A novel robotic radiation shielding device for electrophysiologic procedures: A prospective study.

BACKGROUND: A robotic Radiaction Shielding System (RSS) was developed to provide a full-body protection to all medical personnel during fluoroscopy-guided procedures, by encapsulating the imaging beam and blocking scattered radiation. OBJECTIVES: We aimed to evaluate its efficacy in real-world electrophysiologic (EP) laboratory- both during ablations and cardiovascular implantable electronic devices (CIED) procedures. METHODS: A prospective controlled study comparing consecutive real-life EP procedures with and without RSS using highly sensitive sensors in different locations. RESULTS: Thirty-five ablations and 19 CIED procedures were done without RSS installed and 31 ablations and 24 CIED procedures (17 with usage levels ≥70%) were done with RSS. Overall, there was 95% average usage level for ablations and 88% for CIEDs. For all procedures with ≥70% usage level and for all sensors, the radiation with RSS was significantly lower than radiation without RSS. For ablations, there was 87% reduction in radiation with RSS (76%-97% for different sensors). For CIEDs, there was 83% reduction in radiation with RSS (59%-92%). RSS usage did not increase procedure time and radiation time. User feedback showed a high-level of integration in the clinical workflow and safety profile for all types of EP procedures. CONCLUSIONS: For both CIED and ablation procedures the radiation with RSS was significantly lower than without RSS. Higher usage level brings higher reduction rates. Thus, RSS may have an important role in full-body protection to all medical personnel from scattered radiation during EP and CIED procedures. Until more data is available, it is recommended to maintain existing standard shielding.

Aortic regurgitation assessment by cardiovascular magnetic resonance imaging and transthoracic echocardiography: intermodality disagreement impacting on prediction of post-surgical left ventricular remodeling.

Transthoracic echocardiography (TTE) is the primary clinical imaging modality for the assessment of patients with isolated aortic regurgitation (AR) in whom TTE's linear left ventricular (LV) dimension is used to assess disease severity to guide aortic valve replacement (AVR), yet TTE is relatively limited with regards to its integrated semi-quantitative/qualitative approach. We therefore compared TTE and cardiovascular magnetic resonance (CMR) assessment of isolated AR and investigated each modality's ability to predict LV remodeling after AVR. AR severity grading by CMR and TTE were compared in 101 consecutive patients referred for CMR assessment of chronic AR. LV end-diastolic diameter and end-systolic diameter measurements by both modalities were compared. Twenty-four patients subsequently had isolated AVR. The pre-AVR estimates of regurgitation severity by CMR and TTE were correlated with favorable post-AVR LV remodeling. AR severity grade agreement between CMR and TTE was moderate (ρ = 0.317, P = 0.001). TTE underestimated CMR LV end-diastolic and LV end-systolic diameter by 6.6 mm (P < 0.001, CI 5.8-7.7) and 5.9 mm (P < 0.001, CI 4.1-7.6), respectively. The correlation of post-AVR LV remodeling with CMR AR grade (ρ = 0.578, P = 0.004) and AR volumes (R = 0.664, P < 0.001) was stronger in comparison to TTE (ρ = 0.511, P = 0.011; R = 0.318, P = 0.2). In chronic AR, CMR provides more prognostic relevant information than TTE in assessing AR severity. CMR should be considered in the management of chronic AR patients being considered for AVR.

Association of Pulmonary Hypertension With Clinical Outcomes of Transcatheter Mitral Valve Repair.

Importance: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. Objective: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. Design, Setting, and Participants: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ≥45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017. Interventions: Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention. Main Outcomes and Measures: Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients. Results: Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02). Conclusions and Relevance: These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.

Target Hemoglobin May Be Achieved with Intravenous Iron Alone in Anemic Patients with Cardiorenal Syndrome: An Observational Study.

BACKGROUND: The treatment of anemia in patients with cardiorenal syndrome (CRS) is based mainly on intravenous (IV) iron therapy and/or erythropoiesis-stimulating agents (ESAs). There are concerns about the safety of ESAs due to a potentially higher risk for stroke and malignancy. OBJECTIVE: We aimed to explore whether IV iron alone is sufficient to improve anemia in CRS patients and to define the predictors of treatment response. METHODS: We retrospectively analyzed data of 81 CRS patient treated for anemia at our clinic. All patients received IV iron for 6 weeks. A subset of patients was additionally given subcutaneous ESAs. The end point was the improvement from baseline in hemoglobin (Hb) and ferritin levels at week 7. RESULTS: We retrieved the files of 81 patients; 34 received IV iron alone and 47 were given IV iron and ESAs (the combination group). The Hb levels significantly increased in both groups (in the IV iron alone group: 10.6 ± 1.1 to 11.9 ±1.1 g/dl, p < 0.001; in the combination group: 10.2 ± 0.9 to 12.4 ± 1.3 g/dl, p < 0.001), but more pronouncedly in the combination group (2.17 vs. 1.24 g/dl; p = 0.001). The platelet count decreased significantly in the IV iron alone group but was unchanged in the combination group. Eighty percent of patients attained a Hb target of 11 g/dl, with no significant difference between the two groups (73.5 vs. 85.1%; p = 0.197). Low baseline Hb was the only predictor of a favorable outcome to treatment. CONCLUSION: Our observational study suggests that IV iron treatment without ESAs may substantially raise the Hb level to ≥11 g/dl in CRS patients. This treatment strategy may reduce the use of ESAs and hence its potential adverse effects.

Outcomes of Transfemoral Transcatheter Aortic Valve Implantation in Patients With Previous Coronary Bypass.

Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n = 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n = 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2-adjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p = 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population.

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial.

BACKGROUND: Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. METHODS/DESIGN: Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. DISCUSSION: The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01866800, 30 April 30 2013.

Effect of socioeconomic status on cardio-respiratory fitness: data from a health screening program.

AIM: Lower socioeconomic status (SES) is associated with reduced cardio-respiratory fitness (CRF) and predicts adverse cardiovascular outcomes. We questioned whether this association remains significant among an apparently healthy population with a presumed higher SES. METHODS: This cross-sectional study enrolled attendees of a health screening program between September 2002 and November 2010. Linear regression models included the metabolic equivalents achieved during an exercise treadmill stress test as the dependent variable and adjusted for self-reported SES parameters (level of education, occupational status, financial strain and a combined variable), cardiovascular risk factors, as well as to multiple potential confounders. RESULTS: Data on 8471 individuals (5463 men and 3008 women) with a mean (SD) age of 44 (11) years were collected. We found a statistically significant difference in mean exercise capacity between the categories of SES, especially for the level of education and occupation, when adjusted for age, sex, cardiovascular risk factors, SES variables and multiple confounders. CONCLUSIONS: Multiple factors affect CRF in apparently healthy screened individuals. When adjusted for those factors, SES correlates with CRF even within a more specific highly educated cohort.

The missed opportunities to diagnose and treat iron deficiency in patients hospitalized with heart failure.

INTRODUCTION: Iron Deficiency (ID) is common in heart failure (HF), and is an independent contributor to mortality and morbidity. We examined whether patients with previously known HF who were recently hospitalized, had previous treatment for ID, were investigated for it at the time of hospitalization, and, if ID was found, were prescribed iron on discharge. METHODS: We examined the records of 76 consecutive patients admitted to our hospital medical wards with a primary diagnosis of HF. RESULTS: Anemia (Hb<12 g/dl) was found in 42/76 patients (55.3%). In 55/76 patients (72.4%) there was no iron workup, in 6 (7.9%) an incomplete iron workup with serum iron, transferrin or ferritin lacking and in 15/76 (19.7%) a complete iron workup. If ID was defined as either a serum ferritin of <100 µg/l or a serum ferritin of 100-299 µg/l and a %Transferrin Saturation of <20% it was found in 12/15 (80%) of those with a complete workup; in 9 of 10 (90%) of the anemic patients and in 3 of 5 (60%) of those non-anemic patients. At discharge 11/15 (73.3%) of those with a complete iron workup were given iron, 10 orally and 1 IV. In those 6 with an incomplete workup 2 were started on oral iron (33.3%) and in those without any workup, 1 of 55 (1.8%) was given oral iron. IN CONCLUSIONS: ID is common in hospitalized HF patients but is usually not sought after by physicians at the time of admission. However if detected the physicians usually treated it.

Intraperitoneal N-acetylcysteine for acute iron intoxication in rats.

Free radical formation and release of oxidant agents have been suggested as possible mechanisms for tissue damage in acute iron intoxication. N-acetylcysteine (NAC), a glutathione substitute and an antioxidant, is widely used as an antidote for various intoxications. Our aim was to determine whether intraperitoneal (i.p.) NAC would reduce the mortality of rats after acute, toxic oral doses of iron. Male Wistar rats were studied in three phases. In the first phase, animals were assigned to groups 1 (distilled water by gavage) and 2 (i.p. NAC) and observed for survival. In the second phase, rats were assigned to groups 3 (400 mg/kg elemental iron orally) and 4 (400 mg/kg elemental iron, followed by 150 mg/kg i.p. NAC). Survival was observed. Because most rats in Group 3 died within 90 minutes after iron administration, a third phase was conducted in order to allow for comparison of iron and transaminase serum levels after the administration of iron and NAC (group 5: n = 10). Mortality was significantly lower in rats treated with iron and NAC, compared to those treated with iron (P = 0.016). Median serum iron level was significantly lower among rats treated with iron and NAC, compared with rats treated with iron alone (P = 0.002). In a rat model of acute iron intoxication, i.p. administration of NAC may decrease serum iron levels and mortality.

Changes in serum hepcidin levels in acute iron intoxication in a rat model.

Hepcidin is an important and recently discovered regulator of iron homeostasis. Acute iron intoxication is one of the leading causes of overdose mortality in children. It is difficult to estimate the degree of iron intoxication since iron serum levels do not correlate with the actual clinical severity. In the current study we aimed to investigate whether serum hepcidin levels are elevated in acute iron intoxication. Rats were divided into two iron dose groups and one control group. Each group was further subdivided into four time groups following the administration of iron. Levels of hepcidin, iron and liver enzymes were measured, and animals were followed for signs of toxicity. Serum hepcidin levels were significantly higher in the group treated with toxic doses of iron (p=0.005). No significant difference in serum iron levels was found between the groups. In acute iron intoxication serum hepcidin levels increase significantly and remain elevated for at least 6h. We postulate that beyond the first hour after iron administration, serum hepcidin levels provide a better estimate of the amount of iron intake than do serum iron levels.