Outcomes in patients with aortic stenosis and severely reduced ejection fraction following surgical aortic valve replacement and transcatheter aortic valve replacement.

BACKGROUND: Patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction demonstrate improvement in left ventricular injection fraction (LVEF) after aortic valve replacement (AVR). The timing and magnitude of recovery in patients with very low LVEF (≤ 25%) in surgical or transcatheter AVR is not well studied. OBJECTIVE: Determine clinical outcomes following transcatheter aortic valve replacement (TAVR) and surgical aortic valve repair (SAVR) in the subset of patients with severely reduced EF ≤ 25%. METHODS: Single-center, retrospective study with primary endpoint of LVEF 1-week following either procedure. Secondary outcomes included 30-day mortality and delayed postprocedural LVEF. T-test was used to compare variables and linear regression was used to adjust differences among baseline variables. RESULTS: 83 patients were enrolled (TAVR = 56 and SAVR = 27). TAVR patients were older at the time of procedure (TAVR 77.29 ± 8.69 vs. SAVR 65.41 ± 10.05, p < 0.001). One week post procedure, all patients had improved LVEF after both procedures (p < 0.001). There was no significant difference in LVEF between either group (TAVR 33.5 ± 11.77 vs. SAVR 35.3 ± 13.57, p = 0.60). Average LVEF continued to rise and increased by 101% at final follow-up (41.26 ± 13.70). 30-day mortality rates in SAVR and TAVR were similar (7.4% vs. 7.1%, p = 0.91). CONCLUSION: Patients with severe AS and LVEF ≤ 25% have a significant recovery in post-procedural EF following AVR regardless of method. LVEF doubled at two years post-procedure. There was no significant difference in 30-day mortality or mean EF recovery between TAVR and SAVR. TRIAL REGISTRATION: Indiana University institutional review board granted approval for above study numbered 15,322.

Continuous or interrupted pledgeted suture technique in stented bioprosthetic aortic valve replacement: a comparison of in-hospital outcomes.

BACKGROUND: There is ambiguity in the literature regarding the continuous suture technique (CST) for aortic valve replacement (AVR). At our center, there has been a gradual shift towards CST over the interrupted pledgeted technique (IPT). This study aims at comparing outcomes for both techniques. METHODS: We performed a retrospective analysis of a single-center study of patients undergoing AVR between January 2011 and July 2020. Patients were divided into two groups: Continuous suture technique and interrupted pledget-reinforced sutures. The pre-operative and In-hospital clinical characteristics and echocardiographic hemodynamics (i.e. transvalvular gradients and paravalvular leakage) were compared between CST and IPT. RESULTS: We compared 791 patients with CST to 568 patients with IPT (median age: 73 and 74 years, respectively, p = 0.02). In CST there were 35% concomitant procedure vs. 31% in IPT (p = 0.16). Early mortality was 3.2% in CST versus 4.8% in IPT (p = 0.15), and a second cross-clamp due to a paravalvular-leak in 0.5% vs. 1.2%, respectively (p = 0.22). The CST was not associated with new-onset conduction-blocks mandating pacemaker implants(OR 1.07, 95% CI 0.54-2.14; P = 0.85). The postoperative gradients on echocardiography were lower in CST compared to IPT, especially in smaller annuli (peak gradients: 15.7mmHg vs. 20.5mmHg, in valve size < 23 mm, p < 0.001). CONCLUSIONS: The continuous suture technique was associated with lower postoperative gradients and shorter cross-clamp time compared to interrupted pledgeted technique. Differences in paravalvular leaks were non-significant, although slightly less in the continuous suture technique. There were no further differences in valve-related complications. Hence, continues suture technique is safe, with better hemodynamics compared to the interrupted pledgeted technique. This may be of clinical importance, especially in smaller size annular size.

[Mitral valve surgery via minimally invasive and conventional access]. / Mitral'naya khirurgiya iz mini- i traditsionnogo dostupov.

OBJECTIVE: To compare the immediate results of mini-thoracotomy and sternotomy in patients with mitral valve disease. MATERIAL AND METHODS: The study included 52 patients who underwent mitral valve surgery (25 cases - mini-thoracotomy, 27 cases - sternotomy). RESULTS: Aortic cross-clamping time was significantly longer in sternotomy compared to mini-thoracotomy group - 110 vs 94 min (p=0.03). Ventilation time was also significantly longer in the sternotomy group (12 vs. 8 hours, p=0.01). Postoperative morbidity was similar (postoperative wound infection, neurological complications, coronavirus disease, overall in-hospital mortality). CONCLUSION: In addition to cosmetic effect, minimally invasive approach in mitral valve surgery has some other advantages including less duration of aortic cross-clamping and mechanical ventilation, availability of reconstructive interventions due to better exposition of the mitral valve and subvalvular structures.

Large Animal Translational Validation of 3 Mitral Valve Repair Operations for Mitral Regurgitation Using a Mitral Valve Prolapse Model: A Comprehensive In Vivo Biomechanical Engineering Analysis.

BACKGROUND: Various mitral repair techniques have been described. Though these repair techniques can be highly effective when performed correctly in suitable patients, limited quantitative biomechanical data are available. Validation and thorough biomechanical evaluation of these repair techniques from translational large animal in vivo studies in a standardized, translatable fashion are lacking. We sought to evaluate and validate biomechanical differences among different mitral repair techniques and further optimize repair operations using a large animal mitral valve prolapse model. METHODS: Male Dorset sheep (n=20) had P2 chordae severed to create the mitral valve prolapse model. Fiber Bragg grating force sensors were implanted to measure chordal forces. Ten sheep underwent 3 randomized, paired mitral valve repair operations: neochord repair, nonresectional leaflet remodeling, and triangular resection. The other 10 sheep underwent neochord repair with 2, 4, and 6 neochordae. Data were collected at baseline, mitral valve prolapse, and after each repair. RESULTS: All mitral repair techniques successfully eliminated regurgitation. Compared with mitral valve prolapse (0.54±0.18 N), repair using neochord (0.37±0.20 N; P=0.02) and remodeling techniques (0.30±0.15 N; P=0.001) reduced secondary chordae peak force. Neochord repair further decreased primary chordae peak force (0.21±0.14 N) to baseline levels (0.20±0.17 N; P=0.83), and was associated with lower primary chordae peak force compared with the remodeling (0.34±0.18 N; P=0.02) and triangular resectional techniques (0.36±0.27 N; P=0.03). Specifically, repair using 2 neochordae resulted in higher peak primary chordal forces (0.28±0.21 N) compared with those using 4 (0.22±0.16 N; P=0.02) or 6 neochordae (0.19±0.16 N; P=0.002). No difference in peak primary chordal forces was observed between 4 and 6 neochordae (P=0.05). Peak forces on the neochordae were the lowest using 6 neochordae (0.09±0.11 N) compared with those of 4 neochordae (0.15±0.14 N; P=0.01) and 2 neochordae (0.29±0.18 N; P=0.001). CONCLUSIONS: Significant biomechanical differences were observed underlying different mitral repair techniques in a translational large animal model. Neochord repair was associated with the lowest primary chordae peak force compared to the remodeling and triangular resectional techniques. Additionally, neochord repair using at least 4 neochordae was associated with lower chordal forces on the primary chordae and the neochordae. This study provided key insights about mitral valve repair optimization and may further improve repair durability.

To repair or to replace in mitral valve infective endocarditis? an updated meta-analysis.

BACKGROUND: Valve infective endocarditis (IE) is a potentially life-threatening condition that affects patients' livelihoods. Current surgical options in mitral valve IE include mitral valve repair (MVr) or replacement (MVR). While each procedure boasts its merits, doubt remains as to which type of surgery is superior. METHODS: We searched PubMed, Scopus, Web of Science, and Cochrane literature databases for studies comparing MVR and MVr in mitral valve IE. Any randomized controlled trial (RCT) or observational studies that compare MVR vs. MVr in mitral valve IE were eligible. Our dichotomous outcomes were extracted in the form of event and total, and risk and hazard ratio (RR)(HR) with 95% confidence interval (CI) and were pooled and calculated using RevMan 5.0. RESULTS: Our study included 23 studies with a total population of 11,802 patients. Compared to MVR, MVr had statistically significant lower risks of both early mortality with RR [0.44; 95% CI, 0.38-0.51; p < 0.001] and long-term follow-up mortality with HR [0.70; 95% CI, 0.58-0.85; p = 0.0004]. Moreover, MVr was associated with a statistically significant lower risk of IE recurrence with RR [0.43; 95% CI, 0.32-0.58; p < 0.001]; however, no statistically significant differences between both groups in terms of re-operations with RR [0.83; 95% CI, 0.41-1.67; p = 0.60]. CONCLUSION: Our results suggest that MVr was superior in terms of in-hospital mortality, long-term survival, and risk of recurrence without significance in valve reoperation. Therefore, MVr is appropriate as a primary treatment choice and should be considered whenever possible in most IE patients.

Early Outcomes of Minimally Invasive Right Anterior Thoracotomy vs. Median Full Sternotomy in Isolated Aortic Valve Replacement: A Propensity Score Analysis.

INTRODUCTION: This study aimed to compare the early postoperative outcomes of right anterior thoracotomy minimally invasive aortic valve replacement (RAT-MIAVR) surgery with those of median full sternotomy aortic valve replacement (MFS-AVR) approach with the goal of identifying potential benefits or drawbacks of each technique. METHODS: This retrospective, observational, cohort study included 476 patients who underwent RAT-MIAVR or MFS-AVR in our hospital from January 2015 to January 2023. Of these, 107 patients (22.5%) underwent RAT-MIAVR, and 369 patients (77.5%) underwent MFS-AVR. Propensity score matching was used to minimize selection bias, resulting in 95 patients per group for analysis. RESULTS: After propensity matching, two groups were comparable in preoperative characteristics. RAT-MIAVR group showed longer cardiopulmonary bypass time (130.24 ± 31.15 vs. 117.75 ± 36.29 minutes, P=0.012), aortic cross-clamping time (76.44 ± 18.00 vs. 68.49 ± 19.64 minutes, P=0.004), and longer operative time than MFS-AVR group (358.47 ± 67.11 minutes vs. 322.42 ± 63.84 minutes, P=0.000). RAT-MIAVR was associated with decreased hospitalization time after surgery, lower postoperative blood loss and drainage fluid, a reduced incidence of mediastinitis, increased left ventricular ejection fraction, and lower pacemaker use compared to MFS-AVR. However, there was no significant difference in the incidence of major complications and in-hospital mortality between the two groups. CONCLUSION: RAT-MIAVR is a feasible and safe alternative procedure to MFS-AVR, with comparable in-hospital mortality and early follow-up. This minimally invasive approach may be a suitable option for patients requiring isolated aortic valve replacement.

Sub-coronary aortic root replacement post-aortic valve dehiscence: a case report.

This is a case report of a 78-year-old male who underwent a sub-coronary aortic valve and root replacement due to valve dehiscence and aortic root pseudoaneurysm. The patient had complex anomalous coronary anatomy and had undergone a previous tissue aortic valve replacement in 2013. The patient made an uneventful recovery and was discharged from the hospital five days later. The authors suggest that the sub-coronary root replacement technique should be considered in elderly patients and patients with complex coronary anatomy.

Standardization and validation of neoLVOT assessment using three-dimensional trans-esophageal echocardiography before trans-catheter mitral valve replacement.

BACKGROUND: Trans-catheter mitral valve replacement (TMVR) procedures had emerged as an alternative solution for patients who are at high risk for mitral valve surgery. Although cardiac computed tomography (CT) remains the standard method for procedural planning, there is no full agreement on the best systolic phase for quantitation of the neoLVOT. Furthermore, a new three-dimensional trans-esophageal echocardiography (3DTEE) based software was developed to serve as filter and or an alternative for patients who cannot have CT due to any contraindication. AIM: To determine the systolic phase of the cardiac cycle that shows the narrowest NeoLVOT area in order to standardize the way of using these software and then to validate the 3DTEE-based software against the CT-based one as a gold standard, in mitral valve annulus (MA) and NeoLVOT assessment. METHODS: A single center, observational, retrospective study. Initially, a sample of 20 patients (age 62 ± 4 years, 70% men) had CT-based analysis at mid-diastole (80%), early-systole (10%), mid-systole (20%), late-systole (30%-40%), in order to detect the best systolic phase at which the neoLVOT area is the narrowest after TMVR. Then, the end systolic phase was standardized for the analysis of 49 patients (age 57 ± 6 years, 60% men), using both the commercially available CT-based software and the newly available 3DTEE-based software (3mensio Structural Heart, Pie Medical Imaging, The Netherlands). The 3DTEE derived parameters were compared with the gold standard CT-based measurements. RESULTS: The neoLVOT area was significantly narrower at end-systole (224 ± 62 mm2), compared to early-systole (299 ± 70 mm2) and mid-systole (261 ± 75 mm2), (p = .005). Excellent correlation was found between 3DTEE and CT measurements for MA AP diameter (r = .96), IC diameter (r = .92), MA area (r = .96), MA perimeter (r = .94) and NeoLVOT area (r = .96), (all p-values < .0001). Virtual valve sizing was based on annulus measurement and was identical between CT and 3DTEE. Interobserver and intraobserver agreements were excellent for all the measurements with ICCs > .80. CONCLUSIONS: End-systole is the phase that shows the narrowest neoLVOT and hence should be the standard phase used during the analysis. The 3DTEE based analysis using this new software is reliable compared to the CT-based analysis and can be serve as an alternative analysis tool in patients who cannot have CT for any clinical contraindication or as a screening test and/or filter for all patients before proceeding to a detailed CT scan.

Impact of Prosthesis-Patient Mismatch After Surgical Aortic Valve Replacement: Systematic Review and Meta-Analysis of Reconstructed Time-to-Event Data of 122 989 Patients With 592 952 Patient-Years.

BACKGROUND: It remains controversial whether prosthesis-patient mismatch (PPM) impacts long-term outcomes after surgical aortic valve replacement. We aimed to evaluate the association of PPM with mortality, rehospitalizations, and aortic valve reinterventions. METHODS AND RESULTS: We performed a systematic review with meta-analysis of reconstructed time-to-event data of studies published by March 2023 (according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses). Sixty-five studies met our eligibility criteria and included 122 989 patients (any PPM: 68 332 patients, 55.6%). At 25 years of follow-up, the survival rates were 11.8% and 20.6% in patients with and without any PPM, respectively (hazard ratio [HR], 1.16 [95% CI, 1.13-1.18], P<0.001). At 20 years of follow-up, the survival rates were 19.5%, 12.1%, and 8.8% in patients with no, moderate, and severe PPM, respectively (moderate versus no PPM: HR, 1.09 [95% CI, 1.06-1.11], P<0.001; severe versus no PPM: HR, 1.29 [95% CI, 1.24-1.35], P<0.001). PPM was associated with higher risk of cardiac death, heart failure-related hospitalizations, and aortic valve reinterventions over time (P<0.001). Statistically significant associations between PPM and worse survival were observed regardless of valve type (bioprosthetic versus mechanical valves), contemporary PPM definitions unadjusted and adjusted for body mass index, and PPM quantification method (in vitro, in vivo, Doppler echocardiography). Our meta-regression analysis revealed that populations with more women tend to have higher HRs for all-cause death associated with PPM. CONCLUSIONS: The results of the present study suggest that any degree of PPM is associated with poorer long-term outcomes following surgical aortic valve replacement and provide support for implementation of preventive strategies to avoid PPM after surgical aortic valve replacement.

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction.

BACKGROUND: Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. OBJECTIVES: The authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. METHODS: We used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. RESULTS: In this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). CONCLUSIONS: With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Comparative analysis of early postoperative results of transcatheter aortic valve implantation and surgical aortic valve replacement with a biological prosthesis.

OBJECTIVE: . Aim: The choice of aortic valve stenosis correction method is determined by a number of clinical and technical parameters. The task was to compare early postoperative outcomes in patients after correction of aortic valve stenosis using TAVI and surgical aortic valve replacement with a biological prosthesis. PATIENTS AND METHODS: Materials and Methods: This retrospective study analyzed the medical records of adult patients (18 years of age and older) who had transcatheter aortic valve implantation or surgical aortic valve replacement with a biological prosthesis at the State Institution "Heart Institute of the Ministry of Health" in the period from 2018 to 2022. RESULTS: Results: In 47 (47.5%) cases, TAVI was performed and in 52 (52.5%) cases, SAVR with a biological prosthesis was performed. Patients who underwent TAVI were significantly older (p=0.002) and had a higher EuroSCORE II operative risk score (p<0.001). In patients with TAVI, larger diameter aortic valve prostheses were significantly more often used compared with the SAVR group with biological prosthesis (27.5±2.74 vs. 22.5±1.84, p<0.001). The early postoperative period in patients with TAVI was characterized by an 11.4% (p=0.046) and 15.4% (p=0.006). The length of stay in the ICU (p=0.024), as well as the duration of hospitalization in general (p=0.005), was also significantly lower in patients with TAVI compared with patients with biological prosthesis SAVR. CONCLUSION: Conclusions: Despite the higher surgical risk of surgery according to EuroSCORE II, TAVI was characterized by a lower incidence of postoperative complications, with shorter duration of stay in ICU and hospitalization in general in comparison with patients undergoing SAVR with a biological prosthesis.

Long-term function of a novel autologous transcatheter pulmonary heart valve implant in an adult animal model.

BACKGROUND: Current heart valve implants entail major disadvantages in the treatment for younger patients or those with congenital heart defects. AIM: Evaluation of novel transcatheter pulmonary valve implant made from autologous pericardium with natural crosslinking agent in an in vitro setup and in vivo animal model METHODS: Valves were tested in a pulse duplicator according to ISO-standard 5840. For in vivo studies computer tomography was performed to measure sheep's native pulmonary valve dimensions. Pericardium was harvested by thoracotomy, personalized implants were manufactured and deployed in pulmonary valve position of the same sheep. Every 3 months implant functionality was evaluated by intracardiac echocardiography, intracardiac pressure measurements and cardiac magnetic resonance imaging (cMRI). Implants were explanted for macroscopic and histological examination. RESULTS: In vitro experiments showed compliance with regulatory requirements in terms of valve opening and insufficiency. Five sheep successfully received an autologous valve implant. Two animals had to be euthanized due to trauma sustained in the stable. Long-term valve function was excellent in three out of four animals with median implant cMRI regurgitation fraction of 9% (n = 4) at 3 months, 8% (n = 3) at 6, 8% (n = 3) at 9, 12% (n = 3) at 13, 8% (n = 2) at 17% and 8% (n = 2) at 20.5 months after implantation. Despite good adherence to neighboring tissue and endothelization, histological assessment revealed some signs of degeneration. CONCLUSION: Transcatheter pulmonary valve implants showed promising function for up to 20.5 months encouraging research to further improve this approach.

Management of right ventricular outflow tract with percutaneous Melody valve implantation in pediatric patients: experience in a high complexity center in Colombia.

BACKGROUND: Congenital heart disease poses a therapeutic challenge, specifically pulmonary valve stenosis. This has been treated for many years with invasive procedures and bioprostheses, which over time, become dysfunctional due to the accumulation of fibrous tissue and calcification. OBJECTIVE: The aim of this study is to describe the use of endovascular management in the right ventricular outflow tract, as the beginning of an ongoing effot to improve pediatric outcomes in developing countries. METHODS: Seven pediatric patients with endovascular management of the right outflow tract are presented. Three of them underwent surgical valvuloplasty with persistent pulmonary stenosis. They decided to insert a percutaneous transcatheter pulmonary valve (PPVI) with a Melody valve using the valve-in-valve technique, with 100% stenosis and no complications associated with the procedure. RESULTS: Four patients with successful percutaneous valve implantation had different congenital heart diseases. In addition, the case of a patient in whom an intentional pulmonary valve fracture was performed, an innovative procedure in pediatric endovascular management in the country, is highlighted. CONCLUSIONS: The procedure was minimally invasive, safe, and effective. The IVPP technique could be a viable option in our country for managing failed primary valve implantations or even in native tracts.

ANTECEDENTES: Las cardiopatías congénitas plantean un desafío terapéutico, específicamente la estenosis de la válvula pulmonar. Esta ha sido tratada durante muchos años con procedimientos invasivos e inserción de bioprótesis, que con el tiempo se vuelven disfuncionales y pueden reestenosarse por acumulación de tejido fibroso y calcificación. Debido a las complicaciones generadas por la injuria quirúrgica, se han descrito medidas menos invasivas para el manejo de la estenosis residual e inicial por medios endovasculares en adultos y más recientemente en población pediátrica. OBJETIVO: El objetivo de este reporte es describir la misma en el manejo endovascular del tracto de salida del ventrículo derecho, como el inicio de un trabajo continuo para la mejoría de los resultados pediátricos en países en vía de desarrollo. MÉTODOS: Se presentan siete casos pediátricos de manejo endovascular del tracto de salida derecho; tres de ellos sometidos a valvuloplastia quirúrgica con persistencia de la estenosis pulmonar, por lo cual se decidió inserción percutánea de una válvula pulmonar (IVPP) transcatéter con válvula Melody utilizando la técnica valve-in-valve, con lo que se consiguió una resolución del 100% de la estenosis y no se presentó ningún tipo de complicación asociada al procedimiento. RESULTADOS: En cuatro pacientes se logró una implantación exitosa de la válvula por vía percutánea en diferentes cardiopatías congénitas, siendo uno de ellos en tracto nativo; además, destaca el caso de un paciente en quien se realizó fractura intencional de la válvula pulmonar, procedimiento innovador en el manejo endovascular pediátrico en Colombia. CONCLUSIONES: En estos pacientes el procedimiento resultó ser poco invasivo, seguro y efectivo. La técnica IVPP podría ser considerada una opción viable en Colombia (y en otros países en desarrollo) para el manejo de implantes valvulares primarios fallidos o incluso en tractos nativos.

Paediatric aortic valve replacement using decellularized allografts: a multicentre update following 143 implantations and five-year mean follow-up.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced in 2008 as a further option for paediatric aortic valve replacement (AVR). METHODS: Prospective, multicentre follow-up of all paediatric patients receiving DAH for AVR in 8 European centres. RESULTS: A total of 143 DAH were implanted between February 2008 and February 2023 in 137 children (106 male, 74%) with a median age of 10.8 years (interquartile range 6.6-14.6). Eighty-four (59%) had undergone previous cardiac operations and 24 (17%) had undergone previous AVR. The median implanted DAH diameter was 21 mm (interquartile range 19-23). The median operation duration was 348 min (227-439) with a median cardiopulmonary bypass time of 212 min (171-257) and a median cross-clamp time of 135 min (113-164). After a median follow-up of 5.3 years (3.3-7.2, max. 15.2 years), the primary efficacy end-points peak gradient (median 14 mmHg, 9-28) and regurgitation (median 0.5, interquartile range 0-1, grade 0-3) showed good results but an increase over time. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 5 years were 97.8 ± 1.2/88.7 ± 3.3/99.1 ± 0.9/100 and 99.2 ± 0.8%, respectively. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 10 years were 96.3 ± 1.9/67.1 ± 8.0/93.6 ± 3.9/98.6 ± 1.4 and 86.9 ± 11.6%, respectively. In total, 21 DAH were explanted. Seven were replaced by a mechanical AVR, 1 Ross operation was performed and a re-do DAH was implanted in 13 patients with no redo mortality. The calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.4 years), and in the same range as for Ross patients (9.2 years) and mechanical AVR (13.0 years). CONCLUSIONS: This large-scale prospective analysis demonstrates excellent mid-term survival using DAH with adverse event rates comparable to paediatric Ross procedures.

Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS: The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.