Excellent Hemodynamic Performance Research Articles

Clinical outcomes, hemodynamics, and leaflet thrombosis following transcatheter aortic valve replacement with novel intra-annular devices.

The indication of transcatheter aortic valve replacement (TAVR) is becoming more prevalent among younger and lower-risk patients. However, data on the latest intra-annular TAVR devices are limited. This study aims to compare the short-term clinical outcomes of two intra-annular transcatheter aortic valve replacement (TAVR) devices in Japan: SAPIEN 3 Ultra RESILIA (S3UR) and Navitor. Of the 286 patients who underwent TAVR between May 2022 and October 2023 at our center, we enrolled 97 consecutive patients who received either S3UR or Navitor. We compared the intraprocedural invasive and echocardiographic hemodynamic assessment and post-procedural multidetector computed tomography (MDCT). The basic characteristics of the 97 patients (median age, 86 years [interquartile range, 81-89 years]) were similar. Technical success, defined by the Valve Academic Research Consortium, was achieved in all cases. Despite a smaller annulus, Navitor demonstrated decreased mean pressure gradient by TTE, 9.2 [7.3-13.6] mmHg versus 7.5 [5.9-9.5] mmHg, p = 0.006; but not by invasive measurement 5.1 [3.4-7.7] mmHg versus 5.3 [3.2-7.9] mmHg, p = 0.986). Discordance between echocardiographic and invasive assessment was more prominent with S3UR. However, severe prosthesis-patient mismatch was similarly noted between the two devices. Mild paravalvular leak (PVL) (24.5% vs. 54.5%, p = 0.002) was more frequent with the Navitor, despite no moderate-severe PVL in each group. The incidence of hypoattenuated leaflet thickening (HALT) detected by MDCT was similar between the two groups. Both intra-annular valves demonstrated excellent hemodynamic performance with minimal PVL after TAVR. The incidence of HALT in both devices was comparable.

Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study.

The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery. The FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years. TAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two-thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001). In clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.

Aortic valve replacement with rapid-deployment bioprosthesis in case of infective endocarditis: a literature review.

Recently, the use of rapid deployment (RD) aortic valve prostheses has been introduced for the treatment of aortic valve replacement (AVR), showing excellent hemodynamic performances.According to these data, some groups have proposed new RD valves as an alternative solution in the case of infective aortic endocarditis (IAE) to reduce the use of foreign materials, and the manipulation of the annulus.The aim of this review is to report the results of early clinical experiences with the use of RD bioprostheses in the case of IAE, in order to discuss technical and clinical aspects of this emerging strategy to better elucidate its advantages and limitations as a potential therapeutic solution. An in-depth search of PubMed from January to March 2023 was performed. English-language articles were selected independently by authors following the criteria in order to consider all available experiences (full papers, case reports, and case series) that have investigated the use of RD in case of IAE. The use of rapid deployment bioprosthesis represents a bailout strategy in case of severe aortic valve endocarditis and should be evaluated with caution in selected cases. This review collects the first, initial, and pioneering experiences of the use of the RD prosthesis in case of infective endocarditis, particularly when the fragility of the annular tissues precludes a secure anchoring of sutured prostheses.The reduced use of foreign materials by minimizing the number of stitches, the reduced cardiopulmonary bypass (CPB) and aortic cross-clamp times, and the excellent hemodynamic performances associated with the use of RD bioprosthesis represent the most important advantages that could justify their use in the setting of aortic valve endocarditis. Although there are few anecdotal experiences, surgical aortic valve replacement with the use of RD represents an emerging strategy in case of aortic valve endocarditis. Its advantages, pros, and cons are under debate, and robust clinical trials are needed to demonstrate its safety and efficacy.

Recent progress in functional modification and crosslinking of bioprosthetic heart valves.

Valvular heart disease (VHD), clinically manifested as stenosis and regurgitation of native heart valve, is one of the most prevalent cardiovascular diseases with high mortality. Heart valve replacement surgery has been recognized as golden standard for the treatment of VHD. Owing to the clinical application of transcatheter heart valve replacement technic and the excellent hemodynamic performance of bioprosthetic heart valves (BHVs), implantation of BHVs has been increasing over recent years and gradually became the preferred choice for the treatment of VHD. However, BHVs might fail within 10-15 years due to structural valvular degeneration (SVD), which was greatly associated with drawbacks of glutaraldehyde crosslinked BHVs, including cytotoxicity, calcification, component degradation, mechanical failure, thrombosis and immune response. To prolong the service life of BHVs, much effort has been devoted to overcoming the drawbacks of BHVs and reducing the risk of SVD. In this review, we summarized and analyzed the research and progress on: (i) modification strategies based on glutaraldehyde crosslinked BHVs and (ii) nonglutaraldehyde crosslinking strategies for BHVs.

Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry

BackgroundThe CONtrolled delivery For ImproveD outcomEs with cliNiCal Evidence registry was initiated to characterize the clinical safety and device performance from experienced transcatheter aortic valve implantation (TAVI) centers in Europe and Australia that use the Portico valve to treat patients with severe aortic stenosis. We herein report for the first time the valve performance at 30-day across all implanted valve sizes and the 1-year survival from this registry. MethodsThis was a prospective, multicenter, single-arm observational clinical investigation of patients clinically indicated for implantation of a Portico valve in experienced TAVI centers. Patients were treated with a commercially available valve (size 23, 25, 27, or 29 mm) using either the first-generation delivery system (DS) (n = 501) or the second-generation (FlexNav) DS (n = 500). Adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiographic outcomes were assessed at 30 days by an independent core laboratory, and a survival check was performed at 1 year. ResultsWe enrolled 1001 patients (82.0 years, 62.5% female, 63.7% New York Heart Association functional class III/IV at baseline) from 27 clinical sites in 8 countries across Europe and one site in Australia. Implantation of a single valve was successful in 97.5% of subjects. Valve hemodynamics at 30 days were substantially improved relative to baseline, with large aortic valve areas and low mean gradients across all implanted valve sizes (aortic valve areas were 1.7 ± 0.4, 1.7 ± 0.5, 1.8 ± 0.5, and 2.0 ± 0.5 cm2, and mean gradients were 7.0 ± 2.7, 7.5 ± 4.7, 7.3 ± 3.3, and 6.4 ± 3.3 mmHg for 23, 25, 27, and 29 mm valve sizes, respectively). Across all implanted valve sizes, most patients (77.1%) had no patient-prosthesis mismatch. Death from any cause within 1 year occurred in 13.7% of the patients in the first-generation DS group as compared with 11.0% in the second-generation DS group (p = 0.2). ConclusionsThe Portico valve demonstrated excellent hemodynamic performance across all valve sizes in a large cohort of subjects implanted in experienced TAVI centers. One-year survival rates were favorable when using both the first-generation and second-generation (FlexNav) DSs in this high-risk cohort. ClinicalTrials.gov IdentifierNCT03752866.

The Ozaki Procedure: Standardized Protocol Adoption of a Complex Innovative Procedure

BackgroundThe Ozaki procedure using autologous pericardium is an interesting but complex alternative for aortic valve replacement. We present a standardized approach to minimize the learning curve and confirm reproducibility. MethodsAfter careful preparation, from May 2015 to February 2021, an Ozaki procedure was performed on 46 patients age 51 ± 14 years. Seven had unicuspid (15%), 29 bicuspid (63%), and 10 tricuspid (22%) aortic valves, and 2 patients had endocarditis. Endpoints were operative learning curves, perioperative outcomes, intermediate-term valve hemodynamics, reintervention, health-related quality of life (MacNew Heart Disease Health-Related Quality of Life questionnaire), and mortality. ResultsCardiopulmonary bypass and aortic clamp times decreased from 145 to 125 ​minutes and 120 to 100 ​minutes, respectively, over the first 20 cases, reflecting the learning curve. There was no major perioperative morbidity or mortality. Median postoperative stay was 6.9 days. Aortic regurgitation was mild or less in all but 2 patients who developed moderate aortic regurgitation. Mean aortic valve gradient was 7.9 mmHg postoperatively, 9.2 mmHg by 6 months, and constant thereafter. Left ventricular ejection fraction was 58% preoperatively, 60% at 6 months, and remained stable thereafter. One patient developed infective endocarditis 7 months postoperatively, failed medical management, and underwent valve replacement at 14 months. Two-year survival was 96%, with 1 noncardiac death at 16 months. Health-related quality of life in mental, physical, and emotional domains was better than matched norms, global 6.2 vs. 5.0 (p < 0.0001). ConclusionsUsing a well-prepared standardized approach, the Ozaki procedure is reproducible with a short learning curve, excellent hemodynamic performance, and good quality of life.

Numerical Analysis of a Novel Rotating Piston Blood Pump Based on CFD

Currently, centrifugal and roller pumps are primarily used as ECMO blood pumps, but their high pressure or high shear force may lead to complications such as hemolysis and platelet activation. Thus, a new blood pump structure was designed by improving the rotating piston pump and applying it to the blood pump. The blood pump flow field was simulated using CFD simulation software to ensure that this pump can produce pulsatile blood flow and guarantee good distribution of flow velocity, pressure, and shear stress in the blood pump. The hemolysis value of the pump was calculated using the Lagrangian particle tracking method. The research results demonstrate that this pump has excellent hemodynamic performance and that most of the shear stresses are less than 100 Pa, as well as a small hemolysis index. Furthermore, the pump combines the advantages of pulsatile and non-pulsatile pumps. This newly developed pump is expected to provide a new direction for ECMO blood pump development and provides important evidence for further optimization and performance evaluation of rotating piston blood pumps.

Transcatheter Aortic Valve Replacement in Degenerated Perceval Bioprosthesis: Clinical and Technical Aspects in 32 Cases.

Sutureless aortic bioprostheses are increasingly being used to provide shorter cross-clamp time and facilitate minimally invasive aortic valve replacement. As the use of sutureless valves has increased over the past decade, we begin to encounter their degeneration. We describe clinical outcomes and technical aspects in patients with degenerated sutureless Perceval (CorCym, Italy) aortic bioprosthesis treated with valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). Between March 2011 and March 2023, 1310 patients underwent aortic valve replacement (AVR) with Perceval bioprosthesis implantation. Severe bioprosthesis degeneration treated with VIV-TAVR occurred in 32 patients with a mean of 6.4 ± 1.9 years (range: 2-10 years) after first implantation. Mean EuroSCORE II was 9.5 ± 6.4% (range: 1.9-35.1%). Thirty of thirty-two (94%) VIV-TAVR were performed via transfemoral and two (6%) via transapical approach. Vascular complications occurred in two patients (6%), and mean hospital stay was 4.6 ± 2.4 days. At mean follow-up of 16.7 ± 15.2 months (range: 1-50 months), survival was 100%, and mean transvalvular pressure gradient was 18.7 ± 5.3 mmHg. VIV-TAVR is a useful option for degenerated Perceval and appears safe and effective. This procedure is associated with good clinical results and excellent hemodynamic performance in our largest single-center experience.

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. clinicaltrials.gov: NCT03666741.

C59 CLINICAL AND ECHOCARDIOGRAPHIC FOLLOW–UP IN PATIENTS WITH SUTURELESS AORTIC PERCEVAL BIOPROSTHESIS: SINGLE CENTER ANALYSIS IN ELEVEN–YEARS EXPERIENCE

Abstract Aims We describe long–term clinical and echocardiographic follow–up in the largest single center cohort of patients underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. Methods Between March 2011 and September 2022, 1237 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 78 ± 4 years and mean EuroSCORE II was 6.9 ± 2.8%. Concomitant procedures were performed in 272 patients (22%). Results Thirty–day mortality was 1.37% (17/1237). 890 of 951 (93.5%) isolated AVR underwent minimally invasive surgery with a ministernotomy (n = 221) or right minithoracotomy (n = 669) approach. Cardiopulmonary bypass and aortic cross–clamp times were 80.6 ± 21.5 and 50.1 ± 10.5 minutes for isolated AVR and 145.8 ± 33.6 and 95.8 ± 20.7 minutes for combined procedures. At mean follow–up of 55.09 ± 6.7 months (range: 1–138.5 months), survival was 95.4% and mean transvalvular pressure gradient was 13.3 ± 4.2 mmHg. LV mass decreased from 153.5 g/m2 to 114.6 g/m2 (p&amp;lt; 0.001) and moderate paravalvular leakage occurred in 3 patients without hemolysis not requiring any treatment. Freedom from reoperation was 97.4%. Nine patients required surgical reintervention and 21 patients transcatheter valve–in–valve procedure for structural prosthesis degeneration at mean of 6.3 years after first operation (range: 2–10 years). Conclusion AVR with Perceval bioprosthesis is associated with good clinical results and excellent hemodynamic performance in our eleven–years experience. Structural degeneration rate of Perceval is comparable with others bioprosthetic aortic valve. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Ten-year experience with sutureless Perceval bioprosthesis: single-centre analysis in 1157 implants.

We describe long-term clinical and echocardiographic outcomes in the largest single-centre cohort of patients who underwent aortic valve replacement (AVR) with sutureless Perceval (CorCym, Italy) bioprosthesis. Between March 2011 and March 2021, 1157 patients underwent AVR with Perceval bioprosthesis implantation. Mean age was 77 ± 6 years (range: 46-89 years) and mean EuroSCORE II was 6.7 ± 3.2% (range: 1.7-14.2%). Concomitant procedures were performed in 266 patients (23%). Thirty-day mortality was 1.38% (16/1157). Eight hundred and twenty of 891 (92%) isolated AVRs underwent minimally invasive surgery with a ministernotomy (n = 196) or right minithoracotomy (n = 624) approach. Cardiopulmonary bypass and aortic cross-clamp times were 81.1 ± 24.3 and 50.6 ± 11.7 min for isolated AVR and 144.5 ± 34.7 and 96.4 ± 21.6 min for combined procedures. At mean follow-up of 53.08 ± 6.7 months (range: 1-120.5 months), survival was 96.5% and mean transvalvular pressure gradient was 13.7 ± 5.8 mmHg. Left ventricular mass decreased from 152.8 to 116.1 g/m2 (P < 0.001) and moderate paravalvular leakage occurred in three patients without haemolysis not requiring any treatment. Freedom from reoperation was 97.6%. Eight patients required surgical reintervention and 19 patients transcatheter valve-in-valve procedure for structural prosthesis degeneration at a mean of 5.6 years after first operation (range: 2-9 years). AVR with a Perceval bioprosthesis is associated with good clinical results and excellent haemodynamic performance in our 10-year experience. Structural degeneration rate of Perceval is comparable with other bioprosthetic aortic valves. Sutureless technology may reduce operative time especially in combined procedures and enable minimally invasive AVR.

Conventional Biological versus Sutureless Aortic Valve Prostheses in Combined Aortic and Mitral Valve Replacement.

Sutureless aortic valve prostheses have proven to provide a significant decrease in procedural, cardiopulmonary bypass and cross-clamp time, leading to a significant reduction in mortality risk in elderly high-risk cohorts. In this study, we sought to review our institutional experience on the sutureless aortic valve replacement (SU-AVR) and the concomitant mitral valve replacement (SMVR), comparing the combined conventional surgical aortic valve replacement (SAVR) with SMVR. Between March 2018 and July 2022, 114 consecutive patients underwent a combined aortic and mitral valve replacement at our institution. We stratified the patients according to the operative procedures into two groups and matched them 1:2: Group 1 underwent a combined conventional SAVR and SMVR (n = 46), and Group 2 included combined SU-AVR with Perceval prosthesis and SMVR (n = 23). No significant differences in the preoperative characteristics were present. SU-AVR combined with SMVR demonstrated excellent haemodynamic performance, comparable to that of SAVR plus SMVR, with median postoperative gradients over the aortic valve of 4 mmHg (IQR 3.0-4.0) in Group 1 and 4 mmHg (IQR 3.0-4.0) in Group 2 (p = 0.67). There was no significant difference in the occurrence of postoperative major adverse events such as death, stroke, myocardial infarction and kidney failure between the groups. There was also no significant difference in the permanent pacemaker implantation rate, paravalvular leakage or valve dislocation. We also could not detect any significant difference in postoperative mortality between the groups. SU-AVR has proven to be a reliable alternative to conventional valve prostheses in patients with multivalve disease undergoing combined aortic and mitral valve replacement, offering shorter procedural time and outstanding hemodynamic performance compared to the conventional surgical method.

Rapid-Deployment Aortic Valve Replacement: Patient Selection and Special Considerations.

Sutureless or rapid deployment valves in the setting of aortic valve replacement (AVR) is an emerging surgical technique using the transcatheter valve technology, which may lead to reduction in cross-clamp time and potentially better hemodynamics compared to a stented bioprosthetic valve. The absence of subannular pledgets results to excellent hemodynamic performance with reduced turbulent flow and larger effective orifice area. However, complications from both surgical and transcatheter AVR may still occur and impact survival. The incidence of paravalvular leakage and permanent pacemaker implantation are not low. Although technical modifications can improve these outcomes, there is a learning curve effect. Therefore, technical and anatomical considerations as well as better patient selection are paramount for better outcomes. In this review, we discuss the use of sutureless or rapid deployment valves in setting of (1) complex procedures, (2) minimally invasive AVR, and (3) small aortic annulus. The advantage of sutureless or rapid deployment valves in terms of mortality remains to be clarified; therefore, it is necessary to accumulate long-term outcomes in an appropriate patient cohort.

Biohybrid elastin-like venous valve with potential for in situ tissue engineering.

Chronic venous insufficiency (CVI) is a leading vascular disease whose clinical manifestations include varicose veins, edemas, venous ulcers, and venous hypertension, among others. Therapies targeting this medical issue are scarce, and so far, no single venous valve prosthesis is clinically available. Herein, we have designed a bi-leaflet transcatheter venous valve that consists of (i) elastin-like recombinamers, (ii) a textile mesh reinforcement, and (iii) a bioabsorbable magnesium stent structure. Mechanical characterization of the resulting biohybrid elastin-like venous valves (EVV) showed an anisotropic behavior equivalent to the native bovine saphenous vein valves and mechanical strength suitable for vascular implantation. The EVV also featured minimal hemolysis and platelet adhesion, besides actively supporting endothelialization in vitro, thus setting the basis for its application as an in situ tissue engineering implant. In addition, the hydrodynamic testing in a pulsatile bioreactor demonstrated excellent hemodynamic valve performance, with minimal regurgitation (<10%) and pressure drop (<5 mmHg). No stagnation points were detected and an in vitro simulated transcatheter delivery showed the ability of the venous valve to withstand the implantation procedure. These results present a promising concept of a biohybrid transcatheter venous valve as an off-the-shelf implant, with great potential to provide clinical solutions for CVI treatment.

Sutureless aortic valve replacement in high-risk patients with active infective endocarditis.

BackgroundSurgical aortic valve replacement remains the gold standard of treatment in patients with active infective endocarditis. Such procedures tend to carry a significantly higher operative risk when compared to the conventional aortic valve replacement for a non-infective aortic valve disease. Sutureless aortic valve replacement (SU-AVR) has been introduced into cardiac surgery to allow for a simpler implementation of minimally invasive procedures. Although SU-AVR in several extended indications has proven to be successful, the data on the implementation of SU-AVR in patients with infective aortic valve endocarditis remain scarce. The aim of the study was to examine the feasibility of SU-AVR in high-risk patients with active infective aortic valve endocarditis.MethodsBetween December 2019 and March 2022, a total of 151 consecutive patients underwent a SU-AVR for various indications at our institution. Of those, in 13 consecutive high-risk patients SU-AVR was indicated because of infective aortic valve endocarditis. In all cases Perceval S aortic valve prosthesis (Corcym, Saluggia, Italy) was used and the implantation has been performed with Snugger-method.ResultsThe mean age of the patients at operation was 74.05±11.6 years. Eight of the patients suffered from prosthesis endocarditis while the other five patients presented with the endocarditis of the native aortic valve. All patients suffered from multiple comorbidities, as reflected by a mean logistic EuroSCORE of 47.9%±23.1% and EuroSCORE II of 28.7%±22.0%. In 8 patients (61.5%) a concomitant procedure was necessary. Also 8 patients (61.5%) underwent a redo procedure. Bypass- and cross-clamp (CC) times were 89.8±33.6 and 59.1±27.8 minutes, respectively. We observed no paravalvular leakage and no cases of left-ventricular outflow tract obstruction. Postoperative mean gradients after SU-AVR implantation were 8.1±4.8 mmHg.ConclusionsSU-AVR in patients presenting with active infective endocarditis is a safe and feasible surgical alternative to the conventional operation. Clearly, this operative approach should be considered particularly for high-risk patients in whom successful operative outcomes are determined by a reduction in bypass and CC time. SU-AVR provides excellent hemodynamic performance with a low risk of paravalvular leakage and low transvalvular gradients, whilst simplifying the surgical procedure.

Durabilidad de la bioprótesis Trifecta™ a medio plazo: experiencia de un centro

Introduction and backgroundAlthough most studies have shown that the Trifecta™ bioprosthesis (Abbott Vascular, Santa Clara, California) has an excellent hemodynamic performance, there have been an increase of premature structural failure of the Trifecta™ bioprosthesis. The main objective of this study weas to report our single-center experience. MethodsWe performed a retrospective analysis including all patients undergoing aortic valve replacement with Trifecta™ prosthesis from 2013 July to 2021 July in our center. Fine-Gray regression model was created with structural valve degeneration and death as competing risk events. Results453 patients underwent an aortic valve replacement with a Trifecta™ aortic bioprosthesis. Mean age was 71.6±10.1 years, with 55.4% (n=251) men. Median follow-up was 40 (IQR 20-58) months. The incidence of moderate-severe structural valve deterioration was 5.5% (n=25). Overall freedom from moderate-severe structural valve degeneration at 1year, 3years and 5years was 99.7%, 97.5% and 92.7%, respectively. The multivariable analysis age over 80years was detected as an independent protective factor for early structural valve deterioration (sHR 0.21 [0.05-0.86], P=.03). A higher incidence in prosthetic sizes less than or equal to 21mm was not detected (sHR 0.46 [0.21-1.01], P=.054). ConclusionsThe Trifecta™ bioprosthesis presented a rate of early structural deterioration higher than expected. Patients with Trifecta™ prostheses should be closely followed-up with yearly echocardiograms.

Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath.

Background: The rapid development of transcatheter treatment methods has made transcatheter aortic valve replacement (TAVR) a feasible alternative to conventional surgical aortic valve replacement (SAVR). Recently, indications for TAVR have been expanded to intermediate- and low-risk patients, although there still remains a portion of ineligible patients. We sought to evaluate and compare our experience with sutureless SAVR and transapical TAVR in the “grey-area” of patients unsuitable for transfemoral access. Methods: Between April 2018 and June 2021, 248 consecutive patients underwent a sutureless SAVR (SU-SAVR) or TA-TAVR at our institution. We performed a pair-matched analysis and identified 56 patient pairs based on the EuroSCORE II. All transcatheter procedures were performed using SAPIEN XT/3™ prostheses, while all surgical procedures deployed the Perceval (LivaNova) aortic valve. Results: All patients presented with multiple comorbidities as reflected by the median EuroSCORE-II of 3.1% (IQR 1.9–5.3). Thirty-four patients from the surgical group (60.7%) underwent a concomitant myocardial revascularization. There was no significant difference in major adverse events, pacemaker implantation or postoperative mortality during follow-up. Both interventions demonstrated technical success with similar mean postoperative pressure gradients at follow-up and no cases of paravalvular leakage. Conclusions: Sutureless aortic valve replacement constitutes a feasible treatment alternative for patients with aortic valve disease who are ineligible for transfemoral access route and/or require concomitant coronary revascularization. With its excellent hemodynamic performance, similar survival compared to TA-TAVR, and high cost-efficiency without compromising the postoperative outcomes and in-hospital length of stay SU-AVR might be considered for patients in the “grey-area” between TAVR and SAVR.

Less invasive aortic valve replacement using the trifecta bioprosthesis

Objectives. The safety and effectiveness of the Trifecta GT bioprosthesis (introduced in 2016) in less invasive aortic valve replacement are scarcely investigated. Our aim was to evaluate the immediate and initial follow-up results of this device in the context of less invasive surgery. We discuss patient-specific strategies for the selection of the surgical approach. Methods. A retrospective review of 133 patients undergoing AVR with the Trifecta GT through three less invasive accesses (UMS, Upper ministernotomy; RMS, Reversed ministernotomy; RAMT, Right anterior minithoracotomy) was performed. In-hospital, follow-up and hemodynamic performance (PPM, Patient-prosthesis mismatch) data were collected. Results. Among patients, 79% received UMS, 11% RMS and 10% RAMT. Selection of approach was based on preoperative anatomical analysis (CT-scan) and planned concomitant procedures. There was no operative mortality, no valve-related adverse events. There were 36 concomitant procedures. No significant intergroup differences occurred in cardiopulmonary bypass, aortic clamp, mechanical ventilation time, ICU stay and average bleeding. There were two cases of moderate PPM (1.5%) and no instances of severe PPM; there were no significant (≥2/4) perivalvular leaks. Average mean gradient at discharge was 8 ± 3 mmHg. At follow-up (average: 2.5 ± 0.9 years, 100% complete, 315 patient years) there was no mortality and no valve-related adverse event. Hemodynamic performance was maintained at follow-up. Conclusions. The optimal device for less invasive AVR needs to be individualized, as well as the selection of the surgical approach. The use of the Trifecta GT bioprosthesis appears to be reproductible whatever less invasive approach is employed, with confirmed excellent hemodynamic performance.

Sutureless bioprosthesis as an alternative to conventional aortic valve replacement surgery

Abstract Background Aortic valve stenosis is the most common adult valve disease in industrialized countries. The ageing population and the rising in comorbidities have urged the development of safer alternatives to the current gold standard surgical treatment. Sutureless bioprosthesis have shown promising results, especially in technically difficult procedures and as more and more patients need concomitant surgeries. Purpose Assess clinical and haemodynamic performance, safety and durability of the sutureless bioprosthesis implanted in patients with aortic valve disease, over a period of 5 years, both in isolated aortic valve replacement surgeries as well as in concomitant procedures. Methods Single centre retrospective longitudinal cohort study collected data of all adult patients with aortic valve disease who underwent valve replacement with a sutureless bioprosthesis between February 2015 and October 2020. Of the 196 patients analysed (mean age 77.20±5.08 years; 45.40% were female; mean logistic EuroSCORE 2.91±2.20%), the majority had aortic stenosis. To assess the comparative risk of adding concomitant procedures, patients were divided into two groups and compared: one comprised patients who underwent isolated valve implantation (n=132) and the other patients who had concomitant coronary artery bypass graftings (n=49). 15 patients had other heterogeneous concomitant procedures and were therefore not considered in this comparison. Results Overall mean cross-clamp and cardiopulmonary bypass times were 45.50±19.04 and 36.50±11.40 minutes, respectively. 4 valves were reimplanted due to misplacement. Mean transvalvular gradients were 7.82±3.62 mmHg. Mean ICU and total hospital stay were 3.32±3.20 and 7.70±5.82 days, respectively. Procedural success was 99%, as two explantations occurred. Pacemaker implantation occurred in 12.8% of patients, atrial fibrillation de novo in 21.9% and renal replacement support was necessary in 3.1%. Early mortality was 0.51%. We report no structural valve deterioration, strokes or endocarditis and one successfully treated valve thrombosis. By comparison, patients with concomitant procedures had worse left ventricular function (40.8 vs 79.5%; p=0.030), longer aortic clamping (43.33±11.60 vs 27.30±8.10 minutes; p&amp;lt;0.001) and cardiopulmonary bypass times (59.98±17.60 vs 37.45±11.30 minutes; p&amp;lt;0.001), as expected. ICU stay after surgery was also longer (3.96±3.20 vs 2.80±2.70 days; p=0.016). Apart from this, there were no other significant differences in postoperative complications and survival, even up to 5 years. Conclusion Our study confirms the excellent clinical and haemodynamic performance and safety of a truly sutureless aortic valve, even up to the 5-year follow-up. These results were consistent both in isolated and concomitant interventions, solidifying this device as a viable treatment of isolated aortic valve disease, and now also in patients needing concomitant procedures. Funding Acknowledgement Type of funding sources: None.

The Ross procedure in children: a systematic review.

The Ross procedure involves autograft transplantation of the native pulmonary valve into the aortic position and reconstruction of the right ventricular outflow tract (RVOT) with a homograft. The operation offers the advantages of a native valve with excellent hemodynamic performance, the avoidance of anticoagulation, and growth potential. Conversely, the operation is technically demanding and imposes the risk of turning single-valve disease into double-valve disease. This systematic review reports outcomes of pediatric patients undergoing the Ross procedure. An electronic search identified studies reporting outcomes on pediatric patients (mean age <18 years, max age <21 years) undergoing the Ross procedure. Long-term outcomes, including early mortality, late mortality, sudden unexpected unexplained death, reoperation due to failure of the pulmonary autograft or RVOT reconstruction, thromboembolic events, bleeding events, and endocarditis-related complications, were evaluated. Upon review of 2,035 publications, 30 studies and 3,156 pediatric patients were included. Patients had a median age of 9.5 years and median follow-up period of 5.7 years. Early mortality rates varied from 0.0 to 17.0% and were increased in the neonatal population. Late mortality rates were much lower (0.04-1.83%/year). Reoperation due to pulmonary autograft failure occurred at rates of 0.37-2.81%/year and reoperation due to RVOT reconstruction failure was required at rates of 0.34-4.76%/year. Thromboembolic, bleeding, and endocarditis events were reported to occur at rates of 0.00-0.58, 0.00-0.39, and 0.00-1.68%/year, respectively. The Ross operation offers a durable aortic valve replacement (AVR) option in the pediatric population that offers favorable survival, excellent hemodynamics, growth potential, decreased risk of complications, and avoidance of anticoagulation. Larger multi-institutional registries focusing on pediatric patients are necessary to provide more robust evidence to further support use of the Ross procedure in this population.