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Purpose: To evaluate clinical outcomes in patients undergoing carotid artery stenting (CAS) with routine use of a cerebral embolic protection device (EPD)., Methods: A retrospective cohort analysis was conducted of 490 consecutive patients (365 men; mean age 70.7+/-8.5 years) who underwent CAS with EPD between January 1999 and December 2007 at 2 institutions with large referral practices. There were 163 symptomatic patients with stenosis >or=50% and 327 asymptomatic patients with >or=80% diameter stenosis treated in 536 CAS procedures. Nearly a quarter (116, 23.7%) of the cohort had diabetes. High-risk surgical features were present in 141 (28.8%): 73 (14.9%) aged >or=80 years, 25 (5.1%) with significant heart disease, 23 (4.6%) with postsurgical restenosis, and 16 (3.2%) with contralateral carotid occlusion. An EPD was successfully placed in 512 (95.5%) patients., Results: The incidence of any stroke within 30 days was 3.3% (16/490), of which the majority (13, 2.6%) were ipsilateral [5 (1.0%) major and 8 (1.6%) minor]. The incidence of major adverse events (MAE), i.e., any stroke, death or myocardial infarction, within 30 days was 3.7% (18/490); the incidence of 30-day any stroke/death was 3.7% (18/490), while the cumulative incidence of any stroke/death at 1 year was 6.1% (30/490). In symptomatic patients, the 30-day MAE rate was 6.7% (11/163) versus 2.1% (7/237) in the asymptomatic group (p = 0.02). A subgroup analysis based on surgical risk showed that the 30-day MAE rate was similar between high-risk and non-high-risk patients [4.9% (7/144) versus 3.2% (11/346); p = 0.5]., Conclusion: In this large real-world cohort, CAS with routine use of EPDs was technically feasible, clinically safe, and associated with a low rate of periprocedural and 1-year events; results were similar irrespective of surgical risk.

Background: The aim of this study was to evaluate enoximone echocardiography (EE) for the identification of residual myocardial viability in postinfarction patients. Findings obtained during EE were compared with those acquired by myocardial uptake of fluorine-18 fluorodeoxyglucose ((18)F-FDG) positron emission tomography (PET) and functional follow-up results., Methods: Twenty-five patients underwent EE and PET (18)F-FDG studies. An asynergic segment was considered as having contractile enhancement when the wall motion score decreased by > or = 1 grade during EE and was defined as viable if (18)F-FDG uptake score was > or = 2 grade on PET., Results: Of 293 dysfunctional segments at baseline, 139 (47%) were viable by PET criteria; 117 (40%) had contractile enhancement induced by enoximone (P = 0.07). Agreement between EE and PET was found in 75% of involved segments (K = 0.46, P < 0.001). The majority of discrepancies (65%, P < 0.01) were mainly due to discordant segments in which PET revealed evidence of (18)F-FDG uptake but EE showed no change in wall motion. In 179 revascularized segments, negative predictive value for functional recovery of both tests reached the same value (89% for both), whereas positive predictive value was 82% for EE and 68% for PET, respectively (P < 0.05). Sensitivity was 85% for EE and 88% for PET (P = ns); specificity was 87% and 70%, respectively (P < 0.01)., Conclusions: EE yields a fair concordance with PET study. Compared with PET, despite a similar negative accuracy, EE shows a greater specificity for prediction of function recovery after revascularization. (Echocardiography 2010;27:544-551).

Percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains one of the major challenges in interventional cardiology. The appropriate use of the rapidly increasing range of tools available to interventional cardiologists is bringing more and more CTOs into the 'treatable' category. The bar has now been raised to 80% success rates by some expert operators around the world, which, in our view, cannot be achieved without a thorough understanding of technique and technical know-how. CTO procedures are increasingly becoming a sub-specialist field within interventional cardiology and we would encourage centers to consider appointing 'super-specialists' who are able to concentrate experience and expertise in this area. In this paper we detail the principal characteristics of the over the wire balloons, microcatheters and guidewires at present available, the most popular and recent of which are listed in Table 1 and 2. The knowledge and the specific choice of these materials and the criteria for selection of your guidewire or microcatheter can mean the difference between success and failure. Moreover, we discuss on the most important and groundbreaking techniques to approach a CTO. Finally, considering the greater risk of coronary perforation related to a CTO procedure compared to routine PCI, we describe which are best strategy and devices for treating coronary perforations and other major complications.

Objectives: To assess the procedural and clinical outcomes from a modified subintimal tracking and re-entry (STAR) procedure performed using contrast guidance., Background: Previous data showed that recanalizing a chronic total occlusion (CTO) with the STAR technique was possible. However, this technique was considered difficult and therefore has only been adopted by a limited number of experienced operators., Methods: Patients (n = 68) with a CTO of a native coronary artery treated by a single operator with this technique were included., Results: The right coronary artery was involved in 79.4%, the morphology was blunt in 77.9%, and CTO length was longer than 20 mm in 67.6%. Angiographic success rate was 80.9% with a 70.6% rate of complete recanalization. Stent implantation was performed in 82.3% of cases, with drug-eluting stents (DES) implanted in the majority (92.7%). Procedural complications occurred in 10.3% of cases. There were no episodes of myocardial infarction during follow-up, with 1 case (1.5%) of cardiac death. There were no cases of definite or probable stent thrombosis, and there was 1 (1.5%) possible stent thrombosis. The overall rate of in-segment binary restenosis was 44.7%, and target lesion revascularization (TLR) was performed in 25% of lesions. The rate of TLR in lesions treated with DES was 29.4% and in those treated with bare-metal stents was 50%., Conclusion: The contrast-guided STAR technique appears to be feasible and relatively safe. However, this procedure is limited by a high rate of restenosis even with DES, and a second procedure may be necessary to obtain a definitive result., ((c) 2008 Wiley-Liss, Inc.)

Aims: To evaluate the occurrence of late and very late stent thrombosis (ST) following elective drug-eluting stent (DES) implantation in unprotected left main coronary artery (LMCA) stenosis in a large multicentre registry., Methods and Results: All 731 consecutive patients who had sirolimus- or paclitaxel-eluting stent electively implanted in de novo lesions on unprotected LMCA in five centres were included. ST was defined according to Academic Research Consortium definitions. Four (0.5%) patients had a definite ST: three early (two acute and one subacute) and one late ST, no cases of very late definite ST were recorded. All patients survived from the event. Three patients had a probable ST. Therefore, 7/731 (0.95%) patients had a definite or a probable ST and all were on dual antiplatelet therapy at the time of the event. Possible (eight late and 12 very late) ST occurred in 20 (2.7%) patients. At 29.5 ± 13.7 months follow-up, a total of 45 (6.2%) patients had died; 31 (4.2%) of cardiac death. Ninety five (12.9%) patients had a target-vessel and 76 (10.4%) a target-lesion revascularization. Angiographic follow-up was performed in 548 patients (75%): restenosis occurred in 77 (14.1%) patients., Conclusion: Elective treatment of LMCA stenosis with DES appears safe with a 0.9% incidence of definite and probable ST at 29.5 ± 13.7 months.

Objectives: To assess the utilization of microinjection of contrast for the recanalization of chronic total occlusions (CTO)., Background: Microchannels in CTOs have been considered important conduits for CTO crossing, utilizing dedicated guidewires. We postulated that microinjection of contrast immediately distal to the proximal cap of the CTO could identify and enlarge these microvessels, creating a passage for crossing the CTO with a floppy guidewire., Methods: A total of 32 patients with a CTO were treated with this technique. Following few millimetres penetration of the proximal fibrous cap of the occlusion with a dedicated CTO guidewire, the over-the-wire balloon was advanced into the proximal portion of the occlusion, and 50-100 microg of nitroglycerine followed by 1 ml of contrast was gently injected into the occluded segment. Technical success of the microchannel technique was defined as the ability to visualize the distal true lumen with microinjection of contrast and thereafter cross the CTO with a floppy guidewire in the absence of any dissection., Results: Overall, technical success of the microchannel technique was obtained in 20 (63%) with angiographic success in 19. In 12 (37%) cases there was a technical failure because of dissection, and we obtained recanalization of the artery in 7 of these 12 cases with another technique. There was only one case of periprocedural myocardial infarction in an unsuccessful procedure and no major adverse cardiac events or subacute stent thromboses were observed., Conclusions: Microinjection of contrast immediately distal to the proximal fibrous cap of a CTO may be an additional technique to facilitate recanalization of CTO., (Copyright 2008 Wiley-Liss, Inc.)

Background: There is no specific study evaluating the outcome of DES implantation in trifurcation lesions., Objective: To evaluate the mid-term clinical and angiographic outcome of drug-eluting stent (DES) implantation in trifurcation lesions., Methods: All complications and major adverse cardiac events, including cardiac death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and during clinical follow up., Results: A total of 15 consecutive patients undergoing percutaneous coronary intervention with DES in de novo trifurcation lesions were identified. Lesions were located as follows: 13 (86.7%) at the distal left main coronary artery (LMCA) comprising the left anterior descending artery (LAD), the left circumflex artery (LCX) and an intermediate branch; 1 between the LAD, diagonal, and septal branches; and 1 between the LCX, obtuse marginal and posterior lateral branches. Stenting was performed in all 3 branches in 8 patients, in 2 branches in 6 patients, and in 1 branch in 1 patient. The mean follow-up period was 19.0 +/- 8.3 months. TLR occurred in 3 patients (20%) with LMCA lesions. TVR occurred in 6 patients (40%). Of those, 3 were due to TLR, while the other 3 for progression of nontarget lesions. No deaths, Q-wave MIs or stent thromboses were recorded., Conclusion: Most trifurcation lesions were found in the distal LMCA. DES implantation in trifurcation lesions can be performed with a low incidence of death, Q-wave MI or stent thrombosis.

Objectives: To evaluate safety and efficacy of the CROSSER CTO Recanalization System (CROSSER)., Background: The CROSSER, a novel device dedicated to recanalization of chronic total occlusions (CTO), relies on a monorail catheter delivering vibrational energy to facilitate the crossing of occluded coronary arteries., Methods: We included de novo or restenotic occlusions in native coronary arteries with typically unfavorable characteristics and a prior failed guidewire attempt either performed in a previous procedure or just before the usage of the CROSSER. The end points analyzed were technical success (ability to cross or facilitate a guidewire crossing into the true lumen), angiographic success (<20% residual stenosis and TIMI flow grade 3), and clinical success (angiographic success and freedom from major adverse cardiac events at 30 days)., Results: Twenty-eight patients (30 lesions) were included. The morphology was blunt in 83.3% and the length of the occlusion was >20 mm in 76.6%. The median age of the CTO was 9 months (range 3-60 months). Technical success was obtained in 19 (63%) occlusions and angiographic success in 16 (53%): 26.3% in lesions with prior procedural failure and 73.7% when CROSSER was attempted after initial guidewire failure. Complications were: one guidewire perforation without consequences and one peri-procedural myocardial infarction (MI). No events occurred within 30-day follow-up after discharge., Conclusions: In our experience, the CROSSER System is safe and increases the success of opening CTO refractory to guidewires. This novel device may represent an useful adjunct to the armamentarium of the interventional cardiologist., (Copyright 2006 Wiley-Liss, Inc.)

Aims: In this first multicentre study we assessed the safety and efficacy of percutaneous transendocardial skeletal myoblast injection as a stand alone procedure in congestive heart failure patients., Methods and Results: 15 patients (14 male), age 63+/-7 (Mean+/-SD), NYHA class 2-4 were injected with 216+/-119 cells (81+/-19% Desmin+) using a NOGA or fluoroscopy guided injection catheter. The cells were injected in the scarred regions 6+/-4 years after myocardial infarction as a stand alone procedure. After treating the first 6 patients, the protocol was amended to require that remaining patients be fitted with an ICD prior to the cellular cardiomyoplasty procedure. Holter monitoring, ECG and ICD readings were obtained at multiple intervals. Stress echocardiography and LV angiography was performed at baseline, 3, 6 and 12 months post procedure.After 1 year follow-up 13 patients were still alive. Patient # 6 died suddenly 9 days post procedure. Patient #15 (ICD patient) survived an electrical storm 12 days post procedure, but died 2 days later due to cardiogenic shock. Two non-ICD patients received an ICD because of observed ventricular arrhythmias. It remains unknown whether these events are directly related to the cell injections.LV ejection fraction (%) changed from 34.4+/-10.3 to 36.6+/-10.4 (baseline versus 12 months FU, p=0.26). Wall motion score index improved both at rest (3.0+/-0.5 to 2.7+/-0.7, p=0.049) and under low-dose dobutamine stress (2.8+/-0.4 to 2.5+/-0.6, p=0.07, baseline versus 12 months FU)., Conclusion: Percutaneous autologous skeletal myoblast injection is feasible, resulting in wall motion and functional class improvement, but is potentially associated with an increased risk for ventricular arrhythmias. Randomised studies are needed, however, to further assess overall safety, efficacy and the potential for initial increased risk for arrhythmia following cell injection in these high-risk patients.

Objective: We tested whether gadolinium-based contrast agent is less nephrotoxic than iodinated-contrast media., Background: Iodinated contrast agents are nephrotoxic. Some data suggest that gadolinium-based contrast agent may be less nephrotoxic than iodinated-contrast media., Methods: Twenty-five consecutive patients with chronic renal insufficiency (creatinine concentration > or = 2.0 mg/dl and/or clearance < or = 40 ml/min), referred to our institution for coronary procedures, were assigned to receive gadolinium-based contrast agents, a solution of gadolinium chelates diluted 3:1 by iso-osmolality contrast media (Gadolinium-based group). A control group of 32 patients with comparable clinical characteristics and treated with iodinated iso-osmolality contrast agent alone (Iodinated-based group) was selected from our database and compared with the Gadolinium-based group. In all cases, prophylactic administration of 0.45% saline intravenously and NAC (1200 mg orally twice daily) was used., Results: Baseline creatinine levels and creatinine clearance were similar in the 2 groups (Gadolinium-based group = 2.30 [IQR: 2.01-2.68] mg/dl and 33 +/- 13 ml/min; Iodinated-based group = 2.24 [IQR: 2.05-2.65] mg/dl and 30 +/- 10 ml/min; P > 0.05 for all). Increase of at least 0.5 mg/dl of the creatinine concentration 48 hr after the procedure occurred in 7/25 (28%) patients in the Gadolinium-based group and in 2/32 (6.5%) patients in the Iodinated-based group (P = 0.034; OR = 4.48; 95% CI = 1.01-19.17). Renal failure requiring temporary dialysis occurred in 2 (8%) patients in the Gadolinium-based group and in none in the Iodinated-based group (P = 0.19)., Conclusions: The strategy of gadolinium-based contrast agent administration does not seem to reduce the rate of CAN, as compared to the iodinated iso-osmolality contrast agent in patients with chronic renal insufficiency., (2006 Wiley-Liss, Inc.)

Aims: To evaluate the outcomes of sirolimus-eluting stent (SES) implantation for the treatment of chronic total occlusion (CTO)., Methods and Results: We identified 122 patients who underwent revascularization in CTO lesions with SES from April 2002 to April 2004 (SES group). A control group was composed of 259 consecutive patients with CTO lesions treated with bare metal stents (BMS) in the 24 months immediately before the introduction of SES (BMS group). At 6-month follow-up, the cumulative rate of major adverse cardiac events (MACE) was 16.4% in the SES group and 35.1% in the BMS group (P<0.001). The incidence of restenosis was 9.2% in the SES group and 33.3% in the BMS group (P<0.001). The need for revascularization in the SES group was significantly lower, both target lesion revascularization (7.4 vs. 26.3%, P<0.001) and target vessel revascularization (9.0 vs. 29.0%, P<0.001). BMS implantation (HR: 2.97; 95% CI: 1.80-4.89; P<0.001), lesion length (>20 mm) (HR: 2.02; 95% CI: 1.37-2.99; P=0.0004), and baseline reference vessel diameter (>2.8 mm) (HR: 0.62; 95% CI: 0.42-0.92; P=0.02) were identified as predictors of MACE during 6-month follow-up., Conclusion: Compared with BMS, SES implantation in CTO lesions appears to be effective in reducing the incidence of restenosis and the need for revascularization at 6 months.

Objective: This open label, prospective, non-comparative trial is the first to evaluate the safety and feasibility of bivalirudin (Angiomax(R), the Medicines Company, Parsippany, NJ), during PCI with implantation of the sirolimus eluting stent (Cypher, Cordis a J & J, Warren, NJ) or the paclitaxel eluting stent (Taxus, Boston Scientific, Natick, MA)., Methods: Patients who were referred for elective PCI suitable for stent implantation were recruited. Bivalirudin was administrated as a bolus of 1.0 mg/kg followed by 2.5 mg/kg/hour infusion for up to 4 hours in the first 68 patients. Following REPLACE 2 study, patients were treated with a lower dose of bivalirudin (0.75 mg/kg followed by 1.75 mg/kg/hour infusion)., Results: 111 patients with 139 lesions were included in the study. Thirty-one (27.9%) were diabetics, 14 (12.6%) had unstable angina and 79 (66.6%) had multivessel disease. Complex lesion morphology was present in 65 (46.7%), in-stent restenosis in 32 (23%), total occlusion 7 (5%) and bifurcations 22 (15.8%). Activated clotting time (ACT) was verified to be therapeutic following bivalirudin administration. During the index procedure no patients required provisional use of glycoprotein (GP) IIb/IIIa inhibitors. One patient had intracoronary thrombosis which resolved after stenting. An additional 2 patients had non-Q wave myocardial infarction (MI). No patients died, had major bleeding, required transfusions or sustained vascular complications. 1 patient developed thrombosis at 4 months with a documented MI. At 6 month follow-up, 3 (2.7%) patients died and 12 (10.8%) patients had target lesion revascularization (1 CABG and 11 re-PCI). Angiographic follow-up was achieved in 98 patients (89.9%)., Conclusions: This study indicates the safety and feasibility of Cypher or Taxus stent implantation in conjunction with bivalirudin administration, with no elective use of GP IIb/IIIa inhibitors.

Successful recanalization of coronary total occlusions (CTOs) remains an area where improvements are needed. We propose an approach similar to the one utilized in treating some peripheral artery occlusions and aimed to create a subintimal dissection with distal reentry. A 0.014' hydrophilic wire with a J-configuration is utilized for this purpose. We applied this technique to CTO of native coronaries in 31 patients where previous attempts failed in 21 of them (67%). The right coronary artery (RCA) was the index vessel in 87% of patients. Recanalization of the vessel and of most of distal branches was achieved in 21 patients; patency of at least one major distal branch was achieved in 9 patients. Drug-eluting stents (DESs) were implanted in 53% of patients. Three patients had intraprocedural vessel perforation without consequences. Five patients (16%) had in-hospital non-Q-wave myocardial infarction. No other adverse events occurred at a mean follow-up of 5.1 +/- 3.7 months except for one noncardiac death. Angiographic follow-up was performed in 21 (67%) patients and 53% of them developed restenosis. Reintervention on the target vessel was performed in 11 patients (52%). Complete success with the procedure was originally obtained in 8 of the 10 patients who did not develop restenosis and in 8 of them DESs were originally implanted. This technique appears a promising approach to recanalize difficult total occlusions, particularly the ones localize on the RCA, which has the most important side branches located distally., (Copyright 2005 Wiley-Liss, Inc.)

We evaluated the safety and effectiveness of postdilating a 3.0 mm sirolimus-eluting stents (SESs; six cells) with a 3.5-4.0 mm balloon. We identified 254 consecutive patients who underwent percutaneous coronary interventions using SESs with a nominal diameter of 3.0 mm (six cells). Patients were divided into two groups based on whether they were subsequently postdilated with a 3.0 mm (group 1: 168 patients, 251 lesions) or a 3.5-4 mm balloon (group 2: 86 patients, 102 lesions). There were no significant differences regarding the incidence of in-hospital and long-term follow-up. Angiographic follow-up was available in 72% and 74% of groups 1 and 2, respectively. The two groups had no significant differences regarding late lumen loss (0.51 +/- 0.36 vs. 0.52 +/- 0.33; P = 0.3) and binary restenosis rates (10.7% vs. 8.8%; P = 0.1). Six-month clinical follow-up was available in all patients. At long-term follow-up (mean: 10.6 +/- 3.7 for group 1 and 11.3 +/- 3.9 months for group 2), there were no significant differences between the two groups regarding major adverse cardiac events (8.9% vs. 9.2%; P = 0.9). Implantation of a 3.0 mm SES with postdilation with a 3.5-4 mm balloon did not result in any significant difference in complications, in-hospital non-Q-wave myocardial infarction, binary restenosis, or target lesion revascularization. These data should lessen concern that overdilation may dilute the beneficial effects of SESs., (2005 Wiley-Liss, Inc.)

The novel device Frontrunner coronary catheter (FCC), dedicated to recanalization of chronic total occlusions (CTOs), relies on blunt microdissections inside the plaque, allowing passage of guidewire through the lesion and adjunctive angioplasty. In order to evaluate efficacy and safety of recanalization using the FCC device, we included patients with de novo or restenotic CTOs in a native coronary artery with prior failure using a guidewire or considered unsuitable for guidewire attempt in which the FCC was attempted first. Between October 2000 and June 2003, 50 patients with 50 CTOs were included in the study. Thirty-two patients had prior failure with a mechanical wire. Device and angiographic success were obtained in 25 (50%) occlusions: 53% in lesions with prior guidewire failure and 44% when FCCs were attempted first (P = 0.8). During the first year of experience, angiographic success was 42% (5 occlusions) and in the third year 75% (12 occlusions; P = 0.12). Coronary perforation occurred in nine (18.0%) patients, leading to tamponade in two (4%) patients. Perforations occurred in 5 out of 12 attempted patients during the first year and in 4 out of 38 patients in the following period (41.7% vs. 10.5%; P = 0.04). Serious adverse events occurred in five (10%) patients within 30-day follow-up. Four non-Q-wave myocardial infarctions occurred in hospital (clinical success 42%) and one death 7 days after the index procedure. The use of FCC increases the success to open chronic total occlusions refractory to mechanical guidewires or that were considered unsuitable for an attempt with a guidewire. The risk of coronary perforation due to FCC use is relatively high and it can decrease with experience., (2005 Wiley-Liss, Inc.)