Maurizio D’Amico

Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients

Aims The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Methods and results Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with <12 months of DAPT, and EES/ZES with >12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. Conclusion Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.

Percutaneous Closure of Patent Foramen Ovale in Patients with Anatomical and Clinical High-Risk Characteristics: Long-Term Efficacy and Safety

BACKGROUND Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure, but no randomized study on its outcome in high-risk patients is available. Our aims were to determine the efficacy and safety of this procedure in a cohort of high-risk patients through the observation of clinical adverse events and residual shunt, to evaluate the impact of transesophageal echocardiography (TEE) guidance during the procedure, and investigate the relationship between the anatomical and clinical characteristics and the outcome. METHODS AND RESULTS Ninety-five patients underwent PFO closure for cryptogenic cerebral ischemia; each of them presented one or more of the following risk factors: recurrent cerebral ischemia (9.5%), atrial septum aneurysm (ASA, 74.5%), prominent Eustachian valve (EV, 23.2%), severe basal shunt (9.5%), thrombophilic factors (20%), deep vein thrombosis (4.2%). The procedure was performed successfully in all patients. On median follow-up of 18 months, the neurologic recurrent events rate was 1.1% and the major adverse cardiac event (MACE) rate was 1.1%. At 6-month TEE follow-up, the residual shunt rate was 12.6% (3.1% moderate to severe). A significant correlation was found between residual shunt and prominent EV alone (P = 0.036) or in association with ASA (P = 0.021). All adverse events occurred in the first 8 months, and the event-free survival rate was 86.2%. CONCLUSIONS Our study suggests that transcatheter PFO closure is a safe procedure even in a selected population of high-risk patients, presenting satisfactory efficacy and safety. The presence of a prominent EV alone or with ASA correlates positively with the occurrence of residual shunt.

One-year follow-up of conduction disturbances following transcatheter aortic valve implantation.

Aims To describe the postprocedural and 1-year follow-up incidence of heart conduction disturbances in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Methods Ninety-five patients were enrolled from 2008 to 2011 (mean age 81.8 ± 7.2 years, 63.1% women). Clinical and ECG data were recorded at admission, discharge, and 3, 6 and 12 months following TAVI. Results Fifty-seven Edwards SAPIEN (31 transapical, 26 transfemoral) and 38 transfemoral CoreValve implants were used. Two (2.1%) patients died during the procedure and 11 (11.6%) patients received a pacemaker prior to discharge (7 CoreValve, 3 transapical, 1 transfemoral SAPIEN; P = 0.18). Among the surviving patients not receiving a pacemaker, TAVI increased the PQ interval (176 ± 29 vs. 188 ± 36 ms; P = 0.001), QRS width (90 ± 15 vs. 108 ± 26 ms; P < 0.001), and first-grade atrioventricular block (17 vs. 29%; P < 0.001). Postprocedural complete left bundle branch block was reported most in transapical (from 10 to 36%; P = 0.01) and CoreValve (from 8 to 64%; P < 0.001) recipients compared to the transfemoral SAPIEN group. At the 12-month follow-up, 24 (25.3%) patients had died [two (2.1%) sudden deaths] and four (4.2%) required pacemaker implantation. Among the survivors not receiving a pacemaker at the 1-year follow-up, the PQ interval (178 ± 27 vs. 188 ± 36 ms; P = 0.39) remained unchanged in the ECG, whereas the QRS width (100 ± 22 vs. 108 ± 26 ms; P = 0.008) decreased compared to measurements taken at discharge. Conclusion Conduction disturbances following TAVI primarily develop during hospitalization and subsequently stabilize. However, the small percentage of patients suffering sudden death or pacemaker implantation requires attention.

Effects of statins on plaque rupture assessed by optical coherence tomography in patients presenting with acute coronary syndromes: insights from the optical coherence tomography (OCT)-FORMIDABLE registry

Aims Chronic pre-treatment with statins may reduce mortality and morbidity in patients experiencing acute coronary syndromes (ACS), but mechanisms accounting for these findings are not completely understood. Methods and results The optical coherence tomography (OCT)-Formidable registry retrospectively enrolled 285 consecutive patients with ACS undergoing OCT in 9 European centres. Mean age was 60.4 ± 12.8 years, 148 (51.9%) patients had hyperlipemia, 45 (15.8%) diabetes mellitus and 142 (49.8%) presented with ST Segment Elevation Myocardial Infarction (STEMI). Patients were stratified according to statin prescription: 150 (52.6%) were on chronic pre-treatment with statins before ACS and were more likely to present with non-ST segment elevation acute coronary syndromes (NSTE-ACS) at admission (111, 74%) rather than STEMI, while the opposite was observed for patients not on statins. The primary end-point of ruptured plaque at OCT occurred significantly less frequently in the patients on chronic pre-treatment with statins [odds ratio (OR) 0.375, 95% confidence interval (CI) 0.185-0.759, P = 0.006]. The secondary end-point of thin-cap fibro-atheroma (TCFA) at any site was significantly less frequent in the statin group (OR 0.423, 95%CI 0.213-0.840, P = 0.014). No differences were observed for the secondary end-point of not-ruptured TCFA as the culprit lesion. Pre-specified sensitivity analysis was conducted according to the pattern of ACS: the reported differences were confirmed for NSTE-ACS patients, with a trend towards less plaque rupture and a significant reduction of TCFA at any site with statins, but not for STEMI. Conclusions Chronic pre-treatment with statins is associated with a reduced prevalence of ruptured plaques in patients presenting with ACS, particularly in those with NSTE-ACS. Statins bear hence the potential to reduce morbidity during the acute phase of ACS.

Real time triplane echocardiography in aortic valve stenosis: validation, reliability, and feasibility of a new method for valve area quantification.

Aims: The aim of the study was to validate a novel formula for aortic valve area (AVA) based on the principle of continuity equation, that substitutes Doppler‐derived stroke volume (SV) by SV directly measured with real time simultaneous triplane three‐dimensional echocardiography (RT3P). RT3P has proved accuracy for left ventricular volume calculation. So far, however, neither this potential has been applied to hemodynamic assessment, nor RT3P has succeeded in the evaluation of aortic valve disease. Methods and results: AVA was measured in 21 patients with aortic stenosis using Gorlins equation, Doppler continuity equation (two‐dimensional echocardiography), the novel RT3P method, and by substituting Doppler‐derived SV by SV measured with two‐dimensional stroke volume (2DSV). RT3P has the best linear association (R2= 0.61) and the best correlation with Gorlin of all noninvasive methods (even if not statistically significant). RT3P carries significantly lower mean differences with catheterization, as compared with 2D and 2DSV (Table 4). Standard deviations of mean differences between RT3P and catheterization and between the other echocardiographic methods are not statistically different, even if RT3P seems to be nearer to catheterization. Inter‐ and intraobserver variability were, respectively, 0.03 ± 0.11 cm2 and 0.02 ± 0.03 cm2, better than 2D and 2DSV. Conclusions: RT3P has revealed to be more accurate than two‐dimensional method in AVA quantification, with a better intraobserver agreement. In addition, it allows simple and fast image acquisition. (Echocardiography 2010;27:644‐650)

Sex-related differences in patients with ST-elevation myocardial infarction undergoing primary PCI: A long-term mortality study

OBJECTIVES To assess sex differences in clinical presentation, in-hospital and long-term outcome in ST-elevated myocardial infarction (STEMI) patients undergoing primary PCI (PPCI). BACKGROUND Several studies have shown higher rates of mortality in women. These differences are not always confirmed after adjusting for confounding variables. METHODS From January 2007 to December 2011, 325 consecutive patients (23.1% females and 76.9% males) were prospectively treated and retrospectively analyzed. Primary outcome was in-hospital and long-term mortality. RESULTS Women were older (71.8±11.7 vs. 62.5±12.6years; p<0.0001), presented more renal failure (45.3% vs. 20.8%; p<0.0001) and severe haemodynamic impairment (9.3% vs. 3.6%; p=0.04). In-hospital overall mortality (14.7% vs. 4.8%; p=0.003) and cardiac death (12% vs. 2%; p=0.002) were significantly higher in women. The multivariate analysis identified age (OR 1.07; 95% CI: 1.01-1.13), resuscitated cardiac arrest (CCA) and cardiogenic shock (CS) (OR 15.31; 95% CI: 4.30-61.75), renal failure (OR 0.20; 95% CI: 0.06-0.68), but not sex (OR 1.49; 95% CI: 0.53-4.22) as independent prognostic factors of in-hospital mortality. During a median follow-up of 46.5months (IQR range 32.7-63.1months), long-term overall mortality (24.2% vs. 11.0%; p=0.007) and cardiac death (4.8% vs. 1.7%; p=0.02) were significantly higher in women. The multivariate analysis identified age (HR 1.06; 95% CI: 1.02-1.11), previous AMI (HR 3.9; 95% CI: 1.63-9.35), renal failure (HR 5.21; 95% CI: 2.12-12.85), technical success (HR 0.35; 95% CI: 0.14-0.84) but not sex (HR 0.90; 95% CI: 0.42-1.94) as independent prognostic factors of long-term mortality. CONCLUSIONS Worse clinical presentation rather than sex may explain the excess of mortality in women with STEMI undergoing PPCI.

Fracture of coronary artery sirolimus eluting stent with formation of four aneurysms

Coronary stent fracture is a relatively rare but potentially serious complication of coronary artery stenting, in particular with sirolimus-eluting stents. It has been recognized as one possible cause of in-stent restenosis as well as acute stent thrombosis. The formation of coronary artery aneurysm is one of the critical complications after percutaneous coronary intervention and it has been described after a stent fracture too. We report here a case of formation of four coronary artery aneurysms associated with the fracture of a sirolimus-eluting stent.

Clinical perspective of optical coherence tomography and intravascular ultrasound in STEMI patients

In the last years, the intravascular ultrasound study (IVUS) and further the optical coherence tomography (OCT) became two helpful tools to characterize of the atherosclerotic plaque.

Diagnostic accuracy of functional, imaging and biochemical tests for patients presenting with chest pain to the emergency department: A systematic review and meta-analysis

Background: Non-invasive ischaemia tests and biomarkers are widely adopted to rule out acute coronary syndrome in the emergency department. Their diagnostic accuracy has yet to be precisely defined. Methods: Medline, Cochrane Library CENTRAL, EMBASE and Biomed Central were systematically screened (start date 1 September 2016, end date 1 December 2016). Prospective studies (observational or randomised controlled trial) comparing functional/imaging or biochemical tests for patients presenting with chest pain to the emergency department were included. Results: Overall, 77 studies were included, for a total of 49,541 patients (mean age 59.9 years). Fast and six-hour highly sensitive troponin T protocols did not show significant differences in their ability to detect acute coronary syndromes, as they reported a sensitivity and specificity of 0.89 (95% confidence interval 0.79–0.94) and 0.84 (0.74–0.9) vs 0.89 (0.78–0.94) and 0.83 (0.70–0.92), respectively. The addition of copeptin to troponin increased sensitivity and reduced specificity, without improving diagnostic accuracy. The diagnostic value of non-invasive tests for patients without troponin increase was tested. Coronary computed tomography showed the highest level of diagnostic accuracy (sensitivity 0.93 (0.81–0.98) and specificity 0.90 (0.93–0.94)), along with myocardial perfusion scintigraphy (sensitivity 0.85 (0.77–0.91) and specificity 0.92 (0.83–0.96)). Stress echography was inferior to coronary computed tomography but non-inferior to myocardial perfusion scintigraphy, while exercise testing showed the lower level of diagnostic accuracy. Conclusions: Fast and six-hour highly sensitive troponin T protocols provide an overall similar level of diagnostic accuracy to detect acute coronary syndrome. Among the non-invasive ischaemia tests for patients without troponin increase, coronary computed tomography and myocardial perfusion scintigraphy showed the highest sensitivity and specificity.

Contrast-induced kidney injury: how does it affect long-term cardiac mortality?

Aims Contrast-induced acute kidney injury (CIAKI) is a common complication after coronary angiography or percutaneous revascularization (PCI). This study aimed to investigate the association of CIAKI with long-term cardiovascular adverse events. Methods In total, 980 patients undergoing coronary angiography/PCI were assessed in this prospective cohort study. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) and cardiac death (CVD) during an 8-year follow-up. Glomerular filtration rate change during the follow-up was the secondary endpoint. CIAKI was defined as a serum creatinine increase at least 0.3 mg/dl in 48 h or at least 50% in 7 days. Results CIAKI was observed in 69 patients (7%). Chronic kidney disease [relative risk (RR) = 4, P < 0.01], reduced ejection fraction (RR = 2.88, P < 0.01), CIAKI risk score at least 4 (RR = 2.64, P = 0.02), and emergency coronary angiography/PCI (RR = 3.87, P < 0.01) increased CIAKI risk, whereas statins were protective (RR = 0.32, P < 0.01). Patients with CIAKI had higher rates of 8-year cardiovascular adverse events: 54 versus 15% MACCE (RR = 6.67, P < 0.01), 38 versus 4% CVD (RR = 15.73, P < 0.01). Among other factors, CIAKI was the strongest predictor of 8-year MACCE (RR = 3.16, P < 0.01) and CVD (RR = 7.34, P < 0.01). During the follow-up, glomerular filtration rate declined drastically in CIAKI patients: 70 versus 39% had chronic kidney disease stage worsening (P < 0.01) and 8 versus 0.3% started hemodialysis (P < 0.01). Conclusion We found a strong correlation between CIAKI and poor long-term cardiac outcomes. Apparently showing up as a transient, functional impairment of kidney function, CIAKI implies an organic damage with structural modifications leading to significant kidney deterioration over time, responsible for an increased risk of long-term cardiac events. Statins significantly reduced CIAKI occurrence. A careful management of high-risk patients is needed to limit long-term complications of coronary angiography/PCI.