One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation

Mehilli, Julinda; Jochheim, David; Abdel‐Wahab, Mohamed; Rizas, Konstantinos D.; Theiß, Hans; Spenkuch, Nina; Zadrozny, Magda; Baquet, Moritz; El-Mawardy, Mohamed; Sato, Takao; Lange, Philipp; Kuppatt, Christian; Martin, Guillaume; Hausleiter, Jörg; Bauer, Axel; Schwarz, Florian; Pichlmaier, Maximilian; Hagl, Christian; Richardt, Gert; Maßberg, Steffen

doi:10.4244/eijv12i10a213

Cited by 41 publications

(34 citation statements)

References 26 publications

(29 reference statements)

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“…On the other hand, we only compared one percutaneous device with the surgical procedure. Here, the comparison was made specifically with the Perclose ProGlide™ system, which prevailed in a head-tohead comparison with the also used ProStar™ device (Abbott, Chicago, IL, USA) [15,16].…”

Section: Discussionmentioning

confidence: 99%

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Eckner

Pollari

Santarpino

et al. 2021

JCM

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Background: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. Methods: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. Results: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). Conclusions: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

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Section: Discussionmentioning

confidence: 99%

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Eckner

Pollari

Santarpino

et al. 2021

JCM

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“…With the first-generation TAVI devices, major vascular complications (VC) occurred in ∼10% of patients (6)(7)(8)(9)(10). The occurrence of major VC proved to be associated with higher rates of morbidity and mortality (6,(11)(12)(13).…”

Section: Introductionmentioning

confidence: 99%

Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices

Gonska

Reuter

Mörike

et al. 2021

Front. Cardiovasc. Med.

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Background: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) are associated with morbidity and mortality. However, consistent predictors have not been identified yet. The size of the implantation sheath seems to play a role, though especially with new generation TAVI devices and their improved sheaths and delivery systems this remains uncertain.Objectives: This study aimed to determine the incidence and predictors of access site-related vascular complications (VC) in the era of new generation TAVI devices.Methods and Results: Four hundred consecutive patients receiving TAVI in an experienced tertiary care center were analyzed. VC occurred in 89 patients (22.25%) with the majority being minor VC (21%) and only 1.25% major VC. Possible predictors for VC were tested, and only peri-interventional dual antiplatelet therapy (DAPT) showed to be predictive for VC [OR 2.11 (95% CI 1.10–4.06, p = 0.025)]. The female gender [OR 0.75 (95% CI 0.44–1.3), p = 0.31], sheath to femoral artery ratio >1.05 [OR 1.18 (95% CI 0.66–2.08, p = 0.58)], calcification of the access site vessel [OR 0.83 (95% CI 0.48–1.42, p = 0.48)], known peripheral artery disease [OR 0.95 (95% CI 0.4–2.25, p = 0.9)], and BMI ≥ 25 kg/m2 [OR 0.69 (95% CI 0.41–1.19, p = 0–19)] were not predictive of VC. The larger sheath with 20 French even showed less VC than the smaller sheath with 16 French [OR 0.43 (95% CI 0.25–0.74, p = 0.002)].Conclusions: Overall, the rate of major and minor VC was low in this study population (for major VC: rate of 1.25%). Predefined risk factors were not associated with the occurrence of VC, except for peri-interventional treatment with DAPT. Especially, larger sheath size could not be identified as a predictor for VC in the setting of TAVI procedures performed with contemporary devices.

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“…The first percutaneous closure device used was the Prostar ® closure, later came the Proglide ® with a pre-closure system that led to technical simplification and lower costs. The closure of vascular access using two Proglide ® devices carries a lower risk of vascular complications compared to closure with Prostar ® (34). The collagen closure device MANTA ® is now available with similar results to suturebased closure devices (35).…”

Section: Vascular Complicationsmentioning

confidence: 99%

Transcatheter aortic valve replacement (TAVR): expanding indications to low-risk patients

Cubero-Gallego

Dam²,

Meca

et al. 2020

Ann Transl Med

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Aortic stenosis (AS) is the most common cardiac valve disease in developed countries.Transcatheter aortic valve replacement (TAVR) for the treatment of severe symptomatic AS is an accepted therapy option for elderly patients with symptomatic severe AS. Nowadays, TAVR has revolutionized the treatment of AS with an exponential growth worldwide. Both the development of new generation valves and the experience of the operating teams have contributed significantly to decrease the complications rate after TAVR. Several randomized trials have reported similar short-and mid-term results, and even better than surgical aortic valve replacement (SAVR) in patients with high-or intermediate-risk. In addition, two comparison trials in low-risk patients have reported promising results. Therefore, in the future TAVR indications will expand, treating younger and younger patients, with less comorbidities and lower risk. However, the long-term durability of percutaneous prostheses is a matter of debate. The aim of this manuscript is to review available data that support to treat AS in low-risk patients and provide our perspective on the topic.

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One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation

Abstract: In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.

Cited by 41 publications

References 26 publications

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices

Transcatheter aortic valve replacement (TAVR): expanding indications to low-risk patients

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