Real-time MRI Right Heart Catheterization Using Passive Catheters

• To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures
• To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans

Background:

- Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization.

Objectives:

- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters.

Eligibility:

- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure.

Design:

• The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization.
• Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.

Heart catheterization is a minimally invasive procedure to measure pressure and inject dye into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure and which fails to visualize soft tissue.

We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. In the first phase of this protocol we showed that comprehensive right-sided heart catheterization is feasible in adult patients, using commercially available MRI-compatible ( passive ) catheters.

In the second phase of the protocol, we will perform systematic right-sided heart catheterization without X-ray whenever possible. We will use this protocol to further refine the technique.

If successful, this will enable future adult and pediatric testing of MRI-guided catheterization using special active wire guides, which may lead to new non-surgical treatments of cardiovascular disease.

• Caridovascular Disease
• Congenital Heart Disease
• Pulmonary Hypertension

• Device: Balloon catheter for right heart catheterization
  N/A
• Drug: Gadopentate Dimeglumine (Gadolinium); Contrast Agent
  N/A
• Procedure: Right Heart Catheterization
  N/A
• Procedure: Cardiac Real-time MRI
  N/A
• Procedure: Vascular Hemostasis
  N/A

• Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. Review.
• Ratnayaka K, Faranesh AZ, Guttman MA, Kocaturk O, Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance: still tantalizing. J Cardiovasc Magn Reson. 2008 Dec 29;10:62. Review.
• Guttman MA, Lederman RJ, Sorger JM, McVeigh ER. Real-time volume rendered MRI for interventional guidance. J Cardiovasc Magn Reson. 2002;4(4):431-42.Erratum in: J Cardiovasc Magn Reson. 2003;5(2):407.

• INCLUSION CRITERIA:

Adult patients, age greater than or equal to 21

Undergoing medically necessary diagnostic or interventional right and/or left cardiovascular catheterization

EXCLUSION CRITERIA :

Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure.

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)= 175 x standardized S(cr) (-1.154) x age(-0.203) x 0.742 (if the subject is female) or x 1.212 (if the subject is black)(29)

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