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Device therapy in advanced HF.
- 1. DEVICES IN HEARTFAILURE SYNDROMES DR ASADULLAH KHAN SOOMRO Adult Cardiologist Prince Sultan Cardiac Centre Al-Ahssa. KSA ( Email,[email protected] )
- 2. Introduction Heart Failure isnot a disease itself but a complex and costly life threatening syndrome with multiple etiologies. At present ,approximately 30 million worldwide are living with heart failure. The out look for such patients is poor, with survival rates worse than many cancers. Furthermore ,heart failure has tremendous impact on patients, families, caregivers and healthcare system indeed, and is predicted to increase dramatically over the next decade. Heart failure is a major public health problem with high morbidity and mortality, PSCCH is a prestigious advanced heart center and a regional leader , has unique heart failure program & is certified by JCI indeed .
- 3. Definition of HeartFailure Heart Failure is a costly, deadly and complex clinical syndrome characterized by typical symptoms, like breathlessness (orthopnoea or paroxysmal nocturnal dyspnea), fatigue, and ankle swelling, usually accompanied by signs ( like raised, JVP, displaced apex impulse, gallop and murmur), according to etiology and triggering factors with and without signs of congestion (pulmonary crackles, ascites, peripheral edema). Caused by structural and or functional cardiac or non- cardiac abnormality.
- 4. Why device therapyin Advanced Heart Failure Syndromes Despite improvements in medical & device therapy for treatment of heart failure ,the incidence and prevalence of HF continue to increase. New pharmacological therapies including ARNI are not expected to change this situation significantly; the drug has been shown to delay ,not eliminate the progression of heart failure. Novel device therapy have shown promising clinical results in preclinical and early clinical studies.
- 5. Heart failure DeviceTherapy 1) Implanted Electrical devices ; CRT& . ICD 2) Mechanical circulatory support Devices,( MCS ) short term versus long term devices ( ECMO & VAD ). 3) Valvular closure or replacement devices . 4) Monitoring Devices. 5) Stimulation HF devices. 6) Personal wearable devices.
- 6. Recommendations for ImplantableCardioverter-Defibrillator in patients with Heart Failure Secondary Prevention An ICD is recommended to reduce the risk of sudden death and all cause mortality in patients who have recovered from a ventricular arrhythmia causing hemodynamic instability, and who are expected to survive for >1 year with good functional status (class 1A) Primary Prevention An ICD is recommended to reduce the risk of sudden death and all cause mortality in patients with symptomatic HF (NYHA class II-111) and an LVEF <35% despite >3 months of Optimum Medical Treatment, provided they are expected to survive substantially longer than 1 year with good functional status, and the have: IHD ( unless they have had an MI in the prior 40 days ) Class 1A. And DCM (Class 1B ) ICD Implantation is not recommended within 40 days of an MI as implantation at this time does not improve prognosis (Class 111A). ICD is not recommended in patients NYHA class 1V, with severe symptoms refractory to pharmacological therapy unless they are candidates for CRT, a ventricular assist device or cardiac transplant ( Class 111 C )
- 7. Recommendations for ImplantableCardiac resynchronization therapy implantation in patients with Heart Failure 1) CRT is recommended for symptomatic patients with HF in sinus rhythm with QRS duration > 150msec and LBBB QRS morphology with LVEF < 35% despite optimal medical therapy. ( Class 1 A) 2) CRT rather than RV pacing is recommended for patients with HFrEF regardless of NYHA class who have an indication for ventricular pacing and high degree AV block in order to reduce morbidity. This includes patients with AF. ( Class 1 A)
- 8. Recommendations for ImplantableCardiac resynchronization therapy implantation in patients with HF 3) CRT is recommended for symptomatic patients with HF in sinus rhythm with QRS duration of 130 – 149 msec and LBBB QRS morphology with LVEF < 35% despite optimal medical therapy.in order to improve symptoms and reduce morbidity and mortality( Class 1 B) 4) Patients with HFrEF who have received a conventional pacemaker or an ICD and subsequently develop worsening heart failure despite optimal medical therapy and who have high proprtion of RV pacing may be considered for upgrade to CRT,but this does not apply to stable heart failure. ( Class 11b B) 5) CRT is contraindicated in patients with QRS duration < 130 msec. ( Class 111 A)
- 9. Patients Potentially eligiblefor implantation of LV assist device. Patients with more than 2 months of severe symptoms despite optimal medical treatment and device therapy and more than one of the following LVEF < 25 % and if measured peak VO2 < 12 ml/kg/min > 3 heart failure hospitalizations in previous 12 months without an obvious precipitating cause. Dependence on I/V ionotropic therapy Progressive end organ dysfunction ( worsening renal and /or hepatic function) due to reduced perfusion and not to inadequate ventricular filling pressure( PCWP>20mmHg and SBP < 80-90mm Hg or CI < 2 L /min/m2. Absence of severe RV dysfunction together with severe tricuspid regurgitation.
- 10. Various indications formechanical circulatory support. ( MCS ) Bridge to decision , Use of MCS ( eg, ECMO ) in patients with cardiogenic shock untill haemodynamics and end organ perfusion are stablized. Contraindications for long term MCS are excluded ( Brain damage after resuscitation) and additional therapeutic options including long term VAD therapy or transplantation can be evaluated. Bridge to candidacy , Use of LVAD to improve end organ function in order to make an ineligible patient eligible for heart transplant. Bridge to transplantation , Use of LVAD or bi VAD to keep patient alive who is other wise at high risk of death before transplantation untill donar organ is available. Bridge to recovery, Use of LVAD to keep patient alive untill cardiac function recovers sufficiently to remove MCS device. Destination therapy . Long term use of LVAD as an alternative to transplantation in patients with end stage heart failure ineligible for transplantation or long term waiting for transplantation.
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- 12. Advanced Heart FailureSyndrome Prevalence of advanced heart failure range from 6% to 25%. Largest registry of chronic advanced HF suggest that roughly 5% patients with heart failure have end stage disease with symptoms refractory to guideline based medical therapy. Recognizing Advanced HF requires integration of clinical, imaging, hemodynamic, functional and biomarker parameters in setting of unresponsive optimal medical treatment should raise concern over progression to stage D heart failure.
- 13. European society ofcardiology definition of Advanced heart Failure 1) NYHA class 111or 1V symptoms. 2) Episodes of volume overload /or peripheral hypoperfusion. 3) Objective evidence of severe cardiac dysfunction ( EF <30%, restrictive filling pattern, PCWP >16mm, or RAP >12mm Hg) 4) Severely impaired functional capacity( inability to exercise 6min walk <300m, peak oxygen consumption<12-14ml/kg/min). 5) HF hospitalization ( >1 in past 6month). Above occurring despite attempts to optimize diuretics, RAAS antagonists, beta blockers, CRT or in setting of intolerance to optimal medical treatment)
- 14. Advanced Heart FailureSyndrome Dyspnea is often characteristic ,they usually have RV failure so more of a fatigue, edema and ascites, usually become intolerant to drugs on previously tolerated doses leads to hypotension and major organ dysfunction. Central sleep apnea, depression and cardiac cachexia suggestive of advanced HF. Advanced heart failure is a discrete clinical syndrome that deserves recognition as its own entity. There is marked variability, and no one feature that reliably identifies the AHF patients.
- 15. Advanced Heart FailureSyndrome Aminorityof patients have a rapid progression and never achieve sustained compensation, however, over long term, a progressive decline to advanced heart failure with debilitating symptoms ( FC111& 1V) refractory to optimal medical treatment ( Stage D heart failure). Usually inotropic dependent yet with repeated / prolonged admissions, due to volume overload and dysrrhythmias further complicated by major organ dysfunction, strokes , pulmonary and systemic embolization.
- 16. Advanced Heart FailureSyndrome Progression to advanced heart failure from stage C to stage D may be gradual and it is often complex, and indeed difficult to determine weather decompensation in a previously stable heart failure patient is an isolated incident due to reversible precipitants or the transition to a refractory stage
- 17. Advanced Heart FailureSyndrome To facilitate recognition of this phase so that advanced therapy or a more palliative approach as under ( in eligible patients) can be considered. Like Cardiac Transplant , LVAD, ( as bridge or destination therapy), ICD, CRT Assist devices. A subset of patients may experience marked improvement in symptoms with cardiac resynchronization therapy for variable length of time ,re-setting their progressive course upward.
- 18. Advanced Heart FailureSyndrome Another subset of patients may exit the “ heart failure natural history” after receiving cardiac transplantation or left ventricular assist device ( LVAD) placement, this group currently represent a tiny subset of heart failure population. Those who survive require intense resource utilization and need close follow up at advanced heart failure clinic .
- 19. Advanced Heart Failure (ESCAPE SCORE ) 1) Age>70 years 2) BUN >40 3) 6 min walk < 300met. 4) Serum sodium < 130meq. 5) Diuretics dose at discharge >240mg. 6) Absence of beta blocker at discharge. 7) CPR & mechanical ventilation. 8) Discharge BNP > 500. Score zero had a 5% six month mortality and score 8 had a 94% six month mortality.
- 20. INTERMACS ( Interagency Registryfor Mechanically Assisted Circulatory Support) Advanced heart Failure Profiles 1) Critical Cardiogenic shock. Patients with life threatening hypotension despite rapidly escalating inotropic support, critical organ hypoperfusion, often confirmed by worsening acidosis and /or lactate levels ” Crash and burn”. 2) Progressive decline, patient with declining function despite intravenous inotropic support, may be manifested by worsening renal function, nutritional depletion, inability to restore volume balance “ Sliding on inotropes”. Also describes declining status in patients unable to tolerate inotropic therapy. 3) Stable but inotrope-dependent. Patients with stable blood pressure ,organ function, nutrition,and symptoms on continuous intravenous inotropic support( or a temporary circulatory support device or both),but demonstrating repeated failure to wean from support because of recurrent symptomatic hypotension or renal dysfunction “Dependent stability). 4) Resting Symptoms. Patients can be stabilized close to normal volume status but experiences daily symptoms of congestion at rest or during activities of daily living. Doses of diuretics generally fluctuate at very high levels. More intensive management and surveillance strategies should be considered, which may in some cases reveal poor compliance that would compromise outcomes with any therapy. Some patients may shuttle between profile 4 & 5.
- 21. INTERMACS Advanced heart FailureProfiles 5) Exertion –intolerant. Comfortable at rest and with activities of daily living but unable to engage in any other activity, living predominantly within the house. Patients are comfortable at rest without congestive symptoms, but may have underlying refractory elevated volume status, often with renal dysfunction. If underlying nutritional status and organ function are marginal, patient may be more at risk than ( INTERMACS) profile 4 and require definitive intervention. 6) Exertion Limited. Patients without evidence of fluid overload is comfortable at rest and with activities of daily living and minor activities outside the home but fatigue after few minutes of any meaningful activity. Attribution to cardiac limitation requires careful measurement of peak oxygen consumption, in some cases with hemodynamic monitoring to confirm severity of cardiac impairment “ Walking wounded”. 7) Advanced New York Heart Association Class 111. A placeholder for more - precise specification in future ,this level includes patients who are without current or recent episodes of unstable fluid balance ,living comfortably with meaningful activity limited to mild physical exertion. ( Patients in Profile 4 to 7 having better survival and shorter length of stay post implantation compared with those in patients in profile 1 to 3)
- 22. INTERMACS Advanced Heart FailureProfiles Patients in Profile 1 cardiogenic shock ECMO is usually indicated untill decision. Profile 11 ECMO and LVAD is indicated . INTERMACS profile 1 to V are in FC 1V. Profile 1V & V are in FC 1V yet can be ambulatory. Profile V1 and V11 are in FC 111 , in these patients LVAD indicated and is an option to discuss. INTERMACS Profile 1 patients “ crash and burn” one year survival with LVAD therapy is 50-55%. Profile 11 survival is around 63 to 66%. Profile 111 survival is 78 to 80%. Profile 1V survival is 79 to 82%. Profile V survival is 93 to 97%. Profile V1 & V11 one year survival with LVAD therapy above 97%.
- 23. Patients selection andtiming for destination LVADs The accepted criteria for LVAD implantation for DT are based on REMATCH trial are as under. 1) NYHA FC 1V symptoms who have failed to respond to optimal medical management for at least 45 of the past 60 days. 2) Or IABP dependent for 7 days. 3) Or IV ionotropic dependent for 14 days. 4) LV ejection fraction < 25%. 5) Functional limitation with peak oxygen consumption < 14 ml/kg/min
- 24. Patients selection andtiming for destination LVADs According to 2013 International society of Heart Lung Transplant guidelines , Reversible causes of Heart failure should be addressed prior to consideration for long term MCSDs. All patients referred for MCSDs should have their transplant candidacy assessed prior to implantation, Destination therapy patients generally have contraindications for heart transplantation, such as age > 70 years, malignancy with in 5 years, elevated pulmonary vascular resistance and end organ damage.
- 25. Patients selection andtiming for destination LVADs Appropriate selection of the candidates and timing of LVAD implantation are critical for improved outcomes. Data from ITERMACS ,a North American registry since 2006 in patients receiving MCSDs therapy to treat advanced HF provide valuable information. INTERMACS scale seven levels based on hemodynamic profile and functional capacities. INTERMACS level 1 is used to describe the most critically ill patients with cardiogenic shock, level 2 progressively declining despite ionotropic support ,level 3 who are stable but ionotropic dependent. level 4 who have resting symptoms on oral therapy, level 5 have exertion intolerance ( “ house bound”),level 6 have limited exertion tolerance and level 7 have NYHA FC 111.
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