Heart Failure Devices and treatment evolution.pptx

Current concepts in heart failure treatment evolution

1. HEART FAILURE TREATMENT EVOLUTION Overview of Device Therapy in Heart Failure (HF)

2. Introduction At the end of the previous century, disease-modifying neurohormonal blockers to treat HF with reduced ejection fraction ( HFrEF ) improved survival and decreased HF hospitalizations significantly. In the same era, the first left ventricular assist device (LVAD) was approved by the Food and Drug Administration (FDA) to avoid patients from dying while waiting for a heart transplant.

3. Current State and Challenges Despite the use of vastly improved treatment options, up to 20% of ambulatory HFrEF patients still experience a HF hospitalization or die within 2 years. 50% of hospitalized HFrEF patients have a readmission within 6 months despite optimal medical therapy. Therapeutic options for patients with HF with preserved ejection fraction ( HFpEF ) remain limited and only sodium-glucose cotransporter 2 (SGLT2) inhibitors have been convincingly shown to reduce HF hospitalizations.

4. Advancements in Device Therapy The last decade has seen leaps in the use of devices in HF, either to provide monitoring with the aim of improved tailoring of care, or directly providing therapy in synergistic with medical therapies.

5. Rationale for the Use of Device Therapy in Heart Failure

6. Haemodynamic Alterations Increased filling pressures and impaired cardiac output are common to both HFrEF and HFpEF , but both can be normal (at rest) in a ‘compensated’ state. Some devices have been developed to monitor or intervene upon these haemodynamic derangements.

7. Cardiac remodeling HFrEF : Left ventricle undergoes remodeling with progressive dilatation, potentially causing secondary mitral regurgitation (MR) due to tethering forces, decreased closing forces, and altered mitral valve function. HFpEF : Left ventricle exhibits hypertrophy, while the atrium dilates, both potentially leading to secondary MR via annular dilatation. This secondary MR in both cases is associated with poor outcome

8. Arrhythmias Heart failure patients can develop a wide range of arrhythmias during their disease course. Tachy-arrhythmias such as atrial fibrillation (AF) and ventricular arrhythmias (VAs), Brady-arrhythmias.

9. AF occurs in one third of HF patients, common precipitant of decompensation. AF with high ventricular rates can also cause LV dysfunction and HF. VAs can be a life-threatening complication of HF and VA-related death can be prevented by ICDs . Brady-arrhythmias and conduction abnormalities leading to a standard pacemaker indication occur more frequently in people with HF, and the presence of important LV systolic dysfunction often require a personalized approach.

10. Cardiorenal Interaction Heart failure and chronic kidney disease often coexist and complicate treatment. The physiological age-related decline in glomerular filtration rate (−0.5 to −1 mL/min/1.73 m² per year) is accelerated in HF patients (up to −3 to −5 mL/min/1.73 m² per year). Importantly, renal dysfunction can also lead to a reduced response to diuretic therapy. Increased central venous pressures, observed in many acute HF cases, can drive further deterioration in renal function. In cases of severe renal impairment, diuretics remain the first-line therapy to relieve volume. Several devices have been studied that can assist in sodium and volume homeostasis in such patients.

11. Devices aimed at management of electrical abnormalities Implantable cardioverter-defibrillator How does it work? Function: Monitors heart rhythm , delivers shocks for dangerous rhythms (ventricular fibrillation, fast VT). Goal: Reduces sudden cardiac death risk. Placement options: Endovascular (in a vein): Provides anti-tachycardia pacing (ATP) to stop abnormal rhythm before shock needed. Can also function as a pacemaker for slow heart rhythms. Subcutaneous (under skin): No ATP, limited to shock therapy. Potential downsides: Unnecessary shocks/pacing, extra pacing of right ventricle (RV), device complications (lead issues, infection).

12. In whom to implant a cardioverter-defibrillator? High-risk patients: Primary prevention: LVEF < 35% (ischemic) or considered for (non-ischemic) on optimal medical therapy. Secondary prevention: Reduce all-cause mortality risk. Annual risk of fatal arrhythmia: 4-5% (primary prevention) 10-20% (secondary prevention) DANISH trial: ICDs reduced sudden cardiac death in non-ischemic patients, but not overall mortality except in those under 70. Combined approach: Disease-modifying drugs and ICDs work together to reduce both all-cause mortality and sudden cardiac death.

13. How to implement implantable cardioverter-defibrillator therapy? Despite clear guidelines, ICDs are underused only 10% in Swedish registry especially for preventing sudden cardiac death (SCD) in HF patients. Reasons for low use: Physician inertia Misconception of low SCD risk in HF (especially younger patients) Skepticism due to mixed results in non-ischemic cardiomyopathy (DANISH trial) Nuances of DANISH trial: ICD reduced all-cause mortality in non-ischemic patients under 70. Overall, ICD reduced SCD.

14. Future directions: More precise patient selection using multiparametric risk scores (e.g., scar on cardiac MRI, gene mutations ). Prediction models (e.g., MADIT-ICD score, Seattle model ) for risk stratification and patient discussions. Improved multidisciplinary HF care and access to cardiology specialists. Shared decision-making: Consider patient's life expectancy and quality of life when deciding on ICD implantation.

15. Cardiac resynchronization therapy How does it work? Targets : HFrEF patients with prolonged QRS on ECG (electrical dyssynchrony ). Problem : Delayed left ventricle activation due to conduction issues, leading to inefficient heart contractions and worsening HF by structural,electrical and contractile remodelling Solution: CRT uses two leads (RV + LV) to resynchronize electrical activation, improving heart function.

16. Benefits: More effective heart contractions and relaxation Improved hemodynamics Can halt or reverse HF progression ( by addressing dyssynchrony ) Device options: CRT-P (pacing only) CRT-D (pacing + ICD function )

17. In whom to implant a cardiac resynchronization therapy device? Targets : HFrEF patients with:LVEF < 35%Sinus rhythm Wide QRS (>130ms) OR Left Bundle Branch Block (LBBB) Benefits: Reduced symptoms, hospitalizations, and mortality. Strongest benefit: LBBB or QRS > 150ms . Atrial Fibrillation (AF ): Less clear benefit, achieving rhythm control is crucial by ablation or Alternative by AV Block : CRT-P over RV pacing in some cases. NOT indicated: Patients with narrow QRS and mechanical dyssynchrony (increased mortality risk).

18. How to implement cardiac resynchronization therapy? Strong evidence supports CRT for specific HF patients, but only 1/3 receive it in Europe. Call to action: Increase referrals and optimize CRT care. Education needed: Primary care, secondary care physicians, nurses, and allied health professionals. Misconception: Don't focus solely on reverse remodeling (heart improvement). Success of CRT: Disease stabilization (LV function & clinical condition) is key. Best response measures : Reduced hospitalization, improved quality of life, and better survival.

19. Comorbidities shouldn't stop referrals: CRT works for many patients with other health conditions. Post-CRT care is crucial: Optimize medication and device settings through a multidisciplinary team. Expertise matters: Improper selection, placement, or optimization can negate benefits and pose risks. LV lead position is key for effective resynchronization.

20. Conduction system pacing How does it work? Conventional RV pacing: Stimulates right ventricle apex/septum. Can worsen desynchrony and reduce LVEF, especially in HF patients. Alternatives for more natural heart activation : His bundle pacing: Requires specific training and may not work for all patients. Needs backup RV lead due to potential capture loss. May have reduced battery life. Left bundle branch (LBB) pacing: Avoids limitations of His bundle pacing. Targets left bundle for more natural left ventricle activation. Narrower QRS complex compared to conventional RV pacing.

21. In whom to implant a conduction system pacing lead? Goal: More natural heart activation compared to conventional RV pacing. Techniques: His bundle pacing: Considered to prevent pacing-induced cardiomyopathy in some patients, but large studies are lacking. Left bundle branch (LBB) area pacing: Shows promise, but needs more RCTs Current limitations of both techniques: May not work for all patients with conduction problems. Large-scale data on safety, long-term benefits, and efficacy is missing. European guidelines: Only recommend considering His bundle pacing in some cases due to limited data on both techniques.

22. How to implement conduction system pacing? More data is needed: To move beyond using conduction pacing as a last resort (bail-out strategy). Physician training needed: If proven beneficial, widespread adoption will require proper training. Electrophysiological guidance: Often needed for conduction system pacing, but not always (LBB area pacing ). Implementation potential: Many pacemaker implantation centers could adopt it once clear guidelines are established.

23. Cardiac contractility modulation How does it work? Device: Similar to a pacemaker, implanted with 2 leads in the right ventricle septum. Function: Delivers non-excitatory high voltage electrical pulses [+/- 7.5V,long duration 20 ms,biphasic stimulation during ARP within 30 ms after QRS]to improve calcium handling in heart muscle cells. Benefits:Increased contractility (pumping strength) without affecting oxygen use. Potential for cellular improvements in calcium handling and gene regulation. Current limitations:Only one device (OPTIMIZER) available, requiring weekly battery recharge.

24. In whom to implant cardiac contractility modulation? Cardiac contractility modulation improved the quality of life and exercise capacity in symptomatic patients in sinus rhythm with LVEF <45% and QRS <130 ms in three open-label randomized trials, but the effect was rather small. There are no blinded, sham-controlled trials limiting the robustness of the data to influence guidelines. However, the AIM HIGHer clinical trial is a prospective , multicentre , randomized, quadruple-blind, sham-controlled, trial in subjects with HF and an LVEF >40% and <60% (NCT05064709).

25. How to implement cardiac contractility modulation? Further evidence is needed to guide the role of CCM in routine practice, but in general CCM is only advised in selected patients by experienced operators working within a multidisciplinary HF service capable of follow-up and trouble shooting.

26. Telemonitoring Telemonitoring via implantable cardiac rhythm management devices How does it work? All current cardiac implantable electronic devices (CIED) can be connected with a wireless telemonitoring system that enables follow-up of device and lead functioning and monitors arrhythmias. Different manufacturers also provide additional data such as thoracic impedance and patient activity or multiparametric integrated monitor systems aimed at early detection of worsening HF.

27. In whom to use cardiac implantable electronic device telemonitoring? Studies on Early Detection of Heart Failure (HF) Decompensation: DOT-HF (Implantable Impedance Monitoring): No improvement in mortality/hospitalizations. Increased HF hospitalizations and outpatient visits. Audible alerts may be counterproductive. IN-TIME (Multiparameter Telemonitoring): Improved clinical outcomes (mortality, hospital admissions, symptoms) Automatic, daily monitoring with ICD/CRT-D devices.

28. Early Detection of Heart Failure (HF) Decompensation: Mixed Results REM-HF (remote monitoring): trends in measured parameters, No improvement , may differ due to monitoring specifics (parameters, frequency, actions taken). Uncertainties: Need for more research to clarify the best approach for early detection of HF decompensation.

29. How to implement cardiac implantable electronic device telemonitoring? Remote Monitoring for Heart Failure (HF): Guidelines and Considerations Goals: Reduce in-person visits, early detection of problems in high-risk patients. Guidelines advocate for remote monitoring, but: Both patient and underlying heart disease need attention. Structured remote monitoring unit with defined roles for staff is crucial. More evidence from RCTs needed: To confirm monitoring HF status beyond device/arrhythmias.

30. Remote pulmonary artery pressure monitoring How does it work? Device: Small, implantable sensor for monitoring pulmonary artery pressure (PAP). Implantation: Percutaneous procedure via femoral or jugular vein. Device in tip of delivery catheter in to branch PA released by self expandable side anchors Function: Powered by external source (no battery). Estimates PAP through resonance frequency. Real-time PAP wave monitoring. Benefits: Early detection of congestion before symptoms. Remote monitoring by healthcare providers.

31. In whom to use remote pulmonary artery pressure monitoring? Remote Pulmonary Artery Pressure Monitoring for Heart Failure (HF): Clinical Trials CardioMEMS System (Abbott): CHAMPION trial: Reduced hospitalizations by 28% in high-risk HF patients (NYHA III) after 6 months, effect lasted up to 18 months. GUIDE-HF trial: No overall mortality in class ii-iv/HF event reduction, but positive trend pre-pandemic. MONITOR-HF trial: Improved quality of life and reduced hospitalizations by 44% in high-risk HF patients (NYHA III). Cordella Sensor ( Endotronix ): Reliable PAP data, user-friendly design. Guidelines: Consider PAP sensors for select HF patients regardless of ejection fraction.

32. How to implement remote pulmonary artery pressure monitoring? Patient selection is crucial: Target high-risk HF patients with potential for hospitalization reduction. Not ideal for very high-risk patients with limited treatment options (advanced disease, kidney dysfunction). Success relies on: Patient compliance with monitoring. Prompt response from HF care team to pressure changes. Clinical trials show promise: CardioMEMS system reduced hospitalizations in high-risk patients. Potential cost benefits observed in Europe. Optimizing treatment based on data: Current focus on mean pulmonary artery pressure (PAP) for guiding therapy (diuretics, neurohormonal blockers). Future may involve multi-metric analysis (trends over cutoffs) for personalized treatment strategies.

33. Devices aimed at cardiac reverse remodeling Mitral valve transcatheter therapies How does it work? Goal: Reduce mitral regurgitation (MR) using devices delivered through a vein. Devices: Mitraclip (Abbott) PASCAL (Edwards Lifesciences) More in development Procedure: Access via femoral vein. Grasps and clips posterior and anterior mitral valve leaflets together (creating double orifice). Reduces mitral valve opening, reducing MR. Guided by TEE (usually under general anesthesia). Considerations: Multiple devices may be needed. Avoid excessive reduction to prevent valve stenosis. Treats both primary and secondary MR.

34. More Minimally Invasive Mitral Valve Repair Techniques for Heart Failure (HF) Beyond TEER: Other percutaneous approaches to reduce mitral regurgitation (MR). Carillon device: Inserted via coronary sinus. Squeezes the mitral valve annulus indirectly to reduce MR and left ventricle size.Externally clinches posterior MV annulus Effective even in patients unsuitable for TEER due to enlarged left ventricle. Cardioband Mitral System (no longer marketed): Not commercially available anymore. Used a ring system to directly tighten the mitral valve annulus from the atrial side of posterior annulus.

35. In Whom to use MV transcatheter mitral valve therapies?

36. Minimally Invasive Mitral Valve Repair (TEER) for Heart Failure (HF): Mixed Results TEER with MitraClip : Studied for treating severe secondary mitral regurgitation (MR) in HF patients. MITRA-FR trial: 304 symptomatic patients. Inconclusive - No overall benefit observed. COAPT trial: 614 symptomatic HF patients. Successful - 47% Reduced hospitalizations, improved outcomes for patients meeting specific criteria. Reasons for difference: Patient selection, additional medical and device therapies, evaluation methods. TEER with MitraClip : Consider for HF patients meeting COAPT criteria MRO >30mm, EF 20-50%. LVEDD </=70mm Other approaches: Consider TEER or Carillon device for patients outside COAPT criteria, based on local expertise and comorbidities. Ongoing Trials: RESHAPE-HF2, MATTERHORN results Needed to clarify broader use of TEER for HF.

37. How to implement mitral valve transcatheter therapies? Treating Secondary Mitral Regurgitation (MR) in Heart Failure (HF): A Step-by-Step Approach Before considering minimally invasive mitral valve repair (TEER ): Optimize medical and device therapy: Address fluid buildup and high pressure (diuretics). Maximize tolerated medications (neurohormonal blockers). Consider cardiac resynchronization therapy (CRT) for appropriate patients (improves valve function). Heart Team evaluation: Discuss options including surgery, revascularization, and advanced therapies (LVAD, transplant).

38. Who may benefit from TEER with MitraClip (based on COAPT trial): Symptomatic HF Moderate-severe secondary MR LVEF 20-50% LV size limit Not a candidate for mitral valve surgery TEER with MitraClip : Ongoing research for broader use in HF patients. Alternative approaches for some patients: TEER or Carillon device (depending on expertise and health). Overall: A multi-step approach is crucial for optimal outcomes in HF patients with secondary MR.

39. Tricuspid valve transcatheter therapies Tricuspid Valve Repair (TEER) for Heart Failure (HF) Similar to mitral valve TEER, but for tricuspid valve. Tricuspid valve has 3 leaflets, so multiple strategies exist for device placement: Anteroseptal (2 leaflets) or anteroseptal+posteroseptal (3 leaflets) approaches. Devices: TriClip (Abbott) and PASCAL (Edwards Lifesciences) are available. Procedure: Access via femoral vein. Grasps and clips leaflets together using a catheter. May require multiple devices. Guided by fluoroscopy and echocardiography. Other techniques in development: Annuloplasty, valve replacement, bicaval valves.

40. In whom to use tricuspid valve transcatheter therapies? Severe tricuspid regurgitation (TR) worsens survival in HF. Surgery for TR is risky , so minimally invasive TEER is gaining interest. Limited data but promising results: TEER ( TriClip , PASCAL devices) reduces TR and improves quality of life/exercise capacity in small studies . TEER may improve outcomes compared to medical therapy alone (registry study). TRILUMINATE Pivotal trial : TEER safe, reduces TR, improves quality of life.

41. How to implement tricuspid valve transcatheter therapies? Before guideline recommendations can be made on how to implement tricuspid valve TEER or other percutaneous techniques in HF patients, ou prospective data on relevant 0utcomes from randomized controlled trials with long follow-up are needed . These trials would also need to report on clinical outcomes in HF patients specifically. Importantly, surgical tricuspid repair of isolated severe TR has also not been associated with improved survival compared with medical therapy. Therefore, medical therapy currently remains the cornerstone of treatment, primarily consisting of diuretic therapy to treat volume overload and treatment of any underlying LV disease or pulmonary hypertension.

42. DEVICES AIMED TO DIRECTLY IMPROVE HAEMODYNAMICS

43. Short-term mechanical circulatory support How does it work? Short-term MCS devices are designed to temporarily unload the failing ventricle and/or to increase cardiac output. Current available devices include the intra-aortic balloon pump (IABP) Impella ( Abiomed , Danvers, MA, USA), TandemHeart ( LivaNova , London, UK), IVAC 2L (Pulse Cath BV, Amsterdam, The Netherlands) and veno arterial extracorporeal membrane oxygenation (VA-ECMO ). An overview of the device characteristics is provided in Table 1. Two main types of pumps for heart failure (HF): Intra-aortic balloon pump (IABP): Inserted via groin artery. Inflates during diastole (heart relaxes) to improve coronary blood flow. Deflates during systole (heart contracts) to reduce workload. Offers temporary support. Impella device: Inserted via groin or surgically. Continuously pumps blood from left ventricle to aorta. Reduces workload and increases blood flow. Offers varying levels of support, some sufficient for full heart replacement.

44. Table 1. Comparison of temporary mechanical circulatory support devices Device IABP Impella TandemHeart IVAC 2L VA-ECMO Pump system Pulsatile Continuous, axial flow Continuous, centrifugal Pulsatile Continuous, centrifugal Catheter size (Fr) 7–8 12–22 12–21 17 18–29 Access site Femoral artery Femoral artery Arterial: 15–19 <br> Venous: 17–21 Femoral artery Arterial: 15–21 <br> Venous: 17–21 Fluoroscopic guiding Yes Yes Yes <br> Arterial: femoral vein Yes No Location pump system Thoracic aorta Transvalvular aortic valve Extracorporeal Extracorporeal Extracorporeal Inflow driver – Left ventricle Left atrium Left ventricle Right atrium Inflow Descending aorta Ascending aorta Left atrium Ascending aorta Descending aorta Outflow driver – – Iliac and afterload <br> 2.5–1 L/min – – Outflow – Ascending aorta Iliac and afterload Ascending aorta Descending aorta LV cardiac index output 1.5–1 L/min 1–6 L/min <br> 1 preload 2 L/min 1–2 L/min 7 L/min Increase cardiac output 5–10% 11–20% 11–20% 11–20% 11–20% Availability time weeks 5–30 days^1,2 30 days³ 24 h Weeks Maximal duration – 5–30 days^1,2 30 days³ – Weeks Implantation complexity – 5–10 s for extracorporeal oxygenation insertion (Impella 5.0 and 5.5), <br> 15 s for intra-balloon pump (IABP) 10–20 s for extracorporeal oxygenation insertion – – IABP: intra-aortic balloon pump; ECMO: venoarterial extracorporeal membrane oxygenation. ³  TandemHeart requires 1–2 h for placement and cannulation in an operating room.

45. Heart Pumps for Heart Failure Two main pump types: Impella : Improves blood flow by unloading the left ventricle. TandemHeart : Reduces pressure in the left atrium (preload). Increases pressure in the aorta (afterload) but improves blood flow to organs. Can add oxygen to the blood (extracorporeal oxygenation). Both: Reduce stress on the heart muscle. Can be inserted via groin artery (percutaneous).

46. Heart Pumps for Heart Failure (Short Version) Three additional pump options: iVAC 2L (new): Pulsatile flow, reduces pressure on both sides of the heart ventricle and modestly increases blood flow. VA-ECMO: Provides full blood flow support and oxygenation (for both ventricles). Inflow cannula: Right atrium. Outflow cannula: Descending aorta.

47. Two main ECMO cannula insertion sites: Peripheral (groin) - most common Central (chest surgery) - less common Peripheral VA-ECMO cannulas: Venous: Placed in femoral vein, reaches right atrium (blood in). Arterial: Placed in femoral artery (blood out). Additional small cannula may be needed to prevent leg ischemia (circulation issues). VA-ECMO blood flow: Supports both ventricles (unlike other devices). Increases blood flow to organs, reduces left ventricle workload. May increase left ventricle afterload due to blood flow direction.

48. Monitoring and potential adjustments for VA-ECMO: Close monitoring of ventricle emptying with echocardiography. LV unloading strategies may be needed to prevent complications: Medications to improve emptying. Additional heart support devices. Creation of openings in the heart.

49. Right Ventricle (RV) Support Devices for Heart Failure Limited experience with dedicated RV support devices. Two main types: Impella RP: Inserted via groin, pumps blood from right atrium to pulmonary artery. Protek Duo: Single catheter inserted via neck vein, achieves similar blood flow as Impella RP. Both require careful monitoring and may need additional support in some cases. VA-ECMO: More widely used for both LV and RV failure, bypasses both ventricles.

50. All short-term MCS devices require anticoagulation (mostly done with unfractionated heparin), exposing the patient to an increased bleeding risk. In the setting of acute coronary syndromes and dual antiplatelet therapy, clopidogrel is the preferred P2Y12 inhibitor because of the lower bleeding risk than ticagrelor and prasugrel, Access site complications, limb ischaemia , haemolysis and thromboembolic complications are persistent risks despite anticoagulation.

51. Who Needs Short-Term Heart Pump Support (for Heart Failure)? Main use: Support patients in cardiogenic shock while awaiting recovery or long-term solutions (transplant, long-term pump). Other uses: High-risk percutaneous coronary interventions. High-risk myocardial infarction without shock. Limited evidence for many devices: Ongoing research needed. Intra-aortic balloon pump (IABP): Not routinely recommended for cardiogenic shock. Impella / TandemHeart : May improve heart function but don't improve short-term survival in some cases (myocardial infarction with shock). ECMO: May offer better short-term survival than IABP in some studies (myocardial infarction with shock). iVAC 2L: No clear data on outcomes. Data lacking: Use in cardiogenic shock outside myocardial infarction. Not for everyone: Consider patient's specific condition ( e.g.mechanical , aortic valve and severe AR )

52. Implementing Short-Term Heart Pump Support (for Heart Failure): Key Points Limited data and experience: Best approach varies depending on expertise. Cardiogenic shock patients: Need care in specialized centers with shock teams. Shock teams include intensivists, cardiologists, heart failure specialists, and surgeons. Early referral to such centers is crucial for better outcomes. Decision to use short-term pumps: Requires careful consideration of patient's potential for recovery or long-term solutions. Not suitable for all patients (depends on specific condition). Referral pathways: Develop systems for transferring patients from smaller hospitals to specialized centers 24/7.

53. Long-term mechanical circulatory support Long-Term Heart Pumps for Heart Failure (LVADs) Main type: Left ventricular assist devices (LVADs) surgically implanted to support the left ventricle. Current devices: HeartMate II (Abbott) - continuous flow, implanted in abdominal pocket. HeartMate 3 (Abbott) - continuous flow with pulsatility , fully intrapericardial. HVAD (Medtronic) - removed from market due to safety concerns. All LVADs feature: Inflow cannula in left ventricle. Outflow cannula in ascending aorta. Adjustable pump speed for optimal blood flow. Driveline for connection to external controller and power source.

54. Benefits: Unloads left ventricle. Increases blood flow. Complications (HeartMate 3 example): Bleeding (0.71 events per year). Driveline infection (0.21 events per year). Stroke (0.07 events per year). Pump thrombosis risk very low (0.01 events per year). For biventricular heart failure: Biventricular assist devices ( BiVADs ) and total artificial hearts are available.

55. Advanced Heart Pumps for Heart Failure (Short Version) BiVAD (biventricular assist device): Two pumps support both ventricles (bridge to transplant for very selected cases only). Right pump: Inflow from right atrium, outflow to pulmonary artery. Uses same pump technology as LVADs. Total artificial heart: Replaces entire heart (bridge to transplant for very selected cases only). Requires similar external equipment as LVADs. Both BiVAD and total artificial heart: High complication rates. Limited improvement in quality of life (based on observations).

56. Who Gets Long-Term Heart Pumps (LVADs) for Heart Failure? LVADs have expanded uses beyond initial bridge-to-transplant: Originally for very advanced heart failure patients awaiting transplant. Now used for various purposes: Bridge to transplant (waiting for heart transplant). Bridge to recovery (hoping for heart improvement). Bridge to decision (uncertain about transplant eligibility). Most common use: Destination therapy (not eligible for transplant). LVADs are not for everyone: Not suitable for patients with severe right ventricle failure (LVADs only support left ventricle). May require additional procedures for patients with: Significant aortic regurgitation (valve repair or closure). Mechanical aortic valves (replacement or exclusion). Careful patient selection is crucial for LVAD therapy.

57. How to implement long-term mechanical circulatory support? Despite the survival benefits of LVADs in advanced HF patients , only a minority of eligible patients ultimately receive an LVAD. Financial constraints, the need for referral, and under appreciation of the prognostic and quality of life benefits might be some important reasons for the low uptake of LVADs in clinical practice.

58. Table 2 : Patients for whom implantation of a left ventricular assist device is advised HF heart failure; i.v. , intravenous: LVAD, left ventricular assist device: LVEF. left ventricular ejection fraction: MCS, mechanical circulatory support; PCWP. pulmonary capillary wedge pressure: SBP, systolic blood pressure; TR, tricuspid regurgitation; VOy , oxygen consumption. Patients with persistence of severe symptoms despite optimal medical and device therapy, without severe right ventricular dysfunction and/or severe TR, with a stable psychosocial background and absence of major contraindications", and who have at least one of the following: LVEF <25% and unable to exercise for HF or, if able to perform cardiopulmonary exercise testing, with peakVO2 <12 ml/kg/min and/or <50% predicted value. > 3 HF hospitalizations in previous 12 months without an obvious precipitating cause. Dependence on i.v. inotropic therapy or temporary MCS. Progressive end-organ dysfunction (worsening renal and/ hepatic function, type Il pulmonary hypertension, cardiac cachexia ) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP 220 mmHg and SBP ≤90 mmHg or cardiac index ≤2 L/min/m*).

59. Who Qualifies for Long-Term Heart Pumps (LVADs) for Heart Failure? Not everyone qualifies for an LVAD. Here's a summary: Suitable candidates: Strong social support system (caregiver needed at home). Understand the technology involved. Not suitable candidates: Unable to take long-term blood thinners. Have severe kidney problems. Have frequent irregular heartbeats. Ideal timing: Before going into shock for better survival rates. May be considered in severe cases even after shock with ongoing symptoms. Awareness and earlier referrals are crucial for better patient outcomes.

60. Improving Long-Term Heart Pump (LVAD) Care for Heart Failure Multidisciplinary team approach: Heart Team at specialized centers decides LVAD candidacy considering: Patient's wishes Heart condition Other medical conditions Social support Comprehensive follow-up: Includes specialists from various fields for optimal care. Challenges: Regulations and reimbursement limit LVAD use in some European countries. Need for more data: European outcome data can support wider LVAD use.

61. Other device therapies Regulatory issues on device therapy and selected device therapies like interatrial shunt devices , non-implantable devices for telemonitoring, to treat hypertension, sleep apnea , and renal dysfunction as well as some devices for autonomic modulation are discussed in the online Supporting Information. While some of them are already mentioned in the guidelines, many are still under investigation.

62. Integration of implantable device therapies in heart failure care

63. New Approach to Heart Failure (HF) Treatment: Early Integration of Devices Current practice: Focus on optimizing medications before considering devices. Potential downside: Delays in device therapy may reduce its effectiveness. New approach: Evaluate patients for potential device therapy at diagnosis. Benefits: Creates a clear treatment plan with both medications and devices. Allows for devices and medications to work together more effectively. Enables starting both therapies simultaneously when appropriate. Treatment plan should be: Tailored to the patient's specific condition (phenotype). Flexible and updated as the patient's condition changes. Doctor's role: Be aware of both medication and device options for HF patients.

64. Multidisciplinary Team for Heart Failure Device Therapy Crucial for discussing and implementing device therapy for heart failure (HF). Team composition varies by device type, but always includes: Heart failure (HF) specialist HF nurse Other potential team members: Imaging specialists Interventional cardiologists Cardiac intensivists Cardiac surgeons Nephrologists Psychologists Physiotherapists Nutritionists Primary care physicians Importance of well-trained HF specialists is emphasized for optimal patient care.

65. Multidisciplinary Heart Failure Care with Devices: Key Takeaways Teamwork is key: Heart failure (HF) device therapy requires a multidisciplinary team for best results. This team should include specialists based on the specific device but always involves HF specialists and nurses. Patient involvement: Shared decision-making is crucial. Patients empowered about device therapy can participate more actively in their care. Raising awareness: All levels of healthcare providers and patients need better education on device therapy options for HF. Early referral: Early referral (or guidance) from primary care to specialized centers is essential to avoid delays in care. Hospital networks should facilitate this process. Integrated follow-up: Trained providers working together in a multidisciplinary HF program (led by HF specialists) ensure proper device follow-up. Support networks should be available for all team members.

66. Role of heart failure nurses and other allied professionals in device care Nurses and Allied Professionals in Heart Failure (HF) Device Management Play a vital role in everyday device management for HF patients. Specific team members depend on the device type and available resources. Specialized HF nurses are key throughout the process: Understand various devices, their functions, and potential risks. Help screen patients for device eligibility within the multidisciplinary team. Educate patients and families about device implantation, function, and risks. Help patients adjust to life with a device, manage expectations, and make informed decisions.

67. Nurses and Heart Failure (HF) Devices: Key Roles Monitoring and education: After device implant, HF nurses: Monitor device function and side effects. Help patients understand alarms, restrictions, and device impact on daily life (sex, exercise, etc.). Educate on managing expectations and optimizing quality of life. Long-term support: As a patient's HF progresses, the nurse may: Reassess device needs. Advise on long-term device care. Discuss telemonitoring and deactivation options. Help with end-of-life planning related to the device.

68. In addition, allied professionals and healthcare scientists can have an important role as part of the HF multidisciplinary team, although these professions currently only exist in a small number of Euro-pean countries. Some healthcare systems allow for pharmacist-led HF clinics that provide opportunities to screen for device eligibility, optimize medical therapies and provide patient information

69. Cardiac device technicians can have an important role in device optimization including recognizing patients who require escalation of care. HF nurses, allied professionals and healthcare scientists involved in the management of HF should have the appropriate level of training and competence to improve patient care and appropriate access to HF therapies.

70. Conclusion An increasing number of medical devices have been added to the HF management armamentarium. Some of these are supported by robust clinical evidence, while others are currently undergoing testing in clinical trials. Devices and drugs work synergistically but due to intrinsic risks associated with the procedure and permanence of implantation, a device 'prescription' requires careful and well-documented multidisciplinary decision-making and a coordinated follow-up process embedded into a combined HF-device care programme .

71. Thank You !