Mid-term assessment of structural valve deterioration of perceval S sutureless prosthesis using the last European consensus definition

Abstract OBJECTIVES Durability of sutureless aortic bioprosthetic valves remains a major issue. The aim of this study was to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) of the Perceval bioprosthesis using the new proposed standardized definitions. METHODS All patients who underwent aortic valve replacement with sutureless Perceval S prostheses up to September 2016 were included. Clinical and echocardiographic follow-up was performed. New standardized definitions were used to assess the durability of sutureless bioprosthetic valves. From 2013 to 2016, 214 patients were included. RESULTS The mean age and EuroSCORE II were 79 years and 2.74. Thirty-day mortality was 0.47%. The survival rate was 96.8%, 88.1% and 85.7% at 1, 3 and 4 years, respectively. The median echocardiographic follow-up was 3.28 years. The mean pressure gradient was 11.3 mmHg. No cases showed evidence of severe SVD, 17 patients had moderate SVD with a mean pressure gradient of 24 mmHg and 8 patients had definite late BVF. The incidence of moderate SVD and BVF at 4 years was 8.8% and 2.9%, respectively. CONCLUSIONS Mid-term follow-up to 6.3 years after aortic valve replacement with the Perceval bioprosthesis documents favourable haemodynamic and clinical outcomes and low rates of SVD and BVF.

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P1840Mid-term results of bioprosthetic aortic valve replacement with the Trifecta valve: A word of caution

European Heart Journal ◽

10.1093/eurheartj/ehz748.0592 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

P Werner ◽

M Russo ◽

M Seewald ◽

I Coti ◽

T Haberl ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Pressure Gradient ◽

Valve Replacement ◽

Composite Endpoint ◽

Surgical Aortic Valve Replacement ◽

Structural Valve Deterioration ◽

Mean Pressure ◽

Overall Mortality

Abstract Background Structural valve deterioration (SVD) with associated bioprosthetic valve dysfunction remains an unsolved problem, exposing patients to the risk of aortic valve re-intervention after surgical aortic valve replacement (SAVR). Several strategies have been proposed to improve prosthesis design for optimal performance. The leaflets of the Trifecta valve are mounted on the outside of the prosthetic stent to achieve a larger orifice area. Although favourable early clinical outcomes have been reported, long-term durability still needs to be assessed. Purpose The aim of the current study was to assess the mid-term overall mortality and re-intervention rate in patients who received a Trifecta valve with a follow-up >5 years. Methods Patients who underwent SAVR at our centre between 2011 and 2012 were identified in the internal, prospective database. All patients with implantation of a Trifecta valve in aortic position were included. Primary endpoints were freedom from overall mortality and from re-operation at latest follow-up (FU). Additionally, assessment of echocardiographic parameters at baseline and follow-up was performed. Results Seventy-six patients (age 77.3±9.5 years, BMI 28.6±5.8, 68% male) were included in the study. EuroScore II was 7.2% (± 7.7) while mean STS-Mortality score was 2.4±1.1%. Of all procedures, 53% were isolated aortic valve replacements, whereas concomitant procedures were performed in 47% of cases (37% CABG, 12% mitral surgery, 8% tricuspid surgery). Baseline echocardiographic assessment showed a mean pressure gradient (MPG) of 51±21 mmHG, a peak pressure gradient (PPG) of 78±36 mmHG and a peak velocity (Vmax) of 4.2±1.1 m/s. Thirty-day mortality was 7%. Freedom from overall mortality at 1 year and 5 years was 84% and 73%, respectively. Freedom from death and freedom from re-operation at latest FU (6.7±0.5 years) was 68% and 90%, respectively. In a composite endpoint analysis, freedom from death or re-intervention at latest follow up was 60%. A total of 7 patients underwent aortic valve re-interventions (re-replacements n=5, valve-in-valve n=2). Indications for re-interventions were SVD (n=5), NSVD (n=1, pannus ingrowth) and endocarditis (n=1). One case of re-stenosis occurred in a patient who was deemed not feasible for aortic valve re-intervention and died. Kaplan Meier analysis Conclusion(s) To our knowledge, this patient cohort presents with the lowest rate of freedom from re-operation (90%, 6.7±0.5 years) after SAVR with the Trifecta valve. A relatively high number of SVD and NSVD has been observed, which might be attributable to the specific leaflet mounting or the deformable valve frame of the first generation. Current results call for further investigation with prospective echocardiographic follow-up in this patient group. Acknowledgement/Funding None

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Minimally Invasive Transaortic Repair of the Mitral Valve

The Heart Surgery Forum ◽

10.1532/hsf98.20101133 ◽

2011 ◽

Vol 14 (4) ◽

pp. 232 ◽

Cited By ~ 2

Author(s):

Orlando Santana ◽

Joseph Lamelas

Keyword(s):

Mitral Valve ◽

Aortic Valve ◽

Mitral Regurgitation ◽

Aortic Valve Replacement ◽

Minimally Invasive ◽

Valve Replacement ◽

Operative Mortality ◽

The Mean ◽

Transaortic Approach

Objective: We retrospectively evaluated the results of an edge-to-edge repair (Alfieri stitch) of the mitral valve performed via a transaortic approach in patients who were undergoing minimally invasive aortic valve replacement.Methods: From January 2010 to September 2010, 6 patients underwent minimally invasive edge-to-edge repair of the mitral valve via a transaortic approach with concomitant aortic valve replacement. The patients were considered to be candidates for this procedure if they were deemed by the surgeon to be high-risk for a double valve procedure and if on preoperative transesophageal echocardiogram the mitral regurgitation jet originated from the middle portion (A2/P2 segments) of the mitral valve.Results: There was no operative mortality. Mean cardiopulmonary bypass time was 137 minutes, and mean cross-clamp time was 111 minutes. There was a significant improvement in the mean mitral regurgitation grade, with a mean of 3.8 preoperatively and 0.8 postoperatively. The ejection fraction remained stable, with mean preoperative and postoperative ejection fractions of 43.3% and 47.5%, respectively. Follow-up transthoracic echocardiograms obtained at a mean of 33 days postoperatively (range, 8-108 days) showed no significant worsening of mitral regurgitation.Conclusion: Transaortic repair of the mitral valve is feasible in patients undergoing minimally invasive aortic valve replacement.

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Use and success evaluation of percutaneous aortic balloon valvuloplasty in different hemodynamic entities of severe aortic stenosis in the TAVR era

European Heart Journal ◽

10.1093/ehjci/ehaa946.1934 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

K Piayda ◽

A Wimmer ◽

H Sievert ◽

K Hellhammer ◽

S Afzal ◽

...

Keyword(s):

Heart Failure ◽

Aortic Valve ◽

Aortic Stenosis ◽

Aortic Valve Replacement ◽

Pressure Gradient ◽

Severe Aortic Stenosis ◽

Primary Treatment ◽

Low Flow ◽

Mean Pressure ◽

The Mean

Abstract Background In the era of transcatheter aortic valve replacement (TAVR), there is renewed interest in percutaneous balloon aortic valvuloplasty (BAV), which may qualify as the primary treatment option of choice in special clinical situations. Success of BAV is commonly defined as a significant mean pressure gradient reduction after the procedure. Purpose To evaluate the correlation of the mean pressure gradient reduction and increase in the aortic valve area (AVA) in different flow and gradient patterns of severe aortic stenosis (AS). Methods Consecutive patients from 01/2010 to 03/2018 undergoing BAV were divided into normal-flow high-gradient (NFHG), low-flow low-gradient (LFLG) and paradoxical low-flow low-gradient (pLFLG) AS. Baseline characteristics, hemodynamic and clinical information were collected and compared. Additionally, the clinical pathway of patients (BAV as a stand-alone procedure or BAV as a bridge to aortic valve replacement) was followed-up. Results One-hundred-fifty-six patients were grouped into NFHG (n=68, 43.5%), LFLG (n=68, 43.5%) and pLFLG (n=20, 12.8%) AS. Underlying reasons for BAV and not TAVR/SAVR as the primary treatment option are displayed in Figure 1. Spearman correlation revealed that the mean pressure gradient reduction had a moderate correlation with the increase in the AVA in patients with NFHG AS (r: 0.529, p<0.001) but showed no association in patients with LFLG (r: 0.145, p=0.239) and pLFLG (r: 0.030, p=0.889) AS. Underlying reasons for patients to undergo BAV and not TAVR/SAVR varied between groups, however cardiogenic shock or refractory heart failure (overall 46.8%) were the most common ones. After the procedure, independent of the hemodynamic AS entity, patients showed a functional improvement, represented by substantially lower NYHA class levels (p<0.001), lower NT-pro BNP levels (p=0.003) and a numerical but non-significant improvement in other echocardiographic parameters like the left ventricular ejection fraction (p=0.163) and tricuspid annular plane systolic excursion (TAPSE, p=0.066). An unplanned cardiac re-admission due to heart failure was necessary in 23.7% patients. Less than half of the patients (44.2%) received BAV as a bridge to TAVR/SAVR (median time to bridge 64 days). Survival was significantly increased in patients having BAV as a staged procedure (log-rank p<0.001). Conclusion In daily clinical practice, the mean pressure gradient reduction might be an adequate surrogate of BAV success in patients with NFHG AS but is not suitable for patients with other hemodynamic entities of AS. In those patients, TTE should be directly performed in the catheter laboratory to correctly assess the increase of the AVA. BAV as a staged procedure in selected clinical scenarios increases survival and is a considerable option in all flow states of severe AS. (NCT04053192) Figure 1 Funding Acknowledgement Type of funding source: None

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The Impact of Valvuloarterial Impedance on Left Ventricular Geometrical Change after Transcatheter Aortic Valve Replacement: A Comparison between Valvuloarterial Impedance and Mean Pressure Gradient

Journal of Clinical Medicine ◽

10.3390/jcm9103143 ◽

2020 ◽

Vol 9 (10) ◽

pp. 3143

Author(s):

Satoshi Yamaguchi ◽

Yuka Otaki ◽

Balaji K. Tamarappoo ◽

Tetsuya Ohira ◽

Hiroki Ikenaga ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Pressure Gradient ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Left Ventricular ◽

Transcatheter Aortic Valve ◽

Lv Mass ◽

Mean Pressure ◽

Geometrical Change

Increase in left ventricular (LV) mass develops as a compensatory mechanism against pressure overload in aortic valve stenosis. However, long-standing LV geometrical changes are related to poor prognosis. The LV geometrical change occurs after transcatheter aortic valve replacement (TAVR). The present study aimed to investigate the relationship between improvement in valvuloarterial impedance (Zva) and change in LV mass index (LVMI) and the ratio of LVMI to LV end-diastolic volume index (LVMI/LVEDVI). We compared these relationships to that between Zva and mean pressure gradient (MPG). Baseline and follow-up transthoracic echocardiograms of 301 patients who underwent TAVR from November 2011 to December 2015 were reviewed. Spearman correlation coefficient (ρ) was used to compare ΔLVMI and ΔLVMI/LVEDVI with Zva or MPG. The correlation between ΔZva and ΔLVMI (ρ = 0.47, p < 0.001) was superior to that between ΔMPG and ΔLVMI (ρ = 0.15, p = 0.009) (p for comparison < 0.001). The correlation between ΔZva and ΔLVMI/LVEDVI was statistically significant (ρ = 0.54, p < 0.001); in contrast, that of ΔMPG and ΔLVMI/LVEDVI was not. The improvement in Zva after TAVR was more closely related to LVMI and LVMI/LVEDVI reduction than MPG reduction.

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Predicting the Ideal Valve Size During Aortic Valve Replacement with Rapid Deployement Bioprosthetic Valves. Is Intraoperative Transesophageal Echocardiogram Reliable?

10.22541/au.162672107.74961308/v2 ◽

2021 ◽

Author(s):

Ali Al-Alameri ◽

Alejandro Macias ◽

Daniel Buitrago ◽

Alvaro Montoya ◽

Evan Markell ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Transesophageal Echocardiography ◽

Valve Replacement ◽

Aortic Annulus ◽

Significant Difference ◽

Valve Size ◽

The Mean ◽

Rapid Deployment ◽

Bioprosthetic Valves

Objective: To describe experience with using intraoperative Transesophageal Echocardiography to reliably predict the size of the rapid deployment prosthetic valve by measuring the native aortic annulus Methods: Retrospective review of single institution series of patients undergoing Aortic Valve Replacement with Rapid Deployement Bioprosthetic Valves. Included were patients that had their native aortic valve replaced either isolated or as part of any additional procedure. Aortic annulus was measured prior to initiation of the operation using transesophageal echocardiography (TEE). Correlation analysis was conducted between Echocardiographic annular measurements and actual implanted valve sizes. Results: Twenty five patients underwent rapid deployment valve implantation in the aortic position. Of these, 36% of patients had the same size valve as the measured aortic annulus, 48% of patients had a valve implanted that was 1 mm different, and 16% of patients had 2 mm difference. The mean annular size based was 22.4 mm (range: 21-28 mm). The mean valve size implanted was 23.3 mm (range: 21-27 mm). There was no statistically significant difference between the mean annular measurement and the valve size selected (0.9 mm , p = 0.8). Conclusion: TEE can further enhance valve sizing and guidance through a proper and safe deployment. Although evident in our experience, larger scale studies are needed to further elucidate conclusions on the importance of avoiding under-sizing valves.

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Intermediate Outcomes after Rapid Deployment Aortic Valve Replacement in Multiple Valve Surgery

The Thoracic and Cardiovascular Surgeon ◽

10.1055/s-0039-1685178 ◽

2019 ◽

Vol 68 (07) ◽

pp. 595-601

Author(s):

Markus Schlömicher ◽

Matthias Bechtel ◽

Zulfugar Taghiyev ◽

Hamid Naraghi ◽

Peter Lukas Haldenwang ◽

...

Keyword(s):

Mitral Valve ◽

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Valve Surgery ◽

Actuarial Survival ◽

Intermediate Outcomes ◽

The Mean ◽

Rapid Deployment

Abstract Background Multiple valve surgery is associated with significant higher operative risks. Reduced cross-clamp and cardiopulmonary bypass times in multiple valve surgery may potentially be beneficial as they can be considered independent risk factors for increased morbidity and mortality following cardiac surgery. We report first intermediate outcomes of the Edwards Intuity valve system (Edwards Lifesciences, Irvine, California, United States) in combined procedures Methods Fifty-eight patients underwent rapid deployment aortic valve replacement with concomitant mitral valve surgery between January 2014 and November 2017 in our institution. The valve was assessed echocardiographically after 12 months. The median follow-up was 1.7 years with a cumulative follow-up time of 115.3 patient years. Results The mean age was 73.5 ± 6.2 years and the mean logistic Euroscore was 11.6 ± 3.1%. Concomitant mitral valve repair was performed in 43 cases (74.1%), and mitral valve replacement in 15 cases (19.0%). The mean cross-clamp time was 93 ± 21 minutes along with a mean bypass time of 118 ± 24 minutes. All-cause mortality after 30 days was 8.6%. Overall actuarial survival at 1 year was 87.2 ± 4.5% and after 2 years 82.8 ± 5.3%, respectively. Conclusions Rapid deployment aortic valve replacement in multiple valve surgery can be performed safely with good intermediate outcomes in elderly, high-risk patients.

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Regression of Left Ventricular Mass after Implantation of the Sutureless 3f Enable Aortic Bioprosthesis

Texas Heart Institute Journal ◽

10.14503/thij-13-3943 ◽

2015 ◽

Vol 42 (2) ◽

pp. 117-123

Author(s):

Giovanni Concistrè ◽

Antonio Miceli ◽

Federica Marchi ◽

Francesca Chiaramonti ◽

Mattia Glauber ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Stenosis ◽

Aortic Valve Replacement ◽

Left Ventricular Mass ◽

Valve Replacement ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Ventricular Mass ◽

The Mean

Left ventricular hypertrophy in aortic stenosis is considered a compensatory response for the maintenance of systolic function but a risk factor for cardiac morbidity and death. We investigated the degree of left ventricular mass regression after implantation of the sutureless Medtronic 3f Enable® Aortic Bioprosthesis. We studied 19 patients who, from May 2010 through July 2011, underwent isolated aortic valve replacement with the 3f Enable bioprosthetic valve, with clinical and echocardiographic follow-up at 6 months. The mean age was 77.1 ± 5.1 years (range, 68–86 yr); 14 patients were women (73.7%); and the mean logistic EuroSCORE was 15.4% ± 11.8%. Echocardiography was performed preoperatively, at discharge, and at 6 months' follow-up. The left ventricular mass was calculated by means of the Devereux formula and indexed to body surface area. The left ventricular mass index decreased from 146.1 ± 47.6 g/m2 at baseline to 118.1 ± 39.8 g/m2 at follow-up (P=0.003). The left ventricular ejection fraction did not change significantly. The mean transaortic gradient decreased from 57.3 ± 14.2 mmHg at baseline to 12.3 ± 4.6 mmHg at discharge and 12.2 ± 5.3 mmHg at follow-up (P <0.001), and these decreases were accompanied by substantial clinical improvement. No moderate or severe paravalvular leakage was present at discharge or at follow-up. In isolated aortic stenosis, aortic valve replacement with the 3f Enable bioprosthesis results in significant regression of left ventricular mass at 6 months' follow-up. However, this regression needs to be verified by long-term echocardiographic follow-up.

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Structural valve deterioration after aortic valve replacement with the Trifecta valve

Interactive CardioVascular and Thoracic Surgery ◽

10.1093/icvts/ivaa236 ◽

2020 ◽

Vol 32 (1) ◽

pp. 39-46

Author(s):

Paul Werner ◽

Jasmin Gritsch ◽

Sabine Scherzer ◽

Christoph Gross ◽

Marco Russo ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Surgical Aortic Valve Replacement ◽

Kaplan Meier ◽

Single Centre Experience ◽

Structural Valve Deterioration ◽

Long Term Follow Up ◽

Valve In Valve

Abstract OBJECTIVES Despite promising short- and mid-term results for durability of the Trifecta valve, contradictory reports of early structural valve deterioration (SVD) do exist. We investigated the incidence of SVD after surgical aortic valve replacement (SAVR) with the Trifecta in our single-centre experience. METHODS Data of 347 consecutive patients (mean age 71.6 ± 9.5 years, 63.4% male) undergoing SAVR with the Trifecta between 2011 and 2017 were analysed. Clinical and echocardiographic reports were obtained with a median follow-up of 41 months (1114 patient years). RESULTS Isolated SAVR was performed in 122 patients (35.2%), whereas 225 patients (64.8%) underwent concomitant procedures. The median EuroSCORE II was 4.0 (0.9; 7.1) and 30-day mortality was 3.7% (n = 13). Kaplan–Meier estimates for the freedom of overall mortality at 1, 5 and 7 years were 88.7 ± 1.7%, 73.7 ± 2.6% and 64.7 ± 4.2%, respectively. SVD was observed in 25 patients (7.2%) with a median time to first diagnosis of 73 months. Freedom of SVD was 92.5 ± 0.9% at 5 years and 65.5 ± 7.1% at 7 years. Thirteen patients underwent reintervention for SVD (6 re-SAVR, 7 valve-in-valve), resulting in a freedom of reintervention for the SVD of 98.5 ± 1.1% at 5 years and 76.9 ± 6.9% at 7 years. CONCLUSIONS We herein report one of the highest rates of SVD after SAVR with the Trifecta. These data indicate that the durability of the prosthesis decreases at intermediate to long-term follow-up, leading to considerable rates of reintervention due to SVD.

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Impact of anticoagulation therapy on valve haemodynamic deterioration following transcatheter aortic valve replacement

Heart ◽

10.1136/heartjnl-2017-312514 ◽

2018 ◽

Vol 104 (10) ◽

pp. 814-820 ◽

Cited By ~ 16

Author(s):

María Del Trigo ◽

Antonio J Muñoz-García ◽

Azeem Latib ◽

Vincent Auffret ◽

Harindra C Wijeysundera ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Transcatheter Aortic Valve Replacement ◽

Vitamin K Antagonists ◽

Anticoagulation Therapy ◽

Transcatheter Aortic Valve ◽

Increased Risk ◽

The Mean

ObjectiveTo evaluate the changes in transvalvular gradients and the incidence of valve haemodynamic deterioration (VHD) following transcatheter aortic valve replacement (TAVR), according to use of anticoagulation therapy.Methods and resultsThis multicentre study included 2466 patients (46% men; mean age 81±7 years) who underwent TAVR with echocardiography performed at 12-month follow-up. Anticoagulation therapy was used in 707 patients (28.7%) following TAVR (AC group). A total of 663 patients received vitamin K antagonists, and 44 patients received direct oral anticoagulants. A propensity score matching analysis was performed to adjust for intergroup (AC vs non-AC post-TAVR) differences. A total of 622 patients per group were included in the propensity-matched analysis. VHD was defined as a ≥10 mm Hg increase in the mean transprosthetic gradient at follow-up (vs hospital discharge). The mean clinical follow-up was 29±18 months. The mean transvalvular gradient significantly increased at follow-up in the non-AC group within the global cohort (P=0.003), whereas it remained stable over time in the AC group (P=0.323). The incidence of VHD was significantly lower in the AC group (0.6%) compared with the non-AC group (3.7%, P<0.001), and these significant differences remained within the propensity-matched populations (0.6% vs 3.9% in the AC and non-AC groups, respectively, P<0.001). The occurrence of VHD did not associate with an increased risk of all-cause death (P=0.468), cardiovascular death (P=0.539) or stroke (P=0.170) at follow-up.ConclusionsThe lack of anticoagulation therapy post-TAVR was associated with significant increments in transvalvular gradients and a greater risk of VHD. VHD was subclinical in most cases and did not associate with major adverse clinical events. Future randomised trials are needed to determine if systematic anticoagulation therapy post-TAVR would reduce the incidence of VHD.

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Safety, feasibility and performance of Valvosoft non-invasive ultrasound therapy in patients with severe symptomatic calcific aortic valve stenosis. First-in-Man

European Heart Journal ◽

10.1093/ehjci/ehaa946.1932 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

E Messas ◽

A Ijsselmuiden ◽

G Goudot ◽

S Vlieger ◽

P Den Heijer ◽

...

Keyword(s):

Aortic Valve ◽

Pressure Gradient ◽

Ultrasound Therapy ◽

Funding Source ◽

Non Invasive ◽

Post Procedure ◽

Mean Pressure ◽

Valve Opening ◽

The Mean

Abstract Objectives We recently developed a unique transthoracic non-invasive ultrasound therapy device called Valvosoft to treat aortic stenosis. The therapy consists in delivering trans-thoracically precisely focused and controlled short ultrasound pulses (<20μsec) at a high acoustic intensity to produce non-thermal mechanical tissue softening of the calcified aortic valve with the ultimate aim of improving the valve opening. Ultrasound imaging enables to follow valve movements in real-time and thus targets the ultrasound waves on the valve with great precision. After having validated this concept in pre-clinical studies, we aimed at applying this technique in human. The primary objectives were to assess the safety and feasibility of this novel technique along with its performance by evaluation of the valve leaflets mobility and valve opening area. Methods This is a multi-center, prospective, controlled first-in-man study. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. The therapy consists of 6 sessions of ultrasound therapy. The Valvosoft transducer is applied on the patient's chest and coupled at its center with an echocardiography phased array probe to allow real-time control of the therapy (cavitation bubble detection). Preselection of the region of interest is performed by echo still frame before each session. Ultrasonic evaluation was performed by an independent core lab at baseline, discharge, 30-day and 3 month follow-up along with clinical follow up. Results Enrolled patients were advanced in age (84.1±6.5 yrs) with severe comorbidities (8 with heart failure, 5 with coronary heart disease and 5 with kidney failure). All had extensive aortic valve calcification (mean calcification volume of 687.28 mm3) with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg (6 patients had SV<35ml/m2). No adverse events were recorded during the procedures other than some benign ventricular extrasystoles. The mean treatment time was 52 minutes. At 3 months follow-up, one patient had died due to end stage heart failure not linked to the procedure (9 weeks post procedure) and another got finally TAVI (45 days post procedure). Of the other 8 patients, 6 experienced an improvement of their NYHA status. No device or procedure related major adverse events nor deterioration of neurological status were observed at 3 months follow-up. Of the 7 patients that had echo follow-up at 3 months (one patient refused to get echo evaluation), 5 increased the AVA (between 14% and 46%) and 4 patients decreased the mean pressure gradient (from 6% to 44%). No AI or EF deterioration occurred during follow up. Conclusion Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and is able to improve AVA and pressure gradient in some patient. Larger studies with longer follow up will need to be conducted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Cardiawave SA, Paris, France

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