Temporal Trends in Patient Characteristics and Outcomes of Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement: A Nationwide Study

Abstract

With increased use of transcatheter aortic valve implantation (TAVI) in treatment of aortic stenosis, it is important to evaluate real life data trends in outcomes. This nationwide register-based study aimed to present an outlook on temporal trends in characteristics and outcomes, including mortality.First-time consecutive Danish patients who underwent TAVI from 2010 to 2019 were included in this study.The chi-square and Kruskal–Wallis tests were performed to assess the differences in the characteristics over time and Cochrane–Armitage trend tests were used to examine changes in complications and mortality. Between 2010 and 2019, 4,847 patients (54.6% men, median age 82 [quartile 1 to quartile 3: 77 to 85] years) underwent first-time TAVI. A statistically significant decrease over time was observed for preprocedural hypertension, ischemic heart disease, and heart failure, whereas preexisting chronic obstructive lung disease and preprocedural pacemaker remained stable. We observed a significant decrease in 30- and 90-day postoperative preprocedural pacemaker implantation from 2011 to 2017, with 15.1% and 15.9% in 2011 and 8.6% and 8.9% in 2017, respectively. The incidence of for 30- and 90-day heart failure significantly decreased from 19.3% and 20.3% to 8.5% and 9.1%, respectively. We observed significant changes for 30-day atrial fibrillation, whereas the changes over time for 90-day atrial fibrillation and 30- and 90-day stroke/transient ischemic attack remained insignificant. The all-cause mortality within 30- and 90 days significantly decreased over time from 6.7% and 9.2% in 2011 to 1.5% and 2.7% in 2019 and 2016, respectively. In conclusion, this national study provides general insight on the trends of complications and mortality of TAVI, demonstrating significant reductions over time. With increased use of transcatheter aortic valve implantation (TAVI) in treatment of aortic stenosis, it is important to evaluate real life data trends in outcomes. This nationwide register-based study aimed to present an outlook on temporal trends in characteristics and outcomes, including mortality. First-time consecutive Danish patients who underwent TAVI from 2010 to 2019 were included in this study. The chi-square and Kruskal–Wallis tests were performed to assess the differences in the characteristics over time and Cochrane–Armitage trend tests were used to examine changes in complications and mortality. Between 2010 and 2019, 4,847 patients (54.6% men, median age 82 [quartile 1 to quartile 3: 77 to 85] years) underwent first-time TAVI. A statistically significant decrease over time was observed for preprocedural hypertension, ischemic heart disease, and heart failure, whereas preexisting chronic obstructive lung disease and preprocedural pacemaker remained stable. We observed a significant decrease in 30- and 90-day postoperative preprocedural pacemaker implantation from 2011 to 2017, with 15.1% and 15.9% in 2011 and 8.6% and 8.9% in 2017, respectively. The incidence of for 30- and 90-day heart failure significantly decreased from 19.3% and 20.3% to 8.5% and 9.1%, respectively. We observed significant changes for 30-day atrial fibrillation, whereas the changes over time for 90-day atrial fibrillation and 30- and 90-day stroke/transient ischemic attack remained insignificant. The all-cause mortality within 30- and 90 days significantly decreased over time from 6.7% and 9.2% in 2011 to 1.5% and 2.7% in 2019 and 2016, respectively. In conclusion, this national study provides general insight on the trends of complications and mortality of TAVI, demonstrating significant reductions over time. Aortic stenosis is a chronic and the most frequent valvular heart disease that affects 2% to 7% of the population of the Western world over the age of 65 years1Spaccarotella C Mongiardo A Indolfi C Pathophysiology of aortic stenosis and approach to treatment with percutaneous valve implantation.Circ J. 2011; 75: 11-19Crossref PubMed Scopus (44) Google Scholar,2Vahanian A Baumgartner H Bax J Butchart E Dion R Filippatos G Flachskampf F Hall R Lung B Kasprzak J Nataf P Tornos P Torracca L Wenink A Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European Society of Cardiology.Eur Heart J. 2007; 28: 230-268Crossref PubMed Scopus (1) Google Scholar and the prevalence is increasing as the length of life increases in the western world.3Chakos A Wilson-Smith A Arora S Nguyen TC Dhoble A Tarantini G Thielmann M Vavalle JP Wendt D Yan TD Tian DH Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond.Ann Cardiothorac Surg. 2017; 6: 432-443Crossref PubMed Scopus (85) Google Scholar Severe symptomatic aortic stenosis has traditionally been treated by surgical aortic valve replacement (SAVR) with a mechanical or biologic valve prosthesis. Within the last decades, transcatheter aortic valve implantation (TAVI) has become the preferred choice of treatment for patients presenting with symptomatic disease in whom SAVR presents a high procedural risk and now also in moderate- and lower-risk patients. In the context of a 2-year mortality of 50% in patients with severe symptomatic aortic stenosis left untreated, the advent of TAVI represents an improvement in treatment options for many patients.1Spaccarotella C Mongiardo A Indolfi C Pathophysiology of aortic stenosis and approach to treatment with percutaneous valve implantation.Circ J. 2011; 75: 11-19Crossref PubMed Scopus (44) Google Scholar,3Chakos A Wilson-Smith A Arora S Nguyen TC Dhoble A Tarantini G Thielmann M Vavalle JP Wendt D Yan TD Tian DH Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond.Ann Cardiothorac Surg. 2017; 6: 432-443Crossref PubMed Scopus (85) Google Scholar, 4Popma JJ Deeb GM Yakubov SJ Mumtaz M Gada H O'Hair D Bajwa T Heiser JC Merhi W Kleiman NS Askew J Sorajja P Rovin J Chetcuti SJ Adams DH Teirstein PS Zorn GL Forrest JK Tchétché D Resar J Walton A Piazza N Ramlawi B Robinson N Petrossian G Gleason TG Oh JK Boulware MJ Qiao H Mugglin AS Reardon MJ Evolut Low Risk Trial InvestigatorsTranscatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380: 1706-1715Crossref PubMed Scopus (2300) Google Scholar, 5Leon MB Smith CR Mack M Miller DC Moses JW Svensson LG Tuzcu EM Webb JG Fontana GP Makkar RR Brown DL Block PC Guyton RA Pichard AD Bavaria JE Herrmann HC Douglas PS Petersen JL Akin JJ Anderson WN Wang D Pocock S PARTNER Trial InvestigatorsTranscatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607Crossref PubMed Scopus (5809) Google Scholar, 6Mack MJ Leon MB Smith CR Miller DC Moses JW Tuzcu EM Webb JG Douglas PS Anderson WN Blackstone EH Kodali SK Makkar RR Fontana GP Kapadia S Bavaria J Hahn RT Thourani VH Babaliaros V Pichard A Herrmann HC Brown DL Williams M Davidson MJ Svensson LG Akin J 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.Lancet. 2015; 385: 2477-2484Abstract Full Text Full Text PDF PubMed Scopus (1288) Google Scholar Several complications are associated with TAVI, including permanent pacemaker (PM), new-onset atrial fibrillation or flutter (AF), new-onset heart failure (HF), and stroke or transient ischemic attack (TIA), among others. In everyday clinical practice, these temporal trends of short-term and midterm complications are often not analyzed, and consistent data over a decade are rare. Analyzing the trends in complications over time is critical with increasing experience, changes in valve types and techniques, and transitions toward treating lower-risk populations. Therefore, in this nationwide study including a Danish cohort of first-time TAVI recipients from 2010 to 2019, we investigated the temporal trends in patient characteristics, including age, gender, and co-morbidities, together with outcomes within 30- and 90 days after the procedure, including mortality, and complications of PM implantation, new-onset AF, stroke or TIA, and HF. This study is a nationwide retrospective registry-based study, and follow-up data for study patients were obtained from nationwide registries. All residents in Denmark have a unique civil personal registration number that is used in all health care contacts, allowing detailed data to be collected from the Danish National Patient Registry. These data include hospital-based diagnoses (inpatient and outpatient) and surgical procedures, and these are classified according to the International Classification of Diseases, Tenth Revision and the Nordic Classification of Surgical Procedures, respectively. In addition, prescription drug information based on the Anatomical Therapeutic Chemical Classification was obtained from the Danish National Prescription Registry. All patients who underwent first-time TAVI in Denmark between January 1, 2010 and December 31, 2019 were included in this study. By January 1, 2010, the population of Denmark was 5,534,738, and by January 1, 2019, it had increased to 5,806,081. The procedures were carried out at 4 different centers across the nation, beginning in 2007 in 1 center, followed by 2 centers joining the TAVI program in 2008 and the last in 2010. Only a limited number of procedures were carried out before 2010; therefore, we limited this study on trends to include patients from 2010 to 2019. We included only patients in whom percutaneous transfemoral, transapical, and transaortic access were performed. Co-morbidities were based on the hospital diagnoses and for certain co-morbid conditions, either by hospital diagnoses or relevant prescription medication. Hypertension was defined as any relevant hospital diagnosis within the last 5 years or prescription filling of at least 2 antihypertensive drugs in 2 consecutive quarters before study inclusion. Diabetes and AF were defined as a relevant diagnosis code within 10 years before TAVI. For the definition of diabetes, we additionally included prescription medication for antidiabetics within 180 days before study inclusion. Preprocedural ischemic heart disease was defined by a diagnosis of angina pectoris, previous myocardial infarction, chronic ischemic heart disease, and/or earlier revascularization (coronary artery bypass graft or percutaneous coronary intervention [PCI]) treatment 10 years before the TAVI procedure. Previous PM was also defined as an implantation within 10 years before TAVI. HF before the procedure was defined by relevant diagnosis codes. We studied complications within the first 30 and 90 days after TAVI. These complications included PM implantation, AF, stroke or TIA, and HF. Furthermore, we evaluated the 30- and 90-day all-cause mortality. Descriptive data were reported as frequencies by counts and percentages for categorical variables and median with twenty-fifth to seventy-fifth percentiles (first to third quartiles [Q1 to Q3]) for continuous variables. Accordingly, the chi-square and Kruskal–Wallis tests were performed to test for the differences in the characteristics over time. The Cochrane–Armitage trend test was used to assess the temporal calendar year trends in the outcomes after first-time TAVI. A 2-sided p <0.05 was regarded as statistically significant. Data management and analysis were performed using SAS, version 9.4 (SAS Institute Inc., Cary, North Carolina) and R, version 4.0.3.7R Core a and for R for Scholar The within the of Denmark has use of data for this study to By Danish is not for register-based Between January 1, 2010 and December 31, 2019, we the characteristics and outcomes of 4,847 patients who underwent first-time TAVI in Denmark at 4 different The of TAVI increased from patients in 2010 to in 2019 among the 4 centers 1 to 1 the of the TAVI cohort over characteristics in TAVI median before or heart myocardial fibrillation or obstructive lung coronary artery bypass percutaneous coronary TAVI transcatheter aortic valve transient ischemic in a coronary artery bypass percutaneous coronary TAVI transcatheter aortic valve transient ischemic The median age of the cohort was 82 years to 77 to years) and were In the study patients had a had preexisting AF, had preexisting and had preexisting stroke or Hypertension was observed in of the and had diabetes, whereas ischemic heart disease of the patients. The changes over calendar time for characteristics and were statistically for previous diabetes, stroke or TIA, previous chronic disease and chronic obstructive disease significant decrease over calendar time was observed for hypertension, ischemic heart disease, previous coronary artery bypass graft and and HF. 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PubMed Scopus Google Scholar, N A W D D D J T J H TAVI and the National Institute for aortic valve implantation in the temporal of and a from the transcatheter aortic valve implantation (TAVI) 2007 to 2015; PubMed Scopus Google Scholar, A JJ S C RT B C D and outcomes after transcatheter aortic valve implantation (TAVI) in J Heart 2017; Google Scholar, RA Thourani VH Tuzcu EM S J S Mack MJ outcomes with transcatheter valve from the Surg. Full Text Full Text PDF PubMed Google Scholar, R A H P R S M E R S J Aortic of mortality after transcatheter aortic valve implantation for severe symptomatic aortic J Full Text Full Text PDF PubMed Scopus Google Scholar, SJ W B S Thourani VH Webb JG HC changes in mortality after transcatheter and surgical aortic valve retrospective analysis of patients Heart PubMed Scopus Google Scholar, MJ Leon MB Thourani VH Makkar R Kodali SK M Kapadia P J Hahn RT P Williams Brown DL Babaliaros V S P A Pocock SJ Webb JG Smith CR PARTNER InvestigatorsTranscatheter aortic-valve replacement with a valve in low-risk patients.N Engl J Med. 2019; 380: PubMed Scopus Google Scholar, V T E H B R P P JP T G D P F D JP G S A D L F E T F T P B L L B C L T M F JP A A A A L C C D L L P C S V J M H TAVI trends in transcatheter aortic valve replacement in 2 to 2017; PubMed Scopus Google Scholar, S A D D S T R S E F M F J C M T P S trends in and outcomes of transcatheter aortic valve a Heart J 2019; PubMed Scopus Google Scholar, D A P H procedural and patient analysis of Cardiothorac Full Text Full Text PDF PubMed Scopus Google Scholar have trends in patient to the of on temporal trends over a of 10 years are and only limited data on short-term mortality F J JJ JG JJ A J in patient characteristics and clinical over years of transcatheter aortic valve Heart J. PubMed Scopus Google S D S A A trends of transcatheter aortic valve implantation over a Med. PubMed Scopus Google Scholar We a significant decrease in 30-day PM implantation with 15.1% in 2011 and 8.6% for trend by The 30-day PM for 2019 is in previous 30-day PM of and A Wilson-Smith A Arora S Nguyen TC Dhoble A Tarantini G Thielmann M Vavalle JP Wendt D Yan TD Tian DH Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond.Ann Cardiothorac Surg. 2017; 6: 432-443Crossref PubMed Scopus (85) Google S A D D S T R S E F M F J C M T P S trends in and outcomes of transcatheter aortic valve a Heart J 2019; PubMed Scopus Google Scholar we a significant trend toward patients before the TAVI over this trend cannot the significant decrease in PM over time in study. and to for the 30-day PM implantation, 2 observed a significant in the incidence of PM the Society of of in and in with p for trend and the in 2010 and in with p for trend RA Thourani VH Tuzcu EM S J S Mack MJ outcomes with transcatheter valve from the Surg. Full Text Full Text PDF PubMed Google V T E H B R P P JP T G D P F D JP G S A D L F E T F T P B L L B C L T M F JP A A A A L C C D L L P C S V J M H TAVI trends in transcatheter aortic valve replacement in 2 to 2017; PubMed Scopus Google Scholar For the this in PM implantation was observed for whereas the that observed was of the of the These the for on outcomes to valve Data on valve types used the study were not with for 30-day new-onset AF, the observed a significant decrease in of AF for trend In addition, we reported a 30-day incidence for AF in 2019 of is to that of the AF of reported by A Wilson-Smith A Arora S Nguyen TC Dhoble A Tarantini G Thielmann M Vavalle JP Wendt D Yan TD Tian DH Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond.Ann Cardiothorac Surg. 2017; 6: 432-443Crossref PubMed Scopus (85) Google Scholar to of the and PARTNER were 7% and RA Thourani VH Tuzcu EM S J S Mack MJ outcomes with transcatheter valve from the Surg. Full Text Full Text PDF PubMed Google MJ Leon MB Thourani VH Makkar R Kodali SK M Kapadia P J Hahn RT P Williams Brown DL Babaliaros V S P A Pocock SJ Webb JG Smith CR PARTNER InvestigatorsTranscatheter aortic-valve replacement with a valve in low-risk patients.N Engl J Med. 2019; 380: PubMed Scopus Google Scholar We mortality for all included patients and an all-cause 30-day mortality of 6.7% in 2011 to 1.5% by 2019. In SJ W B S Thourani VH Webb JG HC changes in mortality after transcatheter and surgical aortic valve retrospective analysis of patients Heart PubMed Scopus Google Scholar a decrease in the all-cause 30-day mortality of to from to 2019. Furthermore, we a statistically significant decrease in the all-cause 30- and 90-day mortality the temporal in with the of the also reported a significant decrease in 30-day mortality from 2010 to for trend V T E H B R P P JP T G D P F D JP G S A D L F E T F T P B L L B C L T M F JP A A A A L C C D L L P C S V J M H TAVI trends in transcatheter aortic valve replacement in 2 to 2017; PubMed Scopus Google Scholar In the changes in temporal trends for all-cause 30-day mortality from 2007 to not to be of for trend N A W D D D J T J H TAVI and the National Institute for aortic valve implantation in the temporal of and a from the transcatheter aortic valve implantation (TAVI) 2007 to 2015; PubMed Scopus Google Scholar The with this study, present study This be the of this study with the time of this study provides a outlook on the changes in patient characteristics and outcomes in a time of and of the and the TAVI procedure in The differences in patient and characteristics also be regarded the consistent with study, the age over time was years and co-morbidities, including diabetes, chronic obstructive disease, and previous not over time. ischemic heart disease and procedures over time. the risk over time and the of or to a risk over time is a these data are for the preprocedural risk and the G T C P M H F S S outcomes of a European transcatheter aortic valve implantation cohort according to surgical risk of the 2019; Scopus Google Scholar In patient for TAVI SAVR is by the heart the patient the for aortic valve replacement in the European This is not by national In addition, the study population across the be and the of in valve P S V J H M Piazza N P in the context of transcatheter aortic valve implantation (TAVI) aortic valve replacement an of the Society of 2019; Full Text Full Text PDF PubMed Scopus Google Scholar For HF after TAVI, we a significant decrease in the incidence of HF for 30 and 90 days after the procedure for have that who HF after TAVI or present with preprocedural HF have a risk of A D R D L B R and outcomes of HF after transcatheter aortic valve implantation using a self-expanding Google RA of the of stroke and after transcatheter aortic valve J 2015; Full Text Full Text PDF PubMed Google Scholar This the for a on procedural HF before and after TAVI, and of patients with HF. 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