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

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

Circulation ◽

10.1161/circ.142.suppl_3.17142 ◽

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.

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

Interactive Cardiovascular and Thoracic Surgery ◽

10.1093/icvts/ivaa299 ◽

2020 ◽

Author(s):

José Manuel Martínez-Comendador ◽

Francisco Estevez-Cid ◽

Miguel González Barbeito ◽

Carlos Velasco García De Sierra ◽

Alberto Bouzas Mosquera ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Pressure Gradient ◽

Valve Replacement ◽

Consensus Definition ◽

Structural Valve Deterioration ◽

Mean Pressure ◽

The Mean ◽

Bioprosthetic Valves

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

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez256 ◽

2019 ◽

Vol 21 (10) ◽

pp. 1144-1151 ◽

Cited By ~ 2

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 < 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.

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Balloon dilation of stenosed systemic venous pathways following the Mustard operation

Cardiology in the Young ◽

10.1017/s1047951100003000 ◽

1995 ◽

Vol 5 (3) ◽

pp. 238-242 ◽

Cited By ~ 3

Author(s):

Narayanswami Sreeram ◽

Venkateswararao Dikkala ◽

Robert Arnold

Keyword(s):

Pressure Gradient ◽

Balloon Dilation ◽

Mustard Operation ◽

Mean Pressure ◽

Angiographic Data ◽

Alternative Measures ◽

The Mean ◽

Term Management

SummaryStenoses of the systemic venous pathways are a potentially dangerous complication after the Mustard operation. The acute and intermediate-term efficacy of balloon dilation of these stenoses has not previously been studied in a large group of patients. A retrospective analysis of clinical and angiographic data, with prospective clinical and echocardiographic follow-up, was performed in a consecutive group of 25 patients (17 male, 8 female) who underwent balloon dilation of the superior or inferior caval venous pathways. For 17 dilations of stenoses in the superior pathway, the mean pressure gradient decreased from 9.1±5.7 to 3.4±2.3 mm Hg (p<0.01), while the diameter of the stenosis increased from 5.9±2.9 to 11.2±3.0 mm (p<0.01). For 25 dilations of the inferior pathway, the mean gradient decreased from 4.3±1.8 to 1.4±1.1 mm Hg (p<0.01), while the diameter of the stenosis increased from 7.3±1.5 to 10.6±2.3 mm (p<0.01). Over a median follow-up of 3.5 years, 16 patients have been without symptoms or signs suggestive of recurrence of stenoses. In the remaining nine patients, 11 further procedures were performed at a median of 3.1 years after initial dilation. In five patients who had previously undergone dilation of the superior (3), inferior (1) or both (1) pathways, further dilations of the same pathway(s) and/or stent implantations were performed. Three patients, including one in whom superior caval venous stenosis had recurred, had developed a new stenosis of a previously undilated pathway, while in two patients no further dilations were required. Balloon dilation offers an alternative to reoperation for stenoses of the systemic venous pathways after the Mustard operation, and appears to provide satisfactory intermediate-term palliation. Recurrences of stenoses in previously dilated pathways, and new stenoses in previously unobstructed pathways, are commonly seen at follow-up. Alternative measures, such as placement of stents, need to be considered in the long-term management of these patients.

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

European Heart Journal ◽

10.1093/eurheartj/ehz745.0883 ◽

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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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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Two-Year Clinical Follow-Up Assessment of the Novel Cingular Surgical Bovine Pericardial Valve

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.736877 ◽

2021 ◽

Vol 8 ◽

Author(s):

Jinmiao Chen ◽

Minzhi Lv ◽

Yuntao Lu ◽

Jiahui Fu ◽

Yingqiang Guo ◽

...

Keyword(s):

Pressure Gradient ◽

Prosthetic Valve Endocarditis ◽

Effective Orifice Area ◽

Clinical Safety ◽

Clinical Events ◽

Structural Valve Deterioration ◽

Mean Pressure ◽

The Mean ◽

Hemodynamic Performance

Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis.Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory.Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance.Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.

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Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients

General Thoracic and Cardiovascular Surgery ◽

10.1007/s11748-020-01566-1 ◽

2021 ◽

Author(s):

Naoki Tadokoro ◽

Satsuki Fukushima ◽

Yusuke Shimahara ◽

Tetsuya Saito ◽

Naonori Kawamoto ◽

...

Keyword(s):

Aortic Valve ◽

Pressure Gradient ◽

Pacemaker Implantation ◽

Japanese Patients ◽

Left Ventricular ◽

Risk Scores ◽

Effective Orifice Area ◽

Significant Difference ◽

Mean Pressure ◽

The Mean

Abstract Objectives A new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR). Methods This study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores. Results No in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient–prosthesis mismatch at 1 week postoperatively. Conclusions The new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients.

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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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