Video-Assisted Pericardioscopic Surgery for Epimocardial Lead Implantation - from Bench to Human Application
Nima Hatam1, Frederik Steiner1, Karl Mischke2, Andreas Goetzenich1, Jan Spillner1, Ruediger Autschbach1.
1Cardiovascular and Thoracic Surgery, University Hospital RWTH Aachen, Aachen, Germany, 2Cardiology, Pneumology and Angiology, University Hospital RWTH Aachen, Aachen, Germany.
OBJECTIVE: The expansion of pacemaker therapy has led to an increasing number of cases, where the standard transvenous approach does not apply and alternative, more invasive methods are used for lead implantation. Our goal was to assess and to refine the minimal-invasive technique of video assisted pericardioscopic surgery (VAPS) and translate it to a clinical applicable approach.
METHODS: In an acute (porcine, n=10) and chronic (ovine, n=6) animal model rigid and small-caliber flexible endoscopy was used from a subxiphoid approach following a standardized protocol to implant a newly designed 4 F epicardial screw-in lead. Safety and latitude inside the pericardial cavity using VAPS was studied using a specific trocar, pericardiotomy instrument and delivery catheter, which were developed during the acute trial and their performance tested. In the chronic trial feasibility of reoperation and lead performance were assessed. Epicardial screw-in leads were implanted onto each chamber (Σ: 16), where left-sided leads were representatively connected to a dual-chamber pacemaker for follow-up assessments, held after 3, 6 and 12 months.
RESULTS: The subxiphoid approach presented as very effective for VAPS accessing the pericardium within a short distance. Access to the implantation sites was quick (< 10 min) with overall procedural duration under 60 minutes. There was no bleeding or myocardial injury. The use of bare-metal instruments inside the pericardial cavity without insulation frequently led to malignant arrhythmia leading to one death in the acute group. Exclusive flexible endoscopy was not applicable due to poor navigation and maneuvering. Using the trocar arrhythmia and poor navigation were resolved easily. Lead-dislodgement occurred in one out of 16 leads within the first month.
CONCLUSIONS: Subxiphoid VAPS is a safe and useful minimal-invasive approach for lead implantation when using a standardized protocol and specific instrumentation. Reoperation from the same approach is feasible, if the identical pericardial entry point is avoided. Current and future development of instrumentation can and will extend safety and possible applications. We therefore initiated the human pilot study starting spring 2014.
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