scholarly journals Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients

Author(s):  
Naoki Tadokoro ◽  
Satsuki Fukushima ◽  
Yusuke Shimahara ◽  
Tetsuya Saito ◽  
Naonori Kawamoto ◽  
...  

Abstract Objectives A new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR). Methods This study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores. Results No in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient–prosthesis mismatch at 1 week postoperatively. Conclusions The new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Piayda ◽  
A Wimmer ◽  
H Sievert ◽  
K Hellhammer ◽  
S Afzal ◽  
...  

Abstract Background In the era of transcatheter aortic valve replacement (TAVR), there is renewed interest in percutaneous balloon aortic valvuloplasty (BAV), which may qualify as the primary treatment option of choice in special clinical situations. Success of BAV is commonly defined as a significant mean pressure gradient reduction after the procedure. Purpose To evaluate the correlation of the mean pressure gradient reduction and increase in the aortic valve area (AVA) in different flow and gradient patterns of severe aortic stenosis (AS). Methods Consecutive patients from 01/2010 to 03/2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG) and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic and clinical information were collected and compared. Additionally, the clinical pathway of patients (BAV as a stand-alone procedure or BAV as a bridge to aortic valve replacement) was followed-up. Results One-hundred-fifty-six patients were grouped into NFHG (n=68, 43.5%), LFLG (n=68, 43.5%) and pLFLG (n=20, 12.8%) AS. Underlying reasons for BAV and not TAVR/SAVR as the primary treatment option are displayed in Figure 1. Spearman correlation revealed that the mean pressure gradient reduction had a moderate correlation with the increase in the AVA in patients with NFHG AS (r: 0.529, p<0.001) but showed no association in patients with LFLG (r: 0.145, p=0.239) and pLFLG (r: 0.030, p=0.889) AS. Underlying reasons for patients to undergo BAV and not TAVR/SAVR varied between groups, however cardiogenic shock or refractory heart failure (overall 46.8%) were the most common ones. After the procedure, independent of the hemodynamic AS entity, patients showed a functional improvement, represented by substantially lower NYHA class levels (p<0.001), lower NT-pro BNP levels (p=0.003) and a numerical but non-significant improvement in other echocardiographic parameters like the left ventricular ejection fraction (p=0.163) and tricuspid annular plane systolic excursion (TAPSE, p=0.066). An unplanned cardiac re-admission due to heart failure was necessary in 23.7% patients. Less than half of the patients (44.2%) received BAV as a bridge to TAVR/SAVR (median time to bridge 64 days). Survival was significantly increased in patients having BAV as a staged procedure (log-rank p<0.001). Conclusion In daily clinical practice, the mean pressure gradient reduction might be an adequate surrogate of BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities of AS. In those patients, TTE should be directly performed in the catheter laboratory to correctly assess the increase of the AVA. BAV as a staged procedure in selected clinical scenarios increases survival and is a considerable option in all flow states of severe AS. (NCT04053192) Figure 1 Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 9 (10) ◽  
pp. 3143
Author(s):  
Satoshi Yamaguchi ◽  
Yuka Otaki ◽  
Balaji K. Tamarappoo ◽  
Tetsuya Ohira ◽  
Hiroki Ikenaga ◽  
...  

Increase in left ventricular (LV) mass develops as a compensatory mechanism against pressure overload in aortic valve stenosis. However, long-standing LV geometrical changes are related to poor prognosis. The LV geometrical change occurs after transcatheter aortic valve replacement (TAVR). The present study aimed to investigate the relationship between improvement in valvuloarterial impedance (Zva) and change in LV mass index (LVMI) and the ratio of LVMI to LV end-diastolic volume index (LVMI/LVEDVI). We compared these relationships to that between Zva and mean pressure gradient (MPG). Baseline and follow-up transthoracic echocardiograms of 301 patients who underwent TAVR from November 2011 to December 2015 were reviewed. Spearman correlation coefficient (ρ) was used to compare ΔLVMI and ΔLVMI/LVEDVI with Zva or MPG. The correlation between ΔZva and ΔLVMI (ρ = 0.47, p < 0.001) was superior to that between ΔMPG and ΔLVMI (ρ = 0.15, p = 0.009) (p for comparison < 0.001). The correlation between ΔZva and ΔLVMI/LVEDVI was statistically significant (ρ = 0.54, p < 0.001); in contrast, that of ΔMPG and ΔLVMI/LVEDVI was not. The improvement in Zva after TAVR was more closely related to LVMI and LVMI/LVEDVI reduction than MPG reduction.


Author(s):  
Shahram Lotfi ◽  
Guido Dohmen ◽  
Andreas Götzenich ◽  
Marcus Haushofer ◽  
Jan Wilhelm Spillner ◽  
...  

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.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
T Hayashi ◽  
T Shindo ◽  
Y Misaki ◽  
H Ono

Abstract Introduction Although the diagnostic utility of Doppler-derived hemodynamic parameters of prosthetic aortic valve (PAV) for detecting prosthetic dysfunction has been demonstrated in adults, interpreting these parameters in children is difficult, as the relative size of PAV varies more greatly in them than in adults. We aimed to elucidate how the Doppler-derived hemodynamic parameters change as the PAV size decreases relative to the somatic growth of children. Methods We reviewed 11 echocardiographic examinations of 9 mechanical PAVs in 8 children. The median age at echocardiographic examination was 10.2 (0.5-17.7) years. Underlying diagnoses leading to aortic valve replacement were aortic regurgitation due to dysplastic aortic valve in 3 children, Marfan syndrome in 1, persistent truncus arteriosus in 1, and aortic stenosis associated with interrupted aortic arch/coarctation of the aorta in 3. The PAV functioned normally in all examinations. PAV size was 19 mm in 8 examinations and 17 mm in 3 examination, which was standardized to body surface area at the examination by calculating z-scores based on previously published normative data of aortic valve diameter. We assessed the Doppler-derived hemodynamic parameters, namely peak velocity, mean pressure gradient, and accerelation time of the transprosthetic flow, the velocity-time integral (VTI) ratio of the left ventricular outflow to the transprosthetic flow, and effective orifice area (EOA) of the PAV calculated by using the continuity equation. The Pearson correlation coefficients between the PAV size z-score and Doppler-derived hemodynamic parameters of the normally functioning PAVs were evaluated. A p-value of &lt;0.05 was considered statistically significant. Results All the Doppler-derived hemodynamic parameters except for EOA had a statistically significant correlation with PAV size z-score (Pearson correlation coefficients: peak velocity, -0.76; mean pressure gradient, -0.70; acceleration time, -0.66; and VTI ratio, 0.76). Multivariate analysis revealed that VTI ratio was the sole parameter that independently correlated with PAV size z-score. Conclusions VTI ratio, which is theoretically less dependent on cardiac preload than other hemodynamic parameters, strongly reflects BSA-indexed PAV size. Disproportionately decreased VTI ratio in relation to PAV size might indicate prosthetic obstruction in children with PAV. Abstract P1753 Figure. Correlation of PAV size and VTI ratio


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Meguro ◽  
T Hashimoto ◽  
T Yanagisawa ◽  
T Kitamura ◽  
J Ako

Abstract Background Transcatheter aortic valve implantation (TAVI) has been widely accepted strategy of the treatment for aortic stenosis in patients at intermediate to high or prohibitive surgical risk. The Asian people are of smaller body size compared to Western people. As the result, Asian people have smaller aortic annulus size, which accommodate only smaller transcatheter heart valves (THVs), however, the details and consequences of small aortic annulus size in TAVI is uncertain. Purpose The purposes of this study were to clarify the short-term outcomes of TAVI in patients with small annulus and the differences of intra-annular and supra-annular THVs in small annulus using Japanese national TAVI registry. Methods Multi-detector computed tomography (MDCT) was performed before TAVI and the annulus area was registered. We compared the 30-day clinical outcomes between patients with and without small annulus (annulus area 3.14cm2). Further investigation to compare intra-annular and supra-annular THVs in patients with small annulus was conducted. Results The total of 5,870 patients (103 sites in Japan) who underwent TAVI between August 2013 to December 2017 were enrolled in this study. Out of 5,870 patients, 647 had small annulus. Thirty-day mortality, new pacemaker implantation and stroke rate were comparable between patients with and without small annulus. Echocardiography within 30 days after TAVI revealed that patients with small annulus had significantly smaller indexed effective orifice area (iEOA, 1.10.cm2/m2 [0.92–1.35] vs. 1.16 cm2/m2 [0.96–1.39], p<0.001), higher mean pressure gradient (10.0 mmHg [6.9–14.2] vs. 8.5 mmHg [6.0–11.5], p<0.001) and lower frequency of paravalvular leakage moderate (17.3% vs. 24.4%, p<0.001). Patient-prosthesis mismatch (PPM) were more frequent in patients with small annulus (p=0.002). Logistic regression analysis revealed that small annulus (OR: 1.82; 95% CI: 1.45–2.30, p<0.001), female gender (OR: 0.54; 95% CI: 0.42–0.70, p<0.001), weight (OR: 1.03; 95% CI: 1.02–1.04, p<0.001), height (OR: 1.04; 95% CI: 1.02–1.05, p<0.001), hyperlipidemia (OR: 1.25; 95% CI: 1.07–1.47, p=0.006), femoral access (OR: 0.80; 95% CI: 0.66–0.97, p=0.026) were significantly associated with the PPM after TAVI. The use of SAPIEN 3 20mm THV in patients with small annulus was associated with the smaller iEOA (0.94 cm2/m2 [0.78–1.06] vs. 1.07 cm2/m2 [0.84–1.24], p=0.001) and higher mean pressure gradient (14.0 mmHg [10.0–18.5] vs. 11.0 [7.0–14.0], p<0.001) compared to the usage of Evolut R 23 mm THV. The rate of paravalvular leakage more than moderate was similar in both THVs (14.4% vs. 16.5%, p=0.69). Conclusions Small annulus did not affect clinical 30-day outcomes, however, small annulus was associated with smaller iEOA and higher mean pressure gradient. Supra-annular device might contribute the better hemodynamical improvement in patients with small annulus without increase of paravalvular leakage. Acknowledgement/Funding None


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M Fukui ◽  
L Tiang ◽  
J Lesser ◽  
H Niikura ◽  
M Nunes ◽  
...  

Abstract Background Prosthesis-patient mismatch (PPM) is associated with poor outcomes after surgical aortic valve replacement, but evidence in the era of transcatheter aortic valve replacement (TAVR) is small. Although PPM is conventionally defined by transthoracic echocardiogram (TTE) derived indexed effective orifice area (EOAi), TTE may underestimate left ventricular outflow tract (LVOT) area when compared with cardiac computed tomography angiography (CTA). Purpose To evaluate the inter-modality (TTE vs CTA) agreement and inter-valve (balloon-expanding valve (BEV) vs. self-expandable valve (SEV)) differences in EOAi and the severity of PPM after TAVR. Methods We analyzed all patients who underwent TAVR between 2015 to 2017and who had both of CTA and TTE at 30-days after TAVR. EOAi was calculated using the continuity equation and then indexed to body surface area as per guidelines using TTE derived LVOT diameter (EOAi-TTE) or post-procedure CTA derived LVOT area (EOAi-CTA). The external LVOT diameter was measured at inflow of TAVR bioprosthetic stent frame as per recommendations. The EOAi was used to define the grading severity of PPM: None (&gt; 0.85 cm²/m²); Moderate (0.65 to 0.85 cm²/m²); and Severe (&lt; 0.65 cm²/m²). Paired or Student t-test and Chi-square test were used to assess the inter-modality and inter-valve difference. Results A total of 280 patients were included (the mean age, 81.2 ± 8.1 years; 48%, female). BEV was used in 150 patients (54%). The mean EOAi-TTE vs. EOAi-CTA was 1.00 ± 0.32 and 1.41 ± 0.50 cm²/m², respectively, p &lt; 0.001. Prevalence of severe (TTE 9% versus CTA 4%, p &lt; 0.01) and moderate (TTE 28% versus CTA 7%, p &lt; 0.01) PPM was lower when adjudicated by CTA (Figure-Panel A). There was a trends towards smaller EOAi by either TTE (0.97 ± 0.31 vs. 1.04 ± 0.33, p = 0.07) or CTA (1.38 ± 0.45 vs. 1.46 ± 0.56, p = 0.21) for BEV vs. SEV (Figure-Panel B). There was no significant difference in the severity of PPM defined by either EOAi-TTE (Figure-Panel C) or EOAi-CTA (Figure-Panel D) between these patients. Conclusion EOAi-CTA was larger and downgraded the severity of PPM than the EOAi-TTE. There was no significant difference in the severity of PPM defined by post-procedure CT between patients treated with BEV and those with SEV. Abstract P212 Figure.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Messas ◽  
A Ijsselmuiden ◽  
G Goudot ◽  
S Vlieger ◽  
P Den Heijer ◽  
...  

Abstract Objectives We recently developed a unique transthoracic non-invasive ultrasound therapy device called Valvosoft to treat aortic stenosis. The therapy consists in delivering trans-thoracically precisely focused and controlled short ultrasound pulses (&lt;20μsec) at a high acoustic intensity to produce non-thermal mechanical tissue softening of the calcified aortic valve with the ultimate aim of improving the valve opening. Ultrasound imaging enables to follow valve movements in real-time and thus targets the ultrasound waves on the valve with great precision. After having validated this concept in pre-clinical studies, we aimed at applying this technique in human. The primary objectives were to assess the safety and feasibility of this novel technique along with its performance by evaluation of the valve leaflets mobility and valve opening area. Methods This is a multi-center, prospective, controlled first-in-man study. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. The therapy consists of 6 sessions of ultrasound therapy. The Valvosoft transducer is applied on the patient's chest and coupled at its center with an echocardiography phased array probe to allow real-time control of the therapy (cavitation bubble detection). Preselection of the region of interest is performed by echo still frame before each session. Ultrasonic evaluation was performed by an independent core lab at baseline, discharge, 30-day and 3 month follow-up along with clinical follow up. Results Enrolled patients were advanced in age (84.1±6.5 yrs) with severe comorbidities (8 with heart failure, 5 with coronary heart disease and 5 with kidney failure). All had extensive aortic valve calcification (mean calcification volume of 687.28 mm3) with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg (6 patients had SV&lt;35ml/m2). No adverse events were recorded during the procedures other than some benign ventricular extrasystoles. The mean treatment time was 52 minutes. At 3 months follow-up, one patient had died due to end stage heart failure not linked to the procedure (9 weeks post procedure) and another got finally TAVI (45 days post procedure). Of the other 8 patients, 6 experienced an improvement of their NYHA status. No device or procedure related major adverse events nor deterioration of neurological status were observed at 3 months follow-up. Of the 7 patients that had echo follow-up at 3 months (one patient refused to get echo evaluation), 5 increased the AVA (between 14% and 46%) and 4 patients decreased the mean pressure gradient (from 6% to 44%). No AI or EF deterioration occurred during follow up. Conclusion Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and is able to improve AVA and pressure gradient in some patient. Larger studies with longer follow up will need to be conducted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Cardiawave SA, Paris, France


2022 ◽  
Vol 11 (2) ◽  
pp. 443
Author(s):  
Ahmed Elkoumy ◽  
John Jose ◽  
Christian J. Terkelsen ◽  
Henrik Nissen ◽  
Sengottuvelu Gunasekaran ◽  
...  

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI’s procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.


Author(s):  
José Manuel Martínez-Comendador ◽  
Francisco Estevez-Cid ◽  
Miguel González Barbeito ◽  
Carlos Velasco García De Sierra ◽  
Alberto Bouzas Mosquera ◽  
...  

Abstract OBJECTIVES Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions. METHODS All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included. RESULTS The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively. CONCLUSIONS Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.


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