Novel Micro-Implant to Measure Intracardiac Pressure in Congenital Heart Patients


Principal Investigator: Nader Najafi
Abstract: DESCRIPTION (provided by applicant): Congenital heart disease patients with functional single ventricle (FSV) anatomy usually require a series of surgeries during infancy and childhood in order to provide them with a chance to survive into adulthood. The second stage surgery, termed the hemi-Fontan procedure (HFP) re-routes systemic venous blood from the upper body and head into the pulmonary circulation without passing through an intervening ventricular chamber. Because blood flow into the lungs is largely a passive process, any anatomic obstruction within the pulmonary vasculature, elevated pulmonary vascular resistance, or significant ventricular dysfunction can result in patients having elevated hemi-Fontan pressures. Problems that develop within the hemi-Fontan pathway early in the staged palliation process can result in an increased risk for complications during the Fontan operation and throughout a Fontan patient's life. Therefore, maintaining optimal hemi-Fontan anatomy and physiology is important for long term success and survival for FSV patients. Currently, it is not standard practice at most institutions to routinely measure hemi-Fontan pathway pressures in the immediate post- operative period or in the ambulatory setting while awaiting the Fontan. Post-operative monitoring of the hemi- Fontan pressures requires an indwelling catheter in an upper body or neck vein. This has the potential to lead to complete thrombosis of the systemic vein, which is a devastating complication for the hemi-Fontan patient. Furthermore, serial outpatient cardiac catheterizations to measure hemi-Fontan pressures place infants at risk for procedural complications. Therefore, to provide clinicians in the ICU and in the ambulatory setting with the means to measure hemi-Fontan pressures, investigators are developing a miniaturized pressure sensor that can be implanted directly into the hemi-Fontan pathway at the time of the second stage operation. The proposed implantable pressure monitor will provide readily available hemodynamic assessment of the hemi- Fontan pathway during the immediate post-operative period without the risk of systemic venous thrombosis. Interval testing of the hemi-Fontan pathway pressure in the ambulatory setting will allow clinicians to observe for rising pressure trends, which may provide early indication of a problem that is developing and allow for earlier intervention before irreversible damage has occurred. This will be accomplished without the risk associated with cardiac catheterization. During this study investigators will complete the development of a miniature implantable wireless pressure sensor. Final design freeze will be achieved, and design control requirements, including risk analysis, biocompatibility testing, sterility, and manufacturing processes, will be completed to satisfy FDA requirements. Preclinical animal studies will be carried out, including a chronic GLP animal study, to determine the device's in vivo biocompatibility, functionality, and safety profile. Finally, this study will support investigators during the application process to obtain Investigational Device Exemption from the FDA for the initial feasibility studies in infants with these complex forms of congenital heart disease.
Funding Period: 2011-09-01 - 2014-07-31
more information: NIH RePORT

Detail Information

Research Grants31

  1. Pre-clinical Testing of a VAD for Uni- and Bi-ventricular Support in Infants
    William J Weiss; Fiscal Year: 2013
    ..80 with 80% confidence for a six-month system design, with testing to demonstrate device reliability by sustained operation for periods at least twice as long as the intended use (i.e. one year). ..
    Timothy A Springer; Fiscal Year: 2013
    ..Administrative (Springer) and Protein Expression (Lu) Cores enhance efficiency of the PPG. (End of Abstract) ..
  3. Pediatric Heart Network - The Hospital for Sick Children, Toronto
    Steven M Schwartz; Fiscal Year: 2013
  4. PPG - Mechanisms of Cardiovascular Protection and Disease
    Donald D Heistad; Fiscal Year: 2013
    ..abstract_text> ..
  5. Understanding mechanisms of Fontan failure and key predictors for patient outcome
    Ajit P Yoganathan; Fiscal Year: 2013
    ..Understanding these interconnections will provide the means to develop optimal medical strategies to improve those outcomes. ..
  6. The Role of Histone Deacytelases in Right Ventricular Adaptation in Hypoplastic L
    SHELLEY DEANNE MIYAMOTO; Fiscal Year: 2013
    ..Modulation of HDAC activity, given the distal site of action in the signaling pathway, could have unique therapeutic potential in RV failure in HLHS. ..
  7. Self Regulating Continuous Flow Total Artificial Heart
    Kiyotaka Fukamachi; Fiscal Year: 2013
    ..The single moving component pump is a dramatic advance in the design of total artificial heart when compared to the pulsatile devices currently available for the treatment of end stage biventricular heart failure. ..
  8. A percutaneous cardiac implant to treat mitral valve regurgitation
    Michael Lesh; Fiscal Year: 2013
    ..Our long- term goal is approval by the FDA for commercial sale within the US via the Premarket Approval process. ..
  9. Piezoelectric Pump to supply Ventricular Assist Device for Fontan Patients
    CONAL O'NEILL; Fiscal Year: 2013
    ..for realization of a unique device to aid patients with the Fontan circulation, but it will also provide an outline for the use of compact hih power density piezoelectric devices for use as mechanical circulatory support drivers ..
  10. Synchronous Valveless Pulsatile Support Device for the Failing Heart
    RICHARD WARREN SMALLING; Fiscal Year: 2013
    ..We believe that our technology has the potential to improve patient quality of life while minimizing complications compared to currently available LVADs. ..
  11. Cavopulmonary Assist: Circulatory Support for Fontan Circulation
    Mark D Rodefeld; Fiscal Year: 2013
    ..In patients with univentricular Fontan circulations - young and old - this safe, simple, and reliable method to augment cavopulmonary flow will address their unresolved health needs. ..
  12. Biological Variation in Hemophilia
    JOHN S LOLLAR; Fiscal Year: 2013
    ..The program represents a fertile environment for training the next generation of physician-scientists, clinical, and basic researcher in the management and research of hemostatic disorders ..
  13. Interactive Signaling Modules in Vascular Inflammation
    Linda H Shapiro; Fiscal Year: 2013
    ..abstract_text> ..