Multifunctional catheters combining intracardiac ultrasound imaging and electrophysiology sensing

A family of 3 multifunctional intracardiac imaging and electrophysiology (EP) mapping catheters has been in development to help guide diagnostic and therapeutic intracardiac EP procedures. The catheter tip on the first device includes a 7.5 MHz, 64-element, side-looking phased array for high resolution sector scanning. The second device is a forward-looking catheter with a 24-element 14 MHz phased array. Both of these catheters operate on a commercial imaging system with standard software. Multiple EP mapping sensors were mounted as ring electrodes near the arrays for electrocardiographic synchronization of ultrasound images and used for unique integration with EP mapping technologies. To help establish the catheters' ability for integration with EP interventional procedures, tests were performed in vivo in a porcine animal model to demonstrate both useful intracardiac echocardiographic (ICE) visualization and simultaneous 3-D positional information using integrated electroanatomical mapping techniques. The catheters also performed well in high frame rate imaging, color flow imaging, and strain rate imaging of atrial and ventricular structures. The companion paper of this work discusses the catheter design of the side-looking catheter with special attention to acoustic lens design. The third device in development is a 10 MHz forward-looking ring array that is to be mounted at the distal tip of a 9F catheter to permit use of the available catheter lumen for adjunctive therapy tools.

[1]  O. Oralkan,et al.  3-D ultrasound imaging using a forward-looking CMUT ring array for intravascular/intracardiac applications , 2006, IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control.

[2]  D. Singer,et al.  Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. , 2001, JAMA.

[3]  Stephen Balter,et al.  ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task , 2005, Circulation.

[4]  Atul Verma,et al.  Transcranial Doppler Detection of Microembolic Signals During Pulmonary Vein Antrum Isolation: Implications for Titration of Radiofrequency Energy , 2006, Journal of cardiovascular electrophysiology.

[5]  B. Knight,et al.  Integration of cardiac imaging and electrophysiology during catheter ablation procedures for atrial fibrillation. , 2006, Journal of electrocardiology.

[6]  Mani A Vannan,et al.  Catheter-based interventions guided solely by a new phased-array intracardiac imaging catheter: in vivo experimental studies. , 2002, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[7]  Michael A. E. Schneider,et al.  Radiofrequency Ablation of Cardiac Arrhythmias Using a Three‐Dimensional Real‐Time Position Management and Mapping System , 2002, Pacing and clinical electrophysiology : PACE.

[8]  W. Saliba,et al.  Brief Communication: AtrialEsophageal Fistulas after Radiofrequency Ablation , 2006, Annals of Internal Medicine.

[9]  Hugh Calkins,et al.  Radiation Exposure During Catheter Ablation of Atrial Fibrillation , 2004, Circulation.

[10]  M A Konstam,et al.  Intracardiac, intravascular, two-dimensional, high-frequency ultrasound imaging of pulmonary artery and its branches in humans and animals. , 1990, Circulation.

[11]  Charles J Bruce,et al.  Intracardiac phased-array imaging: methods and initial clinical experience with high resolution, under blood visualization: initial experience with intracardiac phased-array ultrasound. , 2002, Journal of the American College of Cardiology.

[12]  Stephen B. Solomon,et al.  Initial Experience with a Novel Focused Ultrasound Ablation System for Ring Ablation Outside the Pulmonary Vein , 2003, Journal of Interventional Cardiac Electrophysiology.

[13]  P. Kirchhof,et al.  A novel nonfluoroscopic catheter visualization system (LocaLisa) to reduce radiation exposure during catheter ablation of supraventricular tachycardias. , 2002, The American journal of cardiology.

[14]  P. Yock,et al.  Radiofrequency catheter ablation guided by intracardiac echocardiography. , 1994, Circulation.

[15]  N. Pandian,et al.  Intracardiac echocardiographic imaging of cardiac abnormalities, ischemic myocardial dysfunction, and myocardial perfusion: studies with a 10 MHz ultrasound catheter. , 1993, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[16]  C. Lau,et al.  Nonfluoroscopic Magnetic Electroanatomic Mapping to Facilitate Focal Pulmonary Veins Ablation for Paroxysmal Atrial Fibrillation , 2002, Pacing and clinical electrophysiology : PACE.

[17]  P. Sanders,et al.  Virtual Anatomy for Atrial Fibrillation Ablation , 2006, Journal of cardiovascular electrophysiology.

[18]  M. Haissaguerre,et al.  Radiation Exposure During Radiofrequency Catheter Ablation for Atrial Fibrillation , 2003, Pacing and clinical electrophysiology : PACE.

[19]  Stephan Willems,et al.  Catheter Ablation of Common‐Type Atrial Flutter Guided by Three‐Dimensional Right Atrial Geometry Reconstruction and Catheter Tracking Using Cutaneous Patches: , 2004, Journal of cardiovascular electrophysiology.

[20]  Henry R. Halperin,et al.  Pulmonary Vein Anatomy in Patients Undergoing Catheter Ablation of Atrial Fibrillation: Lessons Learned by Use of Magnetic Resonance Imaging , 2003, Circulation.

[21]  Hsuan-Hung Chuang,et al.  Cardiovascular imaging in the management of atrial fibrillation. , 2006, Journal of the American College of Cardiology.

[22]  L. Gepstein,et al.  A novel method for nonfluoroscopic catheter-based electroanatomical mapping of the heart. In vitro and in vivo accuracy results. , 1997, Circulation.

[23]  H. Calkins Prevention of esophageal injury during catheter ablation of atrial fibrillation: is intracardiac echocardiography the answer? , 2006, Heart rhythm.

[24]  N. Theocharopoulos,et al.  Fluoroscopically guided implantation of modern cardiac resynchronization devices: radiation burden to the patient and associated risks. , 2005, Journal of the American College of Cardiology.

[25]  Prashanthan Sanders,et al.  Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. , 2005, European heart journal.

[26]  S. Themistoclakis,et al.  Phrenic Nerve Injury After Catheter Ablation: Should We Worry About This Complication? , 2006, Cardiovascular Electrophysiology.

[27]  H. Crijns,et al.  Acute Results of Transvenous Cryoablation of Supraventricular Tachycardia (Atrial Fibrillation, Atrial Flutter, Wolff‐Parkinson‐White Syndrome, Atrioventricular Nodal Reentry Tachycardia) , 2002, Journal of cardiovascular electrophysiology.

[28]  D. Wildes,et al.  The acoustic lens design and in vivo use of a multifunctional catheter combining intracardiac ultrasound imaging and electrophysiology sensing , 2008, IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control.

[29]  Jeroen J. Bax,et al.  Clinical applications of intracardiac echocardiography in interventional procedures , 2005, Heart.

[30]  J. Cannata,et al.  Clinical application and technical challenges for intracardiac ultrasound imaging catheter based ICE imaging with EP mapping , 2004, IEEE Ultrasonics Symposium, 2004.

[31]  Michael A. E. Schneider,et al.  LocaLisa Catheter Navigation Reduces Fluoroscopy Time and Dosage in Ablation of Atrial Flutter: , 2003, Journal of cardiovascular electrophysiology.

[32]  R N Hauer,et al.  LocaLisa: new technique for real-time 3-dimensional localization of regular intracardiac electrodes. , 1999, Circulation.

[33]  C. Rinaldi,et al.  Electroanatomic Mapping of the Right Atrium with a Right Atrial Basket Catheter and Three‐Dimensional Intracardiac Echocardiography , 2004, Pacing and clinical electrophysiology : PACE.

[34]  M. Schalij,et al.  Reduction of Radiation Exposure in the Cardiac Electrophysiology Laboratory , 2000, Pacing and clinical electrophysiology : PACE.

[35]  G Hindricks,et al.  Electromagnetic Versus Fluoroscopic Mapping of the Inferior Isthmus for Ablation of Typical Atrial Flutter: A Prospective Randomized Study , 2000, Circulation.

[36]  W. Lochner,et al.  Estimation of ventricular volume with an intracardiac ultrasonic catheter , 2004, Pflügers Archiv.

[37]  Katja Zeppenfeld,et al.  Fusion of multislice computed tomography imaging with three-dimensional electroanatomic mapping to guide radiofrequency catheter ablation procedures. , 2005, Heart rhythm.

[38]  C. Aguiar,et al.  Ablation of pulmonary vein foci for the treatment of atrial fibrillation; percutaneous electroanatomical guided approach. , 2002, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[39]  N Bom,et al.  An ultrasonic intracardiac scanner. , 1972, Ultrasonics.

[40]  Mark E. Josephson,et al.  Nonfluoroscopic, in vivo navigation and mapping technology , 1996, Nature Medicine.

[41]  H. Halperin,et al.  Integrated Electroanatomic Mapping With Three-Dimensional Computed Tomographic Images for Real-Time Guided Ablations , 2006, Circulation.

[42]  R. Schilling,et al.  Electroanatomic Versus Fluoroscopic Mapping for Catheter Ablation Procedures: , 2004, Journal of cardiovascular electrophysiology.

[43]  N G Pandian,et al.  Intravascular and intracardiac ultrasound imaging. An old concept, now on the road to reality. , 1989, Circulation.

[44]  O. Oralkan,et al.  CMUT ring arrays for forward-looking intravascular imaging , 2004, IEEE Ultrasonics Symposium, 2004.

[45]  D. Packer,et al.  Three‐Dimensional Mapping in Interventional Electrophysiology: Techniques and Technology , 2005, Journal of cardiovascular electrophysiology.

[46]  F. Marchlinski,et al.  Clinical use of AcuNav diagnostic ultrasound catheter imaging during left heart radiofrequency ablation and transcatheter closure procedures. , 2002, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[47]  S Chierchia,et al.  Circumferential Radiofrequency Ablation of Pulmonary Vein Ostia: A New Anatomic Approach for Curing Atrial Fibrillation , 2000, Circulation.

[48]  R. Schilling,et al.  Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. , 2006, European heart journal.

[49]  N. Pandian,et al.  Intracardiac echocardiography: current developments , 2005, The International Journal of Cardiac Imaging.

[50]  O. Oralkan,et al.  Forward-viewing CMUT arrays for medical imaging , 2004, IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control.

[51]  Stephen Balter,et al.  ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures. A report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task , 2004, Journal of the American College of Cardiology.

[52]  Ricardo Ruiz-Granell,et al.  Atrioventricular Node Ablation and Permanent Ventricular Pacemaker Implantation Without Fluoroscopy: Use of an Electroanatomic Navigation System , 2005, Journal of cardiovascular electrophysiology.