Dataset Information

Post-market surveillance to detect adverse events associated with Melody® valve implantation.

ABSTRACT:

Objective

The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.

Background

In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.

Methods

We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials.

Results

We identified 631 adverse events associated with "on-label" Melody® valve implants and 84 adverse events associated with "off-label" implants. The most frequent "on-label" adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5).

Conclusion

Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody® valve implantation. Further study is needed to evaluate safety of "off-label" uses.

SUBMITTER: Hill KD

PROVIDER: S-EPMC5425318 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

Post-market surveillance to detect adverse events associated with Melody® valve implantation.

Hill Kevin D KD Goldstein Bryan H BH Angtuaco Michael J MJ Chu Patricia Y PY Fleming Gregory A GA

Cardiology in the young 20161110 6

<h4>Objective</h4>The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.<h4>Background</h4>In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.<h4>Methods</h4>We reviewed the United States Food and Drug Administration's ...[more]

PMID: 27829472

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Project description:BackgroundDespite improvements in the safety of transcatheter aortic valve implantation (TAVI), ~4% of patients experience a procedure-related stroke. Understanding long-term health and healthcare implications of these events may motivate the development and adoption of preventative strategies. Aims: We aimed to assess the association of TAVI-related ischaemic stroke with subsequent clinical outcomes and healthcare utilisation.MethodsWe used Medicare fee-for-service claims to identify patients who underwent their first TAVI between January 2012 and December 2017. Previously used ICD-9-CM and ICD-10-CM codes were used to identify TAVI-related ischaemic stroke. Among those with and without TAVI-related ischaemic stroke, we compared the risk of a composite endpoint that included all-cause mortality, acute myocardial infarction, and subsequent stroke using inverse probability treatment weighted Cox regression. We also performed a difference-in-difference analysis to compare 1-year Medicare expenditures and days spent at home during the first year after TAVI.Results Among 129,628 primary TAVI patients, 5,549 (4.3%) had a procedure-related stroke. These patients were more likely to be female and have had prior stroke, peripheral vascular disease, ischaemic heart disease, or renal failure. After adjustment, TAVI-related ischaemic stroke was associated with a higher risk of the 1-year composite outcome (HR 1.67, 95% CI: 1.56-1.78), higher 1-year Medicare expenditures (difference $9,245 [standard error 790], p<0.001), and fewer days at home during the first year (difference 16 days [standard error 1], p<0.001).ConclusionsAmong Medicare beneficiaries undergoing TAVI, procedure-related ischaemic stroke was associated with worse outcomes, increased Medicare expenditures, and less time spent at home. Procedure-related ischaemic stroke during TAVI remains a critically important and potentially preventable source of patient mortality, morbidity and healthcare utilisation.

Dataset Information

Post-market surveillance to detect adverse events associated with Melody® valve implantation.

Objective

Background

Methods

Results

Conclusion

Publications

Post-market surveillance to detect adverse events associated with Melody® valve implantation.

Similar Datasets

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