Ges$one Remota dello scompenso cardiaco nei pazien$ portatori di device: non solo monitoraggio del device ma anche rilevazione di da$ clinici importan$ nella ges$one terapeu$ca del paziente Ermenegildo de Ruvo Policlinico Casilino - Roma
Background
Crescente numero pazien$ CHF Monitoraggio quo$diano Classificazione automa$ca Cura mirata del paziente Cura avanzata del paziente per HF HF Monitor Lung edema
What RM system transmits on a daily basis? RM transmihed data have grown rapidly in the last few years Currently, RM reports include almost all the data interrogated during a normal in- office visit. including tables, trends and EGM track recordings during arrhythmic episodes or periodically for diagnos$c purposes.
Elemen$ predimvi di peggioramento del compenso Incremento della frequenza cardiaca Riduzione dell amvità Fibrillazione Atriale Extrasistolia ventricolare Perdita della risincronizzazione del VSx da parte dello s$molatore Variabilità PP (SDANN) Impedenza intratoracica Pressione arteriosa e peso corporeo
Elemen: predi;vi di peggioramento del compenso Incremento la frequenza cardiaca, per mantenere una sufficiente perfusione " Lechat (1) ha verificato che un incremento di 1 bpm della frequenza cardiaca media corrisponde ad un incremento del 1,8 % del rischio di ospedalizzazione " Opasich (2) ha rilevato una frequenza media > 100 bpm aumenta del 61 % il rischio di scompenso a breve. 1) Lechat P. et al, Circula$on. 2001 Mar 13; 103 (10): 1428 33. 2) Opasich C. et al, Am J Cardiol. 2001 Aug 15; 88 (4): 382 7.
Elemen: predi;vi di peggioramento del compenso Riduzione dell amvità: " La riduzione della distanza percorsa camminando è significa$vamente correlata alla probabilità di morte e scompenso a due anni
Fibrillazione Atriale " l innesco di FA incrementa del 48% il rischio di perdita di compenso a breve (Opasich, 2001) Extrasistolia ventricolare " elevata ectopia ventricolare aumenta del 19% il rischio scompenso (Madsen, 1997) " Perdita della risincronizzazione del VSx da parte dello s$molatore
Variabilità PP (SDANN) Numerosi studi hanno osservato un aumento della variabilità PP (misurata come SDANN: Dev.St. delle mediane su segmen$ da 5 min degli intervalli atriali) nei pazien$ responders alla CRT Gilliam FR et al. Changes in heart rate variability, quality of life, and ac$vity in cardiac resynchroniza$on therapy pa$ents. Pacing Clin Electrophysiol 2007; 30: 56-64 Adamson PB et al. Cardiac Resynchroniza$on Therapy Improves Heart Rate Variability in Pa$ents with Symptoma$c Heart Failure. Circula$on 2003; 108: 266-269 Braunschweig F et al. Monitoring of physical ac$vity and heart rate variability in pa$ents with chronic heart failure using cardiac resynchroniza$on devices. Am J Cardiol 2005; 95: 1104-1107 Piccirilli G et al. Influence of cardiac- resynchroniza$on therapy on heart rate and blood pressure variability: 1- year follow- up. Eur J Heart Fail 2006; 8: 716-722
Heart rate variability dall impianto a oggi
Example of AT/AF
Example of Op$Vol Care Alert Changes of drug treatment could been prescript. The monitoring system could be used to verify the clinical status of the patient after an intervention.
CorVue : Affidabilità dell algoritmo CorVue Congestion Monitoring Feasibility Study (n=75) Sensitivity (%) FER (# FP/year) 71,4% 0,56 Specificità del 98 % 1600 Congestion Monitoring (ohms/day) Trigger Setting - 8 Days 10 Daily Impedance Reference Impedance Ω 900 Pre-Trigger State Post-Trigger State 25 15 07-31-2009 08-31-2009 09-30-2009
Peso corporeo e livello di attività paziente
Due to the rela$vely high incidence of clinical and device- related Adverse Events (AE) expected in a popula$on of CRT- Defibrillator (- D) pa$ents, a standard follow- up program based on 3- or 6- month in- office visits may be associated to an increased risk of AE misdetec$on or delayed detec$on, in absence of a Home Monitoring (HM) system for daily remote control Our aim was to assess whether such risk does exist and to give an es$ma$on for this class of pa$ents. PACE 2010
Methods We retrospec$vely reviewed HM report database and hospital files of 92 consecu:ve pa:ents rou:nely implanted with a CRT- D device in our centre from February 2006 to May 2009. HM Group. 26 pa$ents (28%) were remotely followed with HM in addi$on to in- office visits scheduled every 4 months; SF Group. 66 pa$ents (72%) were followed with a standard program of quarterly in- office visits. There was no selec$on criterion for HM ac$va$on PACE 2010
Clinical and device- related AEs AEs were divided in clinical or device- related: CLINICAL AE DEVICE- RELATED AE atrial and ventricular arrhythmias; insufficient pacing/sensing performances; presence of clinical marks poten$ally leading to heart failure (raised night rate, reduced physical ac$vity, atrial fibrilla$on, low CRT pacing); TIA/Stroke, worsening of HF or hospitaliza$ons for heart failure, deaths. out- of- range impedances; lead dislodgements device/lead failures infec$on implant revision PACE 2010
Clinical AE Survival Rates Kaplan- Meier curves Complete observations Censored PACE 2010 Clinical AE survival rates 1,0 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 SF Group p=0.00004 HM Group 0 100 200 300 400 500 600 700 Time (days from implant)
Independent Predictors of Clinical AE documenta$on Results of a Propor$onal Hazard Cox model Predic$ng variable Follow- up method (HM/in- office visits) LVEF Gender Age Cardiomyopathy (ischemic/non- ischemic) NYHA Class Permanent AF Model Significance level.009.03.18.82.37.34.31 0.0002 Regression coeff. Log, (SE) 1.39 (0.54) - 0.07 (0.03) - 0.78 (0.58) 0.006 (0.025) 0.20 (0.22) 0.71 (0.74) 0.61 (0.60) PACE 2010
Conclusions In our retrospec$ve analysis, the CRT- D pa$ents remotely controlled by HM showed a significantly lower clinical AE survival rate as compared with the other CRT- D pa$ents followed with a standard schedule of quarterly in- office visits. As the pa$ent groups were similar in terms of ICD indica$on and baseline characteris$cs, such difference may only be explained by a higher chance of misdetec$on or delayed detec$on of relevant clinical AEs in the SF Group. the risk reduc$on of misdetec$on or delayed detec$on of clinical AEs with HM remote control was es$mated as high as 87%; Non- diverging survival curves were observed in both groups for device- related AEs (short FU). HM was most frequently useful in early detec$on of clinical AEs rather than for device- related complica$ons. PACE 2010
ADES study 136 consecu$ve pa$ents rou$nely implanted with a CRT- D device. We prospec$vely reviewed HM report database and hospital files HM Group. 70 pa$ents (51%); SF Group. 66 pa$ents (49%). There was no selec$on criterion for HM ac$va$on submitted
Total number of Adverse Events Mean follow- up duration Clinical AEs median No. per pt. Device- related AEs median No. per pt. 27 ± 15 mo. HM Group (n=70) 316 1 (0-3) 81 0 (0-1) SF Group (n=66) 57 1 (0-1) 14 0 (0-0)
Adverse Event detection Clinical Events No. of patients with documentation of New Onset Atrial Fibrillation Non- Sustained /Sust. VT/VF Marks of potential worsening HF Low CRT percentage All causes Hospitalization Worsening HF Hospitalization Death TIA/Stroke Total HM Group (n=70) 21 (30%) 21 (30%) 1 (1%) 11 (16%) 6 (8%) 6 (8%) 6 (8%) 0 (0%) 44 (63%) SF Group (n=66) 13 (20%) 7 (11%) 0 (0%) 0 (0%) 20 (30%)* 12 (18%)* 11 (17%)* 3 (4%) 39 (59%)
Adverse Event detec$on Device- related Events n. of patients with documentation of insufficient pacing/sensing performances out- of- range impedances; lead dislodgements Inappropriate AF/VT detection device/lead failures infection Total Mean Follow- up (mo.) HM Group (n=70) 18 (26%) 5 (7%) 7 (10%) 1 (1%) 0 (0%) 0 (0%) 27 (38%) 9±7 SF Group (n=66) 7 (11%) 0 (0%) 3 (5%) 0 (0%) 0 (0%) 2 (3%) 11 (17%) 8±4
AE free detection rate Clinical Events Complete Censored 1,0 0,9 Adverse Event Free Rate 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 P = 0.0008 0,0 0 200 400 800 1200 600 1000 Days from implant 1400 1600 1800 SF Group HM Group
AE free detection rate Device- related AE Complete Censored 1,0 0,9 Adverse Event Free Rate 0,8 0,7 0,6 0,5 0,4 0,3 0,2 P = 0.0008 0,1 0,0 0 200 400 800 1200 600 1000 Days from implant 1400 1600 1800 SF Group HM Group
Hazard Ra$os for AE misdetec$on or delayed detec$on Clinical AEs Device- related AEs HR = 0.41 (0.26-0.65) HR = 0.32 (0.17-0.61) 0 0,5 1 1,5 HM beher Standard F.- up beher
Clinical AE misdetection/delayed detection risk 25% 0.24 (0.09-0.66) LVEF >25% 0.41 (0.20-0.84) SF 32 34 HM 15 26 Gender male female 0.37 (0.22-0.62) 0.69 (0.25-1.86) 48 18 54 16 Age < 70 70 0.36 (0.15-0.87) 0.48 (0.27-0.83) 31 35 18 52 CMD non- ischemic ischemic 0.38 (0.19-0.78) 0.62 (0.34-1.11) 34 32 29 41 Overall 0.41 (0.26-0.65) 66 70 HR (95%CI) 0 1 2 HM better SF better
Conclusions CRT- D pa$ents remotely controlled by HM showed a significantly lower clinical and device- related AE- free rates as compared with the other CRT- D pa$ents followed with a standard schedule of quarterly in- hospital visits. As the pa$ent groups were similar in terms of ICD indica$on and baseline characteris$cs, such difference may only be explained by a lower risk of misdetec$on or delayed detec$on of relevant AEs in the HM Group. The risk reduc$on was 59% for clinical AEs; 68% for device- related AEs All cause mortality and hospitaliza$ons trended worse in the SF Group Benefit of HM was well balanced in all the considered subgroups.
Thanks