Pasado, presente y futuro de la angioplastia y stent carotídeo

Con más de 45.000 pacientes tratados, 33 registros, 8 estudios aleatorizados y 15 anos ̃ de historia de la angioplastia y stent carotídeo (ASC) existen todavía algunas cuestiones por resolver. La endarterectomía carotídea (ECA) es un tratamiento preventivo con eficacia indudable y establecida en pacientes con enfermedad aterosclerótica de la arteria carótida interna extracraneal. Pero no todo paciente es un perfecto candidato. Si bien en los datos más recientes, la ECA parece el «claro vencedor», la ASC es, sin duda, una herramienta más en nuestro arsenal.With more than 45,000 patients treated worldwide and 33 prospective registries, 8 multicenter randomized trials, and a 15-year history of carotid artery stenting (CAS), there are still many unresolved issues. Carotid endarterectomy (CEA) is a preventive treatment with established preventive efficacy in patients with atherosclerotic disease ofthe extracranial inter- nal carotid artery. But not all patients are perfect candidates. When analyzing the most recent data, CEA seems to be the «clear winner», but CAS is undoubtedly a very welcome addition to our armamentarium

A diffusion-weighted magnetic resonance imaging-based study of transcervical carotid stenting with flow reversal versus transfemoral filter protection

Background: Transfemoral carotid artery stenting (CAS) has been associated with a high incidence of embolic phenomena and silent brain infarction. The goal of this study was to compare the incidence of new ischemic cerebral lesions on diffusion-perfusion magnetic resonance imaging (MRI) sequences after transcervical CAS performed with carotid flow reversal vs stenting via transfemoral approach with distal filter protection. Methods: During a 26-month period, 64 consecutive patients diagnosed with significant carotid stenosis by ultrasound imaging were assigned to transcervical CAS with carotid flow reversal or a transfemoral approach with a distal filter. The Rankin stroke scale was administered by an independent neurologist, and diffusion-weighted MRI (DW-MRI) studies were performed <24 hours before and <24 to 48 hours after the procedure. DW-MRI studies were compared by two neuroradiologists not involved in the study and blinded for time, clinical status, and treatment option. Hyperintense DW-MRI signals found after the procedure were interpreted as postoperative ischemic infarcts. All patients were assessed at 1, 6, and 12 months after the intervention. Results: The distribution of demographic and pathologic variables was similar in both groups. All procedures were technically successful, with a mean carotid flow reversal time of 22 minutes. Twenty-one (70%) and 23 patients (69.69%) were symptomatic in the transcervical and transfemoral groups, respectively (P .869). After intervention, new postprocedural DW-MRI ischemic infarcts were found in four transcervical (12.9%) and in 11 transfemoral (33.3%) patients (P .03), without new neurologic symptoms. No major adverse events occurred at 30 days after the intervention. All patients remained neurologically intact, without an increase in stroke scale scoring. All stents remained patent, and all patients remained stroke-free during follow-up. In multivariate analysis, age (relative risk [RR], 1.022; P < .001), symptomatic status (RR, 4.109; P < .001), and open-cell vs closed-cell stent design (RR, 2.01; P < .001) were associated with a higher risk of embolization in the transfemoral group but not in the transcervical group. Conclusions: These data suggest that transcervical carotid stenting with carotid flow reversal carries a significantly lower incidence of new ischemic brain infarcts than that resulting from transfemoral CAS with a distal filter. The transcervical approach with carotid flow reversal may improve the safety of CAS and has the potential to improve results in especially vulnerable patients such as the elderly and symptomatic. (J Vasc Surg 2012;56:1585-90.

Analysis of the ROADSTER pivotal and extended-access cohorts shows excellent 1-year durability of transcarotid stenting with dynamic flow reversal

Objective: We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes. Methods: This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial. Results: Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymp- tomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin. Conclusions: TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach’s circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA. (J Vasc Surg 2019;69:1786-96.

Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal

Objective: This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Trans- carotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS). Methods: A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with $50$70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee. Results: Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit. Conclusions: The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS. (J Vasc Surg 2015;62:1227-35.

A Prospective Evaluation of Cerebral Infarction following Transcervical Carotid Stenting with Carotid Flow Reversal

Objective: Cerebral embolisation constitutes the main source of complications during transfemoral carotid artery stenting (CAS) and is associated with a high incidence of silent brain infarction. The goal of this study is to evaluate the incidence of new ischaemic cerebral lesions following transcervical CAS with carotid flow reversal for neuroprotection. Materials and Methods: Thirty-one consecutive patients underwent transcervical CAS with carotid flow reversal. A stroke scale and diffusion-weighted magnetic resonance imaging (DW-MRI) were performed within 24 h before and after the procedure. DW-MRI studies were compared blindly by two independent neuroradiologists. New hyper-intense DW signals were interpreted as ischaemic infarcts. The progress of all patients was followed for at least 30 days following intervention. Results: All procedures were technically successful. Nineteen (61%) patients were symptom- atic Mean carotid flow reversal time was 22 min. There were no major adverse events at 30 days. All patients remained neurologically intact without increase in the stroke scale. Thirty subjects had paired DW-MRI studies. Post-procedural DW-MRI ischaemic infarcts were found in four (12.5%) patients, all ipsilateral to the treated hemisphere and asymptomatic. During follow-up, all stents remained patent and all patients remained stroke-free

European Society for Vascular Surgery (ESVS) Certification of Theoretical and Practical Competences in Basic Vascular Ultrasound: Validity Investigation of the Assessment Tools

Objective: The aim of this study was to gather validity evidence for the Assessment of basic Vascular Ultrasound Expertise (AVAUSE) tool, and to establish a pass/fail score for each component, to support decisions for certification. Methods: A cross sectional validation study performed during the European Society for Vascular Surgery’s annual meeting.Validity evidence was sought for the theoretical test and two practical tests based on Messick’s framework. The participants were vascular surgeons, vascular surgical trainees, sonographers, and nurses with varying experience levels. Five vascular ultrasound experts developed the theoretical and two practical test components of the AVAUSE tool for each test component. Two stations were set up for carotid examinations and two for superficial venous incompetence (SVI) examinations. Eight raters were assigned in pairs to each station. Three methods were used to set pass/fail scores: contrasting groups’ method; rater consensus; and extended Angoff. Results: Nineteen participants were enrolled. Acceptable internal consistency reliability (Cronbach’s alpha) for the AVAUSE theoretical (0.93), carotid (0.84), and SVI (0.65) practical test were shown. In the carotid examination, inter-rater reliability (IRR) for the two rater pairs was good: 0.68 and 0.78, respectively. The carotid scores correlated significantly with years of experience (Pearson’s r 1⁄4 0.56, p 1⁄4 .013) but not with number of examinations in the last five years. For SVI, IRR was excellent at 0.81 and 0.87. SVI performance scores did not correlate with years of experience and number of examinations. The pass/fail score set by the contrasting groups’ method was 29 points out of 50. The rater set pass/fail scores were 3.0 points for both carotid and SVI examinations and were used to determine successful participants. Ten of 19 participants passed the tests and were certified. Conclusion: Validity evidence was sought and established for the AVAUSE comprehensive tool, including pass/fail standards. AVAUSE can be used to assess competences in basic vascular ultrasound, allowing operators to progress towards independent practice

Renal Embolization and Nephrectomy in a Single Surgical Act in High-Risk Renal Tumor Pathology

Background: Renal artery embolization is a procedure that has been shown to be useful as a concomitant treatment for the resection of large renal tumors. Over the years, preoperative renal artery embolization concomitant with nephrectomy as a treatment option has proved to be useful in reducing morbi-mortality rates; however this procedure is not exempt from signifi- cant iatrogenia. Performing this technique in conjunction with nephrectomy in a single surgical act helps to maintain the advantages of this treatment, which in turn considerably reduces the associated morbi-mortality rates. Methods: This study presents seven patients selected by the Urology Service in a nonconsecutive manner who underwent renal artery embolization concomitant with nephrectomy in a single surgical procedure for large renal tumors, thus presenting a variation to the usual techniques to improve and simplify the procedure. Results: General data were obtained from all patients including age, gender, characteristics of the tumor, and symptomatology at the time of diagnosis. For all the cases, use of resources was analyzed in terms of duration of surgery, the amount of iodinated contrast medium used during the embolization procedure, and the mean duration of hospital and intensive care unit stay. Complications were evaluated with respect to general morbi-mortality associated with the complete procedure, hematic losses during the procedure, transfusion requirements, and renal function (calculated by measuring preoperative and 48-hour postoperative serum creatinine levels). All patients reported having symptoms at the time of diagnosis, all of them had tumors measuring >13 cm in diameter (major). In all the cases, 100% technical success was obtained with the embolization and nephrectomy. The mean duration of surgery in the case of emboliza- tion with coils was 45 minutes, and 25 minutes in the case of embolization with Amplatzer. A mean volume of 115 mL of contrast medium was used in the case of embolization with coils, whereas for the other cases, a mean volume of 71 mL of iodinated contrast was used. Among all the patients, only two of them required to be cared at the intensive care unit during 24 hours. On an average, reported blood loss was 380 mL. During the procedure, two patients (28.6%) required a transfusion of two units of red cells. No cases of perioperative or postoperative mortality were reported. With respect to morbidity, only one patient (14.3%) experienced a complication in the form of a superficial infection of the surgical wound, which was later resolved by antibiotic therapy. One patient (14.3%) presented a slightly higher preintervention level of creatinine (1.42). Two patients (28.6%), both of whom underwent embolization by using coils, experienced deterioration of postoperative renal function.Conclusion: Preoperative embolization of the renal artery as a coadjuvant treatment option in high-risk renal neoplasia has clear technical benefits for the subsequent nephrectomy and also medical benefits for the patients. Performing both the procedures concomitantly as a single surgical act seems to retain the advantages of the embolization procedure, by reducing mortality rates and producing little associated morbidity. Technically, embolization with Amplatzer plugs seems to be faster and easier as compared with embolization with coils