Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications

Palmisano, Pietro; Guerra, Federico; Dell’Era, Gabriele; Ammendola, Ernesto; Ziacchi, Matteo; Laffi, Mattia; Troiano, Francesca; Prenna, Eleonora; Russo, Vincenzo; Angeletti, Andrea; Guido, Alessandro; Occhetta, Eraldo; Nigro, Gerardo; Biffi, Mauro; Gaggioli, Germano; Capucci, Alessandro; Accogli, Michele; Pacing, Cardiac

doi:10.1016/j.jacep.2019.11.005

Cited by 27 publications

(29 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The negative association between complications and patients' outcome is well reported in the current literature 6 and confirmed in our TV‐ICD population. In contrast, S‐ICD device‐related complications seem to have no significant impact on patients' outcome.…”

Section: Discussionsupporting

confidence: 88%

“…Pocket infection requiring surgical revision was defined as swelling, redness and/or discharge in the pocket region and bacterial growth in wound cultures, without evidence of systemic infection. Non‐septic pocket decubitus requiring surgical revision was defined as thinning of the skin above the generator, with signs of local inflammation due to mechanical decubitus, without skin perforation or evidence of device infection 6 . Pocket hematoma requiring surgical drainage was defined as a palpable mass that protruded >2 cm associated with the presence of tense swelling or causing severe pain.…”

Section: Methodsmentioning

confidence: 99%

“…Lead dislodgement was defined as inadequate capture (only for TV‐ICDs) or sensing irresolvable by device reprogramming associated with a visible change in the lead position on chest X‐ray and requiring surgical revision. Lead failure was defined as a sudden nonphysiological change in impedance associated with changes in the sensing or pacing (only for TV‐ICDs) performance and without evidence of lead dislodgement 5,6,17 …”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

Palmisano¹,

Ziacchi

Ammendola

et al. 2021

Cardiovasc electrophysiol

Self Cite

View full text Add to dashboard Cite

Introduction Comparison data on management of device‐related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter–defibrillator (S‐ICD) and transvenous ICD (TV‐ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long‐term device‐related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S‐ICD or TV‐ICD implantation. Methods and Results A total of 1099 consecutive patients who underwent S‐ICD or TV‐ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device‐related complications were analyzed and compared between two groups. During a mean follow‐up of 30 months, device‐related complications requiring surgical revision were observed in 20 patients: 3 in S‐ICD group (1.8%) and 17 in TV‐ICD group (10.1%; p = .002). Compared with TV‐ICD patients, S‐ICD patients showed a significantly lower risk of lead‐related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket‐related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S‐ICD patients resulted in a significantly lower number of complications‐related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV‐ICD patients. Conclusions Compared with TV‐ICD, S‐ICD is associated with a lower risk of complications, mainly due to a lower risk of lead‐related complications. The management of S‐ICD complications requires fewer and shorter rehospitalizations.

show abstract

Section: Discussionsupporting

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

Palmisano¹,

Ziacchi

Ammendola

et al. 2021

Cardiovasc electrophysiol

Self Cite

View full text Add to dashboard Cite

show abstract

“…Transvenous leads represent a major source of CIED complications -not only dislocation or mechanical damage but also tricuspid regurgitation, venous occlusion, superior vena cava syndrome, cardiac perforation, cardiac device-related infective endocarditis (CDRIE) -and subcutaneous pockets: hematoma, decubitus, inflammation. 6,7,26 Palmisano et al 27 reported a higher risk of all-cause death among patients with CIEDs and early complications -pneumothorax (HR 8.731, 95% CI 1.42-53.63) and pocket hematoma (HR 2.515, 95% CI 1.07-5.94) -whereas CDRIE was most markedly related to increased risk of cardiovascular death (HR 4.025, 95% CI 1.5-10.78) during median follow-up of 56.9 months. An EHRA international consensus on how to prevent, diagnose, and treat CIED-infections 28 states that prevention and careful consideration before implantation are the best treatment for CDRIE.…”

Section: The Weakest Linksmentioning

confidence: 99%

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

Kotalczyk¹,

Kalarus²,

Wright³

et al. 2020

MDER

View full text Add to dashboard Cite

Cardiovascular implantable electronic devices (CIEDs) are essential management options for patients with brady-and tachyarrhythmias or heart failure with concomitant optimal pharmacotherapy. Despite increasing technological advances, there are still gaps in the management of CIED patients, eg, the growing number of lead-and pocket-related longterm complications, including cardiac device-related infective endocarditis, requires the greatest care. Likewise, patients with CIEDs should be monitored remotely as a part of a comprehensive, holistic management approach. In addition, novel technologies used in smartwatches may be a convenient tool for long-term atrial fibrillation (AF) screening, especially in high-risk populations. Early detection of AF may reduce the risk of stroke and other AF-related complications. The objective of this review article was to provide an overview of novel technologies in cardiac rhythm-management devices and future challenges related to CIEDs.

show abstract

“…infection related to CEID is the most common dreaded one. It can be either systemic warranting aggressive management, or pocketrelated which is less serious, yet more prevalent 2,3 …”

Section: Introductionmentioning

confidence: 99%

Low‐budget, single‐session elimination of CIED pocket infection

Roshdy

Seaoud

Elbelbesy

2020

Pacing Clinical Electrophis

View full text Add to dashboard Cite

Background The dramatic increase in the use of cardiovascular implantable electronic devices (CIED) was associated with an increased rate of CIED infection, which has a high management cost. Aim of the Study To test the safety and efficacy of a single‐session protocol, aiming to reuse the infected pocket side and the same device and leads in patients with CIED pocket infection. Patients and Methods We included patients with isolated pocket infection between January 2015 and November 2019. The Patient was prepared by taking a swab for culture and sensitivity before the procedure. The pocket was debrided and the capsule was removed, the pocket was rinsed with povidone‐iodine and hydrogen peroxide mixture, then packed with gauze sponge soaked with povidone‐iodine. The device was debrided using ultrasonic irrigation and sterilized using gas plasma. The device was reimplanted and the wound was closed in layers. Results During the period of the study, we had 12 patients with isolated pocket infection. Nine presented with erosion, two with impending erosion, and one with a chronic sinus. Patient's age was 61.5 ± 7.64 years. The infection was diagnosed 14.2 ± 8.22 weeks post device implantation. They were admitted for 7.6 ± 1.54 days postprocedure. The follow‐up duration was 26.5 ± 15 (1.7–52) months. Only one patient (8%) had a recurrence of the infection after 50 days of the procedure. Conclusion Our protocol was successful in treating 92% of device‐related pocket infection without the need to replace the device or the pocket side.

show abstract

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications

Cited by 27 publications

References 12 publications

Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

<p>Cardiac Electronic Devices: Future Directions and Challenges</p>

Low‐budget, single‐session elimination of CIED pocket infection

Contact Info

Product

Resources

About