Incidence, Predictors, and Impact of Vascular Complications After Transfemoral Transcatheter Aortic Valve Implantation With the SAPIEN 3 Prosthesis

Kesteren, Floortje van; Mourik, Martijn S. van; Vendrik, Jeroen; Wiegerinck, Esther M.A.; Henriques, José P.S.; Koch, Karel T.; Wykrzykowska, Joanna J.; Winter, R.J. de; Piek, Jan J.; Lienden, Krijn P. van; Reekers, Jim A.; Vis, Marije M.; Planken, R. Nils; Baan, Jan

doi:10.1016/j.amjcard.2018.01.050

Cited by 43 publications

(39 citation statements)

References 16 publications

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“…Previously reported rates of the early safety composite endpoint for the ACURATE neo range from 8.6% to 15.8%, while in this analysis we found rates of 17.9%, the main contributor being major vascular complications in 13.9% of patients. This finding may be attributed to the larger sheath size of 18–20 Fr necessary for the deployment of this valve representing a possible downside of this THV, especially when treating patients with small anatomies, as a higher sheath to iliofemoral artery ratio has been described as predictor of vascular complications . To address this issue, a novel, expandable 14 Fr sheath iSleeve (Boston Scientific, Marlborough, MA), specifically designed for the ACURATE neo is now available and may possibly further decrease rates of vascular complications.…”

Section: Discussionmentioning

confidence: 99%

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Pellegrini

Rheude

Trenkwalder

et al. 2019

Cathet Cardio Intervent

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ObjectivesTo evaluate 1‐year outcome using the ACURATE neo (Symetis S.A., a Boston Scientific Company, Ecublens, Switzerland) according to the updated Valve Academic Research Consortium (VARC‐2) with emphasis on the composite endpoints “clinical efficacy after 30 days” and “time‐related valve safety”.BackgroundInitial reports on the clinical performance of patients treated with the ACURATE neo are promising; however, information regarding one‐year outcome is scarce, especially with regard to the composite endpoints proposed by the VARC‐2.MethodsOne hundred and fifty one consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with the ACURATE neo for severe aortic valve stenosis were enrolled. Data were prospectively collected and event rates during follow‐up were calculated as the Kaplan–Meier estimates.ResultsMean age was 81.1 ± 5.9 years and 49.7% (75/151) were female with a median logistic EuroScore of 13.8% [8.2–20.5]. Device success was achieved in 88.1% (133/151) and procedure related mortality was 0.7% (1/151). At one‐year, all‐cause mortality was 3.3% (5/151), while permanent pacemaker implantation occurred in 12.7% (19/151) of patients. The “clinical efficacy after 30 days” was observed in 24.8% (37/151), where the main contributor was symptom worsening in 14.8% (22/151) of cases. “Time‐related valve safety” occurred in 22.0% (33/151) with structural valve deterioration as main contributor in 10.7% (16/151) of cases.ConclusionsUsing the ACURATE neo, we found a favorable safety profile with low all‐cause mortality at 1 year. The reported VARC‐2 defined composite endpoints at 1 year reveal low rates of “clinical efficacy after 30 days” and “time‐related valve safety”.

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Section: Discussionmentioning

confidence: 99%

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Pellegrini

Rheude

Trenkwalder

et al. 2019

Cathet Cardio Intervent

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“…The advent of transcatheter aortic valve implantation (TAVI) has been a milestone in the treatment of this pathology [1] and for the diffusion of new transcatheter based cardiac interventions. The development of new and more reliable prosthesis and catheters has reduced the incidence of vascular complications and paravalvular leaks [2,3] and the indications for transcatheter based approach has dramatically increased [4].…”

Section: Introductionmentioning

confidence: 99%

Minimally invasive surgical versus transcatheter aortic valve replacement: A multicenter study

Paparella

Santarpino

Malvindi

et al. 2019

IJC Heart & Vasculature

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Objectives Treatment of aortic valve stenosis is evolving, indications for transcatheter approach (TAVI) have increased but also surgical valve replacement has changed with the use of minimally invasive approaches. Comparisons between TAVI and surgery have rarely been done with minimally invasive techniques (mini-SAVR) in the surgical arm. Aim of the present study is to compare mini-SAVR and TAVI in a multicenter recent cohort. Methods Evaluated were 2904 patients undergone mini-SAVR (2407) or TAVI (497) in 10 different centers in the period 2011–2016. The Heart Team approved treatment for complex cases. The primary outcome is the incidence of 30-day mortality following mini-SAVR and TAVI. Secondary outcomes are the occurrence of major complications following both procedures. Propensity matched comparisons was performed based on multivariable logistic regression model. Results In the overall population TAVI patients had increased surgical risk (median EuroSCORE II 3.3% vs. 1.7%, p ≤ 0.001) and 30-day mortality was higher (1.5% and 2.8% in mini-SAVR and TAVI respectively, p = 0.048). Propensity score identified 386 patients per group with similar baseline profile (median EuroSCORE II ~3.0%). There was no difference in 30-day mortality (3.4% in mini-SAVR and 2.3% in TAVI; p = 0.396) and stroke, surgical patients had more blood transfusion, kidney dysfunction and required longer ICU and hospital length of stay while TAVI patients had more permanent pace maker insertion. Conclusions Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities. A joint evaluation by the heart-team is essential to direct patients to the proper approach.

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“…4,5 In contrast, van Kesteren et al confirmed that MVC influence survival only in the direct postoperative period in the first 30 days. 24 An actual impact of only access site-related MVC on long-term prognosis, however, has not been described to date. Importantly, we identified that (1) access site-related MVC does not have a significant impact on 3-year mortality, unlike non-access site-related MVC; and (2) access site-related MVC with severe bleeding requiring ≥4 units RBC transfusion is associated with an increased risk of early and late mortality.…”

Section: Non-access Site-related Mvcmentioning

confidence: 99%

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

et al. 2020

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death after TAVR via the transfemoral (TF) approach, in association with bleeding complication. Although minor vascular complications do not have an impact on mortality, 4 major vascular complication (MVC) is associated with a significant risk of mortality. 4,5 Although MVC involving T ranscatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis (AS). 1,2 Although the feasibility of TAVR has been proved, there are inherent complications related to the procedure. 3 Vascular complication is a significant cause of

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Incidence, Predictors, and Impact of Vascular Complications After Transfemoral Transcatheter Aortic Valve Implantation With the SAPIEN 3 Prosthesis

Cited by 43 publications

References 16 publications

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Minimally invasive surgical versus transcatheter aortic valve replacement: A multicenter study

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―

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Incidence, Predictors, and Impact of Vascular Complications After Transfemoral Transcatheter Aortic Valve Implantation With the SAPIEN 3 Prosthesis

Cited by 43 publications

References 16 publications

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

One‐year clinical outcome with a novel self‐expanding transcatheter heart valve

Minimally invasive surgical versus transcatheter aortic valve replacement: A multicenter study

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement ― Results From the FinnValve Registry ―

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Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　― Results From the FinnValve Registry ―