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Ablación por Catéter , Humanos , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Falla de Equipo , Irrigación Terapéutica/efectos adversos , Masculino , Diseño de Equipo , Catéteres Cardíacos/efectos adversos , Fibrilación Atrial/cirugía , Complicaciones Posoperatorias/etiologíaRESUMEN
OBJECTIVES: Direct true lumen cannulation (DTLC) of the aorta is an alternative cardiopulmonary bypass cannulation technique in the context of type A acute aortic dissection (A-AAD). DTLC has been reported to be effective in restoring adequate perfusion to jeopardized organs. This study reports and compares operative outcomes with DTLC or alternative cannulation techniques in a large cohort of patients with A-AAD. METHODS: All patients who underwent surgery for A-AAD between January 2006 and January 2017 in Mainz university hospital were reviewed. The choice of cannulation technique was left to the operating surgeon, however DTLC was our preference in patients who were in state of shock or showed signs of tamponade or hypoperfusion, in cases of potential cerebral malperfusion, as well as in patients who were under resuscitation. RESULTS: A total of 528 patients (63% males, mean age 64±13.8 years) underwent emergency surgery for A-AAD. The DTLC technique was used in 52.4% of patients. The DTLC group of patients had worse clinical status at the time of presentation with more shock, tamponade, true lumen collapse, cerebral and other malperfusion states. New neurologic events were diagnosed in around 8% of patients in each group following surgery, but there was a trend for quicker neurological recovery in the DTLC-group. Early mortality rates, short-term and long-term survival rates did not differ between the two groups. CONCLUSIONS: DTLC is a safe cannulation technique that enables effective antegrade true lumen perfusion in complicated A-AAD scenarios, and is an advantageous addition to the aortic surgeons' armamentarium.
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Aneurisma de la Aorta/cirugía , Disección Aórtica/cirugía , Cateterismo Cardíaco/métodos , Puente Cardiopulmonar/métodos , Complicaciones Posoperatorias/epidemiología , Anciano , Disección Aórtica/diagnóstico , Disección Aórtica/etiología , Disección Aórtica/mortalidad , Aorta/diagnóstico por imagen , Aorta/patología , Aorta/cirugía , Aneurisma de la Aorta/complicaciones , Aneurisma de la Aorta/diagnóstico , Aneurisma de la Aorta/mortalidad , Cánula/efectos adversos , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos/efectos adversos , Puente Cardiopulmonar/efectos adversos , Puente Cardiopulmonar/instrumentación , Angiografía por Tomografía Computarizada , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
The safety and feasibility of transradial approach for cerebral angiography has been confirmed previously. However, this approach has been limited used due to the difficulty during the procedure. This study aimed to introduce a pigtail catheter tailing and long-wire swapping technique to improve the success rate without increasing complications.From August 2015 to December 2018, 560 patients who underwent cerebral angiography via transradial approach were recruited. The data including the type of aortic arch, type of Simmon catheter were collected.The loop was successfully constructed in 553 patients using Simmon-2 or Simmon-1 catheter. Of these patients, 72 patients successfully underwent cerebral and renal angiography, while 481 patients underwent cerebral angiography. The time for angiography was 52.87â±â11.23 minutes and 47.8â±â11.8 minutes, respectively. There were 369 (66.7%), 135 (24.4%), and 49 (8.9%) patients with type I, type II, and type III aortic arches, respectively, and their success rates of looping using Simmon-2 catheter were 97.8%, 97.0%, and 89.8%, respectively. The success rates of angiography in the right internal carotid artery, right vertebral artery, left internal carotid artery, and left vertebral artery were 100%, 100%, 98.9%, and 98.9%, respectively. No serious complications were observed in all patients.The pigtail catheter tailing and long guidewire swapping is considered as a safe procedure with high success rate for loop construction using a Simmon-2 catheter through the right radial artery, subsequently improving the success rate as well as the efficiency of angiography.
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Catéteres Cardíacos/efectos adversos , Angiografía Cerebral/instrumentación , Utilización de Procedimientos y Técnicas/normas , Arteria Radial/cirugía , Anciano , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/patología , Catéteres Cardíacos/tendencias , Arteria Carótida Interna/diagnóstico por imagen , Cateterismo Periférico/métodos , Angiografía Cerebral/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Arteria Vertebral/diagnóstico por imagenRESUMEN
BACKGROUND: The aim of this study was to evaluate the safety and efficacy of the novel NovaCross microcatheter system in patients with ischemic heart disease due to coronary chronic total occlusions (CTO). METHODS: A total of 191 subjects between the ages of 25-80 years were recruited in 10 investigational sites. Each subject underwent a percutaneous coronary intervention (PCI) of a CTO lesion using the NovaCross microcatheter, equipped with expandable nitinol scaffolds to enhance guidewire penetration and crossing of the CTO lesion. The primary safety endpoint was procedural major adverse cardiac events [composite of death, myocardial infarction (MI), or urgent target vessel revascularization]. The primary efficacy endpoint was to assess the ability of the NovaCross microcatheter to successfully facilitate the placement of a guidewire beyond a native coronary CTO in the true vessel lumen. After the PCI, subjects remained in hospital until a 12-lead ECG and blood tests for cardiac biomarkers were taken at 3-6 h and 8-16 h post-procedure. RESULTS: No deaths, urgent revascularization, or urgent coronary artery bypass surgery were reported. The reported MI rate according to the protocol definition was 12.3%, and technical success was achieved in 75.3% of the subjects regardless of CTO procedure technique. In 89.2% of the subjects, the NovaCross succeeded in penetrating the proximal CTO cap, and in 25.8% of the subjects, the extendable portion of the NovaCross crossed the full length of the CTO lesion. CONCLUSIONS: The NovaCross met both the primary safety endpoint and the primary efficacy endpoint. We, therefore, conclude that the device is well tolerated, effective, and could be easily adopted by interventional cardiologists.
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Aleaciones/farmacología , Catéteres Cardíacos , Oclusión Coronaria/cirugía , Vasos Coronarios , Intervención Coronaria Percutánea , Materiales Biocompatibles/farmacología , Catéteres Cardíacos/efectos adversos , Catéteres Cardíacos/normas , Angiografía Coronaria/métodos , Oclusión Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Diseño de Equipo , Femenino , Humanos , Masculino , Ensayo de Materiales/métodos , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/etiología , Isquemia Miocárdica/prevención & control , Evaluación de Resultado en la Atención de Salud , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Stents , Andamios del TejidoRESUMEN
Cardiac catheters are a vital tool in medicine due to their widespread use in many minimally invasive procedures. To aid in advancing the catheter within the patient's vasculature, many catheters are coated with a lubricious hydrophilic coating (HPC). Although HPCs benefit patients, their delamination during use is a serious safety concern. Adverse health effects associated with HPC delamination include pulmonary and myocardial embolism, embolic stroke, infarction, and death. In order to improve patient outcomes, more consistent manufacturing methods and improved quality assurance techniques are needed to evaluate HPC medical devices. The present work investigates the efficacy of two novel methods to image and evaluate HPCs post-manufacturing, relative to industry-standard scanning electron microscopy (SEM)-based methods. We have shown that novel evaluation approaches based on optical microscopy (OM) and optical coherence tomography (OCT) are capable of imaging HPC layers and quantifying HPC thickness, saving hours of time relative to SEM sample preparation and imaging. Additionally, the nondestructive nature of OCT avoids damage and alteration to the HPC prior to imaging, leading to more reliable HPC thickness measurements. Overall, the work demonstrated the feasibility and advantages of using OM and OCT to image and measure HPC thickness relative to industry-standard SEM methods.
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Catéteres Cardíacos , Microscopía/métodos , Control de Calidad , Tomografía de Coherencia Óptica/métodos , Catéteres Cardíacos/efectos adversos , Diseño de Equipo , Estudios de Factibilidad , Interacciones Hidrofóbicas e Hidrofílicas , Industrias , Lubrificación , Microscopía Electrónica de Rastreo , Estándares de ReferenciaRESUMEN
Objectives of the study were the prevalence and clinical consequences of balloon rupture with compliant balloons in balloon aortic valvuloplasty (BAV). Compliant low-profile balloons have been developed to reduce access site complications. Made by thinner materials, these balloons are more prone to rupture. This is a single-center retrospective analysis (2016-2018) of patients undergoing BAV with compliant balloons. Baseline echocardiography and computed tomography (CT) were analyzed. Best cutoff point for calcium score was assessed. Long-term mortality was analyzed with Kaplan-Maier. In vitro test was performed. Rupture occurred in 30/90 (33%) of BAVs independent of risk factors, surgical risk and frailty scores. Patients experiencing rupture had increased mean gradient [53.5 (44-64) vs 44 (35-49) mmHg, p < 0.05] and reduced aortic valve area [0.61 (0.46-0.76) vs 0.76 (0.64-0.83) mm2, p < 0.05]. Valve calcium score on CT > 2686 AU was more frequent in the rupture group (41% vs 10%, p < 0.05) and more patients in the third tertile of calcium score experienced rupture (75% vs 23% vs 41% for second and first tertile, p < 0.05). Median gradient reduction from baseline was similar among groups [30 (20-50) vs 30 (17-39) mmHg]. No patient with rupture had any complication. One-month and long-term mortality were similar (rupture 0% vs 3.5% no rupture from 1 month). In vitro test required more volume and strength to rupture the balloon than used in BAV. Balloon rupture is frequent in BAV using compliant balloons, occurs with more severe aortic stenosis, does not affect BAV efficacy and does not impair outcomes.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Valvuloplastia con Balón/efectos adversos , Catéteres Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/patología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Ecocardiografía/métodos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Retrospectivos , Factores de Riesgo , Tomografía Computarizada por Rayos X/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Use of a universal diagnostic catheter may decrease procedural time and catheter-exchange related spasm when compared with a dual-catheter strategy. The aim of this study was to identify preprocedural predictors of failure to complete a coronary angiogram with a universal catheter alone. METHODS: Consecutive patients (n = 782) who underwent a right transradial/transulnar coronary angiogram with a single operator were retrospectively reviewed. Multivariable predictors of failure to complete the procedure with a universal catheter alone were identified using logistic regression analysis and presented as odds ratio (OR) and 95% confidence interval (CI). RESULTS: Of the study population (n = 558), a total of 216 (38.7%) required exchange to a coronary-specific catheter (44.4% for right coronary artery alone, 25.5% for left coronary artery alone, 30.1% for both) and 342 (61.3%) underwent angiography with a universal catheter alone. Patients who required a catheter exchange were more likely to have the following characteristics compared with patients who underwent an angiogram with a universal catheter alone: age >75 years (27.3% vs 16.4%; P<.01), female sex (34.3% vs 23.1%; P<.01), diabetes mellitus (50.0% vs 38.3%; P<.01), hypertension (88.0% vs 74.6%; P<.001), and chronic kidney disease (29.2% vs 17.8%; P<.01). After multivariable adjustment, age â«75 years (OR, 1.92; 95% CI, 1.21-3.04), female sex (OR, 1.94; 95% CI, 1.20-3.14), hypertension (OR, 2.08; 95% CI, 1.22-3.57), and chronic kidney disease (OR, 1.58; 95% CI, 1.01-2.46) predicted failure of a universal catheter alone to complete angiography. CONCLUSION: Consideration may be given to use an initial dual-catheter strategy if one or more of the following are present: elderly age, female sex, hypertension, and chronic kidney disease.
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Cateterismo Cardíaco/efectos adversos , Catéteres Cardíacos/efectos adversos , Angiografía Coronaria/métodos , Enfermedad Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Anciano , Falla de Equipo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Arteria Radial , Estudios RetrospectivosRESUMEN
The efficacy of drug-coated balloons (DCB) for in-stent restenosis (ISR) in hemodialysis (HD) patients remains unclear.We retrospectively evaluated 153 consecutive patients who underwent DCB for ISR with follow-ups for up to 3 years after the procedure between February 2014 and June 2017. Patients were divided into an HD group (n = 39) and a non-HD group (n = 114). The primary endpoint was target lesion revascularization (TLR). The secondary endpoints were all revascularizations and major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and cerebral infarction. Kaplan-Meier curves of survival free from TLR were compared between the two groups. We also performed propensity score matching and then compared the two matched groups (n = 27 in each group). The acute procedure success rate was similar for the two groups (100% versus 99.1%, P = 0.56). The incidence of TLR was higher in the HD group than in the non-HD group (41.0% versus 9.6%, P < 0.0001). The rate of revascularizations and MACE combined was significantly higher in the HD group than in the non-HD group (64.1% versus 17.5%, P < 0.0001). Kaplan-Meier analyses showed that survival free from TLR was significantly lower in the HD group than in the non-HD group both before and after propensity score matching (P < 0.0001 and P = 0.005, respectively; log-rank test).Contrary to the similar acute procedure success, recurrent ISR and MACE occurred more frequently in HD patients than in non-HD patients after DCB, which indicates poorer long-term efficacy of DCB in HD patients.
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Angioplastia Coronaria con Balón/efectos adversos , Catéteres Cardíacos/efectos adversos , Reestenosis Coronaria/terapia , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Diálisis Renal/métodos , Anciano , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Estudios de Casos y Controles , Causas de Muerte , Materiales Biocompatibles Revestidos , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Estenosis Coronaria/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Hospitales Universitarios , Humanos , Estimación de Kaplan-Meier , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Revascularización Miocárdica/métodos , Revascularización Miocárdica/mortalidad , Paclitaxel/farmacología , Puntaje de Propensión , Diálisis Renal/estadística & datos numéricos , Estudios Retrospectivos , Medición de Riesgo , Análisis de Supervivencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: We aimed at investigating the feasibility and outcome of Micra implant in patients who have previously undergone transvenous lead extraction (TLE), in comparison to naïve patients implanted with the same device. METHODS AND RESULTS: Eighty-three patients (65 males, 78.31%; 77.27 ± 9.96 years) underwent Micra implant at our centre. The entire cohort was divided between 'post-extraction' (Group 1) and naïve patients (Group 2). In 23 of 83 patients (20 males, 86.96%; 73.83 ± 10.29 years), Micra was implanted after TLE. Indication to TLE was an infection in 15 patients (65.21%), leads malfunction in four (17.39%), superior vena cava syndrome in three (13.05%), and severe tricuspid regurgitation in one case (4.35%). The implant procedure was successful in all patients and no device-related events occurred at follow-up (median: 18 months; interquartile range: 1-24). No differences were observed between groups in fluoroscopy time (13.88 ± 10.98 min vs. 13.15 ± 6.64 min, P = 0.45), single device delivery (Group 1 vs. Group 2: 69.56% vs. 55%, P = 0.22), electrical performance at implant and at 12-month follow-up (Group 1 vs. Group 2: pacing threshold 0.48 ± 0.05 V/0.24 ms vs. 0.56 ± 0.25 V/0.24 ms, P = 0.70; impedance 640 ± 148.83 Ohm vs. 583.43 ± 99.7 Ohm, P = 0.27; and R wave amplitude 10.33 ± 2.88 mV vs. 12.62 ± 5.31 mV, P = 0.40). A non-apical site of implant was achievable in the majority of cases (72.3%) without differences among groups (78.26% vs. 70%; P = 0.42). CONCLUSION: Micra implant is an effective and safe procedure in patients still requiring a ventricular pacing after TLE, with similar electrical performance and outcome compared with naïve patients at long-term follow-up.
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Estimulación Cardíaca Artificial , Microelectrodos , Marcapaso Artificial , Implantación de Prótesis/efectos adversos , Infecciones Relacionadas con Prótesis , Anciano , Catéteres Cardíacos/efectos adversos , Estimulación Cardíaca Artificial/métodos , Estimulación Cardíaca Artificial/estadística & datos numéricos , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Marcapaso Artificial/efectos adversos , Marcapaso Artificial/estadística & datos numéricos , Implantación de Prótesis/instrumentación , Implantación de Prótesis/métodos , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/cirugía , Reoperación/efectos adversos , Reoperación/métodos , TiempoRESUMEN
Presently described is a case in which the tip of the delivery catheter system (nose cone) has been broken during catheter removal after valve deployment in a femoral transcatheter aortic valve replacement procedure and the successful management of this rare complication.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/patología , Calcinosis/cirugía , Catéteres Cardíacos/efectos adversos , Insuficiencia Cardíaca/complicaciones , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano de 80 o más Años , Aorta/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Calcinosis/complicaciones , Calcinosis/diagnóstico por imagen , Fluoroscopía , Humanos , MasculinoRESUMEN
A 70-year-old man underwent cardiac surgery including left atrial appendage closure. A pigtail catheter was inserted into the pericardial sac because of delayed tamponade. Removal of the catheter was planned for 2 days after drain insertion. However, the resistance was high and pulsatile. The patient was transferred to the catheterization laboratory and a guide wire was inserted through the catheter, revealing the catheter route around the left atrial appendage. The wire was exchanged for a stiff wire to uncurl the catheter as much as possible, then the catheter was removed. The left atrial appendage does not usually represent an obstacle to catheter removal because it is soft and shrinkable. However, once the left atrial appendage becomes closed off, it can become hard, unshrinkable and an obstacle that might be caught by the drainage catheter.
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Apéndice Atrial/cirugía , Catéteres Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos , Drenaje/instrumentación , Derrame Pericárdico/cirugía , Anciano , Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Ecocardiografía Transesofágica , Humanos , Masculino , Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND/PURPOSE: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters. METHODS/MATERIALS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events. RESULTS: Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon. CONCLUSIONS: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters. SUMMARY: To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.
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Catéteres Cardíacos/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Vigilancia de Productos Comercializados , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Bases de Datos Factuales , Diseño de Equipo , Falla de Equipo , Humanos , Intervención Coronaria Percutánea/mortalidad , Medición de Riesgo , Factores de Riesgo , Resultado del Tratamiento , Estados Unidos , United States Food and Drug AdministrationRESUMEN
BACKGROUND: Transthoracic intracardiac catheters are central catheters placed in the operating room at the conclusion of cardiac surgery for infants and children. Complications associated with these catheters (eg, bleeding, migration, premature removal, infection, leakage, and lack of function) have been described. However, no researchers have addressed the nursing management of these catheters in the intensive care unit, including catheter dressing and securement, mobilization of patients, and flushing the catheters, or the impact of these interventions on patients' outcomes. OBJECTIVES: To internationally benchmark current nursing practice associated with care of infants and children with transthoracic intracardiac catheters. METHODS: In a cross-sectional, descriptive study of nursing practice in infants and children with transthoracic intracardiac catheters, a convenience sample of bedside and advanced practice nurses was recruited to complete an online survey to benchmark current practice. The survey included questions on criteria for catheter insertion and removal, dressing care, flushing practice, securement, and mobilization of patients. RESULTS: Transthoracic intracardiac catheters are used by most centers that provide care for infants and children after open heart surgery. A wide range of practices was reported. CONCLUSIONS: Standardizing the use and care of transthoracic intracardiac catheters can improve the safety and efficacy of their use in infants and children and promote safe and early postoperative mobilization of patients.
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Cateterismo Cardíaco/efectos adversos , Catéteres Cardíacos/efectos adversos , Enfermería de Cuidados Críticos/normas , Enfermería Pediátrica/normas , Pediatría/normas , Benchmarking , Catéteres Cardíacos/normas , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Cateterismo Venoso Central/efectos adversos , Niño , Estudios Transversales , Humanos , Lactante , Unidades de Cuidados Intensivos/normas , Cuidados Posoperatorios/enfermería , Complicaciones Posoperatorias/etiología , Guías de Práctica Clínica como Asunto , Factores de Riesgo , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
Cardiac electrophysiology utilizes nonimplantable, catheter-based devices for diagnosis and treatment of arrhythmias as well as electroanatomical mapping of cardiac chambers. Gross pathology and histopathological assessments in preclinical studies play critical roles in determining the safety and efficacy of cardiac ablation systems used to treat tachyarrhythmias. The pathologist must assess ablation sites, adjacent structures and organs, and downstream organs to characterize the effects of the ablation treatment and determine whether adverse local reactions, collateral injury, or downstream thromboembolism are present. Histopathological assessment serves as an adjunct to electroanatomical data in determining efficacy in preclinical studies. Histopathology is the standard in definitively demonstrating transmurality of ablation lesions, which is necessary for complete conduction block, as well as showing the linear or circumferential distribution of a contiguous, transmural ablation lesion necessary for electroanatomical isolation of entire target structures such as pulmonary veins and the cavotricuspid isthmus, which are involved in propagating certain arrhythmias. This article will detail gross and histological methods for the pathology assessment of preclinical studies evaluating the safety and/or efficacy of cardiac ablation catheter systems as well as discuss correlation of pathology data with other supporting evidence for safety and efficacy such as acute, electroanatomical data.
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Catéteres Cardíacos/normas , Ablación por Catéter/instrumentación , Criocirugía/instrumentación , Seguridad de Equipos , Atrios Cardíacos/patología , Ventrículos Cardíacos/patología , Animales , Catéteres Cardíacos/efectos adversos , Atrios Cardíacos/fisiopatología , Atrios Cardíacos/cirugía , Sistema de Conducción Cardíaco/fisiopatología , Ventrículos Cardíacos/fisiopatología , Ventrículos Cardíacos/cirugía , Taquicardia/cirugíaAsunto(s)
Fibrilación Atrial , Ablación por Catéter , Atrios Cardíacos , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/patología , Fibrilación Atrial/cirugía , Catéteres Cardíacos/efectos adversos , Ablación por Catéter/efectos adversos , Ablación por Catéter/instrumentación , Femenino , Fluoroscopía , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/patología , Atrios Cardíacos/cirugía , Humanos , Persona de Mediana EdadRESUMEN
BACKGROUND: A drug-coated balloon (DCB) has been designed as a new device for the treatment of coronary artery disease. The data regarding DCB-treated lesions in large coronary artery are limited. The purpose of our study was to explore the effectiveness and safety of DCB in large coronary artery. METHODS: We prospectively analyzed all patients treated with DCB in de novo lesions consistent with inclusion criteria between May 2015 and April 2017. The observed outcomes included target lesion revascularization (TLR), myocardial infarction, cardiac death and non-cardiac death, and major adverse cardiac events (MACE). RESULTS: There were 92 patients including 94 coronary de novo lesions treated in all. The most often utilized DCB diameters were 3.0 mm (41.5%) and 3.5 mm (39.4%). Two acute closures occurred in hospital. Six bailout drug-eluting stents were used in the percutaneous coronary interventions (6.4%). Quantitative coronary angiography measurement at follow-up showed late lumen loss was -0.02 ± 0.49 mm. The TLR rate and overall MACE rates were 4.3% and 4.3% during the follow-up period in the whole patient population, respectively. CONCLUSIONS: Our study showed that the "DCB only" strategy is safe and efficient in large vessel lesions of patients whose predilation achieved an acceptable result.
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Angioplastia Coronaria con Balón/instrumentación , Catéteres Cardíacos/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Anciano , Angiografía Coronaria/estadística & datos numéricos , Vasos Coronarios , Muerte , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Revascularización Miocárdica/estadística & datos numéricos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
Noninferiority trials are commonly utilized to evaluate the safety and effectiveness of medical devices. It could happen that the noninferiority hypothesis is rejected while the performance of the active control is clinically not satisfactory. This may pose a great challenge when making a regulatory decision. To avoid such a difficult situation, we propose to conduct a companion test to assess the performance of the active control when testing the main noninferiority hypothesis and to incorporate such a test into the study design. Under our proposal, the noninferiority of the investigational device to the active control can only be claimed when both hypotheses are rejected. The operating characteristics of the proposed study design based on these two tests can be fully evaluated at the design stage. This proposed approach is aimed to facilitate regulatory decision making in a more transparent manner.
Asunto(s)
Bioestadística/métodos , Aprobación de Recursos , Estudios de Equivalencia como Asunto , Proyectos de Investigación/estadística & datos numéricos , Arritmias Cardíacas/cirugía , Catéteres Cardíacos/efectos adversos , Catéteres Cardíacos/estadística & datos numéricos , Ablación por Catéter/efectos adversos , Ablación por Catéter/instrumentación , Ablación por Catéter/estadística & datos numéricos , Interpretación Estadística de Datos , Humanos , Medición de Riesgo , Resultado del TratamientoRESUMEN
PURPOSE: Despite the wide use of cryoenergy, there is a paucity of data regarding the impact of certain ablation parameters on lesion size. Specifically, this study sought to evaluate the impact of catheter type, ablation time, heat load, and tip orientation on lesion dimensions using a porcine thigh model with focal cryoablation catheters. METHODS: In 6 pigs, 251 lesions were created on thigh muscle with parameter permutations to compare the acute impact of catheter type (electrode tip sizes 4, 6, and 8 mm), ablation time (2, 2 × 2, 3, 4, and 2 × 4 min), heat load (1 and 2 L/min), and tip orientation (perpendicular or parallel) on lesion dimensions (length, depth, and cross-sectional area) immediately post-ablation. As a sub-study to evaluate the importance of tissue contact during the cryoablation procedure, a 1-min freeze was performed without tissue contact until an ice ball formed, followed by an additional 2-3 min freeze. RESULTS: The linear regression model revealed that catheter type (p < 0.0001) and the interaction between catheter orientation and catheter type (p = 0.027) were significantly associated with lesion cross-sectional area. Lesion length and depth, but not cross-sectional area, are significantly impacted by the catheter type (p < 0.0001; p = 0.003) and orientation (p < 0.0001; p < 0.0001), respectively. Compared to parallel catheter placement, lesions created with the perpendicular orientation were deeper using 4-mm (p = 0.136), 6-mm (p = 0.005), and 8-mm tip catheter (p = 0.004). Lesion creation with an ice ball significantly reduced lesion depth compared to lesions made without an ice ball (p < 0.05). In contrast, ablation time (p = 0.097) and heat load (p = 0.467) were not significantly associated with lesion size. Additionally, there was no statistical significant difference in lesion size between 2 × 2 and 4 min ablation times. CONCLUSIONS: The present study demonstrated that lesion size was significantly impacted by catheter type and catheter tip orientation and that maintaining tissue contact prior to applying cryoenergy is essential.