Feature | September 17, 2012

TAVI Restricted to Very Old or Very Sick Patients

European registry shows latest trends in transcatheter aortic valve implantation

ESC Heart Valve Repair Hybrid OR Clinical trial/study

Cardiologists are restricting the use of transcatheter aortic valve implantation (TAVI) to very old or very sick patients at high surgical risk, according to research presented at the recent European Society of Cardiology (ESC) Congress. The first results of the Transcatheter Valve Treatment (TCVT) Sentinel Pilot Registry were presented by registry chairman Professor Carlo Di Mario.

The registry is part of the ESC Euro Observational Research Programme (EORP) of surveys and registries.

The 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 Jan. 2011 and May 2012. Patients were from 137 centers in Israel and nine countries in Europe (Czech Republic, France, Spain, Switzerland, U.K., Italy, Poland, Belgium and 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 cardiac surgery or percutaneous coronary intervention (PCI), previous aortic valve replacement (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%) (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%), myocardial infarction (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% of patients treated transfemorally.

“Anesthesia 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 anesthesia used. Poland and the U.K. conduct most transfemoral procedures under general anesthesia while Switzerland and Italy use local anesthesia for more than 60 percent 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 mortality of 7.3 percent, this contemporary registry of the most up-to-date valves and delivery catheters shows that TAVI remains a high risk procedure when applied to very old patients or patients with significant co-morbidities 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 patients.”

For more information: www.escardio.org

Related Content

Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants
News | Heart Valve Technology| August 26, 2016
This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity...
cardiac surgery, simulation training, University of Washington, case studies

Multiple repetitions of bypass grafts on a heart, using the Ramphal simulator. Courtesy of the University of Washington in Seattle.

News | Cardiovascular Surgery| August 25, 2016
August 25, 2016 — Simulation training fo
aortic dissection, family history, same age, clinical study, John A. Elefteriades, Annals of Thoracic Surgery
News | Structural Heart| August 25, 2016
People with a family member who had an aortic dissection — a spontaneous tear in one of the body’s main arteries —...
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Overlay Init