Prospective nonrandomized pilot study to assess safety and

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Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow

Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in patients with HFr. EF and HFp. EF: The AFR-Prelieve Trial (periprocedural and 3 month results) Martin W. Bergmann, MD, FESC; Ramazan Özdemir, MD, FESC; Roman Pfister, MD, FESC; Christina Paitazoglou, MD; Jozef Bartunek, MD; Teoman Kilic, MD, FESC; Alexander Lauten, MD, FESC; Rüdiger C. Braun-Dullaeus, MD, FESC; Alexander Schmeisser, MD, FESC; Mehdi Zoghi, MD; FESC; Stefan Anker, MD, FESC; Horst Sievert, MD, FESC; Felix Mahfoud, MD, FESC; on behalf of the AFR-PRELIEVE Investigators

Background The AFR-Prelieve Trial: atrial flow regulator in heart failure patients • Heart failure

Background The AFR-Prelieve Trial: atrial flow regulator in heart failure patients • Heart failure (HF) is still associated with a poor medium-term prognosis • Patients with HF suffer from secondary elevation of left atrial pressure particular under exercise associated with increased mortality (Dorfs, EJHF 2014) • A first-in-man experience in HFr. EF patients with an implanted left-to-right interatrial shunt demonstrated safety and early beneficial clinical and haemodynamic outcomes (Del Trigo et al, Lancet 2016) • In HFp. EF patients an interatrial shunt device (IASD) implantation was proven safe and reduced PCWD during exercise (Reduce Lap HF 1 trial, Circulation 2018) • non-randomized trials in small cohorts suggest clinical efficacy M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 2

AFR-device – Mode of action The AFR-Prelieve Trial: atrial flow regulator in heart failure

AFR-device – Mode of action The AFR-Prelieve Trial: atrial flow regulator in heart failure patients Elevated LV filling pressure (LVEDP) LA RA M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 symptomatic relief increased exercise tolerance shunt Pulmonary congestion and dyspnea 3

Haemodynamic measurements at rest and sizing PCWP 25 mm. Hg AFR fenestration 8 mm,

Haemodynamic measurements at rest and sizing PCWP 25 mm. Hg AFR fenestration 8 mm, height 5 mm Septal thickness 3 mm M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019

Implantation procedure of the AFR device A C E H J B D F

Implantation procedure of the AFR device A C E H J B D F I K STEP 1 A-B) Transseptal puncture STEP 4 a G pull C-D) Balloon atrial septostomy 14 mm STEP 2 H-I)Deployment of the right atrial disc + pull manoeuvre STEP 4 b M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 E-F)Deployment of left atrial disc G) Grip and lock AFR on the pusher STEP 3 J-L) Release of the device L

Objectives The AFR-Prelieve Trial: atrial flow regulator in heart failure patients Primary objective: Safety

Objectives The AFR-Prelieve Trial: atrial flow regulator in heart failure patients Primary objective: Safety To evaluate safety and tolerability of the Occlutech AFR-device, by assessing the incidence of Severe Adverse Device Events (SADEs) in the 3 months following implantation Secondary objective: Safety + Efficacy To evaluate safety and tolerability of the Occlutech AFR-device, by assessing the incidence of Severe Adverse Device Events (SADEs) between 3 and 12 months following implantation To evaluate improvement in patients symptoms and hemodynamic parameters during the 12 months following implantation M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 6

Trial Flow Chart and Design The AFR-Prelieve Trial: atrial flow regulator in heart failure

Trial Flow Chart and Design The AFR-Prelieve Trial: atrial flow regulator in heart failure patients DESIGN Prospective, multi-center, open-label, nonrandomized pilot study to assess safety and efficacy of implantation of the Occlutech AFRDevice in heart failure patients SPONSOR Occlutech International AB COORDINATING INVASTIGATORS Germany: Prof. Dr. H. Sievert Cardiovascular Center Frankfurt Turkey: Prof. Dr. Ramazan Özdemir, Bezmialem University Belgium: Dr. Jozef Bartunek, OLV Aalst The study is monitored by DSMB M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 7

Study participant disposition flow chart The AFR-Prelieve Trial: atrial flow regulator in heart failure

Study participant disposition flow chart The AFR-Prelieve Trial: atrial flow regulator in heart failure patients Study participant disposition flow chart SCREENING N=15 participants did not meet inclusion/exclusion criteria* STUDY POPULATION Number of participants screened N=51 Number of participants enrolled with successful implantation (D 0) HFr. EF : N=16 *Reasons for exclusion: N=4 PAPs>60 mm. Hg N=5 withdrawal of consent N=5 PCWP<15 mm. Hg N=1 transeptal puncture failure Number of participants enrolled with successful implantation (D 0) HFp. EF : N=20 N=1 participant died (Pneumonia/Sepsis d 21 -30) Number of HFr. EF participants active at : D 1 N=16 D 7 N=16 D 30 N=15 D 90 N=15 M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 Number of HFr. EF participants active at : D 1 N=20 D 7 N=20 D 30 N=20 D 90 N=20 8

Baseline Characteristics The AFR-Prelieve Trial: atrial flow regulator in heart failure patients M. W.

Baseline Characteristics The AFR-Prelieve Trial: atrial flow regulator in heart failure patients M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 9

Procedural characteristics The AFR-Prelieve Trial: atrial flow regulator in heart failure patients *missing TEE

Procedural characteristics The AFR-Prelieve Trial: atrial flow regulator in heart failure patients *missing TEE data, patency 100% in all TEE procedures at 3 months follow up, TTE image quality not adequate to assess shunt patency at 3 months M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 10

Safety events to 3 months follow-up The AFR-Prelieve Trial: atrial flow regulator in heart

Safety events to 3 months follow-up The AFR-Prelieve Trial: atrial flow regulator in heart failure patients All documented events resolved *ADEs: N 2=catheter site reaction, N 1=Oedema, N 1=Anaemia, N 1=supraventricular arrhythmia, N 1=heart failure symptoms, N 1=respiratory abnormal gas exchange, N 1=disturbance in consciousness ADE= adverse device event, AE= adverse event, SADE=serious adverse device event, SAE= serious adverse event M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 11

Hemodynamic measurements The AFR-Prelieve Trial: atrial flow regulator in heart failure patients RA= right

Hemodynamic measurements The AFR-Prelieve Trial: atrial flow regulator in heart failure patients RA= right atrial, LA= left atrial, LVEDP= left ventricular enddiastolic pressure, PAP= pulmonal artery pressure, PCWP= pulmonal capillary wedge pressure, PVR M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 12

Clinical efficacy at 3 months: NYHA class The AFR-Prelieve Trial: atrial flow regulator in

Clinical efficacy at 3 months: NYHA class The AFR-Prelieve Trial: atrial flow regulator in heart failure patients M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 13

Clinical efficacy at 3 months: 6 min walking test The AFR-Prelieve Trial: atrial flow

Clinical efficacy at 3 months: 6 min walking test The AFR-Prelieve Trial: atrial flow regulator in heart failure patients M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 14

Clinical efficacy at 3 months: 6 min walking test The AFR-Prelieve Trial: atrial flow

Clinical efficacy at 3 months: 6 min walking test The AFR-Prelieve Trial: atrial flow regulator in heart failure patients N= 14 M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 N= 14 N= 19 15

Clinical efficacy at 3 months: KCCQ, quality of life The AFR-Prelieve Trial: atrial flow

Clinical efficacy at 3 months: KCCQ, quality of life The AFR-Prelieve Trial: atrial flow regulator in heart failure patients M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 16

Take home The AFR-Prelieve Trial: atrial flow regulator in heart failure patients • Implantation

Take home The AFR-Prelieve Trial: atrial flow regulator in heart failure patients • Implantation of the atrial flow regulator device is safe • Interatrial shunt device patency: 3 months patency confirmed • Individual patients with either HFp. EF and HFr. EF show surrogate parameters of heart failure to improve following AFR implantation • future work: identification of patient subgroups that benefit from L-R shunt M. W. Bergmann et al. , Euro. PCR LBT 22/05/2019 17