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A Novel Percutaneous Technique for Accessing the Normal Pericardium: A Single-Center Successful Experience of 53 Porcine Procedu
January 2003
The pericardium is a two-layered fibro-serous sac that encloses the heart and the roots of the great vessels. The potential space normally contains only a small amount of fluid, approximately 15–30 ml, comprised mainly of an ultrafiltrate of plasma and possibly some overflow of myocardial interstitial fluid and lymph drainage.1 Recently, emerging data progressively suggested that the normal function of pericardial fluid serves not only to prevent friction from occurring when the heart beats, but perhaps also to provide for a particular biochemical microenvironment that bathes the epicardial coronary vessels and myocardium. Therefore, the pericardial space may constitute an ideal site for local drug delivery to prevent and treat coronary artery and heart disease, such as coronary artery restenosis, myocardium ischemia and/or disease and arrhythmia, via local anti-proliferation, angiogenesis and anti-arrhythmia agent instillation.2–5 However, a reliable and safe means to access the minimally non-diseased pericardium using percutaneous methods is still not deemed clinically acceptable. This study reports on a new pericardial access device capable of performing safe and efficient percutaneous access into pericardial space.
Methods
Animal preparation. Fifty-three juvenile, female domestic pigs weighing 23–25 kg were used for the study. All animals received a normal diet and were housed in similar runs. Animal care and handling followed the National Institutes of Health (NIH) Guide for the Care and Use of Laboratory Animals (Department of Health and Human Services, NIH Publication No. 86-23, revised 1985). The Animal Care and Use Committee of the Indiana University School of Medicine approved the protocols.
Prior to the procedure, animals fasted overnight. The animals were sedated with an intramuscular combination of ketamine (20 mg/kg), xylazine (2 mg/kg), and atropine (0.05 mg/kg). Anesthesia was initiated with intravenous delivery of sodium pentothal (25 mg/kg). After intubation, the animals were mechanically ventilated using air mixed with oxygen (2 L/minute) and isoflurane (2.5%). The vascular system was obtained after cut-down of the right carotid artery and a 6 French (Fr) arterial catheter was inserted for pressure monitoring. The ECG and blood pressure were continuously monitored. The entire operation procedure was carried out under sterile conditions.
Description of the PerDUCER® device. The PerDUCER® Pericardial Access Device (Comedicus Incorporated, Columbia Heights, Minnesota) is a sheathed needle that offers an alternate non-surgical percutaneous method for access and placement of a guidewire into a minimal pericardial space. The ability to apply suction at the tip of the device enables capture and puncture of the pericardial tissue without myocardial puncture. The PerDUCER® device is a non-active, non-implantable device designed specifically for transient procedural use, solely to provide puncture for the delivery of a guidewire into the pericardial space. The device consists of a coaxial design, with a 21-gauge stainless-steel needle housed inside a stainless-steel sheath tube. At its proximal end, the sheath tube is fixed with a thermoplastic handle, a Tuohy borst adapter and an integrated luer-lock vacuum port. The handle is designed to provide control of the needle with rotational, radial and axial movements. At its distal end, a thermoplastic view tube containing a hemispherical shaped side-hole allows for suction-based capture and subsequent puncture for immediate delivery of the 0.018´´ guidewire into the pericardium (Figure 1).6
Percutaneous access of the normal pericardium. The PerDUCER® is used for transthoracic insertion of a guidewire into the normal pericardial space, utilizing fluoroscopic guidance. An initial percutaneous tunnel is made below the xiphoid process using a 21-gauge blunt cannula advanced nearly parallel to the skin surface, after which a 0.038´´ guidewire and introducer sheath are placed into the mediastinum over the anterior pericardium. The PerDUCER® device is advanced through the introducer sheath and positioned on the anterior outer surface of the pericardial sac. Manual suction is applied via 20 cc syringe to draw a bubble of pericardial tissue into the hemispherical-shaped tip, which is then pierced by the needle. Finally, the 0.018´´ intrapericardial guidewire is advanced several centimeters through the needle lumen directly into the pericardial space to confirm confinement within the pericardial sac. After removal of the device, a 4 Fr hydrophilic-coated dilator (Cook Inc., Bloomington, Indiana) is advanced over the wire and positioned into the pericardial space. Following wire withdrawal, successful intrapericardial placement is confirmed by contrast injection into the pericardial space (Figures 2 and 3). Through the 4 Fr dilator catheter, a long 0.038´´ J-tipped extra-stiff guidewire can be advanced into the pericardial space. A pigtail intrapericardial catheter can advance over this wire and be placed into the pericardial space, which can drain pericardial fluid. The animals received 10, 25 and 150 ml of 0.9% saline into the pericardial space. The catheter was removed, the entry site puncture was sutured and the animals were allowed to recover.
Results
Pericardial access was successful and tolerated in all animals. The total procedure time was less than 5 minutes from percutaneous subxiphoid access to the 4 Fr dilator catheter insertion into the pericardium. No major adverse cardiac events (acute myocardial infarct, cardiac tamponade, sudden death), severe adverse hemodynamic effects or pneumothorax were found. The mean arterial pressure (80.3 ± 6.9 mmHg pre-procedure and 78.8 ± 5.5 mmHg post-procedure) and heart rate (96.9 ± 8.0 beats per minute pre-procedure and 94.7 ± 8.6 beats per minute post-procedure) did not significantly change during the pericardial access procedure. Most of the animals had occasional ventricular premature complex arrhythmia when the puncture needle was inserted over the diaphragm and the PerDUCER® device was positioned on the pericardium. The arrhythmia disappeared after guidewire insertion. Twelve animals were sacrificed immediately after the experiment with harvest of the pericardium and heart. Histologic examination revealed no epicardial vessel or myocardial damage except for a small puncture hole in the pericardium. Forty-one animals were allowed to recover after the procedure. No later complications were found related to pericardial access with the PerDUCER® device. Twenty-eight days after the initial procedure, the animals were sacrificed. Microscopy again revealed no evidence of pericardial or myocardial injury.
Discussion
Although the intrapericardial space has previously been accessed for therapeutic uses, such as effusion drainage and drug administration, access has depended upon the presence of a threshold volume of pericardial fluid. For patients with normal or small volumes of effusion, the percutaneous puncture would not present a sound method for pericardial access. However, the PerDUCER® device offers unique technology to allow for a “routine approach” to pericardial administration of therapeutic agents as well as diagnostic sampling of pericardial fluids. Herein, we report on the successful use of a novel instrument, the PerDUCER® Pericardial Access Device, which allowed efficient insertion of a guidewire into normal pericardium in 53 pigs. The results demonstrate that the sheathed needle concept provides a safe, efficient and protected puncture of the pericardium, to allow proficient delivery of the intrapericardial guidewire. All procedures were deemed successful for access and placement of the intrapericardial guidewire into the pericardial space using the PerDUCER® device with subsequent introduction of a catheter over the guidewire.
Due to recent technical advances, practical percutaneous approaches are now available for accessing the pericardial space. Both transatrial and transventricular approaches have been used to access the pericardium.7–10 However, these procedures have inherent risks associated with them, such as vessel invasion and atrial or ventricular puncture, which can lead to vessel bleeding or pericardial tamponade. In addition, vessel invasion requires several hours for recovery, and may significantly increase the cost of the procedure. With previous methods, a needle catheter is placed through a right jugular, carotid or femoral artery via a sheath and advanced respectively into either the right or left atrium or ventricle to the cardiac free wall. Upon firm contact with the cardiac wall, the catheter tip punctures the myocardium. In comparison, the enclosed needle design of the PerDUCER® device does not permit puncture of the coronary arteries or myocardium, making its approach a more efficient, safe and cost-effective procedure.
Recently, two initial clinical reports demonstrated that the PerDUCER® device successfully implemented a guidewire into the pericardial space of 13 patients. The results indicated that the procedure was well-tolerated, with no adverse hemodynamic effects or arrhythmia complications present.11,12
This study shows the feasibility and utility of a novel percutaneous access tool, the PerDUCER® pericardial access device, which enables insertion of a guidewire into the normal pericardial space. This approach provides a new opportunity for diagnostic and therapeutic approaches to pericardial entry and eventually, prevention and treatment of heart disease.
Acknowledgment. This work was supported by Cryptic Masons Medical Research Foundation. The authors express their gratitude to Pamela I. Rogers, Patricia J. Rieger and David Mendel for excellent technical assistance in the animal and histochemical labs.
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