This document summarizes a meta-analysis of patients treated with the Parachute ventricular restoration device for ischemic dilated heart failure. The analysis included 91 patients from previous studies who were followed for 6 months. The primary endpoint of successful implantation without device-related complications was met in 90% of patients. Significant reductions in left ventricular volumes and improvements in functional status and exercise capacity were also observed. Ongoing studies of the Parachute device aim to further establish its role in treating heart failure.

1. Meta-Analysis of Percutaneous
Ventricular Restoration (PVR) therapy
using the Parachute® Device in Patients
with Ischemic Dilated Heart Failure
Martyn R. Thomas, MD
St. Thomas’ Hospital
London, United Kingdom

2. Potential conflicts of interest
Speaker's name: Dr Martyn Thomas
 I have the following potential conflicts of interest to report:
Consultant: … Cardiokinetix and Principal Investigator of Parachute III

3. Parachute Patient Target
Ischemic Heart Failure
24% of MIs
Develop HF1
Anterior Infarct
Results in a scarred / thin wall initiating
ventricular remodeling and dilation.
1Jhund
and McMurray. Heart Failure After Acute MI. Circulation. 2008;118:2019-2021
Wall Motion Abnormality
Akinetic, Dyskinetic, and/or Aneursym

4. Mechanism of Action
The primary effect of the Parachute is improving diastolic compliance, which yields
reduced end diastolic filling pressures and positive clinical results.
Reduces wall stress in the upper chamber
by changing LV geometry
Reduces end diastolic filling pressures
due to improved compliance.
Substitutes the stiff/rigid scar with a
more compliant Parachute that also
provides outward force at the anchors
to aid in diastolic filling

5. PARACHUTE Clinical Program
Device has developed through programme
CE MARK APPROVAL DATA
2005
PARACHUTE Cohort A (N=19, 14 implants)
2008
PARACHUTE US Feasibility (N=20, 17 implants)
2011
EU CONFIRMATORY DATA
PARACHUTE Cohort B (N=59, 54 implants)
 Enrollment complete
 3 year data available
 Enrollment complete
New guide catheters and 6 additional implant sizes
2012
EU POST MARKET DATA
PARACHUTE III (N=54, 43 implants)
 Enrollment complete
All data is pooled as a post hoc meta-analysis. All events have been adjudicated by a CEC. All echo data has been
analyzed by a core lab.

6. Population
• 133 Patients Treated with a Parachute to Date
• 91 Intent-to-Treat patients included in this
presentation.
– Enrolled on or before September 26, 2012
– Cohort A, US Feasibility, Cohort B, and Parachute III
– Population is made up of 34 patients from Cohort A
and US Feasibility, 48 patients from Cohort B and 9
patients from Parachute III.

7. Current Parachute® Technology
Size Matrix
65
65s
75
75s
85
85s
95
95s

8. Clinical Case Details
• 87 yr old female
• Anterior STEMI January 2011 with “late”
presentation. No PPCI or thrombolysis.
• By December 2011; NYHA 3 despite optimal
medical therapy and CRT device therapy.
• Diffuse 3V coronary disease with no
percutaneous revascularisation option.
• 6 min walk 194m limited by SOB

10. 16/14F sheath

15. Trial & Analysis Population
•
•
•
•
DESIGN: Non-randomized, multi-center
PATIENTS: 91 ITT (86 Treated)
SITES: 25
Key Inclusion
• NYHA II-IV
• EF 15% - 40%
• LV Wall Motion Abnormality
• Key Exclusion
• Clinically significant untreated CAD
• Revasc, CRT / ICD, or AMI within
60 days of enrollment
• AR or MR > 2+
• ANALAYSIS PLAN: Meta-analysis of
the first 91 Parachute patients to reach
6M follow-up
Intent-to-Treat, N=91
Unsuccessful Treatment, N=5
2 percutaneous snares
2 surgical removals, 1 perforation
Treated, N=86
6 Month, N=86

16. Demographics
N = 91
Age, years
Gender, male
Weight, kg
Height, cm
Smoking History
History of Stroke
History of Hypertension
History of Diabetes
History of Dyslipidemia
Prior ICD Implantation
Prior CRT Device
Prior PCI
Prior CABG Surgery
HF Hosp. 12M Before Enrolled
Months (median) since MI
60.7 ± 10.2
88%
86.6 ± 17.7
172.7 ± 7.8
77%
11%
65%
34%
85%
34%
9%
77%
15%
32%
40

17. Procedural Complications
• Major Procedure / Valve Complications – 6.6%
– (2) aortic valve (requiring AVR).
– (2) left ventricle injury
– (2) bleed
• Minor Procedure Complications – 8.8%
Aortic Valve Damage Investigated and Solution Implemented
– 6Fr intermediate catheter used to create smooth transition from 0.035” wire to dilator
– IFU updated
Before
After

18. Results
• Primary Endpoint: 90% (82/91) of patients were
successfully implanted and free of device-related
MACE
– (5) Unsuccessful implantations
• (3) acute device removals due to positioning
• (1) device removal due to suspected infection
• (1) guide catheter perforation
– (1) mitral apparatus damage leading to death
– (2) heart failure hospitalization
– (1) peripheral embolization (left popliteal)
• Stroke: 1% (1/91)
– Non-device / non-procedure related

19. Efficacy
Mortality + HF Hosp. for Treated Population
1
0.9
0.8
KM Incidence (%)
0.7
0.6
0.5
0.4
0.3
17.9%
0.2
0.1
0
0
30
60
90
120
150
180
Days from Procedure
No. at Risk
86
60
54

20. NYHA Classification, n=86
At 6 Months, 89% of
Patients Improved or
Maintained Functional
Status.
53% Improved
36% Maintained

21. NYHA III Subset, n=51
33% Maintained
35% Improved 1 Class
27% Improved 2 Class

22. LV Volume, n=74
20%
23%
All paired volumes compared to baseline have a p-value of < 0.001

23. How might volume reduction
influence survival: 41 ml (23%) reduction in ESV?

24. 6 Minute Walk Test
p<0.05*
*paired data
Distance (meter) Change from Baseline

25. Discussion
Why the Parachute in light of the STICH results?
• Degree of Volume (LVESV) Reduction
– Parachute 23% vs. STICH 13%
• More than just volume reduction….
– Method of Addressing the Scar
• Parachute partitions with a flexible device
• SVR excises and closes by suturing a non-flexible patch
– Diastolic Filling is directly related to the active process of LV relaxation
leading to a “suction” effect (this suction effect is thought to be caused
by rapid untwisting of the LV apex in early diastole)
• Parachute is flexible and applies a small amount of outward force during filling
• SVR leaves behind a rigid apex
– LV Shape
• Parachute leaves a consistent conical shape and allows “torsion”.
• SVR post-OP shape is operator dependant and tends to result in a “flat” apex
– Parachute procedure is considerably lower risk than SVR

26. Parachute IV
• Pivotal randomised US trial.
• Approx 500 patients randomised to Medical
Therapy and the Parachute v Medical Therapy
alone.
• Primary endpoint is death or rehospitalisation
for heart failure (event driven)

27. Conclusions
(1) The Parachute device has been in development and in Clinical
Programmes since 2005.
(2) There have been important learnings and developments
along the way:
- Sizing: Now 8 different sizes of the device CE marked
- Guide Catheter development and use including strategies to
avoid aortic valve trauma: (now 3 guide shapes available and
new tapered obturator tip and “steerable” guiding catheter in
development).

28. Conclusions
(3) The early clinical data (including a number of FIM
patients with early versions of the device) is very
encouraging including important improvements in
NYHA class and LV volume reduction.
(4) Continued post CE mark clinical experience and the
pivotal US (Parachute IV) trial will establish where this
device sits in the treatment of heart failure.

29. Endpoints
• Primary
– Successful delivery and deployment of the Parachute Implant through
6-month follow-up without the occurrence of Major Adverse Cardiac
Events (MACE) related to the investigational device.
• Secondary
– Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and
End Diastolic {LVEDVI}) measured by echocardiography from baseline
to 6 months
– Change in exercise tolerance from baseline to 6 and 12 month followup as measured by 6-Minute Walk Test
– Combined cardiovascular mortality and morbidity that includes all
cause death, hospitalization for heart failure, myocardial infarction and
stroke from baseline to 6 and 12 months