Invasive strategy for COVID patients presenting with acute coronary syndrome: The first multicenter Italian experience.

OBJECTIVE: To report our initial experience of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/acute coronary syndrome (ACS) patients undergoing standard of care invasive management. BACKGROUND: The rapid diffusion of the SARS-CoV-2 together with the need for isolation for infected patients might be responsible for a suboptimal treatment for SARS-CoV-2 ACS patients. Recently, the group of Sichuan published a protocol for COVID/ACS infected patients that see the thrombolysis as the gold standard of care. METHODS: We enrolled 31 consecutive patients affected by SARS-COV-2 admitted to our emergencies room for suspected ACS. RESULTS: All patients underwent urgent coronary angiography and percutaneous coronary intervention (PCI) when required except two patients with severe hypoxemia and unstable hemodynamic condition that were conservatively treated. Twenty-one cases presented diffuse ST-segment depression while in the remaining cases anterior and inferior ST-elevation was present in four and six cases, respectively. PCI was performed in all cases expect two that were diagnosed as suspected myocarditis because of the absence of severe coronary disease and three with apical ballooning at ventriculography diagnostic for Tako-Tsubo syndromes. Two patients conservatively treated died. The remaining patients undergoing PCI survived except one that required endotracheal intubation (ETI) and died at Day 6. ETI was required in five more patients while in the remaining cases CPAP was used for respiratory support. CONCLUSIONS: Urgent PCI for ACS is often required in SARS-CoV-2 patients improving the prognosis in all but the most advanced patients. Complete patient history and examination, routine ECG monitoring, echocardiography, and careful evaluation of changes in cardiac enzymes should be part of the regular assessment procedures also in dedicated COVID positive units.

Mortality Risk Assessment Using CHA(2)DS(2)-VASc Scores in Patients Hospitalized With Coronavirus Disease 2019 Infection.

Early risk stratification for complications and death related to Coronavirus disease 2019 (COVID-19) infection is needed. Because many patients with COVID-19 who developed acute respiratory distress syndrome have diffuse alveolar inflammatory damage associated with microvessel thrombosis, we aimed to investigate a common clinical tool, the CHA(2)DS(2)-VASc, to aid in the prognostication of outcomes for COVID-19 patients. We analyzed consecutive patients from the multicenter observational CORACLE registry, which contains data of patients hospitalized for COVID-19 infection in 4 regions of Italy, according to data-driven tertiles of CHA(2)DS(2)-VASc score. The primary outcomes were inpatient death and a composite of inpatient death or invasive ventilation. Of 1045 patients in the registry, 864 (82.7%) had data available to calculate CHA(2)DS(2)-VASc score and were included in the analysis. Of these, 167 (19.3%) died, 123 (14.2%) received invasive ventilation, and 249 (28.8%) had the composite outcome. Stratification by CHA(2)DS(2)-VASc tertiles (T1: ≤1; T2: 2 to 3; T3: ≥4) revealed increases in both death (8.1%, 24.3%, 33.3%, respectively; p <0.001) and the composite end point (18.6%, 31.9%, 43.5%, respectively; p <0.001). The odds ratios for mortality and the composite end point for T2 patients versus T1 CHA(2)DS(2)-VASc score were 3.62 (95% CI:2.29 to 5.73,p <0.001) and 2.04 (95% CI:1.42 to 2.93, p <0.001), respectively. Similarly, the odds ratios for mortality and the composite end point for T3 patients versus T1 were 5.65 (95% CI:3.54 to 9.01, p <0.001) and 3.36 (95% CI:2.30 to 4.90,p <0.001), respectively. In conclusion, among Italian patients hospitalized for COVID-19 infection, the CHA(2)DS(2)-VASc risk score for thromboembolic events enhanced the ability to achieve risk stratification for complications and death.

Acute Pulmonary Embolism in SARS-CoV-2 Infection Treated With Surgical Embolectomy.

A cluster of pneumonia cases caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly throughout China, Europe, and the United States. The pneumonia might evolve to acute respiratory distress syndrome, requiring assisted mechanical ventilation. The prolonged immobilization combined with respiratory failure, sepsis, and dehydration might expose SARS-CoV-2 patients to increased risk of complication, including pulmonary embolism. We report a case of SARS-CoV-2 complicated by a massive pulmonary embolism in a patient who underwent successful surgical embolectomy. We believe that maintaining the same proactive attitude suggested by current European Society of Cardiology and European Respiratory Society guidelines might help in reducing morality and improving survival in SARS-COV-2 patients.

Decrease and Delay in Hospitalization for Acute Coronary Syndromes During the 2020 SARS-CoV-2 Pandemic.

The diffusion of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) forced the Italian population to restrictive measures that modified patients' responses to non-SARS-CoV-2 medical conditions. We evaluated all patients with acute coronary syndromes admitted in 3 high-volume hospitals during the first month of SARS-CoV-2 Italian-outbreak and compared them with patients with ACS admitted during the same period 1 year before. Hospitalization for ACS decreased from 162 patients in 2019 to 84 patients in 2020. In 2020, both door-to-balloon and symptoms-to-percutaneous coronary intervention were longer, and admission levels of high-sensitive cardiac troponin I were higher. They had a lower discharged residual left-ventricular function and an increased predicted late cardiovascular mortality based on their Global Registry of Acute Coronary Events (GRACE) scores.

Organizational determinants of hospital stay: establishing the basis of a widespread action on more efficient pathways in medical units.

Given the high hospital costs, the increasing clinical complexity and the overcrowding of emergency departments, it is crucial to improve the efficiency of medical admissions. We aimed at isolating organizational drivers potentially targetable through a widespread improvement action. We studied all medical admissions in a large tertiary referral hospital from January 1st to December 31st, 2018. Data were retrieved from the administrative database. Available information included age, sex, type (urgent or elective) and Unit of admission, number of internal transfers, main ICD-9 diagnosis, presence of cancer among diagnoses, surgical or medical code, type of discharge, month, day and hour of admission and discharge. National Ministry of Health database was used for comparisons. 8099 admissions were analyzed. Urgent admissions (80.5% of the total) were responsible for longer stays and were the object of the multivariate analysis. The variables most influencing length-of-stay (LOS) were internal transfers and assisted discharge: they contributed, respectively, to 62% and 40% prolongation of LOS. Also, the daily and weekly kinetics of admission accounted for a significant amount of variation in LOS. Long admissions (≥ 30 days) accounted for the 15.5% of total bed availability. Type of discharge and internal transfers were again among the major determinants. A few factors involved in LOS strictly depend on the organizational environment and are potentially modifiable. Re-engineering should be focused on making more efficient internal and external transitions and at ensuring continuity of the clinical process throughout the day and the week.

Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions.

BACKGROUND: Calcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland). METHODS: We retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45-50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE. RESULTS: Angiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patients coronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported. CONCLUSION: The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.

One-Year Clinical Outcomes of Forty-Eight Millimeter Everolimus-Eluting Stent Implanted in Very Long Lesions: A Propensity-Matched Comparison (The FREIUS Study).

BACKGROUND: Long coronary lesions still remain a challenge, with poor immediate results and suboptimal outcomes when compared to class A/B1 lesions. The presence of overlapped segments of metal struts and polymer might trigger an abnormal inflammatory reaction, resulting in a higher restenosis rate. The aim of our study was to evaluate the safety, feasibility, and cost effectiveness of a 48 mm everolimus-eluting stent (EES) during treatment of very long coronary lesions. METHODS AND RESULTS: The FREIUS study is a prospective data collection of consecutive patients undergoing 48 mm EES implantation in six high-volume European centers. Each patient was matched through a propensity score to a comparable patient treated with two or more second-generation overlapped drug-eluting stents. The primary endpoint was the combined incidence of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization (device-oriented composite endpoint [DOCE]). The secondary endpoints were all-cause death, each individual component of the primary endpoint, and definite/probable stent thrombosis. From January 2014 to April 2015, a total of 218 patients were treated with at least one 48 mm EES and were compared with 218 matched controls. Overall, 9% of patients reached the primary endpoint. Cumulative survival free from DOCE incidence did not differ between the two groups (7% in the cases vs 10.5% in the controls; P=.10). After multivariable analysis, only clinical presentation with myocardial infarction (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.5-2.1; P=.01) and stent number (HR, 1.4; 95% CI, 1.1-1.8; P=.02) emerged as independent predictors of DOCE. CONCLUSION: The use of 48 mm EES offers a safe and effective strategy for the treatment of very long coronary lesions.

Optical coherence tomography guidance during bioresorbable vascular scaffold implantation.

Bioresorbable vascular scaffold (BRS) represent a revolutionary concept in interventional cardiology. After initial enthusiasm, recent real world registries, including patients with increasing lesion complexity, reported not trivial rates of scaffold thrombosis (ScT). The importance of correct patients selection as well as technical aspects during BRS implantation procedures has been highlighted in several studies suggesting that the high rate of ScT might be related to uncorrected patients/lesions selection together with underutilization of intracoronary imaging guidance leading to suboptimal BRS implantation. The high-resolution power together with the lack of shadowing observed beyond polymer struts makes optical coherence tomography (OCT) the optimal imaging technique to guide BRS implantation and identifies eventually scaffolds failures.

Ticagrelor versus clopidogrel in real-world patients with ST elevation myocardial infarction: 1-year results by propensity score analysis.

BACKGROUND: European guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population. METHODS: To compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in the Cardio-STEMI Sanremo registry between February 2011 and June 2013. Cases and controls were defined according to P2Y12 inhibitors, correcting the bias due to lack of randomization by propensity score analysis. Ticagrelor was introduced in 2012 in both in-hospital and pre-hospital settings independently of this study. RESULTS: Of the 416 patients enrolled in the Cardio-STEMI registry, 401 with a definite diagnosis of STEMI were included in this study. One hundred forty-two patients received ticagrelor and 259 received clopidogrel. Regarding clinical presentation and procedural data, those in the ticagrelor group had lower CRUSADE scores (23 [14-36] vs 27 [18-38]; p = 0.015] but a higher proportion of radial access (33% vs 14%; p < 0.001), percutaneous coronary intervention (PCI; 92% vs 81 %; p = 0.002) and primary PCI ≤ 12 h (82% vs 66%; p = 0.001). The patients in the ticagrelor group had a higher procedural success rate (100% vs. 96%; p = 0.044). There was no difference in Bleeding Academic Research Consortium bleeding and in unadjusted incidence of hospital major adverse cardiovascular events (MACE; cardiac death, myocardial infarction, or stroke) but there was a significant reduction in unadjusted cardiac hospital death in the ticagrelor group (0.7% vs 5.4%; p = 0.024). After correcting for propensity score, hospital death (p = 0.22) and hospital MACE (p = 0.96) did not differ in both groups. The unadjusted survival at 1 year after STEMI was higher in the ticagrelor group (97.8% vs 87.8%; p = 0.024), and this result was confirmed by propensity score analysis (hazard ratio = 0.29 [0.08-0.99]; p = 0.048). CONCLUSIONS: In this real-word propensity score analysis, ticagrelor did not affect the risk of MACE during the hospital phase, or the incidence of hospital bleeding in patients with STEMI. However, in this mono-centric experience, ticagrelor resulted in improved 1-year survival, even after correction by propensity score.

Time-related changes in neointimal tissue coverage of a novel Sirolimus eluting stent: Serial observations with optical coherence tomography.

BACKGROUND: DES has reduced rates of restenosis compared with BMS but it has been associated with delayed healing and increase of stent thrombosis. The aim of our study was to evaluate the vascular time-related changes following implantation of a new SES coated with an amorphous silicon carbide that allows faster re-endothelisation (Orsiro-Biotronik). METHODS: This prospective registry enrolled STEMI-patients with multi-vessel disease, thus candidates for a two-step procedure. PCI of the culprit lesion was performed with at least one Orsiro stent that was OCT-analysed during the second-step procedure (deferred to 30,90 and 180-days). RESULTS: 16 of the 95 patients with MVD underwent an OCT evaluation of the study device implanted in the culprit lesion during the second-step staged procedure and were enrolled in the present Registry. A total of 3060-struts were analysed. The percentage of uncovered struts was 19.6% at30-days, 1.3% at90-days and 1.8% at180-days (p<0.001). The percentage of cross section with ≥1 uncovered struts were 51.3% at30-days, 6.5% at90-days and 5.7% at180-days (p<0.001). The percentage of cross sections containing thrombus was 6.2% at30-days while no thrombus was detected both at90 and 180-days. CONCLUSIONS: Our data shows that the new Orsiro stent promotes early and persistent strut coverage with low peri-strut thrombus. This pilot OCT evaluation might suggest a low incidence of late adverse events and anticipate safe outcome after early withdrawal of dual antiplatelet therapy.

Indications and immediate and long-term results of a novel pericardium covered stent graft: Consecutive 5 year single center experience.

BACKGROUND: The use of covered stent grafts during percutaneous coronary intervention (PCI) is a life saving solution to seal acute iatrogenic vessel rupture. However, the presence of an impenetrable mechanical barrier is also appealing during treatment of friable coronary plaques but the synthetic PTFE-membrane that might trigger excessive neointimal proliferation has limited its elective-use. Pericardium tissue may offer an appealing "natural" alternative. Aim of our study is to report the consecutive 5-year single center experience with the use of pericardium-covered stents (PCS) (ITGI-Medical, Israel) in a variety of emergency and elective applications. METHODS: Nineteen consecutive patients undergoing implantation of PCS at the Royal Brompton in the last 5-years. Reasons for PCS implantation included treatment of degenerated vein grafts, large coronary aneurysms, and acute iatrogenic vessel rupture. RESULTS: Angiographic success, defined as the ability of the device to be deployed in the indexed lesion with no contrast extravasation with residual angiographic stenosis <30% and a final thrombolysis in myocardial infarction (TIMI)-3 flow was achieved in all cases. Procedural success, defined as the achievement of angiographic success without any major adverse cardiovascular event (MACE) was achieved in 94.7% of patients. In-stent restenosis (ISR) was observed in 26.3% and all patients underwent successful target vessel revascularization with DES (mean time to restenosis 9.0 ± 4.0 months). At a mean follow-up of 32.5 ± 23.3 months no acute or late stent thrombosis was observed. CONCLUSION: PCSs were effective in the treatment of friable embolization-prone coronary plaques, sealing of acute iatrogenic vessel rupture and exclusion of large aneurysms with no thrombosis but high target lesion revascularization.

Long-term survival in patients treated with cardiac resynchronization therapy: a 3-year follow-up study from the InSync/InSync ICD Italian Registry.

BACKGROUND: Studies reporting the long-term survival of patients treated with cardiac resynchronization therapy (CRT) outside the realm of randomized controlled trials are still lacking. The aim of this study was to quantify the survival of patients treated with CRT in clinical practice and to investigate the long-term effects of CRT on clinical status and echocardiographic parameters. METHODS: The study population consisted of 317 consecutive patients with implanted CRT devices from eight Italian University/Teaching Hospitals. The patients were enrolled in a national observational registry and had a minimum follow-up of 2 years. A visit was performed in surviving patients and mortality data were obtained by hospital file review or direct telephone contact. RESULTS: During the study period, 83 (26%) patients died. The rate of all-cause mortality was significantly higher in ischemic than nonischemic patients (14% vs 8%, P = 0.002). Multivariate analysis showed that ischemic etiology (HR 1.72, CI 1.06-2.79; P = 0.028) and New York Heart Association (NYHA) class IV (HR 2.87, CI 1.24-6.64; P = 0.014) were the strongest predictors of all-cause mortality. The effects of CRT persisted at long-term follow-up (for at least 2 years) in terms of NYHA class improvement, increase of left ventricular ejection fraction, decrease of QRS duration (all P = 0.0001), and reduction of left ventricular end-diastolic and end-systolic diameters (P = 0.024 and P = 0.011, respectively). CONCLUSIONS: During long-term (3 years) follow-up after CRT, total mortality rate was 10%/year. The outcome of ischemic patients was worse mainly due to a higher rate of death from progressive heart failure. Ischemic etiology along with NYHA class IV was identified as predictors of death. Benefits of CRT in terms of clinical function and echocardiographic parameters persisted at the time of long-term follow-up.

Percutaneous catheter cryothermal ablation of atrioventricular nodal reentrant tachycardia: efficacy and safety of a new ablation technique.

BACKGROUND: Radiofrequency catheter ablation is nowadays a widely used technique for the treatment of arrhythmias; however, due to the possible complications such as atrioventricular block when radiofrequency is delivered in the septal area, this type of energy is not optimal. In contrast, cryoenergy has several positive features; first of all, it allows for the creation of reversible lesions and hence to test the effects of the ablation while the lesion is still forming thus reducing the number of ineffective and useless lesions. In addition, it also allows for the evaluation of the acute effects on the structures adjacent to the ablation site. The aim of the present study was to analyze the effectiveness and safety of catheter cryoablation in the treatment of atrioventricular nodal reentrant tachycardia (AVNRT). METHODS: Thirty-two patients presenting with AVNRT underwent catheter cryoablation using a 7F catheter. When the optimal parameters were recorded, "ice mapping" at -30 degrees C was performed for 80 s to validate the ablation site by means of a reversible lesion. If the expected result was achieved, the cryoablation was carried out lowering the temperature to -75 degrees C for 4 min thus creating a permanent lesion. RESULTS: Slow pathway ablation guided by a slow pathway potential was successfully performed in 31 out of the 32 patients with a mean of 2.6 +/- 1.0 cryoapplications. No complications occurred in any patients. Transient AH prolongation was observed in 2 patients in a midseptal site during the ice mapping phase of AVNRT ablation. CONCLUSIONS: Cryoablation is a safe and effective technique for AVNRT ablation. It may be useful particularly when the ablation must be performed close to the atrioventricular node or His bundle, due to the possibility of validating the site of ablation by means of ice mapping that creates only a reversible lesion.

Combined use of morphology discrimination, sudden onset, and stability as discriminating algorithms in single chamber cardioverter defibrillators.

Morphology Discrimination (MD) is a rhythm discriminator based on QRS morphology analysis that can be combined with other discriminators like Stability, with or without Sinus Interval History (SIH) and Sudden Onset. Thirty-five patients implanted with a St. Jude Medical single chamber ICD were evaluated during exercise testing, during induced AF, and during follow-up for 14 +/- 5 months. At exercise testing (60 episodes detected) MD had a specificity (SP) of 96.7% and Sudden Onset a SP of 91.7%; during induced AF (25 episodes) both MD and Stability had a SP of 96.0%. The diagnostic performance on spontaneous arrhythmias was as follows: for ventricular tachycardia (126 episodes) a sensitivity (SE) of 94.4% for MD, 92.1% for Sudden Onset, 89.7% for Stability without SIH and 79.4% for Stability + SIH; for sinus tachycardia (44 episodes) a SP of 86.4% for MD, 97.7% for Sudden Onset, 2.3% for Stability and of 95.5% for Stability + SIH. For AF (165 cases) a SP of 67.9% for MD, 69.1% for Stability and 90.3% for Stability + SIH, 44.8% for Sudden Onset. Use of MD alone provided a SE of 94.4% and a SP of 71.4% for spontaneous arrhythmias and combined use of the discriminators in a "2 of 3" diagnostic logic implied a SP of 90.9% with maintenance of 96.0% of SE. In single chamber ICDs a wide range of SE/SP ratios may be obtained by use of multiple discriminators, but use of the algorithm in a 2 of 3 diagnostic logic may achieve a SP of 90.9% and a SE of 96.0%.