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About Lesson
DEVICE THERAPY IN CHRONIC HEART FAILURE
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Introduction
Chronic Heart Failure (CHF) remains a significant public health challenge worldwide, despite advances in pharmacotherapy. Device-based therapies have emerged as critical tools in managing patients, especially those with advanced heart failure symptoms who are not responding adequately to medical treatments. This essay reviews the landscape of device therapies for chronic heart failure, focusing on the latest guidelines, technological innovations, and regulatory pathways driving these advancements.
General Indications for Device Therapy in Heart Failure
Indication |
Device Therapy |
Purpose |
Symptomatic Heart Failure Despite GDMT |
CRT, ICD, LVAD |
Improve heart function and reduce symptoms |
Reduced LVEF (≤ 35%) |
CRT, ICD |
Synchronize ventricular contractions (CRT) and prevent sudden cardiac death (ICD) |
Prevention of Sudden Cardiac Death (SCD) |
ICD |
Detect and terminate life-threatening arrhythmias |
Heart Failure with Electrical Dyssynchrony |
CRT |
Improve ventricular synchrony and enhance cardiac output |
Advanced/Refractory Heart Failure |
LVAD |
Mechanical support for end-stage heart failure, bridge to transplantation or destination therapy |
Significant Secondary Mitral Regurgitation |
MitraClip, TMVR |
Reduce mitral regurgitation and improve symptoms |
Severe Tricuspid Regurgitation (TR) |
TriClip |
Reduce TR and alleviate symptoms of right heart failure |
Central Sleep Apnea in Heart Failure |
Phrenic Nerve Stimulation (remedē System) |
Stabilize breathing during sleep, reduce CSA and its impact on heart failure |
Autonomic Dysfunction in HF |
Baroreflex Activation Therapy (BAT), Vagus Nerve Stimulation (VNS) |
Modulate autonomic nervous system to reduce sympathetic tone and improve symptoms |
Volume Redistribution Congestion (HFpEF) |
Splanchnic Nerve Blockade |
Reduce splanchnic venous congestion and alleviate heart failure symptoms |
Major Device Therapies for Chronic Heart Failure
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Cardiac Resynchronization Therapy (CRT) CRT is primarily used in patients with heart failure with reduced ejection fraction (HFrEF) and evidence of electrical dyssynchrony, such as a widened QRS complex. CRT devices improve cardiac efficiency by coordinating the contraction of the ventricles. The latest guidelines recommend CRT for patients in New York Heart Association (NYHA) functional class II-IV symptoms with an ejection fraction of 35% or less and QRS duration >150 ms.
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Mitral Valve Repair Devices
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MitraClip: The MitraClip (Abbott) is used for edge-to-edge repair of the mitral valve, effectively reducing mitral regurgitation (MR) in patients with either primary or secondary MR. The COAPT trial demonstrated the device's effectiveness in reducing hospitalization and mortality rates in patients with heart failure and secondary MR who were on maximally tolerated guideline-directed medical therapy (GDMT).
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Carillon Mitral Contour System: The Carillon system is an indirect annuloplasty device that reduces annular dilatation. It has been shown to significantly reduce mitral regurgitant volume and improve quality of life.
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Transcatheter Mitral Valve Replacement (TMVR) TMVR is an evolving field for patients with severe mitral regurgitation unsuitable for traditional surgery. Devices like Medtronic's Intrepid TMVR system and Abbott's Tendyne have shown promising results in reducing MR severity and improving patient outcomes.
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Tricuspid Valve Repair and Replacement Tricuspid regurgitation (TR) is associated with poor prognosis in heart failure, and transcatheter devices like the TriClip have been developed to address this. The TRILUMINATE Pivotal Trial demonstrated significant reductions in TR severity and improvements in quality of life in patients undergoing TriClip implantation.
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Baroreflex Activation Therapy (BAT) BAT targets autonomic dysfunction by stimulating baroreceptors in the carotid sinus to reduce sympathetic overactivity. The BeAT-HF trial showed improvements in NYHA functional class, quality of life, and NT-proBNP levels after six months of BAT therapy.
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Vagus Nerve Stimulation (VNS) VNS aims to improve autonomic balance in heart failure by increasing parasympathetic activity. Current studies like ANTHEM-HFrEF and ANTHEM-HFpEF are investigating the effectiveness of VNS in improving clinical outcomes in both HFrEF and heart failure with preserved ejection fraction (HFpEF).
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Cardiac Contractility Modulation (CCM) CCM involves delivering high-voltage electrical signals during the absolute refractory period of the cardiac cycle, leading to enhanced contractility without initiating a new contraction. The FIX-HF-5C trial demonstrated the benefits of CCM in improving exercise capacity and quality of life in patients with HFrEF.
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Phrenic Nerve Stimulation for Central Sleep Apnea (CSA) CSA is common in patients with CHF and contributes to poor outcomes. The remedē System stimulates the phrenic nerve, resulting in diaphragmatic contraction and stabilized respiration during sleep. This therapy has been shown to improve sleep quality and reduce apnea episodes.
Latest Guidelines and Recommendations
Recent updates in guidelines have emphasized the integration of these device therapies based on patient characteristics and heart failure subtypes:
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HFrEF: CRT is recommended for patients with wide QRS and symptomatic heart failure despite optimal medical therapy. CCM and BAT can be considered for selected patients who do not meet CRT criteria.
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HFpEF: Device therapy options remain limited; however, ongoing trials are exploring the potential benefits of VNS and other neuromodulatory devices.
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Mitral and Tricuspid Regurgitation: Interventional therapies like MitraClip and TriClip are now recommended for patients with significant MR or TR who are at high surgical risk and are symptomatic despite GDMT.
Table: Overview of Device Therapies and Guidelines
Therapy |
Indications |
Trial Evidence |
Guideline Recommendation |
CRT |
HFrEF, QRS > 150 ms |
Multiple RCTs |
Class I, Level A |
MitraClip |
Secondary MR, NYHA II-IV |
COAPT |
Class IIa, Level B |
TMVR (Intrepid, Tendyne) |
Severe MR, unsuitable for surgery |
APOLLO, SUMMIT |
Emerging evidence |
TriClip |
Severe TR, NYHA II-IV |
TRILUMINATE |
Class IIa, Level B |
BAT |
NYHA II-III, NT-proBNP < 1600 pg/mL |
BeAT-HF |
Class IIb, Level B |
CCM (OPTIMIZER System) |
NYHA III-IV, LVEF 25%-45% |
FIX-HF-5C |
Class IIb, Level B |
Phrenic Nerve Stimulation |
CSA in CHF |
remedē System Pivotal |
Class IIb, Level C |
Indications for Device Therapy in Heart Failure
Device therapy plays a crucial role in managing patients with heart failure, particularly those who remain symptomatic despite optimized medical therapy or have specific heart failure subtypes. The indications for device therapy are guided by the type of heart failure, patient-specific characteristics, and the presence of comorbid conditions. Below is an overview of the major indications for device therapies in heart failure:
1. Cardiac Resynchronization Therapy (CRT)
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Heart Failure Type: Heart Failure with Reduced Ejection Fraction (HFrEF)
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Indications:
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NYHA Class II-IV despite optimal medical therapy.
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Left Ventricular Ejection Fraction (LVEF) ≤ 35%.
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QRS duration ≥ 150 ms, particularly with a left bundle branch block (LBBB) pattern.
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Purpose: CRT helps improve ventricular synchrony and is indicated to reduce morbidity and mortality in patients with significant electrical dyssynchrony.
2. Implantable Cardioverter Defibrillator (ICD)
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Heart Failure Type: HFrEF
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Indications:
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Primary prevention of sudden cardiac death in patients with:
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LVEF ≤ 35%, NYHA Class II-III, despite at least 3 months of guideline-directed medical therapy (GDMT).
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Secondary prevention in patients with a history of ventricular arrhythmias or cardiac arrest.
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Purpose: ICDs are used to prevent sudden cardiac death by detecting and terminating life-threatening arrhythmias.
3. Cardiac Contractility Modulation (CCM)
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Heart Failure Type: HFrEF
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Indications:
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NYHA Class III-IV symptoms.
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LVEF between 25%-45%.
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Patients with narrow QRS (<130 ms) who are not candidates for CRT.
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Purpose: CCM is used to improve cardiac contractility and exercise capacity in symptomatic patients who do not meet criteria for CRT.
4. Baroreflex Activation Therapy (BAT)
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Heart Failure Type: HFrEF
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Indications:
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NYHA Class II-III with LVEF ≤ 35%.
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Patients with elevated NT-proBNP levels who are not suitable candidates for CRT.
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Purpose: BAT helps in autonomic modulation by reducing sympathetic tone and improving symptoms and quality of life.
5. Mitral Valve Repair (e.g., MitraClip)
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Heart Failure Type: HFrEF and Heart Failure with Preserved Ejection Fraction (HFpEF)
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Indications:
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Symptomatic patients with significant secondary mitral regurgitation despite optimized GDMT.
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LVEF between 20%-50% and NYHA Class II-IV symptoms.
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Purpose: The MitraClip device is used to reduce mitral regurgitation, improve symptoms, and decrease hospitalizations.
6. Transcatheter Mitral Valve Replacement (TMVR)
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Heart Failure Type: HFrEF and HFpEF
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Indications:
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Patients with symptomatic, moderate to severe mitral regurgitation who are at high or prohibitive surgical risk.
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Purpose: TMVR is aimed at improving mitral valve function, reducing regurgitation, and alleviating heart failure symptoms.
7. Tricuspid Valve Repair and Replacement (e.g., TriClip)
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Heart Failure Type: Right Heart Failure, Biventricular Failure
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Indications:
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Severe tricuspid regurgitation (TR) in symptomatic patients with NYHA Class II-IV despite optimal medical therapy.
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Purpose: Tricuspid valve repair devices are used to reduce TR, which can significantly alleviate symptoms and reduce right-sided heart failure burden.
8. Phrenic Nerve Stimulation for Central Sleep Apnea (e.g., remedē System)
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Heart Failure Type: HFrEF and HFpEF
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Indications:
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Patients with central sleep apnea (CSA) that worsens heart failure and contributes to poor quality of life.
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Purpose: Phrenic nerve stimulation helps to stabilize breathing during sleep, reducing the impact of CSA on heart failure progression.
9. Left Ventricular Assist Devices (LVAD)
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Heart Failure Type: End-Stage Heart Failure
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Indications:
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Patients with advanced heart failure who are refractory to GDMT and are not eligible for heart transplantation.
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Purpose: LVADs are used as a bridge to transplantation or as destination therapy to prolong survival and improve quality of life in patients with end-stage heart failure.
10. Splanchnic Nerve Blockade
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Heart Failure Type: Heart Failure with Preserved Ejection Fraction (HFpEF)
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Indications:
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Patients with evidence of intravascular volume redistribution leading to congestion despite normal total body fluid volume.
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Purpose: Splanchnic nerve modulation aims to reduce splanchnic venous congestion and alleviate heart failure symptoms.
Summary Table: Indications for Device Therapy in Heart Failure
Device Therapy |
Indications |
HF Type |
CRT |
LVEF ≤ 35%, QRS ≥ 150 ms, NYHA II-IV |
HFrEF |
ICD |
LVEF ≤ 35%, NYHA II-III, history of arrhythmias |
HFrEF |
CCM |
LVEF 25%-45%, NYHA III-IV, narrow QRS |
HFrEF |
BAT |
NYHA II-III, LVEF ≤ 35%, NT-proBNP < 1600 pg/mL |
HFrEF |
MitraClip |
Significant secondary MR, LVEF 20%-50% |
HFrEF, HFpEF |
TMVR |
Moderate to severe MR, unsuitable for surgery |
HFrEF, HFpEF |
TriClip |
Severe TR, NYHA II-IV |
Right HF, Biventricular HF |
Phrenic Nerve Stimulation |
Central Sleep Apnea with HF |
HFrEF, HFpEF |
LVAD |
End-stage HF, refractory to GDMT |
End-Stage HF |
Splanchnic Nerve Blockade |
Volume redistribution congestion, HFpEF |
HFpEF |