Stent fractures in congenital heart disease

Breinholt, John P.; Nugent, Alan; Law, Mark A.; Justino, Henri; Mullins, Charles E.; Ing, Frank F.

doi:10.1002/ccd.21742

Cited by 46 publications

(34 citation statements)

References 44 publications

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“…Although stent fractures have been observed after CoA stenting, 2,7,10,22,30,31 historically, their frequency has seemed to be lower than observed rates in other vascular territories such as right ventricle-topulmonary artery conduits and pulmonary arteries in which the mechanical stressors and risk factors for fracture are more thoroughly understood. In the present cohort, although no stent fractures were observed immediately after stent placement, we have observed some degree of stent fracture in 23 subjects during follow-up, with evidence of progression of stent fractures from single to multiple struts.…”

Section: Stent Fracturementioning

confidence: 99%

“…In the present cohort, although no stent fractures were observed immediately after stent placement, we have observed some degree of stent fracture in 23 subjects during follow-up, with evidence of progression of stent fractures from single to multiple struts. The biomechanics of stent fracture have been reviewed, 31,32 and although fracture has been noted anecdotally after stent redilation, the risk factors for stent fracture in the aorta are otherwise poorly characterized. In this cohort, we could find no association with stent length, subject age, native or recurrent CoA, or other clinical parameters.…”

Section: Stent Fracturementioning

confidence: 99%

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Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST)

et al. 2015

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Background-The Coarctation of the Aorta Stent Trial (COAST) was designed to assess the safety and efficacy of the Cheatham Platinum stent when used in children and adults with native or recurrent coarctation. Acute outcomes have been reported. We report here follow-up to 2 years. Methods and Results-A total of 105 patients underwent attempted implantation, with 104 successes. There were no procedural deaths, serious adverse events, or surgical intervention. All patients experienced immediate reduction in upperto lower-extremity blood pressure difference with sustained improvement to 2 years. Rates of hypertension and medication use decreased from baseline to 12 months and remained largely unchanged at 2 years. Six aortic aneurysms have been identified: 5 were successfully treated with covered stent placement, and 1 resolved without intervention. Stent fractures were noted in 2 patients at 1 year and 11 patients at 2 years, with evidence of fracture progression. To date, only larger stent diameter was associated with stent fracture. Twelve additional fractures have occurred after 2 years. No fracture has resulted in loss of stent integrity, stent embolization, aortic wall injury, or reobstruction. Nine reinterventions occurred in the first 2 years for stent redilation and address of aneurysms, and 10 additional reinterventions occurred after 2 years. Conclusions-The Cheatham Platinum stent is safe and associated with persistent relief of aortic obstruction. Stent fracture and progression of fracture occur but have not resulted in clinically important sequelae. Reintervention is common and related to early and late aortic wall injury and need for re-expansion of small-diameter stents. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552812.

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Section: Stent Fracturementioning

confidence: 99%

Section: Stent Fracturementioning

confidence: 99%

Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST)

et al. 2015

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“…There are considerable risks associated with this approach given the limited experience and formal assessments of these modified devices, and a number of adverse events linked to adult device use in children have been reported. [3][4][5][6] Another common practice is to use adult devices "off label," or outside that device' s FDAapproved indication. In pediatric interventional cardiology, for example, reports have estimated that .60% of patients who undergo a therapeutic cardiac catheterization are exposed to off-label use of adult devices.…”

mentioning

confidence: 99%

Postmarketing Trials and Pediatric Device Approvals

2014

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BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described. METHODS: We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)–mandated postmarketing trials. RESULTS: Twenty-two devices were approved for use in children via the premarket approval pathway and 3 via the humanitarian device exemption pathway. Twenty-two (88%) qualified as pediatric despite minimum approval ages of ≥18 years (the FDA Center for Devices and Radiologic Health considers patients 18–21 years old as pediatric). Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (86%). Overall, 21 (84%) devices were not studied in any patients <18 years of age. Postmarketing studies were mandated by the FDA for 19 (76%) devices, although only 3 (18%) required enrollment of pediatric patients. CONCLUSIONS: Most high-risk pediatric devices are approved on the basis of trials in patients ≥18 years old, with few pediatric patients exposed to the devices before market availability. Few postmarketing studies require additional study in pediatric patients.

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“…79 Others have reported a lower frequency, but many patients in that series had much shorter follow-up. 80 This discrepancy highlights the importance of time in evaluating stent fracture, although differences in angioplasty and stenting practices may also play a role in the susceptibility of stents to fracture.…”

Section: Branch Pa Stentsmentioning

confidence: 99%