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.

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.

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.

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.

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.

Cardiac magnetic resonance detection of left ventricular thrombus in acute myocardial infarction.

INTRODUCTION: Left ventricular thrombosis (LVT) is a possible complication of acute myocardial infarction. Aim of our study was to evaluate incidence and clinical characteristics of patients with LVT after ST elevation myocardial infarction (STEMI) using contrast- enhanced magnetic resonance (CMR). METHODS AND RESULTS: In a prospective cohort of 36 consecutive patients with STEMI acutely reperfused with primary percutaneous coronary intervention, CMR was performed within one week. LVT was found in 7 patients (19%), and was located in left ventricle apex or adherent to antero-septum. Compared to the rest of population patients with LVT have lower ejection fraction (38 ± 7% versus 51 ± 6%, P = 0.009), larger left ventricle end systolic volume (95.8 ± 19 ml versus 68.9 ± 19 ml, P = 0.02), higher time to reperfusion (9.3 ± 7.2 versus 5 ± 3.6, P = 0.03) and left anterior descending artery was constantly involved (100% versus 41 %, P = 0.06). In 5 cases the LVT was also detected by echocardiography, however, in 2 cases it was missed. CONCLUSIONS: The incidence of LVT after STEMI is not negligible and was accurately detected by CMR. Localization of myocardial infarction, time to reperfusion, ejection fraction and left ventricle end systolic volume are the most important predictors of left ventricle thrombus formation.

Early and long-term outlook of percutaneous coronary intervention for bifurcation lesions in young patients.

BACKGROUND: Coronary artery disease is most common in older patients, but may occur in younger subjects. The outlook of young patients after percutaneous coronary intervention (PCI) of challenging lesion subsets such as coronary bifurcations, is not established. We thus aimed to appraise the early and long-term results of PCI for bifurcations in young patients. METHODS: A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between 2002 and 2006 in 22 Italian centers. Patients were divided in 2 groups: age ≤ 45 years, and age > 45 years. The primary end-point was long-term rate of major adverse cardiac events (MACE). RESULTS: 4,314 patients were included: 195 (4.5%) in the younger group, and 4119 (95.5%) in the older group. 30-day outcomes did not show significant differences in MACE rates, with 1.0% in the ≤ 45 years group and 2.1% in the >45 years group (p=0.439), with death in 0.5% and 1.2% (p=0.388). At long-term follow-up (24.4 ± 15.1 months), younger patients showed similar rates of MACE, (12.8% vs. 16.6%, p=0.161), myocardial infarction (3.1% vs. 3.7%, p=0.633), target lesion revascularization (11.3% vs. 12.5%, p=0.627), or stent thrombosis (1.5% vs. 2.8%, p=0.294), despite an increased risk of death in older patients (1.0% vs. 5.0%, p=0.012). Even at extensive multivariable analysis, younger patients still faced a similar risk of MACE (HR=0.78 [0.48-1.27], p=0.318). CONCLUSIONS: Despite their low age, young patients undergoing PCI for bifurcation face a significant risk of early and late non-fatal adverse events. Thus, they should not be denied careful medical management and follow-up.

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.

Sodium bicarbonate plus N-acetylcysteine to prevent contrast-induced nephropathy in primary and rescue percutaneous coronary interventions: the BINARIO (BIcarbonato e N-Acetil-cisteina nell'infaRto mIocardico acutO) study.

AIMS: Contrast-induced nephropathy (CIN) is a frequent and potentially harmful complication of percutaneous coronary interventions (PCI), especially in the setting of ST-elevation myocardial infarction (STEMI). We tested the efficacy of a sodium bicarbonate (SB)-based hydration in urgent PCI for STEMI. METHODS AND RESULTS: From June 2009 to September 2010, 262 consecutive STEMI patients undergoing urgent PCI were prospectively enrolled and treated by SB-based hydration (154 mEq/L at 3 ml Kg-1 for one hour followed by 1 ml Kg-1 for six hours) (group A). As controls, 262 consecutive STEMI patients receiving 0.9% saline hydration (1 ml Kg-1 for 24 hours) before June 2009 were retrospectively enrolled (group B). Both groups received high-dose N-acetylcysteine (NAC). The primary endpoint was the composite of in-hospital death, need for dialysis and CIN (≥25% increase in serum creatinine at 48 hours). The two groups were comparable for baseline clinical and procedural characteristics, for Mehran risk score and baseline estimated glomerular filtration rate. The primary combined endpoint was significantly reduced in group A as compared to group B (9.2 vs. 18.7%, p=0.023) with a number needed to treat (NNT) of 11. Specifically, a significant reduction of both in-hospital death (2.3 vs. 6.1%, p=0.049, NNT 27) and CIN (8.0 vs. 14.1%, p=0.03, NNT 17) was observed, with no difference in the need for dialysis. CONCLUSIONS: Our data indicate that hydration with sodium bicarbonate in addition to high-dose NAC in the setting of urgent PCI for STEMI is associated with a net clinical benefit.

Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study.

OBJECTIVES: The purpose of this study was to assess whether transradial access for ST-segment elevation acute coronary syndrome undergoing early invasive treatment is associated with better outcome compared with conventional transfemoral access. BACKGROUND: In patients with acute coronary syndrome, bleeding is a significant predictor of worse outcome. Access site complications represent a significant source of bleeding for those patients undergoing revascularization, especially when femoral access is used. METHODS: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) was a multicenter, randomized, parallel-group study. Between January 2009 and July 2011, 1,001 acute ST-segment elevation acute coronary syndrome patients undergoing primary/rescue percutaneous coronary intervention were randomized to the radial (500) or femoral (501) approach at 4 high-volume centers. The primary endpoint was the 30-day rate of net adverse clinical events (NACEs), defined as a composite of cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding). Individual components of NACEs and length of hospital stay were secondary endpoints. RESULTS: The primary endpoint of 30-day NACEs occurred in 68 patients (13.6%) in the radial arm and 105 patients (21.0%) in the femoral arm (p = 0.003). In particular, compared with femoral, radial access was associated with significantly lower rates of cardiac mortality (5.2% vs. 9.2%, p = 0.020), bleeding (7.8% vs. 12.2%, p = 0.026), and shorter hospital stay (5 days first to third quartile range, 4 to 7 days] vs. 6 [range, 5 to 8 days]; p = 0.03). CONCLUSIONS: Radial access in patients with ST-segment elevation acute coronary syndrome is associated with significant clinical benefits, in terms of both lower morbidity and cardiac mortality. Thus, it should become the recommended approach in these patients, provided adequate operator and center expertise is present. (Radial Versus Femoral Investigation in ST Elevation Acute Coronary Syndrome [RIFLE-STEACS]; NCT01420614).

Impact of vascular approach (transradial vs. transfemoral) on the efficacy of thrombus aspiration in acute myocardial infarction patients.

BACKGROUND: Manual thrombus aspiration improves the efficacy of percutaneous coronary interventions (PCIs) in ST-elevation acute myocardial infarction (STEMI). The transradial approach (TRA) is an emerging vascular approach for PCI but is associated with specific technical requirements. As data on the combination of thrombus aspiration and TRA are scarce, we sought to assess the feasibility of TRA manual thrombus aspiration in STEMI patients. METHODS: All consecutive patients treated with manual thrombectomy for acute STEMI in three Italian hospitals were considered. Patients were divided according to the vascular approach into two groups: TRA and transfemoral (TFA). Two primary end points were defined: thrombectomy feasibility (ability to cross the occlusion with the device) and thrombectomy efficacy (absolute thrombus score reduction after device crossing). RESULTS: From January 2008 to December 2009, 303 patients were included: 151 patients (63±13 years) were treated through TFA, and 152 patients (61±12 years, P=.25) were treated through TRA. There were no significant differences in thrombectomy feasibility (75% in the TRA compared to 74.8% in the TFA group, P=.97) or in thrombectomy efficacy (2.6±.8 for TRA and 2.9±2 for TFA, P=.15). In both groups, there was a significant reduction in thrombus score after manual thrombus aspiration. Angiographically evident distal embolization after device crossing was low and observed in seven cases (5%) either for TFA and TRA (P=.99). CONCLUSIONS: The present study suggests that, in the setting of acute STEMI, manual thrombus aspiration through TRA is feasible, and its efficacy is comparable to the TFA.

Routine upstream versus selective downstream administration of glycoprotein IIb/IIIa inhibitors in patients with non-ST-elevation acute coronary syndromes: a meta-analysis of randomized trials.

BACKGROUND: Glycoprotein (GP) IIb/IIIa inhibitors reduce ischemic complications in patients with non-ST-elevation acute coronary syndromes (NSTEACS) who undergo invasive procedures. However the optimal timing of therapy (upstream - at hospital admission in all patients prior to coronary catheterization, or downstream - after coronary angiography selectively in patients prior to percutaneous coronary intervention) is still debated. The aim of this meta-analysis was to compare the outcome of NSTEACS patients randomized to routine upstream versus deferred selective downstream GP IIb/IIIa inhibitors. METHODS: We scanned the literature from January 1990 to May 2009 to identify all randomized trials comparing upstream administration of GP IIb/IIIa inhibitors versus its downstream use in invasively managed NSTEACS. RESULTS: In 5 randomized trials a total of 9753 patients were randomized to upstream GP IIb/IIIa inhibitors therapy versus 9716 patients randomized to deferred selective downstream therapy. Upstream therapy was associated with reduced in-hospital or 30-day major adverse ischemic cardiac events (odds ratio=0.90 [95% confidence interval 0.82-0.98], p=0.02). However the risk of major bleeding was significantly higher with upstream therapy (odds ratio=1.35 [1.11-1.63], p=0.002). Combining ischemic and hemorrhagic events in a net clinical end-point showed no significant differences between the two approaches (odds ratio=1.01 [0.92-1.10], p=0.88). CONCLUSIONS: In conclusion early administration of GP IIb/IIIa inhibitors in NSTEACS is associated with significant reduction in ischemic events compared to a selective deferred therapy after coronary angiography. However upstream therapy is also associated with increased bleeding complications. This approach should therefore be reserved for patients at high ischemic and/or low hemorrhagic risk.

Catheter ablation of right atrial ganglionated plexi in patients with vagal paroxysmal atrial fibrillation.

BACKGROUND: Catheter ablation of ganglionated plexi (GP) in the left atrium has been proposed in different subgroup of patients with atrial fibrillation (AF). Anatomic studies found a high prevalence of GP in the posterior surface of the right atrium (RA). Experimental data suggested the potential role of right atrial GP in the AF initiation and maintenance. The aim of our study was to assess the efficacy of GP ablation in RA in patients with vagal AF. METHODS AND RESULTS: Thirty-four patients without structural heart diseases were randomly assigned for a selective ablation procedure targeted on the elimination of vagal reflex evoked by high frequency stimulation or an extensive approach at anatomic sites of GP. All patients underwent Holter ECG and heart rate variability evaluation at baseline and at 3, 6, 12, and 18 months of follow-up. At a mean follow-up of 19.7±5.2 months, AF recurred in 5 of 17 patients with anatomic ablation and in 13 of 17 patients with a selective approach (P=0.01). No patient had major complications. After ablation, heart rate variability parameters showed a significant parasympathetic (and sympathetic) denervation in the first 6 months, which was more prominent in patients with anatomic GP ablation and in those without AF recurrence. CONCLUSIONS: This study demonstrates that in a selected population of vagal paroxysmal AF, the anatomic ablation of GPs in the RA is effective in about 70% of patients. These results confirm that atrial vagal denervation can abolish AF, as suggested by experimental and clinical data.

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.

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.

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.

Evaluation of the "learning curve" for left and right radial approach during percutaneous coronary procedures.

The transradial approach for percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or left radial approach (LRA) after an appropriate "learning curve." However, studies evaluating the "learning curve" for RRA and LRA are lacking. In the Transradial Approach (Left vs Right) and Procedural Times During Percutaneous Coronary Procedures (TALENT) study, which randomized 1,540 patients to the RRA or LRA, transradial procedures were performed by either seniors or fellows. Diagnostic procedures performed by fellows were divided into 3 stages: 0 to 100 procedures (stage 1), 101 to 200 procedures (stage 2), and >200 procedures (sage 3). The primary end point of the study was fluoroscopy time during the 3 stages. Six fellows performed 532 procedures, 260 through the RRA and 272 through the LRA. During the training period, fellows showed a progressive significant reduction in fluoroscopy time for the LRA over the 3 stages (stage 1: 258 seconds, interquartile range [IQR] 138 to 377; stage 2: 198 seconds, IQR 126.5 to 375; stage 3: 142 seconds, IQR 95 to 325; p = 0.003), whereas for the RRA, only a slight and nonsignificant reduction in fluoroscopy time was observed (stage 1: 271 seconds, IQR 186 to 364; stage 2: 240 seconds, IQR 156 to 395; stage 3: 218.5 seconds, IQR 145.5 to 300.5; p = 0.20). Cannulation time was progressively reduced over the time for the 2 radial approaches: during stage 1, <40% of procedures required ≤3 minutes for radial cannulation, whereas at stage 3, radial cannulation time was ≤3 minutes in >60% of procedures (p <0.0001). In conclusion, the LRA is associated with a shorter learning curve compared to the RRA.

Operator radiation exposure during percutaneous coronary procedures through the left or right radial approach: the TALENT dosimetric substudy.

BACKGROUND: Transradial percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or the left radial approach (LRA), but data on radiation dose absorbed by operators comparing the two approaches are lacking. The aim of the present study was to evaluate radiation dose absorbed by operators during coronary procedures through the RRA and LRA. METHODS AND RESULTS: Three operators were equipped with 5 different dosimeters (left wrist, shoulder, thorax outside the lead apron, thorax under the lead apron, and thyroid) during RRA or LRA for coronary procedures. Each month, the dosimeters were analyzed to determine the radiation dose absorbed. From February to December 2009, 390 patients were randomly assigned to the RRA (185 patients; age, 66±11 years) or the LRA (185 patients; age, 66±11 years). There were no significant differences in fluoroscopy time (for RRA, 369 seconds; interquartile range, 134 to 857 seconds; for LRA, 362 seconds; interquartile range, 142 to 885 seconds; P=0.58) between the 2 groups. There were no significant differences in monthly radiation dose at the thorax (0.85±0.46 mSv for RRA and 1.12±0.78 mSv for LRA, P=0.33), at the thyroid (0.36±0.2 mSv for RRA and 0.34±0.3 mSv for LRA, P=0.87), and at the shoulder (0.73±0.44 mSv for RRA and 0.94±0.42 mSv for LRA, P=0.27). The dose at the wrist was significantly higher for the RRA (2.44±1.12 mSv) compared with the LRA (1±0.8 mSv, P=0.002). In both radial approaches, the thoracic radiation dose under the lead apron was undetectable. CONCLUSIONS: Compared with RRA, LRA for coronary procedures is associated with similar radiation dose for operators at the body, shoulder, or thyroid level, with a possible significant advantage at the wrist. The cumulative radiation dose for both approaches is well under to the annual dose-equivalent limit. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00282646.