Original Title: État des pratiques: État des pratiques : Profil évolutif de l’utilisation et des résultats cliniques de l’implantation valvulaire aortique par cathéter (TAVI) et par voie chirurgicale (RVA) au Québec : évaluation en contexte réel de soins de 2013 à 2019

Authors' objectives: Aortic valve stenosis occurs when the opening of the aortic valve narrows, reducing or blocking blood flow from the heart’s left ventricle into the aorta. This condition is most common in the elderly population and, when severe, carries a risk of mortality of 50% to 85% within 5 years of symptom onset. Standard treatments for severe and symptomatic aortic stenosis are surgical aortic valve replacement (SAVR), sometimes with coronary artery bypass grafting (CABG) to treat concomitant coronary artery disease, or percutaneous valve replacement (Transcatheter Aortic Valve Implantation, TAVI). The objective of the present document is to describe the use of these procedures, patient management, and clinical outcomes for TAVI and SAVR (+/-CABG) in the ‘real-world’ setting of care in Québec.

Authors' results and conclusions: RESULTS: MAIN FINDINGS FROM 2013-2019 DATA Main findings from 2013-2019 data (Evolution in volumes) • The use of TAVI more than doubled between 2013-2014 and 2018-2019 at the provincial level of Québec, increasing from 9.4 to 19.6 interventions per 100,000 inhabitants. In comparison, the rate of SAVR has remained relatively stable, between 18.1 and 21.5 interventions per 100,000 population for isolated SAVR and between 16.7 and 18.1 interventions per 100,000 population for SAVR+CABG. In other countries like the United States, the large increase in TAVI has been accompanied by a decrease in the volume of surgically-based interventions, with a 20% decline in 2019, the year the Food and Drug Administration (FDA) approved TAVI for patients at low risk of surgical mortality. • The rate of TAVI in Québec has increased over time in the population aged 75 years and older (from 43 to 81 procedures per 100,000 population between 2013 2014 and 2018-2019) and in those younger than 75 years (from 1.7 to 4.5 procedures per 100,000 population during the same period). • A variation in the total number of procedures used to treat severe and symptomatic aortic stenosis is observed between the designated centres, varying from 150 to 1,619 procedures per centre for the period 2016-2019. The volume of TAVI has increased at all centres. In 2016-2019, TAVI accounted for between one-quarter and nearly one-half of severe and symptomatic aortic stenosis treatments performed per hospital (when compared to TAVI and SAVR combined). (Evolution in deaths) • Between 2013-2016 and 2016-2019, the incidence of absolute mortality at 30 days following TAVI decreased from 4.8% to 2.4% among patients aged 75 years and older, and from 3.7% to 2.3% among those younger than 75 years. • In patients aged 75 years and older, 30-day mortality following isolated SAVR decreased from 3.2% to 1.0% between 2013-2016 and 2016-2019. A decrease in 30-day mortality was also observed in patients in the same age group who underwent SAVR+CABG (from 4.7% to 3.4%). In comparison, the incidence of 30-day mortality for both types of procedures (SAVR and SAVR+CABG) in younger patients remained stable between the two periods and was 1.0% and 2.4%, respectively, for 2016-2019. • In Québec, the risk of mortality for patients aged 75 years and older treated with isolated SAVR or TAVI has therefore decreased to levels equivalent to those of patients younger than 75 years, thereby reducing the level of age-related risk for isolated procedures. The incidence of mortality in the province is broadly consistent with averages observed in the most recent data from other jurisdictions such as Canada as a whole, the United States, and Finland. MAIN FINDINGS FROM REAL-WORLD DATA FROM OCTOBER 1, 2018 TO MARCH 31, 2019 (Characteristics and comorbidities) • Patients who underwent TAVI in Québec during the evaluation period from October 1, 2018, to March 31, 2019, tended to be older, have more comorbidities and have a higher surgical risk profile than patients who underwent SAVR. (Wait times) • Patients referred for isolated SAVR generally had shorter evaluation wait times (from consultation referral to treatment decision) than patients who underwent TAVI, but procedural wait times from treatment decision to procedure were twice as long compared to patients selected for SAVR+CABG or TAVI. The total wait time from referral to treatment by TAVI (129.0 days, 25th-75th percentile: 62.0 207.0 days), however, remained longer than for isolated SAVR (93.0 days, 25th-75th percentile: 41.0-168.0 days) or SAVR+CABG (56.0 days, 25th-75th percentile: 13.0-109.5 days). • According to documentation in the patients’ charts, the selection process differs depending on the aortic stenosis treatment for which the patient is referred. Whereas the records of TAVI patients attest to a consultation by a multidisciplinary group and an evaluation requiring various tests at the implanting centre, which are not or less well documented for SAVR patients, patients treated surgically, and particularly by SAVR+CABG, who have a distinct clinical profile, seem to undergo a simplified selection process and experience shorter delays to evaluation, in general. (Clinical outcomes) • In the 6-month evaluation period, TAVI patients had more complications such as stroke (3.3% versus 1.6% for isolated SAVR), pacemaker implantation (17.7% versus 6.2% for isolated SAVR), or unplanned vascular or endovascular surgery (4.7% versus 1.6% for isolated SAVR). As observed in Québec, pacemaker implantation in other countries (United States, Germany, and Finland) was more frequent for TAVI patients than for those who were treated surgically. • Patients aged 75 years and older treated by TAVI had a crude 30-day mortality risk of 2.3% compared with nil (0.0%) for patients treated by isolated SAVR. These two patient cohorts presented different characteristics, particularly with respect to age and comorbidity profile. These data do not allow for determination of longer-term mortality risk. CONCLUSIONS: This portrait shows an increase in the number of TAVI treatments in Québec between 2013 and 2019, which is accompanied by an overall improvement in short-term survival for patients treated for severe and symptomatic aortic stenosis. The increasing use of TAVI does not currently affect rates of SAVR in the province. During the period of the present evaluation, percutaneous treatment was still offered predominantly to patients who were inoperable or at intermediate or high risk of surgical mortality. Although TAVI requires a shorter hospital stay, the (crude) risk of short-term mortality remains higher in patients treated via the percutaneous approach, compared with those undergoing isolated SAVR, presumably because of their higher risk profile and greater number of comorbidities. Clinical practice in severe and symptomatic aortic stenosis is constantly evolving and may lead to changes in the management of this condition in Québec. Questions remain regarding organizational and clinical issues, including patient selection processes for different treatments, wait times, and longer-term clinical outcomes following TAVI.

Authors' methods: Volume and mortality data were collected starting in fiscal year 2013 2014, in collaboration with the clinical teams of the implanting Québec hospitals for TAVI and from the Canadian Institute for Health Information (CIHI) for SAVR (+/-CABG). Data on patient characteristics and processes of care were collected during a 6-month period, from October 1, 2018, to March 31, 2019, in collaboration with the clinical teams, for all TAVI and SAVR (+/-CABG) performed in patients 75 years of age and older.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/profil-evolutif-de-lutilisation-et-des-resultats-cliniques-de-limplantation-valvulaire-aortique-par-catheter-tavi-et-par-voie-chirurgicale-rva-au-quebec-evaluation-en-contexte-reel-de-soins-de-2013-a-2019.html

Year Published: 2021

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/profil-evolutif-de-lutilisation-et-des-resultats-cliniques-de-limplantation-valvulaire-aortique-par-catheter-tavi-et-par-voie-chirurgicale-rva-au-quebec-evaluation-en-contexte-reel-de-soins-de-2013-a-2019.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec