scholarly journals The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

2021 ◽  
Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Valve Thrombosis ◽  
Aortic Valve Implantation ◽  
And Performance ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

scholarly journals 1226 Prognostic impact of concomitant cardiac amyloidosis in aortic stenosis patients referred for transcatheter aortic valve implantation

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
V Ferreira ◽  
S Aguiar Rosa ◽  
I Rodrigues ◽  
L Moura Branco ◽  
A Galrinho ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Functional Class ◽  
Transcatheter Aortic Valve ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background The prevalence of cardiac amyloidosis (CA) and aortic stenosis (AS) both increase with age. Transcatheter aortic valve implantation (TAVI) expands the number of patients (P) eligible for treatment of AS, emphasizing the need to understand the prevalence of CA in AS and its prognostic associations. Echocardiography with speckle tracking has emerged as a useful method to enhance the clinical suspicion and to provide prognostic information. Purpose To estimate the prevalence of CA in P with severe AS referred for TAVI and to evaluate the impact of concomitant CA in prognosis. Methods 94 consecutive AS P who underwent TAVI with maximum left ventricular wall thickness (LVWT)&gt;12 mm were retrospectively identified. Clinical data, pre TAVI echocardiographic parameters and follow up (FU) data regarding all-cause mortality and MACE (including all-cause mortality, admission for heart failure, pacemaker implantation and stroke) were analysed. We registered apical sparing pattern in bull’s eye plots (ASPB), calculated relative apical longitudinal strain formula (RALS) [average apical LS/(average basal LS + mid-LS)] and ejection fraction/global longitudinal strain (EF/GLS) ratio. Results Mean age was 82.2 ± 5.8 years (Y), with 43 men (45.7%). 27.7% were in NYHA functional class II, 64.9% in functional class III and 7.4% in functional class IV. Median EF was 57 ± 15% and 26.6% presented EF &lt; 50%. Suspected CA evaluated by ASPB was found in 39 P (41.5%) and RALS &gt; 1 was identified in 22 P (23.4%). An EF/GLS ratio &gt; 4.1 was obtained in 53 P (56.4%). Over a median follow-up of 13.4 ± 25.8 months, 28 deaths (29.8%) and 31 MACEs (33.0%) occurred. The presence of ASPB was associated with increased all-cause mortality (33.3% vs. 5.6%, p = 0.002), new bundle branch block and indication for pacemaker implantation (46.2% vs 37.0%, p = 0.05) and MACE (48.7% vs 22.2%, p = 0.01). All-cause mortality was also higher in P with RALS (31.8% vs. 12.5%, p = 0.04). P with GLS&gt;-14.8% and ASPB had significantly worse prognosis regarding all-cause mortality (p = 0.003) and MACE (p = 0.007). Kaplan–Meier survival analysis showed that survival was significantly worse for P with ASPB (log-rank 0.002). With multivariate Cox regression analysis, ASPB was independently associated with all-cause mortality (HR = 4.49, p = 0.039). Conclusions Suspected CA appears prevalent among patients with AS and associates with all-cause mortality. The importance of screening for CA in older AS patients and optimal treatment strategies in those with CA warrant further investigation, especially in the era of transcatheter aortic valve implantation. Abstract 1226 Figure. Kaplan–Meier curves and ASPB

Transcatheter aortic valve implantation in low-risk patients: is it too early?

Heart ◽  
2019 ◽  
Vol 105 (Suppl 2) ◽  
pp. s51-s56
Author(s):  
Miguel Sousa Uva
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Low Risk ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Risk Patients ◽  
Aortic Valve Implantation ◽  
Valve Implantation

The median age of patients treated by transcatheter aortic valve implantation (TAVI) is falling across Europe, and low-risk patients with severe aortic stenosis (AS) represent 80% of patients with severe AS undergoing surgical aortic valve replacement (SAVR). There are few data for TAVI in low-risk patients, but there are four ongoing randomised trials of SAVR versus TAVI. The key issues relate to pacemaker implantation rates and the associated potential longer term deleterious effects, and the need to minimise vascular complications and paravalvular leak. Valve leaflet thrombosis and paucity of data on valve durability remain a concern. Given the higher incidence of bicuspid aortic valves in younger patients, outcomes of TAVI in this setting need clarification and are discussed.

Prognostic impact of suspected cardiac amyloidosis in aortic stenosis patients referred for transcatheter aortic valve implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Ferreira ◽  
S Aguiar Rosa ◽  
I Rodrigues ◽  
L Moura Branco ◽  
A Galrinho ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Cardiac Amyloidosis ◽  
Pacemaker Implantation ◽  
Functional Class ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background The prevalence of cardiac amyloidosis (CA) and aortic stenosis (AS) both increase with age. Transcatheter aortic valve implantation (TAVI) expands the number of patients (P) eligible for treatment of AS, emphasizing the need to understand the prevalence of CA in AS and its prognostic associations. Echocardiography with speckle tracking has emerged as a useful method to enhance the clinical suspicion and to provide prognostic information. Purpose To estimate the prevalence of CA in P with severe AS referred for TAVI and to evaluate the impact of concomitant CA in prognosis. Methods 94 consecutive AS P who underwent TAVI with maximum left ventricular wall thickness (LVWT)&gt;12 mm were retrospectively identified. Clinical data, pre TAVI echocardiographic parameters and follow up (FU) data regarding all-cause mortality and MACE (including all-cause mortality, admission for heart failure, pacemaker implantation and stroke) were analysed. We registered apical sparing pattern in bull's eye plots (ASPB), calculated relative apical longitudinal strain formula (RALS) [average apical LS/(average basal LS + mid-LS)] and ejection fraction/global longitudinal strain (EF/GLS) ratio. Results Mean age was 82.2±5.8 years (Y), with 43 men (45.7%). 27.7% were in NYHA functional class II, 64.9% in functional class III and 7.4% in functional class IV. Median EF was 57±15% and 26.6% presented EF&lt;50%. Suspected CA evaluated by ASPB was found in 39 P (41.5%) and RALS &gt;1 was identified in 22 P (23.4%). An EF/GLS ratio &gt;4.1 was obtained in 53 P (56.4%). Over a median follow-up of 13.4±25.8 months, 28 deaths (29.8%) and 31 MACEs (33.0%) occurred. The presence of ASPB was associated with increased all-cause mortality (33.3% vs. 5.6%, p=0.002) and MACE (48.7% vs 22.2%, p=0.01). RALS&gt;1 correlated also with all-cause mortality (31.8% vs. 12.5%, p=0.04) and with new bundle branch block and indication for pacemaker implantation (46.2% vs 37.0%, p=0.05). P with GLS&gt;−14.8% and ASPB had significantly worse prognosis regarding all-cause mortality (p=0.003) and MACE (p=0.007). Kaplan–Meier survival analysis showed that survival was significantly worse for P with ASPB (log-rank 0.002). With multivariate Cox regression analysis, ASPB was independently associated with all-cause mortality (HR=4.49, p=0.039). Conclusions Suspected CA appears prevalent among patients with AS and associates with all-cause mortality. The importance of screening for CA in older AS patients and optimal treatment strategies in those with CA warrant further investigation, especially in the era of transcatheter aortic valve implantation. Funding Acknowledgement Type of funding source: None

scholarly journals Impact of severe mitral annular calcification on paravalvular leak after transcatheter aortic valve implantation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Soulaidopoulos ◽  
M Drakopoulou ◽  
K Stathogiannis ◽  
G Oikonomou ◽  
P Toskas ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Independent Predictor ◽  
Paravalvular Leak ◽  
Cumulative Survival ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Aims Paravalvular leak (PVL) remains a frequent complication after transcatheter aortic valve implantation (TAVI) and seems to affect short- and long-term survival. Purpose The aim of this study was: 1) to identify anatomical predictors of PVL after TAVI and 2) assess the impact of PVL on cumulative survival. Methods and results Patients with severe and symptomatic aortic stenosis [effective orifice area (EOA) ≤1cm2] referred for TAVI at our institution were consecutively enrolled. Prospectively collected demographic, laboratory and echocardiographic data were retrospectively analyzed. Patients were stratified into two groups according to the presence of PVL after TAVI and were followed up postoperatively with clinical and echocardiographic assessment. Primary clinical endpoint was all-cause mortality, as defined by the criteria proposed by the Valve Academic Research Consortium 2. In total, 291 patients were included (male: 50.2%, mean age: 80±7.6 years) in our study. Of these, 165 (56,8%) presented at least mild PVL after TAVI (mild: 85,5%, moderate: 13.3% and severe: 1.2%). The median follow-up period was 27.3 [min. 0, max 113 months. Two patients with severe PVL were excluded from the analysis. In the follow up period, there was no significant difference regarding all-cause mortality between patients with and those without PVL after TAVI, independently from the degree of PVL (log rank: 0.991 - Figure 1). Severe aortic annulus calcification, the presence of a bicuspid aortic valve and aortic root angulation, as assessed by computed tomography (CT), were found to associate with PVL after TAVI in univariate analysis. In the multivariate analysis, severe aortic annulus calcification was found to be the only independent predictor of mild or moderate PVL after TAVI [Exp(B): 1.540, 95% Confidence Interval: 1.067–2.224, B=0.432, p=0.021]. Conclusion The presence of mild or moderate PVL after TAVI was not found to affect cumulative survival in the 27 months of follow up period. Severe annulus calcification assessed by CT-scan, was found to be the only independent predictor of PVL after TAVI. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Device Selection in Patients with Borderline Size Aortic Valve Annulus Undergoing Transcatheter Aortic Valve Implantation

2021 ◽  
Author(s):  
Yeela Talmor-Barkan ◽  
Ran Kornowski ◽  
Noam Bar ◽  
Jeremy Ben-Shoshan ◽  
Hanna Vaknin-Assa ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Severe Aortic Stenosis ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Device Selection ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multidetector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multicenter TAVI registry. TAVI outcomes were assessed according to the Valve Academic Research Consortium-2 (VARC-2). Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of paravalvular leak (PVL), compared to smaller THV (45.3% vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7mmHg vs. 12.5 ± 7.2mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture and/or coronary occlusion did not differ between groups. BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and better hemodynamic profile in patients implanted with SE and BE-THV, respectively, with no effect on procedural complications.

Transcatheter aortic valve implantation in low-risk patients: A case of rational over exuberance. The time is not now

2021 ◽  
pp. 021849232110185
Author(s):  
Manoraj Navaratnarajah ◽  
Suvitesh Luthra ◽  
Sunil Ohri
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Low Risk ◽  
Current Evidence ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Risk Patients ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Background Review of evidence and concerns, relating to extension of transcatheter aortic valve implantation usage to low–risk patients. Methods Comprehensive literature review was conducted identifying articles relating to transcatheter aortic valve implantation. Results Transcatheter aortic valve implantation is effective in patients with aortic stenosis. Currently, long-term durability and cost-effectiveness are unproven, anticoagulation requirement undefined, permanent pacemaker implantation and paravalvular leak rates higher than following surgical aortic valve replacement. Conclusions Current evidence supporting transcatheter aortic valve implantation usage in low-risk patients is insufficient. Extending use now, to this large young patient population is premature, and should be delayed.

New onset left bundle branch block after transcatheter aortic valve implantation and the effect on long-term survival – a UK wide experience

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.S Arri ◽  
A Myat ◽  
I Malik ◽  
N Curzen ◽  
A Baumbach ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Left Bundle Branch Block ◽  
Left Ventricular ◽  
Bundle Branch Block ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
New Onset

Abstract Introduction New onset left bundle branch block (LBBB) is the most common conduction disturbance associated with transcatheter aortic valve implantation (TAVI). It has been shown to adversely affect cardiac function and increase re-hospitalisation, although its impact on mortality remains contentious. Methods We conducted an observational cohort analysis of all TAVI procedures performed by 13 heart teams in the United Kingdom from inception of their structural programmes until 31st July 2013. The primary outcome was 1-year all-cause mortality. Secondary outcomes included left ventricular ejection fraction (LVEF) at 30 days and need for a post-TAVI permanent pacemaker (PPM). Results 1785 patients were eligible for inclusion to the study. The primary analysis cohort was composed of 1409 patients with complete electrocardiographic (ECG) data pre- and post-TAVI. Pre-existing LBBB was present in 200 (14.2%) patients. New LBBB occurred in 323 (22.9%) patients post TAVI, which resolved in 99 (7%) patients prior to discharge. A balloon-expandable device was implanted in 968 (69%) patients, whilst 421 (30%) patients received a self-expandable valve. New LBBB was observed in 120 (12.4%) and 192 (45.6%) patients receiving a balloon- or self-expandable prosthesis respectively. Overall 1-year all-cause mortality post TAVI was 18.7%. New onset LBBB was not associated with an increase in 1-year all-cause mortality (p=0.416). Factors that were associated with mortality included an increasing logistic EuroScore (p=0.05), history of previous balloon aortic valvuloplasty (p=0.001), renal impairment (p=0.003), previous myocardial infarction with pre-existing LBBB (p=0.028) and atrial fibrillation (p=0.039). Lower baseline peak and mean AV gradients were also associated with greater mortality at 1 year (p=0.001), likely reflecting underlying left ventricular dysfunction. In the majority of patients, LVEF remained unchanged following TAVI. Interestingly, the presence or absence of new onset LBBB did not affect LVEF improvement at 30 days. 10% of patients required a PPM post TAVI. Predictors of PPM included new LBBB (OR 2.6, p&lt;0.001), pre-TAVI left ventricular systolic impairment (OR 1.2, p=0.037), a self-expandable device (p&lt;0.001), and pre-existing RBBB (OR 4.0, p&lt;0.001). Conclusions These findings suggest that new onset LBBB post TAVI does not increase mortality at 1 year or adversely affect LVEF at 30 days. Funding Acknowledgement Type of funding source: None

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.

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