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27th May 2021
The heart is composed of four chambers (aorta and ventricles) and two valves: the mitral valve is between the left atrium and ventricle, and the tricuspid valve is between the right atrium and ventricle.1,2
There are a further two valves in the large blood vessels (the pulmonary artery and the aorta) that leave the heart: the aortic and pulmonic valves.1,2The heart valves ensure that blood flows through the heart in one direction and does not flow back into the heart once it has been pumped out.1 The heart pumps oxygenated blood through the aortic valve in the aorta to the rest of the body.3
The aortic valve is comprised of thin leaflets that open and close to regulate blood flow.4 Over time, the valve leaflets can thicken, narrow and stiffen, resulting in the aortic valve failing to open and close properly. As the opening in the valve becomes smaller, the heart becomes less effective and pumps less blood out to the rest of the body. This is termed ‘aortic stenosis’ (AS),3,5,6and it is the most common valvular disease in developed countries among the elderly with a prevalence of 1-3% among those >70 years of age.7 If left untreated, aortic stenosis can lead to compromised heart function, heart failure and death.3,7
Aortic stenosis is a progressive disease and is categorised as mild, moderate or severe, depending on how much damage there is to the aortic valve.7,8 During mild or moderate stages, patients may remain asymptomatic with no noticeable symptoms and may be told that they have a heart murmur during routine check-ups.7,8 Advice for patients with mild or moderate asymptomatic AS is watchful waiting and to maintain a healthy lifestyle.3,9
As stenosis worsens, there is an increase in pressure in the left ventricle, causing the muscle to enlarge as a compensatory mechanism (termed ventricular hypertrophy) to maintain cardiac output.5,7,9,10As the disease progresses, this compensatory mechanism becomes inadequate, leading to symptoms of pulmonary oedema or heart failure.7,9,10Once AS becomes severe, noticeable symptoms may appear such as fatigue, shortness of breath, chest pain, heart palpitations; dizziness, syncope, or oedema of the feet and ankles.3,5,7,11
Although the condition can be asymptomatic for years, when symptoms do appear, untreated patients with severe AS have high mortality (up to 50% within 2 years).12,13 Waiting for treatment for severe symptomatic AS (ssAS) has a 1-month mortality at 3.7% and a 6-month mortality at 11.6% (measured from the time intervention was recommended).14
With a growing and ageing population, the prevalence of valvular heart disease is expected to rise, further increasing the public health burden of the disease.15
For severe symptomatic aortic stenosis, aortic valve replacement (AVR) should be recommended, which can include surgical repair or a less invasive procedure such as transcatheter aortic valve implantation (TAVI).3,7
TAVI is a minimally invasive interventional cardiology procedure catheter-based treatment that is performed under local rather than general anaesthetic.7,16The principle of TAVI is the insertion of a balloon-expandable valve inside the old valve, without the need to remove it.7 A catheter is inserted through a small incision in the groin (transfemoral TAVI) or via the left-hand side of the chest (transapical TAVI). The valve, which sits inside a stent is crimped onto the end of the catheter, and when in place, a small balloon is inflated, which allows the valve to expand.5,16Once expanded, the new valve displaces the native valve leaflets outward and takes over the regulation of blood flow across the aortic valve.7 TAVI significantly improves symptoms and potentially increases life expectancy and quality of life, without the need for open heart surgery.5,16
Clinical trial data have demonstrated that transcatheter AVR (TAVR) for inoperable patients extends median survival by approximately 19 months and significantly improves quality of life compared with medical therapy alone.12 In the same study, it has been suggested that substantial social value can be created as a result of TAVR treatment for these patients: up to $48.1 billion in value, roughly 80% of which accruing to patients (and 20% to device manufacturers).12 Using data from the PARTNER B trial,17 Reynolds and colleagues found that patients with ssAS considered to be at a high surgical risk who underwent TAVR experienced lifetime incremental cost-effectiveness ratios of $55,090 per quality-adjusted life year (QALY) gained and $43,114 per life-year gained.18 Such a perspective is useful for payers and policy makers because it extends the decision-making considerations concerning TAVR adoption beyond a narrow evaluation of short-term cost.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2342 v1.0
24th March 2021
Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3TM valve has been granted the CE mark for all-risk patients with severe symptomatic aortic stenosis (ssAS).1
Switching ssAS patients from other treatment methods to the less-invasive TAVI procedure will pave the way to improved hospital efficiency, including shortening waiting lists and length of stay (LOS) and lowering re-hospitalisation rates, which is of paramount importance during and post-COVID-19,2 as hospitals face tackling the backlog of patients whose care have been placed on hold while hospital resources have been restructured during the pandemic.3
Many studies have consolidated best practices to develop, implement and evaluate a standardized clinical pathway to facilitate safe discharge home at the earliest time after TAVI. These studies aimed to create clinical pathway protocols that supplement the TAVI procedure with the SAPIEN 3TM valve.4-6
Opportunities were first identified to adopt minimalist practices, standardizing post-procedure care, decreasing patients’ length of stay and facilitating safe discharge to home.4 An expanded multidisciplinary heart team designed a comprehensive TAVI clinical pathway that followed the patients’ journey from admission to discharge; the role of the multidisciplinary heart team is invaluable in implementing quality innovation that entails minimalist peri-procedure practices and facilitates early discharge home for patients with ssAS.4 The risk-stratified criteria that was identified informed the development of the multimodality, multidisciplinary but minimalist TAVR (3M TAVR) study.4,5
The barriers to implementing the TAVI clinical pathway were challenging and grounded in historical practices, the complexity and disciplines engaged in the care of TAVI patients, the adoption of length of stay as a programme quality indicator and the operational challenges of implementing peri-procedure practices.5 These barriers were addressed by an expanded multidisciplinary heart team approach that captured the patient’s journey from admission to discharge, in the form of a TAVI Care Team.
This multidisciplinary Care Team enabled communication and discussion of all operational and practice issues related to the clinical pathway initiative; identification of educational initiatives for members of the team; engagement and support of all multidisciplinary stakeholders, all of whom were focused and aligned on the adaptation of new processes, improved outcomes and reduced demand on health service resources; and implementation of practice changes involving the transition to minimalist care.
Consolidating TAVI organisational efficiencies, the results demonstrated that a minimalist, streamlined TAVI pathway with the Edwards Lifesciences SAPIEN 3TM valve, with rapid remobilisation, allows for next-day discharge home, with reproducible, excellent safety and efficiency outcomes. Next-day discharge and 48h discharge was achieved in 80% and 90% of TAVI patients, respectively, and amid concerns that a minimalist approach may affect safety or clinical efficacy, the composite primary endpoint of all-cause mortality or stroke by 30 days occurred in 2.9% of TAVI patients.5
This minimalist clinical pathway that utilised pre-specified risk criteria to allow a safe and timely discharge of patients with ssAS undergoing TAVI, was validated by the European FAST-TAVI trial in 2019. The trial found that the 30-day complication risk did not increase when pre-specified risk criteria was used.6
There are three key areas on which collaboration between Industry and hospitals might be based: evidence, tracking and technology. (Cogora, in-house data)
There is a significant body of TAVI literature that illustrates pre-, peri- and post-procedure processes that positively impact on the safety and efficiency of partnering with Industry. However, these processes can vary from site-to-site and operator-to-operator.
In Edwards Lifesciences, hospitals have a partner that has further consolidated these examples of best practice to create the Edwards BenchmarkTM Programme: an educational standardised care pathway (from admission to discharge) that optimises the TAVI clinical pathway with a programme designed to deliver good, reproducible patient outcomes and access, and improved institutional capacity driven by proven best practice.7
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2172 v1.0
Healthcare organisations have been reconfigured in response to the COVID-19 pandemic, including cancellations of elective procedures, which has resulted in one of the largest official waiting lists on record. There were 4.5 million patients waiting to complete treatment as of December 2020, with 4.7 million fewer completed patient pathways in 2020 vs 2019. Additionally, with 5.9 million referrals fewer in 2020 compared with 2019, there is the concept of the ‘hidden’ waiting list since many of these patients will still require treatment.1
Along with Edwards SAPIEN 3TM Transcatheter Heart Valve (THV) being CE-marked for use in all-risk patients,2-5 and increasing the number of patients eligible for TAVI as a consequence,6 the ongoing COVID-19 pandemic is undoubtedly adding to the increasing ssAS patient population who are eligible for TAVI.7
As COVID-19 restrictions are lifted, the priority for healthcare organisations will be to address the backlog of patients whose care has been placed on hold,8 and TAVI treatment for patients with ssAS has unique organisational benefits that will help healthcare organisations improve organisational efficiency with derivative economic benefits.7
It has been reported that during the peak of the pandemic, ssAS patients who were previously accepted for SAVR were being reconsidered for TAVI.7 Given the increased demand on healthcare resources during the pandemic, TAVI offers unique organisational advantages over SAVR since it is minimally invasive with lower complication rates, enabling faster recovery, shorter length of stay and conservation of resources;7,9 during the pandemic, clinical practice was guided by the large and well-established evidence base of TAVI in patients with severe aortic stenosis.10
Therefore, the COVID-19 pandemic has highlighted the organisational and patient benefits of TAVI vs SAVR. The clinical practice changes observed during the pandemic were based on well-established evidence of TAVI vs SAVR gained outside of a global pandemic environment; this suggests that the pandemic highlighted the existing benefits of TAVI and that these benefits may well extend beyond the pandemic.7,9,10
Consequently, in the hospital, the TAVI-led efficiencies in the management of ssAS patients may have a significant economic benefit when the patient pathway is optimised. As demonstrated in the 3M TAVI study, optimising the patient pathway has benefits for the hospital such as early discharge and excellent patient outcomes, which ultimately, might lead to financial benefits, improved waiting lists and less demand for beds.15
TAVI-led efficiencies with the Edwards Lifesciences SAPIEN 3™ valve can support hospitals with this, and the transition from SAVR to TAVI presents clear opportunities to improve organisational efficiency by: (1) minimising procedural time;5 (2) lowering the rates of complications5,16 (3) reducing the length of hospital stay without compromising safety;5,17 (4) reducing the rate of re-hospitalisation;5,18 (5) shortening waiting lists and (6) lessening demand on rehabilitation beds.
To counter the ever-increasing waiting list of patients,1 there is a proven need to increase hospital efficiencies, including lowering in-hospital complications to improve outcomes for patients as well as increasing access to beds for other patients.11 More importantly, improved efficiency and lower complication rates will improve patient waiting times: studies have shown that increased patient times can adversely affect patient mortality and morbidity while patients wait for intervention.12-14
| Minimising procedural time | |
| Organisational efficiency Procedure time (in minutes) has been shown to be reduced from 208.3 for SAVR to 58.6 for TAVI.5 |
Cost savings More patients can be treated daily in one cath-lab/hybrid room, or costs can be cut by reallocating/releasing staff.5 |
| Lowering the rates of complications | |
| Organisational efficiency In-hospital complications such as bleeding complications, severe kidney failure, and implantation of a second valve19 lead to inefficiencies, such as increased LOS consumption of additional resources and blocked access to hospital beds for other patients.11 |
Cost savings This adds to the hospital’s expenditure for additional nursing time, diagnostics, and pharmaceuticals before possible discharge.11 Potential cost savings that result from lower complication rates compared with surgery have been quantified with the SAPIEN 3 valve at ~€40005,16,19 |
| Reducing the length of hospital stay without compromising safety | |
| Organisational efficiency LOS was reported to be 3 and 7 days for TAVI and SAVR, respectively.5,16 Studies report safe discharge home ≤72h in 73% of TAVI patients, with 27% of these ≤24h and 51% ≤ 48h20 Across the EU, the mean LOS for TAVI patients ranges from 5 (France)21 to 14.5 (Germany) (data on file, Edwards Lifesciences). The UK mean is reported to be 5.5.22 |
Cost savings The TAVI minimalist approach limits direct procedural costs (estimated at a saving of ~€4000 over SAVR).5,16,23 More importantly, it shortens the median LOS (a saving of ~€1000 over SAVR for intensive care unit LOS, and ~€1900 for ward LOS,5,16,24 thereby minimising post-procedure costs.17 |
| Reducing the rate of re-hospitalisation | |
| Organisational efficiency Readmission after cardiac procedures is common and contributes to increased healthcare use.18 The primary cause of cardiac re-hospitalisation is heart failure,18 for which the median LOS is 4 days.25 The SAPIEN 3 valve leads to less hospitalisation at 30 days compared with SAVR, and it is the only TAVI system superior to SAVR for all-cause death, all stroke and re-hospitalisation at 1 year (8.5% versus 15.1%).5 |
Cost savings Re-hospitalisation has hospital costs in terms of staff, beds and procedural resources and lowering re-hospitalisation rates allows these resources to be allocated elsewhere, increasing hospital efficiency, and lowering waiting lists, leading to better outcomes for patients.11 |
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2125 v1.0
Increasing treatment alternatives for patients with ssAS at all levels of surgical risk has renewed the focus on incorporating patient values and preferences in a shared decision-making approach.1 There is increasing interest in integrating the patients’ perspective, expectations and motivation in the decision-making process.2 Patient-centred goals may inform selection of treatment options aligned with patient preferences; elicitation of these preferences is paramount to the continued movement towards increased patient-centred care.3
The most reported patient-defined goals in valvular disease are those goals that will lead to a better quality of life. In elderly populations with ssAS, patient treatment goals favour quality of life outcomes over survival, and patient-defined goals include maintaining independence, reducing symptoms, and increasing functional ability.3
These treatment goals mirror the current understanding and healthcare focus on patient-centred care and shared decision-making, which involve symptom burden, the experienced patient, expectations, healthcare support, logistical barriers/facilitators, obligations and responsibilities.2
Often overlooked, but equally important, is the absence of data on the patient-defined goals of treatment among low-risk patients with AS.1 Patients with ssAS who are of low surgical risk are young with an increased life expectancy, and therefore, long-term valve durability might be a consideration.4
However, in one study, patients aged <60 and ≥60 years placed a greater value on attributes that favoured TAVR than SAVR, such as a lower mortality rate, reduced procedural invasiveness, and quicker time to return to normal quality of life associated with TAVI, than the value on the time over which SAVR has been proven to work.5 It has been described that patients may define “procedural success” as being able to return home following a rapid return to their baseline mobilization and overall functional status, without experiencing delirium or other iatrogenic complications, and able to recover quickly to benefit from the physiological impact of their new valve.6
Patient-related benefits and patients’ quality of life have been reported to be better following TAVI compared with SAVR.
Patient length of stay in hospital following TAVI is reportedly shorter compared with SAVR (3 days vs 7 days).7,8 Similarly, there are reduced re-hospitalisation rates reported in TAVI compared with SAVR.7,9 Overall, studies have reported:
In short, these patients are home sooner, they feel better faster, and are more active compared with surgical patients, and because patients return home sooner, waiting lists are shorter for their fellow patients (critical in a time of increased need, resulting from all-risk patient suitability): all of which becomes of critical importance during and post the COVID-19 landscape. As hospitals attempt to tackle the backlog of patients whose care has been placed on hold during the pandemic, shorter waiting lists will benefit the hospitals’ efficiency.10
Patients’ satisfaction with their care is inextricably linked to the hospital in which they are treated, and hospital reputations can be enhanced or damaged by the satisfaction feedback of its patients.11 Hospital Boards and Senior Management are rightly attuned to the Voice of its patients – and the broadened, younger cohort of ssAS patients know how to use their Voice. Consequently, it has never been more important for hospitals to prioritise patient satisfaction.11
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-1966 v1.0
Aortic stenosis (AS) is the most common valvular heart disease in developed countries.1 It presents in 1.3% of the population aged ≥65 years,2 which rises to 4.1-5.2% in the population aged ≥75 years.3
By 2050, the prevalence of AS is expected to have doubled,2 and the impact of AS on health institutions is expected to increase due to the progressive ageing of the population.4
The only currently accepted treatment for symptomatic patients with severe AS (ssAS) is aortic valve replacement (AVR), and without treatment, prognosis is poor with a 3-year survival rate <30%.5 However, it is estimated that 33% of patients aged ≥75 years are declined for treatment, even when indicated.5 Moreover, many older patients are deemed to be of prohibitive risk for surgical aortic valve replacement (SAVR).1
Instead, patients with ssAS could be considered for transcatheter aortic valve implantation (TAVI).1
After the first successful TAVI procedure in 2002,6 >300,000 TAVI procedures have since taken place,7 and numerous prospective trials and observational studies have reported improved survival of TAVI compared with SAVR in prohibitive,8 high,9 intermediate10 and low surgical risk11 patients with ssAS.
In 2010, the first PARTNER trial enrolled patients with ssAS who were not considered candidates for surgical replacement of the aortic valve and found that, compared with standard therapy, TAVI significantly reduced the rates of death from any cause.8
This was followed by a non-inferiority trial that found similar rates of survival at 1 year in high-risk patients with ssAS who were still considered to be candidates for surgery who were assigned to undergo either SAVR or TAVI.9
By 2015, TAVI for inoperable or high-risk patients with ssAS was well established, but real-world evidence showed that 94% of patients with ssAS fall into the low- (80%) or intermediate-risk (14%) categories for whom TAVI was an option, despite a paucity of data.12 Clinical trial validation was provided by the PARTNER trial investigators in 2016, where intermediate-risk patients with ssAS were assigned to undergo either TAVI or SAVR, and no significant difference was reported in the primary end point of death or disabling stroke between TAVI and SAVR.10 This was supported by data from a propensity score analysis in intermediate-risk patients with ssAS that indicated significant superiority of TAVI compared with surgery for the composite outcome of all-cause death, all strokes and moderate to severe aortic regurgitation, suggesting that TAVI might be the preferred treatment alternative in intermediate-risk patients.13
In 2019, the PARTNER 3 trial was designed to address whether TAVI was a viable treatment alternative to SAVR in patients with ssAS of low risk. Patients were randomised to undergo either TAVI or SAVR and the primary endpoint was a composite outcome of death from any cause, stroke or rehospitalisation at 12 months. The rate of the primary endpoint was reported to be significantly lower in the TAVI group than the SAVR group.11
As TAVI moves into the low-risk patient population, an important consideration should be the increased life expectancy of this group, and therefore, the long-term valve durability needs to be understood.14 Long-term data on the function of TAVI valves post-procedure are just emerging but one study reported at a median follow-up of 5.8 years and a maximum of 10 years, long-term function is excellent with 91% of patients not experiencing any structural valve deterioration.14
It has been reported that there are 115,000 eligible ssAS candidates for TAVI who are deemed inoperable or of high- and intermediate-risk across the EU. With an ever-increasing ssAS population becoming eligible for TAVI, the expansion into young, low-risk patients as well as promising long-term outcome data, the uptake of TAVI across the EU is expected to increase to as much as 177,000 with major implications for healthcare resource planning.15
The ongoing COVID-19 pandemic is undoubtedly adding to the increasing ssAS patient population who are eligible for TAVI: it has been reported that during the peak of the pandemic, ssAS patients who were previously accepted for SAVR were being reconsidered for TAVI. In a pandemic setting, TAVI has some unique organisational advantages over SAVR such as reduced resourcing needs. However, patients should be risk stratified to ensure that the risk of exposure to COVID-19 is balanced with a definitive need to treat their ssAS, allowing those with poor short-term or intermediate-term outcomes to be treated.16
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-1965 v1.0
Ⓒ Cogora 2021
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