Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience

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.

Redo aortic valve replacement with a non-conventional intraoperative decision to avoid left main stem obstruction.

Redo aortic valve surgery for failure of a previously implanted valve is always challenging. In case of small-sized implanted valves, the use of a balloon-expanding Sapien-3 valve can enhance the final effective orifice area, avoid complex annulus enlargement techniques, and can reduce operative time and morbidities. We describe a case where after explanting a failed 19mm St. Jude mechanical aortic valve and further deployment of a 23mm Sapien-3 valve, the left coronary ostia was obstructed by the skirt of the transcatheter prosthesis. After careful removal of a little part of the skirt, we were able to restore the coronary flow and the patient had a favorable outcome.

Two-Year Clinical Follow-Up Assessment of the Novel Cingular Surgical Bovine Pericardial Valve

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.

508 Incidence and determinants of prosthesis-patient mismatch after transcatheter aortic valve replacement using predicted indexed effective orifice area

Aims A small effective orifice area (EOA) by body surface area (BSA), defined as prosthesis–patient mismatch (PPM), is associated with elevated transprosthetic pressure gradients, less ventricular remodelling, and a worse prognosis. Calculating PPM by dividing the normal reference value of EOA for the model and size of the prosthetic valve (predicted PPM), instead of using the continuity equation has been recently confirmed as more accurate after trans catheter aortic valve intervention (TAVI), providing a stronger association with post-procedural haemodynamic outcomes. However, current evidence using this new definition is still limited, thus impairing generalizability. Accordingly, this analysis aims to extend such evidence providing incidence, and determinants of predicted PPM (PPMp) in an all-comers population undergoing TAVR with a high prevalence of self-expandable devices. Methods 395 patients who underwent TAVI at our Institution from September 2008 to November 2020 were included in this analysis. PPMp was then classified as moderate if ≤ 0.85 cm2/m2 and severe if ≤ 0.65 cm2/m2 as well as moderate if ≤ 0.70 cm2/m2 and severe if ≤ 0.55 cm2/m2 for patients with a body mass index > 30, as recommended by the Valve Academic Research Consortium-3 definition. The independent association between baseline clinical and procedural variables and the presence of moderate or severe PPMp was investigated with cross-sectional logistic regression analysis. Results 11 patients (2.78%) had severe and 33 (8.35%) moderate PPMp. Patients with moderate or severe PPMp (m/s PPMp) were younger, female, with a higher prevalence of hypercholesterolaemia, prior aortic valve implantation and balloon expandable device and lower prevalence of chronic obstructive disease (COPD). Post-procedural mean gradient was higher in patients with m/s PPMp. The independent clinical and procedural correlates associated with higher likelihood of m/s PPMp were valve in valve procedure (ViV) and the use of a balloon-expandable device. Conclusions Moderate or severe PPMp was observed only in a small part of patients underwent TAVI, leading, however, a higher post-procedural mean gradient compared to those without PPMp. Balloon expandable devices and ViV were the strongest determinant of moderate or severe PPM.

365 Combining mechanisms of prosthetic valve dysfunction

A 32-year-old female was referred to our outpatient clinic for exertional dyspnoea that had worsened in the preceding months. She had a history of mitral and aortic valve replacement with bileaflet mechanical prosthesis (St. Jude Master n. 25 and Medtronic Open Pivot n. 16, respectively) for rheumatic heart disease. A recent echocardiography showed borderline-high trans-aortic gradients (mean 26 mmHg, peak 42 mmHg). Transthoracic echocardiography revealed abnormal aortic transprosthetic flow (peak velocity 442 cm/s, mean gradient 48 mmHg). Continuous Wave Doppler signal was rounded with a long acceleration time (108 ms). Effective orifice area (EOA) was 0.8 cmq (index EOA 0.48 cmq/mq) and Doppler Velocity Index 0.28. Further investigations revealed no signs of infections but suboptimal anticoagulation (INR 2.5). Transesophageal 3D echocardiography was suggestive for hypomobility of the prosthetic leaflets and the presence of an isoechoic mass encircling the ventricular side of the aortic prosthesis compatible with pannus overgrowth. Cardiac CT confirmed the presence of a symmetrical reduction in the systolic opening of both leaflets. The patient underwent a redo of aortic valve replacement that confirmed the presence of an asymmetric subprosthetic pannus overgrowing on the previously implanted surgical pledgets. After pannus debritment a St. Jude Regent n. 21 was implanted. The patient experienced complete symptomatic resolution. We presented the case of a prosthetic aortic valve dysfunction due to a combination of patient-prosthesis mismatch and pannus overgrowth. In our patient, as assessed in the old echocardiographic examinations, the presence of mildly elevated transprosthetic gradients was suggestive for prosthesis undersizing related to body surface area. In this scenario, subvalvular pannus formation caused significant changes in prosthetic valve transvalvular flow dynamic leading to prosthesis dysfunction. This case emphasises the crucial role of echocardiographic follow up in detection of causes of prosthetic heart valve dysfunction and how optimal valve sizing is paramount in aortic valve replacement.

Converging rapid deployment prostheses with minimal access surgery: analysis of early outcomes

Background Sutureless prostheses may have added benefit when combined with minimal access surgery, although this has not been fully assessed in the literature. This study aims to provide a comparative analysis of the Perceval valve comparing median sternotomy (MS) with mini-sternotomy (MIS). Methods A retrospective analysis of prospectively collected data was conducted for all isolated aortic valve replacement (AVR), using the Perceval valve, for severe aortic stenosis cases in the period 2014 to 2019. Patients undergoing concomitant valve or revascularisation surgery were excluded. Results A total of 78 patients were included: MS group 41; MIS group 37. Operatively, bypass times were comparable between MS and MIS groups (mean 89.3 vs 83.4, p = 0.307), as were aortic cross clamp times (58.4 vs 55.9, p = 0.434). There were no operative deaths or new onset post-operative neurology. MIS was a predictor of reduced stay in the intensive care unit (coef − 3.25, 95% CI [− 4.93, − 0.59], p = 0.036) and hospital stay overall (p = 0.004). Blood transfusion units were comparable as were the incidence of heart block (n = 5 vs n = 3, p = 0.429) and new onset atrial fibrillation (n = 15 vs n = 9, p = 0.250). Follow-up echocardiography found a significant improvement in effective orifice area, left ventricular dimension and volume indices, and LVEF (p > 0.05) for all patients. Multivariate analysis found mini-sternotomy to be a predictor for reduced LV diastolic volume (coef − 0.35, 95% CI [− 1.02, − 0.05], p = 0.05). Conclusions The combination of minimal access surgery and sutureless AVR may enhance patient recovery and provide early LV remodelling.

Comparative Analyses of Blood Flow Through Mechanical Trileaflet and Bileaflet Aortic Valves

The paper describes one of many issues concerning the human circulatory system. The simulation of blood flow through an artificial aortic heart valve using the finite element method (FEM) is the main subject of the paper. The studies aim to verify the performance of mechanical aortic valves of two types, i.e. bileaflet (BIL) and trileaflet (TRI) valves. The blood was modelled as Newtonian and non-Newtonian. Although the design of our TRI valve is preliminary and needs to be optimised, our results highlight some advances of such a valve geometry. This is manifested mainly by a central blood jet, contributing to more physiological blood flow and decreasing the risk of haemolysis. The central flow minimises the risk of leaflet dislocation. In addition, lower stresses extend the durability of the valve. However, the TRI valve geometry has also disadvantages, for instance, the occurrence of small peripheral streams or relatively low effective orifice area. The valves' performance was assessed by means of the reduced stress in the valves, the shear stress in the aortic wall, flow velocity field, and the effective orifice area. The maximum von Mises stress for the BIL valve leaflets is 0.3 MPa, and for the TRI valve: 0.06 MPa. The maximum flow velocity for the BIL valve is 4.52 m/s for 40° and for the TRI valve is 5.74 m/s. Higher shear stress is present in the BIL (151.5 Pa) than for the TRI valve (49.64 Pa).

Aliased Flow Signal Planimetry by Cardiovascular Magnetic Resonance Imaging for Grading Aortic Stenosis Severity: A Prospective Pilot Study

Objectives: Transthoracic echocardiography (TTE) is the standard technique for assessing aortic stenosis (AS), with effective orifice area (EOA) recommended for grading severity. EOA is operator-dependent, influenced by a number of pitfalls and requires multiple measurements introducing independent and random sources of error. We tested the diagnostic accuracy and precision of aliased orifice area planimetry (AOAcmr), a new, simple, non-invasive technique for grading of AS severity by low-VENC phase-contrast cardiovascular magnetic resonance (CMR) imaging.Methods: Twenty-two consecutive patients with mild, moderate, or severe AS and six age- and sex-matched healthy controls had TTE and CMR examinations on the same day. We performed analysis of agreement and correlation among (i) AOAcmr; (ii) geometric orifice area (GOAcmr) by direct CMR planimetry; (iii) EOAecho by TTE-continuity equation; and (iv) the “gold standard” multimodality EOA (EOAhybrid) obtained by substituting CMR LVOT area into Doppler continuity equation.Results: There was excellent pairwise positive linear correlation among AOAcmr, EOAhybrid, GOAcmr, and EOAecho (p < 0.001); AOAcmr had the highest correlation with EOAhybrid (R2 = 0.985, p < 0.001). There was good agreement between methods, with the lowest bias (0.019) for the comparison between AOAcmr and EOAhybrid. AOAcmr yielded excellent intra- and inter-rater reliability (intraclass correlation coefficient: 0.997 and 0.998, respectively).Conclusions: Aliased orifice area planimetry by 2D phase contrast imaging is a simple, reproducible, accurate “one-stop shop” CMR method for grading AS, potentially useful when echocardiographic severity assessment is inconclusive or discordant. Larger studies are warranted to confirm and validate these promising preliminary results.

AORTIC VALVE RECONSTRUCTION SURGERY USING AUTOLOGOUS PERICARDIUM: THE EXPERIENCE IN VIETNAM

Objective: The study aimed to evaluate the indications and describe the aortic valve reconstruction techniques by Ozaki’s procedure in Vietnam and report mid-term outcomes of this technique in Vietnam. Methods: Between June 2017 and December 2019, 72 patients diagnosed with isolated aortic valve disease, with a mean age of 52.9 (19 – 79 years old), and a male:female ratio of 3:1 underwent aortic valve reconstruction surgery by Ozaki’s technique at Cardiovascular Center, E Hospital, Vietnam. Results: The aortic valve diseases consisted of aortic stenosis (42%), aortic regurgitation (28%), and a combination of both (30%). In addition, the proportion of aortic valves with bicuspid morphology and small annulus (≤ 21 mm) was 28% and 38.9%, respectively. The mean aortic cross-clamp time was 106 ± 13.8 minutes, mean cardiopulmonary bypass time was 136.7 ± 18.5 minutes, and 2.8% of all patients required conversion to prosthetic valve replacement surgery. The mean follow-up time was 26.4 months (12- 42 months), the survival rate was 95.8%, the reoperation rate was 2.8%, and rate of postoperative moderate or higher aortic valve regurgitation was 4.2%. Postoperative valvular hemodynamics was favorable, with a peak pressure gradient of 16.1 mmHg and an effective orifice area index of 2.3 cm . Conclusions: This procedure was safe and effective, with favorable valvular hemodynamics and a low rate of valvular degeneration. However, more long-term follow-up data are needed.