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1.
Int J Cardiol ; 395: 131431, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-37832606

RESUMO

BACKGROUND: Recent randomized studies have broadened the indication of transcatheter aortic valve replacement (TAVR) to also include low-surgical-risk patients. However, the data on self-expanding (SE) and balloon-expandable (BE) valves in low-risk patients remain sparse. METHODS: The current study is a post hoc analysis of combined data from both LRT 1.0 and 2.0 trials comparing BE and SE transcatheter heart valves. RESULTS: A total of 294 patients received a BE valve, and 102 patients received an SE valve. The 30-day clinical outcomes were similar across both groups except for stroke (4.9% vs. 0.7%, p = 0.014) and permanent pacemaker implantation (17.8% vs. 5.8%, p < 0.001), which were higher in the SE cohort than the BE cohort. No difference was observed in terms of paravalvular leak (≥moderate) between the groups (0% vs. 1.5%, p = 0.577). SE patients had higher aortic valve area (1.92 ± 0.43 mm2 vs. 1.69 ± 0.45 mm2, p < 0.001) and lower mean gradient (8.93 ± 3.53 mmHg vs. 13.41 ± 4.73 mmHg, p < 0.001) than BE patients. In addition, the rate of subclinical leaflet thrombosis was significantly lower in SE patients (5.6% vs. 13.8%, p = 0.038). CONCLUSION: In this non-randomized study assessing SE and BE valves in low-risk TAVR patients, SE valves are associated with better hemodynamics and lesser leaflet thrombosis, with increased rates of stroke and permanent pacemaker implantation at 30 days; however, this could be due to certain patient-dependent factors not fully evaluated in this study. The long-term implications of these outcomes on structural valve durability remain to be further investigated. CLINICAL TRIAL REGISTRY: LRT 1.0: NCT02628899 LRT 2.0: NCT03557242.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Acidente Vascular Cerebral/etiologia , Trombose/etiologia , Resultado do Tratamento , Desenho de Prótese , Fatores de Risco
2.
Circ Cardiovasc Interv ; 16(5): e012655, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37192308

RESUMO

BACKGROUND: The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years. METHODS: The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years. RESULTS: A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm2) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; P=0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years. CONCLUSIONS: TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02628899.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estudos Prospectivos , Fatores de Risco , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Hemodinâmica , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgia , Trombose/etiologia
3.
Int J Cardiol ; 371: 305-311, 2023 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-36272571

RESUMO

BACKGROUND: Subclinical leaflet thrombosis (SLT) is characterized on computed tomography (CT) imaging as hypoattenuated leaflet thickening (HALT), reduced leaflet motion (RELM), and hypoattenuation affecting motion (HAM). How antithrombotic regimen type impacts SLT remains poorly understood. We evaluated how antithrombotic regimen type impacts SLT in low-risk subjects following transcatheter aortic valve implantation (TAVI). METHODS: This substudy is a post hoc analysis of the LRT 1.0 and 2.0 trials to assess SLT in subjects who underwent CT or transoesophageal echocardiogram (TOE) imaging at 30 days, stratified by antithrombotic regimen received (single antiplatelet therapy [SAPT], dual antiplatelet therapy [DAPT], or oral anticoagulation). We also utilized univariable logistic regression modelling to identify echocardiographic predictors of HALT. RESULTS: Rates of HALT, RELM, and HAM were all significantly lower with oral anticoagulation compared to SAPT or DAPT at 30 days (HALT: 2.6% vs 14.3% vs 17.2%, respectively, with p < 0.001; RELM: 1.8% vs 9.6% vs 13.1%, respectively, with p = 0.004; and HAM: 0.9% vs 8.5% vs 9.8%, respectively, with p = 0.011). Additionally, short-term oral anticoagulation was not associated with higher bleeding rates compared to SAPT or DAPT (0.8% vs. 1.8% vs. 3.6%, p = 0.291). The presence of HALT did not significantly impact echocardiographic haemodynamic parameters at 30 days. CONCLUSION: This is the largest study to date that evaluated the impact of different antithrombotic regimens on SLT in low-risk TAVI patients. Oral anticoagulation was associated with significantly lower rates of SLT at 30 days compared to DAPT or SAPT, and there was no apparent benefit of DAPT over SAPT.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Fibrinolíticos/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Trombose/diagnóstico por imagem , Trombose/tratamento farmacológico , Trombose/etiologia , Resultado do Tratamento , Inibidores da Agregação Plaquetária/efeitos adversos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/cirurgia
4.
Artigo em Inglês | MEDLINE | ID: mdl-36573416

RESUMO

Right ventricular clot-in-transit (CIT) is a rare finding in venous thromboembolic disease and carries a high mortality rate. Its optimal treatments have yet to be established in the literature. Here we describe the usage of a suction-based catheter, the INARI FlowTriever® system (INARI Medical Inc.) to successfully retrieve a CIT from the right ventricle of a patient with coronavirus disease 2019 acute respiratory distress syndrome on veno-veno extracorporeal membrane oxygenation.

5.
EuroIntervention ; 18(5): e407-e416, 2022 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-35321859

RESUMO

BACKGROUND: Given enough time, transcatheter heart valves (THVs) will degenerate and may require reintervention. Redo transcatheter aortic valve implantation (TAVI) is an attractive strategy but carries a risk of coronary obstruction. AIMS: We sought to predict how many TAVIs patients could undergo in their lifetime using computed tomography (CT) simulation. METHODS: We analysed paired CT scans (baseline and 30 days post-TAVI) from patients in the LRT trial and EPROMPT registry. We implanted virtual THVs on baseline CTs, comparing predicted valve-to-coronary (VTC) distances to 30-day CT VTC distances to evaluate the accuracy of CT simulation. We then simulated implantation of a second virtual THV within the first to estimate the risk of coronary obstruction due to sinus sequestration and the need for leaflet modification. RESULTS: We included 213 patients with evaluable paired CTs. There was good agreement between virtual (baseline) and actual (30 days) CT measurements. CT simulation of TAVI followed by redo TAVI predicted low coronary obstruction risk in 25.4% of patients and high risk, likely necessitating leaflet modification, in 27.7%, regardless of THV type. The remaining 46.9% could undergo redo TAVI so long as the first THV was balloon-expandable but would likely require leaflet modification if the first THV was self-expanding. CONCLUSIONS: Using cardiac CT simulation, it is possible to predict whether a patient can undergo multiple TAVI procedures in their lifetime. Those who cannot may prefer to undergo surgery first. CT simulation could provide a personalised lifetime management strategy for younger patients with symptomatic severe aortic stenosis and inform decision-making. CLINICALTRIALS: gov: NCT02628899; ClinicalTrials.gov: NCT03557242; ClinicalTrials.gov: NCT03423459.


Assuntos
Estenose da Valva Aórtica , Oclusão Coronária , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Oclusão Coronária/cirurgia , Humanos , Desenho de Prótese , Tomografia , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
6.
Catheter Cardiovasc Interv ; 99(3): 896-903, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34505737

RESUMO

OBJECTIVES: We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS: We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS: We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS: PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.


Assuntos
Estenose da Valva Aórtica , Endocardite Bacteriana , Endocardite , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Endocardite/etiologia , Endocardite Bacteriana/complicações , Endocardite Bacteriana/diagnóstico , Endocardite Bacteriana/epidemiologia , Próteses Valvulares Cardíacas/efeitos adversos , Humanos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
7.
Am Heart J ; 237: 25-33, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33713618

RESUMO

BACKGROUND: Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. METHODS: The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. RESULTS: The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. CONCLUSIONS: TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Hemodinâmica/fisiologia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia , Estudos de Viabilidade , Feminino , Fluoroscopia , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
8.
Cardiovasc Revasc Med ; 27: 1-6, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33129688

RESUMO

BACKGROUND/PURPOSE: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration. METHODS/MATERIALS: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis. RESULTS: In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT. CONCLUSIONS: This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Estudos Prospectivos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
9.
JACC Cardiovasc Interv ; 13(6): 726-735, 2020 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-32192693

RESUMO

OBJECTIVES: The aim of this study was to evaluate the feasibility of coronary access and aortic valve reintervention in low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve (THV). BACKGROUND: Younger, low-risk TAVR patients are more likely than older, higher risk patients to require coronary angiography, percutaneous coronary intervention, or aortic valve reintervention, but their THVs may impede coronary access and cause coronary obstruction during TAVR-in-TAVR. METHODS: The LRT (Low Risk TAVR) trial (NCT02628899) enrolled 200 subjects with symptomatic severe aortic stenosis to undergo TAVR using commercially available THVs. Subjects who received balloon-expandable THVs and who had 30-day cardiac computed tomographic scans were included in this study. In a subgroup, the feasibility of intentional THV crimping on the delivery catheter to pre-determine commissural alignment was tested. RESULTS: In the LRT trial, 168 subjects received balloon-expandable THVs and had 30-day cardiac computed tomographic scans, of which 137 were of adequate image quality for analysis. The most challenging anatomy for coronary access (THV frame above and commissural suture post in front of a coronary ostium) was observed in 9% to 13% of subjects. Intentional THV crimping did not appear to meaningfully affect commissural alignment. The THV frame extended above the sinotubular junction in 21% of subjects, and in 13%, the distance between the THV and the sinotubular junction was <2 mm, signifying that TAVR-in-TAVR may not be feasible without causing coronary obstruction. CONCLUSIONS: TAVR may present challenges to future coronary access and aortic valve reintervention in a substantial number of low-risk patients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Cateterismo Cardíaco , Estenose Coronária/etiologia , Vasos Coronários , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Estudos de Viabilidade , Feminino , Humanos , Masculino , Tomografia Computadorizada Multidetectores , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Retratamento , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Estados Unidos
10.
Am J Cardiol ; 125(8): 1216-1221, 2020 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-32087995

RESUMO

We aimed to evaluate the burden of coronary artery disease (CAD) using the computed tomography (CT) Leaman score in low-risk transcatheter aortic valve implantation (TAVI) patients. The extent of CAD in low-risk patients with aortic stenosis who are candidates for TAVI has not been accurately quantified. The CT Leaman score was developed to quantify coronary CT angiography (CCTA) atherosclerotic burden and has been validated to evaluate the extent of CAD. CT Leaman score >5 has been associated with an increase in major adverse cardiac events over long-term follow-up. The study population included patients enrolled in the Low Risk TAVI trial who underwent CCTA before the procedure. For the CT Leaman score, we used 3 sets of weighting factors: (1) location of coronary plaques, (2) type of plaque, and (3) degree of stenosis. A total of 200 patients were enrolled in the Low Risk TAVI trial. Excluded were 31 patients who had no analyzable CCTA imaging. For the remaining 169 patients, the mean CT Leaman score was 6.27 ± 0.27, of whom 102 (60.4%) had CT Leaman score >5. Nearly all analyzed patients (97%) had coronary plaques. Furthermore, 33 patients (19.5%) had potentially obstructive coronary plaques (>50% stenosis by CCTA) in proximal segments. Most low-risk TAVI patients have significant CAD burden by CCTA. It should be a priority for future TAVI devices to guarantee unimpeded access to the coronary arteries for selective angiography and interventions.


Assuntos
Estenose da Valva Aórtica/epidemiologia , Doença da Artéria Coronariana/epidemiologia , Estenose Coronária/epidemiologia , Placa Aterosclerótica/epidemiologia , Substituição da Valva Aórtica Transcateter , Idoso , Estenose da Valva Aórtica/cirurgia , Comorbidade , Angiografia por Tomografia Computadorizada/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Placa Aterosclerótica/diagnóstico por imagem , Cuidados Pré-Operatórios , Prevalência , Ajuste de Prótese , Medição de Risco , Tomografia Computadorizada por Raios X
11.
Circ Cardiovasc Imaging ; 12(12): e009608, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31826675

RESUMO

BACKGROUND: This analysis evaluated echocardiographic predictors of hypoattenuated leaflet thickening (HALT) in low-risk patients undergoing transcatheter aortic valve replacement and assessed 1-year clinical and hemodynamic consequences. HALT by computed tomography may be associated with early valve degeneration and increased neurological events. METHODS: Echocardiograms were performed at baseline, discharge, 30 days, and 1 year post-procedure. Four-dimensional contrast-enhanced computed tomography assessed HALT at 30 days. Independent core laboratories analyzed images. Doppler hemodynamic parameters were tested in a univariable regression model to identify HALT predictors. One-year clinical and hemodynamic outcomes were compared between HALT (+) and (-) patients. RESULTS: Analysis included 170 patients with Sapien 3 valves and diagnostic 30-day computed tomographies, of whom 27 (16%) had HALT. Baseline characteristics were similar between groups. After transcatheter aortic valve replacement, aortic flow was nonsignificantly reduced in patients who developed HALT. Regression analysis did not show significant association between baseline or discharge valve hemodynamics and development of HALT at 30 days. Patients with HALT had smaller aortic valve areas (1.4±0.4 versus 1.7±0.5 cm2; P=0.018) and Doppler velocity index (0.4±0.1 versus 0.5±0.1; P=0.003) than those without HALT at 30 days but not at 1 year. There was no difference in aortic mean gradient at 30 days. There was no difference between the groups in New York Heart Association class, 6-minute walk distance, and mortality at 1 year. CONCLUSIONS: There were no early hemodynamic predictors of HALT. At 30 days, patients with HALT had worse valve hemodynamics than those without HALT, but hemodynamic and clinical outcomes at 1 year were similar. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628899.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Hemodinâmica , Trombose/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Ecocardiografia Doppler , Feminino , Tomografia Computadorizada Quadridimensional , Humanos , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Falha de Prótese , Medição de Risco , Fatores de Risco , Trombose/diagnóstico por imagem , Trombose/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
12.
JACC Cardiovasc Interv ; 12(10): 901-907, 2019 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-30860059

RESUMO

OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Estudos de Viabilidade , Feminino , Hemodinâmica , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Índices de Gravidade do Trauma , Resultado do Tratamento , Estados Unidos
13.
J Am Coll Cardiol ; 72(18): 2095-2105, 2018 10 30.
Artigo em Inglês | MEDLINE | ID: mdl-30170075

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. METHODS: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. RESULTS: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. CONCLUSIONS: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco
14.
J Occup Environ Med ; 59(6): 563-570, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28598933

RESUMO

OBJECTIVE: The aim of this study was to assess effects of exercise on shoulder musculoskeletal symptoms among employees with overhead assembly work exposures. METHODS: A voluntary workplace shoulder exercise program was offered to employees in two automotive assembly departments, while two similar departments served as controls. N = 76 total workers participated. Shoulder Rating Questionnaire (SRQ) and Discomfort of the Arm Shoulder and Hand (DASH) symptoms were queried monthly for 7 baseline months, followed by 6 months that included exercise. RESULTS: SRQ scores were higher for exercisers than among controls in the 6 exercising months, but not in the baseline months. Although the group x month interaction was significant (P < 0.05), the temporal trend was inconsistent. CONCLUSIONS: Exercise may have temporarily lessened decline in SRQ. It is not clear whether shorter term differences were clinically meaningful or predictive of longer term disability prevention.


Assuntos
Indústria Manufatureira , Exercícios de Alongamento Muscular , Saúde Ocupacional , Treinamento Resistido , Dor de Ombro/prevenção & controle , Local de Trabalho , Adolescente , Adulto , Automóveis , Humanos , Pessoa de Meia-Idade , Cooperação do Paciente , Estudos Prospectivos , Inquéritos e Questionários , Avaliação de Sintomas , Adulto Jovem
15.
J Surg Res ; 197(2): 265-9, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25963164

RESUMO

BACKGROUND: Ascending aortic dissections (AADs) require prompt diagnosis and surgical treatment. We present the results of implementing a multidisciplinary aortic dissection protocol on the outcomes of AAD treatment at a nonteaching hospital. METHODS: From January 2002-December 2013, 54 patients with the diagnosis of AAD were treated at our institution. Thirty-seven (68.5%) were male with a mean age of 62.3 y. Cardiogenic shock was present in 25.9% of patients. An AAD protocol, focused on educating physicians on presenting signs and symptoms, adequate triaging, and the need for immediate surgical intervention, was implemented, alongside the standardization of surgical treatment. We divided the cohort into two eras, based on AAD program's implementation in 2006, to better assess the impact of this protocol. RESULTS: Patients from the early era had significantly longer time from Emergency Department to the operating room, more postoperative occurrence of prolonged ventilation, and a longer postoperative hospital stay at 8.7 ± 8 versus 3.1 ± 2.6 h (P = 0.002), 63% versus 18% (P = 0.002), and 63% versus 18% (P = 0.002), respectively. The overall mortality for the cohort was 9.3%, decreasing from 12.5% before 2006 to 7.9% after 2006. CONCLUSIONS: The implementation of a multidisciplinary aortic dissection protocol has resulted in faster diagnosis and transport of AAD cases from the emergency room to the operating room, improving outcomes. Our data support the concept that nonteaching institutions can deliver excellent care to patients with acute aortic emergencies.


Assuntos
Algoritmos , Aneurisma Aórtico , Dissecção Aórtica , Técnicas de Apoio para a Decisão , Procedimentos Cirúrgicos Vasculares , Adulto , Idoso , Idoso de 80 Anos ou mais , Dissecção Aórtica/diagnóstico , Dissecção Aórtica/mortalidade , Dissecção Aórtica/cirurgia , Aneurisma Aórtico/diagnóstico , Aneurisma Aórtico/mortalidade , Aneurisma Aórtico/cirurgia , Protocolos Clínicos , Emergências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Equipe de Assistência ao Paciente , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
17.
Echocardiography ; 30(8): 880-8, 2013 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-23488864

RESUMO

BACKGROUND: Echocardiography (echo)-quantified LV stroke volume (SV) is widely used to assess systolic performance after acute myocardial infarction (AMI). This study compared 2 common echo approaches - predicated on flow (Doppler) and linear chamber dimensions (Teichholz) - to volumetric SV and global infarct parameters quantified by cardiac magnetic resonance (CMR). METHODS: Multimodality imaging was performed as part of a post-AMI registry. For echo, SV was measured by Doppler and Teichholz methods. Cine-CMR was used for volumetric SV and LVEF quantification, and delayed-enhancement (DE) CMR for infarct size. RESULTS: Overall, 142 patients underwent same day echo and CMR. On echo, mean SV by Teichholz (78 ± 17 mL) was slightly higher than Doppler (75 ± 16 mL; Δ = 3 ± 13 mL; P = 0.02). Compared to SV on CMR (78 ± 18 mL), mean difference by Teichholz (Δ = -0.2 ± 14; P = 0.89) was slightly smaller than Doppler (Δ = -3 ± 14; P = 0.02), but limits of agreement were similar between CMR and echo methods (Teichholz: -28, 27 mL, Doppler: -31, 24 mL). For Teichholz, differences with CMR SV were greatest among patients with anteroseptal or lateral wall hypokinesis (P < 0.05). For Doppler, differences were associated with aortic valve abnormalities or root dilation (P = 0.01). SV by both echo methods decreased stepwise in relation to global LV injury as assessed by CMR-quantified LVEF and infarct size (P < 0.01). CONCLUSIONS: Teichholz and Doppler calculated SV yield similar magnitude of agreement with CMR. Teichholz differences with CMR increase with septal or lateral wall contractile dysfunction, whereas Doppler yields increased offsets in patients with aortic remodeling.


Assuntos
Ecocardiografia/estatística & dados numéricos , Interpretação de Imagem Assistida por Computador/métodos , Angiografia por Ressonância Magnética/estatística & dados numéricos , Imagem Cinética por Ressonância Magnética/estatística & dados numéricos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/epidemiologia , Volume Sistólico , Algoritmos , Meios de Contraste , Ecocardiografia/métodos , Feminino , Humanos , Aumento da Imagem/métodos , Angiografia por Ressonância Magnética/métodos , Imagem Cinética por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , New York/epidemiologia , Prevalência , Reprodutibilidade dos Testes , Fatores de Risco , Sensibilidade e Especificidade
18.
J Am Coll Cardiol ; 60(25 Suppl): S1-49, 2012 Dec 25.
Artigo em Inglês | MEDLINE | ID: mdl-23257320

RESUMO

The environment in which the field of cardiology finds itself has been rapidly changing. This supplement, an expansion of a report created for the Board of Trustees, is intended to provide a timely snapshot of the socio-economic, political, and scientific aspects of this environment as it applies to practice both in the United States and internationally. This publication should assist healthcare professionals looking for the most recent statistics on cardiovascular disease and the risk factors that contribute to it, drug and device trends affecting the industry, and how the practice of cardiology is changing in the United States.


Assuntos
Cardiologia , Doenças Cardiovasculares/epidemiologia , Cardiologia/economia , Fármacos Cardiovasculares/economia , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/terapia , Procedimentos Cirúrgicos Cardiovasculares/instrumentação , Procedimentos Cirúrgicos Cardiovasculares/tendências , Política de Saúde , Humanos , Prevalência , Fatores de Risco , Sociedades Médicas , Estados Unidos , Recursos Humanos
19.
Prog Cardiovasc Dis ; 55(2): 104-18, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23009907

RESUMO

Group 2 pulmonary hypertension is most frequently caused by left heart disease, a heterogeneous set of disorders. These processes include left ventricular systolic dysfunction, left ventricular dysfunction with preserved ejection fraction and valvular (mitral and/or aortic) diseases. Left heart disease may cause passive backward transmission of pressure leading to elevated left atrial and pulmonary arterial pressures due to a myriad of processes. Increasingly, it has been recognized that some patients may develop pulmonary arterial pressure out of proportion from what is expected. This is believed to be due to increases in vasomotor tone and/or vascular remodeling. Over time patients may go on to develop progressive right ventricular dysfunction, a marker for poor prognosis. This review will explore the different characteristics of these conditions including the incidence, pathophysiology, clinical implications, prognosis and current state of available medical therapies.


Assuntos
Hipertensão Pulmonar , Disfunção Ventricular Esquerda , Disfunção Ventricular Direita , Diagnóstico por Imagem , Humanos , Hipertensão Pulmonar/diagnóstico , Hipertensão Pulmonar/etiologia , Hipertensão Pulmonar/fisiopatologia , Prognóstico , Pressão Propulsora Pulmonar , Índice de Gravidade de Doença , Volume Sistólico , Disfunção Ventricular Esquerda/complicações , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologia , Disfunção Ventricular Direita/diagnóstico , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/fisiopatologia
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