Search Results (110)

Percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) may provide outcomes comparable to drug-eluting stents (DESs) due to the absence of a permanent implant and improved coronary artery remodelling. This study compared clinical outcomes of DCB-only angioplasty with DESs in a real-world setting. All patients undergoing PCI with DCBs or DESs for de novo disease were included in a propensity score-matched analysis using prospective and retrospective collected data from a single centre. The primary outcome was target lesion revascularisation (TLR) at 12 months. The secondary outcomes were major adverse cardiac events (MACEs) defined as a composite of all-cause death, myocardial infarction, or TLR at 12 months. Propensity matching produced 904 DCB lesions (719 patients) matched to 1424 DES lesions (1271 patients). The DCB group had smaller coronary arteries, shorter treated segments, and more bifurcation lesions. The mean age was 65 years, 22% of patients had prior MI, 16% had diabetes, and 58% had acute coronary syndromes. The rate of TLR at 12 months was as follows: 2.3% with DCBs; 2.5% with DESs (OR 0.86, p = 0.726, 95% CI 0.37–2.02). MACE was 8.2% with DCBs and 7.3% for DESs (OR 1.04, 95% CI 0.73–1.47). Results suggest comparable outcomes in patients who received paclitaxel DCBs compared to DESs without excess MACE, highlighting the need for randomised controlled trials. Full article

Background/Objectives: Epidemiological studies over the first decades of the 21st century have reported a decrease in cardiovascular disease (CVD) morbidity and mortality. Changes in coronary care for acute myocardial infarction (AMI) over these years, including the COVID-19 pandemic period, have been less studied in Eastern and Central Europe. The study aimed to assess changes in coronary care—the time of medical assistance and treatment—for AMI patients over 2000–2023 in urban Kaunas residents aged 25–64. Methods: The data source was study cases from the Kaunas Ischemic Heart Disease Registry (Registry)—Kaunas city residents aged 25–64 years included in the Registry according to MONICA project protocol evaluation methodologies. Data were analyzed by sex and age group (25–54 and 55–64 years). Descriptive statistics (chi-square and z-score values) were used to evaluate the data; the significance level was p < 0.05. A logistic regression analysis was performed to assess the odds ratios of death within 28 days across six time periods. Results: The proportion of AMI patients hospitalized up to 2 h from the onset of pain accounted for about one-fifth of all hospitalized patients in 2000–2016, while in 2017–2023, it significantly decreased. In 2017–2023, compared with 2000–2004 and 2009–2016, significantly fewer men who developed AMI were hospitalized within the first 2 h of emergency presentation (p < 0.05). Over the whole study period, fewer women with AMI were hospitalized within the first 2 h of pain as compared to men (p < 0.05). There were no significant differences in time from pain onset to hospitalization between the age groups. At the same time, from 2009 to 2012, more young AMI patients were hospitalized within the first 2 h (p < 0.05). Percutaneous coronary angioplasty (PTCA) with stenting (PCI) increased 30 times from 2000–2004 to 2020–2023. PCI has been the most available treatment for men with AMI since 2009 and stayed stable from 2013 (66.0%) until 2023 (72.1%). Women with AMI tended to get less PCI, PTCA, and coronary artery bypass grafting (CABG) than men. The pre-pandemic and COVID-19 periods did not differ in the proportions of reperfusion treatment methods used in both men and women. Thrombolysis was very rare, and since 2017, it has not been used in Kaunas because PCI has become more accessible. PCI (2000–2016) and CABG (2009–2016) were more prevalent among the 25–54-year-old AMI patients (p < 0.05). From 2017 to 2023, there were no differences between age groups in the reperfusion procedures used, nor were there differences in treatment between these groups during the pre-pandemic (2017–2019) and peri-COVID-19 pandemic (2020–2023) periods. Conclusions: In Kaunas, the treatment of patients with AMI has improved significantly over the past 20 years. The use of PCI has increased greatly, and the rate of CABG surgery stayed stable, while only every fifth patient has been admitted to the hospital in a timely manner. Men were more likely to receive PCI, and older patients were more likely to undergo CABG. Compared to the period of 2000–2004, the chance of dying within 28 days after AMI was significantly lower in 2017. Full article

Background: Iron deficiency (ID) is a prevalent condition in patients with cardiovascular diseases, irrespective of anemia, associated with adverse outcomes. Its incidence and prognostic value in acute coronary syndromes (ACS) are yet to be established. Current literature on the matter is scarce, and further research is necessary to confirm a clear link between ID and possible adverse outcome prediction in this group. Aims: This study aimed to evaluate the incidence and prognostic value of ID in ACS patients, and associations between iron parameters and patients’ characteristics, comorbidities, hospitalization length, laboratory results, electrocardiographic, echocardiographic assessment, and invasive coronary angiography results. Methods: We conducted an observational prospective study enrolling 214 consecutive patients after ACS. Adverse events were defined as all-cause death or non-elective rehospitalization due to cardiovascular causes. Results: ID patients constituted 46.7% of the studied cohort. ID was associated with higher NT-proBNP on admission (p = 0.03). Higher TSAT was independently associated with lower peak troponin levels (β = −0.03, standardized β = −0.15, p = 0.03). Ferritin < 100 ng/mL was paradoxically associated with shorter in-hospital stay (p = 0.03). In multivariable analysis, ID was an independent predictor of the composite endpoint (HR 1.94 [95% CI: 1.02–3.67], p = 0.04); however, no significant differences in event-free survival have been identified between ID and non-ID groups. Conclusions: ID is a common condition in ACS patients, associated with higher values of biomarkers reflecting cardiac damage, and may constitute an important predictor of adverse events after discharge. Further, larger, preferably multicenter studies are required to establish the exact association between ID and mortality among ACS patients treated with percutaneous coronary intervention. Full article

This study aimed to establish the first national diagnostic reference levels (DRLs) for coronary angiography (CAG) and interventional cardiology procedures in Korea, based on a nationwide patient-dose survey conducted in 2024. Radiation dose data were collected from 20 cardiovascular centers between April and December 2024 using a dedicated server system for radiation dose-structured reports, namely, Digital Imaging and Communications in Medicine. We classified 1980 procedures into the following seven procedural groups: CAG, CAG with percutaneous coronary intervention (CAG + PCI), CAG with percutaneous transluminal coronary angioplasty (CAG + PTCA), coronary spasm provocation, acute myocardial infarction (AMI), chronic total occlusion (CTO), and PCI alone. The DRLs were defined as the 75th percentile of the cumulative kerma–area product (KAP) and fluoroscopy time (FT). The established DRLs for KAP (Gy·cm²) were: CAG, 18.68; CAG + PCI, 63.40; AMI, 58.52; and CTO, 106.83. The corresponding DRLs for FT (s) were: CAG, 440.00; CAG + PCI, 1201.50; AMI, 947.64; and CTO, 2819.00. This study established the first official national DRLs for CAG and interventional cardiology procedures in Korea, using real-world clinical data. These reference levels provide a practical framework for institutions to benchmark radiation exposure, evaluate practice patterns, and optimize patient radiation safety. Full article

Patients with heavily calcified coronary arteries represent a challenge in percutaneous coronary intervention (PCI), as severe calcification impairs device delivery and limits optimal stent expansion, leading to higher risks of stent thrombosis, restenosis, and adverse clinical outcomes. Approximately 20% of patients undergoing PCI exhibit severe coronary calcification, which independently predicts incomplete revascularization, increased mortality, and higher rates of major adverse cardiovascular events over mid-term follow-up. Recent advances have focused on improving the assessment and management of calcified lesions. Intracoronary imaging modalities, including intravascular ultrasound and optical coherence tomography, allow precise detection and characterization of calcium burden, overcoming the limitations of angiography. These tools play a pivotal role in guiding procedural strategy, enabling tailored selection of calcium-modifying techniques based on lesion morphology, and optimizing stent deployment. Technological innovations have significantly expanded therapeutic options. While non-compliant balloon angioplasty alone is often insufficient, adjunctive devices such as cutting and scoring balloons improve plaque modification in focal disease. Atherectomy techniques, including rotational and orbital systems, are effective for more complex lesions but require technical expertise and carry procedural risks. Intravascular lithotripsy has emerged as a promising, less aggressive modality capable of fracturing deep calcium, while excimer laser atherectomy offers an alternative for resistant lesions. Despite these advances, current evidence supporting calcium-modifying strategies is largely based on procedural outcomes rather than definitive improvements in long-term clinical endpoints. Meta-analyses and randomized trials have not demonstrated clear superiority of any single technique, and most studies remain underpowered. Intriguingly, recent data suggest that outcomes in treated calcified lesions may approximate those of non-calcified disease, raising the hypothesis that these technologies could mitigate the adverse impact of calcification. However, this remains unproven, highlighting the urgent need for adequately powered randomized trials to determine their true clinical benefit. Full article

Background: Contemporary coronary artery bypass grafting (CABG) is often performed in patients with diffuse atherosclerosis, severe calcification, prior percutaneous coronary intervention (PCI), and fragile myocardium, creating intraoperative scenarios that can compromise target selection, anastomotic quality, and completeness of revascularization. We synthesize operative strategies and outcomes across five predefined “complex CABG” scenarios. Methods: A focused literature review was performed targeting intraoperative CABG challenges in adult patients. Two reviewers independently screened titles/abstracts and selected studies describing operative details, technical considerations, or outcomes relevant to (1) intramyocardial/embedded coronaries, (2) severely calcified or diffuse disease requiring reconstruction, (3) small-caliber targets/flow-limited grafting, (4) iatrogenic right ventricular (RV) injury, and (5) failed PCI/stent-related surgical management. Disagreements were resolved through discussion and consensus. Results: Thirty core publications were synthesized across five complex intraoperative CABG scenarios (intramural/embedded coronaries n = 7; calcified/diffuse disease n = 7; small-caliber/flow-limited targets n = 7; iatrogenic RV injury n = 5; failed PCI/stent-related management n = 5). Intramural/embedded targets: reported intramyocardial LAD prevalence ranged from 2.2–13%, and studies emphasized structured localization strategies with a small but real risk of ventricular injury depending on technique. Severely calcified/diffuse disease: reconstructive approaches (endarterectomy, patch angioplasty, long-segment LAD reconstruction) were used to create graftable beds when standard anastomosis was not feasible, with series reporting acceptable early mortality and generally high early-to-midterm patency when paired with planned antithrombotic and imaging follow-up strategies. Small-caliber targets: vessel size alone did not preclude durable grafting when flow was optimized, with evidence supporting flow-augmenting designs (e.g., sequential grafting) and intraoperative flow verification to reduce low-flow failure in limited runoff beds. Iatrogenic RV injury: bailout techniques prioritized rapid hemostasis while preserving LAD/graft patency using buttressed closure concepts designed for constrained exposure and ongoing bleeding risk. Failed PCI/stent-related pathology: long stented segments shifted operative planning from distal target selection to target reconstruction (stentectomy/endarterectomy with long-segment LAD reconstruction), with angiographic follow-up cohorts demonstrating feasible revascularization but variable patency by territory and lesion extent. Conclusions: Complex CABG is best approached as structured, anatomy-driven problem-solving: deliberate target localization, creation of a graftable bed when needed, flow-augmenting graft design, and predefined bailout options. Standardized comparative studies are needed to define optimal strategies across these common clinically important scenarios. Full article

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are the two dominant revascularisation strategies for obstructive coronary artery disease, yet their relative roles continue to shift because they address coronary pathophysiology differently with ever-evolving techniques. PCI has advanced through iterative improvements, including balloon angioplasty, bare-metal stents, and drug-eluting stents, with contemporary outcomes increasingly driven by procedural optimisation using intracoronary imaging and physiology-guided lesion selection rather than device category alone. CABG has progressed through perioperative management, improvements in operative safety, and, critically, conduit durability. Recognition of progressive saphenous vein graft failure has underpinned a conduit-optimisation era in which the left internal mammary artery to left anterior descending artery remains the gold standard. Further, broader arterial grafting (including radial artery use, multiple arterial grafting, and selected total-arterial strategies) has been increasingly applied, albeit with deliverability and competing-risk constraints highlighted in randomised evidence. This perspective review reframes the CABG versus PCI comparison not as a binary contest, but as a context-dependent assessment in which the relative value of each strategy depends on the specific technologies, techniques, and conduits available at the time of comparison. We summarise comparative effectiveness where evidence is most consistent and where it remains sensitive to anatomy, comorbidity, and endpoint definitions. In diabetes with multivessel disease, trial data favour CABG for long-term survival and clinical outcomes despite higher stroke risk. In left main disease, outcomes depend on lesion pattern and overall complexity, with trial-era stent technology and composite endpoint definitions influencing conclusions. In ischaemic left ventricular dysfunction, a long-term survival benefit is established for CABG added to medical therapy, while multi-vessel PCI has not demonstrated comparable prognostic modification in contemporary data. We then examine hybrid coronary revascularisation as territory-specific allocation, highlighting its physiological rationale, program dependence, and limited, adequately powered randomised evidence. Finally, we outline how artificial intelligence (AI) and robotics may accelerate a precision revascularisation paradigm by standardising lesion assessment, supporting procedural planning, improving procedural reproducibility, and enabling more patient-specific selection among PCI, contemporary CABG with optimised conduits, and hybrid pathways. Full article

Background and Clinical Significance: Polycythemia vera is a myeloproliferative neoplasm associated with a high thrombotic risk. Although this association is well recognized, acute coronary syndrome as the initial manifestation of polycythemia vera is rare. Case Presentation: We report the case of a previously healthy 57-year-old male with no conventional cardiovascular risk factors who presented with an anterior ST-elevation myocardial infarction. Coronary angiography revealed a subocclusive lesion in the left anterior descending artery, which was successfully treated with primary percutaneous coronary intervention. Initial laboratory testing showed markedly elevated hemoglobin (209 g/L) and hematocrit (64.9%), together with thrombocytosis (438 × 10⁹/L). In the absence of conventional risk factors, the combination of a single-vessel coronary lesion and marked hematologic abnormalities raised suspicion for polycythemia vera as a major contributor to coronary thrombosis. Subsequent work-up confirmed polycythemia vera based on the presence of a JAK2 V617F mutation and suppressed erythropoietin levels. The patient underwent therapeutic phlebotomy shortly after angioplasty and was subsequently started on hydroxyurea to maintain a hematocrit below 45%, together with dual antiplatelet therapy. Conclusions: This case highlights acute myocardial infarction as a rare initial presentation of polycythemia vera. It underscores the importance of considering polycythemia vera in patients presenting with acute coronary syndrome and unexplained erythrocytosis, while acknowledging that, in the absence of intracoronary imaging, a definitive causal link between PV and the coronary event cannot be established. Full article

Background and Aim: The correct identification of patients presenting with chest pain and the stratification of their risk for major adverse cardiovascular events (MACE) is essential. The aim of this study was to evaluate subjects who came to the ED for chest pain through the chest pain score, the HEART score and the TIMI risk score in order to assess their validity and prognostic accuracy and to compare their performance. Methods: Patients included in the study met the following criteria: age ≥18 years, reported atraumatic chest pain, and consent to participate in the clinical study. Subsequently, the final scores were calculated based on the information collected and a follow-up was performed to assess the occurrence of adverse cardiovascular events (MACEs) at 30 days. The MACEs considered were a composite endpoint of STEMI or NSTEMI myocardial infarction, positive coronary angiography for critical lesions, percutaneous coronary angioplasty, coronary artery bypass grafting, and death. Results: A total of 102 patients were included in the study sample, divided into 76 patients who did not develop MACEs and 26 patients who experienced MACEs. The AUC values of the ROC curves of the chest pain score, HEART score and TIMI risk score were 0.8312, 0.9757 and 0.9378 respectively. Conclusions: All three scores examined were considered excellent tools to predict the onset of MACEs in patients with chest pain at different points of clinical management, although the HEART score outperformed both the chest pain score and the TIMI risk score in terms of prognostic accuracy. Full article

Background/Objectives: No-reflow phenomenon (NRP) is a frequent and clinically relevant complication during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVGs). The Naples Prognostic Score (NPS), a composite index reflecting systemic inflammation and nutritional status, may help identify patients at increased risk before the procedure. We investigated whether NPS predicts NRP in patients undergoing PCI/percutaneous transluminal coronary angioplasty (PTCA) for SVG stenosis. Methods: In this retrospective multicenter observational study, consecutive post-coronary artery bypass grafting patients undergoing PCI/PTCA for SVG stenosis were analyzed. NRP was defined as post-procedural thrombolysis in myocardial infarction (TIMI) flow grade <3 in the absence of dissection, residual stenosis, or vasospasm. NPS (0–4) was calculated from serum albumin, total cholesterol, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio. Independent predictors of NRP were assessed using logistic regression, and discrimination was evaluated by receiver operating characteristic (ROC) analysis. Results: Among 252 patients, 55 (21.8%) developed NRP. NPS was significantly higher in the NRP group than in the normal-reflow group (2.61 ± 0.95 vs. 1.73 ± 0.95; p < 0.001). In multivariable analysis, NPS independently predicted NRP (per 1-point increase: odds ratio 2.577, 95% CI 1.428–5.384; p < 0.001 for univariate and 6.077, 95% CI 3.194–11.563; p < 0.001 for multivariate analysis), together with high thrombus burden (TIMI thrombus grades 4–5). NPS showed good discrimination for NRP (AUC 0.742; p < 0.001), with 75% sensitivity and 66% specificity at the optimal cut-off. Conclusions: NPS is a simple, readily available score that independently predicts angiographic no-reflow during SVG PCI and may aid preprocedural risk stratification and tailoring of preventive strategies. Full article

Type 2 myocardial infarction (T2MI) is defined as myocardial necrosis caused by an imbalance between oxygen supply and demand in the absence of acute atherothrombotic coronary occlusion/erosion. Unlike type 1 myocardial infarction (T1MI), T2MI comprises a heterogeneous group of clinical scenarios, often triggered by systemic or cardiac conditions, and it frequently affects elderly patients with a high burden of comorbidities. T2MI often underline multivessel coronary artery disease and, despite its growing clinical relevance, the diagnostic and therapeutic approach to T2MI remains challenging and lacks standardized recommendations. In this review, we present an updated and a comprehensive synthesis of current evidence on the diagnosis and management of T2MI, focusing on the role of coronary angiography and interventional strategies. We discuss the utility of high-sensitivity cardiac biomarkers, imaging modalities, and clinical risk scores to guide patient selection for invasive evaluation. Specific attention is given to conservative and alternative revascularization approaches—including drug-coated balloon angioplasty and stentless percutaneous coronary intervention (PCI)—in frail and high-bleeding-risk patients. The review emphasizes the need for individualized decision-making in a population where standard invasive strategies may not always be appropriate, and where a tailored balance between ischemic and hemorrhagic risk is crucial. Full article

Background: Restenosis after coronary stent implantation remains a major clinical challenge, especially in patients with diabetes, long lesions, or multiple stents. Standard therapy with aspirin and P2Y12 inhibitors does not reliably prevent this complication. Objectives: We reviewed experimental and clinical evidence on cilostazol, a selective phosphodiesterase-3 inhibitor, as a strategy to reduce restenosis after percutaneous coronary intervention (PCI). Methods: Preclinical and clinical studies were critically appraised, focusing on the effects of cilostazol on vascular smooth muscle and endothelial cells, platelet aggregation, lipid metabolism, and restenosis rates. Results: Experimental models show that cilostazol inhibits smooth muscle proliferation and intimal hyperplasia after arterial injury. Clinical trials demonstrate reduced restenosis after balloon angioplasty and stent implantation compared with aspirin, ticlopidine, or clopidogrel. Although approved by the FDA for intermittent claudication, cilostazol remains underused in the prevention of coronary restenosis. Conclusions: Current evidence supports cilostazol as an effective adjunctive therapy to reduce restenosis following PCI. Wider adoption and further large-scale trials are warranted to better define its role in contemporary interventional practice. Full article

Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) in percutaneous coronary intervention, delivering antiproliferative drugs without leaving a permanent implant. This review provides a comparative analysis of sirolimus-coated DCBs (DCB-S), paclitaxel-coated DCBs (DCB-P), and DESs across key scenarios: de novo coronary lesions in chronic coronary syndrome (CCS), acute coronary syndromes (ACS), and in-stent restenosis (ISR). We discuss late lumen loss (LLL), target lesion/vessel revascularization (TLR/TVR), vessel patency, and major adverse cardiac events (MACE) outcomes, along with current guidelines and emerging indications for DCB-S. We also examine pharmacological differences between sirolimus and paclitaxel (mechanisms of action, tissue uptake, and healing profiles), trial methodologies, and recent innovations in DCB technology. Across stable de novo lesions (especially small vessels and high bleeding-risk patients), multiple trials show DCB-P can achieve non-inferior clinical outcomes to DES. Early data suggest newer DCB-S may likewise match DES outcomes in broader populations. In ACS, DCB-only strategies have demonstrated feasibility and safety in carefully selected lesions without heavy thrombus, with randomized studies like REVELATION (STEMI) showing non-inferior fractional flow reserve and low revascularization rates compared to DES. For ISR, DCB-P is an established Class I treatment in both BMS-ISR and DES-ISR, yielding similar or lower TLR rates than repeat stenting. DCB-S are now being evaluated as an alternative in ISR, aiming to avoid additional stent layers. Contemporary guidelines endorse DCB use in ISR and small vessels, and experts anticipate expanding indications as evidence grows. Sirolimus and paclitaxel differ in antiproliferative mechanisms and pharmacokinetics—sirolimus (cytostatic, mTOR inhibition) may offer faster endothelial recovery, whereas paclitaxel’s high lipophilicity ensures sustained arterial wall retention. Technological advances (e.g., phospholipid micro-reservoirs for sirolimus) are enhancing drug transfer and addressing prior limitations. In summary, DCB-P and DCB-S now represent viable alternatives to DES in specific scenarios, especially where “leaving nothing behind” could reduce long-term complications. Ongoing large randomized trials, such as SELUTION DeNovo, currently available as conference-presented data, together with longer-term follow-up will further clarify the optimal niches for DCB-S versus DCB-P and DES. Full article

Coronary artery disease (CAD) remains one of the leading causes of mortality worldwide, affecting more than 300 million people. Over the past two decades, percutaneous coronary intervention (PCI) has become the cornerstone of CAD treatment, involving the implantation of coronary stents. This review clarifies how coronary stents emerged, evolved, and ultimately reshaped modern interventional cardiology. Beginning with balloon angioplasty and progressing through bare-metal and drug-eluting stents, we show how each advancement solved key clinical shortcomings—dramatically reducing restenosis, thrombosis, and repeat revascularization. We further review the major technological advances driving modern stent development, such as biodegradable alloys and biomimetic coatings. We also highlight the remaining challenges, including long-term stability, manufacturing complexity, and limited translational readiness. Together, these elements support our central thesis: that the historical evolution of coronary stents is fundamental to understanding present PCI practice and to guiding the next phase of device innovation. Full article

Background/Objectives: The increasing use of endovascular procedures with common femoral artery (CFA) access has led to a rise in iatrogenic arterial injuries at this site. The most frequent injuries are pseudoaneurysms (PSA), retrograde dissections (RD), arteriovenous fistulas (AVF), and arterial perforations. Surgical repair is the standard treatment; however, the use of covered stents (CS) may represent a valid alternative, despite current instructions for use (IFU) not recommending CFA implantation. Methods: We conducted a single-center retrospective study on a prospectively maintained database. Patients undergoing transcatheter aortic valve repair (TAVR), endovascular aortic repair EVAR, diagnostic or therapeutic coronary angiography, or peripheral percutaneous transluminal angioplasty, who were subsequently treated for CFA injury with CS implantation between February 2015 and May 2024, were included. Endpoints were technical success (complete arterial repair), 30-day mortality, overall mortality, reintervention rates, and long-term stent patency. Results: A total of 41 patients were included: 10 (24.4%) PSA, 3 (7.3%) AVF, 27 (65.8%) perforations, and 2 (4.9%) RD. Of which 28 (68.3%) were treated with self-expandable CS and 13 (31.7%) with balloon-expandable CS. Additionally, 33 (80.5%) underwent urgent treatment. Technical success was achieved in 97.5%. Thirty-day mortality was 7.3%, with no procedure-related deaths. At a mean follow-up of 50.8 months (range 1–109), survival was 63.4%, with 100% stent patency and no procedure-related reinterventions. Conclusions: CS implantation for CFA iatrogenic injuries achieved high technical success and excellent long-term patency, representing a viable alternative to open repair. Further studies are needed to integrate CS use for CFA injuries into treatment algorithms and to update device IFUs accordingly. Full article