The document discusses newer advancements in heart failure device therapy. It summarizes that device therapies have greatly improved outcomes for heart failure patients. Some key devices discussed include implantable cardioverter defibrillators (ICDs) which reduce sudden cardiac death, cardiac resynchronization therapy which improves heart function, and left ventricular assist devices (LVADs) which are increasingly being used as long term support devices or as a destination therapy for end stage heart failure patients. The document provides details on the development, indications, benefits and risks of these various heart failure devices.
Anatomy of cardiac structures & conducting system 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
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
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
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
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
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
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
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
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
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
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;
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Not available for sale in the US
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NEWER ADVANCES IN HEART FAILURE
DEVICE THERAPY
Editor's Notes
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.
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.
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
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.
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.
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
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
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
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).