Reshaping of Italian Echocardiographic Laboratories Activities during the Second Wave of COVID-19 Pandemic and Expectations for the Post-Pandemic Era.

BACKGROUND: Cardiology divisions reshaped their activities during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to analyze the organization of echocardiographic laboratories and echocardiography practice during the second wave of the COVID-19 pandemic in Italy, and the expectations for the post-COVID era. METHODS: We analyzed two different time periods: the month of November during the second wave of the COVID-19 pandemic (2020) and the identical month during 2019 (November 2019). RESULTS: During the second wave of the COVID-19 pandemic, the hospital activity was partially reduced in 42 (60%) and wholly interrupted in 3 (4%) echocardiographic laboratories, whereas outpatient echocardiographic activity was partially reduced in 41 (59%) and completely interrupted in 7 (10%) laboratories. We observed an important change in the organization of activities in the echocardiography laboratory which reduced the operator-risk and improved self-protection of operators by using appropriate personal protection equipment. Operators wore FFP2 in 58 centers (83%) during trans-thoracic echocardiography (TTE), in 65 centers (93%) during transesophageal echocardiography (TEE) and 63 centers (90%) during stress echocardiography. The second wave caused a significant reduction in number of echocardiographic exams, compared to November 2019 (from 513 ± 539 to 341 ± 299 exams per center, -34%, p < 0.001). On average, there was a significant increase in the outpatient waiting list for elective echocardiographic exams (from 32.0 ± 28.1 to 45.5 ± 44.9 days, +41%, p < 0.001), with a reduction of in-hospital waiting list (2.9 ± 2.4 to 2.4 ± 2.0 days, -17%, p < 0.001). We observed a large diffusion of point-of-care cardiac ultrasound (88%), with a significant increase of lung ultrasound usage in 30 centers (43%) during 2019, extended to all centers in 2020. Carbon dioxide production by examination is an indicator of the environmental impact of technology (100-fold less with echocardiography compared to other cardiac imaging techniques). It was ignored in 2019 by 100% of centers, and currently it is considered potentially crucial for decision-making in cardiac imaging by 65 centers (93%). CONCLUSIONS: In one year, major changes occurred in echocardiography practice and culture. The examination structure changed with extensive usage of point-of-care cardiac ultrasound and with lung ultrasound embedded by default in the TTE examination, as well as the COVID-19 testing.

Device closure for patent foramen ovale in patients with cryptogenic stroke: which patients should get it?

Patent foramen ovale (PFO) and cryptogenic stroke (CS) both have a high prevalence. The optimal treatment to reduce stroke recurrence after CS remains controversial. Results from clinical trials, meta-analyses, and position papers, support percutaneous PFO device closure and medical therapy compared to medical therapy alone. However, the procedure may be associated with cardiac complications including an increased incidence of new atrial fibrillation. The benefit/risk balance should be determined on a case-by-case basis with the greatest benefit of PFO closure in patients with atrial septal aneurysm and PFO with large shunts. Future studies should address unsolved questions such as the choice of medical therapy in patients not undergoing closure, the duration of antiplatelet therapy, and the role of PFO closure in patients over 60 years old.

Mortality and timing of surgery in the left-sided infective endocarditis: an Italian multicentre study.

OBJECTIVES: Observational studies on early surgery in infective endocarditis have conflicting results. This study aims to compare the treatment strategies for early surgery (within 2 weeks of diagnosis) and late surgery/medical therapy in terms of survival among patients with the left-sided infective endocarditis. METHODS: This study included patients with the left-sided infective endocarditis registered between 2006 and 2010 in the Italian Registry of Infective Endocarditis (RIEI). A Cox proportional hazards model was used to estimate the effect of these treatment strategies on overall survival and included sociodemographic and clinical characteristics associated with treatment, risk factors for mortality and early surgery as a time-dependent covariate to avoid indication and immortal time biases. RESULTS: Among the 502 patients included, 184 (36.7%) underwent early surgery. Of the remaining 318 patients, 138 underwent late surgery. The early surgery group had fewer patients with comorbidities and with enterococcus as the causative microorganism, but this group had more complicated cardiac conditions. No difference in mortality risk was estimated between the treatment groups including early surgery as time-dependent variables (adjusted hazard ratio = 0.95, 95% confidence interval 0.55-1.63), while a distorted and overestimated beneficial effect of surgery was estimated considering surgery as a non-time-dependent variable (adjusted hazard ratio 0.41, 95% confidence interval 0.25-0.70). CONCLUSIONS: Our study did not confirm a better overall survival in patients undergoing early surgery. However, even with the use of statistical techniques to control biases, we could not draw definitive conclusions that early surgery is not beneficial. Our results need to be assessed by randomized trials before any changes in clinical practice can be recommended.

Characteristics, in-hospital management and outcome of late acute ST-elevation myocardial infarction presenters.

BACKGROUND: Patients with delayed presentation of acute myocardial infarction with ST-segment elevation (STEMI) frequently have a poor prognosis but literature about acute complications in intensive cardiac care unit (ICCU) and in-hospital outcome are still limited. METHODS: All STEMI patients admitted to our institution between June 2007 and December 2013 were divided into patients presenting more than 12 h after symptom onset (lateSTEMI) and within 12 h (STEMI). Baselines clinical features including details about treatment of choice were collected. Major acute complications in ICCU and in-hospital mortality were the main end-points. RESULTS: A total of 1372 patients were included, 147 (10.8%) were lateSTEMI. In ICCU lateSTEMI patients compared with STEMI patients experienced more frequently heart failure (75, 51.2% vs. 298, 24.3%; P < 0.001), atrial fibrillation (26, 17.7% vs. 130, 10.6%; P = 0.011), complete atrioventricular block (16, 10.9% vs. 63, 5.1%; P = 0.005), stroke (5, 3.4% vs. 5, 0.4%; P < 0.001), myocardial rupture (6, 4.1% vs. 3, 0.2%; P < 0.001), with higher administration of noninvasive ventilation support therapy (13, 9.8% vs. 44, 3.6%; P = 0.001) and the intra-aortic balloon counter-pulsation use (14, 10.3% vs. 102, 8.3%; P = 0.038). Intrahospital mortality was significantly higher in the lateSTEMI group (19, 13.4% vs. 69, 5.6%; P = 0.001). At the multiple regression analysis age [odds ratio (OR) 2.2 (1.46-2.92.; P = 0.01)], diabetes [OR 2.37 (1.38-4.07); P = 0.002] intra-aortic balloon counter-pulsation implantation [OR 2.78 (1.30-5.9); P = 0.03] and late presentation more than 12 h [2.52 (1.35-4.69); P = 0.001] resulted independently correlated with in-hospital mortality while a successful percutaneous coronary intervention procedure was protective [OR 0.15 (0.08-0.27); P = 0.003; all 95% confidence interval). CONCLUSION: Late presenters STEMI patients present a worse risk profile and prognosis compared with patients who arrive less than 12 h from onset of symptoms. Because of the presence of serious complications such as heart rupture or stroke a careful clinic and echocardiographic monitoring is strongly advisable in these population.

Clinical epidemiology in Italian Registry of Infective Endocarditis (RIEI): Focus on age, intravascular devices and enterococci.

INTRODUCTION: The epidemiology of infective endocarditis (IE) is changing due to a number of factors, including aging and health related comorbidities and medical procedures. The aim of this study is to describe the main clinical, epidemiologic and etiologic changes of IE from a large database in Italy. METHODS: We prospectively collected episodes of IE in 17 Italian centers from July 2007 to December 2010. RESULTS: We enrolled 677 patients with definite IE, of which 24% health-care associated. Patients were male (73%) with a median age of 62 years (IQR: 49-74) and 61% had several comorbidities. One hundred and twenty-eight (19%) patients had prosthetic left side IE, 391 (58%) native left side IE, 94 (14%) device-related IE and 54 (8%) right side IE. A predisposing cardiopathy was present in 50%, while odontoiatric and non odontoiatric procedures were reported in 5% and 21% of patients respectively. Symptoms were usually atypical and precocious. The prevalent etiology was represented by Staphylococcus aureus (27%) followed by coagulase-negative staphylococci (CNS, 21%), Streptococcus viridans (15%) and enterococci (14%). CNS and enterococci were relatively more frequent in patients with intravascular devices and prosthesis and S. viridans in left native valve. Diagnosis was made by transthoracic and transesophageal echocardiography in 62% and 94% of cases, respectively. The in-hospital mortality was 14% and 1-year mortality was 21%. CONCLUSION: The epidemiology is changing in Italy, where IE more often affects older patients with comorbidities and intravascular devices, with an acute onset and including a high frequency of enterococci. There were few preceding odontoiatric procedures.

Colchicine for the prevention of pericarditis: what we know and what we do not know in 2014 - systematic review and meta-analysis.

AIMS: The purpose of this study was to investigate and summarize available evidence on the efficacy and safety of colchicine for pericarditis prevention. Disease recurrence is the major and most common complication of pericarditis and its prevention may reduce morbidity and management costs. Colchicine has been intensively studied in the last decade for pericarditis prevention. METHODS: Controlled clinical studies were searched in several databases and were included provided they focused on the pharmacologic primary or secondary prevention of pericarditis. We performed a meta-analysis including studies of primary outcome, adverse events and drug withdrawal. RESULTS: From the initial sample of 175 citations, seven controlled clinical trials were finally included (1275 patients): five studies were double-blind randomized controlled trials (RCT), and two studies were open-label RCTs. Trials followed patients for a mean of 19 months. Meta-analytic pooling showed that colchicine use was associated with a reduced risk of pericarditis during follow-up [odds ratio (OR) 0.33 (0.25-0.44), P for effect <0.001, P for heterogeneity 0.98, I = 0%] either for primary or secondary prevention without a significant higher risk of adverse events [OR 1.28 (0.84-1.93), P for effect = 0.25, P for heterogeneity = 0.72, I = 0%], and drug withdrawals compared with placebo [OR 1.54 (0.98-2.41), P for effect = 0.06, P for heterogeneity = 0.54, I = 0%]. Gastrointestinal intolerance is the most frequent side-effect (mean incidence 8%), but no severe adverse events were recorded. CONCLUSION: Colchicine is well tolerated and efficacious for the primary and secondary prevention of pericarditis without a significant increase of the risk of side-effects and drug withdrawals.

Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial.

BACKGROUND: Colchicine is effective for the treatment of acute pericarditis and first recurrences. However, conclusive data are lacking for the efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis. METHODS: We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (≥two) were randomly assigned (1:1) to placebo or colchicine (0·5 mg twice daily for 6 months for patients weighing more than 70 kg or 0·5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00235079. FINDINGS: 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21·6%) of 120 in the colchicine group and 51 (42·5%) of 120 in the placebo group (relative risk 0·49; 95% CI 0·24-0·65; p=0·0009; number needed to treat 5). Adverse effects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported. INTERPRETATION: Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications. FUNDING: Azienda Sanitaria 3 of Torino (now ASLTO2).

A randomized trial of colchicine for acute pericarditis.

BACKGROUND: Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. METHODS: In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. RESULTS: A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; P<0.001). Colchicine reduced the rate of symptom persistence at 72 hours (19.2% vs. 40.0%, P=0.001), the number of recurrences per patient (0.21 vs. 0.52, P=0.001), and the hospitalization rate (5.0% vs. 14.2%, P=0.02). Colchicine also improved the remission rate at 1 week (85.0% vs. 58.3%, P<0.001). Overall adverse effects and rates of study-drug discontinuation were similar in the two study groups. No serious adverse events were observed. CONCLUSIONS: In patients with acute pericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

HACEK infective endocarditis: characteristics and outcomes from a large, multi-national cohort.

The HACEK organisms (Haemophilus species, Aggregatibacter species, Cardiobacterium hominis, Eikenella corrodens, and Kingella species) are rare causes of infective endocarditis (IE). The objective of this study is to describe the clinical characteristics and outcomes of patients with HACEK endocarditis (HE) in a large multi-national cohort. Patients hospitalized with definite or possible infective endocarditis by the International Collaboration on Endocarditis Prospective Cohort Study in 64 hospitals from 28 countries were included and characteristics of HE patients compared with IE due to other pathogens. Of 5591 patients enrolled, 77 (1.4%) had HE. HE was associated with a younger age (47 vs. 61 years; p<0.001), a higher prevalence of immunologic/vascular manifestations (32% vs. 20%; p<0.008) and stroke (25% vs. 17% p = 0.05) but a lower prevalence of congestive heart failure (15% vs. 30%; p = 0.004), death in-hospital (4% vs. 18%; p = 0.001) or after 1 year follow-up (6% vs. 20%; p = 0.01) than IE due to other pathogens (n = 5514). On multivariable analysis, stroke was associated with mitral valve vegetations (OR 3.60; CI 1.34-9.65; p<0.01) and younger age (OR 0.62; CI 0.49-0.90; p<0.01). The overall outcome of HE was excellent with the in-hospital mortality (4%) significantly better than for non-HE (18%; p<0.001). Prosthetic valve endocarditis was more common in HE (35%) than non-HE (24%). The outcome of prosthetic valve and native valve HE was excellent whether treated medically or with surgery. Current treatment is very successful for the management of both native valve prosthetic valve HE but further studies are needed to determine why HE has a predilection for younger people and to cause stroke. The small number of patients and observational design limit inferences on treatment strategies. Self selection of study sites limits epidemiological inferences.

Efficacy and safety of colchicine for pericarditis prevention. Systematic review and meta-analysis.

OBJECTIVES: The purpose of this study was to investigate the efficacy and safety of colchicine for pericarditis prevention. BACKGROUND: Recurrent pericarditis prevention is a major management goal that may reduce morbidity and management costs. Although empiric anti-inflammatory therapy is considered the mainstay of treatment, no specific drug has been proven to be efficacious for prevention but colchicine. METHODS: Controlled clinical studies were searched in several databases and were included provided they focused on the pharmacologic primary or secondary prevention of pericarditis. We performed a meta-analysis including studies primary outcome, adverse events, and drug withdrawal. RESULTS: From the initial sample of 127 citations, five controlled clinical trials were finally included (795 patients): three studies were double-blind randomised controlled trials, and two studies were open-label randomised controlled trials. Trials followed patients for a mean of 13 months. Meta-analytic pooling showed that colchicine use was associated with a reduced risk of pericarditis during follow-up (RR=0.40, 95% CI 0.30 to 0.54, p for effect <0.001, p for heterogeneity = 0.95, I(2)=0%) either for primary or secondary prevention without a significant higher risk of adverse events compared with placebo (RR=1.22, 95% CI 0.71 to 2.10, p for effect 0.48, p for heterogeneity = 0.44, I(2)=0%), but more cases of drug withdrawals (RR=1.85, 95% CI 1.04 to 3.29, p for effect 0.04, p for heterogeneity = 0.42, I(2)=0%). Gastrointestinal intolerance is the most frequent side effect (mean incidence 8%), but no severe adverse events were recorded. CONCLUSIONS: Available evidence suggests that colchicine is safe and efficacious for the primary and secondary prevention of pericarditis.

Frequency and prognostic significance of pericarditis following acute myocardial infarction treated by primary percutaneous coronary intervention.

Prospective data were collected from 743 consecutive patients with ST-segment elevation acute myocardial infarctions (AMIs) treated with primary percutaneous coronary intervention (mean age 65.3 +/- 11.6 years, 36.7% women). Early post-AMI pericarditis was diagnosed in 31 patients (4.2%; mean age 62.1 +/- 13.4 years, 41.9% women), with an increasing prevalence according to presentation delay (p <0.001): 1.7% for <3 hours, 5.4% for 3 to 6 hours, and 13.6% for >6 hours. Late post-AMI pericarditis (Dressler syndrome) was recorded in only 1 patient (0.1%). On multivariate analysis, patients with presentation times >6 hours (odds ratio 4.4, 95% confidence interval 2.0 to 9.8, p <0.001) and primary percutaneous coronary intervention failure (odds ratio 2.8, 95% confidence interval 1.1 to 7.4, p = 0.032) were at increased risk for developing early post-AMI pericarditis. Although pericarditis is associated with a larger infarct size, in-hospital and 1-year mortality and major adverse cardiac events were similar in patients with and without pericarditis. In conclusion, early primary percutaneous coronary intervention may reduce the occurrence of early post-AMI pericarditis within the first 3 hours of symptom onset. Early post-AMI pericarditis remains a marker of larger infarct size but without independent prognostic significance.

Infective endocarditis in drug addicts: role of HIV infection and the diagnostic accuracy of Duke criteria.

BACKGROUND: Intravenous drug users (IVDUs) are at increased risk of infective endocarditis. Moreover, HIV infection is common in IVDUs, with a reported prevalence of 40-90%. The clinical features of IVDUs with infective endocarditis and HIV infection may be peculiar. Few data have been reported on the diagnostic accuracy of Duke criteria in IVDUs with or without HIV infection, and a comparison of these two populations is lacking. METHODS: The present study aimed to compare prospectively the clinical features of patients with infective endocarditis with or without HIV infection and to evaluate the diagnostic accuracy of Duke criteria in these patients. The study population consisted of 201 consecutive adult IVDUs with a suspected infective endocarditis (102 patients with HIV infection and 99 patients without HIV infection). RESULTS: Infective endocarditis was the final diagnosis in 40 of 102 patients (38.2%) with HIV infection and in 55 of 99 HIV-negative patients (55.6%). Despite similar baseline features, longer vegetations were recorded in infective endocarditis without HIV infection (23.7 +/- 7.1 mm versus 13.6 +/- 6.8 mm; P = 0.001). Patients with infective endocarditis and HIV infection had a higher total mortality at 2 months (respectively 12.5% versus 1.8%; P = 0.09); almost all the deaths were recorded in patients with AIDS or a CD4 cell count below 200 per microl, and no deaths were recorded in patients with HIV infection and a CD4 cell count > 500 per microl. CONCLUSIONS: Despite no identical clinical features, Duke criteria had a similar sensitivity, specificity and diagnostic accuracy in IVDUs with and without HIV infection.

Are the Duke criteria really useful for the early bedside diagnosis of infective endocarditis? Results of a prospective multicenter trial.

BACKGROUND: To date, no studies have evaluated the usefulness of the Duke vs the modified Duke criteria for the early diagnosis of infective endocarditis (IE), nor is it known whether a probabilistic approach may be useful in establishing an early clinical diagnosis of IE. The aim of this study was (1) to assess and compare the clinical usefulness of the Duke vs the modified Duke criteria for the early diagnosis of IE, and (2) to evaluate the diagnostic utility of a probabilistic approach based on the echocardiographic criterion. METHODS: From January 2000 to December 2001, 267 consecutive patients with suspected IE were enrolled in a prospective multicenter trial. RESULTS: IE was diagnosed in 147 cases (55%) and rejected in 120 cases (45%). The Duke and the modified Duke criteria had a high similar sensitivity, specificity and accuracy. The time to diagnosis was 8.15 +/- 7.4 days for the Duke criteria and 8.18 +/- 7.1 days for the modified Duke criteria. The time to diagnosis based on a probabilistic approach was shorter than that based on the Duke and the modified Duke criteria (4.96 +/- 7.1 days, for all p < 0.001). CONCLUSIONS: Although the Duke and the modified Duke criteria have a very similar sensitivity, specificity and accuracy, the delay in the time to diagnosis may be significant. A probabilistic approach based on clinical suspicion and echocardiographic evidence may be useful for decision-making, whilst awaiting case definition by means of the Duke criteria.

New trends in the epidemiological and clinical features of infective endocarditis: results of a multicenter prospective study.

BACKGROUND: The clinical and epidemiological profiles of infective endocarditis (IE) are continuously evolving. We report the results of a 2-year multicenter prospective survey that investigated new trends in the epidemiology, microbiological and clinical features and the prognosis of IE. METHODS: From January 2000 through December 2001, a prospective multicenter survey on IE was conducted in the region of Piedmont, Italy (4.2 million inhabitants). RESULTS: A total of 267 patients with suspected IE were enrolled, of whom 147 received a definite diagnosis of IE, as confirmed by pathology or follow-up data. The annual estimated incidence of IE was 36 cases per 1 million inhabitants in urban Turin and 30 cases per 1 million inhabitants in the province of Turin. A predisposing heart disease was detected in 70.8% of cases, with prosthetic valve involvement in 27 (18%). The incidence of injection drug use was 10%. Twenty-two cases (15%) were related to invasive procedures. Causative microorganisms included: streptococci 37.4% (oral streptococci 17.7%, group D streptococci 9.5%, pyogenic streptococci 3.4%, enterococci 6.8%), staphylococci 34%, other pathogens 28.5%. Blood cultures were negative in 25% of cases. The mean time between symptom onset and hospital admission was 39.7 days; this interval was shorter and associated with a poorer prognosis in cases of IE due to Staphylococcus aureus infection (p < 0.001). The delay in carrying out echocardiographic and blood culture evaluation often led to a late diagnosis as defined by the Duke criteria (8.2 +/- 7.4 days after admission). Valve surgery was performed in 31% of patients. The in-hospital mortality was 14% and that at 3 months 18%. CONCLUSIONS: In Piedmont, the incidence of IE is similar to the rates reported in other recent series. Still, the diagnosis and management of IE remain a challenge. The variegated clinical manifestations of IE and its changing epidemiology require constant surveillance.