[Stent loss and successful retrieval with the loop snare technique]. / Perdita dello stent e recupero mediante "loop snare technique".

A 79-year-old woman was admitted to our coronary care unit for non-ST-elevation myocardial infarction. Urgent left transradial coronary angiography showed mid-distal high-grade stenosis of the left circumflex coronary artery. During percutaneous coronary intervention, stent dislodgement from the balloon catheter occurred. Fortunately, the guidewire was left in place through the detached stent, but a loop snare failed to cross the proximal circumflex artery. A second wire was placed in parallel to the first one and the first wire was caught in the loop snare, which was pulled back and closed at the level of the stent. Then, we cautiously pulled the guiding catheter together with the stent as a whole unit out of the introducer.

Transradial versus transfemoral intervention for acute myocardial infarction: a propensity score-adjusted and -matched analysis from the REAL (REgistro regionale AngiopLastiche dell'Emilia-Romagna) multicenter registry.

OBJECTIVES: This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach. BACKGROUND: Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty. METHODS: We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching. RESULTS: A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052). CONCLUSIONS: In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry.

BACKGROUND: The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear. METHODS AND RESULTS: We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6 months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group. CONCLUSIONS: In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

Bone marrow cell transplantation improves cardiac, autonomic, and functional indexes in acute anterior myocardial infarction patients (Cardiac Study).

AIMS: Bone marrow (BM) stem cells improve cardiac function and outcome after acute ST-segment elevation myocardial infarction (MI). In this randomized controlled trial, the effects of intracoronary transfer of autologous BM cells on left ventricular ejection fraction (LVEF) and volumes (2D-echo and resting SPECT), stroke volume [impedance cardiography (ICG)], autonomic control [heart rate variability (HRV)], baroreflex sensitivity (BRS), and exercise tolerance (cardiopulmonary exercise test) were assessed in post-MI patients. Exercise stress SPECT was also performed. METHODS AND RESULTS: After percutaneous coronary intervention (PCI), 38 patients with residual LV dysfunction were randomized to either the BM group (optimized treatment plus intracoronary transfer of autologous BM cells 4 + or - 1 days after PCI, n = 19) or control (C) group (optimized treatment only, n = 19). After 12 months, mean LVEF (%) increased 13.1 + or - 1.9 in the BM patients vs. 5.3 + or - 2.0 in C, with an increase in stroke volume (mL, 14.5 + or - 4.0 in BM vs. 1.8 + or - 3.7 in C) associated with improved HRV [SD (ms) 62.4 + or - 8.3 in BM vs. 19.0 + or - 7.5 in C), higher BRS (ms/mmHg, 8.0 + or - 1.8 in BM vs. -1.9 + or - 1.7 in C), and peak VO(2) (mL/kg min(-1), 3.5 + or - 1.0 in BM vs. -0.4 + or - 0.5 in C). Stress SPECT showed improvements in perfusion, regional and global LV function scores (P < 0.05 BM vs. C groups for all comparisons). Cell transfer did not increase the risk of adverse clinical, in-stent restenosis, or proarrhythmic events. CONCLUSION: The beneficial effect of autologous BM cells in post-MI patients with depressed LV function may be mediated by restoration of autonomic control, and improved exercise tolerance.

Comparison of 2-year clinical outcomes with sirolimus and paclitaxel-eluting stents for patients with diabetes: results of the Registro Regionale AngiopLastiche Emilia-Romagna Registry.

BACKGROUND: Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated. OBJECTIVE: This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes. DESIGN: Observational, multicenter, nonrandomized study. SETTING: Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI. PATIENTS: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. MEASUREMENTS: Unadjusted and propensity score-adjusted 2-year clinical outcome. RESULTS: After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.

Clinical impact of an inter-hospital transfer strategy in patients with ST-elevation myocardial infarction undergoing primary angioplasty: the Emilia-Romagna ST-segment elevation acute myocardial infarction network.

AIMS: This study sought to evaluate the impact of an inter-hospital transfer strategy on treatment times and in-hospital and 1 year cardiac mortality of patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous intervention (p-PCI) in the Italian region of Emilia-Romagna, where an efficient region-wide system for reperfusion has been established. METHODS AND RESULTS: 3296 patients with STEMI, undergoing on-site p-PCI (2444 patients) (OS group) or p-PCI after inter-hospital transfer (852 patients) (T group) between 1 January 2004 and 30 June 2006 in the Italian region of Emilia-Romagna, were considered. During the study period, the number of patients undergoing p-PCI increased both for patients admitted to interventional centres and for those admitted to peripheral hospitals. At the same time, the proportion of patients with STEMI initially admitted to peripheral hospitals and not transferred and the door-to-balloon time delays of transfer patients decreased. In spite of longer door-to-balloon delay in the transfer group [112 min (86-147) vs. 71 min (46-104)], in-hospital cardiac mortality (OS 7.0 vs. T 5.4%, P = 0.10) did not significantly differ between the two groups. After multivariable adjustment, the transfer strategy was not associated with increased risk of in-hospital [odds ratio 0.956; 95% confidence interval (CI) 0.633-1.442] and 1 year (hazard ratio 0.817; 95% CI 0.617-1.085) cardiac mortality. CONCLUSION: This study, concerning an established STEMI regional network, suggests that a strategy of inter-hospital transfer for p-PCI, when supported by an organized system of care, may be applied with rapid reperfusion times and favourable short- and long-term clinical outcomes.

Percutaneous treatment of multivessel coronary disease in the drug eluting stent era: comparison of bare-metal stents, drug-eluting stents and a mixed approach in a large multicentre registry.

BACKGROUND: Restenosis and a high incidence of new revascularisations reduce the long-term efficacy of percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease. AIMS: To determine the modality of utilisation and the clinical efficacy of drug eluting stents (DES) in a real world multivessel PCI scenario. METHODS: From July 2002 to December 2004, 1726 consecutive patients enrolled in the REAL Registry (Registro REgionale AngiopLastiche Emilia-Romagna) underwent elective multivessel PCI with multiple stents in at least two different vessels; among them, 939 (54%) received only bare-metal stents (BMS group), 288 (17%) only DES (DES group) and 499 (29%) were treated with BMS and DES in different vessels (MIX group). The incidence of major adverse cardiac events (MACE= death, myocardial infarction and target vessel revascularisation) during follow-up was assessed. RESULTS: Patients in the BMS group were older, diabetes was more frequent in the DES and MIX groups, while more lesions and more often a three vessel treatment was performed in the MIX group. In the DES group, lesions were longer, in smaller vessels and more often in the left main compared with BMS and MIX groups. In the MIX group too, lesions treated with DES were at higher risk for restenosis than those treated with BMS. Procedural success was similar in the three groups (98.9%). Notwithstanding the different risk profile, 12-month follow up did not show differences in clinical end points among the three groups. Multivariate analysis indicated that age, a modified Charlson's comorbidity index and diabetes were independent predictors of death or AMI; total lesion length, use of only DES or MIX approach and treatment of left main were predictors of TVR, while left main treatment along with only DES use, modified Charlson's index and reference vessel diameter independently affected the incidence of MACE. Use of at least one DES reduced the risk of TVR by 37% and MACE by 29%, while DES in every lesion treated reduced TVR risk by 37% and MACE by 39%. CONCLUSIONS: In this large multicentre registry, DES were utilised in only half of the multivessel PCI procedures, mainly to treat high-risk patients and lesions. However, this selective use of DES was independently associated with a lower incidence of 1-year TVR and MACE. Whether increasing the rate of DES utilisation would further improve the clinical outcome remains to be investigated.

Safety and long-term efficacy of sirolimus eluting stent in ST-elevation acute myocardial infarction: the REAL (Registro REgionale AngiopLastiche Emilia-Romagna) registry.

BACKGROUND: Limited data are available for sirolimus eluting stent (SES) implantation in patients with ST-segment elevation myocardial infarction (STEMI). AIM: To confirm the safety and effectiveness of SES in patients with STEMI in a real-world scenario (multicentric registry). METHODS: From July 2002 to June 2004, clinical and angiographic data of 1617 patients with STEMI treated with primary percutaneous coronary intervention (PCI) have been collected. Patients were prospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). RESULTS: Overall, 205 patients received SES (12.5%, SES group) and 1412 received bare metal stent (87.5%, BMS group) in the infarct related artery. Compared with the BMS group, SES patients were younger, had more often diabetes mellitus, anterior localization and less cardiogenic shock at admission. The angiographic characteristics in the SES group showed longer lesions and smaller diameter of vessels. After a median follow-up of 396 days, there was no significant difference in the rate of stent thrombosis (1% in the SES group vs 1.5% in the BMS group, p=ns). The incidence of MACE was significantly lower in the SES group compared to BMS group (HR 0.62 [95% CI: 0.4-0.95]; p=0.03), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2-0.85]; p=0.01). CONCLUSIONS: Utilization of SES in the setting of primary PCI for STEMI, in our "real world" registry, was safe and improved the 1-year clinical outcome compared to BMS reducing the need of TVR.

Transradial approach for renal percutaneous transluminal angioplasty and stenting: a feasibility pilot study.

BACKGROUND: Stent implantation of renal stenosis (RS) has been reported on extensively; this technique is perceived as superior to balloon angioplasty alone and less invasive than surgical revascularization. With the development of new accessories and stents, we can now improve and optimize procedural and clinical results. In this pilot study, we tested an alternative minimally invasive approach for renal stenting: the transradial artery catheterization (TAC) and a 6 French (Fr) system for stenting. METHODS: In this feasibility study, we enrolled patients with RS uncontrolled hypertension and/or chronic renal insufficiency. After assuring good dual blood supply (Allen test), TAC was attempted. The guiding catheters chosen for stenting were 6 Fr (0.70 ) Zuma 2 (Medtronic AVE, Santa Rosa, California). The selection of the guiding catheter was performed with respect to back-up support and coaxial alignment. RS were crossed with a coronary extra support guidewire (0.0.14 mailman, Boston Scientific/Scimed, Maple Grove, Minnesota). A balloon angioplasty before stenting was performed only in presence of subocclusive calcified stenosis, otherwise direct stenting was performed. We used low profile stents (12 16 mm LP Sulzer stent, IntraTherapeutics Inc., Minnesota) manually crimped on monorail balloon (5.0 6.0 mm x 20 mm). Immediately after completion of the procedure, the sheath was removed and a selective radial artery compression device was used for hemostasis. Patients were not restricted to bedrest, but were discharged the following day. RESULTS: There were 25 patients in the study population. Procedural indications were poorly controlled hypertension in 15/25 patients and/or preservation of renal function in 10/25 patients. Procedural success was obtained in 27/27 lesions (100%). Direct stenting was performed in 24/27 stenosis; predilatation was necessary in 3/27. We used 1 stent per lesion. The mean fluoro time was 7 5 minutes/lesion and mean procedural time was 14 5 minutes/lesion. No procedural and clinical complications occurred during the procedures upon the discharge. CONCLUSIONS: Our results confirmed the safety of this approach in the treatment of RS. The devices used in the study were those traditionally used for coronary procedures. The adoption of these materials and techniques have simplified the procedure and has permitted a reduction of fluoro and procedural time. An additional advantage has been the passive achievement of hemostasis by pressure devices reducing the workload of nursing and medical staff with elimination of bleeding complications that allowed immediate post procedural ambulation.