Predictors of recurrent restenosis after repeat drug-coated balloon therapy for drug-coated balloon restenosis in femoropopliteal lesions: Results of the RECURRENCE study.

BACKGROUND: Despite the widespread use of drug-coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions. METHODS: This multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled. RESULTS: The Kaplan-Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79-0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36-7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15-6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001). CONCLUSION: Repeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis.

The Midterm Outcomes of Endovascular Therapy for Femoropopliteal Lesions via Drug-Coated Balloon, Directional Atherectomy and Bare Metal Stent Angioplasty.

Background: This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. Methods: This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. Results: All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. Conclusions: The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions.

An overview of decision-making in cerebrovascular treatment strategies: Part I - unruptured aneurysms.

Introduction: Unruptured intracranial aneurysm treatment has evolved over the last two centuries, starting from the introduction of aneurysm ligation and clipping, up until the inception of endovascular treatment and further advancements in both fields. Research question: The wide variety of aneurysm presentations and possible treatment modalities, complicates the understanding of decision-making for the treatment of a given aneurysm. The goal of this article is to provide an overview of the best available evidence concerning unruptured intracranial aneurysm decision-making and identify insights and hiatuses, as well as providing a scaffold to surpass the subjectiveness of decision-making. Materials and methods: A literature review was performed for the most impactful articles on decision-making in unruptured intracranial aneurysm treatment, to provide an overview on current practice. Results: Two groups of decision-altering factors were identified; patient-related and aneurysm-related factors. A summary is presented of the general evidence, and the influence of age, aneurysmal mass-effect, as well as size, morphological aspects and specific anatomical locations on decision-making. Discussion and conclusion: Decision-making for an unruptured intracranial aneurysm often comes down to combining these different patient- and aneurysm-related factors. In this paper, an evidence-based overview is provided into these different factors which alter management of unruptured saccular aneurysms.

Efficacy of a novel method: VaSodilator injection via the over-the-wire lumen during drug-coated balloon dilatation to prevent the slow-flow phenomenon in treatment of femoropopliteal lesions.

In drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, there are adverse effects of drug embolization on downstream non-target organs following the slow-flow phenomenon. We devised a novel method, known as VaSodilator injection via the over-the-wire lumen during DCB dilatation to prevent the slow-flow phenomenon in treatment of femoropopliteal lesions (V.S.O.P.), and evaluated its efficacy and safety. This single-center, retrospective, observational study analyzed 196 femoropopliteal lesions treated with IN.PACT Admiral between April 2018 and July 2023. The IN.PACT Admiral is a DCB consisting of a 0.035-inch over-the-wire (OTW) lumen balloon coated with high-dose paclitaxel. Regarding the V.S.O.P. method, we injected vasodilators through the OTW lumen during DCB dilation of the lesions. The cohort was classified into two groups according to the use of the V.S.O.P. method (V.S.O.P. group: n = 53; non-V.S.O.P. group: n = 143). The V.S.O.P. group had lower rates of hemodialysis (21% vs. 43%, p = 0.01) and higher rates of critical limb-threatening ischemia (56% vs. 23%, p < 0.01) and severe calcification lesions (Peripheral Arterial Calcium Scoring Systems score 3/4) (53% vs. 34%, p = 0.01) than the non-V.S.O.P. group. The occurrence of the slow-flow phenomenon was significantly lower in the V.S.O.P. group than in the non-V.S.O.P. group. The V.S.O.P. method could be an effective method for preventing the slow-flow phenomenon after DCB angioplasty for femoropopliteal lesions.

Characteristics and prognostic impact of unsuccessful recanalization after endovascular therapy for acute ischemic stroke.

BACKGROUND: Endovascular therapy (EVT) has shown high therapeutic efficacy for acute large vessel occlusion (LVO); however, recanalization is unsuccessful in some cases. This study aimed to examine the characteristics and prognostic impact of unsuccessful recanalization after EVT compared with medical treatment alone. METHODS: We conducted a post hoc analysis of RESCUE-Japan Registry 2, a nationwide registry of 2408 consecutive patients with acute LVO. Patients without successful recanalization after EVT (thrombolysis in cerebral infarction grade ≤ 2a) were classified into the Unsuccessful EVT group, and compared with the No-EVT group. To account for selection bias, the outcomes were compared in a propensity score-matched cohort. The outcomes included the modified Rankin Scale (mRS) score at 90 days and intracranial hemorrhage within 72 h after the LVO onset. RESULTS: Among 188 (14.7 %) patients in the Unsuccessful EVT group out of 1281 who underwent EVT, 147 were matched with the No-EVT group, with comparable baseline characteristics. Patients in the Unsuccessful EVT group had a higher distribution of mRS score at 90 days and were less likely to achieve mRS 0-2 compared to those in the No-EVT group (23 % vs. 34 %, OR:0.58, 95 % CI:0.35-0.98). All-cause mortality was higher in the Unsuccessful EVT group (16 % vs. 6.8 %, OR: 2.54, 95 % CIs: 1.16-5.55). Symptomatic intracranial hemorrhage was more frequently observed in the Unsuccessful EVT group (5.4 % vs. 0.7 %, OR: 8.40, 95 % CIs: 1.04-68.1). CONCLUSIONS: The clinical outcomes of patients without successful recanalization after EVT were worse than those who did not undergo EVT.

An overview of decision-making in cerebrovascular treatment strategies: Part II - Ruptured aneurysms.

Introduction: Decision-making for the treatment of ruptured aneurysms is an intricate process, which involves several factors. There has been a rapid advancement in endovascular, but also in the surgical treating field of ruptured intracranial aneurysms, with a growing body of evidence for either treatment technique. Research question: As there is a wide variety of treatment possibilities, it can be hard to understand the intricacies which lie behind the decision-making process for a given aneurysm. Materials and methods: An overview of the most relevant literature in decision-making on ruptured intracranial aneurysms is given. Results: Different decision-altering factors were identified, which can be divided into information from the general evidence, to influential factors such as the patient's age, initial presenting status, and aneurysmal factors such as size, morphology and aneurysmal location. Discussion and conclusion: This review provides an evidence-based overview of the most pertinent literature on these different aspects of decision-making in ruptured aneurysm cases and provides some recommendations after each of these segments. As always, all different aspects of the patient and aneurysmal factors should be taken into consideration before coming to a conclusion, as to obtain the best possible result for an individual patient.

Understanding physician preferences about combined thrombolysis and thrombectomy in patients with large vessel occlusion: An international cross-sectional survey.

BACKGROUND: A recently published individual participant-level meta-analysis found that EVT alone was not non-inferior to combined intravenous thrombolysis (IVT) and EVT. Our aim was to determine factors that influence physicians' treatment choice of IVT-alone versus EVT-alone versus a combined approach. METHODS: We performed an international, structured, invite-only survey among physicians treating patients presenting with AIS. Respondents were asked 16 multiple choice questions. Fourteen questions involved the respondent being provided with a clinical scenario. In each scenario, a patient was presenting with an AIS with LVO, varying a single clinical or imaging feature. RESULTS: A total of 282 stroke physicians (mean age 46 years, 75 % males) participated in the survey. In LVO stroke, eligible for both IVT and EVT, without other qualifiers, 220 (85.9 %) respondents chose to pursue a combined approach. For age over 80 years, 191 (74 %) participants opted for combined approach, which decreased to 121 (48.2 %) with dementia and 148 (57.4 %) if the patient was on dual anti-platelet therapy (DAPT). Of respondents choosing combination therapy in a patient above the age of 80, only 105 (56.8 %) would pursue the same in a patient with dementia. For imaging factors, 177 (72.8 %) opted for a combined approach for intracranial carotid occlusion, which decreased to 160 (65.3 %) in tandem occlusions. Overall, 88 (38 %) respondents agreed to the statement "I am uncomfortable with uncertainty in patient care". CONCLUSIONS: In a typical patient with AIS due to LVO, most respondents still choose a combined revascularization approach but discrepancy in decision-making increases in complex scenarios.

Clinically Relevant Findings on 24-hour Head CT after Acute Stroke Therapy: the 24-hour CT Score.

BACKGROUND: Routine head computed tomography (CT) is performed 24 hours post-acute stroke thrombolysis and thrombectomy, even in patients with stable or improving clinical deficits. Predicting CT results that impact management could help prioritize patients at risk and potentially reduce unnecessary imaging. METHODS: In this IRB-approved retrospective study, data from 1461 consecutive acute ischemic stroke patients at our Comprehensive Stroke Center (n=8943, 2012-2022) who received intravenous thrombolysis or endovascular therapy, exhibited stable or improving 24-hour exams, and underwent 24-hour follow-up head CT per standard acute stroke care guidelines. CT reports 24 hours post-stroke were reviewed for edema, mass effect, herniation, and hemorrhage. The primary outcome was any clinically relevant 24-hour CT finding that led to changes in antithrombotic treatment or blood pressure goals, extended ICU stays or hospitalizations, neurosurgical interventions, or administration of mannitol or hypertonic saline. Multivariable logistic regression identified independent predictors of clinically meaningful CT abnormalities. A 24-hour CT Score was developed and cross-validated. RESULTS: The mean age was 70 years, with 47% women. The median NIH Stroke Scale (NIHSS) score at admission was 12 (IQR 6-18). Stroke-related abnormalities on 24-hour CT were present in 325 patients (22.2%), with 183 (12.5%) showing clinically relevant findings. Age, admission NIHSS, and blood glucose levels were independent predictors of clinically relevant 24-hour CT findings. The final model C statistic was 0.72 (95% CI, 0.68-0.76) in the derivation cohort and 0.72 (95% CI, 0.67-0.75) in bootstrapping validation. The 24-hour CT score was developed using these predictors: NIHSS score 5-15 (+3); NIHSS score ≥16 (+5); age <75 years (+1); admission glucose ≥140mg/dL (+1). The prevalence of clinically relevant CT findings was 4.3% in the low-risk group (24-hour CT score ≤4), 11.3% in the medium-risk group (score 5), and 21.4% in the high-risk group (score ≥6). The 24-hour CT score demonstrated good calibration. CONCLUSION: In patients undergoing thrombolysis or thrombectomy who undergo routine 24-hour head CT despite remaining clinically stable or improving, only 1 in 8 prove to have 24-hour head CT findings that impact management. The 24-hour CT score provides risk stratification that may improve resource utilization.

Comparison of Clinical Outcomes in Patients with Acute Lower Limb Ischaemia Undergoing Endovascular Therapy and Open Surgical Revascularisation: A Large Scale Analysis in Japan.

OBJECTIVE: The recommended revascularisation methods for acute limb ischaemia (ALI), which is caused by embolism and atherosclerotic thrombosis, include endovascular therapy (EVT) and open surgical revascularisation (OSR); however, treatment choices based on patient characteristics remain controversial. This retrospective analysis from the Japanese Registry of All Cardiac and Vascular Diseases - Diagnosis Procedure Combination database (April 2012 to March 2020) evaluated differences in clinical outcomes and identified prognostic predictors in patients with ALI. METHODS: This study analysed 10 977 patients with lower limb ALI. EVT was defined as catheter directed thrombolysis, percutaneous thrombectomy, or percutaneous angioplasty with balloon dilatation and or stenting. OSR was defined as Fogarty thrombectomy, bypass surgery, or thromboendarterectomy. The EVT and OSR groups were compared after propensity score matching (PSM) considering ten clinical covariables. RESULTS: The EVT group had more patients at higher risk of atherosclerotic disease than the OSR group. The OSR group had more patients at a higher risk of embolism, including atrial fibrillation and atrial flutter, than the EVT group. In the EVT group, 20.4% of patients underwent catheter directed thrombolysis using urokinase, the only thrombolytic agent available in Japan that is covered under insurance. After PSM, in hospital mortality (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.11 - 1.59; p = .002), major amputation rate (OR 1.43, 95% CI 1.19 - 1.72; p < .001), major amputation and or death rate (OR 1.42, 95% CI 1.24 - 1.62; p < .001), and total hospitalisation cost (1.16 vs. 0.97 million yen; p < .001) were statistically significantly more common in the EVT group. In interaction analyses, peripheral artery disease (PAD) was a factor responsible for reducing OSR efficacy in terms of major amputation and or death rate (with PAD, OR 0.94, 95% CI 0.68 - 1.29; without PAD, OR 1.56, 95% CI 1.34 - 1.82; p = .004). CONCLUSION: In Japan, EVT was a less effective primary treatment for patients with ALI than OSR, except for those with PAD.

Treatment Strategies for Acute Aortic Dissection With Malperfusion: A Retrospective Study.

BACKGROUND: Aortic dissection with malperfusion necessitates emergency surgery and is associated with poor outcomes. Therefore, in this study, we analyzed patients' treatment courses from the initial management to hospital discharge in cases of acute aortic dissection (AAD) with malperfusion and investigated the risk factors associated with mortality. METHODS: We evaluated cases of AAD with malperfusion treated at our institution over a 16-year period from 2007 to 2022. The primary endpoint was in-hospital mortality. The study's primary outcome measure was mortality during hospitalization. We collected and analyzed data encompassing preoperative patient characteristics, Stanford classification, sites of preoperative malperfusion, surgical techniques employed, and postoperative complications. These variables were examined to identify factors associated with in-hospital mortality. RESULTS: During the study period, 366 patients were admitted with AAD, 102 of whom had malperfusion. There were 62 men (61%) and 40 women (39%), with a mean age of 64 ± 13 years (range: 28-87 years). According to the Stanford classification, 75 (74%) and 27 (26%) patients had type A and B aortic dissection, respectively, and 29 patients (28%) presented with shock. Preoperative malperfusion sites included the brain, coronary arteries, abdominal viscera, limbs, and spinal cord in 40 (39%), 10 (10%), 34 (33%), 52 (51%), and six (6%) patients, respectively. Eleven (11%) patients required immediate intervention in the emergency department. The treatments administered to the patients were as follows: ascending aortic replacement, 30 (29%) patients; aortic arch replacement, 34 (33%) patients; root replacement, three (3%) patients; thoracic endovascular aortic repair (TEVAR), 12 (12%) patients; non-anatomic bypass, five (5%) patients; and conservative management, five (5%) patients. In-hospital mortality occurred in 23 (23%) patients. Multivariate logistic regression analysis identified preoperative coronary malperfusion as an independent risk factor of mortality. CONCLUSION: Preoperative coronary malperfusion is an independent risk factor for in-hospital mortality in patients with AAD presenting with malperfusion.