preliminary results from the c-pulse options hf european multicenter post-market study holger hotz,...
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American Heart Association meeting - November 2014 1
Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study
Holger Hotz, CardioCentrum Berlin, Berlin, Germany;
Antonia Schulz, Cardiocentrum Berlin, Berlin, Germany; Jan Schmitto, Hannover Medical Sch, Hannover, Germany; Mirko Seidel, Unfallkrankenhaus Berlin, Berlin, Germany; Thomas Krabatsch,
Deutsches Herzzentrum Berlin, Berlin, Germany
American Heart Association Meeting
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Disclosures
H. Hotz: NoneA. Schulz: None J. Schmitto: None M. Seidel: None T. Krabatsch: None
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Sunshine Heart, Inc. is sponsoring the OPTIONS HF Clinical Trial. It is a post market, multi-center surveillance study with up to 15 centers participating throughout Europe. Up to 50 patients will be implanted in the study and be followed up to 5 years.
OPTIONS HF Clinical Study
X Ascending aortic calcification or CABGX Mitral Valve Incompetence, Grade 4+
X Aortic Valve Incompetence, Grade 2 - 4+
X Patient has systolic blood pressure less than 90 or greater than 140 mm Hg
√ NYHA Class III and Ambulatory Class IV√ On optimal medical therapy and remains symptomatic√ Had been evaluated for or have CRT or CRT-D therapy and remain symptomatic or ICD therapy (narrow QRS)√ 6MHW 175 - 375 m√ At least one hospitalization for decompensated HF, while on HF medications, OR BNP level > 300 or NTproBNP > 1500 within 12 months prior to randomization√ Both ischemic and non-ischemic
Key Study Qualifications:
Study Objective: The study is designed to observe the clinical outcomes of heart failure patients treated with the C-Pulse® System in the usual manner and according to the approved indications and contraindications.
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A minimally invasive, non-blood contacting, counter-pulsation heart assist therapy for the treatment of moderate to severe heart failure.
• Reduce LV work, increase flow• Balloon inflates – increases coronary
perfusion (addresses hemodynamics - primary pathophysiology of heart failure)
• Balloon deflates – decrease afterload• Minimally invasive procedure can be
performed in 90 minutes • No blood contact – lower likelihood of clot
or stroke• Ability to disconnect – patient comfort and
convenience
The C-Pulse® System
Extra-Aortic Cuff
ECG Sensing Lead
Driver
Percutaneous Interface Lead
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All Patients (N=8)Mean ±SD (range) Age (in years)
60.8 ± 10.5 (51, 79)
Gender Male 87.5% (7/8) Female 12.5% (1/8)Co-morbidities Arrhythmia 50% (4/8) Diabetes Mellitus 62.5% (5/8) Smoking history 87.5% (7/8) Cardiomyopathy 100% (8/8) - Ischemic 50% (4/8) - Non-Ischemic 50% (4/8)INTERMACS Profile 4: Resting symptoms 37.5% (3/8) 5: Exertion Intolerant 37.5% (3/8) 6: Exertion Limited 25% (2/8)NYHA Class III 87.5% (7/8) IV 12.5% (1/8)CRT 62.5% (5/8)ICD Therapy 75.0% (6/8)
Methods
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• 8/8 (100%) of patients successfully implanted
• No procedural device-related complications
• CPB used in 1 patient with concomitant CABG
• No stroke, myocardial infarction, major bleeding or major infection were reported due to the device through 6 months
• One patient was weaned off the device after 6 months of support and showed an increase in EF from 20% at baseline to 44% at 6-months
• One patient developed non-device related refractory tachycardia with worsening heart failure 12 hours after surgery which prevented C-Pulse from supporting the heart properly resulting in subsequent VAD implant 5 days after the index procedure
Results
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0%
20%
40%
60%
80%
100%
I II III
IV
BaselineN=4
6 months
N=4
Results: NYHA – 6 Months
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0
100
200
300
Baseline
N=4
6 months
N=4
260.5 ± 77
Results: 6MWT – 6 Months
203.3 ± 25
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0
10
20
30
40
50
25 ± 7.9
43.3 ± 4.9
Baseline
N=4
6 months
N=4
Results: LVEF (%) – 6 Months
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Conclusion
• Preliminary results from this small cohort in the European Option HF post-market study demonstrate safety of implantation of the C-Pulse System
• 6 month results show improvements in functional capacity and physician assessed functional status
• Efficacy also demonstrated in cardiac remodeling
• C-Pulse Heart Assist System is a promising therapeutic option for patients with moderate to severe heart failure