RESUMEN
OBJECTIVES: To investigate a novel suspended radiation shield (ZG), in reducing operator radiation exposure during cardiology interventions. BACKGROUND: Radiation exposure to the operator remains an occupational health hazard in the cardiac catheterization laboratory. METHODS: An anthropomorphic mannequin simulating an operator was placed near a phantom, simulating a patient. To measure the operator dose reduction, thermoluminescent detectors (TLDs) were inserted into the head and into the eye bulbs of the mannequin, while electronic dosimeters were positioned on the temple and at the level of the thyroid. Measurements were performed without and with the ZG system in place. Physician exposure was subsequently prospectively measured on the torso, on the left eye and on upper arm using the same electronic dosimeters, during clinical procedures (coronary angiography (CA) and percutaneous coronary intervention (PCI)). The physicians dose reduction was assessed by comparing operator dose when using traditional radioprotection garments (Phase 0) versus using the ZG system (Phase 1). RESULTS: Dose reductions as measured on the mannequin ranged from 66% to the head, to 100% to the torso. No dose was detected at the level of the torso and thyroid with ZG. When comparing CA and PCI procedures between Phase 0 and Phase 1, a significant difference (p < 0.001) was found for the left eye and the left wrist. Dose reduction as measured during clinical procedures for left eye/upper arm were on average 78.9%/95.6% for CA and 83.0%/93.0% for PCI, respectively (p < 0.001 for both). CONCLUSIONS: The ZG systems has a great potential to significantly reduce operator dose through the creation of a nearly zero-radiation work environment.
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Cardiología , Exposición Profesional , Intervención Coronaria Percutánea , Exposición a la Radiación , Protección Radiológica , Angiografía Coronaria/efectos adversos , Humanos , Exposición Profesional/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Dosis de Radiación , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Radiografía Intervencional/efectos adversos , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The use of ionizing radiation during cardiac catheterization interventions adversely impacts the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has proven to significantly reduce radiation exposure in electrophysiological and neuroradiology interventions. Our objective was to analyze whether the Cathpax® RPC reduces radiation dose in coronary and cardiac structural interventions in unselected real-world procedures. METHODS AND RESULTS: In this nonrandomized all-comers prospective study, 119 consecutive cardiac interventional procedures were alternatively divided into two groups: the RPC group (n = 59) and the non-RPC group (n = 60). No significant changes in the characteristics of patients and procedures, average contrast volume, air kerma (AK), dose area-product (DAP) and fluoroscopy time between both groups were apparent. In the RPC group, the first-operator relative radiation exposure was reduced by 78% at the chest and by 70% at the wrist. This effect was consistent during different types of procedures including complex percutaneous interventions and structural procedures. CONCLUSIONS: Our study demonstrates, for the first time, that the Cathpax® cabin significantly and efficiently reduces relative operator radiation exposure during different types of interventional procedures, confirming its feasibility in a real-world setting.
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Cardiología , Exposición Profesional , Exposición a la Radiación , Protección Radiológica , Fluoroscopía , Humanos , Exposición Profesional/efectos adversos , Exposición Profesional/prevención & control , Estudios Prospectivos , Dosis de Radiación , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Radiografía Intervencional/efectos adversos , Resultado del TratamientoRESUMEN
Aim: Traditional percutaneous cardiovascular interventions require close physical proximity between the patients and the healthcare team, posing occupational hazards that range from radiation exposure to interpersonal air contamination. Materials & methods: Prospective single-arm pilot study (n = 10) to investigate robotic-assisted intervention as a strategy to reduce proximity during the procedure. Primary end point: composite of angiographic success, intervention performed with the team positioned >2 meters from the patient for ≥50% procedure duration, and absence of in-hospital death or acute target lesion occlusion. Results: The composite primary end point was achieved in 100% of cases. Conclusion: Robotic-assisted percutaneous intervention provided successful invasive treatment while reducing proximity and shared air space between the care-delivery team and the patient during the procedure. Trial registration number: NCT04379453 (Clinicaltrials.gov).
Lay abstract Minimally invasive therapies for cardiovascular diseases are techniques that limit the size of incisions needed and so lessen wound healing time, but traditionally require close contact between the patients and the healthcare team. This fact poses hazards that range from radiation exposure to the spread of airborne diseases. We developed a small study of ten patients to investigate whether a new method of robotic-assisted stent implantation for the treatment of a heart attack would reduce proximity between the patient and medical staff during the procedure. To evaluate the effectiveness of that strategy, we assessed the success of the procedure (by analyzing the images of the operation), the amount of time the team was positioned more than 2 meters from the patient and the occurrence of complications during the hospitalization. We concluded that this method of robotic-assisted stent implantation after a heart attack provided successful treatment while reducing proximity and shared air space between the care-delivery team and the patient.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Procedimientos Quirúrgicos Robotizados , Mortalidad Hospitalaria , Humanos , Proyectos Piloto , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVES: The purpose of this study was to investigate the influence of simulated reduced-dose three-dimensional angiography (3DA) on the accuracy and precision of linear measurements derived from 3DA datasets. BACKGROUND: Three-dimensional angiography is performed during X-ray guided interventional procedures to aid diagnosis and inform treatment strategies for children and adults with congenital heart disease. However, 3DA contributes substantially to patient radiation dose and may lead to an increased radiation-induced cancer risk. METHODS: Reduced-dose patient 3DA images were simulated by adding quantum noise to the 2D projection angiograms, then reconstructing the projection angiograms into the 3DA dataset. Dose reduction in the range 33-72% was simulated. Five observers performed 46 vessel diameter measurements along prespecified axes within 23 vessel segments from 11 patient 3DA datasets. Statistical tests were performed to assess the influence of radiation dose reduction on the accuracy and precision of vessel diameter measurements. RESULTS: Vessel diameter measurements were in the range 5.9- 22.7 mm. Considering all vessel segments and observers, the influence of dose level on the accuracy of diameter measurements was in the range 0.02 - 0.15 mm (p .05-.8). Interobserver variability increased modestly with vessel diameter, but was not influence by dose level (p = .52). The statistical test for observer recall bias was negative (p = .51). CONCLUSIONS: Simulated dose reduction up to 72% did not affect the accuracy or precision of the diameter measurements acquired from 3DA images. These findings may embolden 3DA radiation dose reduction for pediatric and congenital heart disease patients.
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Cardiología , Reducción Gradual de Medicamentos , Adulto , Angiografía de Substracción Digital , Niño , Humanos , Imagenología Tridimensional , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to determine the accuracy of DoseMap™ software as compared to gafchromic film in real clinical practices. BACKGROUND: The radiation exposure from cardiovascular procedures could expose patients to potential risk of cancer and/or skin injury. New tools like Dosemap software were developed to estimate the patient skin dose in the cardiac catheterization laboratory. However, little data are available to validate this estimation of patient radiation skin dose. METHODS: This is a prospective cross-sectional study comparing the peak skin dose (PSD) measured by gafchromic film used as reference with an estimated PSD given by Dosemap software, in patients with BMI > 30 kg/m2 undergoing elective diagnostic and/or therapeutic interventional cardiology procedures, from April 2016 to December 2016, at the Brest University Hospital Centre, France. RESULTS: After four exclusions of patients for poor quality of gafchromic films, 90 patients were included, with 58 angiography (67.4%), 14 percutaneous interventions (16.3%), and 14 both (16.3%). The median PSDDosemap and PSDFilm were similar with 157 mGy [IQR: 99; 273] versus 158 mGy [IQR: 101; 295] (P = 0.65), respectively, with an excellent correlation (r = 0.95). The comparison between cumulative air kerma and PSDFilm was different 366 mGy [IQR: 246; 575] versus 158 mGy [IQR: 101; 295] (P < 0.01) with moderate correlation (r = 0.79). No correlation was found between the dose area product and PSDFilm (r = 0.51). CONCLUSION: DoseMap is an effective and valid method as compared to gafchromic films to estimate PSDs during interventional cardiologic procedures.
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Cateterismo Cardíaco , Angiografía Coronaria , Intervención Coronaria Percutánea , Dosis de Radiación , Exposición a la Radiación , Monitoreo de Radiación/métodos , Radiografía Intervencional , Piel/efectos de la radiación , Validación de Programas de Computación , Cateterismo Cardíaco/efectos adversos , Angiografía Coronaria/efectos adversos , Estudios Transversales , Femenino , Dosimetría por Película , Humanos , Masculino , Seguridad del Paciente , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Exposición a la Radiación/efectos adversos , Monitoreo de Radiación/instrumentación , Radiografía Intervencional/efectos adversos , Reproducibilidad de los Resultados , Medición de Riesgo , Factores de RiesgoRESUMEN
OBJECTIVES: A retrospective study was performed to investigate if the generation of X-ray system used was an independent factor for radiation dose in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: PCI procedures for CTOs are known to be associated with higher doses of radiation. The authors suspected progressive reductions in radiation doses for CTO PCI as newer X-ray systems were introduced into clinical practice. METHODS: Procedures performed over a five-year period by three interventional cardiologists were retrospectively reviewed. Five different X-ray systems were used across three hospital sites. These included: Axiom Artis and Coroskop HIP (both Siemens), Innova (GE), Allura Xper FD 10, and Allura Clarity FD 10 (both Philips). Procedural and demographic data including body mass index (BMI; kg/m2 ), fluoroscopy time (min), and dose area product (DAP; cGycm2 ) were collated for each procedure. Statistical analysis was performed to compare the influence each X-ray system would have on DAP values after BMI and fluoroscopy time were controlled for. RESULTS: In total, 860 procedures were analyzed. Mean fluoroscopy time was 40.00 ± 19.99 min, mean BMI was 29.90 ± 5.13 kg/m2 , mean DAP 11,980 ± 7,947 cGycm2 . Log values of DAP were used to normalize results in a general linear model. A significant statistical difference in DAP between X-ray systems was demonstrated after fluoroscopy time and BMI were controlled for (P ≤ 0.001). CONCLUSION: There is a significant impact on DAP values resulting from the generation of X-ray system used, measured during PCI for CTOs, with the most modern systems producing the lowest radiation doses.
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Cateterismo Cardíaco/instrumentación , Angiografía Coronaria/instrumentación , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Intervención Coronaria Percutánea/instrumentación , Dosis de Radiación , Exposición a la Radiación , Radiografía Intervencional/instrumentación , Cateterismo Cardíaco/efectos adversos , Enfermedad Crónica , Angiografía Coronaria/efectos adversos , Diseño de Equipo , Humanos , Irlanda del Norte , Intervención Coronaria Percutánea/efectos adversos , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Radiografía Intervencional/efectos adversos , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Escocia , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter aortic valve replacement (TAVR) exposes patients to radiation. OBJECTIVES: We sought to identify factors associated with higher radiation exposure and to quantify their relative influence, which may inform reduction of this hazard. METHODS: All TAVR procedures at Rhode Island Hospital between March 20, 2012 and February 12, 2017 were included. Procedures were performed by two co-primary operators using a Siemens Artis Zeego system. Radiation metrics were generated by the imaging system. The primary metric was dose-area product (DAP, Gy*cm2 ), and secondary metrics were reference point air kerma (mGy) and fluoroscopy time (minutes). Data collected for the STS/ACC TVT Registry were utilized to develop a multivariable linear regression model predicting DAP. RESULTS: In 294 TAVRs, median DAP was 169 Gy*cm2 [interquartile range (IQR) 106-238]. The r2 values for the full 27-variable DAP model and reduced eight-variable model were 0.457 and 0.420, respectively. Valve area, aortic insufficiency, and procedure year (suggesting absence of a learning curve) were non-significant predictors in the full model, while increasing weight, cutdown transfemoral access, higher pre-procedure creatinine and hemoglobin, and vascular complications predicted higher DAP in both models. Results were unchanged when DAP was log-transformed. Secondary models for air kerma and fluoroscopy time revealed similar predictors. CONCLUSION: Factors associated with increased procedural complexity and duration as well as radiation attenuation and scatter predict increased patient radiation exposure during TAVR. Modification of procedural technique, especially using percutaneous femoral vascular access, may facilitate reduction in exposure.
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Válvula Aórtica/cirugía , Dosis de Radiación , Exposición a la Radiación , Radiografía Intervencional , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Femenino , Humanos , Masculino , Tempo Operativo , Seguridad del Paciente , Exposición a la Radiación/efectos adversos , Exposición a la Radiación/prevención & control , Protección Radiológica/métodos , Radiografía Intervencional/efectos adversos , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Dispersión de Radiación , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversosRESUMEN
OBJECTIVES: We aimed to measure the reduction in the estimated dose of radiation received by patients that can be achieved using dose-reduction technology (ClarityIQ, Philips Healthcare, The Netherlands), among all patients undergoing invasive cardiology procedures. BACKGROUND: Medical procedures remain the primary source of exposure to ionizing radiation in the general population. METHODS: The study population comprised all patients (without exclusion criteria) undergoing invasive coronary procedures over a 1-year study period in a large referral centre equipped with two catheterization laboratories (cathlabs). Both cathlabs (A and B) were equipped with the Allura Xper FD10 imaging system (Philips Healthcare, The Netherlands), but only Cathlab B was equipped with ClarityIQ technology. The primary endpoint was the estimated total dose of radiation received by the patient, as assessed by Air Kerma (AK) and dose area product (DAP). RESULTS: In total, 2095 invasive coronary procedures were analyzed. The patients who underwent procedures in Cathlab B received an average estimated dose that was 23% (AK) and 43% (DAP) lower than the dose received by patients undergoing procedures in Cathlab A (P < .0001). The reduction remained significant by multivariate analysis after adjustment for total X-ray time, body mass index, arterial approach, PCI of at least one lesion, sex, and patient age. CONCLUSION: In our study, the ClarityIQ technology reduced the estimated radiation dose received by patients by 23-43%, according to the method of measurement.
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Cateterismo Cardíaco/métodos , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/efectos adversos , Dosis de Radiación , Exposición a la Radiación/prevención & control , Radiografía Intervencional/métodos , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Seguridad del Paciente , Estudios Prospectivos , Exposición a la Radiación/efectos adversos , Protección Radiológica/métodos , Radiografía Intervencional/efectos adversos , Medición de Riesgo , Factores de Riesgo , Adulto JovenRESUMEN
OBJECTIVES: To evaluate radiation reduction by reducing fluoroscopy pulse rate in diagnostic cardiac catheterizations and percutaneous coronary interventions (PCI) as well as outcomes at 30 days and six months. BACKGROUND: Radiation exposure to the public at large has increased dramatically over the past three decades, and the cardiac catheterization laboratory is a large contributor. Fluoroscopy pulse rate is one way to decrease radiation exposure. METHODS: Fluoroscopy pulse rate was reduced from 10 pulses/sec (p/s) to 7.5 p/s as part of an internal quality improvement project. A retrospective analysis of all cardiac catheterizations was performed, evaluating Air KERMA at the interventional reference point (Ka, r ), Air KERMA area product (PKA ), procedural complications and major adverse cardiac events at 30 days and 6 months. RESULTS: In diagnostic catheterization median PKA (µGy·m2 ) and Ka,r (mGy) were significantly reduced (PKA - 5,613.3 vs. 4,400, P < 0.001; Ka,r - 703.0 vs. 621.0, P = 0.041). In PCI, median PKA and Ka,r were further reduced (PKA - 13,481.6 vs. 10,648.0, P < 0.001; Ka,r - 1787.0 vs. 1,459.0, P = 0.002). There was no difference in complications, fluoroscopy time or number of stents placed. There was no difference in MACE after adjustment for number of STEMIs. CONCLUSIONS: Reducing fluoroscopy pulse rates to 7.5 from 10 is an effective way to reduce patient radiation exposure across meaningful dose indices. A pulse rate of 7.5 p/s is safe, with no difference in complications or outcomes. A fluoroscopy pulse rate of 7.5 p/s should be given strong consideration for a new standard. © 2016 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/métodos , Fluoroscopía/métodos , Traumatismos por Radiación/prevención & control , Medición de Riesgo/métodos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pennsylvania/epidemiología , Intervención Coronaria Percutánea , Dosis de Radiación , Traumatismos por Radiación/epidemiología , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: Interventional cardiologists and staff are subject to unique physical demands that predispose them to distinct occupational health hazards not seen in other medical disciplines. METHODS: To characterize the prevalence of these occupational health problems, The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed its members by email. Inquiries included age, years of invasive practice, and diagnostic and interventional cases per year. Questions focused on orthopedic (spine, hips, knees, and ankles) and radiation-associated problems (cataracts and cancers). RESULTS: There were 314 responses. Responders were on average busy and experienced, performing a mean of 380±249 diagnostic and 200±129 interventional cases annually. Of the responders, 6.9% of operators have had to limit their caseload because of radiation exposure and 9.3% have had a health-related period of absence. Furthermore, 153 (49.4%) operators reported at least one orthopedic injury: 24.7% cervical spine disease, 34.4% lumbar spine problems, and 19.6% hip, knee or ankle joint problems. Age was most significantly correlated with orthopedic illnesses: cervical injuries (χ2=150.7, P<0.0001); hip/knee or ankle injuries (χ2=80.9, P<0.0001); lumbar injuries (χ2=147.0, P<0.0001); and any orthopedic illness (χ2= 241.2, P<0.0001). Annual total caseload was also associated: the estimated change in the odds of orthopedic illness for each additional total caseload quintile is 1.0013 (1.0001, 1.0026). There is a small but substantial incidence of cancer. CONCLUSIONS: These findings are consistent with, and extend the findings, of a prior 2004 SCAI survey, in documenting a substantial prevalence of orthopedic complications among active interventional cardiologists, which persists despite increased awareness.