Cardiac Implantation Research Articles

Magnetic Resonance Myocardial Imaging in Patients With Implantable Cardiac Devices: Challenges, Techniques, and Clinical Applications.

Cardiovascular magnetic resonance imaging (MRI) in patients with cardiac implants, such as pacemakers and defibrillators, has gained importance in recent years with the development of modern cardiac implantable electronic devices. The increasing clinical need to perform MRI examinations in patients with cardiac implants has driven the development of new advanced MRI sequences to mitigate image artifacts associated with cardiac implants. More specifically, advances in imaging techniques, such as wideband late gadolinium enhancement imaging, wideband T1 mapping, and wideband perfusion, have been designed to improve image quality and examinations in patients with cardiac implants, enabling a comprehensive and more reliable diagnosis, which was previously unattainable in these patients. This review article explores recent developments and applications of wideband techniques in the field of cardiovascular MRI, offering insights into their transformative potential. Clinical applications of wideband cardiovascular MRI are highlighted, particularly in assessing myocardial viability, guiding ventricular tachycardia ablation, and characterizing myocardial tissue.

A prospective study of a novel pocket compression device to reduce pocket hematoma after cardiac implantable electronic device implantation in a high bleeding risk population

Abstract Background Pocket hematoma (PH) is one of the most common complications after cardiovascular implantable electronic device (CIED) implantation resulting in an up to 9 times higher risk for CIED infections.(1) Different preventive strategies have been proposed with mixed results. Current standard of care consists of preventive elastic adhesive tape leaving 2 major disadvantages: unpredictable pressure on the pocket and inability to visually assess the pocket with the bandage applied. Aim To evaluate the safety and effectiveness of a novel pocket compression device in patients undergoing CIED implantation in a high bleeding population. Material and methods This randomized controlled trial included 32 patients in the study group (pocket compression device) and 33 in the control group (elastic adhesive tape). The studied pocket compression device contains an inflatable compartment to modify the degree of pocket compression which is transparent facilitating pocket evaluation. The primary outcome was the incidence of various grades of PH. The secondary outcomes comprised the incidence of pressure lesion, pain score (0-10) and endocarditis during follow-up. Results There were no clinical or procedural differences between groups (age 78.01±9.71, heart failure 53.8%, kidney failure 20.0% and on antithrombotic drugs 49.2%). There were significantly less pocket hematomas in the study group (1/32 (3.1%) vs 20/33 (60.6%), P<0.001). Most pocket hematomas were grade I for which watchful waiting was applied (1/32 (3.1%) vs 17/33 (51.6%), P<0.001). Grade II and grade III PH only occurred in the control group (respectively 1/33 and 2/33) resulting in hospitalization prolongation and longer interruption of antithrombotic drugs >24hours. Two control patients eventually received the study device to control PH. None underwent reoperation. Pressure lesions did not occur. Patients in the study group had lower pain scores at application (0.75±1.12 vs 1.80±1.38, P=0.009), after 2 hours (0.81±1.36 vs 1.94±1.50, P=0.002) and the next day (0.38±0.91 vs 1.06±1.634, P=0.042). None of the patients experienced endocarditis during mean follow-up of 1 year. Conclusion The use of a pocket compression device in patients undergoing CIED implantation in a high bleeding population leads to less PH and postoperative pain in comparison to conventional elastic adhesive tape.bandage study

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.

Routine chest X-ray post cardiac implantable electronic device implantation: is it really required? Experience from a tertiary centre

Abstract Introduction The 2021 EHRA expert consensus statement on pacemaker (PPM) and transvenous implantable cardioverter defibrillator (ICD) implant technique proposes a chest X-ray (CXR) prior to hospital discharge in all patients. This recommendation serves the dual purpose of excluding pneumothorax following subclavian or axillary access (SAA) and documenting lead position. Purpose Given that cephalic venous access (CA) precludes pneumothorax, the utility of CXR as a tool for identifying early lead displacement (LD) in these patients warrants further examination. We studied the yield of post implant CXR, device interrogation (DI), or both for the identification of pneumothorax and LD in patients undergoing transvenous PPM or ICD implant via SAA or CA. Methods 4,051 consecutive PPM or ICD devices were implanted at a tertiary centre between 2016-2019. Lead position was documented fluoroscopically on conclusion of all procedures. A subsequent post implant CXR was performed in cases of SAA, plus in those CA patients requiring imaging for another indication (e.g. pulmonary oedema). Post implant DI was only performed in patients with a high anticipated burden of ventricular pacing (e.g. high-grade atrioventricular block). All patients underwent clinical review with repeat DI at 30 days post implant. LD was defined as a clinically significant translocation of a lead requiring repositioning or reprogramming. Results For the whole cohort, the incidence of LD at 30 days was 2.2% (n=89), and the incidence of pneumothorax (within the SAA group) was 0.9% (n=11). The venous access method used, post implant investigations, and the incidence of LD is shown in Figure 1. 1,282 patients (31.6%) required SAA; CXR was performed in all, and 9 LDs were identified (0.7%). However, four patients (0.3%) with ‘normal’ CXRs had evidence of LD on inpatient DI, and a further 17 LDs (1.3%) were confirmed on the 30 day DI despite a ‘normal’ CXR. 2,769 patients (68.4%) underwent CA; 309 (11%) required CXR. This identified LD in four patients (1.3%), with three further patients (1%) found to have LD on subsequent inpatient DI despite a ‘normal’ CXR. A further four LDs (1.3%) were diagnosed at 30 day DI. The majority (89%, n=2,460) of CA patients were discharged without CXR. 30% (n=825) of these patients required inpatient DI; this identified 13 LDs (1.6%). Accordingly, 59% (n=1,635) of CA patients had no post procedural investigations; 24 (1.5%) were found to have LD at 30 day DI. Conclusions In patients who developed LD within 30 days of a PPM or ICD implant, a post implant CXR identified this in only 32% of cases (n=13/41), and the overall sensitivity of CXR for LD was low (50%). Additionally, the majority of LDs (54%) occurred after hospital discharge. We suggest that the utility of post implant CXR for identifying LD is limited, and that CXR should not be considered an essential investigation in CA device implants.Figure 1

Acute myocarditis presentation and intra-hospital prognosis: results of the multicenter prospective MYOCARDITIRM study

Abstract Background Acute myocarditis (AM) usually presents as chest pain with rising troponin and normal coronary arteries. Despite frequent favorable evolution at the acute phase, it is associated with heart failure and ventricular rhythm disorders and is considered the leading cause of sudden cardiac death in young apparently healthy adults. There is no recommendation for AM, only expert consensus, given the lack of important databases for a strong level of confidence. Methods We performed a multicenter prospective observational study of patients admitted for AM acknowledged by cardiac MRI to describe baseline characteristics, management, in-hospital and long-term outcomes of AM patients in France. Secondary objectives were to investigate determinants of prognosis, modalities of treatment and follow-up, and to identify gaps between expert consensus and real-life management. Results We enrolled 805 consecutive patients hospitalized for AM in 49 participating centers between May 2016 and February 2019. Median age was 31 (IQR 23-41) with 19% of female. Chest pain was the most frequent symptom (93%) and 112 (14%) had severity criteria upon admission (LVEF<50% or severe ventricular arrythmia or high-grade AV block or cardiogenic shock). ST elevation was observed in 49% of patients. One 26-years old patient died during initial hospital stay. Overall, 62 patients (8%) experienced intra-hospital complication of their AM, defined as a combined endpoint of death, LVEF<40% (MRI), sustained ventricular or supraventricular arrythmia, acute renal failure, cardiogenic shock, need for ventricular assistance device, need for inotropic drugs, temporary cardiac pacing, pace-maker or cardiac defibrillator implantation. Patients with initial severity criteria were 10 times more likely to present intra-hospital complication (33% vs 3.6%, p<0.001). Conclusion This prospective cohort represents the largest database on AM worldwide. Here we report baseline characteristics and in hospital events. Most patients had typical presentation with favorable outcomes but as much as 8% of patients did exhibit intra-hospital complication. The prospective follow up will provide valuable data to better identify subset of patients with poor prognosis that may be of interest to develop new therapeutic strategies.Acute myocarditis on cardiac MRI

Impact of atrial high-rate episodes on new onset of atrial fibrillation and all-cause mortality in elderly patients over 90 years old with dual-chamber pacemaker implantation

Objective: To investigate the impacts of atrial high-rate episodes (AHRE) on the risks of new onset of atrial fibrillation and all-cause mortality in elderly patients over 90 years old after cardiac dual-chamber pacemaker implantation. Methods: This study was a retrospective study. Patients aged 90 years and above who were implanted with cardiac dual-chamber pacemakers and followed up in the People's Liberation Army General Hospital from January 2017 to June 2022 were enrolled and divided into AHRE≥6 h group and AHRE<6 h group according to the onset time of AHRE. The primary endpoint was new onset of atrial fibrillation, and the secondary endpoints were all-cause mortality and cardiovascular mortality. Kaplan-Meier survival curve was poltted, and log-rank test was used to compare the differences in the incidence of new onset of atrial fibrillation, all-cause death and cardiovascular death between AHRE≥6 h and AHRE<6 h groups. Multivariate Cox survival analysis was used to investigate the factors affecting new onset of atrial fibrillation, all-cause death and cardiovascular death in elderly patients aged 90 years and above with dual-chamber pacemaker implantation. Results: A total of 169 patients were enrolled, aged (93.95±3.28) years, including 18 females (11%). The median follow-up time was 28.9 months. There were 87 and 82 patients in AHRE≥6 h group and AHRE<6 h group, respectively. Kaplan-Meier survival curve analysis showed that the incidence of new onset of atrial fibrillation (log-rank P<0.001), all-cause death (log-rank P=0.004) and cardiovascular death (log-rank P=0.026) in AHRE≥6 h group was significantly higher than that in AHRE<6 h group.After adjusting for traditional risk factors, multivariate Cox survival analysis showed that AHRE≥6 h was an independent risk factor for new onset of atrial fibrillation (HR=4.046, 95%CI 2.402-6.814, P<0.001) and all-cause mortality (HR=1.668, 95%CI 1.119-2.487, P=0.012) in elderly patients over 90 years old with cardiac dual-chamber pacemaker implantation. However, AHRE≥6 h had no effect on cardiovascular mortality (P>0.05). Anemia (HR=3.098, 95%CI 1.342-7.153, P=0.008) and heart failure with reduced ejection fraction (HR=3.028, 95%CI 1.181-7.763, P=0.021) were both independently associated with cardiovascular mortality. Conclusions: AHRE is common in cardiac dual-chamber pacemakers recipients aged 90 years and above, and AHRE≥6 h can be used as a predictor of new onset of atrial fibrillation or all-cause mortality in these patients.

Ultrasound-guided versus fluoroscopy-guided axillary vein puncture for cardiac implantable electronic device implantation: a meta-analysis enrolling 1257 patients.

Ultrasound-guided (Echo-AVP) and Fluoroscopy-guided Axillary Vein Puncture (Fluoro-AVP) are both acknowledged as safe and effective techniques for transvenous implantation of leads for cardiac implantable electronic devices (CIEDs). Nonetheless, it is still debated which of the two techniques has a better safety and efficacy profile. Therefore, we performed a meta-analysis to evaluate the efficacy and safety of Echo-AVP versus Fluoro-AVP for CIEDs implantation. We systematically searched Medline, Embase and Cochrane electronic databases up to May 15th, 2024, for studies that evaluated the efficacy and safety of Echo-AVP and Fluoro-AVP reporting at least one clinical outcome of interest. The primary efficacy endpoint was acute procedural success and the primary safety endpoint was a composite endpoint of pneumothorax, pocket hematoma/bleeding, pocket infection and inadvertent arterial puncture. The effect size was estimated using a random-effect model as Odds Ratio (OR) and Mean Difference (MD) with relative 95% Confidence Interval (CI). Overall, 4 studies were included, which enrolled 1257 patients (Echo-AVP: 373 patients; Fluoro-AVP: 884 patients). Echo-AVP led to a significant reduction in the primary safety endpoint (OR: 0.41; p = 0.0009), risk of inadvertent arterial puncture (OR: 0.29; p = 0.003) and fluoroscopy time ( MD: -105.02; p = 0.008). No differences were found between Echo-AVP and Fluoro-AVP for acute procedural success (OR: 0.77; p = 0.27), pneumothorax (OR: 0.66; p = 0.60), pocket hematoma/bleeding (OR: 0.68; p = 0.30), pocket infection (OR: 0.66; p = 0.60), procedural time (MD: 1.99; p = 0.65), success rate at first attempt (OR: 1.25; p = 0.34) and venous access time (MD: -0. 25; p = 0.99). Echo-AVP proved to reduce significantly the primary safety endpoint, inadvertent arterial puncture and fluoroscopy time compared to Fluoro-AVP.

Real-Time Ambulatory ECG Does Not Expedite Care.

Ambulatory ECG (AECG) monitoring is pivotal to the diagnosis of arrhythmias and can be performed with near "real-time" notification of abnormalities. There are limited data on the relative benefit of real-time monitoring compared with traditional Holter monitoring. This is a retrospective observational analysis of University of Utah Health patients who underwent ambulatory ECG studies from 2010 to 2022. The study cohort was stratified by patients with an ambulatory ECG that provides real-time event notification (non-Holter) versus those who do not (Holter). The outcomes were cardiac implantable electronic device procedure, ablation procedure, emergency department/hospitalization visit, and initiation of anticoagulation out to 6 months. We identified 20 259 patients, 16 650 with non-Holter studies and 3609 with Holter studies. Holter patients were younger (mean 52 versus 55, P<0.001), more often women (60.2% versus 57%, P<0.001), and had lower mean CHADS2-VA2Sc scores (1.7 versus 2.1, P<0.001). The median time to ablation procedure was 74 versus 72 (P=0.5), for Holter versus non-Holter, respectively. Median days to new cardiac implantable electronic device implantation was 54 days versus 52 (P=0.6); initiation of anticoagulation among patients not already treated was 42 versus 31 days (P=0.03). Time to first emergency department visit or hospitalization was 63 versus 57 (P=0.6). In multivariable models, there were no significant differences in time to intervention between Holter and non-Holter for each outcome. Real-time monitoring demonstrates mixed results in terms of reducing time to intervention, with the significant benefit limited to oral anticoagulation initiation. It is time to revisit clinical scenarios where real-time ambulatory monitoring may not improve health care efficiency.

Pseudomonas monteilii bacteremia and sepsis following insertable cardiac monitor implantation: a case report

BackgroundInsertable cardiac monitor implantation is a simple and safe procedure commonly performed in patients with embolic stroke with undetermined source. Routine periprocedural antibiotic use is not recommended, because infection rate is very low, although some local infection or gram-positive bacteremia have been reported. We report a case of Pseudomonas monteilii sepsis immediately after insertable cardiac monitor implantation.Case presentationA 55-year-old Korean male with embolic stroke of undetermined source presented with gram-negative sepsis immediately after implantable cardiac monitor implantation as a first reported complication after the procedure. Pseudomonas monteilii was identified in the blood culture, and no other infection source was seen. He was treated with intravenous antibiotics without removing the device.ConclusionsPrompt diagnosis and adequate management is required in such a patient with sepsis post-insertable cardiac monitor implantation procedure. It can be managed with adequate antibiotic treatment without device removal if there is no sign of inflammation at the insertion site. Further reports or studies should be investigated to reinforce this finding.Learning objectivesThe infection rate after insertable cardiac monitor insertion is extremely low; however, sepsis may occur without pocket infections. Physicians should be aware of signs of systemic infection, particularly when the procedure is performed outside the catheterization room. Sepsis after insertable cardiac monitor implantation can be managed with adequate antibiotic treatment without device removal if there is no sign of inflammation at the insertion site.

Treatment of malignant primary cardiac tumors requires attention to cardiovascular complications: a single-center, retrospective study.

Malignant primary cardiac tumors require multimodal approaches including surgery, chemotherapy and radiotherapy, but these treatments can be associated with cardiovascular complications. However, few reports have described the cardiovascular complications related to primary cardiac tumor treatment because of their rarity. Clinical records of patients with primary cardiac tumors treated at Kyushu University Hospital from January 2010 to August 2021 were retrospectively examined. Of the 47 primary cardiac tumor patients, 13 (28%) were diagnosed with malignancy, including 5 angiosarcomas, 3 intimal sarcomas, 3 diffuse large B-cell lymphomas, 1 Ewing's sarcoma and 1 fibrosarcoma. Cardiovascular events were observed in 10 patients (77%), including cardiac dysfunction in 6 patients, arrhythmias in 5 patients, right heart failure in 2 patients, and excessively prolonged prothrombin time due to the combination of warfarin and chemotherapy in 1 patient. Two patients who showed notable cardiac complications are described. Case A involved a 69-year-old woman who underwent surgery for a left atrial intimal sarcoma, followed by postoperative chemotherapy with doxorubicin plus ifosfamide and radiotherapy. After three cycles of chemotherapy and sequential radiotherapy, her left ventricular ejection fraction decreased to 34%, and ongoing heart failure therapy was required. Case B involved a 66-year-old man who received chemotherapy for primary cardiac lymphoma, resulting in tumor shrinkage. However, due to tumor involvement of the intraventricular septum, atrioventricular block developed, requiring cardiac pacemaker implantation. High incidences of cardiac failure and arrhythmias were observed during multimodal treatments for malignant primary cardiac tumors. Proper management of complications may lead to a favorable prognosis in patients with malignant primary cardiac tumors.

Injection of carbon dioxide instead of iodinated contrast to display the common bile duct during endoscopic retrograde cholangiopancreatography.

Common bile duct (CBD) stones are usually caused by biliary tract infection, biliary stricture, duodenal peripapillary diverticulum, Oddis sphincter dysfunction, and so on. Treatment is preferably with endoscopic retrograde cholangiopancreatography (ERCP), where an iodine-containing contrast agent is injected into the CBD to display the stone under fluoroscopy and then to confirm complete removal of the stone(s). We described a 65-year-old woman with CBD stones who had undergone cardiac pacemaker implantation and was allergic to iodinated contrast media. We performed ERCP + lithotomy + stent implantation under local anesthesia, with injection of carbon dioxide instead of iodinated contrast into the CBD, and successfully visualized the stones under fluoroscopy and then confirmed complete removal of them. The patient was generally in good condition without complications. Thus, we have demonstrated in this case report that carbon dioxide can be used as a safe, economical, and effective alternative to iodinated contrast agent during ERCP.

Relationship Between Insurance Status and Receipt of Cardiac Tests and Procedures During Hospitalization: A Cross-Sectional Study.

Prior analyses of the relationship between insurance status and receipt of tests and procedures have yielded conflicting findings and have focused on outpatient care. We sought to characterize the relationship between primary payer and diagnostic and procedural intensity, comparing rates of cardiac tests and procedures in matched hospitalized Medicaid and commercially insured patients. We created a propensity score-matched sample of Medicaid and commercially insured adults hospitalized at all acute care hospitals in Kentucky, Maryland, New Jersey, and North Carolina from 2016 to 2018. The main outcome was receipt of a cardiac test or procedure: echocardiogram, stress test, cardiac catheterization (elective, in acute coronary syndrome, in ST-segment-elevation myocardial infarction), and pacemaker and subcutaneous cardiac rhythm monitor implantation. Generalized linear models with a hospital-specific indicator variable were estimated to calculate the adjusted odds of a commercially insured patient receiving a given test or procedure relative to a Medicaid patient. Models controlled for race, ethnicity, and zip code income quartile. Commercially insured patients were more likely to receive each cardiac test or procedure, with adjusted odds ratios ranging from 1.16 (95% CI, 1.00-1.34) for cardiac catheterization in ST-segment-elevation myocardial infarction to 1.40 (95% CI, 1.27-1.54) for pacemaker implantation. Hospitalized commercially insured patients were more likely to undergo a range of cardiac tests and procedures, some of which may represent low-value care. This may be driven by a combination of physician and patient preference, financial incentives, and social determinants of health. Our findings support the need for hospital payment models focused on increasing value and reducing inequities.

Benchtop Flow Stasis Quantification: In Vitro Methods and In Vivo Possibilities.

Neo-sinus flow stasis has ben correlated with transcatheter heart valve (THV) thrombosis severity and occurrence. Standard benchtop flow field quantification techniques require optical access or modified prosthesis models that may not reflect the true nature of the original valve. En face and fluoroscopic videodensitometry enable visualization of washout in regions otherwise unviewable. This study compares two in vitro methods of assessing flow stasis in scenarios with insufficient optical access for traditional techniques such as particle image velocimetry (PIV). A series of seven paired experiments were conducted using a previously described laser-enhanced video densitometry (LEVD) and fluoroscopic video densitometry (FVD). Both sets of experiments were analyzed to calculate washout time as a measure of flow stasis. A novel flow stasis measure termed contrast attenuation ratio (CAR) is proposed as a viable single measure of flow stasis obtainable from only a small number of cardiac cycles of in vitro or in vivo fluoroscopic data. Retrospective fluoroscopic datasets (n = 72) were analyzed to assess the feasibility of obtaining this metric from routine clinical practice and its ability to stratify results. Neo-sinus flow stasis calculated from in vitro fluoroscopy was well correlated with LEVD (r2 = 0.77, p = 0.009). The newly proposed CAR metric showed good agreement with the commonly used "washout time" measure of flow stasis (r2 = 0.91, p < 0.001) while allowing for assessment with incomplete or truncated data. As a proof of concept, CAR was measured in 72 consecutive retrospective fluoroscopic datasets. CAR averaged 10.6 ± 4.6% with a range of 1.5-20.3% in these patients. This study demonstrates two in vitro methods that can be used to assess relative flow stasis in otherwise optically inaccessible regions surrounding cardiac or vascular implants. In addition, the fluoroscopic benchtop technique was used to validate a metric that allows for extension to routine clinical fluoroscopy. This contrast attenuation ratio (CAR) metric was found to be both accurate and clinically obtainable, and potentially offers a new method for valve thrombosis risk stratification.

Incidence, Time Course, and Outcomes of Worsening Tricuspid Regurgitation Following Transvenous Cardiac Implantable Electronic Device Implantation

Data regarding the incidence, time course, and outcomes of worsening tricuspid regurgitation (TR) after transvenous cardiac implantable electronic device (CIED) implantation are limited. We screened 834 consecutive patients who underwent first-time transvenous CIED implantation. After excluding patients without preoperative or follow-up echocardiography (n = 361) and patients with severe TR before implantation (n = 15), the present study population consisted of 458 patients. Worsening TR was defined as moderate or more TR that was newly developed or increased by at least 1 grade compared with baseline. During the median follow-up period of 2.1 years, worsening TR occurred in 93 patients (20%). The cumulative incidence of worsening TR was 10.2% at 1 year and 18.6% at 3 years. Of the 67 patients with worsening TR who underwent follow-up echocardiography, excluding those who underwent tricuspid valve surgery, 76% showed improvement in TR severity, with 70% having none or mild TR. On the landmark analysis, the 5-year cumulative incidence of all-cause death and heart failure hospitalization was significantly higher in patients with worsening TR at 1 year than those without worsening TR at 1 year (24.8% vs 11.4%, p = 0.002 and 35.2% vs 17.9%, p = 0.012, respectively). When considering worsening TR as a time-dependent covariate, worsening TR was significantly associated with an increased risk of all-cause death and heart failure hospitalization after adjustment for the differences in baseline patient characteristics (hazard ratio 1.99, 95% confidence interval 1.21 to 3.27, p = 0.006 and hazard ratio 2.64, 95% confidence interval 1.59 to 4.37, p <0.001, respectively). In conclusion, worsening TR after transvenous CIED implantation was not uncommon and had a dynamic nature with an improvement in the majority of patients, suggesting the functional etiology. Nonetheless, worsening TR was independently associated with an increased risk for mortality and heart failure hospitalization.

Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study.

In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training. In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance. Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications.

Safety and efficacy of orthodromic snare technique in left ventricular lead delivery in cardiac resynchronization implantation.

Cardiac resynchronization therapy (CRT) improves ventricular function, but a positive response to CRT is often limited due to left ventricular (LV) lead placement in a suboptimal position. Complex coronary venous anatomy can hinder the placement of an LV lead in the target vessel, leading to poor CRT response. To report experience with snare-assisted LV lead delivery in CRT and compare outcomes with the conventional LV lead delivery. This is a single-center retrospective case-control study of CRT implants between 2016 and 2021. Snare-assisted lead delivery was performed in cases where conventional lead placement failed or when a preferred target vessel had anatomy amenable to the technique. Safety and outcomes were compared to conventional LV lead placement cases. Among 180 CRT cases, 33 were snare-assisted, and 147 were conventional LV lead placements. Median follow-up was 924 days in the snare and 618.5 days in the control group. The lead placement was successful in 28/33 snare and 138/147 control cases. A mid-vessel segment was attained in 89.3% of snare and 72.5% of control cases(p=.03). The apical position was more frequently observed in the control group (26.8% vs. 7.1%, p=.03). All-cause mortality trended lower in the snare group (6.1%) compared to (17.1%) in the control group (p=.13). Snare-assisted LV lead delivery is a safe and effective technique that can be utilized for overcoming complex venous anatomy.

Microporous polysaccharide hemospheres for reducing pocket hematomas after cardiac device implantation in patients on antithrombotic therapy.

Various surgical procedures have employed microporous polysaccharide hemosphere (MPH) hemostatic agents. However, data regarding their effectiveness in preventing pocket hematomas (PHs) during the implantation of cardiac implantable electronic devices (CIED) among the Asian population are limited. Therefore, this study aimed to investigate the potential benefits of using MPH hemostatic agents during CIED implantations as a preventive measure against post-procedural PHs. We conducted a retrospective, single-center, observational study involving 255 consecutive Japanese patients who underwent CIED implantation between November 2017 and April 2021. We compared PH occurrences within 28 days after CIED implantation between patients who received MPH hemostatic agents (n = 145) and those who did not (n = 110). PH development was observed in nine (6.2%) patients who received MPH hemostatic agents and in 13 (11.8%) patients without MPH hemostatic (p = .111). Kaplan-Meier analysis of PH development revealed no significant difference between the two groups (log-rank p = .102). However, utilizing MPH hemostatic agents among patients taking antithrombotic drugs, including antiplatelet medications, direct oral anticoagulants, and warfarin, significantly reduced PH incidence (log-rank p = .03). The multivariate Cox proportional hazards model demonstrated that MPH hemostatic agent utilization independently correlated with a decreased PH risk (hazard ratio 0.22, 95% confidence interval 0.08-0.63, p = .004). The findings of this study suggest that the incorporation of MPH hemostatic agents into standard practice may benefit to mitigate PH risk during CIED implantations in patients on antithrombotic therapy. This simple and practical measure may be valuable, especially in high-risk patients, such as those taking antithrombotic medications.

Feasibility, timing and outcome of leadless cardiac pacemaker implantation in patients undergoing cardiac implantable electronic device extraction.

Patients requiring extraction of infected or dysfunctional cardiac implantable electronic devices (CIED) have high morbidity and mortality. The Micra™ leadless cardiac pacemaker (LCP) may be beneficial for patients requiring permanent pacemaker therapy after CIED extraction. This study aimed to assess the feasibility, timing and outcomes of LCP implantation in patients who underwent CIED extraction due to infection or dysfunction. The local Micra™ LCP registry was reviewed for LCP implantations and CIED extractions. Micra™ LCP implantation was scheduled for 48 consecutive patients (21 women, 44%) undergoing CIED extraction for infection (n = 38, 79%) or dysfunction (n = 10, 21%), and feasible in 47 (98%). Complete CIED removal was feasible in 44 patients (92%) and in 37/38 patients with infected CIED (97%). Overall, 32 LCP (67%) were implanted in a single procedure: 3 (6%) before and 13 (27%) after CIED extraction. LCP were implanted in a single procedure in 24/38 patients (63%) with infected CIED and in 8/10 patients (80%) with dysfunctional CIED. The in-hospital mortality rate was 6% (n = 3), and the survival rates at 30days, 90days and 1year were 94% (n = 45/48), 90% (n = 43/48), and 85% (n = 41/48), respectively. No recurrent LCP-related mortality or infections occurred during a median follow-up of 15 (interquartile range, 12-41) months. Two-thirds of LCPs could be implanted in a single procedure with CIED extraction; no recurrent infections were detected. Overall, Micra™ LCP implantation in patients requiring CIED extraction was feasible.

Extracorporeal membrane oxygenation in the therapy of cardiogenic shock: 1-year outcomes of the multicentre, randomized ECMO-CS trial.

Among patients with cardiogenic shock, immediate initiation of extracorporeal membrane oxygenation (ECMO) did not demonstrate any benefit at 30 days. The present study evaluated 1-year clinical outcomes of the Extracorporeal Membrane Oxygenation in the therapy of Cardiogenic Shock (ECMO-CS) trial. The ECMO-CS trial randomized 117 patients with severe or rapidly progressing cardiogenic shock to immediate initiation of ECMO or early conservative strategy. The primary endpoint for this analysis was 1-year all-cause mortality. Secondary endpoints included a composite of death, resuscitated cardiac arrest or implantation of another mechanical circulatory support device, duration of mechanical ventilation, and the length of intensive care unit (ICU) and hospital stays. In addition, an unplanned post-hoc subgroup analysis was performed. At 1 year, all-cause death occurred in 40 of 58 (69.0%) patients in the ECMO arm and in 40 of 59 (67.8%) in the early conservative arm (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.66-1.58; p = 0.93). The composite endpoint occurred in 43 (74.1%) patients in the ECMO group and in 47 (79.7%) patients in the early conservative group (HR 0.83, 95% CI 0.55-1.25; p = 0.29). The durations of mechanical ventilation, ICU stay and hospital stay were comparable between groups. Significant interaction with treatment strategy and 1-year mortality was observed in subgroups according to baseline mean arterial pressure (MAP) indicating lower mortality in the subgroup with low baseline MAP (<63 mmHg: HR 0.58, 95% CI 0.29-1.16; pinteraction = 0.017). Among patients with severe or rapidly progressing cardiogenic shock, immediate initiation of ECMO did not improve clinical outcomes at 1 year compared to the early conservative strategy. However, immediate ECMO initiation might be beneficial in patients with advanced haemodynamic compromise.

Left bundle branch block cardiomyopathy (LBBB-CMP): from the not-so-benign finding of idiopathic LBBB to LBBB-CMP diagnosis and treatment.

two main objectives: (1) to explore the natural history of "asymptomatic" iLBBB carriers; (2) to characterize the outcomes and therapeutic approach used in a "real-world" cohort of possible LBBB-CMP patients (pts). tertiary care centre retrospective study of pts with iLBBB and possible LBBB-CMP, screened from a large hospital electrocardiographic database from 2011 to 2017 (LBBB = 347). To assign the 1st objective, only pts with left ventricular ejection fraction (LVEF) ≥ 50% and available follow-up (FU) data were included (n = 152). Regarding the 2nd objective, possible LBBB-CMP pts were selected and defined as iLBBB pts with LVD (LVEF < 50%) and no secondary causes for LVD (n = 53). Data were based on pts' careful review of medical records. focusing our 1st objective, 152 iLBBB carriers were identified. Median FU time were 8years, and 61% were female. During FU, approximately 25% developed LVD, 20% needed ≥ 1 cardiovascular (CV) hospitalization, and 15% needed a cardiac device implantation. The majority (2/3) of pts with LVD on FU (n = 35) had no secondary causes for LVD, being classified as possible LBBB-CMP pts. Time-to-LVD analysis showed no differences between pts with a known cause for LVD vs LBBB-CMP pts (Log-rank = 0.713). Concerning the 2nd objective, 53 possible LBBB-CMP pts were identified. Median FU time were 10years, and 51% were female. During the FU, 77% presented heart failure (HF) symptoms, and 42% needed ≥ 1 CV hospitalization, mainly due to HF. Half presented severe LVD at some point in time, and 55% needed a cardiac device, most of them a cardiac resynchronization therapy (CRT) device. Comparing CRT with non-CRT pts, no differences were found in terms of medical therapy, but better outcomes were observed in CRT group: LVEF improvement was higher (median LVEF improvement of 11% in non-CRT vs 27% in CRT; p < 0.001), and fully recovery from LVD was more frequent (50% of CRT vs 14% non-CRT; p = 0.028). our data strengthen current evidence on natural history of iLBBB, showing significant CV morbidity associated with the presence of iLBBB, and reinforces the need for a serial and proper FU of these carriers. Our data on "real-world" possible LBBB-CMP pts shows high rates of CV events, namely HF-related events, and supports the growing evidence pointing out CRT as this subgroup of pts' cornerstone of treatment. In conclusion, our work sheds additional light on these largely unknown topics and underlines the urgent need for larger and prospective studies addressing the identification of LVD development predictors in iLBBB carriers, as well as the establishment of diagnostic criteria and therapeutic approach for LBBB-CMP.