Rapid deployment aortic valve implantation in complex patients with infective endocarditis or aortic valve insufficiency.

BACKGROUND: New prosthetic valves and surgical approaches that shorten operation time and improve the outcome of patients with aortic valve (AV) infective endocarditis (IE) and AV insufficiency (AVI) are crucial. The aim of this study was to evaluate the outcome of patients with AV IE or AVI treated with the EDWARDS INTUITY Rapid-Deployment AV prosthesis for this off-label indication. METHODS: This single-centre retrospective study analyzed data from patients who underwent AV replacement with the EDWARDS INTUITY Rapid-Deployment AV prosthesis for AV IE or regurgitation. (n = 8 for IE and n = 6 for AVI). RESULTS: Heart-lung machine times were significantly shorter in the AVI group (111.3 ± 20.7 min) compared to the IE group (171.9 ± 52.4 min) (p = 0.02). Aortic cross-clamp followed a similar trend (73.7 ± 9.9 min for AVI vs. 113.4 ± 35.6 min for IE) (p = 0.02). The length of ICU stay was also shorter in the AVI group (3.8 ± 2.6 days) compared to the IE group (16.9 ± 8.9 days) (p = 0.005). Postoperative echocardiography revealed no paravalvular leakage or significant valvular dysfunction in any patient. One patient died postoperatively from aspiration pneumonia. CONCLUSION: The INTUITY valve demonstrates as a safe option for complex AV IE and AVI surgery. Further prospective studies with larger patient cohorts are necessary to confirm these findings and explore the long-term benefits of this approach.

Thrombocytopenia after Aortic Valve Replacement Using Sutureless Valves.

Background: Sutureless valves are widely used in aortic valve replacement surgery, with Perceval valves and Intuity valves being particularly prominent. However, concerns have been raised about postoperative thrombocytopenia with Perceval valves (Corcym, UK). We conducted a comparative analysis with the Intuity valve (Edwards Lifesciences, USA), and assessed how thrombocytopenia affected patient and transfusion outcomes. Methods: Among 595 patients who underwent aortic valve replacement from June 2016 to March 2023, sutureless valves were used in 53 (Perceval: n=23; Intuity: n=30). Platelet counts were monitored during hospitalization and outpatient visits. Daily platelet count changes were compared between groups, and the results from patients who underwent procedures using Carpentier Edwards Perimount Magna valves were used as a reference group. Results: Compared to the Intuity group, the Perceval group showed a significantly higher amount of platelet transfusion (5.48±1.64 packs vs. 0.60±0.44 packs, p=0.008). During the postoperative period, severe thrombocytopenia (<50,000/µL) was significantly more prevalent in the Perceval group (56.5%, n=13) than in the Intuity group (6.7%, n=2). After initial postoperative depletion, daily platelet counts increased, with significant differences observed in the extent of improvement between the Perceval and Intuity groups (p<0.001). However, there was no significant difference in early mortality or the incidence of neurological complications between the 2 groups. Conclusion: The severity of postoperative thrombocytopenia differed significantly between the Perceval and Intuity valves. The Perceval group showed a significantly higher prevalence of severe thrombocytopenia and higher platelet transfusion volumes. However, thrombocytopenia gradually recovered during the postoperative period in both groups, and the early outcomes were similar in both groups.

The Northern New England Rapid Deployment Valve Experience: Survival and Procedural Outcomes From 2015 to 2021.

OBJECTIVE: The optimal approach and choice of initial aortic valve replacement (AVR) is evolving in the growing era of transcatheter AVR. Further survival and hemodynamic data are needed to compare the emerging role of rapid deployment (rdAVR) versus stented (sAVR) valve options for AVR. METHODS: The Northern New England Cardiovascular Database was queried for patients undergoing either isolated AVR or AVR + coronary artery bypass grafting (CABG) with rdAVR or sAVR aortic valves between 2015 and 2021. Exclusion criteria included endocarditis, mechanical valves, dissection, emergency case status, and prior sternotomy. This resulted in a cohort including 1,616 sAVR and 538 rdAVR cases. After propensity weighting, procedural characteristics, hemodynamic variables, and survival outcomes were examined. RESULTS: The breakdown of the overall cohort (2,154) included 1,164 isolated AVR (222 rdAVR, 942 sAVR) and 990 AVR + CABG (316 rdAVR, 674 sAVR). After inverse propensity weighting, cohorts were well matched, notable only for more patients <50 years in the sAVR group (4.0% vs 1.9%, standardized mean difference [SMD] = -0.12). Cross-clamp (89 vs 64 min, SMD = -0.71) and cardiopulmonary bypass (121 vs 91 min, SMD = -0.68) times were considerably longer for sAVR versus rdAVR. Immediate postreplacement aortic gradient decreased with larger valve size but did not differ significantly between comparable sAVR and rdAVR valve sizes or overall (6.5 vs 6.7 mm Hg, SMD = 0.09). Implanted rdAVR tended to be larger with 51% either size L or XL versus 37.4% of sAVR ≥25 mm. Despite a temporal decrease in pacemaker rate within the rdAVR cohort, the overall pacemaker frequency was less in sAVR versus rdAVR (4.4% vs 7.4%, SMD = 0.12), and significantly higher rates were seen in size L (10.3% vs 3.7%, P < 0.002) and XL (15% vs 5.6%, P < 0.004) rdAVR versus sAVR. No significant difference in major adverse cardiac events (4.6% vs 4.6%, SMD = 0.01), 30-day survival (1.5% vs 2.6%, SMD = 0.08), or long-term survival out to 4 years were seen between sAVR and rdAVR. CONCLUSIONS: Rapid deployment valves offer a safe alternative to sAVR with significantly decreased cross-clamp and cardiopulmonary bypass times. Despite larger implantation sizes, we did not appreciate a comparative difference in immediate postoperative gradients, and although pacemaker rates are improving, they remain higher in rdAVR compared with sAVR. Longer-term hemodynamic and survival follow-up are needed.

Considering alternatives to transcatheter heart valves for managing patients with severe aortic valve stenosis.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is becoming the standard of care for severe symptomatic aortic stenosis (AS). Yet, some patients with AS are not indicated/eligible for TAVI. Several noninvasive, catheter-based or surgical alternatives exist, and other therapeutic options are emerging. AREAS COVERED: This review provides an overview of non-TAVI options for severe AS. Non-invasive, transcatheter, and alternative surgical strategies are discussed, emphasizing their backgrounds, techniques, and outcomes. EXPERT OPINION: Alternative therapies to TAVI, whether device-based or non-device-based, continue to evolve or emerge and provide either alternative treatments or a bridge to TAVI, for patients not meeting indications for, or having contraindications to TAVI.Although TAVI and SAVR are the current dominant therapies, there are still some patients that could benefit in the future from other alternatives.Data on alternative options for such patients are scarce. Many advantages and disadvantages arise when selecting a specific treatment strategy for individual patients.Head-to-head comparison studies could guide physicians toward better patient selection and procedural planning. Awareness of therapeutic options, indications, techniques, and outcomes should enable heart teams to achieve optimized patient selection. Furthermore, it can increase the use of these alternatives to optimize the management of AS among different patient populations.

The effect of balloon-expandable stent and self-expanding stent on changes in mitral annular motion after aortic valve replacement in patients with aortic stenosis.

OBJECTIVES: The purpose of this study was to evaluate the effect of decalcification and existence of stent at the aortic annulus on mitral annular motion after surgery. METHODS: Patients receiving Inspiris (Edwards, CA, USA, n = 117), Intuity (Edwards, n = 36), Perceval (Corcym, London, UK, n = 36), Evolut (Medtronics, MN, USA, n = 81) and Sapien 3 (Edwards, n = 250) were included in the study. Mitral annular motion was evaluated by E', using tissue doppler imaging. RESULTS: After surgery, a significant increase in E' was observed in patients receiving Inspiris (Before: 4.2 ± 1.21 cm/s vs. Discharge: 5.0 ± 1.23 cm/s, p < 0.001). Mid-term echocardiogram performed at 11.8 ± 2.2 months after the surgery, showed a significant increase in E' in patients receiving Inspiris (Before: 4.2 ± 1.21 cm/s vs. Mid-term: 5.2 ± 1.20 cm/s, p < 0.001) and Perceval (Before: 3.9 ± 1.34 cm/s vs. Mid-term: 4.5 ± 1.24 cm/s, p = 0.008). Univariable analysis showed a higher increase in E' in patients with decalcified annulus compared to those without decalcified annulus (Decalcification: 0.15 ± 1.321 cm/s vs. No Decalcification: 0.66 ± 1.420 cm/s, p < 0.001). Multivariable analysis showed that balloon-expandable stent (ß = - 0.6960, p < 0.001) and self-expanding stent (r = - 0.3592, p = 0.042) were independent limiting factors for an increase in E' at discharge. However, balloon-expandable stent (ß = - 0.8382, p < 0.001), and not self-expanding stent (ß = - 0.3682, p = 0.089), was a remaining independent factor associated with E' at mid-term follow-up. CONCLUSIONS: Decalcification was associated with improvement in E' after surgery. Balloon-expandable stent was an independent limiting factor for improvement in E' up to 1 year after the surgery, while self-expanding stent was not a significant factor after 1 year.

Bioprosthetic Valves for Lifetime Management of Aortic Stenosis: Pearls and Pitfalls.

This review explores the use of bioprosthetic valves for the lifetime management of patients with aortic stenosis, considering recent advancements in surgical (SAV) and transcatheter bioprostheses (TAV). We examine the strengths and challenges of each approach and their long-term implications. We highlight differences among surgical bioprostheses regarding durability and consider novel surgical valves such as the Inspiris Resilia, Intuity rapid deployment, and Perceval sutureless bioprostheses. The impact of hemodynamics on the performance and durability of these prostheses is discussed, as well as the benefits and considerations of aortic root enlargement during Surgical Aortic Valve Replacement (SAVR). Alternative surgical methods like the Ross procedure and the Ozaki technique are also considered. Addressing bioprosthesis failure, we compare TAV-in-SAV with redo SAVR. Challenges with TAVR, such as TAV explantation and considerations for coronary circulation, are outlined. Finally, we explore the potential challenges and limitations of several clinical strategies, including the TAVR-first approach, in the context of aortic stenosis lifetime management. This concise review provides a snapshot of the current landscape in aortic bioprostheses for physicians and surgeons.

Sutureless vs. rapid-deployment valve: a systemic review and meta-analysis for a direct comparison of intraoperative performance and clinical outcomes.

Background: Sutureless and rapid-deployment valves are bioprostheses anchoring within the aortic annulus with few sutures, and they act as a hybrid of conventional surgical and transcatheter valves under aortic valve replacement. Considering that the 3F Enable valve is now off-market, the only two sutureless and rapid-deployment valves available on the world marketplace are the Perceval and Intuity valves. However, a direct comparison of the function of these two valves eludes researchers. Purpose: Against this background, we performed this systematic review and meta-analysis comparing the intraoperative performance and early clinical outcomes between the Perceval valve and the Intuity valve under sutureless and rapid-deployment aortic valve replacement. Methods: We systematically searched electronic databases through PubMed/MEDLINE, OvidWeb, Web of Science, and Cochrane Central Register of Controlled Trials (from the establishment of the database to November 17, 2022, without language restriction) for studies comparing the sutureless valve (the Perceval) and the rapid-deployment valve (the Intuity) under aortic valve replacement. Our primary outcomes were early mortality and postoperative transvalvular pressure gradients. The secondary outcomes were defined to include aortic cross-clamp and cardiopulmonary bypass time, paravalvular leak (any paravalvular leak, moderate-to-severe paravalvular leak) after aortic valve replacement, need for pacemaker implantation, postoperative neurological events (stroke), and intensive care unit stay. Results: This meta-analysis included ten non-randomized trials with 3,526 patients enrolled (sutureless group = 1,772 and rapid-deployment group = 1,754). Quality assessments were performed, with the mean scores of the studies reading 6.90 (SD = 0.99) out of 9 according to the Newcastle-Ottawa Scale. Compared with rapid-deployment aortic valve replacement, sutureless aortic valve replacement was associated with higher mean and peak transvalvular pressure gradients postoperatively. In contrast, aortic cross-clamp and cardiopulmonary time were needed less in sutureless aortic valve replacement vs. rapid-deployment aortic valve replacement. There was no evidence of significant publication bias observed by the funnel plot and Egger's test. Conclusions: For postoperative hemodynamics, sutureless aortic valve replacement was associated with increased mean and peak transvalvular pressure gradients compared with rapid-deployment aortic valve replacement. In sharp contrast, sutureless aortic valve replacement significantly reduced the amount of time needed for fixing the aortic cross-clamp and the cardiopulmonary bypass procedure. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022343884.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature.

OBJECTIVES: To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. METHODS: We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. RESULTS: Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. CONCLUSIONS: This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

The effect of stent and decalcification on mitral annular motion after aortic valve replacement.

OBJECTIVE: The purpose of this study was to evaluate the changes in mitral annular motion after surgery in patients with aortic stenosis. METHODS: Patients receiving Edwards (Edwards) valves were included in the study. Echocardiographic findings were compared among the three treatments postoperatively, at discharge, and at 1 year after the surgery. Mitral annular motion was evaluated by e prime, using tissue doppler imaging. RESULTS: There were 111 patients receiving Inspiris, 30 patients receiving Intuity and 241 patients receiving Sapien 3. The patients receiving Sapien 3 were significantly older, (Inspiris: 71 ± 6.7 years vs. Intuity: 75 ± 5.2 years vs. Sapien 3: 84 ± 5.1 years, p < .001), and prevalence of hemodialysis were significantly higher in patients receiving Intuity (Inspiris: 11.7% vs. Intuity: 46.7% vs. Sapien 3: 0.0%, p < .001). There was a significant improvement in mean pressure gradient in all groups (Inspiris: 55 ± 21.2-13 ± 5.2 mmHg, p < .001; Intuity: 48 ± 17.6-12 ± 4.9 mmHg, p < .001, Sapien 3: 55 ± 16.6-14 ± 5.2 mmHg, p < .001). Decalcification was associated with increase in e prime after surgery (no decalcification: 0.10 ± 1.280 cm/s vs. decalcification: 0.68 ± 1.405 cm/s, p < .001) Further, existence of stent was associated with less increase in e prime after surgery (no stent: 0.83 ± 1.210 cm/s vs. stent: 0.10 ± 1.356; p < .001). Multivariate analysis showed that existence of stent but not decalcification of the aortic valve was independently associated with changes in e prime after surgery (ß: -.4679, 95% confidence interval: -0.93389 to -0.00200, p = .049). CONCLUSIONS: Although improvement in pressure gradient was achieved in all treatments, existence of stent inhibited mitral annular motion after surgery.

Early Outcomes of Intuity Rapid Deployment Aortic Valve Replacement Compared With Conventional Biological Valves in Japanese Patients.

BACKGROUND: This study aimed to elucidate the short-term surgical outcomes and hemodynamics of the Intuity valve compared to the standard bioprosthesis in Japanese patients.Methods and Results: Among the 307 consecutive patients who underwent aortic valve replacement (AVR) between February 2019 and March 2021, the Intuity valve was implanted in 95 patients (Intuity group) and a conventional stented bioprosthesis was implanted in 193 patients (conventional group). After propensity score matching, there was no significant difference in in-hospital mortality between the Intuity (n=2, 3%) and conventional groups (n=0, P=0.490). Operation, cardiopulmonary bypass, and aortic cross-clamping times were significantly shorter in the Intuity group. Although the effective orifice area index, trans-prosthetic mean pressure gradient, and peak velocity were similar between the 2 groups at 1 week postoperatively, the Intuity group showed a better mean pressure gradient and peak velocity at 1 year postoperatively. Complete atrioventricular block requiring permanent pacemaker implantation developed in 2 patients (3%) in the Intuity group and none in the conventional group (P=0.476). Mild or greater paravalvular leakage was present in 8 patients (13%) in the Intuity group and 2 patients (3%) in the conventional group (P=0.095). CONCLUSIONS: AVR using the Intuity valve in Japanese patients is satisfactory, with a better valve performance and a low incidence of complete atrioventricular block at 1 year postoperatively.

Evaluation of oversizing in association with conduction disorder after implantation of a rapid deployment valve.

Rapid deployment valve has expanded surgical indication for high-risk patients with aortic stenosis despite its accommodated risk for conduction disorder (CD). The purpose of this study was to evaluate the degree of oversizing in association with postoperative CD. During June 2019 to September 2021, 25 patients underwent aortic valve replacement with Edwards INTUITY. Device size selection was evaluated intraoperatively using provided sizers. Oversizing was evaluated retrospectively by measuring the difference of the dimension of the annulus and left ventricular outflow tract (LVOT) compared to the dimensions of the device used by preoperative-computed tomography. Although there was no incidence of pacemaker implantation, seven patients (28.0%) experienced CD after surgery. There was no difference in device area and annulus area (CD: - 37 ± 22.7 mm2 vs. no CD: - 56 ± 63.6 mm2, p = 0.47), and device circumference and annulus circumference (CD: - 4.4 ± 2.77 mm vs. no CD: - 6.9 ± 5.60 mm, p = 0.26) in patients with and without CD. However, there was a significant difference in area of the device skirt and sub-annular area at the LVOT (CD: 114 ± 28.4 mm2 vs. no CD: - 8 ± 80.0 mm2, p < 0.001), and circumference of device skirt and the LVOT (CD: 3.9 ± 2.08 mm vs. no CD: - 4.6 ± 5.24 mm, p < 0.001) between the two groups. Receiver operating characteristic curve analysis showed that an area difference of 77.7 mm2 and circumference difference of 0.91 mm at LVOT were associated with postoperative CD with specificities of 0.83, 0.78 and sensitivity of 1.0, 1.0, respectively. Preoperative measurement of the LVOT may be useful in evaluating the risk of postoperative CD in patients receiving rapid deployment valve.

Transcatheter aortic valve replacement using the SAPIEN 3 valve versus surgical aortic valve replacement using the rapid deployment INTUITY valve: Midterm outcomes.

OBJECTIVES: Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS: Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS: All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p < .0001). At the discharge, the one-year postprocedure mean gradients were 9 ± 5.1/10 ± 4.5 mmHg, 11 ± 4.1/12 ± 3.8 mmHg, and 10.1 ± 4.3/10.4 ± 2.6 mmHg in the TA-S3, TF-S3, and RD-SAVR groups, respectively. Midterm valve thrombosis, Re-TAVR/SVAR were low and similar among the study groups, whereas endocarditis was higher in the TAVR group. CONCLUSION: RD-SAVR was superior to TA-/TF-S3 in the PVL and PPI rates. We observed similar early outcomes and valve hemodynamics. The endocarditis was higher in the TAVR group.

Rhythm disturbances following rapid-deployment aortic valve replacement.

OBJECTIVES: There have been reports of postoperative conduction disturbances after rapid-deployment aortic valve replacement. Our objective was to assess electrocardiogram changes in patients undergoing this procedure and review the literature on this topic. METHODS: In this retrospective case series, clinical data were extracted from patient records at St Vincent's Hospital Melbourne and the Australia New Zealand Society of Cardiac and Thoracic Surgeons database. Electrocardiogram data were obtained at baseline and postoperatively on day 5 and at week 6 and reviewed for rhythm disturbances and intracardiac conduction problems. Pacemaker status was also recorded. RESULTS: From 2013 to 2017, 100 consecutive patients underwent rapid-deployment aortic valve replacement with 1 valve type at our institution. Three patients were excluded because of paced rhythm preoperatively, leaving 97 patients (mean age 74.7 ± 8.12 years; 56.7% male) for analysis. Some 18.6% of patients developed new left bundle branch block at 5 days postoperatively and only 4.1% of patients found with persistent left bundle branch block at 6-week follow-up compared with preoperatively. No significant changes were observed in the frequencies of atrial fibrillation, first-degree heart block, and right bundle branch block. However, there was evidence of increases in paced rhythm and subsequent need for a permanent pacemaker. A total of 14 patients (14.4%) had a permanent pacemaker implanted at an average of 11.1 ± 2.9 days postoperatively. CONCLUSIONS: Rhythm disturbances and conduction abnormalities are noted with the rapid-deployment aortic valves used at our institution, but appear comparable to other rapid-deployment aortic valve replacement bioprostheses. These abnormalities may be related to the effect of the sub-annular stent frame of the valve system and implantation technique.

Sutureless and rapid deployment valves: implantation technique from A to Z-the INTUITY Elite valve.

In the last two decades, sutureless (Perceval, Livanova PLC, London, UK) and rapid deployment (INTUITY Elite, Edwards Lifesciences, Irvine, CA, USA) valves were introduced to the market as an innovative alternative to traditional valves for patients needing aortic valve replacement (AVR). These devices have been used and studied extensively across these fifteen years, and have proven to be a valid alternative treatment option compared to sutured biological valves, particularly helpful in minimally invasive cardiac surgery, and an almost curative treatment to patients with intermediate to high surgical risk, filling the gap between transcatheter and traditional AVR. However, both sutureless and rapid deployment valves require special steps for implantation, and also a learning curve. Proper specific training to all surgical team members is required as mandatory by the manufacturers. The aim of this review article is to provide cardiac surgeons with a thorough guide on the implantation technique from A to Z, for each of these two prosthetic devices. In this second part of our review article, we will focus on the INTUITY Elite valve.

Short-term outcome of the intuity rapid deployment prosthesis: a systematic review and meta-analysis.

OBJECTIVES: Limited access aortic valve replacement is an alternative approach for the treatment of calcified aortic valve disease. To facilitate limited access aortic valve replacement, rapid deployment valve prostheses have been developed aiming to reduce surgical impact. This systematic review gives an overview of current literature regarding the INTUITY or INTUITY Elite rapid deployment biological valve prosthesis. METHODS: Cochrane, Embase and MEDLINE were searched to identify relevant studies. All studies reporting on patients who underwent isolated or combined surgical aortic valve replacement with the INTUITY or INTUITY Elite valve prosthesis were considered eligible. Primary end points were technical success rate, 30-day mortality, cerebrovascular accident, paravalvular leak and permanent pacemaker implantation. Secondary end points included procedural data such as aortic cross-clamping time, cardiopulmonary bypass time and procedural approach. RESULTS: A total of 16 articles fulfilled the inclusion and exclusion criteria and comprised 4.184 patients. Thirty-day mortality was 2.7% (1.9-3.7%), cerebrovascular accident 2.6% (1.4-4.7%), permanent pacemaker implantation 7.9% (6.6-9.5%) and severe postoperative paravalvular leak requiring a reintervention 3.3% (1.7-6.1%). Technical success rate varied between 93.9% and 100%. Conventional median sternotomy was most commonly performed, ranging from 21.7% to 89.6%. Upper hemi-sternotomy was performed more often than anterior right thoracotomy, ranging from 10.4% to 63.3% and 2.2% to 26.1%. The mean transvalvular pressure gradient ranged between 9.0 and 10.3 mmHg at 1 year postoperatively. CONCLUSIONS: This review demonstrates that the technical success rate of the INTUITY or INTUITY Elite rapid deployment valve system is high, also in limited access aortic valve replacement. Mortality and cerebrovascular accident rates are low, but the need for postoperative permanent pacemaker implantation and reintervention rate for paravalvular leakage is increased.

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-up are needed to evaluate if this result can be replicated over a longer timeframe.

Aortic valve replacement with Edwards INTUITY sutureless bioprosthesis through right anterior minithoracotomy.

Minimally invasive aortic valve replacement through right anterior minithoracotomy has been shown as a reliable and interesting approach. However, the placement of a sutured valve may be challenging and time-consuming in some cases. Sutureless bioprosthesis is an elegant alternative in order to facilitate its placement and to reduce the aortic cross-clamp time. In this video, we report our surgical technique of minimally invasive aortic valve replacement with an Edwards INTUITY sutureless bioprosthesis. Postoperative course was uneventful and the patient was discharged after 6 days.