3η Διημερίδα Καρδιο - Ογκολογίας / Καρδιακής Ανεπάρκειας

Νέες διαδερμικές ή ελάχιστα επεμβατικές τεχνικές

Dr. George Karavolias, MD, PhD, FESC, FACC

Interventional Cardiologist

Metropolitan Hospital

Athens, Greece

Epidemiology of Heart Failure

➢HF incidence ~1% in age≥65

➢Survival has improved in most subgroups

➢ 5 years: 50%

➢ 10 years: 10%

➢ the single most frequent cause of hospitalization in persons aged ≥65 years

➢>1M Hospitalizations and 3.4M office visits

➢Estimated annual costs in US: $40B

Benjamin EJ et al. Heart Disease and Stroke Statistics-2017 Update: A Report From the AHA. Circulation 2017; 135:e146-e603

Primary Targets of Treatment in Heart Failure

NEJM 2003 TCT 2017

N Engl J Med 2003;348:2007-18.

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Electrical Therapy of Heart Failure

ICD CRT

Hemodynamic Support

IABP

Impella

ECMO

Cardiac Interventions Today 2018 Vol. 12, No. 1

Percutaneously Delivered Biological Therapies

Cell therapy for CHF Gene therapy for CHF

Pleger S et al. Circ Res. 2013;113:792-809Sanganalmath S et al. Circ Res. 2013;113:810-834

Transcatheter Structural Heart Interventions forthe Treatment of CHF

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Left Ventricular remodelling devices

Parachute Revivent TC

Parachute Ventricular Partitioning Device

CE mark: 10/2012

Parachute Ventricular Partitioning Device

LVEDVI & LVESVI 6MWD

Marco A. Costa et al. Circ Heart Fail. 2014;7:752-758

34 patients:↓ LV volume↑ NHYA

Parachute Ventricular Partitioning Device

Clinical outcomes

Marco A. Costa et al. Circ Heart Fail. 2014;7:752-758

Revivent TC

Wechsler AS, et al.. Eur J Cardiothorac Surg. 2013;44:e189–92

Hernández-Enríquez et al., Abstract presented at EuroPCR 2016

CE mark: 12/2016

Revivent TC

LVEDVI LVESVI

Wechsler AS, et al Eur J Cardiothorac Surg. 2013;44:e189–92

71 patients:↓ LV volume↑ LVEF ↑ 6MWD

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Left-to-Right Interatrial Shunt Devices

Atrial Flow Regulator TV-Wave deviceIASD system

https://citoday.com/2018/02/technologies-for-treating-left-atrial-decompression-in-heart-failure

Left-to-Right Interatrial Shunt Devices

https://citoday.com/2018/02/technologies-for-treating-left-atrial-decompression-in-heart-failure

Interatrial Septal Device System

https://corviamedical.com/treatment/

The V-Wave device

http://vwavemedical.com/

(unidirectional device)

Left-to-Right Interatrial Shunt Devices

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Neuromodulators

PCR innovators day - 16 May 2016 – Paris

Neuromodulators

Neth Heart JDOI 10.1007/s12471-017-1018-

The Cardiofit device(vagal nerve stimulation)

Eur Heart J. 2014;36(7):425-433.doi:10.1093/eurheartj/ehu345

CE mark: 2009

▪ LVEDD

▪ LVESV

▪ LVEF

▪ BNP

➢↑ quality of life (P = 0.049)

➢↓ NYHA (P = 0.032)

➢↑ SF-36 Physical Component (P = 0.016)

The Cardiofit device

96 implanted patients:

NS vs. Control

European Heart Journal, 2015, 425–433https://doi.org/10.1093/eurheartj/ehu345

Barostim neo Electrical Stimulator(carotid baroreceptor reflex stimulator)

➢ Electrical Therapy of Heart Failure

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Renal Denervation

Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc Interv. 2015;8:e001943

Renal Denervation

6MWT loop diuretic doses

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

▪ Pulmonary Artery Pressure Monitors

▪ Left Atrial Pressure Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

Monitoring Technologies

PCR innovators day - 16 May 2016 – Paris

Pulmonary Artery Pressure Monitoring SystemCardioMEMS

Circ Cardiovasc Interv. 2015;8:e001943DOI: 10.1161/CIRCINTERVENTIONS.114.001943

data are transmitted by telephone line to a website

Pulmonary Artery Pressure Monitoring SystemCardioMEMS

Hospital admissions Freedom from Hospital admissions or mortality

Circ Cardiovasc Interv. 2015;8:e001943DOI: 10.1161/CIRCINTERVENTIONS.114.001943

FDA approved for patients in NYHA Class III who have been hospitalized for HF in the previous year

Left Atrial Pressure Monitoring SystemHeartPOD

Jay Ritzema et al. Circulation. 2010;121:1086-1095doi: 10.1161/CIRCULATIONAHA.108.800490

Left Atrial Pressure Monitoring SystemHeartPOD

Jay Ritzema et al. Circulation. 2010;121:1086-1095doi: 10.1161/CIRCULATIONAHA.108.800490

8 am 12 am

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously delivered biological therapies and interventions

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

▪ Percutaneous Edge-to-Edge Repair

▪ Percutaneous Annuloplasty

▪ Transcatheter Mitral Valve Replacement

➢ Percutaneous Tricuspid Valve Repair

Transcatheter structural heart interventions forthe treatment of CHF

➢Percutaneous Edge-to-Edge Repair ➢ MitraClip System

➢ Pascal System

➢Annuloplasty

➢The Carillon Mitral Contour System

➢The Cardioband System

➢The Mitralign device

➢The Accucinch annuloplasty system

➢Transcatheter Mitral Valve Replacement

Percutaneous Interventions in Functional Mitral Regurgitation

Percutaneous Edge-to-Edge Repair

MitraClip System Pascal System

MitraClip System for the Treatment of Functional Mitral Regurgitation: Ongoing Randomized Trials

Circ Cardiovasc Interv. 2015;8:e001943.DOI: 10.1161/CIRCINTERVENTIONS.114.001943

MitraClip

MitraClip

Baseline Post MitraClip

Annuloplasty

➢The Carillon Mitral Contour System

➢The Cardioband System

➢The Mitralign device

➢The Accucinch annuloplasty system Cardioband

NeoChord

MitraClip

Carillon

ARTO

Mitral Loop Cerclage

Mitralign

The Carillon Mitral Contour System

CE mark: 2011

36 pts, 12-month follow-up:↓ regurgitant jet area↓ left atrium area↓ regurgitant volumes↓ effective orifice area

Eur J Heart Fail. 2012;14:931–938. doi: 10.1093/eurjhf/hfs076.

The Mitralign device

61 pts, 12-month follow-up:↓ MR (≤2+ in 55% of patients)↓ NYHA↑ QoL

Dr Nicking, TVT 2014

The Cardioband System

29 pts, 6-month follow-up:↓ MR (≤2+ in 92% of patients)↓ NYHA (81%)

Francesco Maisano, PCR London Valves 2014

Matteo Pagnesi et al. JCIN 2018;11:517-528

Transcatheter MV Replacement

CardiAQ valve Tiara Valve

Fortis valveTendyne valve

valve systems with available first-in-man data

Transcatheter MV Replacement (Tiara Valve)

EuroIntervention. 2014;10(suppl U):U115–U119.doi: 10.4244/EIJV10SUA17.

➢ Electrical Therapy

➢ Hemodynamic Support

➢ Percutaneously Delivered Biological Therapies And Interventions

➢ Left Ventricular Remodelling Devices

➢ Left-to-Right Interatrial Shunt Devices

➢ Neuromodulators

➢ Renal Denervation

➢ Implantable Hemodynamic Monitoring

➢ Percutaneous Interventions in Functional Mitral Regurgitation

➢ Percutaneous Tricuspid Valve Repair

Transcatheter Structural Heart Interventions forthe Treatment of CHF

TriCinch System

JACC Cardiovasc Interv. 2015;13:e211–e4

TriCinch System

JACC Cardiovasc Interv. 2015;13:e211–e4

FORMA Repair System

J Am Coll Cardiol. 2015;66:2475–83

FORMA Repair System

J Am Coll Cardiol. 2015;66:2475–83

Conclusions

➢ new transcatheter structural heart interventions for chronic HF are currently being developed

➢ preliminary results associated with most of these new interventions are promising

➢ data from most of these technologies are restricted to first-in-man cases and observational studies,limited by experience and number of patients

➢ randomized studies that can provide definite data on the efficacy of these devices