title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Results | LUNG METASTASES | Between November 1, 2018, and March 31, 2021, 40 patients were eligible for this study. The median PFS reached 7.5 months (95% confidence interval [CI] 4.7 to 9.9 months) and 9.4 months (95% CI 6.6 to 12.1 months) in the TP and Sub-BrM, respectively. ORR was 50.5% (20/40). CBR was 75.5% (30/40) and DCR reached 97.5% (3... | PMC9823079 | |
Conclusion | LUNG METASTASES | Pyrotinib plus trastuzumab and chemotherapy offered a promising option with manageable safety profile for heavily pre-treated HER2-positive MBC, especially for those without liver or/and lung metastases. | PMC9823079 | |
Keywords | PMC9823079 | |||
Introduction | Cancer, breast cancer, malignancy, Breast cancer, lung cancer, HER2-positive metastatic breast cancer, malignant disease | BREAST CANCER, BRAIN METASTASES, BREAST CANCER, COMPLICATION, MALIGNANT DISEASE, LUNG CANCER, METASTASES, CANCER | Breast cancer (BC) has surpassed lung cancer as the most commonly diagnosed malignancy in women according to Global Cancer statistics 2020 [Brain metastases (BrM) is a common complication of advanced malignant disease and occurs in 1/3 of HER2-positive metastatic breast cancer [Studies have confirmed the activity of co... | PMC9823079 |
Methods | PMC9823079 | |||
Patients and data collection | leptomeningeal disease, disability | ONCOLOGY, BRAIN METASTASIS, METASTATIC DISEASE | From November 1, 2018, to March 31, 2021, female patients aged ≥ 18 years old with histologically confirmed HER2-positive MBC at National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital (Shenzhen, Guangdong, China) were enrolled in this study. HER2 status was determined by central review based o... | PMC9823079 |
Treatment | All eligible patients were treated with pyrotinib (240–400 mg orally once daily), trastuzumab (6 mg per kilogram of body weight intravenously per 21 days, with an initial loading dose of 8 mg per kilogram) and single chemotherapeutic agent (nab-paclitaxel, 260 mg per square meter of body-surface area intravenously on d... | PMC9823079 | ||
Follow-up and assessment | DISEASE | All patients were followed up until January 20, 2022. Disease response was evaluated according to imaging reports from serial clinical assessments. Patient/disease response assessments were performed at baseline, every 6 weeks for 24 weeks, and every 9 weeks thereafter, including performance status, history, laboratory... | PMC9823079 | |
End points | death | DISEASE, DISEASE PROGRESSION, SECONDARY | The primary end point was PFS (calculated from the date of first treatment with double targeted therapy to the date of documented disease progression or death from any cause or the last follow-up visit) in TP. The secondary end points included PFS in the subgroup with BrM (Sub-BrM) at baseline; objective response rate ... | PMC9823079 |
Statistical analysis | EVENT | All data were analyzed using SPSS 23.0 statistical software (SPSS, Inc., Chicago, IL, USA) and GraphPad Prism 5 software (GraphPad Software, Inc., La Jolla, CA, USA). Descriptive analysis was utilized to display clinicopathological features. The Kaplan–Meier method was used to estimate PFS and 95% confidence intervals ... | PMC9823079 | |
Results | PMC9823079 | |||
Safety | ADVERSE EVENTS | All treatment-related adverse events (TRAEs) reported in the study were summarized in Table Treatment-related adverse events in total population | PMC9823079 | |
Acknowledgements | The authors are grateful to the patients and all the researchers, including the physicians, pathologists, and technicians, who participated in this study. | PMC9823079 | ||
Author contributions | All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by X-FX, Q-YZ, J-YH, L-PC, S-JG, S-LX, and X-FL. Writing-reviewing and editing were performed by X-XF, XB, LS. The first draft of the manuscript was written by X-FX and C-WD. Supervision and pr... | PMC9823079 | ||
Funding | ONCOLOGY | This work was supported by the Chinese Society of Clinical Oncology (CSCO) Research Foundation in Beijing and fund from ShenZhen Science and Technology Program (2018, JCYJ20180306171227129). Cai-Wen Du has received researches supported from Beijing CSCO clinical Oncology Research Foundation and Shenzhen Science and Tec... | PMC9823079 | |
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC9823079 | ||
Declarations | PMC9823079 | |||
Conflict of interest | The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC9823079 | ||
Ethical approval | Cancer | CANCER | All procedures performed involving human participants were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was also approved by institutional review boards and ethics committees (ethical code: 2019-35) of National Cancer Center/National Clinical Rese... | PMC9823079 |
Informed consent | Informed consent was obtained from all individual participants included in the study. The authors affirmed that human research participants provided informed consent for publication. | PMC9823079 | ||
References | PMC9823079 | |||
Subject terms | LBCL, toxicity, B-cell lymphoma, B cell lymphoma | REMISSIONS, B-CELL LYMPHOMA, CYTOKINE RELEASE SYNDROME, SECONDARY, B CELL LYMPHOMA, EVENTS | Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patie... | PMC10579056 |
Main | LBCL, transplant-ineligible | B CELL LYMPHOMA | Large B cell lymphoma (LBCL) is successfully treated in approximately two-thirds of patients with rituximab-based chemoimmunotherapyIn patients with high-risk R/R LBCL considered eligible for ASCT, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 CAR-T cell therapy, demonstrated superior efficacy over the SOC... | PMC10579056 |
Results | aggressive B cell non-Hodgkin lymphoma | ADVERSE EVENTS, SECONDARY | The primary end point was investigator-assessed complete metabolic response (CMR) at 3 months from the axi-cel infusion. Secondary end points were objective response rate (ORR) at 3 months from the axi-cel infusion, CMR at 6 months from the axi-cel infusion, best ORR, best CMR, duration of response (DOR), EFS from leuk... | PMC10579056 |
Patients and treatment | follicular lymphoma | MAY, DISEASE, FOLLICULAR LYMPHOMA | Between 19 March 2021 and 4 May 2022, a total of 69 patients were enrolled and underwent leukapheresis, representing the full analysis set (FAS). Of these 69 patients, 62 (89.8%) received a single axi-cel infusion between 26 April 2021 and 16 June 2022 and were consequently included in the modified full analysis set (m... | PMC10579056 |
Secondary efficacy outcomes | At 3 months from the axi-cel infusion, the investigator-assessed ORR was 75.8% (95% CI, 63.3–85.8%). In total, 37 patients (59.7%) remained in CMR, as assessed by the investigator, at 6 months from the axi-cel infusion (95% CI, 46.5–72.0%) (Extended Data Fig. At a median follow-up of 12.0 months, the median EFS from le... | PMC10579056 | ||
Subgroup analysis | We investigated whether the efficacy and safety of axi-cel were consistent among different patient populations, especially in patients aged ≥70 years and with comorbidities defined by a HCT-CI score ≥3. In patients aged ≥70 years ( | PMC10579056 | ||
Discussion | LBCL | DISEASE, REMISSIONS | Patients with LBCL who are refractory or who relapse early after first-line chemoimmunotherapy are often chemorefractory and have a very limited cure rate after standard chemoimmunotherapyIn this patient population with poor prognostic features, including 54.8% with primary refractory disease and 63.4% who were refract... | PMC10579056 |
Methods | PMC10579056 | |||
Study design | ALYCANTE (ClinicalTrials.gov ID | PMC10579056 | ||
Inclusion and ethics | The study protocol was approved by French Ethics Committee Est I (Dijon) N°20.07.08.66206, in accordance with applicable French laws and regulations. The study was performed in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Written inform... | PMC10579056 | ||
Participants | pneumonitis, tumor, cardiovascular disease, Active hepatitis B, bowel obstruction, aggressive B cell non-Hodgkin lymphoma, renal disease, idiopathic pneumonitis, infection, B cell non-Hodgkin lymphoma, autoimmune disease | PLEURAL EFFUSION, TUMOR, PNEUMONITIS, CARDIOVASCULAR DISEASE, ORGANIZING PNEUMONIA, FOLLICULAR LYMPHOMA, DISEASE, BOWEL OBSTRUCTION, CENTRAL NERVOUS SYSTEM DISEASE, RENAL DISEASE, DRUG-INDUCED PNEUMONITIS, INFECTION, IDIOPATHIC PULMONARY FIBROSIS, AUTOIMMUNE DISEASE | Eligible patients were aged 18 years or older with histologically confirmed aggressive B cell non-Hodgkin lymphoma, diagnosed according to the 2016 World Health Organization classification criteriaThere were in total, three important protocol deviations from the inclusion criteria in the present study, which were all r... | PMC10579056 |
Procedures | toxicities, CRS | Extended Data Fig. Safety was monitored continuously throughout the study. CAR-T cell toxicities such as CRS and ICANS were graded according to the American Society for Transplantation and Cellular Therapy grading system | PMC10579056 | |
Outcomes | lymphoma, toxicities, death, CRS | DISEASE PROGRESSION, ADVERSE EFFECTS, DISEASE, EVENT, ADVERSE EFFECTS, SECONDARY, LYMPHOMA, PMR | The primary end point was investigator-assessed CMR at 3 months from the axi-cel infusion according to the Lugano response criteriaSecondary efficacy end points included investigator-assessed ORR at 3 months from the axi-cel infusion, investigator-assessed CMR at 6 months from the axi-cel infusion and the best investig... | PMC10579056 |
Statistical analysis | DISEASE, EVENT | A one-sample binomial design was used to calculate the initial sample size. We hypothesized that axi-cel would yield a CMR at 3 months of 34% compared to 12% with a historical SOC estimated from a retrospective, real-world cohortEfficacy and safety analyses were performed on the mFAS, which included all patients who si... | PMC10579056 | |
Reporting summary | Further information on research design is available in the | PMC10579056 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02572-5. | PMC10579056 | ||
Supplementary information |
Supplementary Table 1 and Study Protocol.Reporting Summary | PMC10579056 | ||
Extended data |
Study design and overview of study procedures.
| PMC10579056 | ||
Causes of autologous stem cell transplantation (ASCT)-ineligibility in the modified full analysis set (N = 62). | comorbidity | Abbreviation: HCT-CI, hematopoietic cell transplantation-specific comorbidity index.
Metabolic response over time in the modified full analysis set (mFAS) (N = 62).
| PMC10579056 | |
Extended data | is available for this paper at 10.1038/s41591-023-02572-5. | PMC10579056 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02572-5. | PMC10579056 | ||
Acknowledgements | P. | This study was funded by Kite, a Gilead company. We thank the patients, their families and the study personnel involved in this trial. We also thank the ALYCANTE investigators, P. Cony-Makhoul, E. Chareyre and the LYSARC study team (Supplementary Table | PMC10579056 | |
Author contributions | R.H. and F.L. contributed to the conception, design and planning of the study. All authors contributed to the acquisition and analysis of data. All authors contributed to the critical review and revision of the manuscript. All authors approved the final version of the manuscript. | PMC10579056 | ||
Peer review | PMC10579056 | |||
Data availability | This trial is currently ongoing. Requests for access to aggregate data and supporting clinical documents will be reviewed and approved by an independent review panel on the basis of scientific merit. The datasets generated and/or analyzed during the current study are not publicly available due to proprietary considerat... | PMC10579056 | ||
Competing interests | Monahan, Cancer | SACHS, CANCER | R.H. has received honoraria from Kite/Gilead, Novartis, Incyte, Janssen, MSD, Takeda and Roche; and is a member on an entity’s Board of Directors or advisory committees of Kite/Gilead, Novartis, Bristol-Myers Squibb/Celgene, ADC Therapeutics, Incyte and Miltenyi. E.B. has received honoraria from Kite/Gilead, Bristol-My... | PMC10579056 |
References | PMC10579056 | |||
Highlights | depression, psychiatric, PTSD, G-TEP |
Group Traumatic Episode Protocol (G-TEP) may be efficient to treat PTSD symptoms in migrants.G-TEP displayed a tendency toward a decrease in symptoms of depression in migrants.
G-TEP is suitable to improve the access to psychiatric care for migrants. | PMC10093804 | |
Abstract | psychiatric, PTSD, Stress Disorder, MDD, Trauma | DISEASES, MAJOR DEPRESSIVE DISORDER 2, EYE | Introduction: Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) are commonly observed in migrants. Although Eye Movement Desensitization and Reprocessing (EMDR) can be helpful to treat these diseases, it remains difficult to propose EMDR as an individual intervention in help-seeking migrants. Gr... | PMC10093804 |
1. Introduction | PTE, traumatic, psychiatric, PTSD, Stress Disorder, MDD | EVENTS, MAJOR DEPRESSIVE DISORDER 2, EYE, DISORDERS | Migration is a complex and stressful experience. Migrants often experience potential traumatic events (PTE) either in their home country (pre-migration), during migration, and/or after their arrival in the host country (post-migration). Migration and resettlement have been associated with various mental-health problems... | PMC10093804 |
2. Methods | G-TEP, borderline personality disorder, eating or obsessive-compulsive disorder, traumatic, bipolar disorder, PTSD, schizophrenia, schizoaffective disorder, MDD, Trauma, DSM-5 | DISORDER, NEUROLOGICAL DISORDER | This open-label pilot study investigated the clinical effects of G-TEP in help-seeking migrants. First, all participants had an interview with a psychiatrist (P.V.) to control for group eligibility. The inclusion criteria were: PTSD and/or MDD (according to the DSM-5 criteria), the possibility of attending all sessions... | PMC10093804 |
2.1. Participants | MDD, PTSD | The participants were migrants identified as suffering from symptoms of PTSD and/or MDD and referred to our department. We have established a partnership with a charity that helps migrants solve their administrative issues and offers them social support. The sample included 10 migrants coming from various continents (E... | PMC10093804 | |
2.2. Clinical Assessment | MDD, CPTSD, P7–P9, PTSD | The ITQ is a self-reported short and simply-worded measure, focusing on the key symptoms of PTSD and complex-PTSD (CPTSD). The total_ITQ score is composed of a PTSD score and a Disturbances in Self-Organization (DSO) score. The PTSD score is a Likert scale composed of 6 items (P1–P6); the P1 and P2 items represent the ... | PMC10093804 | |
2.3. G-TEP Intervention | G-TEP | The G-TEP intervention consisted of 6 weekly 2-hour sessions. The first 2 sessions were used to train participants on stabilization exercises and for the detailed presentation of the G-TEP worksheet. The following 3 sessions were dedicated to the desensitization process. The last session was dedicated to the self-asses... | PMC10093804 | |
2.4. Statistical Analysis | PTSD | The primary outcome measures were the ITQ sub-scores (total_ITQ scores and functional_ITQ scores) and the PHQ-9 scores completed at baseline and after the completion of the 6 sessions. The Wilcoxon signed rank test was used to compare the pre- and post-intervention scores. Statistical analyses were performed using JASP... | PMC10093804 | |
3. Results | CPTSD, PTSD | All participants except three attended all six sessions of the G-TEP intervention. The two 17-year-old women from Cameroon (Participants 6 and 7) missed the 4th session. Another participant, a 22-year-old man from Guinea (Participant 10), missed the last session and had to be excluded from the analysis because of missi... | PMC10093804 | |
4. Discussion | MDD, PTSD | In this open-label pilot study, G-TEP was found to significantly decrease symptoms of PTSD, especially those relating to disturbances in self-organization, in a group of migrant participants who completed the intervention. This improvement was accompanied by a significant decrease in the functional impact of PTSD sympt... | PMC10093804 | |
Author Contributions | The GTEP intervention was administered by P.V., S.R. and E.C.; P.V. wrote the manuscript with the support of N.C. and J.B. and C.V.; J.B. performed the statistical analysis. N.P. supervised the project. All authors have read and agreed to the published version of the manuscript. | PMC10093804 | ||
Institutional Review Board Statement | No ethical committee approval was obtained for this study involving only validated, and usual psychological treatments. | PMC10093804 | ||
Informed Consent Statement | Informed consent was obtained from all subjects participating in the study after a fair description of the study objectives. | PMC10093804 | ||
Data Availability Statement | For privacy reasons, the data that support the findings of this study cannot be made publicly available. However, they remain available from the corresponding author, PV, upon reasonable request. | PMC10093804 | ||
Conflicts of Interest | The authors don’t have any conflict of interest to declare related to this work. | PMC10093804 | ||
References | depression, post-traumatic stress disorder, PTSD | EVENT | Demographic characteristics of the included participants.Changes in symptoms of post-traumatic stress disorder (PTSD) and depression in participants receiving the 6-session Group Traumatic Event Protocol (G-TEP). | PMC10093804 |
Supplementary Information | toxicities, NHL | INDOLENT NON-HODGKIN LYMPHOMA, NHL | The safety, efficacy, and pharmacokinetics of copanlisib were evaluated in this phase Ib/II study in Japanese patients with relapsed/refractory indolent non-Hodgkin lymphoma (NHL). The primary endpoint was safety at the recommended dose; efficacy endpoints included objective response rate (ORR), progression-free surviv... | PMC9813077 |
Keywords | PMC9813077 | |||
Introduction | NHLs, Non-Hodgkin lymphomas, malignant lymphomas, NHL | PROLIFERATION, NON-HODGKIN LYMPHOMA, NHL, TUMOR GROWTH, MALIGNANT LYMPHOMAS | Non-Hodgkin lymphomas (NHLs) comprise about 95% of the malignant lymphomas diagnosed in Japan [Phosphatidylinositol 3 kinases (PI3K) are a family of membrane-bound kinases involved in the growth and survival of healthy cells that are implicated in tumor growth and proliferation when they are dysregulated or aberrantly ... | PMC9813077 |
Methods | PMC9813077 | |||
Study design | This was an open-label, single-arm, phase Ib/II study conducted at 13 centers in Japan. The study was in two parts: the dose-escalation part (phase Ib) to determine the recommended dose and the expansion part (phase II) to evaluate the antitumor activity and safety of the recommended dose of copanlisib.The protocol was... | PMC9813077 | ||
Patients | inadequate liver, tumor, myocardial infarction, angina, impaired pulmonary function, toxicity, human immunodeficiency virus infection, B-cell NHL, cardiac disease, interstitial lung disease, alopecia | TUMOR, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, HEART DISEASE, CHRONIC HEPATITIS, DIABETES MELLITUS, ALOPECIA, HUMAN IMMUNODEFICIENCY VIRUS INFECTION, SMALL LYMPHOCYTIC LYMPHOMA, SEIZURE DISORDERS, B-CELL NHL, CONGESTIVE HEART FAILURE, CARDIAC DISEASE, JC VIRUS INFECTION, ONCOLOGY, INTERSTITIAL LUNG DISEASE, P... | The study included Japanese patients aged ≥ 20 years with a histologically confirmed diagnosis (central pathology review) of one of the following types of indolent B-cell NHL: FL grade 1, 2, or 3a, small lymphocytic lymphoma with absolute lymphocyte count < 5 × 10Other inclusion criteria were: Eastern Cooperative Oncol... | PMC9813077 |
Study methodology | DLTs, toxicity, toxicities, hyperglycemia, PD | HYPERGLYCEMIA, DISEASE PROGRESSION, ADVERSE EVENT | After a screening period of up to 28 days, three eligible patients began treatment with copanlisib at 45 mg (dose level 1) by 1 h intravenous infusion on days 1, 8, and 15 of a 28-day cycle. Tolerability was assessed at the end of the first cycle, and if no dose-limiting toxicities (DLTs) occurred, three additional pat... | PMC9813077 |
Outcomes and assessments | tumor, DLTs, neutropenia, toxicity, Malignant Lymphoma, hyperglycemia, Cancer | ADVERSE EVENT, TUMOR, NEUTROPENIA, ADVERSE DRUG REACTION, DISEASE, MALIGNANT LYMPHOMA, HYPERGLYCEMIA, PANCREATITIS, EVENTS, HYPERTENSION, CANCER | Patients were assessed for AEs, and blood samples were taken for laboratory assessments at screening, on day 1 of cycle 1, at each visit during treatment, and at the safety follow-up visit 28–35 days after the last administration of copanlisib. AEs were graded using the National Cancer Institute Common Terminology Crit... | PMC9813077 |
Statistical analysis | DLTs | Since the study was primarily a descriptive safety and tolerability assessment, no formal sample size estimate was performed, but we included at least three patients at each dose level to identify any DLTs and 20 patients to determine antitumor activity. Both efficacy and safety were assessed in the full analysis set (... | PMC9813077 | |
Results | PMC9813077 | |||
Treatment exposure | At the time of data cut-off, the median duration of study treatment was 19.3 weeks (4.8 cycles), and the median number of copanlisib infusions was 12. The median total dose per patient was 720 mg, and the median percentage of planned dose was 83.3%. | PMC9813077 | ||
Pharmacokinetics | The maximum plasma concentration and area under the concentration–time curve to 168 h from copanlisib infusion in Japanese patients were both similar to those values determined in non-Japanese patients (Supplementary Fig. S3). | PMC9813077 | ||
Discussion | hypertension, NHL | HYPERGLYCEMIA, HYPERTENSION, NHL | This phase Ib/II study demonstrated that the recommended dose of copanlisib is 60 mg in Japanese patients with relapsed/refractory indolent NHL, and that the safety and tolerability of copanlisib, as well as the antitumor activity, in this population are similar to those reported in the CHRONOS-1 study [In our study, c... | PMC9813077 |
Acknowledgements | Mitali Choudhury of inScience Communications | We would like to thank Catherine Rees and Mitali Choudhury of inScience Communications, Springer Healthcare who wrote the outline and the subsequent drafts of this manuscript, respectively. This medical writing assistance was funded by Bayer Yakuhin, Ltd. | PMC9813077 | |
Author contributions | JGV and BHC: conceptualized and designed the study. NF, DM, KH, HN, SM, KK, TU, SK, JK, CI, MY, NT, YS, HM, and KT: collected and assembled the data. MY, SM, TT, and YT: interpreted the data. All authors critically reviewed the manuscript and approved the final draft for submission. | PMC9813077 | ||
Funding | Bayer Yakuhin | PMC9813077 | ||
Declarations | PMC9813077 | |||
Conflict of interest | Shinichi, Barrett, honoraria/lecture | BARRETT | Noriko Fukuhara has received research grants from AbbVie, Bayer, Eisai, Gilead Sciences, Ono Pharmaceutical, and Solasia Pharma and honoraria from Chugai and Kyowa Kirin. Dai Maruyama has received research grants from Celgene, Novartis, Chugai, Ono Pharmaceutical, Takeda, Janssen, and MSD and honoraria from Janssen, Mu... | PMC9813077 |
References | PMC9813077 | |||
Objectives | aneurysm | ANEURYSM | Differences in indication and technique make a randomised comparison between valve-sparing root replacement (VSRR) and personalised external aortic root support (PEARS) challenging. We performed a propensity score (PS)-matched comparison of PEARS and VSRR for syndromic root aneurysm. | PMC10313978 |
Methods | Aneurysm, connective tissue disease, aortic regurgitation, aneurysm | ANEURYSM, ANEURYSM, AORTIC REGURGITATION, AORTIC VALVE INSUFFICIENCY, CONNECTIVE TISSUE DISEASE | Patients in the PEARS 200 Database and Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry (undergoing VSRR) with connective tissue disease operated electively for root aneurysm <60 mm with aortic regurgitation (AR) <1/4 were included. Using a PS analysis, 80 patients in each cohort were matc... | PMC10313978 |
Results | death, bleeding, impingement, coronary injury, deaths | BLEEDING | Median follow-up was 25 and 55 months for 159 PEARS and 142 VSRR patients. Seven (4.4%) patients undergoing PEARS required an intervention for coronary injury or impingement, resulting in one death (0.6%). After VSRR, there were no early deaths, 10 (7%) reinterventions for bleeding and 1 coronary intervention. Survival... | PMC10313978 |
Conclusions | ’s disease stage | VSRR and PEARS offer favourable mid-term survival, freedom from reintervention and preservation of valve function. Both treatments deserve their place in the surgical repertoire, depending on a patient’s disease stage. This study is limited by its retrospective nature and different follow-ups in both cohorts. | PMC10313978 | |
WHAT IS ALREADY KNOWN ON THIS TOPIC | aneurysm, aortic valve reintervention | ANEURYSM | While valve-sparing root replacement (VSRR) is the established treatment for syndromic root aneurysm, there remains a cumulative risk of aortic valve reintervention. In personalised external aortic root support (PEARS), the dilated aorta is supported using a bespoke mesh, optimally respecting valve anatomy. To date, no... | PMC10313978 |
WHAT THIS STUDY ADDS | aneurysm | DISEASE PROGRESSION, EVENTS, ANEURYSM | VSRR and PEARS both seem to offer favourable mid-term survival, freedom from reintervention and preservation of valve function in syndromic root aneurysm with near-normal valve function. Our study indicates that an earlier intervention in the disease progression via PEARS may be justified with a low probability of deve... | PMC10313978 |
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | aneurysm | DISEASE PROGRESSION, EVENTS, ANEURYSM, COMPLICATIONS | Long-term data are needed to determine the role of all possible treatments in the surgical repertoire. Improved prediction of aortic complications will further help guide patient selection. A shared decision-making process should involve weighing the risk of watchful waiting against the potential risks of all available... | PMC10313978 |
Introduction | aneurysm | ANEURYSM | Valve-sparing root replacement (VSRR) is an established surgical treatment for aortic root aneurysm.(A) ExoVasc implant used to stabilise the ascending aorta during personalised external aortic root support surgery. (B) Intraoperative photograph of valve-sparing root replacement. The corrugations of the relatively rigi... | PMC10313978 |
Methods | PMC10313978 | |||
Study design | Aneurysm | ANEURYSM, AORTIC VALVE INSUFFICIENCY | We present a multicentre study using two existing databases: the ‘PEARS 200’ and ‘AVIATOR’ Database (Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry), both containing prospectively and retrospectively collected data. | PMC10313978 |
Data collection and study endpoints | bleeding, aneurysm, endocarditis, stroke, Loeys-Dietz syndrome, MFS | BLEEDING, MYOCARDIAL INFARCTION, ANEURYSM, ENDOCARDITIS, POSTOPERATIVE COMPLICATIONS, STROKE, LOEYS-DIETZ SYNDROME, ASCENDING AORTIC DISSECTION | From both databases, patients with CTD (MFS, Loeys-Dietz syndrome and ACTA2 mutations) undergoing elective surgery for aortic root aneurysm <60 mm diameter with at most mild AR (grade 0/4 or 1/4) were extracted. Patients with ascending aortic dissection or endocarditis were excluded. The primary endpoint was mid-term s... | PMC10313978 |
Data analysis | Continuous variables were tested for normality with the Shapiro-Wilk test, shown as median (IQR) and compared using Mann-Whitney U test. Categorical variables were shown as n (%) and compared via Χ | PMC10313978 | ||
Patient and public involvement | No patients were involved in the design, conduct or reporting of this study. | PMC10313978 | ||
Results | PMC10313978 | |||
Baseline demographics | AORTIC REGURGITATION | The 159 included PEARS patients were operated at 20 centres between 2004 and 2019, while the 142 patients undergoing VSRR from the AVIATOR underwent surgery at 13 centres between 1996 and 2021. Eighty patients in each cohort were matched using a PS analysis. Before matching, patients undergoing VSRR were significantly ... | PMC10313978 | |
Operative variables and in-hospital outcomes | coronary injury, aortic annuloplasty, impingement, patent foramen ovale | CARDIOPULMONARY, AORTIC REGURGITATION | In both groups, concomitant procedures predominantly involved the mitral valve (12.3%, 20 of 159 for PEARS and 11.3%, 16 of 142 for VSRR). Cardiopulmonary bypass was used in 18.3% (24 of 131) of uncomplicated isolated aortic PEARS cases. For patients undergoing VSRR, 57% were operated via the reimplantation/David techn... | PMC10313978 |
Survival | death | POSTOPERATIVE COMPLICATIONS | Median follow-up duration for PEARS patients was 25 months (IQR 12–52, total of 542 postoperative patient years), while for VSRR patients, it was 55 months (IQR 23–89, 713 postoperative years). No follow-up after discharge could be collected for two (1.3%) PEARS and four (2.8%) VSRR patients. Overall survival at 5 year... | PMC10313978 |
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