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Multicenter Registry of Subcutaneous Cardioverter-Defibrillator Implantations: a preliminary report

Maciej Kempa1, Andrzej Przybylski2, 3, Szymon Budrejko1, Wojciech Krupa4, Krzysztof Kaczmarek5, Anna Kurek6, Paweł Syska7, Adam Sokal8, Marcin Grabowski9, Dariusz Jagielski10, Maciej Grymuza11, Piotr Szafarz2, Stanisław Tubek12, Zbigniew Orski13, Joanna Zakrzewska-Koperska14, Jakub Machejek15, Wojciech Kwaśniewski16

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, School of Medicine with the Division of Dentistry in Zabrze, Silesian Centre for Heart Diseases, 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, Karol Marcinkowski University of Medical Sciences, Poznań, Poland

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

13Department of Cardiology and Internal Diseases, Military Institute of Medicine, Warszawa, Poland

141st Department of Arrhythmia, National Institute of Cardiology, Warszawa, Poland

15Department of Electrocardiology, John Paul II Hospital, Kraków, Poland

161st Department of Cardiology, Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Katowice, Poland

Introduction

Implantation of a subcutaneous cardioverter-defibrillator (S-ICD) is a well-established method for prevention of sudden cardiac death due to ventricular arrhythmias. It may be applied in patients with indications for an implantable cardioverter-defibrillator (ICD) not requiring permanent cardiac pacing nor antitachycardia pacing [1]. First implantation procedures in Poland were performed in 2014 [2, 3]. Due to the lack of clear rules for reimbursement of the procedure in the early days, the total number of implantations performed in Poland at that time was low. Reimbursement rules were changed in 2019 to the level allowing for complete coverage of the costs. It led to an increase in the number of implantations, but the total cumulative number of implantations in Poland has not yet exceeded 450.

Although the Heart Rhythm Section of the Polish Cardiac Society has published an expert opinion on the use of S-ICD in Poland, there is currently no report available that would summarize the Polish experience with S-ICD [4]. Therefore, the Executive Board of the Heart Rhythm Section appointed the Multicenter Registry of Subcutaneous Cardioverter-Defibrillator Implantations. The registry has been approved by Bioethical Committee at the Regional Medical Board in Rzeszow, Poland (decision number 35/B/2020), and launched on the 1st of May 2020.

Methods

The Multicenter Registry of Subcutaneous Cardioverter-Defibrillator Implantations is an open registry run by the Heart Rhythm Section of the Polish Cardiac Society. Centers implanting S-ICD devices add data of consecutive patients undergoing implantation or exchange of the S-ICD system. Participation in the registry does not influence the clinical routine in any way. All data are introduced when the hospitalization is finished, and include age, gender, underlying disease, reasons for indications for S-ICD, electrocardiographic parameters, technique of implantation, and complications during the in-hospital period. The analysis included data reported between May 2020 and January 2021, regarding the periprocedural period, whereas follow-up data will be collected onwards and reported accordingly.

Statistical analysis

Continuous variables were reported as a range, mean and standard deviation, and categorical variables as numbers and percentages. Due to the type of our analysis, only descriptive statistics was used.

Results and discussion

During the initial 8 months, 15 centers reported 123 patients (Supplementary material, Table S1), 90 men, aged 15–79. Most patients were in NYHA II class. Left ventricular ejection fraction (LVEF) was 10%–80%. In 78 patients S-ICD was indicated for primary prevention. The most frequent underlying disease (54 patients, 44%) was nonischemic cardiomyopathy (Table 1).

The most frequent reason for the choice of S-ICD (76%) was the patient’s young age (Supplementary material, Table S2).

In 114 patients (93%) the reported procedure was the first-time implantation of S-ICD, and in the remaining 9 cases (7%) — device exchange. The procedure was performed most often by cardiologists and in general anesthesia — 89 procedures (72%). Local anesthesia was used in 19 cases (15%), and regional anesthesia or blockade — in 15 cases (12%). Three procedures (2%) were assisted by a cardiac surgeon. The 2-incision technique was slightly more prevalent (63 cases, 51%). The device pocket was intermuscular in all cases but one. In 102 cases, the defibrillation test was performed immediately following the surgical part of the procedure, and the 65 J shock was effective in all those patients. In 2 patients no sustained ventricular tachyarrhythmia could be induced. In the remaining 19 patients, the test was abandoned due to contraindications, specifically the risk of thromboembolic complications (10 patients) or extremely low LVEF (4 patients). The mean (SD) procedural time was 75 (32) minutes (range 18–150 min). Mean post-procedural hospitalization continued for 3 days. Complications were observed in 2 patients (pocket hematoma treated conservatively, and unilateral paresis of the lower limb with no apparent pathology on the CT and MRI scans).

S-ICD systems have been implanted in Poland since 2014, but the total number of procedures remains relatively low, due to the high cost of the device and lack of clear rules for reimbursement during the early days of the method. Guidelines for S-ICD implantation in Poland and specified requirements for implantation centers, may potentially limit the access of patients to that method of treatment, but they enforce appropriate experience of implanting teams. Our analysis is based on the results of 123 patients, representing 90% of the total number of procedures performed in Poland between May 2020 and January 2021. According to the yearly report of the National Consultant in Cardiology, 9298 cardioverters-defibrillators were primarily implanted in Poland in 2019 (unpublished data, both ICD and CRT-D). Having taken into account the data from our eight-month period, it could be estimated that S-ICD represented about 2% of cardioverter-defibrillator implantations in our country.

In our study group, 73% of patients were men. That percentage is slightly higher than in other European centers (68.4%) but lower than in American groups (77%) [5, 6]. The mean age was 43 years, and it was lower in comparison with other studies [7].

Data concerning indications for S-ICD in our registry are also different from other reports. In our population, ischemic cardiomyopathy was diagnosed only in 28% of patients, whereas in other reports that percentage was definitely higher, reaching 48%–46% [7, 8]. The main reason for the choice of S-ICD in our study was concurrent with other studies, and it was young age in 76% of patients [9].

In clinical studies, S-ICD successfully terminated ventricular arrhythmias with 65 J test shock in over 90% of cases [10, 11]. In our population, the 65 J test shock was effective in 100% of the 102 tests performed. It may be related to the fact that the device pocket was dissected beneath the latissimus dorsi muscle in all cases of de novo implantations, which led to a dorsal final location of the can. Such a technique may be associated with higher efficacy of defibrillation test shock, due to the low impedance of defibrillation [12]. Implementation of the 2-incision technique in most cases (51%) and regional anesthesia in many cases (28%) indicate the tendency to implement modern implantation techniques in Polish centers [13, 14].

The incidence of surgical complications of S-ICD implantation is currently estimated at approximately 3% during the first month [15]. In our study group, such complications have not been observed.

The most frequent reason for the choice of S-ICD was the patient’s young age, similarly to other reports, but our observations revealed also some differences with regard to qualification for S-ICD implantation between Poland and other countries. High efficacy and lack of surgical complications in the post-operative period confirmed the appropriate selection of centers performing implantation procedures (according to the regulations issued by the National Health Fund, regarding requirements for reimbursement), and satisfactory level of training of implanting teams. The results of our study encourage further promotion of that modality of treatment in our country.

Article information

Conflict of interest: MK received consultancy fees from Boston Scientific. AP received lecturer’s fees from Medtronic Polska, Biotronik Polska; consultancy fees from Medtronic Polska. KK received proctor/trainer and lecturer fees from Abbott Poland, Medtronic Poland and Boston Scientific Poland. PS received lecturer’s fees from Abbott, Biotronik, Boston Scientific, Medtronic; consultancy fees from Biotronik, Boston Scientific. AS received consultancy agreement with Boston Scientific. MG received honoraria from Boston Scientific. DJ received honorarium from Boston Scientific for a lecture during Webinar. ST received a consultancy fee from Boston Scientific. The remaining authors declared no conflict of interest.

Open access: This article is available in open access under Creative Common Attribution-Non-Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0) license, allowing to download articles and share them with others as long as they credit the authors and the publisher, but without permission to change them in any way or use them commercially. For commercial use, please contact the journal office at kardiologiapolska@ptkardio.pl.

How to cite: 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.

REFERENCES

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. Kaczmarek K, Zwoliński R, Bartczak K, et al. A subcutaneous implantable cardioverter-defibrillator — the first implantation in Poland. Kardiol Pol. 2015; 73(1): 62, doi: 10.5603/KP.2015.0010, indexed in Pubmed: 25625342.
3. 3. Kempa M, Budrejko S, Raczak G. 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.
4. 4. Ptaszyński P, Grabowski M, Kowalski O, et al. Subcutaneous implantable cardioverter-defibrillator in prevention of sudden cardiac death in Poland — opinion paper endorsed by the Polish Cardiac Society Working Group on Heart Rhythm. Kardiol Pol. 2017; 75(10): 1057–1060, doi: 10.5603/KP.2017.0196, indexed in Pubmed: 29057442.
5. 5. Lenarczyk R, Boveda S, Haugaa KH, et al. Peri-procedural routines, implantation techniques, and procedure-related complications in patients undergoing implantation of subcutaneous or transvenous automatic cardioverter-defibrillators: results of the European Snapshot Survey on S-ICD Implantation (ESSS-SICDI). Europace. 2018; 20(7): 1218–1224, doi: 10.1093/europace/euy092, indexed in Pubmed: 29762683.
6. 6. Friedman DJ, Parzynski CS, Varosy PD, et al. Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States. JAMA Cardiol. 2016; 1(8): 900–911, doi: 10.1001/jamacardio.2016.2782, indexed in Pubmed: 27603935.
7. 7. Rordorf R, Casula M, Pezza L, et al. Subcutaneous versus transvenous implantable defibrillator: An updated meta-analysis. Heart Rhythm. 2021; 18(3): 382–391, doi: 10.1016/j.hrthm.2020.11.013, indexed in Pubmed: 33212250.
8. 8. Knops R, Olde Nordkamp LRA, Delnoy PP, et al. Subcutaneous or transvenous defibrillator therapy. N Engl J Med. 2020; 383(6): 526–536, doi: 10.1056/nejmoa1915932.
9. 9. Boveda S, Lenarczyk R, Fumagalli S, 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.
10. 10. Lambiase PD, Barr C, Theuns DA, et al. EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD registry. Eur Heart J. 2014; 35(25): 1657–1665, doi: 10.1093/eurheartj/ehu112, indexed in Pubmed: 24670710.
11. 11. Boersma L, Barr C, Knops R, et al. EFFORTLESS Investigator Group. Implant and midterm outcomes of the subcutaneous implantable cardioverter-defibrillator registry: the EFFORTLESS study. J Am Coll Cardiol. 2017; 70(7): 830–841, doi: 10.1016/j.jacc.2017.06.040, indexed in Pubmed: 28797351.
12. 12. 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.
13. 13. 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.
14. 14. 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.
15. 15. 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.