P1788The outcome of TAVI in patients with small annulus and the comparison between intra-annular and supra-annular devices in small anulus: From the analysis of the Japanese nationwide registry

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

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 20 (01) ◽  
pp. 1950074
Author(s):  
AMINA HALAIMI ◽  
BOUALEM CHETTI ◽  
BOUALEM LARIBI ◽  
OMAR LABBADLIA

This work presents a developed zero-dimensional cardiovascular (CV) system model, based on an electrical analogy, with a detailed compartmental description of the heart and the main vascular circulation which is able to simulate normal and diseased conditions of CV system, especially the stenosis valvular aortic. To know the effect of each parameter on hemodynamics, the number of parameters is increased by adding more segments. The developed model consists of 14 compartments. The results show that the severity of aortic stenosis (AS) effect varies with the effective orifice area and the mean pressure gradient for the case of no AS; the effective orifice area is 4[Formula: see text]cm2 and the mean pressure gradient is 0[Formula: see text]mmHg, while for the case of mild AS, the effective orifice area is 1.5[Formula: see text]cm2 and the mean pressure gradient is 27.24[Formula: see text]mmHg. For the case of moderate AS, the effective orifice area is 1.0[Formula: see text]cm2 and the mean pressure gradient is 44.68[Formula: see text]mmHg. For the case of the severe AS, the effective orifice area is 0.61[Formula: see text]cm2 and the mean pressure gradient is 77.51[Formula: see text]mmHg. It is found that the developed model can estimate an accurate value of the effective orifice area for any value of mean pressure gradient in AS. The results obtained for the CV system under normal and diseased conditions show a good agreement compared to published results.


2021 ◽  
Vol 8 ◽  
Author(s):  
Jinmiao Chen ◽  
Minzhi Lv ◽  
Yuntao Lu ◽  
Jiahui Fu ◽  
Yingqiang Guo ◽  
...  

Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis.Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory.Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance.Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.


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&lt;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&lt;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&lt;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 41 (Supplement_2) ◽  
Author(s):  
D Ueshima ◽  
L.N.F Nai Fovino ◽  
S.J.B Brener ◽  
A.P Pavei ◽  
C.F Fraccaro ◽  
...  

Abstract Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve re- placement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker im- plantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR=1.13; 95% CI: 0.88–1.46, p=0.33) and 1-year mortality (OR=1.02; 95% CI: 0.77–1.37, p=0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR=2.35; 95% CI: 1.30–4.23, p=0.005), implantation of a second valve (OR=2.06; 95% CI: 1.31–3.25; p=0.002), moderate/severe paravalvular leakage (PVL) (OR=1.67; 95% CI: 1.29–2.17; p=0.0001) and device failure (OR=1.26; 95% CI: 1.02–1.56; p=0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conver- sion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV. Funding Acknowledgement Type of funding source: None


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Mahmoud Diab ◽  
Gloria Faerber ◽  
Ivliane Tsanava ◽  
Martin Breuer ◽  
Mario Walther ◽  
...  

Purpose: Hemodynamic results of stented tissue valves are influenced by both valve design and sizing strategy. The Mitroflow and the Trifecta have an innovative design where the pericardium is wrapped around the stent. The goal of this study was to compare both valves giving special consideration to the suggested sizing strategies. Methods: We obtained pressure gradients from discharge echocardiograms from all patients having received an isolated Trifecta (n=104) or Mitroflow (n=246) between 01/2007 and 01/2014. We compared the results by size label and by the most likely selected size according to the suggested sizing strategy. This is important because the prostheses, despite having a similar design, have different diameters for the same size label and different sizing strategies. Results: The majority of implanted valves were size labels 21 and 23 (82.7% of the Trifecta and 74.8% of the Mitroflow). Mean pressure radients were lowest with Trifecta (Trifecta vs. Mitroflow, label-21: 11.4±4.65 vs 13.6±5.23 mmHg, label-23: 9.23±3.38 vs. 11.8±4.42 mmHg, p< 0.05, and label-25: 11.2±4.97 vs 12.0±4.46 mmHg, n.s.). The sizers for the Trifecta are metric, while those for the Mitroflow are 2-3 mm larger than the corresponding size label. It is therefore likely that for a patient with a 23 mm aortic annulus, a 23 Trifecta but often only a 21 Mitroflow is selected. Thus, comparing the Trifecta to the Mitroflow not by size label but by selected valve (e.g., 23 vs. 21) would therefore only increase the difference. Conclusion: The Trifecta shows a hemodynamic advantage over the Mitroflow which is not likely associated with the applied sizing strategy.


2009 ◽  
Vol 7 (3-4) ◽  
pp. 0-0
Author(s):  
Sigitas Čibiras ◽  
Eugenijus Kosinskas

Sigitas Čibiras, Eugenijus KosinskasVilniaus universiteto Širdies ir kraujagyslių ligų klinika, Vilniaus universiteto ligoninės Santariškių klinikos, Santariškių g. 2, LT-08661 VilniusE-mail: [email protected] Įvadas Darbo tikslas – apibendrinti 20 metų patirtį ir įvertinti įgimtos plaučių arterijos (PA) stenozės balioninės valvuloplastikos (BPV) tiesioginius, tarpinius ir vėlyvuosius rezultatus. Ligoniai ir metodai 1987–2007 metais Vilniaus širdies ligų klinikoje buvo atlikta 101 BPV, ligonių amžius nuo 1 paros iki – 39 metų. BPV atlikta esant spaudimo per PA vožtuvą skirtumui > 30 mm Hg. Ligoniai prieš BPV suskirstyti į dvi grupes pagal tai, ar pradinis spaudimo per PA vožtuvą skirtumas <50 mm Hg (1 gruoė), ar > 50 mm Hg (2 grupė). Analizuotas duomenų kitimas tiesiogiai po BPV, tarpiniu laikotarpiu (iki dvejų metų po BVP), vėlyvuoju laikotarpiu (praėjus daugiau kaip dvejiems metams). Ligoniai po BPV buvo suskirstyti į dvi grupes: turintys liekamąjį spaudimo skirtumą iki 36 mm Hg ir daugiau kaip 36 mm Hg. Rezultatai BPV atlikta 18 pacientų, kurių spaudimo per PA vožtuvą skirtumas < 50 mm Hg. Iškart po BVP spaudimo skirtumas per PA vožtuvą sumažėjo nuo 39,5 ± 5 iki 15,83 ± 8,37 mm Hg, tarpiniu laikotarpiu – iki 20 ± 6 mm Hg, vėlyvuoju – iki 21,5 ± 5 mm Hg. BPV atliktos 83 pacientams, kurių spaudimo per PA vožtuvą skirtumas > 50 mm Hg. Tiesiogiai po BVP vidutinis spaudimo skirtumas sumažėjo nuo 81,31 ± 21,28 iki 31,32 ± 13,82 mm Hg, tarpiniu laikotarpiu – iki 27,56 ± 12,71 mm Hg, vėlyvuoju – iki 19,89 ± 10,12 mm Hg. Esant liekamajam spaudimo skirtumui po BPV < 36 mm Hg (58 ligoniai), tarpiniu lakotarpiu vidutinis spaudimo skirtumas 23,66 ± 9,29 mm Hg, vėlyvuoju – 16,85 ± 7,98 mm Hg. Esant liekamajam spaudimo skirtumui po BPV > 36 mm Hg (21 ligonis), tarpiniu laikotarpiu vidutinis spaudimo skirtumas 51,99 ± 20,61 mm Hg, vėlyvuoju – 35,7 ± 16 mm Hg. Vėlyvuoju laikotarpiu spaudimo skirtumas mažėja, bet didėja PA nesandarumas. Tuoj po BPV nesandarumas nustatytas 7 %, tarpiniu laikotarpiu – 53 %, vėlyvuoju – 81,7 % ligonių. Išvados BPV yra gerai toleruojamas ir veiksmingas nechirurginis gydymo būdas. Daugumai ligonių išryškėja vėlyvasis nedidelis plaučių arterijos nesandarumas, kurį retai prireikia gydyti chirurginiu būdu. Mūsų studija rodo, kad tinkama ligonių atranka leidžia pasiekti gerų tiesioginių, tarpinius ir vėlyvųjų rezultatų. Reikšminiai žodžiai: įgimtos širdies ydos, įgimta plaučių arterijos vožtuvo stenozė, balioninė valvuloplastika. Balloon pulmonary artery valvuloplasty – immediate, mid-term and long-term follow-up results: 20-year experience Sigitas Čibiras, Eugenijus KosinskasVilnius University Clinic of Heart and Vascular Medicine, Vilnius University Hospital Santariškių Klinikos, Santariškių str. 2, LT-08661 Vilnius, LithuaniaE-mail: [email protected] Background To analyze immediate, mid-term and long-term follow-up results after percutaneous balloon pulmonary valvuloplasty (BPV) of congenital pulmonary artery (PA) stenosis for a 20-year period. Patients and methods During 1987–2007, in the Vilnius Clinic of Heart Diseases 101 BPV were performed, the patients’ age range being 1 day – 39 years. BPV was performed with the primary PA valvular pressure gradient > 30 mm Hg. Patients before BPV had been divided into two groups: (1) with primary PA pressure gradient < 50 mm Hg; (2) with primary PA pressure gradient > 50 mm Hg. Data were analyzed immediately after BPV, in a mid-term (2 years) and a long-term (more than 2 years) follow-up. The same patients after BPV were divided into two groups: with residual pressure gradient < 36 mmHg and > 36 mmHg. Results Eighteen BPV were performed with the primary PA pressure gradient < 50 mm Hg: the immediate mean pressure gradient decreased from 39.5  ±   5 to 15.83 ± 8.37 mm Hg, in the mid-term period to 20 ± 6 mm Hg, and in the long-term to 21.5 ± 5 mm Hg. Eighty-three BPV were performed with the primary PA pressure gradient > 50 mm Hg; the immediate mean pressure gradient decreased from 81.31 ± 21.28 mm Hg to 31.32 ± 13.82 mm Hg, in the mid-term period to 20 ± 6 mm Hg and in the long-term period to mm Hg. With the residual pressure gradient after BPV < 36 mm Hg (58 patients), in the mid-term period the pressure gradient decreased to 23.66 ± 9.29 mm Hg and in the long-term period to 16.85 ± 7.98 mm Hg. With the residual pressure gradient after BPV > 36 mm Hg (21 patients), in the mid-term period the pressure gradient decreased to 51.99 ± 20.61 mm Hg and in the long-term period to 35.7 ± 16 mm Hg. In the long-term follow-up, the pressure gradient decreased, but PA regurgitation (PAR) was progressive. Immediately after BPV, PAR was seen in 7%, in mid-term follow-up in 53 %, and in long-term follow-up in 81.7 % patients. Conclusions BPV is a well tolerated and effective non-surgical treatment method. Late trivial PAR develops in the majority of cases, but rarely requires surgical treatment. Our study has demonstrated that the appropriate patient selection enables achieving good immediate, mid-term and long-term follow-up results. Keywords: congenital heart defects, congenital pulmonary artery stenosis, balloon valvuloplasty.


2021 ◽  
Author(s):  
Arash Shokouhmand ◽  
Chenxi Yang ◽  
Nicole D. Aranoff ◽  
Elissa Driggin ◽  
Philip Green ◽  
...  

2021 ◽  
Author(s):  
Sonia B. Albanese Albanese

Background: Surgical treatment of isolated pulmonary valve stenosis in infants and children has evolved over the years, shifting from the original exclusive aim at lowering right ventricle pressure to the current concomitant focus on preserving pulmonary valve function. In our study, we sought to analyze the effect of such evolving philosophy on long-term results. Methods: All consecutive patients treated in our center between July 1983 and March 2019 were included. Patients were categorized into 2 groups based on the introduction into treatment practice of sparing valve techniques (1995). Actuarial survival, freedom from reintervention on the right outflow tract, transvalvular mean pressure gradient decrease, and pulmonary valve function at follow-up were analyzed. Results: One hundred twenty-three patients operated before (Group I, n=81) or since (Group II, n=42) 1995 were enrolled in the study. Mean age and weight were 3.0 ± 0.36 years and 16.6 ± 1.7kg, respectively. Early mortality occurred exclusively in 3 patients of Group 1. Transvalvular mean pressure gradient decreased in the entire patient population (from 63.28 ± 12.9mmHg to 16.46 ± 7.9mmHg). At a mean follow-up interval of 4.9 ± 33 years, freedom from death was comparable, but freedom from right ventricular outflow tract reintervention was significantly greater in Group II. Although the transvalvular gradient remained stable over time in non-reoperated survivors (mean value of 16.46 ± 7.9mmHg), pulmonary valve function on 2D-Echo showed severe incompetence in 2 patients of Group I and just mild to moderate incompetence in 20 patients of Group II, with a significantly negative effect of unsuccessful preoperative pulmonary balloon valvuloplasty (14/20 vs 6/20, p=0.025) in the latter. Conclusion: Current pulmonary valve sparing techniques are associated with better results, particularly in terms of freedom from re-interventions and pulmonary valve function at follow-up. Balloon valvuloplasty prior to surgery may worsen operative results, promoting pulmonary insufficiency and therefore should probably be avoided in all patients in whom anatomical characteristics predict failure of percutaneous therapy.


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