The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump function. The effect of the Icoms® FlowMaker® is to add an additional quantity of blood flow on top of the native blood flow, during each systole. The heart continues to have its own contribution, but a more satisfactory blood flow is restored by the complementary action of the Icoms® FlowMaker® This study is a first in human test to evaluate the safety and the performance of the Icoms Flowmaker. The study population consists of patients with severe heart failure who are at high risk for a conventional LVAD and at high risk for a percutaneous driveline. Ten patients will be recruited and implanted In France , Slovenia and Czech republic. The study objectives are: o evaluate the safety and performance of the Icoms® FlowMaker® implantable device in patients with severe heart failure resistant to optimal medical therapy. --Primary Objective: Assess safety and performance of the device at 30 days post-implantation. Secondary Objectives: Evaluate the patient's hemodynamic and clinical status, and the device's functionality per technical specifications.
The role of mechanical circulatory support (MCS) in the current landscape of heart failure (HF) therapies can only be appreciated by knowing the potential number of candidates for advanced HF treatment. HF prevalence is 2.6% in the over 300 million US population. Approximately half of all patients with HF have reduced, versus preserved ejection fraction (3.5 million). Only 10-15% of those belong to the New York Heart Association (NYHA) class IIIB-IV. These data suggest that there are as many as 500,000 patients in whom either LVAD or cardiac transplantation could be indicated following current national guidelines.. However, taking into account important limitations based on age, comorbidities, social and financial constraints, the actual number might be less, but nevertheless 125,000 to 250,000 patients remain as potential candidates for this advanced therapy. The INTERMACS Class 4-7 . population presents an incidence of at least 100,000 patients per year in the USA, Canada and Europe. The main indications for the use of implantable LVADs in patients with end-stage HF are either as a bridge to candidacy (BTC), or as long-term option for those who do not qualify for cardiac transplantation, previously referred to as destination therapy (DT). Only 7.000 to 9.000 MCS devices are implanted worldwide every year, which represents a significant lack of treatment in such sick and mostly not elderly patients. Consequently, there is a huge discrepancy between the need for MCS treatment (up to 250,000 patients) and the real proportion of patients implanted, due to known, much feared current LVAD-induced complications. Yet, the greatest increase in LVAD volume has not been in those considered candidates for bridge to heart transplantation (BTT) but for DT, which requires technical improvements to expand MCS devices implants in less severe patients.5-6. The overall survival with LVAD therapy is ≈ 80% at 1 year, and 60% at 5 years, with survival for DT indication lower than other indications at all time points, because of higher incidence of comorbidities and LVAD complications . Presently, the use of the terms BTT or DT to define the indication for LVAD implantation is being replaced by whether the support is intended for temporary or chronic use10. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes 25,000 patients: * 97% benefit from a non-physiological continuous-flow VAD * The average age at implant is 57 years and 80% are male. * Overall, 1- and 2-year survival is 80% and 70%, respectively. * Most implanted patients are INTERMACS Class 1-3 (80-85%). * Patients with ambulatory HF still account for only 16% of durable device implants to date, due to the fear for LVAD-induced complications. * Today, nearly 41% are implanted with an intent for long-term DT. * With the HeartMate 3, neither survival rate, nor infection rate did improve compared to the Intermacs registry cohort only thrombosis and disabling stroke were significantly reduced at 2-year follow-up. All these precious epidemiological data highlight the crucial need for a new type of MCS device, being more physiological and pulsatile, without a percutaneous driveline (i.e. "fully implantable"). It needs to be easier to implant and/or replace, with less invasive surgery without CPB and thus, finally able to address the most important population of severe HF patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Wireless cardiac assist device implanted without using CPB
Hospitalier IKEM
Prague, Czechia
RECRUITINGHôpital la pitié salpètrière
Paris, France
ACTIVE_NOT_RECRUITINGDevice Safety
Survival free from stroke with MRS ≥ 3
Time frame: at 1 month post-implant
Device Safety and Performance
Frequency of device-related reoperations Nota Bene: In case of device replacement or heart transplantation if the patient becomes eligible to transplant during the study, the time of induction of anesthesia must be considered as the success of the bridge to transplant.
Time frame: 1 month post implant
Device Safety
Frequency of Device-related infection
Time frame: 1 month Post - implant
Improvement of the patient clinical condition
1 NYHA functional status improvement
Time frame: At 1 Month, 2 month , 3 month and 6 month post -implant
Improvement of patient clinical condition
Quality of Life Change (EQ-5DL).
Time frame: 1month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Withdrawal of intravenous inotropic drugs.
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical Condition
Blood chemistry (LDH, Free Hemoglobin, Factor of Von Willebrand).
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Improvement in 6-minute hall walk test
Time frame: 1month, 2 month, 3 month and 6 month Post-implant
Device Safety
\- Incidence of adverse events and unanticipated adverse device effects
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Device proper functioning
Hemodynamic improvement (assessed by CO, aortic VTI, LAP, inotropic drugs weaning).
Time frame: 1month, 2 month, 3 month and 6 month post-implant
Device Proper Functioning
Assessment of the external coil of the Transdermal Energy Transfer (TET) System.
Time frame: 1month, 2 month, 3 month and 6 month Post-implant
Device proper functioning
\- Proper functioning of the implanted battery (frequency of impnated battery failure).
Time frame: 1 month, 2 month, 3 month and 6 month Post-implant
Device usability
Patient's ability to manage device alarms and the external controller, based on the device usability tests results and device deficiencies
Time frame: 1 month, 2 month , 3 month and 6 month post-implant
Stephane S Garrigue, PhD, MD
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