RESUMEN
[This corrects the article DOI: 10.1016/j.isci.2023.106444.].
RESUMEN
Monitoring the therapeutic alliance throughout treatment can improve client outcomes and lead to improved care. The individual, couple, and family versions of the intersession alliance measure (IAM) were developed to facilitate routine monitoring of the expanded therapeutic alliance. Psychometric properties of the three versions of the IAM were examined using a clinical sample. Participants were drawn from clinics in the United States participating in the Marriage and Family Therapy Practice Research Network. Using this sample, results indicate that items on each version of the IAM load on one factor, are invariant across sex, and that each version has good internal consistency, test-retest reliability, and concurrent validity. The IAM-C and IAM-F also have good predictive validity, while the IAM-I has more limited evidence for its predictive validity. These results suggest that the IAMs are valid and reliable measures that can facilitate the routine monitoring of the expanded therapeutic alliance in psychotherapy.
Asunto(s)
Terapia Familiar , Psicometría , Alianza Terapéutica , Humanos , Femenino , Masculino , Adulto , Psicometría/normas , Psicometría/instrumentación , Reproducibilidad de los Resultados , Terapia Familiar/normas , Persona de Mediana Edad , Terapia de Parejas , Encuestas y Cuestionarios/normasRESUMEN
The connection between adverse childhood experiences (ACEs) and anxiety disorders is well-documented. Additionally, therapy has been shown to be effective at reducing anxiety symptoms. Yet more needs to be known about how ACEs may shape the process of therapy and the trajectory of anxiety symptoms. This study was designed to compare the trajectory of improvement in anxiety symptoms over the course of 12 sessions of therapy in adults (N = 472), who reported more (greater than four) and fewer (fewer than four) ACEs using a multigroup latent growth curve analysis. Data were drawn from the Marriage and Family Therapy Practice Research Network database. Results suggested that the rate of improvement in those with more and fewer ACEs was not significantly different; however, those with more ACEs had a significantly higher average starting point of anxiety symptoms.
Asunto(s)
Experiencias Adversas de la Infancia , Humanos , Femenino , Adulto , Masculino , Experiencias Adversas de la Infancia/psicología , Ansiedad/terapia , Ansiedad/psicología , Terapia Familiar/métodos , Trastornos de Ansiedad/terapia , Trastornos de Ansiedad/psicología , Persona de Mediana Edad , Adulto JovenRESUMEN
The global impact of the SARS-COV-2 pandemic necessitated a rapid shift to online/teletherapy psychotherapy services. While research suggests the feasibility and efficacy of teletherapy, there is limited investigation into couple teletherapy's impact on satisfaction and therapeutic alliance. This study aimed to address this gap by examining changes in couple satisfaction during tele- and in-person therapy sessions over 12 sessions and exploring whether therapeutic alliance development mediates these changes. Using growth curve modeling in a sample of 416 couples, it found that teletherapy participants initially reported higher couple satisfaction, but improvement in this domain was slower than in-person therapy recipients. The development of the therapeutic alliance mediated this effect via two indirect paths. Implications include the need for focused attention on alliance development in teletherapy and more empirically-informed approaches in couple teletherapy.
RESUMEN
OBJECTIVES: Well-established clinical practice for assessing progress in labor involves routine abdominal palpation and vaginal examination (VE). However, VE is subjective, poorly reproducible and painful for most women. In this study, our aim was to evaluate the feasibility of systematically integrating transabdominal and transperineal ultrasound assessment of fetal position, parasagittal angle of progression (psAOP), head-perineum distance (HPD) and sonographic cervical dilatation (SCD) to monitor the progress of labor in women undergoing induction of labor (IOL). We also aimed to determine if ultrasound can reduce women's pain during such examinations. METHODS: Women were recruited as they presented for IOL in three maternity units. Ultrasound assessments were performed in 100 women between 37 + 0 and 41 + 6 weeks' gestation. A baseline combined transabdominal and transperineal scan was performed, including assessment of fetal biometry, umbilical artery and fetal middle cerebral artery Doppler, amniotic fluid index, fetal spine and occiput positions, psAOP, HPD, SCD and cervical length. Intrapartum scans were performed instead of VE, unless there was a clinical indication to perform a VE, according to protocol. Participants were asked to indicate their level of pain by verbally giving a pain score between 0 and 10 (with 0 representing no pain) during assessment. Repeated measures data were analyzed using mixed-effect models to identify significant factors that affected the relationship between psAOP, HPD, SCD and mode of delivery. RESULTS: A total of 100 women were included in the study. Of these, 20% delivered by Cesarean section, 65% vaginally and 15% by instrumental delivery. There were no adverse fetal or maternal outcomes. A total of 223 intrapartum ultrasound scans were performed in 87 participants (13 women delivered before intrapartum ultrasound was performed), with a median of two scans per participant (interquartile range (IQR), 1-3). Of these, 76 women underwent a total of 151 VEs with a median of one VE per participant (IQR, 0-2), with no significant difference between vaginal- or Cesarean-delivery groups. After excluding those with epidural anesthesia during examination, the median pain score for intrapartum scans was 0 (IQR, 0-1) and for VE it was 3 (IQR, 0-6). Cesarean delivery was significantly associated with a slower rate of change in psAOP, HPD and SCD. CONCLUSIONS: Comprehensive transabdominal and transperineal ultrasound assessment can be used to assess progress in labor and can reduce the level of pain experienced during examination. Ultrasound assessment may be able to replace some transabdominal and vaginal examinations during labor. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Asunto(s)
Estudios de Factibilidad , Presentación en Trabajo de Parto , Ultrasonografía Prenatal , Humanos , Femenino , Embarazo , Ultrasonografía Prenatal/métodos , Adulto , Trabajo de Parto Inducido/métodos , Trabajo de Parto Inducido/estadística & datos numéricos , Primer Periodo del Trabajo de Parto , Perineo/diagnóstico por imagen , Trabajo de Parto/fisiologíaRESUMEN
Percutaneous left atrial appendage occlusion aims to reduce the risk of stroke in patients with AF, particularly those who are not good candidates for systemic anticoagulation. The procedure has been studied in large international randomised trials and registries and was approved by the National Institute for Health and Care Excellence in 2014 and by NHS England in 2018. This position statement summarises the evidence for left atrial appendage occlusion and presents the current indications. The options and consensus on best practice for pre-procedure planning, undertaking a safe and effective implant and appropriate post-procedure management and follow-up are described. Standards regarding procedure volume for implant centres and physicians, the role of multidisciplinary teams and audits are highlighted.
RESUMEN
Percutaneous left atrial appendage occlusion aims to reduce the risk of stroke in patients with AF, particularly those who are not good candidates for systemic anticoagulation. The procedure has been studied in large international randomised trials and registries and was approved by the National Institute for Health and Care Excellence in 2014 and by NHS England in 2018. This position statement summarises the evidence for left atrial appendage occlusion and presents the current indications. The options and consensus on best practice for pre-procedure planning, undertaking a safe and effective implant and appropriate post-procedure management and follow-up are described. Standards regarding procedure volume for implant centres and physicians, the role of multidisciplinary teams and audits are highlighted.
RESUMEN
We sampled routinely collected measures of role and outcome expectations, the expanded therapeutic alliance, and relationship satisfaction completed by 253 heterosexual couples seen by 35 therapists in the Marriage and Family Research Practice Network (Johnson et al., 2017) and investigated these variables as interdependent dyadic processes using the latent congruence model (Cheung, 2009) and the mediated actor-partner interdependence model (Ledermann et al., 2011). Taken together, we found a direct association between a couple's mean role and outcome expectation scores at Session 1 and individual partners' alliance perceptions at Session 3. Further, men rated the alliance more favorably when their outcome expectations were higher and the partners' outcome expectations were less discrepant. In terms of role expectations, both men and women began therapy expecting to be more actively engaged in the process than their partner. Whereas women rated the alliance more favorably when they had high role expectations for their partner as well as themselves, men rated the alliance more favorably when they had high expectations for their female partner's engagement in the therapy. Notably, alliance at Session 3 did not mediate the association between initial expectations and Session 4 relationship satisfaction due to a strong association (r = 0.85) between relationship satisfaction rated prior to Sessions 1 and 4. In other words, although the best predictor of relationship status before the fourth session was how the relationship was perceived before couple therapy began, men's and women's initial role and outcome expectations were important contributors to the early alliance. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
Asunto(s)
Terapia de Parejas , Heterosexualidad , Relaciones Interpersonales , Satisfacción Personal , Alianza Terapéutica , Humanos , Femenino , Masculino , Adulto , Heterosexualidad/psicología , Terapia de Parejas/métodos , Persona de Mediana Edad , Esposos/psicologíaRESUMEN
PURPOSE: Radiotherapy is traditionally given in equally spaced weekday fractions. We hypothesize that heterogeneous interfraction intervals can increase radiosensitivity via reoxygenation. Through modeling, we investigate whether this minimizes local failures and toxicity for early-stage non-small cell lung cancer (NSCLC). METHODS: Previously, a tumor dose-response model based on resource competition and cell-cycle-dependent radiosensitivity accurately predicted local failure rates for early-stage NSCLC cohorts. Here, the model mathematically determined non-uniform inter-fraction intervals minimizing local failures at similar normal tissue toxicity risk, i.e., iso-BED3 (iso-NTCP) for fractionation schemes 18Gyx3, 12Gyx4, 10Gyx5, 7.5Gyx8, 5Gyx12, 4Gyx15. Next, we used these optimized schedules to reduce toxicity risk (BED3) while maintaining stable local failures (TCP). RESULTS: Optimal schedules consistently favored a "primer shot" fraction followed by a 2-week break, allowing tumor reoxygenation. Increasing or decreasing the assumed baseline hypoxia extended or shortened this optimal break by up to one week. Fraction sizes of 7.5 Gy and up required a single primer shot, while smaller fractions needed one or two extra fractions for full reoxygenation. The optimized schedules, versus consecutive weekday fractionation, predicted absolute LF reductions of 4.6%-7.4%, except for the already optimal LF rate seen for 18Gyx3. Primer shot schedules could also reduce BED3 at iso-TCP with the biggest improvements for the shortest schedules (94.6Gy reduction for 18Gyx3). CONCLUSION: A validated simulation model clearly supports non-standard "primer shot" fractionation, reducing the impact of hypoxia-induced radioresistance. A limitation of this study is that primer-shot fractionation is outside prior clinical experience and therefore will require clinical studies for definitive testing.
Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Carcinoma Pulmonar de Células Pequeñas , Humanos , Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Carcinoma de Pulmón de Células no Pequeñas/patología , Neoplasias Pulmonares/radioterapia , Neoplasias Pulmonares/patología , Fraccionamiento de la Dosis de Radiación , HipoxiaRESUMEN
Longitudinal changes in trusting behavior across adolescence and their neural correlates were examined. Neural regions of interest (ROIs) included the medial prefrontal cortex (mPFC), dorsal anterior cingulate cortex (dACC), left anterior insula (AI), bilateral ventral striatum (VS), and right dorsal striatum (DS). Participants (wave 1 age: M = 12.90) played the investor in a Trust Game with an uncooperative trustee three times (1-year interval). Analyses included 77 primarily Dutch participants (33 females). Participants decreased their investments with wave. Furthermore, activity was heightened in mPFC, dACC, and DS during investment and repayment, and in right VS (investment) and AI (repayment). Finally, DS activity during repayment increased with wave. These findings highlight early-middle adolescence as an important period for developing sensitivity to uncooperative behavior.
Asunto(s)
Imagen por Resonancia Magnética , Confianza , Femenino , Humanos , Adolescente , Imagen por Resonancia Magnética/métodos , Neuroimagen , Giro del Cíngulo , Aprendizaje , Corteza Prefrontal/diagnóstico por imagenRESUMEN
PURPOSE: To evaluate the perceived age of patients before and after functional upper blepharoplasty. METHODS: Retrospective chart review of patients who underwent upper blepharoplasty by a single surgeon at an academic center. The inclusion criterion was having external photographs before and after blepharoplasty. Exclusion criteria included any other concurrent eyelid or facial surgery. Primary endpoint: perceived change in age after surgery as judged by the American Society of Ophthalmic Plastic & Reconstructive Surgery (ASOPRS) surgeons. RESULTS: Sixty-seven patients (14 men, 53 women) were included. Mean pre-operative age was 66.9 years (range 37.8-89.4) and mean post-operative age was 67.4 years (range 38.6-89). The mean perceived age pre-operatively was 68.9 years, and the mean perceived age post-operatively was 67.1 years, a change of 1.8 years (p = 0.0001 by two-tailed paired T-test). Inter-rater reliability of the observers was measured by intraclass correlation coefficient of 0.77 for pre-operative and 0.75 for post-operative photos. The decreased perceived age was 1.9 years for women, 1.4 years for men, 0.3 years for Asians, 1.2 years for Hispanics, and 2.1 years for whites. DISCUSSION: Functional upper blepharoplasty by an experienced ASOPRS surgeon was shown to reduce the perceived age of a patient by an average of 1.8 years.
Asunto(s)
Blefaroplastia , Masculino , Humanos , Femenino , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Lactante , Estudios Retrospectivos , Reproducibilidad de los Resultados , Párpados/cirugía , Cara/cirugíaRESUMEN
Despite the risks of rejection and discrimination, "coming out" can be an important psychological milestone for transgender (trans) and gender diverse people (TGD). We evaluated the dimensions of identity that predict coming out to family and friends, and the role of social support in explaining the psychosocial benefits associated with coming out. An online survey was completed by 951 TGD adults, 516 (54.3%) who identify as gender binary (164 transwomen and 352 transmen) and 435 (45.7%) who identify as nonbinary. Overall, gender binary TGD people were more likely than nonbinary people to disclose their identity to family and friends. Hierarchical binary logistic regressions further revealed that appearance congruence and strength of TGD identity are associated with disclosure to family, whereas positive TGD identity is associated with disclosure to friends. Path analyses confirmed that coming out is associated with improved resilience, psychological adjustment, and wellbeing, and that social support is a partial mediator of these associations. The results highlight the importance of coming out in the TGD context and suggest that greater access to social support may account for some of these benefits.
Asunto(s)
Minorías Sexuales y de Género , Personas Transgénero , Transexualidad , Adulto , Humanos , Amigos , Identidad de Género , Personas Transgénero/psicologíaRESUMEN
The RNA modification N6-methyladenosine (m6A) regulates the interaction between RNA and various RNA binding proteins within the nucleus and other subcellular compartments and has recently been shown to be involved in experience-dependent plasticity, learning, and memory. Using m6A RNA-sequencing, we have discovered a distinct population of learning-related m6A- modified RNAs at the synapse, which includes the long noncoding RNA metastasis-associated lung adenocarcinoma transcript 1 (Malat1). RNA immunoprecipitation and mass spectrometry revealed 12 new synapse-specific learning-induced m6A readers in the mPFC of male C57/BL6 mice, with m6A-modified Malat1 binding to a subset of these, including CYFIP2 and DPYSL2. In addition, a cell type- and synapse-specific, and state-dependent, reduction of m6A on Malat1 impairs fear-extinction memory; an effect that likely occurs through a disruption in the interaction between Malat1 and DPYSL2 and an associated decrease in dendritic spine formation. These findings highlight the critical role of m6A in regulating the functional state of RNA during the consolidation of fear-extinction memory, and expand the repertoire of experience-dependent m6A readers in the synaptic compartment.SIGNIFICANCE STATEMENT We have discovered that learning-induced m6A-modified RNA (including the long noncoding RNA, Malat1) accumulates in the synaptic compartment. We have identified several new m6A readers that are associated with fear extinction learning and demonstrate a causal relationship between m6A-modified Malat1 and the formation of fear-extinction memory. These findings highlight the role of m6A in regulating the functional state of an RNA during memory formation and expand the repertoire of experience-dependent m6A readers in the synaptic compartment.
Asunto(s)
Miedo , ARN Largo no Codificante , Animales , Masculino , Ratones , Extinción Psicológica , Miedo/fisiología , Aprendizaje/fisiología , ARN Largo no Codificante/metabolismo , Sinapsis/metabolismoRESUMEN
ABSTRACTObjective: The objective of this study was to investigate the effectiveness of teletherapy compared to in-person couple therapy in outcomes such as couple satisfaction, sexual satisfaction, and the therapeutic alliance.Method: Data from 1157 married clients seeking couple therapy were examined. Individual growth curve models were used to analyze changes in the aforementioned outcomes, with teletherapy as a predictor. The study also examined client age and clinic type as moderators.Results: The results indicated that overall, teletherapy is as effective as in-person therapy in improving outcomes. However, there were notable differences in the development of the therapeutic alliance. The alliance improved at twice the rate in in-person therapy as in teletherapy. Clinic type was also found to be a moderator of changes in sexual satisfaction. Clients in group and private practices reported improvements in sexual satisfaction; whereas clients seen in training clinics reported decreases in sexual satisfaction.Conclusion: The study concludes that although teletherapy may be a viable alternative to in-person couple therapy, there are nevertheless differences in the development of the therapeutic alliance that warrant care and further investigation. The setting of the therapy also plays a role in the effectiveness of therapy, although not specific to therapy modality.
RESUMEN
OBJECTIVE: To determine whether maternal serum glycosylated fibronectin (GlyFn) level in the first trimester increases the sensitivity of the Fetal Medicine Foundation (FMF) triple test, which incorporates mean arterial pressure, uterine artery pulsatility index and placental growth factor, when screening for pre-eclampsia (PE) in an Asian population. METHODS: This was a nested case-control study of Chinese women with a singleton pregnancy who were screened for PE at 11-13 weeks' gestation as part of a non-intervention study between December 2016 and June 2018. GlyFn levels were measured retrospectively in archived serum from 1685 pregnancies, including 101 with PE, using an enzyme-linked immunosorbent assay (ELISA), and from 448 pregnancies, including 101 with PE, using a point-of-care (POC) device. Concordance between ELISA and POC tests was assessed using Lin's correlation coefficient and Passing-Bablok and Bland-Altman analyses. GlyFn was transformed into multiples of the median (MoM) to adjust for maternal and pregnancy characteristics. GlyFn MoM was compared between PE and non-PE pregnancies, and the association between GlyFn MoM and gestational age at delivery with PE was assessed. Risk for developing PE was estimated using the FMF competing-risks model. Screening performance for preterm and any-onset PE using different biomarker combinations was quantified by area under the receiver-operating-characteristics curve (AUC) and detection rate (DR) at a 10% fixed false-positive rate (FPR). Differences in AUC between biomarker combinations were compared using the DeLong test. RESULTS: The concordance correlation coefficient between ELISA and POC measurements was 0.86 (95% CI, 0.83-0.88). Passing-Bablok analysis indicated proportional bias (slope, 1.08 (95% CI, 1.04-1.14)), with POC GlyFn being significantly higher compared with ELISA GlyFn. ELISA GlyFn in non-PE pregnancies was independent of gestational age at screening (P = 0.11), but significantly dependent on maternal age (P < 0.003), weight (P < 0.0002), height (P = 0.001), parity (P < 0.02) and smoking status (P = 0.002). Compared with non-PE pregnancies, median GlyFn MoM using ELISA and POC testing was elevated significantly in those with preterm PE (1.23 vs 1.00; P < 0.0001 and 1.18 vs 1.00; P < 0.0001, respectively) and those with term PE (1.26 vs 1.00; P < 0.0001 and 1.22 vs 1.00; P < 0.0001, respectively). GlyFn MoM was not correlated with gestational age at delivery with PE (P = 0.989). Adding GlyFn to the FMF triple test for preterm PE increased significantly the AUC from 0.859 to 0.896 (P = 0.012) and increased the DR at 10% FPR from 64.9% (95% CI, 48.7-81.1%) to 82.9% (95% CI, 66.4-93.4%). The corresponding DRs at 10% FPR for any-onset PE were 52.5% (95% CI, 42.3-62.5%) and 65.4% (95% CI, 55.2-74.5%), respectively. CONCLUSIONS: Adding GlyFn to the FMF triple test increased the screening sensitivity for both preterm and any-onset PE in an Asian population. Prospective non-intervention studies are needed to confirm these initial findings. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Asunto(s)
Fibronectinas , Proteinas Glicosiladas , Preeclampsia , Primer Trimestre del Embarazo , Femenino , Humanos , Embarazo , Biomarcadores/sangre , Estudios de Casos y Controles , Edad Gestacional , Factor de Crecimiento Placentario/sangre , Preeclampsia/sangre , Preeclampsia/diagnóstico , Primer Trimestre del Embarazo/sangre , Estudios Prospectivos , Flujo Pulsátil , Estudios Retrospectivos , Arteria Uterina , Proteinas Glicosiladas/sangre , Fibronectinas/sangre , AdultoRESUMEN
Multiple recent articles have called for outcomes-based and patient-centered guidelines for periodontal therapy.1-6 Simply put, periodontal therapy must be in accord with evidence-based treatment and doing what is right for the patient at the clinical level. With this in mind, the present authors contend that many patients with periodontal disease are not receiving acceptable and timely treatment and disease management.
Asunto(s)
Enfermedades Periodontales , Humanos , Enfermedades Periodontales/terapiaRESUMEN
PURPOSE: To describe 6 cases and review the current state of knowledge of eosinophilic angiocentric fibrosis (EAF) involving the orbit. DESIGN: Retrospective clinicopathologic case series and review of the current literature METHODS: Clinical records and histopathologic data of orbit-involving EAF were gathered between 2004 and 2022 from a single academic institution. The patients' presenting clinical symptoms and signs, laboratory data, radiographic studies, and management documentation were collected. RESULTS: Retrospective review identified 6 novel cases, totaling 31 cases of EAF involving the orbit described as of this writing. Fourteen patients were male, and the average age of presentation was 49.8 years (range 25-78 years). Eighteen patients had concurrent sinonasal involvement, whereas 13 had primary orbital involvement. The median duration of symptoms prior to evaluation was 24 months, with nasal symptoms, proptosis, periorbital swelling, and pain being the most common presenting symptoms. The majority of patients underwent surgical debulking, as well as treatment with glucocorticoids and steroid-sparing agents, such as rituximab, with varied results. CONCLUSION: EAF involving the orbit is uncommon. The histopathologic findings include a perivascular, eosinophil-rich infiltrate and a pauci-inflammatory storiform type of fibrosis concentrated around small vessels. Orbital involvement usually results from local extension from adjacent sinuses, but primary orbital involvement has been described. Surgical debulking and immunosuppressive agents such as rituximab have been shown to stabilize disease.
Asunto(s)
Eosinofilia , Órbita , Humanos , Masculino , Adulto , Persona de Mediana Edad , Anciano , Femenino , Órbita/diagnóstico por imagen , Órbita/patología , Rituximab/uso terapéutico , Estudios Retrospectivos , Eosinofilia/diagnóstico , Eosinofilia/tratamiento farmacológico , Eosinofilia/patología , FibrosisRESUMEN
Objective. To report the use of a portable primary standard level graphite calorimeter for direct dose determination in clinical pencil beam scanning proton beams, which forms part of the recommendations of the proposed Institute of Physics and Engineering in Medicine (IPEM) Code of Practice (CoP) for proton therapy dosimetry.Approach. The primary standard proton calorimeter (PSPC) was developed at the National Physical Laboratory (NPL) and measurements were performed at four clinical proton therapy facilities that use pencil beam scanning for beam delivery. Correction factors for the presence of impurities and vacuum gaps were calculated and applied, as well as dose conversion factors to obtain dose to water. Measurements were performed in the middle of 10 × 10 × 10 cm3homogeneous dose volumes, centred at 10.0, 15.0 and 25.0 g·cm-2depth in water. The absorbed dose to water determined with the calorimeter was compared to the dose obtained using PTW Roos-type ionisation chambers calibrated in terms of absorbed dose to water in60Co applying the recommendations in the IAEA TRS-398 CoP.Main results.The relative dose difference between the two protocols varied between 0.4% and 2.1% depending on the facility. The reported overall uncertainty in the determination of absorbed dose to water using the calorimeter is 0.9% (k= 1), which corresponds to a significant reduction of uncertainty in comparison with the TRS-398 CoP (currently with an uncertainty equal or larger than 2.0% (k= 1) for proton beams).Significance. The establishment of a purpose-built primary standard and associated CoP will considerably reduce the uncertainty of the absorbed dose to water determination and ensure improved accuracy and consistency in the dose delivered to patients treated with proton therapy and bring proton reference dosimetry uncertainty in line with megavoltage photon radiotherapy.
Asunto(s)
Grafito , Terapia de Protones , Humanos , Protones , Radiometría/métodos , Agua , CalibraciónRESUMEN
BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) is the first U.S. Food and Drug Administration-approved device for severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). OBJECTIVES: One-year safety and effectiveness of the Harmony TPV were evaluated in patients from the Harmony Native Outflow Tract Early Feasibility Study, Harmony TPV Pivotal Study, and Continued Access Study, representing the largest cohort to date of Harmony TPV recipients. METHODS: Eligible patients had severe PR by echocardiography or PR fraction ≥ 30% by cardiac magnetic resonance imaging and clinical indications for pulmonary valve replacement. The primary analysis included 87 patients who received a commercially available TPV22 (n = 42) or TPV25 (n = 45) device; 19 patients who received an early device iteration prior to its discontinuation were evaluated separately. RESULTS: In the primary analysis, median patient age at treatment was 26 years (IQR: 18-37 years) in the TPV22 group and 29 years (IQR: 19-42 years) in the TPV25 group. At 1 year, there were no deaths; 98% of TPV22 and 91% of TPV25 patients were free from the composite of PR, stenosis, and reintervention (moderate or worse PR, mean RVOT gradient >40 mmHg, device-related RVOT reoperation, and catheter reintervention). Nonsustained ventricular tachycardia occurred in 16% of patients. Most patients had none/trace or mild PR (98% of TPV22 patients, 97% of TPV25 patients). Outcomes with the discontinued device are reported separately. CONCLUSIONS: The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year. Further follow-up will continue to assess long-term valve performance and durability.