Procedural outcome & risk prediction in young patients undergoing transvenous lead extraction-a GALLERY subgroup analysis.

Background: The prevalence of young patients with cardiac implantable electronic devices (CIED) is steadily increasing, accompanied by a rise in the occurrence of complications related to CIEDs. Consequently, transvenous lead extraction (TLE) has become a crucial treatment approach for such individuals. Objective: The purpose of this study was to examine the characteristics and procedural outcomes of young patients who undergo TLE, with a specific focus on identifying independent risk factors associated with adverse events. Methods: All patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) were categorized into two groups based on their age at the time of enrollment: 45 years or younger, and over 45 years. A subgroup analysis was conducted specifically for the younger population. In this analysis, predictor variables for all-cause mortality, procedural complications, and procedural failure were evaluated using multivariable analyses. Results: We identified 160 patients aged 45 years or younger with a mean age of 35.3 ± 7.6 years and 42.5% (n = 68) female patients. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2 ± 1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. The all-cause in-hospital mortality rate was 2.5%, with septic shock identified as the primary cause of mortality. Multivariable analysis revealed CKD (OR: 19.0; 95% CI: 1.84-194.9; p = 0.018) and systemic infection (OR: 12.7; 95% CI: 1.14-142.8; p = 0.039) as independent predictor for all-cause mortality. Lead age ≥ 10 years (OR: 14.58, 95% CI: 1.36-156.2; p = 0.027) was identified as sole independent risk factor for procedural complication. Conclusion: TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.

Laser lead extraction in octo- and nonagenarians. A subgroup analysis from the GALLERY registry.

INTRODUCTION: In an aging population with cardiac implantable electronic devices, an increasing number of octo- and even nonagenarians present for lead extraction procedures. Those patients are considered at increased risk for surgical procedures including lead extraction. Here, we investigated safety and efficacy of transvenous lead extraction in a large patient cohort of octo- and nonagenarians. METHODS AND RESULTS: A subgroup analysis of all patients aged ≥80 years (n = 499) in the German Laser Lead Extraction Registry (GALLERY) was performed. Outcomes were compared to the nonoctogenarians from the registry. Primary extraction method was Laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. An analysis of patient- and device characteristics, as well as an assessment of predictors for adverse events via multivariate analyses was conducted. Mean patients age was 84.3 ± 3.7 years in the octogenarians group and 64.1 ± 12.4 years in the nonoctogenarians group. The median lead dwell time was 118.0 months (78; 167) and 92.0 months [60; 133], p < .001 in the octogenarians and nonoctogenarians group, respectively. Clinical procedural success rate was achieved in 97.6% of the cases in octogenarians and 97.9% in nonoctogenarians (p = .70). Overall complication rate was 4.4% in octogenarians and 4.3% in nonoctogenarians (0.91). In octogenarians procedure-related mortality was 0.8% and all-cause in-hospital mortality was 5.4%, while in nonoctogenarians, procedure related and all-cause in-hospital mortality were 0.5% and 3.1%, respectively. A body mass index (BMI) <20 kg/m2 , was the only statistically significant predictor for procedure-related complications in octogenarians, while systemic infection, BMI ≤20 kg/m2 , procedural complications and chronic kidney disease were predictors for in-hospital mortality. CONCLUSIONS: Laser lead extraction in octo- and nonagenarians is safe and effective. BMI ≤20 kg/m2 was the only statistically significant predictor for procedural complications. According to our data, advanced age should not be considered as contraindication for laser lead extraction.

The GermAn Laser Lead Extraction RegistrY: GALLERY.

AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Transplantation of bone marrow stem cells during cardiac surgery.

BACKGROUND: This systematic review with meta-analysis sought to determine the efficacy and safety of intramyocardial transplantation of bone marrow stem cells during coronary artery bypass graft surgery on postoperative cardiac functional parameters such as left ventricular ejection fraction and left ventricular end-diastolic volume. METHODS: Medline/PubMed, Embase, Elsevier, Sciences online database, and Google Scholar literature search were searched. The effect sizes measured were risk ratio for categorical variables and weighted mean difference with 95% confidence interval for calculating differences between mean values of baseline and follow-up cardiac functional parameters. A value of p < 0.1 for Q test, or I(2 )> 50%, indicated significant heterogeneity among studies. The literature search retrieved 2900 studies from screened databases, of which 2866 (98.6%) were excluded and 34 (619 patients) were included for scoping review. The final analysis included 9 studies (335 patients). RESULTS: Pooled effects estimates of left ventricular ejection fraction and left ventricular end-diastolic volume showed that bone marrow stem cell transplantation had a weighted mean difference of 4.06 (95% confidence interval: 0.41-7.72; p = 0.02) and 7.06 (95% confidence interval: -8.58-22.7; p = 0.3), respectively. CONCLUSIONS: Intramyocardial transplantation of bone marrow stem cells improves cardiac functional parameters, significantly increasing left ventricular ejection fraction with a nonsignificant reduction in left ventricular end-diastolic volume. Also, this therapeutic method has no life-threatening complications and was therefore found to be an effective and safe method.

Posterior pericardiotomy in cardiac surgery: systematic review and meta-analysis.

This systematic review with meta-analysis sought to determine the impact of posterior pericardiotomy on incidences of atrial fibrillation and supraventricular arrhythmias, pericardial effusion, pleural effusion, tamponade, and the length of hospital stay after cardiac surgery. We searched for randomized controlled trials, using Medline, Embase, Elsevier and Sciences online databases as well as Google Scholar literature. The effect sizes measured were odds ratio for categorical variables and standard mean difference with 95% confidence interval for calculating differences between mean values of hospital stay in intervention and control groups. A value of p < 0.1 for Q test or I(2 )> 50% indicated significant heterogeneity between the studies. The literature search of all major databases retrieved 20 studies. After screening, 12 suitable trials were identified, which reported outcomes of 2052 patients undergoing cardiac surgery. Posterior pericardiotomy had an odds ratio of 0.33 [95% confidence interval: 0.18-0.61] p < 0.001 for atrial fibrillation; odds ratio 0.32 [0.15-0.67] p = 0.003 for supraventricular arrhythmias; odds ratio 0.09 [0.04-0.19] p = 0.000 for early pericardial effusion and odds ratio 0.04 [0.02-0.08] p < 0.001 for late pericardial effusion; odds ratio 1.64 [1.23-2.20] p = 0.001 for pleural effusion, odds ratio 0.07 [0.02-0.27] p < 0.001 for tamponade, and standard mean difference = 0.01 [-0.12 to 0.14] p = 0.8 for hospital stay. Posterior pericardiotomy is a simple intraoperative technique that can improve postoperative clinical outcomes. However, the incidence of pleural effusion associated with posterior pericardiotomy might be higher.

Should the integrity of the pleura during internal mammary artery harvesting be preserved?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether preservation of the pleura during internal mammary artery (IMA) harvesting improved clinical outcomes after coronary artery bypass graft surgery. More than 210 papers were found using the reported search, of which 18 presented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studies, relevant outcomes, results and study weakness of these papers are tabulated. Most studies dealt with investigating the radiographic changes, pulmonary function tests, ventilation time and also clinical consequences, such as bleeding, the need for blood transfusion, pain scores and the length of hospital stay. There is still no meta-analysis and systematic review regarding this surgical problem. Eighteen articles were found, of which 6 were prospective randomized, controlled trials and 12 were cohort studies. In these studies, some beneficial clinical outcomes were reported including: pleural effusion (15 studies), atelectasis (11 studies), pulmonary function tests (9 studies), arterial blood gases (5 studies), postoperative pain (6 studies), tamponade (2 studies), ventilation time (12 studies with), blood loss (9 studies), transfusion (4 studies), intensive care unit stay (5 studies) and hospital stay (12 studies). Based on our findings, preservation of pleural integrity seems to contribute to decreased pulmonary complications and improved clinical outcomes, such as bleeding, pain and length of hospital stay.