Downloaded from http://heart.bmj.com/ on May 14, 2015 - Published by group.bmj.com
Heart Online First, published on May 12, 2015 as 10.1136/heartjnl-2015-307737
Ventricular assist device: destination UK Neil J Howell, Hoong Sern Lim Advanced heart failure (HF) is a huge problem. First, advanced HF is highly prevalent, particularly in older age groups, the very groups that are now starting to dominate the populations of the developed world. Second, advanced HF is expensive, accounting for a significant proportion of GDP healthcare spending in developed counties. The majority of the cost is spent on a combination of medical therapy, hospital admissions and the dramatic increase in the use of biventricular pacemaker and defibrillators in HF. Third, this condition remains highly lethal despite medical and pacemaker/ defibrillator therapy, with an estimated 1-year freedom from hospitalisation or death as low as 32.9% in one study.1 For decades, heart transplantation has remained the only long-term treatment option for a minority of patients with advanced HF. The REMATCH trial2 marked the emergence of left ventricular assist devices (LVAD). Groundbreaking as the trial was, it did not detract clinicians and patients from the ultimate goal of heart transplantation. The term ‘bridge-to-transplant (BTT)’ was coined to describe the intention to mechanically support a transplant-eligible patient to heart transplantation, typically within 6 months to a year. This time frame was relevant due to the limited durability of the most commonly used device, the HeartMate XVE (Thoratec, Pleasanton, California, USA), at that time, but has been rendered almost irrelevant as the current generation of LVAD (eg, HeartMate II by Thoratec) has supported patients for over 9 years without the need for pump exchange. It was inevitable that the improving clinical outcomes would lead to the use of LVAD therapy as so-called ‘destination therapy’. This term was coined to describe the use of mechanical circulatory support in transplant-ineligible patients. The use of LVAD in this context is now supported by the superior clinical outcomes with the current generation of HeartMate II
Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK Correspondence to Dr Neil J Howell, Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust, Edgbaston, Birmingham B15 2 TH, UK; [email protected]
compared with the previous generation of HeartMate XVE LVAD.3 Despite advances in ventricular assist device (VAD) technology and clinical outcomes, the high cost of the VAD itself in association with significant postoperative care complication and expense profile has led to constrained introduction of this technology in many healthcare systems, particular in the UK where rates of implants lag far behind the USA. The NHS England VAD service-specific framework remains proscriptive, commissioning VAD only as a bridge to transplant and only for those deemed unlikely to survive long enough to receive a transplant on the national urgent heart transplant scheme. VADs are also commissioned for those with adverse pulmonary haemodynamics for which a VAD remains the only option to allow such patients to become transplant eligible. Hence, the majority of patients undergo VAD implants with the explicit intention to bridge to heart transplantation, which is reflected in the listing of stable uncomplicated patients with VAD on the non-urgent transplant scheme in the UK. However, this intention to BTT has been increasingly undermined by the current trends in heart transplantation. The likelihood of heart transplantation for patients not on the urgent transplant scheme is now increasingly remote due to the persistent shortage of donor organs and preferential allocation of donor organs to patients on the urgent and soon to be introduced ‘super-urgent’ transplant schemes. This is further compounded by the growth in the size of the urgent relative to the non-urgent heart transplant scheme, such that the vast majority of heart transplants are now performed on patients on the urgent transplant scheme. Such a pattern is also evident in the USA, prompting a call to trim the size of the waiting list.4 Patients with VAD who are stable and uncomplicated do not qualify for urgent or ‘super-urgent’ listing in the UK, and will therefore wait, potentially for years for a heart transplant. By extension, the intention to BTT is in reality ‘destination therapy’ for the majority of patients with VAD, albeit in transplant-eligible patients. Thus, the key difference between BTT in the UK and ‘destination therapy’ as defined lies in the eligibility for heart transplantation. Howell NJ, et al. Heart Month 2015 Vol 0 No 0
Editorial
Furthermore, stricter use of VAD therapy may interact with the urgent (and ‘super-urgent’) transplant scheme with a number of intended and unintended consequences. As an example, the drive to list patients for urgent heart transplantation rather than offering a VAD may disadvantage those for whom a heart transplant is the only option, as their anatomy or physiology may be less suitable for VAD therapy (eg, patients with restrictive cardiomyopathy and the majority of patients with congenital heart disease). The vanguard of patients with congenital heart disease is now starting to be referred to the heart transplant services and has the potential to completely change the demographics of the transplant population. Arguably, heart transplantation in patients suitable for VAD therapy may divert the limited donor organs and further disadvantage these patients. The review by Kirkpatrick and colleagues5 highlights the dramatic increase in the use of VAD in the USA, particularly in the context of ‘destination therapy’. The latter underlines the growing maturity of the clinical delivery of this technology in the USA. This review is timely in light of the current climate of heart transplantation and VAD therapy in the UK, and the recent publication of the guidance on the use of VAD as destination therapy in people ineligible for heart transplantation by the National Institute of Health and Care Excellence (NICE). The recommendation by NICE that there is now adequate evidence on the efficacy and safety of the implantation of an LVAD for destination therapy in people ineligible for heart transplantation represents a significant change in UK guidance. How will these new recommendations by NICE translate into clinical practice? First, it would be logical to believe that VAD implant number will increase with broadening of indications, just as expansion of indications has resulted in dramatic increases in biventricular pacemaker/defibrillator implant rates. However, the clinical commissioning remains unclear. The expense of the devices, the number of older patients potentially treatable and the current financial climate mean it is unlikely that the UK will follow the USA in terms of implant numbers for at least the foreseeable future. This is in stark contrast to the number of patients being offered TAVI, another very expensive cardiac intervention. Although in the UK this is almost exclusively restricted to the older and conventionally inoperable patients, the rise in implant numbers and also in the number 1
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd (& BCS) under licence.
Downloaded from http://heart.bmj.com/ on May 14, 2015 - Published by group.bmj.com
Editorial of implant centres has seen an inexorable rise of TAVI procedures in the UK. Second, the demographics of patients referred for VAD will change. The key areas of uncertainty remain patient age and comorbidities. Clinical outcomes of VAD therapy in older patients appear to be less favourable compared with younger patients. Nonetheless, a 63% 2-year survival reported by Atluri et al6 may be acceptable in selected patients with advanced HF (almost 75% INTERMACS 1–3), compared with the dismal outcomes in patients on inotropic support. A rigorous process of patient selection is vital, and the approach may be refined as clinical experience in this population develops. Given these challenges, VAD therapy in patients ineligible for transplantation should remain under the domain of an advanced HF service with access to transplantation. The ultimate treatment for end-stage HF is either replacement or augmentation of the patient’s heart. There are now viable mechanical options in addition to heart transplantation, including VAD and artificial hearts. Heart transplantation versus VAD debates have already started and will only intensify as the results of
2
durable mechanical circulatory approach that of heart transplantation. These debates will be further fuelled by the limited donor organs and greater use of marginal organs (and associated risk of severe primary graft dysfunction). Do the results of heart transplantation with marginal organs compare favourably with the predictable, if imperfect, results of VAD implantation? If we decide that it is only acceptable to use a standard criteria organ for patients in whom VAD is a reasonable option, is it morally acceptable to prioritise standard criteria organs for such recipients over recipients who cannot receive a VAD because of the pathophysiology of their HF? The current NICE recommendations in support of VAD therapy in transplant-ineligible patients will widen the debate to an epidemiologically more significant population of patients with advanced HF and signal the arrival of destination therapy in the UK. Competing interests None declared.
▸ http://dx.doi.org/10.1136/heartjnl-2014-306789 Heart 2015;0:1–2. doi:10.1136/heartjnl-2015-307737
REFERENCES 1
2
3
4
5
Provenance and peer review Commissioned; internally peer reviewed. To cite Howell NJ, Lim HS. Heart Published Online First: [ please include Day Month Year] doi:10.1136/ heartjnl-2015-307737
6
Costanzo MR, Mills RM, Wynne J. Characteristics of “Stage D” heart failure: insights from the Acute Decompensated Heart Failure National Registry Longitudinal Module (ADHERE LM). Am Heart J 2008;155:339–47. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end stage heart failure. N Engl J Med 2001;345:1435–43. Slaughter MS, Rogers JG, Milano CA, et al., for the HeartMate II investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;361:2241–51. Stevenson LW. The urgent priority for transplantation is to trim the waiting list. J Heart Lung Transplant 2013;32:861–7. Kirkpatrick JN, et al. Ventricular assist devices for treatment of acute and chronic heart failure. Heart Published Online First 06 May 2015 10.1136/heartjnl2014-306789. Atluri P, Goldstone AB, Kobrin DM, et al. Ventricular assist device implant in the elderly is associated with increased but respectable risk: a multi-institutional study. Ann Thorac Surg 2013;96:141–7.
Howell NJ, et al. Heart Month 2015 Vol 0 No 0
Downloaded from http://heart.bmj.com/ on May 14, 2015 - Published by group.bmj.com
Ventricular assist device: destination UK Neil J Howell and Hoong Sern Lim Heart published online May 12, 2015
Updated information and services can be found at: http://heart.bmj.com/content/early/2015/05/12/heartjnl-2015-307737
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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/
Heart Online First, published on May 12, 2015 as 10.1136/heartjnl-2015-307737
Ventricular assist device: destination UK Neil J Howell, Hoong Sern Lim Advanced heart failure (HF) is a huge problem. First, advanced HF is highly prevalent, particularly in older age groups, the very groups that are now starting to dominate the populations of the developed world. Second, advanced HF is expensive, accounting for a significant proportion of GDP healthcare spending in developed counties. The majority of the cost is spent on a combination of medical therapy, hospital admissions and the dramatic increase in the use of biventricular pacemaker and defibrillators in HF. Third, this condition remains highly lethal despite medical and pacemaker/ defibrillator therapy, with an estimated 1-year freedom from hospitalisation or death as low as 32.9% in one study.1 For decades, heart transplantation has remained the only long-term treatment option for a minority of patients with advanced HF. The REMATCH trial2 marked the emergence of left ventricular assist devices (LVAD). Groundbreaking as the trial was, it did not detract clinicians and patients from the ultimate goal of heart transplantation. The term ‘bridge-to-transplant (BTT)’ was coined to describe the intention to mechanically support a transplant-eligible patient to heart transplantation, typically within 6 months to a year. This time frame was relevant due to the limited durability of the most commonly used device, the HeartMate XVE (Thoratec, Pleasanton, California, USA), at that time, but has been rendered almost irrelevant as the current generation of LVAD (eg, HeartMate II by Thoratec) has supported patients for over 9 years without the need for pump exchange. It was inevitable that the improving clinical outcomes would lead to the use of LVAD therapy as so-called ‘destination therapy’. This term was coined to describe the use of mechanical circulatory support in transplant-ineligible patients. The use of LVAD in this context is now supported by the superior clinical outcomes with the current generation of HeartMate II
Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK Correspondence to Dr Neil J Howell, Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS Foundation Trust, Edgbaston, Birmingham B15 2 TH, UK; [email protected]
compared with the previous generation of HeartMate XVE LVAD.3 Despite advances in ventricular assist device (VAD) technology and clinical outcomes, the high cost of the VAD itself in association with significant postoperative care complication and expense profile has led to constrained introduction of this technology in many healthcare systems, particular in the UK where rates of implants lag far behind the USA. The NHS England VAD service-specific framework remains proscriptive, commissioning VAD only as a bridge to transplant and only for those deemed unlikely to survive long enough to receive a transplant on the national urgent heart transplant scheme. VADs are also commissioned for those with adverse pulmonary haemodynamics for which a VAD remains the only option to allow such patients to become transplant eligible. Hence, the majority of patients undergo VAD implants with the explicit intention to bridge to heart transplantation, which is reflected in the listing of stable uncomplicated patients with VAD on the non-urgent transplant scheme in the UK. However, this intention to BTT has been increasingly undermined by the current trends in heart transplantation. The likelihood of heart transplantation for patients not on the urgent transplant scheme is now increasingly remote due to the persistent shortage of donor organs and preferential allocation of donor organs to patients on the urgent and soon to be introduced ‘super-urgent’ transplant schemes. This is further compounded by the growth in the size of the urgent relative to the non-urgent heart transplant scheme, such that the vast majority of heart transplants are now performed on patients on the urgent transplant scheme. Such a pattern is also evident in the USA, prompting a call to trim the size of the waiting list.4 Patients with VAD who are stable and uncomplicated do not qualify for urgent or ‘super-urgent’ listing in the UK, and will therefore wait, potentially for years for a heart transplant. By extension, the intention to BTT is in reality ‘destination therapy’ for the majority of patients with VAD, albeit in transplant-eligible patients. Thus, the key difference between BTT in the UK and ‘destination therapy’ as defined lies in the eligibility for heart transplantation. Howell NJ, et al. Heart Month 2015 Vol 0 No 0
Editorial
Furthermore, stricter use of VAD therapy may interact with the urgent (and ‘super-urgent’) transplant scheme with a number of intended and unintended consequences. As an example, the drive to list patients for urgent heart transplantation rather than offering a VAD may disadvantage those for whom a heart transplant is the only option, as their anatomy or physiology may be less suitable for VAD therapy (eg, patients with restrictive cardiomyopathy and the majority of patients with congenital heart disease). The vanguard of patients with congenital heart disease is now starting to be referred to the heart transplant services and has the potential to completely change the demographics of the transplant population. Arguably, heart transplantation in patients suitable for VAD therapy may divert the limited donor organs and further disadvantage these patients. The review by Kirkpatrick and colleagues5 highlights the dramatic increase in the use of VAD in the USA, particularly in the context of ‘destination therapy’. The latter underlines the growing maturity of the clinical delivery of this technology in the USA. This review is timely in light of the current climate of heart transplantation and VAD therapy in the UK, and the recent publication of the guidance on the use of VAD as destination therapy in people ineligible for heart transplantation by the National Institute of Health and Care Excellence (NICE). The recommendation by NICE that there is now adequate evidence on the efficacy and safety of the implantation of an LVAD for destination therapy in people ineligible for heart transplantation represents a significant change in UK guidance. How will these new recommendations by NICE translate into clinical practice? First, it would be logical to believe that VAD implant number will increase with broadening of indications, just as expansion of indications has resulted in dramatic increases in biventricular pacemaker/defibrillator implant rates. However, the clinical commissioning remains unclear. The expense of the devices, the number of older patients potentially treatable and the current financial climate mean it is unlikely that the UK will follow the USA in terms of implant numbers for at least the foreseeable future. This is in stark contrast to the number of patients being offered TAVI, another very expensive cardiac intervention. Although in the UK this is almost exclusively restricted to the older and conventionally inoperable patients, the rise in implant numbers and also in the number 1
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd (& BCS) under licence.
Downloaded from http://heart.bmj.com/ on May 14, 2015 - Published by group.bmj.com
Editorial of implant centres has seen an inexorable rise of TAVI procedures in the UK. Second, the demographics of patients referred for VAD will change. The key areas of uncertainty remain patient age and comorbidities. Clinical outcomes of VAD therapy in older patients appear to be less favourable compared with younger patients. Nonetheless, a 63% 2-year survival reported by Atluri et al6 may be acceptable in selected patients with advanced HF (almost 75% INTERMACS 1–3), compared with the dismal outcomes in patients on inotropic support. A rigorous process of patient selection is vital, and the approach may be refined as clinical experience in this population develops. Given these challenges, VAD therapy in patients ineligible for transplantation should remain under the domain of an advanced HF service with access to transplantation. The ultimate treatment for end-stage HF is either replacement or augmentation of the patient’s heart. There are now viable mechanical options in addition to heart transplantation, including VAD and artificial hearts. Heart transplantation versus VAD debates have already started and will only intensify as the results of
2
durable mechanical circulatory approach that of heart transplantation. These debates will be further fuelled by the limited donor organs and greater use of marginal organs (and associated risk of severe primary graft dysfunction). Do the results of heart transplantation with marginal organs compare favourably with the predictable, if imperfect, results of VAD implantation? If we decide that it is only acceptable to use a standard criteria organ for patients in whom VAD is a reasonable option, is it morally acceptable to prioritise standard criteria organs for such recipients over recipients who cannot receive a VAD because of the pathophysiology of their HF? The current NICE recommendations in support of VAD therapy in transplant-ineligible patients will widen the debate to an epidemiologically more significant population of patients with advanced HF and signal the arrival of destination therapy in the UK. Competing interests None declared.
▸ http://dx.doi.org/10.1136/heartjnl-2014-306789 Heart 2015;0:1–2. doi:10.1136/heartjnl-2015-307737
REFERENCES 1
2
3
4
5
Provenance and peer review Commissioned; internally peer reviewed. To cite Howell NJ, Lim HS. Heart Published Online First: [ please include Day Month Year] doi:10.1136/ heartjnl-2015-307737
6
Costanzo MR, Mills RM, Wynne J. Characteristics of “Stage D” heart failure: insights from the Acute Decompensated Heart Failure National Registry Longitudinal Module (ADHERE LM). Am Heart J 2008;155:339–47. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term mechanical left ventricular assistance for end stage heart failure. N Engl J Med 2001;345:1435–43. Slaughter MS, Rogers JG, Milano CA, et al., for the HeartMate II investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 2009;361:2241–51. Stevenson LW. The urgent priority for transplantation is to trim the waiting list. J Heart Lung Transplant 2013;32:861–7. Kirkpatrick JN, et al. Ventricular assist devices for treatment of acute and chronic heart failure. Heart Published Online First 06 May 2015 10.1136/heartjnl2014-306789. Atluri P, Goldstone AB, Kobrin DM, et al. Ventricular assist device implant in the elderly is associated with increased but respectable risk: a multi-institutional study. Ann Thorac Surg 2013;96:141–7.
Howell NJ, et al. Heart Month 2015 Vol 0 No 0
Downloaded from http://heart.bmj.com/ on May 14, 2015 - Published by group.bmj.com
Ventricular assist device: destination UK Neil J Howell and Hoong Sern Lim Heart published online May 12, 2015
Updated information and services can be found at: http://heart.bmj.com/content/early/2015/05/12/heartjnl-2015-307737
These include:
References Email alerting service
Topic Collections
This article cites 5 articles, 0 of which you can access for free at: http://heart.bmj.com/content/early/2015/05/12/heartjnl-2015-307737 #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 Interventional cardiology (2757) Drugs: cardiovascular system (8173)
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/
