Slide 1: Four-year outcomes following HARMONY transcatheter pulmonary valve replacement
Four-year outcomes following HARMONY transcatheter pulmonary valve replacement Allison K. Cabalka, MD Department of Cardiovascular Medicine, Mayo Clinic; Rochester, USA CSI EDUCATION
Slide 2: Disclosure Statement of Financial Interest
DISCLOSURE STATEMENT OF FINANCIAL INTEREST Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below AFFILIATION/FINANCIAL RELATIONSHIP COMPANY • Consultant/Consulting • Medtronic, B. Braun, Edwards Fees/Honoraria
Slide 3: Harmony Transcatheter Pulmonary Valve (TPV)
Harmony Transcatheter Pulmonary Valve (TPV) First FDA approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT) TPV22 TPV25 Our aim: • Report midterm outcomes in Harmony clinical trial participants who received a commercially
Slide 4: Study design and patient flow
Study design and patient flow TPV22 + TPV25 cohort By valve type TPV22 TPV25 21 31 37 21 EFS Early Feasibility Harmony Continued 21 Pivotal 10 Pivotal Study Pivotal Trial Access Study 2 CAS 35 CAS 89 Catheterized 44 45 1 TPV22, implant not attempted Catheterized Catheterized 1 TPV22, attempted, not
Slide 5: Baseline characteristics: Catheterized cohort
Baseline characteristics: Catheterized cohort TPV22 TPV25 TPV22 + TPV25 (N = 44) (N = 45) (N = 89) Female 21 (48%) 15 (33%) 36 (40%) Age, yr 26 (18, 37) 29 (19, 42) 29 (18, 39) Weight, kg 63 (56, 82) 77 (65, 91) 69 (60, 86) Original Diagnosis Tetralogy of Fallot 42 (95%) 35 (78%) 77 (87%) Pulmonary
Slide 6: Adverse events through 4 years
Adverse events through 4 years No. of events (Kaplan-Meier %) TPV22 (N=42) TPV25 (N=44) All-cause mortality 1 (2.5%) 2 (4.5%) Device- or procedure-related mortality 0 0 Embolization of the TPV 0a 0a Endocarditis 1 (2.5%) 1 (3.1%) Thrombosis of the TPV 0 2 (4.5%) Major stent fracture 1 (2.4%) 0 Erosi
Slide 7: Arrhythmias through 4 years
Arrhythmias through 4 years No new ventricular tachycardia after 30 days All resolved except for 1 patient with unconfirmed status No. of events TPV22 (N = 42) TPV25 (N = 45) (Kaplan-Meier %) ≤30 days >30 daysa ≤30 days >30 daysa Ventricular premature beats 3 (7.1%) 0 (0%) 6 (13.6%) 0 (0%) Ventricul
Slide 8: Pulmonary regurgitation
Pulmonary regurgitation TPV22 (N=42) TPV25 (N=44) Implanted Cohort – Echo Core Lab None/Trace Mild Moderate Severe
Slide 9: Surgical and catheter reintervention
Surgical and catheter reintervention Patient Valve type Day Reintervention type 1 TPV22 (EFS) 2 Surgical explant Surgical 2 TPV22 (EFS) 39 Surgical explant 3 TPV25 303 ViV (Melody) 4 TPV25 444 ViV (Sapien) 5 TPV25 610 ViV (Sapien) Catheter 6 TPV25 840 ViV (Sapien) 7 TPV22 (EFS) 881 ViV (Melody) 8 TP
Slide 10: Surgical and catheter reintervention
Surgical and catheter reintervention Kaplan-Meier analysis through 4 years – implanted >24 hours cohort TPV25 TPV22
Slide 11: Ventricular remodeling (RV/LV)
Ventricular remodeling (RV/LV) TPV22 + TPV25 implanted >24 hours cohort – End-Diastolic Volume (EDV) Index
Slide 12: Quality of life: SF-36 questionnaire
Quality of life: SF-36 questionnaire TPV22 + TPV25 patients from the Pivotal Trial and CAS – implanted >24 hours cohort
Slide 13: Summary: 4 yr Harmony outcomes
Summary: 4 yr Harmony outcomes Sustained valve performance with none/trace or mild PR in 100% of TPV22 and 95.2% of TPV25 patients at 4 years. No new ventricular tachycardias and continued low number of safety events through 4 years. Sustained improvement in patient-reported quality of life. Prelimi