bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient-reported outcomes in atrial fibrillation clinical trials: trends, utilisation, and implications
Authors: Lan R , Guerrero E P G , Saeed M S , Perez M V P 
Published: May 2024

Abstract

Background/Introduction
Atrial fibrillation (AF) is the most prevalent clinical arrhythmia, and it is associated with diverse and consequential adverse outcomes that significantly impact the quality of life (QoL) experienced by patients. The evaluation and quantification of QoL have become an important aspect of assessing AF patients, with patient-reported outcomes (PROs) increasingly used in cardiovascular clinical trials. However, there is no consensus on which PROs are most suitable to report, and there is a limited understanding of their prevalence in AF clinical trials.

Purpose
This study aims to characterise the utilisation of PROs in AF clinical trials. We distinguish between AF-specific and AF-agnostic PROs, with the goal of understanding the evolving role of PROs and emphasising the significance of precise measurement of patient QoL in AF research.

Methods
We queried the ClinicalTrials.gov database for all available clinical trials that focused on AF as the primary condition from inception to August 1, 2023. This search yielded 3,208 clinical trials, encompassing a total of 65,545,864 participants. We filtered and manually reviewed each clinical trial for their use of PROs within the "outcomes measures" field and divided the results between AF-specific and AF-agnostic PROs. We displayed these findings over time (Figure) and conducted a linear regression analysis for each PRO.

Results
Of the 3,208 AF clinical trials, 569 (17.7%) reported using at least one PRO, with 178 (5.5%) using AF-specific PROs. There was a statistically significant increase in the use of PROs between 2000 and 2023 (8 vs. 518; P &lt; 0.001; R2= 0.959). This finding held for both AF-specific PROs between 2000 and 2023 (0 vs. 79; P &lt; 0.001; R2=0.930) and AF-agnostic PROs between 2000 and 2023 (8 vs. 360; P &lt; 0.001; R2=0.969). The Atrial Fibrillation Effect on Quality-of-life (AFEQT) was the most used AF-specific PRO, utilized 130 times, with its usage increasing between 2000 and 2023 (0 vs. 61; P = 0.003; R2= 0.888). The EQ-5D was the most frequently used AF-agnostic PRO, employed 131 times.

Conclusion
The study reveals a significant increase in the use of PROs in AF clinical trials over time. While most trials use AF-agnostic PROs for measuring QoL, several AF-specific PROs, especially AFEQT, have gained wide adoption. These findings underscore the importance of patient-centred outcomes and suggest the increasing emphasis on PROs in AF research. However, significant heterogeneity remains in the choice of PROs, with limited utilisation of validated, AF-specific measures. Future research should focus on understanding the distinct strengths and limitations of AF-specific PROs compared to AF-agnostic ones and promoting their appropriate integration into AF clinical trials to improve patient-centred care for AF patients.Figure
Risk of death, thrombotic and hemorrhagic events in patients with atrial fibrillation and systemic autoimmune diseases
Authors: Bucci T , Cardamone C , Triggiani M , Ames P R J , Lip G Y H 
Published: May 2024

Abstract

Background
Growing evidence showing that systemic autoimmune diseases (SAD) are associated with a high risk of incident atrial fibrillation (AF). However, the impact of SAD on the clinical course of AF patients is largely unknown.

Purpose
To assess the risk of all-cause death, thrombotic events, and bleeding in AF patients with SAD.

Methods
Retrospective cohort study within a global health care network (TriNetx). Using ICD codes, AF patients were categorized into two groups: 1) AF patients with SAD (M32: Systemic Lupus Erythematosus; M33: Dermato-polymyositis; M34: Systemic Sclerosis; M35: Sjogren syndrome), and 2) AF controls (without systemic autoimmune, autoinflammatory, or rheumatic diseases). The primary outcomes were the 5-year risks of 1) all-cause death, 2) thrombotic events (ischemic stroke, transient ischemic attack, peripheral arterial thromboembolism, acute myocardial infarction, deep vein thrombosis, and pulmonary embolism), and 3) hemorrhagic outcome (intracranial hemorrhage and gastrointestinal bleeding). Secondary outcomes were each component of the composite primary outcomes. Cox regression analysis before and after propensity-score-matching (PSM) was used to estimate HR and 95% confidence interval (95%CI). Sensitivity analyses were done to investigate the risk of primary outcomes associated with each systemic autoimmune disease and with different types of oral anticoagulant (OAC).

Results
We identified 22,371 AF patients with SAD (67.7±13.7 years, 72.2% females), and 1,478,693 AF controls (69.7±14.0, 42.6% females). Before PSM, AF patients with SAD were younger, more often females, and with a higher prevalence of cardiovascular risk factors; no differences were found after PSM.
After PSM, AF patients with SAD showed a higher risk of all-cause death (HR 1.21, 95% 1.17-1.25), thrombotic events (HR 1.55, 95%CI 1.49-1.61), and hemorrhagic events (HR 1.39, 95%CI 1.32-1.46) compared to AF controls (Table 1). On sensitivity analyses, we found that the risk of primary outcomes in AF patients with SAD was independent from the OAC type, but NOAC was more effective than warfarin in reducing the risk of thrombotic events.
The highest risk of all-cause death was associated with Systemic Sclerosis, while the highest risk of composite thrombotic events was associated with Systemic Lupus Erythematosus, and Dermato-polymyositis. The highest risk of stroke was associated with Sjogren syndrome; and myocardial infarction and deep vein thrombosis with Dermato-polymyositis, Systemic Lupus Erythematosus was associated with the highest risk of Intracranial hemorrhage, while Systemic Sclerosis to the highest risk of gastrointestinal bleeding (Table 2).

Conclusion
In AF patients the coexistence of SAD is associated with a high risk of all-cause death, thrombotic events, and bleeding. A personalized approach aimed to minimize the impact of SAD on the clinical course of AF patients is needed.Figure 1Figure 2
Is the conventional deployment of electrode catheters appropriate to diagnose the circuit of atypical atrioventricular nodal reentrant tachycardia? -New insights into the retrograde slow pathways-
Authors: Kawabata M , Maeda S , Kamata T , Kawashima T , Yonai R , Okishige K , Atarashi H , Hirao K 
Published: May 2024

Abstract

During atypical atrioventricular nodal reentrant tachycardia (AVNRT), the earliest atrial activation site following retrograde slow pathway conduction is either at the exit of the left inferior extension (LIE) in the coronary sinus (CS) or that of the right inferior extension (RIE) on the tricuspid annulus (TA). In an EP study, LIE can be detected by the CS catheter, but absence of catheters at the RIE can lead to it being missed.

Aim
To evaluate the electrophysiological characteristics of the retrograde slow pathway.

Methods
We assessed patients with atypical AVNRT using electro-anatomical 3D mapping.

Results
Among 14 patients (9 females, age 59±17), with a total of 18 atypical AVNRTs (15 fast/slow and 3 slow/slow), 4 patients had LIE, 6 had RIE, and 4 had both. The LIE exits were inside the CS, while those of RIE were on the posterior TA. During AVNRT or ventricular pacing, the local electrogram of RIE preceded that of the CS ostium and HBE by 24±12 and 34±12 ms respectively. Examination of activation times at the CS ostium and HBE showed that the nearer to the exit of RIE they were, the earlier they were excited.

Conclusion
The retrograde slow pathway of atypical AVNRT can have an exit site at the LIE or RIE, or both. Accurate identification of inferior extensions of the AV node is critical for diagnosis and treatment. We recommend placing a catheter on the posterior TA or 3D mapping the area for RIE exit detection in atypical AVNRT patients.
TAVI PACER - a contemporary risk score for pacemaker implantation after TAVI
Authors: Lueg J , Janiszewski A , Schulze D , Juri B , Morell L , Hajduczenia M , Hennig P , Erbay A , Niehues S , Landmesser U , Stangl K , Leistner D M , Dreger H , Tscholl V 
Published: May 2024

Abstract

Background
The need for permanent pacemaker implantation (PPM) remains one of the most frequent complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to develop a novel risk score for the prediction of PPM after TAVI using contemporary transcatheter heart valves.

Purpose
The TAVI PACER score is designed to optimize valve selection and implantation technique based on individual patient factors to reduce the need for PPM.

Methods
Between January 2019 and December 2020, 1039 patients underwent TAVI at Charité Universitätsmedizin Berlin. Patients with prior pacemaker implantation or valve-in-valve procedure were excluded. We retrospectively evaluated clinical, electrocardiographic, echocardiographic, computed tomographic, and periprocedural data and applied logistic regression for predicting pacemaker implantation. For variable selection, we ran regression with a Lasso estimator for optimizing the predictive quality of the selected variables. Additionally, we used multiple imputation with 30 imputed sets to deal with missing data.

Results
We included 840 patients (mean age 80.2 ± 9.1 years, 50.5% female), of whom 140 patients (16.6%) needed pacemaker implantation within 30 days post TAVI. We identified 11 relevant risk factors that were included in the final score. In a first step the TAVI PACER score calculates an individual risk for pacemaker implantation using preprocedural characteristics such as grade of mitral insufficiency, nicotine use, preexisting AV Block I° and RBBB, EF, LVEDD and BMI. In a second step the influence of intraprocedural aspects are added to illustrate the extent to which the risk for pacemaker implantation can change, depending on which type of valve, implantation depth and valve perimeter are chosen. Pacemaker implantation can be predicted with a sensitivity of 60% and specificity of 82%.

Conclusion
The TAVI PACER Score is an intuitive and useful tool to predict the risk for pacemaker implantation after TAVI before the intervention and could thus help to reduce the rate of pacemakers implanted.
Procedural heart rate variability and its effect on short-term symptoms after cardioneuromodulation procedure
Authors: Aygun S , Coteli C , Yorgun H , Aytemir K 
Published: May 2024

Abstract

Background
Syncope is a miscellaneous clinical condition that affects a large portion of the population every year all over the world and responsible for a considerable amount of hospital and particularly emergency department admissions (1) The use of a right-sided approach in catheter ablation of ganglion plexi (GP) has been applied to reduce syncope episodes caused by vasovagal syncope (VVS) and decrease the overall burden of syncope (2).

Purpose
Our aim is to show that right-sided GP ablation which is known as cardioneuromodulation (CNM) is a new and promising way to cease recurrent syncope episodes and assess its effects on heart rate (HR), P-P intervals, ventricular depolarisation/repolarization parameters (QRS,QTc,Tpe durations, QTc/Tpe ratio), recurrence of syncope episodes, and patients symptoms such as fatigue, dizziness, etc. We also aimed to identify changes between pre and post procedural heart rates and its effects on short-term symptoms during follow-up.

Methods
A group of 55 patients with positive tilt table response or recurrent vasovagal syncope with pauses &gt;2 sec in holter monitoring was enrolled this study. During the EP study, GPs determined both anatomically and by EP stimulation then autonomic denervation was performed focused by radiofrequency ablation. All patients followed-up for 12 months.

Results
Right-sided ablation was performed during the procedure and HR increased significantly in all patients after the procedure compared to before. Syncope episodes of the patients decreased significantly after the procedure. The patients who did not complain of syncope at the first, second and third appointment, respectively, 76.4% (n:42), 90.9% (n:50) and 92.7% (n:51). Patients had complaints at most within the first 4 months after the procedure (Table-1). At the first appointment, 4 (7.3%) patients had syncope and 9 (16,4%) patients had sinus tachycardia. Patient group with heart rate variability varying more or less than 20% during the procedure were examined, 81% of those with HR variability &lt;20% did not have any symptoms, while 64.7% of the group with HR variability above 20% did not have any symptoms at first appointment (p:0,461) (Table.2). Tachycardia was seen in 23.5% of those with HR variability &gt;20%, while it was determined as 9.5% in those with a HR variability &lt;20 % Although these comparisons do not show a statistically significant difference due to the number of few patients, it is clinically significant. The same relationship was not observed between HR variability and symptoms in the second and third appointments.

Conclusion
Cardioneuromodulation is a remarkable treatment modality and it should be taken into consideration that more symptoms may develop in the early post-procedural period in the group who has post-procedure heart rate variability over 20%, and a cut-off should be determined for the target heart rate during the procedure.Table-1Table-2
Cardiac implantable electronic devices following orthotopic heart transplantation: insights on indications and outcomes from a single centre experience
Authors: Castagno D , Pulvirenti G , Soro P , Ferraris F , Anselmino M , Matta M , Saglietto A , Giustetto C , Dusi V , Pidello S , Raineri C , Simonato E , Rinaldi M , De Ferrari G M , Boffini M 
Published: May 2024

Abstract

Background
Need for cardiac implantable electronic devices (CIED) after orthotopic heart transplantation (OHT) ranges from 7 to 24% of cases depending on several patient and procedural related factors.

Purpose
The aims of this study were to investigate the frequency, indications and the predictors of CIED implantation (especially permanent pacemaker [PPM]) following biatrial anastomosis OHT.

Methods
A retrospective, single centre, observational study was conducted, including all the patients who underwent OHT between May 1990 and October 2023 at our Institution. For each patient clinical and procedural information were collected and a long-term active follow-up was performed. The primary endpoint of the study was PPM or implantable cardioverter defibrillator (ICD) implantation while all-cause mortality or de novo OHT was a secondary endpoint. Uni- and multivariable logistic regression analyses were performed to identify factors associated with PPM implantation.

Results
Overall, 546 patients were included and followed-up for a median of 8 years [IQR 1.2-14.3]. During this time frame, 89 (16.3%) patients required PPM implantation (only one patient [0.2%] underwent ICD implantation) at median time of 110 days [IQR 25-2230] after OHT. The main indication for PPM implantation was the development of sinus node dysfunction in 60 patients (67.4%) whereas 29 (32.6%) patients with atrioventricular block required PPM implantation. During follow-up, 265 deaths (48.5%) occurred but no significant differences in long-term prognosis were observed between patients requiring CIED implantation and those who did not (45.5% vs. 49.1%, p-value=0.53, figure). At multivariable analysis, impaired renal function (i.e. low eGFR), cardiac allograft vasculopathy, the occurrence of severe heart transplant rejection and a higher BMI were factors associated with PPM implantation (table).

Conclusions
Among patients undergoing OHT with biatrial anastomosis technique, PPM implantation is not uncommon but it does not negatively impact on prognosis. Several factors, especially severe heart transplant rejection, cardiac allograft vasculopathy and impaired renal function can help identifying patients at higher risk of PPM.TableFigure
Sinus nodal denervation by targeting the superior paraseptal ganglionated plexus: randomized comparison of right-atrial and bi-atrial cardioneuroablation guided by ablation index
Authors: Wichterle D , Stiavnicky P , Jansova H , Peichl P , Stojadinovic P , Borisincova E , Haskova J , Cihak R , Kautzner J 
Published: May 2024

Abstract

Background
Radiofrequency (RF) catheter ablation of superior paraseptal ganglionic plexus (SPSGP) that significantly suppresses the vagal modulation of the sinus node is used for the treatment of functional bradyarrhythmias. A reasonable effect can be achieved by targeting this plexus from the endocardial aspect of both the right and left atria.

Purpose
The study aimed to compare the acute efficacy of unifocal right-atrial (RA) and comparably extensive bi-atrial (BA) ablation of SPSGP for sinus nodal denervation as assessed by intraprocedural extracardiac vagus nerve stimulation (ECVS).

Methods
A population of 22 patients (age: 43±9 years, 55% males) undergoing cardioneuroablation (CAN) for functional bradyarrhythmias were randomized 1:1 to two ablation strategies that included: [1] single RF lesion at the very posterior site of the junction between right atrium and superior vena cava with ablation index (AI) = 800 (RA group) and [2] the same but twice smaller RF lesion (AI = 400) complemented with strictly contralateral left-atrial lesion (AI = 400) at the anterior vestibulum of right superior pulmonary vein (BA group). The effect of ablation was investigated by the post-ablation change in sinus rate and the attenuation of the response of the sinus node to ECVS (frequency: 50 Hz, pulse width: 0.05 ms, output: 1 V/kg [&lt;70V], duration: 5 s) via the right internal jugular vein.

Results
Per-protocol ablation resulted in sinus acceleration by 9±15 bpm vs. 15±16 bpm (P=0.40) in RA vs. BA groups, respectively. Inducible sinus arrests were shortened by 4.7±4.2 s vs. 6.2±1.5 s (P=0.27) and reached the post-ablation level of 3.0±3.7 s vs. 1.0±0.3 s (P=0.08) in RA vs. BA groups, respectively. The results are also displayed in the Figure as medians, interquartile range (boxes) and total range (whiskers). Complete sinus nodal denervation was achieved in 8/11=73% vs. 11/11=100% patients (Fisher exact test P=0.21) in RA vs. BA groups, respectively. Practically 100% denervation efficacy in the BA group contrasted with 3 patients in the RA group in whom ablation had virtually no effect on ECVS-based indices (duration of post-ablation sinus arrests: 11.2, 8.7, and 5.2 s). Acute effects did not change substantially during the waiting period of 20±5 min.

Conclusions
In this small study with acute procedural endpoints, unifocal RA ablation of SPSGP appeared numerically less effective for sinus nodal denervation than comparably extensive BA ablation although the difference was formally non-significant. The ECVS-based outcome measure was valuable in detecting the differences between study groups. Change in sinus rate was not a reliable marker of sinus nodal denervation.
In-hospital outcomes of anterior versus non-anterior st elevation myocardial infarction complicated with complete atrioventricular block
Authors: Margolis G , Levi Y , Abu Fanne R , Saada M , Kobo O , Kazatsker M , Roguin A , Leshem E 
Published: May 2024

Abstract

Background
Complete atrioventricular block (CAVB) is an infrequent complication of acute ST-elevation myocardial infarction (STEMI), and information on its outcomes is scarce. We aimed to address the characteristics and in-hospital outcomes of patients with anterior versus non-anterior STEMI complicated with CAVB in a contemporary, nationwide, all-comer registry, in the U.S.

Methods
Using the National Inpatient Sample (NIS) database, we identified patients who were hospitalized with STEMI, complicated with CAVB between 2016- 2019. Patients with any cardiac implantable electronic device (CIED) in-situ were excluded. Baseline characteristics, in-hospital procedures and outcomes including time to temporary or permanent pacemaker (PPM)/implantable cardioverter defibrillator (ICD) implantation, length of stay and mortality were collected.

Results
A total of 17470 patients, were hospitalized with a primary diagnosis of STEMI and concomitant diagnosis of CAVB, 2755(15.8%) with Anterior and 14715(84.2%) with non-anterior STEMI. Non-anterior STEMI patients included more women, had higher prevalence of hypertension, dyslipidemia, smoking history and chronic pulmonary disease, while anterior STEMI patients had higher prevalence of chronic kidney disease and ischemic cardiomyopathy. Anterior STEMI patient had significantly higher rate of in hospital death [955 (35%) vs 2220 (15%), p&lt;0.001], CPR, VT/VF, cardiac arrest, acute heart failure, respiratory failure, mechanical ventilation &gt;96 hours and acute kidney injury. In both groups 40% received temporary pacemaker, but mean time to implantation was longer in anterior STEMI patients [1.1±3.3 vs 0.3±1.2 days, p&lt;0.001]. Rate of any permanent CIED implantation was also significantly higher in the anterior STEMI patients with longer time to PPM implantation, [3.3±3.5 vs 2.8±2.8 days, p&lt;0.001]. Use of mechanical circulatory support devices was significantly higher in anterior STEMI patients.

Conclusion
In STEMI patients complicated with CAVB, in-hospital outcomes of anterior STEMI were worse comparing to non-anterior STEMI, with significantly higher rates of in-hospital death, in-hospital complications and CIED implantations.