Non-compliant Research Articles

REVASCULARIZATION WITHOUT DES: A CASE REPORT ABOUT METALLIC–LESS REVASCULARIZATION TECHNIQUES

Abstract Rational 56 years old patient, admitted to our service for myocardial infarction without ST elevation. In medical history he had dyslipidaemia, hypertension and familiarity for cardiovascular disease, without previous cardiological problems. The patient went to the ER for chest pain, started after his work shift. When admitted to the ER, the patient was still symptomatic for chest pain, with resolution after 3 hours after somministration of analgesics, with normal pressure and heart rate. An ECG was performed, without relevant findings, at the blood exams significative movement of cardiac troponins. At the echocardiogram apical hypokinesia of left ventricle with preserved ejection fraction. Technical Resolution Coronarography was performed, with evidence of severe diffuse atheromatic disease of the left anterior descending artery (LAD) at the proximal segment and sub–occlusive stenosis at the middle segment. Due to the diffuseness of the atherosclerotic disease on the LAD, which would have required a complete stenting of the artery, which using classical Drug Eluted Stents would have led to a complete metallization of the artery, in such a young patient who does not have medical history suggesting a progression of the atheromatic disease, metallic–less techniques were chosen. The two lesions were pre–dilatated with a non–compliant (NC) balloon. The proximal lesion was treated with a bioresorbable scaffold (BVS) Magmaris 3x25 mm, post–dilatated with a NC balloon, without complications. The distal segment was treated with a Drug Eluting Balloon (DEB) Pantera Lux 2.5x20 mm, expanded for 90 seconds, with evidence of focal dissection, not flow limiting.At the clinical follow–up performed at one and three months, the patient was asymptomatic for angina, without any cardiovascular event. Clinical Implications When facing coronaropathy in a young patient, it is a good option to treat the coronary with techniques that do not leave metallic material in the arteries, which exposes young patients to a higher rate of complications if compared to older patients. When it is preferred to use this kind of techniques, the options can be DEB or BVS. As seen in this case report, often the DEB can lead to complications. It’s well–known that every DEB complication needs a DES to fix it. However, little is proven and studied about the use of BVS on de–novo lesions and on coronary injuries as complications of “conventional” PCI, as well as those derived from DEB delivery.

Dividend policy and shareholders’ wealth. A comparative analysis of Shariah-compliant and noncompliant nonfinancial firms in Pakistan

Purpose The purpose of this study is to comparatively analyze the effect of dividend policy on shareholders’ wealth in Shariah-compliant (SC) and noncompliant (NC) nonfinancial firms in Pakistan. Design/methodology/approach All the nonfinancial firms listed on the Pakistan stock exchange have been taken as a sample for 2016–2021. The Karachi Meezan index screening criteria were applied to screen SC firms. Based on the BPLM and Hausman test results, the authors used the fixed-effect and pooled OLS model for SC and NC firms, respectively. The F-test was used to compare the effect of each dividend policy variable on shareholders’ wealth for both firm types. Findings The findings reveal that the dividend policy does affect the shareholders’ wealth in both firm types. Dividend per share (DPS), dividend yield (DY) and earnings per share significantly affect the shareholders’ wealth in SC firms. For NC firms, the dividend payout, DPS and DY are critical. Moreover, the F-test results show that the DPS, DY and leverage effect on the shareholders’ wealth significantly differ for both firm types. Research limitations/implications This study fills the research gap in the Pakistani context specifically as well as globally by providing important insights into the relationship between a firm’s dividend policy and shareholders’ wealth for SC and NC firms. In addition, this study comprehensively compares the results for both firm types, which is also lacking in the existing literature. Because this study is based in Pakistan, the generalizability of the results would be limited. Practical implications The findings of this study are helpful for the management of SC and NC firms in devising their dividend policies that can maximize their shareholders’ wealth. This study also provides guidance and knowledge to investors in choosing companies for their investments that can maximize their wealth. Originality/value To the best of the authors’ knowledge, this is the first study that analyzes the relationship between dividend policy and shareholders’ wealth for SC firms in Pakistan. It is also the first study that comprehensively compares the dividend policy relationship with shareholders’ wealth for SC and NC firms. In addition, using the F-test for joint hypotheses to compare the specific effect of each dividend policy variable is a methodological contribution of the study.

Abstract 14961: Revitalizing Graft Patency: Intravascular Lithotripsy in Calcified Saphenous Vein Graft to Left Anterior Descending Artery Stenosis

A 73-year-old man with coronary artery disease (CAD), coronary artery bypass graft, heart failure [EF 25%] & hypertension presented with Non-ST Segment Myocardial Infarction. Angiography revealed multivessel CAD with chronic total occlusion (CTO) of mid-left anterior descending (LAD) after a large first diagonal branch, CTO of mid-left circumflex & distal right coronary artery. Saphenous vein graft (SVG) to obtuse marginal was patent. SVG-diagonal & SVG-ramus intermedius were occluded. Mid SVG-LAD showed severe calcified stenosis (Fig. 1A). Native LAD beyond the SVG provided left to right collaterals to right posterior descending artery. Complex high-risk coronary intervention was performed on the SVG-LAD with mechanical circulatory support (MCS; Impella CP). SVG-LAD had a balloon undilatable lesion despite high pressure inflation with 4.0 mm cutting balloon (Fig. 1B). Intravascular ultrasound (IVUS) revealed severe stenosis with extensive circumferential calcification (Fig. 1C). Subsequently, intravascular lithotripsy (IVL) with 4.0 mm Shockwave balloon followed by high pressure balloon angioplasty with 4.5 mm noncompliant (NC) balloon was performed with significant luminal gain and fractures in calcium (Fig. 1D). The lesion was treated with 5.0 mm drug eluting stents that were post dilated with 5.0 mm NC balloon with excellent angiographic and IVUS result (Figs. 1E & F). MCS was successfully removed at the end of the case.SVG grafts are associated with poor long-term patency compared to arterial grafts. PCI to SVG has a high failure rate and PCI of native vessel is often preferable. High risk SVG interventions with atherectomy have been recently reported, though data is limited. IVL has been safely used in heavily calcified native coronary arteries, however, its use in SVG disease is rare. We report the first off-label use IVL of SVG-LAD with MCS for treatment of a last-remaining conduit. Additional studies to assess IVL efficacy in vein grafts are warranted.

Role of compliance to dietary and physical activity recommendations for better quality of life in patients with chronic heart failure

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Medical University of Varna, fund Science Background Diet and physical activity are important non-pharmacological determinants for the prognosis in patients with chronic heart failure (HF). The role of nurse in patient education and follow-up of these factors is of paramount importance for improvement the quality of life. Aim to determine the effect of adherence to life style recommendations for the better quality of life of patients in ambulatory HF program. Participants and methods: Overall, 72 patients with HF were included in a structured ambulatory program after hospital discharge, with the active participation of a nurse in it. After a 6-month follow-up, 61 finished the program. All patients were educated at the beginning and at the follow-up visits for their appropriate diet and physical activity by the health care practitioner. The adherence to the above mentioned life style measures was evaluated by asking the participants whether the follow the given recommendations. Quality of life was assessed by the change in NYHA class, 6-minute walking test (6MWT) distance, questionnaires (KCCQ, EQ-5) and self-assessment by visual analogue scale. For continuous variables, t-test and Mann-Whitney test was used depending on the normality of the distribution. For categorical variables, chi-square or Fisher’s exact test were applied where appropriate. Logistic regression was used to test the effect of adherence to advices for life- style parameters. Results There was no difference in age and sex distribution between the compliant (C) and non-compliant (NC) group (Table 1). All patients were medically treated according to the current guidelines. There was significant improvement in the functional capacity in adherent to treatment patients. The increase in 6MWT (Table 1) was on average 39.16 m more in the compliant group (p = 0.016). You have 6 times higher chance to improve your 6MWT performance if you are compliant – OR 6 (95%CI 1.02-31.11, p = 0.047). There was also slightly better improvement in NYHA class – mean change 0.9 vs 0.7, p = NS. The quality of life was also improved more significantly in the C than in NC group (Table 1). Clinically meaningful improvement in overall summary score (OSS) >5 points was observed in 92% in C vs 64% in NC (p = 0.0.029) and moderate to large improvement >10 points – in 82% vs 54.5% (p = 0.05). There was also a trend to better anxiety and depression attitudes at the end of the 6 months in the C than in NC patients. Conclusions The adherence to diet and physical activity advices improves the physical capacity and the quality of life in patients with HF even just after 6 months. In this respect, the role of the health care practitioner is of invaluable importance to promote the life style changes. This includes education and proper ambulatory follow-up by a trained nurse.Table 1

Management of Cerebral 4-Vessel Disease With Anterior Circulation Symptoms by Stenting Both Vertebral Arteries at the Same Session.

Stroke is among the leading causes of mortality and morbidity worldwide. The coexistence of bilateral carotid and vertebral artery (VA) occlusion and/or stenosis is in the very rare entity group in the literature. Here, we present a case with bilateral carotid artery occlusion and bilateral VA stenosis, who presented with an atypical clinical presentation and underwent bilateral vertebral percutaneous transluminal angioplasty (PTA) and stenting in the same session. A 67 year old male patient was brought to the emergency department with complaints of inability to speak and weakness in both legs for 1 day. There were bilateral infarct areas in the anterior cerebral artery region and an additional infarct area in the left middle cerebral artery region. First, the right VA stenosis level was crossed using a 0.14 guidewire. After PTA, balloon-expandable stenting was performed with a 3.0×12 mm NC (non-compliant) balloon, and nearly complete recanalization was observed. Therefore, it was decided to perform an intervention on the left VA in the same session. As in this example case, in cases where cerebral perfusion is severely impaired, medical treatment after recanalization may be one of the best treatment options. The carotid arteries are the main arteries supplying the anterior circulation, and the vertebral arteries supply blood to the posterior circulation. However, in cases where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system. However, in cases such as this, where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system and may be responsible for anterior circulation strokes. The situation becomes more severe if both vertebral artery critical stenosis is added. Synchronous carotid and vertebral artery revascularization is not recommended in the guidelines for patients with combined carotid and vertebral artery disease. In patients with four-vessel occlusion/stenosis, as in this particular case, the intervention method and priorities are unclear. We achieved a favorable clinical outcome with simultaneous bilateral vertebral artery angioplasty and stenting, a hazardous method that can be a guide as an approach option in similar cases.

Clinical Characteristics of Patents who Developed Slow Flow/ no-reflow After Post-dilatation with Non-compliant Balloon during Primary Percutaneous Coronary Intervention

Objectives: Post-dilatation with non-compliant (NC) balloons is a commonly used strategy to improve inadequate stent expansion but this strategy carries an increased risk of slow flow/no-reflow (SF/NR) due to distal embolization. Therefore, our objective was to evaluate the demographic, clinical, angiographic, and procedure characteristics among patients undergoing primary percutaneous coronary intervention (PCI) who developed slow flow/no-reflow (SF/NR) after post-dilatation with non-compliant (NC) balloons. Methodology: In this cross-sectional observational study, we included consecutive patients with SF/NR after post-dilatation using NC balloon post stent deployment during primary PCI. The demographic, clinical, angiographic, and procedure characteristics were evaluated. Results: In the sample of 107 patients, male were 77.6% (83) and mean age was 56.94 ± 10.47 years. The median chest pain to ER (emergency room) arrival time was 292 [180-394] minutes. A majority of the patients (66.4%) had multi-vessel disease. Mean length NC balloon was 10.57±1.98 mm and diameter was 3.5±0.26 mm. The mean number of inflation were 3.62±1.08, at mean maximal pressure of 20.43±2.49 mmHg, proximal edge pressure of 19.25±2.74 mmHg, and distal edge pressure of 14.64±2.01 mmHg. A total of 5.6% (6) patients developed adverse events and final TIMI (thrombolysis in myocardial infarction) III flow was achieved in 89.7% (96) of the patients. Conclusion: SF/NR after post-dilatation during primary PCI is associated with a significant rate of adverse events and sub-optimal (<III) final TIMI flow. The detrimental effects of high pressure, short length, and increased number of inflations on post NC SF/NR need further investigations.

Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry

BackgroundCalcified lesions often lead to difficulty achieving optimal stent expansion. OPN non-compliant (NC) is a twin layer balloon with high rated burst pressure that may modify calcium effectively. MethodsRetrospective, multicenter registry in patients undergoing optical coherence tomography (OCT) guided intervention with OPN NC. Superficial calcification with > 180o arc and > 0.5 mm thickness, and/or nodular calcification with > 90o arc were included. OCT was performed in all cases before and after OPN NC, and after intervention. Primary efficacy endpoints were frequency of expansion (EXP) ≥80 % of the mean reference lumen area and mean final EXP by OCT, and secondary endpoints were calcium fractures (CF), and EXP ≥90 %. Results50 cases were included; 25 (50 %) superficial, and 25 (50 %) nodular. Calcium score of 4 in 42 (84 %) cases and 3 in 8 (16 %). OPN NC was used alone, or after other devices if further modification was needed, NC in 27 (54 %), cutting in 29 (58 %), scoring in 1 (2 %), IVL in 2 (4 %); or if non-crossable lesion, rotablation in 5 (10 %) cases. EXP ≥80 % was achieved in 40 (80 %) cases with mean final EXP post intervention of 85.7 % ± 8.9. CF were documented in 49 (98 %) cases; multiple in 37 (74 %). There were 1 flow limiting dissection requiring stent deployment and 3 non-cardiovascular related deaths in 6 months follow-up. No records of perforation, no-reflow or other major adverse events. ConclusionAmong patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.

Seismic evaluation of existing building structure using United States (ASCE 41-17) and Japanese (JBDPA) standard: Case study office building in Indonesia

In this study, the target evaluation building is a reinforced concrete structure with 4 stories in Surabaya City Indonesia that was over 35 years old. The method used is the U.S standard; ASCE 41:17 and the Japanese standard; JBDPA. The results using the ASCE 41-17 Tier 1 checklist with a 975 years earthquake return period (BSE-2E) and collapse prevention performance target obtained several evaluation items that received noncompliant (NC) status. Out of the 21 checklist items, 5 items were compliant (C), 7 items were noncompliant (NC), 2 items not applicable (N/A), and 7 items are unknown (U). The results of the nonlinear static procedure (NSP) also produce performance object building is still below the target performance level. The evaluation results using JBDPA show that the seismic index of structure (IS) at first and second-level screening procedures is less than the seismic demand index of structure (ISO). The results evaluation of these two methods shows the same results, that the building has a deficiency of strength and ductility, to improve building performance against earthquake loads needs to retrofit.

547 AN UNUSUAL CONSERVATIVE STRATEGY FOR ACUTE AORTIC RUPTURE AFTER TAVI POST-DILATATION

Abstract Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment for symptomatic severe aortic stenosis in patients deemed to be at high operative risk for the surgery. Despite its high success, TAVI is associated with rare life-threatening complications. The frequency of aortic annular rupture (AAR) has been reduced by advances in pre-procedural screening and patient selection but, when occurs, often requires emergency surgery with a very high mortality. We described an unusual case managed conservatively. A 86-year-old female patient with NYHA Class III and STS score for mortality of 4.8% underwent TAVI via a transfemoral approach. At preprocedural MDCT the aortic annular area was 293 mm2 with severe calcification of the valve leaflets extending in the outflow tract and in the sinotubular junction with effacement of the coronary sinuses (Fig. 1A-B). Following deployment of a 23-mm self-expanding valve (Medtronic Evolut Pro+) without predilatation, moderate-to-severe residual aortic regurgitation (AR) was observed (Vid. 1). After balloon post-dilatation using a 20×40mm noncompliant (NC) OSYPKA - VACS III balloon, mild-to-moderate AR still persisted (Fig. 1C, Vid. 2). Accordingly, we decided to perform a second post-dilatation using a 22×40mm NC balloon which reduced AR to mild but caused a contained AAR was observed (Fig. D&E, Vid. 3). The patient remained hemodynamically stable with no chest pain and had no pericardial effusion on echo. The risk of a Bentall operation in such a frail elderly patient was judged prohibitive and a conservative strategy was recommended. Postprocedural MDCT confirmed the presence of a pseudoaneurysm with the maximum dimensions of 24×15 mm (Fig. 1F). Patient was followed-up for 23 days first in hospital keeping a low blood pressure with iv nitrates and then in a rehabilitation centre. An MDCT control on day 10 showed no growth of the pseudoaneurysm with a reduction of the brisk filling initially observed. She was discharged without additional problems, and scheduled for a three month control MDCT. Established risk factors for AAR include valve and balloon oversizing, bicuspid valve, small annulus, shallow Valsalva sinuses, and massive annular or sub/supra-annular calcification. When these recognized risk factors are present, a conservative strategy for valve postdilatation is strongly recommended. Early recognition and prompt surgical management of AAR are essential but occasionally also a conserative strategy can prove successful.

Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study

The present study sought to assess the clinical outcomes of the Mozec™ Non-compliant (NC) Rx PTCA balloon dilatation catheter (BDC) (Meril Life Sciences Pvt. Ltd., Vapi, India) for dilatation of coronary lesions. This was a post-marketing, single-centre, single-arm, retrospective study. In total, 57 patients who had undergone post-dilatation with the Mozec™ NC Rx PTCA balloon dilatation catheter were evaluated. The primary endpoint was procedural success defined as (i) successful delivery of the investigational device to and across the target lesion; (ii) successful inflation, deflation, and withdrawal of the investigational device; (iii) absence of vessel perforation, flow-limiting vessel dissection, increase in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrhythmia requiring medical treatment; and (iv) achievement of final TIMI flow grade 3 after percutaneous coronary intervention of the target lesion after single or multiple attempts to cross the target lesion. Procedural success was achieved in 57 (100%) patients. There were no incidences of major adverse cardiac events (MACE)/target lesion failure (TLF). Mozec™ NC Rx PTCA balloon dilatation catheter has demonstrated favourable outcomes for the dilatation of routine and complex coronary lesions in a small cohort, as evidenced by its 100% procedural success rate and absence of MACE.

The role of calcification in cardiovascular outcome after left main bifurcation revascularization: a single centre experience

Abstract Introduction Left main bifurcation (LMB) disease represents a high-risk subset of advanced coronary artery disease, often associated with severe calcification. Different stenting techniques have been evaluated to overcome challenges of the LMB anatomy, but the role of the calcific burden on cardiovascular (CV) outcome after LMB revascularization is unclear. Purpose We sought to evaluate the CV hospitalization predictors during follow-up of patients who underwent LMB revascularization (LMBR) in a high-volume center in Italy. Methods We performed a retrospective analysis of LMBR patients between 2018 and 2021. Patients were treated with different techniques in the acute or chronic settings and followed-up by telephone or outpatient visit. Coronary calcification (CC) was visually judged as absent, mild, moderate or severe. Predictors of CV hospitalizations were assessed. Results The median follow-up was 511 days. Among 129 patients who underwent LMBR during the study period, 32 (24.8%) were female, with a mean age of 72 (±10.6) years. 105 (81.4%) patients were hypertensive and 49 (38%) diabetics. The mean eGFR value was 66.3 (± 21.8) ml/min/m2. The majority of patients had three vessel disease (79, 61.3%), while only a small minority had one vessel disease (5, 3.9%). The mean SYNTAX score I was 27.1 (± 8.6), with most patients at intermediate risk (65, 50.4%) followed by patients at low (37, 28.7%) and high (27, 20.9%) risk. A provisional technique was used in most cases (79, 61.2%), followed by double-kissing crush (37, 28.7%) and T-stent/T-and-protrusion (13, 10.1%). Intravascular imaging was used in 84 (65.1%) cases. Most patients had no angiographic demonstration of CC (73, 57.9%), while when present, they were mild in 14 (11.1%), moderate in 29 (23%) and severe in 10 (7.9%) patients. Preparation of the CC was performed only with non-compliant (NC) balloons in mild CC (10, 71.4%) and with NC balloons (14, 48.3%) or intravascular lithotripsy (IVL) (13, 44.8%) in case of moderate CC. In the presence of severe CC, lesion preparation was carried out with IVL (4, 40%) or NC balloons (6, 60%). CC were associated with a more unfavorable outcome and, when present in a severe grade, resulted in a statistically significant risk of CV hospitalizations (HR 1.652; 95% CI 1.723–15.793; p=0.003) (Figure 1). After univariate and multivariate Cox regression analysis (Figure 2), only the presence of severe CC was associated with an increased risk of CV hospitalizations (HR 1.9; 95% CI 1.76–19.63; p=0.002), whereas aspirin therapy was a protective factor (HR −1.34; CI 0.07–0.86; p=0.02). Conclusions The presence of severe calcification is associated with a higher risk of CV hospitalizations, despite preparation of calcific lesions was always performed and intravascular imaging use was extensive. There were no differences in outcomes regardless to clinical presentation at admission, different stenting techniques and SYNTAX score I. Funding Acknowledgement Type of funding sources: None.

Capital structure dynamics of Shariah-compliant vs noncompliant firms: evidence from Pakistan

PurposeThis study aims to compare capital structure determinants' effect on the leverage levels of Shariah-compliant (SC) and noncompliant (NC) firms in Pakistan. This study also estimates and compares the capital structure adjustment speed for both firm types.Design/methodology/approachBased on the Karachi Meezan Index screening criterion, a balanced panel of 117 SC and 68 NC firms listed on the Pakistan Stock Exchange from 2008 to 2018 was constituted. This study used the generalized method of moments to identify the significant determinants of capital structure and estimate the speed of adjustment. In addition, the F-test was used to check whether the effect of the determinants on the leverage is same for SC and non-SC firms.FindingsThe authors found that different determinants affect both firm types' leverage levels (book and market) differently. The authors also found that the adjustment speed of SC firms toward their target leverage ratio is slower than their NC peers. Lastly, significant variation was observed in the results under different screening criteria.Research limitations/implicationsThis study fills the literature gap by providing a comprehensive comparison of the capital structure decisions of the SC and non-SC firms. Because this study is limited to Pakistan, generalizability would be an issue.Practical implicationsThis study will guide the management of SC and non-SC firms about which factors are reliably important in choosing their capital structure. The findings also call for bringing harmony in the different Shariah screening criteria being in practice.Originality/valueTo the best of the authors’ knowledge, this is the first comparative study that identifies the significant capital structure determinants for SC and NC firms and investigates their effect on the leverage of both firm types. By testing joint hypotheses of same relationship, this study seeks to determine if, because of Shariah restrictions, the capital structure determinants of SC firms are similar to NC firms or they exhibit different behavior. The authors also repeat their analysis using other prominent screening criteria to assess the consistency of their results.

Assessment of Post-Dilatation Strategies for Optimal Stent Expansion in Calcified Coronary Lesions: Ex Vivo Analysis With Optical Coherence Tomography

IntroductionInterventional cardiologists make adjustments in the presence of coronary calcifications known to limit stent expansion, but proper balloon sizing, plaque-modification approaches, and high-pressure regimens are not well established. Intravascular optical coherence tomography (IVOCT) provides high-resolution images of coronary tissues, including detailed imaging of calcifications, and accurate measurements of stent deployment, providing a means for detailed study of stent deployment. ObjectiveEvaluate stent expansion in an ex vivo model of calcified coronary arteries as a function of balloon size and high-pressure, post-dilatation strategies. MethodsWe conducted experiments on cadaver hearts with calcified coronary lesions. We assessed stent expansion as a function of size and pressure of non-compliant (NC) balloons (i.e., nominal, 0.5, 1.0, and 1.5 mm balloons at 10, 20 and 30 atm). IVOCT images were acquired pre-stent, post-stent, and at all post-dilatations. Stent expansion was calculated using minimum expansion index (MEI). ResultsWe analyzed 134 IVOCT pullbacks from ten ex-vivo experiments. The mean distal and proximal reference lumen diameters were 2.2 ± 0.5 mm and 2.5 ± 0.7 mm, respectively, 80% of times using a 3.0 mm diameter stent. Overall, based on stent sizing, a good expansion (MEI ≥ 80%) was reached using the 1:1 NC balloon at 20 atm, and expansion > 100% was reached using the 1:1 NC balloon at 30 atm. In the subgroup analysis, comparing low-calcified and high-calcified lesions, good expansion (MEI ≥ 80%) was reached using the 1:1 NC balloon at nominal pressure (10 atm) versus using 1:1 NC balloon at 30 atm, respectively. Significant vessel rupture was identified in all the vessels mainly upon post-dilatation with larger balloons, and 60% of the experiments (6 vessels, 3 in each calcium subgroup) presented rupture with the +1.0 mm NC balloon at 20 atm. ConclusionWhen treating calcified lesions, good stent expansion was reached using smaller balloons at higher pressures without coronary injuries, whereas bigger balloons yielded unpredictable expansion even at lower pressures and demonstrated potential harmful damages to the vessels. As these findings could help physicians with appropriate planning of stent post-dilatation for calcified lesions, it will be important to clinically evaluate the recommended protocol.

Propensity-score-matched comparison of safety, efficacy, and outcome of intravascular lithotripsy versus high-pressure PTCA in coronary calcified lesions

Data regarding safety, efficacy, and outcome of intravascular lithotripsy (IVL) in comparison to standard techniques are lacking. This study sought to compare IVL with non-compliant high-pressure balloon percutaneous coronary angioplasty (PTCA).We performed a retrospective propensity-score-matched study to compare procedural success in 57 consecutive patients who received IVL-guided PCI in calcified coronary lesions with 171 matched patients who were treated with high-pressure PTCA with a non-compliant (NC)-balloon. The mean minimal lumen diameter (MLD) for the IVL group was 1.08 ± 0.51 mm, and the median percent diameter stenosis on quantitative angiography was 70.2% (interquartile range, 60.2-78.6%). MLD in the high-pressure dilatation group was 0.97 ± 0.43 mm, and the median percent diameter stenosis was 71.5% (interquartile range, 58.5-77.0%). IVL-guided PCI reduced median stenosis to 17.5% (interquartile range, 9.3-19.8%) with an acute gain of 0.93 ± 0.7 mm. High-pressure dilatation resulted in a final median stenosis of 19.3% (interquartile range, 13.33-28.5%). Procedural success was significantly higher (82.5% vs. 61.4%; p: 0.0035) in the IVL group. MACE through 12 months occurred in 10.5% of cases in the IVL group and in 11.1% of the high-pressure group (p = 0.22). Angiographic complications (coronary dissection, slow or no reflow, new coronary thrombus formation, abrupt vessel closure) were very low (0.2% vs. 0.12%).IVL resulted in a significantly higher rate of procedural success compared to high- pressure NC-balloon dilatation in patients with calcified coronary lesions. The rate of MACE through 12 months was similar to the standard therapy.

Assessment of Prescriptions in Elderly Patients Hospitalized in Medicine Departments.

Drug-related iatrogenesis is an important issue in the elderly population, and preventing iatrogenic accidents helps to reduce hospitalizations. Our study’s objective was to evaluate prescriptions in the geriatric population of our establishment. The study conducted is a targeted clinical audit. Ten criteria were tested on the hospital prescriptions of people over 75 years old in 11 medical departments, before and after improvement actions. The non-compliance threshold was set at 10% of prescriptions for each criterion. In each phase, 165 patients were included. Four criteria were non-compliant (NC) in the first phase: the presence of Potentially Inappropriate Medications for the Elderly (PIMs) (NC = 57.6%), the adaptation of the medication to renal clearance (NC = 24.9%), the presence of illogical combination (NC = 9.7%), and the total anti-cholinergic score of the prescription (NC = 12.1%). After the implementation of improvement actions, the number of non-compliant criteria decreased between the two phases, from four to two. We obtained a significant improvement for three of the four criteria found to be non-compliant in the first phase. The criterion adaptation to renal function is close to compliance (NC = 10.1%) and the PIMs criterion remained non-compliant after reassessment (NC = 32.1%). Vigilance must be ongoing in order to limit drug iatrogeny, particularly in frail elderly patients.

Side-branch expansion capacity of contemporary DES platforms

BackgroundPercutaneous coronary interventions (PCI) of bifurcation stenoses are both complex and challenging. Stenting strategies share that the stents’ side cells must be carefully explored and appropriately prepared using balloons or stents. So far, stent manufacturers have not provided any information regarding side-branch expansion capacity of their stent platforms.AimsGiven that drug-eluting stent (DES) information regarding their mechanical capacity of side-branch expansion is not available, we aimed to evaluate contemporary DES (Orsiro, BIOTRONIK AG; Xience Sierra, Abbott Vascular; Resolute Integrity, Medtronic; Promus Premier Select, Boston Scientific; Supraflex Cruz, Sahajan and Medical Technologies) by their side-branch expansion behavior using in vitro bench testing.MethodsIn this in vitro study, we analyzed five commercially available DES (diameter 3.0 mm), measuring their side-branch expansion following inflation of different high-pressure non-compliant (NC) balloons (balloon diameter: 2.00–4.00 mm), thereby revealing the morphological characteristics of their side-branch expansion capacities.ResultsWe demonstrated that all tested contemporary DES platforms could withstand large single-cell deformations, up to 4.0 mm. As seen in our side-branch experiments, DES designs consisting of only two connectors between strut rings did not only result in huge cell areas, but also in larger cell diameters following side-branch expansion compared with DES designs using three or more connectors. Furthermore, the stent cell diameter attained was below the balloon diameter at normal pressure.ConclusionsWe recommend that the expansion capacity of side-branches should be considered in stent selection for bifurcation interventions.

Associations between Movement Behaviours and Obesity Markers among Preschoolers Compliant and Non-Compliant with Sleep Duration: A Latent Profile Analysis.

This study identifies physical activity (PA) and sedentary behaviour (SB) clusters in preschoolers compliant (C) or non-compliant (NC) with sleep recommendations; and associates these clusters with obesity markers. PA and SB were objectively assessed (Actigraph WGT3-X) in 272 preschoolers (4.4 ± 0.7 years old). Sleep duration was parent-reported, and preschoolers were classified as C (3–4 years old: 600–780 min/day; 5 years old: 540–660 min/day) or NC with sleep recommendations. Body mass index (BMI) and waist circumference (WC) were assessed according to international protocols. Moderate to vigorous physical activity (MVPA) and light physical activity (LPA) were categorized as low/high (<60 min/>60 min/day or <180 min/180 min/day, respectively). SB was defined according to mean values between clusters. Latent profile analysis was performed. Associations between the observed clusters and obesity markers were determined using linear regression (RStudio; 1.3.1073). Four cluster solutions for C and NC preschoolers were identified. A negative association between C/Low MVPA cluster and BMI, and a positive association between NC/Low MVPA and BMI (β = −0.8, 95%CI = −1.6;−0.1, and β = 0.9, 95%CI = 0.1;1.7, respectively) were observed. No association was seen for SB clusters. Adequate sleep duration may have a protective role for preschoolers’ BMI, even if the children do not comply with MVPA recommendations.

Expansion Capacity of Drug-Eluting Stents in Patients with Left Main Coronary Artery Disease: An Intravascular Ultrasound Guided Study

Aims: The aim of this study was to assess the expansion capacity ofcurrent commercially available Drug Eluting Stents (DES) with nominaldiameters of 3.5-4.0mm in patients with Left Main disease.Materials and Methods: This study was conducted on 50Patients who underwent percutaneous coronary intervention(PCI)for Left Main disease at Benha university hospitals and NationalHeart Institute. PCI was done with Drug Eluting Stents(DES) with large diameters of 3.5-4mm and post dilatation wasdone with non-compliant (NC) balloons with diameters of 4.5-5mm. Intravascular ultrasound (IVUS) was used to measuremaximal stent diameter and area.Results: Three commercially available DESs were used in ourstudy; XIENCE Xpeditionᵀᴹ, Ultimasterᵀᴹ and Onyxᵀᴹ. Maximal stentdiameter was 4.5±0.3mm and diameter expansion index was0.96±0.05. Maximal stent area was 14.67±2.06mm² and area expansionindex was 0.86±0.07mm². On IVUS images, significantlymore calcification&lt; 90 ̊ was detected in the group with expansionindex ˂ 0.85 (68.4 percent versus 25.8%, P=0.003) comparedto the group with expansion index &gt;0.85. We found that DESswith diameters of 3.5-4.0mm can be expanded up to diameter of5.3mm after post-dilation. No complications were reported in thestudied patients, including perforation or stent fracture.Conclusion: Current DESs with nominal diameters of 3.5-4.0mmcan be safely and effectively over-expanded to reach the predicteddiameters in the left main, but the presence of calcification&gt;90 may affect the achievement of the predicted area.

Opioid screening and urine toxicology results in outpatient oncology palliative medicine.

e24068 Background: Opioid misuse is a major public health issue. Given widespread opioid prescribing in cancer patients (pts), screening for potential misuse is critical. There is lack of real-world data on opioid screening and urine toxicology testing in outpatient oncology palliative medicine. Methods: This is a retrospective clinical analysis of adult cancer pts previously consented for a pharmacogenomics specimen collection study between August 2019-March 2020. Pts completing ≥ 1 outpatient palliative medicine visit with at least half undergoing urine toxicology screening (UTS) per standard practice were included. Pt demographics, medication(s), UTS results, symptoms using Edmonton Symptom Assessment Scale, and opioid screening using Screener and Opioid Assessment for Patients with Pain - Short Form (SOAPP-SF) were collected at baseline and follow up visits, if available. The primary endpoint was the frequency and type(s) of non-compliant (NC) UTS. Secondarily, risk factors for NC UTS were evaluated using univariate and multivariate logistic regression. Results: Of 189 pts (632 visits), 113 underwent UTS, 125 SOAPP-SF, and 75 had both. The median age was 56, 56% were female, 58% white, 40% black, 48% had stage IV disease, and median pain score was 7. More black pts (72%) underwent UTS compared to white pts (53%) (p = 0.001). The mean age of pts with a UTS was 53 compared to 59 in those without UTS (p = 0.002). Oxycodone was the most prescribed drug (N = 125). Median SOAPP-SF was 3 (range 0-11); 38% had a score ≥ 4 (considered high risk). About half (54%; N = 61) who underwent a UTS were NC. Of these, 32 had 1 NC UTS, whereas 29 had 2 or more. The most common reason was presence of a substance not prescribed (N = 44 pts and 128 results), whereas 33 pts (53 results) were NC for substance(s) not present but prescribed. Four had presence of marijuana only and 21 with marijuana plus another NC substance; presence of cocaine and alcohol were the 2nd and 3rd most frequent aberrant result. Of those with a NC UTS and SOAPP-SF score (N = 44), 59% had a score ≥ 4. In univariate analyses, SOAPP-SF ≥ 4 (p = 0.004), nausea (p = 0.05), depression (p = 0.02), anxiety (p = 0.01), and prescriptions for antidepressants (p = 0.006), acetaminophen (p = 0.03), and/or dronabinol (p = 0.04), were associated with NC UTS. In multivariate analyses, SOAPP-SF Q4 (use of illegal drugs) (OR 2.86, 95% CI 1.64 to 5.02; p &lt; 0.001) and prescription with muscle relaxants (OR 2.90, 95% CI 1.19 to 7.09; p = 0.019) were associated with increased odds of a NC UTS. Conclusions: About half of those undergoing UTS were NC. SOAPP-SF Q4 and prescription with muscle relaxants were associated with a NC UTS. Overall, pt demographics (e.g. younger, more female, more black patients, severe pain) varied from the typical cancer population. Screening using SOAPP-SF, UTS, pain contracts, prescription drug monitoring databases, and evaluating pt-specific risk factors is important to reduce opioid misuse risk.

Comprehensive Analysis to Uncover Determinants of Patient Appointment Compliance in Ophthalmology at the Kresge Eye Institute, USA.

IntroductionAppointment compliance (AC) has a significant impact on patient care; however, determinants of AC in Ophthalmology and its subspecialties remains elusive.MethodsWe performed a five-year retrospective analysis across Kresge Eye Institute (KEI) and its affiliated Michigan locations. A total of 597,364 appointments across >13 subspecialties were included. AC was the primary outcome of interest. Compliant (CO) and non-compliant (NC) groups were compared to the following variables: patient characteristics (gender, race, age, insurance), appointment rank (relative to patient history), scheduling location, month, and ophthalmic specialty, in regard to arrival and no-show.ResultsAmong all appointments, 59.77% were associated with a female patient and 79.16% of the total number of appointments depicted patient compliance. AC differed concerning specialty, with retina representing the highest compliance across all appointments. Among 200+ insurance providers, Medicare was most frequently used and represented the highest share of CO appointments. African Americans were the primary ethnicity served by KEI and had the highest number of NC appointments.ConclusionOur study demonstrates the impact of patient demographics, appointment characteristics, and ophthalmic subspecialty on AC. A better understanding of these determinants could allow for an increased CO for Ophthalmology practices.