TAVI restricted to very old or very sick patients

August 29, 2012

The registry is part of the European Society of Cardiology (ESC) EURObservational Research Programme (EORP) of surveys and registries.

Today's presentation reveals current usage of the most modern TAVI valves and catheters in Europe, and compares indications, techniques and outcomes between different countries. "TAVI is a new technology which has been introduced in Europe but many question marks remain on which patients are most suitable," said Professor Di Mario. "We set up this registry because it was important to have a clear picture of clinical practice in Europe. Since our study was conducted during 2011-2012 we only included the very latest valves and delivery systems and this, together with the increased operator experience, probably explains the reduction in complications from previous studies and registries."

The registry included 4,571 patients who underwent the TAVI procedure using the Sapien XT or the CoreValve between January 2011 and May 2012. Patients were from 137 centres in Israel and 9 countries in Europe (, France, Spain, Switzerland, UK, Italy, Poland, Belgium, Germany).

The average age of patients was 81.4±7.1 years, with equal numbers of men and women. There was a high prevalence of comorbidities in all patients, but patients who were 80 years old or younger had a greater incidence of diabetes, COPD, extracardiac arteriopathy (carotid, peripheral), permanent renal dialysis, previous myocardial infarction, previous or percutaneous (PCI), previous (valve-in-valve procedure). Professor Di Mario said: "This shows that the use of TAVI in younger patients has been restricted to those with more comorbidities, who therefore have high surgical risks."

Overall in-hospital mortality was 7.4%. There were no significant differences in in-hospital mortality based on valve type (6.7% CoreValve, 7.9% Sapien XT, p=0.15) but there were significant differences based on the approach site (transfemoral 5.9%, transapical 12.8%, trans-subclavian and other approaches 9.7%, p<0.01).

The most frequent complication was bleeding requiring blood transfusion(s). The incidence was greater than 20% for the transapical and trans-subclavian approaches and 15.0% for the transfemoral approach (p<0.01).

The need to implant a permanent pacemaker was another frequent complication, with an overall incidence of 13.2%. The incidence of this complication was significantly greater in patients who received the CoreValve (23.4%) than in patients who received the Sapien XT valve (6.0%) (p<0.01).

There were no other differences in the incidence of in-hospital complications between the two valve types. There was a low and similar incidence of major vascular complications (3.1%), stroke (1.8%), (0.9%), and other complications.

The length of hospital stay was 9.3±8.1 days. There was wide variation between countries, from 7 days in Switzerland to more than 12 days in Poland. Patients who received general anesthesia had longer hospital stays than patients who received local anaesthesia (10.2±8.7 days vs 7.9±6.1 days, p<0.01). Hospital stays of more than 10 days occurred in 43.8% of patients treated with a transapical approach, 39.5% treated with other surgical approaches and 22.0% of patients treated transfemorally.

"Anaesthesia has a big influence on cost, duration of the procedure and length of hospital stay," said Professor Di Mario. "There are big differences between countries in the type of anaesthesia used. Poland and the UK conduct most transfemoral procedures under general anaesthesia while Switzerland and Italy use local anaesthesia for more than 60% of these procedures."

Pharmacological treatment varied greatly between countries. There was relatively low use of aspirin (64.3%) and clopidogrel or other thienopyridines (32.6%) at discharge. Professor Di Mario said: "This finding suggests poor compliance with the recommended strategy of using a combination of the two drugs at discharge after TAVI."

He added: "With an in-hospital of 7.3%, this contemporary registry of the most up-to-date valves and delivery shows that TAVI remains a high risk procedure when applied to very old patients or patients with significant comorbidities who are poor surgical candidates."

Professor Di Mario continued: "We now have a clear understanding of how TAVI is being used in these 10 countries. In the majority of cases, patients are very old and very sick, with lots of comorbidities which would have made their journey to surgery a nightmare."

He concluded: "The next step we are considering will be to launch a permanent registry that involves all countries in Europe. Collecting information on how devices are used, whether they are used appropriately, and how practice varies between countries offers enormous opportunities to provide data to regulatory authorities, monitor adherence to best practice guidelines and improve care for ."

Explore further: Gender differences in clinical presentation and outcome of transcatheter aortic valve implantation

Related Stories

Gender differences in clinical presentation and outcome of transcatheter aortic valve implantation

August 29, 2011
Severe aortic stenosis (AS) is increasing in frequency as the population ages. For a subset of patients in whom surgical conventional aortic valve replacement is excluded due to severe co-morbidities, an alternative to surgical ...

Which valve disease treatment—TAVI or conventional valve replacement—is best for which patient

August 27, 2012
The German Aortic Valve Registry (GARY) was started in July 2010 and is the only registry so far to include both transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacements and repair.(1) The ...

Tavi study shows low mortality rate, improvement in function at 30 days

March 26, 2012
Patients who underwent transcatheter aortic valve implantation (TAVI) at experienced medical centers had significant improvement in valve function as well as low mortality and stroke rates at 30 days, according to research ...

Hemodynamic results after Transcatheter Aortic Valve Implantation (TAVI)

August 30, 2011
Since 2007 Transcatheter Aortic Valve Implantation (TAVI) has become an alternative treatment for elderly patients with severe aortic stenosis at high risk for surgical aortic valve replacement. At present, durability and ...

Recommended for you

Could aggressive blood pressure treatments lead to kidney damage?

July 18, 2017
Aggressive combination treatments for high blood pressure that are intended to protect the kidneys may actually be damaging the organs, new research from the University of Virginia School of Medicine suggests.

Quantifying effectiveness of treatment for irregular heartbeat

July 17, 2017
In a small proof-of-concept study, researchers at Johns Hopkins report a complex mathematical method to measure electrical communications within the heart can successfully predict the effectiveness of catheter ablation, the ...

Concerns over side effects of statins stopping stroke survivors taking medication

July 17, 2017
Negative media coverage of the side effects associated with taking statins, and patients' own experiences of taking the drugs, are among the reasons cited by stroke survivors and their carers for stopping taking potentially ...

Study discovers anticoagulant drugs are being prescribed against safety advice

July 17, 2017
A study by researchers at the University of Birmingham has shown that GPs are prescribing anticoagulants to patients with an irregular heartbeat against official safety advice.

Protein may protect against heart attack

July 14, 2017
DDK3 could be used as a new therapy to stop the build-up of fatty material inside the arteries

Heart study finds faulty link between biomarkers and clinical outcomes

July 14, 2017
Surrogate endpoints (biomarkers), which are routinely used in clinical research to test new drugs, should not be trusted as the ultimate measure to approve new health interventions in cardiovascular medicine, according to ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.