Mean Transprosthetic Gradient Research Articles

Routine postdilation after 23 mm Sapien 3 Ultra implantation in the aortic position.

Residual transprosthetic gradient (TG) after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEV) may be due to suboptimal valve expansion. To compare hemodynamics after TAVR with small BEV according to postdilation strategy. This observational, retrospective cohort study included 184 consecutive patients from a single center treated with 23 mm Sapien 3 Ultra (Edwards Lifesciences) BEV implantation in the aortic position and enrolled between January 2020 and April 2023. Patients treated with routine postdilation (RP, n = 73) were compared to patients treated according to local standard practice (SP, n = 111). Primary endpoint was 30-day mean TG. Secondary endpoints were incidence of 30-day prosthesis-patient mismatch (PPM), technical success and device success. Thirty-day mean TG was lower in RP versus SP (12.3 ± 4.6 mmHg vs. 14.1 ± 5.7 mmHg, p = 0.031), and incidence of PPM was less common with RP versus SP (47.3% vs. 71.0%, p = 0.006). Technical success (98.6% vs. 99.1%, p = 0.637) and device success (93.1% vs. 90.1%, p = 0.330) did not differ between groups. Differences in 30-day mean TG were driven by patients at normal flow (12.1 ± 4.0 mmHg vs. 15.0 ± 5.5 mmHg, p = 0.014), while no differences were evident among patients at low flow (12.5 ± 5.5 mmHg vs. 11.7 ± 5.5 mmHg, p = 0.644). RP decreased height and increased width of BEV, and a linear regression established that final BEV width could predict 30-day mean TG (r = -0.6654, p < 0.0001). RP after TAVR with small BEV was associated with more favorable forward-flow hemodynamics than SP.

Porcine or Bovine Tissue Valves: Which are Better for Surgical Aortic Valve Replacement?

Summary The choice between mechanical and bioprosthetic aortic valve implants is affected by relatively clear criteria. However, the choice between porcine or pericardial valve is more complex regarding bioprosthetic devices. We aimed to elucidate any hemodynamic and clinical difference between two widely used bioprosthetic valves: the Sorin Mitroflow bovine pericardial valve and the St. Jude Medical Epic Supra porcine valve. We retrospectively studied 71 consecutive patients separated into two groups based on the valve they received. Clinical outcomes included patient survival and hemodynamic performance of the implanted prostheses. Patients were assessed at one and five years postoperatively. Mean transprosthetic pressure gradients were used as a marker of hemodynamic performance. The Mitroflow valve exhibited lesser mean transvalvular gradients than the Epic valve for all labelled sizes at one and five years postoperatively. The 5-year survival was equal between groups. Both prostheses demonstrated a small but significant increase in mean pressure gradients in the fifth year. Most patients enjoyed significant clinical improvement as assessed by NYHA functional class. Both bioprostheses performed very well with excellent hemodynamic parameters. The pericardial valves are a safe and appropriate choice for surgical bioprosthetic aortic valve replacement.

Impact of leaflet thrombosis on valve haemodynamic status after transcatheter aortic valve replacement

ObjectivesThe effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the...

Circulating Progenitor Cells Are Associated With Bioprosthetic Aortic Valve Deterioration: A Preliminary Study.

Background Mechanisms underlying bioprosthetic valve deterioration are multifactorial and incompletely elucidated. Reparative circulating progenitor cells, and conversely calcification-associated osteocalcin expressing circulating progenitor cells, have been linked to native aortic valve deterioration. However, their role in bioprosthetic valve deterioration remains elusive. This study sought to evaluate the contribution of different subpopulations of circulating progenitor cells in bioprosthetic valve deterioration. Methods and Results This single-center prospective study enrolled 121 patients who had peripheral blood mononuclear cells isolated before bioprosthetic aortic valve replacement and had an echocardiographic follow-up ≥2 years after the procedure. Using flow cytometry, fresh peripheral blood mononuclear cells were analyzed for the surface markers CD34, CD133, and osteocalcin. Bioprosthetic valve deterioration was evaluated by hemodynamic valve deterioration (HVD) using echocardiography, which was defined as an elevated mean transprosthetic gradient ≥30 mm Hg or at least moderate intraprosthetic regurgitation. Sixteen patients (13.2%) developed HVD during follow-up for a median of 5.9 years. Patients with HVD showed significantly lower levels of reparative CD34+CD133+ cells and higher levels of osteocalcin-positive cells than those without HVD (CD34+CD133+ cells: 125 [80, 210] versus 270 [130, 420], P=0.002; osteocalcin-positive cells: 3060 [523, 5528] versus 670 [180, 1930], P=0.005 respectively). Decreased level of CD34+CD133+ cells was a significant predictor of HVD (hazard ratio, 0.995 [95% CI, 0.990%-0.999%]). Conclusions Circulating levels of CD34+CD133+ cells and osteocalcin-positive cells were significantly associated with the subsequent occurrence of HVD in patients undergoing bioprosthetic aortic valve replacement. Circulating progenitor cells might play a vital role in the mechanism, risk stratification, and a potential therapeutic target for patients with bioprosthetic valve deterioration.

194 THROMBOEMBOLIC ACUTE ST ELEVATION MYOCARDIAL INFARCTION AFTER TRANSCATHETER VALVE IMPLANTATION

Abstract Transcatheter aortic valve implantation (TAVI) is an established treatment of severe symptomatic aortic valve stenosis and is an effective and less invasive treatment option compared with conventional surgical aortic valve replacement (SAVR) for patients considered inoperable or at high surgical risk. Thromboembolic and bleeding complications negatively impact recovery and survival after TAVI. This case describes one of the few reported TAVI-associated myocardial infarction due to thrombosis of the prosthetic aortic valve. A 82-years-old woman, suffering from severe symptomatic aortic stenosis, underwent TAVI. Before the procedure, coronary artery disease was excluded by invasive coronary angiography. Since the time of the discharge the patient didn't assume any therapy with aspirin or other antithrombotic drugs. A month after TAVI she complained persistent epigastric pain and was admitted to our department for anterior ST elevation myocardial infarction. Coronary angiography highlighted a monovascular coronary artery disease with thrombotic occlusion of the first diagonal and of the distal left anterior descending coronary artery. In consideration of the thrombotic load thyrofiban was started and it was performed a chest contrast CT which confirmed the diagnostic suspicion of bioprosthetic valve thrombosis. She was first treated with unfractionated heparin (UFH) and then oral anticoagulant therapy with warfarin was started. Echocardiograms (echo) showed a severely reduced systolic function (EF 25%) and high trans-prosthetic gradients (mean transprosthetic pressure gradient of 30 mmHg). On the 8th day after hospitalization she complained chest pain with evidence of moderate pericardial effusion. Epistenocardica pericarditis was therefore diagnosed and the patient started acetylsalicylic acid therapy with progressive clinical, instrumental and laboratory improvement. After 10 days of anticoagulation therapy, she underwent a transesophageal echocardiogram which turned out negative for bioprosthetic valve thrombosis. The predischarge transthoracic echocardiography showed severely reduced systolic function (EF 30%) with a mean transprothesic gradient of 12 mmHg; the circumferential pericardial effusion was mild-moderate but not haemodynamically significative. Therapy at discharged included warfarin and aspirin. Ten days after an echo showed a reduction of the pericardial effusion, an improved systolic function (EF 42%) and mean transprothesic gradient not changed significantly since discharge. Prosthetic valve thrombosis has been reported in up to 40% of patients after TAVI and this case hightlights the importance of antithrombotic therapy after this procedure. Therapeutic anticoagulation appears to be the only non-invasive treatment for resolving valve thrombosis but it is not clear how long this therapy should last for the prevention of prosthetic valve thrombosis.

Abstract 13214: Circulating Progenitor Cells Are Associated With Bioprosthetic Aortic Valve Deterioration

Introduction: Mechanisms underlying bioprosthetic valve deterioration (BVD) are multifactorial and incompletely elucidated. Reparative circulating progenitor cells (CPCs), and conversely calcification-associated osteocalcin expressing CPCs (CPC-OCN), have been linked to native aortic valve deterioration. However, their role in BVD remains elusive. This study sought to evaluate the contribution of different subpopulations of CPCs in BVD. Methods: This prospective study enrolled 121 patients who had peripheral blood mononuclear cells (PBMC) isolated prior to bioprosthetic aortic valve replacement (surgical 104, transcatheter 17) and had an echocardiographic follow-up ≥2 years after the procedure. Using flow cytometry, fresh PBMC were analyzed for the surface markers CD34, CD133, and osteocalcin (OCN). BVD was evaluated by hemodynamic valve deterioration (HVD) using echocardiography, which was defined as an elevated mean transprosthetic gradient ≥30mmHg and/or at least moderate intraprosthetic regurgitation. Multivariable models were constructed to evaluate the association of each subpopulation of CPCs and other clinical characteristics with HVD. Results: Sixteen patients (13.2%) developed HVD during follow-up for a median of 5.9 years. Patients with HVD showed significantly lower levels of reparative CD34 + CD133 + cells and higher levels of OCN + cells than those without HVD (CD34 + CD133 + cells: 125 [80, 210] vs 270 [130, 420], P=0.002; OCN + cells: 3060 [523, 5528] vs 670 [180, 1930], P=0.005 respectively). Decreased level of CD34 + CD133 + cells was a significant predictor of HVD. Conclusions: Circulating levels of CD34 + CD133 + cells and OCN + cells were significantly associated with the subsequent occurrence of HVD in patients undergoing bioprosthetic aortic valve replacement. CPCs might play a vital role in the mechanism, risk stratification and a potential therapeutic target for patients with bioprosthetic valve deterioration.

The ratio of measured and reference effective orifice areas for discriminating prosthetic aortic valve obstruction.

We aimed to evaluate the efficacy of the measured effective orifice area (EOA)/reference EOA ratio in discriminating mechanical prosthetic aortic valve (PAV) obstruction. This is a retrospective study of 193 mechanical PAV patients with an elevated mean transprosthetic pressure gradient (PG) over 20 mmHg or peak velocity over 3 m/s. Of those, 143 patients were objectively proven PAV obstruction with cardiac computed tomography or surgical inspection. The EOA was measured using the continuity equation, and the reference EOA values were obtained from previous guidelines. The measured/reference EOA ratio was significantly lower in the obstruction group (0.63 ± 0.18 vs. 0.86 ± 0.17; P < 0.001). The EOA ratio added incremental value for discriminating obstruction from the conventional parameters recommended in the guidelines. Receiver operating characteristic curve analysis revealed that the measured/reference EOA ratio discriminated PAV obstruction from those without obstruction [area under the curve (AUC), 0.840; 95% confidence interval, 0.783-0.898; P < 0.001]. A cutoff of 0.71 had 73.4% sensitivity and 82.0% specificity. The novel diagnostic algorithm adding the EOA ratio had similar accuracy to previous guideline algorithms, including reference EOA, and conventional Doppler parameters (AUC, 0.763 vs. 0.731; P = 0.309). In patients with a large PAV (≥23 mm), the novel algorithm had higher accuracy than the previous algorithm (AUC, 0.788 vs. 0.642; P = 0.019). The ratio of measured/reference EOA adds incremental value over conventional Doppler parameters and might be helpful for distinguishing PAV obstruction.

Long-term results of a stented bioprosthetic valve in the aortic position: structural valve deterioration and valve haemodynamic deterioration of bovine pericardial and porcine valves.

This study compared the clinical outcomes of bovine and porcine bioprosthetic valves based on structural valve deterioration (SVD) and valve haemodynamic deterioration (VHD) in the aortic position. From January 1995 to December 2014, patients who underwent aortic valve replacement (AVR) using a bovine pericardial valve or porcine valve were enrolled. SVD and VHD were defined according to the mean transprosthetic gradient and the grade of aortic regurgitation on transthoracic echocardiography. The propensity score matching was used to adjust for differences in preoperative and operative characteristics. A total of 520 patients were enrolled. Of these, 372 patients underwent AVR using a bovine pericardial valve and 148 patients underwent AVR using a porcine valve. Then, 135 pairs of patients were extracted after propensity score matching. The median follow-up duration was 8.2 years (interquartile range, 5.4-11.3). Among the matched patients, no significant differences occurred in overall survival (survival at 10 years: 64.7% vs 70.9%) or cardiac death (cumulative incidence at 10 years: 14.2% vs 13.1%) between the 2 groups. The cumulative incidence of moderate or greater SVD and VHD was significantly higher in the porcine valve group than in the bovine valve group (SVD at 10 years-porcine: 29.8% vs bovine: 13%; VHD at 10 years-porcine: 19.8% vs bovine: 3.8%, respectively). However, no significant differences were noted in the cumulative incidence of severe SVD and severe VHD between the 2 groups. The bovine pericardial valve should be considered in AVR because the cumulative incidences of moderate or greater SVD and VHD were significantly lower than those of the porcine valve.

Are small-sized mechanical valves adequate for patients with small aortic roots?

Concerns have been raised over patient outcomes following implantation of small aortic valves (size: 19 and 17 mm). However, in patients with a smaller body surface area, these valves may be adequate. The aim of th study was to assess the hemodynamic and functional performance of these valves and their impact on clinical outcomes in patients with a small aortic root. This was a prospective observational study that included all consecutive patients undergoing aortic valve replacement (AVR) with a small-sized aortic valve over a 3-year period. Patients were followed up at 1 week, 6 weeks, and 1 year. Functional and clinical evaluation along with echocardiography was carried out for hemodynamic assessment. In-hospital mortality and hemodynamic outcomes at 1-year follow-up were recorded. Isolated AVR with a size 17 mm valve was carried out in 15 (25%) and with a 19 mm valve in 45 (75%) patients. The mean annular size was 19.12 ± 2.03 mm. The mean indexed effective orifice area was 1.08 ± 0.16 cm2/m2. Satisfactory decrease in peak and mean trans-prosthetic gradient were evident (peak gradient preoperatively was 92.15 ± 26.2 mmHg, and 25.68 ± 12.28 mmHg at 1 year, mean gradient was 55.31 ± 17.41 mmHg preoperatively and 13.71 ± 7.39 mmHg at 1 year). The functional status of patients also showed significant improvement post AVR. Left ventricular ejection fraction pre-operatively was 59.67% ± 10.38% and 59.57% ± 7.98% at 1-week, 59.15% ± 8.17% at 6 weeks, and 59.59% ± 7.48% at 1 year. When confronted with a small aortic root, AVR with a small-sized prosthesis provides a satisfactory hemodynamic and functional outcome. In patients with small body surface area, implantation of a small-sized valve is a viable option.

Trifecta versus Perimount Magna Ease aortic valves: Failure mechanisms.

BackgroundThere are increasing reports of early externally mounted pericardial Trifecta bioprosthesis failure. We compared the hemodynamic performance of Trifecta and Carpentier–Edwards Perimount Magna Ease valves to determine the failure mechanism.MethodsWe retrospectively included 270 consecutive patients (age: 73.4 ± 8.2 years; 57.5% male; mean follow-up: 48.0 ± 20.3 months) who underwent aortic valve replacement from 2014 to 2021 at a single center and compared the Trifecta (N = 137) and Carpentier–Edwards Perimount Magna Ease valve (N = 133) patients.ResultsThe prosthetic valve major aortic regurgitation incidence was higher for the Trifecta than that for the Carpentier–Edwards Perimount Magna Ease valve (6.3% vs. 0%, P < 0.009). Among the Trifecta failures, 33% developed structural valve deterioration, but all requiring redo aortic valve replacement developed major prosthetic valve aortic regurgitation. Freedom at 5 years from redo aortic valve replacement due to structural valve deterioration was significantly lower for Trifecta (89.4% vs. 100%, P = 0.003). The reoperation hazards were determined for Trifecta (vs. Carpentier–Edwards Perimount Magna Ease): 11.6 (1.47–90.9; P = 0.02), prosthetic valve aortic regurgitation: 2.38 (1.70–3.32; P < 0.01), structural valve deterioration: 20.82 (4.08–106.2; P < 0.01), 5-year mean transprosthetic pressure gradient: 1.14 per 1-point increase (1.03–1.24; P = 0.007), and urgent surgery: 10.1 (2.59–39.0; P = 0.001). The Cox regression analysis identified that prosthetic valve aortic regurgitation solely contributed to redo aortic valve replacement (hazard ratio: 2.38; confidence intervals: 1.70–3.32).ConclusionsSignificantly, more early failures occurred with the Trifecta valve than the Carpentier–Edwards Perimount Magna Ease valve but the Trifecta showed reasonable mean transprosthetic pressure gradient over time. Prosthetic valve aortic regurgitation and calcific structural valve deterioration synergistically contributed to Trifecta valve failure alternatively.

Micro-dislodgement of a self-expanding transcatheter heart valve: Incidence, predictors, and outcomes

ObjectivesMalpositioning of transcatheter heart valves increases the risk of procedural failure. For the ACURATE system, inadvertent movement of the prosthesis to a varying extent is sometimes observed upon full release, but the incidence, mechanisms, and clinical impact of such valve micro-dislodgement (VMD) are poorly understood.The aim of the present study was to assess the incidence, predictors, and clinical outcomes of VMD in an all-comers population that underwent transcatheter aortic valve implantation (TAVI) with the ACURATE neo2 prosthesis (NEO2). MethodsThis was a retrospective analysis of 448 consecutive patients who underwent transfemoral TAVI with NEO2 at our institution. VMD was defined as displacement ≥2 mm between the initial position and immediately after valve release as measured on fluoroscopy at the non-coronary cusp. The initial valve position prior to step 2 was categorized using the radiopaque marker band (RMB) relative to the annular plane. In addition, further anatomical and procedural characteristics were assessed. ResultsA total of 68 (15.2%) cases with VMD were identified. A larger cover index, higher RMB position, partial detachment of the lower crown, and severe parallax prior to deployment were independent predictors of VMD, whereas a position of the delivery system in the outer curvature was protective against VMD. Among patients with VMD, the rates of valvular malpositioning and thus technical failure (VARC-3) were higher, but mean transprosthetic gradients were lower. ConclusionsVMD occurs in a notable proportion of transfemoral TAVI cases with NEO2 and is associated with more frequent technical failure of the procedure.

Transcatheter aortic valve implantation (balloon-expandable versus self-expandable valves) - what echocardiographic parameters should we evaluted?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter aortic valve implantation (TAVI) is currently the recommended treatment for aortic stenosis (AS) in high or intermediate-risk or inoperable patients. Balloon-expandable valve (BEV) and self-expanding valve (SEV) are the two major types of transcatheter heart valves (TTHV). Despite major diferences, both designs are recomended, however, there are only limited data available for the comparison of newer generation BEV and SEV. Purpose Compare echocardiographic and clinical parameters, during 1 year of follow-up of a balloon-expandable (BS) versus self-expanding (SE) transcatheter aortic valve implantantation, with emphasis on the composite endpoits proposed by uptade Valve Academic Researc Consortium (VARC-2). Methods Retrospective, comparative study in patients with symptomatic severe AS with a high operative risk, who implanted BEV or SEV between January 2016 and December 2019. All patients underwent echocardiographic study before an after the procedure (on the day , 6 months and 1 year of follow up), clinical data were collected. The following ecocardiographic parameters were evaluated: transvalvular and prosthetic aortic gradientes and paravalvular leak (PVL). Results We studied 106 patients (81 ± 8 years, 60% female) with severe AS (mean gradient of 49 ± 12 mmHg), who were threated with BE or SE transcatheter aortic valve. Comparative analysis between BEV vs SEV, showed: there were no statistically significant in mean transprosthetic gradients (9.5 ± 4.8 vs 10 ±6.2; p = 0.49). There were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (21% vs. 28%; p = 0.49), death from cardiovascular causes (3.3% vs. 0%; p= 0.26), all strokes (1.6% vs. 1.6%; p = 0.85), pacemaker implatation (18% vs. 15% p = 0.79); major bleeding (3.3% vs 6.5%; p = 0.18) and renal injury (1.6% vs. 2.1%: p = 0.67). There were statistically significant differences between BE and SE valves in the cumulative incidence of moderate or severe PVL (5% vs. 23.9%; p = 0.009) and repeat hospitalization (11.6% vs. 28%;p = 0.04). Device sucess was achieved in 97 % for BEV vs 91% for SEV (p = 0,39). The early safety at 30 days was observed in 5% for BVE vs. 4.3% for SVE (p = 0.87). The clinical efficacy after 30 days was achieved in 1,6% for BVE vs. 4.3% for SVE (p = 0.03), with higher incidence of moderate or severe PVL. The composite endpoint valve safety occured in 3,3 % for BVE vs 26% for SVE (p &amp;lt; 0,001), with moderate or severe PVL in 23%. Conclusion(s): In patients with symptomatic severe aortic stenosis who implanted BEV or SEV transcatheter aortic valve there was a significant improvement in the hemodynamic status. The present study suggests that use of SEV was associated with a higher risk of PVL and repeat hospitalization, with a endpoint clinical efficacy after 30 days (4,3%) and time-related valve safety (26%).

Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes.

BackgroundThe NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented.MethodsTwenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.ResultsPatients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.ConclusionsThe current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Glycoprotein IIb/IIIa receptor targeted PET/CT imaging: a novel diagnostic tool for detecting bioprosthetic valve thrombosis

Abstract Background/Introduction Bioprosthetic valve thrombosis (BPVT) is an important clinical entity eventually following both bioprosthetic surgical and transcatheter aortic valve replacement. Although dynamic contrast-enhanced 4D-MDCT has improved the diagnosis of BPVT, more sensitive and pathology-specific non-invasive imaging tools are lacking. Recently, the glycoprotein IIb/IIIa receptor targeted, elarofiban-derived PET/CT imaging radiotracer [18F]GP1 has been successfully used for visualization of acute venous and arterial thrombi. Purpose We hypothesized that [18F]GP1 PET/CT imaging is suitable to detect BPVT. Methods In this proof-of-concept study, patients after bioprosthetic aortic valve replacement with symptomatic, severe hemodynamic valve dysfunction and confirmed hypoattenuated leaflet thickening (HALT) in dynamic 4D-MDCT were offered to participate in compassionate use examinations to undergo PET/CT imaging with the investigational [18F]GP1 PET tracer at baseline and after a 12-week course of therapeutic oral anticoagulation. Results This case series reports on three patients after aortic valve replacement. Two patients with symptomatic, obstructive BPVT as confirmed by echocardiography and 4D-MDCT fulfilled specified criteria and underwent [18F]GP1 PET/CT imaging. [18F]GP1 PET/CT clearly distinguished between blood pool activity and thrombotic foci. Clot-to-blood ratios at baseline were 8.2 and 4.5, respectively. A 12-week trial of therapeutic oral anticoagulation was associated with a regression of mean transprosthetic pressure gradient and reversal of HALT. Follow-up 4D-MDCT corroborated thrombus resolution in both patients. Correspondingly, [18F]GP1 PET/CT imaging demonstrated decreased tracer uptake in both patients. Clot-to-blood ratio at follow-up visit decreased to 1.2 and 2.9, respectively. While absent tracer uptake was seen in patient #1, residual tracer uptake was observed in patient #2 suggestive of ongoing platelet aggregation. One asymptomatic SAVR patient was examined with [18F]GP1 PET/CT for a different compassionate use and no thrombotic foci were detected on the leaflets. Conclusions [18F]GP1 PET/CT is a novel imaging technique in patients with obstructive BPVT. In a head-to-head comparison we show that [18F]GP1 PET/CT may have incremental diagnostic value over dynamic contrast-enhanced 4D-MDCT alone by detection of sites of ongoing platelet aggregation at the molecular level. [18F]GP1 PET/CT may serve as a novel, highly sensitive tool to overcome some limitations of current diagnostic imaging modalities for detecting BPVT and may prove useful for the monitoring and guidance of therapeutic interventions. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Life Molecular Imaging provided material for [18F]GP1 radiolabeling free of charge as part of an ongoing research collaboration.

Numerical and experimental justification of transcatheter aortic valve prosthesis design

Objective: to justify the design of a self-expanding transcatheter aortic valve prosthesis based on a biomaterial stabilized with ethylene glycol diglycidyl ether using numerical simulation and a series of field experiments with working prototypes to determine the consistency of the proposed design solutions.Material and methods. Numerical computer models of a developed aortic valve prosthesis intended for transcatheter implantation, as well as prototypes of the most promising concepts for a series of field tests, were used in the work. Computer 3D models were subjected to numerical analysis in the Abaqus/CAE environment (Dassault Systemes, France) based on the finite element method with iterative design optimization and repeated numerical experiments. Physical prototypes of the transcatheter prosthesis were subjected to a series of mechanical tests for axial and radial compression, as well as tests on a Vivitro hydrodynamic stand (Vivitro Labs, Canada) under simulated normal flow. All studies were carried out in a comparative aspect with a similar transcatheter aortic valve prosthesis (control), the CoreValve™ bioprosthesis (Medtronic, Inc., USA).Results. Computer simulation demonstrates the stress-strain state values that do not significantly exceed the critical levels (628 and 756 MPa versus the threshold value 1080 MPa) for two basic concepts of support frames. The fatigue strength based on the calculation of the mean and alternating stresses corresponding to normo- and hypertensive states based on the Goodman diagrams, did not reveal any evidence that the threshold values (destruction area after 200 million cycles) were exceeded. The hydrodynamic characteristics of working prototypes made on the basis of computer models correspond to the testing data of CoreValve™ clinical bioprosthesis: the effective orifice area was 1.97 cm2, the mean transprosthetic gradient was 8.9 mm Hg, the regurgitant volume was 2.2–4.1 mL per cycle depending on the prototype model.Conclusion. Generally, experiments carried out showed the consistency of the concepts, including from the point of view of implementation of the leaflet apparatus based on xenogeneic tissues treated with ethylene glycol diglycidyl ether.

Frequency of Bioprosthetic Valve Fracturing Utilization in an All-Comers Valve-in-Valve TAVR Cohort.

Introduction: Valve-in-valve TAVR (ViV-TAVR) is an established treatment for failing surgical aortic valves in patient at high surgical risk. Elevated transprosthetic gradients are common after ViV-TAVR. Previously, bench tests showed feasibility of bioprosthetic valve fracturing (VF) using high-pressure balloons. Small case series show reduced transprosthetic gradients using VF. We present our clinical experience and outcome of VF.Material and Methods: Consecutive ViV-TAVR patients were identified from our institutional TAVR database and utilization of bioprosthetic valve fracturing or intraprocedural postdilatation was reviewed. Surgical valves were categorized as responsive or not responsive to VF. Transprosthetic gradients were compared in procedures with VF and procedures with or without postdilatation.Results: In 67 consecutive ViV-TAVR procedures between January 2018 and September 2020, VF was attempted in 15 cases with eight being successful. Standard postdilatation was performed in 21 patients and 31 cases were without postdilatation. Mean transprosthetic gradients (MPG) decreased from 34.2 + 12.5 to 12.7 + 7.4 mmHg (p < 0.001) for all patients. MPG was 8.6 + 3.5 mmHg after VF, 12.9 + 8.5 mmHg after standard postdilatation (p = 0.18) and 13.4 + 6.8 mmHg in cases without postdilatation (p = 0.04). In small surgical valves with true inner diameter <21 mm MPG was 9.1 + 3.5 mmHg after VF, 14.2 + 8.9 after standard postdilatation (p = 0.068) and 16.2 + 9.2 mmHg without postdilatation (p = 0.152). Failed attempts with BVF occurred with the Perimount standard valve.Conclusion: Bioprosthetic valve fracturing results in lower mean transprosthetic gradients after ViV-TAVR. Responsiveness of BVF in Perimount surgical valves, long-term hemodynamic outcome, and potential survival benefits need further evaluation.

Magna ease bioprosthetic aortic valve: mid-termhaemodynamic outcomes in 1126 patients.

The Magna Ease aortic valve (Edwards Lifesciences, Irvine, CA) is a third-generation bioprosthetic valve developed as a modification of the well-studied Perimount and Magna valve designs. This study's objective is to evaluate a large, single-centre experience with Magna Ease aortic valve replacement (AVR) focusing on clinical outcomes and haemodynamic performance. All patients undergoing AVR between 8/2010 and 10/2018 at our institution implanted with the Magna Ease valve were included except those undergoing ventricular assist device or congenital aortic surgery. Primary outcomes were overall survival and freedom from reoperation. Mean transprosthetic gradient (mTPG) and structural valve deterioration (SVD) served as secondary outcomes. Totally 1126 consecutive implantations of Magna Ease valves were included. Concomitant procedures were performed in 56.5% (n = 636). No severe patient-prosthesis mismatch (PPM) was present at implantation. Overall survival at 30 days, 1 year, 5 years and 9 years was 97.2%, 95.0%, 86.1% and 78.2%, respectively, with improved survival for isolated AVR. Total of 2.4% (n = 27) of patients required reoperation with 0.3% (n = 4) for SVD. Echocardiographic follow-up data revealed low mTPG throughout the study period. SVD occurred in 28.7% of patients at a mean of 3.9 years post implantation. Magna Ease AVR maintained low mean transprosthetic gradients throughout mid-term evaluation and was associated with excellent overall survival and freedom from reoperation at nine years post implantation.

18F-Sodium fluoride PET/CT detects transcatheter aortic valve degeneration

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): This work was supported by the British Heart Foundation, London, United Kingdom Background Early detection of transcatheter aortic valve implantation (TAVI) degeneration is challenging and only feasible when advanced haemodynamic valve dysfunction is apparent. Purpose We tested whether 18F-sodium fluoride (18F-NaF) positron emission tomography and computed tomography (PET/CT) could detect structural TAVI degeneration and haemodynamic valve dysfunction. Methods After TAVI implantation, patients underwent baseline echocardiography, CT angiography and 18F-NaF PET/CT (Figure). We assessed for morphological changes, stenosis or regurgitation on Doppler echocardiography, CT (hypoattenuated leaflet thickening [HALT] or spotty calcification) and PET (18F-NaF uptake; maximum target-to-background ratio, TBRmax). We categorised structural valve degeneration (SVD) according to the standardised definition for surgical and transcatheter bioprosthetic valves, as proposed in a recent consensus statement. Results We recruited 47 patients (81 ± 6 years old, 79% male) 1 month (n = 9), 2 years (n = 22) or 5 years (n = 16) after TAVI: 25 (53%) had received a balloon expanded bioprosthesis and 22 (47%) a self-expanding valve. There was moderate valve dysfunction on Doppler echocardiography in 3 (6%) patients, HALT on CT in 6 (13%) patients, spotty calcification in one patient and 18F-NaF uptake in 7 patients (15%) (TBRmax range: 1.59-5.88); all enrolled 5 years post-TAVI. All patients with increased 18F-NaF uptake (TBRmax ≥1.59) demonstrated either SVD without haemodynamic valve dysfunction (stage 1, n = 4) or structural valve dysfunction with moderate valve dysfunction and mean transprosthetic pressure gradients &amp;gt;20 mmHg (stage 2, n = 3). In patients without increased 18F-NaF uptake there was no evidence of structural valve degeneration (n = 40). Within the increased 18F-NaF uptake (n = 7) group, patients with stage 2 SVD (n = 3) demonstrated higher uptake compared to patients with stage 1 SVD (TBRmax 4.3 [3.02-5.88] versus 1.8 [1.59-2.28]). Patients with stage 2 SVD (n = 3) had over 3 times higher TBRmax than those without SVD (n = 40) (4.30 [3.02, 5.88] versus 1.31 [1.21, 1.46]; p &amp;lt; 0.001); Figure). Conclusion 18F-NaF PET/CT detects patients with SVD and potentially identifies those at risk of valve failure. Abstract Figure.

Long-Term Durability of Transcatheter Aortic Valve Implantation With Self-Expandable Valve System (from a Real-World Registry)

As transcatheter aortic valve Implantation (TAVI) moves to younger and lower risk patients with longer life expectancy, the long-term durability of TAVI is becoming an increasingly relevant issue. We sought to evaluate the long-term clinical outcome and prosthesis performance of the CoreValve self-expandable valve. Clinical registry of 182 patients consecutively treated with TAVI in a tertiary center from January 2009 to July 2017. Of these, 111 died during an average follow-up (FU) of 1,026 ± 812 days (median IQR: 745, 477 to 1,400 days; longest survival 11 years; 61% mortality at Kaplan-Meier analysis). At 1 month, functional profile improved in all survivors, with 93.9% of them achieving NYHA class I or II. At Cox analysis, the Society of Thoracic Surgeons score (HR: 1.55; p = 0.001), left ventricular ejection fraction <40% (HR: 1.65; p = 0.017) and incident acute kidney injury (HR: 1.96; p = 0.001) were independently associated with all-cause mortality. During FU, echocardiographically assessed mean transprosthetic aortic gradient remained substantially unchanged (from 9.0 ± 2.7 after TAVI to 9.0 ± 5.0 mm Hg at FU; p >0.05). Most patients had none and/or trivial (34%), or mild (58%), fewer had moderate (8%) and none had severe perivalvular leak, without significant change during FU. At 11 years, cumulative incidence of bioprosthetic valve failure and moderate structural valve deterioration (SVD) were 2.9% (95% CI 0.8% to 10%) and 9.3% (95% CI 3.3% to 26.7%), respectively. In conclusion, our registry confirmed that TAVI with the self-expandable CoreValve system was associated with favorable long-term clinical outcomes, with a reassuring low rate of significant bioprosthetic valve failure and moderate SVD.

Determining prosthesis‐patient mismatch after TAVR: Which is the best method?

Determining prosthesis‐patient mismatch after TAVR: Which is the best method?