Acute and long-term results of percutaneous coronary intervention of bifurcation lesions with the dedicated Bioss Lim C stent: the Italian BIfurcation Observational Spontaneous Study (IBIOSS).

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions still represents a clinical challenge. The Bioss Lim C is a dedicated device for bifurcation lesions, features a tapered shape and large cells, and thus appears as a promising adjunct to the current interventional cardiologists' armamentarium. We aimed at conducting a prospective multicenter study focusing on early and long-term results after Bioss Lim C implantation for true coronary bifurcation lesions. METHODS: Patients with true bifurcation lesions in whom Bioss Lim C implantation was attempted were enrolled in four Italian centers. An explicit bifurcation management approach was recommended, leaving however the choice between one- vs. two-stent strategies at operator's discretion. Acute and long-term results were systematically appraised, focusing on an acute composite of complex side branch (SB) rewiring, SB pinching, or SB occlusion (primary efficacy endpoint), as well as major adverse events (MACE, i.e. death, myocardial infarction [MI], or target vessel revascularization [TVR]), individual components of MACE, and stent thrombosis. RESULTS: A total of 207 patients were included, with age of 67.3±10.8 years, and 40 (19.3%) women. The target lesion was located in the left main in 48 (23.2%) patients, whereas proximal reference vessel diameter was 3.69±0.48 mm, and lesion length 20.3±3.4 mm. According to the Medina classification, most patients (60 [30.9%]) had 1-1-1 lesions. Drug-eluting stent implantation in the SB was carried out in 19 (9.3%) subjects, and kissing balloon inflation was used in 67 (32.5%). The primary efficacy endpoint occurred in 27 (13.0%), with side branch (SB) occlusion in two (1.0%), SB pinching in 23 (11.1%), and complex SB rewiring in six (2.9%), and was most frequent in patients with lower body mass index or dyslipidemia. After 24.1±19.5 months, MACE were adjudicated in 23 (11.1%) subjects, with death in 10 (4.8%), MI in six (2.9%), and TVR in seven (3.4%), as well as stent thrombosis in one (0.5%). CONCLUSIONS: This study supports a wider adoption of the Bioss Lim C dedicated bifurcation device, thanks to the favorable acute results as well as long-term clinical outcomes, as well as its versatility for the stenting strategy provisionally or eventually adopted by operators.

Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury.

OBJECTIVES: This study compared left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate (UFR)-guided hydration. BACKGROUND: Tailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI). METHODS: Between July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed. RESULTS: The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030). CONCLUSIONS: The study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.

Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.

BACKGROUND: Urine flow rate (UFR)-guided and left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigator-sponsored trial aiming to compare these two hydration strategies. METHODS: Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m2 and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group). Seven-hundred patients (350 in each arm) will be enrolled. In the LVEDP-guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg-1 hr-1 for LVEDP ≤12 mmHg, 3 mL kg-1 hr-1 for LVEDP 13-18 mmHg, and 1.5 mL kg-1 hr-1 for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low-osmolar, nonionic contrast agent) will be administered. RESULTS: The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema. CONCLUSION: The REMEDIAL III will test the hypothesis that the UFR-guided hydration is superior to the LVEDP-guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema.

Cardiogenic Shock Following Acute Myocardial Infarction: What's New?

Cardiogenic shock (CS) is a state of critical end-organ hypoperfusion primarily due to cardiac dysfunction. This condition is the most common cause of death in patients affected by acute myocardial infarction (AMI). Despite early revascularization, prompt optimal medical therapy, and up-to-date mechanical circulatory supports, mortality of patients with CS remains high.The objective of this review is to summarize epidemiology, pathophysiology, and treatment options of CS in light of the new European Society of Cardiology (ESC) recommendations. The latest European guidelines on myocardial revascularization have reviewed the previous guidelines with respect to early multivessel revascularization and routine use of intra-aortic balloon pump (IABP) in patients with AMI-related CS.Most of the current evidences come partly from randomized trials, but mostly from observational registries because of the difficulty to test different treatments in this life-threatening clinical setting.Some of the latest studies highlight the potential crucial benefit of newly introduced mechanical circulatory support devices, although evidences are not sufficient to definitely assess the benefit/risk ratio of the different systems.Many questions remain unanswered in this field, and further trials are advocated to better elucidate the best medical, reperfusion, and circulatory support approaches aimed to improve the poor prognosis of patients with CS after AMI.

Impact of Insulin-Treated and Noninsulin-Treated Diabetes Mellitus in All-Comer Patients Undergoing Percutaneous Coronary Interventions With Polymer-Free Biolimus-Eluting Stent (from the RUDI-FREE Registry).

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.

Time-dependent benefits of pre-treatment with new oral P2Y12 -inhibitors in patients addressed to primary PCI for acute ST-elevation myocardial infarction.

OBJECTIVES: The aim of this observational study was to determine the benefits of the novel, orally delivered P2Y12 -inhibitors (Is) in terms of angiographic endpoints and in relation to the time of the loading dose (LD) administration. BACKGROUND: The goal of ST-elevation myocardial infarction (STEMI) treatment is timely reperfusion. The P2Y12 -Is prasugrel and ticagrelor have improved the angiographic outcome of primary percutaneous coronary intervention (pPCI) and patients' prognosis. However, their onset of action is impaired in STEMI and delayed by their oral administration. METHODS: The 328 eligible patients with STEMI consecutively referred for pPCI were divided into three groups depending on the interval of "P2Y12 -I LD administration-to-balloon time": Group 2 included patients that received P2Y12 -I LD at least 60 min prior to pPCI, Group 1 within 60 min prior to pPCI, and Group 0 at the moment of pPCI. Angiographic, clinical, and biochemical parameters were evaluated. Pre- and post-pPCI TIMI flow grade (TFG) and ST resolution (STR) were used as outcome measures to determine efficacy and optimal timing of pretreatment. RESULTS: Pre-pPCI TFG improved with increasing P2Y12 -I LD administration-to-balloon time; pre-PCI TFG 0/1 was 74.5% in Group 0, 65.5% in Group 1 and 54.9% in Group 2 (P < 0.002). Post-pPCI TFG 3 results also differed significantly between the three groups: 85.2% in Group 0, 88.1% in Group 1, 97.6% in Group 2 (P < 0.013). ST resolution rates were also positively associated with longer pretreatment intervals. CONCLUSIONS: This observational study suggests that the angiographic benefit of P2Y12 -I administration is time-dependent: longer pretreatment improves coronary reperfusion in terms of pre- and post-pPCI TFG and STR.

Safety and efficacy of polymer-free biolimus-eluting stents in all-comer patients: the RUDI-FREE study.

AIMS: Polymer-free biolimus-eluting stents (PF-BES) have been shown to be superior to bare metal stents in high bleeding risk (HBR) patients treated with one-month dual antiplatelet therapy (DAPT). However, limited evidence is available on PF-BES in non-HBR patients. We aimed to evaluate the safety and efficacy of PF-BES in all-comer patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: Patients with stable coronary artery disease or acute coronary syndromes (ACS) undergoing PCI with PF-BES in routine clinical practice were included in a multicentre, prospective registry. DAPT duration was left to the discretion of the operator. The primary endpoint was the composite of cardiovascular death, myocardial infarction (MI), and definite/probable stent thrombosis (ST) at one year. Overall, 1,104 consecutive patients treated with PF-BES were included at 16 Italian centres. Mean age was 68.7±11.2 years, 77.2% of patients were male, 30% had diabetes, 15.1% had chronic kidney disease, and 40.5% had ACS at baseline. Mean CRUSADE score was 24.1±13.1, and 83.7% of patients did not have high bleeding risk features. At one year, the primary endpoint occurred in 4.1% of patients, cardiovascular death in 2.4%, MI in 1.8%, and definite/probable ST in 1.1%. With respect to efficacy, target lesion revascularisation occurred in 1.2% of patients. CONCLUSIONS: This is the first study providing clinical evidence on the use of PF-BES in all-comer patients irrespective of HBR status. Our findings suggest that PF-BES has a favourable safety and efficacy profile in a real-world clinical setting. Further investigation in randomised clinical trials against new-generation DES is warranted.

Patients with non-ST segment elevation acute coronary syndromes managed without coronary revascularization: A population needing treatment improvement.

NSTE-ACS patients are a heterogeneous population, with different clinical features and prognosis. A large proportion of them is medically managed, without any revascularization. In the EYSHOT and FAST-MI registries such patients were 40% and 35%, respectively. These patients are at higher risk of adverse cardiovascular events and have a worse prognosis compared with those receiving revascularization. Medically managed NSTE-ACS patients consist of different subgroups: those not undergoing coronary angiography, those without significant coronary artery disease, and those with coronary stenoses not referred to revascularization. Patients with NSTE-ACS for whom a conservative strategy without coronary angiogram is planned must be very carefully selected. In patients with comorbidities, frailty, or advanced age, a careful balance between benefits and risks is needed to choice the management strategy (perform or not coronary angiography and/or revascularization), as evidence-based medicine data are lacking in the setting of frailty and comorbidities. In this decisional process, it should be also taken into consideration the role of coronary anatomy in risk stratification and treatment guidance. NSTE-ACS patients managed without revascularization less frequently receive guideline-recommended pharmacological treatment. Dual antiplatelet therapy (DAPT) is recommended for 12months also in medically managed patients, after careful balancing of ischemic and bleeding risk. In these patients it is mandatory to optimize pharmacological treatment, including antiplatelet therapy, to improve outcome. In NSTE-ACS medically managed, the proportion of patients discharged with DAPT should be increased in comparison with current practice, and the use of ticagrelor in place of clopidogrel should be considered in selected patients.

[Acute aortic dissection during ineffective attempt of transcatheter implant of a fully resheathable, respositionable and retrievable aortic valve]. / Dissezione aortica acuta durante tentativo inefficace di impianto transcatetere di protesi aortica totalmente riposizionabile e recuperabile.

Aortic injury is a rare but severe complication that may occur during transcatheter aortic valve implantation (TAVI). Few patients with type A dissection are treated surgically because of the high rate of postoperative mortality and neurological complications in this high-risk population; thoracic endovascular aortic repair is rare too, and technically challenging because of the anatomical variations of spiral type A aortic dissection. Sometimes a watchful waiting strategy could be the best solution. We report the case of an acute, extended aortic type A dissection occurred during a TAVI procedure, probably due to the rupture of the dedicated sheath, and conservatively managed.

[Patients with non-ST-elevation acute coronary syndrome managed without coronary revascularization: an undertreated population]. / I pazienti con sindrome coronarica acuta senza sopraslivellamento persistente del tratto ST non sottoposti a rivascolarizzazione coronarica: una popolazione sottotrattata.

Non-ST-elevation acute coronary syndromes (NSTE-ACS) represent one of the most common clinical presentations of ischemic heart disease. Patients with NSTE-ACS are a heterogeneous population, with different clinical features and prognosis. A significant proportion of this population is medically managed, without any revascularization. In the Italian EYESHOT and French FAST-MI registries, patients managed with a conservative strategy were 40% and 35%, respectively. NSTE-ACS patients not undergoing coronary revascularization are at higher risk of adverse cardiovascular events and have a worse prognosis, including short- and long-term mortality, compared with those receiving revascularization. Patients with NSTE-ACS medically managed consist of three different subgroups: those not undergoing coronary angiography, those receiving coronary angiography and without significant coronary artery disease, and those with significant coronary artery disease at angiography but not receiving revascularization. Patients presenting with NSTE-ACS for whom a conservative strategy without coronary angiography is planned should be selected very carefully and coronary angiography should not be denied because of the lack of on-site cath-lab facilities. In addition, advanced age alone, in the absence of severe comorbidities or frailty, should not be considered as a reason for denying coronary angiography and, in general, optimal treatment. Given that evidence-based data are lacking, a careful balance between benefits and risks is needed in the decision to perform or not coronary angiography and/or revascularization in patients with important comorbidities, or frailty, or advanced age. In this decisional process, it should be also taken into consideration the role of coronary anatomy in risk stratification and treatment guidance.NSTE-ACS patients managed without revascularization less frequently receive guideline-recommended pharmacological treatment. Dual antiplatelet therapy is recommended for 12 months also in medically managed patients, after careful balance of ischemic and bleeding risk. Indeed, in this group of patients it is mandatory to optimize pharmacological treatment, including antiplatelet therapy, in order to improve clinical outcome. In NSTE-ACS not undergoing revascularization, the proportion of patients discharged with dual antiplatelet therapy should be increased in comparison to current clinical practice, and the use of ticagrelor instead of clopidogrel should be considered in selected patients.

[Current practice and changing trends in the percutaneous treatment of structural heart disease. Results of a multicenter survey promoted by the Italian Society of Interventional Cardiology in six Italian Regions including Tuscany, Lombardy, Veneto, Emilia-Romagna, Campania and Puglia]. / Pratica clinica attuale e trend di variazione in cardiologia interventistica strutturale. Risultati di una survey multicentrica SICI-GISE in sei Regioni italiane: Toscana, Lombardia, Veneto, Emilia-Romagna, Campania e Puglia.

BACKGROUND: Significant developments have occurred in the field of percutaneous interventions for structural heart disease over the last decade. The introduction of several innovations has expanded significantly the spectrum of therapeutic applications of structural interventional cardiology. However, the translation of the most recent scientific evidence into clinical practice and the adoption of new technologies may be susceptible to large variability, even within the same geographic area. This study aimed at describing current status and changing trends of structural heart interventions within 6 Regions in Italy. METHODS: Between July 2015 and October 2015, 6 regional delegations of the Italian Society of Interventional Cardiology (SICI-GISE) promoted a web-based multicenter survey concerning structural heart interventions. An ad hoc questionnaire was administered to head physicians of the cath-labs of 4 Regions of Northern Italy (Tuscany, Lombardy, Veneto and Emilia-Romagna) and 2 Regions of Southern Italy (Puglia and Campania). Also, in this study we considered previous data from a similar survey that involved Tuscany, Lombardy, Veneto and Emilia-Romagna between April 2014 and May 2014. Data from the two surveys were compared, observing the changing trends between 2014 and 2015. RESULTS: The 2015 survey was completed in more than two thirds (68%) of the 145 eligible cath-labs. According to the survey, the application of percutaneous structural heart interventions and the availability of devices were wide and homogeneous within the 6 Regions involved. The main factors perceived as limiting the execution of structural heart interventions resulted economic (e.g. cost of procedures and devices) or organizational (e.g. limited diffusion of hybrid operating rooms). CONCLUSIONS: In this study, which was based on the results of a recent survey conducted in 6 Italian Regions, structural heart interventions resulted widely growing throughout the investigated area. The indications for treatment and the availability of devices were relatively homogeneous between the regions involved, as well as the limiting factors, which appear to be mainly economic-organizational.

Primary angioplasty of an anomalous right coronary artery complicated by an acute thrombotic occlusion.

A right coronary artery (RCA) arising from the left main is a very uncommon congenital defect. We report on a 69-year-old patient with an acute myocardial infarction submitted to primary percutaneous coronary intervention (PCI) for an anomalous RCA. The PCI procedure was complicated by an acute thrombotic occlusion, successfully treated by an intracoronary bolus of abciximab.

Abciximab for the treatment of an acute thrombotic coronary occlusion during stent implantation in a patient with severe hemophilia B.

Hemophilia B is a severe inherited coagulopathy caused by mutations in the gene that encodes factor IX. Surgical and invasive procedures in patients suffering from this congenital disease are to be considered as being at high risk of hemorrhage. We describe a case of a patient with unstable angina who suffered from severe hemophilia B, pre-treated with plasma purified factor IX concentrate and not on antithrombotic therapy, in whom the use of abciximab induced the complete lysis of an acute thrombus complicating the implantation of a stent on the left anterior descending coronary artery.