Author + information
- Received August 5, 2019
- Revision received November 13, 2019
- Accepted November 13, 2019
- Published online April 20, 2020.
- Pietro Palmisano, MDa,∗∗ (, )
- Federico Guerra, MDb,∗,
- Gabriele Dell’Era, MDc,
- Ernesto Ammendola, MDd,
- Matteo Ziacchi, MDe,
- Mattia Laffi, MDf,
- Francesca Troiano, MDb,
- Eleonora Prenna, MDc,
- Vincenzo Russo, MDd,
- Andrea Angeletti, MDe,
- Alessandro Guido, MDa,
- Eraldo Occhetta, MDc,
- Gerardo Nigro, MD, PhDd,
- Mauro Biffi, MDe,
- Germano Gaggioli, MDf,
- Alessandro Capucci, MDb,
- Michele Accogli, MDa,
- on behalf of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)
- aCardiology Unit, “Card. Giovanni Panico” Hospital, Tricase, Italy
- bCardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital Umberto I-Lancisi-Salesi, Ancona, Italy
- cDivision of Cardiology, University Hospital Maggiore della Carità, University of Eastern Piedmont, Novara, Italy
- dDepartment of Cardiology, Monaldi Hospital, Second University of Naples, Naples, Italy
- eInstitute of Cardiology, University of Bologna, Sant’Orsola-Malpighi University Hospital;, Bologna, Italy
- fDivisione Cardiologia, Ospedale Villa Scassi, Genova ASL 3, Genova, Italy
- ↵∗Address for correspondence:
Dr. Pietro Palmisano, Cardiology Unit, Cardinale Giovanni Panico Hospital, Via Pio X 2, 73039 Tricase (LE), Italy.
Objectives This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up.
Background Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality.
Methods The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation.
Results During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death.
Conclusions All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.
- cardiac implantable electronic device complications
- device infection
- pocket hematoma
- lead dislodgement
- lead failure
↵∗ Drs. Palmisano and Guerra contributed equally to this work and are joint first authors.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received August 5, 2019.
- Revision received November 13, 2019.
- Accepted November 13, 2019.
- 2020 American College of Cardiology Foundation
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