Abstract 17142: Long Term Results of Non-Invasive Ultrasound Therapy (NIUT) in Severe Symptomatic Aortic Valve Stenosis - First-in-Man

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Emmanuel Messas ◽  
Alexander Ijsselmuiden ◽  
Selina Vlieger ◽  
Peter den Heijer ◽  
Guillaume Goudot ◽  
...  
Keyword(s):  
Heart Failure ◽  
Aortic Valve ◽  
Aortic Stenosis ◽  
Pressure Gradient ◽  
Aortic Valve Stenosis ◽  
Long Term Results ◽  
Ultrasound Therapy ◽  
Non Invasive ◽  
Mean Pressure

Background: Not all patients with severe aortic valve stenosis are eligible for open-heart surgery or TAVR. CARDIAWAVE (Paris, France) has developed Valvosoft, a unique non-invasive ultrasound therapy device to treat aortic stenosis. The therapy aims to improve the opening of severely calcified aortic valves by cracking the calcium and reducing the stiffness in the aortic valve tissue by delivering transthoracically local shock waves on the valve leaflets. This study assesses the safety, feasibility and performance of this novel technique. Methods: This is a multi-center, prospective, first-in-man study designed to evaluate the safety and feasibility of the Valvosoft device. Ten patients with severe symptomatic calcific aortic stenosis and not eligible for SAVR/TAVR underwent a Valvosoft ultrasound therapy. Echocardiographic evaluation was performed by an independent core lab at baseline, discharge, and at 1, 3, 6 and 12 months 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 with mean AVA of 0.61±0.17 cm2 and mean pressure gradient of 37.5±10.5 mmHg. At one-month follow-up, six patients had significantly improved their AVA with increase of 27.5% (p=0.03) and mean pressure gradient decrease of 23.2 % (p=0.025). These patients also received the highest dose and longest treatment duration. During one year follow up, 4 patients died due to progression of end stage heart failure not linked to the procedure and one patient had undergone a TAVR procedure. At 12 months, the five remaining patients has no device or procedure related major adverse events nor deterioration of neurological status. Echo, brain-MRI and clinical follow up will be presented. Conclusions: Non-invasive ultrasound therapy is feasible and safe in patients with severe aortic valve stenosis and can improve AVA and hemodynamic parameters. NIUT can be an important tool complementary to TAVI in treating patients with aortic valve stenosis.

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

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

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

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

Abstract 19440: Reintervention Rates Following Balloon Aortic Valvuloplasty versus Surgical Valve Repair in Isolated Congenital Aortic Valve Stenosis - A Meta-analysis

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
May T Saung ◽  
Courtney McCracken ◽  
Ritu Sachdeva ◽  
Christopher J Petit
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Stenosis ◽  
Meta Analysis ◽  
Valve Repair ◽  
Balloon Aortic Valvuloplasty ◽  
Congenital Aortic Stenosis ◽  
Primary Indication ◽  
Aortic Valvuloplasty

Introduction: The optimal treatment for congenital aortic stenosis (AS) is debated despite decades of experience with both balloon aortic valvuloplasty (BAV) and surgical aortic valve repair (SAV). While BAV has been the mainstay of therapy for AS, recent single-center reports suggest optimal results following SAV. Hypothesis: We propose that reintervention rates following SAV and BAV are equivalent. Methods: We queried Medline, EMBASE and Web of Science for eligible studies using the keywords: “congenital aortic stenosis”, “balloon valvotomy”, “aortic valve stenosis surgery” and “treatment outcome or reintervention”. Studies were excluded when cohort size was <20 pts, when follow-up was < 2.5 yrs from primary intervention, and when primary indication was not AS (e.g. SAV in the setting of aortic valve regurgitation (AR)). Outcomes analyzed included death, reintervention and moderate or severe AR. Analysis was performed using Comprehensive Meta Analysis v3 using random effects models. Results: A total of 20 studies were included in our meta-analysis: SAV alone (n=3), BAV alone (n=12), and both (n=5). The mean age at BAV was 3.1 years (range, 4 days - 7 years) with a mean follow-up duration of 6.8 years, while mean age at SAV was 2.8 years (range, 14.2 days - 7.1 years) with a mean follow-up duration of 9.1 years. Mortality rates following BAV and SAV were 12.3% (95% CI: 7.7 - 19.1) and 10.2% (95% CI: 7.0 - 14.5), respectively (p=0.27). Reintervention following initial procedure for treatment of AS was higher following BAV (35.7% [95% CI: 29 - 43.1]) compared to SAV (25.2% [95% CI: 19.9 - 31.3])(p=0.012). Long-term and mid-term follow-up in these studies showed moderate to severe AR was present in 24.1% and 28.1% of BAV and SAV patients, respectively. Conclusions: Notwithstanding publication bias, both survival rates and development of late AR following BAV and SAV are similar. However, reintervention rates are significantly higher following BAV compared to SAV.

scholarly journals Subclinical leaflet thrombosis is associated with impaired reverse remodelling after transcatheter aortic valve implantation

2019 ◽  
Vol 21 (10) ◽  
pp. 1144-1151 ◽  
Author(s):  
Bálint Szilveszter ◽  
Daniel Oren ◽  
Levente Molnár ◽  
Astrid Apor ◽  
Anikó I Nagy ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Aortic Valve ◽  
Pressure Gradient ◽  
Transcatheter Aortic Valve ◽  
Mean Pressure ◽  
Reverse Remodelling ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
Change In Mean

Abstract Aims Cardiac CT is increasingly applied for planning and follow-up of transcatheter aortic valve implantation (TAVI). However, there are no data available on reverse remodelling after TAVI assessed by CT. Therefore, we aimed to evaluate the predictors and the prognostic value of left ventricular (LV) reverse remodelling following TAVI using CT angiography. Methods and results We investigated 117 patients with severe, symptomatic aortic stenosis (AS) who underwent CT scanning before and after TAVI procedure with a mean follow-up time of 2.6 years after TAVI. We found a significant reduction in LV mass (LVM) and LVM indexed to body surface area comparing pre- vs. post-TAVI images: 180.5 ± 53.0 vs. 137.1 ± 44.8 g and 99.7 ± 25.4 vs. 75.4 ± 19.9 g/m2, respectively, both P &lt; 0.001. Subclinical leaflet thrombosis (SLT) was detected in 25.6% (30/117) patients. More than 20% reduction in LVM was defined as reverse remodelling and was detected in 62.4% (73/117) of the patients. SLT, change in mean pressure gradient on echocardiography and prior myocardial infarction was independently associated with LV reverse remodelling after adjusting for age, gender, and traditional risk factors (hypertension, body mass index, diabetes mellitus, and hyperlipidaemia): OR = 0.27, P = 0.022 for SLT and OR = 0.22, P = 0.006 for prior myocardial infarction, OR = 1.51, P = 0.004 for 10 mmHg change in mean pressure gradient. Reverse remodelling was independently associated with favourable outcomes (HR = 0.23; P = 0.019). Conclusion TAVI resulted in a significant LVM regression on CT. The presence of SLT showed an inverse association with LV reverse remodelling and thus it may hinder the beneficial LV structural changes. Reverse remodelling was associated with improved long-term prognosis.

P914Balloon aortic valve valvuloplasty as palliative therapy in severe aortic valve stenosis: 10 years experience in a single centre

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Mantovani ◽  
M A Clavel ◽  
F Jayme ◽  
L Valli ◽  
R M De Mola ◽  
...  
Keyword(s):  
Heart Failure ◽  
High Risk ◽  
Aortic Valve ◽  
Aortic Stenosis ◽  
Palliative Therapy ◽  
Medical Attention ◽  
High Risk Population ◽  
High Risk Patients ◽  
Risk Patients

Abstract Background Improved technology together with greater operator experience has led to refinement of balloon aortic valve valvuloplasty (BAV) in recent years. It may provide a palliative treatment option in high-risk patients, highly symptomatic, for whom no other invasive therapy is available. However, there has not been universal adoption of BAV as a standalone therapy. Methods A retrospective analysis of ten years of practice of BAV as palliative strategy in patient with symptomatic aortic stenosis between March 2008 and June 2018 was performed. Demographic, clinical, procedural, and follow-up data on all patients were collected. Results A total of 152 patients (95 women, 63%) with a mean age of 85±6 years underwent BAV. All patients had severe aortic stenosis, were considered not suitable to aortic valve replacement nor Trans-catheter aortic valve implantation (TAVI) for appreciable comorbidity (STS score 9±5) and had severe symptoms mainly of heart failure which required medical attention. A statistically significant decrease in trans-valvular gradient was observed (peak to peak gradient before BAV 52±22 mmHg, after BAV 29±16 mmHg, delta gradient 24±14 mmHg; p<0.0001). Only one patient, who undergone BAV because of cardiogenic shock, died during the procedure. Considering the high-risk population, intra-hospital mortality was low (7 patients died, 4%). Mortality at 1-year follow-up was 43% and survival free from new hospitalization for heart failure was 63% at 1-year follow-up and 53% at 2 years follow-up. 19 patients (13%) required repeated BAV during follow-up. Conclusion BAV as a palliative procedure in high-risk patients who are highly symptomatic, has a low operative mortality in our experience. BAV is associated with a significant reduction in aortic valve gradient and is valuable since half of the patients were alive without re-hospitalizations for heart failure at 2 years follow-up. Acknowledgement/Funding None

scholarly journals The Immediate And Intermediate Results Of Percutaneous Balloon Aortic Valvuloplasty In Patients With Congenital Valvular Aortic Stenosis

2019 ◽  
Vol 13 (2) ◽  
pp. 51-55
Author(s):  
Hussein A. Alwahab
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Pressure Gradient ◽  
Aortic Regurgitation ◽  
Balloon Aortic Valvuloplasty ◽  
Maximum Peak ◽  
Percutaneous Balloon ◽  
Aortic Valvuloplasty ◽  
Valvular Aortic Stenosis

Background: Aortic valve stenosis results from minor to severe degrees of aortic valve maldevelopment. This stenosis causes mild to severe obstruction of the left ventricular outflow . Objectives : to study the immediate and intermediate results of percutaneous balloon aortic valvuloplasty in patients with congenital valvular aortic stenosis . Type of the study: A prospective study. Methods: The study was done on thirty five patients with congenital valvular aortic stenosis who had percutaneous balloon aortic valvuloplasty  in Ibn Al- Bitar Center for Cardiac Surgery from May 2009 to February 2011. Results: Twenty seven patients were male (77.2%) and 8 patients were female (22.8%), male to female ratio 3.5/ 1, . The aortic valve was bicuspid in 18 patients (51.4%) while 17 patients ( 48.6%) had tricuspid aortic valve. Balloon aortic valvuloplasty was successful in 30 patients (85.7%),. Maximum peak instantaneous Doppler pressure gradient across the aortic valve 24 hours postprocedural echocardiography showed reduction which is statistically significant. New aortic regurgitation had occurred in 15 patients ( 42.8%), it was mild in 9 patients ( 25.6%), moderate in 5 patients ( 14.3%) and severe in 1 patient( 2.9%) which is statistically significant. The follow up of 12.57 ± 3.88 ( 3- 22) months after intervention was done for all patients using echocardiography Doppler study, reveal the maximum peak instantaneous Doppler pressure gradient  across the aortic valve was raised  which is statistically significant. The aortic regurgitation was present in 18 patients (51.4%) , it was mild in 9 patients (25.7%) , moderate in 6 patients (17.1%) and severe in 3 patients  ( 8.6%). No mortality had been reported during the procedure or on follow up.                                                                                  Conclusion: Aortic balloon valvuloplasty is safe and effective procedure in the treatment of congenital valvular aortic stenosis but mild aortic regurgitation is the most common immediate complication of aortic balloon dilatation and progressive aortic regurgitation is a major problem during the intermediate follow up.                                                                                                                                               

scholarly journals Electrocardiographic Strain Pattern Is a Major Determinant of Rehospitalization for Heart Failure After Transcatheter Aortic Valve Replacement

2021 ◽  
Vol 10 (3) ◽  
Author(s):  
Joé Heger ◽  
Antonin Trimaille ◽  
Marion Kibler ◽  
Benjamin Marchandot ◽  
Marilou Peillex ◽  
...  
Keyword(s):  
Heart Failure ◽  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Bundle Branch Block ◽  
Strain Pattern ◽  
Transcatheter Aortic Valve

Background Electrocardiographic strain pattern (ESP) has recently been associated with increased adverse outcome in aortic stenosis and after surgical aortic valve replacement. Our study sought to determine the impact and incremental value of ESP pattern in predicting adverse outcome after transcatheter aortic valve replacement. Methods and Results A total of 585 patients with severe aortic stenosis (mean age, 83±7 years; men, 39.8%) were enrolled for transcatheter aortic valve replacement from November 2012 to May 2018. ESP was defined as ≥1‐mm concave down‐sloping ST‐segment depression and asymmetrical T‐wave inversion in the lateral leads. The primary end points of the study were all‐cause mortality, rehospitalization for heart failure, myocardial infarction, and stroke. A total of 178 (30.4%) patients were excluded because of left bundle‐branch block (n=103) or right bundle‐branch block (n=75). Among the 407 remaining patients, 106 had ESP (26.04%). At a median follow‐up of 20.00 months (11.70–29.42 months), no impact of electric strain on overall and cardiac death could be established. By contrast, incidence of rehospitalization for heart failure was significantly higher (33/106 [31.1%] versus 33/301 [11%]; P <0.001) in patients with ESP. By multivariate analyses, ESP remained a strong predictor of rehospitalization for heart failure (hazard ratio, 2.75 [95% CI, 1.61–4.67]; P <0.001). Conclusions In patients with aortic stenosis who were eligible for transcatheter aortic valve replacement, ESP is frequent and associated with an increased risk of postinterventional heart failure regardless of preoperative left ventricular hypertrophy. ESP represents an easy, objective, reliable, and low‐cost tool to identify patients who may benefit from intensified postinterventional follow‐up.

P4490Safety and feasibility of non invasive transthoracic pulsed cavitational ultrasound therapy (PCUT) on a swine aortic valve model

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Messas ◽  
M Remond ◽  
G Goudot ◽  
R Penot ◽  
D Ladarre ◽  
...  
Keyword(s):  
Side Effects ◽  
Aortic Valve ◽  
High Power ◽  
Ultrasound Therapy ◽  
Antithrombotic Treatment ◽  
Invasive Approach ◽  
Non Invasive ◽  
Valve Model

Abstract Background Aortic valve stenosis is associated with age and comorbidities, which require exploring less invasive therapeutic approach to improve patient outcome. We previously demonstrated in vitro and in vivo that pulsed cavitational ultrasound therapy (PCUT) can improve calcified bioprosthesis stenosis by softening leaflets remotely. To apply this technique noninvasively we aim to test PCUT transthoracicalyin a swine model targeting aortic valve. Because calcified aortic valve model doesn't exist, we tested this technique on a normal valve. Objective Primary objective was to estimate the feasibility and safety of PCUT. Secondary objectiveswere to evaluate occurrence, severity and evolution of cardiovascular side effects during therapy and within follow-up period (30±5 days) with and without double antithrombotic treatment. Methods All the experiments were performed on normal aortic valves (n=19) of swine. The system was composed of a high-power multi-element transducer with electronic steering and 2D echocardiographic probe embedded in the center. Swine were divided in three groups: one with PCUT and no anti thrombotic treatment (n=10), a second with PCUT and one-month treatment of aspirin and clopidogrel (n=5) and third group sham (n=4). All groups were followed up after 30 days. Results The primary feasibility endpoint was successful in 100% of tests performed (n=16). A maximal amplitude of 70 MPa and −19 MPa respectively for positive and negative peak pressure was found at the focus point. Survival at 30 days was 100% and no life-threatening arrhythmia was recorded and no sustained ventricular arrhythmia (SVT >30 s) was noticed. For the secondary safety objectives,we recorded acutely, at the time of procedure, NSVT in 7 pigs which corresponded to a cumulated duration of 2.1 out of the 485.3 min of the total US delivery (0.4% of time). Mean cycle of NSVT was slow 428.9 ms in average (139.6 bpm). The interruption or decrease of power of US delivery allowed immediate cessation of cardiac arrhythmia in all cases. There was no evidence of damage to the valve and no observation of impairment of valvular function by echocardiography. Only one animal showed side effects (RV dilatation) and the RV returned to normal after cessation of the therapy with no sequelae at follow up. At follow up no significant findings biology disturbance or valve thrombosis was observed (creatinine, CK MB, hemoglobin, hematocrit, haptoglobin or red blood cell numbers). Antithrombotic treatment didn't demonstrate any advantage at follow up. Conclusion We demonstrated in vivo feasibility and safety of transthoracic PCUT targeting aortic valve without any serious adverse event and no significant histopathology damage. We hope that this first-time transthoracic delivery of very focused ultrasound at high power will pave the way to new non invasive approach of valve softening in case of human aortic valve calcified stenosis.

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