Chest
Volume 156, Issue 1, July 2019, Pages 53-63
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Original Research: Pulmonary Vascular Disease
Use of Balloon Atrial Septostomy in Patients With Advanced Pulmonary Arterial Hypertension: A Systematic Review and Meta-Analysis

https://doi.org/10.1016/j.chest.2019.03.003Get rights and content

Background

Despite the use and purported benefits of balloon atrial septostomy (BAS), its safety, efficacy, and therapeutic role in the setting of advanced pulmonary arterial hypertension (PAH) are not well defined.

Objective

The goal of this study was to conduct a systematic review and meta-analysis to better determine the evidence supporting the use of BAS in PAH.

Methods

MEDLINE, Scopus, Cochrane Library, and Clinicaltrials.gov were searched from inception through May 2018 for original studies reporting outcomes with PAH prior to and following BAS. Studies comparing BAS vs other septostomy procedures were excluded. Weighted mean differences and 95% CIs were pooled by using a random effects model.

Results

Sixteen studies comprising 204 patients (mean age, 35.8 years; 73.1% women) were included. Meta-analysis revealed significant reductions in right atrial pressure (–2.77 mm Hg [95% CI, –3.50, –2.04]; P < .001) and increases in cardiac index (0.62 L/min/m2 [95% CI, 0.48, 0.75]; P < .001) and left atrial pressure (1.86 mm Hg [95% CI, 1.24, 2.49]; P < .001) following BAS, along with a significant reduction in arterial oxygen saturation (–8.45% [95% CI, –9.93, –6.97]; P < .001). The pooled incidence of procedure-related (48 h), short-term (≤ 30 day), and long-term (> 30 days up to a mean follow-up of 46.5 months) mortality was 4.8% (95% CI, 1.7%, 9.0%), 14.6% (95% CI, 8.6%, 21.5%), and 37.7% (95% CI, 27.9%, 47.9%), respectively.

Conclusions

The present analysis suggests that BAS is relatively safe in advanced PAH, with beneficial hemodynamic effects. The relatively high postprocedural and short-term survival with less impressive long-term survival suggest a bridging role for BAS; its contribution to this change needs to be verified by using a comparator group.

Section snippets

Data Sources and Search Strategy

This systematic review was conducted in accordance with the Preferred Reporting Items of Systematic Review and Meta-Analysis reporting standards.5 MEDLINE, Scopus, Cochrane Library, and Clinicaltrials.gov were searched from inception through May 2018 for original articles reporting outcomes in patients with PAH prior to and following BAS. No restrictions were placed with respect to time of publishing. Only articles in English were considered. The complete list of search terms used in each

Results

The literature search process is detailed in the PRISMA flowchart (Fig 1). Sixteen noncomparative observational studies comprising 204 patients with PAH were included in the final analysis (Table 1).1, 4, 11, 14, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 All individual studies had small (n < 35) sample sizes. The mean age of patients ranged from 6 to 56 years. On average, studies consisted of a majority (73.1%) of women with a history of syncope (50.6%) and RHF (53.4%) as the most commonly

Discussion

This comprehensive systematic review and meta-analysis comprising 212 patients with PAH found that BAS significantly improved important hemodynamic parameters, namely RAP, LAP, and the cardiac index, while also resulting in a reduction in Sao2. The interpretation of mortality rates associated with BAS is challenging because of the high-risk patient population and the absence of randomized or comparative studies as part of the meta-analysis. Despite these issues, approximately 50% of patients

Conclusions

BAS seems to be a relatively safe procedure associated with largely favorable hemodynamic outcomes in carefully selected patients with PAH. Short-term survival supports its consideration as a bridging procedure (ie, to lung transplantation), and longer term survival may rival contemporary medical treatments in patients with advanced stages of this uniformly fatal disease.

Acknowledgments

Author contributions: M. S. Khan: Study inception, study design, data interpretation, and critical review; M. M. M. and E. A.: Study inception, study design, literature search, data collection, statistical analysis, figure creation, data interpretation, writing, and critical review; N. Y., S. U. Khan, V. M. F., S. D., J. D. R., R. L. B., and R. A. K.: Study design, data interpretation, writing, and critical review.

Financial/nonfinancial disclosures: The authors have reported to CHEST the

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  • Cited by (38)

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      Since the first report of septostomy in PAH 30 years ago [15], BAS is used to alleviate RHF symptoms and/or syncope [7,16]. Despite the use and purported benefits of BAS [17,18], it remains a palliative and invasive therapy. In our present study, we substantiated the hemodynamic benefits of BAS, including a decrease in RAP of usually by 2–3 mmHg, a proportional increase in LAP despite a decrease in SaO2, and, more importantly, a 30–35% increase in CI.

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      Atrial septostomy is a well-described procedure for LV decompression to reduce pulmonary edema, prevent pulmonary hemorrhage, and reduce LV distention that may aid in the recovery of function while on ECMO [7]. In adult patients with severe pulmonary hypertension and RV failure, atrial septostomy is used as a “bridging” therapy to lung transplantation or palliative therapy to decrease symptoms when there is no response to medical treatment [8]. Pulmonary hypertension patients with recurrent syncope and World Health Organization functional class III and IV symptoms improve after atrial septostomy because of increased cardiac output [9].

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      The authors cited procedural experience at a high volume center as a reason for the reason for no procedural deaths and suggested that balloon trial septostomy could be a therapeutic option in properly selected patients. A recent meta-analysis of 16 balloon atrial septostomy studies including 212 patients total revealed that atrial septostomy was effective in reducing right atrial pressure and increasing cardiac index, while reducing systemic O2 saturations an average of 8.5%.52 Procedural and 30-day mortality were 4.8% and 14.6%, whereas long-term mortality (mean follow-up of 46.5 months) was 38%.

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    The abstract of this study was presented at the American Heart Association Scientific Sessions, November 10-12, 2018, Chicago, IL.

    FUNDING/SUPPORT: The authors have reported to CHEST that no funding was received for this study.

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