TY - JOUR
T1 - Safety and effectiveness of a 6-French MRI conditional pacemaker lead
T2 - The INGEVITYTM clinical investigation study results
AU - Nielsen, Jens C.
AU - Giudici, Michael
AU - Tolasana Viu, Jose Maria
AU - Chew, Engwooi
AU - Sommerijns, Elke
AU - Wold, Nicholas
AU - Evert, Linda
AU - Love, Charles J.
AU - Stein, Kenneth
AU - Olaf, Hedrich
N1 - Publisher Copyright:
© 2017 Wiley Periodicals, Inc.
PY - 2017/10
Y1 - 2017/10
N2 - Background: The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance, and magnetic resonance imaging (MRI) conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads. Methods: Consecutive patients were included in 77 institutions worldwide, where 1,657 leads (846 right ventricular active fixation leads, 213 right ventricular passive fixation leads, 121 right atrial passive fixation preformed J-leads, and 477 right atrial active fixation leads) were implanted or attempted in 1,060 subjects. Results: At 3-month follow-up, the electrical performance were: mean pacing threshold 0.67 V at 0.5-ms pulse width, pacing impedance 773 ohms, mean P-wave amplitude 4.8 mV, and R-wave amplitude 16.5 ± 6.5 mV. Over a median follow-up of 31 months, 93 subjects died and 33 subjects reported lead-related complications. Lead-related complication-free rate from 0 to 3 months and 3 to 12 months for all leads was 98.4% and 99.7%, respectively. The hazard of lead-related complications was observed to be decelerating over the course of follow-up (Weibull shape = 0.23). The overall lead dislodgment rate observed in the study was 1.3%, the perforation rate was 0.0%, and the pericardial effusion rate was 0.3%. Conclusions: The clinical performance of the INGEVITY lead demonstrated a high lead-related complication-free rate over 12 months of follow-up and excellent electrical characteristics.
AB - Background: The design of pacemaker leads has continued to evolve; ease of lead handling, improved electrical performance, and magnetic resonance imaging (MRI) conditional aspects have become more important, while safety remains critical. The INGEVITY™ family leads was designed to provide MRI conditional aspects, decreased diameter, and improved performance of pacemaker leads. The INGEVITY study is an investigational device exemption trial evaluating the acute and chronic safety and effectiveness of these leads. Methods: Consecutive patients were included in 77 institutions worldwide, where 1,657 leads (846 right ventricular active fixation leads, 213 right ventricular passive fixation leads, 121 right atrial passive fixation preformed J-leads, and 477 right atrial active fixation leads) were implanted or attempted in 1,060 subjects. Results: At 3-month follow-up, the electrical performance were: mean pacing threshold 0.67 V at 0.5-ms pulse width, pacing impedance 773 ohms, mean P-wave amplitude 4.8 mV, and R-wave amplitude 16.5 ± 6.5 mV. Over a median follow-up of 31 months, 93 subjects died and 33 subjects reported lead-related complications. Lead-related complication-free rate from 0 to 3 months and 3 to 12 months for all leads was 98.4% and 99.7%, respectively. The hazard of lead-related complications was observed to be decelerating over the course of follow-up (Weibull shape = 0.23). The overall lead dislodgment rate observed in the study was 1.3%, the perforation rate was 0.0%, and the pericardial effusion rate was 0.3%. Conclusions: The clinical performance of the INGEVITY lead demonstrated a high lead-related complication-free rate over 12 months of follow-up and excellent electrical characteristics.
KW - MRI conditional
KW - bipolar lead
KW - pacemaker lead
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U2 - 10.1111/pace.13159
DO - 10.1111/pace.13159
M3 - Article
C2 - 28727156
AN - SCOPUS:85030164100
SN - 0147-8389
VL - 40
SP - 1121
EP - 1128
JO - PACE - Pacing and Clinical Electrophysiology
JF - PACE - Pacing and Clinical Electrophysiology
IS - 10
ER -