Downloaded from http://heart.bmj.com/ on December 6, 2014 - Published by group.bmj.com

Coronary artery disease

ORIGINAL ARTICLE

Pre-procedural fasting for coronary interventions: is it time to change practice? Tahir Hamid,1,2 Qaiser Aleem,1 Yeecheng Lau,1 Ravi Singh,1 John McDonald,1 John E Macdonald,3 Sanjay Sastry,2 Sanjay Arya,2 Anthony Bainbridge,2 Telal Mudawi,2 Kanarath Balachandran1 1

Royal Blackburn Hospital NHS Trust, Blackburn, UK Royal Albert Edward Infirmary, NHS Trust, Wigan, UK 3 Salford Royal NHS Foundation Trust, Salford, UK 2

Correspondence to Dr Tahir Hamid, Department of Cardiology, Royal Albert Edward Infirmary, NHS Trust, Wigan lane, WN12 NN, Wigan, UK; [email protected] Received 25 November 2013 Revised 9 January 2014 Accepted 19 January 2014 Published Online First 12 February 2014

ABSTRACT Introduction Traditionally, patients are kept nil-per-os/ nil-by-mouth (NPO/NBM) prior to invasive cardiac procedures, yet there exists neither evidence nor clear guidance about the benefits of this practice. Objectives To demonstrate that percutaneous cardiac catheterisation does not require prior fasting. Methods The data source is a retrospective analysis of data registry of consecutive patients who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and stable angina at two district general hospitals in the UK with no on-site cardiac surgery services. Results A total of 1916 PCI procedures were performed over a 3-year period. None of the patients were kept NPO/NBM prior to their coronary procedures. The mean age was 67±16 years. 1349 (70%) were men; 38.5% (738/1916) had chronic stable angina, while the rest had ACS. 21% (398/1916) were diabetics while 53% (1017/1916) were hypertensive. PCI was technically successful in 95% (1821/1916) patients. 88.5% (1697/1916) had transradial approach. 77% (570/738) of elective PCI patients were discharged within 6 h postprocedure. No patients required emergency endotracheal intubation and there were no occurrences of intraprocedural or postprocedural aspiration pneumonia. Conclusions Our observational study demonstrates that patients undergoing PCI do not need to be fasted prior to their procedures.

INTRODUCTION

To cite: Hamid T, Aleem Q, Lau Y, et al. Heart 2014;100:658–661. 658

Patients are usually kept nil-per-os/nil-by-mouth (NPO/NBM) for about 4–6 h prior to cardiac procedures (diagnostic coronary angiograms, percutaneous coronary interventions (PCIs) and device therapy) as these are considered procedures with a potential risk for vomiting and aspiration pneumonia. The risk of developing pulmonary aspiration following emergency coronary artery bypass grafting (CABG) surgery or emergency direct current conversion (DC) in patients without preprocedural NPO/NBM is in the order of 0.0015%.1 Currently no North American2 or European guidelines3 require patients to be NPO/NBM before cardiac procedures. Furthermore, there is little evidence1 available about the benefits of preprocedural fasting, and there exist no clear guidelines that advocate the benefit of fasting in low to medium risk procedures. Patients who are kept NPO/NBM

are potentially at risk of dehydration; contrastinduced nephropathy, hypoglycaemia, and poorly controlled hypertension, particularly in the older age group. However, a period of fasting is still considered beneficial should the patient need to undergo emergency endotracheal intubation in the event of cardiac arrest or emergency cardiac surgery. Currently, no guidelines exist for preprocedural fasting in emergency sedation. In this retrospective study, we aimed to demonstrate that low to medium risk percutaneous coronary procedures could be safely performed without preprocedural fasting.

MATERIAL AND METHODS This study is a retrospective analysis of our database consisting of patients who underwent PCI at two institutions, where no cardiothoracic surgical cover was in place. Data over a period of 3 years, between 2010 and 2013, were analysed. Information was collected from hospital PCI databases and clinic letters. Microsoft Excel was used for data input, and additional statistical methods used including Student t test. There is no primary PCI service at either of the institutions and, therefore, our database includes some patients who were thrombolysed and subsequently underwent coronary interventions. All patients were consented as per local guidelines. Patients were given sedation as per patient request or operator choice. The sedatives used in our practice are intravenous Diazepam (2.5–10 mg), Midazolam (1–4 mg) or Fentanyl (25–50 mcg). The primary endpoint was emergency endotracheal intubation and development of aspiration pneumonia. Currently, although keeping patients NPO/NBM is a standard practice in most UK healthcare providers, the cardiology team in our two institutions have abandoned this practice due to lack of supporting data, following local agreement. All patients at our two institutes, admitted for elective PCI and acute coronary syndrome (ACS), are not kept NBM, and the advice includes that they have a light breakfast in the morning, without the need for being NBM/NPO for 4 h. Patients are listed according to clinical urgency, and go to the catheter laboratory for the procedure as soon as a slot is available. Postprocedure patients are discharged the same day, or according to the clinical need. Patients with renal impairment were given N-actylecysteine, preprocedural and postprocedural hydration, based on

Hamid T, et al. Heart 2014;100:658–661. doi:10.1136/heartjnl-2013-305289

Downloaded from http://heart.bmj.com/ on December 6, 2014 - Published by group.bmj.com

Coronary artery disease individual needs and local trust guidelines. Patients’ procedures have never been cancelled or delayed for not being NBM. The need for postprocedural renal function tests depends on the individual needs, and those who are high risk are either checked the next day or appropriate advice given to their general practitioner.

RESULTS A total of 1916 PCIs were performed over a period of 3 years. Patient demographics are shown in table 1. PCI was technically successful in 95% (1821/1916) of patients; 88.5% (1697/1916) had transradial approach. Glycoprotein IIb/IIIa inhibitors were used in 8% (158/1916). Pressure Wire studies and Intra-Vascular Ultrasound (IVUS) were used in 13% (258/1916) and 9% (181/ 1916), respectively. Other devices used included thrombectomy catheters and distal protection devices for vein graft interventions.

In-hospital complications No patients required emergency intraprocedural endotracheal intubation, and no patients developed either intraprocedural or postprocedural aspiration pneumonia (table 2). Four inpatient deaths occurred (0.2%), none of which was procedure induced. Those patients were admitted with extensive myocardial infarctions (late presentation of STEMI) and cardiogenic shock needing airway support on admission. They were subsequently transferred to the cathlab from the intensive care unit (while intubated and ventilated) for their PCI procedures. None of them died in the cathlab; 2 (0.1%) patients (not intubated) required transfer to regional tertiary centre for emergency CABG. One had a left main stem dissection, and the other had a fractured angioplasty balloon wedged in the proximal circumflex artery during PCI. Both patients had successful CABG surgery. Eleven patients (0.6%) had bleeding complications, six (0.3%) of whom had haematomas requiring blood transfusions and Femstop application to achieve haemostasis. Five patients (0.26%) developed arterial access complications, two (0.1%) of whom developed pseudoaneurysm of the right radial artery requiring thrombin injection and surgical repair. The remaining three patients (0.16%) developed false aneurysms of the femoral artery, with one requiring surgical exploration and two needing localised thrombin injections. One patient (0.05%) required pericardial drainage following cardiac tamponade secondary to PCI-induced left anterior descending artery (LAD) perforation. One patient (0.05%) had catheter induced spiral dissection of the left coronary system requiring left main stem coronary stenting.

Table 1 Demographics of patients undergoing percutaneous coronary interventions n=1916 (^) Male Diabetic Hypertensive Smoker Hyperlipidaemia STEMI Chronic stable angina NSTEMI/unstable angina

1349 398 1017 1048 972 108 738 1070/1916

(71) (20) (53) (54) (29.8) (5.5) (38.5) (56)

Hamid T, et al. Heart 2014;100:658–661. doi:10.1136/heartjnl-2013-305289

Two patients (0.1%) developed strokes, while five (0.26%) had a myocardial infarction following PCI. Two patients (0.1%) had cardiac arrest following transient air embolism from which they were successfully resuscitated within 1–2 min without the need for intubation. The 78% of patients admitted for elective PCI were discharged on the same day. One patient was in hospital for 9 days due to other medical problems. Within our study cohort, out of those patients who received sedation, only one 89-year-old patient needed Flumazenil reversal due to excessive sedation with Midazolam.

DISCUSSION Currently, there is little evidence to support the traditional practice of keeping patients NBM for 4–6 h prior to cardiac catheterisation. Traditionally, patients undergoing any form of surgery are kept NPO/NBM for 4–6 h to minimise the risk of pulmonary aspiration during sedation or general anaesthesia.4 Similarly, patients in some centres undergoing cardiac catheterisation are fasted in case the need arises for emergency intubation during unexpected cardiac arrest situations.1 The incidence of emergency CABG following cardiac catheterisation is between 0.15% and 0.4%,5 6 while that of cardiac arrest is under 1%.7 Unsurprisingly, patients admitted with acute myocardial infarction undergoing primary PCI are not usually fasted beforehand and the need for emergency intubation or emergency CABG remains rare in these patients.8 At our institutions, patients presenting with ACSs as well as for elective admission for cardiac catheterisation, are not kept NPO/NBM, and are brought to the catheter lab when slots are available. Our cohort of patients included day case procedures for elective PCI and patients admitted with ACS. Patients with ACS included unstable angina, Non-ST segment elevation myocardial infarction (NSTEMI) and STEMI ( post-thrombolysis or late-presenters). A study by Warner et al9 has shown a rare occurrence of pulmonary aspiration in general anaesthesia with the risk being 0.02% for elective and 0.1% for emergency procedures. In two randomised controlled trials by Wright et al10 and Chan11 of 69 patients and 87 patients, respectively, neither showed any case of pulmonary aspiration with the use of Midazolam/Diazepam and etomidate. None of their patients were NPO/NBM.

Table 2

Procedural complications n=1916 (%)

Intraprocedural endotracheal intubation and/or aspiration pneumonia On table cathlab death Inpatient death Myocardial Infarction Stroke Emergency transfer for coronary artery bypass grafting Bleeding requiring transfusion Minor bleeding Radial artery aneurysm Femoral artery aneurysm Coronary perforation, tamponade and pericardial drainage Left main coronary dissection requiring emergency stenting Air embolism causing transient cardiac arrest Total

0 (0) 0 (0) 4 (0.2) 5 (0.26) 2 (0.1) 2 (0.1) 6 (0.31) 5 (0.26) 2 (01) 3 (0.16) 1 (0.05) 1 (0.05) 2 (0.1) 33 (1.7)

659

Downloaded from http://heart.bmj.com/ on December 6, 2014 - Published by group.bmj.com

Coronary artery disease Similarly, in an observational study by Dunn et al12 of 48 non-fasting patients using Propofol, no patient developed pulmonary aspiration. A Cochrane review of 38 randomised controlled trials did not show an increased risk of pulmonary aspiration with shorter fluid fast.13 A review article by Thorpe et al14 did not report any increased risk of pulmonary aspiration from not being fasted, in the emergency department. However, a prospective multicentre emergency department study of 2623 patients by Taylor et al15 revealed 461 patients experienced at least one airway event requiring intervention. Only one of the 34 patients who vomited developed aspiration pneumonia following sedation use. Studies have shown that clear oral fluids given up to 2 h before anaesthesia does not increase gastric acidity or gastric fluids volume.13 16 17 Søreide et al18 in a Scandinavian preoperative fasting guideline recommends 2 h fasting for clear fluids, 6 h for solids in healthy individuals, and supports the concept of preoperative oral nutrition using a special carbohydrate-rich beverage.19 Coronary procedures require the use of intravenous contrast, which can precipitate acute renal impairment.20 Keeping patients NPO/NBM, particularly those with pre-existing renal impairment or the elderly could, arguably, precipitate acute kidney injury leading to a prolonged hospital stay and associated health and economic implications. In our study, there were few patients with severe renal failure, but certainly if patients are kept hydrated, the risk of contrast-induced nephropathy will be reduced. A review study by Hiremath et al21 has shown that oral rehydration is as effective as the intravenous route for volume expansion to reduce the risk of contrast-induced acute kidney injury. Similarly, patients mostly do not take their

antihypertensive medication (NPO), which may lead to poorly controlled hypertension during the procedure.

CONCLUSION This retrospective observational study indicates that coronary interventional procedures can be safely undertaken without the need to keep patients NBM/NPO. A prospective randomised trial may be required to convince the majority of cardiologists to abandon the traditional stringent NBM/NPO protocols they currently adopt for their coronary procedures.

LIMITATIONS This is a retrospective observational study with no randomisation and no control arm. Acknowledgements The study was performed at Royal Albert Edward Infirmary NHS Trust, Wigan and Royal Blackburn Hospital NHS Trust. Contributors TH: Planning, conduct, and reporting of the work, described in the article from Royal Blackburn Hospital NHS Trust, Blackburn and Royal Albert Edward Infirmary, NHS Trust, Wigan and writing the manuscript. He is the guarantor. QA and YL: Planning, conduct, data entry and reporting of the work described in the article from Royal Blackburn Hospital NHS Trust, Blackburn and Royal Albert Edward Infirmary, NHS Trust, Wigan. RS and JM: Planning, conduct, and reporting of the work described in the article from Royal Blackburn Hospital NHS Trust, Blackburn. SS: Planning, conduct, literature search and reporting of the work described in the article from Royal Albert Edward Infirmary, NHS Trust, Wigan. SA: Planning, conduct, and reporting of the work described in the article from Royal Albert Edward Infirmary, NHS Trust, Wigan. AB: planning, conduct, and reporting of the work described in the article from Royal Albert Edward Infirmary, NHS Trust, Wigan. TM: Responsible for the overall content as guarantor from Royal Albert Edward Infirmary, NHS Trust, Wigan. KB: Responsible for the overall content as guarantor from Royal Blackburn Hospital NHS Trust, Blackburn. Competing interests None. Ethics approval Local Hospital Committee. Provenance and peer review Not commissioned; externally peer reviewed.

Key messages What is already known on this subject Currently there is little evidence to support the need for preprocedural fasting for coronary interventions. This is a novel study where patients were allowed to eat and drink freely before their coronary interventions, yet with satisfactory clinical outcomes. What this study adds This study is a prime example of quality improvements in providing services to the patients as it has proven that traditional strict rules of preprocedural fasting are not needed based on the available new evidence in our study and the available literature. How might this impact on clinical practice This will have significant impact on the clinical practice as patients would not need to be kept nil by mouth and will therefore have less risk of missing medications. More importantly, there will be an impact on care quality as there will be less risk of procedural cancellations, thereby reducing the risk of delaying the diagnosis and/or PCI treatment. Although this has yet to be confirmed by a randomised study, we also expect that a non-fasting policy shall reduce the risk of dehydration and the need for pre-admissions for rehydration in susceptible patients such as those who are diabetics and/or have renal impairment. 660

REFERENCES 1

2

3

4

5

6

7

8

9 10

Rosengarten J, Ozkor M, Knight C. Fasting and cardiac catheterization should we be following the evidence. Controversies and Consensus in Imaging and Intervention (C2I2) 2007;V5:22–3. Levine GN, Bates ER, Blankenship JC, et al. ACCF/AHA/SCAI guidelines for percutaneous coronary intervention: Executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 2011:e44–e122. plus Data Supplements 3–4. Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2010;31:2501–55. Warner MA, Caplan RA, Epstein BS, et al. Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: A Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting. Anaesthesiology 1999;90:896–905. Williams DO, Holubkov R, Yeh W, et al. percutaneous coronary interventions in the current era with 1985 to 1986; The national heart, lung and blood registries. Circulation 2000;102:2945–51. Grayson AD, Moore RK, Jackson M, et al. Multivariate prediction of major adverse cardiac events after 9,914 percutaneous coronary interventions in the north west of England. Heart 2006;92:658–63. Webb JG, Solankhi NK, Chugh SK, et al. Incidence, and correlates and outcome of cardiac arrest association with percutaneous coronary intervention. Am J Cardiol 2002;90:1252–4. Wharton TP. Should patients with acute myocardial infarction be transferred to a tertiary center for primary angioplasty or receive it at qualified hospitals in the community? The case for community hospital angioplasty. Circulation 2005;112:3509–34. Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology 1993;78:56–62. Wright SW, Chudnofsky CR, Dronen SR, et al. Comparison of midazolam and diazepam for conscious sedation in the emergency department. Ann Emerg Med 1993;22:201–5.

Hamid T, et al. Heart 2014;100:658–661. doi:10.1136/heartjnl-2013-305289

Downloaded from http://heart.bmj.com/ on December 6, 2014 - Published by group.bmj.com

Coronary artery disease 11

12 13 14 15 16

Chan KLL. Etomidate and midazolam for procedural sedation in the emergency department of Queen Elizabeth Hospital: a randomised controlled trial. Hong Kong J Emerg Med 2008;15:75–87. Dunn T, Mossop D, Newton A, et al. Propofol for procedural sedation in the emergency department. Emerg Med J 2007;24:459–61. Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev 2003;(4);Hoboken: John Wiley & Sons. Thorpe RJ, Benger J. Pre-procedural fasting in emergency sedation. Emerg Med J 2010;27:254–61. Taylor DM, Bell A, Holdgate A, et al. Risk factors for sedation-related events during procedural sedation in the emergency department. Emerg Med Australas. 2011;23:466–73. Maltby JR, Sutherland AD, Sale JP, et al. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery?. Anesth Analg 1986;65:1112–16.

Hamid T, et al. Heart 2014;100:658–661. doi:10.1136/heartjnl-2013-305289

17 18 19

20

21

Philips S, Hutchinson S, Davidson T. Preoperative drinking does not affect gastric contents. Br J Anaesth 1993;70:6–9. Soreide E, Eriksson LI, Hirlekar G, et al. Pre-operative fasting guidelines: an update. Acta Anaesthesiol Scand 2005;49:1041–7. Hausel J, Nygren J, Lagerkranser M, et al. A carbohydrate rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg 2001;93: 1344–50. McCullough PA, Wolyn R, Rocher LL, et al. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med 1997;103: 368–75. Hiremath S, Akbari A, Shabana W, et al. Prevention of contrast-induced acute kidney injury: is simple oral hydration similar to intravenous? A systematic review of the evidence. PLoS ONE 2013;8:e60009.

661

Downloaded from http://heart.bmj.com/ on December 6, 2014 - Published by group.bmj.com

Pre-procedural fasting for coronary interventions: is it time to change practice? Tahir Hamid, Qaiser Aleem, Yeecheng Lau, Ravi Singh, John McDonald, John E Macdonald, Sanjay Sastry, Sanjay Arya, Anthony Bainbridge, Telal Mudawi and Kanarath Balachandran Heart 2014 100: 658-661 originally published online February 12, 2014

doi: 10.1136/heartjnl-2013-305289 Updated information and services can be found at: http://heart.bmj.com/content/100/8/658

These include:

References Email alerting service

Topic Collections

This article cites 18 articles, 7 of which you can access for free at: http://heart.bmj.com/content/100/8/658#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.

Articles on similar topics can be found in the following collections Drugs: cardiovascular system (8040) Interventional cardiology (2726) Percutaneous intervention (890)

Notes

To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/

Pre-procedural fasting for coronary interventions: is it time to change practice?

Traditionally, patients are kept nil-per-os/nil-by-mouth (NPO/NBM) prior to invasive cardiac procedures, yet there exists neither evidence nor clear g...
79KB Sizes 2 Downloads 0 Views