EFFECTIVE ORIFICE AREA REFERENCE VALUES WITH THE DIFFERENT SIZES OF THE SAPIEN 3 BALLOON-EXPANDING TRANSCATHETER AORTIC VALVE

Transcatheter aortic valve implantation (TAVI) is now a well-established treatment for severe aortic stenosis. As the number of procedures and indications increase, the age of patients decreases. However, their durability and factors accelerating the process of degeneration are not well-known. The aim of the study was to verify the possibility of using [18F]F-sodium fluoride ([18F]F-NaF) and [18F]F-fluorodeoxyglucose ([18F]F-FDG) positron emission tomography/computed tomography (PET/CT) in assessing the intensity of TAVI valve degenerative processes. In 73 TAVI patients, transthoracic echocardiography (TTE) at initial (before TAVI), baseline (after TAVI), and during follow-up, as well as transesophageal echocardiography (TEE) and PET/CT, were performed using [18F]F-NaF and [18F]F-FDG at the six-month follow-up (FU) visit as a part of a two-year FU period. The morphology of TAVI valve leaflets were assessed in TEE, transvalvular gradients and effective orifice area (EOA) in TTE. Calcium scores and PET tracer activity were counted. We assessed the relationship between [18F]F-NaF and [18F]F-FDG PET/CT uptake at the 6 = month FU with selected indices e.g.,: transvalvular gradient, valve type, EOA and insufficiency grade at following time points after the TAVI procedure. We present the preliminary PET/CT ([18F]F-NaF, [18F]F-FDG) results at the six-month follow-up period as are part of an ongoing study, which will last two years FU. We enrolled 73 TAVI patients with the mean age of 82.49 ± 7.11 years. A significant decrease in transvalvular gradient and increase of effective orifice area and left ventricle ejection fraction were observed. At six months, FU valve thrombosis was diagnosed in four patients, while 7.6% of patients refused planned controls due to the COVID-19 pandemic. We noticed significant correlations between valve types, EOA and transaortic valve gradients, as well as [18F]F-NaF and [18F]F-FDG uptake in PET/CT. PET/CT imaging with the use of [18F]F-FDG and [18F]F-NaF is intended to be feasible, and it practically allows the standardized uptake value (SUV) to differentiate the area containing the TAVI leaflets from the SUV directly adjacent to the ring calcifications and the calcified native leaflets. This could become the seed for future detection and evaluation capabilities regarding the progression of even early degenerative lesions to the TAVI valve, expressed as local leaflet inflammation and microcalcifications.

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The fallacy of indexed effective orifice area charts to predict prosthesis–patient mismatch after prosthesis implantation

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jeaa044 ◽

2020 ◽

Vol 21 (10) ◽

pp. 1116-1122 ◽

Cited By ~ 4

Author(s):

Michiel D Vriesendorp ◽

Rob A F De Lind Van Wijngaarden ◽

Stuart J Head ◽

Arie-Pieter Kappetein ◽

Graeme L Hickey ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Reference Values ◽

Effective Orifice Area ◽

Training Set ◽

Surgical Aortic Valve Replacement ◽

Test Set ◽

Orifice Area ◽

Normal Reference

Abstract Aims Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis–patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM. Methods and results In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi ≤0.85 cm2/m2, and severe PPM was defined as EOAi ≤0.65 cm2/m2. The reference values obtained from the training set ranged from 1.27 cm2 for size 19 mm up to 1.81 cm2 for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%. Conclusion The use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications.

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P2270Clinical characteristics and outcomes after TAVI in patients reclassified to moderate aortic stenosis by integration of multimodality imaging and pressure recovery

European Heart Journal ◽

10.1093/eurheartj/ehz748.0747 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

E W Holy ◽

D L Nguyen-Kim ◽

L Hoffelner ◽

D L Stocker ◽

T Stadler ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Stenosis ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Effective Orifice Area ◽

Orifice Area ◽

Junction Area ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

Abstract Background Accurate assessment of aortic stenosis (AS) severity is critical for the correct management of patients. This has become particularly important because the introduction of transcatheter aortic valve implantation (TAVI) has markedly increased the number of patients eligible for aortic valve replacement Aims To assess whether reclassification of aortic stenosis (AS) grading by integration of fusion imaging using data from transthoracic echocardiography (TTE) and multidetector computed tomography (MDCT) under consideration of the energy loss index (ELI) predicts outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Methods 197 consecutive patients with symptomatic severe AS undergoing TAVI at our University Heart Center were included in this study. AS severity was determined according to current guidelines. Results Left ventricular outflow tract (LVOT) area derived from TTE was smaller than the planimetric area in MDCT due the ovoid shape of the LVOT (3.4±0.12 cm2 vs. 4.5±0.23 cm2; p<0.01). The sinotubular junction (ST-junction) diameter measured in TTE was similar to maximal, minimal, and mean diameters determined by MDCT. The sphericity index confirmed an almost circular anatomy of ST-junction, and its area derived from TTE was similar to the planimetric area in MDCT. Fusion aortic valve area index (fusion AVAi) assessed by inserting MDCT derived planimetric LVOT area in the continuity equation was significantly higher in all patients compared to conventional AVAi. 62 patients were reclassified from severe to moderate AS because fusion AVAi was >0.6 cm2/m2. ELI was calculated for conventional AVAi and fusion AVAi each with ST-junction area determined by both TTE and MDCT. Calculating ELI with fusion AVAi resulted in significantly larger effective orifice area, with values >0.6 cm2/m2 in 83 patients (ST-junction area from echo) and 85 patients (ST-junction area from MDCT). Similarly, calculating ELI with conventional AVAi resulted in significantly larger effective orifice area as compared to AVAi alone. Reclassified patients had lower mean transvalvular pressure gradients, lower myocardial mass, less symptoms according to NYHA classification, and lower proBNP levels at baseline. While both groups exhibited improvement of functional status at 1 year of follow-up, the survival rate at 3 years after TAVI was higher in patients reclassified to moderate AS (81% versus 66%; p=0.02). Conclusion Integration of TTE and MDCT derived values for calculation of ELI reclassifies the severity of AS in 43% of patients initially diagnosed with severe AS.Although reclassified patients display less advanced valve disease at baseline, TAVI results in functional improvement in all patients. Furthermore, patients reclassified to moderate AS exhibit higher survival rates at 3 years after aortic valve replacement.

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Validation and Characterization of Transcatheter Aortic Valve Effective Orifice Area Measured by Doppler Echocardiography

JACC Cardiovascular Imaging ◽

10.1016/j.jcmg.2011.06.021 ◽

2011 ◽

Vol 4 (10) ◽

pp. 1053-1062 ◽

Cited By ~ 72

Author(s):

Marie-Annick Clavel ◽

Josep Rodés-Cabau ◽

Éric Dumont ◽

Rodrigo Bagur ◽

Sébastien Bergeron ◽

...

Keyword(s):

Aortic Valve ◽

Doppler Echocardiography ◽

Effective Orifice Area ◽

Orifice Area ◽

Transcatheter Aortic Valve

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

European Heart Journal Supplements ◽

10.1093/eurheartj/suab147.003 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Michele Antonio Cacia ◽

Sabato Sorrentino ◽

Isabella Leo ◽

Alberto Polimeni ◽

Jolanda Sabatino ◽

...

Keyword(s):

Aortic Valve ◽

Academic Research ◽

Reference Value ◽

Current Evidence ◽

Chronic Obstructive ◽

Effective Orifice Area ◽

Cross Sectional ◽

Orifice Area ◽

Transcatheter Aortic Valve ◽

Independent Association

Abstract 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.

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Low Incidence of Prosthesis-Patient Mismatch Following Extremely Small Transcatheter Aortic Valve Replacement with 20-mm Sapien 3

International Journal of Angiology ◽

10.1055/s-0041-1732316 ◽

2021 ◽

Author(s):

Kazue Okajima ◽

Ikki Komatsu ◽

Todd B. Seto

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Outcome Data ◽

Bleeding Complications ◽

Effective Orifice Area ◽

Transcatheter Aortic Valve ◽

Significant Difference ◽

Sapien 3

AbstractTranscatheter aortic valve replacement has been developed as an emerging technique to treat patients with aortic valve disease. However, safety and outcome data on extremely small transcatheter heart valves (THV) is limited. We aimed to assess hemodynamic profiles and clinical outcome of very small balloon expandable THVs with 20-mm Sapien 3 (SP3).We examined data for all patients who received third-generation SP3 THV at a single hospital. Complications and clinical outcomes were defined based on the VARC-2 criteria. Postoperative prosthesis-patient mismatch (PPM) was defined as indexed effective orifice area (EOA) < 0.85 cm2/m2. We compared clinical characteristics and outcome between patients with 20-mm (n = 21), 23-mm (n = 67), and 26- or 29-mm (n = 113) sized valves.The 20-mm group included significantly higher number of Asian and female populations with lower body surface area. The baseline CT annular area in the 20-mm group was 316.5 ± 24.9 mm2. There was no significant difference between groups in procedural mortality or early safety at 30 days. The higher procedural complication was observed in 20-mm group due to significant differences in minor vascular and bleeding complications. Despite higher post-THV gradients and smaller indexed EOA in 20-mm group, no PPM was observed in 20-mm group. The mortality at 30 days and 1 year in 20-mm group was 4.8% and 16.7%, respectively.The patients who received very small THVs with 20-mm SP3 did not result in PPM and experienced favorable early safety and midterm outcome in our cohort.

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Reclassification of prosthesis-patient mismatch after transcatheter aortic valve replacement using predicted versus measured indexed effective orifice area

Archives of Cardiovascular Diseases Supplements ◽

10.1016/j.acvdsp.2020.10.156 ◽

2021 ◽

Vol 13 (1) ◽

pp. 69

Author(s):

J. Ternacle ◽

L. Guimaraes ◽

Flavien Vincent ◽

N. Côté ◽

M. Côté ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Effective Orifice Area ◽

Orifice Area ◽

Transcatheter Aortic Valve

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Reclassification of prosthesis–patient mismatch after transcatheter aortic valve replacement using predicted vs. measured indexed effective orifice area

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jeaa235 ◽

2020 ◽

Vol 22 (1) ◽

pp. 11-20 ◽

Cited By ~ 2

Author(s):

Julien Ternacle ◽

Leonardo Guimaraes ◽

Flavien Vincent ◽

Nancy Côté ◽

Mélanie Côté ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Clinical Outcomes ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Effective Orifice Area ◽

Orifice Area ◽

Transcatheter Aortic Valve ◽

Device Implantation ◽

Valve In Valve

Abstract Aims The objective was to compare the incidence and impact on outcomes of measured (PPMM) vs. predicted (PPMP) prosthesis–patient mismatch following transcatheter aortic valve replacement (TAVR). Methods and results All consecutives patients who underwent TAVR between 2007 and 2018 were included. Effective orifice area (EOA) was measured by Doppler-echocardiography using the continuity equation and predicted according to the normal reference for each model and size of valve. PPM was defined using EOA indexed (EOAi) to body surface area as moderate if ≤0.85 cm2/m2 and severe if ≤ 0.65 cm2/m2 (respectively, ≤ 0.70 and ≤ 0.55 cm2/m2 if body mass index ≥ 30 kg/m2). The outcome endpoints were high residual gradient (≥20 mmHg) and the composite of cardiovascular mortality and hospital readmission for heart failure at 1 year. Overall, 1088 patients underwent a TAVR (55% male, age 79.1 ± 8.4 years, and STS score 6.6 ± 4.7%); balloon-expandable device was used in 83%. Incidence of moderate (10% vs. 27%) and severe (1% vs. 17%) PPM was markedly lower when defined by predicted vs. measured EOAi (P < 0.001). Balloon-expandable device implantation (OR: 1.90, P = 0.029) and valve-in-valve procedure (n = 118; OR: 3.21, P < 0.001) were the main factors associated with PPM occurrence. Compared with measured PPM, predicted PPM showed stronger association with high residual gradient. Severe measured or predicted PPM was not associated with clinical outcomes. Conclusion The utilization of the predicted EOAi reclassifies the majority of patients with PPM to no PPM following TAVR. Compared with measured PPM, predicted PPM had stronger association with haemodynamic outcomes, while both methods were not associated with clinical outcomes.

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

10.22541/au.164181234.49649159/v1 ◽

2022 ◽

Author(s):

Thomas Theologou ◽

Depaksi Tare ◽

Sara Clivio ◽

Demertzis S ◽

Enrico Ferrari

Keyword(s):

Aortic Valve ◽

Coronary Flow ◽

Operative Time ◽

Valve Surgery ◽

Effective Orifice Area ◽

Aortic Valve Surgery ◽

Left Main ◽

Orifice Area ◽

Sapien 3 ◽

Coronary Ostia

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.

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