Left Ventricular Expanders and Partitioning Devices Novel TransApical

Left ventricular remodeling following acute myocardial infarction Ventricular Remodeling after Infarction (Panel A) and

Left ventricular remodeling Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic

Rationale for left ventricular restoration • Increase in wall stress as a result of

The PARACHUTE-Left ventricular partitioning device Mazzaferri EL Jr 1, . Am Heart J. 2012

PARACHUTE trial Percutaneous left ventricular partitioning in patients with chronic heart failure and a

Functional status and QOL at 12 months Mazzaferri EL Jr 1, . Am Heart

Left ventricular end-diastolic volume index and endsystolic volume index Marco A. Costa et al.

The PARACHUTE-IV • Phase 3 -A Pivotal Trial to Establish the Efficacy and Long-term

Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel

Rationale for left ventricular expander Aurigemma GP, N Engl J Med. 2004 Sep 9;

Left ventricular expander - CORolla® Ventricular Remodeling after Infarction (Panel A) and in Diastolic

Left ventricular expander - CORolla® • An elastic intraventricular(endocardial) device that is implanted via

Left ventricular expander - Im. Cardia® • An elastic self-expanding device attached to the

Summary • LV partitioning devices decrease LV end volume, hence attenuate wall stress and

Conclusions • Implantation of left ventricular expanders and partitioning devices is feasible • Future

Device Main features Outcomes Current stage Acorn Corcap - Pericardial strain - Surgically implanted

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Left Ventricular Expanders and Partitioning Devices: Novel Trans-Apical Therapeutics Selma Mohammed, MD, Ph. D Advanced Heart Failure, Med. Star Heart Institute Assistant Professor of Medicine, Georgetown University CRT 2017 Feb 21, 2017 I have no financial disclosures I will be discussing investigational devices

Left ventricular remodeling following acute myocardial infarction Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). Jessup M, Brozena S. N Engl J Med 2003; 348: 2007 -2018.

Left ventricular remodeling Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). Jessup M, Brozena S. N Engl J Med 2003; 348: 2007 -2018.

Rationale for left ventricular restoration • Increase in wall stress as a result of increased LV size → • ↑ myocardial oxygen demand (higher ATP use) • Sympathetic adrenergic and RAAS stimulation • Progressive LV dilatation, recruitment of border zone myocardium, and worsening of contractile function

The PARACHUTE-Left ventricular partitioning device Mazzaferri EL Jr 1, . Am Heart J. 2012 May; 163(5): 812 -820. e 1.

PARACHUTE trial Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction • A first-in-man, prospective, non-randomized, multicentre trial • 39 patients • Safety – – The device was safely and successfully implanted in 31 of 34 (91%) – 6 MACE at 24 months Mazzaferri EL Jr 1, . Am Heart J. 2012 May; 163(5): 812 -820. e 1.

Functional status and QOL at 12 months Mazzaferri EL Jr 1, . Am Heart J. 2012 May; 163(5): 812 -820. e 1.

Left ventricular end-diastolic volume index and endsystolic volume index Marco A. Costa et al. Circ Heart Fail. 2014; 7: 752 -758

The PARACHUTE-IV • Phase 3 -A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV) • N= 560 • Primary Outcome Measures: Death or rehospitalization for Worsening Heart Failure at least 1 year Mazzaferri EL Jr 1, . Am Heart J. 2012 May; 163(5): 812 -820. e 1.

Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). Left ventricular remodeling in HFp. EF Jessup M, Brozena S. N Engl J Med 2003; 348: 2007 -2018.

Rationale for left ventricular expander Aurigemma GP, N Engl J Med. 2004 Sep 9; 351(11): 1097 -105

Left ventricular expander - CORolla® Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). https: //www. corassist. com/demo. htm

Left ventricular expander - CORolla® • An elastic intraventricular(endocardial) device that is implanted via a minimally invasive procedure (trans apical or percutaneous) • Application of direct internal expansion forces distributed on the left ventricular wall and septum

Left ventricular expander - CORolla® Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). • Open Label - CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFp. EF) and Diastolic Dysfunction (DD) • Groups: – CORolla™ TAA Stand Alone - isolated HFp. EF – AVR and CORolla™ TAA – No Intervention: Control

Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). Left ventricular expander - Im. Cardia® https: //www. corassist. com/demo. htm

Left ventricular expander - Im. Cardia® • An elastic self-expanding device attached to the external left ventricular surface (epicardial) through a thoracotomy • Application of an outward expansion recoiling force on the ventricular wall to increase end diastolic volume and improve diastolic filling

Ventricular Remodeling after Infarction (Panel A) and in Diastolic and Systolic Heart Failure (Panel B). Left ventricular expander - Im. Cardia® • Early Phase 1 - Im. Cardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study (Im. Cardia) • Terminated – Improvement in device needed

Summary • LV partitioning devices decrease LV end volume, hence attenuate wall stress and adverse remodeling • Left ventricular expanders enhance diastole LV compliance, hence improves filling and forward flow

Conclusions • Implantation of left ventricular expanders and partitioning devices is feasible • Future goals: – Demonstrate long term safety, particularly regarding risk of thromboembolic events – Define the specific population who may benefit from this technology

Questions

Device Main features Outcomes Current stage Acorn Corcap - Pericardial strain - Surgically implanted Improvement in NYHA, MLHF Reverse modeling Not FDA approved Paracor Heart. Net Myocor Coapsys - Surgically implanted No survival benefit Improvement in 6 mwt, MLHF, echocardiographic indices, NYHA functional class No improvement in peak VO 2 - No cardiopulmonary bypass - Ventricular tensioning chords - Treats functional MR No survival benefit Survival benefit Decreased adverse events Currently developing transcatheter system (i. Coapsys) Under investigation with phase II study (CONFIGURE-HF) -Elastic ventricular restraint Not FDA approved -Surgically implanted Biometrix Revivent - Minimally invasive - Targeting anteroseptal scars Improvement in quality of life, 6 mwt, NYHA functional class, EF Cardiokinetix Parachute -First catheter-based device Improvement in NYHA functional class. Randomized controlled trial in progress (PARACHUTE IV) - Targeting anterior-apical scars Trend towards improvement in quality of life, 6 mwt Oliveira GH. J Cardiovasc Transl Res. 2014 Apr; 7(3): 282 -91