RESUMEN
Background: This study of radiation exposure (RE) to physicians performing structural heart procedures evaluated the efficacy of a novel comprehensive radiation shield compared to those of traditional shielding methods. A novel comprehensive shielding system (Protego, Image Diagnostics Inc) has been documented to provide superior RE protection during coronary procedures compared to that provided by a standard "drop down" shield. The purpose of this study was to assess the efficacy of this shield in transcatheter aortic valve replacement (TAVR) procedures, which are associated with disproportionate RE to operators. Methods: This single-center, 2-group cohort, observational analysis compared RE to the primary physician operator performing TAVR using the Protego shield (n = 25) with that using a standard drop-down shield with personal leaded apparel (n = 25). RE was measured at both thyroid and waist levels with a real-time dosimetry system (RaySafe i3, RaySafe) and was calculated on a mean per case basis. Data were collected on additional procedural parameters, including access site(s) for device implantation, per case fluoroscopy time, air kerma, and patient factors, including body mass index. Between-group comparisons were conducted to evaluate RE by group and measurement sites. Results: The Protego system reduced operator RE by 99% compared to that using standard protection. RE was significantly lower at both the thyroid level (0.08 ± 0.27 vs 79.2 ± 62.4 µSv; P < .001) and the waist level (0.70 ± 1.50 vs 162.0 ± 91.0 µSv, P < .001). "Zero" total RE was documented by RaySafe in 60% (n = 15) of TAVR cases using Protego. In contrast, standard protection did not achieve zero exposure in a single case. Conclusions: The Protego shield system provides superior operator RE protection during TAVR procedures. This shield allows operators to work without the need for personal lead aprons and has potential to reduce catheterization laboratory occupational health hazards.
RESUMEN
Background: The catheterization laboratory predisposes to occupational health hazards. Chronic radiation exposure (RE) direct injuries include a predilection to cataracts and concerns for cancers. Indirectly adverse effects underly the prevalence of orthopedic maladies in interventionists, linked to the burden of mandatory protective lead aprons. A novel comprehensive shielding system (Protego, Image Diagnostics Inc) has been validated in early studies to provide excellent radiation protection. The system is designed to reduce operator RE sufficient to eliminate the need for personal lead aprons. Recent system refinements offer potentially even greater degrees of protection. This clinical study evaluated the efficacy of this system. Methods: This single-center 2-group cohort study compared physician operator RE utilizing the latest iteration of the Protego shield (n = 25 cases) or standard protection (personal leaded apparel and drop-down shield, n = 25 cases) during routine cardiac catheterization procedures. RE at both thyroid and waist levels were measured with a real-time dosimetry system (Raysafe) and calculated on a mean per case basis at both thyroid and waist levels. Additional parameters collected included procedure type, access site, per case fluoroscopy time, and patient factors including body mass index. Between-group comparisons were conducted to evaluate RE by group and measurement sites. Results: Protection with Protego was superior to standard methods. Protego showed markedly lower RE at both the thyroid level (0.36 ± 0.86 vs 58.5 ± 50.2 µSv; P < .001) and the waist level (0.84 ± 2.99 vs 121.4 ± 171.2 µSv; P < .001. "Zero" total RE was documented in 68% (n = 17) of Protego cases; in contrast, standard protection did not achieve "zero" exposure in a single case. Conclusions: The Protego shield system provides excellent RE protection to the physician operator, achieving "zero" RE in two-thirds of cases. RE was superior to standard protection methods. The magnitude of protection achieves state regulatory standards sufficient to allow operators to perform procedures without orthopedically burdensome lead aprons. This shield system has the potential to reduce occupational health hazards.