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BACKGROUND: The impact of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is uncertain. This study was performed to investigate the risk of all-cause mortality, heart failure hospitalization, and aortic valve reintervention in patients with and without predicted PPM after TAVR. METHODS: This nationwide, population-based cohort study included all patients who underwent transfemoral primary TAVR in Sweden from 2008 to 2022 in the SWEDEHEART register. PPM was defined according to published effective orifice areas for each valve model and size. The patients were divided into those with and without PPM. Additional baseline characteristics and outcome data were obtained from other national health data registers. Regression standardization was used to adjust for intergroup differences. RESULTS: Of 8485 patients, 7879 (93%) had no PPM and 606 (7%) had PPM. The crude cumulative incidence of all-cause mortality at 1, 5, and 10 years in patients with versus without PPM was 7% versus 9%, 40% versus 44%, and 80% versus 85%, respectively. After regression standardization, there was no between-group difference in long-term mortality, and the absolute difference at 10 years was 1.5% (95% confidence interval, -2.9%-6.0%). The mean follow-up was 3.0 years (maximum, 14 years). There was no difference in the risk of heart failure hospitalization or aortic valve reintervention. CONCLUSIONS: The risk of all-cause mortality, heart failure hospitalization, or aortic valve reintervention was not higher in patients with than without predicted PPM following TAVR. Furthermore, PPM was present in only 7% of patients, and severe PPM was almost nonexistent.
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Masculino , Feminino , Suécia/epidemiologia , Estenose da Valva Aórtica/cirurgia , Idoso de 80 Anos ou mais , Idoso , Insuficiência Cardíaca , Sistema de Registros , Valva Aórtica/cirurgia , Complicações Pós-Operatórias/epidemiologia , Reoperação/estatística & dados numéricos , Causas de Morte , Fatores de Risco , Desenho de PróteseRESUMO
BACKGROUND: Previous studies on the impact of sex differences after transcatheter aortic valve replacement (TAVR) have shown conflicting results. The aim was to analyze the risk of long-term mortality, heart failure hospitalization, myocardial infarction, stroke, bleeding and aortic valve reintervention in females versus males after TAVR. METHODS: This nationwide, population-based cohort study included all patients who underwent TAVR in Sweden between 2008 and 2022 from the SWEDEHEART register. Additional baseline and outcome data were gathered from other national health data registers. Regression standardization was used to adjust for differences between the sexes. RESULTS: Of 10,475 patients, 4,886 (47%) were female and 5,589 (53%) were male. The mean age was 81 years. The cumulative incidence of mortality at 1, 5, and 10 years was 8% vs. 10%, 38% vs. 45%, and 75% vs. 82% for females and males, respectively. After regression standardization, the risk of all-cause mortality was lower for females (absolute difference at 10 years of 6.4%, 95% confidence interval [CI] 4.4%-8.4%). The mean follow up was 3.1 years (maximum 14.1 years). Females also had a lower risk of major bleeding than males (absolute survival difference at 10 years of 4.0%, 95% CI 1.9%-6.2%), but there was no difference in the risk of heart failure, myocardial infarction, stroke, or reintervention between the sexes. CONCLUSIONS: Females had a higher survival rate and a lower bleeding risk than males after TAVR. Sex-specific factors are important to consider in the management of patients after TAVR.
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BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the most common treatment in patients with symptomatic severe aortic stenosis (AS). As concomitant coronary artery disease is common in AS patients, access to the coronary arteries following TAVR is of increasing importance. OBJECTIVES: This study evaluated the incidence and risk factors for unplanned coronary angiography following TAVR and, using fluoroscopic time as a surrogate, analyzed the complexity of coronary artery cannulation. METHODS: All patients who underwent TAVR in Sweden between 2008 and 2022 were identified using the SWEDEHEART registry. The cumulative incidence of coronary angiography after TAVR was analyzed with mortality as a competing risk. Angiography and PCI complexity were analyzed using fluoroscopic time and compared across different transcatheter heart valve designs. RESULTS: Out of 9806 patients, 566 subsequently required coronary angiography. The incidence was highest for three-vessel and/or left main disease. Younger age, the extent of prior coronary artery disease, and peripheral vascular disease were associated with an increased risk of coronary angiography. Fluoroscopy time was increased in TAVR patients compared to the control group with the longest fluoroscopy times observed in cases involving supra-annular and self-expanding valves. CONCLUSIONS: The incidence of coronary angiography following TAVR is still low. Younger patients and patients with concomitant coronary artery disease have a higher risk. Procedural time is longer in patients with a previous THV replacement. As TAVR is emerging as the first-line treatment in patients with longer life expectancy, facilitating coronary access is an important factor when considering which THV device to implant.
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BACKGROUND: There is limited experience of using the MANTA plug-based vascular closure device for percutaneous arterial closure of the femoral artery after venoarterial extracorporeal membrane oxygenation. OBJECTIVES: To study femoral artery complications and need for subsequent vascular interventions after percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA ECMO) using the MANTA plug-based vascular closure device. METHODS: We studied 34 consecutive patients who underwent percutaneous decannulation of VA ECMO using the MANTA device. Primary outcomes were conversion to surgical cutdown of the groin at decannulation (immediate) or later. Secondary outcomes were type of vascular complication necessitating conversion to surgical cutdown of the groin. RESULTS: Six (17.7%) patients had to undergo immediate (n = 3) or late (n = 3) conversion to surgical cutdown of the groin. Of these, three were owing to occlusion of the common femoral artery resulting in insufficient distal perfusion and three owing to bleeding or pseudoaneurysm. The mechanism of failure was complete intravascular deployment of the MANTA device in three patients, incomplete MANTA sealing of the arteriotomy in one patient, MANTA-unrelated thrombotic occlusion in one patient, and unknown in one patient. Surgical cut-down was typically performed with concomitant catheter thrombectomy with or without patch reconstruction of the artery. CONCLUSION: Percutaneous decannulation of VA ECMO using the MANTA VCD was feasible but a substantial number of patients needed to be converted to unplanned surgical repair, owing to either closure site-located stenosis/occlusion or bleeding. If suboptimal MANTA positioning is suspected, a low threshold for conversion to surgical cutdown of the groin is recommended.
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Cateterismo Periférico , Oxigenação por Membrana Extracorpórea , Dispositivos de Oclusão Vascular , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Dispositivos de Oclusão Vascular/efeitos adversosRESUMO
OBJECTIVES: To describe the occurrence of postprocedural atrial fibrillation (AF) among patients with cryptogenic stroke undergoing patent foramen ovale (PFO) closure in the REDUCE clinical study and analyze for potential risk factors for the development of postprocedural AF. BACKGROUND: AF is an adverse event that might potentially counterbalance the stroke prevention benefit from PFO closure. Data on AF after transcatheter PFO closure are sparse. METHODS: We evaluated data from patients having PFO closure (Gore HELEX or Gore Cardioform Septal Occluder) in the REDUCE clinical trial (n = 408) in at post hoc explorative analysis. Median follow-up was 5.0 years. RESULTS: AF occurred in 30 patients (7.4%) after PFO closure with a total of 34 AF events. Most were reported as non-serious (68%), detected within 45 days post-procedure (79%), and resolved within 2 weeks of onset (63%). One subject with AF had recurrent stroke. Postprocedural AF occurred more frequently among subjects with higher age and large device sizes. Male sex was the only independent predictor of postprocedural AF. We found no association between the type of occluder (HELEX or Gore Cardioform Septal Occluder) or PFO anatomical characteristics and post-procedural AF. CONCLUSION: In the REDUCE clinical study, postprocedural atrial fibrillation was mostly early onset, transient and with no later recurrence. Postprocedural AF occurred more frequently among patients with higher age and larger devices. Male sex was the only independent predictor of postprocedural AF.
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Fibrilação Atrial , Cateterismo Cardíaco , Forame Oval Patente , Fibrilação Atrial/epidemiologia , Cateterismo Cardíaco/efeitos adversos , Forame Oval Patente/terapia , Humanos , Masculino , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Resultado do TratamentoRESUMO
The objective of the study was to investigate the safety profile of high-risk micro-endomyocardial biopsy (micro-EMB) compared to conventional EMB in a large animal model. Twenty pigs were subjected to a maximum of 30 consecutive biopsies, including sampling from the free ventricular wall, with either micro-EMB (n = 10) or conventional EMB (n = 10). There were no major complications in the micro-EMB group (0/10), compared to six major complications in the EMB group (6/10; p = 0.003). Survival analysis further highlighted these differences (p = 0.004). There were significantly higher volumes of pericardial effusion in the EMB group (p = 0.01). The study shows a safety advantage of micro-EMB compared to standard EMB in the experimental high-risk circumstances investigated in this animal study. These results indicate enhanced possibilities to collect samples from sensitive areas by using the micro-EMB technique instead of standard EMB.
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Miocárdio , Derrame Pericárdico , Animais , Biópsia/efeitos adversos , Biópsia/métodos , Cateterismo Cardíaco , Ventrículos do Coração/diagnóstico por imagem , Ventrículos do Coração/patologia , Humanos , Miocárdio/patologia , SuínosRESUMO
BACKGROUND: The mechanisms underlying rupture of a coronary atherosclerotic plaque and development of myocardial ischemia-reperfusion injury in ST-elevation myocardial infarction (STEMI) remain unresolved. Increased arginase 1 activity leads to reduced nitric oxide (NO) production and increased formation of reactive oxygen species due to uncoupling of the NO-producing enzyme endothelial NO synthase (eNOS). This contributes to endothelial dysfunction, plaque instability and increased susceptibility to ischemia-reperfusion injury in acute myocardial infarction. OBJECTIVE: The purpose of this study was to test the hypothesis that arginase gene and protein expression are upregulated in patients with STEMI. METHODS: Two cohorts of patients with STEMI were included. In the first cohort (n = 51), expression of arginase and NO-synthases as well as arginase 1 protein levels were determined and compared to a healthy control group (n = 45). In a second cohort (n = 68), plasma arginase 1 levels and infarct size were determined using cardiac magnetic resonance imaging. RESULTS: Expression of the gene encoding arginase 1 was significantly elevated at admission and 24-48 h after STEMI but not 3 months post STEMI, in comparison with the control group. Expression of the genes encoding arginase 2 and endothelial NO synthase (NOS3) were unaltered. Arginase 1 protein levels were elevated at admission, 24 h post STEMI and remained elevated for up to 6 months. No significant correlation between plasma arginase 1 protein levels and infarct size was observed. CONCLUSION: The markedly increased gene and protein expression of arginase 1 already at admission indicates a role of arginase 1 in the development of STEMI.
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Arginase , Traumatismo por Reperfusão Miocárdica , Infarto do Miocárdio com Supradesnível do Segmento ST , Arginase/sangue , Arginase/genética , Humanos , Traumatismo por Reperfusão Miocárdica/genética , Óxido Nítrico Sintase Tipo III , Infarto do Miocárdio com Supradesnível do Segmento ST/genética , Resultado do TratamentoRESUMO
BACKGROUND: Conflicting evidence exists concerning the cardioprotective efficacy of remote ischemic conditioning as an adjunct to primary percutaneous intervention (PCI) in ST-elevation myocardial infarction (STEMI) and data on long-term outcomes are scarce. We evaluated final infarct size by cardiac magnetic resonance (CMR) performed 6 months after anterior STEMI treated with remote ischemic conditioning and clinical outcomes up to 3 years after the event. METHODS: One hundred and fifteen patients with anterior STEMI were randomized to remote ischemic per-postconditioning (RIperpostC) or sham procedure as adjunct to primary PCI. The primary outcome was myocardial salvage index (MSI) on CMR 6 months after the event. Secondary outcomes were absolute infarct size, left ventricular function, cardiac mortality, major adverse cardiac and cerebrovascular events (MACCE-composite of all-cause mortality, myocardial infarction, readmission for heart failure, ischemic stroke, and target lesion revascularization) and all the individual components of MACCE. RESULTS: There was no difference in MSI or left ventricular function between the RIperpostC and the control group after 6 months. Nor did clinical outcomes at 6 months or 3 years differ between the groups. CONCLUSIONS: RIperpostC as an adjunct to PCI in anterior STEMI did not result in better MSI or left ventricular function 6 months after the event. Furthermore, clinical outcomes at 6 months and 3 years were not altered.
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Pós-Condicionamento Isquêmico , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do TratamentoRESUMO
AIMS: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder. METHODS AND RESULTS: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2). CONCLUSION: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.
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Apêndice Atrial , Fibrilação Atrial , Isquemia Encefálica , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Idoso , Idoso de 80 Anos ou mais , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Cateterismo Cardíaco , Feminino , Humanos , Masculino , Estudos Prospectivos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do TratamentoRESUMO
BACKGROUND: The efficacy of closure of a patent foramen ovale (PFO) in the prevention of recurrent stroke after cryptogenic stroke is uncertain. We investigated the effect of PFO closure combined with antiplatelet therapy versus antiplatelet therapy alone on the risks of recurrent stroke and new brain infarctions. METHODS: In this multinational trial involving patients with a PFO who had had a cryptogenic stroke, we randomly assigned patients, in a 2:1 ratio, to undergo PFO closure plus antiplatelet therapy (PFO closure group) or to receive antiplatelet therapy alone (antiplatelet-only group). Imaging of the brain was performed at the baseline screening and at 24 months. The coprimary end points were freedom from clinical evidence of ischemic stroke (reported here as the percentage of patients who had a recurrence of stroke) through at least 24 months after randomization and the 24-month incidence of new brain infarction, which was a composite of clinical ischemic stroke or silent brain infarction detected on imaging. RESULTS: We enrolled 664 patients (mean age, 45.2 years), of whom 81% had moderate or large interatrial shunts. During a median follow-up of 3.2 years, clinical ischemic stroke occurred in 6 of 441 patients (1.4%) in the PFO closure group and in 12 of 223 patients (5.4%) in the antiplatelet-only group (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.62; P=0.002). The incidence of new brain infarctions was significantly lower in the PFO closure group than in the antiplatelet-only group (22 patients [5.7%] vs. 20 patients [11.3%]; relative risk, 0.51; 95% CI, 0.29 to 0.91; P=0.04), but the incidence of silent brain infarction did not differ significantly between the study groups (P=0.97). Serious adverse events occurred in 23.1% of the patients in the PFO closure group and in 27.8% of the patients in the antiplatelet-only group (P=0.22). Serious device-related adverse events occurred in 6 patients (1.4%) in the PFO closure group, and atrial fibrillation occurred in 29 patients (6.6%) after PFO closure. CONCLUSIONS: Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).
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Forame Oval Patente/tratamento farmacológico , Forame Oval Patente/terapia , Inibidores da Agregação Plaquetária/uso terapêutico , Prevenção Secundária/métodos , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral/prevenção & controle , Adolescente , Adulto , Fibrilação Atrial/etiologia , Terapia Combinada , Feminino , Seguimentos , Forame Oval Patente/complicações , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Recidiva , Dispositivo para Oclusão Septal/efeitos adversos , Método Simples-Cego , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Adulto JovemAssuntos
Forame Oval Patente/terapia , AVC Isquêmico/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Dispositivo para Oclusão Septal , Seguimentos , Forame Oval Patente/complicações , Humanos , AVC Isquêmico/etiologia , Inibidores da Agregação Plaquetária/efeitos adversos , Prevenção Secundária , Dispositivo para Oclusão Septal/efeitos adversosRESUMO
PURPOSE OF REVIEW: The goal was to evaluate published data on the incidence, diagnosis, and management of symptomatic combined mitral and aortic valvular disease. Furthermore, to identify the role of treatment using contemporary transcatheter techniques. RECENT FINDINGS: Up to a quarter of symptomatic adult valvular disease is caused by multiple left-sided valvular lesions. The etiologic spectrum of this combined disease has shifted from rheumatic to degenerative. Both presentation and diagnosis of lesions are modified compared with isolated disease. Based upon narrative review, there are only limited observational experiences, insufficient to provide robust guidance. These data, however, indicate the feasibility of interventions such as transcatheter aortic valve replacement and edge-to-edge mitral valve repair to treat such disease and mitigate the risks of open surgery. Combined aortic and mitral valve disease is commonly encountered. There is a role for transcatheter interventions based on limited data; however, more research is needed.
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Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Substituição da Valva Aórtica Transcateter , Adulto , Valva Aórtica , Humanos , Valva Mitral , Insuficiência da Valva Mitral/cirurgiaRESUMO
Percutaneous aortic valve replacement is performed predominantly via the transfemoral approach. The transaxillary (subclavian) approach may be utilized if an alternative route access is required. Conventional access and closure for this approach necessitates open surgical techniques. We report a nonsurgical fully percutaneous axillary TAVR using a collagen-based vascular closure device.
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Valva Aórtica/cirurgia , Artéria Axilar , Cateterismo Periférico/métodos , Hemorragia/prevenção & controle , Técnicas Hemostáticas/instrumentação , Substituição da Valva Aórtica Transcateter , Dispositivos de Oclusão Vascular , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Artéria Axilar/diagnóstico por imagem , Desenho de Equipamento , Feminino , Hemorragia/etiologia , Humanos , Punções , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate the feasibility of fully percutaneous closure using a novel collagen-based vascular closure device after transfemoral aortic valve replacement (TAVR). BACKGROUND: TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen-based device (MANTATM ) and preliminary data suggest this could be used as a routine percutaneous closure device. METHODS: A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was closure success and time to hemostasis. Secondary outcomes included VARC-2 defined major and minor vascular and bleeding complications within 30 days using suture-based closure with Prostar-XL within the same center. RESULTS: A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular closure with MANTATM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0-600). The composite of all-cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02). CONCLUSION: The novel use of a collagen-based vascular closure device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture-based closure. These data should prompt larger studies to evaluate efficacy and safety.
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Periférico/efeitos adversos , Artéria Femoral , Hemorragia/prevenção & controle , Técnicas Hemostáticas/instrumentação , Substituição da Valva Aórtica Transcateter/efeitos adversos , Dispositivos de Oclusão Vascular , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Cateterismo Periférico/mortalidade , Estudos Transversais , Estudos de Viabilidade , Feminino , Hemorragia/etiologia , Hemorragia/mortalidade , Técnicas Hemostáticas/efeitos adversos , Técnicas Hemostáticas/mortalidade , Humanos , Masculino , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do TratamentoRESUMO
OBJECTIVES: To describe the rationale and design of a global prospective registry on catheter-based left atrial appendage (LAA) occlusion using the second generation AMPLATZER Amulet LAA occlusion device and to provide a comprehensive perspective on available/ongoing registries for catheter-based LAA occlusion. BACKGROUND: Given the increasing clinical application of catheter-based LAA occlusion, there is an important need for prospective real-world clinical data regarding this cardiac intervention. METHODS: The Global Amplatzer Amulet LAA registry aims to provide prospective real-world data from an all-comer population of atrial fibrillation (AF) patients undergoing catheter-based LAA occlusion for stroke prevention. This observational, prospective, multicenter registry will provide peri-procedural and long-term clinical outcome data for catheter-based LAA occlusion using a second generation LAA occlusion device. The global registry will enroll 1,000 patients at up to 75 institutions. Patients will be followed for 2 years after implantation. Primary endpoints will report procedural and long-term data on ischemic stroke, systemic embolism, cardiovascular death and major bleeding. The study will involve independent event adjudication and echocardiographic core laboratory evaluation. Long-term follow-up data are expected in 2018. RESULTS: The Global Amplatzer Amulet LAA registry will collect safety and efficacy information on catheter-based LAA occlusion. Characteristics of available and ongoing catheter-based LAA occlusion registries are described. CONCLUSIONS: There is an important need for prospective real-world clinical data of catheter-based LAA occlusion given the increasing application of this intervention. The present global real-world registry will expand our knowledge on peri-procedural and long-term outcome of catheter-based LAA occlusion using a second generation occlusion device.
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Apêndice Atrial/fisiopatologia , Fibrilação Atrial/terapia , Cateterismo Cardíaco/instrumentação , Sistema de Registros , Projetos de Pesquisa , Acidente Vascular Cerebral/prevenção & controle , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/mortalidade , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Humanos , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO. METHODS AND RESULTS: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up. CONCLUSION: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/instrumentação , Forame Oval Patente/terapia , Dispositivo para Oclusão Septal , Adulto , Cateterismo Cardíaco/efeitos adversos , Europa (Continente) , Feminino , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/fisiopatologia , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Patent foramen ovale (PFO) is associated with cryptogenic stroke (CS) and migraine with aura (MA). Endothelial dysfunction (ED) is a risk factor for development of cardiovascular disease, but might also be involved in migraine pathophysiology. Short-term worsening of migraine has been described after closure of PFO. We evaluated endothelial function in patients with CS and PFO, before and after closure of PFO, and in patients with migraine, whether changes in endothelial function was related to a change in migraine frequency. MATERIAL AND METHODS: Patients with CS and PFO were included; 20 with planned closure of PFO and seven controls on medical treatment only. Endothelial function was assessed by peripheral arterial tonometry (EndoPatR ) and biomarkers of endothelial activation. Patients were followed longitudinally at baseline, day 1, 1 month, and 6 months. A headache diary was used to assess migraine frequency. RESULT: Mean age of the cohort was 45.4 years, and migraine prevalence was 50% whereof 84.6% had MA. Median EndoPatR index (RHI) at baseline was 1.60 (IQR 1.41-2.00). There was no change in RHI over time, either in closure patients (P = 0.66), nor in controls (P = 0.31), and there was no change in biomarkers of endothelial activation. Three migraine patients experienced worsening of migraine frequency directly after closure. DISCUSSION: Endothelial function did not change after closure of PFO. Although patients were lacking cardiovascular risk factors, a high proportion had impaired endothelial function. Whether ED can have predictive value, identifying PFO at higher risk for recurrent stroke warrants further investigations.
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Cateterismo Cardíaco , Endotélio Vascular , Forame Oval Patente , Enxaqueca com Aura , Complicações Pós-Operatórias , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Adulto , Biomarcadores/análise , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Progressão da Doença , Endotélio Vascular/metabolismo , Endotélio Vascular/fisiopatologia , Feminino , Forame Oval Patente/complicações , Forame Oval Patente/metabolismo , Forame Oval Patente/fisiopatologia , Forame Oval Patente/cirurgia , Humanos , Masculino , Manometria/métodos , Pessoa de Meia-Idade , Enxaqueca com Aura/complicações , Enxaqueca com Aura/diagnóstico , Enxaqueca com Aura/fisiopatologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Fatores de Risco , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/fisiopatologia , Suécia , Resultado do TratamentoRESUMO
Collateral pathways in vascular disease are important natural "bypass" conduits that protect against ischemia. Endovascular diagnostic and therapeutic procedures via peripheral access sites are performed frequently. This case report underlines the importance of being aware of collateral circulation in patients with chronic aortoiliac occlusive disease undergoing subclavian transcatheter aortic valve implantation to avoid acute limb ischemia. (©) RSNA, 2016.
Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Artéria Ilíaca/anormalidades , Artéria Ilíaca/diagnóstico por imagem , Tomografia Computadorizada Multidetectores/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Ecocardiografia , Feminino , HumanosRESUMO
BACKGROUND: Previous studies indicate that remote ischemic conditioning performed before percutaneous coronary intervention (PCI) reduces infarct size in patients with ST-elevation myocardial infarction (STEMI). It remains unclear whether remote conditioning affords protection when performed in adjunct to primary PCI. We aimed to study whether remote ischemic per-postconditioning (RIperpostC) initiated after admission to the catheterization laboratory attenuates myocardial infarct size in patients with anterior STEMI. METHODS: In this prospective multicenter trial 93 patients with anterior STEMI were randomized to RIperpostC or sham procedure as adjunct to primary PCI. RIperpostC was started on arrival in the catheterization laboratory by 5-minute cycles of inflation and deflation of a blood pressure cuff around the left thigh and continued throughout the PCI procedure. Infarct size and myocardium at risk were determined by cardiac magnetic resonance at day 4 to 7. The primary outcome was myocardial salvage index. RESULTS: There was no significant difference in myocardial salvage index between the RIperpostC and control group (median 48.5% and interquartile range 30.9%-60.8% vs 49.2% [42.1%-58.8%]). Neither did absolute infarct size in relation to left ventricular myocardial volume differ significantly (RIperpostC 20.6% [14.1%-31.7%] vs control 17.9% [13.4%-25.0%]). The RIperpostC group had larger myocardial area at risk than the control group (43.1% (35.4%-49.7%) vs 37.0% (30.8%-44.1%) of the left ventricle, P=.03). Peak value and area under the curve for troponin T did not differ significantly between the study groups. CONCLUSIONS: RIperpostC initiated after admission to the catheterization laboratory in patients with anterior STEMI did not confer protection against reperfusion injury.
Assuntos
Pós-Condicionamento Isquêmico/métodos , Traumatismo por Reperfusão Miocárdica/prevenção & controle , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Idoso , Feminino , Ventrículos do Coração/diagnóstico por imagem , Humanos , Precondicionamento Isquêmico Miocárdico/métodos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Traumatismo por Reperfusão Miocárdica/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Índice de Gravidade de Doença , Troponina T/sangueRESUMO
The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.