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Interventional cardiology in Poland in 2019. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) and Jagiellonian University Medical College*

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Editorial

Corresponding author:

Zbigniew Siudak MD, PhD, Collegium Medicum, Jan Kochanowski University, 19 IX Wieków Kielc St, 25-516 Kielce, Poland, e-mail: zbigniew.siudak@ujk.edu.pl

Received: 10.05.2020, accepted: 11.05.2020.

Interventional cardiology in Poland in 2019. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK)

and Jagiellonian University Medical College*

Dariusz Dudek1, Zbigniew Siudak2, Marek Grygier3, Aleksander Araszkiewicz3, Maciej Dąbrowski4, Jacek Kusa5, Michał Hawranek6, Zenon Huczek7, Paweł Kralisz8, Tomasz Roleder9, Wojciech Wojakowski10, Radosław Parma10, Krzysztof P. Malinowski1, Stanisław Bartuś1

1Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland

2Collegium Medicum, Jan Kochanowski University, Kielce, Poland

31st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland

4Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw, Poland

5Pediatric Cardiology Department, Regional Specialist Hospital – Research and Developement Centre, Wroclaw, Poland

63rd Department of Cardiology, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Poland

71st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland

8Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland

9Regional Specialist Hospital, Research and Development Center, Wroclaw, Poland

10Department of Cardiology and Structural Heart Diseases, 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland

*This publication presents an analysis of individual procedural data from 153 interventional cardiology centers in Poland that have voluntarily joined the ORPKI database since 2004. To account for possible underreporting observed in 2019, AISN PTK makes every effort to correct for missing data and provide reliable information on interventional cardiology in Poland.

Adv Interv Cardiol 2020; 16, 2 (60): 123–126 DOI: https://doi.org/10.5114/aic.2020.96054

As previously reported, the ORPKI electronic data cap- ture is monitored continuously and modified according to the needs of the rapidly changing everyday practice of interventional cardiology not only in Poland but also worldwide [1, 2]. The database is endorsed by Associa- tion of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) and is operated by the Jagiellonian University Medical College, with currently 153 interven- tional cardiology centers in Poland reporting daily. The ORPKI database analysis of various trends and patterns is published each year [3–5]. On 31st of December 2019 there were 541 percutaneous coronary intervention (PCI) operators and 32 diagnosticians certified by AISN PTK in Poland.

According to the current analysis of the ORPKI da- tabase, in comparison to 2018, there was a substantial decrease in the total number of reported coronary angi- ographies (CAG) [1]. There were 172 521 CAG [(4481 per 1 million inhabitants per year) in 2019, which corresponds

to a decrease of 5.5% vs. 2018 (Figure 1). This trend has been observed since 2015, and current numbers are com- parable to that of the year 2009. The distribution of pri- mary diagnosis as indications for CAG was: 11% ST-eleva- tion myocardial infarction (STEMI), 14% non-ST-elevation myocardial infarction (NSTEMI), 26% unstable angina (UA), and 49% stable angina. The radial approach was utilized in 88% of all CAG cases, which is a  2% rise in comparison to 2018 (in STEMI patients, 85% had the ra- dial access site used). Complications of coronary angiog- raphy in 2019 were rare and corresponded to the rates reported in previous years (Table I).

The total number of PCI procedures was 101 716 and is 2.9% lower (2642 PCIs per 1 million inhabitants per year) than that reported to the ORPKI database in 2018 (Figure 1). The majority of the procedures were done in the setting of the acute coronary syndromes (ACS):

40% acute myocardial infarction (20% STEMI and 20%

NSTEMI), 24% unstable angina (decrease by 2% from

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Dariusz Dudek et al. Interventional cardiology in Poland in 2019

124 Advances in Interventional Cardiology 2020; 16, 2 (60)

2018) and the remaining 36% for stable angina. The number of primary PCI per 1 million inhabitants per year is currently 505. There were 19 440 PCIs in STEMI and 20  078 in NSTEMI. Drug-eluting stents (DES) are used in 99.9% of all cases, while bioresorbable vas-

cular scaffold (BVS) were implanted in 66 procedures only. Rotablation was used in 1172 procedures (1.1% of PCI) – a  38% increase in comparison to the previous year. Aspiration thrombectomy was used in only 1845 STEMI cases, which means a  26% decrease in com- parison to 2018. We observed a  substantial increase in the use of guideline-recommended ticagrelor as an adjunct pharmacotherapy both for STEMI (49%) and NSTEMI (30%) with the use of prasugrel less than 2%

in either indication. In terms of complex procedures, the number of chronic total occlusion (CTO) procedures was 2299. PCI complications are still rare and are pre- sented in Table II.

An increase in the use of adjunctive imaging and di- agnostic procedures during CAG and PCI was observed in 2019 vs. 2018, especially for intravascular ultrasound (IVUS) (Table III).

Figure 1. The number of coronary angiography (A) and PCI (B) procedures in Poland in the years 2002–2019

NN

250 000

200 000

150 000

100 000

50 000

0

140 000

120 000

100 000

80 000

60 000

40 000

20 000

0

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Year

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Year

85,000

34,500 106,678

48,067 120,667

58,105 134,151

66,919 135,828

69,820 148,538

78,467 166,008

90,238 175,445

98,352 188,006

105,728 197,284

109,291 217,126

119,746 216,322

120,084 223,524

124,099 221,625

124,876 214,669

121,455 198,362

114,282 182,226

104,283 172,521

101,716

Table I. Complications of coronary angiography in Poland in 2019

Parameter % In comparison to 2018

Death 0.20

Stroke 0.01

Major bleeding at access site 0.04

Sudden cardiac arrest 0.18

Allergic reaction 0.01

A

B

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Dariusz Dudek et al. Interventional cardiology in Poland in 2019

125

Advances in Interventional Cardiology 2020; 16, 2 (60)

Structural procedures are a vital part of interventional cardiology in Poland and are mainly performed by cer- tified interventional cardiologists. Following recommen- dations of the European Society of Cardiology, 22 multi- disciplinary Heart Teams involving 57 certified interven- tional cardiologists were established in all 22 transcatheth- er aortic valve implantation (TAVI) centers. There were 1550 TAVI procedures performed in 22 centers (including 55 from apical access). Evolut/Evolut Pro (Medtronic, USA) was implanted in 893, Sapien 3/Sapien XT (Edwards Life- sciences, USA) in 316, Acurate (Boston Scientific, USA) in 177, Portico (Abbott, USA) in 127, MyValve (Merill, India) in 21, Hydra (Vascular Innovations Company, Thailand) in 10 (only as a part of a clinical study) and Lotus Edge (Boston Scientific, USA) in 6 patients. Moreover, there were 29 procedures of pulmonary valve implantation including Melody (Medtronic, USA) in 18 and Sapien 3/

Sapien XT (Edwards Lifesciences, USA) in 11 patients.

The median number of TAVI procedures per center per annum increased to 70 in 2019 (Figure 2). Although the total number of procedures increased by 22% (year to year), Poland with the number of 40 TAVI procedures per million inhabitatants in 2019 is far below the European

Table II. Complications of PCI in Poland in 2019

Parameter % In comparison to

2018

Death: 0.32

STEMI 0.83

NSTEMI 0.36

UA 0.10

SA 0.02

Myocardial infarction 0.13

Major bleeding from access site 0.11

Suden cardiac arrest 0.41

Allergic reaction 0.01

Artery perforation 0.24

No reflow 0.70

Table III. Additional intracoronary assessment in 2019 during angiography and PCI

Parameter N % change from 2018

FFR 9916 ↑ 9

IVUS 4400 ↑ 21

OCT 381

average. In 2017 the annual number of TAVI procedures in Germany reached almost 20 000, with the TAVI rate of 250 per million inhabitants [6]. The data presented at the EuroPCR and ESC events in 2019 confirmed an increase of the number Tavi procedures in France from 7,500 in 2014 to 20,000 in 2018 (137%) with the TAVI penetration of 193 per million inhabitants in 2018 [7]. Then finally Portugal, often compared to Poland, recorded a  signifi- cant increase of TAVI procedures during the last 5 years from 29 in 2015 to 72 in 2019 per million inhabitants [8].

It is worth mentioning that all three countries participate in the Valve-for-Life Initiative of the EAPCI ESC (Poland and France since 2015 and Portugal since 2017).

MitraClips (Abbott, USA) were implanted in 187 pa- tients in 12 centers (including one performing proce- dures only within clinical trials). Although the number of procedures increased by 26% (year to year), Poland with about 4.6 MitraClip procedures per million inhabitans is far below the clinical needs (Figure 3).

As many as 597 left atrial appendage closure procedures were performed in 28 centers including 315 Watchman/Watchman FLX (Boston Scientific, USA), 262 Amulet (Abbott, USA) and 20 Lambre (Lifetech, Chi- na). The number of LAA closure procedures increased by almost 50% (year to year).

In summary, we can observe a continuous decreasing trend in both diagnostic and therapeutic percutaneous coronary procedures in comparison to previous years.

However, it has to be interpreted cautiously because the data are reported on a voluntary basis. On the other hand, the use of a radial approach, IVUS and ticagrelor in MI pa-

2014 2015 2016 2017 2018 2019 Year

Figure 2. The number of TAVI procedures in Po- land (22 centres)

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Year

Figure 3. The number of MitraClip procedures in Poland

1800 1600 1400 1200 1000 800 600 400 200 0

200 180 160 140 120 100 80 60 40 20 0 453

6 5 5

12/mln 17/mln 22.5/mln 27/mln 33/mln 40/mln

670

23 870

37 1041

40 1261

75

139 148

1550 187

TAVI MitraClip

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Dariusz Dudek et al. Interventional cardiology in Poland in 2019

126 Advances in Interventional Cardiology 2020; 16, 2 (60)

tients is well in line with ESC recommendations. Use of the bare-metal stent (BMS) and BVS is almost completely abandoned. The number of structural procedures shows a steady rise in the last years, although it is still limited by reimbursement issues and is far below the European average and current clinical needs in Poland (especially for TAVI and MitraClip).

Conflict of interest

Wojciech Wojakowski: Medtronic advisory board, Ab- bott, Edwards, Balton, Moston Scientific, Astra Zeneca – lecture honoraria. Other authors declare no conflict of interest.

References

1. Dudek D, Siudak Z, Grygier M, et al. Interventional cardiology procedures in Poland in 2018. Summary report of the Associa- tion of Cardiovascular Interventions of the Polish Cardiac Soci- ety (AISN PTK) and Jagiellonian University Medical College. Adv Interv Cardiol 2019; 15: 391-3.

2. Kleczyński P, Siudak Z, Dziewierz A, et al. The network of invasive cardiology facilities in Poland in 2016 (data from the ORPKI Pol- ish National Registry). Kardiol Pol 2018; 76: 805-7.

3. Zabojszcz M, Januszek R, Siudak Z, et al. Association between the mortality rate and operator volume in patients undergoing emergency or elective percutaneous coronary interventions.

Kardiol Pol 2020; 78: 138-46.

4. Tokarek T, Dziewierz A, Plens K, et al. Radial approach exper- tise and clinical outcomes of percutanous coronary interven- tions performed using femoral approach. J Clin Med 2019; 8: pii:

E1484.

5. Januszek R, Siudak Z, Reczuch K, et al. Current trends and proce- dural outcomes in the era of rotational atherectomy expansion in Poland in the period 2014-2017 (based on the nationwide ORPKI registry). Adv Interv Cardiol 2019; 15: 158-66.

6. Eggebrecht H., Mehta R. H. Transcatheter aortic valve implanta- tion (TAVI) in Germany: more than 100,000 procedures and now the standard of care for the elderly. EuroIntervention 2019; 14:

e1549-52.

7. https://www.escardio.org/Sub-specialty-communities/Euro- pean-Association-of-Percutaneous-Cardiovascular-Interven- tions-(EAPCI)/Advocacy/valve-for-life-france.

8. https://www.escardio.org/Sub-specialty-communities/Euro- pean-Association-of-Percutaneous-Cardiovascular-Interven- tions-(EAPCI)/Advocacy/valves-for-life-portugal

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