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1.
JACC Cardiovasc Interv ; 17(7): 874-886, 2024 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-38599690

RESUMO

BACKGROUND: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients. OBJECTIVES: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves. METHODS: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed. RESULTS: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation. CONCLUSIONS: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763).


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , 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 , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda , Cateterismo Cardíaco/métodos
2.
Interv Cardiol Clin ; 13(2): 227-235, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38432765

RESUMO

Mitral valve dysfunction is prevalent amongst older patients. Of those not suitable for surgical therapy, mitral transcatheter edge-to-edge repair (TEER) can treat as large proportion of patients, many are not suitable TEER candidates. As such, orthotopic transcatheter mitral valve replacement (TMVR) is an important innovation but it faces significant challenges. Orthotopic TMVR requires a prosthesis with stable anchoring, adequate sealing, minimal footprint in the left ventricle and long term durability. Multidisciplinary expertise in advanced imaging, surgery, heart failure are needed for success.


Assuntos
Insuficiência Cardíaca , Doenças das Valvas Cardíacas , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Ventrículos do Coração , Implantação de Prótese
3.
J Thorac Dis ; 16(2): 1565-1575, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38505020

RESUMO

The treatment of aortic and mitral valve disease requiring replacement has shifted to an increasing use of bioprosthetic heart valves. Due to their limited durability, there is a growing need for reintervention in the setting of failing bioprosthesis. Even though the gold standard for the treatment of failed bioprosthesis remains surgical repair or replacement, valve-in-valve (ViV) transcatheter aortic and mitral valve replacement have emerged as safe and effective alternatives for patients who are at high or prohibitive risk for surgery. Both procedures are associated with a substantial risk of postprocedural thromboembolic events and valvular thrombosis that is often higher than transcatheter replacement of native valves. With guidelines lacking specific protocols and a limited number of available studies, the optimal postprocedural antithrombotic therapy remains to be clarified. Multiple factors including valvular hemodynamics, the characteristics of the failing surgical valve, and the choice of the new transcatheter heart valve (THV) must be considered. Additionally, patients are often at an advanced age with multiple comorbidities and may require oral anticoagulation (OAC) due to other indications such as atrial fibrillation. Although the recommended antithrombotic strategy for native transcatheter aortic valve replacement (TAVR) is antiplatelet monotherapy with aspirin or a P2Y12 inhibitor in the absence of another anticoagulation indication, the use of oral anticoagulants including vitamin K antagonists (VKAs) and direct thrombin inhibitors has been shown to be effective in reducing valvular thrombosis and are commonly used after ViV procedures. Prospective studies investigating these results specifically for ViV transcatheter aortic and mitral valve replacement are needed to identify the optimal antithrombotic therapy.

4.
Radiol Clin North Am ; 62(3): 419-434, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38553178

RESUMO

The range of potential transcatheter solutions to valve disease is increasing, bringing treatment options to those in whom surgery confers prohibitively high risk. As the range of devices and their indications grow, so too will the demand for procedural planning. Computed tomography will continue to enable this growth through the provision of accurate device sizing and procedural risk assessment.


Assuntos
Valva Aórtica , Tomografia Computadorizada por Raios X , Humanos , Valva Aórtica/cirurgia , Tomografia Computadorizada por Raios X/métodos , Medição de Risco , Resultado do Tratamento , Tomografia Computadorizada Multidetectores/métodos
5.
Cardiovasc Revasc Med ; 64: 1-4, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38355340

RESUMO

BACKGROUND: Transcatheter mitral valve replacement (TMVR) faces anatomical challenges, currently limiting widespread adoption. OBJECTIVES: To describe the natural history and prognosis of patients ineligible for various TMVR devices. METHODS: During a 4-year period (2019-2023) 3 TMVR devices (SAPIEN M3, Intrepid and Alta Valve) became available at a single institution (The Christ Hospital, Cincinnati, OH) in the setting of pivotal clinical trials or early feasibility study. Consenting patients who were deemed ineligible ≥1 of these trials were prospectively studied to capture anatomical reasons for ineligibility, cross-over to alternative mitral valve therapies (surgery or high-risk mitral transcatheter edge to edge repair [M-TEER]), and clinical events. RESULTS: A total of 61 patients (out of 71 consenting patients or 85.9 %) were deemed ineligible for TMVR during the study period. The mean age was 79.2 ± 8.8 years, 65.6 % were female, with elevated surgical risk (median STS 4.3, IQR: 2.7-7.3). The 2 most common anatomical reasons for ineligibility were increased risk of left ventricular outflow tract obstruction (LVOTO) (n = 24, 39.3 %) and annular size (n = 29, 47.5 %). During follow-up (median 277 [162-555] days) there were 7 deaths (11.5 %) and 12 (19.7 %) hospitalizations for heart failure. Management strategies included high-risk M-TEER in 11 patients (1 death [9.0 %], 0 HF hospitalizations [0 %]), surgery in 9 patients (0 deaths, 1 HF hospitalizations [11.1 %]), and medical management in 41 patients (6 deaths [14.6 %], 11 HF hospitalizations [26.8 %]) (p = 0.715 for mortality and p = 0.093 for HF hospitalizations). Residual MR ≥ moderate was 0 %, 50 %, and 100 % for surgery, M-TEER and medical treatment, respectively (p < 0.001). CONCLUSIONS: One third of patients deemed ineligible for TMVR are candidates for high-risk M-TEER or surgery with acceptable morbidity and mortality. Our results have practical implications for patient management.


Assuntos
Cateterismo Cardíaco , Definição da Elegibilidade , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Valva Mitral , Seleção de Pacientes , Humanos , Feminino , Masculino , Idoso , Valva Mitral/cirurgia , Valva Mitral/fisiopatologia , Valva Mitral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Idoso de 80 Anos ou mais , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Resultado do Tratamento , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Fatores de Tempo , Medição de Risco , Estudos Prospectivos , Recuperação de Função Fisiológica , Desenho de Prótese , Tomada de Decisão Clínica
6.
JACC Cardiovasc Interv ; 17(5): 648-661, 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38385922

RESUMO

BACKGROUND: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. OBJECTIVES: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. METHODS: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. RESULTS: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. CONCLUSIONS: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335).


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Masculino , Humanos , Idoso , Feminino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Cateterismo Cardíaco/métodos , Sistema de Registros
7.
J Am Coll Cardiol ; 83(2): 317-330, 2024 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-37879489

RESUMO

BACKGROUND: Evidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. OBJECTIVES: The goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. METHODS: Medicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score-matched analysis was used. RESULTS: A total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). CONCLUSIONS: In this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Idoso , Estados Unidos/epidemiologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Reoperação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cateterismo Cardíaco/efeitos adversos , Medicare , Próteses e Implantes , Resultado do Tratamento
8.
Eur J Cardiothorac Surg ; 65(1)2024 Jan 02.
Artigo em Inglês | MEDLINE | ID: mdl-38152923

RESUMO

OBJECTIVES: Relevant paravalvular leakage (PVL) due to prosthesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning manoeuvres. METHODS: From 2017 to 2021, N = 18 patients who underwent secondary tether retensioning were identified. Baseline, procedural and follow-up data were available from N = 11 patients and analysed according to the Mitral Valve Research Consortium definitions. Continuous variables are shown as median with interquartile range. RESULTS: All patients [age 75 years (73.5, 85.0), 64% male (N = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N = 7) with PVL ≥3+]. Of these, 54% (N = 6) showed signs of haemolysis. The majority were severely symptomatic [New York Heart Association ≥III (91%, N = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N = 10) of patients with 1 case of remaining moderate PVL. At 30 days, Mitral Valve Research Consortium device success was achieved in 82% (N = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N = 8) of patients with successful retensioning procedure, New York Heart Association class was I/II. There was no 30-day mortality. CONCLUSIONS: This multicentre study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk.


Assuntos
Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Masculino , Idoso , Feminino , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento , New York , Cateterismo Cardíaco/métodos
9.
Am J Cardiol ; 214: 8-17, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38104756

RESUMO

This study aimed to evaluate the incidence and clinical implications of myocardial injury, as determined by cardiac biomarker increase, in patients who underwent mitral bioprosthesis dysfunction treatment with transcatheter mitral valve replacement (TMVR) versus surgical mitral valve replacement reoperation (SMVR-REDO). Between 2014 and 2023, 310 patients with mitral bioprosthesis failure were included (90 and 220 patients for TMVR and SMVR-REDO, respectively). Multivariable analysis and propensity score matching were performed to adjust for the intergroup differences in baseline characteristics. Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTn) were collected at baseline and 6 to 12, 24, 48, and 72 hours after intervention. The cardiac biomarkers values were evaluated in relation to their reference values. The outcomes were determined according to the Mitral Valve Academic Research Consortium criteria. CK-MB and cTn increased above the reference level in almost all patients after SMVR-REDO and TMVR (100% vs 94%, respectively), with the peak occurring within 6 to 12 hours. SMVR-REDO was associated with a two- to threefold higher increase in cardiac biomarkers. After 30 days, the mortality rates were 13.3% in the TMVR and 16.8% in the SMVR-REDO groups. At a median follow-up of 19 months, the mortality rates were 21.1% in the TMVR and 17.7% in the SMVR-REDO groups. Left ventricular ejection fraction, estimated glomerular filtration rate, CK-MB, and cTn were predictors of mortality. In conclusion, some degree of myocardial injury occurred systematically after the treatment of mitral bioprosthetic degeneration, especially after SMVR, and higher CK-MB and cTn levels were associated with increased cumulative late mortality, regardless of the approach.


Assuntos
Doenças das Valvas Cardíacas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Valva Mitral/cirurgia , Reoperação , Implante de Prótese de Valva Cardíaca/efeitos adversos , Volume Sistólico , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Resultado do Tratamento , Função Ventricular Esquerda , Doenças das Valvas Cardíacas/cirurgia , Biomarcadores , Cateterismo Cardíaco/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos
10.
J Cardiothorac Surg ; 18(1): 315, 2023 Nov 10.
Artigo em Inglês | MEDLINE | ID: mdl-37950282

RESUMO

BACKGROUND: Transcatheter mitral valve replacement (TMVR) using the Tendyne™ valve is regarded as one of the most studied TMVR systems. The first human experience with the procedure was reported in 2013. The present study aims to systemically revise the published literature to document the global experience with TMVR using the Tendyne™ valve. METHODS: The present review was conducted in line with the PRISMA statement on systematic reviews. Database included in the search process were Scopus, Web of Science and Pubmed. Search was processed using multiple keywords combinations and was adjusted to English literature only. RESULTS: We included 26 articles in the final analysis reporting data from 319 patients. Patients recruited by the included studies comprised 192 males (60.2%) and 127 females (39.8%). In the studied patients, mitral annular calcification (MAC) was reported in 107 patients (33.5%). Preoperatively, MR grades 1,2 and 3-4 were reported in 3,5 and 307 patients respectively. Postoperatively, MR grades 1, 2 and 4 were reported in only 12, 3 and 1 patients respectively. Technical success was achieved in 309 patients (96.9%). Follow up durations widely varied among different studies from just days before discharge to 6 years. At the end of follow up, 79 patients died (24.8%) including 52 patients (16.3%) due to cardiovascular causes. CONCLUSIONS: Management of mitral valve disease using the Tendyne system appears to be a promising minimally invasive option for many high-risk patients with accepted procedural feasibility and safety profile.


Assuntos
Doenças das Valvas Cardíacas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Masculino , Feminino , Humanos , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Doenças das Valvas Cardíacas/cirurgia , Doenças das Valvas Cardíacas/etiologia , Catéteres , Resultado do Tratamento , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia
12.
Artigo em Inglês | MEDLINE | ID: mdl-37839658

RESUMO

OBJECTIVE: Transatrial transcatheter mitral valve replacement reduces complexity during mitral valve replacements involving high-risk patients with mitral annular calcification. This study examines trends in transatrial transcatheter mitral valve replacement use and outcomes. METHODS: Patients in the Society of Thoracic Surgeons database from 2014 to 2021 with mitral annular calcification undergoing transatrial transcatheter mitral valve replacement were included. Exclusion criteria were hypertrophic cardiomyopathy, congenital mitral valve disease, ventricular assist device placement, or prior mitral valve surgery. Primary outcomes were operative mortality and major adverse cardiac events compared between the Early (2014-2017, N = 71) and Recent (2018-2021, N = 151) eras. Parsimonious multivariable regression assessed select possible confounders for trends in major adverse cardiac events. RESULTS: Overall, 222 transatrial transcatheter mitral valve replacements at 104 hospitals were identified. Annual volume increased from 6 in 2014 to 43 in 2021. Median hospital volume was 1, maximum hospital volume was 17, and 10 or more replacements were performed at 4 hospitals. Mortality and major adverse cardiac events occurred in 10.4% and 22.5% of patients, respectively. Compared with the Early era patients, Recent era patients were more often elective (79.5% vs 64.8%) and were approached via sternotomy (90.1% vs 80.3%, all P < .05). Despite similar predicted risk of mortality (9.6% ± 11.1% vs 11.0% ± 6.0%; P = .61), Recent patients had reduced mortality (3.3% vs 25.4%, P < .001) and major adverse cardiac events (18.5% vs 31.0%; P = .057). On univariate and multivariable analyses, the Recent surgical era was significantly associated with lower mortality (0.10 [0.04-0.29]; P < .001) and lower major adverse cardiac events (0.48 [0.25-0.94]; P = .032), respectively. There were no preoperative characteristics that were significant confounders for the difference in major adverse cardiac events. CONCLUSIONS: Mortality and major adverse cardiac events after transatrial transcatheter mitral valve replacement have decreased significantly in the contemporary era independent of changes in major patient and operative characteristics. Transatrial transcatheter mitral valve replacement will have a future role in patients with mitral annular calcification.

13.
JACC Cardiovasc Interv ; 16(18): 2211-2227, 2023 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-37758379

RESUMO

BACKGROUND: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve-in-mitral annular calcification (ViMAC). OBJECTIVES: The aim of this study was to evaluate 5-year outcomes among these patients. METHODS: A multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. RESULTS: A total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. CONCLUSIONS: MViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.


Assuntos
Calcinose , Cardiomiopatias , Doenças das Valvas Cardíacas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Doenças Vasculares , Humanos , Idoso , Idoso de 80 Anos ou mais , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Cateterismo Cardíaco/métodos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/etiologia , Calcinose/cirurgia , Doenças Vasculares/etiologia
14.
JACC Cardiovasc Interv ; 16(18): 2195-2210, 2023 09 25.
Artigo em Inglês | MEDLINE | ID: mdl-37758378

RESUMO

Mitral annular calcium (MAC) with severe mitral valvular dysfunction presents a complex problem, as valve replacement, either surgical or transcatheter, is challenging because of anatomy, technical considerations, concomitant comorbidities, and advanced age. The authors review the clinical and anatomical features of MAC that are favorable (green light), challenging (yellow light), or prohibitive (red light) for surgical or transcatheter mitral valve interventions. Under the auspices of the Heart Valve Collaboratory, an expert working group of cardiac surgeons, interventional cardiologists, and interventional imaging cardiologists was formed to develop recommendations regarding treatment options for patients with MAC as well as a proposed grading and staging system using both anatomical and clinical features.


Assuntos
Calcinose , Doenças das Valvas Cardíacas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Resultado do Tratamento , Doenças das Valvas Cardíacas/complicações , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/terapia , Calcinose/diagnóstico por imagem , Calcinose/terapia , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/terapia
15.
Heart Int ; 17(1): 19-26, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37456353

RESUMO

Mitral annular calcification (MAC) is a progressive degenerative calcification of the mitral valve (MV) that is associated with mitral stenosis, regurgitation or both. Patients with MAC are poor candidates for MV surgery because of technical challenges and high peri-operative mortality. Transcatheter MV replacement (TMVR) has emerged as an option for such high surgical risk patients. This has been described with the use of the SAPIEN transcatheter heart valve (valve-in-MAC) and dedicated TMVR devices. Careful anatomic assessment is important to avoid complications of TMVR, such as left ventricular outflow tract obstruction, valve migration, embolization and paravalvular mitral regurgitation. In this review, we discuss the pathology, importance of preprocedural multimodality imaging for optimal patient selection, clinical outcomes and complications associated with TMVR in patients with MAC.

16.
JACC Cardiovasc Interv ; 16(12): 1437-1447, 2023 06 26.
Artigo em Inglês | MEDLINE | ID: mdl-37380225

RESUMO

Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments.


Assuntos
Cardiologia , Medicare , Idoso , Humanos , Estados Unidos , Resultado do Tratamento , Catéteres , Centers for Medicare and Medicaid Services, U.S. , Estudos Multicêntricos como Assunto
17.
Front Cardiovasc Med ; 10: 1137663, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37378395

RESUMO

Background: Valve-in-valve transcatheter mitral valve replacement (ViV-TMVR) is a minimally invasive option for patients with bioprosthetic mitral valve failure. Since January 2019, our center has been using a new innovative option, J-Valve, to treat patients with bioprosthetic mitral valve failure who were at high risk for open heart surgery. The aim of this study is to explore the effectiveness and safety of J-Valve and report the results from the four-year follow-up period of the innovative application of the transcatheter valve. Methods: Patients who underwent the ViV-TMVR procedure between January 2019 and September 2022 in our center were included in the study. J-Valve™ system (JC Medical Inc., Suzhou, China) with three U-shape grippers was used for ViV-TMVR via transapical approach. Data on survival, complications, transthoracic echocardiographic results, New York Heart Association functional class in heart failure, and patient-reported health-related quality of life according to the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) were collected during the four-year follow up. Results: Thirty-three patients (mean age 70.1 ± 1.1 years, 13 men) were included and received ViV-TMVR. The surgery success rate was 97%: only one patient was converted to open-heart surgery due to intraoperative valve embolization to the left ventricle. During the first 30 days all-cause mortality was 0%, risk of stroke 2.5% and risk of mild paravalvular leak 15.2%; mitral valve hemodynamics improved (179.7 ± 8.9 at 30 days vs. 269 ± 49 cm/s at baseline, p < 0.0001). Median time from operation to discharge was six days, and there were no readmissions within 30 days from operation. The median and maximum follow-up durations were 28 and 47 months, respectively; during the entire follow-up, all-cause mortality was 6.1%, and the risk of cerebral infarction 6.1%. Cox regression analysis did not identify any variables significantly associated with survival. The New York Heart Association functional class and the KCCQ-12 score improved significantly compared with their preoperative values. Conclusion: The use of J-Valve for ViV-TMVR is safe and effective with a high success rate, low mortality and very few associated complications, representing an alternative surgical strategy for the elderly, high-risk patients with bioprosthetic mitral valve failure.

18.
Methodist Debakey Cardiovasc J ; 19(3): 37-49, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37213881

RESUMO

Transcatheter mitral valve replacement (TMVR) using the SAPIEN platform has been performed in failed bioprosthetic valves (valve-in-valve), surgical annuloplasty rings (valve-in-ring), and native valves with mitral annular calcification (MAC) (valve-in-MAC). Experience over the past decade has identified important challenges and solutions to improve clinical outcomes. In this review, we discuss the indication, trend in utilization, unique challenges, procedural planning, and clinical outcomes of valve-in-valve, valve-in-ring, and valve-in-MAC TMVR.


Assuntos
Calcinose , Doenças das Valvas Cardíacas , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Calcinose/diagnóstico por imagem , Calcinose/etiologia , Calcinose/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/cirurgia
19.
Eur J Cardiothorac Surg ; 64(2)2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37067485

RESUMO

OBJECTIVES: The Commando technique for reconstruction of the aortomitral intervalvular fibrous body is effective to facilitate double valve surgery in cases of endocarditis or infiltrative calcification. The length of patch utilized in reconstruction of the intervalvular fibrous body has an important relationship to the geometry of the mitral valve (MV) and aortic valve (AV) and may impact on potential future valve-in-valve (VIV) therapy. Here we report anatomic measurements after Commando reconstruction in a small group of patients and analyse the impact of reconstruction techniques on transcatheter VIV therapies. METHODS: Seven patients from January 2018 to April 2022 who underwent double valve surgery with the Commando technique with postoperative computed tomography (CT) scans were identified. Computed tomographic reconstruction of the AV and MV was performed using 3mensio software and virtual transcatheter valve replacement was performed. Two of these patients who had preoperative imaging was analysed to assess the change in aortomitral geometry resulting from reconstruction. RESULTS: Measurements for each patient post-reconstruction are given in the table. Aortomitral length was grossly inversely proportional to aortomitral angle (AMA). AMA and aortomitral curtain (AMC) length were significantly altered post-Commando in 2 analysed patients with pre- and postoperative computed tomography scan. Transcatheter AV and MV replacements were feasible in all patients post-Commando. The AMA was larger and more favorable for mitral VIV in patients in which the AMC was short. CONCLUSIONS: AMC length, as determined by location of AV annular sutures, may be an important consideration in surgical decision-making for VIV after the Commando procedure.


Assuntos
Endocardite , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Implante de Prótese de Valva Cardíaca/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Endocardite/cirurgia , Resultado do Tratamento
20.
JACC Case Rep ; 8: 101672, 2023 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-36860564

RESUMO

Radiation therapy is the standard of care for achieving cure for many thoracic malignancies, but it can result in long-term cardiovascular sequelae such as valve disease. We describe a rare case of severe aortic and mitral stenosis due to prior radiation therapy for giant cell tumor treated successfully with percutaneous aortic and off-label mitral valve replacements. (Level of Difficulty: Intermediate.).

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