Elsevier

International Journal of Cardiology

Volume 241, 15 August 2017, Pages 133-137
International Journal of Cardiology

Impact of closure devices on vascular complication and mortality rates in TAVI procedures

https://doi.org/10.1016/j.ijcard.2017.01.088Get rights and content

Abstract

Background

Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown.

Methods

Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n = 215) and Perclose-Proglide® (n = 183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7 ± 481.8 (727) days.

Results

There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p = 0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p] = 0.02), suture rupture (4.7% vs. 1.3%, p = 0.04), and pseudoaneurysms (10.2% vs. 1.2%, p < 0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3–3.8, p = 0.002) and closure devices (OR 0.5; 95% CI 0.3–0.8, p = 0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6 ± 1.6% vs. Proglide: 4.9 ± 1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p = 0.03).

Conclusion

Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.

Introduction

Transcatheter aortic valve implantation (TAVI) is increasingly recognized as a therapeutic option for patients with severe symptomatic aortic stenosis who cannot undergo conventional surgical aortic valve replacement [1]. Since the introduction of the technique in 2002, tens of thousands of TAVI interventions have been performed worldwide, contributing to an improved procedure quality by reducing associated morbidity and mortality [2].

Despite the procedure's minimally invasive approach, vascular complications may occur early and, in rare cases, even late after a TAVI intervention. These include iliofemoral dissections and stenoses, femoral perforations and vessel ruptures, and bleeding with or without hemodynamic compromisation [2]. Vascular complications are relatively frequent (4–19%) and cause significant morbidity and mortality [3], [4]. Furthermore, they seem to occur more frequently in women, although there may be a higher overall survival rate in female patients [5], [6].

Whereas in the early days of femoral catheterization hemostasis was achieved by manual compression, suture-based closure devices, which were introduced in the early 2000s, have contributed to a significant reduction of the period until hemostasis is achieved as well as to a lower rate of vascular complications [7], [8]. Commonly used devices are Prostar® and ProGlide® (both from Abbott Vascular Inc., Santa Clara, CA, USA). In one study, the reported overall complication rate in diagnostic catheterizations were found to be higher in patients treated with the Prostar-device than for those receiving manual compression. However, the same study showed that these findings did not apply to interventional catheterization [9].

So far, only a few publications have compared the Prostar® and ProGlide® devices with regard to vascular complications and patient mortality, and the results are partly contradictory. Barbash et al. in 2015 reported a significantly higher proportion of vascular complications when using Prostar®. However, results from Barbanti et al. came to the opposite conclusion, although in-hospital mortality was similar in both groups [10], [11].

Therefore, our study aims at comparing the impact of Prostar® (one per patient) and ProGlide® (two per patient) closure devices on the rate of vascular complications and mortality in transfemoral aortic valve implantation (TAVI TF).

Section snippets

Patients

Patients were considered for TAVI if they had severe symptomatic aortic valve stenosis and were classified to be at high risk in conventional surgery due to comorbidities, age, or the presence of a porcelain aorta. All patients underwent coronary angiography, and if significant coronary artery disease (CAD) was present, percutaneous coronary intervention was performed prior to TAVI. Multi-slice computed tomography (MSCT) was part of the screening process in all patients. The resulting CT data

Baseline characteristics and complications in the entire study cohort

Baseline characteristics are presented in Table 1. The Cook sheath was applied in 233 patients (58.5%), the Medtronic sheath in 34 patients (7.8%), the eSheath in 112 patients (28.1%), the Direct Flow sheath in 8 patients (2%), and the SoloPath in 10 patients (2.5%). Table 2 details the complications observed in the whole collective. The average follow-up was 679.7 ± 481.8 (727) days.

Baseline characteristics and complications in the two groups

The baseline data of both groups were not significantly different (Table 1). In the Prostar® group the Cook Sheath

Discussion

Vascular complications occur frequently in TAVI and are associated with significant morbidity and mortality. Suture-based closure devices significantly reduce both time until hemostasis and the incidence of vascular complications [7], [8]. However, there were no conclusive data on the specific advantages and disadvantages of the Prostar® and ProGlide® devices (both from Abbott Vascular Inc., Santa Clara, CA, USA). The aim of the present study was to compare these devices with respect to their

Conclusion

In conclusion, we found that 1) vascular complications occurred more often in the Prostar® group, 2) 30-day mortality did not differ significantly between the groups, and 3) the mortality over the complete follow-up was significantly lower in the ProGlide® group. These findings are of considerable clinical importance since they are based on long-term data collection over two years after the intervention. The results may aid in clinical decision-making regarding the choice of a suture-based

Limitations

This study has some main limitations. First, it is a retrospective, non-randomized study, and, therefore, selection bias cannot be excluded. A randomized prospective study would provide a more reliable analysis. Second, the use of the two devices alternated chronologically. Until 2012, we used the Prostar®; from 2012 on, the Proglide® device was deployed. A synchronous observation of the two devices' effects would have been preferable. However, there were no significant differences in the

Funding

There was no funding of this manuscript.

Conflicts of interest

Zisis Dimitriadis, Marcus Wiemer, Cornelia Piper, Marios Vlachojannis, Dieter Horstkotte, and Lothar Faber declare that they have no conflict of interest.

Smita Scholtz and Werner Scholtz have received honoraria for lectures from Medtronic and Direct Flow Medical and for proctor activities from Direct Flow Medical.

Jochen Börgermann has received horonaria for lectures from Edwards, Maquet, Medtronic and Symetis and for proctor activities from Medtronic.

Stephan Ensminger is proctor and consultant

References (24)

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  • Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis

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  • Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement

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This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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