Disclosures. LGH TAVR: Presentation Outline 2/2/2016. Updates in Transcatheter Aortic Valve Replacement (TAVR) and the LGH Experience

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1 Updates in Transcatheter Aortic Valve Replacement (TAVR) and the LGH Experience The LGH TAVR Program James E. Harvey, MD, MSc Medical Director, Structural Heart Intervention The Heart Group of Lancaster General Health Disclosures Speaker s Bureau: LifeSciences LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? 1

2 LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? Aortic Stenosis: Background Valve Heart Disease: 10-20% of all cardiac surgery 2/3 rds are for Aortic Valve Replacement Majority are for Aortic Stenosis Aortic Stenosis: Etiology Bicuspid Tricuspid 2

3 Calcification and immobilization of valve leaflets Healthy Aortic Valve Closed Open Stiffening and narrowing Valve opening Cardiac output Diseased Aortic Valve Closed Open Aortic Stenosis: Diagnosis Echocardiogram Severe symptomatic aortic stenosis AVA cm2 Mean Gradient 40mmHg Max velocity 4m/s LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? 3

4 Why do we care? Severe aortic stenosis has a very high mortality Poor quality of life Medical therapy does not improve mortality Many people are not able to be effectively treated Aortic Stenosis: Clinical Presentation Cardinal symptoms Exertional dyspnea Angina pectoris Syncope Heart failure Most diagnosed without symptoms Systolic murmur- echocardiography Aortic Stenosis: Symptoms and Survival Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 1 Surgical intervention for severe aortic stenosis should be performed promptly once even minor symptoms occur 2 1. Ross and Braunwald, Circulation 1968; 38,

5 Survival, % 2/2/2016 LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? Aortic Stenosis: Management Symptoms?.. Replace the valve Exercise echocardiogram Rapid progression Markedly high velocity (> 6m/s) Aortic Valve Replacement Improves Survival AVR, no Sx 100 Patient Survival AVR, Sx 90 No AVR, no Sx No AVR, Sx Years 5

6 Survival, % 2/2/2016 Undertreatment is Profound Greater 40% of patients aren t treated Mortality of Untreated Aortic Stenosis Year Survival Breast Cancer* 4 Lung Cancer* Colorectal Cancer* Prostate Cancer* Ovarian Cancer* 3 Severe Inoperable AS * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Accessed November 16, Using constant hazard ratio. Data on file, Lifesciences LLC. Analysis courtesy of Murat Tuczu. First RCT: TAVR vs. Medical Therapy September 22, 2010 in NEJM.org 6

7 PARTNER B Results 37.5% Reduction in Repeat Hospitalization Benefit with a cost Higher incidence of stroke Higher incidence of vascular complication 7

8 Dramatic improvement in Symptoms What about quality of life?: KCCQ The KCCQ, followed by the NYHA and the 6-minute walk test, most accurately reflect clinical change in patients with heart failure 10 Patients feel much better 13 MCID, minimum clinically important difference. 8

9 TAVR vs. SAVR PARTNER A Results More Rapid Clinical Improvement than SAVR 9

10 Complications vs. SAVR TAVR: Durability at 5 years Toggweiler S et al. J Am Coll Cardioll 2013;61: Medtronic CoreValve 10

11 Medtronic Corevalve Medtronic Corevalve Medtronic Corevalve Complications 11

12 Evolution of Valves 1960 s Starr- Mechanical Carpentier- PERIMOUNT Pericardial Carpentier- PERIMOUNT Magna Ease Pericardial Cribier- Transcatheter 2011 SAPIEN Transcatheter SAPIEN XT Transcatheter SAPIEN 3 Transcatheter 2015 Evolution of 1960 s Starr- Mechanical Carpentier- PERIMOUNT Pericardial Carpentier- PERIMOUNT Magna Ease Pericardial Cribier- Transcatheter 2011 SAPIEN Transcatheter SAPIEN XT Transcatheter SAPIEN 3 Transcatheter Evolution of MedTronic 12

13 Evolution of MedTronic Lancaster General Hospital 13

14 Lancaster General Hospital Lancaster General Hospital Lancaster General Hospital 14

15 Lancaster General Hospital Lancaster General Hospital Lancaster General Hospital 15

16 Lancaster General Hospital The A-Team 16

17 Lancaster General Hospital- add Rahul Jhaveri The A-Team Sherri Delgado, NP TAVI COORDINATOR Ron Jacob, MD CARDIAC IMAGING Rupal Dumasia, MD James Harvey, MD INTERVENTIONAL CARDIOLOGY Mark Epler, MD Jeff Cope, MD CARDIOTHORACIC SURGERY Roy Small, MD INTERVENTIONAL CARDIOLOGY CONGESTIVE HEART FAILURE LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? Length of Stay & Readmission Rates FY13 FY14 FY15 Q1 AVG LOS days days days 30 Day Valve Related Readmission 30 Day All Cause Readmission 0% 0% 0% 8.3% 26.3% 14.2% 17

18 Outcomes at Discharge FY13 FY14 FY15Q1 Cumulative Device Success 88% 90.9% 100% 91.2% New PPG/ICD Implant 4.2% 0% 7.1% 3.5% TIA 0% 0% 0% 0% Stroke 0% 0% 7.1% 1.8% New A Fib 0% 10.5% 0% 3.5% Major Bleeding 0% 5.3% 0% 1.8% Life Threatening Bleeding Vascular Access Site Complication Requiring Treatment 0% 0% 14.2% 3.5% 8.3% 5.3% 7.1% 7.0% Device Related Events 4.2% 0% 0% 1.8% Aortic Valve Performance Metrics at Discharge Aortic Insufficiency Perivalvular FY13 FY14 FY15Q1 None 0% 28.6% 54.5% Mild 100% 71.4% 45.5% Moderate 0% 0% 0% Severe 0% 0% 0% Central - - None 100% 100% 100% Mild 0% 0% 0% Moderate 0% 0% 0% Severe 0% 0% 0% Outcomes Data at 30 Days 30 Days FY13 FY14 FY15 Q1 Cumulative Myocardial Infarction 0% 0% 0% 0% TIA 0% 0% 0% 0% Stroke (any) 0% 0% 7.1% 1.8% Acute Kidney Injury 0% 0% 0% 0% Major Bleeding 20.8% 11.1% 7.1% 14% Life Threatening Bleeding Vascular Access Site Comps All Cause Mortality 0% 5.6% 21.4% 7% 8.3% 5.6% 14.3% 8.8% 12.5% 0% 0% 4.5% 18

19 Aortic Valve Performance Metrics at 30 Days Aortic Insufficiency Perivalvular FY13 FY14 FY15Q1 None 0% 25% 54.5% Mild 100% 75% 45.5% Moderate 0% 0% 0% Severe 0% 0% 0% Central - - None 100% 100% 100% Mild 0% 0% 0% Moderate 0% 0% 0% Severe 0% 0% 0% Outcomes Metrics at 1 Year 1 Year Myocardial Infarction 0% TIA 0% Stroke (any) 0% Acute Kidney Injury 0% Life Threatening Bleeding or disabling bleeding Vascular Access Site Comps 0% 8.3% All Cause Mortality 16.7% TAVR Discharge Disposition Discharge FY13 FY14 FY15 Q1 Cumulative Home 61.9% 63.2% 71.4% 64.8% ECF/TC 33.3% 31.6% 28.6% 31.5% Other Acute Hospital 0% 0% 0% 0% Nursing Home 4.8% 5.3% 0% 3.7% Hospice 0% 0% 0% 0% 19

20 Quality of Life Kansas City Cardiomyopathy Questionnaire at 30 Days and 1 Year KCCQ 30 Day (FY13) 1 Year (FY13) 30 Day (FY14) 1 Year (FY14Q1) No Change 27.3% 8.3% 27.8% 0% Increased by >/= 2 points Increased by >/=6 points 72.7% 91.7% 66.7% 100% 72.7% 91.7% 61.1% 100% 20

21 LGH TAVR: Presentation Outline What is aortic stenosis? Why do we care? How do we treat it? How are we doing? Where are we going? Future? 21

22 QUESTIONS? Thank you! 22