Interatrial Shunt Devices in Management of Heart Failure: A Systematic Review and Meta-Analysis

doi:10.21203/rs.3.rs-3010010/v1

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Interatrial Shunt Devices in Management of Heart Failure: A Systematic Review and Meta-Analysis

https://doi.org/10.21203/rs.3.rs-3010010/v1

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Background

Recent studies have shown that interatrial shunt devices (ISDs) can improve cardiac function and exercise tolerance in people with heart failure (HF). In this systematic review and meta-analysis, we assessed the efficacy of ISDs in the treatment of HF.

Methods

The Medline, Cochrane Library, Embase, and PubMed databases were searched through to December 7, 2022, to identify clinical studies that evaluated the effect of ISDs on HF. The primary endpoint was change in left ventricular ejection fraction (LVEF). Secondary endpoints included left atrial volume index, left ventricular end-diastolic diameter, right ventricular diameter, and tricuspid annular plane systolic excursion. Clinical functional capacity, including the 6-minute walk distance, New York Heart Association functional class, and N-terminal pro-B-type natriuretic peptide level, were also evaluated.

Results

Six trials that included 182 individuals were included in the quantitative analysis. Pooled analyses showed that LVEF increased by a mean of 3.07% (95% confidence interval [CI] 0.30, 5.84; P = 0.03) after ISDs implantation. There was no significant change in left atrial volume index (mean difference [MD] -0.33 mL/m², 95% CI -4.80, 4.13; P = 0.88; I² = 0), left ventricular end-diastolic diameter (MD -0.53 cm, 95% CI -1.58, 0.53; P = 0.33; I² = 80%), right ventricular diameter (MD 1.40 mm, 95% CI -1.72, 4.51; P = 0.38; I² = 36%), or tricuspid annular plane systolic excursion (MD 0.74 mm, 95% CI -0.49, 1.98; P = 0.24; I² = 0) after ISDs implantation. The 6-minute walk distance, N-terminal pro-B-type natriuretic peptide level, and New York Heart Association functional class were improved.

Conclusions

An ISDs can increase LVEF in patients with HF. Studies in larger sample sizes and with longer follow-up times are needed to confirm our findings.

interatrial shunt devices

heart failure

left ventricular ejection fraction

Heart failure (HF) is a complex and heterogeneous syndrome marked by congestion and fatigue and is associated with reduced quality of life and survival. It is also a major and growing public health problem that leads to considerable morbidity and mortality [1]. According to 2021 American Heart Association statistics, with our aging population, the prevalence of HF is projected to increase by 46% between 2012 and 2030 [2]. Although considerable progress has been made in the treatment of HF in recent years, drug therapy remains a great challenge for patients [3]. In this context, novel interventional devices and techniques have emerged in the treatment of HF.

The observation that patients with mitral stenosis and interatrial septal defect (Lutembacher syndrome) have fewer symptoms than those with mitral stenosis alone because of left atrial pressure (LAP) offloading [4] supports the notion that opening a shunt channel between the left and right atrium could be effective in reducing LAP and relieving the symptoms of HF. Recognition of this concept led to development of novel interatrial shunt devices (ISDs) for the treatment of HF [5]. ISDs relieve the volume excess from the left to right atrium by regulating the interatrial pressure gradient and creating an auto-regulating reduction in LAP [6]. One of the concerns regarding left-to-right shunting is potential overloading of the right heart and an increase in pulmonary artery pressure. However, a previous study in patients with atrial septal defects found that small shunts (usually < 10 mm) were not associated with any deleterious hemodynamic effects [7]. Thus far, several studies in chronic HF have demonstrated various ISDs to be feasible and safe in patients who remain symptomatic despite optimal medical therapy [8–10].

Our previous meta-analysis showed that ISDs improve the hemodynamic index in patients with HF primarily by reducing pulmonary capillary wedge pressure and increasing cardiac output [11]. Another meta-analysis showed that implantation of an ISDs for HF is feasible and associated with significant improvements in patient-centered outcomes, such as the 6-min walk distance (6MWD) and health-related quality of life [12]. However, there is little information on how cardiac structure and function changes after implantation of an ISDs. Therefore, we performed this meta-analysis of previously published studies to evaluate cardiac structure and function after ISDs implantation for management of HF.

Literature search and study selection

A systematic review of the published literature was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines and registered on PROSPERO as CRD42023401896 [13]. We performed a comprehensive online search of the published literature through to December 7, 2022 using the Medline, Cochrane Library, Embase, and PubMed databases to identify all published clinical studies that evaluated the effects of interatrial shunting in patients with HF. The search strategy used relevant keywords and medical subject heading terms, including “heart failure”, “interatrial septal defect”, and “atrial septostomy”. Further potentially eligible publications were identified by hand-searching the bibliographies of the included articles and reviews.

Eligibility criteria

Studies qualified for inclusion if they included sufficient information on key points. The inclusion criteria were as follows: 1) study reported in detail with rigorous eligibility criteria; 2) subjects were patients with HF; 3) cardiac structure and function was assessed at baseline and during follow-up by echocardiographic or magnetic resonance imaging (MRI); and 4) if a primary study had more than one follow-up, only those with results of echocardiographic or MRI assessment and the longest follow-up time was included. Abstracts, case reports, conference presentations, editorials, and expert opinions were excluded.

Extraction of data and critical appraisal

Data were extracted by two authors working independently using a predefined standardized protocol and data collection instrument. Information on study design, demographic characteristics, echocardiographic or MRI assessment, functional changes, and major adverse events was recorded. The Newcastle–Ottawa Scale was used to evaluate the quality of the included studies [14]. Scores of 0–3, 4–6, and 7–9 were considered as poor, fair, and good, respectively. Any discrepancies were resolved by consensus between the authors.

Primary and secondary endpoints

The primary endpoint was defined as change in left ventricular ejection fraction (LVEF). Secondary endpoints were changes in other parameters of cardiac structure and function, including left atrial volume index (LAVI), left ventricular end-diastolic diameter (LVEDD), right ventricular diameter (RVD), and tricuspid annular plane systolic excursion (TAPSE). Clinical functional capacity, including the 6MWD, New York Heart Association (NYHA) class, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, was also evaluated. The major adverse event was defined as the incidence of serious device-associated adverse events reported in the included studies.

Statistical analysis

Continuous variables are reported as the mean ± standard deviation and numerical data as the number (percentage). The standard deviation was calculated from the sample size, median, range, and/or interquartile range if not reported in an included trial [15]. Pooled estimates were calculated using fixed-effect models (I² < 50%), whereas random-effect models were applied in the event of heterogeneity across studies (I² ≥ 50%). We checked for publication bias by visual examination of funnel plots for LVEF and assessment of asymmetry using Egger’s regression test. To test the stability of our meta-analysis further, we performed multiple subgroup analyses based on baseline mean age, type of device, sample size, duration of follow-up, and type of HF. All statistical analyses were performed using the RevMan software package (Review Manager, version 5.1; The Cochrane Collaboration, Oxford, UK) and Stata software 12.0 (Stata Corp, College Station, TX, USA). All P-values were 2-tailed and considered statistically significant at < 0.05. As with other analyses using similar methods [11, 16], the patient cohort pre-procedure was defined as the comparison group.

Study selection and characteristics

The search yielded 304 potentially relevant records, 237 of which were excluded after screening of the title and abstract. Three of the remaining articles were excluded owing to incomplete data [17–19]. Six studies that included a total of 182 patients were enrolled (Table 1 and Online Fig. 1).

Table 1

Characteristics of Included Studies
Study and reference citation	Year	LVEF	NYHA	Device	Design	Included Number	Follow up(M)	Device occlusion/stenosis (N)	NOS Score
REDUCE LAP-HF^[8]	2016	≥ 40%	II - IV	IASD	open-label, single-arm study	64	12	NR	7
First-generation v-Wave^[9]	2018	> 15%	III - IV	V-Wave	open-label, single-arm study	38	12	19	7
Second-Generation V-Wave Shunt^[20]	2020	NR	≥ III	V-Wave	open-label, single-arm study	10	12	0	7
PRELIEVE^[10]	2021	≥ 15%	III- IV	AFR	open-label, single-arm study	53	12	0	7
Trevor Simard^[21]	2020	NR	III- IV	LA-to-CS	open-label, single-arm study	11	201 day	0	7
D-shant^[22]	2021	NR	II– IV	D-shant	open-label, single-arm study	6	6	0	7
LVEF, left ventricular ejection fraction; M, month; N, number; NYHA, New York Heart Association; NOS, Newcastle–Ottawa Scale..

Table 1 and Online Table 1 summarize the characteristics of the included studies. One study [8]used the InterAtrial Shunt Device (IASD, DC Devices Inc, Tewksbury, MA, USA), two studies [9, 20] used the V-Wave interatrial shunt device (V-Wave Ltd, Or Akiva, Israel), one [10] used the Atrial Flow Regulator (Occlutech, Istanbul, Turkey), one used a Levoatrial-to-Coronary Sinus device (Transcatheter Atrial Shunt System, Edwards Lifesciences, Irvine, CA, USA) [21], and another trial used a D-shant device[22] (Wuhan Vickor Medical Technology Co., Ltd). Most of the included patients were receiving standard medications for heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF), except in one study that only included patients with an LVEF ≥ 40%[8]. The follow-up duration ranged from 6 to 12 months. The Newcastle–Ottawa Scale scores indicated that all studies met the required quality standards.

Primary endpoint

Primary endpoint data were available for all trials. Pooled analyses showed that there was a significant increase in LVEF (mean difference [MD] 3.07%, 95% confidence interval [CI] 0.30–5.84; P = 0.03) after ISDs implantation. There was no heterogeneity between the studies (I² = 0, P = 0.53; Fig. 1).

Secondary endpoints

There was no significant change in LAVI (MD -0.33 mL/m², 95% CI -4.80, 4.13; P = 0.88; I² = 0) or LVEDD (MD -0.53 cm, 95% CI -1.58, 0.53; P = 0.33; I² = 80%). There was also no significant change in RVD (MD 1.40 mm, 95% CI -1.72, 4.51; P = 0.38; I² = 36%) or TAPSE (MD 0.74 mm, 95% CI -0.49, 1.98; P = 0.24; I² = 0; Fig. 2).

Other endpoints

Five trials evaluated the effect of an ISDs on 6MWD. Pooled analyses showed that there was a significant increase in 6MWD (MD 49.31 m, 95% CI 31.06–67.56; P < 0.001; I² = 0). Furthermore, pooled data from three trials that evaluated the effect of ISDs implantation on symptoms showed a significant improvement in mean NYHA functional class (MD -1.02; 95% CI -1.34, -0.70; P < 0.001). There was also a significant decrease in the NT-proBNP level (MD -295.78 pg/mL; 95% CI -474.87, -116.69; P = 0.001) after ISDs implantation (Fig. 3).

Major events

Four studies (containing 165 patients) provided information on the incidence of serious device-related adverse events. Analysis showed that 6% (95% CI 1.37–26.27) of these patients had serious adverse device-related events. The most common events were complications at the vascular access site (n = 5). The details of these adverse events are shown in Online Table 2.

Subgroup analysis

There were no significant differences in type of device used (P = 0.39) or type of HF (P = 0.26) according to change in LVEF. There was also no significant difference in baseline mean age, sample size, or follow-up duration between the included studies (Fig. 4).

Publication bias

For the primary endpoint of change in LVEF, visual inspection of funnel plots for all studies showed partial symmetry (Online Fig. 2). Egger’s linear regression test revealed no potentially significant publication bias in terms of the endpoint (95% CI -1.67, 2.51; P = 0.603).

This meta-analysis evaluated the effect of ISDs implantation on HF and found a significant association with an increase in LVEF. There was also an improvement in clinical functional capacity with no significant change in LAVI, LVEDD, RVD, or TAPSE.

Dilatation of the left atrium followed by an increase in LAP is the common pathway leading to pulmonary congestion and acute pulmonary edema and accounts for more than 90% of admissions for acutely decompensated HF [23]. Reduction of LAP has the potential to improve hemodynamics and outcomes in HF [24]. Therefore, decompression of LAP by creating a unidirectional but restrictive left-to-right interatrial shunt has emerged as a novel therapeutic strategy for these patients. Søndergaard et al published the first report on ISDs in patients with HFpEF in 2014, in which they indicated that ISDs implantation could reduce LAP and alleviate symptoms [17]. Since then, numerous clinical trials have investigated the effect of ISDs in HF. Lauder et al performed a meta-analysis of the effect of ISDs in patients with HF in which they focused on exercise capacity and found that ISDs implantation can increase 6MWD and health-related quality of life [12]. They also investigated several indicators of cardiac structure and function, including LVEF, LAVI, and TAPSE, evaluated by echocardiography but did not find any statistically significant differences. However, owing to differences in inclusion and exclusion criteria, we focused primarily on LVEF, expanded our pooled results by incorporating novel outcomes, and found that ISDs implantation could increase LVEF in patients with HF. In view of the differences in pathogenesis between HFpEF and HFrEF, the effect of ISDs on LVEF may vary according to type of HF. One study found an increase in LVEF from 23 ± 7% to 26 ± 8% (P = 0.007) after ISDs implantation in patients with HFrEF [9] whereas another study found no statistically significant change in LVEF after ISDs implantation in patients with HFpEF [8]. In theory, a significant decrease in LAP with no volume overload of the right chamber may lead to improvement of LVEF [23]. All the studies included in our meta-analysis used echocardiography to evaluate LVEF with the exception of the D-shant study, which used MRI [22]. Considering that the imaging examination modality used may affect the results, we removed this study and found that LVEF still showed an increasing trend after ISDs implantation (MD 2.53%; 95% CI -0.30, 5.37; P = 0.08; I² = 0). More studies are needed to confirm the impact of ISDs on LVEF.

One randomized controlled trial that included 626 participants demonstrated that patients with a right atrial volume index ≥ 29.7 mL/m² who received an ISDs had worse outcomes in terms of HF events [19]. The effect of left-to-right atrial shunt on right heart load remains the main problem of this interventional treatment in clinical practice. Our meta-analysis showed that RVD did not increase significantly and that TAPSE tended to increase after ISDs implantation. Our previous meta-analysis [11] found that right atrial pressure and mean pulmonary artery pressure did not increase after ISDs implantation, indicating that an ISDs does not significantly increase right heart pressure. From the perspective of the left heart, there is also a downward trend in LAVI and LVEDD after ISDs implantation, which suggested that left heart pressure may also be improved to some extent. A computer simulation study in HF showed that an 8-mm shunt with a Qp/Qs ratio of approximately 1.3 to 1.4 appeared to be sufficient to reduce LAP without major RV overload[25]. A randomized controlled study also found no significant change in right atrial pressure or mean pulmonary artery pressure at 1 month after IASD implantation [5]. Another study found that RVD was higher in an ISDs group (7.9 ± 8.0 mL/m²) than in a control group (-1.8 ± 9.6 mL/m²; P = 0.002) at 6 months after implantation with no further increase at 12 months [18]. Therefore, ISDs with an appropriate shunt diameter do not increase right heart load.

Our meta-analysis also found significant improvements in 6MWD, NYHA functional class, and the NT-proBNP level after ISDs implantation. The improved results for some clinical indicators were consistent with those of two previous meta-analyses [11, 12]. The 6MWD is an objective measure of cardiopulmonary functional capacity and has become increasingly recognized as an important outcome in patients with HF in terms of symptom status [26]. The 6MWD is a strong independent predictor of morbidity and mortality in patients with left ventricular dysfunction [27]. In general, a 30–50-m increase in 6MWD is considered a clinically significant improvement and is associated with significant improvements in NYHA functional class and health-related quality of life [28]. In current clinical practice, the NYHA classification is widely used to classify patients with HF, including as an enrollment criterion and outcome measure in clinical trials, and in guidelines, where medication, therapy, and referral to an advanced HF center are recommended depending on the NYHA classification [29]. Worsening NYHA class also appears to correlate well with decreasing 6MWD [30]. The REDUCE LAP-HF II study showed that NYHA class improved to a greater extent in shunt device-treated patients than in sham-treated controls (P = 0.006) between baseline and 12 months. A decrease in NYHA class means improved cardiac function. The NT-proBNP level is a useful marker for detection and evaluation of HF [31]. NT-proBNP increases with the severity of congestive heart failure because of left ventricular dysfunction, and the increase is correlated with LVEF [32]. More importantly, NT-proBNP levels have been associated with clinical event rates [28]. The improvement in these clinical indicators further demonstrates the effectiveness of ISDs in patients with HF.

No statistically significant difference was found in patient baseline mean age, type of device used, follow-up duration, or number of study participants in the subgroup analysis. There was also no statistically significant difference in types of HF. An IASD is mainly used in patients with HFpEF [8]. Other devices used in HFpEF and HFrEF are listed in Online Table 1. Although the causes of these two types of HF are different, one of the common mechanisms leading to end-stage HF is elevation of LAP after left atrial dilation [23]. Therefore, ISDs could be used in either type of HF.

Although a novel and invasive therapy, ISDs showed a good safety profile with a serious device-related adverse event rate of 6% in our analysis. The most common events were vascular access site complications. Therefore, operators should be vigilant about access site problems during surgery. There is good evidence showing that ultrasound-guided puncture can effectively reduce the risk of complications at the access site[33].

Study limitations. This research has several limitations. First, some of the studies included were small and did not include a control group, which may have introduced selection bias. Second, it did not distinguish between HFpEF and HFrEF. One randomized controlled trial[18] did not find an increase in LVEF, which might reflect the fact that it mainly included patients with HFpEF. All patients in that study had an LVEF ≥ 40%, so the change in LVEF after IASD may have been small. Therefore, there is a need for further investigation of the impact of ISDs implantation in the different types of HF. Third, the longest follow-up duration in the studies included in this meta-analysis was 12 months. Although ISDs implantation was confirmed to be effective in the short term, maintained of efficacy in the long-term is an important issue. Studies with a longer follow-up duration are required to confirm the long-term effectiveness of the procedure.

A key insight from our analyses was that ISDs implantation is associated with significant and clinically relevant increases in LVEF that are accompanied by improvement in 6MWD, NYHA functional class, and NT-proBNP, without changes in LAVI, LVEDD, RVD or TAPSE. However, randomized controlled trials with larger sample sizes and longer follow-up periods are needed to confirm that ISDs implantation is an effective treatment for HF.

6MWD, 6-min walk distance

CI, confidence interval

HF, heart failure

HFpEF, heart failure with preserved ejection fraction

HFrEF, heart failure with reduced ejection fraction

ISDs, interatrial shunt devices

LAP, left atrial pressure

MRI, magnetic resonance imaging

LVEF, left ventricular ejection fraction

LAVI, left atrial volume index

LVEDD, left ventricular end-diastolic diameter

MD, mean difference

NYHA, New York Heart Association

NT-proBNP, N-terminal pro-B-type natriuretic peptide

RVD, right ventricular diameter

TAPSE, tricuspid annular plane systolic excursion

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no conflicts of interest.

Funding statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Authors’ contributions

Min Li: Data curation, Formal analysis, Writing original draft. Tieci Yi: Data curation, Writing original draft. Wei Ma and Yan Zhang: Writing review and editing. Fangfang Fan: Data curation. Wei Ma: Supervision, Writing review and editing. Lin Qiu, Zhi Wang and Haoyu Weng: Writing, review and editing.

Acknowledgments

None.

Author details

1. Department of Cardiovascular Disease, Peking University First Hospital

2. Key Laboratory of Molecular Cardiovascular Sciences (Peking University), Ministry of Education

3. Echocardiography Core Lab, Institute of cardiovascular Disease at Peking University First Hospital

4. Hypertension Precision Diagnosis and Treatment Research Center, Peking University First Hospital, Beijing, China.

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No competing interests reported.

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Interatrial Shunt Devices in Management of Heart Failure: A Systematic Review and Meta-Analysis

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Abstract

Background

Methods

Results

Conclusions

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INTRODUCTION

METHODS

Literature search and study selection

Eligibility criteria

Extraction of data and critical appraisal

Primary and secondary endpoints

Statistical analysis

RESULTS

Study selection and characteristics

Primary endpoint

Secondary endpoints

Other endpoints

Major events

Subgroup analysis

Publication bias

DISCUSSION

CONCLUSIONS

Abbreviations

Declarations

References

Additional Declarations

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