Percutaneous Ventricular Restoration Therapy (PVRT) in patients with ischemic, dilated heart failure: 2‐year clinical and echo outcomes of the first‐in‐human study of the Parachute left ventricle partitioning device Marco A. Costa, MD, PhD, FACC, FSCAI Professor of Medicine, Director Interventional Cardiovascular Center Director Research and Innovation Center University Hospitals, Case Western Reserve University, Cleveland, OH On Behalf of Sinisa Gradinac, Ernest Mazzaferri, Horst Sievert, Igor Gregoric, Charlie Davidson, Peter Berger, Sinisa Gradinac, Albrecht Elsasser, Ron Waksman, Frank Smart, William Abernethy, Hiram Bezerra, William Abraham
33
Embed
Percutaneous Ventricular Restoration Therapy (PVRT) in with …schipperweb.com/cardiokinetix/wp-content/uploads/2012/05/... · 2015-06-10 · Percutaneous Ventricular Restoration
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
2‐year clinical and echo outcomes of the first‐in‐human study ofthe Parachute left ventricle partitioning device
Marco A. Costa, MD, PhD, FACC, FSCAIProfessor of Medicine, Director Interventional Cardiovascular Center
Director Research and Innovation CenterUniversity Hospitals, Case Western Reserve University, Cleveland, OH
On Behalf of Sinisa Gradinac, Ernest Mazzaferri, Horst Sievert, Igor Gregoric,
Charlie Davidson, Peter Berger, Sinisa Gradinac, Albrecht Elsasser, Ron
Waksman, Frank Smart, William Abernethy, Hiram Bezerra, William Abraham
Presenter Disclosure:
Advisory/Speaker Bureau: Boston Scientific, St Jude LightLab, Cordis, Abbott, Medtronic, Scitech, CardioKinetix
Institutional research support: St Jude LightLab, Cordis, Abbott, Medtronic
Problem Statement:Congestive Heart Failure
A Global Healthcare Problem in Need of a Therapeutic Solution
Aghababian RV. Rev Cardiovasc Med 2002; 3:S3Jong P et al. Arch Intern Med 2002; 162:1689Jencks and Williams. NEJM 2009; 360:1418
0
25
50
75
100
20%
50%
30Days
6Months
Hospital Readmissions
0
25
50
75
100
12%
50%
30Days
12Months
33%
5Years
Mortality
Among Medicare beneficiaries, 27% of HF patients are re‐hospitalized within 30 daysMedian LOS: 6 days; N = 38,702
Rationale: LV Volume and Geometry Impact HF Outcomes
Konstam et al, JACC 2011
High LV Filling Pressure due to Larger Volume and Stiffer Wall
Increase in LV Volume to Compensate for Abnormal Wall Motion
Hypertrophy
Myocardial Infarction
Kramer et al, J Am Coll Cardiol 2010
LV Volume and Outcomes
1. Partition damaged myocardium
2. LV Volumes Reduction
3. Restore LV Conical Shape
4. Preserve Torsional Contraction
5. LVED Pressure Reduction
6. Increase LV Apical Ejection
7. Minimize procedural risk
8. Minimize risk of scar‐related ventricular arrhythmias
Goals of PVRT
Percutaneous Ventricle Restoration Therapy (PVRT)
This image cannot currently be displayed.
This image cannot currently be displayed.
This image cannot currently be displayed.
This image cannot currently be displayed.
This image cannot currently be displayed. This image cannot currently be displayed.
• Nitinol struts with anchors
• ePTFE membrane
• Radiopaque polymer foot
Parachute ImplantParachuteSize Matrix
65 65s75 75s85 85s95 95s
The Parachute™ device is comprised of a fluoropolymer (ePTFE) membrane stretched over a nitinol frame
Nitinol frame supports torsional contraction and optimize LV outflow ejection
Shape was designed to restore conical/longitudinal geometry
The device is deployed into the apex of the left ventricle and partitions off non‐contractile damaged myocardium to reduce LV volume and optimize performance of contractile, healthy myocardial
75, 75s, 85, 85s sizes currently have CE Mark
Implanted shape
Front Lateral Top
R
F
H
L
Guide Catheter (Sheath)
• 3D MSCT Modeling (Ao Arch, LVOT, LV Apex)– Images are 2D projections of the 3D curves– F/L/T views rotated 30°off true A‐P for clarity
Population:● NYHA Class II-IV● EF >15% and < 40%● Post LAD MI, no revascularization option ● Dilated apical region with akinetic or dyskinetic wall motion
abnormality● Warfarin and ASA 1yr post implantIndependent Clinical Event AdjudicationIndependent Echocardiographic and EKG Core Labs
PARACHUTE Cohort A + US Feasibility EnrollersPARACHUTE Cohort A (19 subjects)
– Belgrade, Serbia | PI: Dr. Sinisa Gradinac | 12 subjects
The luminal surface is completely endothelialized by smooth, glistening tan-white tissue. The foot is centered at the LV apex.
Foot is well apposed to the endocardialsurface at the LV apex, with good healing response characterized by endothelialization on both sides of the ePTFE membrane.
European Cohort B Feasibility Trial ‐ 40 Patients Enrolled to dateCE Mark PMS Trial ‐ Enrollment to start May 22, 2012
Conclusions• Percutaneous Ventricular Restoration (PVR) therapy using the
Parachute™ device in patients with ischemic heart failure and LV anterior‐apical wall dilatation was shown to be safe, associated with sustained reduction in LV volumes by echocardiography and relatively low clinical events and up to 2 years.
• These promising results led to the design and conduct of a large multicenter, multinational randomized pivotal trial to evaluate the efficacy of PVR utilizing the Parachute™ LV partitioning device compared with optimal medical therapy (OMT) in patients with ischemic HF and dilated anterior‐apical wall.