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Newer advancements in heart
   failure device therapy
                                           » DR. GOPI KRISHNA




         NEWER ADVANCES IN HEART FAILURE
                 DEVICE THERAPY
Introduction
• Heart failure prevalence is rising throughout the world.

• The reasons for this pandemic include
       • the aging populations of both industrialized and
         developing nations;
       • a growing incidence of obesity, diabetes, and
         hypertension .
       • improved survival after myocardial infarction; and
         success in preventing sudden cardiac death .
• Fortunately, therapies that have emerged during the
  past few decades can greatly improve outcomes in
  heart failure patients.
                      NEWER ADVANCES IN HEART FAILURE
                              DEVICE THERAPY
Prevalence rates of heart
failure by gender and age in
the United States




                                Data from American Heart Association:
                      NEWER ADVANCES IN HEART FAILURE and Stroke Statistics
                                Heart Disease
                             DEVICE THERAPY
Stages of Heart Failure




      NEWER ADVANCES IN HEART FAILURE
              DEVICE THERAPY
management




NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
•   I.C.D
•   C.R.T.-P/D.
•   TEMPERORY SUPPORT DEVICES.
•   PERMENENT SUPPORT DEVICES.
•   OTHER SUPPORT DEVICES.




                NEWER ADVANCES IN HEART FAILURE
                        DEVICE THERAPY
I.C.D
                   SCD Rates in CHF Patients with LV Dysfunction
                                                                                                    Total Mortality
                           30
                                                                                                    Sudden Death
 Control Group Mortality




                                      20
                           20                                                   19
                                                                                                    17
                                                 15

                                                                                         11
                           10                                    9
                                                                                                                  8
                                                                                               7
                                                                                                           6
                                                                                                                        4


                           0     CHF-STAT    GESICA          SOLVD         V-HeFT I      MERIT-HF    CIBIS-II   CARVEDILOL-US
                                45 months   13 months     41.4 months    27 months      12 months   16 months   6 months


Total Mortality ~15-40%; SCD accounts for ~50% of the total deaths.
                                                      NEWER ADVANCES IN HEART FAILURE
                                                              DEVICE THERAPY
ICD




NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Evolution of ICD Therapy:
                1980 to Present                                                         2000
                                                                                                       2002
                                                                                                          MADIT-II
                                                                                               ICDs
                                                                                               with
                                                                                               Cardiac    2004
                                                                          1997/8               Resynch
                                                                                                          SCD-HeFT
    Number of Worldwide ICD Implants Per Year
                                                                                Dual-Chamber
                                                                                ICDs                  COMPANION
                                                                                Size
                                                                                Reduction
             1980                               1989                            AVID
90,000          First Human                                                    CASH
                                                   •Transvenous Leads
80,000          Implant
                                1985               •Biphasic Waveform           CIDS

70,000                             FDA
                                   Approval of
60,000                             ICDs                  1993
                                                             Smaller              1999
50,000                                                       Devices
                                                                                       AT Therapies
                                                                                       MUSTT
40,000                                   1988

30,000                             Tiered
                                   Therapy
                                                                         1996
                                                                          MADIT
20,000                                                                    Steroid-eluting Leads

10,000                                                                    Increased Diagnostic and
                                                                           Memory Capacity
     0
    1980               1985                1990               1995
                                       NEWER ADVANCES IN HEART FAILURE
                                               DEVICE THERAPY
                                                                                   2000                  2005
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Cardiac resynchronistion therapy




           NEWER ADVANCES IN HEART FAILURE
                   DEVICE THERAPY
SCD in Heart Failure
                      100%                                QRS
                                                          Duration
                                                          (msec)           • QRS duration is an
                                                                             independent predictor
Cumulative Survival




                      90%                                  <90
                                                                             of mortality (>140 ms)
                                                           90-120
                                                                           • Other factors are:
                      80%
                                                           120-170
                                                                             age, creatinine, EF,
                                                           170-220           and HR
                      70%


                                                           >220
                      60%
                                 0   60 120 180 240 300 360
                                           Days
                             .                     NEWER ADVANCES IN HEART FAILURE
                                                           DEVICE THERAPY
Cardiac resynchronistion therapy


Right Atrial
   Lead




                    Left Ventricular
                          Lead




               Right Ventricular
                     Lead




                       NEWER ADVANCES IN HEART FAILURE
                               DEVICE THERAPY
Achieving Cardiac
             Resynchronization
Goal: Atrial synchronous
biventricular pacing            Right Atrial
                                   Lead
Transvenous approach for left
ventricular lead via coronary
sinus
                                                    Left Ventricular
Back-up epicardial approach                               Lead




                                               Right Ventricular
                                                     Lead
Cumulative Enrollment in Cardiac
          Resynchronization Randomized
                      Trials
          4000
Cum ulat ive Pat ient s



                                                                                                      CARE HF
                                                                MIRACLE ICD
                          3000                        MIRACLE
                                       MUSTIC AF                                     MIRACLE ICD II
                          2000    MUSTIC SR
                                                                                COMPANION

                          1000   PATH CHF
                                                                      PATH CHF II
                                                          CONTAK CD
                             0
                             1999           2000       2001         2002            2003       2004    2005
                                                        Result s Present ed

                                                   NEWER ADVANCES IN HEART
                                                    FAILURE DEVICE THERAPY
Anatomical Challenges

• Enlarged right atrium
• Abnormal CS location
• Presence of valves in CS
• Altered CS angulation
• Acute branch take offs
• Tortuous vessel anatomy

               NEWER ADVANCES IN HEART FAILURE
                       DEVICE THERAPY
CRT Procedure and Device Related Risks
           relative to CS placement

•   CS lead dislogdement 8%
•   CS dissection or perforation 5%
•   Failure of lead placement 8%
•   Phrenic nerve stimulation 2%

    – ALL other risks associated with pacer or ICD implantation
      and anesthesia in these patients.


                       NEWER ADVANCES IN HEART FAILURE
                               DEVICE THERAPY
The 3 levels of asynchrony
1. Intraventricular asynchrony is best treated by
   placing the LV lead in the best anatomic location-
   usually the lateral or posterolateral (proven my
   multiple studies). Get the LV working.
2. Interventricular asynchrony is dealt with by
   adjusting the V-V interval. Get the RV and the LV to
   work together.
3. A-V asynchrony is dealt with by adjusting the A-V
   interval. Get the atria and the ventricles working
   together.

                   NEWER ADVANCES IN HEART FAILURE
                           DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Extending indications to class II
• REVERSE.
• MADIT-CRT.
• RAFT




               NEWER ADVANCES IN HEART FAILURE
                       DEVICE THERAPY
The HF clinical composite response.




                     Linde C Europace 2009;11:v72-v76


Published on behalf of the European Society of Cardiology. All rights reserved. © The AuthorHEART
                                                                  NEWER ADVANCES IN                 FAILURE
 2009. For permissions please email: journals.permissions@oxfordjournals.org. DEVICE THERAPY
Mean LVESVi, LVEDVi, and LVEF at baseline and 12-month follow-up in the CRT-OFF and
                                     CRT-ON groups.




        Linde C Europace 2009;11:v72-v76


.                                          NEWER ADVANCES IN HEART FAILURE
                                                   DEVICE THERAPY
Time to first HF hospitalization or death in the 18-month follow-up period in the CRT-OFF and
                                            CRT-ON groups.




           Linde C Europace 2009;11:v72-v76


.                                             NEWER ADVANCES IN HEART FAILURE
                                                      DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Other trials

• rethinQ
• PROSPECT trial.




                    NEWER ADVANCES IN HEART FAILURE
                            DEVICE THERAPY
Assist devices
• Percutaneous.
• Implanted.




                  NEWER ADVANCES IN HEART FAILURE
                          DEVICE THERAPY
I.A.B.P   balloon




                    NEWER ADVANCES IN HEART FAILURE
                            DEVICE THERAPY
I.A.B.P




NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Indications for Intraaortic Balloon Pump
            Counterpulsation




             NEWER ADVANCES IN HEART FAILURE
                     DEVICE THERAPY
complications
• vascular compromise
•  aortic dissection,
•  aortoiliac laceration,
• femoral artery pseudoaneurysm
•  retroperitoneal hemorrhage,
• renal ischemia from malposition,
• myocardial ischemia from poor timing of balloon
  augmentation,
• deep wound infection requiring operative débridement


                     NEWER ADVANCES IN HEART FAILURE
                             DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
TANDEM HEART




 NEWER ADVANCES IN HEART FAILURE
         DEVICE THERAPY
IMPELLA LP2.5 SYSTEM




     NEWER ADVANCES IN HEART FAILURE
             DEVICE THERAPY
Effect of IABP and Impella 2.5 device on
 important hemodynamic parameters




            NEWER ADVANCES IN HEART FAILURE
                    DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Contraindications
• 1. Mural thrombus in the left ventricle
• 2. The presence of a mechanical aortic valve device
• 3. Moderate aortic stenosis or moderate to severe aortic
  insufficiency
• 4. Abnormalities of the aorta that would preclude surgery,
  including aneurysms and extreme tortuosity or
  calcifications.
• 5. Renal failure (creatinine>4 mg/dL)
• 6. Liver dysfunction or markedly abnormal coagulation
  parameters.
• 7. Recent (within 3 months) stroke or transient
    ischemic attack

                     NEWER ADVANCES IN HEART FAILURE
                             DEVICE THERAPY
THE REITAN CATHETER PUMP

PUMP IMPLANTATION                HEMODYNAMIC EFFECTS




                NEWER ADVANCES IN HEART FAILURE
                        DEVICE THERAPY
Algorithm for device selection.




         NEWER ADVANCES IN HEART FAILURE
                 DEVICE THERAPY
PERMENENT V.A.D.




   NEWER ADVANCES IN HEART FAILURE
           DEVICE THERAPY
History of lvad




  NEWER ADVANCES IN HEART FAILURE
          DEVICE THERAPY
Mechanical Circulatory Support




          NEWER ADVANCES IN HEART FAILURE
                  DEVICE THERAPY
Mechanical Circulatory Support
INDICATION NOMENCLATURE                   DEFINITION
Bridge to transplantation                 Patient is listed for heart transplantation

                                          Patient initially deemed ineligible for heart
                                          transplantation because of comorbidity
Bridge to candidacy                       (cardiorenal syndrome or pulmonary
                                          hypertension), which improves during
                                          mechanical support

                                          Patient with a potentially reversible cause
                                          of cardiac decompensation (acute
Bridge to recovery
                                          myocarditis, postcardiotomy syndrome,
                                          peripartum cardiomyopathy)
                                          Patient in whom the potential for
Bridge to decision
                                          transplantation or recovery is yet unclear
                                          Patient in whom recovery or
Destination therapy
                                          transplantation is not feasible
                            NEWER ADVANCES IN HEART FAILURE
                                   DEVICE THERAPY
First generation                               Second generation




                          Third generation
                   NEWER ADVANCES IN HEART FAILURE
                           DEVICE THERAPY
1st generation




2nd generation




NEWER rd
    3 ADVANCES IN HEART FAILURE
         generation
         DEVICE THERAPY
FIRST GENERATION DEVICES
FEATURES                              The Abiomed BVS 5000i
• is a short-term uni- or
  biventricular support
  system .
• comprised of two 100 mL
  polyurethane blood sacs.
• the inlet and outlet
  portions of which are
  guarded by polyurethane
  valves

                     NEWER ADVANCES IN HEART FAILURE
                             DEVICE THERAPY
Pulsatile Devices

• has a titanium-alloy external
  housing, with inflow and
  outflow conduits that use
  porcine xenograft valves.

•    Internal blood-contacting
    surface is made of textured
    titanium that results in the
    development of a pseudo-
    neointima on which thrombus
    formation is greatly reduced,
    thereby decreasing the need
    for anticoagulation.

                         NEWER ADVANCES IN HEART FAILURE
                                 DEVICE THERAPY
Thoratec paracorporeal VAD
                                          Para carporial
• actual pump chamber is
  outside of the body.
• this device can be used on
  patients with body sizes too
  small to house the HeartMate
  or Novacor devices (i.e., <1.5
  m2).
• Pneumatic drivers provide
  alternating air pressure to fill
  and empty the blood pump.
• Anticoagulation with warfarin
  is necessary, as for patients
  with mechanical valves.

                         NEWER ADVANCES IN HEART FAILURE
                                 DEVICE THERAPY
2 generation
 nd




 NEWER ADVANCES IN HEART FAILURE
         DEVICE THERAPY
The Jarvik 2000 implanted in the apex of the left ventricle
            outflow graft anastomosed to the
                    descending aorta.




                    NEWER ADVANCES IN HEART FAILURE
                            DEVICE THERAPY
• BI VENTRICULAR SUPPORT




                  NEWER ADVANCES IN HEART FAILURE
                          DEVICE THERAPY
• A Jarvik 2000-C removed for
  transplant after 3 months
  with no thrombus present
  on the cone bearings.




                     NEWER ADVANCES IN HEART FAILURE
                             DEVICE THERAPY
• The junction of the
  microsphere coating with
• the myocardial tissue at the
  apex is well healed by 2
• months, and free of
  thrombus.
• A healthy adherent
  neointema is seen growing
  into the porous
  microsphere surface.
                      NEWER ADVANCES IN HEART FAILURE
                              DEVICE THERAPY
Miniature Ventricular Assist Device




            NEWER ADVANCES IN HEART FAILURE
                    DEVICE THERAPY
CircuLite Synergy Pocket Micropump




           NEWER ADVANCES IN HEART FAILURE
                   DEVICE THERAPY
• RV dysfunction is an important source
  of morbidity and mortality after LVAD
  insertion.
• Recent data demonstrates that early planned
  institution of RV support can mitigate the
  potential adverse consequences of RV
  dysfunction after LVAD placement.



                NEWER ADVANCES IN HEART FAILURE
                        DEVICE THERAPY
Parameters identified as risk factors for RV
     failure after LVAD placement




       NEWER ADVANCES IN HEART FAILURE
               DEVICE THERAPY
INTERMACS: profiles for patient
         selection




          NEWER ADVANCES IN HEART FAILURE
                  DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
The C-Pulse ( implantable, extra-aortic counterpulsation
                        device)




                  NEWER ADVANCES IN HEART FAILURE
                          DEVICE THERAPY
Symphony Counterpulsation Device




          NEWER ADVANCES IN HEART FAILURE
                  DEVICE THERAPY
TOTAL ARTIFICIAL HEART




      NEWER ADVANCES IN HEART FAILURE
              DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Effects of Chronic Hemodynamic Unloading with Ventricular
                       Assist Devices


Structural
• Regression of myocyte
   hypertrophy.
• Reduction in
   neurohormonal activation
• Normalization in expression
   of contractile proteins .
• Enhanced electron
   transport chain respiratory
   function
• Decreased apoptosis and
                                 NEWER ADVANCES IN HEART FAILURE
   cellular stress markers               DEVICE THERAPY
• Functional
• Improvement in left ventricular ejection
  fraction and diastolic and systolic dimension
• Recovery from spherical to more elliptical left
  ventricular shape
• Improvement in heart failure–specific indices
  of quality of life
• Improvement in peak aerobic capacity
                 NEWER ADVANCES IN HEART FAILURE
                         DEVICE THERAPY
complications
•   Anticoagulation.
•   Drive line infections .
•   Noise.
•   Durability.
•   Activation of immune system.




                  NEWER ADVANCES IN HEART FAILURE
                          DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
epicardial pads secured and used to
tighten the device.
         NEWER ADVANCES IN HEART FAILURE
                 DEVICE THERAPY
The CorCap device




    NEWER ADVANCES IN HEART FAILURE
            DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Percutaneous Leaflet Repair and Annuloplasty for Mitral
                    Regurgitation




                  NEWER ADVANCES IN HEART FAILURE
                          DEVICE THERAPY
EVEREST II Randomized Clinical Trial
                          Key Inclusion/Exclusion Criteria

                Inclusion                                                Exclusion
– Candidate for MV Surgery                              – AMI within 12 weeks
– Moderate to severe (3+) or                            – Need for other cardiac surgery
  severe (4+) MR                                        – Renal insufficiency
      • Symptomatic                                            • Creatinine >2.5mg/dl
            – >25% EF & LVESD ≤55mm                     – Endocarditis
      • Asymptomatic with one or more                   – Rheumatic heart disease
        of the following
            –   LVEF 25-60%
                                                        – MV anatomical exclusions
            –   LVESD ≥40mm                                    • Mitral valve area <4.0cm2
            –   New onset atrial fibrillation                  • Leaflet flail width (≥15mm) and
            –   Pulmonary hypertension                           gap (≥10mm)
                                                               • Leaflet tethering/coaptation
     ACC/AHA Guidelines JACC                                     depth (>11mm) and length
     52:e1-e142, 2008
                                                                 (<2mm)

                                    Investigational Device only in the US;
90
                                       Not available for sale in the US
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
NEWER ADVANCES IN HEART FAILURE
        DEVICE THERAPY
Figure 6. Core laboratory tracings of the mitral annulus and leaflet line of coaptation from 3D
   echo data sets recorded at preprocedure baseline and follow-up time points noted from
             patients with PTMA implants still observed by x-ray to be in place.




    Sack S et al. Circ Cardiovasc Interv 2009;2:277-284



Copyright © American Heart Association
From: Percutaneous Leaflet Repair and Annuloplasty for Mitral Regurgitation


J Am Coll Cardiol. 2011;57(5):529-537. doi:10.1016/j.jacc.2010.10.012




      Figure Legend:
      Direct Annuloplasty

     The Guided Delivery Systems Accucinch device is delivered through
     retrograde catheterization of the left ventricle. (Left) Anchors are placed in the
   Date of download:mitral annulus and (right) connected with a “drawstring” to cinch the
     posterior                    Copyright © The American College of Cardiology.
   11/6/2012                                    All rights reserved.
     annular circumference.
nk you
•T ha


    NEWER ADVANCES IN HEART FAILURE
            DEVICE THERAPY

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Newer Advances in Heart Failure Device Therapy

  • 1. Newer advancements in heart failure device therapy » DR. GOPI KRISHNA NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 2. Introduction • Heart failure prevalence is rising throughout the world. • The reasons for this pandemic include • the aging populations of both industrialized and developing nations; • a growing incidence of obesity, diabetes, and hypertension . • improved survival after myocardial infarction; and success in preventing sudden cardiac death . • Fortunately, therapies that have emerged during the past few decades can greatly improve outcomes in heart failure patients. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 3. Prevalence rates of heart failure by gender and age in the United States Data from American Heart Association: NEWER ADVANCES IN HEART FAILURE and Stroke Statistics Heart Disease DEVICE THERAPY
  • 4. Stages of Heart Failure NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 5. management NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 6. I.C.D • C.R.T.-P/D. • TEMPERORY SUPPORT DEVICES. • PERMENENT SUPPORT DEVICES. • OTHER SUPPORT DEVICES. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 7. I.C.D SCD Rates in CHF Patients with LV Dysfunction Total Mortality 30 Sudden Death Control Group Mortality 20 20 19 17 15 11 10 9 8 7 6 4 0 CHF-STAT GESICA SOLVD V-HeFT I MERIT-HF CIBIS-II CARVEDILOL-US 45 months 13 months 41.4 months 27 months 12 months 16 months 6 months Total Mortality ~15-40%; SCD accounts for ~50% of the total deaths. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 8. ICD NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 9. Evolution of ICD Therapy: 1980 to Present 2000 2002 MADIT-II ICDs with Cardiac 2004 1997/8 Resynch SCD-HeFT Number of Worldwide ICD Implants Per Year Dual-Chamber ICDs COMPANION Size Reduction 1980 1989 AVID 90,000 First Human CASH •Transvenous Leads 80,000 Implant 1985 •Biphasic Waveform CIDS 70,000 FDA Approval of 60,000 ICDs 1993 Smaller 1999 50,000 Devices  AT Therapies  MUSTT 40,000 1988 30,000 Tiered Therapy 1996  MADIT 20,000  Steroid-eluting Leads 10,000  Increased Diagnostic and Memory Capacity 0 1980 1985 1990 1995 NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY 2000 2005
  • 10. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 11. Cardiac resynchronistion therapy NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 12. SCD in Heart Failure 100% QRS Duration (msec) • QRS duration is an independent predictor Cumulative Survival 90% <90 of mortality (>140 ms) 90-120 • Other factors are: 80% 120-170 age, creatinine, EF, 170-220 and HR 70% >220 60% 0 60 120 180 240 300 360 Days . NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 13. Cardiac resynchronistion therapy Right Atrial Lead Left Ventricular Lead Right Ventricular Lead NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 14. Achieving Cardiac Resynchronization Goal: Atrial synchronous biventricular pacing Right Atrial Lead Transvenous approach for left ventricular lead via coronary sinus Left Ventricular Back-up epicardial approach Lead Right Ventricular Lead
  • 15. Cumulative Enrollment in Cardiac Resynchronization Randomized Trials 4000 Cum ulat ive Pat ient s CARE HF MIRACLE ICD 3000 MIRACLE MUSTIC AF MIRACLE ICD II 2000 MUSTIC SR COMPANION 1000 PATH CHF PATH CHF II CONTAK CD 0 1999 2000 2001 2002 2003 2004 2005 Result s Present ed NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 16. Anatomical Challenges • Enlarged right atrium • Abnormal CS location • Presence of valves in CS • Altered CS angulation • Acute branch take offs • Tortuous vessel anatomy NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 17. CRT Procedure and Device Related Risks relative to CS placement • CS lead dislogdement 8% • CS dissection or perforation 5% • Failure of lead placement 8% • Phrenic nerve stimulation 2% – ALL other risks associated with pacer or ICD implantation and anesthesia in these patients. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 18. The 3 levels of asynchrony 1. Intraventricular asynchrony is best treated by placing the LV lead in the best anatomic location- usually the lateral or posterolateral (proven my multiple studies). Get the LV working. 2. Interventricular asynchrony is dealt with by adjusting the V-V interval. Get the RV and the LV to work together. 3. A-V asynchrony is dealt with by adjusting the A-V interval. Get the atria and the ventricles working together. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 19. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 20. Extending indications to class II • REVERSE. • MADIT-CRT. • RAFT NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 21. The HF clinical composite response. Linde C Europace 2009;11:v72-v76 Published on behalf of the European Society of Cardiology. All rights reserved. © The AuthorHEART NEWER ADVANCES IN FAILURE 2009. For permissions please email: journals.permissions@oxfordjournals.org. DEVICE THERAPY
  • 22. Mean LVESVi, LVEDVi, and LVEF at baseline and 12-month follow-up in the CRT-OFF and CRT-ON groups. Linde C Europace 2009;11:v72-v76 . NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 23. Time to first HF hospitalization or death in the 18-month follow-up period in the CRT-OFF and CRT-ON groups. Linde C Europace 2009;11:v72-v76 . NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 24. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 25. Other trials • rethinQ • PROSPECT trial. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 26. Assist devices • Percutaneous. • Implanted. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 27. I.A.B.P balloon NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 28. I.A.B.P NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 29. Indications for Intraaortic Balloon Pump Counterpulsation NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 30. complications • vascular compromise • aortic dissection, • aortoiliac laceration, • femoral artery pseudoaneurysm • retroperitoneal hemorrhage, • renal ischemia from malposition, • myocardial ischemia from poor timing of balloon augmentation, • deep wound infection requiring operative débridement NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 31. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 32. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 33. TANDEM HEART NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 34. IMPELLA LP2.5 SYSTEM NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 35. Effect of IABP and Impella 2.5 device on important hemodynamic parameters NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 36. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 37. Contraindications • 1. Mural thrombus in the left ventricle • 2. The presence of a mechanical aortic valve device • 3. Moderate aortic stenosis or moderate to severe aortic insufficiency • 4. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications. • 5. Renal failure (creatinine>4 mg/dL) • 6. Liver dysfunction or markedly abnormal coagulation parameters. • 7. Recent (within 3 months) stroke or transient ischemic attack NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 38. THE REITAN CATHETER PUMP PUMP IMPLANTATION HEMODYNAMIC EFFECTS NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 39. Algorithm for device selection. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 40. PERMENENT V.A.D. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 41. History of lvad NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 42.
  • 43.
  • 44.
  • 45. Mechanical Circulatory Support NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 46. Mechanical Circulatory Support INDICATION NOMENCLATURE DEFINITION Bridge to transplantation Patient is listed for heart transplantation Patient initially deemed ineligible for heart transplantation because of comorbidity Bridge to candidacy (cardiorenal syndrome or pulmonary hypertension), which improves during mechanical support Patient with a potentially reversible cause of cardiac decompensation (acute Bridge to recovery myocarditis, postcardiotomy syndrome, peripartum cardiomyopathy) Patient in whom the potential for Bridge to decision transplantation or recovery is yet unclear Patient in whom recovery or Destination therapy transplantation is not feasible NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 47. First generation Second generation Third generation NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 48. 1st generation 2nd generation NEWER rd 3 ADVANCES IN HEART FAILURE generation DEVICE THERAPY
  • 49. FIRST GENERATION DEVICES FEATURES The Abiomed BVS 5000i • is a short-term uni- or biventricular support system . • comprised of two 100 mL polyurethane blood sacs. • the inlet and outlet portions of which are guarded by polyurethane valves NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 50. Pulsatile Devices • has a titanium-alloy external housing, with inflow and outflow conduits that use porcine xenograft valves. • Internal blood-contacting surface is made of textured titanium that results in the development of a pseudo- neointima on which thrombus formation is greatly reduced, thereby decreasing the need for anticoagulation. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 51. Thoratec paracorporeal VAD Para carporial • actual pump chamber is outside of the body. • this device can be used on patients with body sizes too small to house the HeartMate or Novacor devices (i.e., <1.5 m2). • Pneumatic drivers provide alternating air pressure to fill and empty the blood pump. • Anticoagulation with warfarin is necessary, as for patients with mechanical valves. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 52. 2 generation nd NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 53. The Jarvik 2000 implanted in the apex of the left ventricle outflow graft anastomosed to the descending aorta. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 54. • BI VENTRICULAR SUPPORT NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 55. • A Jarvik 2000-C removed for transplant after 3 months with no thrombus present on the cone bearings. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 56. • The junction of the microsphere coating with • the myocardial tissue at the apex is well healed by 2 • months, and free of thrombus. • A healthy adherent neointema is seen growing into the porous microsphere surface. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 57. Miniature Ventricular Assist Device NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 58. CircuLite Synergy Pocket Micropump NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 59.
  • 60.
  • 61. • RV dysfunction is an important source of morbidity and mortality after LVAD insertion. • Recent data demonstrates that early planned institution of RV support can mitigate the potential adverse consequences of RV dysfunction after LVAD placement. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 62. Parameters identified as risk factors for RV failure after LVAD placement NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 63. INTERMACS: profiles for patient selection NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 64. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 65. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 66. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 67. The C-Pulse ( implantable, extra-aortic counterpulsation device) NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 68. Symphony Counterpulsation Device NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 69. TOTAL ARTIFICIAL HEART NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 70. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 71. Effects of Chronic Hemodynamic Unloading with Ventricular Assist Devices Structural • Regression of myocyte hypertrophy. • Reduction in neurohormonal activation • Normalization in expression of contractile proteins . • Enhanced electron transport chain respiratory function • Decreased apoptosis and NEWER ADVANCES IN HEART FAILURE cellular stress markers DEVICE THERAPY
  • 72. • Functional • Improvement in left ventricular ejection fraction and diastolic and systolic dimension • Recovery from spherical to more elliptical left ventricular shape • Improvement in heart failure–specific indices of quality of life • Improvement in peak aerobic capacity NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 73. complications • Anticoagulation. • Drive line infections . • Noise. • Durability. • Activation of immune system. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 74.
  • 75. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 76. epicardial pads secured and used to tighten the device. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 77. The CorCap device NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 78. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 79. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 80. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 81. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 82. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 83. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 84. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 85. Percutaneous Leaflet Repair and Annuloplasty for Mitral Regurgitation NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 86.
  • 87.
  • 88.
  • 89. EVEREST II Randomized Clinical Trial Key Inclusion/Exclusion Criteria Inclusion Exclusion – Candidate for MV Surgery – AMI within 12 weeks – Moderate to severe (3+) or – Need for other cardiac surgery severe (4+) MR – Renal insufficiency • Symptomatic • Creatinine >2.5mg/dl – >25% EF & LVESD ≤55mm – Endocarditis • Asymptomatic with one or more – Rheumatic heart disease of the following – LVEF 25-60% – MV anatomical exclusions – LVESD ≥40mm • Mitral valve area <4.0cm2 – New onset atrial fibrillation • Leaflet flail width (≥15mm) and – Pulmonary hypertension gap (≥10mm) • Leaflet tethering/coaptation ACC/AHA Guidelines JACC depth (>11mm) and length 52:e1-e142, 2008 (<2mm) Investigational Device only in the US; 90 Not available for sale in the US
  • 90. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 91. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 92. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 93. NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY
  • 94. Figure 6. Core laboratory tracings of the mitral annulus and leaflet line of coaptation from 3D echo data sets recorded at preprocedure baseline and follow-up time points noted from patients with PTMA implants still observed by x-ray to be in place. Sack S et al. Circ Cardiovasc Interv 2009;2:277-284 Copyright © American Heart Association
  • 95. From: Percutaneous Leaflet Repair and Annuloplasty for Mitral Regurgitation J Am Coll Cardiol. 2011;57(5):529-537. doi:10.1016/j.jacc.2010.10.012 Figure Legend: Direct Annuloplasty The Guided Delivery Systems Accucinch device is delivered through retrograde catheterization of the left ventricle. (Left) Anchors are placed in the Date of download:mitral annulus and (right) connected with a “drawstring” to cinch the posterior Copyright © The American College of Cardiology. 11/6/2012 All rights reserved. annular circumference.
  • 96. nk you •T ha NEWER ADVANCES IN HEART FAILURE DEVICE THERAPY

Notes de l'éditeur

  1. CHF-STAT: Singh SN, et al. Amiodarone in patients with congestive heart failure and asymptomatic ventricular arrhythmia. N Engl J Med 1995; 333: 77-82. GESICA: Doval, HC. Lancet. 1994. SOLVD: Cooper H, et al. Dirueticsand Risk of Arrhythmic Death in Patients with Left Ventricularl Dysfunction. Circulation . 1999; 100: 1311-1315. V-HEFT I: Goldman S, Johnson G, Cohn JN, Cintron G, Smith R, Francis G. Mechanism of death in heart failure. The Vasodilator-Heart Failure Trials. The V-HeFT VA Cooperative Studies Group. Circulation. 1993 Jun;87(6 Suppl):VI24-31 MERIT-HF: Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomized intervention trial in Congestive Heart Failure (MERIT-HF). Lancet 1999; 353: 2001-07. CIBIS II: The Cardiac Insufficiency Bisoprolol Study II (CIBIS II): a randomized trial. THE LANCET: 353: 9-13. CARVEDILOL-US: The Effect of Carvedilol on Morbidity and Mortality in Patients with Chronic Heart Failure. N Engl J Med 1996; 334: 1349-55.
  2. Major milestones in ICD therapy evolution: 1985: First FDA approval of basic implantable defibrillator. Implants are reserved for the highest risk patients. 1988: Introduction of tiered-therapy: painless antitachycardia pacing, low-energy cardioversion, and high-energy defibrillation. 1989: Transvenous leads eliminate the need for open heart procedures in most cases. Biphasic waveforms allow more effective defibrillation and greater patient safety. 1993: The beginning of the reductions in size which allow pectoral implants (shorten procedure times and hospital stays). 1996: Steroid-eluting leads are introduced, which minimize tissue inflammation and provide up to 48% greater ICD longevity. MADIT is also published: the first prospective study to prove that ICD therapy improves survival in high-risk post-MI patients who have not experienced VT/VF. 1997: Dual-chamber ICDs receive FDA approval: one device can provide multiple therapy options. 1997/1998: Large randomized studies AVID, CASH and CIDS prove that ICD therapy improves VT/VF patient survival compared to antiarrhythmic drug therapy. 1998: Actual worldwide implant volume 55,000 ICDs. AT therapies introduced in Europe. 1999: MUSTT data point to significant reductions in mortality for high-risk post-MI patients. 2000: By the year 2000, it is expected that more VT/VF and high-risk patients will have access to ICD therapy, bringing the projected worldwide implant volume to over 80,000 implants/year. Major milestones in ICD therapy evolution: 1985: First FDA approval of basic implantable defibrillator. Implants are reserved for the highest risk patients. 1988: Introduction of tiered-therapy: painless antitachycardia pacing, low-energy cardioversion, and high-energy defibrillation. 1989: Transvenous leads eliminate the need for open heart procedures in most cases. Biphasic waveforms allow more effective defibrillation and greater patient safety. 1993: The beginning of the reductions in size which allow pectoral implants (shorten procedure times and hospital stays). 1996: Steroid-eluting leads are introduced, which minimize tissue inflammation and provide up to 48% greater ICD longevity. MADIT is also published: the first prospective study to prove that ICD therapy improves survival in high-risk post-MI patients who have not experienced VT/VF. 1997: Dual-chamber ICDs receive FDA approval: one device can provide multiple therapy options. 1997/1998: Large randomized studies AVID, CASH and CIDS prove that ICD therapy improves VT/VF patient survival compared to antiarrhythmic drug therapy. 1998: Actual worldwide implant volume 55,000 ICDs. AT therapies introduced in Europe. 1999: MUSTT data point to significant reductions in mortality for high-risk post-MI patients. 2000: By the year 2000, it is expected that more VT/VF and high-risk patients will have access to ICD therapy, bringing the projected worldwide implant volume to over 80,000 implants/year.
  3. Main purpose: Illustrate for referral clinicians how the leads are placed to achieve cardiac resynchronization. Many outside the implant world may not be entirely aware of how the device is placed. Key messages: The implant procedure, while typically of longer duration, is similar to that of a standard pacemaker or implantable defibrillator implantation. A key difference is the placement of a left ventricular lead via the coronary sinus opening. Coronary venous anatomy varies significantly between patients. In a small percentage of cases it may not be possible to place the left ventricular lead transvenously. Some centers are opting for an epicardial approach if the transvenous approach is unsuccessful. Additional information: Standard pacing leads are placed in the right atrium and right ventricle. The LV lead is placed via the coronary sinus in a cardiac vein, preferably a lateral or postero-lateral vein in the mid part of the LV. The successful deployment of this lead to physician-guided development of left-heart delivery systems, and new LV leads to meet varying patient
  4. Main purpose: Show that a large number of patients have been studied in completed and ongoing randomized controlled studies of CRT. Use in conjunction with previous slide. Key messages: Over 3000 patients have been enrolled in randomized controlled clinical trials presented to date. When CARE-HF, another landmark trial assessing mortality and hospitalization, is reported, close to 4,000 patients will have been studied.
  5. Main purpose: Explain the risks of a CRT system implant to referral clinicians. Based on Medtronic’s MIRACLE study program and on Guidant’s Contak CD trial. Source of complications is abstract presented at NASPE 2003. Key messages: Each clinical trial utilized a clinical events review committee to evaluate complications, including defined procedure-related mortality. Chiefly due to challenging venous anatomy, implants have been unsuccessful in approximately 10% of patients attempted. Complication rates by category appeared to be reduced with the Medtronic Attain 4193, with an over-the-wire delivery system, used in the InSync III trial. Coronary sinus dissection or perforation generally were resolved without further complication. For comparison, the 30-day mortality in the CABG-PATCH and the AVID trials were 5.4% and 2.4% respectively. Left ventricular lead complications, primarily dislodgements, occurred in 9% of all cases (4% in the InSync II study). There is a learning curve. Implant times came down with increased center-based experience.
  6. The HF clinical composite response. The primary endpoint, comparing the proportion of worsened subjects at 12 months of CRT, was not different between CRT-ON and CRT-OFF groups (P = 0.10). Reprinted with permission from Linde et al.12
  7. Mean LVESVi, LVEDVi, and LVEF at baseline and 12-month follow-up in the CRT-OFF and CRT-ON groups. A significant reduction in volume indexes and LVEF was observed in the CRT-ON group when compared with the CRT-OFF group. Error bars represent 95% confidence intervals. LVESVi, left ventricular end-systolic volume index; LVEDVi, left ventricular end-diastolic volume index; LVEF, left ventricular ejection fraction. Reprinted with permission from Linde et al.12
  8. Time to first HF hospitalization or death in the 18-month follow-up period in the CRT-OFF and CRT-ON groups. Reprinted with permission from Abraham et al.13
  9. Figure 6. Core laboratory tracings of the mitral annulus and leaflet line of coaptation from 3D echo data sets recorded at preprocedure baseline and follow-up time points noted from patients with PTMA implants still observed by x-ray to be in place. Actual tracings are full 3D datasets that also capture full contour information (eg, the “saddle shape” character of the annulus).