scholarly journals Transcatheter aortic valve replacement using the iSleeve expandable sheath in small femoral arteries

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001703
Author(s):  
Natalie Glaser ◽  
Crochan J. O'Sullivan ◽  
Nawzad Saleh ◽  
Dinos Verouhis ◽  
Magnus Settergren ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Femoral Artery ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Femoral Arteries ◽  
Transcatheter Aortic Valve ◽  
Significant Difference

BackgroundSmall femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries.MethodsIn this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5–9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9–5.4).ResultsThere was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter.ConclusionTransfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.

Low Incidence of Prosthesis-Patient Mismatch Following Extremely Small Transcatheter Aortic Valve Replacement with 20-mm Sapien 3

2021 ◽  
Author(s):  
Kazue Okajima ◽  
Ikki Komatsu ◽  
Todd B. Seto
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Outcome Data ◽  
Bleeding Complications ◽  
Effective Orifice Area ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
Sapien 3

AbstractTranscatheter aortic valve replacement has been developed as an emerging technique to treat patients with aortic valve disease. However, safety and outcome data on extremely small transcatheter heart valves (THV) is limited. We aimed to assess hemodynamic profiles and clinical outcome of very small balloon expandable THVs with 20-mm Sapien 3 (SP3).We examined data for all patients who received third-generation SP3 THV at a single hospital. Complications and clinical outcomes were defined based on the VARC-2 criteria. Postoperative prosthesis-patient mismatch (PPM) was defined as indexed effective orifice area (EOA) < 0.85 cm2/m2. We compared clinical characteristics and outcome between patients with 20-mm (n = 21), 23-mm (n = 67), and 26- or 29-mm (n = 113) sized valves.The 20-mm group included significantly higher number of Asian and female populations with lower body surface area. The baseline CT annular area in the 20-mm group was 316.5 ± 24.9 mm2. There was no significant difference between groups in procedural mortality or early safety at 30 days. The higher procedural complication was observed in 20-mm group due to significant differences in minor vascular and bleeding complications. Despite higher post-THV gradients and smaller indexed EOA in 20-mm group, no PPM was observed in 20-mm group. The mortality at 30 days and 1 year in 20-mm group was 4.8% and 16.7%, respectively.The patients who received very small THVs with 20-mm SP3 did not result in PPM and experienced favorable early safety and midterm outcome in our cohort.

Abstract 17539: Conventional vs. Transcatheter Aortic Valve Replacement - Propensity Score Adjusted Comparison of 3,751 Unselected Patients

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Jochen Börgermann ◽  
Eric Emmel ◽  
Smita Scholtz ◽  
Stephan Ensminger ◽  
Werner Scholtz ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Aortic Valve ◽  
Propensity Score ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Moderate Risk ◽  
Transcatheter Aortic Valve

Background and Hypothesis: Transcatheter aortic valve replacement (TAVR) is an established method in high-risk patients. Two aspects of this procedure are currently under discussion: 1.) Do the data acquired from randomized studies and registers justify expansion of the procedure to include younger and healthier patients? 2.) Is the transfemoral approach superior to the transapical approach with regard to mortality and periprocedural complications? Against this background we examined the mortality and morbidity of all patients who received an isolated conventional, transapical or transfemoral aortic valve replacement in accordance with the criteria of the Valve Academic Research Consortium (VARC)-2. Methods: A prospective register was taken from a single center recording all conventional (CONV, n=2,881), transapical (TAVR-TA, n=363) and transfemoral (TAVR-TF, n=570) aortic valve implantations during the period from 07/2009 to 10/2014. Using propensity score (PS) matching, first CONV and TAVRall (TA+TF) and then TAVR-TA and TAVR-TF were paired on the basis of 21 risk variables, creating comparable groups. Results: 393 pairs CONV vs. TAVRall within a moderate risk could be created (EuroSCORE 18.7 vs. 18.5; STS 5.0 vs. 5.4). Comparison revealed no difference for 30d mortality (4.6% CONV vs. 5.1% TAVRall, p=0.74), stroke (2.8% vs. 2.0%, p=0.48) or myocardial infarction (0.0 vs. 0.3%, p=0.50). Bleeding complications were significantly more frequent in the CONV, SM implantations and vascular complications in the TAVRall group. In the PS-adjusted comparison TAVR-TA vs. TAVR-TF (289 pairs; EuroSCORE 25.1 vs. 22.1; STS 6.8 vs. 6.7) there was also no difference in the hard endpoints (30d mortality 4.9% TA vs. 4.2% TF, p=0.70; stroke 3.1% vs. 2.8%, p=0.81; myocardial infarction 0.4% vs. 0.4%, p=1.00). Here bleeding complications were significantly more frequent in the TA group, SM implantations and vascular complications in the TF group. Subgroup analyses show an advantage of the TAVR procedure in patients with high STS or low LVEF. Conclusions: These data show that 1.) conventional aortic valve replacement and TAVR are comparable in the moderate risk group, and 2.) the two approaches, transapical and transfemoral, produce comparable results.

Surgical Cutdown Avoids Vascular Complications in Transcatheter Aortic Valve Replacement in Calcified and Small Femoral Arteries

2021 ◽  
Author(s):  
Melchior Burri ◽  
Hendrik Ruge ◽  
Magdalena Erlebach ◽  
Rüdiger Lange
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Third Generation ◽  
Femoral Arteries ◽  
Percutaneous Access ◽  
Transcatheter Aortic Valve ◽  
Sapien 3

Abstract Background Third-generation transcatheter heart valves (THV) are predominantly implanted through a percutaneous, transfemoral access. To reduce vascular complications, we selectively performed surgical vascular access (cutdown) in patients with particular calcified or small femoral arteries. We aim to review our experience with this approach. Methods All patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with a third-generation THV at our institution between March 2014 and April 2019 were included in the study. All available computerized tomography studies were reassessed for access vessel diameter and visual graduation of calcifications. Vascular complications are reported according to Valve Academic Research Consortium-2 criteria. Results A total of 944 patients were included. Among them, 879 patients underwent a percutaneous access and 65 patients underwent surgical cutdown. Also, 459 Evolut R/PRO and 420 Sapien 3/ultra were implanted percutaneously and 40 Evolut R/PRO and 25 Sapien 3 were implanted with a surgical cutdown. Patients with surgical cutdown were older (80.0 ± 7.5 vs. 83.8 ± 7.5 years, p < 0.001), had smaller femoral arteries (8.0 ± 1.6 vs. 7.6 ± 1.6 mm, p = 0.034) and more severe vessel calcifications (17.5 vs. 1.0%, p < 0.001). Procedure time was similar for cutdown and percutaneous access (64.0 vs. 64.5 minutes, p = 0.879). With percutaneous access, 80 major vascular complications (10%) occurred, whereas with surgical cutdown, no major vascular complications occurred (p < 0.005). No wound infection occurred after surgical cutdown. The mean length of stay was 8 days in both groups. Conclusion Surgical cutdown for vascular access avoids vascular complications in patients with small or severely calcified femoral arteries.

scholarly journals Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

2020 ◽  
Vol 28 (12) ◽  
pp. 639-644 ◽  
Author(s):  
J. Halim ◽  
L. Missault ◽  
M. Lycke ◽  
J. Van der Heyden
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Closure Device ◽  
Single Centre ◽  
Access Site ◽  
Transcatheter Aortic Valve

Abstract Objectives The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). Background To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. Methods In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. Results Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. Conclusions This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Abstract 15741: Long Term Survival Following Transcatheter Aortic Valve Replacement: Results From a Single US High Volume Center

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ricardo O Escarcega ◽  
Rebecca Torguson ◽  
Marco A Magalhaes ◽  
Nevin C Baker ◽  
Sa’ar Minha ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Term Survival ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
Long Term Mortality

Introduction: Mortality following Transcatheter aortic valve replacement (TAVR) has been reported up to 5 years. However, mortality after 5 years remains unclear. Hypothesis: We aim to determine the mortality in patients undergoing TAVR >5 years follow up. Methods: From our institution’s prospectively collected TAVR database we analyzed all patients undergoing TAVR to a maximum follow up of 8 years. We divided our population into transapical TAVR (TA-TAVR) and transfemoral TAVR (TF-TAVR) groups. A Kaplan-Meier survival analysis was conducted. Results: A total of 511 patients who underwent TAVR were included in the analysis. Patients undergoing TA-TAVR had higher rates of peripheral vascular disease compared with TF-TAVR (56% vs 29%, p<0.001) and Society of Thoracic Surgeons Score (10.9 ± 4 vs 9.2 ± 4, p<0.001). TA-TAVR was associated with higher mortality at 1 year (32% vs 21%, p=0.01). However, there was no significant difference in very-long term mortality of patients undergoing TA-TAVR vs TF-TAVR (Figure). Conclusions: Long-term mortality following TAVR surpasses 50%. While in the first 2 years TA-TAVR is associated with higher mortality rates after three years the survival rates are similar in both approaches.

Bleeding Complications Drive In-Hospital Mortality of Patients with Atrial Fibrillation after Transcatheter Aortic Valve Replacement

2020 ◽  
Vol 120 (11) ◽  
pp. 1580-1586 ◽  
Author(s):  
Achim Lother ◽  
Klaus Kaier ◽  
Ingo Ahrens ◽  
Wolfgang Bothe ◽  
Dennis Wolf ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Factor ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Hospital Mortality ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Bleeding Complications ◽  
Hospital Outcome ◽  
Transcatheter Aortic Valve

Abstract Background Atrial fibrillation (AF) is a risk factor for poor postoperative outcome after transfemoral transcatheter aortic valve replacement (TF-TAVR). The present study analyses the outcomes after TF-TAVR in patients with or without AF and identifies independent predictors for in-hospital mortality in clinical practice. Methods and Results Among all 57,050 patients undergoing isolated TF-TAVR between 2008 and 2016 in Germany, 44.2% of patients (n = 25,309) had AF. Patients with AF were at higher risk for unfavorable in-hospital outcome after TAVR. Including all baseline characteristics for a risk-adjusted comparison, AF was an independent risk factor for in-hospital mortality after TAVR. Among patients with AF, EuroSCORE, New York Heart Association classification class, or renal disease had only moderate effects on mortality, while the occurrence of postprocedural stroke or moderate to major bleeding substantially increased in-hospital mortality (odds ratio [OR] 3.35, 95% confidence interval [CI] 2.61–4.30, p < 0.001 and OR 3.12, 95% CI 2.68–3.62, p < 0.001). However, the strongest independent predictor for in-hospital mortality among patients with AF was severe bleeding (OR 18.00, 95% CI 15.22–21.30, p < 0.001). Conclusion The present study demonstrates that the incidence of bleeding defines the in-hospital outcome of patients with AF after TF-TAVR. Thus, the periprocedural phase demands particular care in bleeding prevention.

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