Evidence is weak for the ability of long-term non-invasive positive pressure ventilation (NPPV) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease (COPD). ...Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings. This study investigated the effect of long-term NPPV, targeted to markedly reduce hypercapnia, on survival in patients with advanced, stable hypercapnic COPD.
This investigator-initiated, prospective, multicentre, randomised, controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure (PaCO2) of 7 kPa (51.9 mm Hg) or higher and pH higher than 7.35. NPPV was targeted to reduce baseline PaCO2 by at least 20% or to achieve PaCO2 values lower than 6.5 kPa (48.1 mm Hg). Patients were randomly assigned (in a 1:1 ratio) via a computer-generated randomisation sequence with a block size of four, to continue optimised standard treatment (control group) or to receive additional NPPV for at least 12 months (intervention group). The primary outcome was 1-year all-cause mortality. Analysis was by intention to treat. The intervention was unblinded, but outcome assessment was blinded to treatment assignment. This study is registered with ClinicalTrials.gov, number NCT00710541.
Patients were recruited from 36 respiratory units in Germany and Austria, starting on Oct 29, 2004, and terminated with a record of the vital status on July 31, 2011. 195 patients were randomly assigned to the NPPV group (n=102) or to the control group (n=93). All patients from the control group and the NPPV group were included in the primary analysis. 1-year mortality was 12% (12 of 102 patients) in the intervention group and 33% (31 of 93 patients) in the control group; hazard ratio 0.24 (95% CI 0.11-0.49; p=0.0004). 14 (14%) patients reported facial skin rash, which could be managed by changing the type of the mask. No other intervention-related adverse events were reported.
The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic, stable COPD when NPPV is targeted to greatly reduce hypercapnia.
German Lung Foundation; ResMed, Germany; Tyco Healthcare, Germany; and Weinmann, Germany.
Four respiratory medicine disease categories appear in the global top 10 causes of mortality 1, resulting in 600 000 people dying from respiratory disease in Europe each year. The economic burden of ...respiratory diseases in Europe exceeds 380 billion euros. In a fast-developing environment, new clinical challenges have arisen for pulmonary specialists; techniques and procedures have evolved and become more complex.
The extent of lymphadenectomy in the treatment of non-small cell lung cancer is still a matter of controversy. While some centers perform mediastinal lymph node sampling with resection of only ...suspicious lymph nodes, others recommend a radical, systematic mediastinal lymphadenectomy (LA) to improve survival and achieve a better staging. Herein we report on the impact of LA on tumor staging in a controlled, prospective, randomized clinical trial comparing lymph node sampling and LA in a total of 182 patients with operable non-small cell lung cancer. Regardless of the type of lymphadenectomy performed, the percentage of patients with pathologic N1 or N2 (sampling: n = 23, 23.0%0; LA: n = 22, 26.8%) disease was very similar in both groups, indicating that systematic radical lymphadenectomy is not an essential prerequisite to determine the N stage of a patient. In contrast, the number of patients detected to have lymph node involvement at multiple levels was significantly increased by LA. In the lymph node sampling group only 4 of 23 patients (17.4%) with N2 disease were found to have more than one lymph node level involved, whereas LA results in the detection of excessive N2 disease in 12 of 21 patients (57.2%; p = 0.007), which was associated with a shorter distant metastases-free (p = 0.021) and overall survival. In conclusion, LA is not essential to determine the N stage of a patient, but results in a more detailed staging of the N2 region, which is of prognostic significance. Therefore, it might be useful to identify patients with a higher risk for tumor relapse.
To evaluate the effectiveness of lymphadenectomy in the treatment of non-small cell lung cancer (NSCLC).
The extent of lymphadenectomy in the treatment of NSCLC is still a matter of controversy. ...Although some centers perform mediastinal lymph node sampling (LS) with resection of only suspicious lymph nodes, others recommend a radical, systematic mediastinal lymphadenectomy (LA) to improve survival and to achieve a better staging.
In a controlled, prospective, randomized clinical trial, the effects of LA on recurrence rates and survival were analyzed, comparing LS and LA in 169 patients with operable NSCLC.
After a median follow-up of 47 months, LA did not improve survival in the overall group of patients (hazard ratio: 0.78; 95% confidence interval: 0.47-1.24). Although recurrences rates tended to be reduced among patients who underwent LA, these decreases were not statistically significant (hazard ratio: 0.82; 95% confidence interval: 0.54-1.27). However, analysis of subgroups of patients according to histopathologic lymph node staging revealed that LA appears to prolong relapse-free survival (p = 0.037) with a borderline effect on overall survival (p = 0.058) in patients with limited lymph node involvement (pN1 disease or pN2 disease with involvement of only one lymph node level); in patients with pN0 disease, no survival benefit was observed.
Radical systematic mediastinal lymphadenectomy does not influence disease-free or overall survival in patients with NSCLC and without overt lymph node involvement. However, a small subgroup of patients with limited mediastinal lymph node metastases might benefit from a systematic lymphadenectomy.
Although locally advanced lung cancer frequently necessitates extended resections to preserve a chance for cure, a higher morbidity is associated with extended resections. It is not known whether the ...increased morbidity is of relevance for the long-term outcome. It also remains unclear whether exclusion of certain patients according to their risk factors can diminish mortality in these patients. This study therefore investigated whether certain risk factors predispose patients undergoing extended pulmonary resections to increased morbidity or mortality. It also assessed the long-term survival. The cases of 126 consecutive patients with locally advanced lung cancer (stage T3 or T4) were prospectively documented. Seventy-five percent of the patients required an extended resection and 25% a nonextended resection. Extended resections were associated with a significantly increased overall morbidity (
p < 0.002). However, mortality, severe complications, or multiple complications were not significantly increased after extended resections. No risk factor predisposed to an increased mortality. Risk factors that were associated with particular postoperative complications were pathologic ergonometry (
p < 0.002), a positive cardiac score (
p < 0.003), coronary artery disease (
p = 0.021), and an increased pulmonary risk score (
p < 0.05). Overall 3-year survival was 31%. Patients undergoing extended resections for stage T3 or T4 tumors with no residual tumor (70% of the patients) showed a 3-year survival of 33%. We conclude that postoperative mortality cannot be reduced by excluding patients on the basis of particular risk factors from operations that require extended resections. If a patient is considered to be eligible to undergo pulmonary resection, he or she can be considered to be eligible to undergo extended pulmonary resection. Because prognosis is dismal in nonresected locally advanced lung cancer, we recommend an aggressive surgical approach.(J T
HORAC C
ARDIOVASC S
URG 1995;110:386-95)
Invasive home mechanical ventilation is used for patients with chronic respiratory insufficiency. This elaborate and technology-dependent ventilation is carried out via an artificial airway (tracheal ...cannula) to the trachea. Exact numbers about the incidence of home mechanical ventilation are not available. Patients with neuromuscular diseases represent a large portion of it.
Specific research questions are formulated and answered concerning the dimensions of medicine/nursing, economics, social, ethical and legal aspects. Beyond the technical aspect of the invasive home, mechanical ventilation, medical questions also deal with the patient's symptoms and clinical signs as well as the frequency of complications. Economic questions pertain to the composition of costs and the differences to other ways of homecare concerning costs and quality of care. Questions regarding social aspects consider the health-related quality of life of patients and caregivers. Additionally, the ethical aspects connected to the decision of home mechanical ventilation are viewed. Finally, legal aspects of financing invasive home mechanical ventilation are discussed.
Based on a systematic literature search in 2008 in a total of 31 relevant databases current literature is viewed and selected by means of fixed criteria. Randomized controlled studies, systematic reviews and HTA reports (health technology assessment), clinical studies with patient numbers above ten, health-economic evaluations, primary studies with particular cost analyses and quality-of-life studies related to the research questions are included in the analysis.
Invasive mechanical ventilation may improve symptoms of hypoventilation, as the analysis of the literature shows. An increase in life expectancy is likely, but for ethical reasons it is not confirmed by premium-quality studies. Complications (e. g. pneumonia) are rare. Mobile home ventilators are available for the implementation of the ventilation. Their technical performance however, differs regrettably. Studies comparing the economic aspects of ventilation in a hospital to outpatient ventilation, describe home ventilation as a more cost-effective alternative to in-patient care in an intensive care unit, however, more expensive in comparison to a noninvasive (via mask) ventilation. Higher expenses arise due to the necessary equipment and the high expenditure of time for the partial 24-hour care of the affected patients through highly qualified personnel. However, none of the studies applies to the German provisionary conditions. The calculated costs strongly depend on national medical fees and wages of caregivers, which barely allows a transmission of the results. The results of quality-of-life studies are mostly qualitative. The patient's quality of life using mechanical ventilation is predominantly considered well. Caregivers of ventilated patients report positive as well as negative ratings. Regarding the ethical questions, it was researched which aspects of ventilation implementation will have to be considered. From a legal point of view the financing of home ventilation, especially invasive mechanical ventilation, requiring specialised technical nursing is regulated in the code of social law (Sozialgesetzbuch V). The absorption of costs is distributed to different insurance carriers, who often, due to cost pressures within the health care system, insurance carriers, who consider others and not themselves as responsible. Therefore in practice, the necessity to enforce a claim of cost absorption often arises in order to exercise the basic right of free choice of location.
Positive effects of the invasive mechanical ventilation (overall survival and symptomatic) are highly probable based on the analysed literature, although with a low level of evidence. An establishment of a home ventilation registry and health care research to ascertain valid data to improve outpatient structures is necessary. Gathering specific German data is needed to adequately depict the national concepts of provision and reimbursement. A differentiation of the cost structure according to the type of chosen outpatient care is currently not possible. There is no existing literature concerning the difference of life quality depending on the chosen outpatient care (homecare, assisted living, or in a nursing home specialised in invasive home ventilation). Further research is required. For a so called participative decision - made by the patient after intense counselling - an early and honest patient education pro respectively contra invasive mechanical ventilation is needed. Besides the long term survival, the quality of life and individual, social and religious aspects have also to be considered.
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