Initial clinical experience with perducer® device: Promising new tool in the diagnosis and treatment of pericardial disease

Abstract

Buckground: The idea to enter the normal pericardial sac safely was unrealistic until recently. The development of a novel instrument (PerDUCERO pericardial access device) for percutaneous access to the pericardium could potentially have a significant impact, not only on patients with pericardial diseases but even more, or primarily, on diagnosis and treatment of myocardial and coronary disease and arrhythmias. Hypothesis: The overall objective of the present study was to evaluate the feasibility and safety of the percutaneous pericardial access with PerDUCER in patients with pericardial disease, and to analyze our initial experience with this new technique, with particular emphasis on sequential procedural steps. Methods: The device was studied in five patients with pericardial disease (two men, mean age 50.4 years, range 30-68, four with normal body mass index). The procedure consists of two distinct techniques: (1) access to the mediastinal space, and (2) pericardial capture, puncture, and insertion of the guidewire. Access to the mediastinal space includes the introduction of a blunt cannula, a 0.038 guidewire, a dilator-introducer sheath set, and insertion of the PerDUCER device. Key points of the PerDUCER procedure are as follows: introduction of the blunt cannula without resistance, placement of the dilator-introducer sheath at the upper third of the heart, systolic movements of the PerDUCER device, successful vacuum and capture of pericardium, puncture and introduction of the intrapericardial guidewire.

Cytokine Activation in Pericardial Fluids in Different Forms of Pericarditis

“…Immunoserology is of even greater sensitivity for an inflammatory or autoreactive antibody-mediated process, because these antimembrane antibodies were detected in high levels in autoreactive induced effusions. Immunosuppressive therapy in patients with autoreactive effusion for example with triamcinolone in a crystalloid suspension given intrapericardially as previous reported or installation of an anti-OKT3 antibody in case of the proven lymphocytic effusion in patients with perimyocarditis may provide new specific therapeutic options [1,7,18,31]. If we focus on the ELISA results, there is some evidence that the demonstration of activation markers and soluble mediators of inflammation such as Il-6, Il-8 and IFN-gamma in pericardial effusion and the simultaneously lack of these mediators in sera of the patients first may be helpful in the discrimination of autoreactive and lymphocytic effusion.…”

Intrapericardial drug delivery: pharmacologic properties and long-term safety in swine

“…A pericardial access device (PerDUCER, Comedicus, Columbia Heights, MN, USA) was used for insertion of a guidewire into the normal pericardial space as previously described [4,6,7]. The concept of this device has been previously described in detail [4,6,7].…”

“…The concept of this device has been previously described in detail [4,6,7]. In brief, it contains a stainless steel sheath, which ends with a plastic tube with a hemispheric side-hole cavity, where the pericardium is captured by a vacuum and tangentially punctured by a 21-gauge introducer needle.…”

“…Recent developments in catheter-based techniques to access the intact pericardial space have increased interest in intrapericardial delivery for local cardiac therapy [2][3][4][5][6][7][8][9]. The pericardium acts as a natural barrier that minimizes systemic absorption and, hence, side effects.…”

Transthoracic epicardial catheter ablation to treat recurrent ventricular tachycardia

“…Another device has been recently introduced to allow minimally invasive access to the normal pericardium [13]. It consists of a 21-gauge needle housed inside a 12-French stainless steel sheath tube 20 cm in length (PerDUCER; Comedicus, Columbia Heights, MN).…”