[Single-center retrospective observational study on predictors of residual mitral regurgitation 1 year after MitraClip® implantation]. / Studio osservazionale retrospettivo monocentrico sui predittori di insufficienza mitralica residua a 1 anno dall'impianto di MitraClip®.

BACKGROUND: The extent of residual mitral regurgitation (MR) (1+ vs ≥2+) has a notable impact on the outcome of MitraClip (MC) repair of significant functional MR. In this retrospective single-center study, we evaluated the predictors of MI ≥2+ at 1 year in one of our case series. METHODS: Overall, 58 patients with moderate severe functional MR underwent MC implantation; of these, 48 patients had instrumental clinical follow-up for 1 year. RESULTS: At 1 year, 10 patients died (mortality 17.2%). In the remaining 48 patients, the incidence of rehospitalization was 8.3%, and the incidence of MR grade 1+ and ≥2+ was 54.1% (n = 26) and 45.9% (n = 22), respectively. In patients with MR ≥2+, clinical and instrumental outcomes were worse than in patients with MR 1+. The height of the posterior leaflet and the extent of immediate postprocedural MR were independent predictors of MR ≥2+. CONCLUSIONS: Percutaneous repair with MC of moderate/severe functional MR has favorable 1-year outcomes in terms of mortality and rehospitalizations. The best results are achieved in patients with residual MR 1+. Echocardiographic parameters are independent predictors of residual MR ≥2+.

QTc Interval Prolongation and Life-Threatening Arrhythmias During Hospitalization in Patients With Coronavirus Disease 2019 (COVID-19): Results From a Multicenter Prospective Registry.

BACKGROUND: Prolonged QTc intervals and life-threatening arrhythmias (LTA) are potential drug-induced complications previously reported with antimalarials, antivirals, and antibiotics. Our objective was to evaluate the prevalence and predictors of QTc interval prolongation and incidences of LTA during hospitalization for coronavirus disease 2019 (COVID-19) among patients with normal admission QTc. METHODS: We enrolled 110 consecutive patients in a multicenter international registry. A 12-lead electrocardiograph was performed at admission, after 7, and at 14 days; QTc values were analyzed. RESULTS: After 7 days, 15 (14%) patients developed a prolonged QTc (pQTc; mean QTc increase 66 ± 20 msec; +16%; P < .001); these patients were older and had higher basal heart rates, higher rates of paroxysmal atrial fibrillation, and lower platelet counts. The QTc increase was inversely proportional to the baseline QTc level and leukocyte count and directly proportional to the basal heart rate (P < .01).We conducted a multivariate stepwise analysis including age, male gender, paroxysmal atrial fibrillation, basal QTc values, basal heart rate, and dual antiviral therapy; age (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.13; P < .05), basal heart rate (OR, 1.07; 95% CI, 1.02-1.13; P < .01), and dual antiviral therapy (OR, 12.46; 95% CI, 2.09-74.20; P < .1) were independent predictors of QT prolongation.The incidence rate of LTA during hospitalization was 3.6%. There was 1 patient who experienced cardiac arrest and 3 with nonsustained ventricular tachycardia. LTAs were recorded after a median of 9 days from hospitalization and were associated with 50% of the mortality rate. CONCLUSIONS: After 7 days of hospitalization, 14% of patients with COVID-19 developed pQTc; age, basal heart rate, and dual antiviral therapy were found to be independent predictors of pQTc. Life-threatening arrhythmias have an incidence rate of 3.6%, and were associated with a poor outcome.

A narrative review of diagnosis of infective endocarditis-imaging methods and comparison.

The profile of infective endocarditis (IE) has changed over the past few decades. The modified Duke's criteria is currently employed for diagnosis of IE. Emphasis on imaging modalities however, have been increasing due to the variety of presenting symptoms leading to diagnostic conundrums. This wide range of diagnostic tools must be adapted to permit localization of the infectious field which may involve multiple valves on either side of the heart. The availability of such diagnostic tools is also variable in different centres. The use of echocardiography has long been the default position, however the lack of specificity and sensitivity especially in prosthetic valve endocarditis has been highlighted throughout the literature. We therefore aimed to look at the different imaging modalities available and the strengths and weaknesses of each of these modalities to enhance the diagnostic yield and allow timely intervention for this condition. We highlight the role of the different forms of echocardiography, multi-detector computed tomography (MDCT), Nuclear Medicine, Magnetic Resonance Imaging and identify the special indications such as right sided infective endocarditis (RSIE) and cardiac implantable electronic device (CIED) endocarditis. Input from a specialist heart team is essential to ensure timely diagnosis and care are afforded. The role of alternative imaging techniques such as nuclear medicine in determining timing of cardiac surgery should be evaluated further by randomised trials.

RARE CO-EXISTENCE OF CORONARY ANOMALIES: ANOMALY OF ORIGIN AND DISTRIBUTION TOGETHER WITH ANOMALY OF INTRINSIC CORONARY ARTERY ANOMALY.

We describe a 63 year old Romanian female patient admitted to our institution with complaints of typical angina and a diagnosis of non ST-elevation myocardial infarction. Coronary arteriography unveiled anomalous origin of a left circumflex coronary artery from the right coronary sinus of Valsalva near the right coronary ostium and a hyperdominant left anterior descending coronary artery giving off a posterior descending coronary artery with small distal-posterolateral left ventricular branch. The co-existence of a left circumflex coronary artery originating ectopically from the right sinus of Valsalva together with a posterior descending coronary artery originating from the distal end of the anterior descending artery is important to keep in mind especially by those doing coronary angiography in the cardiac catheterization laboratory.

Transcatheter Aortic Valve Implantation in Patients With Advanced Chronic Kidney Disease.

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m2 stage 4 (S4), <15 ml/min/1.73 m2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.

Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study.

INTRODUCTION: Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes. METHODS: Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. RESULTS: In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014). CONCLUSIONS: The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.

Comparative assessment of "plaque/media" change on three modalities of IVUS immediately after implantation of either everolimus-eluting bioresorbable vascular scaffold or everolimus-eluting metallic stent in Absorb II study.

The purpose of the study to assess the comparability of immediate changes in plaque/media volume (PV) on three modalities of intravascular ultrasound (IVUS) after implantation of either bioresorbable vascular scaffold (BVS) or everolimus-eluting metallic stent (EES) in Absorb II Study. The two devices have different device volume and ultrasound backscattering that may interfere with the "plaque/media" assessed by three modalities on IVUS: grayscale, backscattering of radiofrequency and brightness function. In a multicenter randomized controlled trial, 501 patients with stable or unstable angina underwent documentary IVUS pre- and post- implantation. The change in plaque/media volume (PV) was categorized into three groups according to the relative PV change in device segment: PV "increased" >+5% (PVI), PV unchanged ±5% (PVU), and PV decreased <-5% (PVD). The change in PV was re-evaluated three times: after subtraction of theoretical device volume, after analysis of echogenicity based on brightness function. In 449 patients, 483 lesions were analyzed pre- and post-implantation. "PVI" was more frequently observed in BVS (53.8%) than EES group (39.4%), p = 0.006. After subtraction of the theoretical device volume, the frequency of "PVI" decreased in both BVS (36.2%) and EES (32.1%) groups and became comparable (p = 0.581). In addition, the percentage of "PVI" was further reduced in both device groups after correction for either radiofrequency backscattering (BVS 34.4% vs. EES 22.6%) or echogenicity (BVS 25.2% vs. EES 9.7%). PV change in device segment was differently affected by BVS and EES devices implantation due to their differences in device volume and ultrasound backscattering. It implies that the lumen volume was also artifactually affected by the type of device implanted. Comparative IVUS assessment of lumen and plaque/media volume changes following implantation of BVS and EES requires specific methodological adjustment.

Age-Related Differences in 1- and 12-Month Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation (from a Large Multicenter Data Repository).

Scarce data are available on the impact of age on transcatheter aortic valve implantation (TAVI) outcomes. We therefore, analyzed 1,845 consecutive patients from 9 Italian centers who underwent TAVI with the Corevalve Revalving System from September 2007 to March 2014; patients were dichotomized according to their age in the date of the procedure, as follows: 75 to 85 years old and >85 years old. End points were defined according to Valve Academic Research Consortium definitions. In-hospital, 30-day, and 1-year clinical and echocardiographic data were available for 100% of the patients included. Propensity matching was performed. Procedural success rates were high (>94%) and comparable between groups. Although worse baseline renal function was observed in the older group, the incidence of acute kidney injury after procedure was comparable (17.1% and 17.4%, respectively for the 75- to 85- and >85-year-old group, p = 0.877); importantly, >99% of acute kidney injury episodes in both groups were grades 1 and 2. Procedural complications rates were low without between-group differences. In-hospital death (3.7% and 4.6%, p = 0.379) and stroke/transient ischemic attack (1.9% and 1.9%, respectively, p = 0.960) were comparable. The 1-year death rates were 14.9% and 17.2% (p = 0.197) in the 75- to 85- and >85-year-old group, respectively. Cardiovascular death was observed in 7.8% and 7% (p = 0.542), while stroke/transient ischemic attack was demonstrated in 5.2% and 4.4% (p = 0.496), respectively. Results were sustained after propensity matching. In conclusion, advanced age did not negatively impact the outcomes of TAVI through 1-year after procedure.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

The beneficial effects of TAVI in mitral insufficiency.

BACKGROUND: Previous studies have suggested that concomitant mitral regurgitation (MR) is a risk factor for acute transcatheter aortic valve implantation (TAVI) failure, but may improve afterwards. Aim of this study was to assess the prevalence, clinical meaning and modifications of MR in patients undergoing TAVI. METHODS: In a retrospective, two-center (Potenza-San Carlo and Roma- San Camillo) study, from January 2010 to June 2014 we enrolled 165 consecutive patients (age =80 ± 5 years, 74 males, Ejection Fraction 51 ± 9 %) referred for TAVI with either Medtronic Core-ReValving System (in 114 patients, 69%) or balloon-expandable Edwards SAPIEN/SAPIEN XT (in 51 patients, 31%). All patients underwent TTE and TEE assessment of MR (from 1, mild to 4 = severe according to ESC latest guidelines) with core lab reading by a single observer blinded to patient identity and status. Assessment was performed at baseline (24 h prior to intervention) and at 1, 6, 12 and 24 months. RESULTS: Mild-to-Moderate MR (grade 1-2) was present in 137 patients and Moderate-to-Severe MR (grade 3-4) was present in 28 patients. No significant differences were seen comparing perioperative mortality and morbidity between the two groups. In the group of preoperative MR grade 3-4 the mean decrease from MR pre-TAVI to MR at 1 month post-TAVI was 0.464 (p < 0.0001) and this improvement was persistent at 6 months (p < 0.0001) and at 12 months (p < 0.0001), with partial benefit loss at 1 and 2 years. The mean difference from Left Atrial volume post-TAVI at 1 month was 16.5 ml (p < 0.0001) and this improvement was persistent at 12 months 12.12 ml (p < 0.0001). CONCLUSIONS: TAVI effectively treats the aortic valve but as a beneficial by product also ameliorates concomitant MR. The presence of moderate-to-severe MR does not increase the acute risk of failure of TAVI. In successful procedures, the MR improves immediately and persistently.

Effect of Abciximab Therapy in Patients Undergoing Coronary Angioplasty for Acute ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

BACKGROUND: The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention (PCI) is not clear. METHODS AND RESULTS: We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio [HR], 1.02; 95% confidence interval [95% CI]: 1.01-1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12-1.96, P=0.05), post-PCI TIMI flow grade 0-1 (HR, 2.08; 95% CI: 1.52-2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70-1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively. CONCLUSIONS: Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0-1 and oro-tracheal intubation are predictors of death.

One-year clinical outcome of elderly patients undergoing angioplasty for ST-elevation myocardial infarction complicated by cardiogenic shock: the importance of 3-vessel disease and final TIMI-3 flow grade.

BACKGROUND: The influence of age on clinical results of primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarctions (STEMI) complicated by cardiogenic shock (CS) is poorly investigated. METHODS: In this study, we evaluated the outcome of 216 consecutive all-comer patients with STEMI and CS undergoing PCI who were divided into 2 groups according to age: <75 years (n = 131) or ≥75 years (n = 81). The study endpoint was the incidence of death at 1-year follow-up. The predictors of mortality at 1 year were also investigated. RESULTS: The group <75 years had a significantly lower incidence of death compared with the group ≥75 years at 30 days (39% vs 69%; P=.01) and 1 year (51% vs 79%; P<.001). Cox proportional hazards model identified: age (adjusted hazard ratio [HR] = 1.02; 95% confidence interval [CI], 1.00-1.03; P=.02), 3-vessel disease (HR = 1.47; 95% CI, 1.00-2.17; P=.05), post-PCI TIMI flow grade 0-1 (HR = 2.48; 95% CI, 1.66-3.70; P=.01) and grade 2 (HR = 1.68; 95% CI, 1.01-2.80; P=.05) after PCI as independent predictors of death at 1-year follow-up. CONCLUSIONS: Patients ≥75 years with STEMI complicated by CS and treated by PCI have higher 1-year mortality compared with younger counterparts. Final TIMI 0-2 and 3-vessel disease are strong predictors of death. This finding may be valuable in risk stratification of these patients.

Interplay between mitral regurgitation and transcatheter aortic valve replacement with the CoreValve Revalving System: a multicenter registry.

BACKGROUND: Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement in MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System-TAVR. METHODS AND RESULTS: Among 1007 consecutive patients, 670 (66.5%), 243 (24.1%), and 94 (9.3%) presented with no/mild, moderate, and severe MR, respectively. At 1 month after TAVR, patients with severe or moderate MR showed comparable mortality rates (odds ratio, 1.1; 95% confidence interval [95% CI], 0.7-1.55; P=0.2), but both were significantly higher compared with patients with mild/no MR (odds ratio, 2.2; 95% CI, 1.78-3.28; P<0.001; and odds ratio, 1.9; 95% CI, 1.1-3.3; P=0.02, respectively). One-year mortality was also similar between patients with severe and those with moderate MR (hazard ratio, 1.4; 95% CI, 0.94-2.4; P=0.06) and still significantly higher compared with patients with mild/no MR (hazard ratio, 1.7; 95% CI, 1.2-3.41; P<0.001; and hazard ratio, 1.4; 95% CI, 1.2-2.2; P=0.03, respectively). Severe pulmonary hypertension, atrial fibrillation, and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1 year. At 1 year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of low implantation was consistent across groups with improved, unchanged, or worsened MR. A functional type of MR and the absence of severe pulmonary hypertension and atrial fibrillation independently predicted the improvement in MR severity. CONCLUSIONS: Baseline MR greater than mild is associated with higher mortality after CoreValve Revalving System-TAVR. A significant improvement in MR was more likely in patients with functional MR and without severe pulmonary hypertension or atrial fibrillation. The improvement in MR did not independently predict mortality.

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes.

BACKGROUND: The ideal device for percutaneous patent foramen ovale (PFO) occlusion should provide effective closure with long-term biocompatibility and it should have a low profile without interfering with adjacent cardiac structures. Long-term data regarding safety and efficacy of the GORE Septal Occluder (GSO) are lacking. The aim of this study was to investigate the short- and mid-term clinical and echocardiographic outcomes of this device. METHODS AND RESULTS: Forty-five consecutive patients with clinically significant PFO were treated with GSO and their results were compared with those of 45 consecutive patients treated with Amplatzer PFO device (APO). Primary endpoint was the incidence of 6-month residual right-to-left shunting (rRLS). The procedural results and the recurrence of embolic events (REE) at 1 year were also investigated. No differences in terms of embolic risk profile and echocardiographic parameters were observed between the 2 groups. GSO was successfully implanted in all patients without device-related complication. In 2 patients for whom device position was not optimal, the GSO was easily retrieved and a new GSO was successfully repositioned. Immediate moderate-severe rRLS was similar in 2 groups. No cases of severe 6-month rRLS were registered. Two patients (4%) and 1 patient (2%) had moderate 6-month rRLS in the GSO and APO group, respectively (P=NS). No cases of REE were registered at 1-year follow-up. CONCLUSIONS: GSO appears a valuable alternative to Amplatzer device for PFO occlusion.

Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study.

OBJECTIVES: To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables. BACKGROUND: SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors. METHODS: we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch). RESULTS: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated. CONCLUSIONS: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.

Five-year outcomes in patients with chronic total coronary occlusion treated with drug-eluting vs bare-metal stents: a case-control study.

BACKGROUND: Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS). METHODS: We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years. RESULTS: After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively. CONCLUSIONS: After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.

One-year clinical outcome of patients treated with or without abciximab in rescue coronary angioplasty.

BACKGROUND: The clinical results of abciximab administration during rescue angioplasty (PCI) are poorly investigated. METHODS: We evaluated the outcome of 406 consecutive patients undergoing rescue PCI treated with (n=218) or without (n=188) abciximab and a clopidogrel loading dose of 300 mg. The end point was the incidence of major cardiac adverse events (MACE) defined as death, recurrent acute myocardial infarction (AMI) and target vessel revascularization at 30 days and 1 year. The predictors of MACE were also investigated. RESULTS: No differences were found in MACE between the groups treated with or without abciximab at 30 days (15 and 20, p=0.67) and 1 year (23 and 29, p=0.85). Stepwise logistic regression analysis identified: cardiogenic shock (Odds Ratio [OR]=17.8, 95% confidence interval [CI] 5-99, p=0.0001), age (OR=1.099, 95% CI 1.04-1.15, p=0.0001), TIMI flow 0-1 after procedure (OR=5.51, 95% CI 1.72-17.6, p=0.004) as independent predictors of MACE at 30 days. Cox proportional hazards model identified: cardiogenic shock (adjusted hazard ratio [HR]=3.83, 95% confidence interval [CI] 1.76-8.35, p=0.01), age (HR=3.7, 95% CI 1.75-8.3, p=0.01), TIMI flow 0-1 after procedure (HR=1.04, 95% CI 1.01-1.07, p=0.001 as predictors of MACE at 1 year). After propensity score adjustments the predictors of MACE did not change. CONCLUSION: There were no differences in MACE at 30 days and 1 year in patients treated with or without abciximab during rescue PCI after a clopidogrel loading dose of 300 mg. Cardiogenic shock, age and TIMI flow 0 and 1 after PCI were predictors of MACE.

Long-term outcome of sirolimus-eluting vs bare-metal stent in the setting of acute myocardial infarction: 5-year results of the SESAMI trial.

BACKGROUND: few long-term randomized data on safety and effectiveness of sirolimus-eluting stent (SES) in the ST-segment elevation myocardial infarction (STEMI) setting are available. The aim of the present investigation was to evaluate the 5-year clinical outcome of SES vs bare-metal stent (BMS) implantation in patients with STEMI. METHODS: 320 STEMI patients were randomized to receive SES or BMS. The primary end-point was the incidence of target vessel failure (TVF) at 5-year follow-up. The secondary end-points were the rate of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), death or non-fatal MI and stent thrombosis (ST). Event rates from 1 to 5 years in patients undergoing TLR and those TLR free at 1 year were also investigated. RESULTS: The 5-year survival rate free from TVF and TLR was significantly higher in the SES than in the BMS group (85% vs 76% p=0.038; 92% vs 85% p=0.045, respectively). The lower incidence of adverse events was achieved in the first year of follow-up. The cumulative incidence of MACE, death or non-fatal MI and ST was comparable in the 2 groups at 5-year follow-up. Moreover death or MI incidence was 5% in the patients who did not experience TLR within 1-year and 16% in those who experience TLR in the same period (p=0.033). Predictors of death or MI during 5-year follow-up were TLR within 1 year (OR 3.4, 95% CI 1.1-10.1; p=0.04) and small vessels treatment (OR 4.8 95% CI 1.7-13.0; p=0.002). CONCLUSIONS: The clinical benefits of SES are maintained up to 5years without safety concerns.