Endovascular treatment of persistent sciatic artery aneurysm with the multilayer stent.

PURPOSE: To describe the successful management of a symptomatic persistent sciatic artery (PSA) aneurysm using the Multilayer Aneurysm Repair System (MARS). CASE REPORT: A 50-year-old man with history of smoking, hypertension, and hypercholesterolemia suddenly developed pain in the buttock radiating to the left lower limb, mimicking sciatica. The ∼57×54-mm incomplete type PSA aneurysm was treated with two 14×80- and 14×60-mm MARS devices through a surgical left axillary artery access. There were no periprocedural complications. Thirty-day imaging documented patency of the stents and a minor reduction (∼47×55 mm) in the aneurysm, with slightly hyperdense content and no signs of perfusion. At 6 months, duplex and computed tomographic angiography showed complete thrombosis of the sac, patency of the multilayer stents, and further aneurysm shrinkage (40×37 mm). CONCLUSION: The multilayer stent can alter the hemodynamics inside a peripheral aneurysm to promote sac thrombosis and redirect flow to collaterals originating from the sac.

Endovascular abdominal aneurysm repair and impact of systematic preoperative embolization of collateral arteries: endoleak analysis and long-term follow-up.

PURPOSE: To report our results of endovascular aneurysm repair (EVAR) over a 10-year period using systematic preoperative collateral artery embolization. METHODS: From 1999 until 2009, 124 patients (117 men; mean age 70.8 years) with abdominal aortic aneurysm (AAA) underwent embolization of patent lumbar and/or inferior mesenteric arteries prior to elective EVAR procedures. Embolization was systematically attempted and, whenever possible, performed using microcoils and a coaxial technique. Follow-up included computed tomography and/or magnetic resonance imaging and abdominal radiography. RESULTS: The technical success for EVAR was 96% (119/124), with 4 patients dying within 30 days (3.2% perioperative mortality) and 1 type III endoleak accounting for the failures. Collateral arteries were occluded spontaneously or by embolization in 60 (48%) of 124 patients. The endoleak rate was 50.9% (74 in 61 patients), most of which were type II (19%). Over a mean clinical follow-up of 60.5±34.1 months (range 1-144), aneurysm sac dimensions decreased in 66 patients, increased in 19 patients, and were stable in 35. The endoleak rate was significantly higher in the patients with increasing sac diameter (p<0.001). Among the patients with patent collateral arteries, 38/64 (59.3%) developed 46 leaks, while 28 leaks appeared in 23 (41%) of 56 patients with collateral artery occlusion (p=0.069). The type II endoleak rate significantly differed between these two groups (47.8% vs. 3.6%, p<0.001). CONCLUSION: Preoperative collateral embolization seems to be a valid method of reducing the incidence of type II endoleak, improving the long-term outcome.

In vivo assessment of coronary stents with 64-row multidetector computed tomography: analysis of metal artifacts.

OBJECTIVE: To evaluate stent-induced artifacts by 64-row multidetector computed tomography (MDCT). METHODS: We studied 26 stented patients with MDCT before conventional coronary angiography (CCA). The CT values were measured. Stents were classified as occluded, with significant stenosis, with nonsignificant stenosis, or patent. For the patent stents, mean in-stent and out-stent CT values were compared; stents 3 mm or smaller were compared with stents larger than 3 mm. Multidetector CT was compared with CCA. RESULTS: We analyzed 42 stents. At CCA, 34 stents were patent, 5 were nonsignificantly stenosed, 1 was significantly stenosed, and 2 were occluded. At MDCT, 33 of 34 patent stents, 2 occluded stents, and 1 stent with significant stenosis were correctly diagnosed; nonsignificant stenoses were undetected, 1 patent stent was misdiagnosed as occluded (κ = 0.727). The out-stent CT value was lower than in-stent CT value both in stents 3 mm or smaller (P = 0.001) and stents larger than 3 mm (P < 0.001). The in-stent CT value of stents 3 mm or smaller was higher (P = 0.011) than that of stents larger than 3 mm. CONCLUSIONS: Metal artifacts cause overlooking of nonsignificant stenosis.

Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry.

AIMS: To compare long-term clinical outcome following drug-eluting stents (DES) or bare-metal stents (BMS) implantation on lesions located at the ostium or the shaft of the left main in a large real-world population. The advent of DES decreased the risk of unprotected left main coronary artery (ULMCA) restenosis when compared with BMS, but it is unclear if this advantage continues when non-bifurcational lesions are considered. METHODS AND RESULTS: The GISE-SICI registry is a retrospective, observational multicentre registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centres enrolled 1453 consecutive patients who underwent percutaneous coronary intervention on ULMCA between January 2002 and December 2006. From the registry, a total of 479 consecutive patients with ostial and shaft lesions who underwent DES (n = 334) or BMS (n = 145) implantation were analysed with extensive multivariable and propensity score adjustments. At 3-year follow-up, risk-adjusted survival rates were higher in patients treated with DES than in those treated with BMS. The adjusted hazard ratio (HR) for the risk of mortality after DES implantation relative to BMS implantation was 0.37 (95% CI: 0.15-0.96, P = 0.04). The adjusted HR for the risk of cardiac mortality was 0.31 (95% CI: 0.09-1.04, P = 0.06). The adjusted 3-year rates of target lesion revascularization (TLR) were not significantly lower in the DES group than in the BMS group (P = 0.60). CONCLUSION: In a large population of patients with lesions located at the ostium or the shaft of the left main in a real-world setting, DES were associated with favourable clinical outcomes when compared with BMS, although there was no evidence of a significant reduction in TLR with DES vs. BMS.

Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology.

AIMS: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.

Long-term clinical benefit of drug-eluting stents over bare-metal stents in diabetic patients with de novo left main coronary artery disease: results from a real-world multicenter registry.

BACKGROUND: Few data are available on diabetic patients undergoing percutaneous coronary intervention (PCI) in the context of unprotected left main coronary artery (ULMCA) disease. The main goal of this study was to present the long-term relative benefits of using drug-eluting stent (DES) instead of bare-metal stent (BMS) for diabetic patients submitted to percutaneous ULMCA treatment in a large real world multicenter registry. METHODS: The GISE-SICI registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent PCI on ULMCA between January 2002 and December 2006. From the registry, a total of 398 consecutive patients with diabetes mellitus who underwent DES (n = 321) or BMS (n = 77) implantation were analyzed, with extensive multivariable adjustments. RESULTS: At 3-years, use of DES in diabetic patients resulted in no significant differences with respect to death (HR 0.56, 95% CIs 0.24-1.28), myocardial infarction (HR 0.82, 95% CIs 0.21-3.26), and the composite end-point of death or myocardial infarction (HR 0.56, 95% CIs 0.27-1.20). Conversely, DES were associated with significant reduction of target lesion revascularization (TLR, HR 0.33; 95% CIs 0.14-0.80, P = 0.001) rates. CONCLUSIONS: Patients presenting with ULMCA disease in the context of diabetes mellitus who are treated with stent-supported PCI have a significant reduction in the rate of TLR with no increased risk of death or myocardial infarction.

Long-term outcome in diabetic heart failure patients treated with cardiac resynchronization therapy.

BACKGROUND: Diabetes mellitus is an independent risk factor for increased morbidity and mortality in heart failure (HF) patients. AIMS: To compare functional and structural improvement, as well as long-term outcome, between diabetic and non-diabetic HF patients treated with cardiac resynchronization therapy (CRT). METHODS: We compared response to CRT in 141 diabetic and 214 non-diabetic consecutive patients. Major events were; death from any cause, urgent heart transplantation and implantation of a left ventricular (LV) assist device. Frequencies of hospitalisation and defibrillator (CRT-D) discharges were also analyzed. RESULTS: CRT was able to significantly improve functional capacity, ventricular geometry and neurohumoral imbalance in both diabetic and non-diabetic patients over a median follow-up time of 34 months. Overall event-free survival was similar in diabetic and non-diabetic patients (HR 1.23, p=0.363), as was survival free from CRT-D interventions (HR 1.72; p=0.115) and hospitalisations (HR 1.12; p=0.500). On multivariable analysis, NYHA class IV (p=0.002), low LV ejection fraction (p=0.002), absence of beta-blocker therapy (p<0.001), impaired renal function (p=0.003), presence of an epicardial lead (p=0.025), but not diabetes (p=0.821) were associated with a poor outcome after CRT. CONCLUSIONS: Diabetic HF patients treated with CRT had a very favourable functional and survival outcome, which was comparable to non-diabetic patients.

Carbon dioxide (CO2) angiography as an option for endovascular abdominal aortic aneurysm repair (EVAR) in patients with chronic kidney disease (CKD).

To assess feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with chronic kidney disease (CKD). After Ethical Committee approval, the records of 13 patients (all male, mean age 74.6 ± 8.0 years) with CKD, who underwent EVAR to exclude an abdominal aortic aneurysm (AAA) under CO2 angiography guidance, were reviewed. The AAA to be excluded had a mean diameter of 52.0 ± 8.0 mm. CO2 angiography was performed by automatic (n = 7) or hand (n = 6) injection. The endograft was correctly placed and the AAA was excluded in all cases, without any surgical conversions. Two patients (15.4%) had an endoleak: one type-Ia, detected by CO2-DSA and effectively treated with prosthesis dilatation; one type-III, detected by CO2-DSA, confirmed using 10 ml of ICM, and conservatively managed. In one patient, CO2 angiograms were considered of too low quality for guiding the procedure and 200 ml of ICM were administered. Overall, 11 patients (84.6%) underwent a successful EVAR under the guidance of the sole CO2 angiography. No patients suffered from major complications, including those typically CO2-related. Two patients suffered from abdominal pain during the procedure secondary to a transient splanchnic perfusion's reduction due to CO2, and one patient had a worsening of renal function probably caused by a cholesterol embolization during the procedure. In patients with CKD, EVAR under CO2 angiography guidance is feasible, effective, and safe.

Bioresorbable vascular scaffold (BVS) for in-stent chronic total occlusion: Antegrade recanalization and IVUS-guided BVS implantation by radial access.

The completely absorbable stents represent one of the latest innovations in the field of interventional cardiology, prospecting the possibility of "vascular repair". In the published trials (ABSORB Cohort A and B, ABSORB EXTEND, and ABSORB II, III and IV) chronic total occlusions (CTOs) were considered an exclusion criteria. More recently the CTO-ABSORB pilot study demonstrated the safety and feasibility of bioresorbable vascular scaffold (BVS) use in case of CTO recanalization. We present the first case, to our knowledge, of in-stent occlusion successfully treated with an everolimus-eluting BVS and discuss its potential advantages in such kind of lesions.

Randomized evaluation of polytetrafluoroethylene-covered stent in saphenous vein grafts: the Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial.

BACKGROUND: Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. METHODS AND RESULTS: We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P=0.047) and was mainly attributed to MI (10.3% versus 3.4%, P=0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P=0.237). Although the 6-month non-Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P=0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P=0.153). CONCLUSIONS: The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

[The radial access approach in complex coronary anatomy: case report and literature review]. / L'accesso arterioso radiale nell'anatomia coronarica complessa: caso clinico e revisione della letteratura.

The radial artery approach has been accepted as an alternative to the traditional femoral approach in both diagnostic and interventional procedures, including treatment of complex coronary lesions such as chronic total occlusions. Catheterization of the left internal mammary artery (LIMA) graft is frequently performed through this route in order to limit catheter manipulation and avoid dissection of the subclavian and mammary artery, a dramatic event rarely reported in the literature. Nonetheless, indication for this approach should be carefully evaluated, especially if an unfavorable angle of origin of the mammary artery is present. We report the case of a patient who, following iatrogenic dissection of the LIMA during catheterization through the left radial artery, was electively treated with percutaneous coronary angioplasty on a complex anatomy, rather than with high-risk redo coronary artery bypass surgery. Using a combined radial and femoral approach, retrograde disobstruction of the left anterior descending artery, followed by plaque debulking with rotational atherectomy through the struts of a previously implanted stent in the left main-left circumflex artery, was performed. Although the radial approach might be considered even for the treatment of complex coronary anatomy subsets, appropriate use in diagnostic and interventional settings should always be carefully evaluated.

A randomized comparison of direct stenting versus stenting with predilatation in native coronary artery disease: results from the multicentric Crosscut study.

Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries. Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DS group versus 3.0% for PS group; p = NS). Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.

[SICI-GISE position paper on the requirements for diagnostic and interventional procedures in patients with peripheral arterial disease]. / Documento di posizione SICI-GISE sui requisiti di processo diagnostico ed interventistico riferiti a pazienti affetti da patologia vascolare periferica.

Interventional procedures on peripheral vessels are the field of a novel specialty dedicated to the diagnosis and minimally invasive endovascular treatment of diseases involving the cerebral, thoracic and abdominal arteries (including renal and visceral arteries), as well as the peripheral arteries (femoro-popliteal arteries and the arteries below the knee). At present, physicians with three different types of medical training, each involving particular strengths and characteristics, specialize in endovascular treatment of patients with peripheral arterial disease: vascular surgeons, interventional radiologists and interventional cardiologists. Treatment of high-risk patients in terms of anatomical and clinical (serious comorbidities) complexity raised the need for the interventional cardiologist to face issues related to technical aspects of the procedure, multilevel pathology management and adequate indication. To achieve this goal, interventional cardiologists require particular facilities and clinical skills. The objectives of this position paper from the Italian Society of Interventional Cardiology (SICI-GISE) are (i) to define the theoretical background and practical training required to ensure that interventional cardiologists maintain high-quality standards also in the field of treatment of peripheral arterial disease, by establishing shared rules and drafting papers; (ii) to standardize the procedures of interventional cardiology operational units that treat patients with peripheral arterial disease in Italy on the basis of scientific evidence, and (iii) to establish common requirements in terms of facilities and regulations.

The Virtual histology In CaroTids Observational RegistrY (VICTORY) study: a European prospective registry to assess the feasibility and safety of intravascular ultrasound and virtual histology during carotid interventions.

BACKGROUND: Carotid occlusive disease is the most common determinant of thromboembolic stroke. However, limited insights in vivo into the pathophysiology and pathology of carotid plaques are available. We designed a prospective multicenter registry to appraise the safety and feasibility of intravascular ultrasound (IVUS) and IVUS-virtual histology (IVUS-VH) imaging before and immediately after carotid stenting. METHODS: Symptomatic and asymptomatic patients scheduled for carotid stenting were included. IVUS-VH pullbacks were performed before and after stenting. Angiographic, IVUS and IVUS-VH analyses were performed. The primary objective was to appraise feasibility and safety of IVUS-VH, and secondary objectives were to correlate plaque composition and plaque type derived from IVUS-VH with acute and 30-day complications. RESULTS: A total of 119 patients were enrolled. IVUS-VH could be performed in all cases (100%), with additional runs after completion of the stenting procedure in 85%. Most plaques were stable by IVUS-VH, with vulnerable ones at minimum lumen area in 7%. Conversely, vulnerable plaques were significantly more common elsewhere in the internal carotid artery (ICA, 24% of patients, p<0.001). Acute and 30-day adverse events were uncommon (2 strokes, 1 transient ischemic attack), with no significant association between these and IVUS-VH features. CONCLUSIONS: IVUS and IVUS-VH examinations during carotid interventions are feasible and safe, and provide important insights on qualitative and quantitative compositions of carotid plaques. Whether carotid IVUS-VH can predict clinical events remains uncertain, awaiting long-term follow-up of the VICTORY study and additional clinical trials.

[ST-elevation myocardial infarction: reperfusion strategy based on the results from large clinical trials]. / Strategie riperfusive nell'infarto miocardico acuto: cosa dicono i trial.

The efficacy of reperfusion therapy, both pharmacological and mechanical, in patients with ST-elevation myocardial infarction (STEMI) is time-dependent. The relation is closer the earlier we are from symptom onset and is valid for thrombolysis within 6h and for primary angioplasty till to at least the twelfth hour. Benefits of reperfusion bring to an advantage both in terms of myocardial salvage and left ventricular systolic function and in terms of quality of life and long-term survival. Although mortality and morbidity of STEMI patients have been greatly reduced in the last 20 years, the need for guideline revision and implementation remains urgent, mostly because mortality of real-world STEMI patients keeps to be always much higher compared to what reported in big randomized controlled trials. The most important indications from big trials and guidelines regarding both pharmacological and non-pharmacological reperfusion strategy in STEMI patients are discussed.

Comparison of drug-eluting stents and bare-metal stents for the treatment of unprotected left main coronary artery disease in acute coronary syndromes.

The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non-ST-segment elevation myocardial infarction who underwent DES (n=611) or BMS (n=238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals [CI] 0.59 to 1.38, p=0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p=0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p=0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p=0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS.