Single versus Double Stenting in NSTEMI Patients with Complex Left Main Bifurcation Disease.

Background: Among patients with non-ST-segment elevation myocardial infarction (NSTEMI) the presence of a bifurcation left main (LM) disease represents a particular subset graved by both clinical and technical challenges. We sought to assess the long-term outcomes of patients with NSTEMI treated either by single or double stent strategy, having an LM bifurcation culprit lesion. Methods: We retrospectively analyzed the procedural and medical data of consecutive patients referred to our center for NSTEMI due to complex LM bifurcation disease as the culprit lesion, treated using either single or dual stenting (provisional stenting, T or T-and-Protrusion (TAP), Culotte, and Nano-inverted-T (NIT)) techniques between January 2008 and May 2018. Target lesion failure (TLF) was defined as the composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR). Results: Four hundred and forty-five patients (54.1% males, mean age 70.3 ± 12.8 years, mean Syntax score 31.6 ± 6.3) were evaluated. Of these, 155 patients (34.8%) were treated using a single stent while the remaining were treated with a double stent strategy. After a mean follow-up of 37.1 months (IQR 22.1-39.3), TLF rate was 8.7% (n = 39): 5/155 (3.2%) in the crossover group; 10/53 (18.8%) in T/TAP group, 14/89 (15.7%) in the culotte group, and 10/148 (6.7%) in the NIT group of patients. Cardiovascular mortality rate was 2.9% (n = 13) while stent thrombosis was 0.89% (n = 4). On multivariate analysis dyslipidemia, Syntax score > 25, triple vessel disease, additional LM ostial, or LM body lesions and the use of Rotablator, were independent predictors of TLF. Conclusions: Either a single or double stent strategy resulted in low rates of TLF, cardiovascular death, and stent thrombosis in the long-term period in NSTEMI LM patients with contraindications or refusal of surgery. A single stent strategy appeared to have a slightly better outcome compared to a 2-stent strategy.

[ANMCO Position paper: Care pathway for advanced heart failure patients candidate for heart transplantation/ventricular assist device]. / Position paper ANMCO: Percorso assistenziale del paziente con insufficienza cardiaca avanzata candidabile a trapianto/assistenza ventricolare meccanica.

Heart failure is a complex clinical syndrome with a severe prognosis, despite therapeutic progress. The management of the advanced stages of the syndrome is particularly complex in patients who are referred to palliative care as well as in those who are candidates for cardiac replacement therapy. For the latter group, a prompt recognition of the transition to the advanced stage as well as an early referral to the centers for cardiac replacement therapy are essential elements to ensure that patients follow the most appropriate diagnostic-therapeutic pathway. The aim of this document is to focus on the main diagnostic and therapeutic aspects related to the advanced stages of heart failure and, in particular, on the management of patients who are candidates for cardiac replacement therapy.

COVID-19, Vaccines, and Thrombotic Events: A Narrative Review.

The coronavirus disease 2019 (COVID-19), a deadly pandemic that has affected millions of people worldwide, is associated with cardiovascular complications, including venous and arterial thromboembolic events. Viral spike proteins, in fact, may promote the release of prothrombotic and inflammatory mediators. Vaccines, coding for the spike protein, are the primary means for preventing COVID-19. However, some unexpected thrombotic events at unusual sites, most frequently located in the cerebral venous sinus but also splanchnic, with associated thrombocytopenia, have emerged in subjects who received adenovirus-based vaccines, especially in fertile women. This clinical entity was soon recognized as a new syndrome, named vaccine-induced immune thrombotic thrombocytopenia, probably caused by cross-reacting anti-platelet factor-4 antibodies activating platelets. For this reason, the regulatory agencies of various countries restricted the use of adenovirus-based vaccines to some age groups. The prevailing opinion of most experts, however, is that the risk of developing COVID-19, including thrombotic complications, clearly outweighs this potential risk. This point-of-view aims at providing a narrative review of epidemiological issues, clinical data, and pathogenetic hypotheses of thrombosis linked to both COVID-19 and its vaccines, helping medical practitioners to offer up-to-date and evidence-based counseling to their often-alarmed patients with acute or chronic cardiovascular thrombotic events.

Unexpected huge post-stenting coronary perforation during complex left main revascularization.

A 78-year-old man with a tight left main and a long calcified disease of the left anterior descending coronary artery refused surgery. After stenting, the patient went into a shock because of a large coronary artery ruptur. Pericardial drainage with blood reinfusion, without heparin reversal, allowed for completion of revascularization.

[COVID-19, vaccines, and thrombotic events]. / COVID-19, vaccini ed eventi trombotici.

COVID-19, a deadly pandemic that has affected millions of people worldwide, is also associated with cardiovascular complications, such as venous and arterial thromboembolic events. The viral spike protein, in fact, may promote the release of prothrombotic and inflammatory mediators. Vaccines, coding for the spike protein, are the primary measure for preventing COVID-19. However, some unexpected thrombotic events at unusual sites, most frequently the cerebral venous and splanchnic districts, with associated thrombocytopenia, have emerged in subjects who received adenovirus-based vaccines, especially in fertile women. This clinical entity has been rapidly recognized as a new syndrome, named vaccine-induced immune thrombotic thrombocytopenia, probably caused by cross-reacting antiplatelet factor 4 antibodies activating platelets. This prompted the regulatory agencies of various countries to restrict the use of adenovirus-based vaccines to specific age groups. The prevailing opinion of most experts, however, is that the risk of developing COVID-19 disease, including thrombosis, clearly outweighs this potential extremely low risk.This paper aims at providing a comprehensive review of epidemiological issues, clinical data and pathogenetic hypotheses of thrombosis linked to both COVID-19 and its vaccines, helping cardiologists to offer an up-to-date and evidence-based counseling to their often-alarmed patients with acute or chronic coronary syndromes.

[ANMCO Position paper: Reorganization of cardiology in the era of the COVID-19 pandemic]. / Position paper ANMCO: Riorganizzazione della cardiologia in epoca di pandemia COVID-19.

The COVID-19 pandemic represents an unprecedented event that has brought deep changes in hospital facilities with reshaping of the health system organization, revealing inadequacies of current hospital and local health systems. When the COVID-19 emergency will end, further evaluation of the national health system, new organization of acute wards, and a further evolution of the entire health system will be needed to improve care during the chronic phase of disease. Therefore, new standards for healthcare personnel, more efficient organization of hospital facilities for patients with acute illnesses, improvement of technological approaches, and better integration between hospital and territorial services should be pursued. With experience derived from the COVID-19 pandemic, new models, paradigms, interventional approaches, values and priorities should be suggested and implemented.

Secundum atrial septal defects transcatheter closure versus surgery in adulthood: a 2000-2020 systematic review and meta-analysis of intrahospital outcomes.

INTRODUCTION: Technologically, advances in both transcatheter and surgical techniques have been continuing in the past 20 years, but an updated comprehensive comparison in device-based versus surgery in adults in terms of incidence of in-hospital mortality, perioperative stroke, and atrial fibrillation onset is still lacking. We investigate the performance of transcatheter device-based closure compared to surgical techniques by a systematic review and meta-analysis of the last 20 years literature data. MATERIAL AND METHODS: The analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Literature search was performed based on Cochrane Library, Embase, PubMed, and Google Scholar to locate articles published between January 2000 and October 2020, regarding the comparison between short-term outcome and post-procedural complications of atrial septal defect patients receiving transcatheter or surgical closure. The primary outcome was the comparison of in-hospital mortality from all causes between patients treated with transcatheter closure or cardiac. Secondary outcomes were the onset of post-procedural atrial fibrillation or perioperative stroke. RESULTS: A total of 2360 patients were included of which 1393 [mean age 47.6 years, 952 females (68.3%)] and 967 [mean age 40.3 years, 693 females (71.6%)] received a transcatheter device-based and surgery closure, respectively. In-hospital mortality [OR 0.16 (95% CI (0.66-0.44)), p = 0.0003, I2 = 0%], perioperative stroke [OR 0.51 (95% CI (0.31-0.84)), p = 0.003, I2 = 79%], and post-procedural atrial fibrillation [OR 0.14 (95% CI (0.03-0.61)), p = 0.009, I2 = 0%] significantly favoured transcatheter device-based closure. CONCLUSION: Transcatheter atrial septal defect closure resulted safer in terms of in-hospital mortality, perioperative stroke, and post-procedural atrial fibrillation compared to traditional surgery.

Feasibility, safety and long-term outcomes of complex left main bifurcation treatment using the nano-inverted-t stenting: a multicentre prospective registry.

The role of double stenting techniques in distal bifurcation left main (LM) disease has gaining interest over the latest years. We present the 3-year multicentre registry outcomes of dual stenting using ultra-thin strut stents and the Nano-Inverted-T (NIT) technique in complex unprotected true LM bifurcation disease. We analysed the procedural and medical data of consecutive patients enrolled between 1st January 2014 and 1st December 2019 in a multicentre registry for complex LM bifurcation disease treated with the double stenting technique called NIT due contraindications and/ or refusal to surgical treatment. Target lesion failure (TLF) was defined as the composite of cardiovascular death, target-vessel MI (TVMI) and clinically driven target lesion revascularization (TLR). Among two hundred-ninety-five patients (138 males, mean age 70.3 ± 12.8 years), post-operative success was achieved in 100% of cases. Contrast volume, procedural time, and radiation exposure were 139.2 ± 23.4 ml, 15.3 ± 4.9 min, and 1080 ± 1034 cGy/m2, respectively. At a mean follow-up of 39.5 ± 0.6 months TLF rate was 6.1% (n = 18) while TLR and cardiovascular mortality rates were 3.0 (n = 9) and 2.6% (n = 8), respectively. Clinically-driven angiographic follow-up was available in 26.4% of patients at a mean time from the procedure of 7.5 ± 0.4 months. Clinically restenosis rate was 3.3%.Revascularization of complex LM bifurcation disease using the NIT double stenting technique resulted feasible and safe with a low incidence of TLF, excellent survival rate and no stent thrombosis.

Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

BACKGROUND: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines. STUDY DESIGN: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. CONCLUSIONS: The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.

Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Although oral P2Y12 inhibitors are key in the management of patients with non-ST-segment elevation acute coronary syndrome, the optimal timing of their administration is not well defined. OBJECTIVES: The purpose of this study was to compare downstream and upstream oral P2Y12 inhibitors administration strategies in patients with non-ST-segment elevation acute coronary syndrome undergoing invasive treatment. METHODS: We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit). RESULTS: We randomized 1,449 patients to downstream or upstream oral P2Y12 inhibitor administration. A pre-specified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes; nonfatal myocardial infarction or nonfatal stroke; and Bleeding Academic Research Consortium type 3, 4, and 5 bleeding through day 30, did not differ significantly between the downstream and upstream groups (percent absolute risk reduction: -0.46; 95% repeated confidence interval: -2.90 to 1.90). These results were confirmed among patients undergoing percutaneous coronary intervention (72% of population) and regardless of the timing of coronary angiography (within or after 24 h from enrollment). CONCLUSIONS: Downstream and upstream oral P2Y12 inhibitor administration strategies were associated with low incidence of ischemic and bleeding events and minimal numeric difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of 1 strategy over the other. (Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non-ST Elevated Acute Coronary Syndromes With Initial Invasive Indication [DUBIUS]; NCT02618837).

Electrogram-only guided approach to His bundle pacing with minimal fluoroscopy: A single-center experience.

INTRODUCTION: His bundle pacing (HBP) is the most physiological pacing. The standard technique based on fluoroscopic approach might be challenging and fluoro consuming. Targeting the His guided exclusively by the electrical signals could enable a precise lead implant, thus reducing fluoroscopy time (FT) and X-ray dose, desirable both for patients and operators. The aim of the study is to evaluate the feasibility, efficacy, and safety both acutely and at 30 days of the electrogram (EGM)-guided HBP with minimal or no fluoroscopy. METHODS AND RESULTS: Between October and December 2018, 41 consecutive patients underwent EGM-guided HBP. Successful HBP was obtained in 39 (95%) patients, (30 males, 78 ± 10 years). Selective HBP (S-HBP) was achieved in 23 (59%), nonselective HBP (NS-HBP) in 16 (41%) patients. The final HBP lead position was reached in 31 (79.4%) patients without fluoroscopy, only guided by electrical signals. In eight patients a minimal fluoroscopy (mean, 8 seconds) has been required. The sheath's cutting and the slack of the lead were routinely performed under fluoroscopy. No difference was observed in FT for HBP lead placement in S-HBP and NS-HBP (mean, 8.1 ± 25 vs 7.5 ± 20 seconds, P = .8; median value 0 vs 0 seconds). No differences were observed in FT for the entire procedure, total dose area product and total procedural time in S-HBP and NS-HBP. Lead dislodgement occurred in one (2.6%) patient 1 day after the procedure. CONCLUSIONS: HBP could be performed safely and efficiently using the EGMs, with minimal or no fluoroscopy. Fluoroscopy was required during sheath removal and atrial lead placement.

Long-Term Clinical Outcomes of Isolated Ostial Left Anterior Descending Disease Treatment: Ostial Stenting Versus Left Main Cross-Over Stenting.

BACKGROUND: The optimal strategy for treating ostial left anterior descending coronary artery (LAD) disease remains matter of speculation. We evaluated the impact on long-term outcomes of ostial LAD disease treated by means of ostial stenting (the floating-stent) or left main (LM)-to-LAD cross-over stenting. METHODS: Clinical and instrumental records of 74 consecutive patients with isolated ostial LAD disease, enrolled between the 1st January 2012 and the 1st January 2017 were reviewed. Patients have been stratified according the stenting techniques adopted: ostial stenting (OS) or LM cross-over (CO). RESULTS: Seventy-four consecutive patients (54 males, mean age 73.39 ±â€¯9.54 years old) have been analyzed. In CO patients the SYNTAX score (16.2 ±â€¯3.3 vs 24.1 ±â€¯2.5, p < 0.0001) and the percentages of rotablation resulted higher than in OS group. IVUS has been predominantly used in CO groups revealing a significant extension of plaque burden of at least 10 mm of LM proximal to the LAD ostium in all the 18 out of 21 patients (85.7%) undergone IVUS-guided procedure. Fluoroscopy time and contrast medium volume were higher in OS versus CO group of patients. On a mean follow-up of 49.7 ±â€¯7.9 months, MACE and target vessel revascularization (TVR) were 21.0% and 21.0% in OS groups versus 10.1 and 5.6% in the CO group (p = 0.20 and p = 0.04, respectively). Restenosis was higher in the OS than in CO group of patients and was located angiographically at the ostium. CONCLUSIONS: On long-term follow-up CO seems to be superior to OS technique for isolated ostial LAD disease especially in the presence of heavy calcification.

Culotte versus the novel nano-crush technique for unprotected complex bifurcation left main stenting: difference in procedural time, contrast volume and X-ray exposure and 3-years outcomes.

To assess the procedural performance and 3-years outcomes of unprotected complex bifurcation Left Main (LM) stenting using either Culotte or the novel nano-crush techniques, consisting in the use of two ultra-thin strut stents with a 1-ring stent crushed into the LM. We analysed the records of patients with complex distal/bifurcation LM disease and contraindications and/or refusal of bypass surgery, who from 1 January 2014 to 1 November 2017, received at operators' discretion LM double stenting by means of nano-crush technique using Orsiro (Biotronik Inc, Bulack, Switzerland) or Onyx (Medtronic Inc, Galway, Ireland) stents or Culotte stenting using same stent platforms. Among 65 patients (28 females, mean age 77.2 ± 6.2 years), 32 received nano-crush while 33 patients received Culotte technique. Mean angles between left anterior descending coronary artery and left circumflex was 63.6 ± 21.3°. Post-operative success was achieved in 100% of cases. Nano-crush patients showed lower contrast medium volume and X-ray exposure, shorter fluoroscopy and procedural times compared to Culotte patients group. At a mean follow-up of 27.4 ± 10.8 months, clinical-driven target lesion revascularization, myocardial infarction and cardiovascular death were 0 versus 4/33 (12.1%, p = 0.04), 1/32 (3.1%) versus 6/33 (18.1%, p = 0.03) and 2/32 (6.2%) versus 8/33 (24.2%, p = 0.04) in nano-crush versus Culotte patients, respectively. In this single center study, the nano-crush technique was associated with less use of contrast, less procedural time and less X-ray exposure compared to the culotte technique for the treatment of unprotected left main bifurcation lesions.