Subcutaneous ICD

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Subcutaneous ICD Boston Scientific / Cameron Health Model 1010 (side view, left the electrode next to the sternum)

The subcutaneously implantable cardioverter / defibrillator ( subcutaneous ICD ) belongs to the family of ICD devices and is implanted in people at risk of sudden cardiac arrest. In contrast to ICD systems, the complete S-ICD system is used extracardially, lying on the outside of the chest under the skin (subcutaneous).

history

In Germany, around 65,000 people suffer sudden cardiac death every year. The numbers in the UK are similar. ICD devices can be implanted in high-risk patients and reduce the risk of sudden cardiac death. Clinical studies have shown decisive survival benefits for TV-ICD patients with advanced heart failure, various cardiomyopathies or ion channel diseases. Research on the ICDs has been steadily advanced since the first implantation in the 1980s. In the meantime, the devices have become much smaller and lighter and have a wide range of diagnostic and monitoring functions. A major weak point of TV ICDs is not the device itself, but rather the electrodes that are inserted into the heart by the ICD device. Since these electrodes have to be advanced into the heart, they are relatively thin and flexible, which in turn can make them more susceptible to electrode breakage and corresponding complications. The electrode is permanently under load in the body. If the insulation of the electrode or conductor breaks as a result, inadequate shocks can occur, which can increase morbidity and mortality. The electrode must be replaced, which poses a risk of infection.

Advantages of the S-ICD

The S-ICD was developed, among other things, to reduce the risk of complications associated with transvenous electrodes, such as pneumothorax, hemothorax, tamponade or electrode perforation. Potential complications such as blood circulation infections and the need to remove or replace the electrodes in the heart are minimized or completely eliminated with the S-ICD system. In contrast to a transvenous ICD, in which electrodes are passed through a vein and connected to the heart wall, the electrode of an S-ICD, like the ICD device itself, is located on the outside of the chest directly under the skin and not in the heart. This leaves the heart and vein completely untouched. This reduces possible complications (e.g. systemic infections). The position of the electrodes outside the chest also has a positive effect. The electrode can be thicker and is therefore more robust. The number of possible electrode breaks can thereby be minimized or reduced and the main weak point of the TV-ICDs can be avoided as far as possible.

Manufacturer

So far, Boston Scientific the only manufacturer of S-ICD systems.

Comparison of implantation methods: transvenous versus subcutaneous

Implantation procedure for the transvenous ICD Implantation procedure for the subcutaneous ICD
A transvenous ICD is implanted in the left shoulder area near the collarbone. The right side is rarely preferred for certain patients or for special reasons. In contrast to the transvenous ICD , the device is implanted in the left chest area next to the chest; the electrode is placed just under the skin above the breastbone.
Under fluoroscopy, the electrodes are passed through a vein and over the heart valve into the heart . The subcutaneous ICD electrode is placed under the skin using anatomical landmarks . The subcutaneous ICD does not require electrodes implanted in the heart to deliver therapy.
Depending on the condition of the heart, 1, 2 or 3 electrodes are placed in the heart. Once the electrodes are in place, they are connected to the heart wall for optimal connectivity. The subcutaneous ICD leaves the heart and blood vessels completely untouched and intact.

Individual evidence

  1. ^ Incidence of sudden cardiac death in Germany: results from an emergency medical service registry in Lower Saxony. Eimo Martens, Moritz F. Sinner, Johannes Siebermair, Carsten Raufhake, Britt M. Beckmann, Stefan Veith, Dieter Düvel, Gerhard Steinbeck and Stefan Kääb.
  2. ↑ | http://www.aerztezeitung.de/medizin/krankheiten/herzkreislauf/herzinfarkt/article/866033/ploetzlicher-herztod-erstmals-deutschland-genaue-zahlen.html .
  3. ↑ Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Pier D. Lambiase, Craig Barr, Dominic AMJTheuns, Reinoud Knops, Petr Neuzil, Jens Brock Johansen, Margaret Hood, Susanne Pedersen, Stefan Kääb, Francis Murgatroyd, Helen L. Reeve, Nathan Carter, and Lucas Boersma, and on behalf of the EFFORTLESS Investigators.
  4. ↑ Kadish A, Dyer A, Daubert JP, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004; 350: 2151-8.
  5. ↑ Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-83.
  6. ↑ Moss AJ, Hall WJ, Cannom DS et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med 1996; 335: 1933-1940.
  7. ↑ Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-883.
  8. ↑ Bardy GH, Lee KL, Mark DB et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-237.
  9. ↑ Kuck KH, Cappato R, Siebels J et al. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest: the Cardiac Arrest Study Hamburg (CASH). Circulation 2000; 102: 748-754.
  10. ↑ Mirowski M, Reid PR, Mower MM, Watkins L, Gott VL, Schauble JF, Langer A, Heilman MS, Kolenik SA, Fischell RE, Weisfeldt ML. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980; 303: 322-324.
  11. ↑ The subcutaneous defibrillator (S-ICD) - the beginning of a new era in the prevention and treatment of sudden cardiac death? Jürgen Kuschyk, Martin Borggrefe, Susanne Röger.
  12. ↑ Duray GZ, Schmitt J, Cicek-Hartvig S et al. Complications leading to surgical revision in implantable cardioverter defibrillator patients: comparison of patients with single-chamber, dual-chamber, and biventricular devices. Europace 2009; 11: 297-302.
  13. ↑ Kleemann T, Becker T, Doenges K et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of> 10 years. Circulation 2007; 115: 2474-2480.
  14. ^ Poole JE, Johnson GW, Hellkamp AS et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008; 359: 1009-1017.
  15. ↑ Klug D, Balde M, Pavin D. et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation. 2007; 116: 1349-55.
  16. ↑ Risk Factors Related to Infections of Implanted Pacemakers and Cardioverter-Defibrillators Results of a Large Prospective Study. Didier Klug, MD, PhD; Mamadou Balde, MD; Dominique Pavin, MD; Françoise Hidden-Lucet, MD; Jacques Clementy, MD; Nicolas Sadoul, MD; Jean Luc Rey, MD; Gilles Lande, MD; Arnaud Lazarus, MD; Jacques Victor, MD; Claude Barnay, MD; Bruno Grandbastien, MD; Salem Kacet, MD; for the PEOPLE Study Group.
  17. ↑ Grimm W, Menz V, Hoffmann J, et al. Complications of third-generation implantable cardioverter defibrillator therapy. Pacing Clin Electrophysiol 1999; 22: 206-11.
  18. ↑ van Rooden CJ, Molhoek SG, Rosendaal FR, Schalij MJ, Meinders AE, Huisman MV. Incidence and risk factors of early venous thrombosis associated with permanent pacemaker leads. J Cardiovasc Electrophysiol 2004; 15: 1258-62.
  19. ↑ Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005; 28: 926-32.
  20. ↑ Khairy P, Landzberg MJ, Gatzoulis MA, et al. Transvenous pacing leads and systemic thromboemboli in patients with intracardiac shunts: a multicenter study. Circulation 2006; 113: 2391-7.
  21. ^ Epstein AE, Baker JH II, Beau SL, Deering TF, Greenberg SM, Goldman DS. Performance of the St. Jude Medical Riataleads. Heart Rhythm 2009; 6: 204-9.
  22. ↑ Lambiase PD, Barr C, Theuns DA et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J 2014; 35: 1657-1765.
  23. ↑ Burke MC, Gold MR, Knight BP et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol 2015; 65: 1605-1615.