Patients with heart disease who have surgery have significantly better longer-term outcomes than patients opting for heart stents or transcatheter aortic valve implantation (TAVI), according to new evidence presented last Saturday at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Lisbon.
The new findings from several international studies raise questions about whether the innovations have been adopted too quickly in some instances leading to worse five year survival rates for patients. Leading international experts gathering in Lisbon will facilitate an important debate about the most effective treatment options for heart patients as EACTS highlights the importance of introducing new innovation safely and ensuring patients are able to discuss their individual risks and benefits with a multi-disciplinary heart team before having a procedure.
The findings were presented at the EACTS conference, the largest cardiothoracic conference in the world, and included:
- For several decades bypass surgery (CABG) has been known to offer better survival and a much reduced risk of subsequent myocardial infarction (heart attack) and need for further interventions compared to stents. It was also thought that patients with less severe disease could do as well with stents. However, a new study (Excel: Everolimus-Eluting Stent of Bypass Surgery for Left Main Artery Disease) now suggests that even patients with less severe forms of this disease who have bypass surgery have a significantly better chance of surviving for five or more years if they choose surgery. The Excel study not only shows that surgery gives patients around a one-third improved survival rate in comparison to stents but that at 5 years that survival benefit appears to be accelerating.
- The results of the Partner 2 Trial, to be presented for the first time in Europe, found that the five year outcomes for patients with ‘intermediate’ operative risk having surgical aortic valve replacement (SAVR) were significantly better than for those having the TAVI procedure. This means that for every 100 patients dying within 5 years of having the TAVI procedure, 75 people would have died having had surgery.
- An analysis in Italy of the long-term outcomes of TAVI vs SAVR led by Dr Barili, Cuneo, Italy, found that while early results are promising for TAVI, from 40 months onwards TAVI has significantly worse outcomes than conventional surgery. TAVI procedures are undertaken by both cardiologists and surgeons.
- The latest update from the North American TAVI registry reveals that the “real world” outcomes for patients are worse than those of the randomised trials. Data also shows that complication rates are not decreasing with time even though the numbers of TAVI procedures are growing.
Discussing the findings of the Excel study, Professor David Taggart, Professor of Cardiovascular Surgery at the University of Oxford, said:
“The EXCEL study looked at the best treatment for a potentially particularly lethal form of coronary artery disease called ‘Left main disease’ as it affects the most important blood vessel supplying blood to the heart muscle. While it is widely accepted that for severe patterns of disease that bypass surgery is best it was also previously thought that for less severe forms of disease the same result could be obtained with stents. However, the EXCEL study, the most definitive study of its kind for this type of disease, now shows that, assuming a patient is relatively fit, their chances of being alive after five years are dramatically better – by almost one-third – if they have heart bypass surgery rather than stent treatment. This confirms the importance of doing randomised clinical trials to ensure that potentially innovative techniques are actually as safe as the tried and tested standard techniques and that newer techniques must be implemented with caution. If a patient has blockages in the main heart artery or in more than two arteries and especially if the patient is diabetic, I strongly recommend that they get the opinion of a surgeon. Thankfully, in the UK, we have strong ‘Heart Teams’ consisting of cardiologists, surgeons and other experts who working closely together can recommend the best treatment to the individual patient. However, in most parts of the world the decision to recommend treatment is made by a cardiologist and, regrettably, the patient does not get any opinion from a surgeon.
Professor Nick Freemantle, Director Institute Clinical Trials and Methodology, University College London UK, said:
“The Partner 2 findings should be considered very carefully in clinical practice. They serve as a wake up call for the profession. It appears that some people may have adopted TAVI for too broad a range of patients. We know that for patients in need of aortic valve replacement – and who are not well enough for surgery – the TAVI procedure can be a lifeline. But now we have clear evidence – even for those patients with an intermediate level of risk – that the longer-term survival rates for patients who have surgical aortic valve replacement are significantly better than for those who have the TAVI procedure.
Dr Rita Redberg, Cardiologist at University of California San Francisco, co-chaired the debate on Saturday 5 October, said:
“These new findings highlight that some patients are living longer if they opt for surgery over some other techniques. This should focus minds: when advising on the right procedure for a patient, we need to know and share the data on risks and benefits. While avoiding surgery seems attractive in the short run, this short term benefit pales if it is at the price of longer survival with surgery. Patients will benefit from having their risks and benefits explained by a multi-disciplinary heart team to ensure they are able to access the best and personalized treatment. Innovation is vital and it’s how practice evolves but we must ensure innovation is introduced safely and is best for patients. We should avoid a race to widely adopt new techniques until such innovations can demonstrate equivalent sustainable results to established surgical techniques.”