Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences?

Torbica, Aleksandra; Banks, H. Stanley; Valzania, Cinzia; Boriani, Giuseppe; Fattore, Giovanni

doi:10.1002/hec.3470

Cited by 27 publications

(20 citation statements)

References 23 publications

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“…Moreover, the programming may affect the occurrence of ICD therapy . The ICD implantation rate is lower in Sweden than in many comparable countries, which should be kept in mind when applying these findings to different contexts . While offering validated real‐world data, this is a smaller study, which increases the risk of type 2 errors.…”

Section: Limitationsmentioning

confidence: 99%

Long‐term follow‐up of implantable cardioverter defibrillator patients with regard to appropriate therapy, complications, and mortality

Mattsson

Magnusson

2020

Pacing Clinical Electrophis

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Background An implantable cardioverter defibrillator (ICD) is recommended for patients with symptomatic heart failure with ejection fraction ≤35% despite optimal medical therapy. More recently, the benefits of ICDs have been questioned in nonischemic cardiomyopathy (CM). Aim To examine the incidence of appropriate therapy, complications, mortality, and cause of death among ICD patients in an unselected validated cohort. In primary prevention, appropriate therapy in ischemic versus nonischemic CM will be evaluated. Methods A retrospective observational study of patients in Region Gävleborg, Sweden, who underwent ICD implantation or replacement between 2007 and 2017. Results In total, 438 patients (mean age at implant: 65.9 ± 11.2 years, 82.0% males, mean follow‐up: 5.2 ± 4.0 years) were included. There were 108 (24.7%) deaths (49.1% due to heart failure) and 94.9% survived the first year. Cumulative incidence of appropriate therapy at 5‐year was 31.6%. Cumulative incidence of inappropriate shock at 5‐year was 9.1%. A total of 98 complications requiring surgical intervention occurred (annual rate: 4.3%). In total, 236 patients with primary prevention due to ischemic (61.9%) or nonischemic (38.1%) CM were included. During a mean follow‐up of 3.9 ± 2.5 years, for appropriate therapy, there was no significant difference (P = .985) between ischemic (cumulative incidence at 1, 3, and 5 years: 6.4%, 17.1%, and 19.6%) and nonischemic CM (cumulative incidence at 1, 3, and 5 years: 5.6%, 13.6%, and 24.4%). Conclusion Ischemic and nonischemic CM confer similar risk of ventricular arrhythmia. This supports current guidelines regarding primary‐prevention ICD. Short‐term survival is excellent but complications remain a problem.

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Section: Limitationsmentioning

confidence: 99%

Long‐term follow‐up of implantable cardioverter defibrillator patients with regard to appropriate therapy, complications, and mortality

Mattsson

Magnusson

2020

Pacing Clinical Electrophis

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“…However, using predefined algorithms to measure metastases and secondary tumours in administrative data alone has proven challenging elsewhere and should therefore be tested [38]. The reliability and completeness of coding for symptoms and treatment effects in administrative data can be sub-optimal, given marked variability in number and detail of diagnostic and procedure codes in administrative data, as has been found in multi-country projects [39][40][41]. Specific codes may be identified for some outcomes, but whether they are routinely recorded in hospital discharge summaries needs evaluation.…”

Section: Synthesis Of Resultsmentioning

confidence: 99%

A scoping review of core outcome sets and their ‘mapping’ onto real-world data using prostate cancer as a case study

Meregaglia

Ciani

Banks

et al. 2020

BMC Med Res Methodol

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Background: A Core Outcomes Set (COS) is an agreed minimum set of outcomes that should be reported in all clinical studies related to a specific condition. Using prostate cancer as a case study, we identified, summarized, and critically appraised published COS development studies and assessed the degree of overlap between them and selected real-world data (RWD) sources. Methods: We conducted a scoping review of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database to identify all COS studies developed for prostate cancer. Several characteristics (i.e., study type, methods for consensus, type of participants, outcomes included in COS and corresponding measurement instruments, timing, and sources) were extracted from the studies; outcomes were classified according to a predefined 38-item taxonomy. The study methodology was assessed based on the recent COS-STAndards for Development (COS-STAD) recommendations. A 'mapping' exercise was conducted between the COS identified and RWD routinely collected in selected European countries. Results: Eleven COS development studies published between 1995 and 2017 were retrieved, of which 8 were classified as 'COS for clinical trials and clinical research', 2 as 'COS for practice' and 1 as 'COS patient reported outcomes'. Recommended outcomes were mainly categorized into 'mortality and survival' (17%), 'outcomes related to neoplasm' (18%), and 'renal and urinary outcomes' (13%) with no relevant differences among COS study types. The studies generally fulfilled the criteria for the COS-STAD 'scope specification' domain but not the 'stakeholders involved' and 'consensus process' domains. About 72% overlap existed between COS and linked administrative data sources, with important gaps. Linking with patient registries improved coverage (85%), but was sometimes limited to smaller follow-up patient groups. Conclusions: This scoping review identified few COS development studies in prostate cancer, some quite dated and with a growing level of methodological quality over time. This study revealed promising overlap between COS and RWD sources, though with important limitations; linking established, national patient registries to administrative data provide the best means to additionally capture patient-reported and some clinical outcomes over time. Thus, increasing the combination of different data sources and the interoperability of systems to follow larger patient groups in RWD is required.

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“…In their paper in this supplement, Torbica et al (2017) report the first investigation of the determinants of temporal and geographical variations in pacemaker (PM) and implantable cardioverter defibrillator (ICD) implants and replacements at regional level across five EU countries. They found that (i) regional per capita GDP appears to have no effect on implant rates of cardiac implantable electrical devices (CIEDs); (ii) regions with greater proportion of residents with higher level of tertiary education, an aged population, and greater life expectancy have higher implant rates of CIEDs and (ii) higher numbers of implanting centres foster access to technologies.…”

Section: Optimizing the Diffusion Of Medical Devicesmentioning

confidence: 99%

Key Recommendations from the MedtecHTA Project

2017

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There are particular characteristics of Medical Devices, such as the device-user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for health technology assessment (HTA). The project explored key aspects of the conduct and methods of HTA for MDs. Systematic reviews and original research studies were conducted to determine improvements in processes and methods that could enhance the potential for HTA and optimize the diffusion of MDs.Regulatory processes for MDs should be more closely aligned, the HTA evaluative framework should be harmonized and processes for conditional coverage and evidence development should be used. The methods for HTA should consider MDs as complex interventions, require the establishment of high quality registries, consider an iterative approach to the evaluation over time, recognize and allow for the particular characteristics of devices and use appropriate approaches for confounder adjustment in comparative effectiveness studies. To optimize the diffusion, a common classification should be developed across countries in order to facilitate international comparisons, factors driving diffusion should be explored in HTA reports and physiciansˈ personal goals and motivation should be better understood.The key recommendations of the MedtecHTA project should improve the conduct and use of HTA for MDs.

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Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences?

Cited by 27 publications

References 23 publications

Long‐term follow‐up of implantable cardioverter defibrillator patients with regard to appropriate therapy, complications, and mortality

Long‐term follow‐up of implantable cardioverter defibrillator patients with regard to appropriate therapy, complications, and mortality

A scoping review of core outcome sets and their ‘mapping’ onto real-world data using prostate cancer as a case study

Key Recommendations from the MedtecHTA Project

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