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Evolution of implantation technique and indications for a subcutaneous cardioverter-defibrillator: over 7 years of experience in Poland

Maciej Kempa1, Andrzej Przybylski2, 3, Szymon Budrejko1, Wojciech Krupa4, Krzysztof Kaczmarek5, Mateusz Ostręga6, Paweł Syska7, Adam Sokal8, Marcin Grabowski9, Dariusz Jagielski10, Maciej Grymuza11, Janusz Romanek2, 3, Stanisław Tubek12, Marcin Janowski13, Zbigniew Orski14, Joanna Zakrzewska-Koperska15, Adrian Stanek16, Michał Orszulak17

1Department of Cardiology and Electrotherapy, Medical University of Gdansk, Gdańsk, Poland

2Cardiology Department with the Acute Coronary Syndromes Subdivision, Clinical Provincial Hospital No. 2, Rzeszów, Poland

3Medical College, University of Rzeszow, Rzeszów, Poland

4Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

5Department of Electrocardiology, Medical University of Lodz, Łódź, Poland

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

72nd Department of Arrhythmia, National Institute of Cardiology, Warszawa, Poland

81st Department of Cardiology and Angiology, Silesian Centre of Heart Diseases, Zabrze, Poland

91st Chair and Department of Cardiology, Medical University of Warsaw, Warszawa, Poland

10Department of Cardiology, Centre for Heart Diseases, 4th Military Hospital, Wrocław, Poland

111st Department of Cardiology, Chair of Cardiology, Poznan University of Medical Sciences, Poznań, Poland

12Department of Heart Diseases, Wroclaw Medical University, Wrocław, Poland

13Chair and Department of Cardiology Medical University of Lublin, Lublin, Poland

14Department of Cardiology and Internal Diseases, Military Institute of Medicine, Warszawa, Poland

151st Department of Arrhythmia, National Institute of Cardiology, Warszawa, Poland

16Department of Electrocardiology, John Paul II Hospital, Kraków, Poland

171st Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland

Introduction

Implantation of a subcutaneous cardioverter-defibrillator (S-ICD) may be used to prevent sudden cardiac death (SCD) due to ventricular arrhythmias in patients not requiring permanent cardiac pacing or antitachycardia pacing [1, 2]. That method of treatment was first applied in Poland in 2014 [3, 4]. However, it took several years before in 2019 S-ICD became reimbursed to the extent necessary to cover all costs incurred by implant centers. That, in turn, led to an increase in the number of procedures performed in Poland [5]. Currently, there is no report available on how that updated reimbursement regulations might have influenced the qualification procedure, implantation technique, and results in comparison to the preceding period.

The aim of our analysis was to investigate, whether there was any change to indications for S-ICD implantation, operational technique, and patient outcomes over 7 years of S-ICD utilization in Poland.

Methods

We compared data collected at two registries in different time intervals: Registry A (September 2014 to December 2015) and Registry B (May 2020 to May 2021). Registry A was a multicenter query reporting data of 18 patients from 5 centers that pioneered S-ICD implantations in Poland [6]. Registry B is a nationwide initiative held by the Heart Rhythm Section of the Polish Cardiac Society [7], and 16 centers performing S-ICD implantations report data on subsequent patients undergoing implantation or exchange of the device. The analysis comprised only 144 patients from Registry B undergoing the first-time implantation of the system. We compared the data describing the general characteristics of patients, underlying diseases, implantation techniques, as well as reasons for the choice of a subcutaneous, instead of a transvenous cardioverter-defibrillator.

Statistical analysis

Continuous variables were presented as the median and interquartile range (IQR) due to non-normal distribution confirmed with the Shapiro-Wilk test. The Mann-Whitney U test was used to compare continuous variables. Categorical parameters were presented as numbers and percentages, and Fisher’s exact test was used for comparisons. A P-value of below 0.05 was considered statistically significant. Statistical analysis was performed with the use of Statistica 13.1 software (StatSoft, Tulsa, OK, USA).

Results and discussion

Detailed data of the patients in both groups are presented in Table 1.

Inter-group comparisons revealed that during the early period of S-ICD implementation in Poland it was less often implanted in primary prevention of SCD (22 % vs 65%; P <0.001), and dilated cardiomyopathy was less frequently the main underlying disease (17% vs 47%; P = 0.02). Patients in the early group had higher left ventricular ejection fraction (LVEF) (median value, 52.5% vs 35%; P = 0.005), whereas the main indications prompting the choice of S-ICD were lack of venous access (44%) and high risk of infective complications (61%). In the more recent group, young age was the main reason for the choice of S-ICD (76%). The change in operational technique over time was expressed as a significant increase in the percentage of procedures performed without general anesthesia (0% vs 26%; P = 0.01). The 2-incision technique has become more frequently applied instead of the 3-incision one (11% vs 56%; P <0.001), and now the device pocket is more frequently intramuscular than before (72 vs 100%; P <0.001). Defibrillation test tends to be less frequently performed nowadays (100% vs 83%; P = 0.08). In the patients from Registry B, 3 cases of postoperative complications were reported: pocket hematoma treated conservatively, inadequate shock possibly due to air entrapment in the device connector or pocket, and unilateral lower limb paresis (with no lesions found on imaging of the central nervous system).

During the initial years of S-ICD use in Poland, the number of implanting centers and procedures was limited. It resulted from the high cost of the system and troublesome reimbursement procedure. Therefore, S-ICD implantation was reserved for secondary prevention of SCD and patients not eligible for a transvenous system (either with limited vascular access or high risk of infective complications) because only in such cases the implanting center was certain it would be fully reimbursed. Once complete reimbursement was introduced, the method became more applicable in the primary prevention of SCD, and the patient’s young age might have become an indication for the choice of S-ICD. That selection factor became dominant, which brought Polish data closer to European reports [8]. Novel operational techniques reported in the literature, such as regional anesthesia, 2-incision technique, and intramuscular pocket [9–12], have been introduced in Polish centers ever since. Those techniques have become most common, and our results suggest that general anesthesia may be replaced by local and regional anesthetic techniques soon. Our analysis shows that in many cases (17% in the Registry B) the defibrillation test is currently waived. It may result from the high efficacy of S-ICD in the termination of ventricular fibrillation, which reached 100% of performed tests in both registries. Alternatively, it may be due to the concerns about the safety of inducing ventricular fibrillation in patients with more reduced LVEF, as a tendency to implant S-ICD in patients with more severe LVEF impairment was observed in Registry B, as compared to Registry A (median LVEF 35% vs 52.5%, respectively). Notably, that did not significantly increase the complication rate, which remains below 2% in our data and is lower than reported by other groups [13].

Our analysis confirms the increasing role of S-ICD as a method of primary prevention of SCD in Poland. Recent administrative regulations resulted in a change of profile of patients qualified for the procedure. Currently, the main reason for the choice of S-ICD is the young age of a patient. A tendency to incorporate new operational techniques used in European centers is observed, with no increase in the perioperative complication rate. The influence of updated reimbursement regulations on the use of S-ICD in Poland suggests that other modern methods might be successfully introduced on condition that they are accompanied by clear regulations covering all the costs borne by the implanting centers.

Article information

Conflict of interest: MK received proctoring and lecturer fees from Boston Scientific. AP received lecturer’s fees from Medtronic Polska, Biotronik Polska and consultancy fees from Medtronic Polska. KK received proctoring, and lecturer fees from Boston Scientific. MO: proctorship agreement with Boston Scientific. PS received lecturer’s fees for Abbott, Biotronik, Boston Scientific, Medtronic, and consultancy fees for Biotronik, Boston Scientific. ASo: consultancy agreement with Boston Scientific. MG received consultant and lectures fees from Medtronic, Biotronik, Abbott and Boston Scientific. DJ received lecturer fees from Boston Scientific. ST received consultancy fee from Boston Scientific. SB, WK, MG, JR, MJ, ZO, JZK, ASt, MO declared no conflict of interest.

1. 1. Priori SG, Blomström-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015; 36(41): 2793–2867, doi: 10.1093/eurheartj/ehv316, indexed in Pubmed: 26320108.
2. 2. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society. Heart Rhythm. 2018; 15(10): e190–e252, doi: 10.1016/j.hrthm.2017.10.035, indexed in Pubmed: 29097320.
3. 3. Kaczmarek K, Kempa M, Grabowski M, et al. A subcutaneous implantable cardioverter-defibrillator - the first implantation in Poland. Kardiol Pol. 2015; 73(1): 62–771, doi: 10.5603/KP.2015.0010, indexed in Pubmed: 25625342.
4. 4. Kempa M, Budrejko S, Sławiński G, et al. Subcutaneous implantable cardioverter-defibrillator (S-ICD) for secondary prevention of sudden cardiac death. Arch Med Sci. 2016; 12(5): 1179–1180, doi: 10.5114/aoms.2016.61921, indexed in Pubmed: 27695509.
5. 5. Regulation of the Minister of Health of 9 January 2019 amending the regulation on guaranteed services in the field of hospital treatment. The Journal of Laws of the Republic of Poland: item 77 [text in Polish].
6. 6. Kaczmarek K, Kempa M, Grabowski M, et al. Multicentre early experience with totally subcutaneous cardioverter-defibrillators in Poland. Arch Med Sci. 2020; 16(4): 764–771, doi: 10.5114/aoms.2019.83817, indexed in Pubmed: 32542076.
7. 7. Kempa M, Przybylski A, Budrejko S, et al. Multicenter Registry of Subcutaneous Cardioverter-Defibrillator Implantations — preliminary report. Kardiol Pol. 2021; 79(6): 697–699, doi: 10.33963/KP.a2021.0002, indexed in Pubmed: 34013514.
8. 8. Jędrzejczyk-Patej E, Boveda S, Kalarus Z, et al. Factors influencing the use of subcutaneous or transvenous implantable cardioverter-defibrillators: results of the European Heart Rhythm Association prospective survey. Europace. 2018; 20(5): 887–892, doi: 10.1093/europace/euy009, indexed in Pubmed: 29432525.
9. 9. Droghetti A, Basso Ricci E, Scimia P, et al. Ultrasound-guided serratus anterior plane block combined with the two-incision technique for subcutaneous ICD implantation. Pacing Clin Electrophysiol. 2018; 41(5): 517–523, doi: 10.1111/pace.13318, indexed in Pubmed: 29493802.
10. 10. van der Stuijt W, Baalman SWE, Brouwer TF, et al. Long-term follow-up of the two-incision implantation technique for the subcutaneous implantable cardioverter-defibrillator. Pacing Clin Electrophysiol. 2020; 43(12): 1476–1480, doi: 10.1111/pace.14022, indexed in Pubmed: 32720398.
11. 11. Quast AFBE, Baalman SWE, Brouwer TF, et al. A novel tool to evaluate the implant position and predict defibrillation success of the subcutaneous implantable cardioverter-defibrillator: The PRAETORIAN score. Heart Rhythm. 2019; 16(3): 403–410, doi: 10.1016/j.hrthm.2018.09.029, indexed in Pubmed: 30292861.
12. 12. Kempa M, Sterliński M, Mitkowski P, et al. Safety issues in selected patients implanted with Boston Scientific EMBLEM subcutaneous cardioverter defibrillator systems. Kardiol Pol. 2021; 79(2): 223–224, doi: 10.33963/KP.15833, indexed in Pubmed: 33635036.
13. 13. Boersma LV, El-Chami MF, Bongiorni MG, et al. Understanding outcomes with the EMBLEM S-ICD in primary prevention patients with low EF study (UNTOUCHED): clinical characteristics and perioperative results. Heart Rhythm. 2019; 16(11): 1636–1644, doi: 10.1016/j.hrthm.2019.04.048, indexed in Pubmed: 31082539.