Clinical Investigations
PFO Closure and Heart Failure
The Risk of Heart Failure Progression in Patients With Patent Foramen Ovale: Differential Risk Associated With Device Closure

https://doi.org/10.1016/j.echo.2023.04.010Get rights and content

Highlights

  • Patients with PFO have a lower risk of HF hospitalization.

  • Device closure for PFO is associated with a higher risk of HF hospitalization.

  • HF risk after PFO closure is high in patients with structural heart disease or AF.

  • HF progression monitoring is needed after PFO closure in such high-risk patients.

Background

A patent foramen ovale (PFO) can unload left atrial pressure via an interatrial shunt. We investigated whether device closure of PFO is associated with a subsequent risk of heart failure (HF), particularly in patients with structural heart disease or atrial fibrillation (AF).

Methods

We enrolled 4,804 consecutive patients who underwent transesophageal echocardiography at tertiary medical centers in Korea between 2007 and 2019. The primary outcome was the 4-year risk of HF hospitalization. Underlying structural heart disease was determined by echocardiography.

Results

A PFO was observed in 981 (20.4%) patients, where 161 underwent device closure. During follow-up (median, 3.5 [1.4–6.4] years), the primary outcome was lower in patients with PFO than in those without (2.6% vs 4.0%; adjusted hazard ratio [aHR], 0.65; 95% CI, 0.45–0.94; P = .021). Among the patients with PFO, the primary outcome was higher in the device closure group than in the no-closure group (5.5% vs 1.2%; aHR, 5.59; 95% CI, 4.26–7.34; P < .001). A consistent result was found in patients with structural heart disease or AF (9.6% vs 3.9%; aHR, 2.55; 95% CI, 1.95–3.33; P < .001), demonstrating an increased risk of the primary outcome proportionate to the number of combined structural abnormalities. However, no significant association was observed between the primary outcome and PFO closure in those without structural heart disease or AF (1.7% vs 1.5%; aHR, 1.22; 95% CI, 0.99–1.50; P = .054).

Conclusion

Patients with underlying structural heart disease or AF may be predisposed to symptomatic HF progression after PFO closure. Therefore, careful medical surveillance with optimal risk management is needed in these patients.

Introduction

Elevated left atrial (LA) pressure is a hallmark feature in patients with heart failure (HF).1 Increased LA pressure contributes to HF progression, with aggravated exertional symptoms and pulmonary congestions.2 Higher LA pressure is also reported to be associated with poor clinical outcomes in HF,3 where the appropriate control of LA pressure showed reductions in adverse events and improvements in functional status.4

The hemodynamic effect of interatrial shunt on relieving LA pressure has been suggested in previous studies. Surgical or device closure of interatrial shunt can aggravate LA pressure and pulmonary edema in patients presenting with left ventricular (LV) dysfunction.5 Recent studies have also introduced an interatrial shunt device for refractory HF, suggesting that it has an effect on reducing LA pressure and symptom improvement.6,7 Regarding long-term clinical events, the presence of an interatrial shunt was reported to be associated with a lower risk of atrial fibrillation (AF) and HF over a 10-year period.8

Patent foramen ovale (PFO) is one of the most common adult congenital heart diseases, observed in approximately 25% of the general population.9 The clinical significance of PFO as a source of paradoxical embolic events has been documented, leading to clinical trials demonstrating the preventive effect of device closure for PFO on recurrent stroke events.10 However, whether the risk of subsequent HF development differs according to device closure for PFO has not been evaluated in light of the potential role of PFO for relieving increased LA pressure via an interatrial shunt. Therefore, the current study investigated the association between device closure for PFO and subsequent HF risk. Additionally, the risk assessment was stratified according to the underlying structural heart disease or AF.

Section snippets

Study Population

In the current study, we screened 7,277 consecutive patients who underwent transesophageal echocardiography (TEE) between 2007 and 2019 at 2 tertiary medical centers (Seoul National University Bundang Hospital and Chungnam National University Hospital) in Korea. The exclusion criteria were a history of significant valvular heart disease, chronic HF, infective endocarditis, open-heart surgery, septal puncture, pulmonary embolism or pulmonary hypertension, cardiomyopathies, and other critical

Baseline Characteristics of the Study Population

Table 1 summarizes the clinical features of the study population according to the presence of PFO and device closure among patients with PFO. Patients with PFO were younger (64 [53–76] vs 69 [58-80] years; P < .001) but had a higher proportion of male patients (66.5% vs 61.4%; P = .004) compared with those without PFO. The prevalence of clinical risk factors was relatively lower, with a significantly lower rate of AF (4.6% vs 12.6%; P < .001) in patients with PFO than in those without PFO. In

Discussion

In the current study, we evaluated the association of device closure for PFO with subsequent risk of HF hospitalization. The presence of PFO was independently associated with a lower risk of the primary outcome. However, the device closure group showed a higher risk of the primary outcome than the no-closure group. A significant association between device closure and the primary outcome was observed in patients with underlying structural heart disease or AF, demonstrating an increasing trend in

Conclusion

The presence of PFO was associated with a lower risk of HF. Patients with underlying structural heart disease or AF may be predisposed to symptomatic HF progression after device closure for PFO. Therefore, careful medical surveillance for clinical symptoms with optimal risk factor management is needed in these patients.

References (21)

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Conflicts of Interest: None.

This research was supported by the Seoul National University Bundang Hospital, South Korea Research Fund (grant no. 14-2021-0039). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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