Luigi Salemme

Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: Data from a multicenter, prospective, observational study (TOAST-GISE)

OBJECTIVES We sought to investigate the success rate and the acute and 12-month clinical outcome of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in the contemporary era. BACKGROUND The technique of PCI involving CTO has improved over time. However, limited data on acute and follow-up results in patients treated with PCI on CTO in recent years are available. METHODS Four hundred nineteen consecutive patients scheduled for PCI of CTO of > or =30 days of duration were enrolled in 29 centers; 390 CTOs were confirmed in 376 patients in an independent core laboratory. The end points were technical and procedural success, in-hospital and 12-month major adverse cardiac events (MACE) occurrence, and 12-month symptomatic status. RESULTS Technical and procedural success was obtained in 77.2% and 73.3% of lesions, respectively. In-hospital major adverse cardiac events occurred in 5.1% of patients. Multivariate analysis identified CTO length >15 mm or not measurable, moderate to severe calcifications, duration > or =180 days, and multivessel disease as significant predictors of PCI failure. At 12 months, patients with a successful procedure experienced a lower incidence of cardiac deaths or myocardial infarction (1.05% vs. 7.23%, p = 0.005), a reduced need for coronary artery bypass surgery (2.45% vs. 15.7%, p < 0.0001), and were more frequently free of angina (88.7% vs. 75.0%, p = 0.008) compared with patients who had an unsuccessful procedure. CONCLUSIONS Successful PCI was achieved in a high percentage of CTOs with a low incidence of complications. At one-year follow-up, patients with successful PCI of a CTO had a significantly better clinical outcome than those whose PCI was unsuccessful.

Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.

Purpose: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries. Methods: In 14 European centers, 157 patients (121 men; mean age 68.0±8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure. Results: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%±7.8% to 6.7%±5.1%. The mean duration of flow blockage was 7.6±5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%. Conclusions: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.

Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis.

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.

Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.

OBJECTIVES This single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population. BACKGROUND In published multicenter registries, the use of PEO for carotid artery stenting (CAS) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions. METHODS From July 2004 to May 2009, 1,300 patients underwent CAS using PEO. Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure. RESULTS Procedural success was achieved in 99.7% of patients. In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction. At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%). The 30-day stroke and death incidence was 1.38% (n = 19). Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs. 0.82%; p < 0.05). No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n = 12) and average surgical risk (1.07; n = 7) (p = NS). Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events. CONCLUSIONS The use of PEO for CAS is safe and effective in an unselected patient population. Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events.

Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results☆

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.

SAT-TAVI (single antiplatelet therapy for TAVI) study: A pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation

BACKGROUND Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy. METHODS AND RESULTS From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group (p<0.05). No differences in the clinical status were detected between the groups up to 6 months. CONCLUSIONS This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI.

The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention.

OBJECTIVES 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. BACKGROUND 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. METHODS 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. RESULTS 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 noninferiority <0.001). CONCLUSIONS 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.

Drug-Eluting Balloons for the Treatment of the Superficial Femoral Artery In-Stent Restenosis: 2-Year Follow-Up

OBJECTIVES The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). BACKGROUND The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up. METHODS From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months. RESULTS During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05). CONCLUSIONS The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.

Excimer laser in acute myocardial infarction: Single centre experience on 66 patients

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.

Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immediate and one-year outcomes

AIMS Surgical endarterectomy is the therapy of choice for atherosclerotic common femoral artery (CFA) obstruction. Recently, some large single-centre series have shown encouraging results for the percutaneous treatment of CFA obstructions. The purpose of this study was to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of CFA obstructions with combined use of directional atherectomy (DA) and a paclitaxel-coated balloon (DCB). METHODS AND RESULTS Between January 2012 and July 2014, 30 consecutive patients with severely calcified obstructions of the common femoral artery were treated in our centre using DA followed by DCB dilatation. Provisional stenting was allowed in the case of a suboptimal result. Twenty cases (66%) were isolated CFA interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively. Chronic total CFA occlusions (CTO) were recanalised in six cases (20%). Procedural success was achieved in all cases; stenting was needed in three cases (10%). At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively. The secondary patency rate was 96.7%. CONCLUSIONS This single-centre prospective study suggests that the combined use of DA and DCB is a safe and effective alternative to surgery, a treatment option for common femoral artery lesions and provides encouraging results in this setting.