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Noninvasive home ventilation for chronic obstructive pulmonarydisease: indications, utility and outcomeStephan Budweiser, Rudolf A. Jo¨rresand Michael aCenter for Pneumology, Hospital Donaustauf, Donaustauf, bInstitute and Outpatient Clinic for Despite its widespread use, the role of noninvasive home mechanical ventilation for the Occupational, Social and Environmental Medicine,Ludwig-Maximilians-University, Munich and management of severe chronic obstructive pulmonary disease and chronic hypercapnic cDepartment of Internal Medicine II, Division of respiratory failure is still controversial. The majority of randomized controlled trials show Respirology, University of Regensburg, Regensburg,Germany methodological weaknesses, including issues of patient selection, insufficient pressuresupport and poor adherence to therapy. Data from short-term trials, while assuring Correspondence to Dr med. Stephan Budweiser,Klinik Donaustauf, Zentrum fu¨r Pneumologie, effective ventilation, are encouraging by demonstrating physiological improvements, in Ludwigstraße 68, 93093 Donaustauf, Germany line with benefits regarding symptoms and quality of life. The role of home mechanical Tel: +49 9403 80 715; fax: +49 9403 80 211;e-mail: ventilation for long-term survival is, however, still unclear.
Recent findings Current Opinion in Pulmonary Medicine 2008, Possible indications of home mechanical ventilation, physiological concepts underlying the effects of noninvasive ventilation and their impact on clinically important long-termoutcomes are reported.
SummaryDue to systemic involvement, the decision to undertake home mechanical ventilationshould probably not be based on symptomatic chronic hypercapnia alone, but on abroader spectrum of factors. In particular, patients with repeated hypercapnicdecompensation are at high risk for death and obvious candidates for home mechanicalventilation. Beyond restoration of chemosensitivity, changes in breathing pattern and areduction of mechanical load are likely mechanisms of home mechanical ventilation,inducing symptom relief and improving functional reserve. To fully utilize its potential,high pressure levels are required. Future prospective controlled studies should take intoaccount these experiences.
Keywordschronic hypercapnic respiratory failure, chronic obstructive pulmonary disease,noninvasive ventilation Curr Opin Pulm Med 14:128–134ß 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Chronic obstructive pulmonary disease (COPD) is one of COPD with chronic hypercapnic respiratory failure the leading causes of death worldwide While phar- (CHRF) has grown to be one of the major indications macotherapy has not yet consistently demonstrated for HMV in Europe, as demonstrated by a survey of 21 526 patients from 329 centers This might imply a (LTOT) is capable of reducing mortality in advanced, high conviction among clinicians regarding the clinical hypoxemic COPD Noninvasive positive-pressure benefit from HMV in COPD, including the view that ventilation (NPPV) is established in the management withholding this therapy could be life-threatening; how- of acute hypercapnic respiratory failure after severe ever, clear-cut evidence that supports this view is still exacerbation whereas the evidence in support of scarce. The survey did not provide details of the criteria domiciliary, long-term NPPV in chronic hypercapnic of HMV, but significant differences between institutions COPD is equivocal. The review aims to integrate current and countries with regard to these and the willingness to clinical and pathophysiological concepts, indications for and the utility of noninvasive home mechanicalventilation (HMV), highlighting its impact on long-term According to the definition of CHRF elevated daytime arterial carbon dioxide tension (PaCO2) is considered as a 1070-5287 ß 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Noninvasive home ventilation Budweiser et al.
key indicator of alveolar hypoventilation and constitutes a adequately described by (chronic) hypercapnia alone.
major criterion for the decision to undertake HMV. Its use Probably more important long-term determinants are in COPD is often based on recommendations of an Inter- the reductions in functional reserves including airway national Consensus Conference According to this, HMV should be considered after optimization of therapy including maximal bronchodilation and LTOT if typicalsymptoms are present and PaCO2 levels are 55 mmHg or These risk factors, and their combination, imply a high above, or if levels are lower (50–54 mmHg) but nocturnal susceptibility for exacerbations and instability, associated oxygen desaturation of 88% or below occurs for 5 min or with a high risk of uncompensated respiratory failure and more consecutively despite continuous administration of death . Noninvasive HMV can reduce the work of 2 l/min or more of oxygen. This statement was derived breathing and evoke beneficial changes in the ventilatory from data demonstrating clinical effects from HMV on pattern thus probably bolstering functional blood gases and sleep quality or quality of life in patients reserves and counteracting life-threatening events, presenting with pronounced nocturnal hypoventilation including those originating during an exacerbation.
and/or hypercapnia . Conversely, in those randomized Following this argument, it seems adequate to base controlled trials which did not observe benefits, patients the decision for HMV on an individual picture covering showed a lower degree of hypercapnia In line with a broad range of risk factors. Such multidimensional this, the Global Initiative on Obstructive Lung Disease approaches are already customary in decisions about (GOLD) proposed long-term HMV particularly in patients lung volume reduction surgery or lung transplantation A further indication for HMV is thought to be given at a In accordance with this, a recent controlled, although not lower degree of hypercapnia (PaCO2 50–54 mmHg) if randomized, study provided further evidence that two or more episodes of hypercapnic respiratory decom- patients showing a profile of known risk factors especially pensation occur per year This basically relied on benefit from HMV which has to be corroborated in reported benefits of HMV in COPD, diffuse bronchiec- randomized controlled trials. Patients who experience a tasis and cystic fibrosis, as reflected in a lower number of severe acute exacerbation requiring the use of NPPV hospitalizations in the year after HMV compared to in the hospital show a high risk for subsequent life- preceding years suggesting a role for HMV threatening events and the continuation of venti- beyond the reversal of chronic hypercapnia.
latory support at home might help to stabilize theirclinical state Correspondingly, a lower frequency The critical limits of hypercapnia are not tightly defined of hospital admissions and lower healthcare or verified in prospective randomized controlled trials.
costs after initiation of HMV have been reported.
Even more intriguing, some authors argue that the Moreover, in a recent observational study, maintenance development of chronic hypercapnia might represent HMV after a prolonged period of weaning implied a natural wisdom preventing respiratory muscle fatigue improved long-term survival, compared to patients dis- This view obviously interferes with the rationale charged without NIV, independent of the patient’s age underlying HMV In fact, large observational and duration of hospital stay As these data were also studies performed prior to the widespread application derived from a retrospective analysis, they need to be of HMV found similar or even lower mortality confirmed. At least they suggest an indication for in moderately hypercapnic compared to normocapnic HMV after difficult weaning, although possibly only in patients. The prognostic value of chronic hypercapnia selected groups of patients and a certain time window.
is thus not clear and base excess might constitute a more reliable parameter, reflecting the long-termmetabolic response Nonetheless, extreme hyper- Table 1 Possible and apparently most appropriate indications capnia or persistent hypercapnia following an acute for the initiation of noninvasive HMV as derived from clinical exacerbation seem to predict a poor long-term trials that favored the use of noninvasive HMV in patients withchronic obstructive pulmonary disease and chronic hypercapnic Although PaCO2 remains a hallmark of CHRF and itsreduction a goal of HMV, none of the currently available recommendations defines a more detailed profile of Unstable course of the disease with recurrent respiratory decompensation and/or repeated hospital admissions patients eligible for HMV. This seems surprising in a Patients at high risk for death or severe exacerbation, systemic, multidimensional disease such as COPD.
Particularly in most severe COPD, the risk of death or Status after prolonged mechanical ventilation severe exacerbations does not appear to be Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Obstructive, occupational and environmental diseases not only underlie the sustained reduction of PaCO but also the positive effects on respiratory muscle A large number of investigations have elucidated the long-term utility of ventilatory support in COPD, using but these results need to be proven in long-term a wide range of clinical outcome measures. Not surpris- prospective controlled trials. In view of the pathophysio- ingly, in this multifaceted disease some issues remain logy of dyspnea it seems plausible that these controversial, but a recent review of 466 patients from six functional improvements correspond to the reduction randomized and nine nonrandomized controlled trials of dyspnea sensation – a consistent result of randomized argued that HMV could well have an adjunctive role controlled clinical trials as exemplified by in the management of COPD through improve- the correlation between the physiological improvements ment of health-related outcomes or respiratory function.
and the Transition Dyspnea Index (TDI) The Again this conclusion, although cautious and not covering observed effects on breathing pattern and/or respiratory patient eligibility, pointed towards a role for HMV mechanics also imply a greater ventilatory reserve which beyond the relief of chronic hypercapnia, in contrast to could be advantageous during both physical exercise and a previous meta-analysis of four randomized controlled As yet, however, exercise capacity as quantified by 6-min Defining the role of HMV precisely is, however, difficult walk distance did not show changes after initiation of in view of the fact that the contributions of the mech- NPPV in most studies addressing this issue anisms underlying noninvasive HMV are not clear .
it was found to be improved in only two short-term The hypothesis that the resting of respiratory muscles randomized controlled trials Dynamic hyperinfla- allows them to restore their capacity is now being tion during exercise probably poses a mechanical limiting questioned as the leading factor in COPD factor not amenable to nocturnal HMV Irrespective of Although the activity of the diaphragm can be reduced by this it seems a promising observation that high-intensity ventilatory support this does not appear to NPPV administered during walking can result in improved translate into an increase of inspiratory muscle strength, oxygenation, decreased dyspnea and increased walking according to most of the controlled studies Other effects such as restoration of chemosensitivity,with subsequent improvements in PaCO2 and alveolar Of utmost importance for achieving these effects are hypoventilation, have been suggested as being more sufficient levels of inspiratory pressure, including a low important Thus, the amelioration of blood gases, positive end-expiratory pressure, to assure effective venti- particularly hypercapnia, during noninvasive ventilation lation. While the controlled studies with unfavorable out- and spontaneous breathing is now considered as a major come predominantly used low inspiratory pressures target of long-term HMV and has been defined as a , a 3-month randomized cross-over trial using therapeutic goal in a current multicenter trial Not levels of 18/2 mbar demonstrated salutary effects on surprisingly, early randomized controlled studies in daytime blood gases. It might be reassuring in this respect which this goal was not reached, mainly due to insuffi- that in clinical short- and long-term investigations cient ventilation pressures or patient noncompliance, also the observed changes in ventilatory pattern showed no clinical effect Conversely, the and PaCO2 were related to inspiratory pressure levels.
improvement of daytime blood gases by HMV was In recent noncontrolled studies the improvement in PaCO2 consistently occurred at inspiratory pressures up and quality of life in a randomized controlled trial to 28 mbar which were still tolerated by the patients It has also been demonstrated that, despite theleakage at higher pressure, the increase in pressure still Valuable insight into the potential of HMV has been gained from short-term controlled or cross-over trials. Byapplying NPPV during close supervision, ascertaining Moreover, the potential of HMV can only be fully utilized when the mental attitude of the patient is strated to be capable of raising tidal volume or minute adequate and compliance sufficient. Clinical practice indicates that this requires experience and familiarization frequency and effective respiratory impedance with the technique on the patients’ side, plus modern These benefits occurred during both ventilatory support ventilator technique. This is underlined by the obser- vation that particularly in the early years of HMV high were correlated with the reduction of PaCO2 levels rates of nonacceptance and a lack of beneficial effects Ameliorations of the ventilatory pattern could Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Noninvasive home ventilation Budweiser et al.
Figure 1 Possible effects and utility of noninvasive home ventilation according to short- and long-term trials with positive outcome Randomized controlled trials are marked in bold. At 3 months. PaCO2, arterial carbon dioxide tension; PaO2, arterial oxygen tension; NPPV,noninvasive positive-pressure ventilation; HMV, home mechanical ventilation; HRQL, health-related quality of life.
In view of pathophysiological interactions it seems reasonable to consider those patients as potentially suited Although the improvement of physiological indices is for HMV who show a high risk of hypercapnic failure or desirable, it has to be kept in mind that these effects death (see Indications) or present the greatest functional should additionally translate into a substantial clinical deficits and/or symptoms. This approach might be cross- benefit. Long-term survival and health-related quality of checked against conditions for which positive effects life (HRQL) are probably most important in this respect, have been reported. Apart from pronounced chronic as in other chronic diseases. The question for a long-term hypercapnia, the presence of marked clinical symptoms benefit is also inevitable in view of the considerable should encourage the initiation of noninvasive HMV.
Indeed, dyspnea or sleep quality are improved byHMV according to noncontrolled and controlledtrials Some of the available reports covered an observationperiod of sufficient length to address long-term HRQL The nonnegligible costs associated with this sophisti- or survival, but most of them in a small number of patients cated therapy call for regular assessment of therapeutic effectiveness including patient willingness to continue ging that the majority of controlled and noncon- HMV Some data indicate a benefit from HMV trolled studies on the long-term effects of HMV even in the case of not being used every day or only for a reported positive findings irrespective of the choice of generic or disease-specific questionnaires. It seems usage has positive effects Thus, it seems important to note that improvements in HRQL also questionable to retract the ventilator only because it is occurred in measures specifically designed for patients not used daily, as it might be helpful in periods of with ventilatory failure, such as the Maugeri Foundation deterioration, provided that the patient has learnt its Respiratory Failure Questionnaire (MRF-28) and the Severe Respiratory Insufficiency (SRI) questionnaire Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Obstructive, occupational and environmental diseases which was recently also validated specifically for COPD In view of the potential of domiciliary noninvasive venti- lation to reduce overall healthcare costs, at least inpatients with recurrent exacerbations HMV should Contrary to the predominantly favorable findings regard- thus be further evaluated in randomized controlled trials ing HRQL, the two randomized clinical trials on long-term and samples of adequate size. As suggested factors mortality which comprised samples of acceptable size and in favor of an improved long-term outcome are the observation periods of 1 and 2 years, respectively, found no selective inclusion of patients with severe COPD and difference in survival rate between patients with HMV high risk for exacerbation or death, sustained adaptation compared to LTOT alone Treatment efficiency to HMV, high pressure levels, and familiarization with and inspiratory pressure levels might, however, have been the technique. Naturally, HMV can only be part of a too low Although changes in overall treatment comprehensive management strategy in COPD and associated with HMV should be taken into account, it should be noted that survival rates of patients treated with pharmacological therapy and LTOT Even in the noninvasive efficient HMV were higher than those of terminal stage of the disease noninvasive ventilation can historical controls In a further observational alleviate symptoms without the undesirable side- study comprising the as yet largest population and longest effect of prolonging the process of dying.
observation period, patients with noninvasive HMVpresented with better long-term survival compared topatients who were not successfully adapted to this therapy . Of course, as the control group was not In patients with COPD and CHRF, studies that used chosen at random, these data also show weaknesses.
high pressure levels and ensured adequate compliance Nonetheless, a detailed analysis which took into account have shown beneficial effects on physiological measures the (minor) differences at baseline between the study and and health-related outcomes such as dyspnea and quality control group unequivocally indicated a benefit from of life. Data on long-term survival are currently weak, but HMV. These results are encouraging and fit well into promising. From recent findings it seems inappropriate to base the decision to undertake HMV on PaCO2 alone. Inparticular, patients with unstable disease, recurrenthypercapnic decompensations, life-threatening events Figure 2 Survival rates of patients with COPD and high adher- or high risk for death should be considered for long-term ence (89%) to HMV (n U 99) as compared to patients not suc-cessfully adapted to HMV (n U 41) according to the data from a HMV. These patients should be part of prospective controlled, although not randomized, design controlled trials to define the role of noninvasive HMVin severe hypercapnic COPD more precisely.
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