Table 4.
Analysis of the effectiveness and complications of TLE.
| Groups of patients | Implantation ages 19–29 | I Implantation and TLE ages 40–80 | A vs. B | ||
|---|---|---|---|---|---|
| A | B | Mann–Whitney U test, Chi2 P |
|||
| Number of patients | 126 | 2659 | |||
| Data for analysis | Count/average | %/SD | Count/average | %/SD | |
| Organizational model of TLE procedure | |||||
| Procedure in cardiac surg. operating room or hybrid room | 70 | 55.55% | 1254 | 47.16% | P = 0.080 |
| Cardiac surgeon as co-operator | 72 | 57.10% | 1262 | 47.46% | P = 0.042 |
| General anesthesia | 64 | 57.10% | 1162 | 43.70% | P = 0.140 |
| Routine TEE monitoring of lead extraction | 59 | 46.80% | 1022 | 38.44% | P = 0.073 |
| Complete radiographic result (only X-ray) | 113 | 89.68% | 2564 | 96.43% | P < 0.001 |
| Partial radiographic result (retained tip of lead) | 5 | 3.97% | 50 | 1.88% | P = 0.202 |
| Partial radiographic result (retained < 4 cm lead fragment) | 7 | 5.56% | 40 | 1.50% | P = 0.003 |
| Lack of radiographic result | 1 | 0.79% | 5 | 0.19% | P = 0.653 |
| Major complications | |||||
| Major complications (all) | 9 | 7.10% | 54 | 2.03% | P < 0.001 |
| Dwell time of extracted lead < 5 years | 0/16 | 0.00% | 6/1036 | 0.579% | P = 0.072 |
| Dwell time of extracted lead 5–9 years | 0/31 | 0.00% | 9/937 | 0.961% | P = 0.384 |
| Dwell time of extracted lead ≥ 10 years | 9/79 | 11.39% | 39/686 | 5.69% | P = 0.083 |
| Hemopericardium | 6 | 4.76% | 35 | 1.32% | P = 0.006 |
| Tricuspid valve damage during TLE (severe) | 4 | 3.14% | 9 | 0.34% | P < 0.001 |
| Other major complications | 0 | 0.00% | 10 | 0.38% | P = 0.572 |
| Rescue cardiac surgery | 4 | 3.17% | 33 | 1.24% | P = 0.150 |
| Minor complications (any) | 16 | 12.70% | 201 | 7.56% | P = 0.053 |
| Procedure-related death (intra-, post-procedural) | 0 | 0.00% | 6 | 0.23% | P = 0.653 |
| Indication-related death (intra-, post-procedural | 0 | 0.00% | 1 | 0.08% | P = 0.876 |
| Radiographic success | |||||
| Complete radiographic success (all material removed) | 109 | 86.51% | 2545 | 95.71% | P < 0.001 |
| Dwell time of extracted lead < 5 years | 16/16 | 100.0% | 1021/1036 | 98.55% | P = 0.564 |
| Dwell time of extracted lead 5–9 years | 30/31 | 96.77% | 904/937 | 96.48% | P = 0.684 |
| Dwell time of extracted lead ≥ 10 years | 63/79 | 79.75% | 620/686 | 90.38% | P = 0.007 |
| Partial radiographic success (retained tip or < 4 cm lead fragment) | 13 | 10.32% | 80 | 3.01% | P < 0.001 |
| Lack of radiographic success (retained lead) | 4 | 3.17% | 34 | 1.28% | P = 0.004 |
| Clinical success | |||||
| Clinical success | 118 | 93.20% | 2611 | 98.12% | P = 0.378 |
| Dwell time of extracted lead < 5 years | 16/16 | 100.0% | 1031/1036 | 99.52% | P = 0.121 |
| Dwell time of extracted lead 5–9 years | 31/31 | 100.0% | 926/937 | 98.83% | P = 0.893 |
| Dwell time of extracted lead ≥ 10 years | 71/79 | 89.87% | 654/686 | 95.33% | P = 0.072 |
| Lack of complete radiographic success in infectious cases | 4 | 3.17% | 28 | 1.28% | P = 0.973 |
| TV damage | 4 | 3.17% | 9 | 0.34% | P < 0.001 |
| Complication—death | 0 | 0.00% | 7 | 0.26% | P = 0.739 |
| Planned cardiac surgery | 0 | 0.00% | 4 | 0.15% | P = 0.175 |
| Procedural success | |||||
| Procedural success | 109 | 86.51% | 2545 | 95.71% | P < 0.001 |
| Dwell time of extracted lead < 5 years | 16/16 | 100.0% | 1021/1036 | 98.55% | P = 0.564 |
| Dwell time of extracted lead 5–9 years | 30/31 | 96.77% | 904/937 | 96.48% | P = 0.684 |
| Dwell time of extracted lead ≥ 10 years | 63/79 | 79.75% | 620/686 | 90.38% | P = 0.007 |
| Lack of complete radiographic success | 13 | 10.32% | 114 | 3.65% | P < 0.001 |
| Permanently disabling complication or death | 4 | 3.178% | 18 | 0.68% | 0. 023 |
| ECHO before and after TLE | |||||
| Tricuspid regurgitation before TLE: moderate/severe | 7 | 5.56% | 362 | 13.61% | P = 0.013 |
| Tricuspid regurgitation before TLE: severe | 2 | 1.59% | 89 | 3.35% | P = 0.407 |
| TLE related TV dysfunction (damage) | |||||
| TR increase by 2 grades | 9 | 7.14% | 40 | 1.50% | P < 0.001 |
| TR increase by 3 grades | 2 | 1.59% | 9 | 0.34% | P = 0.145 |
TEE transesophageal echocardiography, TLE transvenous lead extraction, TV tricuspid valve, TR tricuspid regurgitation.