Combined strategy of device-based contrast minimization and urine flow rate-guided hydration to prevent acute kidney injury in high-risk patients undergoing coronary interventional procedures.

BACKGROUND AND AIMS: Contrast-associated acute kidney injury (CA-AKI) is a major complication following coronary procedures. We aimed to evaluate the effectiveness of a combination of urine flow rate-(UFR) guided hydration (RenalGuardTM) and device-based contrast media (CM) reduction (DyeVertTM) in CA-AKI prevention. METHODS: Stable high-risk patients undergoing coronary procedures with the use of DyeVertTM and RenalGuardTM were prospectively included (Combined group) and matched with a similar cohort of patients treated only with RenalGuardTM in whom CM volume was controlled by operator-dependent strategies (Control group). CA-AKI was defined as a serum creatinine increase ≥0.3 mg/dL at 48 h. RESULTS: Overall, 55 patients were enrolled and matched with comparable controls. Patients in the Combined group were exposed to a lower CM dose (Control: 55 [30-90] mL vs. Combined: 42.1 [24.9-59.4] mL; p = 0.024). A significant interaction was found between treatment allocation and serum creatinine changes (p = 0.048). CA-AKI occurred in five (9.1%) patients in the Combined group and in 14 (25.4%) patients in the Control group (OR 0.29, 95% CI [0.09-0.88]). CONCLUSIONS: A combined strategy of device-based CM reduction plus UFR-guided hydration is superior to operator-dependent CM sparing strategies plus UFR-guided hydration in preventing CA-AKI in high-risk patient.

Kidney Injury After Minimal Radiographic Contrast Administration in Patients With Acute Coronary Syndromes.

BACKGROUND: Acute kidney injury (AKI) is common in patients with acute coronary syndromes (ACS) treated by percutaneous coronary intervention. OBJECTIVES: Contrast media (CM) volume minimization has been advocated for prevention of AKI. The DyeVert CM diversion system (Osprey Medical, Inc) is designed to reduce CM volume during coronary procedures. METHODS: In this randomized, single-blind, investigator-driven clinical trial conducted in 4 Italian centers from February 4, 2020 to September 13, 2022, 550 participants with ACS were randomly assigned in a 1:1 ratio to the following: 1) the contrast volume reduction (CVR) group (n = 276), in which CM injection was handled by the CM diversion system; and 2) the control group (n = 274), in which a conventional manual or automatic injection syringe was used. The primary endpoint was the rate of AKI, defined as a serum creatinine (sCr) increase ≥0.3 mg/dL within 48 hours after CM exposure. RESULTS: There were 412 of 550 (74.5%) participants with ST-segment elevation myocardial infarction (211 of 276 [76.4%] in the CVR group and 201 of 274 [73.3%] in the control group). The CM volume was lower in the CVR group (95 ± 30 mL vs 160 ± 23 mL; P < 0.001). Seven participants (1 in the CVR group and 6 in the control group) did not have postprocedural sCr values. AKI occurred in 44 of 275 (16%) participants in the CVR group and in 65 of 268 (24.3%) participants in the control group (relative risk: 0.66; 95% CI: 0.47-0.93; P = 0.018). CONCLUSIONS: CM volume reduction obtained using the CM diversion system is effective for prevention of AKI in patients with ACS undergoing invasive procedures. (REnal Insufficiency Following Contrast MEDIA Administration TriaL IV [REMEDIALIV]: NCT04714736).

Contrast media volume reduction with the DyeVertTM system to prevent acute kidney injury in stable patients undergoing coronary procedures.

BACKGROUND: Contrast associated acute kidney injury (CA-AKI) can lead to an increased risk of adverse events. Contrast media (CM) volume reduction has been advocated as a pivotal strategy to prevent CA-AKI in stable patients undergoing percutaneous coronary procedures. AIMS: To compare the effectiveness of CM volume reduction with the DyeVertTM system versus conventional strategy in reducing the risk of CA-AKI. METHODS: We prospectively collected data from 136 patients with stable coronary artery disease at high risk of CA-AKI treated with left ventricular end diastolic pressure (LVEDP)- guided hydration and undergoing interventions with the use of the DyeVertTM (Osprey Medical Inc.) system. Patients previously enrolled in the LVEDP-guided hydration arm of the "Renal Insufficiency Following Contrast MEDIA Administration triaL III" (REMEDIAL III) were considered as controls. Propensity score was used to perform 1:1 matching to adjust for major confounders. The primary outcome was the occurrence of CA-AKI, as defined by an absolute increase of creatinine values ≥0.3 mg/dL at 48 h. RESULTS: Patients in the DyeVert group were treated with a significant lower CM volume (median: 47.5 vs. 84.0 mL, p < 0.001). The trend in creatinine increase was lower (p = 0.004) and the Δ of creatinine (0-48 h) showed a higher drop (-0.18 vs. -0.10 mg/dL, p = 0.036) in the DyeVert group. The risk of CA-AKI was significantly lower in DyeVert group compared to control group (5.1% vs. 16.8%; odds ratio 0.27, 95% confidence interval [0.12-0.61]). CONCLUSIONS: CM volume reduction with the DyeVertTM system seems to be superior to conventional strategies in reducing the occurrence of CA-AKI.

Paclitexel versus sirolimus-coated balloon in the treatment of coronary instent restenosis.

BACKGROUND: Few studies compared paclitaxel-coated balloon (PCB) versus sirolimus-coated balloon (SCB) in the treatment of drug-eluting stent (DES) instent restenosis (ISR). METHODS: Between November 5, 2009, and October 14, 2020, in our center 212 patients with first DES-ISR were treated with PCB (Restore®; Cardionovum GmbH, Bonn, Germany), whereas 230 patients were treated with SCB (Devoir®; MINVASYS SAS, Gennevilliers, France). Following a propensity matching, 186 patients were included into PCB group (PCB group), and in the SCB group (SCB group). The primary purpose of the study was the 1-year target lesion failure (TLF) rate, including cardiac death, target vessel-related myocardial infarction, and repeated target lesion or target vessel revascularization. RESULTS: Procedural success occurred in all cases. Fully optimal predilation (that is, balloon-to-stent ratio >0.91, time of DCB inflation >60 sec, and residual percent diameter stenosis after lesion preparation <20%) was observed more often in the SCB group (126 [68%] patients versus 106 [57%] patients; P=0.042). One-year TLF occurred in 29 (15.5%) patients in the SCB group and in 32 (17%) patients in the PCB group (OR=1.12 [0.65-1.95]; P=0.78). By logistic Cox regression analysis fully optimal predilation (OR=0.06; 95% CI: 0.01-0.21; P<0.001) but not DCB type (OR=0.74; 95% CI: 0.41-1.31; P=0.29) was independent predictor of 1-year TLF. CONCLUSIONS: The current study suggests that 1-year TLF is not statistically and clinically different in patients with DES ISR treated with a PCB and a SCB.

Contrast Media Volume Control and Acute Kidney Injury in Acute Coronary Syndrome: Rationale and Design of the REMEDIAL IV Trial.

Background: Although the pathogenesis of acute kidney injury (AKI) in patients with acute coronary syndrome (ACS) undergoing invasive treatment is multifactorial, the role of iodinated contrast media (CM) has been well established. The DyeVert system (Osprey Medical) is designed to reduce the CM volume during invasive coronary procedures while maintaining fluoroscopic image quality. Objective: The aim of the Renal Insufficiency Following Contrast Media Administration Trial IV (REMEDIAL IV) is to test whether the use of the DyeVert system is effective in reducing contrast-associated acute kidney injury (CA-AKI) rate in patients with ACS undergoing urgent invasive procedures. Trial Design: Patients with ACS treated by urgent invasive approach will be enrolled. Participants will be randomly assigned into one of the following groups: (1) DyeVert group and (2) control group. In participants enrolled in the DyeVert group, CM injection will be handled by the DyeVert system. On the contrary, in the control group, CM injection will be performed by a conventional manual or automatic injection syringe. In all cases, iobitridol (a low-osmolar, nonionic CM) will be administered. Participants will receive intravenous 0.9% sodium chloride as soon as moved to the catheterization laboratory. The primary end points are CM volume administration and CA-AKI rate (ie, an increase in serum creatinine concentration of ≥0.3 mg/dL within 48 hours after CM exposure). A sample size of at least 522 randomized participants (261 in each group) is needed to demonstrate an 8.5% difference in the CA-AKI rate between the groups (that is, from 19% in the control group to 10.5% in the DyeVert group), with a 2-sided 95% confidence interval and 80% power (P < .05).

The "locking and dragging" technique a facilitated crossover balloon occlusion technique for complex iliofemoral anatomy in transcatheter aortic valve replacement.

Crossover balloon occlusion technique (CBOT) has been proposed to ensure adequate closure of the arterial access used for transcatheter aortic valve replacement (TAVR). However, the CBOT performed through the contralateral femoral artery could be challenging in cases of excessively tortuous and calcified vessels or in the presence of narrow iliac carina angles. We describe a novel technique to facilitate the advancement the peripheral balloon through the contralateral femoral artery up to the target iliofemoral system in order to facilitate access site hemostasis. The present "locking and drugging" technique takes advantages from two mechanical aspects: (a) the locking of the 0.018″ wire between the vessel wall and the TAVR delivery system or the dedicated sheath, which facilitate the crossover of the balloon in the contralateral iliofemoral system, preventing its prolapse into the aorta at the carina level and (b) the dragging of the balloon advanced into the contralateral iliofemoral system during the retrieve of the TAVR delivery system or the dedicated sheath.

Impact of a contrast media volume control device on acute kidney injury rate in patients with acute coronary syndrome.

BACKGROUND: The DyeVert™ system (Osprey Medical Inc., Minnesota, MN) may reduce contrast media (CM) volume during coronary procedures while maintaining fluoroscopic image quality. Here, we assessed whether the use of the DyeVert system reduces acute kidney injury (AKI) rate in patients with acute coronary syndrome (ACS) undergoing invasive coronary procedures. METHODS: ACS patients scheduled for coronary procedure from January 2017 to December 2019 were included. Two groups were identified: (a) Control group (n = 339), including patients in which a conventional manual injection syringe was used; and (b) DyeVert group (n = 112), in which CM injection was handled by the DyeVert™ system. A propensity score matching was performed to reduce the effect of treatment selection bias and potential confounders. In all cases, a low-osmolar, nonionic CM was administered. The primary objective was the rate of AKI, defined as a serum creatinine increase ≥0.3 mg/dl within 72 hr after CM exposure. RESULTS: CM volume was higher in the Control group than in the DyeVert group (130 [120-188] ml vs. 99 [69-136] ml; p <.001). In the DyeVert group the mean percent CM volume saved was 38 ± 13%. AKI occurred in 7/90 patients (8%) in the DyeVert group and in 17/90 (19%) patients in the Control group (odds ratio = 0.37; 95% confidence interval 0.14-0.95; p =.047). CONCLUSIONS: This preliminary result suggests that CM volume reduction obtained by the DyeVert™ system is an effective strategy to prevent AKI in ACS patients undergoing invasive procedure.

Aspirina solúvel em lisina": estudo espectrofotométrico / Lysine-soluble aspirin": spectrophotometric study

Com a finalidade de verificar a estabilidade do ácido acetil-salicílico em meio aquoso, os autores fizeram um estudo comparativo entre os espectros de absorção do ácido acetil-salicílico solução L-lisina base, mas sim uma mistura de salicilato de lisina e acetato de lisina e acetado de lisina, resultante da composição doacetil-salicílico e posterior combinação com a lisina (AU).