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BACKGROUND A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device(ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. MATERIALS AND METHODS We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥ 180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. RESULTS We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34 % patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (p-0.005) CONCLUSION In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.

Transcatheter treatment of degenerated aortic bioprostheses is nowadays a well-established option (Valve-in-vale, ViV); however, some patients may pose some specific challenges. Perceval® is a sutureless, stent-mounted, aortic valve bioprosthesis that can be placed with a less invasive surgical technique. Its nitinol self-expandable stent frame is a bulky structure that anchors to the aortic annulus without the need of continuous suture, thus reducing aortic cross-clamp and cardiopulmonary bypass time. Performing transcatheter aortic valve replacement (TAVR) in Perceval® may be associated with increased risk of coronary obstruction, impaired coronary access and increased post-procedural gradients. Here we present the cases of two patients with Perceval® degeneration that have been treated with two different tailored approaches following a dedicated Heart Team evaluation. R.M. is a 74-year-old, very low-weight, woman with a history of diabetes, severe COPD, 3b stage CKD, rheumatoid arthritis and previous carotid surgery. She underwent surgical aortic valve replacement (SAVR) with Perceval® “S” bioprosthesis for severe aortic stenosis in 2016. After five years she was diagnosed with severe symptomatic degeneration of the aortic prosthesis (mean gradient 45 mmHg, NYHA class III). The patient was therefore discussed by the Heart Team and scheduled for percutaneous treatment. A ViV with a self-expandable Medtronic 23 mm Evolut™ R bioprosthesis was successfully performed. Hospital stay was uneventful and the patient was discharged on 6th post-operative day in good clinical conditions and good functional class. S.R. is a 70-year-old active smoker woman with a history of previous hemicolectomy for cancer that underwent SAVR in ministernotomy for severe aortic stenosis with Perceval® “L” in 2015. In 2016 she underwent PCI + DES implantation on OM of LCX for an acute coronary syndrome. In 2022 she was diagnosed with severe symptomatic degeneration of the bioprosthesis (mean gradient 40 mmHg, NYHA class II). The patient was referred to Heart Team discussion and scheduled for surgical reintervention. She underwent successful surgery with implantation of a Medtronic Avalus™ 23 mm bioprosthesis, followed by regular rehabilitation. In the first case the severe comorbidities and frailty made the surgical risk almost prohibitive for reintervention (STS-M 9,23%, STS-MM 23,7%, Euroscore II 6,18%). Moreover, there was very little concern about the risk of impaired coronary access afterwards. The second patient, instead, had an acceptable risk for surgery (STS-M 2,2%, STS-MM 10,6%, Euroscore II 4.45%); there was also a significant concern about the risk of impaired coronary access in case of ViV, since she already had a history of percutaneous coronary revascularization. Furthermore, from a lifetime management point of view it is possible to hypothesize easier future reintervention with a TAVR in SAVR instead of a complex TAVR in TAVR in SAVR. Thus, although ViV was technically feasible in both cases with predictable good short-term outcomes, we decided for opposite treatments by looking at individualized long-term needs. In Conclusion the choice between surgical and transcatheter intervention must be based not only on careful evaluation of clinical, anatomical and procedural characteristics but also on future perspectives, especially in patients with longer life expectancy.

Background Estimation of the balance between subendocardial oxygen supply and demand could be a useful parameter to assess the risk of myocardial ischemia. Evaluation of the subendocardial viability ratio (SEVR, also known as Buckberg index) by invasive recording of left ventricular and aortic pressure curves represents a valid method to estimate the degree of myocardial perfusion relative to left ventricular workload. However, routine clinical use of this parameter requires its noninvasive estimation and the demonstration of its reliability. Methods and Results Arterial applanation tonometry allows a noninvasive estimation of SEVR as the ratio of the areas directly beneath the central aortic pressure curves obtained during diastole (myocardial oxygen supply) and during systole (myocardial oxygen demand). However, this “traditional” method does not account for the intra‐ventricular diastolic pressure and proper allocation to systole and diastole of left ventricular isometric contraction and relaxation, respectively, resulting in an overestimation of the SEVR values. These issues are considered in the novel method for SEVR assessment tested in this study. SEVR values estimated with carotid tonometry by "traditional” and "new” method were compared with those evaluated invasively by cardiac catheterization. The “traditional” method provided significantly higher SEVR values than the reference invasive SEVR: average of differences±SD= 44±11% (limits of agreement: 23% – 65%). The noninvasive “new” method showed a much better agreement with the invasive determination of SEVR: average of differences±SD= 0±8% (limits of agreement: ‐15% to 16%). Conclusions Carotid applanation tonometry provides valid noninvasive SEVR values only when all the main factors determining myocardial supply and demand flow are considered.

Aortic pulse wave velocity is a worldwide accepted index to evaluate aortic stiffness and can be assessed noninvasively by several methods. This study sought to determine if commonly used noninvasive devices can all accurately estimate aortic pulse wave velocity. Pulse wave velocity was estimated in 102 patients (aged 65±13 years) undergoing diagnostic coronary angiography with 7 noninvasive devices and compared with invasive aortic pulse wave velocity. Devices evaluating carotid-femoral pulse wave velocity (Complior Analyse, PulsePen ET, PulsePen ETT, and SphygmoCor) showed a strong agreement between each other ( r >0.83) and with invasive aortic pulse wave velocity. The mean difference ±SD with the invasive pulse wave velocity was −0.73±2.83 m/s ( r =0.64) for Complior-Analyse: 0.20±2.54 m/s ( r =0.71) for PulsePen-ETT: −0.04±2.33 m/s ( r =0.78) for PulsePen ET; and −0.61±2.57 m/s ( r =0.70) for SphygmoCor. The finger-toe pulse wave velocity, evaluated by pOpmètre, showed only a weak relationship with invasive aortic recording (mean difference ±SD =−0.44±4.44 m/s; r =0.41), and with noninvasive carotid-femoral pulse wave velocity measurements ( r r =0.23; 1.04±2.27 m/s, r =0.77; and −1.01±2.54 m/s, r =0.71, respectively), revealing a negative proportional bias at Bland-Altman plot. Aortic pulse wave velocity values provided by BPLab and Mobil-O-Graph were entirely dependent on age-squared and peripheral systolic blood pressure (cumulative r 2 =0.98 and 0.99, respectively). Thus, among the methods evaluated, only those assessing carotid-femoral pulse wave velocity (Complior Analyse, PulsePen ETT, PulsePen ET, and SphygmoCor) appear to be reliable approaches for estimation of aortic stiffness.

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Introduction Recent randomized controlled trials have confirmed the ability of renal denervation to lower blood pressure (BP) in patients, resistant to the BP-lowering effect of multiple antihypertensive drug administration. Evidence is limited, however, in patients with end-stage renal disease (ESRD) and haemodialysis, a condition in which a persistent BP elevation, despite administration of many antihypertensive drugs, is common. Aim of the present study was to test the BP-lowering efficacy of renal denervation in patients with resistant hypertension and ESRD on haemodialysis. BP was measured repeatedly in the office and over the 24 h during 1-year follow-up. Methods and results The study was conducted from February 2017 to January 2018 at the Policlinico of Monza, Monza, Italy. We included 24 men and women aged at least 20 years (mean 55 ± 16) who had ESRD, were on long-term haemodialysis and exhibited resistant hypertension, that is, elevated office and ambulatory BP values, despite multidrug antihypertensive treatment (n = 5.4 ± 1). We excluded patients with renal artery stenosis, malignancy, and a probable life expectancy less than 1 year. Twelve patients were included in the renal denervation and 12 in the medical treatment (control) group. All patients underwent office and 24 h ambulatory BP measurements at baseline and at 1, 6 and 12 months during the follow-up. In the renal denervation group, baseline office and 24 h mean SBP were 180 ± 112 and 175 ± 11 mmHg, respectively, the corresponding values in the control group being 181 ± 19 and 181 ± 20 mmHg. Most of the other baseline characteristics were also similar or only slightly different between groups, including the mean number of administered antihypertensive drugs at baseline. SBP showed an early and persistent reduction after renal denervation (office SBP: 165 ± 13; 150 ± 7 and 149 ± 11mmHg; 24 h SBP 163 ± 20, 148 ± 10 and 149 ± 17 mmHg after 1, 6 and 12 months, respectively). The BP-lowering effect was almost always present and statistically significant during both the day and night. DBP changes followed a similar pattern whereas heart rate never showed any significant change. No significant periprocedural complication of renal denervation was seen. The mean number of administered drugs did not show any significant BP change during the study. Conclusion In ESRD patients under long-term haemodialysis in whom BP was markedly elevated despite administration of many antihypertensive drugs, renal denervation lowered both ambulatory and office BP. The reduction persisted over a 1-year follow-up.

Introduction Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD. Methods We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer® PFO Occluder and Group B: 49 patients with a Figulla Flex® device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group. Results The mean follow-up after PFO closure was 53 months. The Amplatzer® PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO. Conclusions Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

Objective:Cuffless blood pressure (BP) measurements are believed to be a potentially alternative to cuff-occlusion-based BP measurement to eliminate some of the inconveniences of the latter approach. A wearable cuff-less monitoring device was developed for ambulatory BP monitoring. We assessed the a

Aim An innovative xenon–chlorine (excimer) pulsed laser catheter (ELCA X80) has been recently used for the treatment of complex coronary lesions, as calcified stenosis, chronic total occlusions and non-compliant plaques. Such complex lesions are difficult to adequately treat with balloon angioplasty and/or intracoronary stenting. The aim of this study was to examine the acute outcome of this approach on a cohort of patients with coronary lesions. Methods and Results Eighty patients with 100 lesions were enrolled through four centers, and excimer laser coronary angioplasty was performed on 96 lesions (96%). Safety and effectiveness data were compared between patients treated with standard laser therapy and those treated with increased laser therapy. Laser success was obtained in 90 lesions (93.7%), procedural success was reached in 88 lesions (91.7%), and clinical success in was obtained in 87 lesions (90.6%). There was no perforation, major side branch occlusion, spasm, no-reflow phenomenon, dissection nor acute vessel closure. Increased laser parameters were used successfully for 49 resistant lesions without complications. Conclusions This study suggests that laser-facilitated coronary angioplasty is a simple, safe and effective device for the management of complex coronary lesions. Furthermore, higher laser energy levels delivered by this catheter improved the device performance without increasing complications.

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.

Aims The success of transfemoral transcatheter aortic valve implantation (TAVI) and thoraco-abdominal aneurysm repair (TAAR) depends on haemostatic control of the access site, which is usually obtained with suture-based closure devices (Prostar or two ProGlide). A single ProGlide/Glubran technique, involving a suture placement on the vessel wall followed by tissue glue injection around the vessel wall, has not been previously investigated in this clinical setting. Our aim was to study the feasibility and safety of a single ProGlide/Glubran technique for vascular access-site closure after transfemoral TAVI and TAAR. Methods and results This technique was used in 250 patients from 2012 to 2017. The primary endpoint was the success of the technique, defined as access-site haemostasis without complications and not requiring any additional intervention within 30 days of the index procedure. Patients had a mean age of 82.4±1.93 years, with a logistic EuroSCORE of 20.2±2.32. A total of 218 TAVI and 32 TAAR procedures were performed with a mean sheath size of 18.09±1.55 Fr. The mean sheath to femoral artery ratio was 1.04±0.16, with mean femoral artery minimal lumen diameter 6.65±0.64 mm. The overall success rate of this technique was 98.4%. Four patients (1.6%) developed critical stenosis of the femoral artery requiring balloon dilatation. No major VARC-2 vascular complications were observed. Thirty-day mortality was 0.4% (non-cardiovascular). Conclusions The results of this study suggest that the single ProGlide/Glubran technique is a safe and effective method of closing the arterial access site after transfemoral TAVI and TAAR. The results of our study need to be confirmed in a randomised controlled trial before being adopted in routine clinical practice.

BACKGROUND Aortic pulse wave velocity (PWV) is an indirect index of arterial stiffness and an independent cardiovascular risk factor. Consistency of PWV assessment over time is thus an essential feature for its clinical application. However, studies providing a comparative estimate of the reproducibility of PWV across different noninvasive devices are lacking, especially in the elderly and in individuals at high cardiovascular risk. METHODS Aimed at filling this gap, short-term repeatability of PWV, estimated with 6 different devices (Complior Analyse, PulsePen-ETT, PulsePen-ET, SphygmoCor Px/Vx, BPLab, and Mobil-O-Graph), was evaluated in 102 high cardiovascular risk patients hospitalized for suspected coronary artery disease (72 males, 65 ± 13 years). PWV was measured in a single session twice, at 15-minute interval, and its reproducibility was assessed though coefficient of variation (CV), coefficient of repeatability, and intraclass correlation coefficient. RESULTS The CV of PWV, measured with any of these devices, was CONCLUSIONS Our study shows that the short-term repeatability of PWV measures is good but not homogenous across different devices and at different PWV values. These findings, obtained in patients at high cardiovascular risk, may be relevant when evaluating the prognostic importance of PWV.

Background General recommendations indicate that, during a carotid artery stenting (CAS), sufficient unfractionated heparin (UFH) has to be given to maintain the activated clotting time between 250 to 300 seconds. Bivalirudin use is able to reduce postprocedural bleedings in percutaneous interventions when compared with UFH. The study purpose was to evaluate, in a randomized study, the safety and efficacy of bivalirudin versus heparin during CAS, using proximal endovascular occlusion (PEO) as a distal protection device. Methods From January 2006 to December 2009, 220 patients undergoing CAS using PEO have been randomly assigned to one of the study arms (control arm: 100 UI/kg UFH or bivalirudin arm: 0.75 mg/kg intravenous bolus and intraprocedural infusion at 1.75 mg/kg/h). Results Procedural success was achieved in all the patients. No episodes of intraprocedural thrombosis occurred. One major stroke occurred in the bivalirudin arm, and two minor strokes occurred, one in each group. A significant difference in the incidence of postprocedural bleedings was observed between the study groups; bivalirudin use was associated with reduced number of bleedings according to Thrombolysis In Myocardial Infarction criteria. Conclusions The use of bivalirudin should be considered a safe and effective anticoagulation regimen during CAS, using PEO as a distal protection device. Bivalirudin use is associated with a reduced incidence of bleedings.

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 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.

Objective:Aortic pulse wave velocity (PWV) is the best indicator of aortic viscoelastic properties. Aim of this study is to investigate if invasively measured aortic PWV is accurately estimated by non-invasive methods which purport to assess it.Design and method:One-hundred and two patients (30% fem

Background Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown. Methods Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)–defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR). Results DM patients were more often complex as compared to non-DM patients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DM patients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DM patients as compared to simple DM patients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42–26.2) but not DM (HR 1.59; 95% CI 0.71–3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DM patients (3.3% vs. 1.9%, P = 0.228). Conclusions In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DM patients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.

Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD.We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer(®) PFO Occluder and Group B: 49 patients with a Figulla Flex(®) device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group.The mean follow-up after PFO closure was 53 months. The Amplatzer(®) PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO.Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.

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.

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

To the Editor: Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with symptomatic and severe aortic stenosis ([1][1]). Transcatheter aortic valve replacement (TAVR) provides a safe and efficient alternative for inoperable and high-risk surgical patients ([2

Background: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians. Purpose: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators. Methods: From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days. Results: 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender. Conclusion: This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines. © 2010 Wiley-Liss, Inc.

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 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.

Transcatheter aortic valve replacement is an emerging therapeutic alternative for patients with severe aortic valve stenosis and high surgical risk. The inability to reposition the current prosthesis is a limiting feature of these devices. Here we report on a case of a 74-year-old woman, in which a balloon expandable aortic valve malpositioning was treated with a second transapical transcatheter aortic valve implant.

Objectives The aim of this study was to assess the safety and effectiveness of carotid artery stenting (CAS) with proximal cerebral protection in patients showing string sign at carotid angiography. Background Presence of string sign is a well-known factor for adverse events in patients with severe carotid artery disease undergoing CAS. Methods We used retrospective analysis of a cohort of patients who underwent carotid angiography with the intention to undergo carotid stenting and had angiographically documented string sign in the target lesion. Results From October 2006 to August 2007, 25 patients (21 men and 4 women, mean age 70.9 ± 8.7 years) presented with string sign during carotid angiography. This was 6.0% of a total of 416 patients studied during the time of the study. Twenty patients (80.0%) were symptomatic, and 5 (20.0%) were asymptomatic. Carotid artery stenting was performed successively in all patients. Proximal cerebral protection was applied in all but 1 patient. The 30-day death/stroke rate was 0%. At 12-month follow-up neurological events did not occur; 1 patient developed a nonfatal myocardial infarction, and another patient died from noncardiac cause. The 12-month death/stroke rate was 4.0%. Conclusions Carotid stenting under proximal cerebral protection seems to be a feasible and safe procedure to manage patients with severe carotid stenosis in presence of angiographic string sign. Further prospective trials are required to prove efficacy of CAS in larger study populations.

Background An 84-year-old man suffering from dyspnoea on mild exertion and a 10-year history of mitral valve replacement with a mechanical prosthesis presented to our department. The patient had an isolated right aortic arch. Investigation Transthoracic echocardiography demonstrated severe LV systolic dysfunction (EF 25%), good function of the previously implanted mechanical prosthesis and severe aortic stenosis. Multislice computed tomography confirmed the presence of an isolated right aortic arch with mirror-image branching. Diagnosis Severe symptomatic aortic stenosis in a patient with right aortic arch at high risk for surgical reintervention. Management Transcatheter aortic valve implantation using conventional delivery system.

At present, transcatheter aortic valve implantation (TAVI) is a proven treatment option for patients with symptomatic degenerative aortic stenosis at high risk for conventional surgery. In countries where TAVI is currently performed, the number of procedures and centers involved has been continuously increasing. The present document from the Italian Society of Interventional Cardiology (SICI-GISE) aims to improve the available evidence and current consensus on this topic through the definition of training needs and knowledge base for both operators and centers.

We examined the effects of peri-procedural intensive glycemic control (IGC) during early percutaneous coronary intervention (PCI) on restenosis rate in hyperglycemic patients with ST-segment elevation myocardial infarction (STEMI).A total of 165 hyperglycemic patients (glucose ≥ 140 mg/dl) with first STEMI undergoing PCI were studied. Patients were randomized to IGC for almost 24 h after PCI (n = 82; glucose, 80-140 mg/dl) followed by multidose sc insulin during the hospital stay or conventional glycemic control (CGC; n = 83; glucose, 180-200 mg/dl) followed by conventional therapy. Coronary angiography was performed at study entry and at 6-month follow-up. Blood samples for glycemia, hemoglobin A1c, inflammatory markers (C-reactive protein and TNF-α), monocyte chemoattractant-protein-1, and oxidative stress (nitrotyrosine) were collected immediately before and 24 h, 30 and 180 d after PCI.After insulin infusion, mean plasma glucose during the peri-procedural period was greater in the CGC group than in the IGC group (CGC, 191 ± 15 mg/dl; IGC, 145 ± 35 mg/dl; P0.001). After the insulin infusion period, the levels of markers of oxidative stress (nitrotyrosine), inflammation (C-reactive protein, TNF-α), and monocyte chemoattractant-protein-1 were significantly higher in CGC patients compared with IGC patients. Moreover, ICG during PCI reduces restenosis by half (48 and 24%) at 6 months. During follow-up, there was no difference in mortality rates, glucose, inflammatory and oxidative stress markers among the groups. In-stent restenosis was positively associated with mean plasma glucose levels as well as oxidative stress and inflammatory markers during the insulin infusion period.In hyperglycemic patients with STEMI, optimal peri-procedural glycemic control by reducing oxidative stress and inflammation may improve the outcome after PCI.

AIMS Transcatheter aortic valve implantation (TAVI) is becoming a safe and effective technique for treating symptomatic aortic valvular stenosis (AVS) as an alternative to surgery in very high-risk patients. A possible consequence of valve implantation is the obstruction of coronary ostia. METHODS AND RESULTS Here we report five cases of angiographically confirmed left main (LM) obstruction, occurred immediately after balloon expandable aortic valve implantations at our institution. In four of these cases, LM obstruction was resolved with an emergency percutaneous coronary intervention (PCI). In the remaining case, obstruction transiently occurred only at the time of balloon valvuloplasty and did not required treatment. During this type of intervention, performing an aortography at the time of balloon valvuloplasty could help to identify patients at risk for coronary obstructions. CONCLUSIONS These cases illustrate that obstruction of the coronary ostia following TAVI is a possible complication. As the use of TAVI becomes widespread, the operators should be aware of this dangerous complication in their case preparation should it arise.

This single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population.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.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.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%; p0.05). 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.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.

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.

AIMS: Proximal endovascular clamping (PEC) appears to be a safe and effective cerebral protection technique for carotid artery stenting (CAS). So far the presence of severe stenosis of the ipsilateral external carotid artery (ECA) was considered a contraindication to PEC. This study presents the results of PEC for CAS in patients simultaneously presenting an ipsilateral ECA stenosis. METHODS AND RESULTS: From September 2004 to December 2006, CAS was performed in 500 unselected cases using PEC. In sixty cases (12%) a severe ipsilateral ECA stenosis (>/=80%) was identified by angiography. In all these cases procedural success, defined as the ability to establish cerebral protection as well as stent deployment with a residual stenosis

Adiponectin, an adipocyte-derived protein, is an essential modulator of insulin sensitivity and several studies suggest an important role of adiponectin in the processes leading to atherosclerosis, thus indicating the adiponectin gene as a potential candidate for coronary artery disease (CAD). In the present study we have studied the association between two single nucleotide polymorphisms (SNPs) (+45TG and +276 GT) of the adiponectin gene and CAD, looking also into the possible influence of these SNPs on adiponectin plasma levels. The SNPs were analysed in a first cohort of 595 subjects, 325 with CAD and 270 matched controls. We observed a significant association (p0.001) between the SNP +276GT in the adiponectin gene and CAD. In multivariate analysis, carriers of the +276GT SNP had an odds ratio (OR) for CAD of 4.99 (p0.0007). A strong interaction between the +276GT SNP and age was also present (OR, 1.03; p0.0001). The increase in CAD risk was most evident among individuals with early-onset CAD (ageor=50 years), whereas in older CAD subjects other factors, and not the adiponectin SNP, were the major determinants. Furthermore, in CAD subjects with early-onset disease this SNP was also a significant determinant of lower levels of serum adiponectin levels. This association resulted independent from the other variables known to be associated with CAD in our population, including sex, body mass index, high-density lipoprotein and Homeostasis Model Assessment for insulin resistance. To confirm the results the +276GT SNP was analysed in a second cohort of CAD and controls. The difference between CAD and controls in the +276GT SNP frequencies showed a similar trend as before, although not significant. The combination of the two cohorts (1,046 subjects: 580 CAD and 466 controls) showed a statistically significant association, particularly in CAD subjects with early-onset of disease. In addition, we confirmed that in younger CAD subjects the SNP was a significant determinant of lower levels of adiponectin. In view of these results, it could be speculated that the adiponectin gene variant, or a mutation in linkage with it, determines lower adiponectin gene expression, causing in turn an increased risk to develop insulin resistance, atherosclerosis and cardiovascular disease. The significant association of the adiponectin gene in subjects with early-onset CAD also suggests that that genetic factors for late-onset diseases may exert a greater influence in younger persons, when other risk factors are not as prevalent as in older age groups.

There is sometimes a need to remove foreign bodies that make their way to the heart and surrounding vessels [1]. These foreign bodies may be coils that go astray during implantation or retained indwelling catheters [2]. Special retrieval catheters inserted percutaneously, usually in the femoral vein, grab onto these foreign bodies and then the catheter and the foreign body are removed from the patient [3]. We describe here a case series of six procedures performed in five patients in our cath lab in the last 5 years.

Background Current evidence demonstrates that positive family history and several alterations in lipid metabolism are all important risk factors for coronary artery disease (CAD). All lipid abnormalities themselves have genetic determinants. Thus, objective of this study was to determine whether 6 genetic variants potentially related to altered lipid metabolism were associated with CAD and with lipid abnormalities in an Italian population. These genetic variables were: apolipoprotein E (Apo E), Apo AI, Apo CIII, Apo B, lipoprotein lipase (LPL) and the hepatic lipase (LIPC) genes. Furthermore, an 8 years prospective analysis of clinical cardiovascular events was related to the various genetic markers. Methods 102 subjects with established coronary artery disease and 104 unrelated normal subjects were studied. CAD Patients were followed up for 8 years, and clinical CAD outcomes (a second coronary angioplasty (PTCA), myocardial infarction, coronary artery by-pass graft (CABG), cardiovascular deaths), available from 60 subjects, were related to the genetic variants by multiple regression analysis. Results. Of the six lipid loci studied (for a total of 11 polymorphisms) only the apolipoprotein E, Apo B and LIPC polymorphisms distinguished between case and controls. However, multivariate analysis accounting for clinical and metabolic predictors of CAD showed that only the ApoB Xba1 and ApoE4 polymorphism associated with CAD in this Italian population. When lipid parameters were related to genotypes, the ApoE, ApoB, and LIPC gene polymorphisms were associated to various markers of dyslipidaemia in the CAD patients, confirming previous reports. When the occurrence of a second cardiovascular event was related to genotypes, an independent role was observed for the LIPC gene T202T variant. Conclusions variation in LIPC (hepatic lipase) gene associates with clinical outcomes in Italian patients with established CAD. Further studies on the LIPC gene in CAD patients are warranted, in particular looking at the possible influences on clinical outcomes.

Despite the use of stent implantation along with percutaneous transluminal angioplasty, the rate of restenosis in high-risk patients is still high. Some studies have proven the ability of platelet glycoprotein IIb/IIIa receptor antagonists to reduce peri- and post-procedural thrombotic complications in endovascular procedures. We present the case of a 62-year-old female with in-stent restenosis who was successfully treated with femoral artery angioplasty with a stent-in-stent technique and tirofiban administration.

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.