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European Journal of Heart Failure 2008 10(3):267-272; doi:10.1016/j.ejheart.2008.01.003
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© 2008 European Society of Cardiology

Outpatient intravenous diuretic therapy; potential for marked reduction in hospitalisations for acute decompensated heart failure

Mary Ryder, Niamh F. Murphy, Dermot McCaffrey, Christina O'Loughlin, Mark Ledwidge and Kenneth McDonald*

Heart Failure Unit, Department of Cardiology, St Vincent's University Hospital Ireland

* Corresponding author. Department of Cardiology, St Vincent's University Hospital, Elm Park, Dublin 4, Ireland. Tel.: +353 1 2304629; fax: +353 1 2304639. E-mail address: kenneth.mcdonald{at}ucd.ie (K. Mcdonald).


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: Heart failure patients have frequent readmissions for acute decompensated heart failure (ADHF).

Aims: To examine the feasibility, safety and outcomes of outpatient intravenous (IV) diuretic therapy in treating ADHF.

Methods: A retrospective analysis was performed of all patients included in a hospital-based heart failure disease management programme, who received outpatient IV diuretic therapy for the management of ADHF between 2002 and 2006. Changes in clinical and biochemical parameters from time of therapy to stability were measured.

Results: One hundred and seven patients (mean age 71 ± 11 years) received outpatient IV diuretic therapy for ADHF IV diuretic administration reduced weight (p <0.001), blood pressure (p<0.01) and BNP (p=0.01). It increased urea (p=0.01) and creatinine (p=0.07). Seventy-two percent of patients stabilised following IV diuretics and did not require admission. No patients were hospitalised for hypotension or hypokalaemia. One patient was hospitalised for renal failure. Two patients died post admission.

Conclusion: Outpatient IV diuretic administration for ADHF is safe, cost effective and reduces hospitalisations. This service may expand the potential of a disease management programme to manage ADHF out of hospital and thereby reduce the hospital dependency of this condition.

Key Words: Heart failure • Disease management programme • Intravenous diuretics • Outpatient

Received May 10, 2007; Revised November 1, 2007; Accepted January 9, 2008


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Heart failure is a chronic illness affecting 1-2% of the population [1], and is characterised by episodes of decompensation often requiring hospitalisation. Disease management programmes (DMPs) have been successful at reducing heart failure admissions by up to 80% [2-6]. One aspect of these programmes is education on matters related to self-care, concentrating on symptom recognition and early intervention to prevent deterioration [5,6]. In such circumstances patients are often advised to increase oral diuretic therapy in response to signs and symptoms of deterioration [7,8]. Nevertheless, failure of this approach often results in admission. However, alternative strategies may help abort admissions. One such approach is outpatient intravenous (IV) diuretic therapy, which may stabilise evolving deterioration and thereby prevent hospitalisation.

The aims of this study are to examine the feasibility, safety and outcomes of administering IV diuretic therapy in an outpatient heart failure unit for treating acute decompensated heart failure (ADHF).


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
This was an observational study from a hospital based, inpatient and outpatient heart failure unit (HFU). The HFU serves a population of 350,000 people with over 3600 outpatient visits per year and a similar number of outpatient telemonitoring contacts. Twenty percent of outpatient visits are unscheduled contacts with patients for emerging clinical deterioration [9].

As this was a retrospective observational study, ethical approval was deemed not to be required by St. Vincent's University Hospital Ethics Committee.

All patients with a weight gain (of 2 kg over 2 days), documented this in their record book, and reported it via telephone to the heart failure nurse specialist. The nurse then followed a hospital-approved protocol to instruct patients to increase oral diuretics. Further telephone contact was made on day 3 following these dose increments, to determine if the weight gain had receded. If there was no change in weight, or if there was symptomatic deterioration, patients were asked to attend the HFU for clinical assessment by a physician experienced in heart failure management. If the clinical assessment confirms heart failure, a second attempt to control deterioration by increasing oral diuretic (loop or thiazide) can be undertaken. If this second attempt also fails, intravenous diuretics are then administered. Intravenous diuretics are given as first approach for symptomatic deterioration in the presence of paroxysmal nocturnal dyspnoea (PND) or features of right heart failure, which may compromise the efficacy of an increment in oral diuretic. In addition, intravenous diuretics are also administered if there is clinical judgement of clinical instability beyond the circumstances outlined previously. B-type natriuretic (BNP) measurements are not used to determine the need for IV diuretics. In most cases, intravenous frusemide is given in doses ranging from 40-80 mgs over a five-minute period. The patient is then observed for a period of 1 h to ensure clinical response (Fig. 1).


Figure 01
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  		Fig. 1 Flow diagram of procedure for the administration of outpatient intravenous diuretic therapy.

 
All patients who receive IV diuretic therapy are reviewed the following day, either in the HFU (weekdays) or in the cardiology department (at weekends) to assess the response to therapy. Review at weekends is performed by staff already on clinical duty as part of the cardiology weekend service. The follow-up includes history, physical examination, and evaluation of urea and electrolytes; based on the clinical findings, an assessment of the need for further IV diuretic therapy or any other change in management is made. IV inotropes are not administered to outpatients in our unit.

All patients are followed-up until clinical stability is achieved or until hospitalisation is required. The number of intravenous therapies prescribed for each episode of ADHF is recorded. For patients requiring IV diuretics for more than one episode of clinical deterioration, subsequent episodes are recorded if there is at least one month of clinical stability occurring between episodes.

2.1. Study endpoints
The primary study endpoint was achievement of clinical stability in patients receiving intravenous diuretics. Clinical stability was defined as resolution of acute symptoms and physical signs, with a return to baseline status including dry baseline weight. In assessing this endpoint, all episodes of clinical deterioration were included. Secondary endpoints included hospitalisation for heart failure and death.

2.2. Statistical analysis
Data are presented as mean±standard deviation (SD) for continuous variables and as frequencies and percentages for categorical and nominal data. Comparisons between patients that received only one IV diuretic administration with those who received multiple IV administrations were made using t-test or Mann-Whitney U test where indicated for continuous variables and chi square test for categorical variables. Changes in biochemical markers and clinical assessments from IV diuretic administration to stability or hospitalisation post IV diuretic administration were assessed using paired samples t-test and Wilcoxon test for non parametric tests where indicated. Univariable and multivariable analysis was conducted using binary logistic regression using failure to stabilise as the outcome measure. The multivariable model included theoretically reasonable variables and those with univariate p values of ≤0.05.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Patient population
One hundred and seven patients attending the HFU between 2002-2006 required IV diuretic therapy for management of 156 episodes of ADHF, requiring 273 separate administrations of IV diuretic therapy (Table 1). These patients represented 12.6% of the patient population attending at that time.


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  		Table 1 Demographics, clinical characteristics and treatments for the overall patient population and for those patients requiring just one administration of diuretic and those needing more than one administration to manage a single episode of ADHF

 
The mean age of the population was 71±11 years (24%≥80 years), 75% were male and 70% had left ventricular ejection fraction (LVEF) <40%. Clinical parameters and medications at the time of IV diuretic therapy are presented in Table 1. The mean BNP level at the most recent stable visit prior to administration of IV diuretic therapy was 628±584 pg/ml, increasing to 1063±1203 at the time of IV diuretic therapy.

3.2. Oral diuretic increase prior to IV diuretic administration
Thirty-six (34%) patients had protocol-guided increase in oral diuretic therapy prior to being administered IV diuretic. The mean number of days taken to assess the response to the increase in oral diuretic was 1.6 days±0.7 (range: 1-3 days) prior to administration of IV diuretic therapy.

3.3. End-points
3.3.1. Achieving clinical stability
Of the 156 episodes of ADHF treated with IV diuretics (n=107 patients), 115 (73%, n=77 patients) did not require a hospitalisation and clinical stability was achieved in the outpatient setting.. Forty-one episodes of ADHF treated with IV diuretics (n=30 patients) subsequently required hospitalisation. Of these 30 patients, 19 were admitted for inpatient management of heart failure, 2 had a cardiovascular cause for admission other than heart failure and 9 had a non-cardiovascular admission one of which was for renal failure. No patients were hospitalised for hypotension or hypokalaemia. Two of the patients admitted for further management of ADHF died after admission. There were no episodes of phlebitis related to IV diuretic therapy. A comparison of outcomes between the 77 patients with one episode of ADHF requiring administration of IV diuretics and the 30 patients with multiple episodes of ADHF requiring IV diuretics is provided in Table 2, and shows no significant differences.


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  		Table 2 Comparison of outcomes between patients requiring IV diuretic administration on one occasion for acute decompensated heart failure and patients requiring IV diuretic administration for >1 episode of acute decompensation

 
3.3.2. Predictors of failure to respond to outpatient intravenous diuretic
Adjusting for age and sex, multivariable analysis identified three independent predictors of hospitalisation within one month of outpatient intravenous diuretic administration; these were lower systolic blood pressure, attempts to stabilise with oral diuretic prior to use of IV therapy and use of beta blockers (Table 3). With regard to systolic blood pressure, for every 1 mmHg decrease there was a 3% increased risk of an event. Eight patients were undergoing beta-blocker dose titration; IV diuretics were required between 2-6 weeks following an increase in beta-blocker dose in these patients. All patients with the exception of one were able to remain on the increased dose of beta-blocker or were titrated to higher doses. In the subgroup of patients on beta-blockers, low systolic blood pressure was not a significant predictor of failure to respond to IV diuretic therapy. Adding heart failure with preserved systolic function (PSF) to the multivariable model was not significant nor did it change the significance of beta-blocker usage. BNP did not predict failure to respond to treatment.


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  		Table 3 Multivariable analysis predictors of hospitalisation within 1-month of an outpatient IV diuretic administration

 
3.4. Changes in biochemical markers and clinical parameters
3.4.1. Clinical assessments
On average weight decreased significantly from decompensation to stability (p<0.001). Both systolic and diastolic blood pressure also decreased over this time period (p=0.006 and p=0.001 respectively). Finally, as anticipated NYHA functional classification levels improved at stability compared to the time of decompensation (p<0.001) (Table 4).


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  		Table 4 Changes in biochemical markers and clinical assessments from administration of IV diuretic therapy to stability post IV diuretic therapy administration

 
3.4.2. Biochemical markers
Urea levels increased significantly from the time point of IV diuretic administration to stability post diuretic therapy (p=0.01). Similarly there was an increase in creatinine levels over this time period (p=0.07). A significant decrease in sodium levels was also observed between decompensation and stability (p=0.01). Except in the case of one patient admitted for acute renal failure, the changes observed in urea, creatinine and sodium levels were not of sufficient clinical relevance to indicate any changes in medical therapy. Potassium levels remained stable. BNP decreased from 1063±1203 pg/ml at time of IV diuretic to 892±1188 pg/ml at stability (p=0.01).


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
This report provides original data on the impact of using outpatient intravenous diuretic administration for the management of ADHF in the setting of a hospital based disease management programme (DMP). The data demonstrate the efficacy and relative safety of this approach, with 72% of patients and 74% of episodes of ADHF responding well with no worrying changes in renal profile. The report also identifies the characteristics of patients less likely to respond to this approach, with those with systemic hypotension, prior increase in oral diuretic and interestingly those on beta-blockers being less likely to respond.

The development of heart failure DMPs represents one of the most significant recent advances in the management of this syndrome [2-6,10]. One of the most important facets of this approach to care is the immediate response to emerging clinical deterioration. Educating patients to report asymptomatic weight gain or development of symptoms can facilitate early intervention, often with an increase in oral diuretic. This can avoid further decompensation, which would otherwise have resulted in hospitalisation. However, failure of this approach often leads to referral to an emergency department where admission usually follows.[11]

There have been no previous reports on expanding the role of DMP in the management of ADHF to include outpatient intravenous diuretic therapy. A hospital based DMP would seem to be appropriately structured to provide this service. Indeed, it would seem preferable to provide this higher intensity of intervention in the heart failure unit where the patient is well known, rather than by referral to an emergency department. Our experience to date demonstrates that this intervention is feasible and effective within the structure of a hospital-based DMP. This finding is particularly important in view of recent data from Maisel et al., showing that the vast majority of similar patients presenting to the emergency room with ADHF require admission to hospital [11]. However, in our view, the provision of continuous specialist medical support is essential when providing outpatient intravenous diuretic therapy, ideally access to a 7-day facility allowing all patients to be reviewed within 24 h of intervention, should be available.

Not all patients responded to outpatient intravenous diuretic therapy. Our study demonstrated that 28% of this population were eventually admitted despite this approach. Those admitted were more likely to be hypotensive, a known poor prognostic indicator in this syndrome. Furthermore, this group had an initial attempt at stabilisation with an increase in oral diuretic prior to use of intravenous diuretic. And finally this group were more likely to be on beta-blockers. However, several of these patients were undergoing beta-blocker titration, a time when decompensation is known to occur in a small proportion of patients [12]. These observations may be useful in the clinical decisions to use intravenous diuretic in this subgroup. Potentially other outpatient interventions such as short courses of inodilator therapy may be of benefit in those patients refractory to diuretic use. Alternatively, this may be the group who should be admitted earlier to expedite stabilisation.

A minority of this population required multiple IV diuretic administrations to achieve clinical stability. Although the numbers are small, this subgroup did not appear to be significantly more susceptible to readmission than those who received only one administration. It is of interest however, that the patient population requiring multiple administrations were similar to the group requiring a single administration in all but two characteristics, a higher blood urea and a more prevalent history of arthritis. This second observation might be explained by concomitant usage of non-steroidal and steroidal therapy for the management of arthritis [13].

Throughout the study period, there were a total of 251 other re-hospitalisations for heart failure within our DMP. Therefore, since we prevented an estimated 99 hospitalisations, the IV diuretic service was responsible for aborting approximately 30% of the total hospitalisation burden of the DMP. However, we know from unpublished data in our unit that one third of heart failure admissions occur within 24 h of symptom deterioration and therefore may not be amenable to an outpatient IV diuretic intervention. Therefore, the potential efficacy of the service may be greater than 30%. However, it appears that many people who may have been suitable for this intervention did not access the service, indicating that there are opportunities for wider application of this approach through patient and practitioner education and a more widespread application of the DMP model in the care of heart failure [9].

If our data were extrapolated to the National situation in Ireland which has a total population of 4 million people and approximately 20,000 heart failure hospitalisations annually, it is estimated that more than 6000 hospitalisations annually could be prevented by this approach. A large component of the cost of heart failure is frequent and recurrent hospitalisations [14]. Accordingly, outpatient administration of IV diuretics is likely to be cost effective.

In interpreting these data it must be emphasized that this is an observational report. There is no comparator arm though the outcome does suggest that this approach is safe and cost effective. The number of patients is also small which makes subset analysis of those failing to respond more questionable. Nonetheless defining those least likely to respond would potentially allow for better triage of patients as they decompensate.

In conclusion, in this observational study of patients presenting with acute decompensation to a heart failure disease management programme, outpatient administration of IV diuretics was successful in aborting the majority of threatened admissions. This approach was safe and well tolerated and resulted in significant cost savings. Further work is required to assess how this service could be more extensively applied to reduce the in-hospital burden of this illness.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

  1. McMurray J.J., Stewart S. Epidemiology, aetiology and prognosis of heart failure. Heart (2000) 83:596–602.[Free Full Text]
  2. Rich M.W., Beckham V., Wittenberg C., Leven C.L., Freedland K.E., Carney R.M. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med (1995) 333:1190–1195.[Abstract/Free Full Text]
  3. Cline C.M.J., Israelsson B.Y.A., Willenheimer R.B., Broms K., Erhardt L.R. Cost effective management programme for heart failure reduces hospitalisation. Heart (1998) 80:442–446.[Abstract/Free Full Text]
  4. Stewart S., Marley J.E., Horowitz J.D. Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with chronic congestive heart failure: a randomised controlled study. Lancet (1999) 354:1077–1083.[CrossRef][Web of Science][Medline]
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  7. Stromberg A., Martensson J., Fridlund B., Dahlstrom U. Nurse-led heart failure clinics in Sweden. Eur J Heart Fail (2001) 3:139–144.[Abstract/Free Full Text]
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  9. Conlon C., O'Loughlin C., Ledwidge M., Mc Donald K. Community direct access service for early detection and treatment of clinical deterioration: effectiveness and impact on the workload pattern of a hospital-based heart failure unit. Dis Manage Health Outcomes (2006) 14(3):185–190.[CrossRef]
  10. Ledwidge M., Barry M., Cahill J., et al. Is multidisciplinary care of heart failure cost effective when combined with optimal medical care? Eur J Heart Fail (2003) 5:381–389.[Abstract/Free Full Text]
  11. Maisel A., Hollander J.E., Guss D., McCullough P., Nowak R., Green G., et al. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A multicenter study of B-type natriuretic peptide levels, emergency department decision-making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol (2004) 44(6):1328–1333.[Abstract/Free Full Text]
  12. Butler J., Khadim G., Belue R., Chomsky D., Dittus R.S., Griffin M., Wilson J.R. Tolerability to s-blocker therapy among heart failure patients in clinical practice. J Card Fail (2003) 9(3):203–209. Jun.[CrossRef][Web of Science][Medline]
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  14. Stewart S., Jenkins A., Buchan S., McGuire A., Capewell S., McMurray J.J. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail (2002) 4(3):361–371.[Abstract/Free Full Text]

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This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
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