Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Jan 4;3(1):e000313.
doi: 10.1136/openhrt-2015-000313. eCollection 2016.

A time-series study of percutaneous closure of patent foramen ovale: premature adoption?

Kian Nian Lew  1 , Gianni D Angelini  2 , William Hollingworth  3
Affiliations

A time-series study of percutaneous closure of patent foramen ovale: premature adoption?

Kian Nian Lew et al. Open Heart. .

Abstract

Objectives: To evaluate the impact of National Institute for Health and Care Excellence (NICE) guidance in January 2005 and subsequent trial evidence on the adoption of percutaneous closure of patent foramen ovale (PCPFO).

Methods: A retrospective time series study was conducted using the Inpatient Hospital Episode Statistics (HES) England. A total of 3801 patients, aged ≥18 and ≤60 years, who had PCPFO from 1 April 2006 to 31 March 2012 in England. Percentage change annualised (PCA) in PCPFO procedure rates between initial NICE guidance and publication of trial results was analysed.

Results: Between Quarter 2, 2006 and Quarter 4, 2009, 2163 PCPFO procedures were performed, with an increasing PCA of 48.4%. The procedure rate peaked before the presentation of equivocal results from the first randomised controlled trial (RCT) in late 2010, and declined between Quarter 4, 2009 and Quarter 4, 2011 (PCA=-15.3%). Of more than 2300 patients recruited to three RCTs, only 71 were recruited in English hospitals.

Conclusions: PCPFO was rapidly adopted after the publication of initial NICE guidance despite the absence of RCT evidence of efficacy. Very few English patients participated in international RCTs of PCPFO, suggesting that NICE recommendations also failed to encourage the generation of RCT evidence.

Keywords: CONGENITAL HEART DISEASE.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trends in the adoption of percutaneous closure of patent foramen ovale (PCPFO), 2006–2013*. *Average quarterly procedures (Q2, 2006 to Q1, 2013) based on aggregate data on PCPFO procedures in patients of all ages; quarterly procedures (Q2, 2006 to Q1, 2012) based on individual patient data on PCPFO procedures in patients aged 18–60 years only.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Davis D, Gregson J, Willeit P et al. . Patent foramen ovale, ischemic stroke and migraine: systematic review and stratified meta-analysis of association studies. Neuroepidemiology 2013;40:56–67. 10.1159/000341924 - DOI - PMC - PubMed
    1. Li L, Yiin GS, Geraghty OC et al. . Incidence, outcome, risk factors, and long-term prognosis of cryptogenic transient ischaemic attack and ischaemic stroke: a population-based study. Lancet Neurol 2015;14:903–13. 10.1016/S1474-4422(15)00132-5 - DOI - PMC - PubMed
    1. Abaci A, Unlu S, Alsancak Y et al. . Short and long term complications of device closure of atrial septal defect and patent foramen ovale: meta-analysis of 28,142 patients from 203 studies. Catheter Cardiovasc Interv 2013;82:1123–38. 10.1002/ccd.24875 - DOI - PubMed
    1. NICE Interventional Procedure Guidance. Percutaneous closure of patent foramen ovale for the prevention of cerebral embolic stroke. National Institute for Health and Care Excellence, 2005. https://www.nice.org.uk/guidance/ipg109 (accessed 27 Jan 2015).
    1. Furlan AJ, Reisman M, Massaro J et al. . Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012;366:991–9. 10.1056/NEJMoa1009639 - DOI - PubMed

Publication types