The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011

Kremers, Mark S.; Hammill, Stephen C.; Berul, Charles I.; Koutras, Christina; Curtis, Jeptha; Wang, Yongfei; Beachy, Jim; Meisnere, Laura Blum; Conyers, Del; Reynolds, Matthew R.; Heidenreich, Paul A.; Al‐Khatib, Sana M.; Piña, Ileana L.; Blake, Kathleen; Walsh, Mary Norine; Wilkoff, Bruce L.; Shalaby, Alaa; Masoudi, Frederick A.; Rumsfeld, John S.

doi:10.1016/j.hrthm.2013.01.035

Cited by 192 publications

(159 citation statements)

References 33 publications

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“…Recent data from the ICD Registry found 40% of ICD procedures were revision procedures for battery depletion or upgrade4; the reason for increasing infection rates, as found by Greenspon et al, may be because of a higher proportion of device replacement procedures, including generator replacement for premature battery depletion 22. Our data extend their observations and further emphasize the morbidity and financial impact of their findings.…”

Section: Discussionsupporting

confidence: 81%

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Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Koneru

Jones

Hammill

et al. 2018

JAHA

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BackgroundThe transvenous implantable cardioverter‐defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database.Methods and ResultsData from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5‐year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications.ConclusionsIncidence of mechanical and infectious complications of transvenous ICD leads over long‐term follow‐up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

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Section: Discussionsupporting

confidence: 81%

“…Approximately 150 000 patients each year have a transvenous defibrillator implanted, of which ≈75% are for a primary prevention of sudden cardiac death 4. A percentage of transvenous system malfunctions is attributable to lead‐related problems and may require additional intervention 5.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Koneru

Jones

Hammill

et al. 2018

JAHA

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“…In 2 recent studies using transvenous ICDs and a more abbreviated testing protocol, there was no significant increase in CK, CK-MB, myoglobin, and NT-proBNP before and after DT, whereas elevated levels of high-sensitive troponin T were observed after DT [206,207]. In the NCDR ICD Registry, the incidence of MI during ICD implantation was reported to be 0.02% [196]. Defibrillator shocks and VF transiently depress contractile function, although fatal pulseless electrical activity is rare at the time of ICD implantation [202,206,[208][209][210].…”

Section: Iia B-nrmentioning

confidence: 98%

“…Using modern ICD technology with transvenous systems and biphasic waveforms, the perioperative mortality rate within 30 days of implantation is reported to be 0.2% to 0.4% [191,196]. Recent data from the National Cardiovascular Data Registry (NCDR) demonstrated an in-hospital mortality of 0.03% following ICD implantation, with death occurring in the laboratory in 0.02% [196]. A Canadian report from 21 implanting centers estimates that 3 of 19,067 deaths (0.016%) are related to DT.…”

Section: Periprocedural Mortalitymentioning

confidence: 99%

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

et al. 2016

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“…In the National Cardiovascular Data Registry (NCDR), which captures the majority of primary prevention ICDs implanted in the United States, the mean age of patients receiving an ICD was 67± 13 years. 11 One study of that dataset showed that more than 40 % of new ICDs are implanted in patients over 70 years of age. 12 This underscores the importance of conducting studies aimed at examining the outcomes of primary prevention ICDs in patients ≥70-75 years of age.…”

Section: Introductionmentioning

confidence: 99%

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients

et al. 2015

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BACKGROUND: Although the implantable cardioverterdefibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.KEY WORDS: stakeholder engagement; cardiovascular disease; decision making.

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The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011

Cited by 192 publications

References 33 publications

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients

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