Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care After Surgical Abortion (the FACTS Study Phase 3): Mixed Methods Prospective Pilot Study.

BACKGROUND: In Canada, 1 in 3 women and people of gestational age undergo an abortion in their lifetime. Despite the liberal legal context, barriers continue to exist for women and people who can become pregnant to access this service. OBJECTIVE: This study aims to (1) conduct a pilot study to demonstrate the feasibility and acceptability of myPostCare to support follow-up care after a procedural abortion; (2) use the findings to understand whether myPostCare has the potential to improve contraceptive behavior and knowledge, emotional well-being, and sexual health knowledge; and (3) develop a better understanding of how innovative mobile solutions can support integrative health programs in British Columbia with the goal of expanding to other sites across Canada. METHODS: People of gestational age (aged 14-45 y) who underwent a procedural abortion were recruited from 2 urban abortion facilities in British Columbia. The participants completed a baseline quantitative survey and were provided access to myPostCare for up to 30 days. A follow-up quantitative survey was sent via email on day 30. Qualitative interviews were conducted to explore user satisfaction and usability of myPostCare. Responses to the survey questions were summarized using descriptive statistics, and the system usability scale (SUS) was scored according to the instructions. A secure analytics platform was implemented to obtain data on the overall use of the website by users. Qualitative analysis was conducted with NVivo using a thematic analysis approach. This study was approved by the Women's and Children's Research Ethics Board. RESULTS: Overall, 62 participants were recruited (average age 30 y); 40% (25/62) of the participants completed the exit surveys, and 24% (6/25) consented to participate in the semistructured interviews; 40 participants had undergone an immediate postabortion intrauterine device (IUD) insertion, and 22 did not have an IUD inserted. Participants were satisfied with myPostCare. The SUS average score was 81.5 (SD 9.7; median 82.5, IQR 77.5-87.5), indicating high usability of the tool. Overall, 88% (22/25) of the participants changed their contraceptive method to an IUD. Web-based analytics demonstrated that there were 61 unique visitors to the site, and the top pages visited were Postprocedure Care, Emotional Well-Being, and Contraception Explorer. The longest time spent on the website was 56 minutes. The overall email open rate was 80%, with a click rate of 36%. CONCLUSIONS: This study demonstrates that communities and individuals are important collaborators in developing a mobile innovation that facilitates access to high-quality patient-centered abortion care. Through the cocreation process, a digital platform such as myPostCare highlighted a gap in abortion care in Canada, particularly around follow-up support after a procedural abortion.

A Canadian survey of patients' attitudes toward donation of products of conception for research at the time of their aspiration abortion.

OBJECTIVE: We explored patients' attitudes toward donating products of conception for research at the time of their aspiration abortion. STUDY DESIGN: We surveyed patients presenting for first or second trimester aspiration abortion to the abortion service at British Columbia Women's Hospital over a 6-month period in 2018. Questions explored demographics, attitudes toward tissue donation, willingness to donate products of conception for research, and how the option of donating tissue influenced patients' perception of their abortion. We analyzed quantitative data using descriptive statistics and answers to open-ended questions using content analysis. RESULTS: The partially tracked response rate to our survey was n = 35 of 46 (76%). Of 98 respondents included for analysis 77 (79%) were willing to donate their products of conception to research. Most respondents (n = 85, 93%), 49 (54%) of whom had ever been offered to actually donate tissue, reported that tissue donation would either positively change (n = 33, 36%) or not change (n = 52, 57%) how they felt at the time of their abortion. The majority of respondents (n = 25, 60%) who were not invited to donate their products of conception would have liked the opportunity to do so. Content analysis of open-ended responses from those willing to donate identified the categories of helping others, contributing to research and providing meaning beyond the respondents' individual experience. CONCLUSION: Patients' willingness to donate products of conception to research and their associated positive attitudes provide important support for researchers and clinicians who are involved in research that uses products of conception. IMPLICATIONS: Our data may inform research programs and abortion clinics involved in research using products of conception by better understanding the patient experience of being involved in this type of research.

Contraceptive counselling in 3 Canadian bariatric surgery clinics: a multicentre qualitative study of the experiences of patients and health care providers.

BACKGROUND: Evidence suggests an increase in fertility and unintended pregnancy after bariatric surgery; contraceptive counselling, traditionally defined as a discussion of contraception options, is therefore an important facet of surgical planning. Our aim was to investigate patient experiences of contraceptive counselling, the attitudes of health care providers (HCPs) toward contraceptive counselling, and their perceptions of the facilitators and barriers to contraceptive counselling in bariatric surgery clinics. METHODS: We conducted a qualitative study using semistructured interviews with patients and HCPs at publicly funded Canadian bariatric surgery clinics from May 2018 to February 2019. We recruited bariatric HCPs from across Canada using snowball sampling, and recruited patient participants from 3 Canadian bariatric surgery programs. Patient participants had to be at risk of pregnancy in the postoperative period, aged 18-45 years old and have completed all preoperative counselling. We included HCPs who delivered care in a publicly funded, hospital-affiliated bariatric surgery clinic in Canada. Team members analyzed transcripts thematically. RESULTS: We completed 27 interviews (patient n = 16, HCP n = 11). Our analysis identified 3 separate themes: missing information in contraception counselling, making assumptions about who would benefit from counselling and strategies for improving contraception counselling. We found patients and HCPs wanted more resources on the safety and efficacy of contraceptive methods. INTERPRETATION: Our study showed a need for structured contraceptive counselling in bariatric surgery clinics. Information resources that support patients and HCPs who provide counselling are needed.

Dispensing and practice use patterns, facilitators and barriers for uptake of ulipristal acetate emergency contraception in British Columbia: a mixed-methods study.

BACKGROUND: Ulipristal acetate 30 mg became available as prescription-only emergency contraception in British Columbia, Canada, in September 2015, as an addition to over-the-counter levonorgestrel emergency contraception. In this study, we determined dispensing and practice use patterns for ulipristal acetate, as well as facilitators of and barriers to emergency contraception for physicians, pharmacists and patients in BC. METHODS: In the quantitative component of this mixed-methods study, we examined ulipristal acetate use from September 2015 to December 2018 using a database that captures all outpatient prescription dispensations in BC (PharmaNet) and another capturing market sales numbers for all oral emergency contraception in BC (IQVIA). We analyzed the quantitative data descriptively. We conducted semistructured interviews from August to November 2019, exploring barriers and facilitators affecting the use of ulipristal acetate. We performed iterative qualitative data collection and thematic analysis guided by Michie's Theoretical Domains Framework. RESULTS: Over the 3-year study period, 318 patients filled 368 prescriptions for ulipristal acetate. Use of this agent increased between 2015 and 2018. However, levonorgestrel use by sales (range 118 897-129 478 units/yr) was substantially higher than use of ulipristal acetate (range 128-389 units/yr). In the 39 interviews we conducted, from the perspectives of 12 patients, 12 community pharmacists, and 15 prescribers, we identified the following themes and respective theoretical domains as barriers to access: low awareness of ulipristal acetate (knowledge), beliefs and experiences related to shame and stigma (beliefs about consequences), and multiple health system barriers (reinforcement). INTERPRETATION: Use of ulipristal acetate in BC was low compared with use of levonorgestrel emergency contraception; lack of knowledge, beliefs about consequences and health system barriers may be important impediments to expanding use of ulipristal acetate. These findings illuminate potential factors to explain low use of this agent and point to the need for additional strategies to support implementation.

Osmotic Dilator Intra-Abdominal Perforation: A Case Report.

BACKGROUND: This report describes an unusual case of a retained hygroscopic osmotic dilator following second trimester dilation and evacuation. CASE: A 24-year-old woman presented for elective pregnancy termination at 16 weeks gestational age. A cervical osmotic dilator could not be retrieved and fractured on attempted removal. Magnetic resonance imaging showed perforation through the cervix, possibly traversing the peritoneum. Hysteroscopy and laparoscopy were performed to remove the retained dilator. Significant inflammation and mesenteric adhesions surrounded the osmotic dilator, which was successfully removed. CONCLUSION: This is the first reported case of an intra-abdominal osmotic dilator. Although this device is inert, close follow-up and timely retrieval, possibly with hysteroscopy or laparoscopy, are recommended to minimize the resulting inflammatory response.

Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care (The FACTS Study Phase II) After Surgical Abortion: User-Centered Design.

BACKGROUND: Human-centered design is a methodology that applies an iterative participatory process that engages the end-user for whom an innovation or intervention is designed for from start to end. There is general evidence to support the use of human-centered design for development of tools to affect health behavior, but specifically for family planning provision. This study is part two of a three-phase study that uses a user-centered design methodology which uses the findings from Phase I to design, develop, and test a digital health solution to support follow-up after an induced surgical abortion. OBJECTIVE: The objectives for this study were to: (1) develop a Web-based intervention based on preferences and experiences of women who underwent an abortion as measured in the formative phase of the Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care Study; (2) conduct usability testing of the intervention to determine user-friendliness and appropriateness of the intervention; and (3) finalize a beta version of the Web-based intervention for pilot testing. METHODS: The study design was based on the "development-evaluation-implementation" process from the Medical Research Council Framework for Complex Medical Interventions. This study is in Phase II of III and is based on user-centered design methodology. Phase I findings demonstrated that women engage with technology to assist in clinical care and they preferred a comprehensive website with email or text notifications to support follow-up care. In Phase II we collaborated with family planning experts and key stakeholders to synthesize evidence from Phase I. With them and a development partner we built a prototype. Usability testing was completed with 9 participants using a validated System Usability Scale. This was then used to refine the intervention for Phase III pilot study. This study was approved by the local Ethics board. RESULTS: We developed a comprehensive Web-based tool called myPostCare.ca, which includes: Post-Procedure Care, Emotional Well-Being Tool, Contraception Explorer, Sexual Health, Book an Appointment, and Other Resources. Additionally, over the course of a month after the procedure, automatic email notifications were sent to women as a form of virtual follow-up support, directing them to myPostCare.ca resources. The Web-based tool was refined based on usability testing results. CONCLUSIONS: This study demonstrated that user-centered design is a useful methodology to build programs and interventions that are women-centered, specifically for abortion care.

Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care in British Columbia: Phase I.

BACKGROUND: Over 30% of women in Canada undergo an abortion. Despite the prevalence of the procedure, stigma surrounding abortion in Canada leads to barriers for women to access this service. The vast majority of care is concentrated in urban settings. There is evidence to support utilization of innovative mobile and other technology solutions to empower women to safely and effectively self-manage aspects of the abortion process. This study is part 1 of a 3-phase study that utilizes user-centered design methodology to develop a digital health solution to specifically support follow-up after an induced surgical abortion. OBJECTIVE: This study aimed to (1) understand how women at 3 surgical abortion clinics in an urban center of British Columbia utilize their mobile phones to access health care information and (2) understand women's preferences of content and design of an intervention that will support follow-up care after an induced abortion, including contraceptive use. METHODS: The study design was based on development-evaluation-implementation process from Medical Research Council Framework for Complex Medical Interventions. This was a mixed-methods formative study. Women (aged 14-45 years) were recruited from 3 urban abortion facilities in British Columbia who underwent an induced abortion. Adaptation of validated surveys and using the technology acceptance model and theory of reasoned action, a cross-sectional survey was designed. Interview topics included demographic information; type of wireless device used; cell phone usage; acceptable information to include in a mobile intervention to support women's abortion care; willingness to use a mobile phone to obtain reproductive health information; optimal strategies to use a mobile intervention to support women; understand preferences for health information resources; and design qualities in a mobile intervention important for ease of use, privacy, and security. Responses to questions in the survey were summarized using descriptive statistics. Qualitative analysis was conducted with NVivo using a thematic analysis approach. This study was approved by the local ethics board. RESULTS: A waiting-room survey was completed by 50 participants, and semistructured interviews were completed with 8 participants. The average age of participants was 26 years. Furthermore, 94% (47/50) owned a smartphone, 85% (41/48) used their personal phones to go online, and 85% would use their cell phone to assist in clinical care. Qualitative analysis demonstrated that women prefer a comprehensive website that included secure email or text notifications to provide tools and resources for emotional well-being, contraceptive decision making, general sexual health, and postprocedure care. CONCLUSIONS: A community-based mixed-methods approach allowed us to understand how women use their cell phones and what women desire in a mobile intervention to support their postabortion care. The findings from this formative phase will assist in the development and testing of a mobile intervention to support follow-up care after an induced surgical abortion.

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results.

BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.

Consecutive Endovascular Treatment of 20 Ruptured Very Small (<3 mm) Anterior Communicating Artery Aneurysms.

BACKGROUND: Small aneurysms located at the anterior communicating artery carry significant procedural challenges due to a complex anatomy. Recent advances in endovascular technologies have expanded the use of coil embolization for small aneurysm treatment. However, limited reports describe their safety and efficacy profiles in very small anterior communicating artery aneurysms. OBJECTIVE: We sought to review and report the immediate and long-term clinical as well as radiographic outcomes of consecutive patients with ruptured very small anterior communicating artery aneurysms treated with current endovascular coil embolization techniques. METHODS: A prospectively maintained single-institution neuroendovascular database was accessed to identify consecutive cases of very small (<3 mm) ruptured anterior communicating artery aneurysms treated endovascularly between 2006 and 2013. RESULTS: A total of 20 patients with ruptured very small (<3 mm) anterior communicating artery aneurysms were consecutively treated with coil embolization. The average maximum diameter was 2.66 ± 0.41 mm. Complete aneurysm occlusion was achieved for 17 (85%) aneurysms and near-complete aneurysm occlusion for 3 (15%) aneurysms. Intraoperative perforation was seen in 2 (10%) patients without any clinical worsening or need for an external ventricular drain. A thromboembolic event occurred in 1 (5 %) patient without clinical worsening or radiologic infarct. Median clinical follow-up was 12 (±14.1) months and median imaging follow-up was 12 (±18.4) months. CONCLUSION: This report describes the largest series of consecutive endovascular treatments of ruptured very small anterior communicating artery aneurysms. These findings suggest that coil embolization of very small aneurysms in this location can be performed with acceptable rates of complications and recanalization.

Aspiration Thrombectomy After Intravenous Alteplase Versus Intravenous Alteplase Alone.

BACKGROUND AND PURPOSE: Thrombectomy, primarily with stent retrievers with or without adjunctive aspiration, provided clinical benefit across multiple prospective randomized trials. Whether this benefit is exclusive to stent retrievers is unclear. METHODS: THERAPY (The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke; NCT01429350) was an international, multicenter, prospective, randomized (1:1), open label, blinded end point evaluation, concurrent controlled clinical trial of aspiration thrombectomy after intravenous alteplase (IAT) administration compared with intravenous-alteplase alone in patients with large vessel ischemic stroke because of a thrombus length of ≥8 mm. The primary efficacy end point was the percent of patients achieving independence at 90 days (modified Rankin Scale score, 0-2; intention-to-treat analysis). The primary safety end point was the rate of severe adverse events (SAEs) by 90 days (as treated analysis). Patients were randomized 1:1 across 36 centers in 2 countries (United States and Germany). RESULTS: Enrollment was halted after 108 (55 IAT and 53 intravenous) patients (of 692 planned) because of external evidence of the added benefit of endovascular therapy to intravenous-alteplase alone. Functional independence was achieved in 38% IAT and 30% intravenous intention-to-treat groups (P=0.52). Intention-to-treat ordinal modified Rankin Scale odds ratio was 1.76 (95% confidence interval, 0.86-3.59; P=0.12) in favor of IAT. Secondary efficacy analyses all demonstrated a consistent direction of effect toward benefit of IAT. No differences in symptomatic intracranial hemorrhage rates (9.3% IAT versus 9.7% intravenous, P=1.0) or 90-day mortality (IAT: 12% versus intravenous: 23.9%, P=0.18) were observed. CONCLUSIONS: THERAPY did not achieve its primary end point in this underpowered sample. Directions of effect for all prespecified outcomes were both internally and externally consistent toward benefit. It is possible that an alternate method of thrombectomy, primary aspiration, will benefit selected patients harboring large vessel occlusions. Further study on this topic is indicated. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.

Medical Abortion.

OBJECTIVE: This guideline reviews the evidence relating to the provision of first-trimester medical induced abortion, including patient eligibility, counselling, and consent; evidence-based regimens; and special considerations for clinicians providing medical abortion care. INTENDED USERS: Gynaecologists, family physicians, registered nurses, midwives, residents, and other healthcare providers who currently or intend to provide pregnancy options counselling, medical abortion care, or family planning services. TARGET POPULATION: Women with an unintended first trimester pregnancy. EVIDENCE: Published literature was retrieved through searches of PubMed, MEDLINE, and Cochrane Library between July 2015 and November 2015 using appropriately controlled vocabulary (MeSH search terms: Induced Abortion, Medical Abortion, Mifepristone, Misoprostol, Methotrexate). Results were restricted to systematic reviews, randomized controlled trials, clinical trials, and observational studies published from June 1986 to November 2015 in English. Additionally, existing guidelines from other countries were consulted for review. A grey literature search was not required. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force for Preventive Medicine rating scale (Table 1). BENEFITS, HARMS AND/OR COSTS: Medical abortion is safe and effective. Complications from medical abortion are rare. Access and costs will be dependent on provincial and territorial funding for combination mifepristone/misoprostol and provider availability. SUMMARY STATEMENTS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care RECOMMENDATIONS: Introduction Pre-procedure care Medical abortion regimens Providing medical abortion Post-abortion care.

Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

IMPORTANCE: Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. OBJECTIVE: To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%). DESIGN, SETTING, AND PATIENTS: VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. INTERVENTIONS: Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). PRIMARY OUTCOME MEASURE: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. RESULTS: Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. The 30-day primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2.9%-19.0%]) vs none in the medical group (95% CI, 0%-5.5%) (P = .06). The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58; 36.2% [95% CI, 24.0-49.9]) vs the medical group (8/53; 15.1% [95% CI, 6.7-27.6]) (P = .02). Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (6/53; 11.3% [95% CI, 4.3%-23.0%]) (P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00816166.

Stenting and angioplasty for idiopathic intracranial hypertension: a case series with clinical, angiographic, ophthalmological, complication, and pressure reporting.

BACKGROUND: Previous studies have demonstrated that cerebral dural sinus stenosis (DSS) may be a potential patho-physiological cause of idiopathic intracranial hypertension (IIH). Endovascular therapy for DSS is emerging as a potential alternative to treat IIH. Here, we present the results of our case series. METHOD: We prospectively collected angiographic and manometric data on patients that underwent angioplasty/stenting for IIH. All patients had failed maximal medical therapy (MMT) and had confirmed sinus stenosis. Demographic, clinical and radiological presentation, and outcomes were collected retrospectively. RESULTS: A total of 18 patients underwent 25 procedures. Demographics revealed a mean age of 30 (range 15-59), 83% (15/18) were female, 72% (13/18) were white, and mean body mass index of 36 (range 23-59.2). All patients presented with classic IIH. Symptom improvement or resolution was reported in 94% (17/18) of patients. All patients had resolution and/or stabilization/improvement of their papilledema. Headaches related to increased pressure improved in 56% (10/18). Re-stenosis and retreatment occurred in 33% (6/18). No procedural related complications were reported. CONCLUSION: Dural sinus angioplasty and stenting is relatively safe, feasible, and clinically efficacious for patients with symptomatic sinus stenosis who have failed standard therapy. The long-term durability of patency and clinical improvement remains unknown.

Endovascular reconstruction for progressively worsening carotid artery dissection.

BACKGROUND: Carotid artery dissection is an important cause of stroke in young patients. Selection criteria for endovascular repair have not been well defined and limited data exist on long-term outcomes of stent reconstruction. OBJECTIVE: To report the immediate and long-term clinical and radiographic outcomes of patients treated with stent placement for progressively worsening symptomatic carotid arterial dissection despite antithrombotic therapy. METHODS: A single institution neuro-endovascular database was accessed to identify consecutive cases in which carotid artery dissection was treated with endovascular repair between 2006 and 2012. Clinical, demographic, radiographic, and procedural data were obtained through chart review. RESULTS: A total of 22 patients were identified and included 27 carotid artery dissection repairs with stent implantation. The mean age was 43 years (±8.7) with 13 patients being women. Traumatic dissections were seen in 9 (40.9%) patients and spontaneous dissections in 13 (59.1%) patients. All patients were symptomatic and were started on antithrombotic therapy on diagnosis. Most common indications for treatment included recurrent ischemia despite antithrombotic therapy in 15 (55.5%) arteries and enlarging dissecting aneurysm in 4 (14.8%) arteries. Mean degree of stenosis was 79.1%. Mean number of stents used was 1.88 (range 1-4). There was 1 (4.5%) asymptomatic peri-procedural thromboembolic event. Median clinical follow-up was 14 months (range 3-40) and median imaging follow-up was 14 months (range 3-38). There was 1 (4.5%) case of recurrent transient ischemic attack. There was no death, significant restenosis or stroke in the territory of the treated vessel during the duration of the follow-up. CONCLUSIONS: Endovascular stent reconstruction for the treatment of selected patients with progressively worsening carotid dissection despite medical management is feasible with acceptable immediate and long-term clinical and radiographic outcomes. To be able to draw more robust conclusions, further evaluation with larger number of patients and longer follow-up is needed.

Stenting and angioplasty of small cerebral arteries in symptomatic intracranial atherosclerotic disease.

BACKGROUND: Intracranial atherosclerotic disease (ICAD) is a common cause of stroke with a poor natural history despite medical therapy. Few studies have investigated endovascular therapies for the treatment of symptomatic ICAD in distal intracranial arteries. Here, we present the feasibility and safety of balloon angioplasty with and without stenting in patients with medically refractory small artery symptomatic ICAD. METHOD: Personal logs were reviewed to identify patients who were treated for small artery ICAD (stenosis > 50%) using angioplasty ± stenting. Small cerebral arteries were defined by a diameter ≤ 2 mm or any branch distal to a large intracranial vessel (i.e. distal to ICA, M1, A1, Vertebrobasilar trunk). Patient characteristics, clinical manifestations, treatment, hospital course, and follow up data was collected and analyzed. RESULTS: Ten patients (12 arteries) were treated with either primary balloon angioplasty (58.3%) or angioplasty with stenting (41.6 %) with 100% technical success rate. Mean pre-treatment stenosis was 79.9% while mean post-treatment stenosis was 19.0%. There were no major peri-procedural complications including symptomatic intracranial hemorrhage or mortality; three cases were complicated by groin hematoma. Patients were followed for a mean total of 18.6 months with only one symptomatic restenosis which was re-treated successfully. All patients had good functional outcome with a mRS of either 0 (80%) or 1 (20%) on follow up. CONCLUSION: In our case series, treatment of symptomatic small artery ICAD with angioplasty ± stenting was safe and effective. These interventions should be considered as an alternative treatment for ICAD patients refractory to medical therapy.

Safety and predictors of aneurysm retreatment for remnant intracranial aneurysm after initial endovascular embolization.

INTRODUCTION: Aneurysmal subarachnoid hemorrhage (SAH) is a rare but devastating form of stroke. Endovascular therapy has been criticized for its higher rate of recanalization and retreatment. The safety and predictors of retreatment are unknown. We report the clinical outcomes, imaging outcomes and predictors for aneurysm retreatment after initial endovascular embolization. METHOD: We identified patients who underwent endovascular retreatment from July 2005 through November 2011. Aneurysm and patient data were collected. Periprocedural complications were reported as intraoperative perforation (IOP) or thromboembolic event (TEE). Aneurysm and patient characteristics were compared between aneurysms requiring retreatment and those not requiring retreatment to evaluate aneurysm retreatment predictors. RESULTS: A total of 111/871 (13%) aneurysms underwent retreatment. Two (0.2%) were retreated for recurrent acute SAH, 82 (74%) aneurysms were located in the anterior circulation, 47 (42%) required stent and 5 (5%) required balloon assist during retreatment. There were a total of 5 (5%) IOP and 6 (5%) TEE from which 2 (2%) and 1 (1%) were symptomatic, respectively. Overall symptomatic events rate were 2.7%. Patients were followed up for an average of 15±14 months. Seven (0.8%) aneurysms required a second retreatment without any recurrent SAH. Multivariable analysis revealed an OR for aneurysms requiring retreatment of 2.965 for aneurysms presenting as aneurysmal SAH, 1.791 for aneurysms in the posterior circulation and 1.053 for aneurysms with large dome size. CONCLUSIONS: Aneurysm retreatment is a safe option without a significant increase in morbidity or mortality. SAH, posterior circulation aneurysms and larger aneurysm dome size are predictors of aneurysms requiring retreatment.

Depressed mood and quality of life after subarachnoid hemorrhage.

BACKGROUND: Cognitive impairment is widely considered the main cause of disability and handicap after subarachnoid hemorrhage (SAH). The impact of depression on recovery after SAH remains poorly defined. We sought to determine the frequency of post-SAH depression, identify risk factors for its development, and evaluate the impact of depression on quality of life (QOL) during the first year of recovery. METHODS: We prospectively studied 216 of 534 SAH patients treated between July 1996 and December 2001 with complete one-year follow-up data. Depression was evaluated with the Center for Epidemiological Studies Depression (CES-D) scale, cognitive status with the Telephone Interview for Cognitive Status (TICS), and QOL with the Sickness Impact Profile (SIP) 3 and 12 months after SAH. RESULTS: Depressed mood occurred in 47% of patients during the first year of recovery; 26% were depressed at both 3 and 12 months. Non-white ethnicity predicted early (3 month) and late (12 month) depressions; early depression was also predicted by previously-diagnosed depression, cigarette smoking, and cerebral infarction, whereas late depression was predicted by prior social isolation and lack of medical insurance. Depression was associated with inferior QOL in all domains of the SIP, and changes in depression status were associated with striking parallel changes in QOL, disability, and cognitive function during the first year of recovery. CES-D scores accounted for over 60% of the explained variance in SIP total scores, whereas TICS performance accounted for no more than 6%. CONCLUSION: Depression affects nearly half of SAH patients during the first year of recovery, and is associated with poor QOL. Systematic screening and early treatment for depression are promising strategies for improving outcome after SAH.

Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial in symptomatic intracranial stenosis.

BACKGROUND: Patients with high-grade symptomatic intracranial stenosis (≥ 70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. METHODS: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥ 70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. RESULTS: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. CONCLUSIONS: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.