Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project - observational study protocol for cost-effectiveness and budget impact analyses.

INTRODUCTION: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses. METHODS AND ANALYSIS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions. ETHICS AND DISSEMINATION: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.

Innovative Guide Extension Catheter Trapping Technique to Retrieve a Lost Stent From a Coronary Artery.

A stent that was being implanted in the left circumflex artery, to treat an iatrogenic dissection, became dislodged at the ostial left circumflex artery on a previously deployed stent implanted for the treatment of a distal left main bifurcation stenosis. We describe here a novel technique to retrieve the device safely. (Level of Difficulty: Advanced.).

Cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in low surgical risk aortic stenosis patients.

BACKGROUND: The PARTNER 3 trial demonstrated clinical benefits of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device, over surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic stenosis (sSAS) at low risk of surgical mortality. Using PARTNER 3 outcomes and Italy-specific costs data, this cost-utility analysis from the perspective of the Italian National Health System aimed to determine the cost-effectiveness of SAPIEN 3 TAVI versus SAVR in low risk sSAS patients in Italy. METHODS: A two-stage cost-utility model was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured utilising the PARTNER 3 dataset. These data fed into a Markov model that captured longer-term outcomes of patients, following TAVI or SAVR intervention. RESULTS: Analysis findings estimated that TAVI with SAPIEN 3 offers benefits over SAVR in terms of increased quality-adjusted life years (QALYs) with only a small increase in costs, representing an incremental cost-effectiveness ratio/QALY gained of €2989 per patient. The results were robust, with TAVI with SAPIEN 3 remaining cost-effective across several scenarios and in probabilistic sensitivity analyses. CONCLUSIONS: This model demonstrated that TAVI with SAPIEN 3 is likely to be cost effective compared with SAVR for the treatment of patients with sSAS who are at low risk of surgical mortality. These findings can inform policy makers to facilitate policy development in Italy on intervention selection for this patient population.

Management of acute coronary syndromes during the COVID-19 outbreak in Lombardy: The "macro-hub" experience.

BACKGROUND: During the COVID-19 outbreak, healthcare Authorities of Lombardy modified the regional network concerning time-dependent emergencies. Specifically, 13 Macro-Hubs were identified to deliver timely optimal care to patients with acute coronary syndromes (ACS). Aim of this paper is to present the results of this experience. METHODS AND RESULTS: This is a multicenter, observational study. A total of 953 patients were included, presenting with STEMI in 57.7% of the cases. About 98% of patients received coronary angiography with a median since first medical contact to angiography of 79 (IQR 45-124) minutes for STEMI and 1262 (IQR 643-2481) minutes for NSTEMI.A total of 107 patients (11.2%) had SARS-CoV2 infection, mostly with STEMI (74.8%). The time interval from first medical contact to cath-lab was significant shorter in patients with COVID-19, both in the overall population and in STEMI patients (87 (IQR 41-310) versus 160 (IQR 67-1220) minutes, P = 0.001, and 61 (IQR 23-98) versus 80 (IQR 47-126) minutes, P = 0.01, respectively). In-hospital mortality and cardiogenic shock rates were higher among patients with COVID-19 compared to patients without (32% vs 6%, P < 0.0001, and 16.8% vs 6.7%, P < 0.0003, respectively). CONCLUSIONS: During the COVID-19 outbreak in Lombardy, the redefinition of ACS network according to enlarged Macro-Hubs allowed to continue with timely ACS management, while reserving a high number of intensive care beds for the pandemic. Patients with ACS and COVID-19 presented a worst outcome, particularly in case of STEMI.

Time course changes of cystatin C and inflammatory and biochemical markers in non-ST-elevation acute coronary syndromes.

BACKGROUND: Serum cystatin C (Cys-C), a good marker of renal function, predicts prognosis in non-ST-elevation acute coronary syndromes (NSTE-ACS). However, no data are available on the time course of Cys-C values after discharge. In this study, Cys-C was measured during admission (ACS sample) and 6 weeks after discharge, and was correlated with troponin (c-TNT), high-sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6) and the N-terminal portion of the pro-brain natriuretic peptide (proBNP) peptide (NT-proBNP) in a highly selected homogeneous group of NSTE-ACS patients. METHODS: In this prospective, multicentre study, patients with a first NSTE-ACS, single-vessel disease and successful percutaneous coronary interventions (PCIs) had their sera collected, aliquoted and stored at the enrolling site and then shipped for analysis to the clinical chemistry core laboratory. RESULTS: Cys-C values slightly, but significantly, increased from the ACS samples to the 6-week samples. In contrast, hsCRP, NT-proBNP and IL-6 values significantly decreased from the ACS to the 6-week sample. Patients with elevated c-TNT levels had higher hsCRP, NT-proBNP and IL-6 values than patients with normal c-TNT levels in the ACS sample, whereas Cys-C levels were similar in patients with and without elevated c-TNT. Cys-C was highly correlated with estimated glomerular filtration rate in both the ACS and 6-week samples. CONCLUSIONS: In contrast to inflammatory and biochemical stress markers, Cys-C is not affected by the occurrence of myocardial necrosis or by acute left-ventricular impairment, being a reliable marker of renal function during NSTE-ACS.

An Early Diagnosis of Gastroepiploic Arterial Aneurysm during a Routine Abdominal Ultrasound Study.

Gastroepiploic arterial aneurysm (GEAA) is a rare condition, but the rupture risk is very high. We report the case of a patient with incidental finding of GEAA during US examination. The diagnosis was confirmed by a computed tomography and an angiographic study. A classic laparotomy with aneurysmectomy has been successfully performed.

Unplanned surgery after drug eluting stent implantation: a strategy for safe temporary withdrawal of dual oral antiplatelet therapy.

We describe four cases of patients with multiple coronary drug eluting stent implantation who underwent major surgery (cardiac and noncardiac) early after stent implantation and needed premature interruption of dual antiplatelet therapy. The transitory withdrawal of oral antiplatelet therapy was accomplished without complications with the use of an IIb/IIIa glycoprotein inhibitor (Tirofiban).

Significance of total and differential leucocyte count in patients with acute myocardial infarction treated with primary coronary angioplasty.

AIMS: The aim of this study was to correlate total and differential leucocyte (WBC) count with myocardial blush, peak CK levels, and left ventricular (LV) functional recovery at 6 months in 238 consecutive acute myocardial infarction (MI) patients treated with successful primary coronary angioplasty (PCI). METHODS AND RESULTS: Total and differential WBC counts were measured on admission and every 24 h for at least 4 days after PCI. ST-segment resolution and myocardial blush were evaluated immediately after successful primary PCI. LV functional recovery (defined as improvement involving at least two segments, or at least one segment, when only two were asynergic on the basal examination) was obtained through echocardiographic evaluation of LV wall motion at the baseline and at 6 months. Basal CK (P<0.001) and increased neutrophil levels (P<0.001) were the only independent factors related to peak CK, whereas neutrophils and monocytes peaks were related to ST-segment resolution as well as to myocardial blush grade (MBG) 2-3. MBG 2-3 and monocytes number (both as continuous values as well as percentile values) were the only variables independently associated with 6-month LV functional recovery. CONCLUSION: The present study shows that neutrophils and monocytes counts on the first days after acute MI treated with primary PCI are related to markers of effective myocardial reperfusion such as MBG 2-3 and ST-segment resolution. However, only monocytes and MBG are significantly and independently associated with contractile recovery of the infarcted area at 6 months.

Use of glycoprotein IIb/IIIa inhibitors in invasively-treated patients with non-ST elevation acute coronary syndrome.

Background In patients with non-ST elevation acute coronary syndrome (NST-ACS) that is treated invasively, glycoprotein (GP) IIb/IIIa inhibitors can be used either as upstream treatment in a coronary care unit or as downstream provisional treatment in selected patients who are undergoing percutaneous coronary intervention (PCI). The relative advantage of either strategy is unknown. The purpose of this study was to assess 30-day outcome of patients enrolled in a prospective NST-ACS registry and treated invasively with either of these two therapeutic strategies. Methods Patients treated invasively (coronary arteriography within 4 days of admission), in the prospective registry ROSAI-2, were divided into two groups according to the upstream use of GPIIb/IIIa inhibitors (n = 241), or not (n = 548). In the latter group, 76 (14%) patients received GPIIb/IIIa in association with a PCI procedure. Clinical and angiographic characteristics as well as in-hospital and 30-day outcome of these two groups of patients were compared. Results The two groups were similar with respect to age, sex, presence of hypertension, diabetes, number of PCI procedures. However, patients treated with upstream GPllb/llla blockers had more frequently ST-segment depression (P = 0.002), a high TIMI risk score (P = 0.01) and were more frequently admitted to centres with Cath Lab facilities (P = 0.001). At 30-day follow-up, the composite of death, acute myocardial infarction and stroke, as well as major bleeding, was not significantly different between the two groups, although it occurred more frequently in patients who received upstream GPIIb/IIIa blockers (9.5% versus 5.7% and 1.7% versus 0.2%, respectively). By multivariate analysis, diabetes [odds ratio (OR) = 2.22, 95% confidence interval (CI) = 1.2-4.09] and a diagnosis on admission of non-Q-wave myocardial infarction (OR = 2.0, 95% Cl = 1.10-3.6) were independently related to outcome. No additional risk or benefit was related to upstream GPIIb/IIIa inhibitor treatment (OR = 1.5, 95% Cl = 0.84-2.68). Conclusions Among invasively-treated patients with NST-ACS, upstream treatment with GPIIb/IIIa inhibitors was used in those with a higher clinical risk profile, whereas downstream treatment was reserved for a limited number of patients undergoing PCI. Thirty-day outcome was similar in the two groups, irrespective of the treatment strategy used.

Effect of a short antibiotic treatment with roxithromycin on circulating adhesion molecules after coronary stenting: a single-center pilot trial.

BACKGROUND: The aim of this study was to assess the effect of periprocedural antibiotic treatment with roxithromycin on circulating cell adhesion molecules and restenosis after coronary stent implantation. METHODS: Case-control study enrolling 25 consecutive patients submitted to coronary stenting for stable, single-vessel coronary artery disease, treated with 300 mg roxithromycin once daily for 5 days, starting 2 days before the procedure (group R). Twenty-five patients, matched for lesion site, length and diameter, as control group (group C). The serological status for Chlamydia pneumoniae (CP) infection (IgG, ELISA) was assessed in all patients. The plasma concentrations of soluble intercellular adhesion molecule-1 (sICAM-1), E-selectin and C-reactive protein at 1 month after coronary stenting were compared with baseline values. Binary restenosis (> or = 50%) was also evaluated at 6 months. RESULTS: sICAM-1 significantly decreased at 1 month in group R vs group C (371 +/- 181 vs 573 +/- 273 ng/ml, p = 0.005). This decrease was more evident in patients with a positive serology for CP (CP+) (group R 373 +/- 131 vs group C 597 +/- 255 ng/ml, p = 0.014). Antibiotic treatment had no effects on circulating E-selectin levels at 1 month (56.7 +/- 97 vs 49.8 +/- 62 ng/ml, p = 0.54). The restenosis rate (9/50, 18%) was similar in the two groups (group R 5/25 [20%], group C 4/25 [16%]). The restenosis rate was similar in the CP+ vs CP- group (6/35 [17%] vs 3/15 [20%]). CONCLUSIONS: A short course of treatment with roxithromycin at the time of coronary stenting induces a significant reduction in the sICAM-1 levels at 1 month but apparently does not influence the restenosis rate.

Different patterns of interleukin-6 and von Willebrand factor antigen changes after coronary stenting in unstable versus stable angina.

BACKGROUND: Inflammation plays an important role in the pathogenesis of acute coronary syndromes. The purpose of our study was to evaluate the time course and the clinical relevance of inflammatory markers in patients with unstable angina undergoing successful coronary stent implantation. METHODS: Fifty-six patients (33 with unstable and 23 with stable angina) scheduled for single vessel coronary angioplasty followed by successful stent implantation were studied. Blood samples for measurements of interleukin-6 (IL-6) and von Willebrand factor antigen (vWf) were taken immediately before coronary angioplasty and 24 hours and 1 month after the procedure. Patients were clinically examined 1 month after the procedure. RESULTS: The mean levels of IL-6 before stenting were significaNtly higher in unstable than in stable angina patients (p = 0.002), whereas baseline values of vWf showed no difference between the two groups. In unstable angina, serum levels of IL-6 and of vWf did not change 24 hours after stent implantation, but significantly decreased 1 month after the procedure (p = 0.005 and p = 0.0015 respectively). In stable patients, serum levels of IL-6, but not of vWf, increased 24 hours after the procedure and returned to baseline levels 1 month after stent implantation (p = 0.046). CONCLUSIONS: In unstable angina, successful treatment of the culprit lesion by coronary stenting results in a significant decrease in the serum levels of IL-6 and of vWf 1 month after the procedure, suggesting that, in this clinical condition, elevated levels of these parameters correlate with the instability of the atheromatous plaque and that their decrease after successful stent implantation is the result of plaque stabilization.

["Cure" and "tactics" interventional strategies in unstable angina/non-Q infarction]. / Strategia di "cure" e "tattiche" interventistiche nell'angina instabile/infarto non Q.

Early risk stratification and an invasive approach (coronary angiography and reperfusion if indicated) have recently emerged as the treatment of choice in non-ST elevation acute coronary syndromes. An aggressive pharmacologic therapy, i.e. glycoprotein IIb/IIIa antagonists, is also more effective in case of risk assessment at the time of the admission of the patient in the coronary care unit. Recent data have assessed the advantages of abciximab over tirofiban in unstable patients submitted to percutaneous coronary intervention (PCI), whereas non-anticorpal molecules (tirofiban, integrilin) are indicated for the medical treatment of high-risk patients in order to reduce myocardial necrosis during the acute phase. A good platelet inhibition with the oral tienopiridine derivative clopidogrel, resulted in a lower incidence of major cardiovascular events at follow-up both in patients treated conservatively as well as in patients submitted to PCI (CURE and PCI-CURE trials). The early risk of myocardial necrosis before coronary revascularization was also reduced by clopidogrel in patients submitted to PCI, an effect already demonstrated with tirofiban and integrilin ("small molecules like" effect). A new therapeutic scheme including, at the time of admission, oral clopidogrel for platelet inhibition, an early risk assessment and the subsequent use of abciximab in the cath lab, if indicated is proposed for the treatment of unstable angina. The advantages associated with the proposed treatment have to be validated by ad hoc studies.

Integrated analysis of myocardial blush and ST-segment elevation recovery after successful primary angioplasty: Real-time grading of microvascular reperfusion and prediction of early and late recovery of left ventricular function.

BACKGROUND: ST-segment elevation (SigmaSTe) recovery and the angiographic myocardial blush (MB) grade are useful markers of microvascular reperfusion after recanalization of the infarct-related artery. We investigated the ability of a combined analysis of MB grade and SigmaSTe changes to identify different patterns of myocardial reperfusion shortly after primary percutaneous coronary angioplasty (PTCA) and to predict 7-day and 6-month left ventricular (LV) functional recovery. METHODS AND RESULTS: MB grade and SigmaSTe recovery were evaluated shortly after successful primary PTCA (restoration of TIMI grade 3 flow) in 114 consecutive patients with SigmaSTe acute myocardial infarction. LV function was assessed by 2D echocardiograms before PTCA and at 7 days and 6 months thereafter. By combining MB and SigmaSTe changes, 3 main groups of patients were identified. Group 1 patients (n=60) had both significant MB (grade 2 to 3) and SigmaSTe recovery (>50% versus basal SigmaSTe) and a high rate of 7-day (65%) and 6-month (95%) LV functional recovery. In group 2 patients (n=21), who showed MB but persistent SigmaSTe, the prevalence of early LV functional recovery was low (24%) but increased up to 86% in the late phase. Group 3 patients (n=28), who had neither significant MB nor SigmaSTe resolution, had poor early (18%) and late (32%) LV functional recovery. CONCLUSIONS: After successful primary PTCA, integrated analysis of MB and SigmaSTe recovery allows a real-time grading of microvascular reperfusion of the infarct area and predicts the time-course and magnitude of LV functional recovery.

[Combination therapy for acute myocardial infarction with glycoprotein IIb/IIIa inhibitors and fibrinolysis]. / Infarto miocardico acuto ST sopra: associazione tra inibitori delle glicoproteine e trombolitico? Pareri a confronto.

Early achievement of TIMI 3 (normal) flow in the infarct-related artery is the goal of therapy of acute myocardial infarction (AMI) in order to reduce infarct size and improve clinical outcome. By the mid 1990s mechanical treatment (primary angioplasty) has been recognized as the best method to gain this goal but fibrinolysis still remains the standard of care because of logistic limitations of angioplasty. Benefit of aspirin in association with fibrinolytic drugs encouraged the use of antagonists of the glycoprotein IIb/IIIa receptor (abciximab, eptifibatide, tirofiban), which block the final common pathway of platelet aggregation in AMI therapy. In dose-finding and dose-confirmation studies the combination of a fibrinolytic agent with a glycoprotein IIb/IIIa receptor antagonist, such as abciximab, resulted in nearly 80% of patients achieving complete reperfusion at 90 min without a substantial increase in side effects. This combination was tested in the phase III GUSTO V study. Compared to full-dose reteplase alone, the association of half-dose of reteplase and abciximab significantly reduced most non-fatal complications of myocardial infarction such as reinfarction and need of urgent revascularization. Failure to show a reduction in mortality with "combo therapy" must be related to the low 30-day mortality observed in both arms of the study, the lowest ever found in fibrinolytic trials. Warning about an increase in non-intracranial bleeding is counterbalanced by similar rates of intracranial hemorrhages and non-fatal disabling strokes in the two groups. On the basis of the GUSTO V results it appears clear that future advances in the management of AMI will only be possible by combining different reperfusion modalities (lytics, IIb/IIIa antagonists and coronary angioplasty). Whichever is the best combination, mechanical reperfusion will play a central role in the management of AMI. A major challenge for cardiologists will be reinforcement of collaboration and synergy between institutions with different levels of resources.