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Background Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. Objectives The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. Methods The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical followup was performed. Results A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity scorematching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. Conclusions Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

Background The use of Directional Atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. Methods: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had Life Limiting Claudication (LLC) (n = 18) and 12 a Critical Limb Ischemia (CLI) with baseline Rutherford class 4.2 ± 1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis > 50%) by visual estimation. After the intervention patients were followed up to 12 months. Results Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2 ± 1.2, ABI was 0.8 ± 0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n = 30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR = 10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. Conclusion The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.

Objectives This study sought to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease. Background Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery. Methods A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events. Results The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients. Conclusions The GAIA (Evaluation of the Biodegradable Peripheral Igaki-Tamai Stent in the Treatment of De Novo Lesions in the Superficial Femoral Artery) study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.

Background N-acetylcysteine (NAC) is considered a promising radio-protector for its antioxidant and anticarcinogenic properties. We examined the ability of NAC to confer protection against radiation-induced chromosomal DNA damage during cardiac catheterization procedures. Methods Sixty-five patients (52 males, age 64.4±11.9years) undergoing invasive cardiovascular procedures (peripheral transluminal angioplasty, n =45; cardiac resynchronization therapy, n =15 and ablation therapy n =5) were enrolled: 35 patients (26 males, age 63.4±11.1years) received the standard hydration protocol consisting of intravenous isotonic saline for 12h after catheterization (Group I), and 30 patients (26 males, age 65.5±12.9years) received a clinically driven double intravenous dose of NAC (6mg/kg/h diluted in 250mL of NaCl 0.9%) for 1h before and a standard dose (6mg/kg/h diluted in 500mL of NaCl 0.9%) for 12h following catheterization (Group II). Micronucleus assay (MN) was performed as biomarker of chromosomal DNA damage before, 2 and 24h after the radiation exposure. Dose-area product (DAP; Gy cm 2 ) was assessed as physical measure of radiation load. Results DAP was higher in NAC-treated patients (I=54.7±23.6 vs II=126.2±79.2Gy cm 2 , p =0.0001). MN frequency was 13.7±4.7‰ at baseline and showed a significant rise at 2h (18.0±6.8 p =0.01) and 24h (17.6±5.9, p =0.03) in the Group I. There was no significant increase of MN in the Group II (13.7±7.0, 15.5±6.0 and 14.9±6.3 for baseline, 2h and 24h respectively, p =0.4). Conclusion NAC treatment given to prevent contrast-induced nephropathy may also reduce DNA damage induced by ionizing radiation exposure during cardiac catheterization procedures.

Background Pulsed-wave ultraviolet excimer laser light at 308 nm can vaporise thrombus, suppress platelet aggregation, and, unlike other thrombectomy devices, ablates the underlying plaque. Aim To evaluate both safety and efficacy of laser ablation in patients presenting with Acute Myocardial Infarction (AMI) complicated by persistent thrombotic occlusion. Methods From May 2003 to October 2006, we enrolled 66 AMI patients (age 59±11 years; 57 men) presenting complete thrombotic occlusion of the infarct related vessel. All patients were treated with laser. Primary acute angiographic end-points was corrected TIMI frame count. Secondary echocardiographic end-point was left ventricular remodeling defined as an increase in end-diastolic volume ≥20% 6 months after infarction. Tertiary clinical endpoint was event-free survival at 6 months follow-up. Results There were no intra-procedural death or coronary perforation. One primary angiographic failure was observed during lasing. Major dissection occurred in 1 (1.5%) and distal embolization in 4 patients (6%). Corrected TIMI frame count was 100 at baseline, 29±0.6 after lasing and 22±3 after stenting. At 6-months follow-up, left ventricular remodeling occurred in 8% patients. Event-free survival was 95% at 6-months follow-up. Conclusion Laser angioplasty is feasible, safe and effective for the challenging treatment of patients with AMI and thrombus-laden lesions. The acute effects on coronary epicardial and myocardial reperfusion are excellent.

Angioplasty of bifurcation lesions represents a continuing challenge. A total of 421 consecutive patients were prospectively followed in a registry on bifurcation stenting with a high-end bare metal stent (Coroflex, BBraun, Berlin, Germany), allowing side branch percutaneous transluminal coronary angioplasty through the stent struts without distraction of the main vessel stent from the vessel wall or other distortions. This approach obviated the 2-wire technique and kissing balloons. Detailed data, including lesion location, stenosis morphology, procedural success, and hospital and follow-up major adverse cardiac events (MACEs; acute myocardial infarction, death, revascularization, hospitalization due to angina), were collected from 6 European centers. Of the patients, 60% had stable angina, 23% had unstable angina pectoris/non-ST-elevation myocardial infarction, and 17% had ST-elevation myocardial infarction. In 17% of patients, the main vessel alone was stented; in 71%, stenting of the main vessel was complemented by side branch percutaneous transluminal coronary angioplasty. Technical success (residual stenosis50%) in the 2 branches was achieved in 90% (main vessel in 99%). The rate of MACEs at discharge was 2%. After 6 months, 17% of patients had undergone target lesion revascularization or coronary artery bypass grafting. The total 6-month MACE rate was 22%. In conclusion, successful bifurcation stenting with a low MACE rate is possible in most patients using a simplified approach with a dedicated high-end bare metal stent.

Direct stenting (DS) was attempted in 99 coronary lesions in 94 patients while standard stenting (SS) was attempted in 113 lesions in 103 patients matched for clinical characteristics, stenosis type, and location and stent type. The angiographic result was also evaluated according to TIMI frame count method (TFC) before and after procedure. A clinical follow-up was performed 1 year after the procedure. Before the procedure, TIMI grade 3 flow was detected in 42 cases (42.4%), grade 2 in 40 cases (40.4%), grade 1 in 5 cases (5.1%), and grade 0 in 12 cases (12.1%) in the DS group; these data were similar in SS group. After the procedure, TIMI grade flow was 3 in 90 cases (92.8%) in DS group and in 87 (77.0%) in SS group (P < 0.005); grade 2 was observed in 7 case (7.2%) in DS group and in 25 (22.1%) in SS group (P < 0.005). Major adverse cardiac events during hospitalization and at follow-up were similar in two groups. Radiation exposure time and procedure costs per lesion were significantly reduced in DS group compared to SS group (10.1 ± 8 min vs. 13.9 ± 4.7 min, P < 0.001; and 1901 ± 687 Euro vs. 2352 ± 743 Euro, P < 0.001, respectively). This study confirms that, in selected patients, direct stenting is a safe and successful procedure, allowing a significant reduction in radiation exposure time and procedural costs compared to standard stenting technique. The angiographic success is confirmed by the improvement in TFC in all cases. Cathet Cardiovasc Intervent 2001;53:464–473. © 2001 Wiley-Liss, Inc.

Objective: The contractile response to digitalis and β adrenoceptor agonists is lower in the senescent than in the adult myocardium, while the development of ventricular arrhythmias is increased. The aim of this study was to examine the effects of aging on cardiac response to digitalis and an adrenergic agonist used clinically. Methods: The electrical and mechanical responses were tested in isolated and perfused hearts from 3-24 month old rats receiving 15 min infusion of digitalis drug (ouabain, 6 × 10−5 M) alone, and after 5 min of β adrenoceptor agonist drug (epinine, 1.5 × 10−7 M). Results: Ouabain action was associated with a rise in left ventricular end diastolic pressure (p

Interventional cardiologists working in high-volume cardiac catheterization laboratory are exposed to significant occupational radiation risks. Common single-nucleotide polymorphisms (SNPs) in DNA repair genes are thought to modify the effects of low-dose radiation exposure on DNA damage, the main initiating event in the development of cancer and hereditary disease. The aim of this study was to determine the relationship between XRCC1 (Arg194Trp and Arg399Gln), OGG1 (Ser326Cys), APE1 (Asp148Glu) and XRCC3 (Thr241Met) SNPs and chromosomal DNA damage. We enrolled 77 subjects: 40 interventional cardiologists (27 male, 41.3+/-9.4 years and 13 female, 37.8+/-8.4 years) and 37 clinical cardiologists (26 male, 39.4+/-9.5 years and 11 female, 35.0+/-9.8 years) without radiation exposure as the control group. Micronucleus (MN) assay was performed as biomarker of chromosomal DNA damage and an early predictor of cancer. MN frequency was significantly higher in interventional cardiologists than in clinical physicians (19.7+/-7.8 per thousand vs. 13.5+/-6.3 per thousand, p=0.0003). Within the exposed group, individuals carrying a XRCC3 Met241 allele had higher frequency than homozygous XRCC3 Thr241 (21.2+/-7.8 per thousand vs. 16.6+/-7.1 per thousand, p=0.03). Individuals with two or more risk alleles showed a higher MN frequency when compared to subjects with one or no risk allele (18.4+/-6.6 per thousand vs. 14.4+/-6.1 per thousand, p=0.02). An interactive effect was found between smoking, exposure10 years and the presence of the two or more risk alleles on the MN frequency (F=6.3, p=0.02). XRCC3 241Met alleles, particularly in combination with multiple risk alleles of DNA repair genes, contribute to chromosomal DNA damage levels in interventional cardiologists.

We sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of antiplatelet therapy and no anticoagulation therapy.Available guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications.From June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI.Procedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% [95% confidence interval: -0.1% to 4.5%], p for superiority = 0.17, p for noninferiority0.001).In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.

We evaluated whether radiation exposure during interventional cardiovascular procedures can induce damage to deoxyribonucleic acid (DNA).Micronucleus assay (MN) was performed as biomarker of chromosomal damage and intermediate endpoint in carcinogenesis. Seventy-two patients (54 males, age = 63.8 +/- 10.5 years) undergoing a wide range of radiation exposure during invasive cardiovascular procedures (coronary angiography, n = 9; percutaneous coronary intervention, n = 9; peripheral transluminal angioplasty, n = 37; and cardiac resynchronization therapy, n = 17) were enrolled. MN frequency was evaluated before, 2, and 24 h after the radiation exposure. Dose-area product (DAP; Gy cm(2)) was assessed as physical measure of radiation load. DAP value was 96.0 +/- 63.9 Gy cm(2). MN frequency was 15.1 +/- 7.1 per thousand at baseline and showed a significant rise at 2 h (17.5 +/- 6.5 per thousand, P = 0.03) and 24 h (18.5 +/- 7.3 per thousand, P = 0.004) after procedures.Our results corroborate the current radioprotection assumption that even modest radiation load can damage the DNA of the cell and induce chromosome alterations which are early predictors of increased cancer risk.

Background Ionising radiation carries an oncogenic risk which is linearly related to the dose. An estimation of the effective dose can be obtained from the measurements of the dose–area product (DAP), which is a measure of stochastic risk and a potential quality indicator. Aim To assess radiation exposure of patients in a large volume cardiac cath-lab. Methods A retrospective analysis of adult cardiac and peripheral percutaneous procedures (April to December 2004) was carried out to determine the DAP and estimated risk of malignancy. We identified 6 groups: Group 1 ( n =100, coronary angiography and ventriculography); Group 2 ( n =50, carotid stenting); Group 3 ( n =50, aortography+coronary angiography+ventriculography); Group 4 ( n =100, inferior extremities angiography+predilatation and stenting); Group 5 ( n =100, coronary angiography+ventriculography+direct coronary stenting); Group 6 ( n =100, coronary angiography+ventriculography+coronary predilation and stenting). Dose–area product meter attached on the X-ray unit was used for the estimation of the radiation dose received by the patient during the procedures. Results DAP values (mean±S.D.) ranged from 41±30 Gy cm 2 in Group 1 (lowest) to 118±89 Gy cm 2 in Group 6 (highest). Within each group, individual radiation exposure varies substantially: from 11 to 200 Gy cm 2 in Group 1, and from 30 to 733 Gy cm 2 in Group 6 patients. Average exposure in a Group 6 patient corresponds to a risk of mortality from a malignancy of about 1 in 1000. Conclusion The radiation dose varies substantially across different types of procedures and up to tenfold within the same procedure. The enhanced knowledge of radiation dose might help the cardiologist to implement radiation sparing procedures eventually minimizing patient and operator radiation hazards in invasive cardiology.

Objectives The purpose of this prospective registry was to evaluate the safety and efficacy, at 1 year, of the use of drug-eluting balloons (DEB) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). Background The use of the self-expanding nitinol stent has improved the patency rate of SFA after percutaneous transluminal angioplasty (PTA). As the population with SFA stenting continues to increase, occurrence of ISR has become a serious problem. The use of DEB has showed promising results in reducing restenosis recurrence in coronary stents. Methods From December 2009 to December 2010, 39 consecutive patients underwent PTA of SFA-ISR in our institution. All patients underwent conventional SFA PTA and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic, Minneapolis, Minnesota). Patients were evaluated up to 12 months. Results Technical and procedural success was achieved in every patient. No in-hospital major adverse cardiac and cerebrovascular events occurred. At 1 year, 1 patient died due to heart failure. Primary endpoint, primary patency rate at 12 months, was obtained in 92.1% (35 patients). At 1 year, patients were asymptomatic for claudication, and duplex assessment demonstrated lack of recurrent restenosis (100% rate of Secondary patency). The presence of an occlusive restenosis at the time of treatment was not associated with an increased restenosis rate, when compared with non-occlusive restenosis, at 1 year. Conclusions The data suggest that adjunctive use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy. These data should be considered hypothesis-generating to design a randomized trial.