CCCardiol CroatCardiologia CroaticaCardiol. Croat.1848-543X1848-5448Croatian Cardiac SocietyCC_13(11-12)_35810.15836/ccar2018.358Extended AbstractEffectiveness of cardiovascular implantable electronic devices with a defibrillator component therapy according to ventricular assist device implant strategy: data from the PCHF-VAD registryUčinkovitost terapije kardiovaskularnim implantabilnim elektroničkim uređajima s defibrilatorskom komponentom ovisno o strategiji liječenja mehaničkom srčanom crpkom: podatci iz Registra PCHF-VADhttps://orcid.org/0000-0001-7304-1127JakušNina1*https://orcid.org/0000-0002-5522-9318BrugtsJasper J.2TimmermansPhilippe3https://orcid.org/0000-0002-2395-1787PouleurAnne-Catherine4https://orcid.org/0000-0002-6979-3411RubisPawel5https://orcid.org/0000-0001-7686-2668Van CraenenbroeckEmeline6GaizauskasEdvinas7https://orcid.org/0000-0002-6416-6873GrundmannSebastian8https://orcid.org/0000-0003-4683-0993PaolilloStephania9Barge-CaballeroEduardo10ttpsD’AmarioDomenico11GkouzioutaAggeliki12https://orcid.org/0000-0003-0561-6704PlanincIvo1https://orcid.org/0000-0001-7234-8266VeenisJesse F.2https://orcid.org/0000-0001-7292-7751HouardLaura4https://orcid.org/0000-0002-6895-4076HolcmanKatarzyna5GigaseArno6https://orcid.org/0000-0003-3362-9596BiočinaBojan1https://orcid.org/0000-0002-2492-3702GašparovićHrvoje1https://orcid.org/0000-0003-1411-4482LundLars H.13https://orcid.org/0000-0002-1373-0630FlammerAndreas14https://orcid.org/0000-0001-5972-0596RuschitzkaFrank14https://orcid.org/0000-0001-9101-1570MiličićDavor1https://orcid.org/0000-0002-4772-5549ČikešMaja1Medicinski fakultet Sveučilišta u Zagrebu, Klinički bolnički centar Zagreb, Zagreb, HrvatskaMedicinski centar Sveučilišta Erasmus, Rotterdam, NizozemskaSveučilišna bolnica Leuven, Leuven, BelgijaKlinika Saint-Luc UCL, Bruxelles, BelgijaMedicinski fakultet Jagielonskog Sveučilišta, Bolnica Ivana Pavla II, Krakov, PoljskaSveučilišna bolnica Antwerpen, Antwerpen, BelgijaSveučilišna bolnica Vilnius, Vilnius, LitvaSrčani centar Sveučilišta u Freiburgu, Medicinski fakultet, Sveučilište u Freiburgu, NjemačkaSveučilište u Napulju Federico II, Napulj, ItalijaSveučilišna bolnica de A Coruña, A Coruña, ŠpanjolskaKatoličko sveučilište Svetog Srca, Rim, ItalijaOnassis centar za kardiokirurgiju, Atena, GrčkaInstitut Karolinska, Medicinski odjel, Stockholm, ŠvedskaSveučilišna bolnica Zurich, Zurich, ŠvicarskaUniversity of Zagreb School of Medicine, University Hospital Centre Zagreb, Zagreb, CroatiaErasmus University Medical Centre, Rotterdam, The NetherlandsUniversity Hospital Leuven, Leuven, BelgiumCliniques Saint-Luc UCL, Brussels, BelgiumJagiellonian University Medical College, John Paul II Hospital, Krakow, PolandUniversity Hospital Antwerp, Antwerp, BelgiumVilnius University Hospital, Vilnius, LithuaniaHeart Center Freiburg University, Faculty of Medicine, University of Freiburg, GermanyUniversity of Naples Federico II, Naples, ItalyHospital Universitario de A Coruña, A Coruña, SpainCatholic University of the Sacred Heart, Rome, ItalyOnassis Cardiac Surgery Centre, Athens, GreeceKarolinska Institute, Department of Medicine, Stockholm, SwedenUniversity Hospital Zurich, Zurich, Switzerland
on behalf of the PCHF VAD-ICD/CRT Registry
ADDRESS FOR CORRESPONDENCE: Nina Jakuš, Klinički bolnički centar Zagreb, Kišpatićeva 12, HR-10000 Zagreb, Croatia. / Phone: +385-91-5605-795 / E-mail: nina.jakush@gmail.com1120181311-1235836028102018051120182018Croatian Cardiac SocietyKLJUČNE RIJEČI: mehanička srčana crpkaimplantabilni defibrilatorzatajivanje srcaKEYWORDS: heart assist devicesimplantable defibrillatorsheart failure
Background: LVAD (left ventricular assist device) candidates are typically stratified according to three most typical treatment strategies – BTT (bridge to transplantation), BTD (bridge to decision) or DT (destination therapy), reflecting the acute vs. chronic state of disease, age, comorbidities and overall condition of the patient. (1, 2) Approximately half of the European LVAD carriers are concomitantly treated with CIED-D (cardiovascular implantable electronic devices with a defibrillator component), in which we have shown substantial survival benefit from concomitant therapy. We aimed to investigate in more detail whether specific LVAD treatment strategies portended a difference in benefit from CIED-D therapy.
Methods: 429 patients with continuous flow LVADs have been included in a multicentre registry formed by 12 European centres (median age 56 (IQR 46-62), 82% male), 53% also had CIED-D. Patients were analyzed according to VAD intention (Table 1). Median follow-up time was 1.1 years (IQR 0.5-2.0) from the time of LVAD implant.
Baseline characteristics of the studied left ventricular assist device population according to implant strategy.
BTT (N=305)
BTD (N=68)
DT (N=56)
P value
Female gender, n (%)
53 (17.4%)
19 (27.9%)
4 (7.1%)
0.01
Age
50.28 ±12.68
51.54 ± 13.36
64.85 ± 7.30
<0.001
Etiology of disease
0.18
Dilated cardiomyopathy, n (%)
140 (45.9%)
23 (33.8%)
18 (32.1%)
Ischemic cardiomyopathy, n (%)
132 (43.3%)
35 (51.5%)
31 (55.4%)
Other cause of heart failure, n (%)
33 (10.8%)
10 (14.7%)
7 (12.5%)
Arterial hypertension, n (%)
61 (20.0%)
15 (22.1%)
23 (41.1%)
0.003
Diabetes mellitus, n (%)
49 (16.1%)
13 (19.1%)
26 (46.4%)
<0.001
Chronic kidney disease, n (%)
63 (20.7%)
14 (20.6%)
24 (42.9%)
0.001
Coronary artery disease, n (%)
65 (21.3%)
17 (25.0%)
22 (39.3%)
0.015
Chronic obstructive pulmonary disease, n (%)
21 (6.9%)
6 (8.8%)
15 (26.8%)
<0.001
Atrial fibrillation/flutter, n (%)
86 (28.2%)
11 (16.2%)
29 (51.8%)
<0.001
Ventricular arrhythmias, n (%)
71 (23.3%)
15 (22.1%)
16 (28.6%)
0.65
Cerebrovascular accidents, n (%)
21 (6.9%)
8 (11.8%)
4 (7.1%)
0.39
No prior cardiac surgery, n (%)
265 (86.9%)
59 (86.8%)
52 (92.9%)
0.45
INTERMACS class, n (%)
<0.001
Class 1
49 (16.3%)
17 (26.2%)
3 (5.6%)
Class 2
94 (31.3%)
18 (27.7%)
5 (9.3%)
Class 3
89 (29.7%)
13 (20.0%)
28 (51.9%)
Class 4-7
68 (22.7%)
17 (26.2%)
18 (33.3%)
Device type, n (%)
<0.001
Heart Mate II
193 (63.3%)
26 (38.2%)
15 (26.8%)
Heart Ware
56 (18.4%)
20 (29.4%)
16 (28.6%)
Heart Mate 3
49 (16.1%)
22 (32.4%)
14 (25.0%)
Other device
7 (2.3%)
0 (0.0%)
11 (19.6%)
Prior life support, n (%)
<0.001
None
214 (73.0%)
42 (61.8%)
52 (92.9%)
Extracorporeal membrane oxygenation
24 (8.2%)
8 (11.8%)
1 (1.8%)
Temporary LVAD
2 (0.7%)
2 (2.9%)
0 (0.0%)
Temporary BiVAD
0 (0.0%)
1 (1.5%)
0 (0.0%)
Intraaortic balloon pump
42 (14.3%)
7 (10.3%)
3 (5.4%)
Other life support
11 (3.8%)
8 (11.8%)
0 (0.0%)
CIED-D therapy during VAD support, n (%)
137 (44.9%)
23 (33.8%)
42 (75.0%)
0.001
BTT = bridge to transplantation; BTD = bridge to decision; DT = destination therapy; INTERMACS = Interagency Registry for Mechanically Assisted Circulatory Support; LVAD = left ventricular assist device; BiVAD = biventricular assist device; CIED-D = cardiovascular implantable electronic devices with a defibrillator component; VAD = ventricular assist device.
Results: Table 1 presents the baseline characteristics of patients according to LVAD treatment strategy. Crude event rates for the primary outcome (all-cause mortality) were equally distributed among the three groups (event rates per 100 person-years): BTT: 22.4 [18.2-27.5], BTD: 23.5 [15.2-36.4], DT: 21.7 [13.7-34.5]), with similar hazard ratios for all-cause death compared to BTT group in unadjusted analysis: HR (95% CI) for BTD and DT was 1.06 (0.65-1.73), p=0.809 and 1.00 (0.60-1.65), p=0.987, respectively. CIED-D use contiguously with an LVAD significantly altered survival in the BTT and DT groups: for BTT patients, CIED-D use carried a 40% mortality reduction (p=0.017) and 65% for DT group (p=0.032). However, LVAD treatment strategy at implantation did not modify the association between CIED-D therapy and mortality reduction (interaction p=0.055).
Conclusion: In this analysis, concomitant CIED-D therapy during LVAD support was associated with a reduction in mortality in patients receiving an LVAD as BTT and DT. However, neither BTT or BTD strategy modified the treatment effect of CIED-D on survival. This finding confirms the relevance of continuation of CIED-D therapy throughout the duration of LVAD support.
LITERATUREClerkinKJTopkaraVKDemmerRTDizonJMYuzefpolskayaMFriedJAImplantable Cardioverter-Defibrillators in Patients With a Continuous-Flow Left Ventricular Assist Device: An Analysis of the INTERMACS Registry.JACC Heart Fail. 2017 Dec;5(12):916–26. 10.1016/j.jchf.2017.08.01429191299BergDDVaduganathanMUpadhyayGASinghJPMehraMRStewartGC. Cardiac Implantable Electronic Devices in Patients With Left Ventricular Assist Systems.J Am Coll Cardiol. 2018 Apr 3;71(13):1483–93. 10.1016/j.jacc.2018.01.06129598870