• „ ORIGINAL ARTICLE

Temporal trends of transcatheter aortic valve implantation in a high-volume academic center over 10 years

Zenon Huczek1*, Bartosz Rymuza1*, Maciej Mazurek1, Radosław Wilimski2, Piotr Scisło1, Karol Zbroński1, Kajetan Grodecki1, Szymon Jędrzejczyk1, Ewa Pędzich-Placha1, Piotr Hendzel2, Krzysztof J Filipiak1, Grzegorz Opolski1, Janusz Kochman1

11st Department of Cardiology, Medical University of Warsaw, Warszawa, Poland

2Department of Cardiosurgery, Medical University of Warsaw, Warszawa, Poland

*Both authors equally contributed to the study.

INTRODUCTION

Transcatheter aortic valve implantation (TAVI) is currently the least invasive procedure available for the definitive treatment of severe symptomatic aortic stenosis (AS). Initially, it has been a highly specialized procedure, carried out only in a few selected academic centers in Poland, and only on inoperable, highest risk patients [1–3]. As time went by, due to positive results from large randomized trials, TAVI was recognized for a broader population of AS patients in European guidelines on the management of valvular heart disease and subsequently became more routine [4–8].

While the standards of care were changing, the number of TAVI procedures in Poland grew slowly but steadily from its introduction in 2008. Parallel to guidelines modifications, improvements in bioprothesis design and function, and changes in procedural technique and periprocedural management of patients were observed. Therefore, the aim of the study was to analyze temporal trends in baseline characteristics, procedural as well as clinical outcomes of patients treated with TAVI based on the experience of a high-volume polish academic center over the period of 10 years.

METHODS

Study population

For the purpose of the study we included 506 consecutive patients who received TAVI from March 2010 to July 2019 and who gave their informed consent to enter Transcatheter Valve Treatment Sentinel Registry (2010–2012), which later was continued by the national POL-TAVI registry database [9, 10]. Data concerning patients’ characteristics and periprocedural outcomes were gathered prospectively. All patients completed a 12-month follow-up, as obligated by the registry protocol. The study was approved by the ethics committee of the Medical University of Warsaw and that patients provided written informed consent to participate in the study.

Given certain changes in clinical practice throughout the studied period, we decided to divide the study population into 3 groups. Group 1 (G1), early experience, procedures performed from March 2010 until the end of 2013. This period was characterised by no clinical practice guidelines or early introduction of the 2012 European Society of Cardiology (ESC) Valvular Heart Disease (VHD) guidelines. Also, first-generation bioprosthetic valves were used. Group 2 (G2), intermediate experience, from January 2014 until the end of 2016. Age of implementing 2012 ESC VHD guidelines with improved and new types of bioprosthesis being introduced. Group 3 (G3), recent experience, from January 2017 until July of 2019. Time of implementing the 2017 ESC VHD guidelines implementation and growing use of second-generation devices use.

Data collection and definitions

Data was acquired using the hospital electronic database and outpatient clinic charts. All patients with an unconfirmed status were followed up remotely by telephone visits. All definitions are in accordance with Valve Academic Research Consortium Criteria-2 [11].

Statistical analysis

The Shapiro-Wilk test was used to confirm or reject the normal distribution of each continuous variable. Continuous variables with normal distribution were presented as means (SD) and compared between three groups using ANOVA with Welch statistics. Tukey post-hoc analysis for ANOVA test was applied when appropriate. Continuous variables with non-normal distribution were presented as medians with interquartile range (IQR) and compared with the Kruskal-Wallis test. Categorical variables, expressed as counts and percentages, were compared using the Chi-square test or Fisher’s exact test, as appropriate.

Kaplan-Meier curves and log-rank tests of the time-to-event data were used to assess the differences of 1-year all-cause mortality between the groups. Cox proportional hazard analysis was performed to find possible predictors of mortality in 1-year observation for all groups. All probability values reported are 2-sided and a value <0.05 was considered to be significant. Data were processed using the SPSS software, version 26 (IBM SPSS Statistics, NY, USA) and Medcalc, version 16 (MedCalc Software, Ostend, Belgium).

RESULTS

Baseline clinical and echocardiographic characteristics

After dividing into subgroups the population of G1 consisted of 130 patients, G2 and G3 of 164 and 212 patients, respectively. There were no significant between-group differences in terms of either mean age or percentage of the female sex (Table 1).

There was however a clear decrease in logistic Euroscore values with G3 being of the lowest risk (G1 = 14.0 [8.4–20.2] vs G2 = 12.0 [7.0–22.2] vs G3 = 5.1 [3.5–8.5]; P <0.001). Patients in G3 also had higher rates of previous percutaneous interventions and the lowest frequency of previous coronary artery bypass grafting. The presence of peripheral artery disease changed with time. There were significant differences in baseline aortic valve area but not in terms of left ventricular ejection fraction (Table 1). Group 1 was characterized by the highest mean pressure gradient before TAVI (G1 = 47 [39–60] mm Hg vs G2 = 43 [34–51] mm Hg vs G3 = 43 [34–51] mm Hg; P <0.001) (Figure 1).

Procedural characteristics

Procedural management changed significantly during the analyzed time (Table 2).

In G1 there were only 2 types of prostheses used (Corevalve 64.6% and Sapien/Sapien XT 34.6%) with the biggest diversification of the devices reached in G2. In G3 there was a visible reversion into utilizing 2 types of valves, both of them being self-expandable (Evolut R/PRO 47.6% and Portico 47.2%).

Procedural anesthesia has also been significantly transformed — from 95.4% of cases done in general anesthesia in G1 to only 26.9% in G3 (replaced by conscious sedation). Time has brought a significant increase in applying trans-femoral access for TAVI with 91.5% of cases performed this way in G3. With the introduction of trans-carotid access in late 2014 [12], more invasive trans-apical and direct-aortic access were gradually withdrawn. With higher rates of application of trans-femoral access came wider use of percutaneous closing devices (Prostar XL in G1, Prostar XL and Proglide in G2 and Proglide in G3) reaching 84.9% in G3.

There has been a gradual decrease in using predilatation before valve implantation (93.8% in G1 to 59.9% in G3) with a parallel increase in postdilatation (20.8% in G1 to 35.8% in G3). The procedural time was shortened and contrast use decreased (Table 2).

Echocardiographic follow-up

All patients achieved significant improvement in the aortic valve area (AVA), which was sustained in 1-year observation (Figure 1). There were between-group differences in terms of post-procedural and 1-year AVA with lowest values recorded for G1 (post-procedural AVA: G1 1.70 [1.5–1.8] cm2 vs G2 1.86 [1.7–2.0] cm2 vs G3 1.90 [1.7–2.1] cm2; P <0.001; 1-year AVA: G1 1.66 [1.5–1.8] cm2 vs G2 1.80 [1.7–1.9] cm2 vs G3 1.80 [1.6–2.0] cm2, P = 0.002). Sustained reduction in mean transvalvular gradients with no significant differences between groups was observed (Figure 1).

Functional status

Almost two-thirds of patients referred to TAVI were severely symptomatic (NYHA class III and IV) (Figure 2).

Figure 2. Functional status before and after TAVI.

Abbreviations: CI, confidence interval; HR, hazard ratio; NYHA, New York Heart Association

In 67.6% of cases performing TAVI helped to completely relieve the signs of heart failure (NYHA I) or leave only minor symptoms (NYHA II 24.1%). This positive effect was maintained in survivors at 1-year observation (NYHA I in 72.4% and NYHA II in 21.3% of cases).

Clinical outcomes and 1-year mortality

Postprocedural outcomes improved significantly over time in terms of reducing major or life-threatening bleeding (G1 26.9%, G2 12.8%, G3 9.4%; P <0.001), major vascular complications (G1 15.4%, G2 8.5%, G3 5.7%; P = 0.02), and moderate to severe paravalvular leakage (G1 16.2%, G2 11%, G3 7.5%; P = 0.046) (Table 3).

Table 3. Clinical outcomes

	All	Group 1 (2010–2013)	Group 2 (2014–2016)	Group 3 (2017–2019)	P-value
	n = 506	n = 130	n = 164	n = 212
Hospital stay, days median (IQR)	10 (4–18)	15 (7–24)	11 (7–17)	7 (4–14)	<0.001
Moderate or severe PVL, n (%)	55 (10.9)	21 (16.2%)	18 (11%)	16 (7.5%)	0.046
Major or life-threatening bleeding, n (%)	76 (15)	35 (26.9%)	21 (12.8%)	20 (9.4%)	<0.001
Major vascular complications, n (%)	46 (9.1)	20 (15.4%)	14 (8.5%)	12 (5.7%)	0.02
Strokea, n (%)	17 (3.4)	5 (3.8%)	4 (2.4%)	8 (3.8%)	0.40
TIAa, n (%)	8 (1.6)	2 (1.5%)	4 (2.4%)	2 (0.9%)	0.37
Permanent pacemaker, n (%)	84 (16.6)	22 (16.9%)	24 (14.6%)	38 (17.9%)	0.63
30-day all-cause mortality, n (%)	34 (6.7)	10 (7.7%)	15 (9.1%)	9 (4.2%)	0.28

aAll cerebroembolic accidents occurred during the index hospitalization.

Abbreviations: IQR, interquartile range; PVL, paravalvular leak; TIA, transient ischemic attack. All definitions according to VARC-2 criteria

Moreover, patients in G3 had the shortest length of hospital stay. On the other hand, stroke rate and need for permanent pacemaker implantation did not decrease with time (Table 3).

During the 12-month follow-up after TAVI, mortality from all causes was significantly lower in G3 (9.1%) as compared with G1 (20%; P = 0.004) and G2 (17.7%; P = 0.02) (Figure 3).

In our dataset, we observed a clear survival improvement in short-term observation accompanied by stable echocardiographic parameters up to 1 year. The aim of future studies and registries should also focus on the assessment of long-term bioprosthetic performance [24, 25].

1. 1. Zembala M, Wilczek K, Przybylski R, et al. POL-TAVI First — Polish report on transcatheter aortic valve implantation (TAVI) of Edwards-Sapien prosthesis in the first 19 high risk patients with severe aortic stenosis and comorbidities [article in Polish]. Kardiol Pol. 2009; 67(8): 936–940, indexed in Pubmed: 19784896.
2. 2. Kleczyński P, Bagieński M, Sorysz D, et al. Short- and intermediate-term improvement of patient quality of life after transcatheter aortic valve implantation: a single-centre study. Kardiol Pol. 2014; 72(7): 612–616, doi: 10.5603/KP.a2014.0065, indexed in Pubmed: 24671914.
3. 3. Wilczek K, Chodór P, Przybylski R, et al. First in Poland transcatheter, transfemoral aortic valve implantation in elderly symptomatic high-risk patient with aortic stenosis — novel Zabrze experience [article in Polish]. Kardiol Pol. 2009; 67(2): 219–223, indexed in Pubmed: 19288389.
4. 4. Smith CR, Leon MB, Mack MJ, et al. PARTNER Trial Investigators, PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23): 2187–2198, doi: 10.1056/NEJMoa1103510, indexed in Pubmed: 21639811.
5. 5. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016; 374(17): 1609–1620, doi: 10.1056/NEJMoa1514616, indexed in Pubmed: 27040324.
6. 6. Kodali S, Williams M, Smith C, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012; 366(18): 1686–1695, doi: 10.1056/nejmoa1200384, indexed in Pubmed: 22443479.
7. 7. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Kardiol Pol. 2012; 70(Suppl VII): S319–S372.
8. 8. Baumgartner H, Falk V, Bax J, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Kardiol Pol. 2018; 76(1): 1–62, doi: 10.5603/kp.2018.0013.
9. 9. Di Mario C, Eltchaninoff H, Moat N, et al. The 2011-12 pilot european sentinel registry of transcatheter aortic valve implantation: in-hospital results in 4,571 patients. EuroIntervention. 2013; 8(12): 1362–1371, doi: 10.4244/eijv8i12a209, indexed in Pubmed: 23256965.
10. 10. Zembala-John J, Wilczek K, Tobota Z, et al. POL-TAVI — Polish Registry of Transcatheter Aortic Valve Implantation — simple tool, great value, rationale and design. Kardiochir Torakochirurgia Pol. 2016; 13(4): 309–315, doi: 10.5114/kitp.2016.64870, indexed in Pubmed: 28096826.
11. 11. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012; 33(19): 2403–2418, doi: 10.1093/eurheartj/ehs255, indexed in Pubmed: 23026477.
12. 12. Huczek Z, Wilimski R, Kochman J, et al. Common carotid artery access for transcatheter aortic valve implantation. Kardiol Pol. 2015; 73(7): 478–484, doi: 10.5603/KP.2015.0122, indexed in Pubmed: 26189468.
13. 13. Auffret V, Lefevre T, Van Belle E, et al. FRANCE TAVI Investigators. Temporal trends in transcatheter aortic valve replacement in France: FRANCE 2 to FRANCE TAVI. J Am Coll Cardiol. 2017; 70(1): 42–55, doi: 10.1016/j.jacc.2017.04.053, indexed in Pubmed: 28662806.
14. 14. Bekeredjian R, Szabo G, Balaban Ü, et al. Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in-hospital data and 1-year results from the German Aortic Valve Registry (GARY). Eur Heart J. 2019; 40(17): 1323–1330, doi: 10.1093/eurheartj/ehy699, indexed in Pubmed: 30445543.
15. 15. Zbroński K, Huczek Z, Gawalko M, et al. Paradoxical low-flow aortic stenosis - baseline characteristics, impact on mortality. Postepy Kardiol Interwencyjnej. 2019; 15(1): 13–19, doi: 10.5114/aic.2019.83770, indexed in Pubmed: 31043980.
16. 16. Huczek Z, Kochman J, Kowara MK, et al. Baseline platelet indices and bleeding after transcatheter aortic valve implantation. Blood Coagul Fibrinolysis. 2015; 26(5): 527–532, doi: 10.1097/MBC.0000000000000283, indexed in Pubmed: 25811449.
17. 17. Kochman J, Rymuza B, Huczek Z, et al. Incidence, predictors and impact of severe periprocedural bleeding according to VARC-2 criteria on 1-year clinical outcomes in patients after transcatheter aortic valve implantation. Int Heart J. 2016; 57(1): 35–40, doi: 10.1536/ihj.15-195, indexed in Pubmed: 26673439.
18. 18. Grodecki K, Zbroński K, Przybyszewska-Kazulak E, et al. Pre-procedural abnormal function of von Willebrand Factor is predictive of bleeding after surgical but not transcatheter aortic valve replacement. J Thromb Thrombolysis. 2019; 48(4): 610–618, doi: 10.1007/s11239-019-01917-7, indexed in Pubmed: 31359325.
19. 19. Rymuza B, Zbroński K, Scisło P, et al. Thromboelastography for predicting bleeding in patients with aortic stenosis treated with transcatheter aortic valve implantation. Kardiol Pol. 2018; 76(2): 418–425, doi: 10.5603/KP.a2017.0225, indexed in Pubmed: 29192952.
20. 20. Zbroński K, Huczek Z, Puchta D, et al. Outcome prediction following transcatheter aortic valve implantation: multiple risk scores comparison. Cardiol J. 2016; 23(2): 169–177, doi: 10.5603/CJ.a2015.0081, indexed in Pubmed: 26711463.
21. 21. Huczek Z, Kochman J, Rymuza B, et al. Paravalvular aortic regurgitation as the reason for second CoreValve bioprosthesis implantation in a patient with native bicuspid valve. Kardiol Pol. 2013; 71(11): 1211, doi: 10.5603/KP.2013.0311, indexed in Pubmed: 24297728.
22. 22. Muralidharan A, Thiagarajan K, Van Ham R, et al. Meta-analysis of perioperative stroke and mortality in transcatheter aortic valve implantation. Am J Cardiol. 2016; 118(7): 1031–1045, doi: 10.1016/j.amjcard.2016.07.011, indexed in Pubmed: 27634034.
23. 23. Thirumala PD, Nguyen FD, Mehta A, et al. Perioperative stroke, in-hospital mortality, and postoperative morbidity following transcatheter aortic valve implantation: a nationwide study. J Clin Neurol. 2017; 13(4): 351–358, doi: 10.3988/jcn.2017.13.4.351, indexed in Pubmed: 28884980.
24. 24. Sorysz D, Dziewierz A, Bagieński M, et al. Early results of the ongoing Polish Registry of Valve Thrombosis after Transcatheter Aortic Valve Implantation (ZAKPOLTAVI). Kardiol Pol. 2020; 78(7–8): 681–687, doi: 10.33963/KP.15426, indexed in Pubmed: 32543799.
25. 25. Piroli F, Franchin L, Bruno F, et al. New advances in the prevention of transcatheter aortic valve implantation failure: current and future perspectives. Kardiol Pol. 2020; 78(9): 842–849, doi: 10.33963/KP.15522, indexed in Pubmed: 32692029.