Pericardiocentesis With Magnetic Resonance Imaging
Pericardiocentesis With Magnetic Resonance Imaging
Background:

 - Pericardiocentesis uses a needle and small tube to drain fluid from space around the heart.
 The most common reason to perform this procedure is that the fluid is interfering with heart
 function. This procedure is usually guided by X-rays. However, researchers want to try the
 procedure using magnetic resonance imaging (MRI) instead of X-rays. MRI guidance may be more
 precise than X-rays, which can make the procedure easier and more effective.

 Objectives:

 - To test whether MRI guidance can improve pericardiocentesis.

 Eligibility:

 - Individuals at least 18 years of age who need to have pericardiocentesis.

 Design:

 -  Participants will have a physical exam before the procedure. Blood samples will be
 taken.

 -  The pericardiocentesis will be performed using MRI guidance. The procedure may take up
 to 2 hours.

 -  If for some reason the MRI guidance is not successful, participants will have the
 regular X-ray procedure. The MRI system will be used to take high-quality pictures
 afterward to check the results....
Pericardiocentesis is a minimally invasive procedure to drain fluid from the pericardial
 space, created by the pericardial sac which cradles the heart. The most common reason to
 perform this procedure is that pericardial fluid is interfering with heart function. The next
 most common reason is to obtain pericardial fluid for testing to make a clinical diagnosis.
 Pericardiocentesis is performed using a long needle that may be guided by various means
 including blindly without imaging guidance, using electrocardiography electrodes to determine
 when the needle accidentally touches the heart, using echocardiography, using X-ray with- or
 without- contrast injections, or using a combination. Each has its advantages and
 limitations.

 We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization
 with tissue visualization but without X-ray radiation. When used to guide needle access to
 the pericardial space or from there even into heart cavities, MRI provides superb imaging
 guidance. What is especially valuable about MRI is that it provides the entire thoracic
 context of needle access, allowing the operator to avoid critical structures including the
 liver, lung, pleural space, and heart muscle.

 We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization
 in patients with tissue visualization but without X-ray radiation. We also have used these
 developments to guide needle access to the heart and pericardium in animal models.

 In this protocol we test the safety and feasibility of pericardiocentesis in adult patients,
 using commercially available MRI-compatible (passive) needles.

 If successful, this will enable more advanced minimally invasive procedures in adults and
 children.
-  INCLUSION CRITERIA:

 -  Adult patients, age greater than or equal to 18

 -  Undergoing medically necessary diagnostic or therapeutic pericardiocentesis

 EXCLUSION CRITERIA:

 -  Cardiogenic shock (sustained systolic blood pressure less than or equal to 80 mm Hg
 despite volume repletion on physical examination or requiring catecholamine support)

 -  Women who are pregnant or nursing

 -  Unable to undergo magnetic resonance imaging

 -  Cardiac pacemaker or implantable defibrillator

 -  Cerebral aneurysm clip

 -  Neural stimulator (e.g. TENS-Unit)

 -  Any type of ear implant

 -  Ocular foreign body (e.g. metal shavings)

 -  Metal shrapnel or bullet.

 -  Any implanted device (e.g. insulin pump, drug infusion device), unless it is
 labeled safe for MRI

 EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS:

 -  Renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73M(2)
 body surface area according to the Modification of Diet in Renal Disease criteria

 -  Glomerular filtration rate will be estimated using the MDRD 2005 revised study
 formula:

 --eGFR (mL/min/1.73M(2))=175x(standardized s(cr)) (-1.154) x (age) (-0.203) x 0.742
 (if the subject is female) or x1.212 (if the subject is black)

 -  Subjects meeting this exclusion criterion may still be included in the study but may
 not be exposed to gadolinium-based contrast agents.

 RATIONALE FOR SELECTION CRITERIA:

 -  This is a technical development study with the prospect of direct benefit to
 individual research subjects. The selection criteria are designed to minimize risk
 while attaining the scientific objectives of the study.

 -  Adult subjects are sought from among patients already undergoing medically necessary
 pericardiocentesis. Children are excluded from this first proof-of-concept experience
 to maximize safety; we anticipate a follow-on protocol that includes children.

 -  Subjects are excluded if they are not suitable for rapid entry into an interventional
 MRI environment, so mechanical ventilation and cardiogenic shock are exclusion
 criteria in this early experience.

 -  Subjects with renal excretory dysfunction might be injured by gadolinium exposure and
 are not exposed to gadolinium-based contrast agents. Pregnant subjects are excluded
 because of unknown risk and no benefit to a fetus. Magnetic resonance imaging will be
 used to guide pericardiocentesis, so subjects must be eligible to undergo magnetic
 resonance imaging safely.