scholarly journals Pacemaker implantation rate after TAVI with the latest generation balloon-expandable valve SAPIEN 3 Ultra

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F De Torres-Alba ◽  
G Kaleschke ◽  
J Vormbrock ◽  
H Deschka ◽  
H Baumgartner
Keyword(s):  
At Risk ◽  
Pacemaker Implantation ◽  
Implantation Rate ◽  
Implantation Technique ◽  
Transcatheter Aortic Valve ◽  
Conduction Abnormalities ◽  
Transcatheter Heart Valve ◽  
Significant Difference ◽  
Patients At Risk ◽  
Sapien 3

Abstract Introduction The latest generation balloon-expandable transcatheter heart valve SAPIEN 3 Ultra (S3-Ultra) was recently released and has shown promising initial results. So far, the pacemaker (PM) implantation rate after transcatheter aortic valve implantation (TAVI) with the S3-Ultra system compared to the SAPIEN 3 (S3) system has not been widely investigated. Aims To compare the PM implantation rate after TAVI with the latest generation S3-Ultra system with the S3 system in an unselected cohort of patients at risk. Methods We analyzed the development of conduction abnormalities after TAVI in 1780 consecutive patients treated with S3 and S3-Ultra between January 2014 and February 2021. After excluding valve-in-valve procedures (n=31) and patients with previously implanted PM (n=203) 1546 patients were finally analyzed. All patients at risk (i. e. those without previous PM) were monitored with ECG for at least 7 days after TAVI. Results Of 1546 patients, 1382 were treated with S3 (20 mm, 14; 23 mm, 524; 26 mm, 558; 29 mm, 286) and 164 with S3-Ultra (20 mm, 0; 23 mm, 77; 26 mm, 87). There were no significant differences in baseline demographic, ECG and procedural characteristics. There was no significant difference in the rate of new developed conduction abnormalities or PM implantation rate between S3 and S3-Ultra in the overall cohort (37.8% S3 vs 33,7% S3-Ultra, p=0.451 for all new conduction abnormalities, 13.8% S3 vs 14.6% S3-Ultra, p=0.756 for PM implantation). This comparable PM implantation rate between the two systems was consistent when analyzing only the 23 and 26 mm valve sizes of the S3 system (12.1% S3 vs. 14.6% S3-Ultra, p=0.361) and when excluding the first period of S3 implantation at our institution (2014) before a modification of the implantation technique that lead to a drop in the rate of PM implantations (S3 2015–2020 12.9% vs S3-Ultra 14.6%, p=0.534). Conclusions In our cohort, the PM implantation rate after TAVI with the S3-Ultra system was comparable to that of its predecessor. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Conduction Abnormalities After Transcatheter Aortic Valve Replacement

2019 ◽  
Vol 13 (1) ◽  
pp. 21-29 ◽  
Author(s):  
Somsupha Kanjanauthai ◽  
Kabir Bhasin ◽  
Luigi Pirelli ◽  
Chad A Kliger ◽  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Therapeutic Option ◽  
Pacemaker Implantation ◽  
Atrioventricular Node ◽  
Transcatheter Aortic Valve ◽  
Conduction Abnormalities ◽  
Transcatheter Heart Valve

Transcatheter aortic valve replacement (TAVR) has been established as a therapeutic option for patients with severe symptomatic aortic stenosis who are of intermediate or higher surgical risk. Several periprocedural complications are reduced with newer transcatheter heart valve generations; however, conduction abnormalities and the need for permanent pacemaker implantation have remained unchanged and are the most frequent TAVR complications. The close relationship of the atrioventricular node and left bundle branch to the subaortic region explains these potential conduction abnormalities. This article highlights conduction abnormalities after TAVR with a focus on basic conduction system anatomy in relation to the aortic valve, the mechanism, incidence, predisposing factors for occurrence, impact on mortality and finally, proposed treatment algorithms for management.

scholarly journals Clinical consequences of consecutive self-expanding transcatheter heart valve iterations

2021 ◽  
Author(s):  
H. G. Kroon ◽  
L. van Gils ◽  
F. Ziviello ◽  
M. P. H. van Wiechen ◽  
J. F. W. Ooms ◽  
...  
Keyword(s):  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Clinical Endpoints ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Significant Difference ◽  
Clinical Consequences ◽  
Multivariable Regression ◽  
Valve Implantation ◽  
Prospective Database

Abstract Objective To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). Methods Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. Results TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. Conclusions TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States

2021 ◽  
Vol 14 (9) ◽  
Author(s):  
Tamim M. Nazif ◽  
Thomas J. Cahill ◽  
David Daniels ◽  
James M. McCabe ◽  
Mark Reisman ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Clinical Outcomes ◽  
Valve Replacement ◽  
Heart Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Sapien 3 ◽  
Transcatheter Valve

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.

The Wattson temporary pacing guidewire for transcatheter heart valve implantation

2021 ◽  
Author(s):  
James Carey ◽  
Anthony Buckley ◽  
Stephen O'Connor ◽  
Mark Hensey
Keyword(s):  
Aortic Valve ◽  
Heart Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Left Ventricular ◽  
Temporary Pacing ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Transcatheter aortic valve implantation and implantation of other transcatheter heart valves, generally requires insertion of a temporary venous pacemaker. Implantation of a temporary venous pacemaker adds complexity, time and risk to the procedure. Guidewire modification to allow pacing is increasingly popular, however it requires technical expertise and provides unipolar pacing resulting in high thresholds and potential capture loss. The Wattson temporary pacing guidewire is a novel device which offers guidewire support for valve delivery and concomitant bipolar pacing. It may offer a safe and effective solution to guidewire pacing for transcatheter aortic valve implantation and other transcatheter heart valve implantations. Herein, we review the literature surrounding left ventricular guidewire pacing along with the features and clinical data of the Wattson wire.

scholarly journals Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve

2016 ◽  
Vol 9 (3) ◽  
pp. 244-254 ◽  
Author(s):  
Oliver Husser ◽  
Costanza Pellegrini ◽  
Thorsten Kessler ◽  
Christof Burgdorf ◽  
Hannah Thaller ◽  
...  
Keyword(s):  
Heart Valve ◽  
Permanent Pacemaker ◽  
Conduction Abnormalities ◽  
Transcatheter Heart Valve ◽  
Sapien 3 ◽  
New Onset

Midterm Outcomes after Transcatheter Aortic Valve Implantation

2014 ◽  
Vol 9 (5) ◽  
pp. 343-348 ◽  
Author(s):  
Shahram Lotfi ◽  
Guido Dohmen ◽  
Andreas Götzenich ◽  
Marcus Haushofer ◽  
Jan Wilhelm Spillner ◽  
...  
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Logistic Euroscore ◽  
Transcatheter Aortic Valve ◽  
Significant Difference ◽  
The Mean ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Objective Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. Methods A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients’ mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). Results The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. Conclusions Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.

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