P3739Differences in short-term outcome between balloon- and self-expandable TAVR devices relating to more than one generation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V V Veulemans ◽  
K Klein ◽  
O Maier ◽  
G Wolff ◽  
A Polzin ◽  
...  
Keyword(s):  
Aortic Regurgitation ◽  
Lower Incidence ◽  
Academic Research ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Permanent Pacemaker ◽  
Bleeding Complications ◽  
Term Outcome ◽  
Pacemaker Therapy ◽  
Conduction Disturbances

Abstract Background Transcatheter aortic valve replacement (TAVR) is the treatment option of choice in inoperable and high-risk patients and only recently even revealed favorable outcome in an intermediate risk cohort. Morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges during balloon- and self-expandable valve-improvement. Purpose We aimed to address safety and effectiveness between balloon- and self-expandable TAVR devices relating to more than one generation. Methods Patients treated with TAVR between 2009 and 2018 were categorized into either balloon-expandable (BAVR, n=516) or self-expandable (SAVR, n=974) groups. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Primary endpoint was 30-day mortality. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (BAVR/SAVR: 25.7%±5.2 vs 25.5%±2.5; p=n.s). Compared to SAVR devices, BAVR devices had significantly higher periprocedural gradients (BAVR/SAVR: 11.7mmHg±0.1 vs 8.3mmHg±0.8; p=0.0175), lower incidence of new renal replacement therapy (BAVR/SAVR: 1.8% vs 4.6%; p=0.0025), and new permanent pacemaker therapy for conduction disturbances (BAVR/SAVR: 8.3% vs 17.3%; p<0.0001), but more frequently disabling bleeding (BAVR/SAVR: 3.9% vs 1.0%; p=0.0003) complications. 30-day mortality was significantly reduced in SAVR-patients (BAVR/SAVR: 4.4% vs 2.4%; p=0.0395). No difference could be observed concerning primary device success (BAVR/SAVR: 1.0%vs 2.0%; p=n.s.), incidence of moderate-to-severe paravalvular leakage (BAVR/SAVR: 3.2% vs 5.0%; p=n.s.), stroke (BAVR/SAVR: 3.3% vs 2.6%; p=n.s.), and major vascular complications (BAVR/SAVR: 2.7% vs 3.5%; p=n.s.). Conclusion Data from the retrospective analysis indicate lower incidence of renal replacement and pacemaker therapy, but higher periprocedural gradients, disabling bleeding complications, and enhanced 30-day mortality for the BAVR device as compared to SAVR. Other issues like paravalvular leackage/aortic regurgitation and stroke still remain unacknowledged.

P3745Differences in short-term outcome between early- and new-generation TAVR devices

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Veulemans ◽  
K Klein ◽  
O Maier ◽  
G Wolff ◽  
A Polzin ◽  
...  
Keyword(s):  
Aortic Regurgitation ◽  
Lower Incidence ◽  
Academic Research ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Permanent Pacemaker ◽  
Bleeding Events ◽  
Term Outcome ◽  
Pacemaker Therapy ◽  
New Generation

Abstract Background For transcatheter aortic valve replacement (TAVR) morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges. New-generation devices for TAVR have been optimized to improve clinical outcome. Purpose We aimed to address safety and effectiveness of new-generation TAVR devices compared with earlier generations in a single centre study. Methods We compared 30 days outcome of the new-generation repositionable MER (n=614) and MEP (n=90) and the balloon-expandable ES3 (n=414) valve with the last-generation self-expandable MCV (n=270) and the balloon-expandable SXT (n=103) in patients treated with TAVR between 2009 and 2018. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (27.3%±2.9 new vs 23.0%±1.4 early; p=n.s.). Compared to early-generation devices (MCV/SXT), new-generation devices (MER/MEP/ES3) had significantly higher primary device success (98.9% new vs 96.8% early; p=0.0089), lower incidence of new renal replacement therapy (2.6% new vs 6.2% early; p=0.0028), new permanent pacemaker therapy for conduction disturbances (12.8% new vs 17.0% early; p=0.0394), and disabling bleeding (1.4% new vs 4.0% early; p=0.0040). No difference could be observed concerning incidence of moderate-to-severe paravalvular leakage (4.2% new vs 5.0% early; p=n.s.), stroke (3.3% new vs 2.1% early; p=n.s.), major vascular complications (2.8% new vs 3.5% early; p=n.s.) and 30-day mortality (2.7% new vs 4.4% early; p=n.s). Conclusion Data from the retrospective analysis indicate higher primary device success and lower incidence of renal replacement, pacemaker therapy and disabling bleeding events in new-generation devices, although praised “hot-item” advantages like paravalvular leackage/aortic regurgitation, vascular complications and mortality remain unacknowledged.

scholarly journals Late onset of new conduction disturbances requiring permanent pacemaker implantation following TAVI

Heart ◽  
2020 ◽  
Vol 106 (16) ◽  
pp. 1244-1251 ◽  
Author(s):  
Nynke H M Kooistra ◽  
Martijn S van Mourik ◽  
Ramón Rodríguez-Olivares ◽  
Alexander H Maass ◽  
Vincent J Nijenhuis ◽  
...  
Keyword(s):  
Risk Factors ◽  
Late Onset ◽  
Pacemaker Implantation ◽  
Early Discharge ◽  
Permanent Pacemaker ◽  
Conduction Delay ◽  
Intraventricular Conduction ◽  
Conduction Disturbances ◽  
Permanent Pacemaker Implantation ◽  
Timing Of Onset

BackgroundThe timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI.Methods and resultsWe performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours.ConclusionsSafe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present.

scholarly journals Use of Electrophysiological Studies in Transcatheter Aortic Valve Implantation

2020 ◽  
Vol 9 (1) ◽  
pp. 20-27
Author(s):  
Oholi Tovia-Brodie ◽  
Yoav Michowitz ◽  
Bernard Belhassen
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Conduction Disturbances ◽  
Permanent Pacemaker Implantation ◽  
Transcatheter Aortic Valve ◽  
Electrophysiological Studies ◽  
Aortic Valve Implantation ◽  
Valve Implantation

New conduction disturbances requiring permanent pacemaker implantation remain common complications following transcatheter aortic valve implantation (TAVI). It has been suggested that electrophysiological studies could help identify patients who will require permanent pacemaker implantation after TAVI. This article summarises contemporary data on the use of electrophysiological studies in patients undergoing TAVI.

Abstract 13675: The Impact of Major Vascular Complications on the Long-Term Outcome for Patient Undergoing Trans-Catheter Aortic Valve Replacement

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Sa’ar Minha ◽  
Marco De Magalhaes ◽  
Ricardo O Escarcega ◽  
Israel M Barbash ◽  
Nevin C Baker ◽  
...  
Keyword(s):  
Academic Research ◽  
Vascular Complications ◽  
Vascular Complication ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Procedural Complication ◽  
Baseline Characteristics ◽  
Research Consortium ◽  
The Impact

Introduction: Major vascular complications (MjVC) of TAVR are associated with poor long term outcome. Since in-hospital mortality is included in the 2nd Valve Academic Research Consortium definitions of MjVC, the long term outcome of patients that had MjVC and survived to discharge and 30 days is less clear. Hypothesis: It is hypothesized that the MjVC is associated with long term mortality even if patients survived the first 30 days post-TAVR as compared to patients with no vascular complication (NVC) or those that had minor vascular complications (MiVC). Methods: 392 patients that underwent trans-femoral TAVR were included. A comparison was completed between patients that had NVC (n=266), MiVC (n=88) and MjVC (n=38). Survival estimate included a landmark analysis capped at 30 days post-TAVR. Results: No differences were noted in the baseline characteristics of patients with MjVC, MiVC or NVC (Age 85.2±4.8,82.9±7.3,82.5±8.6;p=0.05,STS score 10.1±3.7 vs. 9.4±4.1 vs. 9.1±4.6;p=0.4, ejection fraction 52.8±13.6% vs. 52.2±13.1 vs. 53.1±14.1;p=0.8 respectively) . Patients that had MjVC had longer hospitalization (10.4±7.3 vs. 5.7±3.6 vs. 6.3±5.2 days; p<0.001 respectively), higher rate of infections (36.8% vs. 6.8% vs. 9.4%;p<0.001 respectively)and higher rate of post-TAVR transfusions (82.6% vs. 47.7% vs. 25.6%;p<0.001 respectively). These differences translated into long-term higher mortality risk for patients sustaining MjVC even after surviving to 30 days post-TAVR (figure). Conclusions: MjVC continues to be associated with poor outcome after TAVR even if patients survived to 30 days. This might be related to the procedural and post-procedural complication and not to the baseline characteristics of the patient and thus these patients should be subjected to special surveillance and care.

Performance of the Corevalve Evolut R and PRO in severely calcified anatomies: a propensity-score matched analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Piayda ◽  
K Hellhammer ◽  
V Veulemans ◽  
S Afzal ◽  
H Heidari ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Propensity Score ◽  
Aortic Regurgitation ◽  
Statistical Significance ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Aortic Valve Area ◽  
Permanent Pacemaker Implantation ◽  
Native Aortic Valve ◽  
The Mean

Abstract Background The Corevalve Evolut R and PRO belong to the newer generation of self-expandable valves and are increasingly used to treat patients with severe aortic stenosis. Over the years, technical advancements and increasing experience with the procedure itself are responsible for excellent clinical and hemodynamic results. Patients with severely calcified native aortic valve anatomies still pose a special task to the implanting team since the risk for intraprocedural complications might be increased. Purpose To evaluate the hemodynamic and clinical performance of the CoreValve Evolut R and PRO in patients with severely calcified native aortic valve anatomies. Methods Baseline characteristics, imaging data and procedural outcome of patients undergoing transfemoral transcatheter aortic valve implantation with the CoreValve Evolut R and PRO from 09/2015 to 03/2018 were prospectively collected. Patients underwent high-resolution multisclice computed tomography (MSCT). A pre-specific threshold of 600 Hounsfield units was set to account for the hyperdensity of the applied contrast medium and to enable comparability with MSCT thresholds, derived by non-contrast enhanced MSCT scans. Patients were divided by the extent of calcification into a severely calcified anatomy group (men &gt;2062AU, woman &gt;1377AU) or a not severely calcified anatomy group (men &lt;2062AU, woman &lt;1377AU). Propensity score matching with the variables log EuroSCORE, LVOT calcium load and the cover index in a 1:2 fashion was performed and clinical and hemodynamic results in accordance with VARC II were collected. Results Ninety-eight patients with severely calcified anatomies (SC) could be identified and were matched with 196 patients with lower calcified (LC) anatomies. Patients with severely calcified anatomies were older (SC: 83.1 years vs. LC: 80.3 years, p&lt;0.001) and had a smaller aortic valve area (SC: 0.63cm2 vs. LC: 0.70cm2, p=0.028). The mean implantation depth did not differ (SC 5.4mm±2.4 vs. LC: 5.1±2.2, p=0.554). Pre-dilatation was more often performed in the SC group (SC: 30.6% vs. LC: 15.8%, p=0.003) and the stroke/TIA rate did not differ (SC: 5.1% vs. LC: 3.5%, p=0.532). In SC patients, a permanent pacemaker implantation was significantly more often needed (SC: 28.5% vs. LC:7.6%, p&lt;0.001). The mean pressure gradient after the procedure was effectively reduced (SC: 7.1mmHg±3.9 vs. LC: 7.8±3.7mmHg, p=0.477). No aortic regurgitation (AR) was more often present in patients with SC anatomies (SC: 72.5% vs. LC: 85.2%, p=0.011). The aortic regurgitation index numerically differed between groups without reaching statistical significance (SC: 24.1±7.1 vs. LC: 27.3±6.7, p=0.067). Conclusion The CoreValve Evolut R and PRO show a good clinical safety profile and excellent hemodynamic results even in patients with severely calcified anatomies. In those patients, a permanent pacemaker implantation was more often necessary. Funding Acknowledgement Type of funding source: None

scholarly journals Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Arturo Giordano ◽  
◽  
Nicola Corcione ◽  
Paolo Ferraro ◽  
Alberto Morello ◽  
...  
Keyword(s):  
Renal Failure ◽  
Aortic Valve ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Permanent Pacemaker ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
New Generation ◽  
Unadjusted Analysis

AbstractTranscatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.

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