Significant Improvement In Functional Status Research Articles

Efficacy of using autologous cells with graft substitutes for spinal fusion surgery: A systematic review and meta-analysis of clinical outcomes and imaging features.

Over the past several decades, there has been a notable increase in the total number of spinal fusion procedures worldwide. Advanced spinal fusion techniques, surgical approaches, and new alternatives in grafting materials and implants, as well as autologous cellular therapies, have been widely employed for treating spinal diseases. While the potential of cellular therapies to yield better clinical results is appealing, supportive data are needed to confirm this claim. This meta-analysis aims to compare the radiographic and clinical outcomes between graft substitutes with autologous cell therapies and graft substitutes alone. PubMed, Scopus, Web of Science, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials were searched for studies comparing graft substitutes with autologous cell therapies and graft substitutes alone up to February 2024. The risk of bias of the included studies was evaluated using the Downs and Black checklist. The following outcomes were extracted for comparison: fusion success, complications/adverse events, Visual Analog Scale (VAS) score, and Oswestry Disability Index (ODI) score. Thirteen studies involving 836 patients were included, with 7 studies considered for the meta-analysis. Results indicated that the use of graft substitutes with autologous cell therapies demonstrated higher fusion success rates at 3, 6, and 12 months, lower VAS score at 6 months, and lower ODI score at 3, 6, and 12 months. The complication rate was similar between graft substitutes with autologous cell therapies and graft substitutes alone. Although the current literature remains limited, this meta-analysis suggests that the incorporation of cellular therapies such as bone marrow and platelet derivatives with graft substitutes is associated with a higher fusion rate and significant improvements in functional status and pain following spinal fusion. Future well-designed randomized clinical trials are needed to definitively assess the clinical effectiveness of cellular therapies in spinal fusion.

Results of a 24-week open-label, non-interventional study on the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic

In the context of the new coronavirus infection (NCI) COVID-19 pandemic, the rheumatological community is facing new challenges in the treatment of immune-inflammatory rheumatic diseases (IIRDs). It has been shown that rheumatological patients have an increased risk of infections and a severe course of NCI and that IIRD therapy also influences the disease outcomes. In particular, the use of the anti-B-cell medication rituximab (RTM) is associated with a higher risk of severe NCI and increased mortality. The COVID-19 pandemic has highlighted the need to find alternative and safe treatment options for these patients. This work is the continuation of a 12-week study on the efficacy and safety of olok-izumab (OKZ) therapy in patients with rheumatoid arthritis (RA) after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic. Objective: to evaluate the efficacy and safety of OKZ (Artlegia®; solution for subcutaneous administration, 160 mg/ml – 0.4 ml) for the treatment of patients with RA in real-life clinical practice after switching from RTM during the COVID-19 pandemic. Material and methods. The study included 19 patients with a confirmed diagnosis of RA who had received RTM at a dose of 500–1000 mg twice every 14 days at least 6 months ago. As disease activity increased, RTM was replaced with OKZ while therapy with synthetic disease-modifying anti-rheumatic drugs (DMARDs) was continued. At weeks 0, 4, 8, 12 and 24 after switching the biologic DMARD, the number of tender (TJN) and swollen (SJN) joints out of 28, pain intensity on a visual analogue scale, ESR, CRP level, disease activity indices CDAI, DAS28-ESR, DAS28-CRP, HAQ index and the safety profile of the therapy were assessed at each visit. Results and discussion. After 4, 8, 12 and 24 weeks of OKZ administration, there was a statistically significant decrease in mean TJN (from 10 to 6.0, 3.0, 5.0 and 4.0, respectively; p < 0.05) and SJN (from 7.0 to 3.0 by week 4 and to 2.0 by weeks 8, 12 and 24; p < 0.05). At the same time, a decrease in CRP and ESR values was also observed: median CRP decreased from 18 to 0.6 mg/l by week 4 and to 0.5 mg/l by weeks 8, 12 and 24 (p < 0.05), ESR from 30 to 5 mm/h in each study period (p < 0.05). CRP levels normalized by week 4, regardless of baseline values. All RA activity indices showed a positive dynamic compared to baseline values from week 4 onwards in each assessment period. After weeks 4, 8, 12 and 24, the median DAS28-ESR decreased from 5.50 to 3.57; 3.30; 3.08 and 3.01 (p < 0.05); DAS28-CRP – from 5.30 to 3.46; 3.23; 3.26 and 3.12 (p < 0.05); CDAI – from 27.0 to 17.0; 12.0; 15.0 and 12.0 (p < 0.05), respectively. All patients showed a decrease in pain by the 4th week of observation. A statistically significant improvement in functional status was observed after the 4th week of therapy and was maintained until week 24. The median HAQ index decreased from 1.62 to 1.50 at weeks 4, 8 and 12 and to 1.12 at week 24 (p < 0.05). Conclusion. The study showed that the non-medical switch from RTM to OKZ during the COVID-19 pandemic was effective and safe.

Long-term results of treatment of a patient with basilar invagination complicated by distal kyphosis and compressive ischemic cervical myelopathy: a clinical case and a brief literature review

Objective. To present a clinical case of surgical correction of a craniovertebral anomaly complicated after 8 years by distal junctional kyphosis, stenosis, antelisthesis of the C5 vertebra and compressive ischemic cervical myelopathy in the C5–C6 segment.Material and Methods. When treating a 56-year-old patient with multiple anomalies of the craniovertebral region, differentiated surgical technologies were consistently used due to the development of late complications. The sequence and rationale for surgical decision making is described.Results. Initially, the patient underwent transoral decompression and posterior occipitocervical fixation, and after 8 years - reinstallation of the system with distal extension of the instrumentation zone to the C7 vertebra with indirect posterior decompression of the spinal cord, anterior discectomy with direct decompression and cage fixation at the C5–C6 level. Regression of myelopathic syndrome, correction of orthopedic status and significant improvement in functional status were achieved.Conclusion. A rare clinical observation demonstrates a combination of basilar invagination with assimilation of the atlas, which has provided rationale for two-stage surgical treatment in one surgical session (1st stage – transoral resection of the dens and 2/3 of the C2 vertebral body with anterior decompression of the spinal cord, and 2nd stage – occipitocervical fixation). The use of extended systems in this case caused the development of a clinically significant syndrome of the distal adjacent level, which required repeated surgical treatment after 8 years.

Minimally invasive interventions on celiac plexus in patients with persistent abdominal pain caused by pancreatic cancer

Background. Chronic abdominal pain is common in 50 % of patients with intra-abdominal malignancies and has a huge impact on quality of their lives. As the number and doses of systemic analgesics increase, so does the frequency of side effects that can further worsen functional status, which is important for this cohort of patients who have a five-year survival rate of only 8 %. The purpose of the study: to assess the efficacy and safety of computed tomography-guided celiac plexus neurolysis as a method of reducing persistent, severe pain in patients with pancreatic cancer that affects their functional status. Materials and methods. The analysis of the results of 17 interventional procedures on the celiac plexus in 16 participants was conducted, sympatholysis was performed twice in one patient. Inclusion criteria: pancreatic cancer with persistent pharmacoresistant neuropathic abdominal pain for ≥ 3 months, which did not respond to medications, including opioids, anti-inflammatory drugs, and other conservative methods of treatment. Age of patients was 39 to 72 years (mean of 62.6 ± 8.2 years), 10 (62.5 %) research participants were male and 6 (37.5 %) were female. Results. Interventions were successfully performed for all patients on the first attempt. There were no cases of perforations of hollow organs, damage to blood vessels, pleural sinuses, or other structures of the abdominal and thoracic cavities. No neurological complications were recorded, and no one required blood transfusion. All study patients had a significant reduction in pain on the visual analogue scale compared to baseline, both one week after the procedure, from 9.7 ± 0.6 to 4.7 ± 1.4 (P < 0.001), and in six months, from 9.7 ± 0.6 to 4.1 ± 1.4 (P < 0.001). The average Karnofsky Performance Status Scale score compared to the data before the procedure, one week after increased from 64.7 ± 7.9 to 78.2 ± 6.4 (P < 0.001). A significant improvement in functional status was maintained up to three months — 71.2 ± 6.9 (P < 0.001). However, in six months, this indicator was 63.5 ± 6.0 (Р = 0.668), which may be related not only to the intensity of the pain syndrome, but also to other complications of the underlying disease (ascites, cachexia, tumor growth, palliative surgical interventions, etc.). Conclusions. Computed tomography-guided celiac plexus neurolysis is a safe and effective procedure for patients with abdominal pain caused by inoperable pancreatic cancer. Sympatholysis provides a long-term significant reduction in pain syndrome according to the visual analogue scale after 1, 3, 6 months (Р < 0.001) and increases the functional status of patients according to the Karnofsky Performance Status Scale in 1 (Р < 0.001), 3 months (Р = 0.023). Celiac plexus neurolysis should be considered as part of a multidisciplinary approach to the comprehensive treatment of upper abdominal pain associated with cancer in the early stages of the disease.

Comprehensive Geriatric Assessment of Older and Oldest-Old Patients in the Perioperative Period. Russian Gerontology Research and Clinical Centre Experience

With the aging population, the significance of preoperative diagnostics and optimizing the treatment of surgical patients with frailty syndrome is gaining momentum. For such patients a comprehensive geriatric assessment (CGA) is carried out to clarify the severity of frailty and the individual characteristics of the geriatric status [1]. The results of this assessment are used to stratify the risk in the postoperative period and to determine targeted interventions for the correction of geriatric syndromes [2]. The introduction of new geriatric technologies during hip and knee replacement in weakened older patients needs scientific justification and confirmation of effectiveness.Objective: to test the method of complex geriatric management of older and oldest-old patients before and after surgical interventions in the provision of planned inpatient orthopedic care (knee and hip arthroplasty).Materials and methods: the study involved two groups of older and oldest-old patients with frailty: 50 patients, average age 69.2 ± 6.0 years [60 to 87 years] with gonarthrosis and 50 patients, average age 67.6 ± 5.5 years [60 to 81 years] with coxarthrosis. At the prehospital stage, patients were diagnosed with frailty, in accordance with the clinical recommendations of «Senile asthenia» [3]. Upon admission to surgical treatment, a CGA was performed, including indicators of basic (Barthel Activities of daily living Index, Barthel scale [4]) and instrumental activity (The Instrumental Activities of Daily Living Scale, IADL scale [5]), nutrition assessment (Mini Nutritional assessment, MNA scale [6]), cognitive functions (The Montreal Cognitive Assessment, MOCA test [7]), depression (Geriatric Depression Scale, GDS-15 scale [8]), as well as quality of life (A Visual Analogue Scale, EQ-VAS scale [9]), multimorbidity and polypragmasia. An individual plan of perioperative management was drawn up.Results. A comparative analysis demonstrated statistically significant improvements in functional status (based on the Barthel scale), cognitive status (based on the MOCA test), nutritional status (based on the MNA scale) and quality of life (based on the EQ-VAS scale) 12 months after surgical intervention in groups of patients after knee and hip replacement. In the group of patients after hip replacement, there was also an improvement in the quality of life of patients 12 months after surgery. The assessment and dynamics of indicators in functional and cognitive status within the control group were not carried out, which makes it difficult to compare the results. However, there was a reduction in hospital stay for patients using geriatric approaches compared with previously used surgical care in the control group.Conclusion: the management of patients with frailty in the perioperative period with the use of CGA allows for preventive measures aimed at maintaining functional, psycho-emotional status. Individual characteristics of the state of psychoemotional and functional status in older and oldest-old patients may not be considered during the traditional preoperative risk stratification and increase the risks of adverse outcomes of surgical treatment, duration of hospital staying and repeated hospitalizations.

Эффективность программы ранней реабилитации с применением дистанционных технологий на амбулаторном этапе у пациентов после хирургической коррекции приобретенных клапанных пороков сердца

Aim: to investigate the clinical safety and efficacy of a combined rehabilitation consisting of early rehabilitation with physical training in the hospital and remote rehabilitation using a mobile application in the outpatient setting after surgery for acquired valvular heart disease (VHD) using bypass Patients and Methods: the study involved 68 patients who underwent surgery for VHD, with 34 patients in the study group and 34 patients in the control group, based on their rehabilitation approach The study group consisted of two subgroups based on the type of rehabilitation. The subgroup that underwent complex rehabilitation (n=16) participated in treadmill training for 2 weeks in the inpatient setting at least 8 days after surgery, followed by remote rehabilitation in the outpatient setting using a mobile application. The subgroup that underwent remote rehabilitation (n=18) did not undergo early inpatient treadmill training. The control group only received standard cardiac rehabilitation methods Results: there were no significant differences in the rate or type of complications during the early postoperative period A more significant improvement in functional status was reported in the subgroup that underwent complex rehabilitation 24 days after surgery, compared to patients who did not receive early physical training as part of their rehabilitation program. The subgroup undergoing complex rehabilitation showed a significantly greater improvement in exercise tolerance (p=0.03) and peak oxygen uptake (p=0.04) 24 days after surgery. These indices continued to increase (p=0.04; p=0.03) by month 4 of the follow-up compared to postoperative day 7. These changes were more significant in the complex rehabilitation group than in the remote rehabilitation group. Patients who underwent complex rehabilitation showed better adherence to using the mobile application for remote rehabilitation than patients who underwent remote rehabilitation (50% vs. 38.8%; p=0.04). Conclusion: the rehabilitation program for patients after surgery for VHD, which includes early moderate-intensity physical treadmill training followed by outpatient distance rehabilitation using a mobile application, is safe and effective This is demonstrated by a significant improvement in functional status Additionally, early initiation of physical training is associated with better adherence to further use of distance rehabilitation technologies KEYWORDS: valvular heart disease, heart surgery, postoperative cardiac rehabilitation, early rehabilitation, remote rehabilitation FOR CITATION: Lyapina I.N., Argunova Yu.A., Dren E.V.', Chereneva L.A., Barbarash O.L. Effectiveness of early rehabilitation program with remote technologies in the outpatient setting after surgery for acquired valvular heart disease. Russian Medical Inquiry. 2024;8(1):16–25 (in Russ.). DOI: 10.32364/2587-6821-2024-8-1-3.

Effectiveness of Community‐Based Multidisciplinary Integrated Care for Older Adults with General Practitioner Involvement: A Systematic Review and Meta‐Analysis

Background. Changing demographics has led to healthcare systems reorientating healthcare delivery towards the community setting and implementing integrated models of care worldwide. This systematic review examines the effectiveness of community‐based multidisciplinary integrated care strategies with general practitioner (GP) participation for community‐dwelling older adults and describes the level of care integration in each study. Methods. PubMed, Embase, CINAHL, Central Register of Controlled Trials in the Cochrane Library, and MEDLINE were systematically searched in February 2024. Randomised controlled trials (RCTs) or cluster RCTs that focused on interventions for community‐dwelling older adults delivered by health and social care professionals with GPs were included. Two reviewers independently conducted the risk of bias assessment, applied the GRADE tool to quantify the certainty of evidence, and used the rainbow model of integrated care taxonomy to describe the elements of integrated care. Outcomes included functional status, healthcare utilisation, participant satisfaction with care, health‐related quality of life, mortality, nursing home admission, and adverse outcomes. Meta‐analyses were performed using Review Manager 5.4. Results. Twelve trials recruiting 8069 participants across 8 countries were included. Community‐based multidisciplinary team (MDT) integrated care demonstrated significant improvements in functional status (standardised mean difference (SMD): 0.21; 95% confidence interval (CI): 0.05–0.37; low certainty evidence), hospitalisation (risk ratio (RR): 0.77; 95% CI: 0.63–0.95; very low certainty evidence), and participant satisfaction with care (SMD: 0.46; 95% CI: 0.15–0.76; low certainty evidence) from 12 to 36 months. No statistically significant effects favouring community‐based MDT interventions for functional status at 6‐month follow‐up, emergency department presentation, mortality, health‐related quality of life, or nursing home admission were established. Conclusion. Community‐based MDT integrated care with GP participation improves functional status, reduces hospitalisations, and increases patient satisfaction among community‐dwelling older adults in the long term. Future research should focus on models of integrated care that respond to the needs and preferences of older adults. This trial is registered with CRD42022309744.

Abstract 14130: Efficacy and Safety of Endovascular Therapy in Stroke Patients With Large Ischemic Core in Comparison to Medical Management: Meta-Analysis of Randomized Control Studies

Introduction: Endovascular therapy (EVT) is a treatment recommended for stroke patients with large vessel occlusion and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥6. However, the utility of EVT in patients with large core ischemic stroke has not been well established. Methods: This meta-analysis assesses EVT's efficacy and safety using available trials comparing EVT to medical management (MM) in stroke patients with large ischemic core. Eligibility criteria: 1) were randomized controlled trials, 2) compared EVT with MM alone, 3) studied patients presenting with LIC cerebrovascular events, and 4) reported outcomes of interest. We extracted data for the major imaging inclusion criteria, the National Institutes of Health Stroke Scale (NIHSS) score, pre-stroke mRs score, and occlusion site. We also extracted outcome data for the EVT groups vs MM groups, including measurement of early neurological recovery, and definition of sICH. Results: Our primary end point was the mean modified Rankin scale score (RSS) at 90-day follow up. EVT was associated with higher odds of significant improvement in functional status with reduction in mean mRS by -0.31 [-0.47; -0.14]) compared to MM. The odds of achieving mRS 0 to 2 was higher in the EVT arm compared to the MM arm (2.53 [1.59; 4.02]). There was no difference in achieving mRS 0 to 3, early neurologic improvement defined according to NIHSS score, overall 90-day mortality and risk of symptomatic ICH between patients treated with EVT or MM in our analysis. Conclusions: Our study suggests that EVT may lead to improved outcomes in stroke patients with large core ischemia.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Three-level ACDF versus 3-level laminectomy and fusion: are there differences in outcomes? An analysis of the Quality Outcomes Database cervical spondylotic myelopathy cohort.

The authors sought to compare 3-level anterior with posterior fusion surgical procedures for the treatment of multilevel cervical spondylotic myelopathy (CSM). The authors analyzed prospective data from the 14 highest enrolling sites of the Quality Outcomes Database CSM module. They compared 3-level anterior cervical discectomy and fusion (ACDF) and posterior cervical laminectomy and fusion (PCF) surgical procedures, excluding surgical procedures crossing the cervicothoracic junction. Rates of reaching the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) were compared at 24 months postoperatively. Multivariable analyses adjusted for potential confounders elucidated in univariable analysis. Overall, 199 patients met the inclusion criteria: 123 ACDF (61.8%) and 76 PCF (38.2%) patients. The 24-month follow-up rates were similar (ACDF 90.2% vs PCF 92.1%, p = 0.67). Preoperatively, ACDF patients were younger (60.8 ± 10.2 vs 65.0 ± 10.3 years, p < 0.01), and greater proportions were privately insured (56.1% vs 36.8%, p = 0.02), actively employed (39.8% vs 22.8%, p = 0.04), and independently ambulatory (14.6% vs 31.6%, p < 0.01). Otherwise, the cohorts had equivalent baseline modified Japanese Orthopaedic Association (mJOA), Neck Disability Index (NDI), numeric rating scale (NRS)-arm pain, NRS-neck pain, and EQ-5D scores (p > 0.05). ACDF patients had reduced hospitalization length (1.6 vs 3.9 days, p < 0.01) and a greater proportion had nonroutine discharge (7.3% vs 22.8%, p < 0.01), but they had a higher rate of postoperative dysphagia (13.5% vs 3.5%, p = 0.049). Compared with baseline values, both groups demonstrated improvements in all outcomes at 24 months (p < 0.05). In multivariable analyses, after controlling for age, insurance payor, employment status, ambulation status, and other potential clinically relevant confounders, ACDF was associated with a greater proportion of patients with maximum satisfaction on the North American Spine Society Patient Satisfaction Index (NASS) (NASS score of 1) at 24 months (69.4% vs 53.7%, OR 2.44, 95% CI 1.17-5.09, adjusted p = 0.02). Otherwise, the cohorts shared similar 24-month outcomes in terms of reaching the MCID for mJOA, NDI, NRS-arm pain, NRS-neck pain, and EQ-5D score (adjusted p > 0.05). There were no differences in the 3-month readmission (ACDF 4.1% vs PCF 3.9%, p = 0.97) and 24-month reoperation (ACDF 13.5% vs PCF 18.6%, p = 0.36) rates. In a cohort limited to 3-level fusion surgical procedures, ACDF was associated with reduced blood loss, shorter hospitalization length, and higher routine home discharge rates; however, PCF resulted in lower rates of postoperative dysphagia. The procedures yielded comparably significant improvements in functional status (mJOA score), neck and arm pain, neck pain-related disability, and quality of life at 3, 12, and 24 months. ACDF patients had significantly higher odds of maximum satisfaction (NASS score 1). Given comparable outcomes, patients should be counseled on each approach's complication profile to aid in surgical decision-making.

1198 Outcomes Following Internal Bracing for Anterior Sternoclavicular Joint Instability: A Systematic Review

Abstract Aim There is a paucity of data regarding optimal treatment strategies for atraumatic sternoclavicular joint (SCJ) instability, as this is a relatively uncommon aetiology. Atraumatic SCJ instability may be due to capsular laxity, muscle sequencing or a combination of both. This study aims to systematically review the literature regarding SCJ instability with isolated capsular laxity to determine whether anterior capsular surgical plication and augmentation with internal bracing can prevent further episodes of instability in a population that is refractory to non-operative management. Method Studies that reported functional surgical outcomes were identified using the search terms “sternoclavicular AND joint AND dislocation AND reconstruction”. Nine studies and a total of 111 patients were identified to have met the inclusion criteria. Results Of the 111 patients identified, 9% of patients reported residual instability. 5.4% required a reoperation due to persistent impairment of shoulder function related to SCJ instability or osteoarthritis. There were satisfactory reported outcomes in 91% of patients. Conclusions Internal stabilisation techniques for atraumatic sternoclavicular joint (SCJ) instability have shown to be an effective method to improve shoulder function and patient symptoms. Revision rates remained at only 5.4% with a significant improvement in functional status. Complications were rare and included haematoma formation and discharging wound site. Therefore, internal bracing techniques should be considered in patients with chronic anterior SCJ instability after a course of failed conservative treatment.

Introduction of SGLT2 Inhibitors and Variations in Other Disease-Modifying Drugs in Heart Failure Patients: A Single-Centre Real-World Experience.

The sodium-glucose cotransporter-2 inhibitors (SGLT2i) have emerged as a crucial therapeutic option for patients with chronic heart failure with reduced ejection fraction (HFrEF). The aim of this study was to evaluate, in a real-world population from a single centre, the feasibility of introducing SGLT2i and their interaction with other recommended drug classes. Consecutive patients affected by chronic heart failure (CHF) were evaluated beginning in January 2022. At the baseline clinical visit, both the patient's current medication and the prescribed treatments were recorded. Over a 6- to 12-month follow-up, changes in concomitant therapy were analysed. At baseline, among 350 patients evaluated, only 17 (5%) were already taking SGLT2i: 13 with HFrEF, five with mildly reduced (HFmrEF), preserved (HFpEF) or improved (HFimpEF) ejection fraction. After the baseline assessment, SGLT2i were prescribed to 224 (64%) of the patients, including 179 (84%) with HFrEF, 27 (42%) with HFmrEF/HFimpEF, and 18 (22%) with HFpEF/HFimpEF. After follow-up, SGLT2i therapy was well tolerated and was associated with a significant increase in sacubitril/valsartan prescriptions and a decrease in diuretic use. Finally, a significant improvement in functional status and left ventricular systolic function after SGLT2i therapy was observed. In this single-centre, real-world study, SGLT2i were primarily prescribed to HFrEF patients who were already on other recommended drug classes for their treatment. Additionally, there was a noticeable enhancement in the prescribed therapy during a short-term follow-up. These findings further bolster the inclusion of this therapeutic approach in regular clinical practice.

Is Transcatheter Aortic Valve Replacement Futile in Patients Over Ninety Years of Age?

BackgroundClinical outcomes and quality of life (QoL) indices are not well described after transcatheter aortic valve replacement (TAVR) in patients aged ≥ 90 years. MethodsWe conducted a retrospective cohort study of TAVR among nonagenarian patients between 2008 and 2020. The survival of TAVR patients among nonagenarians was compared to the provincial estimated survival for an age- and sex-matched general population. QoL was assessed up to 1 year postintervention, using standardized questionnaires. ResultsDuring the study period, n = 268 patients aged ≥ 90 years were evaluated for severe aortic stenosis. TAVR was performed in n = 171 (48% female; median [IQR] Rockwood Clinical Frailty Scale score: 4 [3-4]); n = 84 underwent medical therapy; and n = 13 underwent surgical aortic valve replacement. Survival was significantly better following TAVR, compared to that after MT (adjusted hazard ratio [95% CI]: 1.99 [1.37-2.88], P < 0.001). TAVR patients demonstrated a survival advantage compared with the general population, with an estimated relative mortality of 0.86 (0.75-0.87). TAVR patients showed sustained improvements in functional status and QoL up to 1 year compared to baseline (all P < 0.05): the 6-minute walk test results improved from 192 to 252 m; the Kansas City Cardiomyopathy Questionnaire score improved from 64 to 81; the Duke Activity Status Index score improved from 13 to 16; and the health state scale result of the Euro Quality of life - 5 Dimensions improved from 63% to 74%. ConclusionsNonagenarians undergoing TAVR experience a slightly better survival rate, compared to that of an age- and sex-matched general population, and they have significant improvements in functional status and several QoL indices following the procedure.

C15 PERCUTANEOUS EDGE–TO–EDGE REPAIR USING EDWARDS PASCAL SYSTEM FOR SEVERE TRICUSPID REGURGITATION IN CONGENITALLY CORRECTED TRANSPOSITION OF THE GREAT ARTERIES

Abstract Introduction Congenitally corrected transposition of the great arteries (ccTGA) is a rare cardiac malformation characterized by ‘double’ discordance of atrioventricular and ventriculo–arterial connections, resulting in a systemic tricuspid atrioventricular valve and a systemic right ventricle. Clinical case We describe a case report of 54 years–old male patient with ccTGA, diagnosed when he was 3 years–old. Patient performed regular follow–up. Since December 2019, the patient reported onset of effort dyspnoea (NYHA III), fatigue and exercise intolerance. Despite medication optimization, his symptoms persisted. He was referred at our Centre for specialist evaluation. Transthoracic echocardiography showed mild dilatation and dysfunction of right ventricle, massive systemic tricuspid valve regurgitation (EROA 42 mm2), due to multiple jets and systolic pulmonary artery pressure of 45 mmHg. As reported by most recent guidelines, indication was given for surgical replacement of the systemic tricuspid valve. However, the patient refused the cardiac surgery option. Transesophageal echocardiography (TEE) screening showed feasibility of percutaneous approach to tricuspid regurgitation. Being the jet central, the strategy was to place one device implant between the septal and the anterior leaflet (9–3 oriented), as central as possible. Following simultaneous leaflet capture and further optimization of leaflet, the result was excellent. Post–implant deployment TEE revealed only mild–to–moderate residual tricuspid regurgitation, with no tricuspid stenosis (mean gradient 2 mm Hg). The result was a percutaneous bicuspidization of a tricuspid systemic valve. The patient recovered quickly and was discharged to home 2 days after the procedure. Patient experienced significant improvement in functional status (NYHA I), exercise capacity and quality of life at 6 months follow–up. Conclusions In ccTGA patients, treatment of severe tricuspid regurgitation and improvement of the systemic ventricle’s systolic function is critical since progression of dysfunction of the RV and tricuspid regurgitation are considered key determinants for morbidity and mortality in these patients. Based on the results obtained in our case, percutaneous edge–to edge repair seems to be a reasonable alternative to the surgical approach and three–dimensional transesophageal echocardiography is imperative for the proper visualization of the leaflets outcome of the procedure and his durability.

PO-01-044 THEOPHYLLINE FOR TREATMENT OF PAINFUL LEFT BUNDLE BRANCH BLOCK

Painful left bundle branch block (LBBB) is characterized by chest pain in setting of transient LBBB, in the absence of ischemia. Management has focused on pharmacological suppression of the sinus rate to prevent LBBB, or invasive therapy with permanent pacing. To determine the feasibility of using oral theophylline for treatment of painful LBBB. N/A A 71-year-old man presented for evaluation of exertional left-sided chest pain that resolved with rest. 12-lead electrocardiogram (ECG) showed sinus bradycardia at 54 bpm. Transthoracic echocardiogram was normal and coronary angiography showed non-obstructive coronary artery disease. Symptoms persisted despite treatment for microvascular angina with beta-blockers and ranolazine. Heart rate and ECG monitoring using an Apple watch demonstrated reproducible symptoms when heart rate increased above 80 bpm and resolution with decrease in heart rate below this threshold. Electrophysiology study demonstrated rate-related left bundle branch block and concurrent onset of symptoms with atrial pacing at a cycle length of 550 ms (∼109 bpm) (Panel A) and prompt resolution of symptoms with narrowing of QRS at lower pacing rates. Transient right bundle branch block was intentionally induced with catheter manipulation (Panel B) and atrial pacing produced 1:1 conduction down the left bundle with right bundle branch block up to 113 bpm with no symptoms and then to 2:1 block above the His (Panel C). Isoproterenol infusion allowed for atrial pacing up to 127 bpm without evidence of LBBB (Panel D). The patient was then discharged on theophylline 100 mg bid, which has a similar chronotropic and dromotropic effect as isoproterenol. He reported significant improvement in functional status with no recurrence in symptomatic LBBB. We report the first case of successful treatment of painful LBBB with oral theophylline. The mechanism may be improvement in conduction in damaged fibers to the left bundle. Theophylline should be considered in patients with painful LBBB in whom sinus node suppression has been unsuccessful and invasive management with permanent pacemaker is not desired.

Right ventricular cardiac resynchronization therapy in patients with right ventricular conduction delay and heart failure

Right ventricular cardiac resynchronization therapy in patients with right ventricular conduction delay and heart failure

Comparative evaluation of pre and post operative functional outcomes determined by Lysholm knee score of patients undergoing arthroscopic anterior cruciate ligament reconstruction

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; The anterior cruciate ligament (ACL) is the primary stabilizer of the knee joint and prevents the knee against anterior translation. After ACL tears, most patients experience recurrent episodes of instability (give way), pain and decreased function. Purpose of our study was to comparative evaluation of functional outcomes of pre and post operative patients after arthroscopic ACL reconstruction by using Lysholm knee score and its complications.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This is a prospective interventional study which were included total 45 patients undergoing arthroscopic ACL reconstruction by using hamstring autograft. Postoperatively patients were followed up at 6, 9 and 12 months for functional assessment by using Lysholm knee score.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; After ACL reconstruction increment in mean Lysholm knee score during follow up from 69.33 to 96.03 at final followup (p&amp;lt;0.001) which indicate that significant improvement in functional status of patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Reconstruction of ACL leads the patient to return to a normal activity level and prevent the occurrence of associate meniscal injury and post-traumatic osteoarthritis. A regular followup based and well-organized rehabilitation program provide a key role in functional outcome of knee after ACL reconstruction.&lt;/p&gt;

Management of Anti-melanoma Differentiation-Associated Gene 5 (Anti-MDA5)-Positive Dermatomyositis in an Acute Rehabilitation Center: A Case Report

Dermatomyositis is an immune-mediated myopathy predominantly characterized by skin and musculoskeletal manifestations. Although often described in the context of its pathognomonic cutaneous features, dermatomyositis may have variable presentations depending on the subtype. In this report, we present a case of anti-melanoma differentiation-associated gene 5 (anti-MDA5)-positive dermatomyositis that initially presented with respiratory symptoms. An appropriate diagnosis and comprehensive interdisciplinary rehabilitation led to a significant improvement in functional status and a better overall prognosis for the patient.

Experiencia ibérica con PASCAL para la reparación percutánea borde a borde en insuficiencia mitral

Introduction and objectivesThe PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. MethodsProcedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. ResultsWe included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). ConclusionsTranscatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

Introduction and objectivesThe PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. MethodsProcedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. ResultsWe included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P<.001). ConclusionsTranscatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.