Impact of closure devices on vascular complication and mortality rates in TAVI procedures
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)
- et al.
Transfemoral aortic valve implantation: new criteria to predict vascular complications
JACC Cardiovasc. Interv.
(2011) - et al.
Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions
Am. J. Cardiol.
(2015) - et al.
Management of vascular access in transcatheter aortic valve replacement part 2: vascular complications
JACC Cardiovasc. Interv.
(2013) - et al.
Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis
J. Am. Coll. Cardiol.
(2012) - et al.
Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis
J. Am. Coll. Cardiol.
(2012) - et al.
Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device
Am. J. Cardiol.
(1999) - et al.
Management of vascular access in transcatheter aortic valve replacement: part 2: vascular complications
JACC Cardiovasc. Interv.
(2013) - et al.
Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document
J. Am. Coll. Cardiol.
(2012) - et al.
Usefulness of percutaneous aortic valve implantation to improve quality of life in patients > 80 years of age
Am. J. Cardiol.
(2010) - et al.
True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications
JACC Cardiovasc. Interv.
(2012)
Incidence, predictors and prognostic value of serious hemorrhagic complications following transcatheter aortic valve implantation
Int. J. Cardiol.
Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve)
J. Am. Coll. Cardiol.
Cited by (27)
Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis
2023, Cardiovascular Revascularization MedicineCitation Excerpt :Recently, MANTA (Teleflex, Wayne, PA, USA), a plug-based VCD, has become available and has demonstrated safe and reliable arteriotomy closure in a single-arm study [6]. Comparisons between these VCDs have been conducted as retrospective observational studies or randomized control trials (RCTs), however, most available studies are two-arm comparisons of either Prostar versus Proglide [7,8] or Proglide versus MANTA [9,10], and the superiority among these three VCDs remains unclear. Furthermore, there was variability in the outcomes due to the limited number of individual events and it is difficult to conclude the risk difference between these devices in the individual studies.
Vascular Closure Devices for Large-Bore Mechanical Circulatory Support Devices: Becoming MANT(d)Atory?
2020, Cardiovascular Revascularization MedicineRisk Factors for Closure Failure following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation
2020, Annals of Vascular SurgeryCitation Excerpt :In this study, PCD failure as a result of arterial stenosis or occlusion at the access site (61.9%, n = 13) was more common than insufficient hemostasis. Similar findings were also observed in several studies.10,15,16 However, the mechanism of arterial stenosis occurrence remains uncertain.
Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA
2019, American Journal of CardiologyCitation Excerpt :Two closure devices were used at the TAVI-access site: Prostar XL (Abbott Vascular, Abbott Park, Illinois) and MANTA (Essential Medical inc., Malvern, Pennsylvenia). The mechanism and design of both closure devices have been previously described.10,11,13 Three interventional cardiologists and 3 cardiac surgeons performed TAVI procedures during the study period.
Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement
2019, International Journal of CardiologyCitation Excerpt :To our best knowledge, the intentional utilization of this hybrid technique for vascular access closure following TF-TAVR has not been previously described in the literature. In previous literature, the failure rates of Prostar and dual PP devices have been reported at 4–19%, with sheath sizes ranging from 18 to 24Fr [1,7,8,14,15]. The rationale of the present hybrid technique is to first shrink the large-bore puncture hole to 8Fr in diameter by the PP suture, and then utilize the re-absorbable collagen plug and the footplate (composed of ploylactide and polyglycolide polymer) of AS device to achieve complete haemostasis.
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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.