Is interventional technique better than the traditional over-the-wire method for left ventricular lead implantation in cardiac resynchronization therapy?

Background: Interventional cardiac resynchronization therapy (I-CRT) for left ventricular lead (LVL) placement works as a supplement to traditional (over-the-wire) cardiac resynchronization therapy (T-CRT). It has been argued that I-CRT is a time-consuming and complicated procedure. Objective: The purpose of this study was to investigate differences in procedure-related, perioperative, postoperative, and clinical endpoints between I-CRT and T-CRT. Methods: This single-center, retrospective, cohort study included all consecutive patients receiving a CRT-pacemaker/defibrillator between January 1, 2012, and August 31, 2018. Patients underwent T-CRT from January 1, 2012, to June 1, 2015, and I-CRT from January 1, 2016, to August 31, 2018. We obtained data from patient record files, fluoroscopic images, and the Danish Pacemaker and ICD Register. Data were analyzed using Wilcoxon rank-sum/linear regression for continuous variables and the Pearson χ2/Fisher exact for categorical variables. Results: Optimal LVL placement was achieved in 82.7% of the I-CRT group and 76.8% of the T-CRT group (P = .015). In the I-CRT group, 99.0% of LVLs were quadripolar vs 55.3% in the T-CRT group (P <.001). Two or more leads were used during the procedure in 0.7% and 10.5% of all cases in the I-CRT and T-CRT groups, respectively (P <.001). Total implantation time was 81.0 minutes in the I-CRT group and 83.0 minutes in the T-CRT group (P = .41). Time with catheters in the coronary sinus was 45.0 minutes for the I-CRT group vs 37.0 minutes in the T-CRT group, respectively (P <.001). Conclusion: I-CRT did not prolong total implantation time despite longer time with catheters in the coronary sinus. I-CRT allowed more optimal LVL placement, wider use of quadripolar leads, and use of fewer leads during the procedure.

Sympathicotomy for isolated facial blushing: long-term follow-up of a randomized trial.

OBJECTIVES: Thoracoscopic sympathicotomy may be an effective treatment for disabling facial blushing in selected patients. Short- and mid-term results are good but very long-term results are scarce in the medical literature and there is no knowledge which extent of sympathicotomy is better long-term for isolated facial blushing. METHODS: We previously randomized 100 patients between a rib-oriented R2 or R2-R3 sympathicotomy for isolated facial blushing, and reported local effects, side effects and quality of life after 12 months. In the present study, we sent identical questionnaires to all patients after a median of 16 years (interquartile range 15-17 years). RESULTS: The response rate was 66%. Overall, 82% reported excellent or satisfactory results on facial blushing, with significant better local effect after R2 sympathicotomy compared with R2-R3 sympathicotomy. Patients who underwent R2 sympathicotomy were also significantly more satisfied with the operation. We found no significant difference between R2 and R2-R3 sympathicotomy in quality of life or rates of compensatory sweating (77%) and recurrence of blushing (41%) which was milder than preoperatively in most patients. CONCLUSIONS: R2 sympathicotomy should be the preferred approach for isolated facial blushing because of better local effect and higher satisfaction rates. Although this was a very long-term follow-up of the only randomized trial of its kind the response rate was limited leaving a risk of undetected bias.

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

Cardiac surgery in patients with cardiac implantable electronic devices and risk of device infections: a nationwide nested case-control study.

PURPOSE: Cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) has been associated with a higher risk of infective endocarditis, but how it influences risk of CIED-specific infections is not known. Our aim was to examine risk of systemic CIED infections after cardiac surgery in patients with CIEDs. METHODS: Based on data obtained from Danish administrative registries and the Danish Pacemaker and ICD Register, we conducted a case-control study nested within a nationwide cohort of patients who underwent a de novo CIED implantation in Denmark between 1998 and 2017. We defined cases as incident systemic CIED infections resulting in device system extraction. Controls were sampled 1:100 on time, age, sex and device type using risk set sampling. Exposure was defined as coronary artery bypass graft, or cardiac heart valve replacement or repair surgery. RESULTS: From a study cohort comprising 67,621 patients, we identified 170 cases and 16,788 controls. In the minimally adjusted model, the incidence rate ratio (IRR) for systemic CIED infection was 6.4 (95% confidence interval (CI) 3.8-10.7) with cardiac surgery, and after additional confounder adjustment, 5.4 (95% CI 3.2-9.2). IRRs were higher with restriction to heart valve replacement surgery (adjusted IRR 7.5, 95% CI 4.0-16.6), and when limiting our exposure time window to one year (adjusted IRR 10.1, 95% CI 4.5-22.3). CONCLUSION: Cardiac surgery in patients with de novo CIEDs was associated with a high risk of systemic CIED infections. Highest risk was observed after heart valve replacement surgery and within the first year of surgery.

Risk factors for cardiac implantable electronic device infections: a nationwide Danish study.

AIMS: Cardiac implantable electronic device (CIED) infection is a severe complication to modern management of cardiac arrhythmias. The CIED type and the type of surgery are recognized as risk factors for CIED infections, but knowledge of patient-related risk factors is scarce. This study aimed to identify lifelong patient-related risk factors for CIED infections. METHODS AND RESULTS: Consecutive Danish patients undergoing a CIED implantation or reoperation between January 1996 and April 2018 were included. The cohort consisted of 84 429 patients undergoing 108 494 CIED surgeries with a combined follow-up of 458 257 CIED-years. A total of 1556 CIED explantations were classified as either pocket (n = 1022) or systemic CIED infection (n = 534). Data were cross-linked with records from the Danish National Patient Registry and the Danish National Prescription Registry. Using multiple-record and multiple-event per subject proportional hazard analysis, specific patient-related risk factors were identified but with several variations amongst the subtypes of CIED infection. CIED reoperations were associated with the highest risk of pocket CIED infection but also CIED type, young age, and prior valvular surgery [hazard ratio (HR): 1.62, 95% confidence interval (CI): 1.29-2.04]. Severe renal insufficiency/dialysis (HR: 2.40, 95% CI: 1.65-3.49), dermatitis (HR: 2.80, 95% CI: 1.92-4.05), and prior valvular surgery (HR: 2.09, 95% CI: 1.59-2.75) were associated with the highest risk of systemic CIED infections. Congestive heart failure, ischaemic heart disease, malignancy, chronic obstructive pulmonary disease, and temporary pacing were not significant at multivariate analysis. CONCLUSION: Specific comorbidities and surgical procedures were associated with a higher risk of CIED infections but with variations amongst pocket and systemic CIED infection. Pocket CIED infections were associated with CIED reoperations, young age and more complex type of CIED, whereas systemic CIED infections were associated with risk factors predisposing to bacteraemia.

Predictors of pocket hematoma after cardiac implantable electronic device surgery: A nationwide cohort study.

Purpose: Clinically significant pocket hematoma (CSH) is a common complication to cardiac implantable electronic device (CIED) surgery. We aimed to evaluate predictors of CSH after CIED surgery. Methods: We performed a nationwide population-based prospective cohort study with systematic patient chart review of all Danish patients undergoing CIED surgery during a 12-month period. Multiple logistic regression analysis was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals for association between predictors and CSH. Results: We included 5918 consecutive patients, 63% males, mean age 72.6 years. A total of 148 (2.5%) patients experienced CSH, including 10 patients (0.2%) requiring re-operation with hematoma evacuation. The risk of CSH was significantly increased in patients treated with aspirin (aOR 1.8; 1.2-2.7), aspirin and clopidogrel (aOR 3.9; 2.3-6.5), or heparin (aOR 2.1; 1.1-4.1), and in patients with INR≥2.0 (aOR 2.0; 1.2-3.2). Patients operated by low-volume operators (aOR 2.7; 1.6-4.6) or undergoing more complex CIED surgery such as cardiac resynchronization therapy (aOR 2.0; 1.1-3.5) or dual-chamber defibrillator (aOR 2.1; 1.2-3.8) also had significantly increased CSH risk. Conclusion: In a large nationwide cohort of consecutive patients undergoing CIED surgery, the risk of CSH was 2.5%, with 0.2% necessitating evacuation. CSH risk was increased both in patients receiving aspirin, dual antiplatelet therapy or continued vitamin K-antagonist therapy. Dual antiplatelet therapy had the highest risk (aOR) of CSH. Both low operator volume and more complex CIED surgery were independently associated with higher CSH risk. These data should be considered when planning CIED surgery.

Validation of the national Danish ablation database: a retrospective, registry-based validation study.

Aim.To validate the National Danish Ablation Database (NDAD) by investigating to what extent data in NDAD correspond to medical records.Type of study. Non-blinded, registry-based, retrospective, validation study. Material and methods. A sample of patients who underwent ablation for atrial fibrillation in Denmark between 1 January 2016 and 31 December 2016 were included. By utilizing medical records as gold standard, positive predictive (PPV) and negative predictive values (NPV) for NDAD were assessed and presented as five main categories: arrhythmia characteristics, demographics, cardiac history, complications, and medication. PPV's and NPV's exceeding 90% were considered as high agreement. Results. 597 patients (71.0% males) were included in the study. Median age was 63.1 (IQR: 54.9-68.4) years. The median PPV and NPV estimates across all variables were respectively 90.4% (95% CI: 68%-95.2%) (PPV) and 99.4% (95% CI: 98.4%-99.8%) (NPV) at baseline, and 91.7% (95% CI: 67.4%-95.4%) (PPV) and 99.3% (98.2%-99.3%) (NPV) at follow-up. Conclusion. The data registered in NDAD agrees to a great extent with the patients' medical records, suggesting NDAD is a database with high validity. As a result of low complication rate, the PPV- and NPV-estimates among complication variables were prone to somewhat greater uncertainty compared to the rest.

Lead complications after cardiac surgery in patients with cardiac implantable electronic devices.

OBJECTIVES: Manipulation of the heart during cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) may result in lead damage or displacement, but whether cardiac surgery truly infers an excess risk of lead failure is not known. The objective of this study was to examine the risk of lead complications after cardiac surgery in patients with CIEDs. METHODS: We conducted a nationwide nested case-control study. The source population comprised all Danish patients ≥18 of age who underwent a de novo CIED implantation during 1998-2017. For inclusion, patients had to be alive and event free 6 months after implantation. Cases were matched 1:30 to controls on time, age, sex, and device type using risk set sampling. We used conditional logistic regression to estimate incidence rate ratios (IRRs) for the association between cardiac surgery and lead-related reoperation. RESULTS: Our final population consisted of 67 621 patients. We identified 1437 (2.1%) incident cases of lead-related reoperations and 42 698 controls. Risk of lead complications was highest within 6 months of cardiac surgery [IRR 9.7, 95% confidence interval (CI) 6.3-14.8, adjusted IRR 9.6, 95% CI 6.2-14.7], and at 1 year, the relative risk of lead-related reoperation was close to unity (adjusted IRR 1.2, 95% CI 0.8-1.7). CONCLUSIONS: Cardiac surgery was associated with a considerable risk of lead complications in patients with de novo CIEDs.

Rate of permanent cardiac implantable electronic device infections after active fixation temporary transvenous pacing: A nationwide Danish cohort study.

BACKGROUND: Temporary transvenous pacing (TP) has been associated with an increased risk of cardiac implantable electronic device (CIED) infections, but there is little data to document this in contemporary populations. OBJECTIVE: To investigate the impact of active fixation TP on rate of CIED infections in a nationwide cohort of Danish patients. METHODS: We identified all patients who underwent a first-time CIED implantation between 2009 and 2017. Patients were categorized according to TP status at implantation and followed for 1 year. The primary outcome was local or systemic CIED infection resulting in device system removal. The secondary outcomes were systemic CIED infections and hospitalization for infective endocarditis (IE). RESULTS: We included a total of 40,601 CIED patients. A total of 2952 were treated with active fixation TP. The primary outcome was met in 246 patients. Risk of CIED infection at 1 year was 0.61% for patients not treated with TP and 0.65% for patients who were, HR of 1.28 (95% CI 0.80-2.05) and adjusted HR 0.85 (95% CI 0.51-1.42). More systemic CIED infections and IE hospitalizations occurred in TP patients; however, these differences did not persist after confounder adjustment. Cumulative mortality at 1 year was 16.8% in patients with TP vs 8.4% in patients without. CONCLUSION: Active fixation TP was not associated with a higher rate of CIED infections. Patients treated with TP had higher mortality, more systemic CIED infections, and more IE hospitalizations within first year of implantation. Most was attributable to an accumulation of risk factors for infection among TP patients.

Microbiological diagnosis in cardiac implantable electronic device infections detected by sonication and next-generation sequencing.

BACKGROUND: Device-related infection (DRI) is a severe complication of treatment with cardiac implantable electronic devices. Identification of the causative pathogen is essential for optimal treatment, but conventional methods often are inadequate. OBJECTIVE: The purpose of this study was to improve microbiological diagnosis in DRI using sonication and next-generation sequencing analysis. The primary objective was identification of causative pathogens. The secondary objective was estimation of the sensitivity of different microbiological methods in detecting the causative pathogen. METHODS: Consecutive patients with clinical signs of DRI between October 2016 and January 2019 from 3 tertiary centers in Denmark were included in the study. Patients underwent a diagnostic approach, including blood cultures and perioperative collection of microbiological samples (pocket swab, pocket tissue biopsies, generator, and leads). Conventional culturing was performed, and device components were sonicated and examined with an amplicon-based metagenomic analysis using next-generation sequencing. The results were compared with a reference standard-identified causative pathogen. RESULTS: In 110 patients with clinical signs of pocket (n = 50) or systemic DRI (n = 60), we collected 109 pocket swabs, 220 pocket tissue biopsies, 106 generators, 235 leads, and a minimum 1 set of blood cultures from 102 patients. Combining all findings, we identified the causative pathogen in 95% of cases, irrespective of DRI type. The usability of each microbiological method differed between DRI types. In pocket DRI, next-generation sequencing analysis of generators achieved sensitivity of 90%. For systemic DRI, blood cultures reached sensitivity of 93%. CONCLUSION: Using a strategy including sonication and next-generation sequencing, we identified the causative pathogen in 95% of DRI. Sensitivity of microbiological methods differed according to the type of DRI.

Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronization therapy reoperations.

AIMS: Cardiac resynchronization therapy (CRT) reoperations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope reduces the occurrence of DRIs in a broad population of moderate-tohigh-risk patients. To investigate the efficacy of an antibacterial envelope in a very high-risk population of patients undergoing CRT reoperation. METHODS AND RESULTS: In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator reoperation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to 2 years. A total of 1943 patients were included in the study of which 736 (38%) received an envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary endpoint of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group [4.1% vs. 2.3%, adjusted hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.021]. This difference persisted in propensity score analysis (HR 0.51, 95% CI 0.29-0.90; P = 0.019). CONCLUSION: Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT reoperations. Our results were comparable to those recently reported from a large randomized controlled trial, which is suggestive of a proportional effect of the envelope even in very high-risk patients.

Periprocedural complications and one-year outcomes after catheter ablation for treatment of atrial fibrillation in elderly patients: a nationwide Danish cohort study.

OBJECTIVES: To investigate complications within 30-days following first-time ablation for atrial fibrillation (AF), including a composite of cardiac tamponade, hematoma requiring intervention, stroke or death, in patients ≥ 75 years of age, compared to patients aged 65-74 years. In addition, one-year all-cause mortality and AF relapse were compared. METHODS & RESULTS: All patients receiving their first catheter ablation for AF between 2012 and 2016 were identified using Danish nationwide registries. Patients aged 65-74 years served as the reference group for patients ≥ 75 years. Relapse of AF within one year was defined as cardioversion following a three-month blanking period, re-ablation or confirmed relapse within follow-up. The composite complication outcome did not differ between the two age groups, with 39/1554 (2.8%) in patients 65-74 years of age, versus 5/199 (2.5%) in older patients (adjusted HR = 0.94), 95% CI: 0.37-2.39, P = 0.896). Patients ≥ 75 years or older had no increased hazard of death within 30 days after the procedure, with an incidence of 3/1554 (0.2%) in younger patients and 2/199 (1.0%) in patients ≥ 75 years of age (adjusted HR = 4.71, 95% CI: 0.78-28.40, P = 0.091). There was no difference in relapse of AF after one year between age groups (≥ 75 years adjusted HR = 1.00, 95% CI: 0.78-1.26, P = 0.969). CONCLUSION: In patients ≥ 75 years of age selected for catheter ablation for AF, the incidence of periprocedural complications, as well as one-year freedom from AF showed no statistical difference, when compared to patients 65-74 years of age.

New onset anxiety and depression in patients with an implantable cardioverter defibrillator during 24 months of follow-up (data from the national DEFIB-WOMEN study).

OBJECTIVE: To examine the cumulative incidence of and covariates' association with new onset anxiety and depression in implantable cardioverter defibrillator (ICD) patients during 24 months of follow-up in patients without depression and anxiety at implant. METHODS: Patients (n = 1040; 155 (14.9%) women; mean age: 64.2 ± 10.6) with a first-time ICD enrolled in the national, multi-center prospective observational DEFIB-WOMEN study comprised the study cohort. We obtained information on demographic and clinical data from the Danish Pacemaker and ICD Register. RESULTS: During 24 months of follow-up, 138 (14.5%) patients developed new onset anxiety and 109 (11.3%) new onset depression. Age ≥ 60 [HR:0.60;95%CI:0.40-0.90] and an anxiety score between 3 and 4 [HR:2.85; 95%CI:1.71-4.75] and 5-7 [HR:5.97; 95%CI:3.77-9.45] on the Hospital Anxiety and Depression Scale (HADS) were associated with different hazards of new onset anxiety during follow-up. Age ≥ 60 [HR:0.62;95%CI:0.42-0.93] and a HADS depression score between 3 and 4 [HR:2.99;95%CI:1.80-4.95] and 5-7 [HR:6.45; 95%CI:4.12-10.10] were associated with different hazards of new onset depression. CONCLUSION: During 24 months of follow-up, respectively 14.5% and 11.3% of patients developed new onset anxiety and depression, suggesting that screening patients at several timepoints, and in particular those with even minimally elevated HADS scores at baseline, may be warranted to identify patients at risk for poor health outcomes.

Anxiety and depression symptoms in Danish patients with an implantable cardioverter-defibrillator: prevalence and association with indication and sex up to 2 years of follow-up (data from the national DEFIB-WOMEN study).

AIMS: To investigate (i) the prevalence of anxiety and depression and (ii) the association between indication for implantable cardioverter-defibrillator (ICD) implantation and sex in relation to anxiety and depression up to 24 months' follow-up. METHODS AND RESULTS: Patients with a first-time ICD, participating in the national, multi-centre, prospective DEFIB-WOMEN study (n = 1496; 18% women) completed the Hospital Anxiety and Depression Scale at baseline, 3, 6, 12, and 24 months. Data were analysed using linear mixed modelling for longitudinal data. Patients with a secondary prophylactic indication (SPI) had higher mean anxiety scores than patients with a primary prophylactic indication (PPI) at baseline, 3, and 12 months and higher mean depression scores at all-time points, except at 24 months. Women had higher mean anxiety scores as compared to men at all-time points; however, only higher mean depression scores at baseline. Overall, women with SPI had higher anxiety and depression symptom scores than men with SPI. Symptoms decreased over time in both women and men. From baseline to follow-up, the prevalence of anxiety (score ≥8) was highest in patients with SPI (13.3-20.2%) as compared to patients with PPI (range 10.0-14.7%). The prevalence of depression was stable over the follow-up period in both groups (range 8.5-11.1%). CONCLUSION: Patients with a SPI reported higher anxiety and depression scores as compared to patients with PPI. Women reported higher anxiety scores than men, but only higher depression scores at baseline. Women with SPI reported the highest anxiety and depression scores overall.

Incidence of device-related infection in 97 750 patients: clinical data from the complete Danish device-cohort (1982-2018).

AIMS: Device-related infection (DRI) is a severe complication to cardiac implantable electronic devices (CIED) therapy. Device-related infection incidence and its risk factors differ between previous studies. We aimed to define the long-term incidence and incidence rates of DRI for different types of CIEDs in the complete Danish device-cohort and identify patient-, operation- and device-related risk factors for DRI. METHODS AND RESULTS: From the Danish Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Register, we included consecutive Danish patients undergoing CIED implantation or reoperation from January 1982 to April 2018, resulting in 97 750 patients, 128 045 operations and follow-up of in total 566 275 device years (DY). We identified 1827 DRI causing device removals. Device-related infection incidence during device lifetime was 1.19% (1.12-1.26) for PM, 1.91% (1.71-2.13) for ICD, 2.18% (1.78-2.64) for cardiac resynchronization therapy (CRT)-pacemakers (CRT-P), and 3.35% (2.92-3.83) for CRT-defibrillators (CRT-D). Incidence rates in de novo implantations were 2.04/1000 DY for PM, 3.84 for ICD, 4.38 for CRT-P, and 6.76 for CRT-D. Using multiple-record and multiple-event per subject proportional hazard analysis, we identified implantation of complex devices (ICD and CRT), reoperations, prior DRI, male sex, and younger age as significantly associated with higher DRI risk. CONCLUSION: Overall risk of infection was low in PM implantations but considerably higher in CRT systems and after reinterventions. These data support the importance of evaluating all patients considered for CIED therapy thoroughly, in order to identify potential modifiable risk factors and reduce the risk of early reoperations.

Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.

OBJECTIVES: Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS. METHODS: The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors. RESULTS: One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103 108 Danish Kroner (Dkr) (€13 818) and 134 945 Dkr (€18 085) by thoracotomy, making the costs for VATS 31 837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29 247 Dkr vs thoracotomy 51 734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51 412 Dkr vs thoracotomy 61 575 Dkr; P = 0.012). CONCLUSIONS: VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS. CLINICAL TRIAL REGISTRATION NUMBER: NCT01278888.

Association between implantable cardioverter-defibrillator therapy and different lead positions in patients with cardiac resynchronization therapy.

Aims: To evaluate the impact of different right and left ventricular lead positions (RV-LP and LV-LP) on the risk of therapy for ventricular tachycardia/ventricular fibrillation in patients with a cardiac resynchronization therapy device (CRT-D). Methods and results: We performed a large nationwide cohort study on patients in Denmark receiving a CRT-D device from 2008 to 2012 from the Danish Pacemaker and implantable cardioverter defibrillator (ICD) registry. Lead positions were registered during the implantation and categorized as anterior/lateral/posterior and basal/mid-ventricular/apical for the LV-LP, and as apical/non-apical for the RV-LP. Appropriate and inappropriate therapies were registered during follow-up via remote monitoring or at device interrogations. Time to event was summarized with Kaplan-Meier plots, and competed risk regression analysis was used to calculate adjusted hazard ratios (aHR) with 95% confidence intervals (CI). Following variables were included in the analysis: gender, age, heart failure aetiology, New York heart association class, left ventricular ejection fraction, QRS duration, indication (secondary or primary prophylactic), RV-LP, LV-LP, and antiarrhythmic therapy. We included 1643 patients [mean age 68 (±10) years, 1343 (83%) men]. After a mean of 2.0 years, 322 (20%) patients received appropriate and 66 (4%) patients received inappropriate therapy. The aHR for appropriate therapy with a non-apical RV-LP was 0.70 95% CI (0.55-0.87, P = 0.002) as compared with an apical. We observed no significant association between appropriate therapy and LV-LP in left anterior oblique or right anterior oblique views or inappropriate therapy between any lead positions. Conclusion: An apical RV-LP is associated with an increased risk of appropriate therapy for ventricular tachyarrhythmia in patients with a CRT-D device.

Association between right ventricular lead position and clinical outcomes in patients with cardiac resynchronization therapy.

Aims: To evaluate the association between an apical vs. non-apical right ventricular lead position (RV-LP) and clinical outcome in a large nationwide cohort of patients treated with cardiac resynchronization therapy (CRT). Methods and results: We included consecutive Danish patients receiving a CRT device from 2008 to 2012, identified from the Danish Pacemaker and ICD Register. Endpoints were mortality, mortality or hospitalization for heart failure (HF), and clinical response (improvement ≥1 New York Heart Association class at follow-up). Subgroup analysis was made for ischaemic heart disease (IHD) and non-IHD. Cox and logistic regression analyses were used to calculate adjusted HR (aHR) and adjusted odds ratios with 95% confidence intervals (CI). A total of 2883 patients received a CRT device during the period. We excluded 301 patients that did not meet standard CRT indication. In 2391 (93%) of the remaining 2582 patients the RV-LP was defined as apical in 647 (27%) and non-apical in 1744 (73%). After mean 3.2 ± 2 years, 660 patients had died, 1275 patients were hospitalized for HF, and 1021 were responders. With a non-apical RV-LP the aHR for mortality was 0.93 (95% CI 0.0.79-1.10, P = 0.40) and the aHR for the combined endpoint of mortality or HF-hospitalization was 0.89 (95% CI 0.79-0.99, P = 0.03). These findings were significant only in patients with non-IHD. There was no association between clinical response and RV-LP. Conclusion: A non-apical RV-LP is associated with lower risk of meeting the combined endpoint of mortality or hospitalization for HF in patients with CRT. In subgroup analysis, this association was present only in patients with non-IHD.

Risk of pacemaker or implantable cardioverter defibrillator after radiotherapy for early-stage breast cancer in Denmark, 1982-2005.

BACKGROUND AND PURPOSE: To examine the risk of cardiac conduction abnormalities or severe ventricular arrhythmias requiring implantation of a cardiac implantable electronic device (CIED), either a pacemaker or an implantable cardioverter-defibrillator, subsequent to breast cancer (BC) radiotherapy (RT). MATERIAL AND METHODS: All women treated for early-stage BC in Denmark from 1982 to 2005 were identified from the Danish Breast Cancer Cooperative Group. By record linkage to the Danish Pacemaker and ICD Registry information was retrieved on CIED implants subsequent to RT. Standardized incidence ratios (SIR) of CIED implantation were estimated for women receiving RT and compared to women not receiving RT for BC. Uni- and multivariate Poisson regression models were used to estimate incidence rate ratios (IRR) among irradiated women compared to non-irradiated. RESULTS: Of 44,423 BC patients, 179 had a CIED implanted among 18,251 women who received RT, and 401 had a CIED in 26,172 who did not receive RT. The unadjusted IRR was 1.09 (0.91-1.30 95% CI) for CIED implants among women receiving RT compared to non-irradiated women and the IRR was 1.13 (0.93-1.38 95% CI) when adjustments were made. CONCLUSIONS: BC RT as practiced in Denmark in 1982-2005 did not increase the risk of CIED implants. This indicates that RT for BC does not increase the risk of severe ventricular arrhythmias or cardiac conduction abnormalities.

An anterior left ventricular lead position is associated with increased mortality and non-response in cardiac resynchronization therapy.

BACKGROUND: Non-response to cardiac resynchronization therapy (CRT) might be due to insufficient resynchronization as a result of a sub-optimal left ventricular lead positon (LV-LP). OBJECTIVE: To evaluate the impact of different LV-LPs on mortality and symptomatic improvement in a large cohort of patients treated with CRT. METHODS: We performed a nationwide cohort study on consecutive patients receiving a CRT device from 1997 to 2012 registered in the Danish pacemaker and ICD register. The LV-LP was defined clockwise in a left anterior oblique (LAO) view and categorized as anterior (≤2 o'clock), lateral (2 to 4 o'clock) or posterior (>4 o'clock), and as basal, mid-ventricular, or apical in a right anterior oblique (RAO) view. Outcomes were all cause mortality and clinical response (improvement in NYHA class). Adjusted hazard ratio (aHR) and odds ratio (aOR) with 95% confidence intervals (CI) were calculated using Cox and logistic regression analysis. RESULTS: A total of 2594 patients were included. A lateral LV-LP, (aHR 0.77, 95% CI 0.64-0.92, p=0.004), and a posterior LV-LP, (aHR 0.71 95% CI 0.53-0.97, p=0.029) were associated with lower mortality as compared to an anterior LV-LP. A lateral LV-PV was associated with higher clinical response rate as compared to an anterior LV-LP (aOR 1.37, 1.03-1.83, p=0.032). No statistically significant associations were observed between LV-LP in the RAO view and mortality or clinical response. CONCLUSION: An anterior left ventricular lead position is associated with increased all-cause mortality and lower clinical response rate in patients treated with CRT and should be avoided.