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Left ventricular lead implantation failure in an unselected nationwide cohort
Daniel J Friedman1, Li Qin2, James V Freeman2
1Electrophysiology Section, Duke University Hospital, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.
Insights
Left ventricular lead implant failure in cardiac resynchronization therapy is uncommon, with coronary sinus access issues being the main cause. Younger age, female sex, minority race/ethnicity, and lack of specialized training are key predictors.
Area of Science:
- Cardiology
- Medical Devices
- Electrophysiology
Background:
- Left ventricular (LV) lead implantation is a critical and challenging step in cardiac resynchronization therapy (CRT).
- Early studies indicated significant LV lead implant failure rates, around 10%.
Purpose of the Study:
- To determine the incidence, causes, and independent predictors of LV lead implant failure.
- To analyze factors associated with successful CRT lead placement.
Main Methods:
- Analysis of over 111,000 patients undergoing planned CRT from 2010-2016, using the National Cardiovascular Data Registry ICD Registry.
- Logistic regression was employed to identify independent predictors of LV lead implant failure.
Main Results:
- LV lead implant failure occurred in 3.6% of patients, with coronary sinus access failure being the most frequent reason (64.3%).
- Independent predictors included younger age, female sex, Black race, Hispanic ethnicity, longer QRS duration, obstructive sleep apnea, and non-electrophysiology-trained implanters.
Conclusions:
- LV lead implant failure is now infrequent, primarily due to challenges with coronary sinus access.
- Identifying patient and procedural factors can help optimize CRT lead implantation success rates.
Background:
Left ventricular (LV) lead implantation is often the most challenging aspect of cardiac resynchronization therapy (CRT) procedures; early studies reported implant failure rates in ∼10% of cases.
Objective:
The purpose of this study was to define rates, reasons for, and factors independently associated with LV lead implant failure.
Methods:
We studied patients with left bundle branch block and ejection fraction ≤ 35% who underwent planned de novo transvenous CRT implantation (2010-2016) and were reported to the National Cardiovascular Data Registry ICD Registry. Independent predictors of LV lead implant failure were determined using logistic regression; age, sex, and variables with a univariable P value of <.15 were considered for inclusion in the model.
Results:
Of the 111,802 patients who underwent a planned CRT procedure, 3.6% of patients (n = 3979) had LV lead implant failure. Reasons for implant failure included venous access (7.5%), coronary sinus access (64.3%), tributary vein access (13.5%), coronary sinus dissection (7.6%), unacceptable threshold (4.4%), and diaphragmatic stimulation (1.7%). Significant independent predictors of LV lead implant failure included younger age (odds ratio [OR] 1.01; 95% confidence interval [CI] 0.1.01-1.02), female sex (OR 1.38; 95% CI 1.29-1.47), black race (vs white, OR 1.44; 95% CI 1.32-1.57), Hispanic ethnicity (OR 1.23; 95% CI 1.08-1.40), QRS duration (OR 1.055 per 10 ms; 95% CI 1.038-1.072 per 10 ms), obstructive sleep apnea (OR 1.14; 95% CI 1.04-1.24), and implantation by a physician without specialized training (vs electrophysiology trained, OR 1.53; 95% CI 1.34-1.76).
Conclusion:
LV lead implant failure is uncommon in the current era and is most commonly due to coronary sinus access failure. Predictors of LV lead implant failure included younger age, female sex, black race, Hispanic ethnicity, increased QRS duration, sleep apnea, and absence of electrophysiology training.
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