Comprehensive Shielding System Enhances Radiation Protection for Structural Heart Procedures.

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.

Comprehensive radiation shield minimizes operator radiation exposure in coronary and structural heart procedures.

OBJECTIVES: This study evaluated the efficacy of a novel comprehensive shield designed to minimize radiation exposure (RE) to Physicians performing coronary and structural heart procedures. BACKGROUND: The Protego™ radiation shielding system (Image Diagnostics Inc., Fitchburg, Ma) is designed to provide comprehensive protection from RE and has been State certified sufficient to allow operators to perform procedures without orthopedically burdensome lead aprons. METHODS: This single center two-group cohort study assessed the efficacy of this shield in a large number of cardiac procedures (coronary and structural), comparing operator RE compared to standard protection methods (personal lead apparel and "drop down" shield). RESULTS: The Protego™ system reduced operator RE by 99 % compared to Standard Protection. RE was significantly lower at both "Head" level by thyroid median dose 0.0 (0.0, 0,0) vs 5.7 (2.9, 8.2) µSv (p < 0.001), as well as waist dose 0.0 (0.0, 0.0) vs 10.0 (5.0, 16.6) µSv (p < 0.001). "Zero" Total RE was documented by Raysafe™ in 64 % (n = 32) of TAVR cases and 73.2 % (n = 183) of the coronary cases utilizing Protego™. In contrast, standard protection did not achieve "Zero" exposure in a single case. These dramatic differences in RE were achieved despite higher fluoroscopy times in the Protego™ arm (11.9 ± 8.6 vs 14.3 ± 12.5 min, p = 0.015). Per case procedural exposure measured by Dose Area Product was higher in the Protego™ group compared to standard protection (115.4 ± 139.2 vs 74.9 ± 69.3, p < 0.001). CONCLUSION: The Protego™ shield provides total body RE protection for operators performing both coronary and structural heart procedures. This shield allows procedural performance without the need for personal lead aprons and has potential to reduce catheterization laboratory occupational health hazards.

Comprehensive Radiation Shield Minimizes Operator Radiation Exposure and Obviates Need for Lead Aprons.

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.

Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification.

BACKGROUND: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak. AIMS: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC. METHODS: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days. RESULTS: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients. CONCLUSIONS: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.

Novel Transcatheter Mitral Valve Prosthesis for Patients With Severe Mitral Annular Calcification.

BACKGROUND: Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak. OBJECTIVES: The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis. METHODS: Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy. RESULTS: Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up. CONCLUSIONS: Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted.

Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated. OBJECTIVES: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis. METHODS: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently. RESULTS: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points. CONCLUSIONS: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.

The ABSORB bioresorbable vascular scaffold: A novel, fully resorbable drug-eluting stent: Current concepts and overview of clinical evidence.

The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.

Interventional Management of Unprotected Left Main Coronary Artery Disease: Patient Selection and Technique Optimization.

For many years, coronary artery bypass graft surgery has been the gold standard for revascularization of patients with left main disease; however, increasing evidence suggests that percutaneous coronary intervention with drug-eluting stents may be an acceptable alternative or even preferred in select cases. This review will present clinical evidence examining the outcomes of drug-eluting stents compared to coronary artery bypass graft surgery for unprotected left main coronary artery disease and discuss the anatomic factors, patient variables, and clinical strategies that may dictate choice of revascularization modality for patients with left main disease. If percutaneous coronary intervention is selected to treat unprotected left main disease, meticulous technique is essential to optimize outcomes, including use of procedural physiology and imaging guidance, optimal stent and adjunct pharmacology use, and expert management of the distal bifurcation. Finally, issues of equipoise and uncertainty are identified, representing areas for future investigation.