Edwards Intuity Research Articles

First Case of Late Onset Valve Dislocation after Aortic Valve Replacement with the Edwards Intuity Elite Rapid-Deployment Bioprosthesis

First Case of Late Onset Valve Dislocation after Aortic Valve Replacement with the Edwards Intuity Elite Rapid-Deployment Bioprosthesis

Infective Endocarditis after Primary TAVI Procedure Treated by a Replacement by Edwards Intuity Valve: A Case Report

Infective Endocarditis after Primary TAVI Procedure Treated by a Replacement by Edwards Intuity Valve: A Case Report

One-year outcomes after rapid-deployment aortic valve replacement

ObjectiveThe goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). MethodsAssessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. ResultsBetween 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm2, and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm2/m2), and 28 of 287 patients (9.8%) exhibited severe prosthesis–patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. ConclusionsThese results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting.

Leaflet Kinematics of Mechanical and Bioprosthetic Aortic Valve Prostheses.

The hemodynamic performance of artificial aortic valves (AVs) and the probability for structural valve deterioration can be linked to the valve kinematics. Comparability among different studies is limited because of variations in the experimental setups and physiologic boundary conditions. This study presents results of kinematic measurements of bioprosthetic and mechanical AVs that were tested in an identical experimental setting such that they can be directly compared with each other. The kinematics of AVs is typically presented in the form of the geometric orifice area and its temporal evolution. These parameters cannot capture asynchronous leaflet motion and out-of-plane leaflet velocity. In this work, each leaflet was tracked individually for a more detailed understanding of the leaflet kinematics, asynchronous leaflet motion, and leaflet tip velocities. A bioprosthetic valve, Edwards INTUITY (EINT), and two mechanical valves, Medtronic ADVANTAGE (MADV) and a Lapeyre-Triflo FURTIVA (TFUR), were tested in a compliant model of the aortic root in a physiologic flow loop. TFUR and MADV opened alike with maximum leaflet tip velocities of 0.77 and 0.66 m/s, respectively. The opening of EINT showed significantly higher local in-plane leaflet velocities of more than 2 m/s. EINT and TFUR exhibited similar early and slow closure. MADV closed significantly later with increased velocity. TFUR had a median maximum leaflet tip velocity of 0.39 m/s during valve closure and that of MADV was 0.83 m/s, whereas EINT exhibited a median maximum local in-plane leaflet velocity of 0.37 m/s. EINT experienced leaflet fluttering during systole with a flapping frequency of 36 Hz.

Direct Comparison of the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

Rapid deployment aortic valve replacement (RDAVR) has emerged as an attractive alternative to conventional aortic valve replacement. This single-center study directly compared two commercially available rapid deployment valves with regard to clinical outcomes, valve-related complications, and hemodynamic performance. A total of consecutive 156 patients underwent RDAVR with the Intuity Elite (Edwards Lifesciences, Irvine, CA [Intuity group, n= 117] or the Perceval S (Sorin Group Italia Srl, Saluggia, Italy [Perceval group, n= 39]) between September 2012 and March 2016 at our institution. Perioperative data, including 30-day all-cause mortality, and echocardiographic measurements were assessed and retrospectively analyzed from our institutional database. Preoperative variables, including mean age (77 ± 5 years), European System for Cardiac Operative Risk Evaluation (6.8 ± 2.1), and body mass index (27 ± 5 kg/m2), did not differ between groups. More male patients (60% versus 15%) with a higher body surface area (1.9 ± 0.2 m2 versus 1.7 ± 0.2 m2) and body weight (78 ± 13 kg versus 71 ± 15 kg) were in the Intuity group compared with the Perceval group, respectively (p < 0.05). Implanted RDAVR size (23.3 ± 1.8 mm versus 23.4 ± 1.5 mm), concomitant coronary artery bypass graft surgery (48% versus 33%), number of grafts, cardiopulmonary bypass, and aortic clamp time were comparable between the Intuity group and the Perceval group. Thirty-day mortality (Intuity 2.6% versus Perceval 5.1%) and valve-related complications (Intuity 12.0% versus Perceval 20.5%), including postoperative pacemaker implantation (Intuity 8.5% versus Perceval 12.8%), did not differ between groups. At discharge echocardiography, indexed effective orifice area was higher in the Intuity group, but peak or mean pressure gradients were comparable between groups. Performing RDAVR with the Intuity and Perceval rapid deployment valves provides comparable good clinical outcomes and valve hemodynamics, with low valve-related complication rates. The rate of pacemaker implantation was comparable for both rapid deployment valves, ranging from 8% to 13%.

Rapid deployment valve system shortens operative times for aortic valve replacement through right anterior minithoracotomy

BackgroundThere is growing evidence from the literature that right anterior minithoracotomy aortic valve replacement (RAT-AVR) improves clinical outcome. However, increased cross clamp time is the strongest argument for surgeons not performing RAT-AVR. Rapid deployment aortic valve systems have the potential to decrease cross-clamp time and ease this procedure. We assessed clinical outcome of rapid deployment and conventional valves through RAT.MethodsSixty-eight patients (mean age 76 ± 6 years, 32% females) underwent RAT-AVR between 9/2013 and 7/2015. According to the valve type implanted the patients were divided into two groups. In 43 patients (R-group; mean age 74.1 ± 6.6 years) a rapid deployment valve system (Edwards Intuity, Edwards Lifesciences Corp; Irvine, Calif) and in 25 patients (C-group; mean age 74.2 ± 6.6 years) a conventional stented biological aortic valve was implanted.ResultsAortic cross-clamp (42.1 ± 12 min vs. 68.3 ± 20.3 min; p < 0.001) and bypass time (80.4 ± 39.3 min vs. 106.6 ± 23.2 min; p = 0.001) were shorter in the rapid deployment group (R-group). We observed no differences in clinical outcome. Postoperative gradients (R-group: max gradient, 14.3 ± 8 mmHg vs. 15.5 ± 5 mmHg (C-group), mean gradient, 9.2 ± 1.7 mmHg (R-group) vs. 9.1 ± 2.3 mmHg (C-group) revealed no differences. However, larger prostheses were implanted in C-group (25 mm; IQR 23–27 mm vs. 23 mm; IQR 21–25; p = 0.009).ConclusionsOur data suggest that the rapid deployment aortic valve system reduced cross clamp and bypass time in patients undergoing RAT-AVR with similar hemodynamics as with larger size stented prosthesis. However, larger studies and long-term follow-up are mandatory to confirm our findings.

Edwards Intuity Elite In a Patient With Bicuspid Aortic Stenosis and Ventricular Septal Defect

This study reports on 65-year-old male with a bicuspid Aortic Stenosis (AS) low flow, low gradient and a congenital Ventricular Septal Defect (VSD) of pars membranosa. A ministernotomy and Cardiopulmonary Bypass (CPB) by aorto-femoral cannulation was performed. The VSD was below the commissure between right and non coronary sinus. It was decided to correct it by a stitch with a pericardial patch and a further safer coverage by the stent of an Intuity Elite aortic valve. To the best of our knowledge this was the first time that a VSD could be covered with a suturless valve for two reasons: International Journal of e and conformable configuration of the valve.

The Use of Rapid Deployment Valves in Combined Aortic and Mitral Valve Surgery: One-Year Clinical and Echocardiographic Outcomes.

Patients undergoing multiple valve surgery represent a high-risk group who could potentially benefit from a reduction of cross-clamp and cardiopulmonary bypass times because prolonged bypass and cross-clamp times are considered independent risk factors for increased morbidity and mortality after cardiac surgery. Between July 2013 and November 2014, 16 patients underwent rapid deployment aortic valve replacement with the EDWARDS INTUITY valve system in the setting of concomitant mitral disease. Fifteen patients showed mitral regurgitation, whereas one patient had severe mitral stenosis. Fourteen patients received mitral valve repair and two patients received biological mitral valve replacement. Tricuspid valve repair was performed additionally in two patients. The mean ± SD age was 72.8 ± 8.4 years, and the mean ± SD logistic EuroSCORE II is 8.7% ± 3.4%. Within a 30-day perioperative period, no patient was lost (n = 0). The mean ± SD follow-up time was 11 ± 2 months. At 1 year, the overall survival was 81% (n = 13). A mean ± SD transaortic gradient of 10.7 ± 2.3 mm Hg and a mean ± SD effective orifice area of 1.7 ± 0.3 cm were measured echocardiographically. No higher-grade paravalvular leak (aortic insufficiency > 1+) occurred. Eight patients (61%) had no residual mitral regurgitation, four patients (30%) showed trivial regurgitation (1/4), and one patient (7.3%) had moderate mitral regurgitation (2/4). No interference of the subannular stent frame with the reconstructed valve or the biological mitral prosthesis was seen. Rapid deployment aortic valve replacement with the EDWARDS INTUITY valve system in combined aortic and mitral valve surgery can be performed safely with reproducible results. One-year follow-up data of this small series shows encouraging results potentially justifying the extension of the indication for rapid deployment valves to patients with concomitant mitral disease. Especially elderly patients undergoing multiple valve surgery may benefit from a reduction of cardiopulmonary bypass and myocardial ischemic times.

Long-term outcomes of a rapid deployment aortic valve: data up to 5 years.

Rapid deployment aortic valve replacement (AVR) has been developed to facilitate minimally invasive approaches for cardiac surgery and shorten procedural times. TRITON is a prospectively designed study to assess safety and efficacy of rapid deployment AVR with Edwards INTUITY valve system. This report presents the 5-year outcomes of the TRITON trial. A total of 295 patients with aortic valve stenosis were enrolled in the TRITON trial and 287 patients received the study valve. Procedural, early (≤30 days) and late (>30 days) outcomes were collected. Valve haemodynamic performance was evaluated at specified time points by an independent Echocardiography Core Laboratory and clinical events adjudicated by an independent Clinical Events Committee. Mean age was 75.3 ± 6.7 years. A total of 158 patients underwent isolated AVR and 129 patients underwent AVR with concomitant procedures. The 5-year survival rates were 85.7 ± 3.4% and 75.2 ± 4.9% for isolated AVR and concomitant AVR, respectively. Overall, freedom from valve-related death at 5 years was 98.2 ± 0.8%. At 5 years, the valve effective orifice area was 1.6 ± 0.3 cm 2 , mean gradient was 10.5 ± 5.4 mmHg and peak gradient was 18.9 ± 9.3 mmHg. The 5-year outcomes of the TRITON trial demonstrate acceptable long-term safety and excellent haemodynamic performance of rapid deployment AVR with the Edwards INTUITY valve system. NCT01445171.

The economic value of rapid deployment aortic valve replacement via full sternotomy.

To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-up are needed to evaluate if this result can be replicated over a longer timeframe.

Rapid-deployment aortic valve replacement for severe aortic stenosis: 1-year outcomes in 150 patients.

This study aimed to evaluate the safety and effectiveness of rapid-deployment aortic valve replacement (RDAVR) for severe aortic stenosis (AS). All consecutive patients with severe AS who underwent RDAVR with the EDWARDS INTUITY bioprosthesis were prospectively included in a single-centre, cohort study between July 2012 and April 2015. Clinical examination and transthoracic echocardiography were performed preoperatively and at 1-month and 1-year follow-up. We included 150 patients: mean age 76.8 ± 6.2 years, 68.7% male and mean EuroSCORE II 3.4 ± 3.7%. Implantation was successful in all: 103 (68.7%) had isolated aortic valve replacement (AVR) and 47 (31.3%) had concomitant procedures. For isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 37.6 ± 13.3 and 59.9 ± 20.4 min, respectively. Overall, the 1-year Kaplan-Meier survival rate was 97.1% (95% confidence interval 92.4-98.9%). At 1 year, stroke occurred in 5 patients (3.34%), myocardial infarction in 1 (0.69%), endocarditis in 1 (0.69%), early explantation in 1 (0.67%), pacemaker implantation in 8 (5.6%) and Grade 2 periprosthetic regurgitation in 4 (3.2%; no grade 3 of 4). There were significant decreases from baseline ( P < 0.001) in the proportion at New York Heart Association Class III/V (35.3-4.1%), mean gradient (54.9 ± 17.3 mmHg to 11.3 ± 4.8 mmHg) and mean left ventricular mass index (160.3 ± 44.8 g/m 2 to 118.5 ± 39.4 g/m 2 ). Mean indexed effective orifice area at 1 year was 1.02 ± 0.37 cm 2 /m 2 . Ten patients (6.6%) had severe patient-prosthesis mismatch. RDAVR for severe AS provided favourable outcomes over 1 year.

Rapid Deployment Aortic Valve Replacement via Partial Sternotomy: A Reasonable Option in Times of TAVI?

Objective: The Edwards Intuity valve (IV) system was designed as a further development of stented bioprostheses for aortic valve replacement (AVR). The application in a minimally invasive setting via partial sternotomy (PS) may represent an alternative to transcatheter aortic valve procedures (TAVI) in selected patients. Herein we present our initial, short-term findings with the IV.

Single-Center Experience with the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

Single-Center Experience with the Edwards Intuity Elite and Sorin Perceval S Rapid Deployment Aortic Valves

Early Failure of an Edwards Intuity Rapid Deployment Sutureless Aortic Valve

Early Failure of an Edwards Intuity Rapid Deployment Sutureless Aortic Valve

PCV49 - The Economic Value of Rapid Deployment Aortic Valve Replacement Via Full Sternotomy

Aim: To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. Data & methods: A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. Results: EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. Conclusion: This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-u...

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve

BackgroundThe TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. MethodsTRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. ResultsBetween 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively. ConclusionsINTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.

Aortic root stiffness affects the kinematics of bioprosthetic aortic valves.

In this study, the influence of aortic root distensibility on the haemodynamic parameters and valve kinematics of a bioprosthetic aortic valve was investigated in a controlled in vitro experiment. An Edwards INTUITY Elite 21 mm sutureless aortic valve (Edwards Lifesciences, Irvine, CA, USA) was inserted in three transparent aortic root phantoms with different wall thicknesses (0.55, 0.85 and 1.50 mm) mimicking different physiological distensibilities. Haemodynamic measurements were performed in an in vitro flow loop at heart rates of 60, 80 and 100 bpm with corresponding cardiac outputs of 3.5, 4.0 and 5.0 l/min and aortic pressures of 100/60, 120/90 and 145/110 mmHg, respectively. Aortic valve kinematics were assessed using a high-speed camera. The geometric orifice area (GOA) was measured by counting pixels in the lumen of the open aortic valve. The effective orifice area (EOA) was calculated from the root-mean-square value of the systolic aortic valve flow rate and the mean systolic trans-valvular pressure gradient. The tested aortic root phantoms reproduce physiological distensibilities of healthy individuals in age groups ranging from 40 to 70 years (±10 years). The haemodynamic results show only minor differences between the aortic root phantoms: the trans-valvular pressure gradient tends to increase for stiffer aortic roots, whereas the systolic aortic valve flow rate remains constant. As a consequence, the EOA decreased slightly for less distensible aortic roots. The GOA and the aortic valve opening and closing velocities increase significantly with reduced distensibility for all haemodynamic measurements. The resulting mean systolic flow velocity in the aortic valve orifice is lower for the stiffer aortic root. Aortic root distensibility may influence GOA and aortic valve kinematics, which affects the mechanical load on the aortic valve cusps. Whether these changes have a significant effect on the onset of structural valve deterioration of bioprosthetic heart valves needs to be further investigated.

The economic value of INTUITY in aortic valve replacement

Objective: The recent development of the EDWARDS INTUITY Elite™ (EIE) valve system enables the rapid deployment of a prosthetic surgical heart valve in an aortic valve replacement (AVR) procedure via both the minimally invasive (MISAVR) and conventional (CAVR) approaches. In order to understand its economic value, this study performed a cost evaluation of the EIE valve system used in a MIS rapid-deployment approach (MIS-RDAVR) vs MISAVR and CAVR, respectively, compared to standard prosthetic aortic valves.Methods: A simulation model was developed using TreeAge (and validated with MS Excel) to compare the inpatient utilization and complication costs for each treatment arm. Thirty-day clinical end-points for the MIS-RDAVR (mortality and complications) were taken from the TRANSFORM trial; and a best evidence review of the published literature was used for the MISAVR and CAVR approaches. Studies were pooled and parameter estimates were weighted by sample size in order to compare the TRANSFORM patients. Cost data (2016 USD) were taken from the Premier database. Incremental cost and cost-effectiveness was assessed and one-way/probabilistic sensitivity analyses performed to gauge the robustness of the results.Results: MIS-RDAVR costs $2,621 less than CAVR and had lower mortality rates, making it a superior (dominant) technology relative to CAVR. MIS-RDAVR costs $4,560 more than MISAVR, but was associated with an additional 0.20 life years-per-patient. This implies a cost-effectiveness ratio of $22,903 per-life-year-gained. Thus, MIS-RDAVR is cost-effective compared to MISAVR.Conclusions: The EIE valve system deployed in a MIS approach appears to be a cost-effective technology compared to MISAVR and CAVR. When compared to CAVR it may achieve cost savings as well. These results suggest that MIS-RDAVR confers superior economic value compared to both standard MISAVR and CAVR via lowered key complication rates (re-operation, renal complications, wound infection, TIA, endocarditis) and utilization (cross-clamp time, hospital ward days).

Thrombocytopenia after sutureless aortic valve implantation: Comparison between Intuity and Perceval bioprostheses

Thrombocytopenia after sutureless aortic valve implantation: Comparison between Intuity and Perceval bioprostheses

Early Outcomes of Sutureless Aortic Valves.

BackgroundIn elderly high-risk surgical patients, sutureless aortic valve replacement (AVR) should be an alternative to standard AVR. The potential advantages of sutureless aortic prostheses include reducing cross-clamping and cardiopulmonary bypass (CPB) time and facilitating minimally invasive surgery and complex cardiac interventions, while maintaining satisfactory hemodynamic outcomes and low rates of paravalvular leakage. The current study reports our single-center experience regarding the early outcomes of sutureless aortic valve implantation.MethodsBetween October 2012 and June 2015, 65 patients scheduled for surgical valve replacement with symptomatic aortic valve disease and New York Heart Association function of class II or higher were included to this study. Perceval S (Sorin Biomedica Cardio Srl, Sallugia, Italy) and Edwards Intuity (Edwards Lifesciences, Irvine, CA, USA) valves were used.ResultsThe mean age of the patients was 71.15±8.60 years. Forty-four patients (67.7%) were female. The average preoperative left ventricular ejection fraction was 56.9±9.93. The CPB time was 96.51±41.27 minutes and the cross-clamping time was 60.85±27.08 minutes. The intubation time was 8.95±4.19 hours, and the intensive care unit and hospital stays were 2.89±1.42 days and 7.86±1.42 days, respectively. The mean quantity of drainage from chest tubes was 407.69±149.28 mL. The hospital mortality rate was 3.1%. A total of five patients (7.69%) died during follow-up. The mean follow-up time was 687.24±24.76 days. The one-year survival rate was over 90%.ConclusionIn the last few years, several models of valvular sutureless bioprostheses have been developed. The present study evaluating the single-center early outcomes of sutureless aortic valve implantation presents the results of an innovative surgical technique, finding that it resulted in appropriate hemodynamic conditions with acceptable ischemic time.