Use Of Adjunctive Devices Research Articles

Abstract Number ‐ 43: Flow Diversion for Intracranial Aneurysms in Large Caliber Vessels: A Case Series

Introduction The safe and effective profile of flow diverters (FD) has allowed neuro‐interventionalists to consider them as a versatile tool for the treatment of aneurysms with different morphologies, locations, and characteristics. Optimal deployment with complete wall apposition affects FD performance. However, few devices are suitable for aneurysms in large caliber vessels. Herein, we aimed to describe the safety and efficacy of a large caliber (5 mm) FD for the treatment of intracranial aneurysms. Methods We performed a retrospective, multi‐center cohort study of adult patients in whom a 5 mm Surpass Streamline FD was implanted between 2018 and 2021 in the United States. Efficacy outcome was complete occlusion at final follow‐up. Safety outcomes were ischemic/hemorrhagic events and mortality up to 30 days following the procedure. Secondary safety was assessed by the rate of adjunctive devices/treatments to overcome technical complications and improve wall apposition. Results A total of 29 patients harboring 29 aneurysms were treated with 39 FDs (36 large‐diameter devices). Mean age was 57.8 ± 15.7 years. Aneurysm morphologies were saccular (n = 15), pseudoaneurysm (n = 7), fusiform (n = 6), and dissecting (n = 1). Locations were internal carotid artery (ICA) petro‐cavernous segment (n = 15), ICA paraophthalmic (n = 5), ICA cervical (n = 4), basilar artery (n = 3), and vertebral artery (n = 2). Aneurysm size mean was 11.4 ± 6.7 mm, and neck size mean 6.5 ± 3.9 mm. Proximal FD landing zone vessel diameter was 4.8 ± 1.3 mm and distal 4.5 ± 1.2 mm. At a mean final follow‐up of 12 ± 6 months, 18 (65%) aneurysms were completely occluded. Ischemic/hemorrhagic events occurred in 2 (7%), and 1 patient died during hospitalization. Balloon‐assisted angioplasty was performed in 19 (66%) cases, adjunctive stenting in 8 (28%), and coiling in 1 (3%). Patients who received an adjunctive device/treatment had an 82% (14/17) complete occlusion compared to 66% (4/6) in those who did not. Conclusions The use of large caliber FDs to treat complex intracranial aneurysms located in large‐diameter dysplastic vessels is technically feasible and safe. The use of adjunctive devices and techniques to achieve optimal wall apposition seems crucial to optimize treatment outcomes. Comparative studies with devices specially designed for this patient population might provide further insights into the best device selection.

Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes.

The long-term safety and efficacy of intrasaccular flow disruption (IFD) for the treatment of brain aneurysms remain unclear. With accumulating experience and increasing use of IFD devices, recent studies have provided additional data regarding their outcomes. This review summarizes the long-term outcomes of IFD-treated brain aneurysms. A systematic literature review was performed on May 23, 2021, in PubMed, Web of Science, and Ovid MEDLINE for aneurysm treatment outcomes with IFD devices. Procedural details, including use of adjunctive devices and complications, were collected. The quality of studies was assessed using the Downs and Black checklist. Angiographic outcomes were classified as complete occlusion, residual neck, and residual aneurysm. Other outcomes included need for retreatment, permanent neurological deficit, and mortality. Pooled analyses were performed. The final analysis comprised 1217 patients with 1249 aneurysms from 22 studies. The mean aneurysm diameter and neck width were 6.9 and 4.5 mm, respectively, and 27.6% of aneurysms were ruptured. The complete occlusion rates at 12 months and final follow-up (pooled mean duration 15.7 months) were 50.1% and 58.2%, respectively. Adjunctive devices were used in 6.4% of cases. The rates of hemorrhage, symptomatic infarction, permanent neurological deficit, and mortality were 1.2%, 2.8%, 1.0%, and 2.6%, respectively. IFD is a very safe treatment for appropriately selected brain aneurysms with low complication and neurological deterioration rates. However, complete occlusion is achieved in only half of IFD-treated aneurysms at 1 year with a modest increase beyond this time point. As the majority of the studies were single arm, the pooled data are subject to selection and reporting biases. Future device developments, increased operator experience, and direct comparisons with alternative endovascular strategies and surgical clipping may clarify the role of IFD in aneurysm management.

WEB vs coiling in ruptured aneurysms: A propensity score matched comparison of safety and efficacy.

We aim to compare the safety and efficacy of WEB with coiling for acutely ruptured aneurysms.METHODS: All consecutive ruptured aneurysms with width suitable for WEB (2-10 mm) treated over 5 years (1/1/2015 to 31/12/2019) were included. We recorded WFNS, Fisher grade, patient demographics and aneurysm characteristics (size, location, D/W and aspect ratio, lobulation). Primary endpoints were mRS status at 3 months, aneurysm occlusion on latest available imaging follow-up, retreatment rate and procedural complications. We applied propensity score matching using aneurysm morphology (size, D/N ratio, ASPECT ratio and lobulation) to optimise matching for WEB versus coil comparison and minimise the effects of confounding. A total of 493 patients were identified, 97 treated with the WEB device. 1:1 propensity score matching was used to establish a matched group of 97 patients treated with coiling. The WEB arm showed 3% procedural complication rate, with no haemorrhagic complications and use of adjunctive device in 4%. Satisfactory occlusion on follow-up (mean 14 months) was 79%, with 19% retreatment rate. The coil arm had 8% complication rate, with use of an adjunctive device in 52% of cases (balloon 44%, stent 8%). Satisfactory occlusion on follow-up (mean 22 months) was 90%, with 8% retreatment rate. Treatment of ruptured wide-necked bifurcation aneurysms with WEB has a lower complication rate than coiling with high rate of satisfactory occlusion. However, there was a higher retreatment rate when compared with patients treated with coiling. An adjunct device (balloon or stent), was used in over 50% of aneurysms in the coiling group.

Novel Endoscopic Technique for Inserting a Sheath into a Slit Ventricle: The Water-Slide Technique

The efficacy and safety of endoscopic procedures for slit ventricle syndrome (SVS) have been presented in recent studies. However, inserting a sheath into a target ventricle is essential in the beginning of endoscopic procedures for SVS, and this maneuver is challenging owing to the quite narrow ventricular space. We report a novel flexible endoscopic technique, the water-slide technique, that can effectively guide a sheath into a slit ventricle without the use of other adjunctive devices, such as a neuronavigation system and an ultrasound machine. Ten endoscopic procedures using the water-slide technique were performed in 9 patients with SVS. All patients had undergone ventriculoperitoneal shunt placement. Using the technique, the sheath was first placed on the flexible endoscope. The endoscope was then inserted into the lateral ventricle along the tract around the pre-existing ventricular catheter with irrigation of artificial cerebrospinal fluid via the working channel of the endoscope. After the endoscope reached the ventricle, the sheath was inserted into the ventricle along the endoscope. The endoscope was then used as a stylet. The endoscopic procedure was performed afterward. Continuous irrigation of artificial cerebrospinal fluid via the working channel is important when using this technique. In all cases, the sheath was successfully introduced to the slit ventricle without the use of adjunctive devices. There were no postoperative complications correlated with the maneuver. This novel endoscopic technique is effective and safe for inserting a sheath into a target ventricle in the management of SVS.

Carotid Stenting as Definitive Treatment for Free Floating Thrombus\u2014Review of 7 Cases

Background and PurposeFree floating thrombus (FFT) is a rare condition. The optimal treatment strategy is yet to be determined although medical management with anticoagulation is the mainstay. This article reports experience of treating FFT with carotid stenting.MethodsA retrospective analysis of a prospectively maintained database was performed to identify all patients with FFT treated with carotid stenting. For each patient the demographic data, clinical presentation, location of the thrombus, type of stent and use of adjunctive devices, e.g. balloon guide catheters, clinical and radiological follow-up information as well as complications were recorded.ResultsA total of 7 patients, 4 female, with mean age of 55.6 ± 14.5 years were identified. The median National Institutes of Health Stroke Scale (NIHSS) was 7 (range 0–13) at presentation. Free floating thrombus was seen on the left in the majority of cases (n = 6, 85.7%). None of the patients had intracranial large vessel occlusion. The FFT was located in the CCA in 2 cases (28.6%) and the proximal ICA in the remaining 5 cases (71.4%). The Wallstent was used in 5 patients and a cGuard stent used in 2 patients. In 1 patient 2 overlapping stents were used but a single stent was used in the remaining patients. In 6 cases a distal filter wire was used and in 2 cases a balloon guide catheter was used as embolic protection. There were no intraoperative complications and no cases of distal clot migration or intracranial large vessel occlusion during the procedure. At last follow-up (n = 7) 6 patients were recorded as modified Rankin Scale (mRS) ≤2 and 1 patient was mRS 3.ConclusionFree floating thrombus of the carotid arteries can be managed with stenting.

Dual microcatheter technique for the treatment of a ruptured wide neck basilar tip aneurysm

Endovascular treatment is a safe and efficient therapy for intracranial aneurysms with lower complication and mortality rates compared to surgical clipping. Wide-neck aneurysms still represent a challenge to complete and safe aneurysm occlusion in spite of techniques such as stent-assisted or balloon-assisted coiling, developed in order to achieve better occlusion rates. These techniques themselves may lead to further complications, so alternative methods such as the dual microcatheter technique were developed. This technique assumes that, via two microcatheters inserted into an aneurysm, simultaneous deployment of two coils achieves a stable coil frame without the use of adjunctive devices. The aim of this paper is to present a successfully treated basilar tip wide-neck aneurysm treated with the dual microcatheter technique.Case report. A 46-year-old male patient with acute onset of severe headache presented in the emergency room with altered state of consciousness. Non-enhanced CT scan showed subarachnoid and intraventricular haemorrhage. CT angiography revealed a wide-neck basilar tip aneurysm. Digital subtraction angiography confirmed the presence of an aneurysm with a wide, 4.9 mm neck.Dual microcatheter technique was chosen as the first treatment option, while a hypercompliant balloon was kept as backup. Two microcatheters were placed inside de aneurysm and two coils were introduced in order to form a stable framing coil mass that served as a support for further coils deployed in an alternately manner through each microcatheter. No procedural complication occurred, and the patient’s evolution was uneventful with no neurological deficits at discharge.Conclusion. The dual microcatheter technique is a safe and effective therapeutic option for wide-neck ruptured or unruptured intracranial aneurysms. Periprocedural complication rates are similar to simple coiling or balloon-assisted coiling, but lower than for stent-assisted coiling.

P113 Efficacy, safety and long-term durability of endovascular treatment of MCA aneuryms: a review of 161 treated aneurysms

ObjectivesThe aim of this study was to assess the long-term outcomes of endovascular treatment of MCA aneurysms and identify factors associated with recurrence.Subjects161 aneurysms in 147 patients treated between January 2008 and August 2011.MethodsA retrospective case note review was performed. Aneurysm occlusion was assessed using the Raymond-Roy classification. Clinical outcome was graded using the mRS.ResultsThe minimum period of follow up was 65 months, with a maximum follow up period of 120 months. 49% of aneurysms were ruptured at the time of treatment. Morbidity was observed in 15% of the unruptured aneurysms (6% permanent neurological deficit), and in 33% of ruptured aneurysms (15% permanent neurological deficit). 84% of aneurysms were fully occluded following first treatment. Of these, 34% demonstrated angiographic recurrence and 10% required re-intervention. 25% of aneurysms≤7 mm in maximal diameter demonstrated angiographic recurrence, as compared with 50% of aneurysms>7 mm. Aneurysm size >7 mm was associated with a significantly shorter time to recurrence (log rank=9.655, p=0.002).ConclusionsThis is a large series of MCA aneurysms with a long period of follow up. Our results demonstrate that endovascular treatment of MCA aneurysms is associated with a low morbidity and mortality. Given the increasing use of adjunctive devices (stents, web devices) full occlusion of ruptured aneurysms in the acute phase is not necessary, and deliberate staged treatment a reasonable strategy.

A new definition for wide-necked cerebral aneurysms.

BackgroundEndovascular management of wide-necked aneurysms often requires assisted-techniques with adjunctive devices. Wide-necked aneurysm can be defined with a dome-to-neck ratio or aspect ratio; however, clinical definitions of wide-necked aneurysms vary. This study aimed to determine the most useful definition of wide-necked aneurysm to predict the need for an adjunctive device.MethodsAmong 552 cases of aneurysms, 343 (62.1%) and 209 (37.9%) cases of unruptured and ruptured aneurysms, respectively, were treated in a single institution. For each aneurysm, the (1) dome-to-neck ratio, (2) aspect ratio, and (3) K-ratio (defined as [dome height+maximum dome width]/[2×maximum neck width]) were measured. We statistically analyzed patient data to determine which of the three ratios was most predictive of the need for adjunctive devices.ResultsAmong 552 cases of aneurysms, 277 (50.2%) and 275 (49.8%) cases were treated with and without adjunctive techniques, respectively. The mean dome-to-neck ratio, aspect ratio, and K-ratio were 1.17±0.39, 1.58±0.61, and 1.37±0.47, respectively. The K-ratio was the strongest predictor of the use of adjunctive devices (P<0.001), and 1.3 was the most appropriate K-ratio cut-off value (sensitivity, 72.9%; specificity, 63.6%).ConclusionsK-ratio was the most useful predictor of the need for adjunctive devices in the treatment of endovascular aneurysms. These results suggest that the K-ratio may be used to define wide-necked aneurysms requiring complicated management via adjunctive devices.

Abstract 112: Hydrocoils Reduce Recurrence Rates in Recently Ruptured Medium Sized Intracranial Aneurysms: A Subgroup Analysis of the HELPS Trial

Background and Purpose: The Hydrocoil Endovascular aneurysm occlusion and Packing Study (HELPS) was a randomized controlled trial comparing Hydrocoil to bare platinum coils . We performed a subgroup analysis of angiographic and clinical outcomes of medium sized aneurysms in the HELPS trial. Methods: We selected all patients with medium sized aneurysms (5mm-9.9mm) in the HELPS trial. The following outcomes were compared between the HydroCoil and control groups: 1) any recurrence, 2) major recurrence, 3) retreatment and 4) good neurological outcome defined as mRS≤2. Outcomes of recently ruptured and non-recently ruptured aneurysms were compared separately. Comparisons between groups were performed using Fisher’s exact test. A multivariate logistic regression analysis adjusting for aneurysm neck size, shape, use of adjunctive device and rupture status was performed. Results: A total of 288 patients with medium sized aneurysms were randomized (144 in each group). At 15-18 months post-treatment, major recurrence rate was significantly lower in the HydroCoil group than the control group (18.6% versus 30.8%, P=0.03, respectively). For recently ruptured aneurysm patients, major recurrence rate was significantly lower for HydroCoil than controls (20.3% versus 47.5%, P=0.003), while rates were similar between coil types for unruptured aneurysms (16.7% versus 14.8%, P=0.80). On multivariate analysis for patients with recently ruptured aneurysms, HydroCoil was associated with lower odds of any recurrence as compared to bare platinum (OR=0.37, 95%CI=0.18-0.76, P=0.006) and major recurrence (OR=0.27, 95%CI=0.12-0.58, P=0.0007). There was a trend towards lower retreatment rates in the recently ruptured group treated with HydroCoil (OR=0.00, 95%CI=0.00-2.01, P=0.12). Conclusion: For recently ruptured, medium sized aneurysms, as compared to bare platinum coils HydroCoils were associated with lower rates of major recurrence that were both statistically significant and clinically relevant. These findings suggest that HydroCoils should be the preferred treatment for this subset of patients.

Periprocedural safety of aneurysm embolization with the Medina Coil System: the early human experience

IntroductionIntracranial saccular aneurysms, if untreated, carry a high risk of morbidity and mortality from intracranial bleeding. Embolization coils are the most common treatment. We describe the periprocedural safety and performance...

P-002 The Financial Impact of Flow Diverters on The Endovascular Treatment of Cerebral Aneurysms

IntroductionIf flow-diverters are to become the preferred mode of treating aneurysms then other than their efficacy, an analysis of their financial impact against coiling is warranted.MethodologyAn IRB approved retrospective analysis...

O-024 Medicare Underpayment is a Major Cause of Deficit in Endovascular Treatment of Aneurysms

BackgroundCoiling remains the current primary therapy for aneurysms. Understanding the economics of coiling will establish a framework against which the financial impact of future devices may be measured.MethodologyA retrospective analysis...

Abstract W MP34: Safety and Efficacy of Hydrosoft Coils in the Treatment of the Aneurysm Neck: Preliminary Results From the GEL THE NEC Registry

Background and Purpose: The HydroSoft coil was developed to be placed along the aneurysm neck to enhance intracranial aneurysm healing. In order to better understand the safety and efficacy of Hydrosoft coils in treating the aneurysm neck, the GEL THE NEC multicenter registry was developed. We report immediate angiographic and clinical results of this prospective registry. Methods: The GEL THE NEC study was undertaken at 30 centers in 5 countries. Patients aged 21-90 years with a ruptured or unruptured aneurysm 3-15 mm in size were eligible for enrollment. For each patient the following data were obtained: demographics and comorbidities, aneurysm geometry, use of adjunctive devices, immediate angiographic outcomes, and early (&lt;30 days) adverse events. Postoperative anatomic results were graded by on-site neuroradiologists using the Modified Raymond Scale (Raymond 1=complete obliteration of aneurysm including the neck, Raymond 2=contrast filling the neck of the aneurysm without opacification of the aneurysm sac, Raymond 3=contrast filling the sac of the aneurysm). Predictors of good angiographic outcome were studied using chi-squared and t-tests. Results: A total of 571 patients with 571 aneurysms have been treated thus far in the study (196 ruptured, 375 unruptured). HydroSoft coils were successfully deployed in 549 (96.3%) of these patients. Adjunctive devices were used in 307 cases (53.8%) (212 balloon assistance, 89 stent). Aneurysmal occlusion rates were the following: 261 patients (47.3%) exhibited Raymond 1 occlusion, 257 patients (47.0%) had Raymond 2, and 29 patients (5.3%) had Raymond 3. Early post-operative stroke occurred in 10 patients (1.8%). Aneurysm perforation occurred in 11 patients (1.9%). Coil prolapse/migration occurred in 8 patients (1.4%). Early post-operative death occurred in 3 patients, all of whom presented with SAH (0.5%). Small aneurysm neck size was a significant predictor of good angiographic outcome (P=0.0003). Conclusions: Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in high rates of satisfactory occlusion (94.3%) and low rates of major clinical complications. Aneurysm neck size was a significant predictor of angiographic outcomes.

Systematic review: comparative effectiveness of adjunctive devices in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention of native vessels.

BackgroundDuring percutaneous coronary intervention (PCI), dislodgement of atherothrombotic material from coronary lesions can result in distal embolization, and may lead to increased major adverse cardiovascular events (MACE) and mortality. We sought to systematically review the comparative effectiveness of adjunctive devices to remove thrombi or protect against distal embolization in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI of native vessels.MethodsWe conducted a systematic literature search of Medline, the Cochrane Database, and Web of Science (January 1996-March 2011), http://www.clinicaltrials.gov, abstracts from major cardiology meetings, TCTMD, and CardioSource Plus. Two investigators independently screened citations and extracted data from randomized controlled trials (RCTs) that compared the use of adjunctive devices plus PCI to PCI alone, evaluated patients with STEMI, enrolled a population with 95% of target lesion(s) in native vessels, and reported data on at least one pre-specified outcome. Quality was graded as good, fair or poor and the strength of evidence was rated as high, moderate, low or insufficient. Disagreement was resolved through consensus.Results37 trials met inclusion criteria. At the maximal duration of follow-up, catheter aspiration devices plus PCI significantly decreased the risk of MACE by 27% compared to PCI alone. Catheter aspiration devices also significantly increased the achievement of ST-segment resolution by 49%, myocardial blush grade of 3 (MBG-3) by 39%, and thrombolysis in myocardial infarction (TIMI) 3 flow by 8%, while reducing the risk of distal embolization by 44%, no reflow by 48% and coronary dissection by 70% versus standard PCI alone. In a majority of trials, the use of catheter aspiration devices increased procedural time upon qualitative assessment.Distal filter embolic protection devices significantly increased the risk of target revascularization by 39% although the use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health outcomes. Distal balloon or any embolic protection device increased the achievement of MBG-3 by 61% and 20% and TIMI3 flow by 11% and 6% but did not significantly impact other intermediate outcomes versus control. Upon qualitative analysis, all device categories, with exception of catheter aspiration devices, appear to significantly prolong procedure time compared to PCI alone while none appear to significantly impact ejection fraction. Many of the final health outcome and adverse event evaluations were underpowered and the safety of devices overall is unclear due to insufficient amounts of data.ConclusionsIn patients with STEMI, for most devices, few RCTs evaluated final health outcomes over a long period of follow-up. Due to insufficient data, the safety of these devices is unclear.

Clinical recommendations for oral cancer screening

To address the benefits and limitations of oral cancer screening and the use of adjunctive screening aids to visualise and detect potentially malignant and malignant oral lesions. Squamous cell carcinomas of the lips and cancers of the oropharynx (including the posterior one-third of the base of the tongue and the tonsils were excluded. A specially convened expert panel evaluated the available evidence which was derived from a systematic search of Medline and the Cochrane Library. Further details about the search are available in a supplement to the published article available on the Journal of the America Dental Association's website (http://jada.ada.org/cgi/content/full/141/5/509). Qualitative synthesis of the data was performed by the panel. Where consensus could not be reached majority voting was employed. Recommendations were reviewed by internal and external scientific experts and organisations. After review recommendations were revised where appropriate and the ADA Council on Scientific Affairs approved the final clinical recommendations. No information provided in article. The key recommendations were all classified as level D being based on grade IV evidence or extrapolated from grade I, II or III evidence using a system based on Shekelle et al.(1) The main recommendations can be summarised as:1) Clinicians should remain alert for signs of potentially malignant lesions or early-stage cancers in all patients while performing routine visual and tactile examinations, particularly for patients who use tobacco or who are heavy consumers of alcohol. 2) For seemingly innocuous lesions, clinicians should follow up in seven to 14 days to confirm persistence after removing any possible cause to reduce the potential for false-positive screening results. 3) For lesions that raise suspicion of cancer or for lesions that persist after removal of a possible cause, clinicians should communicate the potential benefits and risks of early diagnosis. Considerations include the following: a) that even suspicious lesions identified during the course of a routine visual and tactile examination may represent false positives; b) that clinical confirmation (a second opinion) can be sought from a dental or medical care provider with advanced training and experience in diagnosis of oral mucosal disease so as to reduce the potential for a false positive or false negative oral cancer screening result; c) that a malignancy or non-malignancy can be confirmed only via microscopic examination that requires a surgical biopsy; d) that a decision to pursue a biopsy to confirm the presence or absence of malignancy should be made in the context of informed consent. 4) Although transepithelial cytology has validity in identifying disaggregated dysplastic cells, the panel suggests surgical biopsy for definitive diagnosis. In all, 15 separate research recommendations were made ranging from determining the prevalence of potentially malignant oral mucosal lesions in the United States to whether the use of adjunctive devices improves patient education and adherence to follow-up care.

Factors Influencing the Benefit of Adjunctive Devices during Percutaneous Coronary Intervention in ST‐Segment Elevation Myocardial Infarction: Meta‐Analysis and Meta‐Regression

Routine use of adjunctive devices to percutaneous coronary intervention (PCI) for the treatment of patients of ST-segment elevation myocardial infarction (STEMI) is questionable. Also, the clinical characteristics of STEMI patients that can modulate the treatment benefits of adjunctive devices are not fully understood. To synthesize the existing literature to summarize the therapeutic benefit of the adjunctive devices and to identify the patient characteristics which relate to this therapeutic benefit. We conducted (i) meta-analyses of the randomized controlled trials (RCT) comparing the performance of the adjunctive devices with PCI for three reperfusion-related outcomes: myocardial blush grade (MBG) < 3, failed ST-segment resolution (STR), and Thrombolysis In Myocardial Infarction (TIMI) flow grade < 3; (ii) stepwise meta-regressions of the effect of trial characteristics on between-trial heterogeneity; and (iii) analyses to examine whether the reperfusion-related end-points explained the between-trial difference in cardiac death and major adverse cardiac events (MACE). Our meta-analyses represent data from 23 RCT and 5,728 subjects. The overall therapeutic benefit attributable ranged from 32 to 35% for the reperfusion-related outcomes, and thrombectomy devices were more beneficial than the distal protection devices.Meta-regression identified gender, receipt of glycoprotein (GP) IIb/IIIa inhibitor, and baseline TIMI flow grade as significant predictors of improved reperfusion across trials. The available clinical trials were individually underpowered and not designed to detect the influence of adjunctive devices on death or MACE. Routine use of adjunctive devices cannot be recommended. Thrombus burden, treatment with GPIIb/IIIa inhibitors, and gender may modify the reperfusion benefit of adjunctive devices.

Does the use of adjunctive devices increase the incidence of thromboembolic complications?

Does the use of adjunctive devices increase the incidence of thromboembolic complications?

The Outcome of PCI for stent-ThrombosIs MultIcentre Study (OPTIMIST): Rationale and design of a multicenter registry

Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population. We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization). The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.

Use of adjunctive devices in cardiopulmonary resuscitation

Use of adjunctive devices in cardiopulmonary resuscitation