Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial.

BACKGROUND: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI. AIMS: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance. METHODS: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCR-guided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI. RESULTS: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6±44.4 ml vs 90.8±55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7±4.7 vs 11.7±7.6 in the control group; p<0.001). CONCLUSIONS: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614).

Outcomes of Stented vs Nonstented Femoropopliteal Lesions Treated With Drug-Coated Balloon Angioplasty.

PURPOSE: Drug-coated balloon (DCB) angioplasty has been increasingly used for the treatment of lower limb peripheral artery disease (PAD). However, bail-out stenting may be necessary in cases of suboptimal angioplasty. This study investigated the outcomes of femoropopliteal disease treated with DCB with/without bail-out stenting. MATERIALS AND METHODS: This was a single-center retrospective study enrolling 166 consecutive patients (DCB+stent: n=81 vs DCB: n=85) with 253 femoropopliteal lesions (DCB+stent: n=99 vs DCB: n=154) treated with DCB with/without stenting. Bail-out stenting was performed at the operator discretion for postangioplasty dissections or otherwise suboptimal angiographic result (>30% residual stenosis). Cox regression analysis was performed to examine the outcomes of DCB with/without stenting during 2-year follow-up. RESULTS: The baseline clinical characteristics were similar between the 2 groups. About half of the patients presented with critical limb ischemia, with most of the lesions located at the superficial femoral artery. The overall mean lesion length was 147±67 mm. The most frequent bail-out stent types were bare metal stents (BMS) (53.5%) followed by drug-eluting stents (DES) (41.4%). Lesions requiring bail-out stenting were on average longer (177±67 mm vs 127±59 mm; p<0.01) and on average had higher prevalence of flow-limiting postangioplasty dissections. The overall procedural success rate was 94% without any differences between the 2 groups. Both the stented and nonstented treatment modalities were effective and safe, demonstrating similar rates of 2-year freedom from major adverse limb event (stented: 71.3% vs nonstented: 64.4%) and 2-year freedom from target lesion revascularization (stented: 77.1% vs nonstented: 72.3%) during following up. The use of DES as bail-out therapy was associated with a lower risk of 2-year death compared with the use of BMS (DES: 97.2% vs BMS: 75.8%; p=0.01). CONCLUSION: Drug-coated balloon with bail-out stenting is a viable treatment option for cases of suboptimal DCB results, promising similar efficacy with DCB-alone procedures. However, as the patency of stents at the femoropopliteal segment may be a challenge due to the biomechanical stress of the artery, the efficacy of DCB+bail-out stenting should be further evaluated. In addition, future studies are needed to determine which grades of post-DCB dissections should be treated and optimize current bail-out strategies.

Clinical Characteristics and Outcomes Among Patients Undergoing High-Risk Percutaneous Coronary Interventions by Single or Multiple Operators: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background High-risk percutaneous coronary intervention (HR-PCI) is increasingly common among contemporary patients with coronary artery disease. Experts have advocated for a collaborative 2-operator approach to support intraprocedural decision-making for these complex interventions. The impact of a second operator on patient and procedural outcomes is unknown. Methods and Results Patients who underwent HR-PCI from 2015 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity-matched cohorts were generated to compare the outcomes following HR-PCI performed by a single or multiple (≥2) operators. The primary end point was the 12-month rate of major adverse cardiovascular events. We identified 6672 patients who underwent HR-PCI during the study period; 6211 (93%) were treated by a single operator, and 461 (7%) were treated by multiple operators, with a nonsignificant trend toward increased multioperator procedures over time. A higher proportion of patients treated by multiple operators underwent left main (10% versus 7%, P=0.045) or chronic total occlusion intervention (11% versus 5%, P<0.001). Lead interventionalists participating in multioperator procedures practiced at centers with higher annual HR-PCI volumes (124±71.3 versus 111±69.2; standardized mean difference, 0.197; P<0.001) but otherwise performed a similar number of HR-PCI procedures per year (34.4±35.3 versus 34.7±30.7; standardized mean difference, 0.388; P=0.841) compared with their peers performing single-operator interventions. In a propensity-matched cohort, there was no significant difference in major adverse cardiovascular events (32% versus 30%, P=0.444) between patients who underwent single-operator versus multioperator HR-PCI. Adjusted analyses accounting for site-level variance showed no significant differences in outcomes. Conclusions Patients who underwent multioperator HR-PCI had similar outcomes compared with single-operator procedures. Further studies are needed to determine if the addition of a second operator offers clinical benefits to a subset of HR-PCI patients undergoing left main or chronic total occlusion intervention.

Association of Postangioplasty Femoropopliteal Dissections With Outcomes After Drug-Coated Balloon Angioplasty in the Femoropopliteal Arteries.

PURPOSE: Balloon angioplasty for the treatment of femoropopliteal lesions is often complicated by postangioplasty dissections. While dissections are known to affect patency and reintervention after balloon angioplasty, the association between dissections and major adverse limb event (MALE) after drug-coated balloon (DCB) angioplasty remains uncertain. Thus, the postangioplasty dissection and bailout stenting patterns were investigated. MATERIALS AND METHODS: This was a single-center retrospective study enrolling patients with de novo femoropopliteal lesions treated with DCB with/without stenting. Postangioplasty target vessel dissection was graded based to the coronary artery classification grades A-F, with grade C-F considered "severe." Cox regression analysis was performed to examine the association of dissection severity with outcomes during 2-year follow up, among nonstented cases. RESULTS: In 85.3% of the cases (N=203/238) a postangioplasty dissection was observed. The average dissection length was 55.57 mm (SD 36.71 mm), with 1 dissection present in 91.8% (N=180/196) and 2 or more dissections present in 8.2% (N=16/196). Dissection severity was grade A (19.8%), B (20.6%), C (23.1%), D (10.9%), E (10.1%), and F (0.8%). Bailout stenting was required in 40.4% of the patients, being more prevalent among grade C and grade E cases. Among 142 nonstented cases, dissections were present in 85.2%. A total of 75 (52.8%) of these dissections were grade A and B, while 46 (32.4%) were grade C to F. Among nonstented cases, grade C (hazard ratio [HR] 5.83; 95% CI 1.25 to 27.31; p=0.025) and grade D (HR 6.32; 95% CI 1.39 to 28.86; p=0.017) vs grade A dissections were associated with a higher risk for 2-year MALE. Multivariate analysis adjusting for several lesion characteristics demonstrated a statistically significant higher risk for 2-year MALE among the severe dissection group (HR 2.94; 95% CI 1.27 to 6.79; p = 0.012). Interestingly, the risks of limb loss (HR 1.30; 95% CI 0.22 to 7.79; p=0.774) and repeat revascularization (HR 0.95; 95% CI 0.40 to 2.26; p=0.905) during follow-up were similar between the 2 groups. CONCLUSION: This study indicated that nonstented moderate and severe postangioplasty dissections after DCB angioplasty were associated with higher risk for MALE. Future studies are needed to validate our results and determine other dissection characteristics (eg, total dissection length, lumen area, total number of dissections) that may affect the efficacy of DCB.

How the COVID-19 Pandemic Has Affected Cardiology Fellow Training.

With the advent of the COVID-19 pandemic in the United States, resources have been reallocated and elective cases have been deferred to minimize the spread of the disease, altering the workflow of cardiac catheterization laboratories across the country. This has in turn affected the training experience of cardiology fellows, including diminished procedure numbers and a narrow breadth of cases as they approach the end of their training before joining independent practice. It has also taken a toll on the emotional well-being of fellows as they see their colleagues, loved ones, patients or even themselves struggling with COVID-19, with some succumbing to it. The aim of this opinion piece is to focus attention on the impact of the COVID-19 pandemic on fellows and their training, challenges faced as they transition to practicing in the real world in the near future and share the lessons learned thus far. We believe that this is an important contribution and would be of interest not only to cardiology fellows-in-training and cardiologists but also trainees in other procedural specialties.

Development and validation of a predictive score for anterograde crossing of infrapopliteal chronic total occlusions: (The Infrapop-CTO Score).

BACKGROUND: Patients with critical limb ischemia often have infrapopliteal (IP) chronic total occlusions (CTOs). While revascularization is indicated to prevent major amputation, anterograde crossing of these lesions can be challenging, with high failure rates. OBJECTIVE: To develop and validate a scoring system that can adequately predict successful anterograde crossing of infrapopliteal CTOs. METHODS AND RESULTS: A total of 213 IP CTOs (147 successfully crossed with the anterograde approach vs. 66 where anterograde crossing failed) were included in the analysis. Backwards stepwise selection (p for retention <.05) was used to create a multivariable logistic regression model for the prediction of successful anterograde crossing using variables that were found to have a p < .1 in univariate analysis. The model was internally validated with bootstrapping and demonstrated excellent discriminatory ability (C-statistic 0.78 and Hosmer-Lemeshow p value = .61). A point score based on the beta-coefficient of the model variables was created, with one point assigned for presence of a noncentral (blunt) stump, one point for severe calcification at the entry site, and two points each for non-restenotic lesions or lesion length > 200 mm. The score was shown to have an excellent discriminatory ability for successful crossing, with low scores (0-2) associated with low failure rates (10%) and high scores associated with high failure rates (79%). CONCLUSIONS: The Infrapop-CTO score can stratify the procedural complexity of IP CTOs based on the likelihood of successful anterograde crossing. This score may help to direct optimal approaches toward infrapopliteal revascularization of patients with critical limb ischemia.

Amiodarone-related hyponatremia: rare but potentially lethal.

Amiodarone is a one of the most commonly used antiarrhythmic drug with efficacy in both supraventricular and ventricular tachycardia. Hepatic, pulmonary, and thyroid adverse effect profiles of this drug are well described and mandate a close follow-up. We report a case of amiodarone-related hyponatremia, which is one of the rarest side effects associated with this medication and our case was unlike other previous case reports because severity of symptoms required hemodialysis for correction of hyponatremia despite trying dose reduction strategy.

Effect of lisdexamfetamine dimesylate on sleep in children with ADHD.

OBJECTIVE: This study evaluated the potential effects of short-term treatment with lisdexamfetamine dimesylate (LDX) on both subjective and objective sleep characteristics in children aged 6 to 12 years (n = 24) with ADHD. METHOD: Polysomnography (PSG) and actigraph measures as well as assessments of subjective sleep parameters were examined in children before and after treatment with either LDX or placebo in a randomized, double-blind, single-center, parallel-group study. RESULTS: There was no statistically significant increase in the primary endpoint of latency to persistent sleep (LPS) for the LDX-treated group compared to the placebo group. Secondary PSG or actigraph results generally supported primary endpoint results. Subjective sleep measure results indicated the possibility that responses are influenced by sleep hygiene counseling before and throughout the study. CONCLUSIONS: In this pilot sleep study in children with ADHD, LDX did not appear to contribute to any sleep disturbances as measured by both objective and subjective sleep parameters. The sample used in this study was small, and the multifarious nature of findings in this study warranted that the study conclusions be interpreted cautiously and that further study is required focusing on the influence of LDX on sleep in larger samples of ADHD children.