Navigating the Landscape of Medical Device Advisories: A Special Report from the Canadian Heart Rhythm Society Device Advisory Committee.

Cardiac implantable electronic devices (CIED) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most-implanted medical devices, with >1.5 million devices implanted annually. While millions of patients have benefited with improved quality of life and survival, CIED-systems are increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to healthcare providers and patients. Medical device recalls are common, with >35 unique device recalls in the past five years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the healthcare system, as well as disproportionate impact of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device-anomalies is paramount in ensuring patients feel safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implant and throughout follow-up, accessibility of information both in the initial implant and recall action process, and trust in healthcare systems and providers.

Cardiac sarcoidosis with extensive and heterogeneous left ventricular FDG uptake in absence of guidelines indication for an implantable defibrillator: Ventricular tachycardia precipitated by immunosuppressive therapy, should we have done differently?

A 40-year-old man, newly diagnosed with cardiac sarcoidosis (CS) presented with symptomatic ventricular tachycardia three days after starting steroid-based immunosuppressive therapy (IT). There was no clear guideline indication for implantable cardioverter-defibrillator (ICD) before the initiation of IT. Shortly after ICD implantation and the initiation of anti-arrhythmic drugs, recurring ventricular arrhythmias required titration of the anti-arrhythmic drug therapy. One-year follow-up assessment showed no significant arrhythmias and complete PET scan FDG uptake suppression. This case, along with recent publications, suggests transient pro-arrhythmic effects of steroids in patients with CS, which are not appropriately addressed in the current guidelines. We believe ICD implantation should be considered in clinically manifest CS before initiating IT, particularly in cases with heterogeneous and/or extensive FDG uptake on PET scans.

Effects of envelopes on cardiac implantable electronic device pocket healing: A head-to-head preclinical evaluation.

BACKGROUND: The healing response to cardiac implantable electronic device (CIED) implantation results in inflammation that can lead to fibrous pocket formation, which may disrupt pocket healing or complicate future interventions. OBJECTIVE: The purpose of this study was to assess CIED pocket healing with use of the second-generation TYRX absorbable antibacterial envelope (T2), the next-generation (NG) TYRX absorbable antibacterial envelope under development, and the CanGaroo® extracellular matrix envelope (ECM) compared to no envelope. METHODS: A total of 110 CIEDs were implanted in an ovine model, either with (T2, NG, or ECM) or without envelopes. Histopathologic and morphometric analyses were completed at several timepoints after implant (3 days, 7 days, 4 weeks, 12 weeks, 24 weeks). An independent pathologist completed a blinded histopathology assessment of the pockets. RESULTS: TYRX (T2/NG) pockets showed similar inflammatory and healing profiles to controls with more rapid provisional matrix formation compared to controls and ECM. ECM pockets exhibited increased acute (3 and 7 days) and chronic (24 weeks) inflammation. T2/NG had almost complete (T2) or complete (NG) absorption by week 12. ECM remained present at week 24 and was associated with significantly thicker capsules (ECM 0.80 ± 0.14 mm; NG 0.37 ± 0.10 mm; control 0.56 ± 0.17 mm). CONCLUSION: Compared to ECM, pockets with TYRX showed less inflammation, more rapid provisional matrix formation, faster absorption, and thinner capsules. TYRX pockets had low inflammation comparable to controls with accelerated provisional matrix deposition and tissue adhesion. The healing response to CIEDs used with TYRX fosters the formation of a well-healed pocket, which may bring patient benefit beyond its proven infection reduction.

Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation.

BACKGROUND: Subclinical atrial fibrillation is short-lasting and asymptomatic and can usually be detected only by long-term continuous monitoring with pacemakers or defibrillators. Subclinical atrial fibrillation is associated with an increased risk of stroke by a factor of 2.5; however, treatment with oral anticoagulation is of uncertain benefit. METHODS: We conducted a trial involving patients with subclinical atrial fibrillation lasting 6 minutes to 24 hours. Patients were randomly assigned in a double-blind, double-dummy design to receive apixaban at a dose of 5 mg twice daily (2.5 mg twice daily when indicated) or aspirin at a dose of 81 mg daily. The trial medication was discontinued and anticoagulation started if subclinical atrial fibrillation lasting more than 24 hours or clinical atrial fibrillation developed. The primary efficacy outcome, stroke or systemic embolism, was assessed in the intention-to-treat population (all the patients who had undergone randomization); the primary safety outcome, major bleeding, was assessed in the on-treatment population (all the patients who had undergone randomization and received at least one dose of the assigned trial drug, with follow-up censored 5 days after permanent discontinuation of trial medication for any reason). RESULTS: We included 4012 patients with a mean (±SD) age of 76.8±7.6 years and a mean CHA2DS2-VASc score of 3.9±1.1 (scores range from 0 to 9, with higher scores indicating a higher risk of stroke); 36.1% of the patients were women. After a mean follow-up of 3.5±1.8 years, stroke or systemic embolism occurred in 55 patients in the apixaban group (0.78% per patient-year) and in 86 patients in the aspirin group (1.24% per patient-year) (hazard ratio, 0.63; 95% confidence interval [CI], 0.45 to 0.88; P = 0.007). In the on-treatment population, the rate of major bleeding was 1.71% per patient-year in the apixaban group and 0.94% per patient-year in the aspirin group (hazard ratio, 1.80; 95% CI, 1.26 to 2.57; P = 0.001). Fatal bleeding occurred in 5 patients in the apixaban group and 8 patients in the aspirin group. CONCLUSIONS: Among patients with subclinical atrial fibrillation, apixaban resulted in a lower risk of stroke or systemic embolism than aspirin but a higher risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; ARTESIA ClinicalTrials.gov number, NCT01938248.).

Severity of Left Ventricular Dysfunction in Patients With Tachycardia-Induced Cardiomyopathy: Impacts on Remodeling After Atrial Flutter Ablation.

Tachycardia-induced cardiomyopathy is defined as a reversible left ventricular (LV) systolic dysfunction (SeD) resulting from a sustained fast heart rate. LV remodeling in patients with severe LV dysfunction at diagnosis remains poorly understood. In this retrospective cohort study, we described LV remodeling in 50 patients who underwent atrial flutter ablation. These patients were divided into severe LV SeD (LV ejection fraction [EF] ≤30%) and LV nonsevere SeD (LVEF 31% to 50%) at baseline. All continuous variables are expressed as median and interquartile range. LVEF was 18% (13 to 25) and 38% (34 to 41) in the SeD (n = 29) and LV nonsevere SeD (n = 21) groups, respectively. At baseline, patients with SeD had higher LV end-diastolic diameter (56 [54 to 59] vs 49 mm [47 to 52], p <0.01), LV end-systolic diameter (48 [43 to 51] vs 36 mm [34 to 41], p <0.01), LV end-diastolic volume (71 [64 to 85] vs 56 ml/m2 [46 to 68], p <0.01), LV end-systolic volume (56 [53 to 70] vs 36 ml/m2 [27 to 42], p <0.01), and lower tricuspid annular plane systolic excursion (12 [10 to 13] vs 16 mm [13 to 19], p <0.01). At last follow-up, LVEF was not statistically significantly different between groups. However, LV end-systolic diameter (36 [34 to 39] vs 32 mm [32 to 34], p = 0.01) and LV end-systolic volume (29 [26 to 35] vs 25 ml/m2 [20 to 29], p = 0.02) remained larger in the SeD group. Seven patients (14%), all from the SeD group, had a LVEF ≤35% 2 months after rhythm control, and reverse remodeling was observed up to 9 months. In conclusion, more than half of patients with tachycardia-induced cardiomyopathy and atrial flutter had LVEF ≤30% at baseline. LVEF recovery and LV remodeling were observed beyond 2 months, highlighting the importance of rhythm control and early guideline-directed medical therapy in these patients.

Incidence, predictors, and prognostic significance of impaired functional status early after transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: There are scarce data on the factors associated with impaired functional status after transcatheter aortic valve replacement (TAVR) and its clinical impact. This study aimed to determine the incidence, predictors, and prognostic implications of impaired functional class (NYHA class III-IV) following TAVR. METHODS: This multicenter study included 3462 transarterial TAVR patients receiving newer generation devices. The patients were compared according to their NYHA class at 1 month of follow-up (NYHA I-II vs NYHA III-IV). A multivariate logistic regression was performed to identify the predictors of 30-day NYHA class III-IV. Patient survival was compared with the Kaplan-Meier method and factors associated with decreased survival were identified with Cox regression analysis. RESULTS: The mean age of the study population was 80.3±7.3 years, with 47% of women, and a median Society of Thoracic Surgeons score of 3.8% [IQR, 2.5-5.8]. A total of 208 patients (6%) were in NYHA class III-IV 1 month after TAVR. Predictors of 30-day NYHA class III-IV were baseline NYHA class III-IV (OR, 1.76; 95%CI, 1.08-2.89; P=.02), chronic pulmonary obstructive disease (OR, 1.80; 95%CI, 1.13-2.83; P=.01), and post-TAVR severe mitral regurgitation (OR, 2.00; 95%CI, 1.21-3.31; P<.01). Patients in NYHA class III-IV 1 month after TAVR were at higher risk of death (HR, 3.68; 95%CI, 2.39-5.70; P<.01) and heart failure-related hospitalization (HR, 6.00; 95%CI, 3.76-9.60; P<.01) at 1-year follow-up. CONCLUSIONS: Up to 6% of contemporary TAVR patients exhibited an impaired functional status following TAVR. Worse baseline NYHA class, chronic pulmonary obstructive disease, and severe mitral regurgitation predicted 30-day NYHA class III/IV, and this determined a higher risk of mortality and heart failure hospitalization at 1-year follow-up. Further studies on the prevention and treatment optimization of patients with impaired functional status after TAVR are needed.

Canadian Cardiovascular Society 2023 Guidelines on the Fitness to Drive.

Cardiovascular conditions are among the most frequent causes of impairment to drive, because they might induce unpredictable mental state alterations via diverse mechanisms like myocardial ischemia, cardiac arrhythmias, and vascular dysfunction. Accordingly, health professionals are often asked to assess patients' fitness to drive (FTD). The Canadian Cardiovascular Society previously published FTD guidelines in 2003-2004; herein, we present updated FTD guidelines. Because there are no randomized trials on FTD, observational studies were used to estimate the risk of driving impairment in each situation, and recommendations made on the basis of Canadian Cardiovascular Society Risk of Harm formula. More restrictive recommendations were made for commercial drivers, who spend longer average times behind the wheel, use larger vehicles, and might transport a larger number of passengers. We provide guidance for individuals with: (1) active coronary artery disease; (2) various forms of valvular heart disease; (3) heart failure, heart transplant, and left ventricular assist device situations; (4) arrhythmia syndromes; (5) implantable devices; (6) syncope history; and (7) congenital heart disease. We suggest appropriate waiting times after cardiac interventions or acute illnesses before driving resumption. When short-term driving cessation is recommended, recommendations are on the basis of expert consensus rather than the Risk of Harm formula because risk elevation is expected to be transient. These recommendations, although not a substitute for clinical judgement or governmental regulations, provide specialists, primary care providers, and allied health professionals with a comprehensive list of a wide range of cardiac conditions, with guidance provided on the basis of the level of risk of impairment, along with recommendations about ability to drive and the suggested duration of restrictions.

Concomitant symptomatic cardiac sarcoidosis and systemic sclerosis with cardiac involvement: a case report.

Sarcoidosis and systemic sclerosis are two inflammatory multisystemic disorders of unknown etiology that may be life-threatening especially when there is cardiac involvement. Both diseases may coexist, however, there are very few case reports of patients with both cardiac sarcoidosis and systemic sclerosis in the literature. We report the case of a 72-year-old female who was initially referred for dyspnea. A chest computed tomography scan showed multiple hilar and mediastinal adenopathy with a non-specific opacity in the middle pulmonary lobe. FDG-PET-scan showed increased FDG uptake in the adenopathy, the middle lobe and the right ventricular free wall. Sarcoidosis was confirmed with a lung biopsy. Both electrocardiogram and echocardiogram were normal. Four months later, the patient developed a high-grade atrioventricular block deemed secondary to her cardiac sarcoidosis. Two years later, the patient was referred to a rheumatologist for severe Raynaud's symptoms, sclerodactyly and acrocyanosis. After thorough investigations, a diagnosis of limited cutaneous systemic sclerosis with systemic and cardiac sarcoidosis was made. This case demonstrates that both cardiac sarcoidosis and systemic sclerosis may coexist. In the literature, either disease may come first. In cases where cardiac symptoms appear after the diagnosis of concomitant sarcoidosis and systemic sclerosis, it might be difficult for clinicians to confirm which disease is responsible for the heart involvement. This is important since early cardiac sarcoidosis treatment should be done to prevent major complications and may well differ from systemic sclerosis treatment. In this review, we discuss the main clinical manifestations and imaging findings seen with cardiac disease secondary to sarcoidosis and systemic sclerosis.

Acute pacing threshold elevation during simultaneous Micra leadless pacemaker implantation and AV node ablation: Clinical cases, computer model and practical recommendations.

BACKGROUND: In patients with refractory atrial fibrillation (AF), atrioventricular nodal (AVN) ablation and permanent pacemaker implantation is recommended. The Micra Transcatheter Pacing System (Micra) is a single chamber leadless pacemaker (LPM) and thus offers the possibility of AV node (AVN) ablation in the same procedure. Pacing threshold (PT) elevation after radiofrequency (RF) ablation is a potential complication. METHODS: We conducted a single center retrospective cohort study. Patients implanted with a Micra (n = 84) and concomitant or delayed AVN ablation (n = 12) from 2014 to 2022 were included. Two cases of acute Micra PT elevation immediately following RF AVN ablation required device retrieval and implantation of a new Micra. Procedural characteristics and electrophysiological parameters were analyzed, and a computer model was performed to determine factors responsible for acute PT elevations. RESULTS: A total of 84 patients were included. Mean age was 74 ± 10 and 48% were women. Twelve patients (14%) underwent AVN ablation. Two patients had acute PT elevation requiring device retrieval despite no direct contact of the ablation catheter with the Micra. Computer modeling shows that significant dissipated power due to electrical field coupling can occur at the tip or ring electrode if the catheter is not kept at a safe distance (≥35 mm) from the Micra when a maximum power of 100 W is delivered. CONCLUSION: Concurrent AVN ablation and Micra implantation is safe in most patients. To prevent acute PT elevation, keeping a safe distance of ≥35 mm from the tip and ring electrodes of the Micra and using lower power output may prevent this complication.

Cardiac Death After Transcatheter Aortic Valve Replacement With Contemporary Devices.

BACKGROUND: The burden of cardiac death after transcatheter aortic valve replacement (TAVR), particularly from advanced heart failure (HF) and sudden cardiac death (SCD), remains largely unknown. OBJECTIVES: This study sought to evaluate the incidence and predictors of SCD and HF-related death in TAVR recipients treated with newer-generation devices. METHODS: This study included a total of 5,421 consecutive patients who underwent TAVR with newer-generation devices using balloon (75.7%) or self-expandable (24.3%) valves. RESULTS: After a median follow-up of 2 (IQR: 1-3) years, 976 (18.0%) patients had died, 50.8% from cardiovascular causes. Advanced HF and SCD accounted for 11.6% and 7.5% of deaths, respectively. Independent predictors of HF-related death were atrial fibrillation (HR: 2.17; 95% CI: 1.47-3.22; P < 0.001), prior pacemaker (HR: 1.79; 95% CI: 1.10-2.92; P = 0.01), reduced left ventricular ejection fraction (HR: 1.08 per 5% decrease; 95% CI: 1.01-1.14; P = 0.02), transthoracic approach (HR: 2.50; 95% CI: 1.37-4.55; P = 0.003), and new-onset persistent left bundle branch block (HR: 1.85; 95% CI: 1.14-3.02; P = 0.01). Two baseline characteristics (diabetes, HR: 1.81; 95% CI: 1.13-2.89; P = 0.01; and chronic kidney disease, HR: 1.72; 95% CI: 1.02-2.90; P = 0.04) and 3 procedural findings (valve in valve, HR: 2.17; 95% CI: 1.01-4.64; P = 0.04; transarterial nontransfemoral approach, HR: 2.23; 95% CI: 1.23-4.48; P = 0.01; and periprocedural ventricular arrhythmia, HR: 7.19; 95% CI: 2.61-19.76; P < 0.001) were associated with an increased risk of SCD after TAVR. CONCLUSIONS: Advanced HF and SCD accounted for a fifth of deaths after TAVR in contemporary practice. Potentially treatable factors leading to increased risk of HF deaths and SCD were identified, such as arrhythmia/dyssynchrony factors for HF and valve-in-valve TAVR or periprocedural ventricular arrhythmias for SCD.

Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic.

Leucocyte-derived micro-RNAs as candidate biomarkers in Brugada syndrome.

AIMS: Risk stratification for sudden cardiac death in patients with Brugada syndrome remains a major challenge. Contemporary risk prediction models have only modest predictive value. The aim of this study was to assess the role of micro-RNAs from peripheral blood as candidate biomarkers in Brugada syndrome. METHODS AND RESULTS: In this prospective study, Brugada patients and unaffected control individuals were enrolled for analysis of leucocyte-derived microRNAs (miRNAs) levels. Expression levels of 798 different circulating miRNAs were analysed on the NanoString® nCounter platform. All results were cross-validated by using a quantitative polymerase chain reaction. Micro-RNA expression levels of Brugada patients were compared with clinical data. A total of 21 definite Brugada patients (38% with a history of ventricular arrhythmia or cardiac arrest) and 30 unaffected control individuals were included in the study. Micro-RNA analysis showed a distinct expression profile in Brugada patients with 42 differentially expressed markers (38 up-regulated, 4 down-regulated miRNAs). The symptom status of Brugada patients was associated with a distinct miRNA signature. Micro-RNAs 145-5p and 585-3p were significantly up-regulated in symptomatic Brugada patients (P = 0.04). Incorporating miRNAs 145-5p and 585-3p into a multivariable model demonstrated significantly increased symptom prediction (area under the curve = 0.96; 95% confidence interval: 0.88-1.00). CONCLUSION: Brugada patients display a distinct miRNA expression profile compared with unaffected control individuals. There is also evidence that certain miRNAs (miR-145-5p and miR-585-3p) are associated with the symptom status of Brugada patients. The results suggest the principal utility of leucocyte-derived miRNAs as prognostic biomarkers for Brugada syndrome.

Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients.

INTRODUCTION: Superior vena cava (SVC) tear is the most lethal complication during transvenous lead extraction (TLE) with a mortality rate as high as 50%. Treatment involves aggressive attempts to maintain cardiac output and immediate sternotomy to localize and repair the vascular tear. Occlusion balloons have been developed to provisionally occlude the lacerated SVC and to provide hemodynamic stability allowing time for surgery. In case of mediastinal hematoma without hemodynamic instability, the strategy remains unclear. METHODS AND RESULTS: We describe two cases of SVC tear during TLE. The first case was a 60-year-old man who presented with a right ventricular single-chamber defibrillator lead fracture and innominate vein stenosis. The RV lead was removed using a laser sheath causing a mediastinal hematoma with no active bleeding during surgical exploration few hours later. The second case was a 28-year-old man that presented with a right atrial (RA) lead fracture and RV lead insulation failure in a dual-chamber defibrillator (ICD). CONCLUSION: Both the RA and RV leads were removed with mechanical sheaths, and a mediastinal hematoma was medically managed.

Survival, ventricular arrhythmia, and implantable cardioverter-defibrillator usefulness in toxic cardiomyopathy due to substance abuse.

BACKGROUND: Toxic dilated cardiomyopathy (T-DCM) due to substance abuse is now recognized as a potential cause of severe left ventricular dysfunction. The burden of ventricular arrhythmias (VA) and the role of a prophylactic implantable cardioverter-defibrillator (ICD) are not well documented in this population. We aim to assess the usefulness of ICD implantation in a T-DCM cohort. METHODS: Patients younger than 65 years with a left ventricular ejection fraction (LVEF) < 35% followed at a tertiary center heart failure (HF) clinic between January 2003 and August 2019 were screened for inclusion. The diagnosis of T-DCM was confirmed after excluding other etiologies, and substance abuse was established according to the DSM-5 criteria. The composite primary endpoints were arrhythmic syncope, sudden cardiac death (SCD), or death of unknown cause. The secondary endpoints were the occurrence of sustained VA and/or appropriate therapies in ICD carriers. RESULTS: Thirty-eight patients were identified, and an ICD was implanted in 19 (50%) of these patients, only one for secondary prevention. The primary outcome was similar between the two groups (ICD vs. non-ICD; p = 1.00). After a mean follow-up of 33 ± 36 months, only two VA episodes were reported in the ICD group. Three patients received inappropriate ICD therapies. One ICD implantation was complicated with cardiac tamponade. Twenty-three patients (61%) had an LVEF ≥35% at 12 months. CONCLUSION: VA are infrequent in the T-DCM population. The prophylactic ICD benefit was not observed in our cohort. The ideal timing for potential prophylactic ICD implantation in this population needs further studies.

Association of the Timing and Extent of Cardiac Implantable Electronic Device Infections With Mortality.

Importance: Cardiac implantable electronic device (CIED) infection is a potentially devastating complication with an estimated 12-month mortality of 15% to 30%. The association of the extent (localized or systemic) and timing of infection with all-cause mortality has not been established. Objective: To evaluate the association of the extent and timing of CIED infection with all-cause mortality. Design, Setting, and Participants: This prospective observational cohort study was conducted between December 1, 2012, and September 30, 2016, in 28 centers across Canada and the Netherlands. The study included 19 559 patients undergoing CIED procedures, 177 of whom developed an infection. Data were analyzed from April 5, 2021, to January 14, 2023. Exposures: Prospectively identified CIED infections. Main Outcomes and Measures: Time-dependent analysis of the timing (early [≤3 months] or delayed [3-12 months]) and extent (localized or systemic) of infection was performed to determine the risk of all-cause mortality associated with CIED infections. Results: Of 19 559 patients undergoing CIED procedures, 177 developed a CIED infection. The mean (SD) age was 68.7 (12.7) years, and 132 patients were male (74.6%). The cumulative incidence of infection was 0.6%, 0.7%, and 0.9% within 3, 6, and 12 months, respectively. Infection rates were highest in the first 3 months (0.21% per month), reducing significantly thereafter. Compared with patients who did not develop CIED infection, those with early localized infections were not at higher risk for all-cause mortality (no deaths at 30 days [0 of 74 patients]: adjusted hazard ratio [aHR], 0.64 [95% CI, 0.20-1.98]; P = .43). However, patients with early systemic and delayed localized infections had an approximately 3-fold increase in mortality (8.9% 30-day mortality [4 of 45 patients]: aHR, 2.88 [95% CI, 1.48-5.61]; P = .002; 8.8% 30-day mortality [3 of 34 patients]: aHR, 3.57 [95% CI, 1.33-9.57]; P = .01), increasing to a 9.3-fold risk of death for those with delayed systemic infections (21.7% 30-day mortality [5 of 23 patients]: aHR, 9.30 [95% CI, 3.82-22.65]; P < .001). Conclusions and Relevance: Findings suggest that CIED infections are most common within 3 months after the procedure. Early systemic infections and delayed localized infections are associated with increased mortality, with the highest risk for patients with delayed systemic infections. Early detection and treatment of CIED infections may be important in reducing mortality associated with this complication.

Prognostic Value of Tricuspid Valve Gradient After Transcatheter Edge-to-Edge Repair: Insights From the TriValve Registry.

BACKGROUND: Data regarding the impact of the tricuspid valve gradient (TVG) after tricuspid transcatheter edge-to-edge repair (TEER) are scarce. OBJECTIVES: This study sought to evaluate the association between the mean TVG and clinical outcomes among patients who underwent tricuspid TEER for significant tricuspid regurgitation. METHODS: Patients with significant tricuspid regurgitation who underwent tricuspid TEER within the TriValve (International Multisite Transcatheter Tricuspid Valve Therapies) registry were divided into quartiles based on the mean TVG at discharge. The primary endpoint was the composite of all-cause mortality and heart failure hospitalization. Outcomes were assessed up to the 1-year follow-up. RESULTS: A total of 308 patients were included from 24 centers. Patients were divided into quartiles of the mean TVG as follows: quartile 1 (n = 77), 0.9 ± 0.3 mm Hg; quartile 2 (n = 115), 1.8 ± 0.3 mm Hg; quartile 3 (n = 65), 2.8 ± 0.3 mm Hg; and quartile 4 (n = 51), 4.7 ± 2.0 mm Hg. The baseline TVG and the number of implanted clips were associated with a higher post-TEER TVG. There was no significant difference across TVG quartiles in the 1-year composite endpoint (quartiles 1-4: 35%, 30%, 40%, and 34%, respectively; P = 0.60) or the proportion of patients in New York Heart Association class III to IV at the last follow-up (P = 0.63). The results were similar after adjustment for clinical and echocardiographic characteristics (composite endpoint quartile 4 vs quartile 1-quartile 3 adjusted HR: 1.05; 95% CI: 0.52-2.12; P = 0.88) or exploring post-TEER TVG as a continuous variable. CONCLUSIONS: In this retrospective analysis of the TriValve registry, an increased discharge TVG was not significantly associated with adverse outcomes after tricuspid TEER. These findings apply for the explored TVG range and up to the 1-year follow-up. Further investigations on higher gradients and longer follow-up are needed to better guide the intraprocedural decision-making process.