Adult Congenital Heart Disease
Conditions
Keywords
Adult congenital heart disease, Cardiac resynchronization therapy, ACHD, CRT, Heart failure, HF
Brief summary
This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD). Specifically, it seeks to determine whether CRT improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.
Detailed description
Cardiac resynchronization therapy (CRT) is well-established in acquired heart failure, but evidence in ACHD remains limited. Current guidelines, extrapolated from non-congenital populations, may not fully address the anatomical and electrophysiological complexities in ACHD. This retrospective cohort study aims to investigate the real-world efficacy and safety of CRT in adult patients with congenital heart disease (ACHD). The study includes consecutive ACHD patients who underwent either de novo CRT implantation or upgrade procedures, starting from January 2014. The primary objectives are to evaluate changes in QRS duration, systemic ventricular function, and New York Heart Association (NYHA) functional class. The study aims to further examine the impact of CRT in specific ACHD subgroups, including patients with systemic right ventricles (vs. systemic left ventricles), those with non-left bundle branch block (non-LBBB) morphology (vs. LBBB), and those with upgrade procedures (vs. de novo implants). Data collection is based on retrospective review of electronic health records, including patient demographics, clinical characteristics, device-related procedural details, and follow-up data. Outcomes are assessed using standardized echocardiographic and electrocardiographic measurements, alongside clinical evaluations. The study aims to provide comprehensive real-world insights into the efficacy and safety of CRT in the diverse ACHD population and to identify predictors of favorable response, ultimately supporting more individualized decision-making in this complex patient group.
Interventions
DEVICECardiac resynchronization therapy
Cardiac resynchronization therapy pacemaker or defibrillator with a transvenous or epicardial systemic ventricle lead
Sponsors
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ACHD patients who underwent CRT implantation
Exclusion criteria
* Less than 18 years old on the moment of CRT implantation * Patient objection to the use of retrospective data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS duration | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the duration (in ms) of the QRS interval on surface ECG |
| Systemic ventricle function class | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the echocardiographic functional classification of the systemic ventricle (i.e., normal, mildly reduced, moderately reduced, severely reduced) |
| NYHA functional class | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the NYHA functional classification (i.e., Class I, II, III, IV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical - Urgent heart failure visit | From enrollment through study completion, with an average follow-up duration of 1 year. | An unplanned medical contact requiring decongestion, but no overnight stay in the hospital |
| Clinical - Urgent CV visit other than HF | From enrollment through study completion, with an average follow-up duration of 1 year. | An unplanned medical contact due to any primary cardiovascular reason, excluding heart failure and without overnight stay in the hospital |
| Clinical - Enlisting for LVAD | From enrollment through study completion, with an average follow-up duration of 1 year. | Enlisting for left ventricular assist device (LVAD) implantation during the study period |
| Clinical - Enlisting for HTX | One year after implantation | Enlisting for heart transplantation (HTX) during the study period. |
| Clinical - Periprocedurel complications | From enrollment through study completion, with an average follow-up duration of 1 year. | Any complications occurring during or immediately after the procedure, including but not limited to pneumothorax, infection, bleeding, lead dislodgement, and arrhythmic events. |
| CIED-related - Threshold systemic ventricular lead | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal change of the minimum pacing threshold required for consistent ventricular capture, measured in volts (V) at a specific pulse width (ms) |
| CIED-related - Impedance systemic ventricular lead | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal change of the systemic ventricular lead impedance, measured in ohms (Ω), reflecting the integrity of the pacing system and lead-tissue interface. |
| CIED-related - R-wave sensing systemic ventricular lead | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal change of the R-wave amplitude of the systemic ventricular lead, measured in millivolts (mV), indicating the ability of the system to correctly sense the ventricular depolarization |
| CIED-related - ICD therapy | From enrollment through study completion, with an average follow-up duration of 1 year. | Incidence of (in)appropriate ICD therapies, including shock or antitachycardia pacing |
| Medication - GDMT use | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal change in the use of guideline-directed medical therapy (GDMT) for heart failure, including RAAS inhibitors (ACEi/ARB/ARNI), mineralocorticoid receptor antagonists (MRA), beta-blockers (BB), diuretics, and SGLT2 inhibitors (SGLT2i). |
| Clinical parameter - weight | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on weight (kg) |
| Clinical parameter - systolic blood pressure | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on systolic blood pressure (mmHg) |
| Clinical - Mortality | From enrollment through study completion, with an average follow-up duration of 1 year. | Death from any cause during the study period |
| Clinical parameter - heart rate | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on heart rate (beats per minute) |
| Echocardiographic parameter - subpulmonary ventricle function class | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the echocardiographic functional classification of the subpulmonary ventricle (i.e., normal, mildly reduced, moderately reduced, severely reduced) |
| Laboratory parameter - sodium | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on serum sodium (mmol/L) |
| Laboratory parameter - creatinine | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on serum creatinine (μmol/L) |
| Laboratory parameter - eGFR | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on estimated glomerular filtration rate (eGFR, ml/min/1.73m2) |
| Laboratory parameter - NT-proBNP | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on serum NT-proBNP (ng/L) |
| Laboratory parameter - hs-TnT | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on serum high-sensitivity troponin T concentrations (ng/L) |
| Echocardiographic parameter - SAVV regurgitant grade | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the regurgitant grade of the systemic atrioventricular valve, classified as grade I, II, III, or IV. |
| Echocardiographic parameter - PAVV regurgitant grade | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on the regurgitant grade of the pulmonary atrioventricular valve, classified as grade I, II, III, or IV. |
| Echocardiographic parameter - sPAP | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on systolic pulmonary artery pressure (sPAP), estimated by echocardiography. |
| Echocardiographic parameter - IVC diameter | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on inferior vena cava diameter and its collapsibility during respiration, as assessed by echocardiography. |
| Clinical parameter - diastolic blood pressure | From enrollment through study completion, with an average follow-up duration of 1 year. | Evaluation of the longitudinal effect of CRT on diastolic blood pressure (mmHg) |
| Clinical - Heart failure hospitalization | From enrollment through study completion, with an average follow-up duration of 1 year. | At least one overnight stay with cardiac decompensation as the primary reason for hospitalization |
| Clinical - CV hospitalization other than HF | From enrollment through study completion, with an average follow-up duration of 1 year. | At least one overnight stay due to any primary cardiovascular reason, excluding heart failure |
Countries
Netherlands
Contacts
Primary ContactAnastasia D. Egorova, MD, PhD
Outcome results
None listed