First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries

Purpose: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. Materials and Methods: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. Results: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). Conclusion: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

Beneficial Prognostic Effects of Aspirin in Patients Receiving Sorafenib for Hepatocellular Carcinoma: A Tale of Multiple Confounders

Case–control observational studies suggested that aspirin might prevent hepatocellular carcinoma (HCC) in high-risk patients, even if randomized clinical trials are lacking. Information regarding aspirin in subjects who already developed HCC, especially in its advanced stage, are scarce. While aspirin might be a low-cost option to improve the prognosis, multiple confounders and safety concerns are to be considered. In our retrospective analyses of a prospective dataset (n = 699), after assessing the factors associated with aspirin prescription, we applied an inverse probability treatment weight analysis to address the prescription bias. Analyses of post-sorafenib survival were also performed to reduce the influence of subsequent medications. Among the study population, 133 (19%) patients were receiving aspirin at the time of sorafenib prescription. Aspirin users had a higher platelet count and a lower prevalence of esophageal varices, macrovascular invasion, and Child–Pugh B status. The benefit of aspirin was confirmed in terms of overall survival (HR 0.702, 95% CI 0.543–0.908), progression-free survival, disease control rate (58.6 vs. 49.5%, p < 0.001), and post-sorafenib survival even after weighting. Minor bleeding events were more frequent in the aspirin group. Aspirin use was associated with better outcomes, even after the correction for confounders. While safety concerns arguably remain a problem, prospective trials for patients at low risk of bleeding are warranted.

Pulmonary embolism in Bujumbura

Relevance . Pulmonary embolism constitutes a diagnostic and therapeutic emergency. In Africa, data are still difficult to obtain. Thus, the objectives of this work is to describe epidemiological, clinical, therapeutic aspects and short-term outcomes of pulmonary embolism confirmed by thoracic angioscan at Kira hospital in Bujumbura, the biggest city of Burundi with population about 375 000. Patients and Methods . This was a descriptive study of 18 patients who had a pulmonary embolism confirmed by thoracic angioscan in Bujumbura from January 1st, 2015 to December 31st, 2018. We included in our study any patient with pulmonary embolism consenting to participate and processing personal data after some clarified explanations in accordance with the World Medical Associations Declaration of Helsinki. For each registered patient, we collected socio-demographic, past history of cardiac disease and factors risk, clinical, echocardiographic and scannographic findings with Wells score. Variables were presented as means and percentages. Results and Discussion. The average age was 53.5 12.3 years with a sex ratio of 1.25 in favor of women. The modal class was the 50 to 59 age group (33.3%). The clinical probability pre-test by simplified Wells score was high in 66.6% and medium in 33.3% of cases. A history of venous thromboembolic disease was the most common risk factor. Dyspnea was the most reason of consultation with 94.4% of cases. One patient died (5.6%) during hospitalization. Six months after discharge from the hospital, we recorded 3 cases (16.7%) of death, 6 cases (33.3%) of pulmonary heart, 3 cases (16.7%) of recurrent pulmonary embolism and one case of vitamin K antagonist overdose with minor bleeding. Conclusion. Pulmonary embolism is common in relatively young population with a predominance of females and chronic no communicable diseases as risk factors. Examination of a patient with an angioscanner is a sensitive and specific clinical study of pulmonary embolism. The outcome is favorable under appropriate treatment in short term.

A Rare Complication of Fine-Needle Aspiration of Neck Structures

Fine-needle aspiration (FNA) is a generally accepted tool for safe diagnostic evaluation in the workup of lesions and masses. Aside from the commonly discussed risks of infection and minor bleeding related to skin puncture, other more serious complications have been reported sparingly. We present two cases of pneumothorax from FNA of neck structures, which have been theorized but not previously reported to our knowledge. Discussion of cases of this complication rather than solely a theoretical understanding of it will aid in diagnosis and management of this complication.

Meta-Analysis of the Effectiveness and Safety of Intravenous Thrombolysis in Patients with Acute Cerebral Infarction

In this paper, a meta-analysis of the effectiveness and safety of intravenous thrombolysis in patients with acute cerebral infarction was carried out, the original literature inclusion criteria and retrieval strategies were developed, and the collection deadline was about new oral anticoagulants and other methods for the antithrombotic intravenous thrombolytic treatment of patients with acute cerebral infarction for the relevant literature on the safety and effectiveness comparison. First, the quality of the literature is evaluated according to whether the included studies are randomized controlled trials, whether there is randomized concealment, whether blinding is used, and whether they are withdrawn or lost to follow-up, and the RevMan 5.2 software is used for meta-analysis. At the same time, grey literature databases such as dissertations were experimentally searched, and all randomized controlled studies (RCT), nonrandomized controlled studies, case-controlled studies, cohort studies, case series reports, etc. of Wingspan in the treatment of intracranial atherosclerotic stenosis were collected. In the prevention of myocardial infarction in patients with acute cerebral infarction, the difference between the two was not statistically significant ( RR = 0.82 , 95% CI (0.57, 1.17), P = 0.27 ). Compared with other methods, it can significantly reduce the all-cause mortality of patients with nonvalvular venous thrombolysis, and the difference is statistically significant ( RR = 0.90 , 95% CI (0.85, 0.96), P = 0.001 ). Experimental results show that in terms of safety, the new oral anticoagulant is better than other methods in reducing minor bleeding in patients with acute cerebral infarction, and the difference is statistically significant ( RR = 0.87 , 95% CI (0.76, 0 99), P = 0.03 ); the effect is better than other methods in reducing the incidence of serious bleeding events, and the difference is statistically significant ( RR = 0.79 , 95% CI (0.74, 0.85), P < 0.00001 ).

Bleeding management in computed tomography-guided liver biopsies by biopsy tract plugging with gelatin sponge slurry

To evaluate the safety and impact of biopsy tract plugging with gelatin sponge slurry in percutaneous liver biopsy. 300 consecutive patients (158 females, 142 males; median age, 63 years) who underwent computed tomography-guided core biopsy of the liver in coaxial technique (16/18 Gauge) with and without biopsy tract plugging were retrospectively reviewed (January 2013 to May 2018). Complications were rated according to the common criteria for adverse events (NCI-CTCAE). The study cohort was dichotomized into a plugged (71%; n = 214) and an unplugged (29%; n = 86) biopsy tract group. Biopsy tract plugging with gelatin sponge slurry was technically successful in all cases. Major bleeding events were only observed in the unplugged group (0.7%; n = 2), whereas minor bleedings (4.3%) were observed in both groups (plugged, 3.6%, n = 11; unplugged, 0.7%, n = 2). Analysis of biopsies and adverse events showed a significant association between number of needle-passes and overall (P = 0.038; odds ratio: 1.395) as well as minor bleeding events (P = 0.020; odds ratio: 1.501). No complications associated with gelatin sponge slurry were observed. Biopsy tract plugging with gelatin sponge slurry is a technically easy and safe procedure that can prevent major bleeding events following liver biopsy.

Radiofrequency ablation for symptomatic, non-functioning, thyroid nodules: a single center learning curve

Objective: Radiofrequency ablation (RFA) is increasingly considered the prime option for treating symptomatic, benign, non-functioning thyroid nodules (NFTN). However, little is known about the degree of operator experience required to achieve optimal results. This study describes the RFA learning curve of a single-centre team. Methods: Retrospective cohort study of the first 103 patients receiving RFA treatment for a single, symptomatic, and benign NFTN, with a follow-up of at least one year. Primary outcome measure was technique efficacy, defined as the percentage of patients with a 6-month nodal volume reduction ratio (VRR) > 50% after single-session RFA. Optimal treatment efficacy was defined as a 6-month VRR > 50% achieved in at least 75% of patients. Secondary outcomes were complications of RFA and indications of secondary interventions. Results: Median nodal volume at baseline was 12.0 ml (range 2.0–58.0 ml). A 6-month VRR > 50% was achieved in 45% of the first 20 patients, 75% of the next 20, and 79% of the following 63 patients. Complications included minor bleeding (N = 4), transient hyperthyroidism (N = 4), and transient loss of voice (N = 1). Poor volume reduction or nodular regrowth led to diagnostic lobectomy in 11 patients and a second RFA in five. Lobectomy revealed a follicular carcinoma (T2N0M0) in two patients. In one patient, nodule regrowth was caused by an intranodular solitary B-cell lymphoma. Conclusion: About 40 procedures are required to achieve a 6-month VRR > 50% in the majority of patients. Appropriate follow-up with re-evaluation is recommended for all patients with a VRR < 50% and in those with regrowth to exclude underlying malignancy.

478 Clinical outcomes of patients at very high stroke risk undergoing watchman implantation

Aims Left atrial appendage occlusion (LAAO) with the Watchman device is an effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation at high thromboembolic risk. We sought to evaluate the safety and effectiveness of LAAO for stroke and bleeding prevention in patients at very high stroke risk. Methods and results Data were extracted from a prospective database of 488 AF patients who underwent LAA closure with a Watchman device. Periprocedural complications, thromboembolic (TE), and bleeding event rates among patients with a CHA2DS2-VASc ≥ 5 were reported. Predicted annual rates of TE or major bleeding events were compared to the annualized observed risk of the population. Overall, 209 patients with a CHA2DS2-VASc ≥5 (CHA2DS2-VASc: 6.0 ± 1.0; HAS-BLED: 3.7 ± 1.1) were included in the study. The mean age was 78 ± 6 years and 52.2% (n = 109) were males. Watchman implantation was successful in all patients. Overall procedure-related complication rate was 3.3% (n = 7). Two major complications were observed (1.0%): one pericardial tamponade requiring surgery and one major bleeding event at 3 days post-procedure. The incidence of minor complications was 2.3% (n = 5). Specifically, two patients experienced a pericardial effusion that required drainage and three had a groin hematoma. During a mean follow-up duration of 12 ± 5 months (193 pt/years), six TE events (2.9%/annualized rate: 3.1%) were documented after a median of 6.3 months (IQR: 2.2–9.6). Based on the estimated annual TE risk according to the CHA2DS2-VASc score (8.5%), the % risk reduction after LAAO was 63.5%. Four major bleeding events [1.9% (median time to event: 2.1 months; IQR: 1.0–3.4)] and five minor bleeding events occurred (2.5%) during follow-up. Compared to the expected rate of bleeding events as assessed by the HAS-BLED of the population (8.03%), LAAO led to a 42% reduction of bleeding risk. Conclusions In a population at very high TE risk, LAAO with the Watchman device was a safe and effective approach, and led to a 63.5% of stroke risk.

473 Propensity-matched comparison of left atrial appendage occlusion and direct oral anticoagulation for thromboembolic prevention in octogenarians

Aims A significant amount of atrial fibrillation patients does not receive appropriate anticoagulation, owing to contraindications and side effects. Octogenarians have higher competing comorbidities with a remarkable bleeding/thromboembolic (TE) risk. We aimed at analysing the clinical outcomes of LAAO compared with direct oral anticoagulation (DOAC) in octogenarians. Methods and results Data were extracted from two prospective databases including 488 LAAO and 825 DOAC patients. Patients aged 80 years or older accounted for 37.1% (n = 181) and 39.5% (n = 326). In order to attenuate the imbalance in covariates between the groups, a propensity score matching technique was used (covariates: age, sex, CHA2DS2-VASc, and HAS-BLED scores, follow-up duration; tolerance 0.02). This method resulted in matched populations with 108 octogenarian patients per group. The annual stroke/transient ischaemic attack (TIA) risk was estimated based on the CHA2DS2-VASc, and compared to the annualized observed risk, owing to calculate the % risk reduction associated with the two treatment strategies. A total of 216 octogenarians were included in the analysis (84 ± 3 years; CHA2DS2-VASc: 4.9 ± 1.4, HAS-BLED: 3.1 ± 0.9). A Watchman device was successfully deployed in all LAAO ≥ 80 patients; periprocedural adverse events were observed in 2.8% (n = 3) of LAAO patients. During a follow-up of 13 ± 4 months, 3 (2.8%) TE complications (1 stroke, 2 TIA) occurred in LAAO ≥ 80 pts and 4 (3.7%; 1 stroke, 3 TIA) in DOAC ≥ 80 pts (P = 0.99). The annualized risk of stroke/TIA was 2.5% in the first and 3.5% in the second group. Based on the estimated annual TE risk according to the CHA2DS2-VASc score, the % risk reduction after LAAO and DOAC was 54.5% and 36.4%, respectively. Major bleeding events were 3 [1 intracranial, 2 gastrointestinal (GI)] LAAO ≥ 80 pts, and 3 (2 intracranial, 1GI) in DOAC ≥ 80 pts (2.8% in both groups). Minor bleeding events were significantly higher in DOAC ≥ 80 pts [13.0% (n = 14) vs. 2.7% (n = 3); RR: 4.7, 95% CI: 1.4–15.7; P = 0.009]. Conclusions LAAO was safe and similar to DOAC at preventing ischaemic/major bleeding events in a matched population of patients aged ≥80 years. A significantly higher incidence of minor bleeding events was observed in the DOAC group.

426 Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation: a propensity matched analysis of a multicentre registry

Aims The transfemoral (TF) approach appeared to be the safest and the broadest used approach in TAVI, characterized by a lower rate of periprocedural bleedings and vascular complications and is currently recommended by the guidelines as a first line approach when feasible. If in the early experience TF access was achieved using a surgical cutdown approach, through the last years, there has been increasing evidence of the safety and efficacy of a fully percutaneous approach over a surgical access, albeit available evidences are controverting and mostly including first generation prostheses and high risk patients. The aim of the study is to compare percutaneous and surgical access in a large, real-word, multicentre of TF TAVI. Methods and results Consecutive patients undergoing successful TF TAVI were prospectively enrolled in local clinical registries of five high volume centres in Italy: IRCCS Ospedale Policlinico San Martino (Genoa), IRCCS Policlinico San Donato (Milan), Città Della Salute e della Scienza, (Turin), Ospedale Niguarda Ca’ Granda (Milan), Magna Graecia University, (Catanzaro), between January 2014 to December 2019. Univariate and multivariate analysis using IPTW were performed. A total of 1946 TF TAVI patients (female 42.8%) were prospectively included. Patients underwent surgical access had a significantly higher surgical risk (STS score of 8.9 vs. 6.4, P &lt; 0.001, and EuroSCORE of 15.1 vs. 8.7, P &lt; 0.001, respectively). Overall survival was comparable between the two groups (HR: 1.14, 95% CI: 0.76–1.71). Patients who underwent surgical access experienced more VARC-2 major and VARC-2 minor vascular complications (13% vs. 7%, P = 0.003 and 11% vs. 6.1%, P = 0.007, respectively) and more VARC-2 major/life threatening and minor bleeding (27.4% vs. 17.8, P = 0.001, and 9.6% vs. 2.1%, P &lt; 0.001, respectively). After IPTW adjustment, surgical access was associated with an increased risk of major vascular complications (HR: 3.32, 95% CI: 1.84–5.97), minor bleeding (HR: 4.24, 95% CI: 1.16–15.54) and stage 2–3 AKI (HR: 2.60, 95% CI: 1.07–6.33). Conclusions The performance of the percutaneous transfemoral TAVI approach was safe and feasible and resulted in fewer major vascular complications, bleedings and AKI than the surgical femoral isolation. Procedural time and hospital length were also lower in the percutaneous group. Routine application of the percutaneous approach might reduce acute complications in patients undergoing transfemoral TAVI and reduce procedural time and hospital length.