bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparing the adverse outcomes of left atrial appendage occlusion in patients with diabetes
Authors: Gill J 
Published: October 2021

Abstract

Introduction
In patients with atrial fibrillation, it is estimated that greater than 90 percent of left atrial thrombi are located in the left atrial appendage. Multiple percutaneously implanted devices have been approved worldwide for left atrial appendage occlusion (LAAO) to reduce stroke risk in patients not suitable for long-term oral anticoagulation. Device implantation has been associated with a high success rate and low risk for peri-procedural complications. However, as the prevalence of diabetes continues to rise, there is a considerable need to establish peri-procedural risk in these patients.

Purpose
This study aimed to evaluate and compare the in-hospital outcomes of LAAO in patients with and without diabetes.

Methods
We performed a retrospective cross-sectional analysis using the 2018 National Inpatient Sample. All patients aged 18 years and older with atrial fibrillation and LAAO-related hospitalizations were included in this study. To mitigate selection bias and control for patient and institutional imbalances, propensity scoring method was used to select matched sample between patients with diabetes and patients without diabetes. The scoring was based on a multivariate logistic regression model accounting for age, gender, race, hospital type, hospital region, hospital teaching status, median household income, and medical comorbidities. Using an 8-to-1-digit match, we paired each admission in the diabetes group with one admission without diabetes.

Results
We identified a total of 3572 patients admitted for LAAO; 1298 of these patients had comorbid diabetes. Diabetics did not have a higher risk of in-hospital mortality with LAAO (0.2% vs 0.3%, p=0.620). The risk for 17 out of the 18 identified peri-procedural complications was similar in patients with and without diabetes. However, diabetes was associated with an increased risk of acute kidney injury (Adjusted OR 1.75; 95% CI 1.05–2.93, p=0.03). Interestingly, 0 endocarditis events were captured in both groups, indicating that this complication is only seen in long-term follow-up and had a peri-procedural risk of 0%.

Conclusion
As the use of implantable LAAO devices increases worldwide, clinicians should be cognizant of the increased risk for peri-procedural acute kidney injury in diabetics. Patients with diabetes often have diabetes-induced chronic kidney disease with susceptibility to acute injury. Therefore, volume status should be closely monitored in the peri-procedural period to mitigate further damage to the kidneys in these patients.

Funding Acknowledgement
Type of funding sources: None. Characteristics of the matched cohortOutcomes in the matched cohort
Actual management costs of patients with non-valvular atrial fibrillation treated with percutaneous left atrial appendage closure or oral anticoagulation
Authors: D'Ancona G , Arslan F , Safak E , Ince H 
Published: October 2021

Abstract

Background
Left atrial appendage closure (LAAC) is a safe and efficacious alternative to oral anticoagulation (OAC) therapy in patients with non-valvular atrial fibrillation (AF) who are at high risk for both stroke and bleeding. Data on cost-effectiveness of LAAO are limited and existing studies on the topic are based on simulation model approaches rather than on real-world costs.

Purpose
To compare actual management costs in patients with non-valvular AF treated with LAAC or OAC only.

Methods
Percutaneous LAAC was performed only in patients with at least one cerebral thromboembolic event, one major bleeding episode while under OAC, and with absolute contraindication to prolonged OAC. AF patients undergoing percutaneous LAAC were matched with AF patients treated with OAC only. Matching variables were gender, age, and Diagnosis Related Groups (DRG) clinical complexity level. Costs for cardiovascular outpatient clinic visits and hospitalizations were derived from the actual medical claims and reimbursement records. Data were prospectively collected and retrospectively analyzed.

Results
Between 1/2012 and 12/2016, 8478 patients with non-Valvular AF were referred to our institution: 7801 (92%) were managed with OAC only and 677 (8%) with LAAC. A total of 559 patients (279 per group) were matched. Mean age was 74.9±7.5 years, 244 were female (43.7%), and mean DRG clinical complexity level was 1.8±1.1.
Median annualized management cost before LAAC was €3110 (IQR €1281–8127). Median hospitalization cost for LAAC was €9601 (IQR: €9393–10007). After a mean follow-up of 4.5±1.4 years, median annualized management cost was €1297 (€607–2735) in patients with sole OAC and €1013 (IQR €0–4770) in patients after LAAC (p=0.003). Undergoing LAAC was the strongest independent determinant to reduce follow-up management costs (linear regression: beta = −0.335; CI: −1.09 to −0.682; p&lt;0.0001). Estimated 3-year survival was similar in the LAAC (92%) and OAC patients (90%) (p=0.7).

Conclusion
LAAC significantly reduces management costs of patients with non-valvular AF. In patients referred for percutaneous LAAC, the drastic reduction in management costs following LAAC justifies the procedural costs. In spite of their complex comorbid profile, LAAC patients show a follow-up survival rate similar to those of patients solely treated with OAC. Management costs of patients solely on OAC are significantly higher than management costs of patients after LAAC. Future studies are necessary to investigate the potential net economic and clinical benefit of LAAC in patients that are treated with OAC only.

Funding Acknowledgement
Type of funding sources: None.
Benefits for clinical outcomes associated with dual-chamber pacing versus ventricular pacing in patients with sinus-node dysfunction: a nationwide matched control study
Authors: Fauchier L , Bodin A , Bisson A , Herbert J , Spiesser P.H , Ah-Fat V , Pierre B , Clementy N , Babuty D 
Published: October 2021

Abstract

Introduction
Evidence from randomized trials suggests that, in patients with sinus-node dysfunction (SND), physiologic pacing (dual-chamber, DDD) may be superior to single-chamber (ventricular, VVI) pacing because it is associated with lower risks of atrial fibrillation and stroke, better exercise capacity and lower risk of pacemaker syndrome. However, benefits on mortality and risk of heart failure have not been demonstrated and these issues have not been fully evaluated in large “real life” analyses. The aim of our study was to assess and compare clinical outcomes within the first 30 days and during a longer-term follow-up with the two types of pacing at a nationwide level for patients with SND.

Methods
Using the administrative hospital database in France 2010–2020, 52,974 patients with SND were included in the analysis: 4,069 patients had VVI pacing and 48,905 had DDD pacing. Patients with leadless VVI pacemakers were excluded of the analysis. After propensity score matching 2,213 patients with VVI pacemaker were matched 1:1 with 2,213 patients treated with DDD pacemaker.

Results
In the matched analysis, patients with DDD pacemakers had a lower rate of all-cause (hazard ratio HR 0.711, 95% CI 0.61–0.828) and cardiovascular death (HR 0.628, 95% CI 0.48–0.818) within the 30 days after implantation. There were no significant differences for incidence of tamponade (HR 0.666, 95% CI 0.11–3.992), pneumothorax (HR 1.000, 95% CI 0.32–3.105), hemothorax (HR 0.800, 95% CI 0.21–2.982), major bleeding (HR 0.824, 95% CI 0.68–1.005) and transfusion (HR 1.016, 95% CI 0.83–1.243). During subsequent follow-up (mean: 3.0±2.8 years), risk of all-cause death in the matched population was significantly lower in the DDD group than in the VVI pacemaker group (HR 0.683, 95% CI 0.60–0.784). Patients with SND treated DDD pacemakers also had a lower risk of cardiovascular death (HR 0.569, 95% CI 0.44–0.732), new-onset atrial fibrillation (HR 0.638, 95% CI 0.58–0.706), ischemic stroke (HR 0.685, 95% CI 0.53–0.887) and hospitalization for heart failure (HR 0.758, 95% CI 0.68–0.850) than those treated VVI pacemakers, whilst risk of endocarditis was not significantly different (HR 0.986, 95% CI 0.50–1.951).

Conclusion
Patients with SND treated with DDD pacemakers had better clinical outcomes compared to those treated with VVI pacemakers. DDD pacing was associated with lower risks of death, cardiovascular death, new-onset atrial fibrillation, ischemic stroke, hospitalization for heart failure. DDD pacing was neither associated with a higher risk of complication on the short-term nor of endocarditis on the longer-term.

Funding Acknowledgement
Type of funding sources: None.
Leadless pacemaker patients following cardiac valve intervention in a long-term follow-up
Authors: Martinez-Sande J.L , Gonzalez L , Garcia-Seara J , Rodriguez-Manero M , Fernandez-Lopez X.A , Vega D , Gonzalez Juanatey J.R 
Published: October 2021

Abstract

Introduction
Leadless pacemakers (LPM) have demonstrated adequate electrical performance and safety in patients with multiple commorbidities such as heart valve replacements at short-term follow-up.

Purpose
We present our experience in patients with LPM and heart valve replacements at long-term follow-up.

Methods
This was a prospective observational study including all consecutive LPM implantation from June 1 2005 to March 15 2021. Clinical, electrical, echocardiographic characteristics, related complications and electrical parameters were compared in 2 different groups with and with-out valve surgical procedure.

Results
A total of 255 LPM were implanted. Clinical, electrical and echocardiographic characteristics are described in table 1. Mean follow-up was of 24 months. There were no significant differences in electrical performance or related complications in between both groups (Figure 1).

Conclusions
Electrical performance and complications were no significantly different between both groups with and without heart valve replacements.

Funding Acknowledgement
Type of funding sources: None.
Impact of supervised physical training on vasovagal syncope; a randomized controlled trial
Authors: Tajdini M , Tavolinejad H , Aghajani F , Yadangi S , Niyazi S , Bozorgi A , Sadeghian S 
Published: October 2021

Abstract

Background
Therapeutic interventions in vasovagal syncope (VVS) are centered on lifestyle modifications aimed to counteract the recognized mechanisms that precipitate syncope. In patients with recurrent VVS, supervised training might help reduce the symptomatic burden by increasing adherence to lifestyle modifications.

Purpose
We aimed to evaluate the effect of an integrated supervised training program versus standard care on syncopal recurrence rate among patients with VVS.

Methods
This randomized, controlled, 1:1 parallel-design, open-label trial was conducted between November 2019 and February 2021. Eligible patients were those aged between 18 and 70 years with newly-diagnosed medication-naïve VVS who had experienced ≥2 syncopal episodes in the prior year. All participants received education and reassurance about the benign nature of VVS, were advised to increase salt and fluid intake, and practice counter-pressure maneuvers based on 2018 European Society of Cardiology syncope guideline (standard care). Patients were randomized to standard VVS care or the training program. The intervention program consisted of thrice-weekly four-hours-long sessions during the first month after randomization; including tilt training, aerobic exercise (with rowing ergometer, recumbent biking), and standardized counter-pressure maneuvers supervised by a team of physical medicine and rehabilitation specialist and a cardiologist. After the first month, the intervention group were planned to attend a four-hours-long session every three months. The control group were followed by phone calls after the initial visit every three months. The intended follow-up duration was one year and the primary outcome was time to first syncopal episode.

Results
Out of 332 patients screened, 50 (mean age: 33.5 years; 64% female, figure 1) were equally randomized. Follow-up was completed for all participants. After one year, there was a significant reduction in syncope with supervised training compared to standard care (hazard ratio: 0.28; 95% confidence interval: 0.11 to 0.68; p=0.005, figure 2). Furthermore, frequency of syncope was lower in the supervised training arm versus standard of care (median [interquartile range]: 0 [0–1] versus 1 [0–3]; p=0.017).

Conclusions
In patients with recurrent VVS, supervised training showed promising results in reducing syncopal recurrence. Future research should focus on similar approaches to alter patients' lifestyle as an effective treatment for VVS.

Funding Acknowledgement
Type of funding sources: Public Institution(s). Main funding source(s): Tehran University of Medical Sciences Figure 1Figure 2
Gender related differences in brugada syndrome
Authors: Cardoso A , Faria B , Von Hafe P , Dias G , Pereira T , Ribeiro S , Calvo L , Oliveira M , Fernandes M , Sanfins V , Lourenco A 
Published: October 2021

Abstract

Background
Brugada syndrome (BS) is a heritable channelopathy with male predominance. Males (M) seem to have a higher risk of arrhythmic events, although, there is limited data regarding gender differences in BS.

Aim
To compare the differences between genders in a Portuguese sample of BS patients (pts).

Methods
Single-center retrospective study of BS pts followed by the Arrhythmology Department. Pts were divided according to gender and compared regarding baseline characteristics and electrocardiographic (ECG) parameters that possibly predict the arrhythmic risk (significative S wave in DI, R wave sign, Tpeak-Tend interval and fragmented QRS). The events during follow-up were syncope of probable arrhythmic origin, ventricular tachycardia/ventricular fibrillation (VT/VF) and sudden cardiac death (SCD).

Results
A total of 165 pts were included; 64 (39%) were female (F) and the mean age at diagnosis was 47±15 years. The diagnosis was made by family screening (FS) in 72 (44%) pts. Sixty-seven pts (41%) had spontaneous type 1 pattern, 59 (36%) had history of syncope and 5 (3%) had history of aborted SCD. A positive genetic test was identified in 41 (25%) pts. Sixty-three (38%) pts were referred for an electrophysiological study (EEF) which was positive in 17 (27%) pts. A cardioverter-defibrillator was implanted in 45 (27%) pts. Females were more often diagnosed by FS (64% vs 31%, p &lt;.001), had less type 1 spontaneous pattern (22% vs 53%, p&lt;.001) and had no atrial fibrillation (0% vs 7%, p=.043). They performed EEF less frequently (22% vs 49%, p&lt;.001) and had less spontaneous pattern during treadmill stress test (8% vs 33%, p=.004).
Regarding ECG parameters, females had shorter QRS interval (104±12 vs 115±18 ms, p&lt;0.001), less frequent aVR sign (3% vs 27%, p&lt;0.001), less significative S wave in DI (31% vs 55%, p=0.004), and a tendency for a shorter Tp-Te interval (80 vs 100 ms, p=0.051). Corrected QT interval was longer in females (396 vs 392ms, p=0.044). During a median follow-up of 28 (IQR 16–41) months, 7 pts had VT/VF (2F, 5M) and 3 had syncope (3M), with no differences between gender (p=0.287). There were no cardiovascular deaths.

Conclusion
In BS, female pts are more often diagnosed by FS and have less spontaneous type 1 pattern. Gender appears to affect basal ECG characteristics in BS, namely in parameters that may predict arrhythmic risk. Further studies are important to clarify the role of gender in prognosis and risk stratification of BS pts.

Funding Acknowledgement
Type of funding sources: None.
It is possible to predict mortality after ICD implantation?
Authors: Carrington M , Silverio Antonio P , Nunes-Ferreira A , Rodrigues T , Couto Pereira S , Bernardes A , Lima Da Silva G , Magalhaes A , J Pinto F , De Sousa J , Marques P 
Published: October 2021

Abstract

Introduction
Implantable Cardioverter Defibrillators (ICD) therapy is not recommended in patients who do not have a reasonable expectation of survival for at least 1 year, although specific recommendations regarding clinical or functional status evaluation are lacking.

Purpose
To identify predictors of all-cause mortality in patients who implanted an ICD.

Methods
Prospective single-center study of patients who implanted ICD between 2015 and 2019. Clinical characteristics were evaluated at baseline and mortality was assessed using the national registry of citizens. We performed uni and multivariate analysis to compare clinical characteristics of patients who died and who survived using Cox regression and Kaplan-Meier methods. For the predictor creatinine, we assessed the discrimination power and the best cut-off using the area under the ROC curve (AUC) method.

Results
From 2015–2019, 414 ICDs were implanted (81% male, 62±12 years-old), and 50 (13%) of the patients died after a median follow-up of 23 [11–41] months. Patients who died during the follow-up were older (67±9 vs 61±12, p=0.002), had more diabetes (48% vs 33%, p=0.033) and a higher creatinine (1.23 [0.84–1.86] vs 1.00 [0.84–1.22], p&lt;0.001). The remaining comorbidities were similar between groups (Fig. 1). Patients who died had more frequently an ICD implanted after complication associated with a previous device or as a pacemaker upgrade (6% vs 2%, p=0.030). They also had a higher frequency of ischaemic cardiomyopathy (i-CMP) (82% vs 56%, p=0.002) and of ejection fraction (EF) ≤50% (96% vs 82%, p=0.040). The best cut-off value of creatinine to predict mortality with a sensitivity of 65% and a specificity of 72% was 1.2mg/dl (AUC 0.650; CI95% 0.53–0.77). After adjusting for diabetes, i-CMP, EF ≤50% and upgrade/re-implantation after complication, we found that age (HR 1.033; 95% CI 1.00–1.06, p=0.041) and creatinine ≥1.2mg/dl (HR 2.134; 95% CI 1.09–4.19, p=0.028) were independent predictors of all-cause mortality.

Conclusion
In our cohort of patients who underwent ICD implantation for primary or secondary sudden cardiac death prevention, the all-cause mortality over a median follow-up period of 23 [11–41] months was 13%. We found that in addition to age, a baseline creatinine level ≥1.2mg/dl increases by 2-fold mortality in patients who undergo ICD implantation. Decisions regarding ICD candidacy should not be based on age alone but should also consider creatinine that predisposes to mortality despite ICD implantation.

Funding Acknowledgement
Type of funding sources: None. All cause mortality
Feasibility of using his bundle pacing with boston scientific generators
Authors: Mark N , Papageorgiou N , Ramplin J , Monkhouse C , Moore P , Chow A , Hunter R , Sporton S , Providencia R , Earley M , Elliott J , Muthumala A 
Published: October 2021

Abstract

Introduction
His bundle pacing (HBP) aims to deliver physiological activation of the ventricles via the native His-Purkinje conduction system. A challenge of HBP is the limited market of implantation tools, pacing leads and specifically designed pacing algorithms.

Purpose
Over the last three years both Medtronic (MDT) and Boston Scientific (BSC) generators have been used for HBP in a large tertiary centre. We examined whether there was any difference between lead parameters and battery longevity depending on the type of manufacturer used.

Methods
Patients implanted with a MDT Select Secure model 3830 lead were included in this retrospective study. Data collected included HBP thresholds (analysed at 1ms pulse width) at implant and at the most recent device check, HBP percentages and battery longevity (months). Battery longevity were calculated by adding duration of follow up and estimated battery life at last follow up.

Results
A total of 31 patients were included for data analysis (58% male and mean age 72 years). 18 patients had MDT generators of which 3 were PPMs, 5 were CRT-Ps and 10 were CRT-Ds. 13 patients had BSC generators of which 5 were PPMs, 5 were CRT-Ps and 3 were CRT-Ds. Mean follow up of the cohort was 12.7±9.02 months.
Mean HBP percentages were 77±37% and 72.2±42.1% for MDT and BSC, respectively (p=0.430). Mean HBP threshold (Volts) at implant was significantly lower with BSC vs MDT (0.85±0.58 vs 1.84±1.06, p=0.01), and similar after follow up (1.01±0.91 vs 1.32±0.73, p=NS). There were no statistically significant differences between mean HBP threshold at implant compared to follow up for both manufacturers.
Interestingly, mean battery longevity for BSC vs MDT generators was significantly higher (136±29.3 vs 90.5±29.1, p&lt;0.001). Longevity was also compared for PPM/CRT-P and CRT-D separately. For PPM/CRT-P, BSC generators had significantly higher longevity as compared to MDT (141.6±33.1 vs 91.6±34.5, p=0.009). This difference was not observed for CRT-Ds between the 2 manufacturers (p=0.068).

Conclusion
Our results suggest HBP with MDT Select Secure 3830 lead is feasible with BSC generators. There is potentially greater battery longevity with BSC compared to MDT generators. Further studies are needed with greater numbers and longer follow up to confirm this finding.

Funding Acknowledgement
Type of funding sources: None.
Survival among ischemic and non-ischemic heart failure patients with primary implantable cardioverter defibrillator therapy in Korea: a nationwide cohort study
Authors: Yang P.S , Kang Y , Sung J.H , Park H.D , Joung B 
Published: October 2021

Abstract

Background
Concerns still exist about the efficacy of prophylactic implantable electrocardiogram defibrillators (ICD) in patients with non-ischemic heart failure (HF). We evaluated the mortality and predictors of mortality in patients with prophylactic ICD implantation for ischemic and non-ischemic HF.

Methods
From 2008 to 2017, 1097 patients (667 non-ischemic; 430 ischemic) with prophylactic ICD implantation who were aged 19 years or older were identified from the Korean National Health Insurance Service database. We used propensity score overlap weighting to correct for differences between two groups.

Results
Compared with non-ischemic HF patients, ischemic HF patients were older (67.0±10.1 years vs. 61.8±14.2), more often male (71.4% vs. 63.7%), and had more comorbidities. During a median follow-up of 37.3 months (interquartile range (IQR), 14.2–53.8 months), all-cause death was higher in unweighted ischemic than non-ischemic HF patients (10.9 and 6.4 per 100 person-years, hazard ratio [HR] 1.74, 95% confidence interval [CI] 1.38–2.20, p&lt;0.001). However, after weighting, annual all-cause mortality rate was similar in both groups (9.5 vs. 8.8 per 100 person-years) without difference in the risk of all-cause death (HR 1.08, 95% CI 0.68–1.71, p=0.755). Older age and chronic kidney disease were independent predictors of all-cause mortality in both groups. There was also no difference in cardiac and non-cardiac mortality between weighted non-ischemic and ischemic HF groups.

Conclusions
All-cause, cardiac and non-cardiac mortality were similar between non-ischemic and ischemic HF patients undergoing prophylactic ICD implantation. Our findings support the current guidelines recommendation for primary-prevention ICD in HFrEF patients with ischemic and non-ischemic HF.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Korean Healthcare Technology R&D project funded by the Ministry of Health and Welfare