Hugo Londero

Carotid Artery Stenting Protected With an Emboli Containment System

Background and Purpose— Fear of distal embolization and stroke has aroused concern regarding carotid stenting. Devices to protect the cerebral circulation may make carotid stenting safer. Methods— A multidisciplinary study group tested a balloon occlusion-aspiration emboli entrapment device in conjunction with carotid stenting. The device consists of an elastomeric balloon on a steerable wire with a detachable adapter that inflates and deflates the distal temporary occlusion balloon. An aspiration catheter is used to remove trapped emboli after stenting and before occlusion balloon deflation. Results— Seventy-five patients with severe internal carotid artery stenosis were treated with stents deployed with this cerebrovasculature protection system. All 75 patients (100%) had grossly visible particulate material aspirated, and all were treated successfully without major or minor stroke or death at 30 days. Preintervention stenosis was 81±10%, and residual stenosis was 5±7%. Nine patients (12%) had angiographic evidence of thrombus before intervention, but no patient had thrombus or vessel cutoff after the procedure. Four patients (5%) developed transient neurological symptoms during protection balloon occlusion, but symptoms resolved with balloon deflation. The 22 to 667 particles aspirated per patient ranged from 3.6 to 5262 &mgr;m in maximum diameter (mean, 203±256 &mgr;m). These particles included fibrous plaque debris, lipid or cholesterol vacuoles, and calcific plaque fragments. Conclusions— Protected carotid stenting was performed successfully and safely in this study early in the experience with cerebrovascular protection devices. Particulate emboli are frequent with stenting, and cerebral protection will likely be necessary to minimize stroke. Randomized trials comparing protected carotid stenting with endarterectomy are warranted.

Initial multicenter experience with a novel distal protection filter during carotid artery stent implantation

Atheroembolization resulting in transient or permanent neurologic impairment is the most common complication of catheter‐based percutaneous carotid artery intervention. Protection of the distal cerebral vasculature during carotid stent implantation may enhance procedural safety. Carotid stent implantation with distal cerebral protection using the FilterWire EX was performed in 35 consecutive patients undergoing 36 procedures at six centers. The FilterWire was delivered and deployed successfully in all 36 cases, and embolic material was retrieved from 74% of procedures. The 30‐day rate of major adverse events (death, major or minor stroke) was 0%. Transient ipsilateral periprocedural neurologic ischemia developed in two patients (5.7%), both resolving within 30 min. Distal cerebral protection with the FilterWire during carotid stenting is feasible and safe, results in capture and extraction of atheroembolic debris in the majority of patients while affording uninterrupted cerebral perfusion, and in this initial multicenter experience was associated with a high rate of procedural success without major complications. Cathet Cardiovasc Intervent 2003;58:139–146.

Initial Experience With Transradial Access for Carotid Artery Stenting

We report our experience using transradial access (TRA) for carotid artery stenting (CAS). Eighty-eight patients underwent CAS using a nonfemoral approach, 79 of them by TRA. Carotid artery stenting was performed using standard techniques with a long hydrophilic sheath. Mean age was 69.5 years. A total of 46 patients were symptomatic and 34 were asymptomatic. Transradial access and procedural success were achieved in 98.8% and 96.6% of the cases, respectively. There were no deaths, myocardial infarction, or radial access site complications. In all, 2 patients sustained a stroke, 1 hemorrhage, and 1 ischemia. Carotid artery stenting using TRA was safe and technically feasible.

IMPACT trial: angiographic and intravascular ultrasound observations of the first human experience with mycophenolic acid-eluting polymer stent system

The purpose of the study was to examine the safety and efficacy of two different formulations of mycophenolic acid (MPA)‐eluting Duraflex stents on coronary de novo lesions. Recent data indicate that local delivery of MPA in the porcine overstretch coronary model significantly reduces neointimal hyperplasia (NIH). Patients were divided into three consecutive groups. The first (n = 50) and second (n = 55) groups received moderate‐ and slow‐release MPA‐eluting Duraflex stent, respectively. The last group (n = 50) received the bare metal Duraflex stent. Clinical, angiographic, and intravascular ultrasound analysis were performed at 6‐month follow‐up. All stents were successfully deployed and patients were discharged home without clinical events. Compared to controls, 6‐month in‐lesion and in‐stent minimum luminal diameter as well as late lumen loss were not significantly different in the moderate‐ and slow‐release treatment groups. At follow‐up, percentage obstruction and NIH volume were also similar between the three groups. At 30 days and 6 and 12 months, there were no differences noted between the three groups with respect to major adverse cardiac events as well as the individual rates of mortality, myocardial infarction, or repeat revascularization. There were no cases of subacute or late thrombosis. In this feasibility trial, the MPA‐eluting Duraflex stents in either slow‐ or moderate‐release formulations were well tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. Further testing with different drug dosing or delivery rate might improve these results.

Safety and feasibility of balloon-expandable stent implantation for the treatment of type I endoleaks following endovascular aortic abdominal aneurysm repair.

AIMS The occurrence of type I endoleaks represent an ominous sign after endovascular aneurysms repair (EVAR). We report our experience using balloon-expandable stents (BES) for the treatment of proximal Type I endoleaks at five high-volume hospitals in Argentina. METHODS AND RESULTS Of 1,395 patients who underwent EVAR, we retrospectively collected data of 29 (2%) consecutive patients who underwent additional BES to repair proximal type I endoleaks. The mean age was 75.8 years old (range 63-87) and 93% were male. A hostile anatomy was found in 89.6% of the cases. BES oversize (balloon/neck diameter ration ≥ 30%) was frequent (69%); whereas, BES/prosthesis diameter ratio was less than 1 in 79% of the cases. Complete and partial sealing was obtained 72 and 28% of the cases, respectively. There were no immediate or late surgical conversion or major complications related with stent implantation. At a median time follow-up of 14.9 months (25-75% interquartiles: 4.5-17.5 months), there were no cardiovascular deaths, evidence of aneurysm sac enlargement or need for re-intervention. CONCLUSIONS Our preliminary results suggest that BES implantation for the treatment of proximal type I endoleaks is feasible and safe with favourable mid-term results and may preclude the need for surgical conversion.

Perfil demográfico e resultados imediatos dos pacientes submetidos a angioplastia primária no Registro SOLACI

ABSTRACT Patient Demographics and Immediate Resultsof Primary Angioplasty in the SOLACI Registry Introduction: The superiority of primary angioplasty com-pared to fibrinolytic agents has been broadly demonstratedin different studies, but due to logistic issues we haveobserved a delay in the implementation of the recom-mendations in real world scenarios. We compared primaryangioplasty results at three different timepoints in theSOLACI Registry. Methods: The SOLACI Registry includeddata of 43,725 primary angioplasties carried out from1995-97 (n = 6,793), 2000-03 (n = 23,007) and 2007-08(n = 13,925). Results: An increasing complexity of treatedpatients was observed, with an increment in the percentageof women, diabetics, patients with prior myocardial in-farction and patients with moderate to severe ventriculardysfunction. Procedural success remained high (> 91%) atall timepoints, regardless of the device used. In addition,we observed a significant decrease of door-to-balloontime, increased use of stents and a 45% decrease in the useof glycoprotein IIb/IIIa inhibitors. Regarding in-hospitaloutcomes, a decreased mortality (9.1% vs. 5.3% vs. 4.5%),reinfarction (4.1% vs. 2.6% vs. 2.7%) and target vesselrevascularization procedures (3.5% vs. 0.7% vs. 0.7%)was observed.

Densitometric quantitative analysis of intracoronary ultrasound images: anatomopathologic correlation

To establish if the video densitometric analysis (VDA) of the intracoronary ultrasound images (IVUS) can predict the qualitative and quantitative composition of the atherosclerotic coronary plaques, thirty-one patients with anatomopathologic study of directional coronary atherectomy (DCA) samples and pre and post intervention IVUS image were analyzed. The video IVUS images were digitized in a 512 x 512 matrix and analyzed for densitometric differences with an Automatic Image Analysis System (AIAS) (Vidas 2000, Zeiss Kontron). The components of the plaque were arbitrarily divided into three densitometric categories using a 256 gray scale: high density (HD) 121–255, medium (MD) 81–120 and low (LD) 30–80. The relative percentage of each component was automatically recorded. The DCA samples were microscopically examined and input in the AIAS. The components were divided into: collagenous tissue (CT); lipid-necrotic debris (LND); proliferative tissue (PT). The area of each component was expressed as a percentage of the total. Linear correlation analysis was applied. Comparison between the IVUS and the histological composition of the plaque showed that: HD corresponded to CT; MD to PT; LD to LND. The correlation between the percentage distribution of the densitometric categories and the anatomopathologic components showed a correlation coefficient r%equals;0.91 between HD and CT; r%equals;0.87 between MD and PT; r%equals;0.88 between LD and LND. The VDA of the IVUS can distinguish three basic components of the atherosclerotic plaque: fibrous, lipid-necrotic and proliferative tissue, allowing absolute and relative quantitative analysis. This capability may be of interest for device selection and histopathologic correlation.

Totally occluded saphenous vein graft recanalization: A dangerous option

Percutaneous treatment for saphenous vein graft disease continues to be a challenging procedure. High periprocedural morbidity related with distal embolization of atherothrombotic debris [1] and its sequela of myocardial infarction and death, high restenosis rate, even after stent placement [2,3], and high rate of progression of untreated angiographically nonsignificant lesions [4] are the problems to be solved. These difficulties are explained by the pathologic differences with native vessels atherosclerotic disease. Vein graft atherosclerosis tends to be diffuse, soft, and friable with poorly developed or absent fibrous cap. Histologically the vein graft atheroma has more foam and inflammatory cells, necrotic debris, cholesterol crystals and blood elements [5–7]. Thrombus of varying ages is a frequent component of the obstructive material. When graft thrombosis and occlusion occurs the absence of branches favor large and bulky thrombus formation that occupy the entire length of the vein [8,9]. Interventions maneuvers (guiding catheter ostium canalization, coronary wire vein crossing, lesion balloon dilatation, stent implantation, and balloon stent expansion can dislodge friable atherosclerotic and thrombotic material causing distal embolization and slow-flow or no-reflow phenomena. Vasoactive substances can contribute to no-reflow. Creatine kinase-MB (CK-MB) elevation is a frequent consequence after distal embolization [1,10] and it is related with one-year mortality rate despite angiographic results [11]. Selective infusion of urokinase [12], extraction coronary atherectomy [13], directional coronary atherectomy [14], laser angioplasty [15], ultrasound thrombolysis [16], and AngioJet rapid thrombectomy [17] has been used in an effort to reduce distal embolization. These techniques have generally failed in reducing the incidence of complications related with saphenous vein PCI. A novel device under investigation that can be mentioned is the X-sizer, a tromboatherectomy system [18]. Other maneuvers utilized in order to reduce distal embolization are direct stenting and covered stents implantation to isolate the friable atherosclerotic material [19]. The PercuSurge GuardWire system distal protection device combines an elastomeric balloon to occlude distally the conduit with a monorail aspiration catheter to retrieve the debris. The SAFER randomized trial demonstrate a highly significant reduction in major adverse events using this distal protection device compared with stenting over a conventional angioplasty guidewire [20]. Other distal protection devices based on porous filters are under investigation to establish their efficacy in distal embolization prevention [21]. The highest-risk group in the cohort of patients with degenerated saphenous vein graft disease that could be treated by percutaneous intervention are those with occluded vein grafts [22–24]. Large, bulky thrombus that occupies completely the residual vein lumen can be easily dislodged and a large amount of embolic material can be released during the procedure. In these high-risk patients short and longer-term outcome remains poor and the incidence of reocclusion and the need of repeat revascularization is high [23,24]. Potential benefits of totally occluded saphenous vein graft recanalization must be considered on an individual basis and related with the risk of the procedure. It is extremely important to take into account that the attempt can transform a stable condition in a worse situation as a consequence of distal embolization and Q or non-Q wave acute myocardial infarction. In this issue, Rajdeep et al. proposed the association of an occlusive balloon-based distal protection device (PercuSurge GuardWire system, Medtronic AVE, Minneapolis, MN) with a rheolytic thrombectomy device (AngioJet, Possis Medical, Minneapolis, MN) to treat totally occluded saphenous vein grafts. The magnitude of thrombus debris present in totally occluded vein graft made difficult its removal with the monorail aspiration catheter of the PercuSurge GuardWire system. The association of a more efficient system of thrombus retrieval (AngioJet rheolytic thrombectomy system) under the em-

Clinical outcome in nonagenarians undergoing transcatheter valve replacement

Background Nonagenarians are mostly denied from different therapeutic strategies due to high preoperative risk. We present the results of nonagenarians with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Methods Our retrospective analysis include baseline and procedural data along with clinical outcome. Clinical follow-up was performed in all patients after TAVR. Results Out of 689 patients, 33 nonagenarians with a mean age of 90.9 ± 1.4 years suffering from severe AS and elevated comorbidity index (logistic EuroSCORE of 16.3 ± 9.6%, STS score 11.1 ± 9.9%) underwent TAVR between September 2009 and July 2016 using self-expanding prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA) of 0.64 ± 0.12 cm2 with a mean pressure gradient of 56.1 ± 16.1 mmHg. Five (16.2%) patients had postprocedural moderate/severe aortic regurgitation. One patient died intraoperally due to ventricular perforation during predilatation, while two patients died within the first 30 days, one due to cardiogenic shock and the other due to pneumonia. No patient experienced a myocardial infarction or a stroke, while ten (30.3%) required permanent pacemaker placement. At follow-up (mean 20.3 months, range 1–78 months), all cause and cardiovascular mortality was 24.2% and 15.1%, respectively. Two patients presented heart failure and 12 (40%) had exertional dyspnea. By echo, mean valve area was 1.72 ± 0.12 cm2 and mean gradient 11.2 ± 1.4 mmHg. Two patients (16.7%) presented moderate aortic regurgitation. Conclusion Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with TAVR.

Consenso del implante valvular aórtico percutáneo del Colegio Argentino de Cardioangiólogos Intervencionistas 2016

1 Coordinadora: Dra. Carla Agatiello. Comité de Redacción: Dra. Alfonsina Candiello, Dr. Matías Sztejfman, Dr. Carlos Fava, Dr. Diego Grinfeld, Dr. Ignacio Seropian, Dr. Antonio Scuteri, Dr. Aníbal Damonte, Dr. Juan Mieres. Comité de Revisión: Dr. Hugo Londero, Dr. Oscar Mendiz, Dr. Fernando Cura, Dr. Daniel Berrocal, Dr. Miguel Payaslian, Dr. Alfredo Rodríguez, Dr. José Álvarez, Dr. Claudio Cigalini, Dr. Ernesto Torresani, Dr. Arturo Fernández Murga, Dr. José Gómez Moreno, Dr. Marcelo Menéndez, Dr. Alejandro Cherro, Dr. Jorge Baccaro, Dr. Alejandro Álvarez