Higher Periprocedural Risk Research Articles

Role of mechanical circulatory support in VT ablation procedures: data from the German PROTECT VT registry

Abstract Introduction Ventricular tachycardia (VT) ablation in patients with progressed heart failure (HF) is known to be complex and associated with a high periprocedural risk and mortality, in part due due to hemodynamic instability during ongoingVTs. Use of mechanical circulatory support (MCS) systems has been already implemented in complex high-risk percutaneous coronary intervention (CHIP-PCI) workflows. Use and benefit of MCS in VT ablation is still under debate. MCS protected VT ablation (proVT-A) might be associated with improved clinical outcomebut potentially comes along with an increased risk of periprocedural complications. Based on data of four German high-volume centers we aimed to analyze retrospective data on patient characteristics and impact of proVT-A with respect to safety and mid-term efficacy. Methods All patients undergoing proVT-A as a primary approach from four German EP centers were included in the analysis. Use of MCS in bailout scenariosin VT ablation were not included. Patient characteristics, procedural parameters and clinical outcome were evaluated. The primary endpoint was a combined endpoint of VT/VF recurrence and all-cause death. Results 41 patients who underwent proVT-A were included. Mean age was 64±11a, 92% of patients were male (38/41), 65% (27/41) suffered from ischemic cardiomyopathy, mean left ventricular ejection fraction was 33±13%,76% (31/41) of patients presented with a documented hemodynamically not tolerated VT, mean PAAIN-ESD score was 13±7, and 46% (19/41) had a history of a previous VT ablation w/o MCS. During proVT-A procedure at least one VT was inducible and mappable in 35 patients (85%). Acute procedural success was 85%, with only n=6 patients remaining inducible for VT. Mean procedure duration was 245±46min. With respect to periprocedural safety (30days)a total of n=12 relevant procedural complications were reported in 8 patients. This included n=5 vascular access complications, of which n=3 requiring transfusion or surgery. One case of periprocedural death was reported 6h post proVT-A due to PEA. Three patients developed pericardial effusion, one requiring drainage. Freedom from VT/VF was 78% (n=9 VT/VF recurrences) after a mean follow-up (FU) of 15±14 months (figure 1A). Death of any cause occurred in n=9 patients (figure 1B). In summary, after a mean FU of 15±14 months n=16 patients (39%) met the combined endpoint of VT/VF recurrence and all-cause death (figure 1C). Conclusion Patients enrolled in the German PROTECT VT Registry had significant cardiovascular comorbidities and therefore represent a high-risk population for VT ablation. Use of MCS was feasible, comparably safe, associated with high procedural and promising long-term success rate. These results highlight the need for larger registries and future prospective trials evaluating the potential benefit of proVT-A in selected patients. Further, it should be aimed for optimization of periprocedural vascular access site management.

Acute upper and lower gastrointestinal bleeding management in older people taking or not taking anticoagulants: a literature review.

Acute upper and lower gastrointestinal (GI) bleeding may be a potentially life-threatening event that requires prompt recognition and an early effective management, being responsible for a considerable number of hospital admissions. Methods. We perform a clinical review to summarize the recent international guidelines, helping the physician in clinical practice. Older people are a vulnerable subgroup of patients more prone to developing GI bleeding because of several comorbidities and polypharmacy, especially related to an increased use of antiplatelet and anticoagulant drugs. In addition, older patients may have higher peri-procedural risk that should be evaluated. The recent introduction of reversal strategies may help the management of GI bleeding in this subgroup of patients. In this review, we aimed to (1) summarize the epidemiology and risk factors for upper and lower GI bleeding, (2) describe treatment options with a focus on pharmacodynamics and pharmacokinetics of different proton pump inhibitors, and (3) provide an overview of the clinical management with flowcharts for risk stratification and treatment. In conclusion, GI is common in older patients and an early effective management may be helpful in the reduction of several complications.

221 Submaximal Angioplasty Alone Versus Stenting Plus Angioplasty for Symptomatic Intracranial Atherosclerotic Disease a Propensity Score Matched Comparative Study With Long Term Follow-Up

INTRODUCTION: Symptomatic intracranial atherosclerotic disease (ICAD) remains an important cause of recurrent stroke and acute ischemic event. Although the high periprocedural risk of intracranial stenting from recent randomized studies has dampened enthusiasm for such interventions, submaximal angioplasty without stenting may represent a safer endovascular treatment option. METHODS: A prospectively maintained database was retrospectively searched for patients presenting with signs and symptoms of acute ischemic stroke or transient ischemic events. Patients subsequently underwent CT Stroke Study to confirm the diagnosis of symptomatic intracranial atherosclerotic disease. Patient baseline demographic characteristics, procedural details and post-procedure outcomes were recorded. A one-to-one matched propensity score analysis was performed to adjust for treatment selection bias using the nearest-neighbor matching technique without replacement for covariates (baseline comorbidities, previous stroke or TIA, antiplatelet use, anticoagulant use, and baseline percent diameter stenosis). Mann-Whitney U test was performed to compare the procedural parameters and the clinical outcomes between groups. RESULTS: We included 218 patients (Submaximal angioplasty:97 [97 after PSM]; Stenting plus angioplasty:121 [97 after PSM]). After PSM, no difference was seen between the two groups in terms of comorbidities, and initial stroke severity. Submaximal angioplasty group had significantly lower incidence of stroke/TIA secondary to restenosis on follow-up (6.2% vs. 20.6% (OR = 0.87; P = 0.003)), and longer length of follow-up after discharge (4.17 years vs. 2.88 years (OR = 0.98; P = 0.03)) when compared to stenting plus angioplasty group. Both groups had similar rates of intra- (2.1% vs. 6.2% (OR = 0.96; P = 0.15)) and post-procedural complications rates (6.2% vs. 11.3% (OR = 0.95; P = 0.21)). CONCLUSIONS: Submaximal angioplasty alone results in better long-term clinical outcomes in terms of stroke/TIA when compared with stenting and angioplasty for symptomatic intracranial atherosclerotic disease, and represents a potentially promising intervention.

Abstract 18976: In-Hospital Outcomes in Patients Undergoing Protected Left Main Percutaneous Coronary Intervention With Percutaneous Left Ventricle Assist Device Protection

Introduction: Left main disease (LMCA) is a known risk factor for patients’ poor outcomes. Percutaneous revascularization of LMCA in heart failure patients is associated with a particularly high periprocedural risk. Percutaneously introduced left ventricle assist devices (pLVAD) are a potential tool to improve patient outcomes in these high-risk procedures. Hypothesis: Our study aimed to assess short-term clinical outcomes of protected left main percutaneous coronary intervention with the use of a pLVAD. Methods: A prospective registry of patients with chronic heart failure, undergoing protected LMCA PCI included 66 patients, 89% male, the median age of 71.5 y.o, 40 (60.6%) after prior myocardial infarction, 31 (47%) after prior PCI and 12 (18.2%) after CABG, with CTO RCA in 17 (25.6%) of cases. Percutaneous LVAD was used in all patients, 72% access site was the right femoral artery, additional plaque modification techniques were used in 46 (69.7%) patients, IVL was applied in 25 (37.9%) of cases and high-speed rotational or orbital atherectomy was used in 21 (31.2%) of cases. Median of 3 [2;4] DES was implanted. Results: During the in-hospital follow-up, a significant improvement of the left ventricle ejection fraction was observed (median LVEF 30% post PCI vs22% at baseline, p<0.001) as well as a significant decrease of NTproBNP levels (765 [IQR: 194, 6,370] at discharge vs 7113 pg/ml [IQR:1,945, 15,646] at baseline, p=0.01]. There was 1 in-hospital death due to cardiogenic shock. A safety monitoring revealed 11 hematomas, including 3 cases that needed vascular surgery. Bleeding according to BARC 3a was recorded in 17/66 (28%) and BARC 3b in 3/66 (5%) of cases. Conclusions: Percutaneous LVAD support is a feasible method to perform protected left main PCI with a good safety profile when applied by experienced operators A significant improvement of the LVEF can be observed after left main revascularization Further research is needed to confirm the presented results.

Perioperative Impella 5.5 Support for Surgical Aortic Valve Replacement: Pull Back/Push Through Technique, Safeguards, and Pitfalls.

In patients undergoing aortic valve surgery, preoperative reduced left ventricular ejection fraction is not uncommon and is associated with poor outcomes. Mechanical circulatory support (MCS) may be preemptively used in patients presenting with high periprocedural risk. The Impella 5.5 is a percutaneous left ventricular assist device that has been increasingly used in various cardiac surgeries. In this article, we present a step-by-step guide, safeguards, and pitfalls on how to replace the aortic valve and preserve this transaortic MCS device for postoperative support in patients with concomitant aortic valve pathology and left ventricular dysfunction.

Treatment of posterior circulation stroke: Acute management and secondary prevention.

One-fifth of strokes occur in the territory of the posterior circulation, but their management, particularly acute reperfusion therapy and neurointervention procedures for secondary prevention, has received much less attention than similar interventions for the anterior circulation. In this review, we overview the treatment of posterior circulation stroke, including both interventions in the acute setting and secondary prevention. We focus on areas in which the management of posterior circulation stroke differs from that of stroke in general and highlight recent advances.Effectiveness of acute revascularization of posterior circulation strokes remains in large parts unproven. Thrombolysis seems to have similar benefits and lower hemorrhage risks than in the anterior circulation. The recent ATTENTION and BAOCHE trials have demonstrated that thrombectomy benefits strokes with basilar artery occlusion, but its effect on other posterior occlusion sites remains uncertain. Ischemic and hemorrhagic space-occupying cerebellar strokes can benefit from decompressive craniectomy.Secondary prevention of posterior circulation strokes includes aggressive treatment of cerebrovascular risk factors with both drugs and lifestyle interventions and short-term dual anti-platelet therapy. Randomized controlled trial (RCT) data suggest basilar artery stenosis is better treated with medical therapy than stenting, which has a high peri-procedural risk. Limited data from RCTs in stenting for vertebral stenosis suggest that intracranial stenosis is currently best treated with medical therapy alone; the situation for extracranial stenosis is less clear where stenting for symptomatic stenosis is an option, particularly for recurrent symptoms; larger RCTs are required in this area.

246 IMPROVING LUMBAR PUNCTURE TECHNIQUE AMONG INTERN TRAINEES TO ENHANCE QUALITY OF CARE FOR PATIENTS

Abstract Background Lumbar puncture (LP) is a common procedure performed on older adults in acute medical settings. A higher peri-procedural risk has been shown in older patients. Non-consultant doctors (NCHDs) often lack confidence and competence in performing LP. Simulation based training using task trainers has been shown to improve confidence, preplanning skills and technique. Methods A simulation based teaching session was developed in a university teaching hospital (training structure was adapted from the LP training guide published in MedEdPortal). Small group teaching (with 6–8 learners) was delivered to 25 NCHDs with no prior exposure or experience with lumbar puncture completion. Trainees completed one LP simulation without practice to mastery level. On-demand and post-performance feedback was delivered to learners. An assessment checklist was completed by the supervisor. Learners completed an anonymised quantitative and qualitative questionnaire using Qualtrics XM software at a later date to evaluate self-perceived teaching outcomes. Results 16 doctors completed the questionnaire (64% response rate). 55% rated the LP workshop as a ‘strongly positive’ impact on their learning, while 18% indicated a ‘positive’ impact on a 5-point Likert scale. 19% of trainees reported they were ‘very comfortable’ at performing the procedure post training, with 56.5% ‘comfortable’ to perform an LP in their clinical practice. Qualitative learner feedback included ‘more hands on practice’ on the mannequin, ‘smaller groups for the workshops’ and ‘more practice tips’ during the simulation workshop. Conclusion This pilot study demonstrated interest and positive feedback for the LP simulation training from novice doctors with improved self-assessed confidence. Formal development of an LP simulation training curriculum is underway. The impact of this training on patient care should be assessed in practice.

Short-Term Apixaban for Documented Left Atrial Appendage Thrombus in High-Risk Atrial Fibrillation Patients Undergoing Left Atrial Appendage Occlusion.

Stroke prevention with left atrial appendage (LAA) occlusion is an important alternative treatment for high-risk atrial fibrillation (AF) patients with contraindications to oral anticoagulation (OAC).[1] [2] The presence of LAA thrombus detected on preprocedural imaging usually precludes implantation of the endocardial device because of a prohibitively high periprocedural embolic risk.[3] Although successful resolution of LAA thrombus with OAC has been described, all previous reports are in patients without contraindications to OAC.[4] [5] [6] Furthermore, long-term data in these patients are lacking. We hypothesized that short-term OAC with apixaban could safely facilitate resolution of LAA thrombi even in a high-risk population, thereby allowing safe LAA occluder device implantation, with good outcomes over the long term.

Current Anesthetic Care of Patients Undergoing Transcatheter Aortic Valve Replacement in Europe: Results of an Online Survey

Transcatheter aortic valve replacement (TAVR) has become an alternative treatment for patients with symptomatic aortic stenosis not eligible for surgical valve replacement due to a high periprocedural risk or comorbidities. However, there are several areas of debate concerning the pre-, intra- and post-procedural management. The standards and management for these topics may vary widely among different institutions and countries in Europe. Structured web-based, anonymized, voluntary survey. Distribution of the survey via email among members of the European Association of Cardiothoracic Anaesthesiology working in European centers performing TAVR between September and December 2018. Physicians. The survey consisted of 25 questions, including inquiries regarding number of TAVR procedures, technical aspects of TAVR, medical specialities present, preoperative evaluation of TAVR candidates, anesthesia regimen, as well as postoperative management. Seventy members participated in the survey. Reporting members mostly performed 151-to-300 TAVR procedures per year. In 90% of the responses, a cardiologist, cardiac surgeon, cardiothoracic anesthesiologist, and perfusionist always were available. Sixty-six percent of the members had a national curriculum for cardiothoracic anesthesia. Among 60% of responders, the decision for TAVR was made preoperatively by an interdisciplinary heart team with a cardiothoracic anesthesiologist, yet in 5 countries an anesthesiologist was not part of the decision-making. General anesthesia was employed in 40% of the responses, monitored anesthesia care in 44%, local anesthesia in 23%, and in 49% all techniques were offered to the patients. In cases of general anesthesia, endotracheal intubation almost always was performed (91%). It was stated that norepinephrine was the vasopressor of choice (63% of centers). Transesophageal echocardiography guiding, whether performed by an anesthesiologist or cardiologist, was used only ≤30%. Postprocedurally, patients were transferred to an intensive care unit by 51.43% of the respondents with a reported nurse-to-patient ratio of 1:2 or 1:3, to a post-anesthesia care unit by 27.14%, to a postoperative recovery room by 11.43%, and to a peripheral ward by 10%. The results indicated that requirements and quality indicators (eg, periprocedural anesthetic management, involvement of the anesthesiologist in the heart team, etc) for TAVR procedures as published within the European guideline are largely, yet still not fully implemented in daily routine. In addition, anesthetic TAVR management also is performed heterogeneously throughout Europe.

Submaximal Angioplasty for Symptomatic Intracranial Atherosclerotic Disease: A Meta-Analysis of Peri-Procedural and Long-Term Risk.

Symptomatic intracranial atherosclerotic disease (ICAD) is an important cause of stroke. Although the high periprocedural risk of intracranial stenting from recent randomized studies has dampened enthusiasm for such interventions, submaximal angioplasty without stenting may represent a safer endovascular treatment option. To examine the periprocedural and long-term risks associated with submaximal angioplasty for ICAD based on the available literature. All English language studies of intracranial angioplasty for ICAD were screened. Inclusion criteria were as follows:≥5 patients, intervention with submaximal angioplasty alone, and identifiable periprocedural (30-d) outcomes. Analysis was co-nducted to identify the following: 1) periprocedural risk of any stroke (ischemic or hemorrh-agic) or death, and 2) stroke in the territory of the target vessel and fatal stroke beyond 30 d. Mixed effects logistic regression was used to summarize event rates. Funnel plot and rank correlation tests were employed to detect publication bias. The relative risk of periprocedural events from anterior vs posterior circulation disease intervention was also examined. A total of 9 studies with 408 interventions in 395 patients met inclusion criteria. Six of these studies included 113 posterior circulation interventions. The estimated pooled rate for 30-d stroke or death following submaximal angioplasty was 4.9% (95% CI: 3.2%-7.5%), whereas the estimated pooled rate beyond 30 d was 3.7% (95% CI: 2.2%-6.0%). There was no statistical difference in estimated pooled rate for 30-d stroke or death between patients with anterior (4.8%, 95% CI: 2.8%-7.9%) vs posterior (5.3%, 95% CI: 2.4%-11.3%) circulation disease (P>.99). Submaximal angioplasty represents a potentially promising intervention for symptomatic ICAD.

Current Practice of State-of-the-Art Coronary Revascularization in Patients with Heart Failure.

The best treatment for patients with ischemic heart failure (HF) is still on debate. There is growing evidence that coronary artery bypass graft (CABG) benefits these patients. The current recommendations for revascularization in this context are that CABG is reasonable when it comes to decreasing morbidity and mortality rates for patients with severe left ventricular dysfunction (ejection fraction <35%), and significant coronary artery disease (CAD) and should be considered in patients with operable coronary anatomy, regardless whether or not there is a viable myocardium (class IIb). Percutaneous coronary intervention (PCI) does not have enough data to allow the panels to reach a conclusion. The Korean Acute Heart Failure registry (KorAHF) had its data released recently, showing that patients with acute HF who underwent CABG had lower death rates, more complete revascularization and less adverse outcomes compared with patients treated with PCI. Recent ESC/EACTS guidelines on myocardial revascularization clearly recommended CABG as the first choice of revascularization strategy in patients with multivessel disease and acceptable surgical risk to improve prognosis in this scenario of left ventricular dysfunction. However, a high peri-procedural risk must be compared with the benefit of late mortality, and pros and cons of each strategy (either PCI or CABG) must be weighed in the decision-making process. Spurred on by the publication of the above-mentioned article and the release of new guidelines, we went on to write an overview of the current practice of state-of-the-art coronary revascularization options in patients with HF.

Relation of Platelet Indexes to Platelet Reactivity and Periprocedural Myocardial Infarction in Patients Who Underwent Percutaneous Coronary Angioplasty

No comprehensive data are available on the role of platelet indexes (PI) in the periprocedural risk stratification of patients who underwent percutaneous coronary intervention (PCI). The aim of this study was to investigate the relation of PI to platelet reactivity (PR) and periprocedural myocardial infarction (PMI) in patients receiving PCI. A total of 502 PCI patients had preprocedural measurement of PI and PR, the latter assessed by VerifyNow P2Y12 assay. Study end points were incidence of PMI and high platelet reactivity (HPR) according to tertiles of PI and evaluation of PI in HPR patients. Incidence of PMI in the overall population was 6.6%. Rates of PMI were not different in PI tertiles: platelet count (I: 6.0%, II: 7.1%, III: 6.5%; p = 0.74), mean platelet volume (MPV, I: 6.6%, II: 7.3%, III: 5.8%;p = 0.86), platelet distribution width (I: 7.2%, II: 7.2%, III: 5.8%;p = 0.74), and MPV/P ratio (I: 6.6%, II: 6.0%, III: 7.1%; p = 0.91). The occurrence of PMI was significantly different in PR tertiles (I: 3%, II: 5.4%, III: 11.4%; p = 0.006). Platelet count and MPV/P ratio were significantly different in patients with and without HPR (221.8 ± 58.6 × 103/µL vs207 ± 59.4 × 103/µL, p = 0.008; 51.73 ± 15.17 vs 56.7 ± 18.3, p = 0.002).In conclusion, this study showed no relation between PI and PMI in PCI patients but confirms the association of HPR with increased incidence of PMI; thus, PI seem to be not able to identify patients at higher periprocedural risk, but monitoring PR by a bedside assay remains a useful tool for risk stratification.

Nutritional pathway for people with motor neurone disease.

This paper provides an overview of the nutritional management and care of people living with motor neurone disease (MND) in a specialist nutrition clinic. A specialist pathway of care has been developed to enable people living with MND to undergo a percutaneous endoscopic gastrostomy (PEG) procedure in a safe way; the pathway incorporates attendance at a dedicated nutrition clinic, a stratification tool to identify patients with a high periprocedural risk and a PEG insertion team with significant experience in the MND population. Since this pathway has been in place, gastrostomies have been successfully placed in patients with a forced vital capacity (FVC) of less than 50%; previously, this would not have been possible.

Very late cardiac tamponade following successful transcatheter closure of an atrial septal defect with the Amplatzer septal occluder

To avoid late complications, ASDs should be closed even when detected in adults, an endeavor that may be performed surgically or via the transcatheter approach, as is done for secundum-type ASDs that possess suitable anatomy and no associated lesions. Surgical ASD closure carries a higher periprocedural risk compared with transcatheter closure, but has an excellent long-term prognosis. We report the occurrence of a rare but life-threatening long-term complication following transcatheter ASD closure, cardiac perforation with cardiac tamponade, and its successful surgical treatment. Secundum-type ASD was diagnosed in a 30-year-old woman by cardiac catheterization in 1982. Paroxysmal atrial fibrillation (AF) developed at an age of 56. Both transthoracic (TTE) and transesophageal echocardiography (TEE, see Online Resource ESM Fig. 1) demonstrated biatrial enlargement, the volume-overloaded right ventricle appeared dilated and had a reduced function. All pulmonary veins were connected to the LA. Coronary angiography was normal. Cardiac catheterization demonstrated mildly elevated pulmonary artery pressures. Oxymetric analysis confirmed the presence of a predominant left-to-right (67 %) shunt and a small right-to-left shunt (7 %). The balloon-stretched ASD diameter measured 25 mm by angiography, and 26 mm by intracardiac echocardiography (ICE). The ASD was closed with a 28 mm Amplatzer Septal Occluder (ASO, St. Jude Medical, Inc., St. Paul, MN) in 2008. Antiplatelet therapy was prescribed for 6 months, and then TEE documented correct positioning of the ASO with no residual shunts. The sizes of the atria decreased, and the RV function improved. Symptomatic paroxysmal atrial fibrillation necessitated treatment with flecainide and bisoprolol. The patient remained on aspirin. Acute chest pain and shortness of breath required urgent hospitalization three years after transcatheter ASD occlusion. On admission, the patient was in cardiogenic shock due to a large pericardial effusion with tamponade physiology (Fig. 1a). The removal of 350 ml of nonclotting blood (hematocrit = 42 %, identical to peripheral blood) via pericardiocentesis resulted in immediate hemodynamic improvement. The patient was transferred to a tertiary-care hospital. Correct positioning of the ASO, as well as a residual pericardial effusion was shown by TEE. An ECGtriggered cardiac CT scan indicated that the ASO impinged the left atrial dorsal wall (Fig. 1b), causing its erosion. The intact ASO (see Online Resource ESM Fig. 2) was removed, the ASD was closed with a patch, and the left atrial roof was surgically reconstructed 10 days later (Fig. 2). Additionally, a bipolar maze procedure was performed, and the left atrial appendage was ligated. Symptomatic bradycardia required the implantation of a DDDR pacemaker postoperatively. Follow-up exams confirmed excellent long-term operative results. Electronic supplementary material The online version of this article (doi:10.1007/s00392-015-0829-0) contains supplementary material, which is available to authorized users.

Characterization of myocardium and myocardial motion in patients considered for transaortic valve implantation (TAVI)

Background Aortic valve stenosis (AS) is a common disease. In older patients open chest valve replacement is limited due a high periprocedural risk. Therefore transaortic valve implantation (TAVI) has become a potential alternative treatment. AS causes alterations of cardiac rotation and torsion and triggers diastolic dysfunction. A poorer prognosis was observed in the presence of myocardial fibrosis (MF). Cardiac magnetic resonance imaging (CMR) can depict myocardial fibrosis by using the late gadolinium enhancement (LGE) technique. Recently T1-mapping showed promising results for the characterization of myocardial tissue. Aim of this study was to characterize the myocardium functionally and morphologically. Methods A total amount of 30 patients (16 females, age 80.6 ± 5.8 years) with severe AS were considered for TAVI. CMR was performed using a clinical 1.5T MR system (Philips Achieva). Cine imaging was performed using short and long axis orientation. Tagging of three short axis planes (apical, medial, basal) was acquired using the CSPAMM. T1 mapping of the medial short axis slice was performed prior and 10 minutes after contrast application. Quantification of global MF was assessed by using the short-axis LGE images with a threshold of ± 2 SD above a normal region defining MF. LGE images were acquired 10-15 minutes after bolus injection of 0.2 mmol/kg gadoterate meglumine.

Abstract 2187: Are Procedural Characteristics Associated with Early Outcomes in Either Women or Men Revascularized in the Merci Registry?

Introduction: Data suggest a higher periprocedural risk for endovascular treatment than surgery for carotid artery stenosis in women but not in men. The objective of this analysis was to determine if a similar risk profile applies to acute ischemic stroke (AIS). Hypothesis: Sex differences in procedural characteristics could be associated with early outcomes after successful endovascular treatment for AIS. Methods: The study investigated whether procedural characteristics in recanalized patients (TICA 2a, 2b or 3) in the Merci Registry, a prospective database of AIS patients treated with the Merci Retriever, were associated with favorable discharge outcome (mRS 0-2) in either women or in men. Procedural characteristics included the length of the procedure; use of intra-arterial lytics and other devices; intubation; or systolic blood pressure. Clinical variables included age, baseline National Institutes of Health Stroke Scale (NIHSS), time from symptom onset and emergency department (ED) arrival to arterial puncture, intravenous tPA use, co-morbidities and risk factors. The procedural and clinical variables were assessed with univariate and then multivariate analysis for associations with the early outcomes separately in women and in men. Results: Of 872 Merci Registry patients with complete follow-up data, similar numbers of women (327/418 (78%)) and men (369/454 (81%)) had successful revascularization. Revascularized women compared to revascularized men were older, had more hypertension and atrial fibrillation and revascularized men had more history of coronary artery disease than women. Clot location was more often vertebrobasilar in men. While the procedure duration and number of attempts to remove the clot was equivalent in the two groups, angioplasty and stenting proximal to the occlusion occurred more often in men. The number of women and men that had a discharge mRS 0-2 was similar (20.3% and 21.5% respectively). In multivariate analysis, baseline NIHSS (p&lt;0.0001) was negatively associated with discharge outcome in both women and in men. Additionally, while procedure length (p=0.0050) and diabetes (p=0.0228) were negatively associated with outcome in men, in women intubation (p&lt;0.0001), age (p=0.0016) and congestive heart failure (p=0.0124) were negatively associated with discharge outcome. Conclusions: Procedure length and diabetes in successfully revascularized patients in the Merci Registry were negatively associated with discharge outcome in men but not in women in multivariate analysis, while intubation was the only procedural characteristic associated (negatively) with early outcome in women and baseline NIHSS was negatively associated in both groups.

Recent concepts in the management of extracranial carotid stenosis: Carotid endarterectomy versus carotid artery stenting

Carotid stenosis is seen in 10% of patients with ischemic stroke, and carotid endarterectomy (CEA) and carotid artery stenting (CAS) are the two invasive treatments options available. Pooled analysis of the three largest randomized trials of CEA involving more than 3000 symptomatic patients estimated 30-day stroke and death rate at 7.1% after CEA. Some subgroups among the symptomatic patients appeared to have more benefit from CEA. These include patients aged 75 years or more, patients with ulcerated plaques, and patients with recent transient ischemic attacks within 2 weeks of randomization. Selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors, and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences. The recent trials comparing CEA with CAS has not established its superiority over CEA. The carotid revascularization endarterectomy versus stenting (CREST) study showed that CAS is still associated with a higher periprocedural risk of stroke or death than CEA. In patients over 70 years of age, CEA is clearly superior to CAS. The increased risk of nonfatal myocardial infarction in the CREST group subjected to CEA clearly suggests that patients being considered for CEA or CAS require a careful preliminary cardiac evaluation. CAS can be justified for patients whose medical comorbidities or cervical anatomy make them questionable candidates for CEA. The benefit of revascularization by either method versus modern aggressive medical therapy has not been established for patients with asymptomatic carotid stenosis.

Off-Label Use and the Spectre of Drug-Eluting Stent Thrombosis

Off-label use of drug-eluting stents (DES) occurs when the implantation takes place outside the scope of the approved label. In the case of DES, the “on-label” indications are limited to short de novo lesions in coronary arteries measuring 2.5 to 3.75 mm in diameter. As anticipated, the use of paclitaxel-eluting stents (PES) has shown excellent outcomes with low rates of target lesion revascularization at long-term follow-up in on-label indications.1 Article see p 285 However, generalization of these data to the general population is problematic, because most patients fall into the “off-label” indication, which is associated with higher periprocedural risk. Since its launch in March 2004, thanks to its demonstrated ability to decrease target lesion revascularization, indications for PES were rapidly extended to those who would benefit most from it, such as patients with diabetes, renal failure, very small vessels, very long lesions, chronic total occlusions, bifurcations, left main coronary artery disease, in-stent restenosis, multivessel disease, acute myocardial infarction, or saphenous vein graft disease. In general, the more complex the case is, the more likely the occurrence of adverse events. Accordingly, the US Food and Drug Administration (FDA) required manufacturers to follow-up patients in the original clinical trials for 5 years after implantation and conduct registry studies of consecutively enrolled new patients, to collect data on “real-world” use.2 The emergence of the adverse events logically materialized with an increased incidence of very late stent thrombosis (ST). Concerns arose about the impact of this rare complication on cardiac mortality, and the concerns of the scientific community reached their peak at the end of 2006. The article by Lasala et al3 in this issue of Circulation: Cardiovascular Interventions was born out of this surveillance program. The first Peri-Approval Registry: A Multi-Center Safety Surveillance (ARRIVE) trial was an FDA-mandated postmarketing trial …

Endovascular Treatment of Cerebral Aneurysms Using the Leo Stent: Long-Term Follow-Up and Expansion of Indications

The authors share their extended experience using the Leo stent. Building on their earlier work, they present more cases, a longer follow-up period, and expansion of indications for use of the stent. A total of 71 patients with 75 aneurysms were included in this study. 61 saccular and broadnecked intracranial aneurysms and twelve fusiform lesions were treated electively. Stent deployment was successful for 98% of the saccular aneurysms. Initial complete obliteration was achieved in 26 saccular aneurysms, a neck remnant in six, a residual aneurysm in four, while no immediate coil embolization was chosen for 25. Angiographic follow-up after 11 months available for 56 saccular aneurysms revealed unaffected parent arteries in 94%. Eleven saccular aneurysms exhibited spontaneous thrombosing after stent deployment without coiling and four lesions had recanalized (three residual aneurysms, one neck remnant). Regarding long-term follow-up ≥ 12 months, available for 26 saccular aneurysms, none of them showed parent artery affection. A recanalization was evident in three saccular aneurysms. All stents were successfully deployed for the fusiform aneurysms. Three patients with large fusiform aneurysms of the basilar artery had a lethal outcome. No clinical complications occurred in the remaining cases. The authors confirmed the efficacy of the Leo stent for the treatment of saccular and broad-necked intracranial aneurysms. Mid- and long-term follow-up demonstrated intact parent vessels and stable occlusion rates in the majority of patients. This device is a treatment option for fusiform lesions, but may confer a higher periprocedural risk.

Revascularization in Heart Failure: The Role of Percutaneous Coronary Intervention

Despite being technically challenging and carrying a higher periprocedural risk, the performance of revascularization in patients who have heart failure of ischemic origin can provide substantial clinical benefits. Although several studies have demonstrated a benefit of the performance of coronary artery bypass grafting over percutaneous coronary intervention (PCI) among patients who have depressed ejection fraction undergoing revascularization, most of these studies were conducted during the balloon angioplasty era and before the widespread use of drug-eluting stents that have dramatically reduced the need for repeat revascularization among patients undergoing PCI. The use of lower profile intra-aortic balloon catheters and other novel cardiac support devices may extend the use of PCI and lower rates of periprocedural complications among this high-risk population.