Initial clinical experience with PerDUCER (R) device: Promising new tool in the diagnosis and treatment of pericardial disease

Background: The idea to enter the normal pericardial sac safely was unreali stic until recently. The development of a novel instrument (PerDUCER(R) per icardial access device) for percutaneous access to the pericardium could po tentially have a significant impact, not only on patients with pericardial diseases but even more, or primarily, on diagnosis and treatment of myocard ial 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 experienc e with this new technique, with particular emphasis on sequential procedura l 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 med iastinal 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 inse rtion of the PerDUCER device. Key points of the PerDUCER procedure are as f ollows: introduction of the blunt cannula without resistance, placement of the dilator-introducer sheath at the upper third of the heart, systolic mov ements of the PerDUCER device, successful vacuum and capture of pericardium , puncture and introduction of the intrapericardial guidewire. Results: Access to the mediastinal space was accomplished in four of five p atients, as were pc pericardial capture and probably puncture. However, des pite numerous successful captures and probably punctures of pericardium, we were not able to confirm introduction of the intrapericardial guidewire in to the pericardial cavity in any of our patients (0/5). The procedure was v ery well tolerated in all patients (5/5). No major complications: developed during the procedure, bearing in mind that the intrapericardial placement of the guidewire was not achieved. Minor complications included pain at the dilator-introducer sheath entry site (5/5) and mild transient fryer (2/5). Conclusions: According to the present experience, we believe that, with min or modifications, the PerDUCER device could be successfully implemented for pericardial entry in patients with pericardial disease. Further studies an needed to evaluate the feasibility and safety of this new instrument in pa tients with a normal pericardium. This could open a most exciting spectrum of possible inplementations of the device in the future.