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Comparative analysis of MitraClip/TriClip and PASCAL in transcatheter tricuspid valve repair for tricuspid regurgitation: a systematic review and meta-analysis

BMC Cardiovascular Disorders volume 24, Article number: 557 (2024) Cite this article

Abstract

Background

The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices—MitraClip, PASCAL, and TriClip—remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR.

Methods

Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials.

Results

The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices.

Conclusion

The TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results.

Peer Review reports

Introduction

Tricuspid regurgitation (TR) is a prevalent valvular disease associated with worsening heart failure symptoms and an elevated risk of mortality and morbidity [1, 2]. Despite tricuspid valve surgery being the conventional first-line therapy for TR, it poses a substantial peri-procedural mortality risk and may not yield significant clinical improvements [3, 4]. In contrast, transcatheter techniques emerge as a promising alternative for reducing TR in high-surgical-risk patients [5]. These approaches not only enhance symptoms and quality of life compared to medical therapy but also maintain a low peri-procedural mortality rate [6].

Various edge-to-edge transcatheter tricuspid valve repair (TTVR) techniques, including MitraClip and TriClip (both by Abbott, Santa Clara, California, USA), as well as the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, California, USA), have shown promising results [7,8,9]. However, the lack of a comparative analysis among these devices highlights the need for a comprehensive meta-analysis. This analysis should evaluate the safety and effectiveness of these devices for treating TR, helping clinicians in making informed choices about the optimal device for TTVR in patients with TR.

Materials and methods

The current study was conducted following the approaches outlined in the Cochrane Handbook for Systematic Reviews of Interventions [10]. Throughout the drafting of the manuscript, strict adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines was maintained [11].

Search strategy

The following electronic databases were systematically searched up to May 2023: PubMed, Web of Science (WOS), Scopus, Medline, and Cochrane. In addition, we updated the search in the similar databases in May 2024. The search strategy used the following search terms: (Tricuspid) AND (Insufficiency OR Incompetence OR Regurgitation) AND (MitraClip OR Pascal OR TriClip). References from all included studies were screened to ensure no studies were missed and to guarantee high-quality screening.

Eligibility criteria

Studies were included based on the following eligibility criteria: patients undergoing transcatheter tricuspid valve repair (TTVR) with interventions MitraClip, Pascal, or TriClip, and study designs that were either single-arm clinical trials or cohorts. Conversely, we excluded non-human studies, conference abstracts, cohorts, case series, case-control studies, case reports, and studies not in English.

Screening and study selection

Using Zotero software, [12] we compiled records from various databases and eliminated duplicates. The retrieved references underwent screening to assess relevance. This screening process was divided into two steps: first, title and abstract screening, followed by full-text review to determine final eligibility, utilizing Microsoft Excel Spreadsheets [13]. At least two independent authors conducted each step, comparing findings. Any disagreements were resolved through group discussions.

Quality assessment

For all single-arm clinical trials included, the quality was evaluated using the ROBINS-I Cochrane Collaboration tool [14]. This evaluation covers several domains: bias due to confounding, bias in selection of participants for the study, bias in classification of interventions, bias due to deviations from intended interventions, bias due to missing data, bias in measurement of outcomes, and bias in selection of the reported result. The assessment determines whether there is a low, high, or unclear risk of bias. For cohort studies, the Newcastle-Ottawa Scale (NOS) was used [15]. It encompasses the following domains: Sample selection criteria, Comparability and Exposure.

Data extraction

Two independent authors extracted data from the included studies, covering the following aspects: study design, setting, sample size, follow-up duration, protocol registration, population definition, primary outcome measures, and baseline characteristics.

Primary and secondary endpoints

The primary endpoints included Vena contracta width (mm), effective regurgitant orifice area (EROA)(mm2), tricuspid regurgitant volume (ml), Tricuspid annulus diameter (mm), Tricuspid annular plane systolic excursion (TAPSE) (mm), right ventricular fractional area change (%), Systolic pulmonary artery pressure (mm/Hg), left ventricular ejection fraction (%), six-minute walking test (6-MWT), degree of regurgitation after the procedure, and New York Heart Association (NYHA) classification.

The secondary outcomes were Procedural success, Procedure time (min), Fluoroscopy duration (min), Length of hospital stay (days), ICU stay (day), 30-day Mortality, In hospital Mortality, Myocardial infarction, Stroke, Major bleeding, Acute kidney injury, Tamponade, Conversion to surgery, and Single-leaflet device attachment.

Statistical analysis

We used R version 4.2.2 (2022-10-31) and R Studio version 2022.07.2 (2009–2022) RStudio, Inc.). For dichotomous data, we analyzed the risk ratio (RR) and 95% confidence interval (CI), while continuous data were analyzed as mean difference (MD) and 95% CI. To assess statistical heterogeneity among studies, we conducted a visual inspection of the forest plot, in addition to using the I-squared (I^2) and chi-squared (Chi^2) statistics. I^2 values of 50% or higher were considered indicative of significant heterogeneity. When there was significant variation in the data, a random-effects model was employed; otherwise, a fixed-effect model was applied.

Results

Study selection

The comprehensive search across all databases yielded 2239 articles. Once duplicates were removed, 1505 articles were left for screening. After the initial screening, 129 articles were eligible for further evaluation. Following this, a secondary screening of these articles’ full texts resulted in 21 articles [7, 16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35] being selected for inclusion in the study and subsequent analysis (Fig. 1: PRISMA flow diagram).

Fig. 1
figure 1

PRISMA flow diagram of the literature search results, illustrating the process of study selection and inclusion criteria

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Characteristics of the included studies

Table 1 provides a summary of the included studies, which together involve a total of 2178 patients. Detailed characteristics of the participants are presented in Supplementary 2 Table S1.

Table 1 Summary of the included studies
Full size table

Quality assessment

According to the Newcastle–Ottawa Scale, all included studies were assessed as poor quality, except for eight studies deemed of good quality. Detailed quality assessment information is available in Supplementary 3 Table S2. According to the ROBINS-I tool, only the studies by Baldus et al. 2022 [32] and Kodali et al. 2021 [23] were identified as having a moderate risk regarding the measurement of outcomes. (Fig. 2) (Supplementary 3 Table S3).

Fig. 2
figure 2

Risk of bias assessment in non-randomized studies using the ROBINS-I tool, showing an overall moderate to high quality of the included studies

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Primary outcomes

Vena contracta width (mm)

TriClip demonstrated a more substantial reduction in vena contracta width at discharge compared to both MitraClip and PASCAL [(MD = -7.4; 95%CI: -9.24, -5.56; I2 = NA), (MD = -4.04; 95%CI: -5.03, -3.05; I2 = 0%), and (MD = -6.56; 95%CI: -7.76, -5.35; I2 = 0%); respectively]. Test for subgroup difference showed a significant difference among the three groups (P < 0.01) favoring TriClip > Pascal > MitraClip. (Fig. 3).

Fig. 3
figure 3

Forest plot of the single-arm meta-analysis of the mean difference (MD) in vena contracta width (mm). The results show a significant reduction in vena contracta width favoring the TriClip system, indicating its effectiveness in reducing tricuspid regurgitation

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Effective regurgitant orifice area (EROA) (mm²)

There was no significant difference regarding EROA after MitraClip, Pascal and TriClip at discharge [(MD = -37.69; 95%CI: -60.59, -14.79; I2 = 90%), (MD = -30.85; 95%CI: -39.34, -22.37; I2 = 18%), and (MD = -24; 95%CI: -32.82, -15.18; I2 = NA); respectively]. Test for subgroup difference among the three groups (P = 0.39). Following a leave one out sensitivity analysis, the heterogeneity could not be fully resolved due to methodological variations between the pooled studies (Fig. 4).

Fig. 4
figure 4

Forest plot of the single-arm meta-analysis of the mean difference (MD) in effective regurgitant orifice area (EROA) (cm²). No significant differences are observed between the systems, suggesting comparable outcomes in EROA reduction

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Tricuspid regurgitant volume (ml)

Our analysis showed no significant difference regarding the tricuspid regurgitant volume after MitraClip, Pascal and TriClip at discharge [(MD = -21.13; 95%CI: -31.12, -11.14; I2 = 83%), (MD = -17.08; 95%CI: -23.53, -10.63; I2 = 37%), and (MD = -15.90; 95%CI: -22.22, -9.58; I2 = NA); respectively]. Test for subgroup difference showed no significant difference among the three groups (P = 0.68). After sensitivity analysis was done, the heterogeneity could not be fully resolved due to methodological variations between the pooled studies. (Fig. 5).

Fig. 5
figure 5

Forest plot of the single-arm meta-analysis of the mean difference (MD) in tricuspid regurgitant volume (ml). The analysis reveals no significant differences between the systems, indicating uniform effects on tricuspid regurgitant volume

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Tricuspid annular plane systolic excursion (TAPSE) (mm)

The changes in TAPSE after MitraClip, Pascal, and TriClip procedures at discharge were comparable, with no significant differences [MD = -1.21; 95%CI: -1.80, -0.62; I2 = 0%), (MD = -0.19; 95%CI: -0.36, -0.02; I2 = 16%), and (MD = -0.5; 95%CI: -0.44, 1.44; I2 = NA); respectively]. Test for subgroup differences showed a significant difference among the three groups (P < 0.01) (Fig. 6).

Fig. 6
figure 6

Forest plot of the single-arm meta-analysis of the mean difference (MD) in tricuspid annular plane systolic excursion (TAPSE) (mm). The results demonstrate a significant reduction with the MitraClip system, suggesting improved systolic function

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Right ventricular fractional area change (RV-FAC) (%)

The meta-analysis showed no significant difference in RV-FAC after MitraClip, Pascal and TriClip at discharge [MD = -2.15; 95%CI: -4.86, 0.56; I2 = 63%), (MD = -3.56; 95%CI: -6.83, -0.28; I2 = 26%), and (MD = 0.86; 95%CI: -1.19, 2.91; I2 = NA); respectively]. The test for subgroup differences among the three groups revealed no significant difference (P = 0.05). Following a leave one out sensitivity analysis, the heterogeneity could not be fully resolved due to methodological variations between the pooled studies (Fig. 7).

Fig. 7
figure 7

Forest plot of the single-arm meta-analysis of the mean difference (MD) in right ventricular area change (%). No significant differences are observed between the systems, indicating similar effects on right ventricular dimensions

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Left ventricular ejection fraction (LVEF) (%)

No significant difference was detected regarding the postinterventional LVEF following MitraClip, Pascal and TriClip implantation at discharge [(MD = 0.88; 95%CI: -1.43, 3.18; I2 = 0%), (MD = -0.95; 95%CI: -7.61, 5.71; I2 = 77%), and (MD = 0.66; 95%CI: -1.71, 3.03; I2 = NA); respectively]. The test for subgroup differences among the three groups indicated no significant difference (P = 0.88) (Fig. 8).

Fig. 8
figure 8

Forest plot of the single-arm meta-analysis of the mean difference (MD) in ejection fraction (%). The analysis shows no significant differences between the systems, reflecting comparable impacts on overall cardiac function

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Six-minute walking test (6-MWT) (m.)

The change in the six-minute walking test (6-MWT) after MitraClip and Pascal procedures displayed no significant difference at discharge [MD = 54.88; 95%CI: 25.57, 84.20; I2 = 14%), and (MD = 58.52; 95%CI: 29.32, 87.72; I2 = 0%); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.86) (Fig. 9).

Fig. 9
figure 9

Forest plot of the single-arm meta-analysis of the mean difference (MD) in 6-minute walk test (6-MWT). No significant differences are observed between the systems, indicating similar outcomes in exercise capacity

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Secondary outcomes

Procedural success

Procedural success after MitraClip, Pascal and TriClip at discharge was [81%; 95%CI: 74%, 86%; I2 = 72%), (76%; 95%CI: 67%, 84%; I2 = 31%), and (92%; 95%CI: 83%, 97%; I2 = NA); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.05). After sensitivity analysis was done, the heterogeneity could not be fully resolved due to methodological variations between the pooled studies. (Supplementary 4. Figure S1).

Single-leaflet device attachment (SLDA)

SLDAs after MitraClip, Pascal and TriClip at discharge were [8%; 95%CI: 4%, 15%; I2 = 1%), (6%; 95%CI: 2%, 16%; I2 = 0%), and (7%; 95%CI: 2%, 15%; I2 = NA); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.86) (Supplementary 4. Figure S2).

Postoperative NYHA I and II

Number of patients in NYHA I and II after MitraClip, Pascal and TriClip at discharge was [72%; 95%CI: 64%, 80%; I2 = 78%), (75%; 95%CI: 57%, 87%; I2 = 68%), and (82%; 95%CI: 75%, 88%; I2 = 0%); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.15) (Supplementary 4. Figure S3).

Postoperative NYHA III and IV

Number of patients in NYHA III and IV after MitraClip, Pascal and TriClip at discharge was [33%; 95%CI: 21%, 47%; I2 = 85%), (23%; 95%CI: 12%, 38%; I2 = 70%), and (18%; 95%CI: 12%, 25%; I2 = 0%); respectively]. Test for subgroup differences showed also no significant difference among the three groups (P = 0.1) (Supplementary 4. Figure S4).

30-day Mortality

Mortality after 30 days after MitraClip, and Pascal was [(4%; 95%CI: 3%, 5%; I2 = 0%), and (6%; 95%CI: 2%, 19%; I2 = 0%); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.53) (Supplementary 4. Figure S5).

Stroke

Stroke after MitraClip, Pascal and TriClip at discharge was [1%; 95%CI: 0%, 1%; I2 = 0%), (2%; 95%CI: 1%, 5%; I2 = 0%), and (2%; 95%CI: 0%, 10%; I2 = 0%); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.31) (Supplementary 4. Figure S6).

Postoperative major bleeding

Rate of postoperative major bleeding after MitraClip, Pascal and TriClip was [8%; 95%CI: 5%, 13%; I2 = 58%), (5%; 95%CI: 2%, 10%; I2 = 0%), and (2%; 95%CI: 0%, 10%; I2 = 0%); respectively]. Test for subgroup differences showed insignificant difference among the three groups (P = 0.18) (Supplementary 4. Figure S7).

Fluoroscopy time (min)

Fluoroscopy time during MitraClip, Pascal and TriClip procedures was [(MD = 18.80; 95%CI: 12.09, 25.51; I2 = NA), (MD = 37.35; 95%CI: 31.39, 43.31; I2 = 31%), and (MD = 29.60; 95%CI: 26.15, 33.05; I2 = 0%); respectively]. Test for subgroup differences showed a significant longer fluoroscopy time with Pascal more than both other systems (P < 0.01) (Supplementary 4. Figure S8).

Hospital stay duration (day)

Length of hospital stay (LOS) after MitraClip, Pascal and TriClip at discharge was [(M = 10.02; 95%CI: 7.43, 12.61; I2 = 90%), (M = 3.v83; 95%CI: 1.29, 6.38; I2 = 91%), and (M = 4.98; 95%CI: -0.28, 10.25; I2 = 99%); respectively]. Test for subgroup differences showed significant difference among the three groups (P < 0.01) (Supplementary 4. Figure S9).

Procedural time (min)

Procedural time after MitraClip, Pascal and TriClip was [(MD = 117.04; 95%CI: 88.38, 145.69; I2 = 95%), (MD = 84.73; 95%CI: 51.97, 117.49; I2 = 92%), and (MD = 127.54; 95%CI: 116.44, 138.65; I2 = 24%); respectively]. Test for subgroup differences showed no significant difference among the three groups (P = 0.05) (Supplementary 4. Figure S10).

Discussion

This study compared the clinical outcomes and safety profiles of three TTVR devices: MitraClip, PASCAL, and TriClip. TriClip exhibited the greatest effectiveness in reducing vena contracta width, with PASCAL and MitraClip following in effectiveness. There were no significant differences in effective regurgitant orifice area (EROA) or tricuspid regurgitant volume among the devices. Procedural success rates were consistently high for all three devices, and the incidence of single leaflet device attachments (SLDAs) was comparable across the devices. Additionally, there were no significant differences in mortality, stroke rates, or major bleeding events among the three groups.

No significant differences were observed among the three devices regarding effective regurgitant orifice area (EROA) and tricuspid regurgitant volume, indicating that all three devices offer comparable effectiveness in reducing tricuspid regurgitation (TR). However, both the TriClip and PASCAL devices demonstrated a more pronounced reduction in vena contracta compared to the MitraClip. This suggests that the TriClip and PASCAL may be more effective for patients with larger coaptation gaps. These findings could be due to the inherent structural advantages of the TriClip and PASCAL devices over the MitraClip. Notably, the TriClip is specifically designed for the anatomy of the tricuspid valve, whereas the MitraClip was originally developed for mitral valve repair, potentially influencing their relative effectiveness in treating TR [25]. The PASCAL device is designed with a central spacer that optimizes the maximum span width while minimizing excessive tension on the tricuspid leaflets [23, 32, 36]. Furthermore, the PASCAL device features wider clasps compared to the MitraClip, which may distribute forces more evenly across the tricuspid leaflets. The clasps can be operated either simultaneously or independently, allowing for more precise and effective leaflet insertion [23, 32, 36]. It is worth noting that some of these advanced features are now incorporated into the latest generation of MitraClips, known as the MitraClip G4. The MitraClip G4 includes independent grasping capabilities and broader arms, potentially improving its effectiveness in tricuspid valve procedures [37, 38].

TTVR has demonstrated effectiveness in reducing tricuspid regurgitation (TR). This reduction alleviates right ventricular volume overload, thereby improving right ventricular function and reducing venous congestion, which leads to symptom relief [39]. Our meta-analysis revealed that post-interventional changes in right ventricular function, as assessed by TAPSE and RV-FAC, were similar across the three devices, with no significant differences observed. While there was a slight, nonsignificant inclination favoring TriClip, indicating potential additional benefits for patients with impaired right ventricular function, it’s crucial to acknowledge that these variations may be influenced by differences in study cohorts. Further comparative studies are essential to optimize the selection of individual devices for diverse patient cohorts.

The current meta-analysis underscores the efficacy of TTVR in reducing tricuspid regurgitation (TR) and establishes its strong safety profile. The analysis demonstrates high procedural success rates and minimal occurrences of postoperative major bleeding, stroke, and 30-day mortality following TTVR. These positive outcomes were consistent across all three devices examined, highlighting the broader applicability and reliability of TTVR as a safe and effective intervention for TR.

It is important to acknowledge the limitations of this meta-analysis. Firstly, the included studies exhibited significant variations in study design, patient characteristics, and procedural techniques, which could introduce heterogeneity and potential biases. Secondly, the number of studies available for each valve type was limited, particularly for randomized controlled trials (RCTs), affecting the statistical power and generalizability of the findings. Lastly, variations in the follow-up durations of the included studies may have impacted the assessment of long-term outcomes.

Conclusions

The TriClip showed more effectiveness than the MitraClip and PASCAL in reducing vena contracta width, a key measure of tricuspid regurgitation (TR). While all devices have similar safety profiles and procedural success rates, the TriClip’s superior performance in this outcome suggests it may be particularly beneficial for severe TR. Further research is needed to confirm these findings and evaluate long-term outcomes.

Data availability

Most of the data generated or analyzed during this study are included in the supplementary information files. All additional datasets used or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

TR:

Tricuspid regurgitation

TTVR:

Transcatheter tricuspid valve repair

TEE:

Transesophageal echocardiography

MR:

Mitral regurgitation

NYHA:

New York Heart Association

6-MWT:

Six minutes walking test

EROA:

Effective regurgitant orifice area

TAPSE:

Tricuspid annular plane systolic excursion

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Acknowledgements

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Authors and Affiliations

  1. University of Erlangen-Nuremberg, Erlangen, Germany

    Mahmoud Balata

  2. University of Bonn, Bonn, Germany

    Mahmoud Balata & Marc Ulrich Becher

  3. Faculty of Medicine, October 6 University, Giza, Egypt

    Mohamed Ibrahim Gbreel

  4. Theodor Bilharz Research Institute, Giza, Egypt

    Marwa Hassan

  5. Department of Cardiology, City hospital Solingen, Solingen, Germany

    Marc Ulrich Becher

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(MB& MIG) Conceptualization, Methodology, Software, Formal analysis, Project Administration. (MB & MH) Conceptualization, Writing – original draft preparation, Writing – review & editing, Visualization. (MB, MIG & MUB) Writing – review & editing. (MH & MUB) Conceptualization, Methodology, Writing – original draft preparation, Writing – review & editing, Supervision.

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Balata, M., Gbreel, M.I., Hassan, M. et al. Comparative analysis of MitraClip/TriClip and PASCAL in transcatheter tricuspid valve repair for tricuspid regurgitation: a systematic review and meta-analysis. BMC Cardiovasc Disord 24, 557 (2024). https://doi.org/10.1186/s12872-024-04201-6

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Keywords

BMC Cardiovascular Disorders

ISSN: 1471-2261

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