Valve Hemodynamics Research Articles

Bioprosthetic valve dysfunction and failure after TAVI in bicuspid aortic valve stenosis during one-year follow-up according to VARC-3

BackgroundTranscatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) stenosis has become more frequent in the last years. This may pose challenges for long-time valve durability. Therefore, we aimed to evaluate the prevalence of bioprosthetic valve dysfunction (BVD) with the newest-generation devices in BAV stenosis up to one-year follow-up (FU).MethodsThe primary endpoint was defined as the prevalence of BVD during the first procedural year according to Valve Academic Research Consortium (VARC)-3 criteria. Secondary endpoints were defined as failure in device success and clinical endpoints according to VARC-3.ResultsA total of 107 patients were included. Of these, 34 subjects (31.8%) met the criteria for BVD during a mean FU of 263 ± 180 days, of which 20.2% were already documented after thirty days. Device success after one year was lower in the + BVD cohort (57.6% vs. 98.7%, p < 0.0001*). The rates of structural valve deterioration were 6.5%, non-structural valve deterioration (NSVD) 17.8%, subclinical leaflet thickening 10.3%, and endocarditis 0.9%. NSVD was foremost triggered by patient prosthesis mismatch in balloon-expandable valves. Hemodynamic valve deterioration stage 1 and 2 was confirmed in 16.8% of + BVD patients, while stage 1 and 3 bioprosthetic valve failure occurred in 1.9%. There was no impact of BVD on mortality.ConclusionThere is critical evidence of early BVD after TAVI in BAV during one-year FU in one-third of patients, also lowering device success. The most frequently observed bioprosthetic valve dysfunction was NSVD due to patient prosthesis mismatch following TAVI with a balloon-expandable valve.

Transcatheter Aortic Valve Implantation with ACURATE neo: Results from the PROGRESS PVL Registry.

Objectives The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo, a supra-annular self-expanding bioprosthetic aortic valve. Background While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL. Methods The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo. Results The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months (P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient (P < 0.001) and effective orifice area (P=0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months. Conclusions Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance.

BackgroundThe impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation.MethodsConsecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death.ResultsA total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10–22; SA 11%, 95%CI: 6–20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20–23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar.ConclusionIn this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Three-year outcomes of transcatheter aortic valve implantation for bicuspid versus tricuspid aortic stenosis.

Transcatheter aortic valve implantation (TAVI) might be a feasible treatment option for more patients with bicuspid aortic valve (BAV) stenosis. However, long-term follow-up data in this population are scarce. The aim of this study was to evaluate three-year outcomes after TAVI in patients with BAV. A total of 246 consecutive patients who underwent TAVI at a single centre in China between March 2013 and February 2018 were enrolled in this study. Clinical outcomes, health status and echocardiography were followed and recorded for three years. Among 109 (44.3%) BAV patients, 61.5% were Type 0 and 36.7% were Type 1 BAV patients. BAV patients were younger (75 vs 77 years, p=0.041) and had a lower Society of Thoracic Surgeons (STS) score (5.09 vs 6.00, p=0.026) compared to tricuspid aortic valve (TAV) patients. There were no differences in three-year survival rates between bicuspid and tricuspid patients (87.1% vs 79.5%, log-rank p=0.126). Multivariate Cox regression analysis adjusting for confounding factors revealed a similar risk of all-cause mortality in the BAV population (hazard ratio [HR] 0.86, 95% confidence interval [CI]: 0.44-1.70, p=0.666). Except for the rate of permanent pacemaker implantation that was lower in BAV patients (11.9% vs 21.9%, p=0.041), the incidence of other clinical adverse events was comparable between the two groups. Both BAV and TAV patients showed an obvious improvement in valve haemodynamics, which was sustained for three years. In addition, similar left ventricular reverse remodelling was found during follow-up. BAV patients showed similar satisfactory three-year clinical outcomes, persistent valve haemodynamics improvement, and obvious cardiac reverse remodelling after TAVI compared to TAV patients.

Long-Term Follow-Up of Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement.

Early hypoattenuated leaflet thickening (HALT) occurs in at least 10% of all transcatheter aortic valve replacement (TAVR) patients. The long-term prognostic impact of HALT is uncertain. The aim of this study was to assess the long-term risk of early HALT post-TAVR. We report outcome data from our prospective observational registry with post-TAVR computed tomography angiography performed between May 2012 and December 2017. The outcomes were survival, cardiovascular mortality, ischemic cerebrovascular events, and symptomatic hemodynamic valve deterioration. Early HALT was diagnosed in 115 (16.0%) of 804 patients. During a median follow-up of 3.25 years, survival rates did not differ significantly between patients with and without HALT (Kaplan-Meier 3-year estimates for survival 70.1% vs 74.0%, P = 0.597). The 3-year cardiovascular mortality rate was 13.2% versus 11.3% (with vs without HALT, P= 0.733). The 3-year event rate for cerebrovascular events was 2.0% versus 4.4% (with vs without HALT, P = 0.246), and the 3-year event rate of symptomatic hemodynamic valve deterioration was 9.4% versus 1.5% (with vs without HALT, P< 0.001). Multivariable analysis revealed the following predictors of symptomatic hemodynamic valve deterioration: HALT (HR: 6.10; 95%CI: 2.59-14.29; P< 0.001), the mixed valve-type group (HR: 6.51; 95%CI: 2.38-17.81; P<0.001), and prosthesis diameter (HR valve size per 3 mm [HR: 0.37; 95%CI: 0.17-0.79]; P = 0.011). During a median follow-up of more than 3 years, HALT was not associated with mortality or cerebrovascular events. However, we observed an association of HALT with symptomatic hemodynamic valve deterioration.

Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses

BackgroundData comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies. ObjectivesThe purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR. MethodsPatients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography. ResultsA total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs 23 ± 8 mm Hg; P ˂ 0.001; 28 ± 16 mm Hg vs 40 ± 13 mm Hg, P ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively). ConclusionsIn patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101)

Sex Differences in LV Remodeling and Hemodynamics in Aortic Stenosis: Sex-Specific Criteria for Severe Stenosis?

BackgroundThe current criteria for aortic stenosis (AS) severity have not incorporated sex-related differences. ObjectivesThe authors investigated sex-related serial changes in left ventricular (LV) structure/function and hemodynamics in AS. MethodsSerial echocardiograms of patients with severe AS (time 0; aortic valve area [AVA] ≤1 cm2) and ≥1 previous echocardiogram were compared between sexes. ResultsOf 927 patients (time 0: AVA 0.87 ± 0.11 cm2, peak velocity 4.03 ± 0.65 m/s, mean Doppler systolic pressure gradient [MG] 40.6 ± 13.1 mm Hg), 393 (42%) were women. Women had smaller body surface area (BSA) (1.77 ± 0.22 m2 vs 2.03 ± 0.20 m2; P < 0.001), lower stroke volume (SV) (81.1 ± 17.2 mL vs 88.3 ± 18.6 mL; P < 0.001), and more frequent low-gradient severe AS (n = 196 [50%] vs n = 181 [34%]; P < 0.001). Women consistently had smaller AVA, indexed AVA (AVAi), peak velocity, and MG than men. The difference in aortic valve gradient lessened when AVAi ≤0.6 cm2/m2 was applied as severe AS (n = 694, women 43%, AVA 0.95 ± 0.17 cm2, AVAi 0.50 ± 0.07 cm2/m2). Peak velocity (3.83 ± 0.66 m/s) and MG (36.5 ± 13.2 mm Hg) were lower based on AVAi severity criteria compared to those based on AVA. Men had a lower left ventricular ejection fraction (LVEF) (55.8% ± 14.8% vs 61.1% ± 11.7%; P < 0.001) and greater reduction in SV (−13.3 ± 19.6 mL vs −7.4 ± 16.4 mL; P < 0.001) as AS progressed from moderate to severe. Concentric LV hypertrophy was more common and E/eʹ higher in women (21.2 ± 10.9 vs 18.8 ± 9.1; P < 0.001). SV, LVEF, AVA, peak velocity, and MG became precipitously worse when AVA reached 1.2 cm2 in both sexes. ConclusionsSmaller BSA in women yields lower SV, resulting in lower aortic valve gradient than men. Indexed parameters by BSA are thus important in sex-related differences of aortic valve hemodynamics, but AVAi ≤0.6 cm2/m2 includes individuals with moderate AS. Elevated filling pressure is more common in women. Men experience a larger reduction in SV and LVEF as AS progresses. The definition of AS severity may require different criteria between sexes.

Unicuspid Aortic Valve in Patients Undergoing the Ross Procedure

BackgroundThe prevalence and outcomes of the unicuspid aortic valve (UAV) in patients undergoing the Ross procedure have been strongly underreported in the current literature. We sought to evaluate this in comparison with bicuspid (BAV) and tricuspid valve (TAV) in our Ross cohort. MethodsThis was a retrospective observational study of patients undergoing the Ross procedure at 2 dedicated centers between 2009 and 2020. Primary end points were the risks of midterm autograft reoperation and the onset of at least moderate aortic regurgitation during follow-up. The secondary end point was to compare the perioperative outcomes between the groups. ResultsIncluded in the analysis were 286 patients, of those 39% with UAV, 52% with BAV, and 9% with TAV. UAV patients were operated on at the youngest age (P < .001) and more often for a combined hemodynamic aortic valve pathology (P = .02). They had the largest aortic root dimensions: annulus (P = .01), Valsalva sinuses (P = .11), sinotubular junction (P = .001), and ascending aorta (P < .0001). The risks of reoperation (P = .86) and the onset of aortic regurgitation (P = .75) were comparable among the groups over the follow-up of 4.1 years. There was no difference in perioperative outcomes. ConclusionsUAV is a separate unit characterized by a distinct hemodynamic pathology and generated aortopathy. It is not associated with a higher risk of reoperation or new onset of aortic regurgitation after the Ross procedure in the midterm postoperatively. At the current state, UAV remains acceptable for the Ross procedure.

5-Year Follow-Up From the PARTNER 2 Aortic Valve-in-Valve Registry for Degenerated Aortic SurgicalBioprostheses.

The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years. TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown. The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients. In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n=14), the majority of which was due to stenosis (n=6) and combined aortic insufficiency/paravalvular regurgitation (n=3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30days postprocedure through 5 years. At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.

Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation.

Background and Aims of StudyTranscatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high‐risk mitral regurgitation. We aimed to investigate the feasibility of a novel self‐expanding valved stent for TMVI via apical access.MethodsWe designed a novel self‐expanding mitral valve stent system consisting of an atrial flange and saddle‐shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment.ResultsTen animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 ± 0.91 mmHg and 3.42 ± 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation.ConclusionsThis study demonstrated that the novel mitral valve is technically feasible in animals. However, the long‐term feasibility and durability of this valved stent must be improved and verified.

Bicuspid aortic valve morphology and hemodynamics by same-day echocardiography and cardiac MRI.

This study investigated the impact of bicuspid aortic valve (BAV) on valve morphology and motion as well as proximal and aortic hemodynamics using a same-day echocardiography and cardiac MRI. Transthoracic echocardiography, two-dimensional cine MRI of the aortic valve, and aortic 4D flow MRI were performed on the same day in 9 normofunctional BAV patients (age = 41 ± 12, 3 female), 4 BAV with moderate to severe aortic stenosis (AS) (age = 63 ± 5, 1 female), and 36 healthy tricuspid aortic valve controls (age = 52 ± 10, 21 female). Valve opening and closing timings and transvalvular peak velocity were measured using B-mode and Doppler echocardiogram, respectively. Valve orifice morphology at a fully-opened state was characterized using cine MRI. Ascending aortic (AAo) wall shear stress (WSS) was measured using 4D flow MRI data. Valve motion timings were similar between BAV and controls. BAV was associated with an increased orifice aspect ratio (1.44 ± 0.11 vs. 1.10 ± 0.13, P < 0.001), transvalvular peak velocity (1.5 ± 0.3 vs. 1.2 ± 0.2m/s, P < 0.001) and maximum AAo WSS (1.62 ± 0.31 vs. 0.91 ± 0.24Pa, P < 0.001). The increased orifice aspect ratio was associated with the increase in transvalvular peak velocity (r = 0.80, P < 0.0001) and maximum AAo WSS (r = 0.83, P < 0.0001). Transvalvular peak velocity was also positively correlated with maximum AAo WSS (r = 0.83, P < 0.0001). A same-day echo and MRI imaging allows for a comprehensive assessment of the impact of aortic valve disease on valve function and hemodynamics. In this pilot application to BAV, we found increased orifice aspect ratio may be responsible for increased transvalvular peak velocity and maximum AAo WSS.

Impact of Valve Size on Paravalvular Leak and Valve Hemodynamics in Patients With Borderline Size Aortic Valve Annulus.

BackgroundTranscatheter 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.MethodsWe performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multi-detector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multi-center TAVI registry. The aim was to evaluate outcomes of TAVI, mainly paravalvular leak (PVL) and valve hemodynamics, in patients with BAAS (based on MDCT) according to THV sizing selection in between 2 valve sizes. In addition, to investigate the benefit of shifting between different THV types (BE and SE) to avoid valve size selection in BAAS.ResultsOut 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 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 ± 3.7 vs. 12.5 ± 7.2 mmHg; 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.ConclusionBAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and optimized THV hemodynamics with no effect on procedural complications. Additionally, shift from borderline THV to non-borderline THV modified both THV hemodynamics and post-dilatation rates.

Stress exercise haemodynamic performance and opening reserve of a stented bovine pericardial aortic valve bioprosthesis.

Despite unusual high rates of patient-prosthesis mismatch (PPM), excellent midterm clinical outcomes have been reported after surgical aortic valve replacement (SAVR) with the Avalus™ bioprosthetic valve (Medtronic). To elucidate this "PPM conundrum," the Avalus valve haemodynamics were assessed during exercise testing. Of the 148 patients who had undergone SAVR with the Avalus valve at our institution, 30 were randomly selected among those in whom stress test was deemed feasible and underwent a resting transthoracic echocardiography immediately followed by exercise echocardiography. Severe PPM was defined as indexed effective orifice area (iEOA) 0.65 cm2 /m2 and moderate PPM as iEOA 0.65 and 0.85 cm2 /m2 . Measured PPM was determined with the use of the measured iEOA at rest or stress, while the estimated PPM was based on the estimated iEOA, derived from the mean EOA reported for each valve size in the manufacturer chart. Measured EOA significantly increased from rest to peak exercise in all PPM groups (p < .05) and the rates of moderate and severe measured PPM decreased from 40% and 20% to 27% and 0%, respectively. The patients with low-flow state (flow < 250 ml/s) had significantly lower measured rest EOA (p = .03). On the basis of the estimated iEOA, there was no severe PPM and 19 patients had moderate PPM (63.3%), with a significantly lower opening reserve than the patients without estimated PPM (p = .04). The estimated iEOA was more reliably correlated to the measured iEOA at maximal stress than the measured iEOA at rest, especially in patients with a low-flow state. This study supports the concept of an opening reserve of the Avalus valve to explain the PPM conundrum and promotes the use of exercise Doppler-echocardiography to complete the assessment of mismatch, especially in patients with a low-flow state. Published estimated EOA seems reliable to predict the haemodynamic performance of the Avalus valve, whether the flow conditions at rest.

Commentary: Another layer to the "PPM conundrum".

How do manufacturer estimates of valve performance match up to reality and stress testing? We are reviewing a manuscript by Porterie et al. in the Journal of Cardiac Surgery detailing a single-center, assessment of Avalus™ bioprosthetic valve hemodynamics during stress echocardiography. At maximal stress, they found that indexed effective orifice area had better alignment with manufacturer estimates than measurements at rest. In addition, they found a significant difference between EOA and flow rates at rest versus maximal exertion and quantified it as the "opening reserve." Patients without patient prosthetic mismatch had much higher opening reserves. This interesting study helps us to understand how estimates align with reality and draws attention to the concept of the opening reserve. Could differences in opening flow impact the durability or longevity of prosthetics?

WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement

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Patient Prosthesis Mismatch

AbstractConcept of patient prosthesis mismatch came into existence from 1978 onward when Rahimtoola first defined it as “mismatch can be considered to be present when the effective prosthetic valve area, after insertion into the patient, is less than that of a normal human valve.” Patient prosthesis mismatch produces higher than expected pressure gradient through normally functioning valve. Since insertion of first ball caged mechanical valve in descending aorta by Dr. Charles Hufnagel in 1952, prosthetic valve had undergone tremendous improvement in terms of valve design, hemodynamics, durability, and thrombogenicity. Despite these marked changes in valve design, prosthetic valves are still subjected to inherent complications.

Propensity-matched comparison of balloon-expandable and self-expanding valves for transcatheter aortic valve replacement in a Chinese population.

BackgroundBalloon-expandable valves (BEV) and self-expanding valves (SEV) for transcatheter aortic valve replacement (TAVR) have shown promising results in Western populations. Herein, we comparatively evaluated their hemodynamics and early clinical outcomes in a Chinese population.MethodsOne hundred seventy-eight patients with symptomatic aortic stenosis who had undergone transfemoral TAVR using SEV (n=153; Venus-A, 97; VitaFlow, 56) or BEV (n=25; Sapien3) from September 2020 to April 2021 were retrospectively enrolled, and 25 pairs were propensity-score matched for 10 baseline variables. The primary study outcomes were aortic valve hemodynamics and postoperative complications at discharge and 3-month follow-up.ResultsTAVR was successful in all patients. Compared with SEV group, the BEV group had similarly distributed baseline characteristics, procedural time, hospital stay, new pacemaker implantation, and paravalvular regurgitation grade. We also observed that the BEV group had lower rates of balloon pre-dilation (60% vs. 92%, P=0.018), post-dilation (0 vs. 20%, P=0.050) and second valve implantation (0 vs. 24%, P=0.022); higher mean transaortic gradient (14.3±6.1 vs. 10.8±4.9, P=0.030) and proportion of patients with elevated gradients (20% vs. 0, P=0.050) at discharge; and similar rehospitalization, mean transaortic gradient, new pacemaker implantation, and paravalvular regurgitation grade than the SEV group at the 3-month follow-up. There were no deaths in either group. However, the proportion of patients with elevated gradients in SEV group was higher at 3 months than before discharge (24% vs. 0, P=0.022).ConclusionsBEV and SEV for transfemoral TAVR appear comparably safe and effective, with high device success and favorable 3-month clinical outcomes. However, the transaortic gradient and new pacemaker implantation in the SEV group increased during follow-up, warranting larger studies with longer-term follow-up.

An AI Based Detection System of “At Risk” Aortic Stenosis

Aortic Stenosis (AS) causes abnormal aortic valve haemodynamics and changes in cardiac structure (“AS Phenotype”), is associated with high mortality, and has prompted calls for echocardiography report automation. We explored whether Artificial Intelligence (AI) could meet this need by automatically detecting the AS phenotype.

The impact of hypo-attenuated leaflet thickening on haemodynamic valve deterioration following transcatheter aortic valve replacement

BackgroundHypo-attenuated leaflet thickening (HALT) may occur following transcatheter aortic valve replacement (TAVR), however, it remains unclear if HALT is a predictor of haemodynamic valve deterioration (HVD). AimTo determine the impact of HALT on the occurrence of HVD. MethodsWe prospectively evaluated 186 patients for the presence of HALT at a median of 6 weeks following TAVR (Interquartile-range [IQR] 4–12 weeks). HALT depth and area were measured. HVD encompassed any of the following: mean gradient ≥20 ​mmHg with an increase in gradient ≥10 ​mmHg from baseline, Doppler velocity index reduction ≥0.1 or new moderate-to-severe valvular regurgitation. Routine echocardiograms at discharge, one month and annually, were assessed by echo-cardiologists that were blinded to the HALT status. ResultsLT prevalence was 17.7% (33/186). HVD was present in 8.6% (16/186) at a median follow-up of 2 years (IQR 1–3); two required valve re-intervention and five required anticoagulation. HALT was the only independent predictor of HVD on multivariate analysis (OR 33.3, 95%CI 7.4–125). Patients with HALT were more likely to develop HVD, require repeat valve intervention and have higher trans-valvular gradients at up to 3-year follow-up. Patients with HALT had a median cumulative thickness of 2.9 ​mm (IQR 1.9–4.7) and area of 64.2 ​mm2 (IQR 40.9–91.6). Thresholds for HALT in predicting HVD were a cumulative depth of 2.4 ​mm (Specificity 94.1%, Sensitivity 75.0%, AUC ​= ​0.87) and cumulative area of 28 ​mm2 (Specificity 92.2%, Sensitivity 81.3%, AUC ​= ​0.86). ConclusionHALT is an independent predictor of HVD, which exhibits specific depth and area thresholds to predict HVD. CT following TAVR may determine patients at risk of HVD.

Abstract 11037: Procedural Success, Valve Hemodynamics and Outcomes in Patients with Moderate Aortic Stenosis Undergoing Supra-Annular Transcatheter Aortic Valve Replacement

Introduction: Limited evidence supports the hypothesis that early treatment of symptomatic moderate aortic stenosis (AS) may be beneficial. We seek to study procedural success, valve hemodynamics and clinical outcomes in moderate AS patients who underwent transcatheter aortic valve replacement (TAVR) using a supra-annular self-expanding bioprosthesis. Methods: All patients in the STS/ACC/TVT Registry™ with Evolut R, PRO and PRO+ attempted procedures for indication of primary symptomatic (NYHA class II-IV) moderate AS were included. Moderate AS was defined as mean gradient ≥20 and &lt;40 mm Hg, valve area &gt;1.0 and &lt;1.5 cm 2 , and Vmax &gt;3 and &lt;4 m/s. 2.9% of patients had concurrent severe aortic regurgitation at baseline. Valve-in-valve procedures were excluded. Site reported 30-day event rates are reported using Kaplan-Meier analysis. As a quality-of-life metric, KCCQ scores at 30 days and 1 year are compared to baseline scores using paired t-tests. Results: A total of 811 patients (62.1% men, 77.7 ± 8.7 years of age, STS-PROM score 5.3 ± 3.6, baseline LVEF 56.7 ± 13.3 %) were analyzed. The majority of patients underwent elective procedure (n=762, 94.0%) under conscious sedation (n=439, 54.3%) via iliofemoral approach (n=775, 95.6%). Successful device implantation, defined as correct valve positioning, was achieved in 99.3% of patients with low rates of intraprocedural complications (0.4%). Clinical events at 30 days were: all-cause mortality 1.4%, neurological events 2.5%, major bleeding 4.7% and conduction disturbance requiring pacer/ICD 16.1%. Valve hemodynamics improved post procedure compared to baseline (mean gradient 29.8 ± 4.9 to 8.4 ± 4.9 mm Hg, Vmax 3.5 ± 0.2 to 1.9 ± 0.5 m/s), with mean gradient sustained at 1 year (8.6 ± 4.4 mm Hg). Moderate/severe paravalvular regurgitation was present at similar levels at post procedure and 1 year (1.6% and 3.0%). A significant improvement in quality of life was noted from baseline KCCQ score to 30 days (Δ27.5 ± 25.5, 95% CI 25.4 - 29.5, p&lt;0.001) and 1 year (Δ29.1 ± 26.1, 95% CI 26.2 - 32.1, p&lt;0.001). Conclusions: Patients undergoing TAVR with a self-expanding bioprosthesis for symptomatic moderate AS have high procedural success with sustained improvements in valve hemodynamics and quality of life at 30 days and 1 year.