Massimo Giammaria

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.

Incidence, Management, and Immediate- and Long-Term Outcomes After Iatrogenic Aortic Dissection During Diagnostic or Interventional Coronary Procedures

Background— Aortic dissection type A is a disease with high mortality. Iatrogenic aortic dissection after interventional procedures is infrequent, and prognostic data are scarce. Our objective was to analyze its incidence, patient profile, and long-term prognosis. Methods and Results— Between 2000 and 2014, we retrospectively analyzed 74 patients with dissection of the ascending aorta. Clinical and procedural data were reviewed, and later, we performed a prospective clinical follow-up by telephone or in the office. The incidence of aortic dissection was 0.06%. Our patients, predominantly male (67.6%), had a mean age of 66.9±10.8 years. With multiple cardiovascular risk factors, the main reason for cardiac catheterization was an acute coronary syndrome (n=54). The complication was detected acutely in all, trying to engage the right coronary artery in 47 and the left main artery in 30 and after other maneuvers in 2, mostly complex therapeutic procedures (78.4%). A coronary artery was involved in 45 patients (60.8%). Thirty-five patients underwent an angioplasty and stent implantation; 3 had cardiac surgery; and 36 were managed conservatively. Two patients died of cardiogenic shock after the dissection. After a median follow-up of 51.2 months (range, 16.4–104.8 months), none of the remaining patients developed complications as a result of the dissection, progression, ischemia, pain, or dissection recurrence. Conclusions— Iatrogenic catheter dissection of the aorta is a rare complication that carries an excellent short- and long-term prognosis with the adoption of a conservative approach. When a coronary artery is involved as an entry point, it usually can be safely sealed with a stent with good long-term outcomes.

The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial

BACKGROUND The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.

The EUROpean and chinese cardiac and renal Remote ischemic Preconditioning study (EURO-CRIPS): Study design and Methods

Aims Contrast-induced nephropathy (CIN) and periprocedural myocardial infarction (PMI) represent frequent complications of percutaneous coronary intervention (PCI) and negatively impact subsequent length of hospitalization, costs of adjunctive diagnostic–therapeutic measures and mid-term cardiovascular events. The aim of the EURO-CRIPS trial is to test whether remote ischemic preconditioning (RIPC) may reduce the incidence of these complications and improve mid-term outcome. Methods This will be a double-blind, randomized, placebo-controlled multicentre study. Patients will be allocated 1 : 1 to RIPC or standard therapy if they were younger than 85 years old, with a renal clearance in the interval 30–60 ml/min/1.73 m2 and candidate to PCI for all clinical indications except for primary PCI in ST segment elevation myocardial infarction (STEMI), unstable haemodynamic presentations or ongoing severe arrhythmias. Incidence of CIN will be the primary end point and the amount of periprocedural cardiac enzyme leakage will be the secondary end point. In addition, we will evaluate whether the preconditioned patients will have a reduction of MACCE at 6 months (major adverse cardiac and cerebrovascular event). Conclusion The EURO-CRIPS Study will be the first large-scale, multicentre clinical trial to test the role of RIPC in current clinical practice. The results of this randomized trial will provide important insights to optimize management strategy of patients undergoing PCI and to improve their outcome.

Trend in implantable cardioverter defibrillators and relation to need.

Background Rates of implantation of implantable cardioverter defibrillators (ICD) have increased continuously ever since they were first introduced. Notwithstanding guidelines endorsed by international scientific organizations, their use varies greatly across industrialized countries. The aim of this study was to assess whether variations in temporal trends and geographical distribution in the use of ICD devices across Piedmont, Northern Italy, are related to variations in need. Methods We calculated ICD implantation rates in the 19 local health units of Piedmont from 1999 to 2006, and correlated their temporal trend with four proxy indicators of need: coronary heart disease (CHD) mortality, CHD hospital discharge rates, cardiac heart failure discharge rates and bisoprolol or carvedilol prescription rates. Results The ICD implantation rate increased five-fold between 1999–2000 and 2005–2006, mainly among the elderly. Implantation rates were five-fold higher in men compared to women for the entire duration of the study. There were significant differences between local health units, which increased over time. Among men there was only a statistically significant correlation with coronary heart disease mortality (r = 0.66) in the period from 2005 to 2006, and with the use of bisoprolol and carvedilol starting from 2001 to 2002. No significant correlation with need indicators was found in women. Conclusion The use of ICD devices increased in apparent response to new research evidence, and, at least in part, in response to need. However, this process only involved men; ICD devices are largely underused in women and without apparent relation to need.

Resource consumption and healthcare costs of acute coronary syndrome: a retrospective observational administrative database analysis.

The objective of this study was to estimate resource consumption and direct healthcare costs of patients with a first hospitalization for acute coronary syndrome (ACS) in 2008 in the Piedmont Region, Italy. Subjects hospitalized with a first episode of ACS in 2008 were selected from the regional hospital discharge database. All hospitalizations, drug prescriptions, and outpatient episodes of care in the 12 months following discharge were considered to estimate resource consumption and direct healthcare costs from the Piedmont Regional Health Service perspective. The analysis was carried out separately for ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), and unstable angina (UA) populations. In the accrual period, 7765 subjects (1.75‰ of the total population) were hospitalized for ACS (64.2% men). The average age was 66.5 for men and 75.4 for women. The average in-hospital mortality was 6.5% (n = 508). The total ACS population was classified as: STEMI 45.2%, NSTEMI 29.4%, and UA 25.4%. The average yearly costs per patient alive at the end of follow-up (n = 6851) were 14,160.8&OV0556; (18,678.7 USD): 83.9% for inpatient admissions [11,881.2&OV0556; (15,671.8 USD)], 9.3% for drugs [1311.6&OV0556; (1730.1 USD)], 5.0% for diagnostic and therapeutic procedures and outpatient visits [708.2&OV0556; (934.1 USD)], and 1.8% for 1-day hospital stays [259.8&OV0556; (342.7 USD)]. The average yearly direct healthcare costs by ACS event were 14,984.5&OV0556; (19,765.2 USD) for STEMI, 14,554.1&OV0556; (19,197.4 USD) for NSTEMI, and 12,481.5&OV0556; (16,463.6 USD) for UA. In each subpopulation, costs were significantly higher for men than for women. ACS imposes a significant burden in terms of morbidity and mortality and generates major public health service costs.

DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention: rationale and design of the DROP trial, a randomized, open-label, multicenter study.

Objectives Evidence to support the use of pericardial drainage instead of simple pericardiocentesis for nonmalignant pericardial effusions refractory to medical therapy is based on observational studies and experts’ opinions, rather than randomized trials. The aim of the present trial is to fill this knowledge gap and to provide a stronger base of evidence to support a specific interventional treatment in this setting. Methods DRainage Or Pericardiocentesis (DROP) alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention is a randomized, open-label and multicenter study. The primary efficacy endpoints are the incidence of recurrent pericardial effusion, and the need for additional pericardiocentesis or cardiac surgery at 12 months. Secondary endpoints are hospital length stay, disease-related admission and overall mortality. Safety and complications rates of each intervention will be also assessed. Implications and conclusion The DROP trial will be the first multicenter randomized trial to evaluate the efficacy and safety of pericardiocentesis versus pericardiocentesis and extended pericardial drainage for recurrent nonmalignant, nonbacterial pericardial effusions refractory to medical therapy and requiring interventional treatments (ClinicalTrials.gov Identifier: NCT01665495).

Optimization of coronary sinus lead placement targeted to the longest right-to-left delay in patients undergoing cardiac resynchronization therapy: The Optimal Pacing SITE 2 (OPSITE 2) acute study and protocol

Left ventricular (LV) lead positioning at the site of delayed electrical activation is associated with better response to cardiac resynchronization therapy (CRT). We hypothesized that a long electrical conduction delay between right ventricular (RV) and coronary sinus (CS) leads during RV pacing (RLD index) is correlated with a better clinical outcome

Automatic atrial capture device control in real-life practice: A multicenter experience

Device‐based fully automatic pacing capture detection is useful in clinical practice and important in the era of remote care management.

The conflicting regulations on the use of magnetic resonance-conditional devices in Italy: is there room to solve this conflict?

The static magnetic field may exert a mechanical effect on the device because of the ferromagnetic and paramagnetic properties of the device. The dynamic magnetic field may be associated with a thermic effect of radiofrequency-induced current on the biological tissues. Gradient magnetic fields may induce interferences possibly causing inappropriate pacing delivery, inhibition or defibrillation. For this reason, manufacturers have started producing devices that reduce the risks of unintended interferences with magnetic resonance. The absence of risks or the presence of acceptable risks are demonstrated by manufacturers and verified by Notified Bodies within the CE certification, as requested by the European Directive (47/2007).