RESUMO
BACKGROUND: There is a paucity of data regarding the comparative efficacy and safety of Mitral valve transcatheter edge-to-edge repair (MTEER) using the PASCAL or MitraClip systems for patients with mitral regurgitation (MR). METHODS: An electronic search was conducted for MEDLINE, COCHRANE, and EMBASE, through February 2023, for studies comparing the clinical outcomes of MTEER using PASCAL versus MitraClip systems among patients with severe MR. The primary study outcome was residual MR ≤ 2 at discharge. Data were pooled using a random-effects model. RESULTS: The final analysis included six studies with a total of 1581 patients, with a weighted follow-up period of 3.5 months. Two studies only included patients with degenerative MR, while the remaining studies included both degenerative and functional MR. There was no significant difference in procedure duration between MTEER with the PASCAL or MitraClip systems. There was no difference in residual MR ≤ 2 at discharge (94.7% vs. 91.9%; odds ratio [OR]: 1.44; 95% confidence interval [CI]: 0.92-2.27) or residual MR ≤ 2 at the mid-term follow-up (94.6% vs. 91.0%, p = 0.05) among the PASCAL versus MitraClip systems. There was no difference between both groups in residual MR ≤ 1 at discharge (73.1% vs. 63.8%, p = 0.12), while there was greater incidence of residual MR ≤ 1 at midterm follow-up with the PASCAL system (71.3% vs. 56.2%, p < 0.001). There was no difference between the PASCAL and MitraClip MTEER systems in technical success (97.0% vs. 97.9%, p = 0.15), procedural success (89.1% vs. 87.1%, p = 0.78), single leaflet detachment (1.8% vs. 1.4%, p = 0.55), or all-cause mortality (3.6% vs. 4.6%, p = 0.71). CONCLUSION: In this meta-analysis, we demonstrated comparable efficacy and safety between the PASCAL and MitraClip MTEER systems at short- and mid-term assessments. Randomized trials are warranted to evaluate the comparative long-term outcomes between both MTEER systems.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Resultado do Tratamento , Cateterismo Cardíaco/efeitos adversosRESUMO
Background: Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods: We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results: From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. Conclusions: In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Humanos , Estados Unidos/epidemiologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Resultado do Tratamento , Medicare , Insuficiência da Valva Mitral/cirurgia , Cateterismo CardíacoRESUMO
AIMS: Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group. METHODS AND RESULTS: Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001). CONCLUSIONS: Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit. SHORT ABSTRACT: In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).
Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica , Insuficiência Cardíaca , Complicações Pós-Operatórias , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/complicações , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Próteses Valvulares Cardíacas , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Sistema de Registros/estatística & dados numéricos , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.
Assuntos
Valvuloplastia com Balão/instrumentação , Cateteres Cardíacos , Desenho de Equipamento , Análise de Falha de Equipamento , Teste de Materiais , PressãoRESUMO
PURPOSE OF REVIEW: To review the current status and indications of transcatheter edge-to-edge mitral valve repair. RECENT FINDINGS: Mitral regurgitation remains a common valvular disease and can be classified as degenerative (primary) or functional (secondary). Randomized controlled trials have shown that transcatheter edge-to-edge mitral valve repair with MitraClip is successful, safe, and effective in reducing mitral regurgitation. The US Food and Drug Administration approved MitraClip in 2013 for treatment of patients with primary mitral regurgitation at prohibitive surgical risk and in 2019 for secondary mitral regurgitation. Several MitraClip generations exist (NT/R, XT/R, NTW, and XTW) with unique features and considerations. Additional edge-to-edge repair, non-edge-to-edge repair, and transcatheter valve replacement systems are under investigation as stand-alone or adjunctive therapy for patients with mitral regurgitation. Mitral regurgitation remains a significant health burden and many patients are not suitable for surgical repair or replacement. Transcatheter mitral valve therapies can be considered in selected patients and are safe and effective. More research is needed to understand how to best select devices and patients and optimize outcomes.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco , Humanos , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/cirurgiaRESUMO
PURPOSE OF REVIEW: This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR). RECENT FINDINGS: Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown. BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Valva Aórtica/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Desenho de Prótese , Falha de Prótese , Reoperação , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVES: To construct a model to predict long-term bleeding events following percutaneous coronary intervention (PCI). BACKGROUND: Treatment with dual antiplatelet therapy following PCI involves balancing the benefits of preventing ischemic events with the risks of bleeding. There are no models to predict long-term bleeding events after PCI. METHODS: We analyzed 1-year bleeding outcomes from 3,128 PCI procedures in the Patient Risk Information Services Manager (PRISM) observational study. Patient-reported bleeding events were categorized according to Bleeding Academic Research Consortium (BARC) definitions. Logistic regression analysis was used to develop a model predicting BARC ≥ 1 bleeding. RESULTS: BARC 0, 1, 2 or 3 bleeding was observed in 574 (18.4%); 2382 (76.2%); 114 (3.6%); and 58 (1.8%) patients, respectively. Compared to patients who had no bleeding, patients with BARC ≥ 1 bleeding were more often female (30 vs. 23%), Caucasian (94 vs. 83%), had a higher incidence of drug eluting stent (DES) implantation (83 vs. 76%) and warfarin therapy (7.4 vs. 3.9%), and a lower incidence of diabetes (31 vs. 45%; P-value <0.01 for all comparisons). A 27-variable model had moderate discrimination (c-statistic of 0.674), and good calibration, as did a parsimonious model with 10 variables (c-statistic = 0.667). This model performed well in predicting BARC ≥ 2 bleeding events as well (c-statistic = 0.653). CONCLUSIONS: Bleeding is common in the first year after PCI, and can be predicted by pre-procedural patient characteristics and use of DES. Objective estimates of bleeding risk may help support shared decision-making with respect to stent selection and duration of antiplatelet therapy following PCI. © 2016 Wiley Periodicals, Inc.
Assuntos
Hemorragia/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Idoso , Comorbidade , Técnicas de Apoio para a Decisão , Análise Discriminante , Quimioterapia Combinada , Stents Farmacológicos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/terapia , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Seleção de Pacientes , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVES: To assess patients' perspective about factors associated with stent choice. BACKGROUND: Drug eluting stents (DES) markedly reduce the risk of repeat percutaneous coronary intervention (PCI), but necessitate a longer duration of dual anti-platelet therapy (DAPT) as compared with bare metal stents (BMS). Thus, understanding patients' perspective about factors associated with stent choice is paramount. METHODS: Patients undergoing angiography rated, on a 10-point scale, the importance (1 = not important, 10 = most important) of avoiding repeat revascularization and avoiding the following potential DAPT drawbacks: bleeding/bruising, more pills/day, medication costs and delaying elective surgery. The factor, or group of factors, that was rated highest by each patient was identified. RESULTS: Among 311 patients, repeat revascularization was the single most important consideration to 14.4% of patients, while 20.6% considered avoiding one of the DAPT drawbacks as most important. Most patients (65%) considered avoiding at least one DAPT drawback as important as avoiding repeat revascularization. In no subgroup of patients did more than a quarter of patients prefer avoiding repeat revascularization above all other concerns. Among patients undergoing PCI, more than three quarters received a DES, regardless of their stated preferences (DES use among those most valuing DES benefits, avoiding DAPT drawbacks, or both equally were 78.7%, 86.2%, and 85.6%, respectively, P = 0.56). CONCLUSION: Most patients reported that avoiding DAPT drawbacks was as important as avoiding repeat revascularization. Eliciting patient preferences regarding stent type can enhance shared decision-making and allow physicians to better tailor stent choice to patients' goals and values. TRIAL REGISTRATION: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (DECIDE-PCI). ClinicalTrials.gov Identifier: NCT02046902. URL: https://clinicaltrials.gov/ct2/show/NCT02046902 © 2017 Wiley Periodicals, Inc.
Assuntos
Técnicas de Apoio para a Decisão , Stents Farmacológicos , Metais , Preferência do Paciente , Intervenção Coronária Percutânea/instrumentação , Inibidores da Agregação Plaquetária/administração & dosagem , Stents , Tomada de Decisão Clínica , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/terapia , Estudos Transversais , Custos de Medicamentos , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Missouri , Participação do Paciente , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/economia , Desenho de Prótese , Retratamento , Fatores de Risco , Resultado do TratamentoRESUMO
Left atrial appendage closure with the WATCHMAN device is an alternative to chronic oral anticoagulation for thromboembolic prophylaxis in atrial fibrillation patients. Left atrial device-related thrombus (DRT) has been described in the first year after implant with an incidence of ~6%. A 79-year-old man underwent WATCHMAN device placement in 2006. Routine protocol specified follow-up transesophageal echocardiograms (TEE) at 6 weeks, 6 months, and 1 year following implant showed no evidence for DRT or peri-device flow. A decade after device implant, the patient presented with severe symptomatic aortic stenosis and underwent repeat TEE, which revealed a 21 mm × 18 mm DRT on the LA aspect of the WATCHMAN device. He was prescribed apixaban 5 mg po BID. A TEE performed 111 days later demonstrated marked diminution in the DRT (9 mm in diameter). This case demonstrates that WATCHMAN DRT may occur late following implantation.
Assuntos
Apêndice Atrial/cirurgia , Ecocardiografia Tridimensional/métodos , Ecocardiografia Transesofagiana/métodos , Dispositivos de Proteção Embólica/efeitos adversos , Previsões , Cardiopatias/diagnóstico , Trombose/diagnóstico , Idoso , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Seguimentos , Cardiopatias/etiologia , Humanos , Masculino , Falha de Prótese , Trombose/etiologiaRESUMO
BACKGROUND: The foundation of precision medicine is the ability to tailor therapy based upon the expected risks and benefits of treatment for each individual patient. In a prior study, we implemented a software platform, ePRISM, to execute validated risk-stratification models for patients undergoing percutaneous coronary intervention and found substantial variability in the use of the personalized estimates to tailor care. A better understanding of physicians' perspectives about the use of individualized risk-estimates is needed to overcome barriers to their adoption. METHODS: In a qualitative research study, we conducted interviews, in-person or by telephone, with 27 physicians at 8 centers that used ePRISM until thematic saturation occurred. Data were coded using descriptive content analyses. RESULTS: Three major themes emerged among physicians who did not use ePRISM to support decision making: (1) "Experience versus Evidence," physicians' preference to rely upon personal experience and subjective assessments rather than objective risk estimates; (2) "Omission of Therapy," the perception that the use of risk models leads to unacceptable omission of potentially beneficial therapy; and (3) "Unnecessary Information," the opinion that information derived from risk models is not needed because physicians' decision making is already sound and they already know the information. CONCLUSIONS: Barriers to the use of risk models in clinical practice include physicians' perceptions that their experience is sufficient, that models may lead to omission of therapy in patients that may benefit from therapy, and that they already provide good care. Anticipating and overcoming these barriers may improve the adoption of precision medicine.
Assuntos
Atitude do Pessoal de Saúde , Cardiologistas , Tomada de Decisão Clínica , Intervenção Coronária Percutânea , Medicina de Precisão , Medição de Risco , Feminino , Humanos , Masculino , Médicos , Pesquisa QualitativaRESUMO
BACKGROUND: Patients with diabetes mellitus (DM) experience higher rates of in-stent restenosis and greater benefit from drug-eluting stents implant at the time of percutaneous coronary intervention (PCI), necessitating prolonged dual anti-platelet therapy (DAPT). While DAPT reduces risk of ischemic events post-PCI, it also increases risk of bleeding. Whether bleeding rates differ among patients with and without DM, receiving long-term DAPT is unknown. METHODS: Among patients who underwent PCI and were maintained on DAPT for 1 year in a multicenter US registry, we assessed patient-reported bleeding over one year following PCI in patients with and without DM. Multivariable, hierarchical Poisson regression was used to evaluate the association of DM with bleeding during follow-up. RESULTS: Among 2334 PCI patients from 10 US hospitals (mean age 64, 54% ACS), 32.6% had DM. In unadjusted analyses, patients with DM had fewer bleeding events over the year following PCI (DM vs no DM: BARC = 1: 78.0% vs 87.7%, P < .001; BARC ≥2: 4.3% vs 5.3%, P = .33). Following adjustment, patients with (vs without DM) had a lower risk of BARC ≥1 bleeding during follow-up (relative risk [RR] 0.89, 95% CI 0.83-0.96). This decreased bleeding risk persisted after removing bruising from the endpoint definition. CONCLUSIONS: In a real-world PCI registry, patients with DM experienced lower risk of bleeding risk on DAPT. As patients with DM also derive greater ischemic benefit from drug-eluting stents, which requires prolonged DAPT, our findings suggest that the balance between benefit and risk of this therapeutic approach may be even more favorable in patients with DM than previously considered.
Assuntos
Aspirina , Doença da Artéria Coronariana , Diabetes Mellitus/epidemiologia , Hemorragia , Intervenção Coronária Percutânea , Piridinas , Idoso , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Comorbidade , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/terapia , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/métodos , Quimioterapia Combinada/estatística & dados numéricos , Stents Farmacológicos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Efeitos Adversos de Longa Duração/epidemiologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Piridinas/administração & dosagem , Piridinas/efeitos adversos , Sistema de Registros/estatística & dados numéricos , Medição de RiscoRESUMO
With the large number of late breaking clinical trials presented at major meetings, it is often difficult to stay current with advances in interventional cardiology. Therefore, the SCAI Publications Committee summarizes and provides editorial commentary on the most important structural heart and peripheral artery disease late-breaking trials from 2015. © 2016 Wiley Periodicals, Inc.
Assuntos
Cardiologia/métodos , Ensaios Clínicos como Assunto/métodos , Cardiopatias/terapia , Doença Arterial Periférica/terapia , Sociedades Médicas , Humanos , Estados UnidosRESUMO
BACKGROUND: Drug-eluting stents (DES) reduce restenosis, as compared with bare-metal stents (BMS); however, the relationship between stent type and health status is unknown. We examined whether stent type was associated with health status outcomes in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: We evaluated 6- and 12-month health status in 2,694 patients with acute myocardial infarction (AMI) enrolled in the TRIUMPH and PREMIER registries who underwent PCI with DES (n = 1,361) or BMS (n = 1,333). Health status was assessed with the Seattle Angina Questionnaire, Medical Outcomes Study Short Form-12, and Patient Health Questionnaire depression scale. Propensity matching was performed to account for baseline differences in patient characteristics, resulting in a comparison cohort of 784 patients treated with DES and 784 patients treated with BMS. Both groups experienced significant improvements in health status at 6 and 12 months after PCI. Drug-eluting stent use was associated with a small improvement in Seattle Angina Questionnaire quality of life and functional limitation scores at 6 months (3.6 [95% CI 0.96-6.21], P = .007, and 3.8 [1.55-6.01], P < .001, respectively), but not at 12 months (2.3 [-0.46 to 5.03], P = .10, and 0.3 [-2.04 to 2.48], P = .85, respectively). CONCLUSIONS: In patients with AMI undergoing PCI, DES use was associated with transient but unsustained health status benefits over 12 months after AMI.
Assuntos
Nível de Saúde , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/psicologia , Qualidade de Vida , Sistema de Registros , Stents , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/psicologia , Período Pós-Operatório , Prognóstico , Desenho de Prótese , Estudos Retrospectivos , Fatores de TempoRESUMO
Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients.
Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Implante de Prótese de Valva Cardíaca , Hemodinâmica , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Índice de Gravidade de Doença , Humanos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/terapia , Europa (Continente) , Estados Unidos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Aórtica/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. OBJECTIVES: The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT. METHODS: MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH). RESULTS: Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in-hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients. CONCLUSIONS: Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH.
Assuntos
Insuficiência Cardíaca , Insuficiência da Valva Mitral , Humanos , Insuficiência da Valva Mitral/cirurgia , Volume Sistólico , Função Ventricular Esquerda , Insuficiência Cardíaca/cirurgia , Choque CardiogênicoRESUMO
BACKGROUND: A single, multitiered valve center designation has been proposed to publicly identify centers with expertise for all valve therapies. The correlation between transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (MTEER) procedures is unknown. OBJECTIVES: The authors sought to examine the relationship between site-level volumes and outcomes for TAVR and MTEER. We further explored variability between sites for MTEER outcomes. METHODS: Using the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) national registry, TAVR and MTEER procedures at sites offering both therapies from 2013 to 2022 were examined. Sites were ranked into deciles of adjusted in-hospital and 30-day outcomes separately for TAVR and MTEER and compared. Stepwise, hierarchical multivariable models were constructed for MTEER outcomes, and the median OR was calculated. RESULTS: Between 2013 and 2022, 384,394 TAVRs and 53,274 MTEERs (median annualized volumes: 93.6 and 18.8, respectively) were performed across 453 U.S. sites. Annualized TAVR and MTEER volumes were moderately correlated (r = 0.48; P < 0.001). After adjustment, 14.3% of sites had the same decile rank for TAVR and MTEER 30-day composite outcome, 50.6% were within 2 decile ranks; 35% had more discordant outcomes for the 2 procedures (P = 0.0005). For MTEER procedures, the median OR for the 30-day composite outcome was 1.57 (95% CI: 1.51-1.64), indicating a 57% variability in outcome by site. CONCLUSIONS: There is modest correlation between hospital-level volumes for TAVR and MTEER but low interprocedural correlation of outcomes. For similar patients, site-level variability for mortality/morbidity following MTEER was high. Factors influencing outcomes and "centers of excellence" as a whole may differ for TAVR and MTEER.
Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Estados Unidos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Resultado do Tratamento , Sistema de Registros , Hospitais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Fatores de RiscoRESUMO
Background: Baseline left ventricular diastolic dysfunction (LVDD) is associated with poor health status in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but health status improvement after TAVR appears similar across all grades of LVDD. Here, we aim to examine the relationship between changes in LVDD severity and health status outcomes following TAVR. Methods: Patients who underwent TAVR and had evaluable LVDD at both baseline and 1 year in the PARTNER (Placement of Aortic Transcatheter Valves) 2 SAPIEN 3 registries and PARTNER 3 trial were analyzed. LVDD grade was evaluated using echocardiography core lab data and an adapted definition of American Society of Echocardiography guidelines. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. The association between ΔLVDD severity and ΔKCCQ-OS was examined using linear regression models adjusted for baseline KCCQ-OS. Results: Of 1100 patients, 724 (65.8%), 283 (25.7%), and 93 (8.5%) had grade 0/1, 2, and 3 LVDD at baseline, respectively. At 1 year, LVDD severity was unchanged in 790 (71.8%) patients, improved in 189 (17.2%), and worsened in 121 (11.0%). Among 376 patients with baseline grade 2 or 3 LVDD, 50.3% had improvement in LVDD. In the overall cohort, KCCQ-OS score improved by 21.9 points at 1 year. There was a statistically significant association between change in LVDD severity (improved, unchanged, and worsened) and ΔKCCQ-OS at 1 year (p = 0.007). Conclusions: Change in LVDD grade was associated with change in health status 1 year following TAVR.
RESUMO
IMPORTANCE: Bleeding is the most common complication after percutaneous coronary intervention (PCI) and is associated with increased morbidity and health care costs. The incidence of bleeding-related mortality after PCI has not been described in a nationally representative population. Furthermore, the relationships among bleeding risk, bleeding site, and mortality are unclear. OBJECTIVES: To describe the association between bleeding events and in-hospital mortality after PCI and to estimate the adjusted population attributable risk (estimated as the proportion of mortality risk associated with bleeding events), risk difference, and number needed to harm (NNH) for bleeding-related in-hospital mortality after PCI. DESIGN, SETTING, AND PATIENTS: Data from 3,386,688 procedures in the CathPCI Registry performed in the United States between 2004 and 2011 were analyzed. The population attributable risk was calculated after adjustment for baseline demographic, clinical, and procedural variables. To calculate the NNH for bleeding-related mortality, a propensity-matched analysis was performed. MAIN OUTCOME MEASURES: In-hospital mortality. RESULTS: There were 57,246 bleeding events (1.7%) and 22,165 in-hospital deaths (0.65%) in 3,386,688 PCI procedures. The adjusted population attributable risk for mortality related to major bleeding was 12.1% (95% CI, 11.4%-12.7%) in the entire CathPCI cohort. The propensity-matched population consisted of 56,078 procedures with a major bleeding event and 224 312 controls. In this matched cohort, major bleeding was associated with increased in-hospital mortality (5.26% vs 1.87%; risk difference, 3.39% [95% CI, 3.20%-3.59%]; NNH = 29 [95% CI, 28-31]; P < .001). The association between major bleeding and in-hospital mortality was observed in all strata of preprocedural bleeding risk (low: 1.62% vs 0.17%; risk difference, 1.45% [95% CI, 1.13%-1.77%], NNH = 69 [95% CI, 57-88], P < .001; intermediate: 3.27% vs 0.71%; risk difference, 2.56% [95% CI, 2.33%-2.79%], NNH = 39 [95% CI, 36-43], P < .001; and high: 8.16% vs 3.45%; risk difference, 4.71% [95% CI, 4.35%-5.07%], NNH = 21 [95% CI, 20-23], P < .001). Although both access-site and non-access-site bleeding were associated with increased in-hospital mortality (2.73% vs 1.87%; risk difference, 0.86% [95% CI, 0.66%-1.05%], NNH = 117 [95% CI, 95-151], P < .001; and 8.25% vs 1.87%; risk difference, 6.39% [95% CI, 6.04%-6.73%], NNH = 16 [95% CI, 15-17], P < .001, respectively), the NNH was lower for nonaccess bleeding. CONCLUSIONS AND RELEVANCE: In a large registry of patients undergoing PCI, postprocedural bleeding events were associated with increased risk of in-hospital mortality, with an estimated 12.1% of deaths related to bleeding complications.
Assuntos
Hemorragia/etiologia , Hemorragia/mortalidade , Mortalidade Hospitalar , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Sistema de Registros/estatística & dados numéricos , Medição de Risco , Estados Unidos/epidemiologiaRESUMO
INTRODUCTION: Valve-in-valve (VIV) transcatheter valve replacement has emerged as a feasible and potentially safer treatment option for failed bioprosthetic surgical valves (BSVs). However, the VIV procedure carries an inherent risk of prosthesis-patient mismatch (PPM). Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) by either fracturing or stretching the surgical valve ring allows for a more optimal expansion of the transcatheter heart valve (THV) and beneficial effects on post-implant valve hemodynamics and perhaps long-term valve durability. AREAS COVERED: This is an expanded overview of BVF and BVR to facilitate VIV transcatheter aortic valve replacement (TAVR), with detailed discussion on lessons learned from bench testing studies and translation to procedural technique and clinical experience incorporating up-to-date evidence and experience with BVF in non-aortic positions. EXPERT OPINION: BVF and BVR improve valve hemodynamics following VIV-TAVR, with timing of BVF being an important determinant of procedure safety and efficacy; however, longer-term data are needed to determine long-term clinical outcomes including mortality, valve hemodynamics, and valve reintervention. In addition, further research will be needed to understand the safety and efficacy of these procedures in any new generation BSV or THV and to better define the role of these techniques in the pulmonic, mitral, and tricuspid positions.
Assuntos
Estenose da Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Estenose da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Falha de Prótese , Desenho de Prótese , Bioprótese/efeitos adversos , Resultado do Tratamento , Substituição da Valva Aórtica Transcateter/métodosRESUMO
BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. OBJECTIVES: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. RESULTS: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. CONCLUSIONS: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.