tbuckley/cabot-search huggingface dataset:
A systematic review and meta-analysis of double trophectoderm biopsy and/or cryopreservation in PGT: balancing the need for a diagnosis against the risk of harm
Authors: Letizia Li Piani, Pasquale Petrone, Mariafrancesca Brutto, Anick De Vos, Annelore Van Der Kelen, Alberto Vaiarelli, Laura Rienzi, Alessandro Conforti, Danilo Cimadomo, Willem Verpoest
Journal: Human Reproduction Update (2024)

To prevent the transfer of embryos affected by monogenic conditions and/or chromosomal defects, preimplantation genetic testing (PGT) requires trophectoderm biopsy and cryopreservation. In 2-6% of biopsies, the diagnosis may be inconclusive due to DNA amplification failure or low-quality results. In these cases, a round of re-warming, re-biopsy, and re-cryopreservation is required to obtain a genetic diagnosis. In other cases, when the IVF centre starts providing PGT and/or when the patients develop an indication because of multiple failures, miscarriages or the birth of an affected child after IVF, cryopreserved untested embryos may be warmed, biopsied, and then re-vitrified. However, it is still unclear whether multiple manipulations may reduce reproductive outcomes after PGT.
Cost-effectiveness analysis of mHealth applications for depression in Germany using a Markov cohort simulation
Authors: Bettina Freitag, Marie Uncovska, Sven Meister, Christian Prinz, Leonard Fehring
Journal: npj Digital Medicine (2024)

Abstract Regulated mobile health applications are called digital health applications (“DiGA”) in Germany. To qualify for reimbursement by statutory health insurance companies, DiGA have to prove positive care effects in scientific studies. Since the empirical exploration of DiGA cost-effectiveness remains largely uncharted, this study pioneers the methodology of cohort-based state-transition Markov models to evaluate DiGA for depression. As health states, we define mild, moderate, severe depression, remission and death. Comparing a future scenario where 50% of patients receive supplementary DiGA access with the current standard of care reveals a gain of 0.02 quality-adjusted life years (QALYs) per patient, which comes at additional direct costs of ~1536 EUR per patient over a five-year timeframe. Influencing factors determining DiGA cost-effectiveness are the DiGA cost structure and individual DiGA effectiveness. Under Germany’s existing cost structure, DiGA for depression are yet to demonstrate the ability to generate overall savings in healthcare expenditures.
Temporal dynamics of neurovascular unit changes following blood-brain barrier opening in the putamen of non-human primates
Authors: Tiziano Balzano, José A Pineda-Pardo, Noelia Esteban-García, Miguel López-Aguirre, Alejandro Reinares-Sebastián, Inés Trigo-Damas, Masahiko Takada, José A Obeso, Javier Blesa
Journal: Journal of Controlled Release (2024)

Low-intensity focused ultrasound (LIFU) combined with intravenously circulating microbubbles has recently emerged as a novel approach for increasing delivery through the blood-brain barrier (BBB). This technique safely and transiently enables therapeutic agents to overcome the BBB, which typically poses a significant obstacle for treatment of brain disorders. However, the full impact of LIFU on the entire neurovascular unit (NVU), as well as the mechanisms and factors involved in restoring BBB integrity still require further elucidation. We conducted immunohistochemical analyses of the putamen in non-human primates to monitor changes over time [immediately post-treatment (3 h) and at 7- and 30-days post-BBB opening] in vascular, glial, and immune cells. Additionally, we examined the dynamic interactions among these elements and their role in the restorative process at the BBB level. A mild inflammatory response primarily involving microglia, astrocytes, and T- and B-lymphocytes was observed in the treated putamen acutely after BBB opening. These cells, recruited in response to the vascular changes, stimulate upregulation of PDGFRβ, a pericyte-specific marker, and VEGF-A, a pro-angiogenic factor. This was associated with vascular sprouting by 7 days post-BBB opening. Importantly, no notable long-term alterations were observed in the NVU 30 days post-BBB opening. These results offer further evidence regarding the efficacy and safety of LIFU in achieving BBB opening in the primate brain, indicating that nearly all changes in the NVU revert to baseline within 30 days post-treatment. This also suggests that angiogenesis may play an important role in restoring vascular integrity after BBB opening.
A phase II trial of ipilimumab, nivolumab, or ipilimumab and nivolumab with or without azacitidine in relapsed or refractory myelodysplastic neoplasms
Authors: Ian M. Bouligny, Guillermo Montalban-Bravo, Koji Sasaki, Naval Daver, Elias Jabbour, Yesid Alvarado, Courtney D. DiNardo, Farhad Ravandi, Gautam Borthakur, Naveen Pemmaraju, Tapan Kadia, Lucia Masarova, Koichi Takahashi, Michael Andreeff, Alexandre Bazinet, Hui Yang, Rashmi Kanagal, Sherry Pierce, Meghan Meyer, Xuelin Huang, Guillermo Garcia-Manero
Journal: Leukemia (2024)
Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial
Authors: Barry A. Borlaug, Michael R. Zile, Christopher M. Kramer, Seth J. Baum, Karla Hurt, Sheldon E. Litwin, Masahiro Murakami, Yang Ou, Navneet Upadhyay, Milton Packer
Journal: Nature Medicine (2024)

Abstract Patients with obesity-related heart failure with preserved ejection fraction (HFpEF) display circulatory volume expansion and pressure overload contributing to cardiovascular–kidney end-organ damage. In the SUMMIT trial, patients with HFpEF and obesity were randomized to the long-acting glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist tirzepatide ( n = 364, 200 women) or placebo ( n = 367, 193 women). As reported separately, tirzepatide decreased cardiovascular death or worsening heart failure. Here, in this mechanistic secondary analysis of the SUMMIT trial, tirzepatide treatment at 52 weeks, as compared with placebo, reduced systolic blood pressure (estimated treatment difference (ETD) −5 mmHg, 95% confidence interval (CI) −7 to −3; P &lt; 0.001), decreased estimated blood volume (ETD −0.58 l, 95% CI −0.63 to −0.52; P &lt; 0.001) and reduced C-reactive protein levels (ETD −37.2%, 95% CI −45.7 to −27.3; P &lt; 0.001). These changes were coupled with an increase in estimated glomerular filtration rate (ETD 2.90 ml min −1 1.73 m −2 yr −1 , 95% CI 0.94 to 4.86; P = 0.004), a decrease in urine albumin–creatinine ratio (ETD 24 weeks, −25.0%, 95% CI −36 to −13%; P &lt; 0.001; 52 weeks, −15%, 95% CI −28 to 0.1; P = 0.051), a reduction in N-terminal prohormone B-type natriuretic peptide levels (ETD 52 weeks −10.5%, 95% CI −20.7 to 1.0%; P = 0.07) and a reduction in troponin T levels (ETD 52 weeks −10.4%, 95% CI −16.7 to −3.6; P = 0.003). In post hoc exploratory analyses, decreased estimated blood volume with tirzepatide treatment was significantly correlated with decreased blood pressure, reduced microalbuminuria, improved Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and increased 6-min walk distance. Moreover, decreased C-reactive protein levels were correlated with reduced troponin T levels and improved 6-min walk distance. In conclusion, tirzepatide reduced circulatory volume–pressure overload and systemic inflammation and mitigated cardiovascular–kidney end-organ injury in patients with HFpEF and obesity, providing new insights into the mechanisms of benefit from tirzepatide. ClinicalTrials.gov registration: NCT04847557 .
Routine Spironolactone in Acute Myocardial Infarction
Authors: Sanjit S Jolly, Marc-André d'Entremont, Bertram Pitt, Shun Fu Lee, Rajibul Mian, Jessica Tyrwhitt, Sasko Kedev, Gilles Montalescot, Jan H Cornel, Goran Stanković, Raul Moreno, Robert F Storey, Timothy D Henry, Shamir R Mehta, Matthias Bossard, Petr Kala, Ravinay Bhindi, Biljana Zafirovska, P J Devereaux, John Eikelboom, John A Cairns, Madhu K Natarajan, J D Schwalm, Sanjib K Sharma, Wadea Tarhuni, David Conen, Sarah Tawadros, Shahar Lavi, Valon Asani, Dragan Topic, Warren J Cantor, Olivier F Bertrand, Ali Pourdjabbar, Salim Yusuf
Journal: New England Journal of Medicine (2024)

BackgroundMineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain.MethodsIn this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed.ResultsWe enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P=0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P=0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group.ConclusionsAmong patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.)
Colchicine in Acute Myocardial Infarction
Authors: Sanjit S Jolly, Marc-André d'Entremont, Shun Fu Lee, Rajibul Mian, Jessica Tyrwhitt, Sasko Kedev, Gilles Montalescot, Jan H Cornel, Goran Stanković, Raul Moreno, Robert F Storey, Timothy D Henry, Shamir R Mehta, Matthias Bossard, Petr Kala, Jamie Layland, Biljana Zafirovska, P J Devereaux, John Eikelboom, John A Cairns, Binita Shah, Tej Sheth, Sanjib K Sharma, Wadea Tarhuni, David Conen, Sarah Tawadros, Shahar Lavi, Salim Yusuf
Journal: New England Journal of Medicine (2024)

BackgroundInflammation is associated with adverse cardiovascular events. Data from recent trials suggest that colchicine reduces the risk of cardiovascular events.MethodsIn this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients who had myocardial infarction to receive either colchicine or placebo and either spironolactone or placebo. The results of the colchicine trial are reported here. The primary efficacy outcome was a composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization, evaluated in a time-to-event analysis. C-reactive protein was measured at 3 months in a subgroup of patients, and safety was also assessed.ResultsA total of 7062 patients at 104 centers in 14 countries underwent randomization; at the time of analysis, the vital status was unknown for 45 patients (0.6%), and this information was most likely missing at random. A primary-outcome event occurred in 322 of 3528 patients (9.1%) in the colchicine group and 327 of 3534 patients (9.3%) in the placebo group over a median follow-up period of 3 years (hazard ratio, 0.99; 95% confidence interval [CI], 0.85 to 1.16; P=0.93). The incidence of individual components of the primary outcome appeared to be similar in the two groups. The least-squares mean difference in C-reactive protein levels between the colchicine group and the placebo group at 3 months, adjusted according to the baseline values, was −1.28 mg per liter (95% CI, −1.81 to −0.75). Diarrhea occurred in a higher percentage of patients with colchicine than with placebo (10.2% vs. 6.6%; P<0.001), but the incidence of serious infections did not differ between groups.ConclusionsAmong patients who had myocardial infarction, treatment with colchicine, when started soon after myocardial infarction and continued for a median of 3 years, did not reduce the incidence of the composite primary outcome (death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization). (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.)
Sex-Specific Efficacy and Safety in HF Trials
Authors: Sadiya Khan, Clyde W. Yancy, Gregg C. Fonarow
Journal: JAMA Cardiology (2024)

Misato Chimura, MD, PhD; Xiaowen Wang, MD, MPH; Pardeep S. Jhund, MBChB, MSc, PhD; Alasdair D. Henderson, PhD; Brian L. Claggett, PhD; Akshay S. Desai, MD, MPH; Cândida Fonseca, MD, PhD; Eva Goncalvesova, MD; Tzvetana Katova, MD, PhD; Katharina Mueller, Msc; Andrea Glasauer, PhD; Katja Rohwedder, MD; Prabhakar Viswanathan, MBBS, PhD; Savina Nodari, MD; Carolyn S. P. Lam, MD, PhD; Clara Inés Saldarriaga, MD; Michele Senni, MD; Kavita Sharma, MD; Adriaan A. Voors, MD; Faiez Zannad, MD; Bertram Pitt, MD; Orly Vardeny, PharmD; Muthiah Vaduganathan, MD, MPH; Scott D. Solomon, MD; John J. V. McMurray, MD
Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Authors: Misato Chimura, Xiaowen Wang, Pardeep S. Jhund, Alasdair D. Henderson, Brian L. Claggett, Akshay S. Desai, Cândida Fonseca, Eva Goncalvesova, Tzvetana Katova, Katharina Mueller, Andrea Glasauer, Katja Rohwedder, Prabhakar Viswanathan, Savina Nodari, Carolyn S. P. Lam, Clara Inés Saldarriaga, Michele Senni, Kavita Sharma, Adriaan A. Voors, Faiez Zannad, Bertram Pitt, Orly Vardeny, Muthiah Vaduganathan, Scott D. Solomon, John J. V. McMurray
Journal: JAMA Cardiology (2024)

Importance Sex is associated with the clinical presentation, outcomes, and response to treatment in patients with heart failure (HF). However, little is known about the safety and efficacy of treatment with finerenone according to sex. Objective To estimate the efficacy and safety of finerenone compared with placebo in both women and men. Design, Setting, and Participants Prespecified analyses were conducted in the phase 3 randomized clinical trial Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF). The trial was conducted across 653 sites in 37 countries. Participants were adults aged 40 years and older with symptomatic HF and left ventricular ejection fraction (LVEF) of 40% or greater randomized between September 2020 and January 2023. Intervention Finerenone (titrated to 20 mg or 40 mg) or placebo. Main Outcomes and Measures The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events (unplanned HF hospitalizations or urgent HF visits). Results A total of 6001 patients were randomized in FINEARTS-HF, of whom 2732 were women (45.5%), with a mean (SD) age of 73.6 (9.1) years. Women had higher rates of any obesity, higher LVEF (54.6 [7.6%] vs 50.9 [7.6] for men), lower mean (SD) estimated glomerular filtration rate than men (59.7 [19.1] vs 64.1 [20.0] for men; P&amp;amp;lt;.001) , worse New York Heart Association functional class, and lower Kansas City Cardiomyopathy Questionnaire-Total Symptom Scores (KCCQ-TSS) (mean [SD] 62.3 [24.0] vs 71.0 [23.1]). The incident rate of the primary outcome was slightly lower in women (15.7; 95% CI, 14.3-17.3) than in men (16.8; 95% CI, 15.4-18.3) per 100 person-years. Compared with placebo, finerenone reduced the risk of the primary end point similarly in women and men: rate ratio 0.78 (95% CI, 0.65-0.95) in women and 0.88 (95% CI, 0.74-1.04) in men ( P = .41 for interaction). Consistent effects were observed for the components of the primary outcome and all-cause mortality. The mean increase (improvement) in KCCQ-TSS from baseline to 12 months was greater with finerenone, regardless of sex ( P = .73 for interaction). Finerenone had similar tolerability in women and men. Conclusions and Relevance In FINEARTS-HF, finerenone reduced the risk of the primary end point similarly in women and men with heart failure with mildly reduced or preserved ejection fraction. Finerenone had similar tolerability in women and men. Trial Registration ClinicalTrials.gov Identifier: NCT04435626
The Fine Art and Science of Translating Trials Results Into Clinical Practice
Authors: Gregg C. Fonarow, Eric D. Peterson, Adrian F. Hernandez
Journal: JAMA Cardiology (2024)

Orly Vardeny, PharmD, MS; Muthiah Vaduganathan, MD, MPH; Brian L. Claggett, PhD; Akshay S. Desai, MD, MPH; Pardeep S. Jhund, MBChB, MSc, PhD; Carolyn S. P. Lam, MBBS, PhD; Michele Senni, MD; Sanjiv J. Shah, MD; Adriaan A. Voors, MD, PhD; Faiez Zannad, MD, PhD; Bertram Pitt, MD; Shingo Matsumoto, MD; Béla Merkely, MD, PhD; Shelley Zieroth, MD; Mehmet Birhan Yilmaz, MD; James Lay-Flurrie, MSc; Prabhakar Viswanathan, MBBS, PhD; Andrea Horvat-Broecker, MD; Andrea Scalise, MD; John J. V. McMurray, MD; Scott D. Solomon, MD
Power of Digital Nudges to Boost Influenza Vaccination Rates
Authors: Mohammad Madjid, Payam Safavi-Naeini
Journal: JAMA Cardiology (2024)

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Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting
Authors: Ziang Yang, Xieraili Tiemuerniyazi, Fei Xu, Yang Wang, Yang Sun, Peng Yan, Liangxin Tian, Chao Han, Yan Zhang, Shiwei Pan, Zhan Hu, Xi Li, Wei Zhao, Wei Feng
Journal: JAMA Cardiology (2024)

Importance Efficient approaches to prevent postoperative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) are still needed. Objective To investigate whether partial cardiac denervation, achieved by cutting off the ligament of Marshall (LOM) and resecting the fat pad along the Waterston groove, can reduce the risk of POAF following CABG. Design, Setting and Participants This single-center, randomized clinical trial enrolled adult patients scheduled for isolated CABG in China. Enrollment was from August 15, 2022, to December 13, 2023; follow-up visits were 30 days after discharge. Interventions Participants were randomized into the intervention group (CABG plus partial cardiac denervation) and the control group (CABG only) in a 1:1 pattern. All participants were continuously monitored for the incidence of POAF until day 6 after the operation. Main outcome and Measures The primary end point was the incidence of POAF in 6 days, defined as a supraventricular arrhythmia lasting for more than 30 seconds. Results The trial enrolled 430 patients (79 [18.4%] female; mean [SD] age, 61.9 [7.8] years). Compared with the control group, the 6-day incidence of POAF was significantly lower in the intervention group (18.1% vs 31.6%; P = .001; risk ratio, 0.57 [95% CI, 0.41-0.81]). To further support these results, a sensitivity analysis performed with Kaplan-Meier survival curves also showed a significant reduction in the occurrence of POAF in the intervention group (hazard ratio, 0.53 [95% CI, 0.36-0.79]; P = .002). Safety assessments showed no difference between the 2 groups, while postoperative medical cost was reduced in the intervention group. Conclusions and Relevance This randomized clinical trial found that partial cardiac denervation was an effective procedure to reduce the occurrence of POAF after isolated CABG without additional postoperative complications. These results suggest that partial cardiac denervation may be a good option for cardiac surgeons to consider for preventing POAF after CABG. Trial Registration ClinicalTrials.gov Identifier: NCT05009914