First experiences with the balloon-expandable Myval® transcatheter aortic valve from Turkey.
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ABSTRACT:
SUBMITTER: Arslan U
PROVIDER: S-EPMC7791291 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
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First experiences with the balloon-expandable Myval® transcatheter aortic valve from Turkey.
Arslan Uğur U Erdoğan Güney G Uçar Melisa M Yenerçağ Mustafa M
Anatolian journal of cardiology 20201201 6
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Project description:BackgroundIn the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).Materials and methodsA total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.ResultsThe mean age of the study population was 83 (75-87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3-7) days.ConclusionBased on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.
| S-EPMC8512594 | biostudies-literature
Project description: Not available
| S-EPMC9361163 | biostudies-literature
Project description:Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval device. Results: A total of 11 patients from five institutions were gathered between 2019 and 2022 (age 68 ± 7.8, 63% women). The peak and mean transvalvular gradients were 27 ± 5 mmHg and 14.7 ± 2.3 mmHg, respectively, and the predicted neo-left ventricular outflow tract (neo-LVOT) area was 183.4 ± 56 mm2 (range: 171 to 221 mm2). The procedures were performed via transfemoral access in all cases (through echocardiography-guided transeptal puncture (81.8% transesophageal, 11.2% intracardiac)). Technical success was achieved in all cases, with no significant residual mitral stenosis in any of them (peak 7.2 ± 2.7 and mean gradient 3.4 ± 1.7 mmHg) and no complications during the procedure. There were no data of LVOT obstruction, migration, or paravalvular leak in any case. Mean hospital stay was 3 days, with one major vascular complication and no stroke. At 6-month follow-up, there was one case with suboptimal anticoagulation presenting an increase in the transmitral gradients (mean 15 mmHg) that normalized after optimization of the anticoagulation, but no other relevant events. Conclusions: Transseptal ViV mitral implantation with the balloon-expandable Myval device was feasible and safe avoiding redo surgery in high-risk patients with bioprosthesis degeneration.
| S-EPMC9457220 | biostudies-literature
Project description:Bicuspid aortic valve (BAV) remains challenging in transcatheter aortic valve replacement (TAVR) because of unfavorable anatomy. New-generation balloon-expandable valve (BEV) appears to be a valid alternative to surgery, especially in some Asian countries with a higher prevalence of BAV. This tutorial review summarizes current thinking about how to plan and implant BEV in BAVs using versatile techniques. First, the authors depict the main morphological characteristics of BAVs and their effects on the TAVR procedure. Next, the authors provide preprocedural analysis on sizing, obtaining the optimal deployment projection, and how to simplify valve-crossing. Finally, the authors provide step-by-step guidance on how to deploy the BEVs with evolved iterations in terms of specific anatomies, calcified annulus, and giant annulus.
| S-EPMC9627836 | biostudies-literature
Project description: Not available
| S-EPMC8302989 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.AimsWe aimed to evaluate the safety and feasibility of Myval in NCAR.MethodsThis was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.ResultsA total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047).ConclusionsMyval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.
| S-EPMC10500190 | biostudies-literature
Project description:ObjectiveTranscatheter aortic valve replacement is established therapy for high-risk and inoperable patients with severe aortic stenosis, but questions remain regarding long-term durability. Valve design influences durability. Increased leaflet stresses in surgical bioprostheses have been correlated with degeneration; however, transcatheter valve leaflet stresses are unknown. From 2007 to 2014, a majority of US patients received first-generation balloon-expandable transcatheter valves. Our goal was to determine stent and leaflet stresses in this valve design using finite element analyses.MethodsA 26-mm Sapien Transcatheter Heart Valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution microcomputed tomography scanning to develop precise 3-dimensional geometry of the leaflets, the stent, and the polyethylene terephthalate elements. The stent was modeled using 3-dimensional elements and the leaflets were modeled using shell elements. Stent material properties were based on stainless steel, whereas those for leaflets were obtained from surgical bioprostheses. Noncylindrical Sapien valve geometry was also simulated. Pressure loading to 80 mm Hg and 120 mm Hg was performed using ABAQUS finite element software (Dassault Systèmes, Waltham, Mass).ResultsAt 80 mm Hg, maximum principal stresses on Sapien leaflets were 1.31 megaspascals (MPa). Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. Maximum principal stresses for the stent were 188.91 MPa and located at stent tips where leaflet commissures were attached. Noncylindrical geometry increased peak principal leaflet stresses by 16%.ConclusionsUsing exact geometry from high-resolution scans, the 26-mm Sapien Transcatheter Heart Valve showed that peak stresses for both stent and leaflets were present at commissural tips where leaflets were attached. These regions would be prone to leaflet degeneration. Understanding stresses in first-generation transcatheter valves allows comparison to future designs for relative durability.
| S-EPMC5837867 | biostudies-literature
Project description:BackgroundCoronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement.MethodsWe retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not.ResultsAmong 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1 mm; P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9 mm; P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4 mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30 days. After a median follow-up of 351 days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group.ConclusionsLM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.
| S-EPMC11307958 | biostudies-literature
Project description:BackgroundAortic stenosis is the most frequently acquired native valve disease. Transcatheter aortic valve replacement (TAVR) has emerged as a transformative intervention for patients with severe aortic stenosis. Despite its success, studies have shed light on racial and ethnic disparities in utilization and outcomes of TAVR.MethodsUsing the Transcatheter Valve Therapy Registry between November 2011 through June 2023, we evaluated volume trends of SAPIEN balloon-expandable TAVR performed by race/ethnicity, and its association with in-hospital and 1-year outcomes after the procedure.ResultsIn the 12-year period, 395,618 patients were identified; 357,729 (90.42%) were White, 18,810 (4.75%) Hispanic, 15,100 (3.82%) Black, and 3979 (1.01%) Asian. There was an overall rising trend in proportional usage of TAVR among Hispanics (from 3.3% in 2011/2012 to 5.2% in 2023, P < .01) and Asian patients (from 1.1% in 2011/2012 to 1.3% in 2023, P < .01). Adjusted 1-year major adverse cardiac events (all-cause mortality, stroke, or rehospitalization) were comparable among Black patients (hazard ratio [HR], 1.00; 95% CI, 0.97-1.03; P = .82) and lower among Asian (HR, 0.91; 95% CI, 0.86-0.97; P < .01) and Hispanic patients (HR, 0.89; 95% CI, 0.86-0.91; P < .01) compared with White patients.ConclusionsEvidence supports favorable outcomes across different ethnic groups, despite the presence of higher levels of comorbidities and lower TAVR utilization. Modest improvements in TAVR utilization disparities among Asian and Hispanic patients have occurred since its introduction; however, utilization in Black patients remains low despite favorable outcomes. Further efforts are needed to understand the reasons and mitigate disparities in minority patients.
| S-EPMC11916718 | biostudies-literature
Project description:Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team's decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.
| S-EPMC10816957 | biostudies-literature