One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study.

OBJECTIVES: To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES). BACKGROUND: Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents. METHODS: Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria. RESULTS: Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one. CONCLUSIONS: The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Closed versus open cell stent for high-risk percutaneous coronary interventions in ST-elevation acute myocardial infarction: the Closed versus Open Cells stent for High risk percutaneous coronary Interventions in ST-Elevation acute myocardial infarction (COCHISE) pilot study.

BACKGROUND: Stent deployment may be associated with distal embolization and slow flow in coronary thrombotic lesions. There are no data on the risk of distal thrombus embolization according to the stent design. The aim was to evaluate coronary flow after percutaneous coronary interventions (PCI) in acute myocardial infarction according to the employed stent (closed versus open cell design). METHODS: From March 2010 to December 2011, 223 consecutive patients with acute ST-elevation myocardial infarction were randomized to primary PCI either with an open cell (112 patients, 88 men) or with a closed cell stent design (111 patients, 92 men). The primary endpoint was the corrected TIMI frame count (cTFC) after the procedure. RESULTS: There were no significant differences in procedural success nor in-stent deployment in the 2 groups. At baseline, there were no significant differences in cTFC between the 2 groups (70 ± 37 and 67 ± 39, P = .65, respectively). After the procedure, the open cell group showed significantly higher cTFC compared to the closed cell group (18 ± 11 and 15 ± 5, P = .003 respectively). This difference was associated with a significant lower rate of TIMI 3 flow (87% and 95%, P = .037) and myocardial blush grade 3 (65% and 87%, P = .001) in the open compared to the closed cell group. There were 2 cases of death in the open cell and 1 case in the closed cell group. CONCLUSIONS: The use of a closed cell stent design rather than an open cell during PCI for acute ST-elevation myocardial infarction is associated with better coronary angiographic flow after PCI.

Radial versus femoral approach comparison in percutaneous coronary intervention with intraaortic balloon pump support: the RADIAL PUMP UP registry.

BACKGROUND: The role of intraaortic balloon pump (IABP) during percutaneous coronary intervention (PCI) in high-risk acute patients remains debated. Device-related complications and the more complex patient management could explain such lack of clinical benefit. We aimed to assess the impact of transradial versus transfemoral access for PCI requiring IABP support on vascular complications and clinical outcome. METHODS: We retrospectively analyzed 321 consecutive patients receiving IABP support during transfemoral (n = 209) or transradial (n = 112) PCI. Thirty-day net adverse clinical events (NACEs) (composite of postprocedural bleeding, cardiac death, myocardial infarction, target lesion revascularization, and stroke) were the primary end point, with access-related bleeding and hospital stay as secondary end points. RESULTS: Cardiogenic shock and hemodynamic instability were the most common indications for IABP support. Cumulative 30-day NACE rate was 50.2%, whereas an access site-related bleeding occurred in 14.3%. Patients undergoing transfemoral PCI had a higher unadjusted rate of NACEs when compared with the transradial group (57.4% vs 36.6%, P < .01), mainly due more access-related bleedings (18.7% vs 6.3%, P < .01). Such increased risk of NACEs was confirmed after propensity score adjustment (hazard ratio 0.57 [0.4-0.9], P = .007), whereas hospital stay appeared comparable in the 2 groups. CONCLUSIONS: In this observational registry, high-risk patients undergoing PCI and requiring IABP support appeared to have fewer NACEs if transradial access was used instead of transfemoral, mainly due to fewer access-related bleedings. Given the inherent limitations of this retrospective work, including the inability to adjust for unknown confounders, further controlled studies are warranted to confirm or refute these findings.

Resolute Italian study in all comers: immediate and one-year outcomes.

OBJECTIVES: To assess clinical performance of the second-generation Endeavor Resolute(®) drug-eluting stents (DES) in an unrestricted high-risk cohort of patients. BACKGROUND: New-generation DESs aim to further increase its clinical safety and efficacy by means of more biocompatible components limiting inflammatory response, assuring strut coverage and preserving endothelial vascular function. METHODS: Between January 2008 and April 2009 820 unselected consecutive high-risk patients (1,352 lesions) treated with the Endeavor Resolute(®) stent were enrolled in an independent multicenter registry. Primary end-points of this registry were immediate procedural outcome, incidence of target lesion failure (TLF, defined as composite of cardiac death, myocardial infarction, and target lesion revascularization) and rate of ARC stent thrombosis at 12-months follow-up. RESULTS: High-risk patient/lesion profile included acute coronary syndrome diagnosis in 57% of patients, diabetes mellitus in 23% and ACC/AHA type B2/C lesion in 74%. Endeavor Resolute(®) stent was used in an off-label indication in 52% of cases with stent/patient ratio of 1.93 and average stented segment of 39.8±26.6 mm. Immediate procedural success was accomplished in 96.0% of cases and at median 12-month follow-up TLF rate was 7.1% with 4.0% of clinically driven repeat revascularizations and 1.1% of definite/probable stent thrombosis incidence. At multivariable analysis, nor off-label Endeavor Resolute(®) stent use or multiple stent implantations were associated to an increased risk of adverse events. CONCLUSIONS: Extensive use of the new Endeavor Resolute(®) stent was associated with favorable procedural and 12-month outcomes despite the treatment of unselected complex clinical and anatomical presentation. Endeavor Resolute(®) stent showed excellent safety and efficacy profile also in off-label indications.

Transradial approach (left vs right) and procedural times during percutaneous coronary procedures: TALENT study.

BACKGROUND: most of the studies assessing transradial approach for coronary angiography (CA) have been performed through right radial approach (RRA). Our aim was to evaluate the safety and efficacy of left radial approach (LRA) compared with RRA for coronary procedures. METHODS: from January 2009 to December 2009, in 2 hospitals, 1,540 patients were randomized to RRA (770 patients) or LRA (770 patients) for percutaneous coronary procedures. The primary end point was fluoroscopy time for CA and for percutaneous coronary intervention (PCI) evaluated independently. Prespecified subgroup analyses according to patient age and operator experience were planned. RESULTS: in 1,467 patients (732 RRA and 735 LRA), a CA (diagnostic group) was performed, and in 688 (344 each for RRA and LRA), a PCI. In the diagnostic group, LRA was associated with significantly lower fluoroscopy time (149 seconds, interquartile range [IQR] 95-270 seconds) and dose area product fluoroscopy (10.7 Gy cm(2), IQR 6-20.5 Gy cm(2)) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm(2), IQR 7-23.8 Gy cm(2), P = .004, respectively). In the PCI group, there were no significant differences in fluoroscopy time (614 seconds, IQR 367-1,087 seconds for LRA and 695 seconds, IQR 415-1,235 seconds, P = .087 for RRA) and dose area product fluoroscopy (53.7 Gy cm(2), IQR 29-101 Gy cm(2) for LRA and 63.1 Gy cm(2), IQR 31-119 Gy cm(2), P = .17 for RRA). According to subgroup analyses, the differences between LRA and RRA were confined to older patients (≥ 70 years old) and to operators in training. CONCLUSIONS: left radial approach for coronary diagnostic procedures is associated with lower fluoroscopy time and radiation dose adsorbed by patients compared with the RRA, particularly in older patients and for operators in training.

The PREHAMI (PREsillion™ in high-risk acute myocardial infarction) registry: in-hospital and long-term outcomes.

OBJECTIVES: To evaluate the efficacy of the new Cobalt-Chromium (Co-Cr) Presillion™ stent for the treatment of high-risk acute myocardial infarction (MI) patients. BACKGROUND: Percutaneous coronary intervention (PCI) with stent represents the gold standard treatment for acute MI. METHODS AND RESULTS: We enrolled patients with high-risk acute MI (either ST-segment elevation MI or non-ST-segment elevation MI) treated with PCI using a new Co-Cr bare metal stent with closed cells design and limited balloon compliance. We considered high-risk features as one of the following: age ≥ 70 years, ejection fraction ≤ 35%, glomerular filtration rate ≤ 60 mL/min, diabetes mellitus, rescue PCI, or chronic atrial fibrillation or other conditions requiring long-term oral anticoagulation therapy. Primary outcome of the study was rate of major adverse cardiac events (MACE) defined as all-cause death, new MI, and target-vessel revascularization. A total of 129 consecutive patients were enrolled (69 ± 11 years, 74% men): 71 (55%) patients with ST-segment elevation MI and 58 (45%) patients with non-ST-segment elevation MI. A total of 153 vessels (169 lesions and 179 stents) were treated. The device success rate was high (98.8%). In-hospital MACE rate was 5.4% mainly because of death associated with the acute MI. At 1-year follow-up, the MACE rate was 17.3%, with 11% all-cause death (7.9% of cardiac origin), 0.6% of stent thrombosis, and 4.6% target-vessel revascularization. CONCLUSIONS: The use of the Co-Cr Presillion stent in patients with high-risk acute MI treated invasively seems to be safe and efficacious with optimal deliverability and good long-term outcomes and represents a good option in the treatment of these patients.

Transradial percutaneous coronary interventions using sheathless guiding catheters: a multicenter registry.

BACKGROUND: Transradial approach (TRA) for percutaneous coronary interventions (PCIs) is a common alternative to transfemoral approach associated with lower complications. However, a limitation of TRA is the use of large caliber guiding catheters due to the small size of the radial artery. The sheathless guiding catheter system that is in diameter 1-2 French (Fr) smaller than the corresponding introducer sheath may overcome these difficulties. METHODS: From January 2010 through December 2010 in 5 Italian high-volume hospitals, 213 consecutive patients who underwent TRA-PCIs using the sheathless Eaucath guiding catheter system because of small radial artery caliber (Group 1) or undergoing bifurcation PCIs (Group 2) were enrolled in this registry. In patients of Group 1 (n = 79), a 6.5-Fr sheathless guiding catheter was employed, whereas in patients of Group 2 (n = 134) a 7.5 Fr was used. RESULTS: Among the 213 patients enrolled, 270 vessels were treated for 316 lesions. No procedures required conversion to a conventional guiding catheter system. There were significantly more female patients in Group 1, and they were, older, shorter, and thinner than patients in Group 2. No cases of major vascular complications were observed in either groups. During procedures, adjunctive devices employed included intravascular ultrasound, thrombectomy catheters, and distal protection systems. CONCLUSIONS: The use of the sheathless guiding catheter system is feasible for TRA-PCIs in case of small radial artery caliber or intended coronary bifurcation intervention.

Upstream effect for atrial fibrillation: still a dilemma?

Atrial fibrillation is the most common arrhythmia in clinical practice. Ion channel blocking agents are often characterized by limited long-term efficacy and several side effects. In addition, ablative invasive procedures are neither easily accessible nor always efficacious. The "upstream therapy," which includes angiotensin-converting enzyme inhibitors, aldosterone receptor antagonists, statins, glucocorticoids, and ω-3 poly-unsaturated fatty acids, targets arrhythmia substrate, influencing atrial structural and electrical remodeling that play an essential role in atrial fibrillation induction and maintenance. The mechanisms involved and the most important clinical evidence regarding the upstream therapy influence on atrial fibrillation are presented in this review. Some open questions are also proposed.

Early detection of adverse events with daily remote monitoring versus quarterly standard follow-up program in patients with CRT-D.

BACKGROUND: A relative high rate of clinical and device-related adverse events (AE) is generally reported in patients with implantable defibrillators for cardiac resynchronization therapy (CRT-D). Aim of this study was to compare a daily remote monitoring (RM) to a standard program of in-office visits. METHODS AND RESULTS: We retrospectively analyzed RM database and hospital files of 99 CRT-D consecutive patients who were visited in the out-patient clinic every 3-4 months; thirty-three patients were in addition controlled remotely with RM (RM group). Kaplan-Meier curves of clinical or device-related AE-free rates were obtained. During a median follow-up of 7 months, clinical AEs were: ventricular and atrial arrhythmias in 14 and 11 patients, low CRT pacing in nine, heart failure, strokes, or death in 15. Device-related AEs were: insufficient pacing/sensing performances in nine patients, lead dislodgement in five. As comparing the RM group with the remaining patients, Kaplan-Meier curves of clinical AEs diverged to significantly different rates: 23.8% (confidence interval [CI] 0.1%-47.5%) in the RM group and 48.7% (21.6-75.7%) in the remaining patients (P = 0.00002), with a hazard ratio of 0.14 (CI 0.06-0.37). Nondivergent Kaplan-Meier curves were obtained for device-related AE-free rates. CONCLUSION: CRT-D patients followed with quarterly in-office visits without a daily RM system had an 86% higher risk of delayed detection of clinical AEs, during a median follow-up of 7 months.

Predictive value of microvolt T-wave alternans for cardiac death or ventricular tachyarrhythmic events in ischemic and nonischemic cardiomyopathy patients: a meta-analysis.

BACKGROUND: Microvolt T-wave alternans (MTWA) has been proposed as a predictor of the risk of ventricular tachyarrhythmias (VT) and sudden cardiac death (SCD). Aim of this study was to perform a systematic review of the literature and a meta-analysis of MTWA in primary prevention patients with ischemic and nonischemic cardiomyopathy. METHODS: The positive predictive value (PPV), negative predictive value (NPV), and relative risk (RR) of MTWA in predicting death, cardiac death, and SCD during follow-up were reported. RESULTS: Fifteen studies involving 5681 patients (mean age 62 years, mean ejection fraction 32%) were included. The summary PPV during the average 26-month follow-up was 14% (95% CI: 13-15); NPV was 95% (95% CI: 94-96), and the univariate RR was 2.35 (95% CI: 1.68-3.28). The predictive value of MTWA was similar in patients with ischemic and nonischemic cardiomyopathy. The average RR for SCD or VT events of an abnormal MTWA was 2.40, similar to that for cardiac death. When we grouped the studies together depending upon whether beta-blockers were withheld prior to MTWA screening, the beta-blockers group showed an RR of 5.88. By contrast, the group in which beta-blocker therapy was withheld had an RR of 1.63. CONCLUSION: A positive MTWA determined an approximately 2.5-fold higher risk of cardiac death and life-threatening arrhythmia and showed a very high NPV both in ischemic and nonischemic patients. An abnormal MTWA test was associated with a 5-fold increased risk for cardiac mortality in the low-indeterminate group and about a 6-fold increased risk in beta-blockers group.

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS).

BACKGROUND: Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS: A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS: A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS: This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Efficacy of ivabradine in a case of inappropriate sinus tachycardia and ventricular dysfunction.

We present a case of a 49-year-old man with inappropriate sinus tachycardia and ventricular dysfunction. The conventional treatment (ace-inhibitor and beta-blockers) was not well tolerated by the patient, so Ivabradine, a specific inhibitor of If current in the sinus node, was started. After 3 months of using this medication, we observed an improvement of ejection fraction and quality of life.

How many atrial fibrillation ablation candidates have an underlying supraventricular tachycardia previously unknown? Efficacy of isolated triggering arrhythmia ablation.

AIMS: Supraventricular tachycardia may trigger atrial fibrillation (AF). The aim of the study was to evaluate the prevalence of supraventricular tachycardia (SVT) inducibility in patients referred for AF ablation and to evaluate the effects of SVT ablation on AF recurrences. METHODS AND RESULTS: Two hundred and fifty-seven patients (185 males; mean age: 53.4 ± 14.6 years) referred for AF ablation were studied. In all patients only AF relapses had been documented in the clinical history. Twenty-six patients (10.1%; mean age: 43.4 ± 13.3 years; 17 males) had inducible SVT during electrophysiological study and underwent an ablation targeted only at SVT suppression. Ablation was successful in all 26 patients. The ablative procedures are: 12 slow-pathway ablations for atrioventricular nodal re-entrant tachycardia; 9 concealed accessory pathway ablations for atrioventricular re-entrant tachycardia; and 5 focal ectopic atrial tachycardia ablations. No recurrences of SVT were observed during the follow-up (21 ± 11 months). Two patients (7.7%) showed recurrence of at least one episode of AF. Patients with inducible SVT had less structural heart disease and were younger than those without inducible SVT (interventricular septum thickness: 8.4 ± 1.6 vs. 11.0 ± 1.4 mm, P < 0.01; left atrial diameter: 37.0 ± 3.0 vs. 44.0 ± 2.2 mm, P < 0.01; age: 43.4 ± 13.3 vs. 57.3 ± 11.2 years, P < 0.01). Prevalence of paroxysmal AF was higher in patients with inducible SVT when compared with those with only AF (84.6 vs. 24.6%, P < 0.01). CONCLUSION: A significant proportion of candidates to AF ablation are inducible for a SVT. SVT ablation showed a preventive effect on AF recurrences. Those patients should be selected for simpler ablation procedures tailored only on the triggering arrhythmia suppression.

Diagnostic accuracy of a new software for complex fractionated electrograms identification in patients with persistent and permanent atrial fibrillation.

INTRODUCTION: The elimination of complex fractionated atrial electrograms (CFAEs) has been proposed as a potential target for guiding successful AF substrate ablation. The possibility to efficiently map the atria and rapidly identify CFAEs sites is necessary, before the CFAEs ablation becomes a routine approach. The aims of this study, conducted in patients with persistent and permanent atrial fibrillation (AF), were to analyze by CARTO mapping in the right (RA) and in the left atrium (LA) during AF: (1) the diagnostic accuracy of a new software for CFAEs analysis, (2) the spatial distribution of CFAEs, (3) the regional beat to beat AF intervals (FF). METHODS AND RESULTS: Twenty-five consecutive patients (four women, 58.8 +/- 11.4 years) undergoing radiofrequency catheter ablation for persistent and permanent AF were enrolled in the study. The CFAE software showed a high sensitivity (90%) and specificity (91%) in the identification of CFAEs, using a specific setting of parameters. The LA had a significantly higher prevalence of CFAEs as compared with the RA (30.5% vs 20.3%, P = 0.016). The CFAEs were mostly present in the septum and in the area of coronary sinus ostium (CS os). The FF intervals were significantly shorter in the LA than in the RA (P < 0.01). CONCLUSION: CARTO system has a high diagnostic accuracy in the identification of CFAEs. Atrial electrical activity (CFAEs, mean FF intervals) during AF showed a significant spatial inhomogeneity.

Cardiac arrest and myocardial bridging.

Myocardial bridging, a systolic compression of an intramyocardial segment of an epicardial coronary artery, may be an incidental finding during coronary angiography or autopsy. However, some investigators reported a variety of acute coronary syndromes associated with this condition. We describe the case of a relatively young male patient (43 years old) referred to our emergency department for cardiac arrest and subsequent evidence of significant myocardial bridging at coronary angiography. The patient has been treated with an implantable cardioverter-defibrillator to prevent possible subsequent arrhythmic events associated with the myocardial bridging.

Chronic aspirin and statin therapy in patients with impaired renal function and acute coronary syndromes: results from the IN-ACS Outcome Registry.

BACKGROUND: The cardioprotective role that statin and aspirin has appears to be reduced in patients with chronic kidney disease (CKD). This analysis aims to evaluate the impact of statin and aspirin on the outcome of patients with CKD and acute coronary syndrome (ACS). METHODS: All patients who were enrolled in the IN-ACS Outcome registry, diagnosed with CKD, were included in our analysis. We divided patients into four groups, according to previous chronic therapy: neither aspirin nor statin therapy (Group 1), aspirin only therapy (Group 2), statin only therapy (Group 3) and aspirin plus statin therapy (Group 4). RESULTS: Of the 5483 patients enrolled that had data on glomerular filtration rate available, 1484 had CKD: These segregated into 589 patients in Group 1, 477 in Group 2, 89 in Group 3 and 329 in Group 4. Despite having a higher baseline risk profile, groups 3 and 4, as compared to the other two groups, exhibited a significantly lower in-hospital mortality (1% in Group 3, 2% in Group 4; but 8% in Group 1 and 7% in Group 2, p = 0.0007); while at 30 days it remained so, as it was 1% in Group 3, 4% in Group 4 (and 10% in Group 1 and 10% in Group 2 p = 0.0002); and at 1 year it was 11% in Group 3 and 13% in Group 4 (compared to 20% in Group 1 and 23% in Group 2, p = 0.0012). CONCLUSIONS: In a large cohort of patients with CKD and ACS, chronic treatment with statin or the combination of aspirin and statin is associated with short-term and long-term better outcomes for in-hospital mortality, as compared to those receiving no therapy or aspirin therapy alone.

Economic impact of remote monitoring on ordinary follow-up of implantable cardioverter defibrillators as compared with conventional in-hospital visits. A single-center prospective and randomized study.

INTRODUCTION: Few data are available on actual follow-up costs of remote monitoring (RM) of implantable defibrillators (ICD). Our study aimed at assessing current direct costs of 1-year ICD follow-up based on RM compared with conventional quarterly in-hospital follow-ups. METHODS AND RESULTS: Patients (N = 233) with indications for ICD were consecutively recruited and randomized at implant to be followed up for 1 year with standard quarterly in-hospital visits or by RM with one in-hospital visit at 12 months, unless additional in-hospital visits were required due to specific patient conditions or RM alarms. Costs were calculated distinguishing between provider and patient costs, excluding RM device and service cost. The frequency of scheduled in-hospital visits was lower in the RM group than in the control arm. Follow-up required 47 min per patient/year in the RM arm versus 86 min in the control arm (p = 0.03) for involved physicians, generating cost estimates for the provider of USD 45 and USD 83 per patient/year, respectively. Costs for nurses were comparable. Overall, the costs associated with RM and standard follow-up were USD 103 ± 27 and 154 ± 21 per patient/year, respectively (p = 0.01). RM was cost-saving for the patients: USD 97 ± 121 per patient/year in the RM group versus 287 ± 160 per patient/year (p = 0.0001). CONCLUSION: The time spent by the hospital staff was significantly reduced in the RM group. If the costs for the device and service are not charged to patients or the provider, patients could save about USD 190 per patient/year while the hospital could save USD 51 per patient/year.

Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn: the ARGENTO study: a prospective, multicenter registry.

BACKGROUND: To investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤ 15-day or >15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn--ARGENTO study). METHODS: Consecutive patients without ≤ 12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated. RESULTS: Between March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8 ± 13.6 months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤ 15-day and >15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer-Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history, <45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57-6.80, p=0.27) was not independent risk factor for MACEs. CONCLUSIONS: In consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤ 15 days or >15 days).

Impact of respiration on electroanatomical mapping of the right atrium: implication for cavotricuspid isthmus ablation.

PURPOSE: Cavotricuspid isthmus (CTI) ablation for typical atrial flutter (AFL) has become the preferred treatment for this arrhythmia. The aims of this study were to assess the impact of respiratory gating (RG) on electroanatomical mapping of CTI and to assess the efficiency of CTI ablation guided by the Carto3® system equipped with the new respiration gating software. METHODS: Forty-four consecutive patients (mean age, 60 ± 13 years; 25 male) undergoing cavotricuspid ablation for symptomatic common AFL were randomly assigned to CARTO™ mapping with or without enabling RG module (Group A, RG OFF, Group B, RG ON). RESULTS: A significant reduction in mean RA volume, CTI central length and CS ostium maximum diameter has been observed in the RG maps. The mean total procedural, fluoroscopy and radiofrequency (RF) time were 102.9 ± 35.3, 10.6 ± 3.3, 22.9 ± 14.2 min in group A and 75.3 ± 21.7, 3.6 ± 4.5, 10.4 ± 5.7 min in group B, respectively (p < 0.05). CONCLUSIONS: Electroanatomical mapping systems' accuracy may be strongly influenced by respiration movements. The current study showed that automatic respiratory gated acquisition resulted in a better visualization of CTI, and this determines a relevant reduction in fluoroscopy and RF times.