A comparison of simplified or conventional antithrombotic regimens after left atrial appendage closure in patients at high bleeding risk: the PLATEBRISK study.

BACKGROUND: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk. AIMS: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients. METHODS: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy). RESULTS: A total of 1,135 patients were included. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049). CONCLUSIONS: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.

Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion: The ADALA Randomized Clinical Trial.

Importance: Optimal antithrombotic therapy after percutaneous left atrial appendage occlusion (LAAO) is not well established as no randomized evaluation has been performed to date. Objective: To compare the efficacy and safety of low-dose direct oral anticoagulation (low-dose DOAC) vs dual antiplatelet therapy (DAPT) for 3 months after LAAO. Design, Setting, and Participants: The ADALA (Low-Dose Direct Oral Anticoagulation vs Dual Antiplatelet Therapy After Left Atrial Appendage Occlusion) study was an investigator-initiated, multicenter, prospective, open-label, randomized clinical trial enrolling participants from June 12, 2019, to August 28, 2022 from 3 European sites. Patients who underwent successful LAAO were randomly assigned 1:1 to low-dose DOAC vs DAPT for 3 months after LAAO. The study was prematurely terminated when only 60% of the estimated sample size had been included due to lower recruitment rate than anticipated due to the COVID-19 pandemic. Interventions: The low-dose DOAC group received apixaban, 2.5 mg every 12 hours, and the DAPT group received aspirin, 100 mg per day, plus clopidogrel, 75 mg per day, for the first 3 months after LAAO. Main Outcomes and Measures: The primary end point was a composite of safety (major bleeding) and efficacy (thromboembolic events including stroke, systemic embolism, and device-related thrombosis [DRT]) within the first 3 months after successful LAAO. Secondary end points included individual components of the primary outcome and all-bleeding events. Results: A total of 90 patients (mean [SD] age, 76.6 [8.1] years; 60 male [66.7%]; mean [SD] CHADS-VASc score, 4.0 [1.5]) were included in the analysis (44 and 46 patients in the low-dose DOAC and DAPT groups, respectively). A total of 53 patients (58.8%) presented with previous major bleeding events (60 gastrointestinal [66.7%] and 16 intracranial [17.8%]). At 3 months, low-dose DOAC was associated with a reduction of the primary end point compared with DAPT (2 [4.5%] vs 10 [21.7%]; hazard ratio, 0.19; 95% CI, 0.04-0.88; P = .02). Patients in the low-dose DOAC group exhibited a lower rate of DRT (0% vs 6 [8.7%]; P = .04) and tended to have a lower incidence of major bleeding events (2 [4.6%] vs 6 [13.0%]; P = .17), with no differences in thromboembolic events such as stroke and systemic embolism between groups (none in the overall population). Conclusions and Relevance: This was a small, randomized clinical trial comparing different antithrombotic strategies after LAAO. Results show that use of low-dose DOAC for 3 months after LAAO was associated with a better balance between efficacy and safety compared with DAPT. However, the results of the study should be interpreted with caution due to the limited sample size and will need to be confirmed in future larger randomized trials. Trial Registration: ClinicalTrials.gov Identifier: NCT05632445.

A clinical practice guideline for the management of the foot and ankle in rheumatoid arthritis.

Rheumatoid arthritis causes progressive joint destruction in the long term, causing a deterioration of the foot and ankle. A clinical practice guideline has been created with the main objective of providing recommendations in the field of podiatry for the conservative management of rheumatoid arthritis. Thus, healthcare professionals involved in foot care of adults with rheumatoid arthritis will be able to follow practical recommendations. A clinical practice guideline was created including a group of experts (podiatrists, rheumatologists, nurses, an orthopaedic surgeon, a physiotherapist, an occupational therapist and patient with rheumatoid arthritis). Methodological experts using GRADE were tasked with systematically reviewing the available scientific evidence and developing the information which serves as a basis for the expert group to make recommendations. Key findings include the efficacy of chiropody in alleviating hyperkeratotic lesions and improving short-term pain and functionality. Notably, custom and standardized foot orthoses demonstrated significant benefits in reducing foot pain, enhancing physical function, and improving life quality. Therapeutic footwear was identified as crucial for pain reduction and mobility improvement, emphasizing the necessity for custom-made options tailored to individual patient needs. Surgical interventions were recommended for cases which were non-responsive to conservative treatments, aimed at preserving foot functionality and reducing pain. Moreover, self-care strategies and education were underscored as essential components for promoting patient independence and health maintenance. A series of recommendations have been created which will help professionals and patients to manage podiatric pathologies derived from rheumatoid arthritis.

Ultrasound assessment of the spring ligament and posterior tibial tendon in healthy subjects: A descriptive study.

BACKGROUND: The main aim of this study was to ultrasonographically analyse the thickness and the relationship between the Superomedial Bundle of the Spring Ligament and the Posterior Tibial Tendon in healthy subjects and its relationship with different epidemiological variables. METHODS: Fifty-five healthy feet with a mean of 47 years old measuring the same ultrasound model and researcher. Demographic variables (age, sex, laterality, BMI, type of sports activity performed, and type of work activity) were collected from all participants. The thickness of the PTT and the Spring Ligament was measured in both longitudinal and transverse diameters. The intraclass correlation coefficient (ICC) was also analysed to assess the agreement of the measurements between a researcher and the ultrasound specialist radiologist. RESULTS: The mean thickness of the Spring ligament was 5.07 mm (95 % CI 4.75-5.38), while that of the PTT in its long axis was 3.58 mm (95 % CI 3.37-3.79). Regarding the interobserver agreement analysis, the intraclass correlation coefficient for measurements between observers was 0.91 (CI95 %: 0.698-0.977) which denotes a high degree of similarity between the clinician and the radiologist. CONCLUSION: This study describes the relationships between the thickness of the posterior tibial tendon and the superomedial Bundle of the Spring ligament in healthy subjects, as well as their variability according to certain epidemiological variables such as age, gender, occupation, and sport. On the other hand, the measurements taken by a researcher high agreement with those taken by a radiologist specialized in ultrasound.

Patient-Specific Commissural Alignment With a Self-Expanding Transcatheter Heart Valve.

A simple and reproducible technique to achieve commissural alignment during transcatheter aortic valve replacement with the Allegra valve is described. Slight rotation of the system before system insertion is necessary. Moreover, thanks to its permaflow system (Biosensors) and its radiopaque markings, small adjustments before valve deployment can be made to reassess correct alignment.

Left atrial appendage occlusion in patients suffering from advanced chronic kidney disease (stage 4 and 5). Long-term follow-up.

INTRODUCTION AND OBJECTIVES: Advanced chronic kidney disease (A-CKD) combined with atrial fibrillation increases the risk of both thrombogenic and bleeding events. Left atrial appendage occlusion (LAAO) may be an alternative to oral anticoagulation to prevent thromboembolic events. We aimed to evaluate the outcomes of LAAO in patients with A-CKD. METHODS: Comparison at long-term follow-up of patients diagnosed with and without A-CKD (eGFR<30 mL/min/1.73 m2 ) who underwent LAAO between 2009 and May 2022. RESULTS: Five hundred seventy-three patients were included. Eighty-one (14%) were diagnosed with A-CKD. There were no differences in sex, age, and cardiovascular risk factors, except for diabetes which was more frequent in patients with A-CKD. The control group had higher rates of stroke, both ischemic and hemorrhagic. There were no differences in the CHA2 DS2 -VASc score, although A-CKD patients had a higher bleeding risk according to the HASBLED scale. Global procedural success was 99.1%. At follow-up, there were no differences in stroke rate: at 1-year (HR: 1.22, IC-95%: 0.14-10.42, p = 0.861); at 5-years (HR: 0.60, IC-95%: 0.08-4.58, p = 0.594). Although bleeding events were higher in the A-CKD group, no differences were found in major bleeding (defined BARC ≥ 3) at 1-year (HR: 1.34, IC-95%: 0.63-2.88, p = 0.464) or at 5-years follow-up (HR: 1.30, IC-95%: 0.69-2.48, p = 0.434). Mortality rate at 5 years was higher in the A-CKD patients (HR: 1.84, IC-95%: 1.18-2.87, p = 0.012). CONCLUSIONS: LAAO is an effective and safe treatment in A-CKD patients to prevent ischemic events and bleeding. This strategy could be an alternative to oral anticoagulation in this high-risk group of patients.

Effectiveness and Safety of an Outpatient Program for Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a safe and effective alternative to oral anticoagulation for thromboprophylaxis in patients with nonvalvular atrial fibrillation. Technological development in devices and imaging techniques, as well as accumulated experience, have increased procedural success rates and decreased complications. Same-day discharge protocols have been proposed in the field of structural heart disease, but this approach has not been studied in detail for the LAAO procedure. AIM: The aim of this study is to assess the safety and efficacy of an outpatient program for LAAO when compared to the conventional treatment approach. METHODS: We present a retrospective, non-randomized single-center study of 262 consecutive patients undergoing LAAO. Patients were divided into two groups, the first (n = 131) followed a conventional protocol (CP), and the second (n = 131) an outpatient protocol (OP). The primary composite endpoint comprised MACCE (death, stroke, and bleeding), cardiac tamponade, vascular complication, or attendance in the emergency department after hospital discharge at 30 days. RESULTS: The overall success rate was 99.6%, with a periprocedural complication rate of 2.29%. With regards to the CP versus OP group, there were no differences between incidences of the primary composite endpoint (6.1% PC vs. 3.0% PA, p = 0.24), or after an analysis, with propensity score matching. No differences were observed in the individual endpoints. There was a decrease in hospital length of stay in the same-day discharge group (p < 0.01). CONCLUSIONS: A same-day discharge LAAO program is safe, effective, and feasible when compared to the conventional strategy. Moreover, it reduces hospital length of stay, which might have clinical and economic benefits.

The Classic Three-Month Post-Operative Adaptation Phase in Foot and Ankle Surgery-An Expert Perspective.

Foot and ankle disorders are a common reason for orthopedic surgical intervention. After surgery, specific precautions such as partial weight bearing or complete unloading, and the use of walking aids, coupled with a period of rest, are usually implemented to ensure the surgical outcome. However, when these aids are discontinued and the patients resume load increase and normal daily activities, they may enter a transitional phase characterized by inflammation, swelling, and pain. We call this phenomenon the "classic three-month post-operative adaptation phase" (POAP). It is essential to differentiate this physiological transition phase from other conditions, such as from the immediate post-surgical inflammation, complex pain regional syndrome, or an infection. The objective of this expert opinion is to describe and raise medical awareness of this evidence-based phenomenon, which we commonly observe in our daily practice.

Increased subtalar rotational motion in patients with symptomatic ankle instability under load and stress conditions.

PURPOSE: Differentiating subtalar and ankle instability in the clinical setting is challenging. This study aims to analyze the rotational laxity of the subtalar joint bilaterally in patients with asymptomatic and symptomatic ankle instability under simulated load and stress-induced position of the subtalar joint. METHODS: A case-control study was conducted using an adjustable load device (ALD). Patients with chronic ankle instability and healthy volunteers were included. Each subject underwent a CT scan under mechanical stress and simulated weight-bearing conditions, maintaining maximum eversion and inversion hindfoot positions. The images were obtained in a single model, allowing calculations of the motion vector as well as the helical axis. The helical axis was defined by a rotation angle and a translation distance. RESULTS: A total of 72 feet were included in the study. Thirty-one patients with unilateral symptoms and five healthy controls were selected, defining two groups: symptomatic (n = 31) and asymptomatic (n = 41). An absolute difference of 4.6º (95%CI 2-11.1) rotation angle was found on the helical axis of the symptomatic vs. asymptomatic group (p = 0.001). No significant differences were detected in the translation distance (n.s.) between the groups. Additionally, a significant positive correlation was found between the rotation angle and translation distance through the helical axis in the asymptomatic group (r = 0.397, p = 0.027). CONCLUSION: Patients with chronic ankle instability suspected of having subtalar joint instability showed a wider subtalar range of laxity in terms of rotation about the helical axis. Furthermore, differences in kinematics between symptomatic and asymptomatic hindfeet was demonstrated when both feet were compared. LEVEL OF EVIDENCE: III.

Complex Left Atrial Appendage Occlusion Using the Novel Amplatzer Steerable Delivery Sheath.

Left atrial appendage (LAA) occlusion has emerged as an al- ternative to oral anticoagulation in non-valvular atrial fibril- lation. The success rate is high, but we are still facing some challenging LAA anatomies that may increase the risk of sub- optimal results. These images show that the Amplatzer steer- able sheath is useful for LAA occlusion, especially in cases with challenging anatomies. Small variations of the distal end angle can improve the success rate and reduce complications.

Severe equinus cavo-varus correction through triplanar tarsectomy and posterior tibial tendon transfer based on 3D-printed biomodel.

Surgery for severe equine cavo-varus is complex and must be individualized. The interindividual phenotypic variability demands a personalized planning of each foot to be operated. The study's primary goal was to evaluate the function and satisfaction of a series of patients with severe equinus cavo-varus deformity who underwent a triplanar tarsectomy and transposition of the posterior tibial tendon in a single stage surgery after a patient specific 3D biomodel planning. A series of 12 feet (5 patients bilaterally) operated with this technique was analyzed. The cohort comprised 2 females (28.5 %) and 5 males (71.4 %). The median follow-up time was 38.5 months (interquartile range: 24.75-48.75). The Foot and Ankle Disability Index pre (median 32.85; interquartile range: 20-46) and postsurgery (median 72; interquartile range: 56-75.5) were collected and statistically significant differences were observed (p < 0.002). Furthermore, the main variable evaluated was obtaining a plantigrade stable foot. This was clinically evaluated and was achieved in all patients except 1 patient who presented a residual equinus of 5º. This study shows that triplanar tarsectomy and posterior tibial tendon transfer in a single surgical procedure after patient-specific 3D biomodel planning allows for improved function in patients with severe equinus cavus varus foot deformity.

Allograft and Autologous Reconstruction Techniques for Neglected Achilles Tendon Rupture: A Mid-Long-Term Follow-Up Analysis.

Achilles tendon ruptures that are not immediately recognized and treated are sometimes diagnosed as delayed injuries and may require different surgical repair options based on gap size. The potential complications associated with using an allograft for reconstruction may lead some surgeons to prefer the use of autologous techniques. However, allografts are often considered a salvagement option when large defects are present. In this study, we examined the long-term clinical outcomes and complications of 17 patients who underwent surgical repair for chronic ruptures with large gaps using both autologous and allograft techniques. During an 11-year period, nine patients were treated with autologous techniques (mean gap of 4.33 ± 1.32 cm) and Achilles allograft reconstruction was performed in eight patients (47.1%) (mean gap of 7.75 ± 0.89 cm). At a mean of 82 ± 36.61 months of follow-up, all 17 patients (100%) were able to perform a single heel rise and improved AOFAS (American Orthopaedic Foot and Ankle Society) and ATRS (Achilles Tendon Total Rupture Score) scores. No infections, complications, or re-ruptures were recorded at the end of the follow-up. No significant differences were found in the AOFAS and ATRS scales between both techniques. When an extensive defect is present, the reconstruction with an Achilles tendon allograft can be considered a proper treatment option, as it does not show a higher rate of complications than autologous techniques achieving similar functional outcomes.

Hindfoot motion through helical axis image-based on dynamic CT scan using an original simulated weightbearing device.

BACKGROUND: Determining the treatment of subtalar joint (STJ) instability requires a better understanding of the biomechanical principles underlying the condition and, a proper diagnosis. This study aimed to analyze "in vivo" the range of motion of the subtalar joint (STJ) measured on two (2D) and three dimensions (3D) image-based on CT Scan using an original device that maintains a simulated weightbearing. The secondary goal was to correlate the 2D and 3D measurement. METHODS: An observational study was conducted, using an original Dynamic Simulated Weightbearing Device. Asymptomatic ankles were included. Each subject underwent a CT scan under mechanical stress and simulated weightbearing conditions, maintaining maximum eversion and inversion hindfoot positions. The images were obtained, combining both inversion and eversion positions in a single model, which allows for to calculation of the motion vector as well as the helical axis. The helical axis (rotation angle and translation distance), subtalar tilt, anterior drawer, and, subtalar and calcaneocuboid uncoverage were the determinations. RESULTS: Forty asymptomatic ankles were included. The average range of motion of the STJ amounts to 31.5° ± 9.1° of rotation and 1.56 ± 0.8 mm of translation distance. The anterior drawer and subtalar uncoverage variables were statistically significantly related to each other (r = 0.57; P = 0.00001). However, these 2-D measured variables were not related to kinematic measures of rotation through the helical axis (3D) (p = 0.14; p = 0.19) CONCLUSIONS: The average range of motion of the STJ amounts to 31.5° ± 9.1° of rotation and 1.56 ± 0.8 mm of translation distance. We found no significant correlation between 2D and 3D measurements. In our opinion, the rotation angle and translation distance should be considered the most accurate measurements and should be calculated on every STJ instability for comparison with the asymptomatic population LEVEL OF EVIDENCE: Observational study.

Diagnosis of subtle syndesmotic instability using conventional CT-imaging and axial force in different foot positions.

BACKGROUND: Currently, there is no available method that can objectively and reliably detect subtle instability of the distal tibiofibular joint. The purpose of this study is to diagnose, using computerized axial tomography and an adjustable simulated loading device, subtle instability of the tibiofibular syndesmosis. METHODS: Fifteen healthy individuals and 15 patients with clinical suspicion of subtle instability of the tibiofibular syndesmosis (total 60 ankles) were studied using an adjustable simulated loading device (ASLD). This device allows to perform bilateral ankle CT scans in two forced foot and ankle positions (30° of plantar flexion, 15° of inversion, 20° of internal rotation and 15° of dorsal flexion, 15° of eversion, 30° of external rotation). Axial load was applied simultaneously in a controlled manner (70% body weight). Measurements on the axial image of computed tomography were: syndesmotic area (SA), fibular rotation (FR), position of the fibula in the sagittal plane (FPS), depth of the incisura (ID), anterior direct difference (ADD), middle direct difference (MDD) and posterior direct difference (PDD). RESULTS: Statistically significant differences were observed in the variable syndesmotic area between healthy (mean=-0.14, SD=4.33) and diseased (mean=16.82, SD=12.3)(p < 0.001). No statistically significant differences were found in the variables ADD, MDD, PDD, ID, FPS and FR. CONCLUSIONS: Measurement of syndesmotic area employing axial force and forced foot positions using the ASLD may be useful for the diagnosis of subtle tibiofibular syndesmosis instability.

Intraoperative checking of the first ray rotation and sesamoid position through sonographic assistance.

INTRODUCTION: Hallux valgus (HV) deformity affects the orientation of the metatarsophalangeal (MTP) joint in three planes. Displacement in the coronal plane results in axial rotation of the first metatarsal, with progressive subluxation of the first MTP joint. Multiple techniques have been described to correct the malrotation itself. However, none of them have checked intraoperatively the final position of the first metatarsal head and sesamoids previous to the fixation of the Lapidus procedure or first metatarsal bone osteotomies. The aim of this article is to describe a novel technique to check the first ray rotation and sesamoids position through sonographic assistance. MATERIALS AND METHODS: Before fixation of the Lapidus procedure, with the ankle in maximal dorsiflexion, the surgeon takes the linear ultrasound probe and places it on the sole to visualize the sesamoids, which should be viewed at the same level, with the flexor hallucis longus (FHL) centered between both. Once the ideal position of the head of the first ray has been achieved, temporary fixation with K-wires is performed over the first TMT joint and M1-M2 joint for further sonographic verification of the sesamoids beneath the first metatarsal head. The height of the sesamoids relative to the second metatarsal head should be checked by sonographic control too. RESULTS: Four patients were included. Three females and one male. Their mean age was 76.4 years (R 61-72). Their mean BMI was 29 (R 27.5-32.24). The mean IMA (intermetatarsal angle) was 18.2 (R 17.2-19) degrees and the mean MPA (metatarsophalangeal angle) was 50 (R 36-63) degrees. CONCLUSIONS: Sonographic assistance, is a widely available, inexpensive, and comparative imaging technique that can guide the first ray rotation and sesamoids position in HV surgery, theoretically improving radiological outcomes.