Monolithic silicon for high spatiotemporal translational photostimulation.

Electrode-based electrical stimulation underpins several clinical bioelectronic devices, including deep-brain stimulators1,2 and cardiac pacemakers3. However, leadless multisite stimulation is constrained by the technical difficulties and spatial-access limitations of electrode arrays. Optogenetics offers optically controlled random access with high spatiotemporal capabilities, but clinical translation poses challenges4-6. Here we show tunable spatiotemporal photostimulation of cardiac systems using a non-genetic platform based on semiconductor-enabled biomodulation interfaces. Through spatiotemporal profiling of photoelectrochemical currents, we assess the magnitude, precision, accuracy and resolution of photostimulation in four leadless silicon-based monolithic photoelectrochemical devices. We demonstrate the optoelectronic capabilities of the devices through optical overdrive pacing of cultured cardiomyocytes (CMs) targeting several regions and spatial extents, isolated rat hearts in a Langendorff apparatus, in vivo rat hearts in an ischaemia model and an in vivo mouse heart model with transthoracic optical pacing. We also perform the first, to our knowledge, optical override pacing and multisite pacing of a pig heart in vivo. Our systems are readily adaptable for minimally invasive clinical procedures using our custom endoscopic delivery device, with which we demonstrate closed-thoracic operations and endoscopic optical stimulation. Our results indicate the clinical potential of the leadless, lightweight and multisite photostimulation platform as a pacemaker in cardiac resynchronization therapy (CRT), in which lead-placement complications are common.

Left bundle branch pacing lead for sensing ventricular arrhythmias in implantable cardioverter-defibrillator: A pilot study (LBBP-ICD study).

BACKGROUND: Left bundle branch pacing (LBBP) has been suggested as an alternative modality for biventricular pacing in cardiac resynchronization therapy (CRT)-eligible patients. As it provides stable R-wave sensing, LBBP has been recently used to provide sensing of ventricular arrhythmia in patients receiving implantable cardioverter-defibrillator (ICD) with CRT. OBJECTIVE: The aim of this study was to analyze the long-term safety and efficacy of the LBBP lead for appropriate detection of ventricular arrhythmia and delivery of antitachycardia pacing (ATP) in patients requiring defibrillator therapy with CRT. METHODS: CRT-eligible patients who underwent successful LBBP-optimized ICD and LBBP-optimized CRT with defibrillator were enrolled. The LBBP lead was connected to the right ventricular-P/S port after capping the IS-1 connector plug of the DF-1-ICD lead. LBBP-optimized ICD or LBBP-optimized CRT with defibrillator was decided on the basis of correction of conduction system disease. Documented arrhythmic episodes and therapy delivered were analyzed. RESULTS: Thirty patients were enrolled. The mean age was 59.7 ± 10.5 years. LBBP resulted in an increase in left ventricular ejection fraction from 29.9% ± 4.6% to 43.9% ± 11.2% (P < .0001). During a mean follow-up of 22.9 ± 12.5 months, 254 ventricular arrhythmic events were documented. Appropriate events (n = 225 [89%]) included nonsustained ventricular tachycardia (VT) (n = 212 episodes [94%]), VT (n = 8 [3.5%]), and ventricular fibrillation (n = 5 [2.5%]). ATP efficacy in terminating VT was 75%. Eleven percent of episodes (n = 29) were inappropriately detected because of T-wave oversensing. Inappropriate therapy (ATP) was delivered for 14 episodes (5.5%). Three patients (10%) had worsening of tricuspid regurgitation. CONCLUSION: Sensing from the LBBP lead for arrhythmia detection is safe as ∼90% of the episodes were detected appropriately. Future studies with a dedicated LBBP-defibrillator lead along with algorithms to avoid oversensing can help in combining defibrillation with conduction system pacing.

Right sided approach for left bundle branch pacing using lumen-less lead: Technical considerations and follow-up outcome.

INTRODUCTION: Left bundle branch pacing has gained significant momentum in the last few years. The procedure involves deploying the lead deep inside the interventricular septum through left subclavian vein. We aimed at analyzing the feasibility, efficacy and long-term outcome of left bundle branch pacing (LBBP) using lumen-less lead through the right subclavian vein. METHODS: This was a retrospective-institutional, single center observational study done in consecutive patients who underwent LBBP using 3830 selectsecuretm lead. Left subclavian venous access was the primary strategy for lead implantation. Patients requiring right sided approach due to venous obstruction or persistent left superior-vena-cava (PLSVC) for LBBP were included in the study. RESULTS: Right sided approach was successful in 16 out of 19 (84%) attempted patients. C315-His catheter was used in all patients without modifying its curvature. PLSVC (n = 7), left venous obstruction (n = 7), right sided device upgradation (n = 1) and left pocket infection (n = 1) were the reasons for right sided approach. Mean follow-up duration was 17 ± 12 months. LBBP resulted in reduction in QRS duration from 137.3 ± 37.8 ms to 122.3 ± 9.5 ms (p -.13) and increase in LV ejection fraction from 46.2 ± 16.3% to 54.4 ± 11.6% (p -.11). The mean fluoroscopy duration and radiation dose were significantly high in right sided approach (n = 16) as compared to left sided approach (n = 293). In patients requiring cardiac-resynchronization therapy (CRT), right sided LBBP resulted in reduction in QRS duration from 171.8 ± 18.5 to 125.5 ± 11.9 ms (p -.0001) and increase in LVEF from 29.1 ± 3.8 to 45.1 ± 11.9% (p -.005). CONCLUSION: Right sided LBBP is feasible, safe and effective in patients requiring pacing for symptomatic bradyarrhythmia and CRT. Further development in dedicated tools for right-sided approach would help in reducing the fluoroscopy-duration and radiation-dose.

Role of monocytes and dendritic cells in cardiac reverse remodelling after cardiac resynchronization therapy.

BACKGROUND AND AIMS: Monocytes and dendritic cells (DC) are both key inflammatory cells, with recognized effects on cardiac repair. However, there are distinct subsets of monocytes with potential for beneficial or detrimental effects on heart failure (HF) pathogenesis. The connection between reverse cardiac remodelling, the potential anti-inflammatory effect of cardiac resynchronization therapy (CRT) and monocytes and DC homeostasis in HF is far from being understood. We hypothesized that monocytes and DC play an important role in cardiac reverse remodelling and CRT response. Therefore, we aimed to assess the potential role of baseline peripheral levels of blood monocytes and DC subsets and their phenotypic and functional activity for CRT response, in HF patients. As a secondary objective, we aimed to evaluate the impact of CRT on peripheral blood monocytes and DC subsets, by comparing baseline and post CRT circulating levels and phenotypic and functional activity. METHODS: Forty-one patients with advanced HF scheduled for CRT were included in this study. The quantification and phenotypic determination of classical (cMo), intermediate (iMo) and non-classical monocytes (ncMo), as well as of myeloid (mDC) and plasmacytoid DC (pDC) were performed by flow cytometry in a FACSCanto™II (BD) flow cytometer. The functional characterization of total monocytes and mDC was performed by flow cytometry in a FACSCalibur flow cytometer, after in vitro stimulation with lipopolysaccharide from Escherichia coli plus interferon (IFN)-γ, in the presence of Brefeldina A. Comparisons between the control and the patient group, and between responders and non-responders to CRT were performed. RESULTS: Compared to the control group, HF population presented a significantly lower frequency of pDC at baseline and a higher proportion of monocytes and mDC producing IL-6 and IL-1ß, both before and 6-months after CRT (T6). There was a remarkable decrease of cMo and an increase of iMo after CRT, only in responders. The responder group also presented higher ncMo values at T6 compared to the non-responder group. Both responders and non-responders presented a decrease in the expression of CD86 in all monocyte and DC populations after CRT. Moreover, in non-responders, the increased frequency of IL-6-producing DC persisted after CRT. CONCLUSION: Our study provides new knowledge about the possible contribution of pDC and monocytes subsets to cardiac reverse remodelling and response to CRT. Additionally, CRT is associated with a reduction on CD86 expression by monocytes and DC subsets and in their potential to produce pro-inflammatory cytokines, contributing, at least in part, for the well described anti-inflammatory effects of CRT in HF patients.

[ANMCO Position paper: Ionizing radiation exposure and radioprotection in the cath-lab]. / Position paper ANMCO: Radioesposizione e radioprotezione nei laboratori di cardiologia interventistica.

In the last decades, because of the improvements in the percutaneous treatment of coronary heart disease, valvular heart disease, congenital heart defects, and the increasing number of cardiac resynchronization therapy and cardioverter-defibrillator implantations, the interventional cardiologists' radio-exposure has importantly risen, causing concerns for ionizing radiation-associated diseases such as cancer and neurodegenerative disorders. Consequently, the radiation exposure issue importantly affects operators' safety. However, our knowledge of this field is poor and most operators are unaware to be at risk, especially because of the absence of effective preventive measures. The aim of this ANMCO position paper is to improve the awareness of operators and identify new ways of reducing operator ionizing radiation dose and minimizing the risk.

[Left Hemothorax without Pericardial Effusion due to Pacing Lead Penetration Through Right Ventricular Wall:Report of a Case].

Cardiac perforation by a pacemaker lead that causes left hemothorax without pericardial effusion is rare and life threatening. So, we report a surgically salvaged case. A 55-year-old man underwent insertion of adevice for cardiac resynchronization therapy and defibrillation. On the second postoperative day, the patient fell into shock state after defecation. Electrocardiogram showed pacing failure and computed tomography (CT) showed left hemothorax without pericardial effusion. A drainage tube was placed in the left pleural cavity, and bleeding was massive and continuous. We then performed emergency surgery for suspected cardiac perforation by the pacemaker lead. The right ventricular lead had penetrated the ventricle, which was surgically repaired.

Efficacy and safety of cardiac resynchronization therapy in chemotherapy-induced cardiomyopathy: A systematic review.

OBJECTIVE: The aim of the study was to assess the efficacy of cardiac resynchronization therapy (CRT) in patients with chemotherapy-induced cardiomyopathy (CIC). METHODS: With the increasing incidence of CIC, the association of CRT with improvement in clinical outcomes, echocardiographic parameters, and New York Heart Classification (NYHA) class was assessed through this qualitative systematic review. RESULTS: The five studies included a total of 169 patients who underwent CRT after CIC, and of these, 61 (36.1%) patients were males. All studies showed an improvement in left ventricular ejection fraction (LVEF), among other echocardiographic parameters of LV volume. However, these findings are limited by short follow-up periods, small sample sizes, and the absence of a control group. CONCLUSION: CRT was associated with improvement in all patient parameters with CIC.

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

Efficacy of CRT upgrade in pacemaker-induced cardiomyopathy in an outpatient clinic - Results of a prospective registry.

PURPOSE: The aim of this prospective, monocentric registry study was to investigate whether upgrading to cardiac resynchronization therapy (CRT) in pacemaker-induced cardiomyopathy (PICM) can improve left ventricular function in typical outpatient clinical patients. METHODS: We screened for PICM in a pacemaker outpatient clinic between 2017 and 2021. The follow-up period was 6 months. The primary endpoint was decreased left ventricular end systolic volume (LVESV), and the responder criterion was decreased LVESV >15%. Secondary endpoints were LVEF, NYHA class, device-associated complications and death. RESULTS: 66 patients were newly diagnosed with PICM. 55 of them received a CRT upgrade. For the primary endpoint, LVESV decreased from 101.6 ± 48.2 ml to 75.9 ± 35.8 ml (p < 0.001). Secondary endpoints were: a) LVEF increased from 31.5 ± 5.4% to 46.1 ± 7.6% (p < 0.001) and b) NYHA class improved by an average of one class in both groups (p < 0.001). The overall complication rate was 1.8%. CONCLUSIONS: CRT upgrade in outpatient clinic patients with PICM improves left ventricular function and functional capacity and is associated with an acceptable complication rate.

Implantable Cardioverter Defibrillator for the Primary Prevention of Sudden Cardiac Death among Patients With Cancer.

Data are limited regarding the characteristics and outcomes of patients with cancer who are found eligible for primary defibrillator therapy. We performed a single-center retrospective analysis of patients with preexisting cancer diagnoses who become eligible for a primary prevention implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) defibrillator. Multicenter Automatic Defibrillator Implantation Trial-ICD (MADIT-ICD) benefit scores were calculated. The study included 75 cancer patients at a median age of 73 (interquartile range 64, 81) years at heart failure diagnosis. Active cancer was present in 51%. Overall, 55% of the cohort had coronary artery disease and 37% were CRT eligible. We found that 48%, 49%, and 3% of cohorts had low, intermediate, and high MADIT-ICD Benefit scores, respectively. Only 27% of patients underwent primary defibrillator implantation. Using multivariate analysis, indication for CRT and intermediate/high MADIT-ICD Benefit categories were found as independent predictors for implantation (odds ratio 8.42 p <0.001 and odds ratio 3.74 p = 0.040, respectively). During a median follow-up of 5.3 (interquartile range 4.5, 7.2) years, one patient (5%) with a defibrillator had appropriate shock therapy and 2 patients (10%) had bacteremia. Of 13 patients with CRT defibrillator-implants, one patient was admitted for heart failure exacerbation (8%). Using a time-varying covariate model, we did not observe statistically significant differences in the survival of patients with cancer implanted versus those not implanted with primary defibrillators (hazard ratio 0.521, p = 0.127). In conclusion, although primary defibrillator therapy is underutilized in patients with cancer, its relative benefit is limited because of competing risk of nonarrhythmic mortality. These findings highlight the need for personalized cardiologic and oncologic coevaluation.

Retrograde carbon dioxide coronary sinus venography.

It is potentially harmful to perform coronary sinus (CS) angiography in patients with severe contrast allergy or severe renal dysfunction due to the risk of contrast-induced nephropathy (CIN). However, angiography is a well-established method to guide LV-lead position during cardiac resynchronization therapy-implantation. These two case reports describe the first successful applications of carbon dioxide CS angiography in patients requiring cardiac resynchronization therapy.

Efficacy of intrinsic antitachycardia pacing for ventricular tachycardia refractory to conventional burst pacing: A case series.

Intrinsic antitachycardia pacing (iATP) is a novel automated ventricular ATP algorithm that designs ATP sequences based on the analysis of prior failed ATP. Real-world data on the efficacy and safety of iATP are lacking. Among 124 ventricular tachycardia (VT) episodes in 130 consecutive patients (mean age at implantation: 63.8 ± 14.9 years; sex, 95 male and 35 female) for whom implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator equipped with iATP algorithm was implanted, we investigated the efficacy and safety of iATP for VT refractory to conventional burst pacing. Eight patients had a total of 17 episodes of iATP therapy after failed conventional burst pacing within 11.2 ± 6.6 months of follow-up. Eleven VT episodes (64.7%) in seven patients (87.5%) were successfully terminated by iATP, and only one patient (12.5%) experienced VT acceleration. iATP might be useful for VTs refractory to conventional burst pacing with a low risk of VT acceleration.

Antitachycardia pacing success in implantable cardioverter-defibrillators by patient, device, and programming characteristics.

BACKGROUND: Antitachycardia pacing (ATP) is an established implantable cardioverter-defibrillator (ICD) therapy that terminates ventricular tachycardias (VTs) without painful ICD shocks. However, factors influencing ATP success are not well understood. OBJECTIVE: The purpose of this study was to examine ATP success rates by patient, device, and programming characteristics. METHODS: This retrospective analysis of the PainFree SmartShock Technology study included spontaneous ATP-treated monomorphic VT episodes. ATP success rates were calculated for various factors. Also, the relationship of ATP programming on shock burden and syncope were investigated. RESULTS: Of the 2770 enrolled patients (2200 [79%] male; mean age 65 years), 1699 (61%) received an ICD and 1071 (39%) a cardiac resynchronization therapy - defibrillator. ATP had >80% rate of success for terminating VTs overall, with similar rates observed between ICD and cardiac resynchronization therapy - defibrillator devices (82.2% vs 80.3%, respectively; P = .81) as well as between primary and secondary prevention patients with ICDs (77.2% vs 83.9% respectively; P = .25). Arrhythmias with a median cycle length of ≥320 ms had a significantly higher ATP success rate (88.0%; 95% confidence interval 84.8%-90.6%). The cumulative percentage of ATP success increased from 71% at 1 ATP sequence delivered to 87% at ≥8 sequences delivered. Programming more ATP sequences was associated with lower shock burden (P = .0005). There was no evidence that more sequences were associated with higher rates of syncope (P = .16). CONCLUSION: Delivering more ATP sequences resulted in a higher overall success of terminating VTs, while programming more ATP was associated with decreased shock burden and no evidence of increased syncope or acceleration. This suggests that more ATP sequences should be programmed when possible, but confirmation in prospective studies will be necessary.

Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial.

BACKGROUND: Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BiVP). Randomized studies comparing both therapies are scarce and do not include left bundle branch pacing. OBJECTIVES: This study aims to compare ventricular resynchronization achieved by CSP vs BiVP in patients with cardiac resynchronization therapy indication. METHODS: LEVEL-AT (Left Ventricular Activation Time Shortening with Conduction System Pacing vs Biventricular Resynchronization Therapy) was a randomized, parallel, controlled, noninferiority trial. Seventy patients with cardiac resynchronization therapy indication were randomized 1:1 to BiVP or CSP, and followed up for 6 months. Crossover was allowed when primary allocation procedure failed. Primary endpoint was the change in left ventricular activation time, measured using electrocardiographic imaging. Secondary endpoints were left ventricular reverse remodeling and the combined endpoint of heart failure hospitalization or death at 6-month follow-up. RESULTS: Thirty-five patients were allocated to each group. Eight (23%) patients crossed over from CSP to BiVP; 2 patients (6%) crossed over from BiVP to CSP. Electrocardiographic imaging could not be performed in 2 patients in each group. A similar decrease in left ventricular activation time was achieved by CSP and BiVP (-28 ± 26 ms vs -21 ± 20 ms, respectively; mean difference -6.8 ms; 95% CI: -18.3 ms to 4.6 ms; P < 0.001 for noninferiority). Both groups showed a similar change in left ventricular end-systolic volume (-37 ± 59 mL CSP vs -30 ± 41 mL BiVP; mean difference: -8 mL; 95% CI: -33 mL to 17 mL; P = 0.04 for noninferiority) and similar rates of mortality or heart failure hospitalizations (2.9% vs 11.4%, respectively) (P = 0.002 for noninferiority). CONCLUSIONS: Similar degrees of cardiac resynchronization, ventricular reverse remodeling, and clinical outcomes were attained by CSP as compared to BiVP. CSP could be a feasible alternative to BiVP. (LEVEL-AT [Left Ventricular Activation Time Shortening With Conduction System Pacing vs Biventricular Resynchronization Therapy]; NCT04054895).

Preoperative QRS Duration Predicts the Responsiveness of Chronic Heart Failure Patients with Pacemaker Indications to Left Bundle Branch Area Pacing Treatment.

BACKGROUND: This study investigated the predictive value of preoperative QRS duration (QRSd) in responsiveness of chronic heart failure (CHF) patients with pacemaker indications to the left bundle branch area pacing (LBBAP). METHODS: Thirty-one CHF patients with cardiac function categorized as NYHA class II or above and indications for pacemaker therapy who successfully underwent LBBAP treatment were enrolled in this study. Based on the 12-month postoperative responsiveness to treatment, patients were divided into a responsiveness group (N = 16) and a no-responsiveness group (N = 15). Data from all patients were collected for analysis. Multivariate binary logistic regression analysis was used to determine the independent factors associated with the responsiveness to LBBAP treatment. RESULTS: Among the 31 patients with LBBAP, 16 patients (51.6%) responded to the treatment, and 15 patients (48.4%) had no response. There were significant differences between the two groups with regard to complete left bundle branch block (CLBBB), preoperative QRSd, and preoperative left ventricular peak time (LVAT). Univariate logistic regression analysis showed that CLBBB, preoperative QRSd, and preoperative LVAT all were significantly correlated with responsiveness to LBBAP. Multivariate binary logistic regression analysis showed that QRSd was an independent predictor of responsiveness to LBBAP. The maximum area under the ROC curve for QRSd was 0.827 (95%C.I.:0.663-0.991), the maximum Youden index was 0.679, with the optimal cutoff point of QRSd ≥ 153 ms, a sensitivity of 81.3%, and a specificity of 86.7%. CONCLUSION: Preoperative QRSd predicts the responsiveness of CHF patients with pacemaker indications to LBBAP.

Randomized Trial of Left Bundle Branch vs Biventricular Pacing for Cardiac Resynchronization Therapy.

BACKGROUND: Left bundle branch pacing (LBBP) is the most rapidly growing conduction system pacing technique that is capable of correcting intrinsic left bundle branch block (LBBB). As such, it is potentially an optimal alternative to cardiac resynchronization therapy (CRT) with biventricular pacing (BiVP). OBJECTIVES: The authors sought to compare the efficacy of LBBP-CRT with BiVP-CRT in patients with heart failure and reduced left ventricular ejection fraction (LVEF). METHODS: This is a prospective, randomized trial of patients with nonischemic cardiomyopathy and LBBB with 6-month preplanned follow-up. Crossovers were allowed if LBBP or BiVP were unsuccessful. The primary endpoint was the difference in LVEF improvement between 2 groups. The secondary endpoints included changes in echocardiographic measurements, N-terminal pro-B-type natriuretic peptide (NT-proBNP), New York Heart Association functional class, 6-minute walk distance, QRS duration, and CRT response. RESULTS: The study included 40 consecutive patients (20 males, mean age 63.7 years, LVEF 29.7% ± 5.6%). Crossovers occurred in 10% of LBBP-CRT and 20% of BiVP-CRT. All patients completed follow-up. Intention-to-treat analysis showed significantly higher LVEF improvement at 6 months after LBBP-CRT than BiVP-CRT (mean difference: 5.6%; 95% CI: 0.3-10.9; P = 0.039). LBBP-CRT also appeared to have greater reductions in left ventricular end-systolic volume (-24.97 mL; 95% CI: -49.58 to -0.36 mL) and NT-proBNP (-1,071.80 pg/mL; 95% CI: -2,099.40 to -44.20 pg/mL), and comparable changes in New York Heart Association functional class, 6-minute walk distance, QRS duration, and rates of CRT response compared with BiVP-CRT. CONCLUSIONS: LBBP-CRT demonstrated greater LVEF improvement than BiVP-CRT in heart failure patients with nonischemic cardiomyopathy and LBBB. (Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy [LBBP-RESYNC]; NCT04110431).

Impact of remote monitoring in heart failure patients with cardiac implantable electronic devices during COVID-19 pandemic: a single center experience.

BACKGROUND: Coronavirus disease 2019 (COVID-19) had spread into a pandemic affecting healthcare providers worldwide. Heart failure patients with implanted cardiac devices require close follow-up in-spite of pandemic related healthcare restrictions. METHODS: Patients were retrospectively registered and clinical outcomes were compared of 61 remote monitored (RMG) versus 71 conventionally (in-office only) followed (CFG) cardiac device implanted, heart failure patients. Follow-up length was 12 months, during the COVID-19 pandemic related intermittent insitutional restrictions. We used a specified heart failure detection algorithm in RMG. This investigation compared worsening heart failure-, arrhythmia- and device related adverse events as primary outcome and heart failure hospitalization rates as secondary outcome in the two patient groups. RESULTS: No significant difference was observed in the primary composite end-point during the first 12 months of COVID-19 pandemic (p = 0.672). In RMG, patients who had worsening heart failure event had relative modest deterioration in heart failure functional class (p = 0.026), relative lower elevation of N terminal-pro BNP levels (p < 0.01) at in-office evaluation and were less hospitalized for worsening heart failure in the first 6 months of pandemic (p = 0.012) compared to CFG patients. CONCLUSIONS: Specified remote monitoring alert-based detection algorithm and workflow in device implanted heart failure patients may potentially indicate early worsening in heart failure status. Preemptive adequate intervention may prevent further progression of deteriorating heart failure and thus prevent heart failure hospitalizations.

Cardiac resynchronization therapy response in cardiac sarcoidosis.

INTRODUCTION: Cardiac sarcoidosis (CS) is a nonischemic cardiomyopathy (NICM) characterized by infiltration of noncaseating granulomas involving the heart with highly variable clinical manifestations that can include conduction abnormalities and systolic heart failure. Cardiac resynchronization therapy (CRT) has shown significant promise in NICM, though little is known about its efficacy in patients with CS. OBJECTIVE: To determine if CRT improved cardiac remodeling in patients with CS. METHODS: We retrospectively reviewed all patients with a clinical or histological diagnosis of CS who underwent CRT implantation at the Mayo Clinic enterprise from 2000 to 2021. Baseline characteristics, imaging parameters, heart failure hospitalizations and need for advanced therapies, and major adverse cardiac events (MACE) were assessed. RESULTS: Our cohort was comprised of 55 patients with 61.8% male and a mean age of 58.7 ± 10.9 years. Eighteen (32.7%) patients had definite CS, 21 (38.2%) had probable CS, while 16 (29.1%) had presumed CS, and 26 (47.3%) with extracardiac sarcoidosis. The majority underwent CRT-D implantation (n = 52, 94.5%) and 3 (5.5%) underwent CRT-P implantation with 67.3% of implanted devices being upgrades from prior pacemakers or implantable cardioverter defibrillators. At 6 months postimplantation there was no significant improvement in ejection fraction (34.8 ± 10.9% vs. 37.7 ± 14.2%, p = .331) or left ventricular end-diastolic diameter (58.5 ± 10.2 vs. 57.5 ± 8.1 mm, p = .236), though mild improvement in left ventricular end systolic diameter (49.1 ± 9.9 vs. 45.7± 9.9 mm, p < .0001). Within the first 6 months postimplantation, 5 (9.1%) patients sustained a heart failure hospitalization. At a mean follow-up of 4.1± 3.7 years, 14 (25.5%) patients experienced a heart failure hospitalization, 11 (20.0%) underwent cardiac transplantation, 1 (1.8%) underwent left ventricular assist device implantation and 7 (12.7%) patients died. CONCLUSIONS: Our findings suggest variable response to CRT in patients with CS with no overall improvement in ventricular function within 6 months and a substantial proportion of patients progressing to advanced heart failure therapies.