bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical outcomes after upgrade to resynchronization therapy: a propensity-score matched comparative analysis
Authors: Brandao M , Goncalves Almeida J , Fonseca P , Rosas F , Santos E , Ribeiro J , Oliveira M , Goncalves H , Fontes-Carvalho R , Primo J 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

BACKGROUND
Upgrade to resynchronization therapy (CRT) is common practice in Europe. However, guideline recommendations are discordant and randomized trials are lacking. Previous studies have shown worse outcomes in upgraded patients.

AIM
To compare clinical outcomes in a cohort of patients receiving de novo or upgrade to CRT.

METHODS
Single-center retrospective study of consecutive patients submitted to CRT implantation (2007-2018). Major adverse cardiac events (MACE) included heart failure hospitalization or all-cause mortality. Clinical response was defined as NYHA class improvement without MACE in the 1st year of follow-up (FU). Left ventricle end-systolic volume reduction of &gt;15% designated echocardiographic (echo) response. Survival analysis with Kaplan-Meier method and Log-rank test was performed. Propensity-score matching (PSM) analysis was performed to adjust for possible confounder variables.

RESULTS
295 CRT patients (70.5% male, mean age 67 ± 11 years, 72.5% non-ischemic cardiomyopathy, 54.6% implanted with CRT-D) were included. Fifty-six patients (19%) underwent an upgrade: 43 (78.2%) from a pacemaker and 12 (21.8%) from a defibrillator device. Indications for upgrade were mainly pacemaker dependency or pacing-induced LV dysfunction (76.6%) and de novo left bundle branch block (23.4%).
Upgraded patients were older (70 vs 66 years, p=.034), with larger baseline QRS (185 ± 25 vs 163 ± 30 ms, p&lt;.001) and higher rates of atrial fibrillation (58.2% vs 26.7%, p&lt;.001), coronary artery disease (41.8% vs 26.2%, p=.033), moderate to severe valve disease (42.9% vs 22.6%, p=.003) and chronic kidney disease (36.4% vs 18.7%, p=.008). Upgraded patients more frequently received CRT-P (71.4% vs 39.3%, p&lt;.001). CRT-D were more often implanted for secondary prevention (53.3% vs 20.2%, p=.011) in the upgrade group. There were no differences in procedural complications, clinical (59.3 vs 62.6%, p=.765) or echo (72.2% vs 71.9%, p=.970) response rates. During a median FU of 3 ± 5 years, all-cause mortality was similar among groups (Log-rank test, p=.688). MACE occurred more frequently in the upgrade group (Log-rank test, p=.025). No differences emerged in lead complications (8.9% vs 8.4%, p=.892) or device infection (1.8% vs 2.9%, p=.986).
PSM analysis identified 106 matched pairs (56 upgrade/50 de novo patients), without baseline statistical differences. All-cause mortality (Log-rank test, p=.555) and MACE (Log-rank test, p=.574) were comparable between groups.

CONCLUSION
In this cohort, upgrade to CRT was comparable to de novo implantation in terms of clinical and echo response. Moreover, upgrade to CRT was not associated with higher complication rates. All-cause mortality and MACE were similar between groups.
Time delay to peak left ventricular pressure rise identifies the substrate for dyssynchronous heart failure and detects disease modification with resynchronization- an observational clinical study
Authors: Odland H , Holm T , Ross S , Gammelsrud LO , Cornelussen R , Kongsgard E 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Norwegian South East Health Authorities

Introduction
Identification of disease modification prior to implantation of Cardiac Resynchronization Therapy may help select the right patients, increase responder-rates and promote the utilization of CRT. We tested the hypothesis that shortening of time-to-peak left ventricular pressure rise (Td) with CRT is useful to predict long-term volumetric response (End-systolic volume (ESV) decrease &gt;15%) to CRT.

Methods
Forty-five heart failure patients admitted for CRT implantation with a class I/IIa indication according to current ESC/AHA guidelines were included in the study. Td was measured from onset QRS at baseline and from onset of pacing with CRT.

Results
Baseline characteristics were mean age 63 ± 10 years , 71% males, NYHA class 2.5, 87% LBBB, QRS duration 173 ± 15ms, EF biplane 31 ± 1%, ESV 144 ± 12mL and end-diastolic volume 2044 ± 14mL. At 6-months follow-up six patients increased ESV by 5 ± 8%, while 37 responders (85%) had a mean ESV decrease of 40 ± 2%. Responders presented with a higher Td at baseline compared to non-responders (163 ± 4ms vs 119 ± 9ms, p &lt; 0.01). Td decreased to 156 ± 4ms (p = 0.02) with CRT in responders, while in non-responders Td increased to 147 ± 10ms (p &lt; 0.01) with CRT. A decrease in Td of less than +3.5ms from baseline accurately identified responders to therapy (AUC 0.98, p &lt; 0.01, sensitivity 97%, specificity 100%). AUC was 0.92 for baseline Td and a cut-off at 120ms yielded a sensitivity of 100% and specificity of 80% to identify volumetric responders. A linear relationship between the change in Td from baseline and ESV decrease on long term was found (β=-61, R = 0.58, P &lt; 0.01).

Conclusions
Td at baseline and the shortening of Td with CRT accurately identifies responders to CRT, with incremental value on top of current guidelines, in a population with already high response rates. Td carries the potential to become the marker for prediction of long-term volumetric response in CRT candidates. Abstract Figure.
Optimal percentage of biventricular pacing to obtain CRT response: how high is high enough
Authors: Esteves AF , Parreira L , Mesquita D , Fonseca M , Farinha JM , Pinheiro A , Ferreira J , Coelho R , Amador P , Lopes A , Fonseca N , Caria R 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
The greatest benefit with cardiac resynchronization therapy (CRT) is achieved when biventricular pacing (BivP) percentage (%) is close to 100%. However, in some patients that goal can be challenging to obtain.

Purpose
Determine whether a lower BivP% could lead to similar CRT response and events, as compared with patients with BivP% &gt;98%.

Methods
Patients with CRT followed up in a remote-monitoring network were retrospectively analyzed. BivP% was assessed and response to CRT was defined as an absolute increase in left ventricle ejection fraction (LVEF) &gt;5% or a relative increase in LVEF &gt;15%.
Low BivP% was defined as &lt;98%. Clinical, echocardiographic data and all-cause death during follow-up were evaluated. ROC curve and AUC were obtained to determine the discriminative power of BivP% as predictor of CRT response. Optimal cut-point value was obtained and patients were divided according to this value. Kaplan-Meyer survival function was used to compare survival in the different groups and the Log-rank test was used for comparison between the groups.

Results
88 patients, 76% male, median age 73.5 (IQR 65.75-79.25) years were included. A CRT-D was implanted in 69%. Etiology was ischemic in 44%. 93% were under beta-blockers. Median LVEF before CRT was 27% (IQR 20.25-32).
44 patients (50%) had low BivP% (median 91%, IQR 96-99), 55% due to atrial fibrillation and 52% due to frequent premature ventricular complexes. After optimization of medical therapy, device programming and/or interventional procedures, we obtained a BivP &gt;98% in 26 out of the 44 patients (59%). However, in 18 patients (20%) BivP% was &lt;98% (median 95, IQR 92.25-96). 66% patients were CRT responders. Median follow-up was 36 (IQR 23.75-84) months. During follow-up, all-cause mortality was 27% (24 patients).
Optimal cut-point value for predicting CRT response was 91% BivP% (AUC 0.644, p-value 0.047, 95% CI 0.496-0.792). The characteristics of the two groups didn’t differ significantly (Table).
Survival was significantly higher in patients with BivP% &gt;91% (Log-rank 3.667, p-value 0.050) – Figure.

Conclusion
In this population, BivP% &gt;91% was sufficient to achieve CRT-response and was associated with a better survival. BivP% &lt;91%(n = 4)BivP% &gt;91%(n = 84)p-valueAge in years, median (IQR)72.50 (70.50-73.75)74.00 (65.00-80.00)0.666CRT-D, n (%)3 (75.0)58 (69.0)0.999Ischemic cardiopathy, n (%)3 (75.0)35 (41.7)0.311LVEF before CRT, median (IQR)27 (19-39)27 (20-32)0.795Beta-blockers, n (%)4 (100.0)78 (95.1)0.999Abstract Figure.
Implantable cardioverter defibrillator multisensor monitoring during home confinement caused by the covid-19 pandemic
Authors: Diemberger I , Guerra F , Calo" L , D"onofrio A , Manzo M , Santini L , Giubilato G , Carriere C , Santobuono VE , Savarese G , La Greca C , Arena G , Talarico A , Valsecchi S , Ziacchi M 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Utilization of remote monitoring platforms was recommended amidst the COVID-19 pandemic. The HeartLogic algorithm combines data from multiple implantable cardioverter defibrillator (ICD) sensors (first and third heart sounds, intrathoracic impedance, respirations, night heart rate, and patient activity) to provide integrated data that may allow for detection of early signs of worsening HF.

Purpose
We examined whether the HeartLogic platform may elucidate behavioral changes that impact HF decompensation, and the possible consequences of home confinement caused by the COVID-19 pandemic.

Methods
The Italian lockdown was imposed from March 8th to May 18th. On March 8th 2020, the HeartLogic feature was active in 349 ICD and cardiac resynchronization therapy ICD patients at 20 Italian centers. The period from January 1st to July 19th was divided in 3 phases: Pre-Lockdown (weeks 1-11), Lockdown (weeks 12-20), Post-Lockdown (weeks 21-29).

Results
Immediately after the implementation of stay at home orders (week 12) we observed a significant drop in median activity level (65min [36-103] in week 12 vs. 101min [61-140] in Pre-Lockdown; p &lt; 0.001), while there was no difference in the other contributing sensors. The median composite HeartLogic index increased at the end of Lockdown (4.7 [1.3-10.2] in week 20 vs. 2.5 [0.7-7.0] in Pre-Lockdown; p = 0.019). The weekly rate of HeartLogic alerts was significantly higher during Lockdown (1.56 alerts/week/100pts, 95%CI:1.15-2.06; IRR = 1.71, p = 0.014) and Post-Lockdown (1.37 alerts/week/100pts, 95%CI:0.99-1.84; IRR = 1.50, p = 0.072) than that reported in Pre-Lockdown (0.91 alerts/week/100pts, 95%CI:0.64-1.27). However, the median duration of alert state and the maximum index value did not change among phases, as well as the proportion of alerts followed by clinical actions at the centers (Pre-Lockdown: 31%, Lockdown: 22%, Post-Lockdown: 28%), and the proportion of alerts fully managed remotely (i.e. no in-clinic visits) (Pre-Lockdown: 89%, Lockdown: 90%, Post-Lockdown: 88%).

Conclusions
The system was sensitive to the behavioral changes occurred during the lockdown, i.e. decrease in activity. However, the home confinement had no impact on the other sensors. The higher rate of HeartLogic alerts during lockdown and the increase in the median index after 8 weeks of home confinement suggest the worsening of the HF status, possibly explained by the behavioral changes. Nonetheless, the management of the HF detected events (actions performed and management strategy) was not impacted by the restrictions.
Cardioverter-related complications: observations from an institutional implantable cardioverter defibrillator registry
Authors: Prepolec I , Pasara V , Ciglenecki E , Putric Posavec J , Bogdanic JE , Matasic R , Krpan M , Lovric-Bencic M , Pezo-Nikolic B , Puljevic M , Puljevic D , Milicic D , Velagic V 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
Implantable cardioverter defibrillator (ICD) is gold standard therapy for primary and secondary prevention of sudden cardiac death (SCD) and ventricular tachyarrhythmias. While reducing arrhythmic mortality in patients with left ventricular dysfunction of various causes, inherited primary arrhythmia syndromes and after aborted SCD, these devices can have serious adverse effects including inappropriate shocks and device-related infection.

Purpose
The aim of this study was to create an institutional ICD registry and to examine the major complications after ICD implantation.

Methods
We analysed the data concerning all newly implanted ICDs in our institution from 2011 to 2017. All patients received periprocedural antibiotic prophylaxis according to relevant guidelines. Follow-up data was collected from hospital electronic medical records.

Results
Total number of implanted ICDs was 507 (85.4% male, 57.6 ± 14.0 years-old) and mean follow-up was 34.3 ± 23.8 months. Major complications (infection, large haematoma/hemorrhage, lead displacement/dysfunction) occurred in 18 (3.6%) patients. In 9 (1.8%) cases patients were diagnosed with ICD infection (8 surgical wound/pocket infections and 1 confirmed endocarditis of the lead). Device was explanted in 5 cases (1.0%) while the rest were treated only with antibiotic therapy (empirically or according to swab/blood culture results). All of the infections were successfully resolved and no relapses were noted. Eventually, 3 of 5 devices were reimplanted. One death was recorded 5 month after the explanation. Second most common complication was lead displacement/dysfunction which occurred in 5 (1.0%) patients and was successfully repaired in all cases. Large haematoma and/or hemorrhage at the implantation site were present in 5 (0.8%) patients (2 required surgical revision and transfusion while 2 were managed by needle aspiration). Pneumothorax (2 cases, 0.4%) had to be drained in one patient. There was one case of subclavian vein thrombosis which was treated by anticoagulation.

Conclusion
Despite appropriate antibiotic prophylaxis, the rate of ICD infections in our institution was relatively higher than the one reported in similar registries. The prevalence of other major complications, including lead dysfunction was quite low. Institutional registries could help monitor and plan actions to resolve ICD-related complications to improve patient outcomes.
Incidence of pocket infection during long- term follow- up
Authors: Vujadinovic N , Radovanovic NN , Milasinovic G , Pavlovic SU , Kircanski B , Brankovic N , Sajic V , Milasinovic A , Zivkovic M , Bisenic V 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: None.

Introduction
Cardiac implantable electronic devices (CIEDs) are being implanted worldwide in increasing numbers, so the incidence of hospitalizations due to their infections is also increasing.

Purpose
The aim of this study was to analyze the incidence of pocket infection related to the CIED procedure, as well as clinical presentation, diagnostic approach and methods of treatment during long-term follow- up on large cohort of patients. Methods: This was a retrospective, observational, single-center study. We enrolled patients who underwent CIED procedure between January 2011 and December 2015. The CIED procedure included implantation and replacement of the device. Pocket infection is defined as an infection limited to the generator pocket and can be presented from redness, swelling, pain to the skin erosion with exposure of the generator and/or leads. It may also be associated with lead infections and systemic CIED infections and/or infective endocarditis. All patients with CIED infection underwent the same diagnostics: complete blood count and inflammatory markers, pocket swab, three sets of blood cultures and echocardiography. Results: During the observed period 5 969 CIED procedures were performed (anti-bradycardia pacemakers 68.6%; ICD 21.4%; CRT-P/D 10.0%; CIED replacement 26.1%). CIED infection was registered in 41 patients (0.68%), most often after the ICD procedure (59.0%). In 22 patients (53.6%) the infection occurred after primo-implantation. The average time from intervention to infection was 17 ± 7.3 months. The mean follow-up was 52.2 ± 13.4 months. The most common manifestations of infection were redness (68.1%) and swelling (56.0%), then the protrusion of the generator or electrode (41.5%). Pacemaker pocket swabs and wound swabs were positive in 61.1% of samples and coagulase negative staphylococcus was found to be the most prevalent cause of infection (64.2%). The hemoculture test was positive in 10 patients, and the isolated causative agent matched the swab finding. The valvular vegetation was found in 4 patients. Pacemaker removal and surgical wound treatment were performed in all patients. Complete removal of all leads was achieved in 32 patients. In all pacemaker dependent patients and patients with ICD implanted in the secondary prevention of sudden cardiac death, reimplantation of the new device was performed in the same hospitalization on the opposite side. The remaining patients were operated on 3 to 4 weeks after the end of treatment. Conclusions: It has been shown that the risk of pocket infection was low in a large number of patients, during long-term follow-up. The risk was higher in patients with ICD devices, and slightly higher after primo-implantation.
The incidence and clinical ramifications for leadless pacemaker fixation mechanism exposure on the epicardial surface
Authors: Breeman KTN , Burke MC , Shuros A , Soltis B , Brisben A , Kilvington J , Swackhamer B , Knops RE , Tjong FVY 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Boston Scientific and Abbott

Background
Leadless pacemaker (LP) fixation mechanism exposure (FE) by penetration of the epicardial surface has been described. Previously reported animal model studies showed FE for 7/10 Micra LPs, versus 4/10 CapSureFix Novus RV pacing leads (both Medtronic). However, it is unknown whether FE causes pericardial effusion or pericarditis or does not have clinical significance.

Purpose
To determine the incidence of FE of a novel LP in a chronic animal model and its association with acute or chronic pericardial effusion.

Methods
Canine subjects were implanted with novel LPs (Boston Scientific) in an ongoing study. Acute pericardial effusion was assessed by post-procedural transthoracic echocardiography (TTE). Chronic pericardial effusion was assessed by TTE 90 days after implantation and post-mortem assessed pericardial fluid colour (PFC) and volume (PFV). FE was assessed visually at necropsy. Mann-Whitney U tests and chi-squared tests were used to determine whether greater PFV, more haemorrhagic PFC or LP implantation location differed significantly between subjects with and without FE.

Results
Results to date are reported. Canine subjects (n = 71) were chronically implanted with LPs. Due to 14 in-vivo retrievals, data is shown of 57 subjects with LPs in situ at necropsy. Pre-deployment radiocontrast injection confirmed LP position (RV apex n = 41; RV apicoseptal n = 16), and mechanical stability and electrical testing confirmed adequate talon fixation after deployment. Necropsy after median 94 days (IQR 91-540) demonstrated FE in 11 cases (19%) (figure). No acute nor chronic pericardial effusion was seen on TTE. Mean PFV for animals with and without FE was 1.8 and 1.6 cc, respectively. FE did not show an association with PFV or colour (p= 0.53 and p = 0.83, respectively). For two animals, PFV and PFC are not available; FE was not observed in either of these cases. LP implantation location was not associated with incidence of FE (p = 1.00).

Conclusion
Fixation mechanism exposure by the talons of a novel leadless pacemaker was observed in 19% of animals implanted and was not associated with acute or chronic pericardial effusion. Abstract Figure 1
Tricuspid and mitral valve regurgitation in a chronic canine model implanted with a novel leadless pacemaker
Authors: Breeman KTN , Knops RE , Swackhamer B , Kilvington J , Soltis B , Shuros A , Brisben A , Carter N , Burke MC , Tjong FVY 
Published: May 2021

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Boston Scientific and Abbott

Background
One of the presumed advantages of leadless pacemaker (LP) therapy is that tricuspid regurgitation (TR) occurrence and severity would be less than with conventional pacemakers due to the absence of leads. However, TR and mitral regurgitation (MR) may also worsen due to chronic right ventricular (RV) pacing per se.

Purpose
To determine whether a novel LP is associated with increased TR and MR severity in a chronic canine model and to evaluate predictors of TR and MR worsening.

Methods
Healthy canine subjects were implanted with a novel LP programmed at a lower rate of 80/min. TR and MR were assessed by transthoracic echocardiography (TTE) prior to implant, at 90 days and at 18 months after implant. Further were assessed percentage of pacing, presence of pacing during TTE, and wall motion abnormalities (WMA) observed during TTE, indicating ventriculo-ventricular dyssynchronous pacing. Paired t-tests were performed to compare TR and MR severity before and after implant. Univariable and multivariable generalized estimating equation (GEE) models were used to evaluate factors predictive of increased TR and MR severity. Paired t-tests were used to evaluate whether the increase of TR and MR differed between subgroups where pacing or WMA were observed or not.

Results
An LP was implanted in 73 subjects. TR and MR severity at 90 days (n = 55) were significantly increased from baseline (p = 0.02 and 0.001, confidence intervals [CIs] 0.05-0.64 and 0.20-0.75, respectively); at 18 months (n = 37) TR severity remained significantly increased but MR did not (p = 0.01 and 0.62, CI [0.09, 0.69] and [-0.15, 0.25], respectively). Multivariable GEE (figure) showed that WMA and absence of TR at baseline are significant predictors for increased TR, while WMA and a shorter RV long axis are significant predictors for increased MR. Subgroup analysis demonstrated that TR and MR at day 90 were only significantly increased in subjects with observed pacing or WMA (n = 29; p = 0.0014 and p &lt; 0.0001 respectively), but not in subjects without observed pacing or WMA (n = 26; p = 0.56 and 0.16, respectively). At 18 months, the same observation was found for TR but not MR (pacing or WMA [n = 15], p &lt; 0.0001 and p = 0.33 respectively: no pacing or WMA [n = 26], p = 0.23 and 1, respectively).

Conclusion
In absence of pacing, the novel EMPOWER LP was not associated with increased TR and MR severity in a canine model. When pacing was observed TR and MR did increase. Increased MR severity did not persist at 18 months. Abstract Figure 1