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PD05 Novel Non-Thermal Ablation Technology For The Treatment Of Atrial Fibrillation
- Ana Isabel Hijas-Gómez, Setefilla Luengo-Matos, Begoña Rodriguez-Ortiz-de-Salazar, Amparo Arias-Pacheco, Luis Maria Sánchez-Gómez, Maria del Mar Polo-de-Santos
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, pp. S91-S92
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Introduction
Pulsed-field ablation (PFA) is a new non-thermal ablative approach for treating paroxysmal and persistent atrial fibrillation (AF). It provides an alternative to the conventional thermal techniques of radiofrequency ablation and cryoablation. PFA is currently performed with the Farapulse PFA system (Boston Scientific, USA), which recently received CE marking in Europe. In this study, we describe the current evidence on the efficacy, safety, and cost-effectiveness of this new technology.
MethodsThe Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias-at the Instituto de Salud Carlos III- identified this new ablation approach in June 2021. An early technology assessment was conducted by reviewing relevant literature published to November 2021. The literature was identified by searching PubMed, Embase, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Library.
ResultsSeven relevant publications were identified, including three open-label trials for paroxysmal AF and one for persistent AF. Three studies comparing PFA with conventional thermal ablation techniques were also included. The safety results showed a lower incidence of complications (esophageal injury, pulmonary venous stenosis, pericardial effusion, and aortic injury) after PFA relative to conventional techniques. In terms of efficacy, PFA resulted in lower rates of AF recurrence in the medium and long term, compared with conventional techniques, and there were no differences in the lengths or success rates of the procedures. No cost-effectiveness studies were identified. Seven ongoing trials were identified, but no results have been published.
ConclusionsThe current evidence for PFA in the treatment of AF showed good safety and promising efficacy. However, there is a lack of information on its effect on quality of life and the risk of death, disabling stroke, or cardiac arrest. Early evaluation of new and emerging technologies makes it possible to gather the minimum information necessary to support decisions on their inclusion in the healthcare system. In this case, based on current evidence, the widespread use of PFA is not recommended, except under a rigorous research protocol.
PP110 An External Combined Occipital And Trigeminal Neurostimulation Device For Migraine Treatment
- Begoña Rodríguez-Ortiz-de-Salazar, Ana Isabel Hijas-Gómez, María del Mar Polo de Santos, Amparo Arias-Pacheco, Luis Sánchez-Gómez, Seteffilla Luengo-Matos
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S76
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Introduction
Migraine is a multifactorial pathology that affects 12 percent of the world’s population. Relivion® MG (Neurolief Inc., USA) is a non-invasive self-administered device for external combined occipital and trigeminal nerve stimulation that has been recently approved for marketing in Europe and the USA. The objective of this study was to conduct an early assessment of the efficacy and safety of Relivion for the treatment of migraine episodes.
MethodsRelivion was identified by the early awareness and alert system, SINTESIS- nuevas tecnologías, of the Agencia de Evaluación de Tecnologías Sanitarias at the Instituto de Salud Carlos III. An early assessment of the technology was conducted by reviewing relevant clinical studies published to 29 September 2021. The literature was identified by searching PubMed, Embase, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Library.
ResultsTwo randomized, sham-controlled double-blind trials were found. They assessed side effects and pain relief, response rate, and pain freedom two hours after treatment. One study included 55 patients and the other (the RIME study) included 131 patients. The rate of pain relief two hours after treatment ranged from 60 to 76 percent in the treatment group and from 31 to 37 percent in the control group (p<0.01). The response rate, defined as at least 50 percent pain reduction two hours after treatment, was significantly higher in the treatment group (67 to 70% versus 32 to 42%). The percentage of patients free of pain two hours after treatment ranged from 42 to 46 percent in the treatment group, compared with 11 to 12 percent in the control group (p<0.0001). No notable adverse events were recorded.
ConclusionsPreliminary results indicated that Relivion effectively and safely relieves or eliminates acute migraine pain. However, more comparative studies are needed. The use of Relivion could improve the control of symptoms and improve quality of life in patients with migraine.
PP109 Efficacy And Safety Of High-Intensity Focused Ultrasound In Parkinson’s Disease
- Amparo Arias-Pacheco, María del Mar Polo-de-Santos, Setefilla Luengo-Matos, Ana Isabel Hijas-Gómez, Begoña Rodríguez-Ortiz-de-Salazar, Luis María Sánchez-Gómez
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S75
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Introduction
Parkinson’s disease (PD) is the second most common neurodegenerative disease in the world. High-intensity focused ultrasound (HIFU) is a new non-invasive therapeutic option for treating the motor symptoms of PD. HIFU is an imaging-guided procedure for therapeutic brain ablation that has been used for patients with essential tremor and neuropathic pain. It is indicated for patients older than 22 years of age who have PD that is refractory to drug treatment and are ineligible for surgery. The objective of this study was to conduct an early assessment of HIFU subthalamotomy for the treatment of motor symptoms in patients with PD.
MethodsHIFU was identified by the early awareness and alert system, SINTESIS- nuevas tecnologías, of the Agencia de Evaluación de Tecnologías Sanitarias at the Instituto de Salud Carlos III. Relevant literature published to October 2021 was identified by searching PubMed, EMBASE, ClinicalTrials.gov, and the Cochrane Library.
ResultsOne prospective study and one randomized controlled trial (RCT) were found that assessed the efficacy and safety of HIFU subthalamotomy for treating the motor symptoms of PD. The Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) was used to measure changes in symptoms (>30% change from baseline was considered clinically relevant). Both studies reported a reduction of symptoms in the intervention group. The MDS-UPDRS III score changed from 16.6 to 7.5 six months after treatment in the prospective study and from 19.9 to 9.9 four months after treatment in the RCT (a decrease of 11.6 points was observed after 12 months). The main adverse events reported were dyskinesia, speech and gait disturbances, and weakness, all of which resolved without treatment.
ConclusionsThe results regarding the efficacy and safety of HIFU for treating the motor symptoms of PD are promising. HIFU is a non-invasive procedure that eliminates the risks associated with surgery. Although rapid diffusion of this technology is expected, further studies and economic evaluation are needed.
OP54 The Early Detection And Warning System ‘SINTESIS-New Technologies’: A Horizon Scanning Experience In Spain
- Ana Isabel Hijas-Gómez, Setefilla Luengo-Matos, Amparo Arias-Pacheco, Begoña Rodriguez-Ortiz-de-Salazar, Luis Maria Sánchez-Gómez, Maria del Mar Polo-de-Santos
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- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S21
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Introduction
SINTESIS-new technologies is the early warning system for new and emerging technologies of the Agencia de Evaluación de Tecnologías Sanitarias, Instituto de Salud Carlos III. SINTESIS is part of the Action Plan for the Early Detection of New and Emerging Technologies of the Spanish Network of Health Technology Assessment Agencies (RedETS). In RedETS, four agencies are responsible for the identification of innovative technologies. These agencies have been collaborating since 2016 according to the early awareness methods contained in the EuroScan Methods Toolkit. SINTESIS focuses on secondary information sources (i.e., experts and literature). This study describes the experience of SINTESIS in identifying and filtering new technologies in recent years.
MethodsRetrospective analysis of all new and emerging technologies notified by SINTESIS to RedETS since 2018. Technologies were analyzed on a year-by-year basis for their source of information, the clinical specialties involved, and whether technologies found in the identification phase were selected for further assessment.
ResultsBetween 2018–2020, SINTESIS identified 69 emerging and new technologies. Most of the information came from medical press news (35%), and medical web news (22%); other sources included experts (15%), licensing news search (12%), general press (12%), and scientific websites (6%). Almost 37 technologies (54%) were selected for further analysis. Reasons for exclusion included too early identification of technologies/prototypes without enough evidence (52%), technologies already implemented (28%), overlapping technologies between agencies (17%), and not being medical technologies (3%).
ConclusionsExperience suggests that news sections of general and medical journals, websites, and expert consultation are useful sources to identify new and emerging health technologies. The main limitation is that the technologies identified are often at too early a stage of development for further assessment. SINTESIS contributes, within a national horizon scanning system with other agencies, to broaden the information sources and provide useful data on early awareness of innovative technologies. Further studies are needed to assess the impact of emerging technologies detection on healthcare delivery.
PP152 Epigenetic In Vitro Diagnostic Test For Early Diagnosis In Lung Cancer: An Early Assessment
- Ana Isabel Hijas-Gómez, Mar Polo-de-Santos, Setefilla Luengo-Matos, Luis Maria Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 37 / Issue S1 / December 2021
- Published online by Cambridge University Press:
- 03 December 2021, p. 23
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Introduction
Lung cancer is a leading cause of morbidity and mortality, and early diagnosis is essential for patient survival. Epigenetics is an innovative discipline that provides biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. Each type of tumor may present specific patterns of gene methylation, the analysis of which may be useful as a diagnostic tool. The aim of this study was to conduct an early assessment of novel in vitro diagnostic (IVD) tests based on the identification of DNA hypermethylation epigenetic signatures developed for the early detection of lung cancer.
MethodsWe identified this technology through the Early Awareness and Alert System “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias - Instituto de Salud Carlos III. A literature search of PubMed, the Trip Medical Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials was conducted. Studies published up to November 2019 were reviewed.
ResultsThree tests were identified. Epi proLung® analyzes the hypermethylation status of SHOX2/PTGER4 genes in blood samples using polymerase chain reaction (PCR) and showed good discrimination capacity with respect to healthy controls (area under the curve [AUC] = 0.91) and patients with non-malignant lung diseases (AUC = 0.86). The Epi proLung BL Reflex Assay® for determining the hypermethylation state of the SHOX2 gene in bronchoalveolar lavage samples by PCR had modest sensitivity (69%, 95% confidence interval [CI]: 64–75) and high specificity (96%, 95% CI: 97–100). A test in development for determining the hypermethylation state of BCAT1/CDO1/TRIM58/ZNF177 genes in aspirated or bronchoalveolar lavage samples by pyrosequencing yielded a sensitivity of 85 percent and a specificity of 81 percent, with an AUC of 0.91 at the optimal cutoff point.
ConclusionsThe evidence for the three tests showed promising results in terms of diagnostic validity. However, although personalized medicine is becoming increasingly widespread in the field of cancer diagnosis, more studies are needed to evaluate the clinical utility of these diagnostic tests, either as a complementary or a screening test, and the economic impact of their use.
PP209 Analysis Of The Efficacy And Safety Of Robotic Spinal Surgery
- María del Mar Polo-deSantos, Setefilla Luengo-Matos, Ana Isabel Hijas-Gómez, Esther Elena García-Carpintero, Luis María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 37 / Issue S1 / December 2021
- Published online by Cambridge University Press:
- 03 December 2021, p. 27
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Introduction
Robotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.
MethodsA systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.
ResultsEight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.
ConclusionsWe found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.
PP262 PapSEEK: Liquid Biopsy For Endometrial And Ovarian Cancer Screening
- Ana Isabel Hijas-Gómez, Mª Mar Polo-de-Santos, Setefilla Luengo-Matos, Luís María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 36 / Issue S1 / December 2020
- Published online by Cambridge University Press:
- 28 December 2020, pp. 22-23
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Introduction
Endometrial and ovarian cancer are the first and second leading causes of death from gynecological cancer in Spain. Survival is generally determined by stage at diagnosis, but there is no test currently used for early detection of both tumor types. PapSEEK is a test developed to diagnose endometrial and ovarian cancer by detecting aneuploidies and somatic mutations commonly associated with both tumor types through DNA next-generation sequencing (NGS) of liquid from Papanicolaou test (Pap smear) samples. The objective of this work was to assess the effectiveness and safety of PapSEEK.
MethodsPapSEEK was identified by the Early Awareness and Alert System, “SINTESIS-new technologies”, of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). An early assessment of the technology was conducted through a literature search of the following databases: PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and The Cochrane Library. Clinical studies on the effectiveness and safety of PapSEEK published up to February 2019 were reviewed.
ResultsThe evidence comprised proof of concept and diagnostic accuracy studies, which showed good preliminary results regarding the accuracy of the test for diagnosing endometrial cancer (sensitivity ranged from 0.81 to 0.93), but not for ovarian cancer (sensitivity ranged from 0.33 to 0.45). The specificity for both tumor types ranged from 0.99 to 1.00. Since PapSEEK uses a sampling method that is routinely used in clinical practice (the Pap smear), no evidence was found in the literature on the safety of the test.
ConclusionsPapSEEK is a novel technology developed to diagnose endometrial and ovarian cancer by means of DNA-NGS of Pap smear samples. The identified studies showed good preliminary results regarding the ability of the test to diagnose endometrial cancer, but not ovarian cancer. PapSEEK may be useful as a screening tool for endometrial cancer. However, further research on PapSEEK is needed to prospectively evaluate its diagnostic accuracy, compare it with current tests used in the early diagnosis of both cancer types, evaluate its effect on patient survival and disease progression, and measure its economic impact.
PP255 Epigenetic Profile Predicts Response To Immunotherapy In Patients With Non-Small-Cell Lung Cancer: An Early Assessment
- Ana Isabel Hijas-Gómez, Mª Mar Polo-de-Santos, Setefilla Luengo-Matos, Montserrat Carmona-Rodríguez, Luís María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 36 / Issue S1 / December 2020
- Published online by Cambridge University Press:
- 28 December 2020, p. 22
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Introduction
Epigenetics is an innovative discipline that aims to provide biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. The identification of therapeutic targets is of particular interest in cancer therapy for selecting groups of patients who may benefit most from an intervention. Understanding the relationships between the immune system and tumor cells has led to new immunotherapy-based therapies that provide a promising alternative to conventional cancer therapies. The aim of this study was to conduct an early assessment of a novel epigenetic signature (EPIMMUNE) that could predict response to programmed cell death protein 1 (PD-1) inhibitor immunotherapy in patients with non-small cell lung cancer (NSCLC).
MethodsWe identified the novel epigenetic signature EPIMMUNE through the Early Awareness and Alert System, “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). A literature search of PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, The Cochrane Library, and the Centre for Reviews and Dissemination databases was conducted. Clinical studies on EPIMMUNE published in English or Spanish up to August 2019 were reviewed.
ResultsOnly one retrospective study was found. Identification of EPIMMUNE was accomplished through interrogation of the DNA methylation status of CpG sites in 142 samples from adult patients with NSCLC who were treated with PD-1 inhibitors. EPIMMUNE was defined by 301 CpG sites whose methylation status was significantly associated with clinical response (progression-free and overall survival). No studies assessing the long-term clinical utility, impact on therapeutic decision making, or economic implications of EPIMMUNE were found.
ConclusionsThe EPIMMUNE signature could provide an accurate and valid biomarker for identifying patients with NSCLC who may benefit from treatment with PD-1 inhibitors. However, the technology is under development, and there is only a single study on detecting the EPIMMUNE epigenetic profile and identifying the DNA methylation profiles associated with increased survival after PD-1 inhibitor therapy. More diagnostic accuracy studies and prospective, long-term trials are needed to evaluate the clinical impact this technology may have on therapeutic decision making. Given the limited evidence available, further research is needed before the technology can be disseminated.
PP264 Effectiveness And Safety Of Pressurized Intraperitoneal Aerosol Chemotherapy For Peritoneal Carcinomatosis: A Systematic Review
- Ana Isabel Hijas-Gómez, Nadia Lingán-Cubas, Mª Mar Polo-de-Santos, Esther García-Carpintero, Setefilla Luengo-Matos, Luis María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 36 / Issue S1 / December 2020
- Published online by Cambridge University Press:
- 28 December 2020, p. 23
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Introduction
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a minimally invasive therapeutic option for stage IV or terminal stage peritoneal carcinomatosis, which has a very low survival rate. PIPAC is aimed at patients whose only therapeutic alternative is systemic chemotherapy because they are unable to undergo other treatments, such as cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. PIPAC consists of a micro-pump connected to a double-contrast injector, which is used to apply cytotoxic agents laparoscopically using pressurized aerosols. The objective of this study was to update the evidence regarding the effectiveness and safety of PIPAC.
MethodsA systematic review (SR) was conducted by searching PubMed, Embase, and The Cochrane Library database. ClinicalTrials.gov and the European Union Drug Regulating Authorities Clinical Trials Database were consulted to identify registered clinical studies. All articles published up to April 2019 were considered for inclusion. Abstracts, letters, single case studies, non-clinical and animal studies, and studies published in languages other than English or Spanish were excluded. Validated checklists were used to assess the quality of the included studies.
ResultsSeventeen studies were included (three SRs and fourteen cases series) and eighteen ongoing clinical trials were identified. The quality of the SRs and cases series studies was low and moderate, respectively. Adverse events were categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events as grade 1–2 (mild-moderate: 11% to 40% of patients) and grade 3–4 (severe-fatal: 0% to 37% of patients). Overall complete histological regression according to the Peritoneal Regression Grading Score and the Peritoneal Cancer Index occurred in at least sixty percent of patients. The survival time ranged from 11 to 16 months.
ConclusionsEffectiveness data for PIPAC were promising, with high carcinomatosis regression rates. Most studies showed a moderate safety profile, with generally mild to moderate complications (nausea, abdominal pain, and vomiting). This is an advantage over systemic chemotherapy, which has severe systemic side effects. Economic evaluation studies are needed to estimate the cost effectiveness and cost utility of this technology. Diffusion of PIPAC is expected, but the criteria used to select patients in the studies carried out so far must be considered, as well as the need to follow strict safety protocols for preventing leakage of aerosolized cytotoxic drugs.
VP92 Portable Robotic Exoskeleton Stride Management Assist (SMA®)
- Luis María Sánchez-Gómez, Ana Isabel Hijas-Gómez, Mar Polo-DeSantos, Setefilla Luengo-Matos
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 95
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Introduction
The Stride Management Assist (SMA®) device consist in a portable robotic exoskeleton designed for gait rehabilitation and training by repetition of walking patterns with automated regular gait cycles. Used for adult population with gait disorders of neurological or musculoskeletal origin that require rehabilitation. The objective of this work is to assess its efficacy and safety.
MethodsThis technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of AETS-ISCIII. An early assessment of the technology was conducted. The searched databases were: Pubmed, Embase, WOS, Tripdatabase, ClinicalTrials.org and Cochrane Library. Clinical studies using the device published in any language until 10 October 2018 were reviewed.
ResultsWe found 3 abstracts to congresses and 6 clinical trials that evaluated the use of the device. Outcomes measures among studies included spatiotemporal gait parameters, energy expenditure, muscular activity and functional performance. Five studies consisted in proof-of-concept analysis; 3 studies evaluated the effect of gait training with SMA® compared with conventional therapy alone in individuals after stroke (2 studies) and Parkinson disease (1 study); and 1 before-and-after study assessed the effect of gait training with SMA® in elderly adults. During its use, improvements in spatiotemporal gait parameters were described in 4/5 studies, and 2/5 studies showed less energy expenditure versus 2/5 studies that found no differences. After gait training, 3/4 studies described greater improvements in gait parameters when associated its use. Only one clinical trial collected safety data reporting no adverse events.
ConclusionsThe SMA® device allows to increase the efficiency and parameters of the march during its use. The assistance in the stride might have an impact on health by facilitating the recovery of the gait; however, further research is needed to determine the feasibility in the latter case since comparative studies with conventional therapy are limited.
PP141 Functional Connectivity Magnetic Resonance Imaging To Detect Autism
- Mar Polo-DeSantos, Juan Pablo, Chalco Orrego, Ana Isabel Hijas-Gómez, Setefilla Luengo-Matos, Luis María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, pp. 64-65
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Introduction
Autism is a neurodevelopmental disorder characterized by alterations in the intellectual, social, communication, and behavioral capabilities of an individual, and is rarely detected in children before 24 months of age. Early diagnosis and intervention may be more effective at a younger age. Functional connectivity magnetic resonance imaging (fcMRI) of 6-month old infants may be able to identify brain connection patterns related to at least one of the characteristics of autism, which normally appear at 24 months of age, by using a mathematical model to analyze the neuroimaging data.
MethodsClinical studies published up to December 2018 that used fcMRI to detect autism in infants were reviewed. The literature databases searched included PubMed, Web of Science, the Trip Database, DynaMed, the Cochrane Library, the International Clinical Trials Registry Platform, and ClinicalTrials.gov. Early assessments of fcMRI analysis were identified through the Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias.
ResultsOnly one prospective study of 59 infants at 6-months of age was retrieved. A fcMRI analysis was performed to identify 2,635 pairs of functional connections from 230 brain regions. The infants were subsequently assessed for autism at 24 months of age using gold standard tests. The functional connections correlated with at least one of the behaviors related to autism evaluated at 24 months of age. Eleven infants (19%) were diagnosed with autism at 24 months. Compared with the gold standard test results, the predictive model achieved the following: sensitivity 0.82 (95% confidence interval [CI]: 0.52 - 0.95); specificity 1.00 (95% CI: 0.93–1.00); positive predictive value 1.00 (95% CI: 0.70–1.00); negative predictive value 0.96 (95% CI: 0.87–0.99); and negative likelihood ratio 0.18 (95% CI: 0.05–0.64). Adverse effects were not reported in the study.
ConclusionsThe fcMRI analysis could help in early detection of autism and the development of preventive interventions. However, the evidence is sparse and more well-designed studies are needed.
PP107 Harpoon™: A Novel Device For Transapical Mitral Valve Repair
- Ana Isabel Hijas-Gómez, Mar Polo-DeSantos, Setefilla Luengo-Matos, Luis María Sánchez-Gómez
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, pp. 57-58
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Introduction
Mitral regurgitation (MR) is the most prevalent heart valve condition in Western countries. Open-heart mitral valve reconstruction is the conventional surgical treatment for MR, whereby the valve's cords are replaced with expanded polytetrafluoroethylene cords. Novel devices have introduced minimally invasive alternatives, such as transapical beating-heart valve repair. Among these alternatives, the Harpoon™ Mitral Valve Repair System (Edwards Lifesciences LLC) may have potential advantages (a smaller diameter valve introducer to minimize bleeding and a different anchoring mechanism). This study aimed to assess the efficacy and safety of Harpoon in minimally invasive mitral valve surgery.
MethodsAn early assessment of the technology was conducted by reviewing relevant literature from the following databases: PubMed, EMBASE, Web of Science, the Trip Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, the Cochrane Library, and the Centre for Reviews and Dissemination. Relevant clinical studies published up to 30 January 2018 were included.
ResultsOnly two publications, by the same research group, were included: an observational study of 11 patients and the prospective, nonrandomized TRACER trial (n = 30). During the procedure, MR was reduced from severe to none in 73 to 86 percent of patients and severe to mild in 14 to 27 percent. At one month, MR was rated as mild or lower in 82 to 89 percent of patients. At six months, MR had worsened to moderate or severe in 16 percent of patients from the TRACER trial. Safety issues within 30 days (18% to 27% of patients) included intraoperative conversion to open surgery, reoperation, pleural effusion, hemopericardium, and atrial fibrillation. There were no intra- or postoperative deaths.
ConclusionsCurrent evidence on the Harpoon device is scarce. Although published studies showed improvement in MR in most patients, there are still issues regarding safety, lack of long-term results, comparability with other procedures, and costs. While promising, further research is required before recommending routine use of this technology.