity (prior normal activity)
• Attitude / Courage (includes realistic understanding)
• Associated diseases
• Ability to tolerate medical therapy

Jimmy V’s 5 A

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!!!!!