Cardiac resynchronization therapy complications
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- Bleeding and Hematomas: The incidence in clinical trials is 2.4%; in routine clinical practice, the actual incidence of pocket hematomas is probably higher as the trials only reported those hematomas, which needed surgical intervention. It is important to note that early re-intervention of pocket hematomas is associated with a 15-fold increase in infection.
- Lead dislodgement. (CRT trials demonstrated a rate verying from 2.9% to 10.6%; the MIRACLE-ICD study demonstrated a higher occurence of lead dislodgement with left ventricular lead than right atrial and right ventricular leads-6.8%, 15 and 0.6% respectively).
- Pneumothorax (0.9% in CRT trials, Medicare registry reported 1.2%),
- Myocardial injury
- Coronary sinus dissection (1.3%) or perforation (1.3%)(complication rate related to coronary veins has been reported in 2%)
- Pericardial tamponade.
- Pocket erosion
- Lead fracture
- Inappropriate phrenic nerve stimulation: Given the proximity of the posterior wall of the left ventricle to the phrenic nerve, there remains the risk of inappropriate phrenic nerve stimulation.
For CRT patients, the average in-hospital mortality is 0.3% and the 30 day mortality is 0.7%. Reynolds et al. showed a 1.1% in-hospital mortality in 30,984 Medicare patients undergoing CRT. This disparity in the in-hospital mortality rates can be explained by the strict inclusion criteria of the trials, where the selected patients are healthier than the unselected patients in clinical practice.
- Klug D, Balde M, Pavin D, Hidden-Lucet F, Clementy J, Sadoul N; et al. (2007). "Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study". Circulation. 116 (12): 1349–55. doi:10.1161/CIRCULATIONAHA.106.678664. PMID 17724263.
- Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B; et al. (2003). "Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial". JAMA. 289 (20): 2685–94. doi:10.1001/jama.289.20.2685. PMID 12771115.
- Reynolds MR, Cohen DJ, Kugelmass AD, Brown PP, Becker ER, Culler SD; et al. (2006). "The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators". J Am Coll Cardiol. 47 (12): 2493–7. doi:10.1016/j.jacc.2006.02.049. PMC 1800827. PMID 16781379.
- van Rees JB, de Bie MK, Thijssen J, Borleffs CJ, Schalij MJ, van Erven L (2011). "Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices a systematic review of randomized clinical trials". J Am Coll Cardiol. 58 (10): 995–1000. doi:10.1016/j.jacc.2011.06.007. PMID 21867832.