DISCLOSURE INFORMATION

Transcript

1 DISCLOSURE INFORMATION Carlo D Agostino negli ultimi due anni ho avuto i seguenti rapporti anche di finanziamento con soggetti portatori di interessi commerciali in campo sanitario: NONE

2 Leadless cardiac pacemaker: back to the future Carlo D Agostino U.O.C. Cardiologia Ospedaliera A.O.U. Policlinico Bari

3 External Pacemaker Implantable Pacemaker Rate Responsive Pacemaker MRI Conditional Pacemaker

4 Nearly 1 million pacemakers annually worldwide Acute traumatic complication (pneumothorax, tamponade) in 2.8% of implants 11% lead complications rate at 5 years 8% pocket complications rate at 5 years Complication requiring reoperation in 8% implants % Infections Kirkfeldt RE, EHJ 2014

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6 The transcather leadless pacing system

7 Cantillon DJ, Heart Rhythm 2018

8 Reynolds D, et al. N Engl J Med. 2016;374: Kirkfeldt R, et al. Eur Heart J. 2014;35: Udo EO, et al. Heart Rhythm. 2012;9: Cantillon DJ, Heart Rhythm 2018

9 Major complications: perforation / effusion rates trending lower Perforations/ Effusions* 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% 1,6% Micra IDE (N=726) 0,4% Micra PAR (N=1817) *For the IDE study, there were 13 total perforations/effusions (1.8%), 11 met the major complication criteria. For the Registry, there were 14 total perforations/effusions (0.77%), 8 met the major complication criteria. Duray GZ Heart Rhythm 2017 El Chami, MF Presented at: HRS 2018

10 Perforation/effusion risk factors Risk Factors Low BMI Female sex Old age COPD 1 Mont L, et al. Risk Factors For Cardiac Perforation/Effusion in Leadless Pacemaker Patients: Experience With The Micra Transcatheter Pacemaker. HRS 2018; May 9, 2018; Boston, MA.

11 ALL SUBGROUP FARED BETTER WITH TRANS CATHETER THAN TRANSVENOUS PACEMAKER Duray GZ, Heart Rhythm 2017 Cantillon DJ, Heart Rhythm 2018

12 La procedura

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17 Nessuna complicanza vascolare

18 Quali pazienti non possono beneficiare di un sistema di stimolazione transcatetere (leadless)? I PM leadless sono controindicati in pazienti con defibrillatore impiantato in quanto lo shock ad alta energia potrebbe danneggiare il PM. Dovrebbero essere evitati in soggetti con pressione ventricolared estra elevata per un teorico maggior rischio di embolizzazione E precluso l utilizzo di un PM leadless in presenza di una valvola meccanica in sede tricuspidalica o di filtro in vena cava inferiore.

19 Physicians Consistent With Guidelines Indications for Pacing Other 4% Reasons for selecting VVIR Bradycardia with Permanent or Persistent AT/AF 64% AVB 15% SND 18% Infrequent pacing expected Advanced age Sedentary lifestyle Anatomical limitations Comorbidities increasing complication risk Consistent with Guideline Recommendations for VVI Pacing*

20 El Chami MF, Heart Rhythm 2018 HIGH % VP WITH AF, LOW % WITHOUT AF

21 Pccinni JP, ACC 2018

22 Laboratorio di Elettrofisiologia - Cardiologia Ospedaliera Policlinico Bari 10% 12% 36% Bradi-Tachi/ISC FA BAV CIED infections 42%

23 Age and infrequent pacing 28 y, M, Syncope Loop recorder transmission Leadless PM Implanted 8 month fu 98% VS EOL expected at the last control 11,5 years

24 Anatomy

25 Anatomy

26 Unique indication: Prior device infection 13% 13% 35% Bradi-Tachi/ISC FA BAV CIED Carriers 39% 26

27 Patients with traditional infected device Population Male 7/9 (78%) Age 79±8 EF 53.8%±3.7 Diabetes 2/9 (22%) Hypertension 8/9 (88%) Cancer 2/9 (22%) Kifney failure (1 pt wiyh trasplant) 4/9 (44%) Coronaropathy 1/9 (11%) PM 7/9 (78%) ICD 2/9 (22%) 27

28 Paz 1 Right ventricular failure Bradi-tachi 2 Pocket infection (Staphyilococcus aereus) Lead infection S. Hominis spp hominis+ Epidermidis Sepsis ICD prim prev Paross AVB III 3 Pocket infection (Serratia marcescens + Pseudomonas aeroginosa) Lead infection P. Aeroginosa Sepsis Bradi-tachi 4 Pocket infection (staphylococcus epidermidis e Pseudomonas aeroginosa) Lead infection P. Aeroginosa Parossistic high grade AVB 5 Pocket infection (Staphylococcus epidermidis) Lead infection S. Hominis spp hominis Sepsis BAV III 6 Pocket infection (Staphylococcus epidermidis + capitis) Sepsis haemocolture + ICD PRIM. Prev AF + AVB 7 Right ventricular faiulure AF 8 Pocket infection (Staphylococcus epidermidis) Lead infection per S. epidermidis Sepsis haemocolture + AF 9 Right ventricular failure SND 28

29 TIMING to RE-IMPLANT Time 0 1 month 3 months Total device Estraction antibiotics LEADLESS Pt 2 Pt 5 Pt 9 Pt 1 Pt 6 Pt 7 Pt 8 Pt 3 Pt 4 29

30 2005: First PM left side 04/2016: device estraction (leads in situ) and new controlateral implant 07/2016 leads decubitus and revision 02/2017 new revision 04/2017 sepsis, haemoculture + Staphylococcus Epidermidis PCR 91,4 mg/l (v.n. <2.9) 30

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34 CRP 91.4 Fever days 34

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36 CRP 91.4 fever estraction 2nd estraction days 36

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40 CRP Pt 4 Pt 3 Pt 6 Pt days 40

41 The leadless system is a completely self-contained closed device that is delivered via a catheter delivery system directly to the heart; there is no contact at all with the operator and the external environment.

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43 Omdahl P, Pace 2016

44 Prospettive Future

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46 Conclusioni La più bassa incidenza di complicanze e di fastidio per il paziente potrebbero rendere l impianto di un PM leadless la prima scelta nei pazienti che necessitino una stimolazione monocamerale VVI: bradiaritmia in FA o previsione di bassa percentuale di stimolazione in RS. (15-20% di tutti gli impianti di PM) Il PM leadless rappresenta la prima opzione in pazienti che hanno subito un espianto per infezione. E necessario accettare che ad eccezione del primo periodo il device non potrà essere espiantato ed un eventuale up grade potrà essere effettuato inserendo un nuovo device o un sistema tradizionale Il paziente non ha nulla che ricordi un problema cardiaco ed avrà minime restrizioni he impattino sulla sua vita futura.

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48 Complications related to pulse generators infection, pocket hematoma, skin erosion and from the patient point of view Potential increase pacemaker patient satisfaction No chest scar, bump, and no visible or physical reminder Minimally invasive procedure Potential for fewer post implant activity restrictions 48