A usability study in patients with stroke using MERLIN, a robotic system based on serious games for upper limb rehabilitation in the home setting.

BACKGROUND: Neuroscience and neurotechnology are transforming stroke rehabilitation. Robotic devices, in addition to telerehabilitation, are increasingly being used to train the upper limbs after stroke, and their use at home allows us to extend institutional rehabilitation by increasing and prolonging therapy. The aim of this study is to assess the usability of the MERLIN robotic system based on serious games for upper limb rehabilitation in people with stroke in the home environment. METHODS: 9 participants with a stroke in three different stages of recovery (subacute, short-term chronic and long-term chronic) with impaired arm/hand function, were recruited to use the MERLIN system for 3 weeks: 1 week training at the Maimonides Biomedical Research Institute of Cordoba (IMIBIC), and 2 weeks at the patients' homes. To evaluate usability, the System Usability Scale (SUS), Adapted Intrinsic Motivation Inventory (IMI), Quebec User Evaluation of Satisfaction with assistive Technology (QUEST), and the ArmAssist Usability Assessment Questionnaire were used in the post-intervention. Clinical outcomes for upper limb motor function were assessed pre- and post-intervention. RESULTS: 9 patients participated in and completed the study. The usability assessment reported a high level of satisfaction: mean SUS score 71.94 % (SD = 16.38), mean QUEST scale 3.81 (SD = 0.38), and mean Adapted IMI score 6.12 (SD = 1.36). The results of the ArmAssist Questionnaire showed an average of 6 out of 7, which indicates that MERLIN is extremely intuitive, easy to learn and easy to use. Regarding clinical assessment, the Fugl-Meyer scores showed moderate improvements from pre- to post-intervention in the total score of motor function (p = 0.002). There were no significant changes in the Modified Ashworth scale outcomes (p = 0.169). CONCLUSIONS: This usability study indicates that home-based rehabilitation for upper limbs with the MERLIN system is safe, useful, feasible and motivating. Telerehabilitation constitutes a major step forward in the use of intensive rehabilitation at home. Trial registration ClinicalTrials.gov, NCT04405609. Registered 06 January 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04405609.

La insuficiencia tricúspide, y no la insuficiencia mitral, determina la mortalidad en pacientes que presentan insuficiencia mitral no grave previa a TAVI / Tricuspid but not mitral regurgitation determines mortality after TAVI in patients with nonsevere mitral regurgitation

Introducción y objetivos: Muchos pacientes sometidos a implante percutáneo de válvula aórtica (TAVI) presentan insuficiencia mitral (IM) de grado moderado o menor. El impacto de la insuficiencia tricuspídea (IT) sigue sin resolverse. Se analiza el impacto de la IM moderada frente a leve-ausente y su evolución, y de la IT concomitante y su interacción con la IM. Métodos: Estudio retrospectivo multicéntrico de 813 pacientes tratados con TAVI entre 2007 y 2015 con IM ≤ 2 y abordaje transfemoral. Resultados: La edad media fue 81 ± 7 años y el Society of Thoracic Surgeons-score fue de 6,9 ± 5,1%. El 37,3% presentó IM moderada, con resultados comparables intrahospitalarios y de mortalidad a 6 meses frente a IM < 2 (11,9 frente a 9,4%; p = 0,257). Sin embargo, experimentaron más rehospitalizaciones y peor clase de la New York Heart Association (p = 0,008 y 0,001, respectivamente). Solo un 3,8% demostró un aumento en el grado de IM > 2 tras el TAVI. La presencia de IT moderada/grave se asoció con una mortalidad intrahospitalaria y de seguimiento del 13 y el 34,1%, independientemente del grado de IM. La IT moderada-grave fue predictor independiente de mortalidad (HR = 18,4; IC95%, 10,2-33,3; p < 0,001). Conclusiones: La presencia de IM moderada no supuso mayor mortalidad a corto-medio plazo tras el TAVI, pero asoció más rehospitalizaciones. La presencia de IT moderada/grave implicó mayor mortalidad. Esto sugiere que una evaluación minuciosa de los mecanismos subyacentes entre ambas insuficiencias valvulares debe realizarse para determinar la mejor estrategia para evitar la futilidad relacionada con TAVI

Introduction and objectives: Many patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant mitral regurgitation (MR) of moderate grade or less. The impact of coexistent tricuspid regurgitation (TR) remains to be determined. We sought to analyze the impact of moderate vs none-to-mild MR and its trend after TAVI, as well as the impact of concomitant TR and its interaction with MR. Methods: Multicenter retrospective study of 813 TAVI patients treated through the transfemoral approach with MR ≤ 2 between 2007 and 2015. Results: The mean age was 81 ± 7 years and the mean Society of Thoracic Surgeons score was 6.9% ± 5.1%. Moderate MR was present in 37.3% of the patients, with similar in-hospital outcomes and 6-month follow-up mortality to those with MR < 2 (11.9% vs 9.4%; P = .257). However, they experienced more rehospitalizations and worse New York Heart Association class (P = .008 and .001, respectively). Few patients (3.8%) showed an increase in the MR grade to > 2 post-TAVI. The presence of concomitant moderate/severe TR was associated with in-hospital and follow-up mortality rates of 13% and 34.1%, respectively, regardless of MR grade. Moderate-severe TR was independently associated with mortality (HR, 18.4; 95%CI, 10.2-33.3; P < .001). Conclusions: The presence of moderate MR seemed not to impact short- and mid-term mortality post-TAVI, but was associated with more rehospitalizations. The presence of moderate or severe TR was associated with higher mortality. This suggests that a thorough evaluation of the mechanisms underlying concomitant mitral and tricuspid valve regurgitation should be performed to determine the best strategy for avoiding TAVI-related futility

Tricuspid but not Mitral Regurgitation Determines Mortality After TAVI in Patients With Nonsevere Mitral Regurgitation.

INTRODUCTION AND OBJECTIVES: Many patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant mitral regurgitation (MR) of moderate grade or less. The impact of coexistent tricuspid regurgitation (TR) remains to be determined. We sought to analyze the impact of moderate vs none-to-mild MR and its trend after TAVI, as well as the impact of concomitant TR and its interaction with MR. METHODS: Multicenter retrospective study of 813 TAVI patients treated through the transfemoral approach with MR ≤ 2 between 2007 and 2015. RESULTS: The mean age was 81 ± 7 years and the mean Society of Thoracic Surgeons score was 6.9% ± 5.1%. Moderate MR was present in 37.3% of the patients, with similar in-hospital outcomes and 6-month follow-up mortality to those with MR < 2 (11.9% vs 9.4%; P = .257). However, they experienced more rehospitalizations and worse New York Heart Association class (P = .008 and .001, respectively). Few patients (3.8%) showed an increase in the MR grade to > 2 post-TAVI. The presence of concomitant moderate/severe TR was associated with in-hospital and follow-up mortality rates of 13% and 34.1%, respectively, regardless of MR grade. Moderate-severe TR was independently associated with mortality (HR, 18.4; 95%CI, 10.2-33.3; P < .001). CONCLUSIONS: The presence of moderate MR seemed not to impact short- and mid-term mortality post-TAVI, but was associated with more rehospitalizations. The presence of moderate or severe TR was associated with higher mortality. This suggests that a thorough evaluation of the mechanisms underlying concomitant mitral and tricuspid valve regurgitation should be performed to determine the best strategy for avoiding TAVI-related futility.

Mitral Regurgitation After Transcatheter Aortic Valve Replacement: Prognosis, Imaging Predictors, and Potential Management.

OBJECTIVES: This study sought to analyze the clinical impact of the degree and improvement of mitral regurgitation in TAVR recipients, validate the main imaging determinants of this improvement, and assess the potential candidates for double valve repair with percutaneous techniques. BACKGROUND: Many patients with severe aortic stenosis present with concomitant mitral regurgitation (MR). Cardiac imaging plays a key role in identifying prognostic factors of MR persistence after transcatheter aortic valve replacement (TAVR) and for planning its treatment. METHODS: A total of 1,110 patients with severe aortic stenosis from 6 centers who underwent TAVR were included. In-hospital to 6-month follow-up clinical outcomes according to the degree of baseline MR were evaluated. Off-line analysis of echocardiographic and multidetector computed tomography images was performed to determine predictors of improvement, clinical outcomes, and potential percutaneous alternatives to treat persistent MR. RESULTS: Compared with patients without significant pre-TAVR MR, 177 patients (16%) presented with significant pre-TAVR MR, experiencing a 3-fold increase in 6-month mortality (35.0% vs. 10.2%; p < 0.001). After TAVR, the degree of MR improved in 60% of them. A mitral annular diameter of >35.5 mm (odds ratio: 9.0; 95% confidence interval: 3.2 to 25.3; p < 0.001) and calcification of the mitral apparatus by multidetector computed tomography (odds ratio: 11.2; 95% confidence interval: 4.03 to 31.3; p < 0.001) were independent predictors of persistent MR. At least 14 patients (1.3% of the entire cohort, 13.1% of patients with persistent MR) met criteria for percutaneous mitral repair with either MitraClip (9.3%) or a balloon-expandable valve (3.8%). CONCLUSIONS: Significant MR is not uncommon in TAVR recipients and associates with greater mortality. In more than one-half of patients, the degree of MR improves after TAVR, which can be predicted by characterizing the mitral apparatus with multidetector computed tomography. According to standardized imaging criteria, at least 1 in 10 patients whose MR persists after TAVR could benefit from percutaneous mitral procedures, and even more could be treated with MitraClip after dedicated pre-imaging evaluation.

Telerehabilitation: toward a cost-efficient platform for post-stroke neurorehabilitation.

Motor deficits in the growing population of stroke survivors continue to strain global healthcare capacities. The use of telerehabilitation to address this need has been discussed for over a decade without a clear consensus on development strategy or a clear market success. In this paper, the cyclic and iterative phases of the Planning, Execution, Assessment (PLEXAS) rehabilitation cycle are discussed, and the potential roles of an integrated telerehabilitation platform within this cycle are presented. Some preliminary work on a multicenter project called TeleREHA is presented along with relevant clinical insight and discussion.

Virtual histology intravascular ultrasound assessment of cardiac allograft vasculopathy from 1 to 20 years after heart transplantation.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is the main cause of graft loss and death in heart transplant (HTx) recipients surviving >1 year. There is a dual etiology for coronary disease in HTx: classic atherosclerosis and an immunologically mediated disease. Intravascular ultrasound (IVUS) is highly sensitive for CAV detection; however, gray-scale IVUS is of limited value for identification of specific plaque components. We sought to characterize graft coronary artery disease by means of IVUS-virtual histology (IVUS-VH) at different time-points of follow-up and to correlate plaque composition with clinical factors. METHODS: In our study we included 67 patients, who were 7.6 +/- 5.7 years post-HTx. IVUS gray-scale evaluation was performed on all patients. IVUS-VH analysis was done in those patients showing intimal thickening >0.5 mm at the three more significant lesions (three cross-sections for each) of the left anterior descending artery. RESULTS: IVUS-VH analysis was obtained done on 58 patients (86.5%). We found a significant correlation between time of HTx and IVUS gray-scale parameters (plaque area and plaque burden), with both increasing over time. We also found a significant correlation between time and IVUS-VH-derived plaque components, necrotic core and calcium, which increased with time, and fibrous and fibrofatty components, both decreased at follow-up. IVUS-VH results were also related to donor age and cardiovascular risk factors. CONCLUSIONS: We observed a time-related change in IVUS-VH-derived plaque composition. Necrotic core and calcium, typical atheromatous components, become more prevalent with time after HTx, especially when influenced by cardiovascular risk factors. The presence of a necrotic core in the early stages was linked to older donor age.

Avoidance of calcineurin inhibitors with use of proliferation signal inhibitors in de novo heart transplantation with renal failure.

BACKGROUND: This study describes our experience with proliferation signal inhibitors in de novo heart transplant recipients with significant renal impairment. To circumvent further nephrotoxicity, calcineurin inhibitors were avoided in the peri-operative period. METHODS: Immunosuppression in 20 patients was with a proliferation signal inhibitor (sirolimus, 14; everolimus, 6), an anti-mitotic drug, and corticosteroids from the time of transplantation. Induction was used in 9 patients (45%). All patients had preoperative significant renal dysfunction (mean glomerular filtration rate <30 ml/min/1.73 m(2)), and 4 patients required dialysis. RESULTS: Post-operatively, the glomerular filtration rate significantly increased (>65 ml/min/1.73 m(2) at Month 1, remaining stable thereafter). No patients required dialysis after the first month of transplantation. Mean follow-up was 500 days. Rejection episodes occurred in 11 patients (55%), and 4 patients died (2 of rejection, although 1 death occurred 48 days after conversion to conventional treatment with tacrolimus). Half of the patients were eventually converted to conventional calcineurin-inhibitor therapy because of proliferation signal inhibitor adverse events. CONCLUSION: Although this immunosuppressive approach was associated with a somewhat high rate of rejection and frequent side effects, it represents an attractive alternative in the complicated peri-operative setting of patients with significant renal impairment. This approach could serve as a temporary bridge to a conventional treatment.

Everolimus-related pulmonary toxicity in heart transplant recipients.

Pulmonary toxicity (PT) is emerging as a frequent and serious complication of sirolimus, a proliferation signal inhibitor (PSI) used in solid-organ transplantation. Everolimus is a more recently developed PSI with molecular structure very similar to that of sirolimus. Surprisingly, although experience with everolimus is increasing and becoming substantial, there remains very little information about everolimus-related PT. Herein we report 2 heart transplant recipients who developed a non-infectious pulmonary syndrome after everolimus treatment was started. Transbronchial pulmonary biopsy specimens showed typical interstitial pneumonitis, and everolimus discontinuation resulted in rapid clinical and radiological improvement. Although PT seems to be more common after sirolimus exposure, everolimus is by no means spared from this potentially lethal complication and should always be suspected in the relevant clinical setting.

Sirolimus in de novo heart transplant recipients with severe renal impairment.

Two patients with end-stage heart failure and advanced renal dysfunction (under chronic dialysis therapy) underwent heart transplantation. In order to avoid further renal impairment, a calcineurine inhibitor-free immunosuppression regimen based on the sirolimus was used. Although temporary perioperative support with hemofiltration and dialysis was needed, both patients eventually regained a reasonable renal function with no episodes of clinical rejection and normal cardiac function at 13 and 11 months, respectively, after transplantation. Sirolimus-based immunosuppression might be an interesting alternative to calcineurine inhibitors in the management of patients with significant renal impairment.