Complications After Cardiac Device Implantations
Complications After Cardiac Device Implantations
A total of 5942 patients underwent a CIED procedure during the study period. Patients with epicardial systems were excluded (n = 24). The final study population consisted of 5918 consecutive patients.
The majority of patients underwent new CIED implants ( Table 1 , see Supplementary Material Online, Table S1 ). Median age at implantation was 74 years (interquartile range: 65–83).
In the two groups with centre volume <500 procedures (non-university centres), only PM procedures were performed. In the third group (500–749 procedures), 53% of procedures were CRT-P, ICD, or CRT-D procedures, and in the highest volume centres (>750 procedures), 40% were CRT-P, ICD, or CRT-D procedures. During the study period, 68 physicians performed CIED procedures. Emergency procedures involved new implant of single or dual-chamber PMs.
A total of 9.5% of all patients experienced at least one complication ( Table 2 ), while 33 patients (0.6%) had more than one. Lead-related re-intervention was the single most common complication (2.4%). System upgrades or lead revisions had higher overall complication risk primarily because of infection (P = 0.001), and pocket revision due to pain (P < 0.001). The risk of infection was higher in generator replacement procedures compared with first implants (P = 0.001).
Women had higher risk of pneumothorax (2.2 vs. 1.1%, P = 0.02), and cardiac perforation (1.1 vs. 0.4%, P < 0.001). Risk of pneumothorax increased with decreasing BMI from 0.8% in overweight or obese, 2.3% in normal weight, to 5.5% in underweight patients (P < 0.001). Furthermore, minor haematomas were more frequent in underweight than in normal weight patients (4.9 vs. 2.3%, P = 0.001). Patients older than 80 years had lower risk of any lead-related re-intervention (1.0 vs. 3.1%, P = 0.001) compared with patients who were 60–79 years of age. Centres with <750 annual procedures had higher complication risks with no predisposition to any specific complication. In dual-chamber ICD and CRT-D procedures, higher complication risks were observed compared with dual-chamber PM procedures, primarily lead-related re-interventions (dual-chamber ICD: 3.6 vs. 2.3%, P = 0.001; CRT-D: 4.7 vs. 2.3%, P = 0.001). Low volume operators (<50 annual procedures) had higher complication risks overall. Particularly, their risks of cardiac perforation (1.4 vs. 0.5%, P = 0.04), infection (1.7 vs. 0.5%, P = 0.02), and minor haematoma (4.3 vs. 1.9%, P = 0.005) were higher compared with higher volume operators. Emergency, out-of-hours procedures had higher risk of cardiac perforation (2.3 vs. 0.6%, P = 0.003).
Large differences in risk of any complication were observed between device and procedure types (Figure 1).
(Enlarge Image)
Figure 1.
Risk of any complication according to procedure and CIED type (with 95% CI).
The risk of right ventricular lead complications resulting in re-intervention was 1.2% after PM and CRT-P procedures, and 2.4% after ICD and CRT-D procedures. The risk of atrial lead complications was 1.2% (PM/CRT-P), and 1.3% (ICD/CRT-D), and the risk of left ventricular lead complications was 2.9% (CRT-P), and 1.8% (CRT-D).
In multivariate analyses, increased risk of any complication was seen if the patient was a female, underweight, implanted in a centre with an annual volume <750 procedures, had a dual-chamber ICD or CRT-D implanted, underwent a system upgrade or lead revision, had an operator with an annual volume <50 procedures, or underwent an emergency, out-of-hours procedure (Figure 2). Decreased risk was present in patients older than 80 years, or receiving a generator replacement. These trends in predictor associations were also observed for the occurrence of any major or minor complication, although the strength of associations varied ( Table 3 ).
(Enlarge Image)
Figure 2.
Predictors of any complication.
The risk of re-intervention due to right ventricular lead complications was higher in ICD and CRT-D procedures (i.e. high-voltage leads) compared with pacing leads, aRR 3.2; 95% CI 1.7–5.8, P < 0.001.
A total of 327 patients (5.5%) died within the first 6 months. One death was possibly procedure-related; a patient, who had severe chronic obstructive pulmonary disease, was discharged from hospital with an unrecognized minor pneumothorax, and died few days later because of an unknown cause. There was no indication that any other patients died from procedure-related complications. Ninety-day mortality was 3.2% (n = 187). Thirty-day mortality was 1.4% (n = 81). In-hospital mortality was 0.1% (n = 7).
In multivariate analysis, a higher 6-month mortality was observed in patients older than 80 years (aRR 2.2), underweight (aRR 2.3), or receiving a single-chamber ventricular PM (aRR 2.4).
Results
Study Population
A total of 5942 patients underwent a CIED procedure during the study period. Patients with epicardial systems were excluded (n = 24). The final study population consisted of 5918 consecutive patients.
Patient and Procedural Characteristics
The majority of patients underwent new CIED implants ( Table 1 , see Supplementary Material Online, Table S1 ). Median age at implantation was 74 years (interquartile range: 65–83).
In the two groups with centre volume <500 procedures (non-university centres), only PM procedures were performed. In the third group (500–749 procedures), 53% of procedures were CRT-P, ICD, or CRT-D procedures, and in the highest volume centres (>750 procedures), 40% were CRT-P, ICD, or CRT-D procedures. During the study period, 68 physicians performed CIED procedures. Emergency procedures involved new implant of single or dual-chamber PMs.
Complication Risk
A total of 9.5% of all patients experienced at least one complication ( Table 2 ), while 33 patients (0.6%) had more than one. Lead-related re-intervention was the single most common complication (2.4%). System upgrades or lead revisions had higher overall complication risk primarily because of infection (P = 0.001), and pocket revision due to pain (P < 0.001). The risk of infection was higher in generator replacement procedures compared with first implants (P = 0.001).
Women had higher risk of pneumothorax (2.2 vs. 1.1%, P = 0.02), and cardiac perforation (1.1 vs. 0.4%, P < 0.001). Risk of pneumothorax increased with decreasing BMI from 0.8% in overweight or obese, 2.3% in normal weight, to 5.5% in underweight patients (P < 0.001). Furthermore, minor haematomas were more frequent in underweight than in normal weight patients (4.9 vs. 2.3%, P = 0.001). Patients older than 80 years had lower risk of any lead-related re-intervention (1.0 vs. 3.1%, P = 0.001) compared with patients who were 60–79 years of age. Centres with <750 annual procedures had higher complication risks with no predisposition to any specific complication. In dual-chamber ICD and CRT-D procedures, higher complication risks were observed compared with dual-chamber PM procedures, primarily lead-related re-interventions (dual-chamber ICD: 3.6 vs. 2.3%, P = 0.001; CRT-D: 4.7 vs. 2.3%, P = 0.001). Low volume operators (<50 annual procedures) had higher complication risks overall. Particularly, their risks of cardiac perforation (1.4 vs. 0.5%, P = 0.04), infection (1.7 vs. 0.5%, P = 0.02), and minor haematoma (4.3 vs. 1.9%, P = 0.005) were higher compared with higher volume operators. Emergency, out-of-hours procedures had higher risk of cardiac perforation (2.3 vs. 0.6%, P = 0.003).
Large differences in risk of any complication were observed between device and procedure types (Figure 1).
(Enlarge Image)
Figure 1.
Risk of any complication according to procedure and CIED type (with 95% CI).
The risk of right ventricular lead complications resulting in re-intervention was 1.2% after PM and CRT-P procedures, and 2.4% after ICD and CRT-D procedures. The risk of atrial lead complications was 1.2% (PM/CRT-P), and 1.3% (ICD/CRT-D), and the risk of left ventricular lead complications was 2.9% (CRT-P), and 1.8% (CRT-D).
Predictors
In multivariate analyses, increased risk of any complication was seen if the patient was a female, underweight, implanted in a centre with an annual volume <750 procedures, had a dual-chamber ICD or CRT-D implanted, underwent a system upgrade or lead revision, had an operator with an annual volume <50 procedures, or underwent an emergency, out-of-hours procedure (Figure 2). Decreased risk was present in patients older than 80 years, or receiving a generator replacement. These trends in predictor associations were also observed for the occurrence of any major or minor complication, although the strength of associations varied ( Table 3 ).
(Enlarge Image)
Figure 2.
Predictors of any complication.
The risk of re-intervention due to right ventricular lead complications was higher in ICD and CRT-D procedures (i.e. high-voltage leads) compared with pacing leads, aRR 3.2; 95% CI 1.7–5.8, P < 0.001.
Mortality
A total of 327 patients (5.5%) died within the first 6 months. One death was possibly procedure-related; a patient, who had severe chronic obstructive pulmonary disease, was discharged from hospital with an unrecognized minor pneumothorax, and died few days later because of an unknown cause. There was no indication that any other patients died from procedure-related complications. Ninety-day mortality was 3.2% (n = 187). Thirty-day mortality was 1.4% (n = 81). In-hospital mortality was 0.1% (n = 7).
In multivariate analysis, a higher 6-month mortality was observed in patients older than 80 years (aRR 2.2), underweight (aRR 2.3), or receiving a single-chamber ventricular PM (aRR 2.4).
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