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TAVI: value for the patient and the hospital

Hélène Eltchaninoff
10 May, 2016  

The number of TAVI procedures is increasing rapidly with excellent results. Innovation and increased experience are set to further improve patient’s outcomes, as well as hospital efficiencies for this procedure

Hélène Eltchaninoff 
Chief of Interventional Cardiology
Charles Nicolle University Hospital Rouen, France
 
Transcatheter aortic valve implantation (TAVI) has become standard therapy in the last few years for patients at prohibitively high risk for conventional surgery. The use of TAVI procedures has therefore rapidly increased, which implicitly leads to greater activity and budget considerations at the hospital level.
 
As a result, the heart team community has begun to show how it is possible to provide selected patients with a more streamlined procedure and a faster recovery. With the evolution of the technology and greater experience, the procedure has been transformed, and TAVI is becoming ever simpler to perform. 
 
Recent experiences have shown clear opportunities to improve the efficiency and economics of TAVI by bringing down the rates of complications associated with TAVI and reducing the length of hospital stay without compromising safety. 
 
Streamlining the patient journey could have several benefits for patients, with fewer complications, shorter hospitalisation times, and improved quality of life. Hospitals can also benefit with lower costs, shorter waiting lists and increased volume of procedures.
 
Fig. 1: TAVI and surgical AVR numbers in Germany. Source: AQUA institute.1
 
The number of TAVI procedures is increasing rapidly with excellent results
In Germany, there has been a 20-fold increase in the use of TAVI since 2008 according to data from the AQUA Institute.1 The institute leads a national quality assurance programme, which registers all TAVI procedures and surgical aortic valve replacements (SAVR). Participation is mandatory for all hospitals and is linked to reimbursement. 
 
These annual quality reports show that the number of TAVI procedures rose from 637 in 2008 to 13,264 in 2014, while use of SAVR steadily declined. 
 
TAVI patients were older and had more comorbidities than SAVR patients, and older age was the most common reason for local heart teams to select TAVI over SAVR. The average age of TAVI patients has stayed about the same over time, at around 80 years. There has been a recent trend towards TAVI being performed in lower and intermediate risk cases because patients say they would prefer to have TAVI instead of SAVR.
 
Complications associated with TAVI have rapidly decreased, and fell from 9.4% in 2012 to 3.9% in 2014. Severe complications such as annular rupture, aortic dissection and coronary occlusions are rare, occurring in less than 0.3% of patients, and fewer patients (0.6%) now require emergency cardiac surgery. 
 
Dialysis is less often needed after TAVI than in 2008 and is now more often required after SAVR.
 
In-hospital mortality after TAVI has halved from 10.4% in 2008 to 4.2% in 2014, but mortality for SAVR has not changed. TAVI patients spend less time in hospital than in previous years (10.7 days in 2014), but length of stay has not changed for SAVR patients (12.1 days).
 
According to the authors, the increased use of TAVI and the accompanying fall in complications and death may be due to improvements in technology, operator experience, and growing numbers of patients at lower risk.
 
Similar findings have been reported in France, where use of TAVI has rocketed from 380 procedures in 2009 to 5164 procedures in 2014.2
 
Average length of hospital stay for TAVI patients in 2015 was 10.3 days (notably one day shorter for the balloon-expandable valves compared to the self-expandable valves).
 
Fig. 2: Proportion of early discharge patients (<3 days) from 2009 to 2014 in Rouen.
 
Latest technology set to further improve hospital economics and efficiencies 
The average length of stay after TAVI reported in European countries is still somewhat high compared to the potential that the technology can offer today. This can partly be explained by the reimbursement system in place in some countries. For example, hospitals in Germany, France and Switzerland receive full reimbursement for the TAVI procedure when patients stay in hospital for a minimum number of days, yet in some cases lengths of stay are more than three times higher than this minimum.
 
Germany’s minimum length of stay (for transfemoral approach) is four days yet the average is 11.9 days, while Switzerland’s average is 10.6 days despite a minimum of just three days. France requires patients to stay four to seven days (depending on the severity level of the case), yet the average stay is higher than 10 days.
 
In the meantime, a few experienced centres have recently shown that there are opportunities to provide patients with a faster recovery and reduce length of stay without compromising safety.
 
Less invasive approaches to TAVI using local anaesthesia and fluoroscopic or transthoracic echocardiography (TTE) have become feasible due to device development, including smaller catheters, the routine use of preprocedure computed tomography (CT) to guide device choice and increasing institutional and operator experience with the implantation technique. These approaches can shorten hospital stays and reduce costs. 
 
Early discharge (less than three days) after TAVI has been shown to be feasible and safe. In Rouen, France, using the Edwards SAPIEN 3 transcatheter heart valve, 64% of patients were discharged within three days.3 The patient pathway for early discharge included outpatient screening with TTE and CT, careful patient selection and communication with relatives. Patients received local anaesthesia with or without conscious sedation and stayed in the intensive care unit (ICU) overnight. Discharge home between 24 and 72 hours after the procedure was permitted unless there were complications or new persistent left bundle branch block (LBBB).
 
Predictive factors for late discharge included post-TAVI blood transfusions.4 The results show that early discharge is feasible and safe in selected patients using an uncomplicated planned transfemoral procedure with the Edwards SAPIEN valve and local anaesthesia.
 
Investigators in Catania, Italy, have reported a similar experience.5 During the entire study, nearly one quarter (23%) of patients were discharged within three days of the transfemoral TAVI procedure. Adoption of an early discharge strategy increased over time, reaching nearly 40% of patients in the last 18 months of the study. This was achieved with greater experience in postprocedural management, teaching programmes for physicians, nurses and physiotherapists on how to manage patients early after transfemoral TAVI, and a slight reduction in the risk profile of patients.
 
Early discharge was not associated with an increased risk of mortality, bleeding, pacemaker implantation or rehospitalisation at 30 days, showing that early discharge could be safe in selected patients.
 
Patients were more likely to have a prolonged hospital stay if they had advanced heart failure or bleeding after the TAVI procedure. Factors associated with reduced length of stay included having a pacemaker before TAVI.
 
Similarly, in a study done in Belfast, Northern Ireland, 21.7% of patients receiving transfemoral TAVI were discharged the same or next day, 32.5% were in hospital for more than 1–4 days, and 45.8% were discharged after four days.6 After implementing an early discharge algorithm, the proportion of same or next day discharges increased from 4.1% to 21.0% within one year.
 
There was no difference in 30-day mortality between the three groups. There was also no association between time to discharge and readmission rate, dispelling concerns that a shorter stay in hospital could increase the risk of patients being readmitted. Patients who required a new pacemaker were in hospital longer, and none were implanted in the group discharged on the same or next day. The same or next day discharge group was more likely to have a percutaneous procedure with the Prostar vascular closure system or the Edwards SAPIEN 3 or SAPIEN XT prostheses.
 
In this experience, an economic analysis showed that shorter lengths of stay achieved with a less invasive approach led to substantial savings in bed days. The procedure cost per patient (including cost of bed-days, cost of transesophageal echocardiography (TEE) and cost of general anaesthesia) was three times higher for patients discharged after four days compared to patients discharged between one and four days.  
 
Finally, by minimising the rates of complications, the latest valve technologies can reduce the ‘hidden costs’ of TAVI procedures. In the PARTNER trial, approximately 25% of non-implant related hospital costs were attributed to complications.7 Major bleeding, arrhythmias, death, and postprocedural renal failure led to the greatest increase in overall hospital costs.
 
A single-centre prospective German study found that the average incremental cost of a single complication was €3438.8 This was largely due to ICU costs, and most likely attributable to the complexity of patients and the severity and timing of their complications. Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers. The authors concluded that strategies and advances in device design that reduce these complications could significantly reduce hospital costs.
 
Conclusions
The use of TAVI procedures has increased rapidly, with excellent results. Technological advancements and the growing experience of heart teams is enabling hospitals to discharge patients earlier and reduce complications, which is accompanied by reduced costs. These improvements will become increasingly important as the number of TAVI patients increases further and resources need to be optimised.
 
The key ingredients to successfully implementing a more streamlined patient pathway for TAVI include excellent staff organisation, communication with patients and families, thorough selection of patients, and use of the appropriate technology.
 
References
  1. Eggebrecht H, Mehta RH. Transcatheter aortic valve implantation (TAVI) in Germany 2008-2014: on its way to standard therapy for aortic valve stenosis in the elderly? EuroIntervention 2016;11:1029–33.
  2. Data presented at the High Tech congress, January 2016, Marseille, France, by Hervé Le Breton from Rennes, France.
  3. Presented by Hélène Eltchaninoff (Rouen, France) at PCR London Valves, September 2015, Berlin, Germany.
  4. Durand E et al. Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation with the Edwards SAPIEN-XT prosthesis. Am J Cardiol 2015;115(8):1116–22.
  5. Barbanti M et al. Early discharge after transfemoral transcatheter aortic valve implantation. Heart 2015;101(18):1485–90.
  6. Noad RL et al. A pathway to earlier discharge following TAVI: Assessment of safety and resource utilization. Catheter Cardiovasc Interv 2015. doi: 10.1002/ccd.26005.
  7. Arnold SV et al. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement. Circ Cardiovasc Interv 2014;7:829–36.
  8. Gutmann A et al. Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System. Int J Cardiol 2015;179:231–7.