d7602 - ESC 2016 Pub-v2.indd 1 10/08/2015 13:22 CARDIOLOGY www.healthcare-in-europe.com 11 IABP: Aortic counter-pulsation reduced hospital mortality Evidence at last Following medical studies in Giessen, Essen and Houston, Kevin Pilarczyk MD became a researcher at the Mayo Clinic Rochester. He is now senior resident at Westdeutsches Herzzentrum, the West German heart centre in Essen, Germany. His clinical and research focus is cardio-surgical intensive care, particularly extracorporeal cardiac and pulmonary support systems. He is secretary and coordinator of the interdisciplinary S3 guideline for the use of intra-aortic balloon counter-pulsation in heart. Editor-in-Chief: Brenda Marsh Art Director: Olaf Skrober Editorial team: Sascha Keutel, Marcel Rasch Senior Writer: John Brosky Executive Director: Daniela Zimmermann Founded by Heinz-Jürgen Witzke Correspondents Austria: Michael Kraßnitzer, Christian Pruszinsky. China: Nat Whitney France: Annick Chapoy, Jane MacDougall.Germany: Anja Behringer, Annette Bus, Walter Depner, Bettina Döbereiner, Matthias Simon, Axel Viola, Cornelia Wels- Maug, Holger Zorn. Great Britain: Brenda Marsh, Mark Nicholls. Malta: Moira Mizzi. Poland: Pjotr Szoblik. Russia: Olga Ostrovskaya, Alla Astachova. Spain: Mélisande Rouger, Eduardo de la Sota. Switzerland: Dr. André Weissen. USA: Cynthia E. Keen, i.t. Communications, Nat Whitney. Subscriptions Janka Hoppe, European Hospital, Theodor-Althoff-Str. 45, 45133 Essen, Germany Subscription rate 6 issues: 42 Euro, Single copy: 7 Euro. Send order and cheque to: European Hospital Subscription Dept Printed by: WVD, Mörfelden-Walldorf, Germany Publication frequency: bi-monthly European Hospital ISSN 0942-9085 Representatives China & Hongkong: Gavin Hua, Sun China Media Co, Ltd. Phone: +86-0755-81 324 036 E-Mail: gh@european-hospital.com Germany, Austria, Switzerland: Ralf Mateblowski Phone: +49 6735 912 993 E-Mail: rm@european-hospital.com France, Italy, Spain: Eric Jund Phone: +33 493 58 77 43 E-Mail: ej@european-hospital.com GB, Scandinavia, BeNeLux: Simon Kramer Phone/Fax: +31 180 6200 20 E-Mail: sk@european-hospital.com Israel: Hannah Wizer, International Media Dep. of El-Ron Adv. & PR Co., Ltd. Phone: +972-3-6 955 367 E-Mail: hw@european-hospital.com South Korea: CH Park, MCI Phone: +82 2 730 1234 E-Mail: chp@european-hospital.com USA & Canada: Hanna Politis, Media International Tel: +1 301 869 66 10 E-Mail: hp@european-hospital.com Cardiac surgeons have finally found what cardiologists had reported missing three years ago: evidence to support the use of the oldest mechanical circulatory assist devices: IABP. Nevertheless, EH correspondent Holger Zorn expects the findings to have only limited impact. A small study at the small University of Halle (Saale), Germany, triggered the most significant business kill of the current decade. Confirmed by a multi-centre study, the IABP Shock II trial, it prompted the worldwide revision of guidelines: the recom- mendation regarding the use of intra-aortic counter-pulsation (IABP – intra-aortic balloon pump) was downgraded from a Class I ‘strong’ recommendation to a simple recom- mendation (see European Hospital, 4/2013 p. 20-21 and EH 4/2014 p. 14-15). Why: There was no differ- ence in 30-day and one-year mor- tality between patients who had received IABP in addition to con- ventional therapy after infarction- induced cardiogenic shock and those who had not received IABP (30d, 40% vs. 41%; 1a, 52% vs. 51%). Consequently, in Germany, the num- ber of implantations decreased by almost one third (see figure). Meanwhile, the sister clinical dis- cipline cardiac surgery, where in the early 2000s significantly more IABPs had been implanted, made renewed efforts to assess the oldest and most easily implantable mechani- cal circulatory assist device and published a specific S3 guideline on the use of intra-aortic counter- pulsation in cardiac surgery (S3 Leitlinie zum Einsatz der intraaor- talen Ballongegenpulsation in der Herzchirurgie [Source: www.awmf. org/leitlinien/detail/ll/011-020.html, viewed 30.07.2015]. These guidelines clearly recom- mend the following: For haemodynamically stable patients with high surgery risk, IABP implantation is recommended, based on the second-highest evi- dence category IB. For patients with pre-surgical car- diac decompensation, implantation should be taken into consideration. This is a class B recommendation – just like the one mentioned above – however, evidence is three classes lower: class IV rather than I. Evidence is equally weak regard- ing the recommendation on the point in time of implantation: early if HLM weaning of the patient is dif- ficult or impossible. Very strong evidence (IA) - and strong recommendation – for the operation of IABP: Pre-surgery implanted IABP is recommended for use during the actual cardiac sur- gery, to transform non-pulsatile flow of the HLM to pulsatile flow. Dr Kevin Pilarczyk, cardiac sur- geon and coordinator of the guide- line, which was drafted in coop- eration with the national profes- sional organisations for cardiology, intensive and trauma medicine and extra corporeal techologies, sums up the recent data: ‘The results of the IABP shock II trial, with patients who almost exclusively had received interventional treatment, cannot readily be applied to cardiac surgery patients. Considering pathophysical conditions ‘A patient in infarct-induced cardio- genic shock who has to undergo balloon dilatation or stent implan- tation in the cardiac cath lab can- not be compared to a compara- tively stable non-infarction patient who has an increased perioperative risk profile due to reduced pump function. Surgery involving general anaesthesia, heart-lung machine and temporary cardiac arrest differs fun- damentally from cardiac therapy.’ Such pathophysiological con- siderations are supported by a recent meta analysis assessing sev- eral randomised studies on preop- erative IABP in high-risk cardiac surgery patients: it showed that aortic counter-pulsation is associ- ated with reduced hospital mortality and reduced length of stay – even when limited to more recent studies [DOI: 10.1093/ejcts/ezv258]. Data regarding the continuation of IABP- induced pulsatility during HLM are equally reliable [Source: Int J Artif Organs. 2009;32:50-61]. In contrast, IABP in high-risk patients before stent implantation does not seem to have any benefits [DOI: 10.1016/j. ijcard.2012.12.027]. Dr Pilarczyk concludes: ‘While there are no ded- icated studies for this particular setting, we recommend consider- ing IABP implantation in infarction- induced cardiogenic shock with sur- gical revascularisation due to the differences to cardiology.’ It remains to be seen to what extent these data will lead to an increase in implantations. Today, cardiologists are familiar with other, more difficult to implant systems – with remarkable results: attacked as business killers two years ago, they have now turned into business boosters. All other relevant systems – Impella, TandemHeart and ECLS – are significantly more expensive than IABP. The reimbursement a hospital receives for ECLS is at least ten times the amount reimbursed for IABP. The implantation figures of all other systems totalled and projected into the future indicate that these other systems will overtake IABP in 2017 – despite the fact that, to date, no randomised study has demon- strated an advantage over – shown to be useless – IABP. Development of the use of circulatory assist devices in Germany. In 2009, 10,205 percutaneously implanted IABPs were recorded (2009 was chosen as the base year because the first patients for the IABP shock II trial were recruited in that year). In 2013, the year following the publication of the results, the figure had fallen to 5,712. In the same period the number of Impella implantations had risen from 153 to 372, and of ECLS (without purely perioperative use) from 273 to 2,268. * Source: own illustration, based on data provided by Statistisches Bundesamt (Destatis) and personal conversations. d7602 - ESC 2016 Pub-v2.indd 110/08/201513:22 Phone: +86-0755-81324036 Phone: +496735912993 Phone: +33493587743 Phone/Fax: +31180620020 Phone: +972-3-6955367 Phone: +8227301234 Tel: +13018696610