Implantable Devices Research Articles

Early discharge following cardiac implantable electronic device implantation: a systematic review and meta-analysis

Abstract Background As the demand for cardiac implantable electronic device (CIED) placement rises, healthcare expenses, including the post-procedure hospital stay costs, have been on the increase. This systematic review and meta-analysis were undertaken to evaluate the safety and viability of same-day discharge (SDD) following cardiac device implantations. Methods We conducted a systematic searched of PubMed, Embase and Cochrane database during November 2023 for studies comparing SDD versus discharge after overnight stay (OS) after CIED. Outcomes included all-cause mortality and complications after the procedure (lead/device dislodgment, re-hospitalization, pneumothorax, local hematoma and wound complications). Data from each study were combined using the random-effects model to calculate pooled odds ratio (OR) with 95% confidence interval (CI). Results Eleven studies, including two randomized clinical trials, were incorporated, with a total of 64,646 patients, providing 918 pooled death events (74 in SDD and 844 in OS). The meta-analysis revealed that SDD was associated with a significantly lower risk of all-cause mortality compared to OS (pooled HR 0.72; 95% CI: 0.55-0.93; I2=0%) and no difference was found regarding re-hospitalization (pooled HR 0.96; 95% CI: 0.88-1.05; I2 55%). SSD was not associated with higher lead/device dislodgement (pooled HR 0.93; 95% CI: 0.50-1.71; I2=0%), pneumothorax (pooler HR 1.04; 95% CI: 0.31-3.50; I2 0%) and wound complications (pooled HR 0.65; 95% CI 0.22-1.01; I2 0%). SSD was associated with more episodes of local hematoma (pooled HR 0.31; 95% CI 0.09-1.05; I2 0%). Conclusion Our meta-analysis suggests that SDD is associated with a decreased all-cause mortality compared to OS. Although associated with more episodes of local hematoma, SDD was not significantly different regarding lead/device dislodgment, pneumothorax, re-admissions and wound complications. SDD after CIED appears to be a safe and feasible alternative.

Impact of digoxin on gastrointestinal bleeding following left ventricular assist device implantation: a systematic review and meta-analysis

Abstract Introduction Gastrointestinal bleeding (GIB) is a common complication post Left Ventricular Assist Device (LVAD) implantation for patients with advanced heart failure. Recent observational evidence suggested a potential association of digoxin use and GIB reduction post LVAD; however, the proposed benefit remains uncertain. Therefore, we conducted a systematic review and meta-analysis to assess the impact of digoxin use on GIB post LVAD. Methods We performed a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed and EMBASE for the studies published in English exploring GIB with chronic digoxin use following LVAD implantation, till 15/01/2024. Two independent reviewers assessed the quality and risk of bias of the included studies. A random-effect model was used to combine data. The primary outcome was all-cause GIB associated with digoxin use in comparison to non-digoxin use. Heterogeneity was assessed using Q test and I2, with I2 > 50% indicating marked heterogeneity. Results A total of three peer-reviewed observational studies (n= 14277) were included in the analysis of the primary outcome. More than 50% of patients received ACE inhibitors/angiotensin receptor blockers. Digoxin use post LVAD was associated with similar GIB incidence in comparison to non-digoxin use (Odds Ratio [OR]= 0.61; 95% CI, 0.33-1.14, I2= 81%, P=0.12), as shown in Figure 1. Interestingly, one study of 199 recipients of LVAD reported significantly lower gastrointestinal angiodysplasia-induced GIB with digoxin use (3% versus 13%, P=0.039). Conclusion Among patients with advanced HF requiring LVAD implantation, the use of digoxin demonstrated similar effectiveness of GIB prevention compared to non-digoxin use. Future studies needed to explore the potential use of digoxin for gastrointestinal angiodysplasia-induced GIB.Figure 1.Forest plot of gastrointestina

Calculation of intraprocedural hemodynamics with computational functional dynamic in mitral valve edge-to-edge repair

Abstract Background Hemodynamic outcomes in patients undergoing transcatheter edge-to-edge-repair of the mitral valve (M-TEER) are difficult to predict. Computational functional dynamic (CFD) is frequently used in biomedical engineering to simulate blood flow patterns under various conditions. The authors developed a standardized workflow for individualized analyses and investigated the hemodynamic of mitral regurgitation volumes and gradients by using CFD. Methods 20 patients from two high volume centers who suffered from severe mitral regurgitation (MR) and underwent full cycle cardiac computed tomography (CT) prior procedure were enrolled. Baseline computed tomography and intraprocedural data were analyzed. Based on the specific valve morphology, individualized CFD-simulations were performed to calculate MR volumes prior to intervention and estimate hemodynamics after M-TEER. Results CFD-analyses of 20 patients (mean age 80±4 years, 60% male) showed excellent correlation between baseline PISA method-based MR volumes (45±23ml) measured in transesophageal echocardiography (TEE) and CFD-based calculation (45±26ml; R=0.917; P<0.001) as well as between TEE-measured mean baseline effective regurgitant orifice area (EROA; 27±16mm²) and CFD-measured EROA (24±18mm²; R=0.869; P<0.001)). After device implantation, correlation between intraprocedural TEE-measured and CFD-estimated correlation for residual MR volumes (R=0.949; P<0.001) and EROA (R=0.841; P<0.001) remained robust. Post-interventional mean diastolic pressure gradient (TEE) was 3.6±2.8mmHg which was in close correlation with the CFD estimated gradient (3.0±1.8mmHg, R=0.905; P<0.001). Conclusions This is the first study to use a CFD-standardized workflow for predicting hemodynamic changes in patients undergoing M-TEER using data from two different centers. In the future, CFD-based analyses might serve as a key-diagnostic tool for predicting residual MR volumes and gradients for M-TEER-procedures.Comparison of TEE and CFD flow patternBland-Altman-Blots

Defibrillator shocks and their effect on objective asian patient outcomes: results of the painfree SST clinical trial

Abstract Background The implantable cardioverter defibrillator (ICD) reduces mortality in patients at risk of sudden cardiac death. However, the effect of ICD shock on device-measured activity is unknown. The aim of this analysis was to analyze the acute and long-term effects of ICD shock on objective behavioral data. Methods The PainFree SST study was a prospective, multicenter, global study that enrolled 2770 patients including 225 from from Asia (181 from Japan, 25 from India, and 19 from Malaysia). Patient physical activity was determined from the device built-in accelerometer. The device translates the accelerometer output into a count of active minutes, which is stored as a daily total value in device memory for a rolling window of 425 days. Obviously, activity is measured only after device implantation. Early after implant, activity is reduced due to the procedure and thus not representative. Therefore, no baseline can be reported for activity. The follow-up activity data was analyzed with a linear mixed model, with a random effect for patient and an auto-regressive correlation matrix for subsequent measurements of individual patients. Results Figure 1 shows average daily activity between 90 days before and 90 days after a shock. The dashed vertical line indicates the day of shock. Both patients from Asia and from other countries show a drop in activity after a shock with recovery in the subsequent 30-60 days. The curve for Asian patients is more variable than the curve for other countries due to the lower number of patients (there were 33 Asian patients with shocks contributing data). Figure 2 shows average daily activity before and after ATP therapy. Any post shock measurement is excluded. Contrary to the temporary reduction in activity around a shock (Figure 1), ATP therapies do not seem to have an impact on activity. In patients from the other countries, activity is significantly reduced when patients are hospitalized (-66.3 minutes/day, p<0.0001), but not in Asian patients (-5.1 minutes/day, p=0.71). Both in Asian and other countries, activity is significantly reduced after an ICD shock (Asian: -47.5 minutes/day, p=0.0002; Other countries: -21.5 minutes/day, p<0.0001). The effect of shock for Asian is greater than the other countries (p=0.054). In the month after the shock there is a significant recovery, +34.8 minutes/day in Asian patients (p=0.0077) and +7.7 minutes/day in patients from other countries (p=0.031). The recovery is trended to be bigger in Asian patients (p=0.058). Conclusions ICD shocks have a lasting adverse impact on objective, device-measured physical activity, particularly among Asian individuals. Successful management of patients with an ICD necessitates specific attention to clinically relevant behavioral outcomes, aiming to expedite recovery and facilitate a return to activities of daily living, with a particular focus on the Asian population.

Association of R2-CHA2DS2-VASc score and clinical outcomes after bioprosthetic valve replacement: Subanalysis from BPV-AF registry

Abstract Background Although bioprosthetic valve (BPV) replacements are becoming more common, there are limited studies about prognostic prediction method for patients after BPV replacement. R2-CHA2DS2-VASc score is modified CHA2DS2-VASc score by adding reduced estimated glomerular filtration rate (eGFR < 60 mL/min/1.73m2). It is increasingly used for the prediction of cardiovascular (CV) events in patients with atrial fibrillation (AF), device implantation, and acute coronary syndrome. Purpose We aimed to evaluate the predictive value of R2-CHA2DS2-VASc score for future CV events in patients after BPV replacement. Methods BPV-AF, an observational, multicenter, prospective registry, enrolled AF patients that underwent BPV replacement. Patients were stratified into three risk groups according to their R2-CHA2DS2-VASc score as follows; low (scores, 0–1), moderate (scores, 2–4), and high (scores, 5–11). The primary outcome measure was a composite of stroke, systemic embolism, CV events including heart failure hospitalization, and cardiac death. Results A total of 766 patients were included in the analysis. The mean age was 80.3 years and 419 patients (54.7%) were female. Mean R2-CHA2DS2-VASc score was 4.1±1.5. Low, moderate, and high R2-CHA2DS2-VASc score groups consisted of 12 (1.6%), 178 (23.2%), and 576 (75.2%) patients, respectively. Median follow up period was 491 (interquartile range: 393-561) days. Kaplan-Meier analysis showed higher incidence of the composite CV events in high R2-CHA2DS2-VASc score group (Log rank test; p<0.01). Multivariate Cox proportional hazards regression analysis revealed that the R2CHA2DS2-VASc score as a continuous variable was an independent predictor of CV events (hazard ratio 1.33, 95% confidence interval 1.18 to 1.51, p<0.01). Conclusion The R2-CHA2DS2-VASc score is useful for CV risk stratification in AF patients after BPV replacement.Cumulative Incidence for Composite CV Ev

Long-term prognosis and predictors of death in chronic Chagas cardiomyopathy in women and men

Abstract Background Chronic Chagas cardiomyopathy (CCC) is one of the leading causes of heart failure (HF) in Latin America and carries high morbidity and mortality. Previous studies showed conflicting results in epidemiological and clinical evidence of a gender-associated risk of death in patients with HF due to CCC. Purpose This study analysed the long-term prognosis and the main predictors of death in women and men with HF due to CCC. Methods From March 2009 to January 2023, we followed a cohort of outpatients with HF due to CCC. Specific serological tests diagnosed Chagas disease. Baseline data included clinical characteristics and echocardiographic findings. Statistical analyses were performed using the Kaplan-Meier (K-M) method to analyse time-to-event data and Cox proportional hazards methods to search for predictors of death. Results We studied 739 patients, with a mean age of 57.0 ± 12.1 years, 387 (52%) male. Women had a higher mean age (58.4 ± 11.7 vs. 55.8 ± 12.3 years; p=0.001), had a higher mean baseline left ventricular ejection fraction (LVEF) (44.3±14.5 % vs. 37.0±14.5%; p<0.001) and a smaller left ventricular diastolic diameter (LVDD) (56.8±8.9 vs. 62.5±9.4 mm; p<0.001). Over a median follow-up period of 10 years, 213 (56%) men and 169 (44%) women died (K-M: log-rank p=0.043; Figure). Men received more beta-blocker therapy (52.4% vs. 47.6%; p=0.040) and had a higher prevalence of chronic kidney disease (CKD) (p=0.003) and stroke (p=0.007). HFpEF was more prevalent in women and HFrEF in men (p<0.001). Device implantation and transplant were similar between women and men. Cox regression analysis for death adjusted for age, sex, myocardial infarction, diabetes, CKD, stroke, atrial fibrillation (AF), and LVEF showed LVEF (HR= 0.98;95%CL:0.97-0.98), age (HR=1.03;95%CL1.02-1.04) and CKD (HR= 1.32;95%CL:1.10-1.64) as the main predictors of death. In men, the main predictors were age (HR=1.02;95%CL:1.01-1.04), CKD (HR=1.409;95%CL:1.07-1.86), and LVEF (HR=0.98;95%CL:0.97-0.99), and in women AF (HR=1.41;95%CL:1.03-1.91), age (HR=1.03;95%CL:1.01-1.04), and LVEF (HR=0.97;95%CL:0.96 -0.98). Conclusion women had a better prognosis than men, but gender was not an independent predictor of death. Prevention of comorbidities, especially CKD in men and AF in women, and higher beta-blocker therapy can significantly reduce the death rate in women and men with HF from CCC.

Assessing the impact of implantable loop recorder placement on anxiety level

Abstract Background Anxiety is a prolonged state of apprehension or worry that can be an independent predictor of cardiovascular events, associated with a 48% increased risk of cardiac death. About one-third of patients with arrhythmias present with high anxiety levels, and subsequently worse quality of life. In our experience of patient care, many patients feel anxious about the possibility of an arrhythmia that could lead to their demise, especially if their symptoms are undiagnosed. Purpose Our project aims to explore the change in patients’ anxiety levels following implantable loop recorder (ILR) placement. Methods This is a survey-based observational study that was performed in an outpatient clinic and hospital using validated General Anxiety Disorder-7 (GAD-7) questionnaires. Individuals who met indications to undergo ILR implantation including palpitations, syncope, subclinical atrial fibrillation, and cryptogenic stroke underwent baseline assessment of anxiety prior to implantation. Individuals had repeat assessments at 6 weeks and 12 weeks post-implantation to evaluate the effect of ILR placement. Results Our study included 50 individuals. Out of the initial subjects, 10/25 females and 11/25 males were lost to follow-up. The average initial GAD-7 score was 3.3 (Range 0, 15), average 6-week score was 1.6 (Range 0, 14), and average 12-week score was 0.9 (Range 0, 10). Total decrease in GAD-7 score after 6 weeks of having ILR was 50%. Total decrease in GAD-7 score after 12 weeks of ILR was statistically significant at 73% (P=0.03). Females showed greater improvement of GAD-7 scores in comparison to males at 6 weeks (67% vs 36%) and 12 weeks (81% vs 66%). Conclusion Studies have suggested an overall decreased level of anxiety in patients receiving implantable devices that have the potential to treat arrhythmias such as implantable cardiac defibrillators and pacemakers. Our results suggest that the benefit may extend to implantable devices that seek to provide further diagnostic information and aid in the prognostication of disease burden. As seen in our study population, GAD-7 scores showed dramatic improvement with greater percentage in female than male population. After the placement of loop recorders, many patients experience a sense of security with having a device that monitors them. Our study is the first to address the association between ILR and anxiety. Future studies evaluating this association would help increase the power of the study.Figure 1:Bar graph of GAD-7 Scores

Preclinical assessment of transcatheter-delivered expandable endoluminal polymeric graft fabricated by electrospinning of microfiber

Abstract Background Matrix fabricated from electrospinning of micro fibre of polyester is porous and permeable to blood, facilitates cell infiltration and late resorption of the biodegradable material. This biomaterial opens an avenue of research in recreating a novel and favourable endoluminal lining in diseased vessel. Previous preclinical work has shown that implants in aorta of rodents generate layers of endoluminal elastin. In humans, one of the most impervious arteries to atherosclerosis is the intra-thoracic artery; therefore, an attempt to induce similar structures with an implantable device was made. Methods For this study, novel tissue-engineered vascular grafts (T-TEVGs) were used in a preclinical rabbit iliac artery model. It was made of resorbable polyester biomaterial processed into fibrous tubular conduits. These T-TEVGs were implanted percutaneously. In total, twelve T-TEVGs in iliac arteries of nine rabbits were implanted. Follow-up were conducted on five rabbits with eight T-TEVGs at three months, two rabbits with two T-TEVGs at six months, and two rabbits with two T-TEVGs at twelve months. At follow-up, percutaneous optical coherence tomography (OCT) was performed, and OCT-derived luminal vessel wall dimensions and fractional flow reserve (OFR) derived from OCT were assessed. Results The overall pooled analysis at different timepoints on follow-up, documented an average MLA of 1.74±0.48mm2, average of proximal and distal reference area of 4.55±0.99 mm2, average area stenosis of 61±12%, and mean OFR value of 0.96±0.03 (OFR ranging from 0.89 to 0.99). There was a moderate positive correlation between minimum lumen area and OFR (r=0.590, p< 0.01). There was a strong negative correlation between percentage area stenosis and OFR (r= - 0.846, p< 0.01). At no timepoint in follow-up and in every vessel analysed, OFR value was lower than 0.89, suggesting that none of these vessels exhibited flow-limiting narrowing. Our study has a few limitations. 1) The preclinical model is a non-atherosclerotic rabbit; 2) There was no barotrauma prior to the implantation of the device; 3) Limited sample size, short and medium follow-up duration, and pooling of assessment at different timepoints. Conclusion The current study shows the durability and favourable hemodynamics of this bioresorbable fibrillated scaffold at short and medium term follow-up, supporting the potential utility of T-TEVEGs for peripheral human artery revascularisation. Long-term follow-ups are mandatory to confirm the durability of these results. Histopathology of this preclinical model should confirm the endoluminal elastin as previously documented in rodents (rats) and will be presented at the time of the congress.

Holter monitoring in neuromuscular disorders: frequency and importance in clinical management

Abstract Introduction Cardiac involvement is a common manifestation in a variety of neuromuscular disorders (NMD) and initial cardiac manifestations in these patients are often asymptomatic. Hence, regular 24h-Holter monitoring is recommended to identify conduction disturbances and rhythm disturbances. Purpose In this study, we aimed to assess abnormal findings in 24h-Holter monitoring to screen for conduction disturbances and arrhythmias in patients with NMD and evaluate its impact in patients’ treatment. Methods A retrospective single-centre study was conducted including all adult patients with NMD who received a 24h-Holter from January 2013 to September 2023. Results A total of 76 patients with NMD were included, 39 (51.3%) were male, and mean age was 46,3 ± 11,5 years. Most patients were asymptomatic. A total of 220 Holter recording was analysed. An average of 2,9 ± 1,6 Holter recordings per patient was performed. Abnormal Holter results were found in 47 (61,8%) patients, and mainly consisted of conduction disorders such as atrioventricular block in 31 (65,9%) patients. Other abnormalities included atrial fibrillation/flutter in 6 (12,8%) patients, supraventricular tachycardia in 4 (8,5%) patients, and non-sustained ventricular tachycardia in 6 (12,8) patients. Out of the group of the patients with abnormal Holter findings, ten patients had direct clinical treatment consequences, namely implantation of cardiac electronic devices or initiation of anticoagulation therapy. Conclusion In this study, holter findings resulted in relevant clinical treatment consequences in 10 out of 76 patients (13,2%). These results suggest that 24h-Holter monitoring may improve routine cardiac screening in patients with NMD.

Right ventricular to pulmonary artery coupling credicts poor outcomes after interatrial shunting in heart failure

Abstract Background Left atrial decompression is under investigation for heart failure (HF) with the potential to improve symptoms and potentially clinical outcomes. However, heterogeneous outcomes have been observed in randomized controlled studies. Purpose This study aimed to explore whether right ventricular (RV) -pulmonary artery (PA) coupling, as assessed from the tricuspid annular plane systolic excursion (TAPSE) /systolic PA pressure ratio, can be useful in predicting outcomes after implantation of the interatrial shunting device. Methods A total of 106 HF patients, n=62 with reduced ejection fraction (HFrEF), n=44 with preserved ejection fraction (HFpEF), were prospectively enrolled in the PRELIEVE registry with the Atrial Flow Regulator (AFR) implantation. Serious adverse events included cardiovascular mortality and HF worsening (W). Results Serious adverse events (SAEs) occurred in a total of 19 (18%) patients. There were no differences in baseline comorbidities, KCCQ scores, the 6-minute walking distance between patients with and without SAEs (Table). Patients with SAEs showed higher systolic pulmonary arterial pressure, NT-proBNP, serum creatinine and lower TAPSE/PASP ratio. Incidence of SAEs was higher in patients within the first TAPSE/PASP vs the third tertile (59% vs 12%, p=0.026), respectively. A TAPSE/PASP of <0.55 was identified to bear the most optimal sensitivity to predict the event (AUC=0.683, CI95% (0.533-0.833). Conclusion The reduced TAPSE/PASP ratio was associated with higher rates of serious adverse events in patients with heart failure undergoing controlled inter-atrial shunting. The hypothesis generating finding that reduced RV-PA coupling may identify potential clinical non-responders to left atrial decompression should be further prospectively validated.

Do patients maintain improvement in physical capacity achieved after hybrid telerehabilitation implemented as part of managed care after acute myocardial infarction program at one-year follow-up?

Abstract Background Managed Care after Acute Myocardial Infarction (MC-AMI) is a one-year comprehensive care program dedicated to patients with acute coronary syndrome introduced in Poland. It includes acute intervention, complex revascularization, implantation of cardiovascular electronic devices (in case of indications), rehabilitation or hybrid rehabilitation (HTR) and scheduled outpatient follow-up. HTR is a unique component of MC-AMI program. Purpose The purpose of this study was to evaluate whether the effect of improving physical capacity achieved after 5-week HTR was maintained during one-year follow-up. Methods The study enrolled 84 patients (90% males, aged 57.5 ± 10.2 years, LVEF 54,6 ± 6.8%) who underwent a 5-week HTR based on Nordic walking training and completed the entire one-year MC-AMI program. Unless there were contraindications, HTR began no later than 14 days after discharge from the hospital and consisted of an initial phase (1 week) conducted in an outpatient center and 4 weeks of telemonitored exercise training at home, five times weekly. Exercise capacity was assessed by comparing the exercise test results at baseline (before HTR), immediately after HTR and at the end of one-year MC-AMI program. Results HTR resulted in significant improvement in workload [METS] and workload duration in exercise test. This valuable effects were maintained after one-year follow-up. All results are presented in Table 1 and Figure 1. Conclusion The improvement in physical capacity achieved after 5-week of the hybrid telerehabilitation was maintained in patients who completed MC-AMI program in one-year follow-up.

Single center experience of internal jugular vein as alternative access for implantation of a wireless pulmonary artery pressure sensor

Abstract This single-center study delves into the novel use of the internal jugular vein (IJ) as an alternative access pathway for the implantation of the CardioMEMS device, a wireless pulmonary artery pressure sensor. This approach is compared to the conventional femoral vein access in terms of procedural times, contrast volume, and patient outcomes. The study spans five years, from 2018 to 2023, evaluating the efficacy and safety of IJ access for CardioMEMS implantation. The analysis revealed a tendency towards shorter procedural times and reduced contrast volume with IJ access, although statistical significance was not reached due to the small sample size. Notably, IJ access provided a quicker needle-to-door time, suggesting benefits such as improved patient throughput and potentially shorter hospital stays, which are pivotal in a healthcare landscape that prioritizes efficiency and cost-effectiveness. In conclusion, this investigation offers initial evidence that IJ vein access is a feasible and potentially superior alternative for CardioMEMS device implantation. While the findings are preliminary due to the study's limited scale, they pave the way for future larger-scale, multicenter studies. Such research could confirm the benefits of IJ access and possibly influence clinical practices, enhancing the management of heart failure patients.

Efficacy and safety of the Aria pulmonary endovascular device in pulmonary hypertension

Abstract Background and aims A common feature of various forms of pulmonary hypertension (PH) is progressive decline of pulmonary arterial compliance (CPA), which correlates with reduced survival. In this acute study, we evaluated feasibility, safety and hemodynamic performance of the Aria pulmonary endovascular device in patients with PH associated with left heart disease (PH-LHD) and chronic lung disease (PH-CLD). Methods 8 patients with PH-LHD and 10 patients with PH-CLD were included in this study. The device was placed in the main pulmonary artery via the right femoral vein and was connected by a catheter to a gas-filled reservoir outside the body. During systole, gas shifts from the balloon to the reservoir, leading to deflation of the balloon. In diastole, the gas returns from the reservoir to the balloon, leading to balloon inflation and enhancing diastolic blood flow to the distal pulmonary capillary bed. Hemodynamics were assessed at baseline, and again with device off, device on and device off. The primary safety endpoint was the incidence of serious adverse events through 30 days after the procedure. Results No complications or investigational device-related serious adverse events occurred. Device activation in PH-LHD and PH-CLD patients decreased pulmonary arterial pulse pressure by 5.6±4.2mmHg (-12%; p=0.003) and 4.2±2.2mmHg (-11%; p<0.001), increased CPA by 0.4±0.2mL/mmHg (+23%; p=0.004) and 0.4±0.3mL/mmHg (+25%; p=0.001), and increased RV-PV coupling by 0.24±0.18 (+40%; p=0.012) and 0.11±0.07 (+21%; p=0.001), respectively. Conclusions Temporary implantation of the Aria endovascular device was feasible and safe. Device activation resulted in acute improvement of CPA and RV-PV coupling.Figure

Extracellular volume analysis on cardiac computed tomography is useful to predict prognosis after cardiac resynchronization therapy

Abstract Background Left-ventricular (LV) extracellular volume (ECV) (LVECV) is often evaluated on magnetic resonance imaging (MRI), and the value is well correlated with biopsy-identified myocardial fibrosis. Recently, mechanical development has been achieved, and ECV analysis on cardiac computed tomography (CCT) has been eligible using the latest software, and the ECV on CCT is well correlated with the ECV on MRI. Cardiac resynchronization therapy (CRT) has been usually performed in cases with severe heart failure, but almost 30 percent of them are non-responders. Therefore, the indicators to predict non-responders to cardiac resynchronization therapy (CRT) have been sought in advance. Purpose The purpose of this study is to reveal the utility of LVECV on CCT for the prediction of patient prognosis in the candidates of cardiac resynchronization therapy (CRT) who have low LV function. Methods We analyzed 53 patients (30 males, 65 ± 14 years old) with heart failure who underwent CCT, including late phase scan, using 320-row detector CT (Aquilion One or Aquilion One ViSion Edition, Cannon Medical Systems) or 256-row detector CT (Revolution CT Apex, GE Healthcare), before the implantation of a CRT device from December 2008 to January 2024. The primary outcomes were defined as cardiac death, hospitalization due to HF, and fatal arrhythmia after CRT implantation. CRT responders were defined as the patients whose LV endo-systolic volume was decreased by 15% or more on transthoracic echocardiography. Results Twenty-two patients (42%) had primary outcomes (10 cardiac death, 7 fatal arrhythmia, 5 hospitalization due to HF). LVECV was lower in CRT responder (n = 23) than the others (n = 25) (35 ± 6.3% vs 41 ± 6.8%, P = 0.006). LVECV was higher in the patients with primary outcomes (n = 22) than the others (n = 31) (35 ± 5.0% vs 41 ± 7.8%, P = 0.019). Based on the receiver-operating characteristics curve analysis, the best cut-off of LVECV for predicting primary outcomes was 44.03% (B). In the survival analysis using the Cox proportional hazard model, LVECV on CCT was a significant predictor of primary outcomes (HR, 1.07; 95% CI, 1.13-1.01; P = 0.012). On Kaplan-Meier analysis, the higher LVECV group (≥ 44.03%) had a significantly greater number of primary outcomes than the others (P = 0.010) (C). Conclusion LVECV on CCT may be useful for predicting responders of CRT and prognosis after CRT implantation.ROC curve and Kaplan-Meier analysis

Long-term outcomes of cardiogenic shock survivors: a contemporary retrospective analysis from a tertiary center

Abstract Background Cardiogenic shock (CS) is a complex syndrome that still portends a dismal short-term prognosis. However, in patients that survive the initial admission and are later discharged, the long-term prognosis remains ill-characterized. Aim We aimed to describe the long-term morbidity and mortality outcomes of patients surviving the index admission for CS. Methods Retrospective analysis of all consecutive patients admitted to a cardiac intensive care unit (CICU) between December 2016 and December 2022 with a diagnosis of CS. All etiologies were included and further categorized as: acute myocardial infarction (AMI-CS), acute-on-chronic heart failure (HF-CS) and secondary causes [(S-CS): myocarditis, arrhythmic storm, acute pulmonary embolism, among others]. Our primary endpoint was defined as all-cause death, conditional to being discharged alive. Secondary endpoints comprised heart transplant, durable left ventricular assist device (LVAD) implantation, implantable cardioverter-defibrillator (ICD) insertion and hospital readmission during follow-up. Results A total of 208 patients were included [median age 68 years (IQR 57-80), 66% males, mean Charlson comorbidity index 4±3], of whom 52% (n=108) had AMI-CS, 27% (n=56) HF-CS and 21% (n=44) S-CS. During the index admission, mean SAPS II score was 49±18 and most patients were in SCAI-C (66%, n=137) stage. Organ support in the form of invasive mechanical ventilation, renal replacement therapy or temporary mechanical circulatory assist devices was necessary in 62% (n=129), 27% (n=56) and 26% (n=55) of patients, respectively. 53% of patients (n=110) survived the index admission [median CICU length of stay 8 (IQR 3-15) days; median hospital length of stay 13 (IQR 4-25) days]. At discharge, mean left ventricular ejection fraction was 38±16% and 28% (n=26) of patients underwent ICD implantation. Median follow-up after discharge was 679 (IQR 373-1056) days, with 4 (4%) patients lost to follow-up. Overall mortality was 22% (n=24) and was numerically higher for AMI-CS when compared to HF-CS and S-CS (9% vs 7% vs 6% respectively, p=0.640). Secondary endpoint analysis showed that 10% (n=11) had a heart transplant, 2% (n=2) received a durable LVAD, 9% (n=10) received an ICD and 26% (n=28) were re-hospitalized during that period. Conclusions Although the long-term mortality of patients discharged alive after the index admission for CS is not overwhelming, one in every four will be readmitted and a small proportion will be eligible for advanced heart failure therapies. Healthcare strategies to improve the morbidity and mortality of many CS survivors should be devised.

Elevated cancer biomarkers in patients with severe heart failure could be a potential predictor of mortality during LVAD support

Abstract Introduction Owing to increasing numbers of heart failure patients a search for new biomarkers predicting prognosis is desirable. Background The purpose of this study was to analyze levels of cancer biomarkers in patients with severe heart failure before or after left ventricular assist device (LVAD) implantation and estimate its impact on survival during LVAD support. Methods We retrospectively analyzed data of all consecutive 168 LVAD recipients (92.8%- male, mean age 53.3 years ( median - 56.6, SD 12.0 ), median INTERMACS profile- 3.0, ischemic etiology of heart failure- 52.4%, 41.0% post CRT-D and 54.8% post ICD implantation, 36.9 post IABP, 5.4% post ECMO%, 11.9% post CABG and 8.9% post other cardiac surgery before LVAD implantation) implanted with continuous-flow LVAD (59.5%-HeartMate3, 35.1%- HeartWare, 5.4%-Heart Mate II) in our institution within years 2009-2023. Among comorbidities 63% of patients had atrial fibrillation or flutter, 41.6%- diabetes, 37.5%- arterial hypertension, 48.8%-renal failure, 7.1% pulmonary obstructive disease, 56.5% had pulmonary hypertension with mean pulmonary artery pressure above 25 mm Hg in right heart catheterization and 47% of patients had a history of cardiac arrest or sustained ventricular arrythmia before LVAD implantation. The overall mortality was 44.0 %. 31% patients were transplanted during LVAD support and in 4 patients (2.3%) LVAD was explanted or deactivated. Patient were followed to death, heart transplantation, LVAD explantation or the end of observation in our institution. Mean time of LVAD support was 885 days (1-2570). 23% of patients had right ventricular failure (RVF) early post LVAD implantation while 7.7% had late form of RVF. Results Serum concentrations of cancer biomarkers: carcinoembryonic antigen (CEA), carbohydrate antigen (CA)19-9, carbohydrate antigen(CA)-125 and alpha fetoprotein (AFP) taken before (56 patients -33.3%) or after (24 patients-14.3%) LVAD implantation were analyzed. Mean values, rate of abnormal results and correlation of abnormal results of CEA, CA19-9, CA-125, AFP with mortality during LVAD support were depicted in Table 1. No statistically significant correlations were found between levels of abovementioned cancer biomarkers and mortality though a trend towards increased mortality could be observed for abnormal results of CEA and Ca 19-9 taken before LVAD implantation. No malignant neoplasms were found in all analyzed patients except of one in whom a recurrence of lymphoma was found 2 months after LVAD implantation. Conclusions Patients with severe heart failure before and after LVAD implantation may present abnormal values of cancer biomarkers despite no found neoplasms. Our observation suggests that elevated cancer biomarker levels could predict mortality in heart failure patients after LVAD implantation. Further research is needed to confirm this thesis and investigate mechanisms of this phenomenon.

High incidence of malignant arrhythmias and heart failure in patients with RBM20-associated cardiomyopathy: a multicenter cohort study and review of the literature

Abstract Background Patients with RBM20 cardiomyopathy commonly experience malignant arrhythmias, sudden cardiac death (SCD), and progressive heart failure (HF). Objective The aim of this study is to investigate genotype-phenotype correlations, clinical outcomes and causes of death in patients with RBM20-associated cardiomyopathy in a multicenter cohort, combined with an overview of the current literature. Methods This international, multicenter cohort included all patients with cardiomyopathy who had a pathogenic (P) or likely pathogenic (LP) RBM20 variant. For survival and regression analysis, we matched a control group based on sex, age, and presence of left ventricular dysfunction. Additionally, we conducted a literature search on studies investigating RBM20-associated cardiomyopathy. Results Sixty-two patients (45% male) were included in the study, with a mean age of 42 ± 15 years at presentation. Of the LP/P RBM20 variants identified, 9 were novel. Eleven variants were truncating, while the remaining variants consisted of missense and splice-site variants. Patients with a truncating variant who developed HF were on average older at the time of diagnosis compared to patients with missense variants (mean age 62 ± 9 vs. 45 ± 14; p=0.01). After a median follow-up duration of 5.0 [1.0 – 10.5] years, 21 (34%) patients reached the composite endpoint of ventricular arrhythmias (VA), implantable cardioverter-defibrillator therapy, heart transplantation (HTx), left ventricular assist device (LVAD) implantation, or cardiovascular death. Of these, 19 (31%) patients experienced malignant VA (mean age 45 ± 15 years, 63% males). Males were at higher risk for the composite endpoint (log-rank p= 0.02), particularly for VA (log-rank p=0.007). The literature review analyzed 34 studies with a total of 678 patients, of whom 53% were male. In these studies, 123 (24%) patients experienced a VA, 58 (12%) underwent HTx or were treated with LVAD, and 52 (11%) died. Conclusion In this multicenter study the patients carrying a LP/P variant in RBM20 variants had a severe phenotype, with a high incidence of VA, particularly in males. Additionally, this study presents 9 novel DNA variants, of which 8 were truncating, and were mainly observed in older individuals. Finally, we report a lower mortality rate compared to the literature, possibly due to a higher number of heart transplantations performed in our patient cohort.Survival composite endpoint for sex

Exercise stress testing recovery kinetics: the forgotten phase

Abstract Background Impaired exercise capacity is a cardinal feature of heart failure (HF). Peak oxygen uptake (pVO2) and ventilatory efficiency (VE/VCO2 slope) during exercise are well-consolidated prognostic markers in patients with HF. A previous study suggested that abnormally prolonged VO2 recovery, specifically the failure to decrease VO2 from peak exercise by 10.5 mL/kg/min at 180 seconds of the recovery phase, predicts adverse outcomes in HF. However, it is unknown to what extent the recovery of VEqCO2, a marker of ventilation/perfusion mismatch, adds prognostic value to the already existing parameters. Purpose The aim of this study was to characterize the functional and prognostic significance of VEqCO2 kinetics following peak exercise in individuals with HF. Methods This retrospective single-center study included consecutive adult patients with chronic (>3 months) and stable HF with left ventricular ejection fraction (LVEF) <50% who underwent cardiopulmonary exercise testing (CPET) between 2015 and 2020. Following maximal exercise, patients recovered over a 3-minute period (walking 2km/h for 1 minute and sittng passively for 2 minutes). VO2 and VEqCO2 kinetics during recovery, described as the absolute difference to peak VO2 (difVO2) and VEqCO2 (difVEqCO2), were measured at 30, 60, 120, and 180 seconds. Outcomes were assessed as a composite of cardiovascular (CV) death, urgent cardiac transplant, or left ventricular assist device (LVAD) implantation at 1 year. Results A total of 238 patients were included (mean age 58 ± 12 years; 82% males; mean LVEF 34 ± 10%; 68% with ischemic HF; 75% in NYHA class II-III; mean pVO2 18 ± 6 mL/kg/min; mean VE/VCO2 slope 41 ± 12). During the 1-year follow-up, 19 patients met the endpoint (8 CV deaths, 8 urgent heart transplants, and 3 LVAD). ROC curve analysis showed that the best correlation between difVEqCO2 and outcomes was apparent at difVEqCO2 of 180 seconds (AUC 0.83) with a cut-off value of 1 (sensitivity 93%, specificity 58%). These patients, who had a decrease in VEqCO2 (difVEqCO2 >1) at 180 seconds, were significantly older (p=0.02), had a lower LVEF (p<0.001), and higher NYHA (p<0.001). They were at an increased risk of cardiovascular events compared to those with an increase in VEqCO2 (difVEqCO2 <1) at 180 seconds (event-free survival at 1 year 86% vs. 98%, log-rank p<0.001). In multivariate analysis, the statistical association between difVEqCO2 and outcomes remained significant, even after adjusting for difVO2 at 180 seconds (HR 4.315, CI95% (1.349-13.804), p=0.014). Conclusion Abnormal VEqCO2 kinetics in the recovery period of CPET is an easily recognizable non-invasively derived measurement that predicts outcomes in HF. VEqCO2 may complement the evaluation of VO2 and other parameters during recovery to further improve prognostic risk stratification in HF.

Association of gut microbiota imbalance with risk of postoperative infections in patients with left ventricular assist device

Abstract Background Infections are the most common complications following left ventricular assist device (LVAD) implantation and associated with adverse events. Gut microbial imbalance may predispose to mucosal colonization with pathogens, resulting in a risk of subsequent serious infections. However, it remains unclear whether gut microbiota imbalance is associated with postoperative infections in patients with LVAD. Purpose The aim of this study was to investigate whether gut microbiota imbalance was associated with postoperative infections in patients with LVAD. Methods We prospectively examined 22 consecutive LVAD patients who were admitted to a university hospital for routine check-ups and had stool cultures taken between March 2022 and December 2023. All patients had no signs of infection. The patients were divided into two groups according to positive (normal bacterial flora and other bacteria including Streptococcus viridans, Klebsiella, or Extended-spectrum β-lactamase Escherichia coli; n = 7) and negative (normal bacterial flora only; n = 15) for stool culture. The primary outcome was serious infection requiring hospitalisation treated with intravenous antimicrobial agents. Results Patients were predominantly male (68%) and the median age was 49 (interquartile range [IQR] 29-58) years. There were no significant differences in age, sex, primary aetiology of heart failure, type of LVAD devices, time on LVAD support, the history of infection, or antibiotics use within six months between the groups. During a median follow-up period of 316 days (IQR 242-559), the primary outcome occurred in seven patients (32%), including four hospitalisation for driveline infections, two pneumoniae and bacterial bloodstream infections, and one lung abscess and bacterial bloodstream infection. Kaplan–Meier analysis showed that the adverse events more frequently occurred in LVAD patients with positive for stool culture (P = 0.010) (Figure). A multivariable Cox regression analysis showed that positive for stool culture was independently associated with an increased subsequent risk of the primary outcome (hazard ratio 6.99, 95% confidence interval 1.17-41.7, P = 0.033), even after adjustments for age, male, body mass index, diabetes, INTERMACS profile, mechanical circulatory support, serum creatinine, serum albumin, and white blood cell count, which are known to be strong determinants of worse clinical outcomes in patients with LVAD. Conclusions In patients with LVAD, gut microbial imbalance was associated with subsequent serious infections. These findings suggest that the screening of stool culture might be useful for early identification of high-risk patients for infectious complication after LVAD implantation.

Feasibility of hybrid telerehabilitation and telecare in heart failure patients with implanted left ventricular assist device LVAD

Abstract Background Left ventricular assist device (LVAD) implantation is increasingly used as a treatment option for patients with advanced heart failure (HF). There is a need to provide patients with LVAD with long-term care, preferably at home. The implementation of home-based telerehabilitation (HTR) and telecare offers new opportunities in this field. Purpose The purpose of this study was to assess feasibility and safety of HTR and telecare in HF patients with implanted LVAD and evaluate patients’ acceptance of and adherene to HTR. Methods The study enrolled 30 HF patients with recent implanted LVAD (21 Heart Mate III, 9 Heart Ware) (29 males, 19–67, mean 59 years) who underwent a 12-week telecare and HTR program based on walking, respiratory and resistance training, five times weekly. HTR was telemonitored with a device adjusted to register electrocardiogram (ECG) recording and to transmit data via mobile phone network to the monitoring center. The moments of automatic ECG registration were pre-set and coordinated with exercise. The influence on physical capacity was assessed by comparing changes in peak oxygen consumption (VO2 peak; [ml/kg/min]) and workload duration (t; [sec]) in cardiopulmonary exercise test. Results HTR resulted in a significant physical capacity improvement pVO2 12.5±2.9 vs 15.1±3.0 (p<0.001), and workload duration t 628±204 vs 728±222 (p<0.001) in cardiopulmonary exercise test. There were neither deaths nor adverse events during HTR. Patients accepted HTR, including the need for interactive everyday collaboration with the medical team from monitoring center. All patients completed HTR. Conclusions HTR is a feasible, safe form of rehabilitation, well accepted by patients. The adherence to HTCR was high.