ABSTRACT
BACKGROUND: Left ventricular (LV) lead implantation for cardiac resynchronization therapy (CRT) is associated with lead dislodgement rates ranging from 3% to 10%, and some implant approaches to prevent dislodgement may contribute to suboptimal CRT response. We report our early human experience with an LV lead with a side helix for active fixation to the coronary vein wall. OBJECTIVES: To assess the feasibility and safety of the Model 20066 LV lead and to evaluate the implant procedure. METHODS: The Model 20066 is a 4-F bipolar steroid eluting lead that has a small exposed side helix and can be delivered using a guidewire or stylet. At the desired vein location, the lead body is rotated clockwise until the helix is fixated. This study was a single-arm, prospective, nonrandomized trial that enrolled 40 patients from 4 centers who met standard indications for CRT. RESULTS: The lead was successfully implanted in 39 of 40 (98%) patients. In 38 of 40 (95%) patients, the implanters were successful at implanting at a predetermined target site. There were no Model 20066 LV lead dislodgements reported within 12 months of follow-up. The electrical performance of the tip and ring electrodes was stable through the 12-month follow-up visit and similar to other LV leads. Overall lead handling was rated as acceptable for all implants. CONCLUSION: This new LV lead specifically designed with an active fixation mechanism for stability and precise placement was successfully and safely deployed in the coronary vasculature.
Subject(s)
Cardiac Resynchronization Therapy/methods , Coronary Vessels/surgery , Electrodes, Implanted , Adult , Aged , Aged, 80 and over , Cardiac Resynchronization Therapy/adverse effects , Coronary Vessels/physiopathology , Equipment Design , Equipment Failure , Feasibility Studies , Female , Follow-Up Studies , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Treatment OutcomeABSTRACT
PURPOSE: Video-assisted pericardioscopic surgery (VAPS) for epimyocardial lead implantation has demonstrated positive acute results concerning the safety and degree of freedom inside the pericardium. We evaluated the employment of a newly developed trocar for pericardioscopy with regard to long-term effects and feasibility of reoperation. DESCRIPTION: Eight adult sheep were divided into three groups. In two animals, VAPS was used exclusively. All other animals received four small-caliber epicardial leads through VAPS. After 6 and 12 months (n = 3 each), reoperation was conducted for reevaluation of entry site, intrapericardial adhesions, lead position, and morphology of the implantation site. EVALUATION: Reentry close to the previous entry site proves unproblematic. Adhesions were mild to moderate in the immediate area of the implanted leads. Throughout the follow-up, pacing parameters were satisfactory. Lead dislodgement occurred in 1 of 24 leads. The deployment of small-caliber flexible endoscopes through the new trocar provided sufficient navigation, stability, and maneuverability. CONCLUSIONS: Reoperation from the same subxiphoid approach proved feasible. Lead removal and reimplantation were feasible at both 6 months and 12 months after initial implantation. The intrapericardial adhesions caused by VAPS alone are mild.
Subject(s)
Electrodes, Implanted , Heart Failure/therapy , Pericardium/surgery , Video-Assisted Surgery/methods , Animals , Disease Models, Animal , Feasibility Studies , Female , Follow-Up Studies , Incidence , Sheep , Time Factors , Tissue Adhesions/epidemiology , Tissue Adhesions/pathologyABSTRACT
OBJECTIVE: Current alternative approaches for pacemaker lead implantation imply the breach of the pleural space. Recently, the feasibility of experimental lead implantation by rigid endoscopy has been described. The use of flexible endoscopes and a standardised application has not been realised yet. Our main goal was to compare rigid and flexible endoscopy and to establish a standardised protocol for the implementation of a closed-chest subxiphoid approach for epimyocardial lead implantation. METHODS: Rigid and flexible endoscopes were used for placement of screw-in pacing leads (4-F). A total of 17 adult pigs (80 kg) were anaesthetised and a 10-mm subxiphoid axial incision performed. The pericardium was opened and entered under endoscopic vision. Epimyocardial electrodes were implanted through the endoscope onto all four chambers. Standard haemodynamic measurements and pacing measurements were carried out. RESULTS: Both methods were deployed in the first three individuals. Superior endorsement of rigid endoscopy, due to better orientation and stability, led to its exclusive deployment in the remaining 14 individuals. Access to the implantation sites was quick (<10 min). A plastic cover had to be applied to reduce arrhythmia (VentricularExtraSystoles(bare): 17 ± 2.2 min(-1) vs VentricularExtraSystoles(cover): 5 ± 1.9 min(-1); n = 4). Measured pacing parameters were comparable with classic endocardial-derived thresholds. Post-mortem examination revealed no relevant damage/injury and/or bleeding in the heart and circumjacent tissue. There was no evidence of injury at the implantation sites and the corresponding pericardium. The electrodes showed excellent anchorage inside the myocardial tissue (penetration depths: 3 ± 0.2mm) and resisted high tractive forces. CONCLUSION: Flexible endoscopy is not suitable for exclusive deployment inside the pericardial space, whereas rigid endoscopy presented itself as a safe, fast and simple approach for epimyocardial lead implantation using an insulating trocar. Without cover, malignant arrhythmia constrains the implementation of video-assisted pericardioscopic surgery (VAPS). Subxiphoid VAPS permits optimal lead positioning under direct vision without fluoroscopy, without the breach of the pleural space and with a short procedural duration (<60 min). Our standardised minimal-invasive approach allows visualisation and intervention, potentially of all intrapericardial structures.
