RESUMO
BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Resultado do Tratamento , Cateterismo CardíacoRESUMO
BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.
Assuntos
Cateterismo Periférico , Desenho de Equipamento , Hemorragia , Técnicas Hemostáticas , Punções , Artéria Radial , Humanos , Estudos Prospectivos , Masculino , Feminino , Idoso , Técnicas Hemostáticas/instrumentação , Técnicas Hemostáticas/efeitos adversos , Pessoa de Meia-Idade , Resultado do Tratamento , Cateterismo Periférico/efeitos adversos , Fatores de Tempo , Hemorragia/prevenção & controle , Hemorragia/etiologia , Quitosana , Hemostáticos/administração & dosagem , Hemostáticos/efeitos adversos , Fatores de Risco , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Bandagens , Trombose/etiologia , Trombose/prevenção & controleRESUMO
OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.
Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Idoso de 80 Anos ou mais , Bioprótese/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Falha de Prótese , Sistema de Registros , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia , Intervenção Coronária Percutânea , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hospitalização/estatística & dados numéricos , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/mortalidade , Falha de Prótese , Volume Sistólico , Resultado do Tratamento , Disfunção Ventricular Esquerda/etiologiaRESUMO
Transcatheter aortic valve implantation (TAVI) has established as a gold standard in the treatment of elderly patients with severe aortic stenosis. Vascular access marks the first step in a TAVI procedure where the transfemoral access is preferred. Therefore, vascular complications are one of the main concerns of operators. With the increasing number of TAVIs performed, the focus is on the prevention and management of vascular complications. Illustrated by a clinical case, this article attempts to review the main vascular complications, their management and how to prevent them.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/cirurgia , Complicações Intraoperatórias/prevenção & controle , Complicações Intraoperatórias/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
AIMS: As transcatheter mitral valve (MV) interventions are expanding and more device types and sizes become available, a tool supporting operators in pre-procedural planning and the clinical decision-making process is highly desirable. We sought to develop a finite element computational simulation model to predict the results of transcatheter edge-to-edge repair (TEER) interventions. METHODS AND RESULTS: We prospectively enrolled patients with secondary mitral regurgitation (MR) referred for a clinically indicated TEER. The 3D trans-oesophageal echocardiograms performed at the beginning of the procedure were used to perform the simulation. On the 3D dynamic model of the MV that was first obtained, we simulated the clip implantation using the same clip type, size, number, and implantation location that was used during the intervention. The 3D model of the MV obtained after the simulation of the clip implantation was compared with the clinical results obtained at the end of the intervention. We analysed the degree and location of residual MR and the shape and area of the diastolic MV area. We performed computational simulation on five patients. Overall, the simulated models predicted well the degree and location of the residual regurgitant orifice(s) but tended to underestimate the diastolic mitral orifice area. CONCLUSION: In this proof-of-concept study, we present preliminary results on our algorithm simulating clip implantation in five patients with functional MR. We show promising results regarding the feasibility and accuracy in terms of predicting residual MR and the need to improve the estimation of the diastolic MV area.
Assuntos
Cateterismo Cardíaco , Simulação por Computador , Ecocardiografia Tridimensional , Ecocardiografia Transesofagiana , Insuficiência da Valva Mitral , Estudo de Prova de Conceito , Humanos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Feminino , Masculino , Estudos Prospectivos , Idoso , Cateterismo Cardíaco/métodos , Ecocardiografia Tridimensional/métodos , Ecocardiografia Transesofagiana/métodos , Implante de Prótese de Valva Cardíaca/métodos , Resultado do Tratamento , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgiaRESUMO
BACKGROUND: Whether ticagrelor in chronic coronary syndrome patients undergoing complex percutaneous coronary intervention (PCI) can prevent cardiovascular events is unknown. OBJECTIVES: The authors sought to evaluate outcomes of complex PCI and the efficacy of ticagrelor vs clopidogrel in stable patients randomized in the ALPHEUS (Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting) trial. METHODS: All PCI procedures were blindly reviewed and classified as complex if they had at least 1 of the following criteria: stent length >60 mm, 2-stent bifurcation, left main, bypass graft, chronic total occlusion, use of atherectomy or guiding catheter extensions, multiwire technique, multiple stents. The primary endpoint was a composite of type 4a or b myocardial infarction (MI) and major myocardial injury during the 48 hours after PCI. We compared the event rates according to the presence or not of complex PCI criteria and evaluated the interaction with ticagrelor or clopidogrel. RESULTS: Among the 1,866 patients randomized, 910 PCI (48.3%) were classified as complex PCI. The primary endpoint was more frequent in complex PCI (45.6% vs 26.6%; P < 0.001) driven by higher rates of type 4 MI and angiographic complications (12.2% vs 4.8 %; P < 0.001 and 19.3% vs 8.6%; P < 0.05, respectively). The composite of death, MI, and stroke at 48 hours (12.7% vs 5.1 %; P < 0.05) and at 30 days (13.4% vs 5.3%; P < 0.05) was more frequent in complex PCI. No interaction was found between PCI complexity and the randomized treatment for the primary endpoint (Pinteraction = 0.47) nor the secondary endpoints. CONCLUSIONS: In chronic coronary syndrome, patients undergoing a complex PCI have higher rates of periprocedural and cardiovascular events that are not reduced by ticagrelor as compared with clopidogrel.
Assuntos
Síndrome Coronariana Aguda , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Síndrome Coronariana Aguda/complicações , Clopidogrel/efeitos adversos , Clopidogrel/uso terapêutico , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Ticagrelor/efeitos adversos , Ticagrelor/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. OBJECTIVES: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. METHODS: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). RESULTS: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. CONCLUSIONS: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.
Assuntos
Cateterismo Cardíaco , Ensaios de Uso Compassivo , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Insuficiência da Valva Tricúspide , Valva Tricúspide , Humanos , Feminino , Masculino , Estudos Retrospectivos , Idoso , Resultado do Tratamento , Fatores de Tempo , Idoso de 80 Anos ou mais , Valva Tricúspide/cirurgia , Valva Tricúspide/fisiopatologia , Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/mortalidade , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Fatores de Risco , Mortalidade Hospitalar , Complicações Pós-Operatórias/etiologia , Veias JugularesRESUMO
BACKGROUND: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. OBJECTIVES: The authors sought to assess the impact of residual TR severity post-TTV repair on survival. METHODS: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). RESULTS: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). CONCLUSIONS: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.
Assuntos
Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca , Índice de Gravidade de Doença , Insuficiência da Valva Tricúspide , Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/fisiopatologia , Insuficiência da Valva Tricúspide/mortalidade , Masculino , Feminino , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Valva Tricúspide/fisiopatologia , Idoso , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Cateterismo Cardíaco/instrumentação , Fatores de Tempo , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Fatores de Risco , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Medição de Risco , Sistema de RegistrosRESUMO
Background: The use of trans-catheter treatment for tricuspid regurgitation (TR) is currently increasing, especially trans-catheter edge-to-edge repair (TEER). However, patients with very large coaptation gaps are usually considered not eligible for this treatment. Case summary: We present the case of an 87-year-old man with symptomatic [New York Heart Association (NYHA) functional Class IV, right-sided heart failure signs] isolated torrential TR due to chronic atrial fibrillation who was initially considered not eligible for a tricuspid valve (TV) TEER because of a very large coaptation gap. A leadless pacemaker was implanted, and the patient received high doses of intravenous diuretics at home during 2 months. After heart team discussion, he was then considered suitable for a TEER procedure. A 'zipping' technique was performed, with the implantation of four TriClip devices, based on the anatomy of the TV and guided by fluoroscopy and bi- and tri-dimensional trans-oesophageal echocardiography, allowing an excellent procedural result (mild TR and mean TV gradient = 1â mmHg). At 6 months, TR was still mild, the patient reported a remarkable improvement (NYHA I, no heart failure signs), and 6-min walk test increased from 260 to 375â m. Discussion: This case underscores the need for heart valve centres with dedicated and experienced teams and networks of care to adequately manage patients with severe TR from pre-procedural choice of cardiac pacing type and optimization of diuretic therapy to customized interventions with appropriate number and location of clips according to the anatomy of the valve and the mechanism of TR, guided by high-quality bi- and tri-dimensional echocardiography.
RESUMO
BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.
Assuntos
Fibrilação Atrial , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Constrição Patológica/etiologia , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Hemodinâmica , Sistema de Registros , Desenho de PróteseRESUMO
AIMS: Tricuspid regurgitation (TR) is associated with significant morbidity and mortality. Its independent prognostic role has been repeatedly demonstrated. However, this valvular heart condition is largely undertreated because of the increased risk of surgical repair. Recently, transcatheter techniques for the treatment of TR have emerged, but their implications for the clinical endpoints are still unknown. METHODS AND RESULTS: The Tri.fr trial will be a multicentre, controlled, randomized (1:1 ratio), superior, open-label, and parallel-group study conducted in 300 patients with severe secondary TR that is considered non-surgical by heart teams. Inclusion will be possible only after core laboratory review of transthoracic and transoesophageal echocardiography and after validation by the clinical eligibility committee. A description of the mechanisms of the TR will be conducted by the core laboratory. Atrial or ventricular impacts on the severity of the secondary TR will be taken into account for the randomization. The patients will be followed for 12-month, and the primary outcome will be the Packer composite clinical endpoint [combining New York Heart Association class, patient global assessment (PGA), and major cardiovascular events]. It will test the hypothesis that a tricuspid valve percutaneous repair strategy using a clip dedicated to the tricuspid valve is superior to best guideline-directed medical therapy in symptomatic patients with severe secondary TR. CONCLUSION: Tri.fr will be the first randomized, academic, multicentre study testing the value of percutaneous correction in patients with severe secondary TR.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Cateterismo Cardíaco/métodos , Resultado do Tratamento , Instrumentos Cirúrgicos , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.
Assuntos
Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Sistema de Registros , Insuficiência Cardíaca/etiologia , Cateterismo Cardíaco , Falha de PróteseRESUMO
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a first-line therapeutic option in patients with severe, symptomatic aortic stenosis at increased surgical risk. Despite its success, the TAVI procedure has been associated with acute life-threatening complications as myocardial infarction secondary to periprocedural coronary occlusion, annular rupture, or vascular injury. CASE SUMMARY: A 79-year-old woman with a dysfunctional bioprosthetic valve following previous surgical valve replacement was hospitalized in our institution to perform a Valve-in-Valve Transcatheter Aortic Valve Replacement (ViV TAVR). Shortly after the implantation of an Evolut R valve (without complication), left ventricle dysfunction with apical akinesia and basal hyperkinesia was identified during bedside transthoracic echocardiography, in spite of a good prosthesis implantation and function. A concomitant Troponin elevation was noted, and the day-after resting electrocardiogram showed a lateral T-wave inversion. Coronary computed tomography angiography showed no coronary stenosis or occlusion, cardiac magnetic resonance imaging showed no necrosis or fibrosis, and no argument for myocarditis. The patient remained asymptomatic during her hospital stay, and the aforementioned anomalies spontaneously regressed after an in-hospital 2-week surveillance. In the presence of these transient anomalies and after ruling out myocardial infarction and myocarditis, post-procedural stress cardiomyopathy (takotsubo) was diagnosed. DISCUSSION: Post-TAVR stress-related cardiomyopathy seems to be an extremely rare entity. To our knowledge, this is the first case of a takotsubo cardiomyopathy after ViV TAVR. Though the association between the two seems likely to be causal, no clear physiopathological explanation can be formulated.
RESUMO
[Figure: see text].
Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Obstrução do Fluxo Ventricular Externo , Cateterismo Cardíaco/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Sistema de Registros , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/etiologia , Obstrução do Fluxo Ventricular Externo/cirurgiaRESUMO
BACKGROUND: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR. METHODS: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries. RESULTS: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk. CONCLUSIONS: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.
Assuntos
Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/etiologia , Medição de Risco/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso de 80 Anos ou mais , Angiografia Coronária , Feminino , Seguimentos , Saúde Global , Mortalidade Hospitalar/tendências , Humanos , Incidência , Masculino , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Fatores de TempoRESUMO
OBJECTIVES: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO). BACKGROUND: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication. METHODS: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR. RESULTS: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days. CONCLUSIONS: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.
Assuntos
Valva Aórtica/cirurgia , Oclusão Coronária/terapia , Próteses Valvulares Cardíacas , Intervenção Coronária Percutânea/instrumentação , Stents , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/etiologia , Oclusão Coronária/mortalidade , Reestenose Coronária/etiologia , Trombose Coronária/etiologia , Europa (Continente) , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Oriente Médio , América do Norte , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
BACKGROUND: Ischemic mitral regurgitation is a condition characterized by mitral insufficiency secondary to an ischemic left ventricle. Primarily, the pathology is the result of perturbation of normal regional left ventricular geometry combined with adverse remodeling. We present a comprehensive review of contemporary surgical, medical, and percutaneous treatment options for ischemic mitral regurgitation, rigorously examined by current guidelines and literature. METHODS: We conducted a literature search of the PubMed database, Embase, and the Cochrane Library (through November 2018) for studies reporting perioperative or late mortality and echocardiographic outcomes after surgical and nonsurgical intervention for ischemic mitral regurgitation. RESULTS: Treatment of this condition is challenging and often requires a multimodality approach. These patients usually have multiple comorbidities that may preclude surgery as a viable option. A multidisciplinary team discussion is crucial in optimizing outcomes. There are several options for treatment and management of ischemic mitral regurgitation with differing benefits and risks. Guideline-directed medical therapy for heart failure is the treatment choice for moderate and severe ischemic mitral regurgitation, with consideration of coronary revascularization, mitral valve surgery, cardiac resynchronization therapy, or a combination of these, in appropriate candidates. The use of transcatheter mitral valve therapy is considered appropriate in high-risk patients with severe ischemic mitral regurgitation, heart failure, and reduced left ventricular ejection fraction, especially in those with hemodynamic instability. CONCLUSIONS: The role of mitral valve surgery and transcatheter mitral valve therapy continues to evolve.