Velletri 2030 Innovazione tecnologica in cardiologia e ... · Micra Major Complications1 13 Within...
Transcript of Velletri 2030 Innovazione tecnologica in cardiologia e ... · Micra Major Complications1 13 Within...
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Natale Di Belardino M.D. Ph.D.
Direttore UOC Cardiologia-UTIC Anzio-Nettuno
Velletri 2030
Innovazione tecnologicain cardiologia e cardiochirurgia
da Barnard ad oggi
Velletri, 22 Giugno 2020
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BROCHURE ILLUSTR
ATIVA
LIFEPAK® 15 MONITOR / DEFIBRILLATOREper gli Ospedali
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1959 2013Pacing Innovation
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First ExternalPacemaker
Synergist
1989
Activitrax
1986
Byrel
1979
5858
1970
5800
1958
Chardack - Greatbatch
1960
MicroMinix
1990
Elite
1991
Kappa™
1998
Thera™
1995
Adapta™
2006
EnPulse
2004
First Implantable Pacemaker
Pediatric AsynchronousPulse Generator
Rate response Radicallysmaller size
1st Micro-processor-based, Mode switching
Full automaticity
MVP™, Fullautomaticity
Rate response via activity & minute ventilation
Dual chamber rate response
2011
EnRhythmMRI™
1st MRI-Conditional
Advisa MRI™
2nd MRI-Conditional
2013
Micra™
TranscatheterPacing System
2015
Historical perspective
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New opportunities to: REDEFINE THE PATIENT EXPERIENCE
– Potential to increase pacemaker patient satisfaction – No chest scar, bump, and no visible or physical reminder– Minimally-invasive procedure – Potential for fewer post-implant activity restrictions
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Miniaturized
93% smaller than other modern-day pacemakers1, Micra™ is the world’s smallest pacemaker2, yet it offers a complete set of features.
1 Williams, Eric, Whiting, Jon; Micra Transcatheter Pacing System Size Comparison, November 2014, Medtronic Data on File.2 Nippoldt, Doug, Whiting, Jon; Micra Transcatheter Pacing System Device Volume Characterization Comparison, November 2014, Medtronic Data on File.
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Micra™ CardiocAPSULE1
Size• Volume: 0.8 cc• Mass: 1.75 g• Length: 25.9 mm• Width: 20 Fr
Battery• 12 year estimated average longevity2
Capabilities• Pacing Mode: VVIR• Bipolar sensing • MRI SureScan™, allowing 1.5 T or 3 T full body
MRI scans • Capture Management™• Rate Response• Diagnostics: battery status, threshold, impedance, % paced• Device can be manually deactivated and automatically deactivates at EOS
FlexFix™ Nitinol Tines
18mm electrode to ring
spacing
Cathode
Anode
Proximal Retrieval
Feature
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1 Medtronic Micra MC1VR01 Clinician Manual, November 20142 Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Eng J Med. Published online November 9, 2015
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Complete feature set
Micra™ is the only TPS to offer a complete feature set1,2
• 12+ year estimated average battery longevity3*
• MRI SureScan™, which allows the patient to be safely scanned using either a 1.5 T or 3 T full body MRI
• Accelerometer based rate response
• CareLink™ 2090 Programmer compatible; no accessories requirility; currently not yet available
12
;
.
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Micra Major Complications1
13
Within 30 days
30 days– 6 Mos > 6 Mos Events
(Patients, %)Total 24 6 2 32 (29, 4.0%)
Cardiac Perforation/Effusion 10 1 0 11 (11, 1.5%)AV Fistula/Pseudoaneurysm 5 0 0 5 (5, 0.7%)Cardiac Failure 0 4 2 6 (6, 0.8%)Elevated Thresholds 2 0 0 2 (2, 0.3%)Pacemaker Syndrome 1 1 0 2 (2, 0.3%)Acute MI 1 0 0 1 (1, 0.1%)Deep Vein Thrombosis 1 0 0 1 (1, 0.1%)Metabolic Acidosis 1 0 0 1 (1, 0.1%)Presyncope 1 0 0 1 (1, 0.1%)Pulmonary Embolism 1 0 0 1 (1, 0.1%)Syncope 1 0 0 1 (1, 0.1%)
1Ritter P, et al. Long-Term Performance of a Transcatheter Pacing System: 12 month results from the Micra Global Clinical Trial. Presented at: European Society of Cardiology Congress 2016; August 28, 2016; Rome, Italy.
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Micra DESIGN JOURNEY
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Development
Clinical
Commercialization
Prototyping / Assessment
Ideation
14
MICRA DESIGN JOURNEY
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Development
Clinical
Commercialization
Prototyping / Assessment
Ideation
40
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“Everyone here has the sense that right now is one of those moments when we are influencing the future.”
-Steve Jobs
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A Revolutionary SystemThe Complete Monitoring Solution
Mobile Alerts
Streamlined Reports
Improved CareLink®
User Interface
Patient Assistant
MyCareLink™ Patient Monitor
Simplified Insertion Procedure
Reveal LINQ™ ICM
Wireless
Cellular
All patient and clinical data are fictitious and for demonstration purposes only
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Location
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*Compared to Reveal XT ICM
87% Smaller*
Linear dimensions rounded to the nearest mm
Volume rounded to the nearest tenth of a cc
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Proven AF algorithm accurately detects AF in 99.1% of patients*5
Simplified procedure and redesigned titanium nitride electrode coating support high-fidelity signals
1. Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):262-269.2. Krahn AD, Klein GJ, Yee R, Norris C. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing.Am J Cardiol. July 1,
1998;82(1):117-119.3. Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. January 26, 1999;99(3):406-410.4. Krahn AD, Klein GJ, Yee R, Hoch JS, Skanes AC. Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial. J Am Coll Cardiol. August 6, 2003;42(3):495-501.5. Pürerfellner H, Pokushalov E, Sarkar S, et al. P-wave evidence as a method for improving algorithm to detect atrial fibrillation in insertable cardiac monitors. Heart Rhythm. Published online June 6, 2014.
*In patients with known AF
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Componenti di un circuito
di stimolazione:
una foto ai raggi X
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Funzioni principali di unsistema di stimolazione
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FORNIRE INFORMAZIONIsul funzionamento del cuore del
paziente e del pacemaker(DIAGNOSTICA)
RISPONDEREad un aumento della richiesta
metabolica accrescendo la frequenza della
depolarizzazione cardiaca quando il cuore non è in grado di
farlo da solo
RILEVAREquando il cuore funziona
correttamente così da evitare una stimolazione inutile
STIMOLAREin modo efficace e costante
in armonia con il ritmo cardiaco naturale
Funzioni Principali di un sistema di stimolazione
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…il circuito di stimolazione è un circuito elettrico, dunque…
Le misure elettriche sono l’unico metodo per avere informazioni sul suo corretto funzionamento (posizione cateteri, stimolazione, sensing…)
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Si misurano…• Soglia di stimolazione• Sensing (ampiezza del
segnale spontaneo rilevato)
• Impedenza
Per programmare
ØUscita del PM
ØSensibilità del PM
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• Sensing:- Ampiezza onda P (endocavitaria): > 1mV- Ampiezza onda R (endocavitaria): > 5 mV
• Soglia di stimolazione:- Atriale: < 1 V- Ventricolare: < 1 V
• Impedenza di stimolazione:dipende dal tipo di elettrocatetere, tipicamente da 500 Ohm a 1400 Ohm
LE MISURE ELETTRICHEVALORI TIPICI
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• 1958 Pm asincroni
• 1962 Pm a sincronizzazione atriale
• 1965 Pm a domanda
• 1980 Pm bicamerali
• 1986 Pm rate responsive monocamerali
• 1988 Pm rate responsive bicamerali
L’evoluzione dei pacemakers
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Michel Miroscki
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Medtronic InSync®ICD Cardiac Resynchronization
System
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Il Sistema S-ICDL’approccio sottocutaneo
• Nessun catetere all’internoo sul cuore
� Sistema venoso preservato
� Impianto semplicechirurgicamente� Puri riferimenti
anatomici� In generale senza
bisogno di fluoroscopia� Tempo di impianto
prevedibile
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• Case performed by Dr. Vias Markides, Royal Brompton and Harefield NHS Foundation Trust
Ultra High density mappingNew Voltage mapping window
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Pre-ablation RSPV EGM’s with IntellaMap Orion
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Post-ablation RSPV EGM’s with IntellaMap Orion
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Pre-ablation Activation and
Voltage Map During CS
Pacing
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SOVRACCARICO IDRICO
• Priming: 1000 ml• Cardioplegia: 1000 ml• Fluidi e farmaci: 1500 ml
• Totale: 3500 ml
C.E.C.Aspetti negativi
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Attività cardiochirurgica dal Settembre 2000Complicanze neurologiche
1464 CABG puri
On-Pump8 di 676 Pz.
98,8%
1,2%
No-Complicanze Complicanze
Off-Pump1 di 788 Pz.
0,1%
99,9%
No-Complicanze Complicanze
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Attività cardiochirurgica dal Settembre 2000Tempi di degenza media
• Intubazione: 4 h
• Degenza in T.I.: 18 h
• Degenza postoperatoria: 5 gg
• Intubazione: 7,5 h
• Degenza in T.I.: 27 h
• Degenza postoperatoria: 8 gg
Off-Pump On-Pump
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Rivascolarizzazione miocardicaa cuore battente
Vantaggi
•Significativa riduzione della mortalità e della morbilità
Svantaggi
•Curva di apprendimento di maggiore durata
•Maggiore difficoltà tecnica
•Tendenza ad un numero inferiore di anastomosi
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ConclusioniGli interventi di Bypass aortocoronarico
a cuore battente possono migliorare sensibilmente i risultati chirurgici degli
interventi di rivascolarizzazione miocardicase effettuati in un centro che, negli anni,ha introdotto e sviluppato questa tecnica,
aggiornando atrezzature e strumentario ed addestrando con gradualità i propri operatori.
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ENTITA’ DEL PROBLEMA
85% delle MORTI 70% della DISABILITA’
• Malattie CardioVascolari (MCV)• Diabete• Obesità• Malattie Croniche Polmonari• Alcuni Tumori
Atherosclerosis Supplements 2009; 10: 1-30
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• Infarto Miocardico• Aneurismi aortici• Angina Pectoris• Ictus• Demenza• Arteriopatie Arti inferiori
• Piede diabetico
• Ostruzioni carotidee• Disfunzione erettile• Insufficienza Renale• Etc etc
MALATTIE CARDIOVASCOLARI
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In Italia le M.C.V. à 250.000 morti/anno (54% Donne)
1 Italiano su 4 è affetto da Malattie Cardio Vascolari
1.000.000 à il N° di persone sopravvissuto ad un Infarto
Frequenza anno di eventi coronarici età 35 à 69 anni • Donne 1.7/ 1000 abitanti• Uomini 5.7 /100 abitanti
Dopo i 65 anni la frequenza di eventi coronarici /annoè maggiore nelle donne rispetto agli uomini
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Stima Numero Casi x Anno
• Stati Uniti ® 300.000
• Europa ® 500.000
• Germania ® 80.000
• Italia ® 57.000
…la morte cardiaca improvvisa…
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Incidenza per Regioneü Trentino ® 1 caso ogni 9 ore
üLombardia ® 1 caso ogni 57 minutiü Friuli ® 1 caso ogni 7 oreü Veneto ® 1 caso ogni 2 oreü Piemonte ® 1 caso ogni 2 oreü Liguria ® 1 caso ogni 5 oreü EmiliaRomagna ® 1 caso ogni 2 ore e 20ü Marche ® 1 caso ogni 6 oreü Toscana ® 1 caso ogni 2 ore
…la morte cardiaca improvvisa…
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Eziologia
…la morte cardiaca improvvisa…
5% ALTRO
15% CARDIOMIOPATIE
80% CORONAROPATIA
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NEI Paesi membri dell’Unione Europea i morti per malattie cardiovascolari sono ogni anno à 2 milioni e rappresentano il 42% del totale dei decessi.
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Fumo ● trigliceridi ObesitàIpertensione ● LDL Piccole/dense ● Obesità addominale
● colesterolo-LDL ● Infiammazione/PCR Sedentarietà●¯ colesterolo-HDL ● lipoproteina(a) ● Familiarità per MCV
● Diabete ● omocisteina ● Caratteristiche etniche
● Età avanzata ● Fattori protrombotici Fattori psico-sociali
Quali sono i Fattori di rischio?
Maggiori Condizionanti Predisponenti
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Chi presenta tutti i nove fattori di rischio ha una probabilità
Avere un infarto che è più di 330 volte superiore a quella di chi non ne ha nessuno
I fattori di rischio,spiegano” oltre il 90% degli infarti miocardici”
•“
• L’associazione di più fattori di rischio moltiplica la probabilità di infarto
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Rischio relativo: Mortalità per Malattia Ischemica di cuore, età 18-74 anni. Firenze 2001-2005.
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• 1.3oo.ooo.ooo di FUMATORI
• 600.ooo.ooo di Ipertesi
• 220.ooo.ooo Diabetici
L’incremento di Diabete è molto preoccupante438 milioni di diabetici previsti nel 2030
.
2 Miliardi di Persone sono ad alto rischio di MCV
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Come i F.D.R. determinano le malattie cardiovascolari?
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Plaque RuptureThrombus
Distal Embolization
Serotonin ReleaseVasoconstriction
Mechanical Plugging
Vasoconstrictive
Pathophysiology
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Aorta
Coronaria dxCoronaria sn
Circonflessa
Discendenteanteriore
Sintomatico80%
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Quanto ci costa il SSNed in particolare le
Malattie cardiovascolari ?
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ITALIA: Voci Bilancio dello Stato Costi /anno
1° PENSIONI > 300 Mliardi
2° interessi DEBITO PUBBLICO > 120 Mliardi>2000 Mliardi
3° SISTEMA SANITARIO 110 Mliardi 2014
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COSTI Malattie C. V.
Europa 192 Mliardi
ITALIA 22 Mliardi 14 Ml Costi Sanitari Diretti
4 Ml Costi sanitari Indiretti4 Ml Perdità di produttività
http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf http://www.epicentro.iss.it/focus/cardiovascolare/StatisticheEuropa.asp
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Costi sanitari diretti ed indiretti x MCV 2010 sono stati pari a $450 bilioni 2030 saranno pari a $ 1 trilione
Circulation 2011; 124 (8): 967-90 Lancet 2011; 378 (9793): 752-3.
Politiche sanitarie che modifichino lo stile di vita sono efficaci in termini di riduzione di spesa e di eventi evitati
Costi :StimaAmerican Heart Association AHA
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Ogni aumento del 10% di Infarto ed Ictus
Determina
Un rallentamento della crescita dello 0,5 %
Heart@Work: Fondazione Svizzera di Cardiologia: programma di prevenzione per le aziende
ALTRI EFFETTI ECONOMICI DELLE MALATTIE C.V.
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La ripresa economica
passa anche per politiche sanitarie che riducano tali enormi spese migliorando la salute e l’aspettativa di vita:
1)Prevenzione
2)diagnosi precoce
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Perché Investire in
- PREVENZIONE- Diagnosi precoce
Worksite Wellness Programs for Cardiovascular Disease Prevention: A Policy Statement from
the American Heart Association. Circulation 2009;120;1725-1741
Questi programmi riducono, in mediale assenze per malattia del 28 %i costi della salute del 26 % i costi di risarcimento e le rendite di invalidità del 30 %
. Esiste una relazione diretta tra il numero di fattori di rischio di un collaboratore e i suoi giorni d’assenza
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Perché Investire in
- PREVENZIONE- Diagnosi precoce
Worksite Wellness Programs for Cardiovascular Disease Prevention: A Policy Statement from the American HeartAssociation. Circulation 2009;120;1725-1741
I collaboratori con 3 o 4 fattori di rischio CVsi assentano dal lavoro da due a tre volte più di quelli che
non hanno fattori di rischio o ne hanno uno solo.
Riducendo di un solo fattore di rischio questo fenomeno diminuisce del 9 %.
I Collaboratori malati producono di meno di quelli sani
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PREVENZIONE e Diagnosi precoce
La prevenzione apporta benefici dimostrabili
Ogni anno si manifestano in circa 30'000 infarti cardiaci16'000 ictus cerebrali 8'000 arresti cardiocircolatori improvvisi
Più di metà di questi eventi sarebbero evitabili .
Fondazione Svizzera Heart@Work sito www.heartatwork.ch.
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•Meno disturbi di salute e uno stile di vita sano
• aumentano il benessere fisico e psichico con incremento della produttività
• I processi lavorativi si svolgono con maggior comunicatività ed efficienza
• i risultati Produttivi si ottengono più rapidamente e sono di qualità migliore.
• Le attività di prevenzione delle MCV sia nella grande sia nelle media e piccola industria, hanno effetti positivi durevoli.
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OGNI euro
Investito apporta un Return on Investment di
2,5-13,8 franchi
VANTAGGI ECONOMICI DELLA PREVENZIONE
Fondazione Svizzera Heart@Work sito www.heartatwork.ch
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PROGRAMMI DI PREVENZIONE DIAGNOSI PRECOCE
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DIAGNOSI PRECOCE
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DIAGNOSI PRECOCE
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BISOGNA ALIMENTARSI CON
Come dimagrire IN MODO SANO?
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High Risk Groups for SCD
High Coronary Risk
Post M I
Heart Failure/E F < 35%)
Previous VF / VT
Syncope /Heart Disease
0 100 200 30050
(thousands)(millions)
Population Size
0 10 20 501 2 5
SCD Percent / Year Total SCD / Year
0 101 2 5 20
(percent)
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5 5
14
17
14
20
3 4
911 10
17
MUSTT MADIT 1 AVID MADIT 2 COMPANION SCD-HeFT2Y. 5Y. 2Y. 3Y. 2Y. 3Y. 2Y. 3Y. 1Y. 2Y. 2Y. 5Y.
Impact of F-U Time on NNT
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U-Shaped Curve for ICD Efficacy
Goldenberg et al. J. Am. Coll. Cardiol. 2008;51;288-296
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TVNS
Katritsis DG, Camm L, European Heart Journal 2004 25, 1093-1099
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Brugada Circulation 2003
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Different morphologies of fQRS
The fQRS included various RSR’patterns with or without the Q waveand was defined by the presence ofan additional R wave (R’ prime), ornotching in nadir of the S wave,notching of R wave, or the presenceof more than one R prime(fragmentation) in two contiguousleads corresponding to a majorcoronary artery territory.
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Effects of recording site and filtering on f-QRS.
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Kaplan-Meier analysis showingmajor cardiac events in patientswith fragmented QRS (fQRSgroup) and without fragmentedQRS (non-fQRS group).
Average follow up was 57±23 months
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Measurement of TWA with CH-2000• 21 elettrodi, 14 standard e 7
speciali.
Adaptive cancellation reduces noise due to patient movement
Even Beats
Odd BeatsMean
ValtValt
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Elevato Valore Predittivo Negativo (97% al follow-up di 21 mesi)
Basso Valore Predittivo Positivo (19% al follow-up di 21 mesi)
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(J Am Coll Cardiol 2009;53:471–9)
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JACC 2005;45:1104-8.
- 48 pazienti con CAD ed indicazione a SEF
- ceMRI entro 32±6 giorni dal SEF
- “infarct surface area” e “infarct mass” hanno identificato, meglio della FE, i pazienti con substrato aritmico (TV monomorfa)
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J Am Coll Cardiol 2006;48:1977– 85
101 DCM pts with the presence or absence of midwall fibrosis followed up prospectively for 658 ± 355 days for events
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CONCLUSIONI
Lo studio della fibrosi ventricolare con cardio-RMN LGE è probabilmente il più importante progresso degli ultimi anni nella valutazione del rischio di MI.Nei pz con EF severamente depressa, l’ assenza di fibrosi ventricolare nella CMPD ischemica o la scarsa estensione della fibrosi, in particolare nella zona periinfartuale, identificano un sottogruppo di pz con rischio di MI relativamente basso nei quali l’ impianto di ICD in prevenzione primaria potrebbe essere attentamente riconsiderata.
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CONCLUSIONI
Nei pz con EF solo moderatamente depressa , la presenza di fibrosi, in particolare in cuori di pz diabetici senza chiari segni di necrosi infartuale, identificano un sottogruppo di pz a rischio relativamente alto di MI nei quali l’ indicazione all’ impianto di ICD in prevenzione primaria potrebbe essere presa in considerazione.
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Testo….......
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Thank y
ou