PeriPort™ Applications
As a standalone product
Pericardial Effusion
Web MD, 2008:
A higher incidence
of pericardial effusion is associated with many diseases.
Twenty-one percent of cancer patients have metastases to the
pericardium. The most
common are lung (37% of malignant effusions), breast (22%), and
leukemia/lymphoma (17%).
Patients with HIV, with or without AIDS, are found to have increased
prevalence, with 41-87% having asymptomatic effusion and 13% having
moderate-to-severe effusion.
As a delivery vehicle for electrophysiology devices
Atrial Fibrillation
National Heart, Lung, and Blood Institute, 2005:
Atrial fibrillation (AF) is a major public health burden with a
lifetime risk of 1 in 4 for its development (1 in 6, even if no
heart failure or Myocardial Infarction is present) and costs of $6.4
billion per year.
The prevalence of AF in the
"The development of novel
techniques for percutaneous access to the pericardial space is
changing our view of the usefulness of this space to treat
cardiovascular disease.
However, the idea of nonsurgically entering the normal
pericardial sac for diagnostic or therapeutic purposes was
unrealistic until recently.
This was largely due to the perception that access to the
pericardial space by a pericardial puncture approach was only safely
possible in the presence of a sizeable pericardial effusion.”
The paper concludes:
“An understanding of this
pericardial anatomy…is important as more cardiologists and
electrophysiologists begin to exploit this novel approach to the
heart.
This is true not
just for catheter ablation of arrhythmias but also for a number of
other potential cardiovascular applications ranging from
cardiovascular drug delivery to cardiac pacing.”
Additionally, as
recently as 2009, studies are showing that implantation of a cardioverter defibrillator inserted subxiphoid via a pericardial
window in children. They
concluded that: “Intrapericardial placement of an ICD coil
system can be safely and successfully carried out through
a minimally invasive subxiphoid approach in small infants
and children. This novel ICD configuration demonstrates excellent performance, and provides a particularly efficacious approach to ventricular tachyarrhythmia therapy
in pediatric patients.”
The use of electrophysiology equipment for pacing, cardioverters and
arrthymia treatments are beginning to be focused on the outside of
the heart rather than the inside of the heart.
PeriPort™ is an ideal candidate to provide delivery of these
devices as it can provide access to the normal pericardial
space.
For drug delivery
Cardiac Rhythm and Disease Management division of Medtronic,
Xiao, et al:
The interest is spreading from the research environment to
commercial enterprises. For example, the lead four of the six
authors of the Xiao, et al paper concludes, “Worldwide, millions of
patients die annually from sudden cardiac death. More than half of
such deaths occur within one hour following an acute myocardial
infarction, and this is typically associated with sustained
ventricular arrhythmias.” “Therefore, pericardial infusion of n-3
PUFAs was considered to be an effective way to build up a high
concentration around the heart. It was also considered that high
concentrations of n-3 PUFAs should rapidly enhance their protective
effects on myocardium, since they are highly lipid-soluble.
Furthermore, previous studies with the pericardial administration of amiodarone and procainamide have shown that the active motion of the heart within the pericardium mixes and distributes the drugs throughout the epicardium and that deep penetrations can occur.” Further, “Here, we report that a novel delivery approach with dosed DHA directly to the pericardial space had a dramatic cardioprotective effect.”
Cardiovascular Week:
“Intrapericardial (IPC) delivery of drugs to the heart may allow
higher drug efficiencies with lesser side effects, researchers say.
"Targeting drugs to the heart by intrapericardial (IPC) delivery may
be a promising strategy to obtain higher drug efficiencies with
lesser side effects.”
Kumar, et al:
“Interest is increasing in the direct delivery of agents into the
pericardial space for local treatment of cardiovascular disorders to
achieve maximum therapeutic effects and to minimize side effects of
systemic administration.
The intrapericardial approach to local cardiac drug delivery possesses several intrinsic advantages: 1) Delivery into a low-turnover reservoir, which maximizes contact with tissue and minimizes loss of agent into circulation; 2) Access to coronary vessels and to the sympathetic and parasympathetic efferent fibers, both of which have significant segments of epicardial exposure, particularly at the base of the heart. Perfusion of atrial and ventricular epicardial tissue to affect ionic currents; 4) Reduced exposure to degradative enzymes, notably those contained in erythrocytes; and 5) Avoidance of systemic effects. Safe, rapid, reliable access without thoracotomy to the normal pericardial space has been demonstrated.”
It continued, “The well-established vascular effects of nitric oxide (NO) donors are augmented when administered intrapericardially. The NO donor sodium nitroprusside more effectively protected against platelet aggregation in stenosed and injured coronary arteries when administered intrapericardially than intravenously. Intrapericardial nitroglycerin (NTG) produced persistent coronary vasodilation without systemic hypotension or reflex elevations in heart rate (HR). The vasodilatory effect, measured by intravascular ultrasound, was more pronounced and enduring (3 to 15 min) than an equal intracoronary dose (200 µg bolus). Baek, et al, demonstrated a prolonged vasodilatory effect and positive remodeling by the NO donor diazeniumdiolated bovine serum albumin, which has 22-h intrapericardial residence time, and suggested a clinical application in protecting against restenosis after angioplasty.” The paper concluded, “Intrapericardial nitroglycerine exerts a robust antifibrillatory action.”
Baek, et al:
The paper concludes, “The data suggest that intrapericardial
delivery of NO (nitric oxide) donors for which NO release rates and
pericardial residence times are matched and optimized might be a
beneficial adjunct to coronary angioplasty.”
Laham, et al:
The paper concludes, “A single intrapericardial bolus of basic
fibroblast growth factor may be a useful therapeutic strategy for
the treatment of myocardial ischemia in patients with coronary
artery disease.”
Conclusion:
The
pericardial space is unique and region-specific to give effective
cardio active drug therapy without many of the systemic side effects
of conventional drug delivery methods. The PeriPort™ provides a
minimally invasive and safe method of delivery of drug therapy to
the heart via the pericardial space.