Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

OBJECTIVE: To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. METHODS: Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. RESULTS: Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. CONCLUSIONS: The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.

E/A ratio before cardiac resynchronization therapy predicts left ventricle reverse remodeling.

AIM: Clinical experience shows that about 2 out of 3 patients with indication to resynchronization therapy (CRT) may have improvements in NYHA class, echocardiographic parameters and survival. However, specific clinical or technical parameters that identify responder patients have not yet been found. Aim of the present study was to assess the efficacy of CRT and to estimate the predictive value of specific echocardiographic parameters. METHODS: All patients who underwent CRT from January 2004 till June 2009, at our Institution, were clinically examined and evaluated by echo and ECG before implant. Between January and February 2010, among a population of 55 patients (41 M, 14F, mean age 66.3±5.9), 42 patients (33 M) were considered in the final multiparametric analysis. Of the 13 excluded patients, 6 died, 2 underwent cardiac transplantation and 5 were lost to follow-up. Basal characteristics of the study population were: ischemic etiology in 15 out of 42 patients, back-up defibrillation in 39 patients. The mean follow-up period was 26.2±13.0 months. Patients had been classified as CRT responders if they showed an inverse left ventricle (LV) remodeling, defined as a 10% reduction of end-diastolic diameter (LVEDD) compared to the basal measure. RESULTS: Echo parameters significantly improved after CRT: LVEDD was significantly (P<0.05) reduced (basal vs. CRT: 76±7 mm vs. 64±10 mm, P=0.00004); basal ejection fraction (EF) was 21±5% vs. 37±14% after CRT (P=0.00001); mitral regurgitation (MR) (grading from 1 to 4) was 2.8±0.6 vs. 2.3±0.9 (P=0.00998); QRS duration was 157±25 ms vs. 135±23 ms (P=0.00036), and NYHA class 2.6±0.5 vs. 2.1±0.4, P=0.00006). Only a positive trend of the E/A ratio was observed (P=0.088). Among 42 patients, 24 (57%) had an inverse LV remodeling and were defined as CRT responders. By comparing responder with no-responder patients, the basal values of echo parameters like EF, LVEDD, MR, QRS, NYHA class were similar in the two groups; while E/A was statistically different between the two groups (P=0.02), being less severe in responder patients. CONCLUSION: Our experience confirms that about 2 out of 3 patients are responder to CRT and their clinical improvements remain stable in a long term follow-up. Patients with a less severe E/A ratio are more likely to improve their clinical condition as shown by the reverse remodeling measured through the LVEDD.

Direct coronary stenting versus stenting with balloon pre-dilation: incidence of enzyme release and follow-up results of a multicentre, prospective, randomized study. The CK and Troponin I Estimation in direct STenting (CK TEST) trial.

AIM: The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination. METHODS: We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory. RESULTS: Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively). CONCLUSION: Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but procedural costs (as measured by resource consumption) and duration of the procedure are lower in direct stenting. Overall success rate and mid-term clinical outcome are similar with both techniques.

Early evaluation of coronary microcirculation by echocardiography with contrast medium in patients with acute myocardial infarction treated with primary percutaneous transluminal coronary angioplasty.

AIM: In about 30% of patients with ST elevated myocardial infarction (STEMI), in which a TIMI 3 flow is obtained in the infarct related artery (IRA) after primary percutaneous transluminal coronary angioplasty (PTCA), it's not possible to obtain a good perfusion of coronary microcirculation (no reflow). Aim of the study is to estimate the prognostic value of microcirculation study by echocardiography with contrast medium (MCE) within 48 h from procedure and to point out if there're clinical or procedural factors correlated with no reflow. METHODS: From February 2002 to June 2003 we have analyzed the integrity of microcirculation by MCE in patients with STEMI treated with PTCA. We have included in this study 62 patients with anterior myocardial infarction (MI) (first event), within 12 h from symptoms onset, with great echocardiographic window and TIMI 3 flow in the IRA after PTCA, excluding shock. We have obtained the evaluation of myocardial perfusion by MCE within 48 h from the treatment. We have used Sonovue as contrast medium, infused through peripheral vein. In each patient we have measured: perfusion index (PI) (sum of single segments scores divided by total number of myocardial segments) and regional perfusion index (RPI) (number of normal perfused segments between the diskinetic ones divided by diskinetic segments). RPI varies from 0 to 1: when >0.5 it has been considered index of good perfusion. Ejection fraction (EF) and wall motion score index (WMSI) have been calculated within 48 h and at 6 weeks follow up. ST resolution (STR) has been evaluated at 90 min from procedure and it was considered significant when >70%. RESULTS: Patients have been divided into 2 groups by myocardial perfusion: group R (33 patients with RPI>0.5) and group NR (29 patients with RPI =/<0.5). The 2 groups were similar for age (group R: mean age 61 years old; group NR: mean age 64 years old, P=n.s.), glycoprotein inhibitors use (group R 90%, group NR 97%, P=n.s.), diabetes (group R 12%, group NR 17%, P=n.s.), hypertension (group R 22%, group NR 23%, P=n.s.), incomplete revascularization (group R 12%, group NR 10%, P=n.s.). Group NR has shown a major women percentage (33%) than group R (9%) P=0.026. In group R we have appreciated a trend to a major percentage of TIMI 2-3 flow preprocedure (66% vs 36%, P=n.s.), a shorter ischemic time (209 min vs 258 min, P=n.s.) and a major STR at 90 min (72% vs 53%, P=n.s.), not statistically significant. Echocardiographic analysis and MCE show a better myocardial perfusion in group R (RPI 0.7 vs 0.14 and PI 0.96 vs 0.86, P<0.0001); better left ventricular kinetics at 6 weeks follow up (EF 54.2% vs 50.8%, P=n.s. and WMSI 1.07 vs 1.2, P=0.014) but not in the acute phase (EF 46.8 vs 42.9 and WMSI 1.3 vs 1.34, P=n.s.) 30 days mortality is similar in the 2 groups (both 3%). CONCLUSIONS: Myocardial perfusion evaluation correlates with left ventricular contractility measured at 6 weeks from acute MI, but doesn't correlate with contractility in the acute phase or 30 days mortality.

[A 'lucky' patient]. / Un caso 'fortunato'

A 72-year-old male diabetic patient admitted to our operative unit of nephrology and dialysis underwent hemodialytic treatment because of rapidly progressive renal failure. A moderate hypertensive state was associated to nephrotic proteinuria and microematuria. Renal angiography showed a severe stenosis of the right renal artery and a smaller left kidney. Right renal artery stenting induced a significant reduction in serum creatinine (Cr) and the patient discontinued with the dialytic treatment.

[Acute myocardial infarction in pregnancy in a patient with pseudoaneurysm of the left main coronary artery]. / Infarto miocardico acuto in gravidanza, in paziente con pseudoaneurisma del tronco comune della coronaria sinstra.

Myocardial infarction during pregnancy is a rare event and it can be associated both with obstructive coronary artery disease and with functional conditions such as vasospasm. We report a 28-year-old woman without coronary artery disease risk factors, who suffered a Q infarction at 38th week of gestation, complicated by ventricular fibrillation. A healthy child was delivered by cesarean section and the woman made a full recovery. A coronary pseudoaneurysm was detected angiographically, suggesting an initial spontaneous coronary artery dissection followed by ectatic evolution. Coronary dissection associated with coronary vasospasm should be kept into account as etiopathogenetyc mechanisms of acute myocardial infarction.

[Effects of hypertrophy on cardiac systolic and diastolic performance in athletes with mild hypertension]. / Effetti dell'ipertrofia sulla performance cardiaca sistolica e diastolica in atleti con ipertensione lieve.

Aims of the study has been the evaluation of morphological and functional aspects of left ventricle in subjects undergoing mild hypertension and sport adaptation effects. These evaluations have been carried out by Echo-Doppler both at rest and during sharp increase in after load induced by isometric stress. Together with the morphological parameters represented by mass index and by radius to thickness ratio, we have studied stroke volume and transmitral flow pattern assessing the maximum flow velocity during rapid filling phase (E), during atrial contraction phase (A) and their ratio (E/A). We have studied 31 male subjects from 39 to 60 (average 47) exercising twice or three times a week (in the main, aerobic sports such as road cycling). They were subdivided into two groups, the first included 16 subjects with mild hypertension (AP = 155 +/- 9/97 +/- 5 mmHg) the second included 15 normotensive subjects without known pathologies, comparable for age and body surface (AP = 125 +/- 15/77 +/- 10 mmHg). Hypertensive subjects exercising regularly, showed a mass index (164 +/- 42 g/m2) significantly higher than the controls (139 +/- 35 g/m2, P less than 0.01) but they ke a normal filling pattern at rest and similar stroke volume values. During isometric exercise instead, the velocities of E and A waves showed a different trend in the two groups with a higher reduction in E/A ratio in hypertensive subjects. The per cent decrease in this ratio turned out to be 15% in the control group and 33% in hypertensive subjects (P less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

[Non-fistulized aneurysm of the right sinus of Valsalva. Pre- and postoperative echocardiographic aspects]. / Aneurisma non fistolizzato del seno di Valsalva destro. Aspetti ecocardiografici pre e post-operatori.

The case considered concerns as 57 year-old patient who was submitted for heart tests because of a slight diastolic aortic murmur and hypertension. Echocardiographic investigation diagnosed an aneurysm of the sinus of Valsalva. The patient underwent a surgical intervention to reconstruct, on a dacron piece, the right sinus of Valsalva from which the aneurysmal cavity originated, retaining the aortic valve. After a short description of the etiology and the natural history of this condition we explain the importance of echocardiographic tests for the diagnosis and post-operative follow-up of these patients who run a high risk of severe and often lethal complications.

[Malfunctioning of the Meadox bioprosthesis placed in mitral position. Description of 2 clinical cases]. / Malfunzionamento della bioprotesi di Meadox posizionata in sede mitralica. Descrizione di due casi clinici.

The Meadox valve, made up by a single bovine pericardial leaflet fixed in glutaraldehyde, is a "new-generation" bio-prostheses. In two patients those bio-prostheses revealed early malfunction with abnormal stretching of the valvular tissue. In both cases the beginning symptom was a strong fremitus caused by the vibration, during systole, of valvular leaflet. In the first case mechanical solicitation onsed partial laceration of valvular leaflet with subsequent regurgitation into the left atrium and cardiac failure. In both cases, the evaluation by Doppler Echocardiography and polygraphic examination, allowed the diagnose of malfunction which was confirmed at surgery. The replacement of a new prosthesis was successful in both cases.

Methodology for identification of serum middle molecules.

Filtration through membranes with different nominal cut-off was used for isolation of middle molecule fractions from uremic serum. Comparison was made with test substances which in gel filtration did not show a regular relationship between molecular weight and partition coefficient. The XM50 membrane (cut-off 50,000 D) showed the highest permeability to middle molecules (greater than 84%) whereas CF50 (same cut-off) retained middle molecules to some extent if filtration was carried out only once. The UM05 membrane (cut-off 500 D) was highly permeable for small molecules less than 300 D, intermediary permeable for molecules between 300 and 1000 D and retained molecules between 1,100 and 1,350 D more efficiently. It is concluded that filtration through membranes is a suitable method for identification of middle molecules.