Τεχνολογικές εξελίξεις & καινοτοµίες στις συσκευές βηµατοδότησης & απινίδωσης

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1 Τεχνολογικές εξελίξεις & καινοτοµίες στις συσκευές βηµατοδότησης & απινίδωσης Georgios Giannopoulos, MD, FESC Cardiology Dept., Athens General Hospital G. Gennimatas, Athens, Greece Adj. Asst. Professor of Medicine (Cardiology), Yale University School of Medicine, New Haven, CT, USA web: Tuesday, March 10, 15

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4 J Am Coll Cardiol 2006 Perception: mortality rate is 50% in 5 years in patients with heart failure Reality: this was true of early CRT experience, but has dramatically changed over time Tuesday, March 10, 15

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6 In MADIT-CRT, at 7 years, >80% of CRT-D patients with LBBB were alive Danish Registry: median survival after CRT QRS : 95 months (7.9 years) QRS : 82.2 months (6.9 years) QRS 200: 70.0 months (5.8 years) Tuesday, March 10, 15

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10 Impact of increased ICD/CRT longevity on costs

11 ICD and CRT-D Battery Longevity: savings

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14 CRT-D Battery Longevity: Closing the Gap

15 CRT-D Battery Longevity: Closing the Gap

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17 MRI with MR conditional devices

18 MRI with MR conditional devices

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20 Going up to 3T

21 Going up to 3T

22 Going up to 3T

23 Clinical use of 3T is increasing While 1.5 T machines remain the clinical standard, 3.0 T MRI scanners improve image quality and reduce scan time. Higher definition 3T MRI scans help physicians see intricate details in soft tissue, for example in the brain! Useful for acute stroke, TIA, brain tumors. Shorter scan times are helpful for patients who experience claustrophobia or have difficulty remaining motionless, such as young children 25% of new MRI machine installations are 3T 7. Advancements in MRI imaging technologies, Demand for non-invasive and ionizing radiationfree diagnostic procedures are a few growth drivers Tuesday, March 10, 15

24 Clinical use of 3T is increasing While 1.5 T machines remain the clinical standard, 3.0 T MRI scanners improve image quality and reduce scan time. Higher definition 3T MRI scans help physicians see intricate details in soft tissue, for example in the brain! Useful for acute stroke, TIA, brain tumors. Shorter scan times are helpful for patients who experience claustrophobia or have difficulty remaining motionless, such as young children 25% of new MRI machine installations are 3T 7. Advancements in MRI imaging technologies, Demand for non-invasive and ionizing radiationfree diagnostic procedures are a few growth drivers Tuesday, March 10, 15

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30 If ICDs were even smaller, what benefits do you think that could have? Tuesday, March 10, 15

31 If ICDs were even smaller, what benefits do you think that could have? Tuesday, March 10, 15

32 Smaller generator " Easier to fit for replacements " Smaller incision for initial implant " Lower risk of pocket-related complication " Lower skin pressure " More options to offer patients Tuesday, March 10, 15

33 ICD Volume Thinness MINI cc 9.9mm MDT Evera cc 13.0mm STJ Ellipse cc 12.0mm BIO Iforia cc 11.0mm SORIN Paradym cc 11.0mm MINI ICD VR is 20% smaller and 24% thinner than Evera TM VR. 1 MINI ICD: Boston Scientific Physician Technical Manual EN Europe EVERA XT VR DVBB1D St. Jude Medical High-Voltage Devices User s Manual 2013 page Biotronik Iforia TM 3/5/7 Manual 13-X-20 Revision: D( ) 5 Sorin Paradym TM RF VR model 9250 Implant manual 0561C-en Tuesday, March 10, 15

34 ICD Volume Thinness MINI cc 9.9mm Battery and Capacitor make up 2/3rds of ICD size Industry Avg. MINI VR DR MDT Evera cc 13.0mm STJ Ellipse cc 12.0mm BIO Iforia cc 11.0mm SORIN Paradym cc 11.0mm MINI ICD VR is 20% smaller and 24% thinner than Evera TM VR. 1 MINI ICD: Boston Scientific Physician Technical Manual EN Europe EVERA XT VR DVBB1D St. Jude Medical High-Voltage Devices User s Manual 2013 page Biotronik Iforia TM 3/5/7 Manual 13-X-20 Revision: D( ) 5 Sorin Paradym TM RF VR model 9250 Implant manual 0561C-en Tuesday, March 10, 15

35 Question Which pathology has up to 80% prevalence in HF population, with about 80% remaining undiagnosed, is linked to several clinical major events and has therapeutical options available? Tuesday, March 10, 15

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37 increased hypoxia autonomic distress (from hypoxia) decreased ejection fraction increased LV afterload decreased cardiac output increased heart rate increased blood pressure

38 Sleep Apnea and cardiovascular consequences

39 Sleep Apnea and cardiovascular consequences Heart Failure Mortality HF mortality increased by 2-fold. Worsened survival in HF patients with untreated sleep apnea vs. no or mild Sleep Apnea patients (76% vs. 88%). Increased survival for treated sleep apnea. Heart Failure Morbidity OSA can lead to a progression of HF and refractoriness to therapy. OSA increases HF morbidity by 2.2- fold. Cardiovascular Events Severe OSA increased risk of fatal cardiovascular events by 3-fold. Tuesday, March 10, 15

40 Sleep Apnea and cardiovascular consequences Sudden Death Sleep Apnea increases risk for VT/VF & appropriate ICD therapies by 2-3 fold. Sleep Apnea increases risk of nocturnal SCD compared to daytime (RR: 2.57). Event-free survival from appropriate ICD therapies in HF population with CSA, OSA, no or mild SDB Atrial Fibrillation Sleep Apnea is an independent predictor of new onset AF, and may be a causative factor in the development of AF. Sleep Apnea increases likelihood for AF recurrence post cardioversion (from 42% to 82%). Recurrence decreases after CPAP therapy. Bitter, EHJ 2011 Tuesday, March 10, 15 Mehra, AJRCCM 2006

41 Butt et al. Circ Heart Fail. 2012

42 Butt et al. Circ Heart Fail. 2012

43 Butt et al. Circ Heart Fail Colish, CHEST 2012 Tuesday, March 10, 15

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45 Screening for apnea

46 Screening for apnea

47 AP Scan /ApneaScan allow you to identify implanted patients at risk of severe sleep apnea, who may benefit from further investigation and potential better treatment.! AP Scan /ApneaScan displays the average number of Respiratory Disturbance Events (RDE) per hour that the patient experiences during the programmed sleep period.! The number of occurred RDE define the different grade of sleep-disordered breathing. Severe sleepdisordered breathing is identified with > 30 Events/hr.! AP Scan on PM population showed the following performance 145 :! RDE is correlated with clinical AHI (R=0.8)! with 82% sensitivity and 88% specificity! and 88% PPV in identifying Severe Sleep Apnea patients (AHI >= 30) Tuesday, March 10, 15

48 AP Scan /ApneaScan allow you to identify implanted patients at risk of severe sleep apnea, who may benefit from further investigation and potential better treatment.! AP Scan /ApneaScan displays the average number of Respiratory Disturbance Events (RDE) per hour that the patient experiences during the programmed sleep period.! The number of occurred RDE define the different grade of sleep-disordered breathing. Severe sleepdisordered breathing is identified with > 30 Events/hr.! AP Scan on PM population showed the following performance 145 :! RDE is correlated with clinical AHI (R=0.8)! with 82% sensitivity and 88% specificity! and 88% PPV in identifying Severe Sleep Apnea patients (AHI >= 30) Tuesday, March 10, 15

49 AP Scan /ApneaScan allow you to identify implanted patients at risk of severe sleep apnea, who may benefit from further investigation and potential better treatment.! AP Scan /ApneaScan displays the average number of Respiratory Disturbance Events (RDE) per hour that the patient experiences during the programmed sleep period.! The number of occurred RDE define the different grade of sleep-disordered breathing. Severe sleepdisordered breathing is identified with > 30 Events/hr.! AP Scan on PM population showed the following performance 145 :! RDE is correlated with clinical AHI (R=0.8)! with 82% sensitivity and 88% specificity! and 88% PPV in identifying Severe Sleep Apnea patients (AHI >= 30) Tuesday, March 10, 15

50 Diagnostic-Therapeutic Pathway

51 My insurance plan didn t have coverage for a regular pacemaker