Fluoroscopy and contrast media use in cryoballoon ablation of atrial fibrillation using a novel imaging system.

Pulmonary vein (PV) isolation using cryoballoon (CB) catheter is generally characterized by a high radiation and contrast media exposure. A new dielectric imaging system (KODEX-EPD imaging system) allows pulmonary vein (PV) occlusion assessment without dye use. The purpose of this study was to verify the feasibility of reducing the radiation and dye use during CB ablation in patients with atrial fibrillation (AF) using the new dielectric imaging system. In a retrospective, single center study, we enrolled 34 consecutive patients with paroxysmal AF divided in two groups: 17 patients in Conventional Group underwent the procedure under fluoroscopy guidance before the new system introduction, while 17 patient in KODEX-EPD Group underwent the procedure under fluoroscopy and KODEX-EPD imaging system guidance. There were no differences in any clinical and anatomical characteristics between the two study groups. Overall procedure time was comparable between the two groups (69 [IQR 63-98] min in Conventional Group vs. 65 [IQR 58-74] min in KODEX-EPD Group, p = 0.16), while fluoroscopy time (8 [IQR 5-9] min vs. 11 [IQR 9-12] min, p = 0.014) and dye use (35 [IQR 28-45] ml vs. 70 [IQR 57-83] ml, p < 0.001) were significantly lower in the KODEX-EPD Group. No 30-day complications were observed. At 12-month follow-up 7/37 (19%) patients had an atrial arrhythmias recurrence, without any difference between the two study groups (17.6% vs. 23.5%, p = 0.68). The use of a new dielectric imaging system allowed a significantly reduction in radiation exposure and dye use during CB ablation in patients with AF.

Efficacy and safety of novel anticoagulants versus vitamin K antagonists in patients with mild and moderate to severe renal insufficiency: Focus on apixaban.

The high risk of both stroke and major bleeding in atrial fibrillation (AF) patients with chronic kidney disease (CKD) defines an important population for whom the assessment of the balance between the risk of ischemic stroke and of bleeding is essential. The use of novel oral anticoagulants (NOACs) may be a viable option in this population due to their greater net clinical benefit than warfarin, as demonstrated by the results of the clinical phase III trials. NOACs have been found to have a greater net clinical benefit than warfarin in patients at high risk of either stroke (CHADS2≥1 or CHA2DS2-VASc score≥2) or bleeding (HAS-BLED≥3). Noteworthy, it has been found also a positive net clinical benefit with apixaban and dabigatran 110mg BID in patients with CHADS2 score=0 and HAS-BLED score≥3. At CHA2DS2-VASc score=1, apixaban and both doses of dabigatran were superior to warfarin in terms of the net clinical benefit. Available scientific evidence might help in clinical decision-making regarding the use of NOACs in patients with CKD who are at high risk for both stroke and bleeding. Overall, current findings provide a rationale for the choice of apixaban or rivaroxaban over dabigatran in patients with AF and stage III CKD. Out of the NOACs, only apixaban has been recently approved for the use in patients with end-stage renal dysfunction on hemodialysis (the recommended dose of 5mg twice daily should be halved in patients with body weight of ≤60kg and or age≥80years).

Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial.

BACKGROUND: The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. METHODS: The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The "fixed group" was given an ODFC of perindropil 10mg plus indapamide 2.5mg plus amlodipine 5 or 10mg plus atorvastatin 20mg. The "free group" was given a FDC of the 3antihypertensive agents plus atorvastatin 20mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. RESULTS: At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p=0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. CONCLUSION: This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539.

Cystic hygromas, nuchal edema, and nuchal translucency at 11-14 weeks of gestation.

OBJECTIVE: To estimate the incidence of septations in fetuses with increased nuchal translucency (NT) thickness, and to investigate the relationship between the length and thickness of the translucency and whether the length or septations provide useful information concerning the fetal karyotype in addition to that provided by the NT thickness alone. METHODS: We examined 386 fetuses with NT thickness equal to or above the 95th percentile for crown-rump length (CRL). A transverse suboccipitobregmatic section of the fetal head was taken to determine whether the sonolucency was septated, and a midsagittal longitudinal section was used to measure NT thickness, CRL, the longitudinal distance between the occiput and the lower end of the sonolucency toward the fetal sacrum (NT length) and the length between the occiput and the sacral tip (spinal length). Logistic regression analysis was used to investigate the effect on abnormal karyotype of CRL, NT thickness, and percentage of NT length to spinal length. RESULTS: Septations within the translucency were observed in all fetuses. The fetal karyotype was abnormal in 83 (21.5%) pregnancies, and multiple regression showed that the only significant independent predictor of abnormal karyotype was fetal NT thickness. CONCLUSION: Septations within the translucency can be seen in all fetuses, and therefore this feature cannot be used to distinguish between increased NT and cystic hygromas. The length of the translucency is related to its thickness and does not give useful information concerning the fetal karyotype in addition to that provided by the NT thickness alone. LEVEL OF EVIDENCE: II-2.

Antepartum management and neonatal outcome of triplet pregnancies.

MATERIALS AND METHODS: The maternal and neonatal outcome of 27 triplet and 1 quadruplet gestations was studied at the University Hospital of Verona. RESULTS: Mean maternal age was 31.7+/-3.7 years; 24 women (85.7%) were nulliparous. Six (21.4%) patients had conceived spontaneously. Common maternal complications were: preterm labor (78.6%), anemia (57.1%), preeclampsia (25.0%). Thirteen patients (46.4%) had cervical cerclage, 21(75%) received tocolysis, 20 (71.4%) corticosteroid prophylaxis, 4 (14.3%) unfractionated heparin. All patients underwent Caesarean section with mean gestational age of 32+/-2.5 weeks and mean postoperative stay was 9 days. Three patients were treated in ICU after delivery, 1 was hysterectomized and 6 received blood transfusions. The live newborns were 80, the stillborns 5. Mean birth weight was 1,520+/-516 g (range 650-2,665), 95.0% being LBW. The following neonatal complications were observed: RDS (28.7%), cerebral hemorrhage (26.2% of II degrees and 1.2% of III degrees ), anemia (20%), PDA (12.5%), ROP (6.5%), polyglobulia (3.75%), NEC (2.5%). Mean hospitalization time was 30.6 days (range 2-132). DISCUSSION: Iatrogenic multiple births are increasing as the use of assisted conception techniques expands. Gynecologists should be aware of maternal complications and neonatal outcome of triplet pregnancies and infertility management strategies should try to avoid iatrogenic multiple gestations.