Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy

Palmisano, Pietro; Accogli, Michele; Zaccaria, Maria; Luzzi, Giovanni; Nacci, Frida; Anaclerio, Matteo; Favale, Stefano

doi:10.1093/europace/eus337

Cited by 120 publications

(97 citation statements)

References 40 publications

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“…4,6,7,[10][11][12] The rate of CRT upgrade varies widely among studies: in a retrospective single center study, the upgrade rates from ICD to CRT-D at 1, 3, and 5 years were 0.03%, 2.4%, and 5.1%, respectively, 10 and Palmisano et al report a 3.2% rate of upgrade from pacemaker to CRT-P or ICD to CRT-D in their survey of 2671 consecutive procedures from 2 centers in Italy. 6 Conversely, in the European Cardiac Resynchronization Therapy Survey of 2367 CRT implant procedures, 29.2% were identified as having an upgrade from pacemaker to CRT-P or ICD to CRT-D. 7 Previously cited reasons for not performing upgrades in potential candidates include increased cost if performed before ICD generator change, an increased risk of complications, and lack of established trial data demonstrating efficacy of CRT in this patient population. 10 The initial success rate of ICD upgrade to CRT-D in our study was 91% during RAFT and 90% in the substudy, after the presentation of the RAFT results.…”

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confidence: 99%

“…Because of the added risks of repeat surgery, the risk benefit of CRT in patients requiring upgrade to CRT is less clear. 6 Data on the success rate and risk of acute complications with upgrade to CRT are sparse. 6,7 To date, no randomized trial of upgrading to CRT versus continued standard care has been performed.…”

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confidence: 99%

“…6 Data on the success rate and risk of acute complications with upgrade to CRT are sparse. 6,7 To date, no randomized trial of upgrading to CRT versus continued standard care has been performed. It is generally believed that upgrading to CRT carries a higher risk of acute complications versus a de novo implant because of venous access issues, the risk of damage or extraction of old leads, the higher risk of infection, and the additional time that may be required.…”

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confidence: 99%

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Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy

Essebag

Joza

Birnie

et al. 2015

Circ: Arrhythmia and Electrophysiology

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Background-The resynchronization-defibrillation for ambulatory heart failure trial (RAFT) study demonstrated that adding cardiac resynchronization therapy (CRT) in selected patients requiring de novo implantable cardiac defibrillators (ICD) reduced mortality as compared with ICD therapy alone, despite an increase in procedure-related adverse events. Data are lacking regarding the management of patients with ICD therapy who develop an indication for CRT upgrade. Methods and Results-Participating RAFT centers provided data regarding de novo CRT-D (CRT with ICD) implant, upgrade to CRT-D during RAFT (study upgrade), and upgrade within 6 months after presentation of study results (substudy). Substudy centers enrolled 1346 (74.9%) patients in RAFT, including 644 de novo, 80 study upgrade, and 60 substudy CRT attempts. The success rate (initial plus repeat attempts) was 95.2% for de novo versus 96.3% for study upgrade and 90.0% for substudy CRT attempts (P=0.402). Acute complications occurred among 26.2% of de novo versus 18.8% of study upgrade and 3.4% of substudy CRT implantation attempts (P<0.001). The most common complication was left ventricular lead dislodgement. The principal reasons for not yet attempting upgrade in the substudy were patient preference (31.9%), New York Heart Association Class I (17.0%), and a QRS <150 ms (13.1%). Conclusions-Among a broad group of implant physicians, CRT upgrades were performed in patients with an ICD in situ with no difference in implant success rate and a reduced acute complication rate as compared with a de novo CRT implant. Decisions to upgrade were influenced by predictors of benefit in subgroup analyses of the RAFT study and other trials. (Circ Arrhythm Electrophysiol. 2015;8:152-158.

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confidence: 99%

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Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy

Essebag

Joza

Birnie

et al. 2015

Circ: Arrhythmia and Electrophysiology

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“…Such treatment, despite its potential attractiveness, can lead to loss of venous approach in the future and generate the necessity for epicardial stimulation. The above described procedure including lead extraction in order to regain the venous approach is safe and creates the possibility of effective long-term transvenous stimulation even in spite of occurring technical problems [25][26][27][28][29].…”

Section: Discussionmentioning

confidence: 99%

Lead extraction: The road to successful cardiac resynchronization therapy

et al. 2015

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“…The implantation of biventricular resynchronization therapy seems to be the procedure at most risk of infection. 21 CIED infection is significantly higher when they were installed by operators with low volume of implants. 22 The use of prophylactic intravenous antibiotics should be routine before all CIED procedures.…”

Section: Procedures Relatedmentioning

confidence: 94%

<div>Review of cardiac implantable electronic device related infection</div>

Saliba¹,

Massie²,

Sia³

2016

RRCC

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Cardiac implantable electronic devices (CIEDs) are being used more and more often nowadays. Indications have grown, and access to implantation facilities has increased as well. These devices are often lifesaving, and they can be associated with many other benefits. However, as with any medical procedure, complications can occur. In fact, CIED infection is a prevalent complication that can cause high morbidity and can even lead to death. It is important that most clinicians be familiar with signs and symptoms associated with CIED infection as early diagnosis and treatment lead to better outcomes. Nonetheless, the prevention of such infections remains the cornerstone in the management of CIED-related infections. In this paper, we will review in detail the most significant risk factors that can lead to CIED infection. We will also explore the different available tools that can help decrease the incidence of this complication. In addition, we will summarize the different treatment modalities and the major prevention methods.

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Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy

Abstract: Cardiac resynchronisation therapy implantation was the procedure with the highest risk of complications requiring surgical revision. Complications were associated with substantial clinical consequences and a significant increase in the number and length of hospitalizations.

Cited by 120 publications

References 40 publications

Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy

Incidence, Predictors, and Procedural Results of Upgrade to Resynchronization Therapy

Lead extraction: The road to successful cardiac resynchronization therapy

<div>Review of cardiac implantable electronic device related infection</div>

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