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Background: Atrial septal defect (ASD) patients commonly experience severe pulmonary arterial hypertension (SPAH), which is frequently associated with a poor prognosis. While serum bilirubin levels, indicative of liver function, are known predictors of right heart failure (RHF), their potential to differentiate SPAH in ASD patients is yet to be ascertained. The purpose of this study was to discover the potential correlations between serum bilirubin levels and ASD patients with SPAH. Methods: In this cross-sectional study, 102 ASD patients admitted from December 2019 to November 2020 were enrolled and divided into two cohorts: those with SPAH and those without. Blood tests were conducted to measure serum direct bilirubin (DBIL), total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), uric acid (UA) and N-terminal pro B-type natriuretic peptide (NT-proBNP). Additionally, all participants underwent transthoracic echocardiography, and invasive hemodynamic data were gathered through right heart catheterization. Results: ASD patients with SPAH exhibited significantly elevated serum DBIL (5.2 ± 3.0 vs. 2.4 ± 1.5 µmol/L, p < 0.001) and TBIL (24.6 ± 20.7 vs. 10.1 ± 4.8 µmol/L, p < 0.001) levels in comparison to those without SPAH. However, ALT and AST levels remained comparable between the cohorts. Additionally, the SPAH cohort displayed higher serum UA (403.5 ± 131.6 vs. 317.8 ± 67.9 µmol/L, p < 0.001) and NT-proBNP levels. Serum DBIL levels, when analyzed independently of other variables, correlated with an increased risk of mean pulmonary arterial pressure (mPAP) in ASD patients ( ß = 1.620, p = 0.010). A DBIL concentration of 2.15 mg/dL effectively differentiated ASD patients with SPAH from those without, with a sensitivity of 92.9% and a specificity of 51.4% (area under the curve [AUC]: 0.794, 95% confidence interval [CI]: 0.701-0.886, p < 0.001). Notably, the combination of DBIL and UA had a higher sensitivity of 92.9% and specificity of 71.6% (AUC: 0.874, 95% CI: 0.799-0.949, p < 0.001). Conclusions: Elevated serum DBIL and TBIL levels in ASD patients with SPAH were correlated with poor cardiac function and heightened pulmonary artery pressure. The combination of DBIL and UA has emerged as a strong noninvasive predictor for SPAH in ASD patients, presenting a potentially novel therapeutic biomarker.
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BACKGROUND: Previous research has revealed the potential impact of circadian rhythms on pulmonary diseases; however, the connection between circadian rhythm-associated Thyrotroph Embryonic Factor (TEF) and Pulmonary Arterial Hypertension (PAH) remains unclear. We aim to assess the genetic causal relationship between TEF and PAH by utilizing two sets of genetic instrumental variables (IV) and publicly available Pulmonary Arterial Hypertension Genome-Wide Association Studies (GWAS). METHODS: Total of 23 independent TEF genetic IVs from recent MR reports and PAH GWAS including 162,962 European individuals were used to perform this two-sample MR study. Gain- and loss-of-function experiments were used to demonstrate the role of TEF in PAH. RESULTS: Our analysis revealed that as TEF levels increased genetically, there was a corresponding increase in the risk of PAH, as evidenced by IVW (OR = 1.233, 95% CI: 1.054-1.441; P = 0.00871) and weighted median (OR = 1.292, 95% CI for OR: 1.064-1.568; P = 0.00964) methods. Additionally, the up-regulation of TEF expression was associated with a significantly higher likelihood of abnormal circadian rhythm (IVW: P = 0.0024733, ß = 0.05239). However, we did not observe a significant positive correlation between circadian rhythm and PAH (IVW: P = 0.3454942, ß = 1.4980398). In addition, our in vitro experiments demonstrated that TEF is significantly overexpressed in pulmonary artery smooth muscle cells (PASMCs). And overexpression of TEF promotes PASMC viability and migratory capacity, as well as upregulates the levels of inflammatory cytokines. CONCLUSION: Our analysis suggests a causal relationship between genetically increased TEF levels and an elevated risk of both PAH and abnormal circadian rhythm. Consequently, higher TEF levels may represent a risk factor for individuals with PAH.
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Ritmo Circadiano , Estudo de Associação Genômica Ampla , Análise da Randomização Mendeliana , Ritmo Circadiano/fisiologia , Ritmo Circadiano/genética , Humanos , Análise da Randomização Mendeliana/métodos , Estudo de Associação Genômica Ampla/métodos , Hipertensão Arterial Pulmonar/genética , Hipertensão Arterial Pulmonar/diagnóstico , Masculino , FemininoRESUMO
BACKGROUND: As compared to treatment of aortic stenosis (AS), transcatheter aortic valve replacement (TAVR) using the commercially available valves to treat pure aortic regurgitation (PAR) has a lower device success rate and higher complication rates. AIMS: The study compared the acute results between TAVR using a novel noncoronary sinus pivot implantation (NCPI) method and that using the conventional method, aiming to explore a more optimized and effective operation method for TAVR in PAR. METHODS: PAR patients who underwent TAVR with self-expanding valves in our center from September 2021 to September 2023 were enrolled were divided into the NCPI (group A, N = 16) and conventional method (group B, N = 39) groups. We analyzed the pre-operative evaluation parameters and procedural and postoperative data of the two subgroups. RESULTS: The total patients' mean age was 71.2 ± 8.7 years and most were male (61.8%), with a mean Society of Thoracic Surgeons score of 3.4 ± 1.9%. The device success rate of groups A and B was 100% and 71.8%, respectively. In group B, 48.7% had major adverse cardiac events (MACE); 46.2% patients had permanent pacemaker implantation or valve in valve implantation. None had MACE in group A. The noncoronary sinus implantation depth in NCPI was -1.1 + 1.0 and 4.2 + 3.7 mm in groups A and B (p < 0.001), respectively. CONCLUSIONS: TAVR with a self-expanding valve using the NCPI method had a higher procedure success rate and dramatically low complications than that using the conventional method in PAR patients.
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Insuficiência da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Desenho de Prótese , Recuperação de Função Fisiológica , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/efeitos adversos , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Idoso , Resultado do Tratamento , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Valva Aórtica/diagnóstico por imagem , Estudos Retrospectivos , Fatores de Tempo , Fatores de Risco , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , HemodinâmicaRESUMO
BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) with the self-expandable Venus P-valve system is a promising treatment for patients with pulmonary regurgitation (PR) and a native right ventricular outflow tract (RVOT). However, limited data is available regarding its midterm outcomes. This study assessed the midterm clinical and echocardiographic outcomes following Venus P-valve implantation. METHODS: From 2013 to 2018, 55 patients with moderate or severe PR after surgical RVOT repair with a transannular or RVOT patch were consecutively enrolled from six hospitals in China. Five-year clinical and echocardiographic outcomes were collected and evaluated. The primary endpoint was a freedom from all-cause mortality and reintervention. RESULTS: At 5 years, the primary endpoint was met for 96% of patients, corresponding to a freedom from all-cause mortality of 96% (95% confidence interval [CI]: 86%-99%) and freedom from reintervention of 98% (95% CI: 87%-100%). Endocarditis was reported in five patients (four patients within 1 year and one patient at 5 years) following PPVI. Transpulmonary gradient and stent orifice diameter remained stable compared to at discharge (pï¼0.05). No paravalvular leak was reported while only 1 patient gradually increased to moderate PR during follow-up. Significant improvement of RV diameter and LVEF (pï¼0.001) sustained over the 5-year follow-up, in consistent with remarked improved New York Heart Association(NYHA) functional class (pï¼0.001). CONCLUSION: The 5-year results of the China VenusP Study demonstrated the midterm benefits of Venus P-valve implantation in the management of patients with severe PR with an enlarged native RVOT by providing sustained symptomatic and hemodynamic improvement.
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Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar , Valva Pulmonar , Obstrução do Fluxo Ventricular Externo , Humanos , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Insuficiência da Valva Pulmonar/etiologia , Insuficiência da Valva Pulmonar/cirurgia , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Seguimentos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Desenho de Prótese , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/etiologia , Obstrução do Fluxo Ventricular Externo/cirurgiaRESUMO
Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation, refers to a minimally invasive technique that replaces the pulmonary valve by delivering an artificial pulmonary prosthesis through a catheter into the diseased pulmonary valve under the guidance of X-ray and/or echocardiogram while the heart is still beating not arrested. In recent years, TPVR has achieved remarkable progress in device development, evidence-based medicine proof and clinical experience. To update the knowledge of TPVR in a timely fashion, and according to the latest research and further facilitate the standardized and healthy development of TPVR in Asia, we have updated this consensus statement. After systematical review of the relevant literature with an in-depth analysis of eight main issues, we finally established eight core viewpoints, including indication recommendation, device selection, perioperative evaluation, procedure precautions, and prevention and treatment of complications.
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Procedimentos Cirúrgicos Cardíacos , Valva Pulmonar , Humanos , Valva Pulmonar/diagnóstico por imagem , Valva Pulmonar/cirurgia , Resultado do Tratamento , Ásia , CatéteresRESUMO
OBJECTIVES: The study aimed to investigate the prognostic value of pre-transcatheter aortic valve replacement (TAVR) computed tomography angiography (CTA) in assessing physiological stenosis severity (CTA-derived fractional flow reserve (CT-FFR)) and high-risk plaque characteristics (HRPC). MATERIALS AND METHODS: Among TAVR patients who underwent pre-procedure CTA, the presence and number of HRPCs (minimum lumen area of < 4 mm2, plaque burden ≥ 70%, low-attenuating plaques, positive remodeling, napkin-ring sign, or spotty calcification) as well as CT-FFR were assessed. The risk of vessel-oriented composite outcome (VOCO, a composite of vessel-related ischemia-driven revascularization, vessel-related myocardial infarction, or cardiac death) was compared according to the number of HRPC and CT-FFR categories. RESULTS: Four hundred and twenty-seven patients (68.4% were male) with 1072 vessels were included. Their mean age was 70.6 ± 10.6 years. Vessels with low CT-FFR (≤ 0.80) (41.7% vs. 15.8%, adjusted hazard ratio (HRadj) 1.96; 95% confidence interval (CI): 1.28-2.96; p = 0.001) or lesions with ≥ 3 HRPC (38.7% vs. 16.0%, HRadj 1.81; 95%CI 1.20-2.71; p = 0.005) demonstrated higher VOCO risk. In the CT-FFR (> 0.80) group, lesions with ≥ 3 HRPC showed a significantly higher risk of VOCO than those with < 3 HRPC (34.7% vs. 13.0%; HRadj 2.04; 95%CI 1.18-3.52; p = 0.011). However, this relative increase in risk was not observed in vessels with positive CT-FFR (≤ 0.80). CONCLUSIONS: In TAVR candidates, both CT-FFR and the presence of ≥ 3 HRPC were associated with an increased risk of adverse clinical events. However, the value of HRPC differed with the CT-FFR category, with more incremental predictability among vessels with negative CT-FFR but not among vessels with positive CT-FFR. CLINICAL RELEVANCE STATEMENT: In transcatheter aortic valve replacement (TAVR) candidates, pre-TAVR CTA provided the opportunity to assess coronary physiological stenosis severity and high-risk plaque characteristics, both of which are associated with worse clinical outcomes. KEY POINTS: ⢠The current study investigated the prognostic value of coronary physiology significance and plaque characteristics in transcatheter aortic valve replacement patients. ⢠The combination of coronary plaque vulnerability and physiological significance showed improved accuracy in predicting clinical outcomes in transcatheter aortic valve replacement patients. ⢠Pre-transcatheter aortic valve replacement CT can be a one-stop-shop tool for coronary assessments in clinical practice.
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INTRODUCTION: Atrial septal defect (ASD) is one of the most common congenital heart malformations. Although not recommended, a significant proportion of patients with aortic root defects receive ASD closure, some of whom have improved right ventricular function. The study aimed to investigate the safety of interventional therapy in ASD patients with complete aortic rim deficiency and explore the predictors of right atrial (RA) non-reverse remodeling. METHODS: 1,011 patients with ASD who underwent transcatheter closure in the Department of Cardiology, Zhongshan Hospital, affiliated to Fudan University from June 2017 to June 2023 were enrolled in the study. They were divided into a complete aortic rim deficiency group and without absent aortic rim group. Furthermore, patients who had an enlarged RA in the absent aortic rim group were divided into two subgroups according to whether their RA remodeling was reversed post-procedure. Multivariate logistic regression was used to determine the predictors of RA reverse remodeling. RESULTS: During the 1-year follow-up, no major operative complications occurred in all patients with the absence of an aortic rim and a normal edge. After the operation, the right heart remodeling was significantly reversed, multivariate logistic regression analysis was performed, and it was found that no coronary heart disease before an operation, lower plasma creatinine level, and larger RA and RV dimensions were the predictive factors for the reverse of RA remodeling after treatment. CONCLUSION: Transcatheter closure of ASD with complete aortic rim deficiency is safe and feasible. For patients without coronary heart disease, the lower the creatinine value and the lower the tricuspid regurgitation before an operation, the more improvement of RA remodeling after the operation.
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Patients with previous interatrial shunt device (IASD) implantation may face greater challenges during future left atrial interventional procedures. Herein, we report the first case of left atrial appendage closure (LAAC) in a patient with previous IASD implantation. The patient successfully underwent LAAC using the LAmbre device without complications.
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Apêndice Atrial , Fibrilação Atrial , Cateterismo Cardíaco , Humanos , Apêndice Atrial/fisiopatologia , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Resultado do Tratamento , Cateterismo Cardíaco/instrumentação , Masculino , Feminino , Ecocardiografia Transesofagiana , Idoso , Função do Átrio Esquerdo , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/terapia , Forame Oval Patente/complicações , Forame Oval Patente/fisiopatologia , Forame Oval Patente/cirurgia , Oclusão do Apêndice Atrial EsquerdoRESUMO
Bicuspid aortic valve (BAV) is the most common congenital heart defect in human beings, with an estimated prevalence in the general population of between 0.5 and 2%. Moreover, BAV is the most common cause of aortic stenosis in the pediatric population. Patients with BAV may have no symptoms for life, and some of them may progress to aortic stenosis. Genetic factors increase the susceptibility and development of BAV. However, the pathogenesis and BAV are still unclear, and more genetic variants are still needed for elucidating the molecular mechanism and stratification of patients. The present study carried out screening of variants implicated in disease in BAV patients. The whole-exome sequencing (WES) was performed in 20 BAV patients and identified 40 different heterozygous missense mutations in 36 genes (MIB2, FAAH, S100A1, RGS16, MAP3K19, NEB, TTN, TNS1, CAND2, CCK, KALRN, ATP10D, SLIT3, ROS1, FABP7, NUP205, IL11RA, NPR2, COL5A1, CUBN, JMJD1C, ANXA7, TRIM8, LGR4, TPCN2, APOA5, GPR84, LRP1, NCOR2, AKAP11, ESRRB, NGB, AKAP13, WWOX, KCNJ12, ARHGEF1). The mutations in these genes were identified as recurrent variants implicated in disease by in silico prediction tool analysis. Nine genes (MIB2, S100A1, TTN, CCK, NUP205, LGR4, NCOR2, ESRRB, and WWOX) among the 36 genes were identified as variants implicated in disease via unanimous agreement of in silico prediction tool analysis and sequenced in an independent cohort of 137 BAV patients to validate the results of WES. BAV patients carrying these variants demonstrated reduced left ventricular ejection fractions (LVEF) (63.8 ± 7.5% vs. 58.4 ± 5.2%, P < 0.001) and larger calcification volume [(1129.3 ± 154) mm3 vs. (1261.8 ± 123) mm3, P < 0.001]. The variants in TTN, NUP205 and NCOR2 genes are significantly associated with reduced LVEF, and the variants in S100A1, LGR4, ESRRB, and WWOX genes are significantly associated with larger calcification volume. We identified a panel of recurrent variants implicated in disease in genes related to the pathogenesis of BAV. Our data speculate that these variants are promising markers for risk stratification of BAV patients with increased susceptibility to aortic stenosis.
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Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Doenças das Valvas Cardíacas , Valva Aórtica/anormalidades , Valva Aórtica/patologia , Estenose da Valva Aórtica/patologia , Proteínas de Transporte/genética , Criança , Doenças das Valvas Cardíacas/genética , Doenças das Valvas Cardíacas/patologia , Humanos , Histona Desmetilases com o Domínio Jumonji , MAP Quinase Quinase Quinases/genética , Proteínas do Tecido Nervoso/genética , Oxirredutases N-Desmetilantes , Proteínas Tirosina Quinases/genética , Proteínas Proto-Oncogênicas/genética , Ubiquitina-Proteína Ligases , Sequenciamento do ExomaRESUMO
BACKGROUND: The ValveClasp system is a novel transcatheter edge-to-edge repair (TEER) device with an arm-width-expandable clip that allows treatment of patients with only one clip more frequently. OBJECTIVES: This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. METHODS: Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate-to-severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. RESULTS: The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double-orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30-day follow-up, no adverse events occurred. All patients' vena Contracta width (from 8.04 0.71 mm to 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2 , p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. CONCLUSIONS: The novel arm-width-expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Animais , Humanos , Cateterismo Cardíaco/efeitos adversos , Ecocardiografia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Suínos , Resultado do TratamentoRESUMO
PURPOSE: The ValveClamp system is a novel edge-to-edge mitral valve repair system designed for the ease of operation. We report the outcomes of our initial experience of treating functional mitral regurgitation (MR) with the ValveClamp system. METHODS: The subjects of this study were patients with symptomatic functional MR despite standard medical therapy, who were treated with transapical ValveClamp implantation. The patients were divided into an atrial functional mitral regurgitation (AFMR) group and a ventricular functional mitral regurgitation (VFMR) group. Clinical and echocardiographic outcomes were evaluated at baseline and then at the 3-month follow up. RESULTS: Twelve patients, with a median age of 71 years (range 65-78 years), were assigned to the AFMR group (n = 5) or the VFMR group (n = 7). The device implantation rate was 100%, and 10 (83.3%) patients required implantation of only one clamp. The catheter time was less than 10 min in half of the patients, the fastest time being 5 min. There were no procedure-related complications. At the 3-month follow up, all patients were free from all-cause mortality, surgery, and rehospitalization. MR improved to ≤ 2 + in all 12 patients with MR grade 3 + or 4 + at baseline, (100%) and to ≤ 1 + in 9 of these patients (75%), with a low-pressure gradient. The left atrial diameter and the left ventricular end diastolic diameter decreased significantly in both the AFMR and VFMR groups. The left ventricular eject fraction at the 3-month follow up showed a rising trend in both the AFMR and VFMR groups, whereas PASP decreased remarkably. All 12 patients with baseline NYHA functional class III/IV (100%) showed improvement of at least 1 class, and 2 of these patients (16.7%) showed improvement of at least 2 classes. CONCLUSIONS: The ValveClamp system is simple and effective for transapical transcatheter edge to edge repair in patients with functional MR.
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Fibrilação Atrial , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Idoso , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Fibrilação Atrial/cirurgia , Resultado do Tratamento , Catéteres/efeitos adversosRESUMO
Background: This study aimed to investigate the predictors and prognosis of acute kidney injury (AKI) occurrence among Chinese patients following left atrial appendage closure (LAAC). Methods: We retrospectively enrolled 512 consecutive patients who underwent LAAC between January 2014 and December 2019. AKI was clinically defined according to the Kidney Disease Improving Global Outcomes serum creatinine criteria. Major adverse cardiovascular events were defined as the composite of all-cause mortality, readmission due to heart failure, cardiac surgery, systemic embolism, or bleeding events. Results: The incidence of AKI was 5.3% and was highest in patients with chronic kidney disease (CKD) stages 4-5 (25.0%), followed by those with CKD stages 3a-3b (9.1%), and those with CKD stages 1-2 or without CKD (3.9% only). Multivariate logistic regression showed that lower body mass index (odds ratio [OR] = 0.889; 95% confidence interval [CI], 0.803-0.986; p = 0.017), hypertension (OR = 5.577; 95% CI, 1.267-24.558; p = 0.023), and CKD stages 4-5 (OR = 6.729; 95% CI, 1.566-28.923; p = 0.010) were independent risk factors for AKI development after LAAC. AKI after LAAC was associated with 3-year major adverse cardiovascular events (33.3% vs. 7.5%, p < 0.001) and all-cause mortality (11.1% vs. 0.9%, p < 0.001) compared to that in the non-AKI group. Conclusions: AKI is relatively common after LAAC in patients with a baseline impaired glomerular filtration rate. Moreover, AKI after LAAC is mainly related to increased midterm mortality and morbidity, which require more strategies for prevention and treatment.
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Percutaneous balloon mitral valvuloplasty (PBMV) is not traditionally suitable for patients with mitral stenosis (MS) and left atrium (LA) thrombus. Moreover, PBMV cannot be performed in patients with LA thrombus not resolving after anti-coagulation treatment. Here we present a case of PBMV using a novel technique employing both a veno-arterial loop and neuro-embolic protection, in a patient with MS and LA thrombus resistant to warfarin therapy. The patient successfully underwent PBMV without any complications.
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Valvuloplastia com Balão , Procedimentos Cirúrgicos Cardíacos , Embolia , Estenose da Valva Mitral , Trombose , Valvuloplastia com Balão/métodos , Humanos , Estenose da Valva Mitral/complicações , Estenose da Valva Mitral/diagnóstico por imagem , Estenose da Valva Mitral/terapia , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/terapia , Resultado do TratamentoRESUMO
The ValveClamp system is a novel edge-to-edge mitral valve repair system that is designed for ease of operation. We aimed to report the 1-year outcomes of the early feasibility study of this system.Patients with severe degenerative mitral regurgitation (MR) at higher surgical risk and who received transapical ValveClamp implantation were followed for 1 year for clinical and echocardiographic outcomes.Twelve patients (mean age, 76.5 ± 6.3 years; mean Society of Thoracic Surgery score, 6.9 ± 1.9%) were enrolled at three sites in China. At 1 year, no patient died, received reoperation, or had long-term complications. Of the 12 patients with MR of 3+ or 4+ at baseline, 11 patients (91.67%) remained with MR ≤ 2+ at 1 year, and no patient had mitral stenosis. Significant reductions in maximum MR area (from 15.1 ± 6.51 cm2 to 4.45 ± 1.85 cm2, P < 0.001), effective orifice area (from 4.34 ± 0.34 cm2 to 2.38 ± 0.45 cm2, P < 0.001), and vena contracta width (from 8.03 ± 1.11 to 3.38 ± 2.11 mm, P < 0.001) were observed. The left cardiac dimensions were decreased, especially the mitral valve annulus diameter (from 34.79 ± 4.27 mm to 31.42 ± 2.81 mm, P < 0.05). Of the 12 patients with baseline New York Heart Association functional class III/IV, all patients experienced an improvement of at least one class (P < 0.05).Our study provides evidence that transapical ValveClamp implantation in high-risk patients with severe degenerative MR is safe and feasible, with good efficacy in the mid-long term.
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Implante de Prótese de Valva Cardíaca/instrumentação , Insuficiência da Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco , Ecocardiografia , Estudos de Viabilidade , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Estudos Prospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: We sought to assess the acute intraprocedural effects of the ValveClamp system in DMR patients on the mitral valve (MV) three-dimensional (3D) geometry and the association of these effects with mitral regurgitation (MR) reduction. BACKGROUND: Few data are available about the specific impact of transcatheter edge-to-edge repair in patients with degenerative mitral regurgitation (DMR). METHODS: Thirty-five symptomatic patients (age 74.26 ± 6.61 years) with Grade 3 to 4+ degenerative MR underwent 3D transoesophageal echocardiography (TEE) during ValveClamp implantation. Volumetric data sets were retrospectively analyzed using mitral valve quantitative 3D modeling software. RESULTS: Mitral valve annular anterior-posterior (AP) diameter decreased from 33.24 ± 4.03 to 31.12 ± 3.66 mm (p < .001), and prolapse height from 4.78 ± 2.19 to 2.32 ± 1.92 mm (p < .001), and total exposed leaflet area from 1,110.29 ± 224.21 mm2 to 1,013.44 ± 228.71 mm (p = .004). Accordingly, we observed a significant reduction of MR severity after ValveClamp implantation. Multivariable analysis revealed postprocedural MR reduction was associated with shortening in anterior-posterior diameter (coefficient 0.427, p = .008) and reduction in prolapse height (coefficient 0.369, p = .021). CONCLUSIONS: ValveClamp implantation exerts an acute effect on the 3D MV geometry. Postprocedural reduction in AP diameter and reduction in prolapse height correlates with MR downgrading in patients with degenerative MR.
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Ecocardiografia Tridimensional , Insuficiência da Valva Mitral , Idoso , Ecocardiografia Transesofagiana , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
MitraClip edge-to-edge (E2E) repair system is the only transcatheter device recommended in the current guidelines for treating mitral regurgitation (MR). The percutaneous femoral venous transseptal access of MitraClip requires a complex steerable delivery system and may thus be technically complex to optimally position and deploy the clip onto the mitral valve. A transapical approach for E2E repair has been devised to treat MR for the ease of operation (ValveClamp system, Hanyu Medical Technology, Shanghai). The first-in-human study of ValveClamp has demonstrated its early feasibility and effectiveness for the treatment of patients with degenerative MR. Transesophageal echocardiography (TEE) is the only imaging modality required for intraoperative guidance of ValveClamp implantation. Successful implantation depends on accurate localization and orientation of the clamp and efficient intraoperative communication between the echocardiographer and the intervention team. Thus, the focus of this review is on elaborating how two-dimensional (2D) and three-dimensional (3D) TEE are used in clinical practice to guide ValveClamp implantation and it may facilitate the understanding of simplicity and safety of this novel procedure. We also describe the implementation of several novel advancements in 3D TEE imaging, which improve the confidence of image interpretation for intraoperative guidance and expedite implantation times.
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Ecocardiografia Transesofagiana/métodos , Insuficiência da Valva Mitral/cirurgia , Cirurgia Assistida por Computador/métodos , Ecocardiografia Tridimensional/métodos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnósticoRESUMO
OBJECTIVE: This study reports the 1-year clinical outcomes of the VitaFlow™ transcatheter aortic valve system in the treatment of severe aortic stenosis. BACKGROUND: The VitaFlow™ system (MicroPort®, Shanghai, China) was developed as a novel transcatheter aortic valve replacement system to mitigate or circumvent some of the challenges associated with heavily calcified valves and bicuspid valves. METHODS: From September 2014 to November 2017, a prospective, multicenter, single arm study was conducted in 11 centers in China. The primary end point was all cause mortality at 12 months. RESULTS: One hundred and ten symptomatic aortic stenosis patients (60 men, 50 women; mean age 77.73 ± 4.78 years) at prohibitive or high risk for surgery were enrolled. Mean society of thoracic surgeons score was 8.84 ± 5.58%. All-cause mortality was 2.7% at 1-year. Major stroke, major vascular complication, coronary artery obstruction, new pacemaker implantation occurred in 2.7, 2.7, 1.8, and 19.1% at 1-year follow-up, respectively. No patients had moderate or severe paravalvular leak at 1-year. At 1 year follow-up, 97% of patients had New York heart association ≤II. Patients with bicuspid valves had similar outcomes as those patients with tricuspid aortic valve stenosis. CONCLUSIONS: The 12-month clinical results support the safety and efficacy of VitaFlow™ in the treatment of patients with severe aortic stenosis, including patients with bicuspid aortic valve.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/anormalidades , Valva Aórtica/patologia , Calcinose/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Doença da Válvula Aórtica Bicúspide , Calcinose/diagnóstico por imagem , Calcinose/mortalidade , Calcinose/fisiopatologia , China , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Hemodinâmica , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
BACKGROUND: A new technique has been developed for treating mitral regurgitation (MR) via a transapical approach, which encompasses an easy-to-use leaflet clamp and a smaller-sized delivery system (14F-16F). OBJECTIVES: We aimed to evaluate the effectiveness of this device in a porcine model of acute MR. METHODS: Acute MR was induced in 36 anesthetized porcine subjects by severing the chordae supporting the corresponding segment of the leaflet. The ValveClamp system was then transapically implanted on the prolapsing segment under epicardial echocardiographic guidance. Echocardiographic assessments were performed before and after the transapical interventions. All of the animals were killed 30 days after the procedure to verify the proper location of the implanted devices. RESULTS: Epicardial echocardiography revealed severe MR (n = 26) or moderate to severe MR (n = 10) in the pig model of acute MR. Overt MR reduction was observed following the procedure through echocardiography; residual MR was absent in 10 cases, mild in 17 cases, and moderate in 9 cases. There was no evidence of mitral stenosis at the end of the procedure in terms of mitral valve area and mitral valve pressure gradient. Autopsy demonstrated that all ValveClamp devices were precisely placed to clamp the prolapsing segment of the mitral valve. CONCLUSIONS: Transapical implantation of the ValveClamp device under epicardial echocardiographic guidance was effective and safe in reducing acutely induced MR in this pig model. It is potentially applicable as a novel user-friendly transcatheter edge-to-edge mitral valve repair device for the treatment of MR in humans.
RESUMO
OBJECTIVES: The present study was performed to evaluate the feasibility and safety of the ValveClamp system for transcatheter edge-to-edge mitral valve repair in a porcine model. BACKGROUND: The ValveClamp system is a novel, transapically delivered edge-to-edge mitral valve repair system designed for ease of operation. METHODS: Thirteen young adult swine were enrolled in the study. The procedure was performed via the transapical approach under epicardial echocardiography guidance. RESULTS: The acute procedure success rate was 92.3% (12/13). The catheter manipulation time was just 18.5 ± 8.2 min. Four pigs were explanted on the 14th day after the procedure. One pig died at the 20th day because of pneumonia. The other eight pigs lived to the study endpoint (140 days). No pig had severe mitral valve dysfunction. The gross observation showed that the clamp device was securely attached and created a double-orifice mitral valve in all pigs except the failed one. In the eight pigs living to the endpoint, the clamp device was noted to be completely endothelialized. None of the 13 pigs developed infective endocarditis, thrombosis, thromboembolism, or valve impairment. In two pigs for which mitral regurgitation (MR) was created, the degree of MR was reduced from severe to trace after the device implantation. CONCLUSIONS: It was feasible and safe to use ValveClamp to perform a catheter-mediated edge-to-edge mitral valve repair in a porcine model. This system is potentially applicable as a novel user-friendly system for the treatment of MR.
Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Animais , Cateterismo Cardíaco/efeitos adversos , Modelos Animais de Doenças , Estudos de Viabilidade , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Masculino , Teste de Materiais , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Desenho de Prótese , Sus scrofaRESUMO
BACKGROUND: The aim of this study is to investigate the prevalence and outcome of tricuspid regurgitation (TR) in the Chinese population. METHODS: The echocardiography database, including 134,874 patients at our heart center from 2010 to 2012, was retrospectively analyzed. RESULTS: The rates of mild, moderate, and severe TR were 2.96, 2.22, and 1.39%, respectively. Of these patients, 4.86% had primary TR, 91.41% had functional TR, and 3.73% had unexplained TR. The rate of TR was increased in elders (odds ratio: 1.038 for 1 year's increment; 95% confidence interval: 1.037-1.040; p < 0.001) and females (odds ratio: 1.386; 95% confidence interval: 1.327-1.448, p < 0.001). The major etiologies of TR were left-sided valve heart disease (VHD) and dilated cardiomyopathy. The survival rate of severe TR patients with pulmonary artery hypertension (PAH) was lower than in those without PAH (p < 0.0001). There was a positive association between the prevalence of TR and impaired left ventricular ejection fraction. Compared to the non-left-sided VHD group, the left-sided VHD group had a better prognosis among severe TR patients. The 5-year survival rates were 79.69, 71.12, and 77.01% in the groups of left-sided VHD, non-left-sided VHD, and all patients. CONCLUSIONS: Patients with severe TR have a bad prognosis, especially those with non-left-sided VHD and those with PAH.