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

Author(s):  
Kazue Okajima ◽  
Ikki Komatsu ◽  
Todd B. Seto

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.

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001703
Author(s):  
Natalie Glaser ◽  
Crochan J. O'Sullivan ◽  
Nawzad Saleh ◽  
Dinos Verouhis ◽  
Magnus Settergren ◽  
...  

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.


Author(s):  
Tamim M. Nazif ◽  
Thomas J. Cahill ◽  
David Daniels ◽  
James M. McCabe ◽  
Mark Reisman ◽  
...  

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score–matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P =0.10), major vascular complications (1.1% versus 1.0%, P =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P =0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ricardo O Escarcega ◽  
Rebecca Torguson ◽  
Marco A Magalhaes ◽  
Nevin C Baker ◽  
Sa’ar Minha ◽  
...  

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.


2020 ◽  
Vol 120 (11) ◽  
pp. 1580-1586 ◽  
Author(s):  
Achim Lother ◽  
Klaus Kaier ◽  
Ingo Ahrens ◽  
Wolfgang Bothe ◽  
Dennis Wolf ◽  
...  

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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