Long-term effectiveness and safety of transcatheter closure of patent foramen ovale compared with antithrombotic therapy alone: a meta-analysis of six randomised clinical trials and 3,560 patients with reconstructed time-to-event data

Abstract Background Transcatheter atrial septal defect (ASD) and patent foramen ovale (PFO) closure might have opposite short- and long-term haemodynamic consequences compared with restricted interatrial shunt creation, which recently emerged as a potential treatment modality for patients with heart failure with preserved ejection fraction (HFpEF). Given the opposing approaches of ASD and PFO closure versus shunt creation, we investigated the early and sustained cardiac structural and functional changes following transcatheter ASD or PFO closure. Methods In this retrospective study, adult secundum-type ASD and PFO patients with complete echocardiography examinations at baseline and at 1‑day and 1‑year follow-up who also underwent transcatheter closure between 2013 and 2017 at the University Medical Centre Groningen, the Netherlands were included. Results Thirty-nine patients (mean age 48 ± standard deviation 16 years, 61.5% women) were included. Transcatheter ASD/PFO closure resulted in an early and persistent decrease in right ventricular systolic and diastolic function. Additionally, transcatheter ASD/PFO closure resulted in an early and sustained favourable response of left ventricular (LV) systolic function, but also in deterioration of LV diastolic function with an increase in LV filling pressure (LVFP), as assessed by echocardiography. Age (β = 0.31, p = 0.009) and atrial fibrillation (AF; β = 0.24, p = 0.03) were associated with a sustained increase in LVFP after transcatheter ASD/PFO closure estimated by mean E/e’ ratio (i.e. ratio of mitral peak velocity of early filling to diastolic mitral annular velocity). In subgroup analysis, this was similar for ASD and PFO closure. Conclusion Older patients and patients with AF were predisposed to sustained increases in left-sided filling pressures resembling HFpEF following ASD or PFO closure. Consequently, these findings support the current concept that creating a restricted interatrial shunt might be beneficial, particularly in elderly HFpEF patients with AF.

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POWER CONSIDERATIONS FOR CLINICAL TRIALS USING MULTIVARIATE TIME-TO-EVENT DATA

Statistics in Medicine ◽

10.1002/(sici)1097-0258(19970430)16:8<865::aid-sim541>3.0.co;2-d ◽

1997 ◽

Vol 16 (8) ◽

pp. 865-882 ◽

Cited By ~ 20

Author(s):

MICHAEL D. HUGHES

Keyword(s):

Clinical Trials ◽

Event Data ◽

Time To Event ◽

Time To Event Data

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COMPARISON OF DEVICES UTILIZED FOR TRANSCATHETER CLOSURE OF PATENT FORAMEN OVALE: A META ANALYSIS

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(12)60239-3 ◽

2012 ◽

Vol 59 (13) ◽

pp. E238

Author(s):

Shikhar Agarwal ◽

Navkaranbir Bajaj ◽

E. Murat Tuzcu ◽

Samir Kapadia

Keyword(s):

Patent Foramen Ovale ◽

Transcatheter Closure ◽

Meta Analysis ◽

Foramen Ovale

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ODACH: A One-shot Distributed Algorithm for Cox model with Heterogeneous Multi-center Data

10.1101/2021.04.18.21255694 ◽

2021 ◽

Author(s):

Chongliang Luo ◽

Rui Duan ◽

Yong Chen

Keyword(s):

Likelihood Function ◽

Cox Model ◽

Meta Analysis ◽

Event Data ◽

Time To Event ◽

Hazard Functions ◽

Patient Level ◽

Time To Event Data ◽

Level Data ◽

Center Time

Objective: We developed and evaluated a privacy-preserving One-shot Distributed Algorithm for Cox model to analyze multi-center time-to-event data without sharing patient-level information across sites, while accounting for heterogeneity across sites by allowing site-specific baseline hazard functions and feature distributions. Materials and Methods: We constructed a surrogate likelihood function to approximate the Cox log partial likelihood function which is stratified by site, using patient-level data from a single site and aggregated information from other sites. The ODAC estimator was obtained by maximizing the surrogate likelihood function. We evaluated and compare the performance of ODACH with meta-analysis by extensive numerical studies. Results: The simulation study showed that ODACH provided estimates close to the pooled estimator, which is obtained by directly analyzing patient-level data from all sites via a stratified Cox model. The relative bias was <1% across all scenarios. As a comparison, the meta-analysis estimator, which was obtained by the inverse variance weighted average of the site-specific estimates, had substantial bias when the event rate is <5%, with the relative bias reaching 12% when the event rate is 1%. Conclusions: ODACH is a privacy-preserving and communication-efficient method for analyzing multi-center time-to-event data, which allows the baseline hazard functions as well as the distribution of covariate variables to vary across sites. It provides estimates that is close to the pooled estimator and substantially outperforms the meta-analysis estimator when the event is rare. It is thus extremely suitable for studying rare events with heterogeneous baseline hazards across sites in a distributed manner.

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Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials

Angiology ◽

10.1177/0003319718802635 ◽

2018 ◽

Vol 70 (4) ◽

pp. 325-331 ◽

Cited By ~ 5

Author(s):

Simone Vidale ◽

Filippo Russo ◽

Carlo Campana ◽

Elio Agostoni

Keyword(s):

Medical Treatment ◽

Patent Foramen Ovale ◽

Transcatheter Closure ◽

Meta Analysis ◽

Cochrane Library ◽

Transient Ischemic Attacks ◽

Foramen Ovale ◽

End Points ◽

Pfo Closure ◽

New Onset

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.

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