Balloon Inflation Research Articles

CineECG for visualization of changes in ventricular electrical activity during ischemia

Abstract Background CineECG is a newly developed method which provides an anatomical visualization of ventricular de- and repolarization in a non-invasive manner. It combines the electrical information from the 12-lead electrocardiogram (ECG) with a 3D heart model. The location and direction of the average ventricular de- and repolarization over time is projected on the model. Until now, it has not been used for visualization of ventricular electrical activity during myocardial ischemia. Purpose We aimed to visualize changes in ventricular de- and repolarization during acute ischemia with CineECG and relate these to changes in the ECG. Methods CineECG was used to provide the location and direction of the average ventricular de- and repolarization over time, using a standardized 3D heart/torso model. Continuous ECG’s during percutaneous transluminal coronary angioplasty with prolonged balloon inflation from the STAFF III database were used as study sample. ECG’s at baseline and at every 10 seconds during the first 150 seconds of balloon inflation were analyzed with CineECG. For the terminal QRS-complex, ST-segment and terminal T-wave, the direction of the CineECG was determined. The changes in CineECG direction relative to the direction at baseline were quantified by calculating the Δangle between the CineECG direction at baseline and the direction after every 10 seconds of inflation. Additionally, the root mean square amplitude (rmsA) of the ST-segment of all ECG leads was computed for every ECG. Results 94 patients from the STAFF III database were included, 10 patients were excluded due to too much signal noise of the ECG. Within 10 seconds after start inflation, the median Δangle for the terminal QRS-complex, ST-segment and terminal T-wave were 21.8° [11.4 – 34.2] , 20.6° [8.0 – 43.9] and 23.5° [11.8 – 48.0], respectively. The median Δangle for the terminal QRS-complex reached its maximum after 130 seconds (41.0° [23.0 – 70.8]). The median Δangle of the ST-segment gradually increased to 26.1° [13.1 – 56.0] after 140 seconds of inflation. The Δangle of the terminal T-wave was greatest 30 seconds after start inflation (26.3° [12.6 – 49.2]), and changed only slightly during inflation. The rmsA of the ST-segment was 0.04 mV [0.03 – 0.08] during the first 10 seconds of inflation, and gradually increased until 0.08 mV [0.05 – 0.15] mV at 150 seconds. Conclusions CineECG proves to be very sensitive in detection of early changes in the ECG during prolonged balloon inflation, even before great changes occur in ST-amplitude. Therefore, CineECG might support the early detection of acute ischemia, even before clear ECG changes are visible.

Computed tomographic predictors of a lipid-rich plaque identified by near-infrared spectroscopy

Abstract Background In a phase of primary prevention, individuals with high coronary calcium scores (CACS) assessed by computed tomographic coronary angiography (CTCA) are known to be associated with higher risk of atherosclerotic cardiovascular disease. However, clinical significance of CACS in patients requiring revascularization and its relevance to lipid core burden remains unknown. Purpose This study aimed to examine the relationship between lipid components assessed by near-infrared spectroscopy (NIRS) and coronary artery calcium score (CACS) assessed by preprocedural CTCA imaging. We also aimed to investigate CTCA-derived predictors of target vessels with high lipid core burden. Methods Consecutive patients who underwent preprocedural CTCA imaged within 3 months before elective NIRS-intravascular ultrasound-guided percutaneous coronary intervention (PCI) for de novo lesions in 1 coronary artery were included. Patients who had undergone stent deployment before inclusion were excluded. Target vessels requiring lesion modification such as balloon inflation or debulking before NIRS imaging were also excluded. Lipid rich plaque (LRP) was defined as a target lesion with maximum LCBI in 4 mm (maxLCBI4mm) >500. Clinical demographics, angiographic, and CTCA-derived morphological findings were compared between target vessels with and without LRP. Results A total of 95 target vessels in 95 patients were evaluated for the final dataset. NIRS identified 25 LRP and 70 non-LRP. Clinical demographics and angiographic findings showed no significant differences between vessels with versus without LRP. On CTCA, prevalence of high-risk plaque (HRP) that contains two or more of napkin-ring sign, positive remodeling, low attenuation plaque and spotty calcification at the target vessel was significantly higher in LRP group (56.0 % vs. 25.7 %, P=0.01). Target vessel CACS and total amount of 3-vessel CACS tended to be higher in patients with LRP than those without LRP (282 [124-479] vs. 114 [25-248], P=0.01; 882 [233-1501] vs. 308 [99-753], P=0.01, respectively). Multivariate logistic regression analyses to predict LRP at the target vessel revealed that the presence of HRP (odds ratio [OR] 3.52, 95% confidence interval [CI] 1.28-9.69, P=0.01) and higher 3-vessel CACS (per 100, OR 1.09, 95% CI 1.03-1.16, P <0.01) were independently predictive of LRP. Conclusions Preprocedural CTCA-derived high-risk plaque and total amount of 3-vessel CACS were independent predictors of LRP defined by NIRS.

Double kissing inflation outside the stent versus jailed balloon technique for coronary bifurcation lesions

Abstract Background Side branch (SB) occlusion remains challenging in percutaneous coronary intervention (PCI) for bifurcation lesions even in the era of jailed balloon technique (JBT). Our previous single-arm study introduced a novel method to protect SB named double kissing inflation outside the stent (DKo), which features twice inflation of the protective balloon kissing with the stent balloon and post-dilation balloon. Objective To confirm whether DKo can protect SB better than JBT in a large sample of bifurcation lesions. Methods This retrospective, single-center cohort study enrolled 875 consecutive patients underwent bifurcation PCI either in DKo (n=209) or JBT group (n=666). The primary endpoint was transient SB loss after removal of the protective balloon. The secondary endpoints included rates of SB rewiring, final kissing balloon inflation (FKBI), SB stenting, final SB loss, and peri-procedural myocardial infarction (PMI). Results Transient SB loss occurred in only 1 patient (0.5%) in DKo but 32 patients (4.8%) in JBT (p<0.005). Transient loss in JBT group was triggered by rewiring (n=21), post-dilation (n=8) and severe dissection (n=3). DKo caused lower rates of rewiring (0.5% vs. 13.8%, p<0.001), FKBI (0.5% vs. 7.7%, p<0.001) and PMI (0.5% vs. 2.9%, p=0.045). SB stenting and final SB loss showed a lower tendency in DKo [0% vs. 0.8%, p=0.21; 0% vs. 1.2%, p=0.11]. DKo was the only protector against transient SB loss [odds ratio=0.08, 95% confidence interval (0.01-0.59), p=0.013]. Conclusion DKo protects SB better than JBT in PCI for bifurcation lesions. Randomized controlled studies are required to confirm the long-term benefit.

Ticagrelor induces ischaemic preconditioning in coronary artery disease

Abstract Ticagrelor is a reversibly P2Y12 antagonist used in patient undergoing coronary interventions, able to block adenosine re-uptake through inhibition of ENT-1 cotransporter. The increased levels of adenosine are responsible for some of its side effects (dyspnea, bradycardia), but adenosine bioavailability increase could also provide beneficial effects. We sought to investigate whether ticagrelor, as compared to clopidogrel, could enhance ischemic preconditioning in patients with stable CAD undergoing PCI. Methods and results The "Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S)" trial was a prospective, randomized 1:1, blinded end-point trial enrolling stable patients with CAD requiring fractional flow reserve (FFR)-guided PCI. Ischemic preconditioning was assessed by measuring the ST-segment elevation at intracoronary ECG during a two-step sequential coronary balloon inflation (2 minutes each, with a 5-minute interval) in the reference vessel. The primary endpoint of the study was the comparison of the delta (difference in millimeters) of ST-segment elevation extent at first and second coronary balloon inflations between ticagrelor and clopidogrel arms. Secondary endpoints were: 1) changes in coronary flow reserve (CFR), index of mcrovascular resistance (IMR), and FFR measured in the index vessel before and at the end of PCI; 2) difference in anginal pain (measured with VAS) during inflations. Also, lab tests with assessment of adenosine serum concentration and ENT-1 expression were conducted at baseline and after index procedure. The study was stopped by the DSMB after two thirds (n=53) of the patients qualifying for the primary endpoint were enrolled. Indeed, an independent statistical report evaluating the blinded results at a pre-specified interim analysis found a statistically significant difference in primary endpoint between the groups. The primary endpoint was significantly higher with ticagrelor as compared to clopidogrel (p < 0.0001). Ticagrelor group was also associated with lower extent of chest pain during coronary balloon inflations (p=0.04), wheras no difference was observed in the delta between pre and post PCI values of FFR (p=0.70), CFR (p=0.72) or IMR (p=0.72). Among lab tests, ticagrelor administration promoted a statistically significant increase in adenosine serum concentration when compared with clopidogrel group, while ENT-1 expression was not different. Conclusions Ticagrelor induces ischemic preconditioning among patients with stable CAD undergoing PCI and reduces intraprocedural anginal pain. Adenosine bioavailability was confirmed to be increased in ticagrelor-treated patients. However, since ENT-1 expression was proved not to be different between groups and all patients in this study underwent adenosine infusion during pre-PCI FFR, our results suggest ticagrelor can further induce ischemic preconditioning via non-adenosine mediated mechanisms.

Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes

Purpose:Evaluation of a catheter design which protects its tip with the retaining balloon when inflated, and has eyeholes at the base of the balloon to improve drainage. Materials and methods:Preclinical tests included assessment of retaining balloon performance, and microbiological blockage. Clinical testing evaluated short-term use and safety in hospital (stage 1) or the patient’s usual residence (stage 2). Results:The retaining balloon supported static loads of 0.7kg, with reduced trauma when modelling forced evulsion. In vitro time to blockage with P. Mirabilis was significantly slower for FLUME compared with latex Foley catheters, but not the silicone Foley. Stage 1 testing (10 patients) confirmed balloon inflation, drainage, retention and removal, with no serious adverse events caused by catheterisation; one balloon failed to inflate, one patient could not be catheterised. Of five patients at stage 2, one had the catheter for 28 days without complication, one experienced spontaneous balloon deflation (14th day) and three needed early removal (blood clot, bypassing, difficulty connecting the drainage bag). Bacterial profiles of two FLUME catheters retained at least 2 weeks matched the Foley catheters. Acquired catheter colouration (two FLUME, one Foley) was not associated with biochemical change in the material. Conclusion:FLUME catheter performed well in preclinical blockage and balloon tests. Tests in 15 patients confirmed basic function and additional training was not needed for staff familiar with Foley catheterisation. Clinical issues commonly seen with catheters included failed catheterisation, clot blockage and bypassing. In addition, an unintended balloon deflation and a failure of bag connection occurred. Plain language summary:This article describes a new catheter design which aims to improve patient comfort and safety, and maximise bladder drainage, by protecting the bladder from the exposed catheter tip and by locating the drainage holes better. Various tests were done to check the catheter retaining balloon was safe and how well the catheter did when exposed to bacteria that could block it. The catheter was also used in people for the first time, to check it could be put in safely and functioned as intended. The results showed the FLUME catheter did well in the balloon and blockage tests. Tests in 15 patients confirmed basic function and showed placement was easy for staff familiar with conventional catheters. There were some clinical issues typical of urinary catheters and some possible improvements were identified.

Abstract 148: Balloon‐assisted retrograde Cerebral Venography in Cerebral Venous Interventions: A novel avenue for diagnostic venous imaging

Introduction Angiographic imaging of cerebral venous system is derived from the delayed phase of a cerebral arteriogram. The venous phase of arteriogram provides washed out images, quality of which is determined by the direction of dominant venous outflow, iodinated contrast ratio and flat panel imaging resolution*. Direct venous injections are limited in visualization due to injections against the direction of blood flow. We identified a method of cerebral phlebography under temporary venous balloon occlusion of jugular vein or venous sinus to obtain high resolution 2D and 3D images for diagnosis and treatment of cerebral venous pathology. We propose the addition and use of large diameter compliant balloon guide catheters in the workflow of cerebral venous imaging to optimize filling of cerebral venous system and significantly improve venous imaging. Methods A case series of 15 patients who underwent Intracranial Venous Interventions were collected from the Hospital of the University of Pennsylvania. All patients underwent 2 and 3‐dimensional retrograde phlebography assisted by temporary inflation of balloon guide catheter. Results 9 females and 6 males received venous access predominantly located in right cubital fossa in the cephalic or basilic vein using an 8 and 9 french sheaths. The balloon guide catheters employed included Walrus Balloon Guide 8F (Q’apel medical) 8 cases, Dr Banner Balloon Guide ( EO solutions corp) 5 cases, Bobby Balloon guide (microvention)1 case, Emboguard Balloon Guide ( Cerenovus) 1 case. Utilization of balloon catheters resulted in minimal increase in average procedure time with improved filling and depiction of venous vessels, and no complications. Conclusion Balloon assisted retrograde phlebography using compliant balloon guide catheters is an effective way to image cerebral veins while decreasing the difficulty associated with working against the flow of venous blood.

Analysis of Intra-Aortic Balloon Performance in Open-Heart Surgery

A failing heart can be supported in several ways, including cardiopulmonary bypass pumps (CPB), extracorporeal membrane oxygenators (ECMOs), and other types of auxiliary heart pumps. The intra-aortic-balloon-pump (IABP) is one technique of internal counter-pulsation that supports maintaining the circulatory system It continues to be used as a vascular support device to critically unwell cardiac patients. Many recent studies have focused on the problems of the (IABP) in open-heart surgery, while other researchers concentrated on the positioning and size of the balloon, some of them studied the timing of the balloon's inflation and deflation. this paper has reviewed a brief Introduction, the basic principles of the balloon, how to trigger the balloon pump as well as the use of IABP in Coronary Artery Bypass Graft (CABG), balloon mistiming of inflation and deflation, balloon timing usage within open-heart surgery and finally a balloon position and sizing.

Outcomes of Provisional Stenting With Versus Without Side Branch Intervention in Patients With Bifurcation Lesion–Related ST-Segment Elevation Myocardial Infarction

To date, the best approach to coronary bifurcation lesion remains unsettled, and the parameters to guide side branch ballooning or stenting are not yet defined. This study aimed to compare the survival outcomes after provisional stenting with versus without side branch intervention. A cohort was conducted on 132 patients who underwent coronary angiography at Toulouse University Hospital for ST-segment elevation myocardial infarction with large culprit nonleft main coronary bifurcation lesion. Study participants were divided into 2 groups depending on the performance or not of a side branch intervention. We observed the living status at 1-year after hospital discharge. Side branch intervention by balloon inflation or final balloon kissing technique was performed in 34.1% of study participants. At 1-year follow-up, the incidence of all-cause mortality was 7.8 per 100 person-years (95% confidence interval [CI] 4.1 to 15), and although it seemed higher in the side branch intervention group (10 per 100 person-years [95% CI 3.8 to 26.7] vs 6.6 per 100 persons-years [95% CI 2.8 to 15.9]), the survival analyses showed no differences in survival outcomes (hazard ratio side branch intervention 1.55 [0.42 to 5.78], p=0.513). In conclusion, in the setting of a coronary bifurcation causing ST-segment elevation myocardial infarction, simple provisional stenting without side branch intervention showed a low mortality rate and no differences in the 1-year survival outcomes.

Critical systolic blood pressure threshold for endovascular aortic occlusion-A multinational analysis to determine when to place a REBOA.

Systolic blood pressure (SBP) is a potential indicator that could guide when to use a resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma patients with life-threatening injuries. This study aims to determine the optimal SBP threshold for REBOA placement by analyzing the association between SBP pre-REBOA and 24-hour mortality in severely injured hemodynamically unstable trauma patients. We performed a pooled analysis of the aortic balloon occlusion (ABO) trauma and AORTA registries. These databases record the details related to the use of REBOA and include data from 14 countries worldwide. We included patients who had suffered penetrating and/or blunt trauma. Patients who arrived at the hospital with a SBP pre-REBOA of 0 mm Hg and remained at 0 mm Hg after balloon inflation were excluded. We evaluated the impact that SBP pre-REBOA had on the probability of death in the first 24 hours. A total of 1,107 patients underwent endovascular aortic occlusion, of these, 848 met inclusion criteria. The median age was 44 years (interquartile range [IQR], 27-59 years) and 643 (76%) were male. The median injury severity score was 34 (IQR, 25-45). The median SBP pre-REBOA was 65 mm Hg (IQR, 49-88 mm Hg). Mortality at 24 hours was reported in 279 (32%) patients. Math modeling shows that predicted probabilities of the primary outcome increased steadily in SBP pre-REBOA below 100 mm Hg. Multivariable mixed-effects analysis shows that when SBP pre-REBOA was lower than 60 mm Hg, the risk of death was more than 50% (relative risk, 1.5; 95% confidence interval, 1.17-1.92; p = 0.001). In patients who do not respond to initial resuscitation, the use of REBOA in SBPs between 60 mm Hg and 80 mm Hg may be a useful tool in resuscitation efforts before further decompensation or complete cardiovascular collapse. The findings from our study are clinically important as a first step in identifying candidates for REBOA. Prognostic and Epidemiological; Level IV.

Percutaneous transvenous coil embolization (PTCE) for treatment of single extrahepatic portosystemic shunt in dogs

BackgroundThere is limited information regarding percutaneous transvenous coil embolization (PTCE) for single extrahepatic portosystemic shunt (PSS). This study aimed to describe the procedure and outcome of PTCE in dogs with a single extrahepatic PSS. Forty-two privately owned dogs were included in this study. All dogs were diagnosed with extrahepatic PSS by computed tomography (CT). Preoperative CT images were used to evaluate the diameter of the PSS for coil placement. A multipurpose balloon catheter was percutaneously inserted into the PSS via the jugular vein, and transvenous retrograde portography (TRP) and measurement of blood pressure in the PSS (pPSS) were performed during balloon inflation; one or more embolization coils were implanted via the catheter.ResultsIn most cases, preoperative median fasting and postprandial serum total bile acid (TBA) concentrations were high (fasting, 86.5 μmol/L [ 3.7–250.0 μmol/L]; postprandial, 165.5 μmol/L [ 1.5–565.0 μmol/L]). CT revealed that 30 dogs had left gastrophrenic shunt; eight had left gastroazygos shunt; and one each had left gastrocaval, splenocaval, splenophrenic, and left colocaval shunt. TRP revealed that intrahepatic portal vascularity was clearly detectable in all dogs. The median values of pPSS before and during the balloon occlusion were 4.8 mmHg [2.0–13.0 mmHg] and 8.6 mmHg [5.0–18.0 mmHg], respectively. The median number and diameter of coils used were 2 coils [1 – 5 coils] and 8.0 mm [4.0 – 12.0 mm], respectively. The median times of irradiation and PTCE were 9 min [4–26 min] and 40 min [23–75 min], respectively. The median fasting and postprandial TBAs significantly decreased to 8.2 μmol/L [0.3–45.1 μmol/L, n = 38, p = 0.0028] and 19.8 μmol/L [0.3–106.7 μmol/L, n = 38, p = 0.0018], respectively, approximately 1 month after PTCE. The clinical success rate of PTCE without requirement for a second surgery was 95.2% (40/42 dogs). During revision surgery, one dog underwent surgical ligation and, in another dog, an ameroid constrictor was placed.ConclusionsPTCE was clinically effective in treating single extrahepatic PSS in dogs. Preoperative CT and TRP prior to PTCE might be clinically valuable for choosing the size of embolization coils, deciding the appropriate location of coil implantation, and estimating the number of coils to be implanted. PTCE is a promising alternative to conventional surgical procedures for single extrahepatic PSS in dogs.

Impact of prolonged drug-coated balloon inflation on residual stenosis and clinical outcomes in coronary artery disease patients: A propensity score matched analysis.

There is a paucity of data regarding the optimal duration of drug-coated balloon (DCB) inflation for coronary lesions. We sought to explore the effect of DCB angioplasty with versus without long inflation time on residual stenosis and clinical outcomes in patients with coronary artery disease. This study included 314 consecutive patients with 445 lesions undergoing paclitaxel DCB angioplasty using different inflation time, divided according to whether the total inflation time of the DCB was ≥180 s (prolonged group) or <180 s (standard group). The primary clinical endpoint, defined as a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization, was examined in 92 propensity score matched pairs. In the matched cohort, the median clinical follow-up period was 947 days. Postprocedural angiographic diameter stenosis was smaller in the prolonged group than in the standard group (30.0% [22.0-37.0] vs. 33.5% [25.5-40.5]; p = 0.042). Intravascular ultrasound measurements revealed that longer DCB inflation time resulted in smaller area stenosis (66.6 ± 7.8% vs. 69.4 ± 7.0%; p = 0.044) and a less mean increase in percent atheroma volume (-11.2 ± 7.1% vs. -7.4 ± 5.9%; p = 0.004) after angioplasty. The rate of the primary endpoint was lower in the prolonged group than in the standard group (log-rank p = 0.025). The efficacy of prolonged DCB inflation was prominent in patients with in-stent restenosis and longer lesions. Prolonged DCB inflation was associated with reduced residual stenosis and improved clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary intervention. Prospective randomized trials are warranted to validate the benefits of DCB angioplasty with long inflation time.

Comparison of trace image colors for kids-book with two active distractions in reducing pain and fear of children during the venipuncture procedure

This study investigated the effectiveness of trace image and coloring for kids-book (TICK-B), cough trick, and balloon inflation techniques in reducing pain and fear in children during venipuncture. The current study is a prospective, controlled, and randomized trial (RCT). School-aged children who required venipuncture were involved in the study. Pediatric patients were randomly assigned to four groups: the TICK-B group, the cough trick group, the inflation of balloons, and the control groups. Before and after the procedure, the children and their parents were interviewed. Wong-Baker (FACES) Pain Rating Scale was applied to measure the severity of pain. Children’s Fear Scale was applied to measure children’s fear. This study involved the 160 children (mean age, 8.39–2.18 years). The severity of pain and fear levels among the children during and after the procedure were significantly different (p = 0.001). Pain and fear were significantly decreased in children in the intervention groups compared with those in the control group (p < 0.05). In the TICK-B group, participants reported significantly less pain and fear during the venipuncture procedure than in the cough trick, balloon inflation, and control groups (P = 0.001, p = 0.001, p = 0.001) and after the procedure (p = 0.001, p = 0.002, p = 0.002). There was a similar significance found in the level of fear during the procedure (p = 0.001, p = 0.002, p = 0.006), and after the procedure (p = 0.001, p = 0.008, p = 0.015). Conclusion: TICK-B was the most effective method for decreasing the pain and fear of children associated with venipuncture procedures. Furthermore, the distraction technique of coughing and inflating balloons also proved efficacious in decreasing the pain and fear of children during venipuncture. Trial registration: The study has been registered with ClinicalTrials.org under the number NCT04983303. It was retrospectively registered on July 26, 2021.What is Known:• Venipuncture, one of the most painful and uncomfortable procedures for children, caused great fear and discomfort during the procedure.What is New:• The TICK-B technique, music listening, and cartoon watching techniques are effective, simple, and safe ways to reduce children’s fear and pain. These interventions provide a good way for children and their parents to collaborate during painful medical procedures.• No studies have compared the impact of TICK-B during venipuncture.

Strategy of delayed intervention without stent implantation in myocardial infarction with ST segment elevation caused by massive thrombosis of the infarct-related artery

Aim. TIntroduction. To evaluate in-hospital angiographic and five-year posthospital clinical outcomes of percutaneous intervention strategy without stent implantation with immediate coronary artery stenting technique in STEMI patients with massive coronary thrombosis.Material and methods. The study enrolled 116 patients with primary STEMI myocardial infarction with the signs of massive thrombosis in the lumen of the main epicardial coronary artery with TIMI thrombus grade greater than 3 after antegrade blood flow restoration. In the 1st group of delayed intervention at the primary stage the blood flow was restored by small diameter balloon inflation and/ or manual vacuum thrombus aspiration until stable TIMI grade 3 blood flow was achieved, at control CAG on day 5-6 in 36 people the stent was not implanted due to insignificance of infarct-related coronary artery stenosis (stenosis less than 50% according to QCA). Immediate stent implantation was performed in 78 patients (group 2). The primary endpoint was the incidence of adverse cardiovascular events, including total mortality, recurrent myocardial infarction, repeated revascularization of the infarct-responsive artery. Secondary endpoint: frequency of achieving optimal myocardial perfusion as measured by angiography – TIMI blood flow and Myocardial Blush Grade.Results. The median follow-up period was 47 months. The incidence of the primary end point (MACE) was 15,8% in group 1 and 23,1% in group 2, with no statistically significant difference (p=0,408). Overall mortality (10,5% and 11,7%), the rate of repeat myocardial infarction (2,6% and 5,1%), and the rate of repeat target vessel revascularization (2,6% and 6,4%) were without significant advantage between subgroups. Optimal reperfusion (TIMI-3 and Myocardial Blush Grade 2-3 after primary procedure was achieved in significantly (p=0,02) more patients in group 1 (89%) than in group 2 (69,2%) ST segment resolution ≥70% after intervention was achieved in 87% of cases in group 1 and in 64,1% of cases in group 2 (p=0,011).Conclusion. In STEMI patients with massive coronary thrombosis, the method of delayed percutaneous intervention increases the rate of achieving optimal blood flow and allows avoiding stent implantation in the infarct-related artery in 50% of cases as compared to the method of immediate stenting. Both methods have comparable hospital and five-year clinical risks.

Impact of coronary bifurcation angle on stent malapposition in a randomized comparison between proximal optimization technique followed by side branch dilatation and kissing balloon inflation.

The impact of coronary bifurcation angle (BA) on incomplete stent apposition (ISA) after crossover stenting followed by side branch (SB) intervention has not been established. A total of 100 crossover stentings randomly treated with proximal optimization technique followed by short balloon dilation in the SB (POT-SBD group, 48 patients) and final kissing balloon technique (KBT group, 52 patients) were analyzed in the PROPOT trial. Major ISA with maximum distance>400μm and its location was determined using optical coherence tomography before SB intervention and at the final procedure. The BA was defined as the angle between the distal main vessel and SB. Optimal POT was determined when the difference in stent volume index between the proximal and distal bifurcation was greater than the median value (0.86mm3/mm) before SB intervention. Major ISA was more frequently observed in the POT-SBD than in the KBT group (35% versus 17%, p<0.05). In the POT-SBD group, worsening ISA after SBD was prominent at the distal bifurcation. The BA was an independent predictor of major ISA (odds ratio 1.04, 95% confidence interval 1.00-1.07, p<0.05) with a cut-off value of 59.5° (p<0.05). However, the cases treated with optimal POT in the short BA (<60°) indicated the lowest incidence of major ISA. In the KBT group, BA had no significant impact. A wide BA has a potential risk for the occurrence of major ISA after POT followed by SBD in coronary bifurcation stenting.

Investigating Balloon-Vessel Contact Pressure Patterns in Angioplasty: In Silico Insights for Drug-Coated Balloons

Drug-Coated Balloons have shown promising results as a minimally invasive approach to treat stenotic arteries, but recent animal studies have revealed limited, non-uniform coating transfer onto the arterial lumen. In vitro data suggested that local coating transfer tracks the local Contact Pressure (CP) between the balloon and the endothelium. Therefore, this work aimed to investigate in silico how different interventional and device parameters may affect the spatial distribution of CP during the inflation of an angioplasty balloon within idealized vessels that resemble healthy femoral arteries in size and compliance. An angioplasty balloon computational model was developed, considering longitudinal non-uniform wall thickness, due to its forming process, and the folding procedure of the balloon. To identify the conditions leading to non-uniform CP, sensitivity finite element analyses were performed comparing different values for balloon working length, longitudinally varying wall thickness, friction coefficient on the balloon-vessel interface, vessel wall stiffness and thickness, and balloon-to-vessel diameter ratio. Findings indicate a significant irregularity of contact between the balloon and the vessel, mainly affected by the balloon’s unfolding and longitudinal thickness variation. Mirroring published data on coating transfer distribution in animal studies, the interfacial CP distribution was maximal at the middle of the balloon treatment site, while exhibiting a circumferential pattern of linear peaks as a consequence of the particular balloon-vessel interaction during unfolding. A high ratio of balloon-to-vessel diameter, higher vessel stiffness, and thickness was found to increase significantly the amplitude and spatial distribution of the CP, while a higher friction coefficient at the balloon-to-vessel interface further exacerbated the non-uniformity of CP. Evaluation of balloon design effects revealed that the thicker tapered part caused CP reduction in the areas that interacted with the extremities of the balloon, whereas total length only weakly impacted the CP. Taken together, this study offers a deeper understanding of the factors influencing the irregularity of balloon-tissue contact, a key step toward uniformity in drug-coating transfer and potential clinical effectiveness.

A finite element framework for fluid–membrane interactions involving fracture

We propose a novel framework for investigating fluid–membrane interactions involving fracture, and apply it to simulate initial stages during the bursting of a balloon. Fluid flow is computed using a stabilized space–time finite element method over a body-fitted mesh. The membrane is modelled as a hyperelastic material and the equations are solved using the standard Galerkin method. Structural failure is incorporated using the element deletion technique based on a simple strain based criterion. Change in topology of the fluid domain due to element deletion is handled without resorting to remeshing. The coincident fluid nodes on either side of the deleted membrane elements on the surface of the balloon are connected, thereby allowing the fluid to gush through the opening. First, fluid–membrane interaction, without failure, in a square sail with fixed edges is studied. The sail exhibits vibration owing to vortices shed from its edges. We then study the inflation and deflation of a spherical balloon equipped with an inlet pipe. A hydrostatic pressure gradient is applied to drive the flow into the balloon. Effect of different values of membrane density, stiffness and the hydrostatic pressure gradient on inflation rate and balloon shape is studied. The bursting of the inflated balloon is initiated by deleting one structural element on its surface. The proposed algorithm is then applied to simulate the subsequent dynamics of the fluid–membrane system.

Pepsin concentration in oral lavage fluid of rabbit reflux model constructed by dilating the lower esophageal sphincter.

The aim of this study was to explore the changes in pH and pepsin concentrations in oral lavage fluid of rabbit reflux model. A total of 18 New Zealand rabbits were randomly divided into two groups. The lower esophageal sphincters (LESs) of the rabbits in the experimental group (EG) were dilated by balloon after the LESs were localized by manometry. The pH levels of the throat and the lower esophagus were monitored 1 week before and 2 weeks after inflation. Oral lavage fluid was collected 1 week before, and 2 and 8 weeks after inflation. The pH monitoring showed that the percentage of reflux time, the number of reflux events, and the longest time of reflux after the dilation (AE) in the EG were significantly higher than before the dilation (P < 0.01). The pepsin concentrations at 2 and 8 weeks AE in the EG were significantly higher than that before and that in the control group (P < 0.05). Based on receiver operating characteristic curve analysis, the best diagnostic threshold value was 30.3 ng/ml. The reflux model constructed by balloon inflation of the LES in rabbits is characterized by a decrease in throat pH and an increase in salivary pepsin concentration.

Stenting the unprotected left main coronary artery- mid-term outcomes of the observational registry

Abstract Background New imaging modalities such as IVUS had improved results of Stenting of the unprotected left main coronary artery (UPLM). The results of stenting UPLM without these new modalities but with meticulous care need to be studied more. Methods This prospective and retrospective study was performed in multiple local centers. The local ethics committee approved the study, and the patients signed informed consent. In addition, the local heart team, including a cardiac surgeon, was consulted for a joint decision agreement. In the last five years, one hundred twenty patients with left main disease &amp;gt;50% were subjected to stenting with drug- eluted stents.All patients were subjected to detailed history taking with particular emphasis on acute coronary syndrome, angina duration, class, previous coronary interventions, and medications. In addition, 12 lead ECGs were revised with an evaluation of ST/T changes and any old infarction. An echocardiographic examination was done on all patients. Relevant laboratory tests were done.Risk assessment was calculated for every patient, including Euro SCORE and Syntax score. Patient selection: Consecutive patients arriving for primary Stenting or acute coronary episode were included. Medications: All patients received clopidogrel and aspirin before the planned procedure. Anticoagulation with unfractionated heparin in a dose of 10000 IU was given at the beginning of the PCI. Post PCI, all patients received B blockers, ACE inhibitors, statins, and dual antiplatelets in the guidelines recommended doses. Calcification was assessed by angiographic imaging only. We estimated the vessel diameter as 2/3 diameter of the branches. PCI technique: A steerable guidewire was advanced in LAD, followed by PCI with pre-dilatation or direct Stenting according to the operator’s discretion. One or two stent strategy was utilized according to the situation of the lesions. Results 92 patients (77.3%) presented with ACS, of which 65 patients (54.6%) had no Previous Intervention, and 27 patients (22.7%) had a previous PCI. Left ventricular ejection fraction significantly correlates with the complication at six months follow-up; all 16 patients with reported complications (100%) had baseline LVEF of &amp;lt;40% (P-value = 0.023). Syntax score 11 patients (55%) with a high score of more than 32 had adverse events, P = 0.004. Residual syntax shows a less significant correlation with a mean value of 7.3 in the complication group vs. 4.9 in the other group (P = 0.016). Final kissing balloon inflation shows no statistically significant difference. Conclusions PCI in UPLM is a safe, feasible option with a high technical success rate and acceptable outcome at follow-up, even without the utilization of IVUS

The Usefulness of Intracoronary Imaging in Patients with ST-Segment Elevation Myocardial Infarction.

Intracoronary imaging (ICI) modalities, namely intravascular ultrasound (IVUS) and optical coherence tomography (OCT), have shown to be able to reduce major adverse cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). Nevertheless, patients with ST-segment elevation myocardial infarction (STEMI) have been practically excluded from contemporary large randomized controlled trials. The available data are limited and derive mostly from observational studies. Nevertheless, contemporary studies are in favor of ICI utilization in patients who undergo primary PCI. Regarding technical aspects of PCI, ICI has been associated with the implantation of larger stent diameters, higher balloon inflations and lower residual in-stent stenosis post-PCI. OCT, although used significantly less often than IVUS, is a useful tool in the context of myocardial infarction without obstructive coronary artery disease since, due to its high spatial resolution, it can identify the underlying mechanism of STEMI, and, thus, guide therapy. Stent thrombosis (ST) is a rare, albeit a potential lethal, complication that is expressed clinically as STEMI in the vast majority of cases. Use of ICI is encouraged with current guidelines in order to discriminate the mechanism of ST among stent malapposition, underexpansion, uncovered stent struts, edge dissections, ruptured neoatherosclerotic lesions and coronary evaginations. Finally, ICI has been proposed as a tool to facilitate stent deferring during primary PCI based on culprit lesion characteristics.

A nomogramic model for predicting the left ventricular ejection fraction of STEMI patients after thrombolysis-transfer PCI.

The prognosis of ST-segment elevation myocardial infarction (STEMI) is closely linked to left ventricular ejection fraction (LVEF). In contrast to primary percutaneous coronary intervention (PPCI), thrombolysis-transfer PCI (TTPCI) is influenced by multiple factors that lead to heterogeneity in cardiac function and prognosis. The aim of this study is to develop a nomogram model for predicting early LVEF in STEMI patients with TTPCI, based on routine indicators at admission. We retrospectively reviewed data from patients diagnosed with STEMI at five network hospitals of our PCI center who performed TTPCI as door-to-balloon time (the interval between arrival at the hospital and intracoronary balloon inflation) over 120 min, from February 2018 to April 2022. Categorical variables were analyzed using Pearson χ2 tests or Fisher exact tests, while Student's t-test or Mann-Whitney U-test was used to compare continuous variables. Subsequently, independent risk factors associated with reduced LVEF one week after TTPCI were identified through comprehensive analysis by combining All-Subsets Regression with Logistic Regression. Based on these indicators, a nomogram model was developed, and validated using the area under the receiver operating characteristic (ROC) curve and the Bootstrap method. A total of 288 patients were analyzed, including 60 with LVEF < 50% and 228 with LVEF ≥ 50%. The nomogram model based on six independent risk factors including age, heart rate (HR), hypertension, smoking history, Alanine aminotransferase (ALT), and Killip class, demonstrated excellent discrimination with an AUC of 0.84 (95% CI: 0.78-0.89), predicted C-index of 0.84 and curve fit of 0.713. The nomogram model incorporating age, HR, hypertension, smoking history, ALT and Killip class could accurately predict the early LVEF ≥ 50% probability of STEMI patients undergoing TTPCI, and enable clinicians' early evaluation of cardiac function in STEMI patients with TTPCI and early optimization of treatment.