Assuntos
Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/etiologia , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Resultado do Tratamento , Próteses Valvulares Cardíacas , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Valva Tricúspide/fisiopatologia , Feminino , Função Ventricular Direita , Masculino , Idoso , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/fisiopatologia , Disfunção Ventricular Direita/diagnóstico por imagemAssuntos
Endocardite Bacteriana , Próteses Valvulares Cardíacas , Infecções Relacionadas à Prótese , Rifampina , Infecções Estafilocócicas , Humanos , Rifampina/uso terapêutico , Infecções Estafilocócicas/tratamento farmacológico , Próteses Valvulares Cardíacas/efeitos adversos , Endocardite Bacteriana/tratamento farmacológico , Infecções Relacionadas à Prótese/tratamento farmacológico , Antibacterianos/uso terapêuticoAssuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Desenho de Prótese , Humanos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Resultado do Tratamento , Valvuloplastia com Balão , Masculino , Feminino , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , IdosoAssuntos
Valva Aórtica , Bioprótese , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Masculino , Idoso , Falha de Prótese , Feminino , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Complicações Pós-Operatórias/etiologiaRESUMO
RATIONALE: Complete dislodgement of a mechanical valve is extremely uncommon as a long-term issue after getting a substitute mitral valve, and this report details an incident of complete detachment of a mechanical valve. PATIENT CONCERNS: A 50-year-old woman, who underwent mitral mechanical valve replacement 2 decades earlier at another facility, was urgently admitted due to sudden cardiogenic shock. DIAGNOSES: Transthoracic echocardiograms revealed severe malfunction of the mitral valve prosthesis, characterized by significant mitral regurgitation and moderate pulmonary hypertension. Following the insertion of extracorporeal membrane oxygenation and an intra-aortic balloon pump, the hemodynamics stabilized. Coronary angiography displayed the prosthetic mitral valve ring and leaflet floating in the left atrium, as confirmed by preoperative real-time 3-dimensional transesophageal echocardiography. A complete separation of the prosthetic ring and leaflet from the suture ring was observed. INTERVENTIONS: The patient promptly underwent bioprosthetic mitral valve replacement. OUTCOMES: The patient's postoperative course was uneventful, leading to discharge in good condition. LESSONS: A crucial aspect is comprehending the structure of the prosthetic valve itself. The use of transthoracic echocardiography and real-time 3-dimensional transesophageal echocardiography provides additional structural and functional details, enhancing support for potential life-saving interventions. Echocardiography plays a significant role in evaluating the morphology and function of prosthetic valves.
Assuntos
Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Falha de Prótese , Humanos , Feminino , Pessoa de Meia-Idade , Próteses Valvulares Cardíacas/efeitos adversos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Ecocardiografia Transesofagiana , Choque Cardiogênico/etiologia , Ecocardiografia Tridimensional/métodosRESUMO
Tissue engineered heart valves (TEHVs) demonstrates the potential for tissue growth and remodel, offering particular benefit for pediatric patients. A significant challenge in designing functional TEHV lies in replicating the anisotropic mechanical properties of native valve leaflets. To establish a biomimetic TEHV model, we employed melt-electrowriting (MEW) technology to fabricate an anisotropic PCL scaffold. By integrating the anisotropic MEW-PCL scaffold with bioactive hydrogels (GelMA/ChsMA), we successfully crafted an elastic scaffold with tunable mechanical properties closely mirroring the structure and mechanical characteristics of natural heart valves. This scaffold not only supports the growth of valvular interstitial cells (VICs) within a 3D culture but also fosters the remodeling of extracellular matrix of VICs. The in vitro experiments demonstrated that the introduction of ChsMA improved the hemocompatibility and endothelialization of TEHV scaffold. The in vivo experiments revealed that, compared to their non-hydrogel counterparts, the PCL-GelMA/ChsMA scaffold, when implanted into SD rats, significantly suppressed immune reactions and calcification. In comparison with the PCL scaffold, the PCL-GelMA/ChsMA scaffold exhibited higher bioactivity and superior biocompatibility. The amalgamation of MEW technology and biomimetic design approaches provides a new paradigm for manufacturing scaffolds with highly controllable microstructures, biocompatibility, and anisotropic mechanical properties required for the fabrication of TEHVs.
Assuntos
Valvas Cardíacas , Hidrogéis , Ratos Sprague-Dawley , Engenharia Tecidual , Alicerces Teciduais , Engenharia Tecidual/métodos , Animais , Alicerces Teciduais/química , Anisotropia , Ratos , Hidrogéis/química , Materiais Biocompatíveis/química , Próteses Valvulares Cardíacas , Poliésteres/química , Células Cultivadas , Humanos , Matriz Extracelular/química , MasculinoRESUMO
BACKGROUND: We aimed to summarise the existing knowledge regarding antithrombotic medications following surgical aortic valve replacement (SAVR) using a biological valve prosthesis. METHODS: We performed a meta-analysis of studies that reported the results of using antithrombotic medication to prevent thromboembolic events after SAVR using a biological aortic valve prosthesis and recorded the outcomes 12 months after surgery. Since no randomised controlled trials were identified, observational studies were included. The analyses were conducted separately for periods of 0-12 months and 3-12 months after surgery. A random effects model was used to calculate pooled outcome event rates and 95% confidence intervals (CIs). RESULTS: The search yielded eight eligible observational studies covering 6727 patients overall. The lowest 0- to 12-month mortality was observed in patients with anticoagulation (2.0%, 95% CI 0.4-9.7%) and anticoagulation combined with antiplatelet therapy (2.2%, 95% CI 0.9-5.5%), and the highest was in patients without antithrombotic medication (7.3%, 95% CI 3.6-14.2%). Three months after surgery, mortality was lower in anticoagulant patients (0.5%, 95% CI 0.1-2.6%) than in antiplatelet patients (3.0%, 95% CI 1.2-7.4%) and those without antithrombotics (3.5%, 95% CI 1.3-9.3%). There was no eligible evidence of differences in stroke rates observed among medication strategies. At 0- to 12-month follow-up, all antithrombotic treatment regimens resulted in an increased bleeding rate (antiplatelet 4.2%, 95% CI 2.9-6.1%; anticoagulation 7.5%, 95% CI 3.8-14.4%; anticoagulation combined with antiplatelet therapy 8.3%, 95% CI 5.7-11.8%) compared to no antithrombotic medication (1.1%, 95% CI 0.4-3.4%). At 3- to 12-month follow-up, there was up to an eight-fold increase in the bleeding rate in patients with anticoagulation combined with antiplatelet therapy when compared to those with no antithrombotic medication. Overall, the evidence certainty was ranked as very low. CONCLUSION: Although this meta-analysis reveals that anticoagulation therapy has a beneficial tendency in terms of mortality at 1 year after biological SAVR and suggests potential advantages in continuing anticoagulation beyond 3 months, it is limited by very low evidence certainty. The imperative for cautious interpretation and the urgent need for more robust randomised research underscore the complexity of determining optimal antithrombotic strategies in this patient population.
Assuntos
Valva Aórtica , Fibrinolíticos , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Fibrinolíticos/uso terapêutico , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Tromboembolia/prevenção & controle , Tromboembolia/etiologia , Bioprótese , Complicações Pós-Operatórias/prevenção & controle , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêuticoRESUMO
Intra-cardiac thrombosis is a potentially devastating complication of extracorporeal membrane oxygenation (ECMO) mechanical circulatory support. We present here a patient who suffered complete thrombosis of a fresh mitral prosthesis and left atrium in the setting of ECMO with aortic insufficiency who was treated with repeat valve replacement and thrombectomy. To our knowledge, she is the only patient in the reported literature to have survived this complication.
Assuntos
Bioprótese , Oxigenação por Membrana Extracorpórea , Átrios do Coração , Próteses Valvulares Cardíacas , Valva Mitral , Trombose , Feminino , Humanos , Bioprótese/efeitos adversos , Oxigenação por Membrana Extracorpórea/métodos , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Mitral/cirurgia , Trombectomia/métodos , Trombose/etiologia , Trombose/cirurgia , IdosoAssuntos
Cateterismo Cardíaco , Anuloplastia da Valva Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/etiologia , Resultado do Tratamento , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/efeitos adversos , Masculino , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Feminino , Valva Tricúspide/cirurgia , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/fisiopatologia , Idoso , Fatores de Risco , Lesões do Sistema Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/etiologia , Lesões do Sistema Vascular/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/lesões , Vasos Coronários/cirurgia , Traumatismos Cardíacos/etiologia , Traumatismos Cardíacos/diagnóstico por imagem , Traumatismos Cardíacos/terapia , Traumatismos Cardíacos/cirurgia , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Fatores de Tempo , Próteses Valvulares CardíacasRESUMO
OBJECTIVES: Prothesis choice in isolated mitral valve replacement for patients aged 75 years or younger remains debated as most studies comparing prothesis type have included large proportions of combined operations and benefits are influenced by concomitant procedures. This study compared long-term outcomes of isolated mechanical versus bioprosthetic mitral valves in different age groups of propensity-matched populations. METHODS: This is a retrospective, multicentre, propensity-matched observational study. Baseline characteristics, operative details and long-term outcomes (mortality and freedom from surgical/transcatheter reintervention) were collected. RESULTS: Totally, 1536 isolated mitral valve replacements (806 mechanical, 730 bioprosthetic) were performed between 2000 and 2017. Over 90% of eligible patients successfully underwent propensity matching, yielding 226 each of mechanical and bioprosthetic valves in patients aged <65 years and 171 each of bioprosthetic and mechanical valves in patients aged 65-75 years with median follow-up of 13 years (maximum 20 years). In matched patients <65 years, 10-year survival was superior with mechanical valves versus bioprosthetic valves (78.2% vs 69.8%, P = 0.029), as was 10-year freedom from reintervention (96.2% vs 81.3%, P < 0.001). For matched patients between 65 and 75 years, there were no differences between mechanical and bioprosthetic valves in 10-year survival (64.6% vs 60.8%, P = 0.86) or 10-year freedom from reintervention (94.0% vs 97.2%, P = 0.23). Rates of post-operative stroke, gastrointestinal bleeding, renal failure and permanent pacemaker insertion were similar. CONCLUSIONS: In patients requiring isolated mitral valve replacement, mechanical valves confer significantly better long-term survival and freedom from reintervention for patients <65 years, while no benefit is observed at age 65-75 years compared to bioprosthetic valves.
Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Valva Mitral , Pontuação de Propensão , Humanos , Idoso , Masculino , Feminino , Estudos Retrospectivos , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/instrumentação , Pessoa de Meia-Idade , Fatores Etários , Resultado do Tratamento , Desenho de Prótese , Doenças das Valvas Cardíacas/cirurgia , Complicações Pós-Operatórias/epidemiologiaRESUMO
OBJECTIVES: Limited data are available from randomized trials comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgery in patients with different risks and with follow-up of at least 4 years or longer. In this large, population-based cohort study, long-term mortality and morbidity were investigated in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis using a surgically implanted bioprosthesis (surgical/biological aortic valve replacement; sB-AVR) or TAVR. METHODS: Individual data from the Austrian Insurance Funds from 2010 through 2020 were analysed. The primary outcome was all-cause mortality, assessed in the overall and propensity score-matched populations. Secondary outcomes included reoperation and cardiovascular events. RESULTS: From January 2010 through December 2020, a total of 18 882 patients underwent sB-AVR (n = 11 749; 62.2%) or TAVR (n = 7133; 37.8%); median follow-up was 5.8 (95% CI 5.7-5.9) years (maximum 12.3 years). The risk of all-cause mortality was higher with TAVR compared with sB-AVR: hazard ratio 1.552, 95% confidence interval (CI) 1.469-1.640, P < 0.001; propensity score-matched hazard ratio 1.510, 1.403-1.625, P < 0.001. Estimated median survival was 8.8 years (95% CI 8.6-9.1) with sB-AVR versus 5 years (4.9-5.2) with TAVR. Estimated 5-year survival probability was 0.664 (0.664-0.686) with sB-AVR versus 0.409 (0.378-0.444) with TAVR overall, and 0.690 (0.674-0.707) and 0.560 (0.540-0.582), respectively, with propensity score matching. Separate subgroup analyses for patients aged 65-75 years and >75 years indicated a significant survival benefit in patients selected for sB-AVR in both groups. Other predictors of mortality were age, sex, previous heart failure, diabetes and chronic kidney disease. CONCLUSIONS: In this retrospective national population-based study, selection for TAVR was significantly associated with higher all-cause mortality compared with sB-AVR in patients ≥65 years with severe, symptomatic aortic stenosis in the >2-year follow-up.
Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Feminino , Masculino , Idoso , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/mortalidade , Idoso de 80 Anos ou mais , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/estatística & dados numéricos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Aórtica/cirurgia , Seleção de Pacientes , Estudos Retrospectivos , Pontuação de Propensão , Próteses Valvulares Cardíacas , Resultado do Tratamento , Bioprótese , Fatores de Risco , SeguimentosRESUMO
BACKGROUND: Bioprostheses with RESILIA tissue demonstrate a reduction in calcification and improve health outcomes in pre-clinical and clinical studies. Prior economic analyses which relied on 5 years of evidence from the COMMENCE trial demonstrate financial savings for RESILIA tissue valves relative to mechanical valves after surgical aortic valve replacement (SAVR). Given the recent release of 7-year COMMENCE data, this economic evaluation updates the estimate for long-run savings of bioprosthetic valves with RESILIA. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients each in the US. The primary comparison calculated the SAVR-related expenditures associated with each valve type ($US, 2023). Health outcome probabilities were based on the COMMENCE trial though year 7 and projected for an additional 8 years based on prior studies of tissue and mechanical SAVR. Costs for key outcomes (mortality, reoperation, bleeding, thromboembolism, endocarditis) and anticoagulant monitoring were sourced from the literature. Incidence rates of health outcomes associated with mechanical valves relied on relative risks of tissue valve versus mechanical valve patients. RESULTS: Seven-year savings are $13,415 (95% CI = $10,472-$17,321) per patient when comparing RESILIA versus mechanical SAVR. Projected 15-year savings were $23,001 ($US, 2023; 95% CI = $17,802-$30,421). Most of the 15-year savings are primarily attributed to lower anti-coagulation monitoring costs ($21,073 in ACM savings over 15 years), but lower bleeding cost (savings: $2,294) and thromboembolism-related expenditures (savings: $852) also contribute. Reoperation and endocarditis expenditures were slightly larger in the RESILIA cohort. If reoperation relative risk reverts from 1.1 to 2.2 (the level in legacy tissue valves) after year 7, savings are $18,064. RESILIA SAVR also reduce costs relative to legacy tissue valves. CONCLUSION: Patients receiving RESILIA tissue valves are projected to have lower SAVR-related health expenditures relative to mechanical and legacy tissue valves.
Assuntos
Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Próteses Valvulares Cardíacas/economia , Implante de Prótese de Valva Cardíaca/economia , Implante de Prótese de Valva Cardíaca/métodos , Valva Aórtica/cirurgia , Bioprótese/economia , Redução de Custos , Análise Custo-Benefício , Reoperação/economia , Gastos em Saúde/estatística & dados numéricos , Endocardite/economia , Masculino , Feminino , Complicações Pós-Operatórias/economia , Desenho de Prótese , Progressão da Doença , Modelos Econométricos , Tromboembolia/economia , Tromboembolia/prevenção & controleAssuntos
Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Masculino , Feminino , Idoso , Resultado do Tratamento , Idoso de 80 Anos ou mais , Desenho de PróteseRESUMO
BACKGROUND: Coronary access (CA) is a major concern in redo-transcatheter aortic valve implantation (TAVI) for failing supra-annular self-expanding transcatheter aortic valves (TAVs). AIMS: This ex vivo study evaluated the benefit of leaflet splitting (LS) on subsequent CA after redo-TAVI in anatomies deemed at high risk of unfeasible CA. METHODS: Ex vivo, patient-specific models were printed three-dimensionally. Index TAVI was performed using ACURATE neo2 or Evolut PRO (TAV-1) at the standard implant depth and with different degrees of commissural misalignment (CMA). Redo-TAVI was performed using the balloon-expandable SAPIEN 3 Ultra (TAV-2) at different implant depths with commissural alignment. Selective CA was attempted for each configuration before and after LS in a pulsatile flow simulator. The leaflet splay area was assessed on the bench. RESULTS: In matched comparisons of 128 coronary cannulations across 64 redo-TAVI configurations, the overall feasibility of CA significantly increased after LS (60.9% vs 18.7%; p<0.001). The effect of LS varied according to the sinotubular junction height, TAV-1 design, TAV-1 CMA, and TAV-2 implant depth, given TAV-2 alignment. LS enabled CA for up to CMA 45° with the ACURATE neo2 TAV-1 and up to CMA 30° with the Evolut PRO TAV-1. The combination of LS and a low TAV-2 implant provided the highest feasibility of CA after redo-TAVI. The leaflet splay area ranged from 25.60 mm2 to 37.86 mm2 depending on the TAV-1 platform and TAV-2 implant depth. CONCLUSIONS: In high-risk anatomies, LS significantly improves CA feasibility after redo-TAVI for degenerated supra-annular self-expanding platforms. Decisions on redo-TAVI feasibility should be carefully individualised, taking into account the expected benefit of LS on CA for each scenario.
Assuntos
Valva Aórtica , Próteses Valvulares Cardíacas , Desenho de Prótese , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/instrumentação , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Impressão Tridimensional , Estenose da Valva Aórtica/cirurgia , Vasos Coronários/cirurgia , Falha de Prótese , ReoperaçãoRESUMO
Over the last 2 decades, experience with transcatheter pulmonary valve replacement (TPVR) has grown significantly and has become an effective and reliable way of treating pulmonary valve regurgitation, right ventricular outflow (RVOT) obstruction, and dysfunctional bioprosthetic valves and conduits. With the introduction of self-expanding valves and prestents, dilated native RVOT can be addressed with the transcatheter approach. In this article, the authors review the current practices, technical challenges, and outcomes of TPVR.
Assuntos
Cateterismo Cardíaco , Cardiopatias Congênitas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar , Valva Pulmonar , Humanos , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Valva Pulmonar/cirurgia , Cardiopatias Congênitas/cirurgia , Insuficiência da Valva Pulmonar/cirurgia , Insuficiência da Valva Pulmonar/diagnóstico , Obstrução do Fluxo Ventricular Externo/cirurgia , Desenho de Prótese , BiopróteseAssuntos
Stents , Humanos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Desenho de Prótese , Resultado do Tratamento , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagemRESUMO
BACKGROUND: Perioperative management and cardiac surgery in pregnant women with anti-phospholipid syndrome combined with heart valve disease have been rarely reported. CASE PRESENTATION: We describe a case of transcatheter mitral valve-in-valve replacement in a pregnant woman with bioprosthetic valve failure and anti-phospholipid syndrome at 18 weeks' gestation. The patient underwent a cesarean section delivery at 34 weeks of gestation, resulting in the birth of a healthy baby. CONCLUSIONS: Transapical mitral valve-in-valve surgery resulted in safe maternal and infant outcomes in a pregnant woman with anti-phospholipid syndrome combined with mitral bioprosthetic valve failure. The success of this procedure underscored the importance of multidisciplinary teamwork.
Assuntos
Síndrome Antifosfolipídica , Bioprótese , Implante de Prótese de Valva Cardíaca , Valva Mitral , Complicações Cardiovasculares na Gravidez , Humanos , Feminino , Gravidez , Síndrome Antifosfolipídica/complicações , Valva Mitral/cirurgia , Adulto , Implante de Prótese de Valva Cardíaca/métodos , Complicações Cardiovasculares na Gravidez/cirurgia , Próteses Valvulares Cardíacas , Cesárea , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/cirurgia , Falha de PróteseRESUMO
BACKGROUND: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. METHODS: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. RESULTS: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported. CONCLUSIONS: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS. TRIAL REGISTRATION: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).