Angioplasty Research Articles

Vasospasm in Pediatric Subarachnoid Hemorrhage.

Cerebral vasospasm (CV) is a common severe complication of subarachnoid hemorrhage (SAH), a severe type of intracranial bleeding that is uncommon in children. The purpose of this article is to review the current literature regarding this potentially devastating complication. CV may be asymptomatic and is less common in children compared to adults. Several molecular phenomena, including inflammatory ones, contribute to its pathophysiology. Better collateral circulation and higher cerebral blood flow are protective factors in children. When clinically apparent, CV may manifest as a change in the child's neurologic status or vital signs. CV can be diagnosed using brain vessel imaging, such as computed tomography angiography, magnetic resonance angiography, digital subtraction angiography, transcranial Doppler ultrasonography, and computed tomography perfusion. A reduction of < 50% in the artery's caliber confirms the diagnosis. Besides general supportive measures and causative treatment of SAH, CV management options include the administration of calcium channel blockers and neurointerventional approaches, such as intra-arterial vasodilators and balloon angioplasty. Long-term outcomes in children are usually favorable.

MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data

Study designReview of database. SettingTertiary care neurotology center. PatientsPatients undergoing adverse events. InterventionMAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction. Main outcome measuresMedical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates. ResultsThere were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %. ConclusionsETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.

Outcomes of Concurrent Balloon Eustachian Tuboplasty and Tympanostomy Tube Placement in Children.

Balloon dilation eustachian tuboplasty (BDET) has been proven to be a safe treatment option for children with eustachian tube dysfunction (ETD). This study aims to analyze the long-term outcomes of children who underwent concurrent BDET and tympanostomy tube (TT) placement. We hypothesize that patients who underwent simultaneous therapy have experienced a low overall rate of middle ear pathology and have consistent hearing quality at subsequent office visits. Retrospective chart review of 19 pediatric patients (36 ears) who previously underwent concurrent BDET and TT placement. Patient charts within the extended postoperative period were reviewed. Specific data points included need for reoperation, rates of middle ear pathology, audiological outcomes, and number of previous TT placements. Pediatric patients who underwent concurrent BDET and TT placement had long-term success in 34/36 ears (94.4%). All postoperative tympanograms and audiograms (100%) were normal when performed within 12 months after the procedure. Notably, 34/36 ears (94.4%) had history of tube placement in the past. Patients had an average of three sets of tympanostomy tubes prior to undergoing concurrent BDET and TT. Concurrent BDET and TT placement may be an effective treatment option for pediatric patients with persistent eustachian tube dysfunction. Specifically, BDET may be a useful adjunct tool in pediatric patients with refractory ETD despite having multiple sets of tympanostomy tubes. This study aims to strengthen the argument of performing multimodal therapy in pediatric patients with recurrent middle ear disease. 4 Laryngoscope, 134:4799-4802, 2024.

The prognosis of acute myocardial infarction due to stent thrombosis after 2nd generation drug eluting stents era (comparative study with acute myocardial infarction due to plaque rupture or erosion)

Abstract Backgrounds Stent thrombosis (ST) is a rare complication after percutaneous coronary intervention (PCI), and more than 70% of ST cases result in acute myocardial infarction (AMI). Although a new generation of drug-eluting stents (DES) and newer antiplatelet therapies have been shown to reduce the incidence of ST, ST-related AMI continues to be observed in contemporary practice. The prevalence and prognosis of ST results in AMI have not been well evaluated after the 2nd generation DES (G2-DES) era. Purpose The purpose of this study was to evaluate the prevalence and prognosis of AMI due to ST after the G2-DES era compared with AMI due to plaque rupture or erosion. Methods Among 6601 AMI patients enrolled in the Mie ACS registry from January 2013 to November 2022, 6273 AMI patients with AMI due to ST(ST) and AMI due to plaque rupture and erosion (AMI:P) were included for this analysis after excluding other types of AMI. ST was confirmed by angiography. The primary endpoint was defined as all-cause mortality, and revascularization after PCI for AMI was also evaluated. Results Seventy-eight patients, or 1.2% of all AMI in this study, had AMI due to ST, including early ST n=13 (16.7%), late ST n=4 (5.1%), and very late ST n=61 (78.2%). Stent types were G2-DES n=35 (44%), G1-DES n=18 (23.1%), bare metal stent (BMS) n=12 (15.4%), and unknown n=13 (16.7%). According to the KM survival curve, the 30-day mortality rate of ST was 2.6%, while the AMI:P rate was 6.7%, which was not statistically significant, but the ST was half the mortality rate. Furthermore, in the landmark analysis, the 2-year mortality rates were 6.2% for ST and 7.0% for AMI:P (P=0.66, Figure 1). ST was not an independent predictor of poor prognosis by multivariate Cox regression analysis. Even after the propensity score matching analysis as a sensitivity analysis, ST was not an independent predictor of poor prognosis in AMI patients. Among ST patients, 82.2% were treated with balloon angioplasty (without additional stenting) at the time of AMI, whereas 9.7% of AMI:P patients were treated with balloon angioplasty (P&amp;lt;0.001). Compared to patients with AMI:P, patients with ST had a higher incidence of revascularization after PCI for AMI within 2 years (21.8% vs. 11.2%; P=0.02, Figure 2A). Multivariate Cox regression analysis also showed that ST was an independent predictor of revascularization after PCI for AMI with a hazard ratio of 2.00 (P&amp;lt;0.01, Figure 2B). Conclusion The prognosis of ST patients tended to be better than that of AMI:P patients. The proportion of ST in AMI has decreased in the G2-DES era, and the higher proportion of VLST in ST suggests that its prognosis may be better than that of AMI:P . However, the rate of revascularization is higher in ST patients because stenting was not performed in the acute phase of PCI for AMI, and the appropriate use of stents depending on the type of ST may lead to a reduction in revascularization.Figure1Figure2

Percutaneous coronary intervention of in-stent restenosis: A three-arm analysis from SWEDEHEART

Abstract Background During the last decades, there have been substantial improvements in treatment techniques for percutaneous coronary intervention (PCI). Yet, in-stent restenosis (ISR) continues to pose significant challenges as they account for 10% of all PCI cases and are associated with worse outcome compared to de-novo lesions. When assessing ISR with PCI, balloon angioplasty with drug-coated balloons (DCB) is frequently used. Purpose Despite frequent use of DCB, there is a lack of long-term data ensuring the safety of DCB for ISR as no randomized trial has extended beyond a 3-year follow-up. We aimed to study the long-term outcome and conducted a nationwide three-arm investigation on the outcome of ISR, comparing DCB with drug-eluting stents (DES) or plain old balloon angioplasty (POBA) within a 5-year follow-up. Methods We conducted a nationwide analysis using the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. The SWEDEHEART registry was used to include any ISR undergoing coronary angiography between June 11, 2013, and December 31, 2020. Target lesion revascularization (TLR) was the primary outcome. Secondary outcomes included all-cause mortality, myocardial infarction, and any PCI. The outcomes were analysed using a multivariable Cox regression model. Results A total of 9304 segments from 7987 patients were eligible. Compared to POBA, the use of DCB was associated with lower rates of TLR, hazard ratio (HR) 0.62 (95% confidence interval [CI]: 0.50-0.78), all-cause mortality, HR 0.60 (95% CI: 0.50-0.72), and any PCI, HR 0.78 (95% CI: 0.66-0.93). No difference was observed for myocardial infarction. Compared to DES, the use of DCB was associated with higher rates of TLR, HR 1.24 (95% CI: 1.08-1.42). No difference was observed for all-cause mortality, cardiovascular mortality, myocardial infarction, or any PCI. Conclusions In this nationwide analysis including any ISR undergoing PCI, the use of DCB showed superior outcomes compared to POBA within 5 years but higher rates of repeat revascularizations compared to DES. While DES demonstrated lower TLR rates than DCB, the lack of mortality differences indicates that DCB is a viable option, particularly for patients where DES might not be suitable, but that DES should be considered as the first line strategy.Table 1.5-year outcomeFigure 1.Kaplan-Meier curves

Safety and efficacy of low-dose versus high-dose paclitaxel-coated balloons in patients with femoropopliteal lesions: an updated and meta-analysis

Abstract Introduction Drug-coated balloons (DCBs) have reduced restenosis and reintervention of femoropopliteal lesions compared to uncoated percutaneous transluminal angioplasty (PTA). However, limited data are available on different dosages of the DCBs. Purpose We aimed to give a comprehensive analysis in this regard and update the current evidence. Methods We searched Scopus, Cochrane, PubMed, and WOS from inception till February 2024 to include all randomized controlled trials (RCTs) that addressed different dosages of DCBs in femoropopliteal lesions. The primary endpoint was all-cause death, primary patency, and amputation at six months, while the secondary outcomes were all-cause death, primary patency, and amputation at 12 months. Dichotomous data were pooled using Odds Ratio (OR) and 95% Confidence Interval (CI) in a random-effect model. Results A total of 21 studies, including 4081 patients in the analysis. Low-dose DCB was associated with high rates of primary patency compared to the standard dose at both 6 and 12 months of follow-up with the following values (OR: 2.46, 95% CI: 1.48 to 4.08, and 1.93, 95% CI: 1.5 to 2.49, receptively). Also, low-dose DCB reduced the incidence of clinically driven target lesion revascularization (CD-TLR) compared to the standard dose at 12 months (OR: 0.45, 95% CI: 0.31 to 0.65). Regarding high-dose DCB, higher primary patency rates were observed when compared to standard doses at 6 and 12 months (OR: 1.89, 95% CI: 1.19 to 2.99, and 5.47, 95% CI: 4.31 to 6.95, respectively). Moreover, high-dose DCB reduced the incidence of CD-TLR at 6 and 12 months of follow-up (OR: 0.33, 95% CI: 0.18 to 0.63, and 0.63, 95% CI: 0.48 to 0.84, respectively). Conclusion Low-dose DCBs were associated with higher primary patency without significant differences in all-cause mortality or amputation. On the other hand, high-dose DCBs were associated with a higher incidence of amputation without significant differences in other studied outcomes.Low dose Paclitaxel coated balloon vs CoHigh dose Paclitaxel coated balloon vs C

Drug-eluting devices versus angioplasty in infrapopliteal artery disease:an updated systematic review and meta-analysis

Abstract Background Clinically driven target lesion revascularization (CD-TLR) and restenosis are common complications in individuals with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease undergoing percutaneous transluminal angioplasty (PTA). Drug-eluting balloons, stents, and resorbable scaffolds have emerged as an alternative therapy that may decrease the recurrence of these complications compared to PTA. However, their efficacy and safety are still controversial. Purpose This study aims to update and provide new insights about coated balloons, stents, and resorbable scaffolds as drug-eluting devices compared to PTA in patients with CLTI and infrapopliteal artery disease. Methods We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing drug-eluting devices, such as stents, coated balloons, and resorbable scaffolds, to PTA in patients with CLTI and infrapopliteal artery disease. The primary endpoint of interest was (1) CD-TLR. We only included trials defining this outcome as angiographically confirmed restenosis associated with wound changes or change in Rutherford classification at 12 months follow-up. This study also reported the following secondary outcomes: (2) binary restenosis and (3) amputation. We performed a subgroup analysis of the drug-eluting devices and between the drug-eluting pharmacological class, comparing the limus drug family subgroup and Pactlitaxel subgroup. Results We included 6 RCTs, encompassing 1263 patients, of whom 761 (60.2%) received a drug-eluting device. The mean age was 70.94 years. In the pooled analysis, the primary endpoint of CD-TLR was not statistically significant(OR 0.79; 95% CI 0.56-1.12; p=0.64; figure 1A). Although binary restenosis (OR: 0.62; 95% CI 0.36-1.05; p= 0.04; Fig.1B) was not statistically significant, our subgroup analysis of different drug-eluting pharmacological classes was significantly different(p&amp;lt;0.01; Fig.1B). Furthermore, the -limus family subgroup presented with a significant lower (OR 0.39; 95% CI 0.25 - 0.61; p&amp;lt;0.01; Fig. 1B) binary restenosis. There was no significant difference in the amputation endpoint (OR: 1.12; 95% CI 0.52 - 2.49; p= 0.74) and among the drug-eluting devices subgroup (p=0.63; Fig. 1A) for the CD-TLR endpoint. Conclusion In this updated meta-analysis of patients with CLTI and infrapopliteal artery, drug-eluting devices were not associated with CD-TLR compared to PTA. However, the -limus drug family is associated with a more significant reduction in the binary restenosis endpoint.

Novel balloon catheter containing therapeutic mRNA with smart RNA switch alleviate restenosis after vascular injury

Abstract Background Cardiovascular diseases are the leading cause of death worldwide, and vascular intervention is an effective method for ischemic heart diseases. However, vascular restenosis significantly affects the long-term therapeutic outcomes, which mainly caused by excessive proliferation of vascular smooth muscle cells (VSMCs). While drug-eluting stents and drug-coated balloons have successfully decreased the incidence of restenosis by inhibiting the VSMCs proliferation, they concurrently suppress the repair of endothelial cells (ECs) and re-endothelialization, thereby increasing the risk of late thrombotic events and mortality. Consequently, it is urged to develop novel high-selectively therapeutic devices to overcome vascular restenosis. In current mRNA therapies of cardiovascular diseases, there are few effective systems for cell-specific expression. Therefore, we propose to utilize RNA editing (based on ADAR1 RNA editing) to investigate a smart RNA molecular switch capable of cell-specific recognition and selectively releasing payload in targeted cells or tissues for cell precision therapy. However, the application of gene editing in the cardiovascular system faces challenge of low delivery efficiency. We innovatively take the balloon as a specific and efficient tool to delivery therapeutic mRNA, which may be a potential therapy for vascular restenosis. Objective We investigated therapeutic mRNA containing a smart RNA switch to selectively suppress the VSMCs proliferation while promoting re-endothelialization and delivered by balloon as a novel therapy in vascular restenosis animal models. Results For RNA switch high-throughput screening, we utilized PiggyBac transposon system to establish monoclonal overexpressing cell lines and chose the cell strain with expression levels closely mimicking VSMCs and ECs. We found the most effective RNA switch from dozens of potential candidates which could specifically recognize VSMCs but not ECs. Therapeutic mRNA sequences containing the RNA switch efficiently initiated payload translation in VSMCs while maintaining payload silence in primary vascular endothelial cells, which effectively and selectively inhibited VSMCs excessive proliferation and promoted endothelial repair. Additionally, we developed an interventional balloon delivery system for mRNA drugs, achieving in situ delivery to cardiovascular lesions in vivo, demonstrating therapeutic effects consistent with cellular phenotypes in animal models. Conclusion We suggest that the smart RNA switch can serve as a novel, cell-specific therapeutic tool for restenosis and other cardiovascular diseases. Additionally, utilizing a balloon for mRNA delivery represents a new paradigm for mRNA therapy and gene editing in the cardiovascular field.

Safety and efficacy of brachial approach for coronary angiography and percutaneous coronary intervention

Abstract Background There are many feasible ways to reach the coronary arteries through a percutaneous technique. Till now, the most commonly used approach is the radial artery approach because it has the lowest risk of known vascular adverse events. However, it could not be an option in some situations as congenital radial artery hypoplasia and radial artery spasm. In these cases, the second most common access is the femoral artery access. The current literature over the brachial artery access is controversial. Our study's objective is to verify the brachial artery approach's effectiveness and safety. Methods We studied 300 patients who underwent elective coronary angiography and percutaneous angioplasty in our institution with failed radial access between August 2022 and February 2023. They were classified into two groups; 150 patients in a group with brachial access and 150 in a group with femoral access. Baseline clinical and demographic traits of all enrolled patients were obtained from hospital records and the cardiovascular risk factors were identified. Venous blood samples, resting 12-lead electrocardiogram and transthoracic echocardiography were done before the coronary angiography. Access, procedural and fluoroscopy times were recorded. Doppler evaluations of both brachial and femoral arteries were done the day after the procedure. All patients were examined carefully immediately after the procedure and before discharge to assess any complications. Results Our data showed that no statistically significant difference between the studied groups regarding the cardiovascular risk factors, demographic, clinical and laboratory characteristics. Left brachial access was used more frequently than left femoral access (32.7% vs. 22.7%, p= 0.05), but no significant difference regarding right sided or bilateral access. Procedure time, fluoroscopy time, and contrast volume did not differ significantly (p=0.19, 0.06 and 0.1 respectively). However, brachial group had shorter access time (2.6 ±1.1 vs. 3.4 ± 0.7 minutes, p=0.05) and shorter hospital stay (3.5 ± 1.1 vs. 5.9 ± 1.3 days, p&amp;lt;0.001). Regarding complications, both major and minor complications were significantly lower in the brachial arm (p=0.04 and 0.05, respectively). Conclusion Brachial artery access is a safe, efficient alternative and non-inferior to the femoral route for coronary intervention whenever radial access is not an option.

Long-term clinical and imaging outcomes of patients undergoing percutaneous femoral intervention following TAVI-related vascular access complications

Abstract Introdcution: Vascular access complications (VAC) are the most common in-hospital adverse event following transcatheter aortic valve implantation (TAVI). Often, ileo-femoral VAC requires bail-out percutaneous interventions with either prolonged balloon inflation and/or stent implantation. The long-term outcomes of these procedures have not been characterized. We aim to assess the clinical and imaging outcomes of patients who underwent bailout percutaneous vascular interventions due to VAC following TAVI. Methods Single-centre prospective study including all consecutive patients with a VAC following trans-femoral TAVI, between 2015-July 2023. VAC was defined as uncontrolled bleeding, acute occlusion or flow limiting stenosis of the femoral vessel leading to percutaneous treatment. Clinical and imaging follow-up was performed with bilateral arterial ultrasound (US) Doppler to assess patency and peak systolic velocity of common femoral arteries. Results A total of 1518 patients underwent TF-TAVI, of which 107 (7%) underwent concomitant ileo-femoral percutaneous angioplasty (PTA) intervention in the same day as TAVI. In patients submitted to PTA, 7 were treated to gain access for TAVI, and 100 (7%) were performed to treat vascular access complications. At a mean follow-up time of 23±3 months, 37 patients died (37%), 6 (16%) from in-hospital complications and 31 (84%) from non-vascular causes after discharge. From the surviving 63 patients (study group) – mean age 83±6 years-old, 29% male, 46% with previous peripheral arterial disease –, 24 underwent bilateral US. Unable to perform imaging on 39 patients due to geographical or mobility issues. At a mean follow-up time of 30±23 months, only 6 patients (10%) reported intermittent claudication, of which 4 (67%) had pre-TAVI symptoms. No patient had at rest symptoms or amputation history. All but one had patent vessel on US. The mean peak systolic velocity of the treated vessel and the contralateral vessel were 71.1±22.9cm/s and 73.1±23.8cm/s, respectively, with no statistically significant difference between them in each patient (mean difference 1.9±25.4, p=0.709). We found no statistically significant differences between peak systolic velocities between both vessels in each patient, accordingly with the treated vessel (Table 2). Conclusion This prospective study shows that patients submitted to percutaneous bailout iliofemoral interventions have a very low rate of lower limb adverse events with very good patency rates at mean follow up of 2.5 years.

Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study

Abstract Introduction The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique. Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments. Results Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p &amp;lt; 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 mm, 95% CI:−0.28 to−0.10, p &amp;lt; 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.45, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p &amp;lt; 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. Conclusions For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

Continuous heart monitoring to evaluate treatment effects in pulmonary hypertension

Abstract Background The treatment of pulmonary hypertension (PH) has improved rapidly in recent years, and there is increasing evidence to support the role of early intervention. However, studies demonstrate that timely intervention is often still lagging which affects clinical outcomes in patients with PH. Purpose To assess treatment effects after escalation of specific PH treatments using continuous heart monitoring via a Reveal LINQ loop recorder. Methods The patients change in heart rate variability (HRV), heart rate (HR), and physical activity were assessed before and after treatment escalation. Treatment escalation was defined as an additional PAH drug, pulmonary endarterectomy (PEA), percutaneous balloon angioplasty (PBA), or bilateral lung transplantation (BLTX). Results In this prospective study, 41 patients (27 with PAH and 14 with chronic thromboembolic pulmonary hypertension) were enrolled. Among them, 15 patients (36.6%) underwent PH treatment escalation. Prior to escalation, patients were monitored for a median of 100 (range: 68–100) days and after therapy escalation for a median duration of 165 (range: 89–308) days. In the escalation group, a significant increase in HRV (Figure), physical activity indexed by daytime HR was observed, while a significant decrease was seen in nighttime HR assessed at baseline and after treatment escalation. These changes were found both in the PAH and CTEPH group. In parallel a significant improvement in WHO functional class, 6-minute walking distance, and N-terminal pro-b-type natriuretic peptide (NT-proBNP) was observed. Conclusions This is the first study to demonstrate a direct association between specific PH therapies and changes in HRV, HR nighttime and physical activity in patients with PAH and CTEPH. Continuous monitoring allows for an early intervention with supplementary treatment for PH. This is especially relevant considering the increasing availability of wearables that allow for a convenient measurement of relevant prognostic parameters in PH.

Radial versus femoral access for rotational atherectomy angioplasty

Abstract Introduction The transfemoral approach (TFA) is a potentially advantageous acess site for complicated and prolonged percutaneous coronary angioplasty like rotational atherectomy (RA). Despite this, there is mounting data that suggests the transradial approach (TRA), an alternative to the TFA acess, is linked to reduced rates of mortality and access site complications. Aim This study was conducted with the aim of providing a quantitative appraisal of clinical outcomes of TRA for patients undergoing RA procedure. Methods In this retrospective study, we analyzed all RA procedures performed from March 2013 to June 2019 at our single center institution. Primary endpoints were procedural success, in-hospital mortality, and major adverse cardiovascular events (MACE) during hospitalization. Results Of the 98 patients undergoing RA, the TRA approach was chosen for 79% patients, and the TFA approach for 21% patients. No significant difference in procedural success rates was observed (94% vs. 91%, p=0.19). The use of RA via TRA correlated with a lower contrast volume (p=0.027) and a decreased post-procedure hospital stay (p=0.005). After multivariate adjustment, TRA demonstrated a noteworthy reduction in in-hospital mortality odds (OR: 0.62; 95% CI: 0.44 to 0.87; p = 0.003), major bleeding (OR: 0.48; 95% CI: 0.33 to 0.70; p &amp;lt; 0.001), MACE (OR: 0.68; 95% CI: 0.51 to 0.89; p = 0.015), and 30-day mortality (OR: 0.68; 95% CI: 0.51 to 0.89; p = 0.015). Conclusions Even though RA is a complex procedure, employing radial access (TRA) might be associated with favorable outcomes. These include a lower contrast volume, shorter hospital stay, and reduced odds of in-hospital mortality, major bleeding, MACE, and 30-day mortality compared to femoral access (TFA).

Analyzing the economic ramifications of the broad implementation of generic prasugrel

Abstract Introduction The 2023 European Acute Coronary Syndrome (ACS) guidelines state that prasugrel (PRG) should be considered in preference to ticagrelor (TCG) in patients (pts) who proceed to percutaneous coronary angioplasty (PCI). In Portugal, PRG is less available due to earlier evidence considering pretreatment and contraindications for each drug. PRG (10mg) is currently a generic drug, while TCG is not. We aimed to evaluate the proportion of pts that could be switched from TCG to PRG, and the economic impact of a widespread national adoption. Methods To determine eligibility for generic PRG 10mg, we examined a single center prospective database of consecutive ACS pts undergoing PCI in a full year. Eligibility for TCG and PRG was based on drug specific contraindications, previous stroke for PRG and chronic liver disease (CLD) for TCG, and indication for PRG dose reduction (≤60 kg and ≥75 years). To estimate hospital costs we used the price per pill indicated by the pharmacy (0.98€ TCG, 0.67€ PRG). To obtain post-discharge and NHS savings we used the INFARMED public information. We estimated 3500 PCIs per year on a national level, based on published data. Results A total of 780 pts were included, median age 68±10.4years, 523 (67.1%) were male, 51.9% (n=406) had non-ST elevation ACS. Mean admission time was 8.36 days. Considering PRG and TCG contraindications, 157 pts (20.3%) had a previous history of stroke and 20pts (2.6%) had CLD. 150 pts (19.2%) had PRG dose reduction criteria. Eligible for PRG 10mg and TCG 90mg were 434 pts (57.8% of total PCI pts). Cost per admission would be 33 697.35€ for TCG and 17 617.28€ for PRG. At a national level, hospital costs can be reduced by 16080.07€. Considering the 1-year outpatient setting and a widespread generic PRG 10mg adoption, NHS savings are estimated in 898 323.59€, and patient savings in 401248.25€ (198.38€ per patient). Conclusions ACS pts in real-world scenarios exhibit both eligibility for PRG and TCG. Considering the lower cost, the NHS can potentially save 914 403,66€ (figure 1) annually through the widespread adoption of generic PRG 10mg.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Impact of the lower extremity arterial calcification score on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease

Abstract Background Severe calcification, assessed using the peripheral artery calcification scoring system (PACCS), is associated with poor clinical outcomes after endovascular treatment (EVT) for de novo femoropopliteal lesions. However, the PACCS classification is a qualitative assessment performed in the angiographic room, and there are no established indicators for the quantitative assessment of calcification prior to treatment. Purpose We aimed to investigate the impact of the lower extremity arterial calcification score (LEACS) calculated using non-contrast lower limb computed tomography on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Methods We retrospectively analyzed the clinical outcomes of 141 consecutive patients treated at our center for de novo femoropopliteal artery disease using a drug-coated balloon between April 2018 and December 2022. Patients who did not undergo lower limb computed tomography before EVT were excluded from the analyses. LEACS was determined based on the method used to calculate the Agatston score for the coronary arteries. Each patient’s score consisted of a sum of calcification scores from ostium of superficial artery to the popliteal artery at the knee joint of treated limb. The primary and secondary outcomes measured were primary patency and clinically-driven target vessel revascularization (CD-TVR) at 1 year. Cox proportional hazards analysis was used to explore independent predictors of clinical outcomes. The study population was divided into higher and lower LEACS groups based on the cut-off value (1750), which best discriminated patency, and the outcomes were compared between the two groups. Results In the higher and lower LEACS groups, the mean age was 75.1 ± 9.1 years and 75.5 ± 11.0 years (p = 0.87) and the mean lesion length was 170.3±102.8 mm and 157.7±112.1 mm (p = 0.64), respectively. The higher LEACS group showed significantly lower 1-year patency than the lower LEACS group (53.5% vs. 84.3%, log-rank, p = 0.041). In addition, freedom from 1-year CD-TVR was significantly lower in the higher LEACS group than in the lower LEACS group (66.8% vs. 93.7%, p = 0.047). The Cox proportional hazard analysis showed that the higher LEACS group was an independent predictor of 1-year restenosis (odds ratio: 2.80, 95% confidence interval: 1.24–8.84, p=0.037), along with a small (&amp;lt; 5 mm) reference vessel diameter (odds ratio: 3.55, 95% confidence interval: 1.44–9.53, p=0.028). Conclusion Higher LEACS scores were independently associated with clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Non-contrast lower limb computed tomography is an acceptable and feasible option for predicting the outcomes in patients with de novo femoropopliteal artery disease prior to treatment.

Characterization of myocardial ischemia-reperfusion injury in a pig model with novel CW T1r and RAFF2 MRI methods in 1.5T

Abstract Introduction Myocardial ischemia-reperfusion injury (IRI) occurs after myocardial infarction when reperfusion aggravates the initial damage in myocardium by vast infiltration of inflammatory cells and elevated oxidative stress in myocardium that may lead to cardiac remodeling, heart failure and even death [1]. Magnetic resonance imaging (MRI) can accurately determine the anatomy of the heart and to characterize myocardial tissue. Novel endogenous rotating frame MRI methods, including continuous wave (CW) T1r and relaxation along a fictitious field with rank 2 (RAFF2), have been shown to characterize MI and other CVD in mouse and human myocardium with high sensitivity and specificity [2,3]. CW T1r and RAFF2 contrasts are occurring during radio frequency (RF) pulse (in kHz range) making them to be sensitive to slow molecular motions [2]. Comparing to conventional endogenous T1 and T2 methods, these are occurring after the RF pulse (in Larmor frequency (MHz) range) and therefore, these are non-selectively sensitive to different correlation times [4]. Golden standard to image MI is to use contrast agent (CA) in late gadolinium enhancement (LGE) method [2,4]. Using CA has drawbacks and therefore, there is an urgent need for optimizing the endogenous MRI methods in clinical practice. Purpose To characterize myocardial IRI in a pig model and to determine the sensitivity of both novel and conventional cardiac MRI methods. Methods IRI operation was done in 7 pig (30-35 kg) by occluding the LAD with a balloon catheter for 50 minutes. Imaging was done with 1.5T (MAGNETOM Aera) at 3 days and 28 days after the operation. Pig hearts were imaged with conventional native T1, T2, LGE, and with novel CW T1r and RAFF2 methods in both time points. These were imaged before CA injection and LGE was done 25 minutes after CA injection. Relaxation time mappings were done in a pixel-by-pixel manner with monoexponentially fitting. Region-of-interest (ROI) analysis was done to determine the relaxation times in IRI and remote areas. LGE was used to confirm the IRI areas in the myocardium. Relative relaxation time difference (RRTD)-values were calculated with the function of (((Relaxation Time of IRI area) – (Relaxation Time of Remote Area))/ (Relaxation Time of Remote Area)) to determine the contrast difference between IRI and remote areas. Results Relaxation times were elevated in IRI areas compared to remote areas (Figure 1A). Novel rotating frame RRTD-values were significantly higher than RRTD-values in conventional methods. This means that novel methods have larger contrast difference between IRI and remote areas compared to conventional methods, which indicates that novel methods are sensitive to characterize IRI area (Figure 1B). The location of MI areas was similar in both novel rotating frame and conventional methods compared to LGE (Figure 2). Conclusion Novel rotating frame relaxation time methods are sensitive to characterize the IRI area in pig model.Relaxation times, RRTD-valuesRelaxation times maps and LGE

The influence of epicardial resistance on Microvascular Resistance Reserve (MRR)

Abstract Background The optimal index of microvascular function should be specific for the microvascular compartment. Yet, coronary flow reserve (CFR), despite being widely used to diagnose coronary microvascular dysfunction (CMD), is influenced by both epicardial and microvascular resistance. Conversely, microvascular resistance reserve (MRR) adjusts for fractional flow reserve (FFR), and thus is theoretically independent of epicardial resistance. Purpose We tested the hypothesis that MRR, unlike CFR, is not influenced by increasing epicardial resistance, and thus is a more specific index of microvascular function. Methods In a cohort of 16 patients that had undergone proximal left anterior descending artery stenting, we created four grades of artificial stenosis (no stenosis, mild, moderate, and severe) using a coronary angioplasty balloon inflated to different degrees within the stent. For each stenosis grade, we calculated CFR and MRR using continuous thermodilution (64 measurements of each) in order to assess their response to changing epicardial resistance. Results Graded balloon inflation resulted in a significant sequential decrease in mean FFR (no stenosis: 0.82 ±0.05; mild: 0.72 ±0.04; moderate: 0.61 ±0.05; severe: 0.48 ±0.09, p&amp;lt;0.001). This translated into a linear decrease in mean hyperaemic coronary flow (no stenosis: 170.5 ±66.8 ml/min; mild: 149.8 ±58.8 ml/min; moderate: 124.4 ±53.0 ml/min; severe: 94.0 ±45.2 ml/min, p&amp;lt;0.001) (Figure 1). CFR exhibited a marked linear decrease with increasing stenosis (no stenosis: 2.5 ±0.9; mild: 2.2 ±0.8; moderate: 1.8 ±0.7; severe: 1.4 ±0.6), corresponding to a decrease of 0.3 for a decrease in FFR of 0.1 (p&amp;lt;0.001). Conversely, MRR exhibited a minimal decrease across all stenosis grades (no stenosis: 3.0 ±1.0; mild: 3.0 ±1.0; moderate: 2.9 ±1.0; severe: 2.8 ±1.0), corresponding to a decrease of just 0.05 for a decrease in FFR of 0.1 (p&amp;lt;0.001) (Figure 1). Conclusion MRR, unlike CFR, is minimally influenced by epicardial resistance, and thus should be considered the most specific index of microvascular function.Figure 1.Absolute blood flow (Q) vs FFRFigure 2.MRR/CFR vs FFR

Does initial use of large versus small burr size in left main stem bifurcation impact clinical and procedural outcomes?

Abstract Background Coronary calcifications, detected in up to 25% of treated coronary lesions nowadays, has a well-known association with complications during PCI, particularly for left main stem (LMS) interventions. Current guidelines recommend coronary artery bypass grafting for patients with LMS disease, particularly with high SYNTAX score ≥ 33. However, in those with increased surgical risk, PCI can be used particularly with use of rota-ablation (RA). RA is a well-established treatment for heavily calcified disease particularly in non LMS sites. However, data on the safety and efficacy of use of RA in LMS bifurcation management is limited. Current guidelines recommend using a small burr size at the start, with upsizing burrs if required. Whether upfront use of large burr size ≥ 1.75 versus smaller burr size in this context in is safe or effective is unknown. Methods This was a retrospective, single centre, study. Included patients undergoing RA to LMS bifurcation disease. Standard procedures for RA were applied to each case, following current national and international intraprocedural standards. The main study outcomes were overall mortality at 1 year, and a comparison of mortality at 1 and 4 years between groups and repeat target lesion revascularization at 4 years. Results To our knowledge, this is the largest series of LMS rota-ablation cases, with the longest available follow up. Between June 2009 and October 2021, we included 243 patients with a mean age of 74.7±9 years. Males formed 80% of the cases. 51.4% of patients were treated with a large bur size ≥ 1.75mm, with more males being treated with large burr size. Most treated lesions were true bifurcations (85.6%). Treated lesions were complex (Syntax score = 35.3 ± 10.6). Radial access was used in almost two thirds of patients, with size 7F sheath being the most used. Intravascular ultrasound was more commonly used with large burr size (p = 0.017). Upfront 2-stent techniques, predominantly culotte, was employed more often with large burr size. Provisional technique was used more often in the small burr size group. The burr size to vessel size was 0.4 in small burr group versus 0.48 in large burr size using stent size as a surrogate for vessel size. Post dilatation balloons were larger as well as stent size in the large burr group. The overall 1-year mortality for the group was 12.7% similar to international literature. Importantly, procedural complications were not different between groups, and similarly mortality at 1 and 4 years, p = 0.082 and p = 0.384 respectively. There was no difference between groups in terms of repeat vessel revascularization at 4 years p=0.487. Conclusions Upfront use of large burr size ≥ 1.75 is feasible and safe to treat LMS bifurcation disease with no increase in procedural complications or mortality and target lesion revascularization on long term follow up. It is notable that in-hospital mortality for this cohort was low at 1.6% in comparison to previous studies.1 and 4 year mortality KM curves

First experience of endovascular balloon occlusion of the aorta in the wounded with hemorrhagic shock during the war in Ukraine

Background. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used worldwide to stop bleeding in trauma and wounds in patients with hemorrhagic shock. REBOA allows for the hemodynamic stabilization, patient transportation and final bleeding control. The study aims to demonstrate the capabilities of REBOA as a method of bleeding control in the wounded with hemorrhagic shock in the context of war in Ukraine. Materials and methods. Five AFU servicemen who sustained mine-blast wounds in the Eastern Ukraine as a result of shelling by Russian troops were delivered with signs of internal bleeding and hemorrhagic shock to the primary and secondary levels of medical care (Role 1, 2). The REBOA balloon catheter was inserted and inflated by surgeons working in stabilization centers or advanced surgical teams. Upon admission, all patients underwent chest and abdominal ultrasound according to the FAST protocol. We used COBRA-OS 4 Fr and ER-REBOA 7 Fr balloon catheters. The positioning of the balloon in the aorta was performed according to external anatomical landmarks (3 cases) and ultrasound (2 cases). In all clinical cases, the balloon catheter was placed in zone I. In one case, the balloon was moved from zone I to zone III (control of the source of bleeding). The duration of aortic occlusion ranged from 15 to 50 minutes. Immediately after removal of the introducer, manual compression of the puncture site was used (3 cases) or suturing of the arteriotomy (2 cases). Results. The sources of bleeding in our clinical cases were injuries of the iliac vessels (2 cases), the renal artery (1 case), and injuries of the inferior vena cava and liver (2 cases). Four patients were evacuated to a higher level of medical care after the REBOA was installed. In one case, there were complications from vascular access (femoral artery thrombosis). We were unable to save one wounded soldier, most likely due to the delay in evacuation from the previous stage, the severity of injury, and massive blood loss. Conclusions. As our observations have shown, the use of REBOA in combat conditions allows not only to stabilize hemodynamics in the wounded with severe combined trauma and bleeding but also to conduct a successful evacuation to a higher level of medical care to stop bleeding ultimately. REBOA can be successfully used at the prehospital stage. This requires clearly defined indications for the technique’s use, training of medical personnel, and provision of balloon catheters to medical units of the Armed Forces of Ukraine.