Rapid Deployment Aortic Valve Research Articles

Determination of risk factors for pacemaker requirement following rapid-deployment aortic valve replacement.

Rapid-deployment aortic valve replacement (RD-AVR) potentially reduces procedure times providing excellent haemodynamic results compared to standard tissue aortic valve replacement. However, concerns have been raised regarding higher rates of postoperative pacemaker (PPM) requirement compared to standard aortic valve replacement. In this study, we sought to determine the PPM rate and its potential risk factors in RD-AVR patients. Between 2011 and 2017, 193 patients underwent RD-AVR. The main outcome investigated was PPM. Other outcome parameters included hospital mortality, major morbidity, length of stay and discharge condition. Predictors of PPM were determined using multivariable regression models. Isolated RD-AVR was performed in 72 (37%) patients and 121 (63%) patients underwent combined RD-AVR [coronary artery bypass grafting (n = 110), mitral repair (n = 6) and others (n = 5)]. Aortic cross-clamp and cardiopulmonary bypass times were 57.1 ± 25.1 min and 90.0 ± 40.1 min in the overall RD-AVR population and 39.4 ± 13.5 min and 67.6 ± 24.5 min, respectively, in isolated RD-AVR procedures. PPM occurred in 20 (10.4%) patients. Multivariable analysis revealed bypass grafting of the circumflex artery [odds ratio = 2.8] and preoperative right branch bundle block (odds ratio = 11.7) as independent predictors for PPM. RD-AVR is a safe and simple procedure resulting in favourable short aortic cross-clamp and cardiopulmonary bypass times and considerable low gradients in postoperative echocardiography. PPM following isolated RD-AVR remains in the range of standard aortic valve replacement. However, patients undergoing concomitant coronary artery bypass grafting, particularly of the circumflex artery, face a 3-fold increased risk for PPM implantation enhanced if right branch bundle block is present. Follow-up examination is necessary to determine whether these patients remain pacer dependent during long-term follow-up.

Right Anterior Minithoracotomy for Aortic Valve Replacement with The Edwards Rapid Deployment Aortic Valve System

1. Abstract 1.1. <span style=font-size:10.0pt;font-family: times= new= roman,serif;mso-ansi-language:en-us=>Background : Rapid deployment aortic valve systems may ease aortic replacement in challenging minimally invasive approaches. We report our results of a single-center observational study with the Edwards Rapid Deployment (RD) Valve System in Patients with a Right Anterior Mini-Thoracotomy Approach (RAT-AVR). 1.2. <span style=font-size:10.0pt;font-family: times= new= roman,serif;mso-ansi-language:en-us=>Methods : From 9/2013 to 3/2015, 30 consecutive patients received RAT-AVR with the RD valve system. Hemodynamic parameters and clinical outcome were assessed perioperatively, and at hospital discharge. To evaluate the learning curve patients were divided into three groups (Group 1; No.1-10 RD-AVR, group 2; No.11-20 RD-AVR, and group 3; No.21-30 RD-AVR) according to the chronological sequence. 1.3. <span style=font-size:10.0pt;font-family: times= new= roman,serif;mso-ansi-language:en-us=>Results : The median aortic clamp and cardiopulmonary bypass time for the entire patient cohort was 44.5 (35.0-54.3) min and 75.0 (63.8-102) min . Aortic <span style=font-size: 10.0pt;font-family: times= new= roman,serif;mso-ansi-language:en-us=> clamp time (p=0.011) and cardiopulmonary bypass time (p=0.032) differed significantly between groups. Mortality rate was 6.7% and conversion rate was 6.7%, with no differences between groups. There was neither paravalvular leakage nor patient prosthesis mismatch. 1.4. <span style=font-size:10.0pt;font-family: times= new= roman,serif;mso-ansi-language:en-us=>Conclusions : RAT-AVR with the RD valve system is a feasible safe and reproducible procedure. Reproducible short cross-clamp-times can be achieved in a RAT-AVR setting within a short period of time, which might increase the acceptance of RAT-AVR among surgeons. 2. Keywords: Intuity Elite System; Minimally Invasive AVR; Right Anterior Thoracotomy

Step-by-Step Aortic Valve Replacement With a New Rapid Deployment Valve

Rapid deployment/sutureless aortic valve replacement is aimed at minimizing the invasiveness of surgical aortic valve replacement. We describe the implantation techniques of a new rapid deployment aortic valve, focusing on its unique and challenging features. The EDWARDS INTUITY Elite aortic valve (Edwards Lifesciences, Irvine, CA) represents a hybrid between the surgical PERIMOUNT Magna Ease (Edwards Lifesciences) pericardial valve, but with advanced features of the percutaneous SAPIEN valve system (Edwards Lifesciences). A flexible delivery system, with a balloon-expandable subannular frame, facilitates insertion. Important implantation steps include an extended oblique "hockey-stick" aortotomy, symmetrical annular debridement, intra-annular and supra-annular sizing, guiding suture placement, and balloon expansion of the subannular valve frame. Although this valve provides advantages over conventional aortic valves, its implantation is unique, and special operative considerations must be heeded for optimal outcomes. Implantation requires minimal suturing, enabling smaller incisions. Also, the intra-annular inflow frame may promote improved hemodynamics. The INTUITY Elite system represents a significant innovation in bioprosthesis technology. It has been shown to be safe and effective, but its implantation requires detailed attention to several unique operative steps.

Rapid deployment aortic valve replacement in a minimal access setting: intermediate clinical and echocardiographic outcomes†

Transcatheter procedures have overtaken conventional operations in Germany. Considering that this is a highly competitive field, a rate of 25% for minimal access aortic valve replacement seems to be disappointingly low. One way to promote minimal access techniques is through the systematic use of rapid deployment valves. A total of 143 patients underwent rapid deployment aortic valve replacement via upper right hemisternotomy between March 2012 and September 2015. All patients were followed up annually. Echocardiographic assessment of the valve was performed after 12 months. The cumulative follow-up time was 275.2 patient-years. The median follow-up time was 1.9 years. The mean age was 76.4 ± 6.2 years, and the mean logistic EuroSCORE was 11.0 ± 4.3%. Early all-cause mortality was 2.8% (n = 4). Actuarial survival after 1 year was 91.6 ± 2.4%, and after 3 years, it was 84.4 ± 3.6%. Mean transprosthetic gradient after 12 months was 10.3 ± 3.8 mmHg. New onset of higher grade paravalvular leakage did not occur during the follow-up period. Perioperatively, higher grade paravalvular leakage (aortic insufficiency >1+) occurred in 2 cases (1.4%) . Rapid deployment aortic valve replacement can be performed safely in a minimal access setting with low complication rates and good haemodynamic results. Therefore, rapid deployment valves are a relevant option in minimal access surgery.

Rapid Deployment Aortic Valve Replacement versus Transcatheter Aortic Valve Replacement: A Comparison of Two Self-expanding and Stented Aortic Bio-prostheses

Rapid Deployment Aortic Valve Replacement versus Transcatheter Aortic Valve Replacement: A Comparison of Two Self-expanding and Stented Aortic Bio-prostheses

Early-term Results of Rapid-Deployment Aortic Valve Replacement versus Sutured Bioprostheses Implantation in Combined Coronary Artery Bypass Grafting

Early-term Results of Rapid-Deployment Aortic Valve Replacement versus Sutured Bioprostheses Implantation in Combined Coronary Artery Bypass Grafting

Rapid Deployment Aortic Valve Replacement: Excellent Results and Increased Effective Orifice Areas

The aim of this study was to evaluate the effects of rapid deployment aortic valve replacement (RDAVR) on surgical outcome and hemodynamics compared with standard aortic valve replacement (AVR). One hundred sixty-three RDAVR patients (isolated, n= 67; combined with coronary artery bypass graft surgery [CABG], n= 96) were compared with a propensity matched control group (n= 163). Primary endpoints included association between valve type and procedure times, prosthesis size, transvalvular gradient, and indexed effective orifice area. Secondary endpoints were postoperative mortality and morbidity. Aortic cross-clamp and cardiopulmonary bypass times in the RDAVR group were 55 ± 23 and 88 ± 38 minutes, respectively, compared with 77 ± 22 and 105 ± 38 minutes in the control group (p < 0.001). In the subgroup of patients undergoing isolated RDAVR (n= 67 of 163), the aortic cross-clamp and cardiopulmonary bypass times were 38 ± 13 and 66 ± 22 minutes, respectively, compared with 55 ± 14 and 81 ± 18 minutes in the control group (n= 67 of 163; p < 0.001). The RDAVR patients received larger prostheses (23.3 ± 1.8 mm) compared with standard AVR (22.8 ± 1.5 mm; p= 0.002). Mean transvalvular gradients and indexed effective orifice areas were 9 ± 5 mm Hg and 1.11 ± 0.11, respectively, in the RDVAR group compared with 13 ± 5 mm Hg and 0.95 ± 0.08 in the control group (p < 0.001). Hospital mortality was similar in both groups (1.8%, n= 3 of 163; p= 1.000). Postoperative pacemaker rates were 3.5% (n= 3 of 67) for isolated RDAVR versus 3.0% (n= 2 of 67; p= 0.649) for isolated AVR and 12.5% (n= 12 of 96) for RDAVR/CABG versus 4.2% (n= 4 of 96; p= 0.032) for AVR/CABG. RDAVR facilitates reduced aortic cross-clamp and cardiopulmonary bypass times compared with standard AVR, particularly in patients undergoing concomitant procedures, allowing the use of larger prostheses and resulting in lower transvalvular gradients and higher indexed effective orifice area compared with standard AVR. Therefore, RDAVR may help to overcome patient-prosthesis mismatch in some patients.

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.

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%.

Early Outcomes with Rapid-deployment vs Stented Biological Valves: A Propensity-match Analysis

Rapid-deployment valves could potentially reduce cross-clamping time and cardiopulmonary bypass time in complex combined procedures and facilitate minimally invasive surgery. This propensity-matched study compared clinical and echographic outcomes between patients undergoing rapid-deployment aortic valve replacement (RDAVR) compared with stented biological aortic valve replacement (SAVR), with or without concomitant procedures. Between 2012 and 2015, 61 consecutive patients (age 70 ± 7 years, European System for Cardiac Operative Risk Evaluation [EuroSCORE] II 2.1%) underwent aortic valve replacement with Intuity prosthesis (Edwards, Irvine, CA) at the Montreal Heart Institute. This group was compared to 1496 consecutive patients (age 74 ± 8 years, logistic EuroSCORE II 2.8%) who underwent SAVR in the same period. After propensity score matching (1:3), 59 patients in the RDAVR group were matched to 177 patients in the SAVR group. Preoperative characteristics and risk scores were similar in matched groups. Cardiopulmonary bypass, cross-clamp, and total surgical times were lower in the RDAVR group compared with the SAVR group (P < 0.001). Within 30 days, 1 patient died in the SAVR group and none died in the RDAVR group (P = 0.31). The need for pacemaker implantation was higher in the RDAVR group, although the difference was not significant (12% vs 5%, P = 0.13). RDAVR patients less frequently required transfusions (P = 0.025) and had a shorter intubation time (P = 0.002). RDAVR facilitates minimally invasive aortic valve replacement and is associated with shorter bypass and cross-clamp times. Moreover, RDAVR compares favorably with SAVR in terms of mortality and outcome variables.

Rapid Deployment Aortic Valves Deliver Superior Hemodynamic Performance in Vitro

Rapid Deployment Aortic Valves Deliver Superior Hemodynamic Performance in Vitro

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.

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.

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

Rapid Deployment Aortic Valve Replacement versus Transcatheter Valve Implantation: Which Strategy Is Better?

Rapid Deployment Aortic Valve Replacement versus Transcatheter Valve Implantation: Which Strategy Is Better?

Intermediate Results after Minimal Access Rapid Deployment Aortic Valve Replacement: Clinical and Echocardiographic Outcomes

Intermediate Results after Minimal Access Rapid Deployment Aortic Valve Replacement: Clinical and Echocardiographic Outcomes

Early Outcomes of Rapid Deployment Aortic Valve Replacement: The Prince Charles Experience

Early Outcomes of Rapid Deployment Aortic Valve Replacement: The Prince Charles Experience