Research methodology and practical issues relating to the conduct of a medical device registry

Bisdas, Theodosios; Bohan, Patrick; Lescan, Mario; Zeebregts, Clark J.; Tessarek, Joerg; Herwaarden, Joost A. van; Berg, Jos C. van den; Setacci, Carlo; Riambau, Vincent

doi:10.1177/1740774519855395

Cited by 11 publications

(7 citation statements)

References 91 publications

(104 reference statements)

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“…In addition, the longer-term results and outcomes of these innovations remain to be demonstrated. Consequently, observational, realworld experience has some value in this respect [18].…”

Section: Discussionmentioning

confidence: 99%

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

et al. 2020

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Purpose To assess outcomes of a low-profile thoracic stent-graft in the treatment of thoracic aortic pathologies. Methods A retrospective analysis of all consecutive patients with aortic thoracic pathologies treated with the RelayPro device in two university hospitals between October 2018 and July 2019. Results 23 patients (65% men; mean age 63.4 ± 15 years) were treated. Pathologies included aortic dissections (n = 10), 5 residual type A (22%) and 5 type B (22%), 6 degenerative aortic aneurysms (26%), 4 penetrating aortic ulcers (17%), and aortic erosion, intramural hematoma and aortic rupture (n = 1 and 4% in each case). Two cases (9%) were emergent and two urgent. Proximal landing was achieved in zones 0 (4%), 1 (4%), 2 (43%), and 3 (26%). Five grafts were frozen elephant trunk extensions. Technical success was 100% with accurate device deployment in the intended landing zone of the aortic arch in all 23 patients and with no Ia/III endoleaks and three (13%) type II endoleaks. Apposition was adequate in 96%. Two patients had post-implantation syndromes (one fever, one leukocytosis). Mean follow-up was 11.6 ± 3.7 months (range, 2–16) with no other complications, secondary interventions or conversions to open surgery. There was no 30-day mortality and no aortic-related mortality; all-cause mortality was 4% during follow-up. Conclusion A 3–4 French reduced profile in the current generation of stent-grafts facilitates TEVAR particularly in patients with smaller vessels access. Early safety and effectiveness outcomes are favorable, even in endpoints such as deployment accuracy and apposition which may be surrogates for longer-term clinical success and durability.

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“…In addition, the longer-term results and outcomes of these innovations remain to be demonstrated. Consequently, observational, realworld experience has some value in this respect [18].…”

Section: Discussionmentioning

confidence: 99%

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

et al. 2020

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“…It is important to determine whether patient consent needs to be obtained from each patient, or whether anonymization is sufficient [ 5 , 38 ]. When designing a patient consent form, it is important to clearly indicate that the analysed data will be used for publication and reports, as well as any secondary uses of data (e.g.…”

Section: Designmentioning

confidence: 99%

Design, implementation, and management of an international medical device registry

Mauch

Kaur

Irwin

et al. 2021

Trials

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Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. Methods We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. Results We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. Conclusions Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. Trial registration ClinicalTrials.gov NCT02004353. 9th December 2013.

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“…Legal and Ethics Aspects: It is important to determine whether patient consent needs to be obtained from each patient, or whether anonymization can be considered a substitute for patient consent [Bisdas 2019, Zaletel 2015]. When designing a patient consent form, it is important to include clear reference of utilizing analysed data for publication and reports as well as any secondary uses of data (e.g.…”

Section: Designmentioning

confidence: 99%

Design, Implementation and Management of an International Medical Device Registry

Mauch

Kaur

Irwin

et al. 2021

Preprint

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Background Registries are powerful clinical investigational tools. More challenging, however, is an international registry conducted by industry. That requires considerable planning, clear objectives and endpoints, resources and appropriate measurement tools. Methods This paper aims to summarize our learning from ten years of running a medical device registry monitoring patient-reported benefits from hearing implants. Results We enlisted 113 participating clinics globally, resulting in a total enrolment of more than 1500 hearing-implant users. We identify the stages in developing a registry specific to a sensory handicap such as hearing loss, its challenges and successes in design and implementation, and recommendations for future registries. Conclusions Data collection infrastructure needs to be maintained up to date throughout the defined registry lifetime and provide adequate oversight of data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to provide accurate and timely data entry we facilitated easy access to their own data which helped to support their clinical routine. Trial registration: ClinicalTrials.gov NCT02004353

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Research methodology and practical issues relating to the conduct of a medical device registry

Cited by 11 publications

References 91 publications

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

Design, implementation, and management of an international medical device registry

Design, Implementation and Management of an International Medical Device Registry

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