2024 HFSA科学声明：心力衰竭的器械治疗（更新版）

其他心血管内科· 心力衰竭 · 2024

Authors

Abstract

In the DAPA-HF (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure) trial, 4744 patients with HFrEF were enrolled in the outpatient setting, and approximately 70% had New York Heart Association (NYHA) class II symptoms. 6 Patients with an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m 2 were excluded. Importantly, these patients were exceptionally well treated at baseline, with 94% of patients taking an ACEi/ARB/ARNI, 96% taking a betablocker and 71% taking an MRA. Also, patients were receiving protocol-driven follow-up in a clinical trial setting. Despite having characteristics of being very well managed, the annualized event rate for HF hospitalization or cardiovascular death for patients in the dapagliflozin arm was 11.6 per 100 person-years. The EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction) trial had a patient population similar to that of DAPA-HF, including baseline medical therapy, yet allowed modestly higher natriuretic peptide levels and lower kidney function enrollment criteria of eGFR 20 mL/min/1.73m. 7 These modest changes were associated with an incidence of cardiovascular mortality or hospitalization for HF that was about » 40% higher, with an annualized event rate of 15.8 per 100 person-years in the empagliflozin group.

Based on contemporary medication-management data, and despite the availability of newer drug therapies for HF, there is a need for further innovation in treatment. The residual risk for patients receiving optimized GDMT remains on par with or worse than other major cardiovascular diseases. Even the "lower-risk" subsets of patients with HF have adverse event rates higher than thresholds referenced as being high or very high risk for cholesterol guidelines for the management of atherosclerotic cardiovascular disease, as an example. 3 Importantly, it should be noted that the use of evidence-based GDMT is lower in patients with higher-risk HF, in part due to higher rates of absolute or relative contraindications (such as renal disease) and/or intolerance for GDMT in patients with advanced HF symptoms. 8 Currently, several therapies either are contraindicated or have little to no randomized data in populations with eGFR < 30 mL/min/1.73 m 2 .

Role of Device Therapies in Bridging Current Gaps in Chronic HF

Alongside pharmacological treatment and prevention of HF, a number of device-based therapies have emerged to show efficacy. These range from implantable defibrillators for the prevention of sudden cardiac death, to pulmonary artery sensor monitors to reduce HF hospitalizations, to more structural interventions, such as transcatheter edge-to-edge repair devices and durable left ventricular assist devices and beyond. 9 linical trial designs that compare device-based therapies to pharmacological therapy alone have contributed to biases in choosing 1 therapeutic approach vs another, when, in fact, integrated strategies incorporating a combination of pharmacological and devicebased therapies often allow for tailored optimal treatment of HF. Broadly, device-based therapies may be divided into 7 categories, summarized in Table 1 .

Timing, Screening, and Referral Process for Novel Device-Based Therapies and the Role of the Heart Team Despite the growing evidence of success of novel devicebased therapies in the management of HF, evidencebased, standardized approaches to their implementation (akin to GDMT) are lacking, resulting in their delayed use or under use.

We propose the following pathway to implement the FDA approved novel device-based therapies in the workflow of HF management (Fig. 1 ):

1. Following a diagnosis of HF, special attention should be paid to appropriate characterization and classification, with timely initiation and up-titration of relevant GDMT. In addition, identification of the etiology of HF (eg, coronary artery disease, hypertension, valvular heart disease, arrhythmia, left bundle branch block) and proper management of these etiologies should be considered (eg, revascularization, ambulatory blood pressure monitoring). Also, those who meet the guideline criteria for CRT should be referred for CRT implantation. Depending on the severity of disease, risk profile and setting (hospitalized vs at home), patients may be seen by a general cardiologist, cardiology practitioner or advanced HF specialist. 2. At follow-up visits, providers should aim to evaluate symptoms burden, functional status (eg, NYHA class hospitalizations for HF, associated structural abnormalities, and the response to GDMT and its tolerability. The persistence of NYHA class II or above symptoms following 3À6 months after initiation of pharmacological GDMT and CRT (where applicable) should result in consideration of device-based therapies for HF.

Further, progressive disease, such as low blood pressure, escalating diuretics, need for inotropes, endorgan dysfunction, defibrillator shock, recurrent HF hospitalizations, imaging features suggestive of worsening disease (eg, worsening LV dilation, LA dilation, MR, or TR), and worsening biochemical markers (eg, NT-proBNP) should lead to a referral to an advanced HF specialist for consideration of advanced HF therapies, such as LVAD and heart transplantation. 10 tegral to the evaluation for device-based therapies is the identification of the ideal patient population for each therapy, so as to improve the benefit-risk ratio of these therapies. The currently approved and investigational device-based therapies for HF generally target similar and broad patient populations, and as more device-based therapies are approved, more patients may be eligible for more than 1 device-based therapy (Fig. 2 ). The potential eligibility for multiple device-based therapies in 1 patient underscores the need for dedicated studies to examine the comparable and additive effects of device-based therapies as well as possible multidevice interactions. It is important to better understand multidevice interactions, because pathophysiological pathways may be altered in different ways, even though patients share common etiologies of HF and/or pathophysiological features. Developing tools to assess pathophysiological interactions may improve patient selection for various device-based therapies (eg, patients with greater degrees of baroreflex dysfunction may experience more benefits from BAT compared with other patients who have lesser degrees of baroreflex dysfunction). In addition, given that 1 patient may be a candidate for more than 1 device therapy, fiscal responsibility needs to be addressed. Based on recent evidence, invasive hemodynamic phenotyping may be needed to identify those who would benefit from certain device-based therapies and to exclude those who may experience harm. 11 These observations highlight the importance of early clinical, hemodynamic, structural, proteomic, and radiomics phenotyping to better direct the delivery of HF therapies.

Heart failure (HF) is 1 of the major challenges of our time, given its increase in prevalence and related mortality rates. Foundational pharmacological therapies, including angiotensin receptor neprilysin inhibitors (ARNIs), beta-blockers, mineralocorticoid receptor antagonists (MRAs), and sodium-glucose co-transporter inhibitors (SGLTis), have been established for HF with reduced ejection fraction (HFrEF). Moreover, recent trials have established the role of SGLTis in patients with HF with preserved ejection fraction (HFpEF). However, even with these therapies, a substantial residual risk persists in both HFrEF and HFpEF. Alongside pharmacological advancements, device-based therapies have shown efficacy in HF management, including implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT). More recently, devices such as cardiac contractility modulation (CCM) and baroreflex activation therapy (BAT) have been approved by the FDA, although they lack comprehensive guideline recommendations. This scientific statement outlines the unmet needs in chronic HF, reviews contemporary data and provides a framework for integrating novel device-based therapies into current clinical workflows. It emphasizes the importance of early diagnosis and phenotyping, proper patient stratification and a personalized approach to combining pharmacological and device therapies. The document also highlights the need for further research into device interactions and patient selection to optimize outcomes, while recognizing the need for a more integrated approach to treatment so as to address the unmet needs and residual risks in HF management. (J Cardiac Fail 2024;00:1À17) Despite recent advancements, heart failure (HF) remains common and is associated with significant adverse events, impaired quality of life and mortality. 1 New drugs and devices have been developed for the the management of HF. Currently 4 drugs are considered foundational medicines for patients with HF and reduced ejection fraction (HFrEF), including angiotensin receptor neprilysin inhibitors (ARNIs), beta-blockers, mineralocorticoid receptor antagonists (MRAs), and sodium glucose co-transporter inhibitors (SGLTis). Similarly, recommendations for the use of established devices, including implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are well established. 2 Other, more recently approved devices by the Food and Drug Administration (FDA), such as cardiac contractility modulation (CCM) and baroreflex activation therapy (BAT), lack society-based use recommendations. This consensus document defines the unmet need in chronic HF and the role of novel device From the

therapies in bridging current HF gaps, provides categories of HF device therapy and reviews contemporary outcome data and guideline recommendations of selected FDA-approved devices (CCM, BAT, valve interventions with transcatheter aortic valve replacement, mitral valve edge-to-edge repair, tricuspid repair, CardioMEMS pulmonary artery pressure monitoring, and HeartMate [HM] 3 left ventricular assist device [LVAD] ). In addition, we propose a clinical pathway to implement FDA-approved device-based therapies that align with current HF management workflow and define device HF technology under current clinical investigation. Established device therapies, such as CRT and ICD, are not discussed in this consensus document, because the recommendations related to the indications and timing of implantation of these devices are well described in contemporary HF guidelines.

Unmet Need and Residual Risk an Chronic Heart Failure

Guideline-directed medical therapy (GDMT) with the use of ARNI/ACE inhibition/ARB, beta blockers, MRAs, and SGLTis can reduce the relative risk of cardiovascular death risk by almost 75% and translate into an absolute risk reduction of approximately 25% with treatment over 2 years. These data translate into a number needed-totreat of only 4 for patients with HFrEF. 3 Moreover, after decades without new successful therapies, 2 recent trials with SGLTis have been shown to reduce the risk of hospitalization due to HF and, to a lesser degree, cardiovascular death in patients with HF and mildly reduced EF (HFmrEF) and HF with preserved EF (HFpEF). 4, 5 In parallel, there have been advances with device-based therapies for HFrEF as well, including ICDs and CRT in indicated patients.

It is important to note upfront that the M in GDMT accounts for drug-and device-based therapies, and both classes of therapy are to be considered synergistic rather than in competition with each other. Although implementation efforts for existing GDMT are important, many patients are unable to tolerate some drugs, rendering them at higher risk. Even if medication therapies were provided, unacceptably high residual risks remain, underscoring the need for ongoing research, including the development of novel devicebased therapies.

Sympatho-vagal imbalance is well known to predict adverse prognoses and symptoms in HFrEF. Baroreflex activation therapy (BAT) is delivered by a pacemaker-like device (Barostim Neo System, CVRx, Minneapolis, MN) that generates electrical stimulation of the carotid sinus with the intent of limiting sympathetic nervous system activation and enhancing parasympathetic nervous system effects. The system consists of an infraclavicular, subcutaneously implanted pulse generator connected to a 2 mm electrode placed on the carotid sinus that stimulates the baroreceptors, creating a signal that dampens sympathetic activity and boosts parasympathetic activity (Fig. 3, B ). 23À25 The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial. Subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group). 26 Four patient cohorts were created from 408 randomized patients with HFrEF by using the following enrollment criteria: current NYHA functional class III or II with a recent history of class III; EF 35%; stable medical management for 4 weeks; and no class I indication for CRT. 26 e intended-use population (1 of the 4 patient cohorts) that reflected the U.S. FDA-approved instructions for use (enrollment criteria plus NT-proBNP < 1600 pg/mL) consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT proved to be safe, with a major adverse neurological or cardiovascular system or procedure-related free event rate of 97% (95% CI: 93%À100%; P < 0.001). In the BAT group vs the control group, QOL score using MLWHFQ improved (D = À14.1; 95% confidence interval [CI]: -19 to -9; P < 0.001), 6MHW distance increased (D = 60 m; 95% CI: 40À80 m; P < 0.001), NT-proBNP levels decreased (D = -25%; 95% CI: -38% to -9%; P = 0.004). 26 sed on the BeAT-HF study, the FDA granted premarket approval in 2019 to the Barostim Neo activation therapy to improve symptoms of HF, QOL, 6-minute hall walk, and functional status for patients who remain symptomatic (NYHA class III or II with recent histories of NYHA class III) despite GDMT and have an LVEF 35% with NT-proBNP < 1600 pg/mL and excluding patients indicated for CRT. This was the first FDA-approved neuromodulation technology for HFrEF, and the FDA required the manufacturer to continue the randomized BeAT-HF study to examine mortality and HF hospitalization rates after BeAT-HF. The results of the extended BeAT-HF were recently presented at the Technology and Heart Failure Therapeutics 2023 meeting, which showed no statistical difference in the primary endpoint (ie, composite of cardiovascular mortality and HF morbidity) between the 2 groups (relative risk: 0.94 [95% CI: 0.57À1.57]; P = 0.82) or in the individual components of the primary endpoint. 27 In a prespecified win ratio analysis using a hierarchical composite of cardiovascular mortality, LVAD/heart transplant, HF hospitalizations, and quality of life using MLWHF, the results were in favor of BAT (win ratio: 1.26 [95% CI: 1.02À1.58]; P = 0.04). 27 An additional analysis was performed by Coates et al., who performed an individual patient data meta-analysis on the 2 trials that randomized 545 HFrEF patients to BAT and GDMT or GDMT alone (open label). 28 n all patients, BAT provided a significant improvement in the 6-minute walk distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QOL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving by at least 1 NYHA class (95% CI 2.3, 4.9) when compared to baseline and 6month metrics.

A specific recommendation regarding BAT use for HF is not addressed in the 2022 AHA/ACC/HFSA guidelines. 2 In the 2021 ESC guidelines for the diagnosis and treatment of HF, the following was stated: "Technologies that involve modification of the activity of the autonomic nervous system, e.g. baroreflex activation therapy, have also been shown to offer a modest improvement in effort capacity and QOL. However, currently, the evidence is considered insufficient to support specific guideline recommendations for a reduction in mortality or hospitalization for these and a variety of other implantable electrical therapeutic technologies." 22 additional effort to enhance the adoption of BAT is based on the use of a novel and less invasive interventional implantation technique than the standard surgical carotid sinus approach. This minimally invasive technique using a BAT wire Implant Kit and ultrasound guidance to place the stimulation lead near the carotid baroreceptors is currently under investigation (NCT04600791), with enrollment planned in 100 subjects at up to 35 U.S. sites.

Valve Device Interventions for the Treatment of HF

In patients with HF and valvular heart disease, it is recommended (class 1) that management be directed by a multidisciplinary team in accordance with clinical practice guidelines to prevent worsening of HF and adverse clinical outcomes. 2, 29 In patients with valvular heart disease, HF is multifactorial, HF-related events are prevalent, and morbidity and mortality can be significantly improved by valve interventions. 30

Devices to Treat Aortic Stenosis

In patients with aortic stenosis (AS) and HFrEF, a surgical risk assessment guides team decision making on surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Anatomy of the valve is the most important determinant in decision making, along with lifetime management of aortic stenosis. Although surgical risk can be defined as low, intermediate-to-high or prohibitive, TAVR can be considered across all risk profiles in anatomically appropriate candidates. 30, 31 There are 3 valves that are currently approved by the FDA for TAVR: the EvolutFX TAVR system (Medtronic, Minneapolis, MN), which is supra-annular and self-expandable, and Sapien S3 Ultra valve system (Edwards Lifesciences, Irvine, CA), which is a balloon-expandable transcatheter heart valve, and Navitor valve (Abbott Industries, Abbott Park, IL), which is a self-expanding intra-annular device. All 3 device types have evolved; they are easier to use, have fewer complications and have favorable short-and long-term outcomes when compared with SAVR in randomized clinical trials.

There are very few randomized head-to-head trials that permit comparing device technologies, and despite inherent differences in expansion mode, stent frame and leaflet characteristics in the device types, clinical outcomes and, particularly, mortality rates have been considered comparable. There are no data to suggest a more favorable safety and effectiveness profile in a particular device type in patients with underlying HF.

In patients with HFrEF, moderate AS has been associated with a marked incremental risk of mortality. 32, 33 The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical randomized control trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal GDMT vs GDMT alone in patients with moderate AS. 34 In this study, moderate AS was defined by a mean transaortic gradient 20 mmHg and < 40 mmHg, and an aortic valve area > 1.0 cm 2 and 1.5 cm 2 at rest or after dobutamine stress echocardiography and reduced ejection fraction. The results are expected to be presented soon.

Transaortic Valve Intervention in Aortic Regurgitation

Severe aortic regurgitation (AR) associated with symptoms (stage D) or asymptomatic AR combined with a LVEF < 55% or undergoing another cardiac surgery is a class 1 recommendation for SAVR. 29 Transcatheter aortic valve implantation (TAVI) for isolated chronic AR is challenging for multiple reasons, including dilation of the aortic annulus and aortic root and lack of sufficient leaflet calcification. 35 Risks of TAVI for treatment of AR include transcatheter valve migration and significant paravalvular leak.

41 remains important to highlight that in patients with symptomatic severe primary MR, regardless of LV function, MV surgery is a class 1 indication, with MV repair recommended in preference to MV replacement when the anatomical cause of MR is degenerative disease, and if a successful and durable repair is possible. 29 mTEER with the MitraClip system (Abbott) was approved by the FDA for commercial use in patients with severe symptomatic, primary MR who are at prohibitive surgical risk; this is a Class 2a recommendation. 2 The ongoing PRIMARY (Percutaneous or Surgical Mitral Valve Repair) and REPAIR MR (Percutaneous Mitra-Clip Device or Surgical Mitral Valve REpair in Patients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery) clinical trials will be crucial in comparing the safety and effectiveness of mTEER to surgical mitral valve repair for treatment of primary MR with contemporary techniques and treatment strategies. 43

Devices to Treat Tricuspid Regurgitation

The TRISCEND II trial examined the safety and effectiveness of TTVR in the EVOQUE system based on the first 150 patients enrolled in the trial. While the rate of major adverse events was less than the expected rate (27.4% vs 43.8%), early findings showed TTVR with EVOQUE effectively eliminated TR in a vast majority of patients, despite more than 55% having massive or torrential TR and the remainder being categorized as severe. 46 The FDA approved this device as the first transcatheter tricuspid valve-replacement device based on results from the TRIS CEND II trial. In patients with severe TR, the device significantly improved TR grade and led to meaningful improvements in functional status and symptoms. The EVOQUE system received CE Mark in 2023 and FDA approval in 2024, making it the world's first transcatheter valve-replacement therapy to receive regulatory approval to treat TR. Careful decision making is key for patients being considered for TTVR, because it may have implications for future transvenous devices.

Valve guidelines focus largely on surgical TV interventions, given the paucity of data concerning transcatheter TV repair and/or replacement and that the 2 studies discussed above were completed only recently. The 2021 Valvular Heart Disease guidelines of the European Society of Cardiology give a 2b, level C recommendation for transcatheter treatment of severe symptomatic TR in inoperable patients. 31 Contemporary outcome observations will likely influence future guideline recommendations.

Remote Monitoring Devices in Heart Failure

It is well established that elevated cardiac ventricular filling pressures at rest and with changes over time are associated with the morbidity and mortality rates that define HF, regardless of underlying LVEF. 47À49 Examples of device technologies for remote monitoring of HF include devices to monitor weights and vital signs, multiparameter scoring of risk through implanted rhythm ICD and CRT devices, lung congestion based on dielectric sensing through vest devices, radiofrequency through adhesive patch technology, thoracic impedance through device leads, and direct measurement of cardiac pressures by left atrial and pulmonary artery (PA) sensors. 49 PA pressure monitoring is the device technology with the most robust evidence for monitoring patients with HF. 49, 50

CardioMEMS HF System

CardioMEMS (CardioMEMS HF System, Abbott, Sylmar, CA) is the most extensively studied system among remote monitoring devices to guide HF management and prognosis. 47À49 It is currently the only invasive HF remote monitoring sensor with FDA approval and CE mark. The CardioMEMS device is an implantable wireless sensor that is placed in the left lower lobe pulmonary artery (through a 12-Fr catheter-delivery system) and is capable of measuring pulmonary artery pressure. 47 There have been 3 RCTs testing the safety and efficacy of this system. 47, 49, 51 The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA functional class III patients with HF (CHAMPION) trial was an RCT conducted in 64 centers in the U.S. 47 Trial investigators found that hemodynamic-guided pharmacotherapy reduced HF hospitalization risk in outpatients (rate of HF related hospitalizations at 6 months: 0.32 vs 0.44; HR: 0.72; 95% CI 0.60À0.85; P < 0.01). 47 e randomized arm of the hemodynamic-guided management of Heart Failure (GUIDE-HF) trial was a multicenter, single-blind study at 118 centers in the U.S. and Canada. 51 Patients with NYHA functional class IIÀIV chronic HF, all ejection fractions, and either a recent hospitalization due to HF or elevated natriuretic peptide levels were randomly assigned (1:1) to either hemodynamicguided HF management or a usual-care control group. The primary endpoint was a composite of all-cause mortality and total HF events (HF hospitalizations and urgent HF hospital visits) at 12 months. The cumulative incidence of HF events was not reduced by hemodynamic-guided management (0.85, 0.70À1.03; P = 0.096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0.76, 0.61À0.95; P = 0.014). 51 s in the CHAMPION trial, freedom from device-or system-related complications was excellent, with 1014 (99%) of 1022 patients free of device-or system-related complications. The pre-COVID-19 impact analysis indicated a possible benefit of hemodynamic-guided management on the primary outcome in the pre-COVID-19 period, driven primarily by a lower HF hospitalization rate compared with the control group. 51 Based on a more recent analysis of the Guide-HF study's patients, hemodynamically-guided HF management decreases HF-related endpoints across the EF spectrum in an expanded patient population of patients with HF, including those with NYHA class IIÀIV with either previous hospitalizations or natriuretic peptide elevations. 48 Research findings led to the expansion of the 2014 approval of this device, issued by the FDA for patients meeting the CHAMPION study criteria and extended to patients with NYHA class II or elevated natriuretic peptide levels.

Based on the AHA/ACC/HFSA HF guideline, in selected patients with advanced HFrEF and NYHA class IV symptoms who are deemed to be dependent on continuous intravenous inotropes or temporary MCS, durable LVAD implantation was effective in improving functional status, QOL and survival (class 1 recommendation; level of evidence A). 2 In contrast, in select non-inotrope-dependent patients with advanced HFrEF who have NYHA class IV symptoms despite GDMT, durable MCS can be beneficial to improve symptoms, improve functional class and reduce mortality rates (Class 2a recommendation; level of evidence: B-R). 2 Current recommendations are coupled with a value statement defined as uncertain (B-NR) with durable MCS devices associated with low to intermediate economic value based on current costs and outcomes. 2 ased on the ESC HF guidelines, LVAD use was deemed a class 2a recommendation as a bridge to heart transplant candidacy or use as destination therapy. 22 Several other novel devices are currently in various stages of investigation. 9, 59 mmary and Future Directions Device-based therapies are becoming integral to managing HF, offering a promising avenue to address the high residual risk, overcome certain limitations of drug therapy (eg, adherence and tolerance), and effectively target some of the HF-related pathophysiological alterations that may not be amenable to pharmacological therapy. Despite the growing role of device-based therapies in HF, there exist gaps in the field that necessitate better identification of the ideal patient population by employing clinical, hemodynamic and structural phenotyping of HF. Additionally, establishing a systematic approach to integrate device interventions into the HF management workflow through evidence-based sequencing strategies is crucial. A large number of device-based therapies are under investigation, and they target a myriad of intra-and extra-cardiac pathologies (Fig. 2 ). While some therapies may not be proven to be beneficial and safe, a significant number will likely be approved and join the ranks of a rapidly growing field of therapies for patients with HF. Several HF devices are currently being examined to address the unmet needs of patients with HF and to close the residual gap that exits despite use of GDMT; these devices are summarized in Table 2 .

|Categories of device therapies|| |---|---|

|for HF|Example|

|Remote monitoring devices|Continuous pulmonary artery|

||pressure monitoring|

|Valvular device-based|Transcatheter edge-to-edge|

|therapies|repair of the mitral valve|

|Autonomic modulators|Baroreflex activation therapy,|

||vagus nerve stimulation,|

||splanchnic nerve modulation|

|Electrophysiological|Cardiac resynchronization|

|modulators|therapy, cardiac contractility|

||modulation|

|Respiratory modulators|Asymptomatic diaphragmatic|

||stimulation, phrenic nerve|

||stimulation|

|Structural device-based|Interatrial shunt devices, basi-|

|interventions|lar ventriculoplasty, LV|

||reconstruction|

|Left ventricular assist devices||

|(LVADs)||

|||ARTICLE IN PRESS||||| |---|---|---|---|---|---|---|

|||||FDA Approval|Trial Leading to||

|Device categories Mechanistic target Device (company)|Suggested Solution|Status|FDA Approval|Ongoing Trials|||

|Remote|Increased|1. CardioMEMS|Continuous|Y|CHAMPION trial||

|monitoring|intracardiac|system (Abbott)|pulmonary||and GUIDE-HF for||

|devices|filling pressure|2. Cordella system|artery pressure||CardioMEMS;||

|||(Endotronix)|monitoring||PROACTIVE-HF||

||||||for Cordella||

|||1. SAVE Sensor|Using seismocar-|N|N A||

|||System (Acorai)|diography, phono-||||

|||2. Cardiotag|cardiography,||||

|||(Cardiosense)|photoplethysmog-||||

||||raphy, and elec-||||

||||trocardiograph||||

||||data to noninva-||||

||||sively estimate||||

||||intracardiac||||

||||pressure||||

|||Fire1 system|Inferior vena caval|N|NA|1.FUTURE-HF|

||||size monitoring|||(NCT04203576)|

|||||||2. FUTURE-HF2|

|||||||(NCT05763407)|

||Surrogates of vol-|1. HeartLogic TM (Bos-|Remote monitoring|Y (approved for|NA||

||ume status (eg,|ton Scientific)|using cardiovascu-|other inidca-|||

||third heart sound,|2. TriageHF TM (Med-|lar implantable|tions but not|||

||thoracic dielectric|tronic)|electronic devices|for remote|||

||sensing, and tho-|3. HeartInsight (Bio-||monitoring|||

||racic impedance)|tronik)||indication)|||

||and other parame-||||||

||ters (eg, resting||||||

||heart rate, heart||||||

||rate variability,||||||

||respiratory rate||||||

||statistics)||||||

||Cardiac acoustic|Audicor (Inovise Medi-|Automated acoustic|N|N A||

||biomarkers, such|cal)|cardiography||||

||as electromechan-||systems||||

||ical activation time||||||

||(the time from||||||

||QRS onset to the||||||

||first heart sound||||||

||interval) and the||||||

||third heart sound||||||

||strength||||||

||Radiofrequency to|Zoll Heart Failure Man-|Wearable|N (FDA cleared) NA|N (FDA cleared) NA||

||measure thoracic|agement System|patch-based||||

||fluid for early||sensor||||

||detection of||||||

||changes in pulmo-||||||

||nary fluid levels||||||

||assessed by a||||||

||patch-based||||||

||sensor||||||

|||||||(Continued)|

|||||FDA Approval|Trial Leading to|| |---|---|---|---|---|---|---|

||Mitral annular dilata-|MitraClip TM (Abbott)|Edge-to-edge mitral|Y|COAPT trial|1. Reshape-HF2|

||tion, leaflet tether-||valve repair|||(NCT02444338)|

||ing, papillary|||||2. EVOLVE-MR|

||muscle desyn-|||||(NCT03891823)|

||chrony, and valve||||||

||tenting resulting in||||||

||mitral||||||

||regurgitation||||||

|||Carillon mitral contour|Indirect mitral annu-|N|NA|1. EMPOWER Trial|

|||system (Cardiac|loplasty system.|||(NCT03142152)|

|||Dimensions)|||||

|||1. Intrepid (Medtronic)|Transcatheter mitral|N|NA|1. APOLLO|

|||2. Tendyne (Abbott)|valve replacement|||(NCT03242642)|

|||3. Sapien M3 (Edwards||||2. SUMMIT|

|||Lifesciences)||||(NCT03433274)|

|||||||3. ENCIRCLE|

|||||||(NCT0415329)|

||Tricuspid regurgita-|TriClip TM (Abbott)|Edge-to-edge tri-|Y|TRILUMINATE Piv-||

||tion leading to||cuspid valve repair||otal Trial||

||progression of||||||

||right heart failure||||||

||and/or right heart||||||

||failure leading to||||||

||tricuspid||||||

|||1. EVOQUE (Edwards|Transcatheter tricus-|Y (only EVOQUE) TRISCEND II (for the|TTVR Early Feasi-||

|||Lifesciences)|pid valve replace-||EVOQUE system)|bility Study|

|||2. Interpid TTVR (Med-|ment system|||(NCT04433065)|

|||tronic)|||||

|||ARTICLE IN PRESS|ARTICLE IN PRESS|ARTICLE IN PRESS|ARTICLE IN PRESS|ARTICLE IN PRESS| |---|---|---|---|---|---|---|

|Autonomic|Overactivation of|Barostim neo System TM|Baroreceptor|Y|BeAT-HF||

|Modulators|the sympathetic|(CVRx, Inc)|stimulation||||

||nervous system||||||

||and decreased||||||

||parasympathetic||||||

||activity||||||

|||MobiusHD|Endovascular baror-|N|NA|HF-FIM|

||||eflex amplification|||(NCT04590001)|

||Overactivation of|VITARIA systems (Liva-|Vagus nerve|N|N A||

||the sympathetic|Nova)|stimulation||||

||Disrupted intravas-|Satera Ablation Sys-|Splanchnic nerve|N|N A||

||cular fluid distribu-|tems (Axon Thera-|modulation||||

||tion in heart failure|pies)|||||

|cal Modulators|lar calcium han-|(Impulse Dynamics)|tion, high-voltage|||(NCT03970343)|

||dling of the||electrical signal||||

|based|atrial filling pres-|Device (IASD,|shunt|||(NCT05425459)|

|interventions|sures with exercise|Corvia Medical)||||2. Alleviant ALLAY-|

|||¢ V-Wave Ò interatrial||||HF|

|||shunt device||||(NCT05685303)|

|||¢ Occlutech AFR|||||

||Increased basal left|¢ AccuCinch (Ancora|Transcatheter direct|N|NA|CorCinch-EU Study|

||ventricle and|Heart)|mitral valve annu-|||(NCT03183895)|

||mitral annular||loplasty and ven-||||

||dimensions||triculoplasty||||

||||system||||

||Left ventricular|ReVivent TC|Left ventricular|N|NA|ALIVE|

||remodeling in|(BioVentrix)|reconstruction|||(NCT02931240)|

||heart failure||||||

||Distribution of mitral|V-sling system|Transcatheter ven-|N|N A||

||valve geometry|(Cardiac Success|tricular repair sys-||||

||and left ventricle|Ltd)|tem to||||

||dilation||reapproximates||||

||||the papillary||||

||||muscles||||

|||Carillon mitral|Transcatheter coro-|N|NA|EMPOWER|

|||contour system|nary sinusÀbased|||(NCT03142152)|

||||mitral||||

||||annuloplasty||||

|Durable mechani-|End-stage left ven-|1. First-generation|Left ventricular|Y|REMATCH trial (for||

|cal circulatory|tricular heart|devices: (Heartmate I)|assist devices||HeartMate I);||

|support|failure|2. Second-generation|||HeartMate II trial||

|||devices (Heartmate II)|||(for HeartMate II);||

|||total artificial heart|||||

|||3. FLOWMAKER (Fine-|||||

|||Heart): a fully implant-|||||

|||able cardiac output|||||

|||management system|||||

|||4. CorWave: a fully|||||

|||implanted LVAD that|||||

|||uses wave membrane|||||

|||technology to repro-|||||

|||duce physiological|||||

|||flow pulsatility|||||

Marat Fudim

Disclosures

Categories of device-based therapies for heart failure

Approved and investigational devices for heart failure

(Continued)

JDE reports being a consultant/advisor for Abbott, Getinge, Zoll, and the Cleveland Clinic/Amwell. JB reports grant support from Abiomed, Axon Therapies, Ancora Heart, Edwards Lifesciences. Consulting for Aquapass, Axon Therapies, Orchestra Biomedical, Corvia, Edward Lifesciences, Harvi Dynamics, IMPULSE Dynamics, and Zoll Medical. SH reports being a consultant/advisor for Abbott, Abiomed, Evaheart, CareDx, and Natera. MF is a consultant/has ownership interest in Abbott, Ajax, Alio Health, Alleviant, Artha, Audicor, AxonTherapies, Bayer, Bodyguide, Bodyport, Boston Scientific, Broadview, Cadence, Cardioflow, Coridea, CVRx, Daxor, Edwards LifeSciences, Echosens, EKO, Feldschuh Foundation, Fire1, FutureCardia, Galvani, Gradient, Hatteras, HemodynamiQ, Impulse Dynamics, Intershunt, Medtronic, Merck, NIMedical, NovoNordisk, NucleusRx, NXT Biomedical, Orchestra, Pharmacosmos, Presidio, Procyreon, Proton Intelligence, ReCor, Rockley, SCPharma, Shifamed, Splendo, STAT Health, Summacor, SyMap, Verily, Vironix, Viscardia, Zoll. All other authors report no disclosures.

References

||Physiological|Bodyport Cardiac Scale Weight scale with|Bodyport Cardiac Scale Weight scale with|N (FDA cleared) NA|N (FDA cleared) NA||

||parameters, such||ability to measure||||

||as weight, ECG,||multiple hemody-||||

||impedance||namic parameters||||

||plethysmography,||||||

||and ballistocar-||||||

||diography signals||||||

||assessed by stand-||||||

||ing on a scale||||||

||Cardiopulmonary|Sensinel Cardiopulmo-|Wearable cardiopul-|N (FDA cleared) NA|N (FDA cleared) NA||

||indicators, such as|nary System|monary monitor-||||

||diastolic heart||ing device||||

||sound strength,||||||

||heart sounds,||||||

||heart rate, relative||||||

||tidal volume, tem-||||||

||perature, thoracic||||||

||impedance, respi-||||||

||ratory rate, body||||||

||posture, and sin-||||||

||gle-lead ECG||||||

||assessed using a||||||

||wearable sensor||||||

||for cardiopulmo-||||||

||nary monitoring||||||

|Based Therapies|flow obstruction|(Medtronic)|valve replacement||NER 2, and PART-|EXPAND TAVR II|

||due to aortic ste-|2. Sapien S3 Ultra valve|||NER 3 trials|(NCT05149755)|

||nosis leading to|(Edwards Lifescien-||||2. ENVISION|

||adverse left ven-|ces)||||(NCT05932615)|

||tricular|3. Navitor valve|||||

||remodeling|(Abbott)|||||

||Hypertrophy and|1. J-Valve (JC Medical)|Transcatheter aortic|N|NA|1. JVTF EFS|

||dilatation of the|2. JenaValve (JenaValve|valve replacement|||(NCT06034028)|

||left ventricle to|Technology)||||2. J-Valve Compas-|

||allow for increased|||||sionate Use|

||left ventricular|||||(NCT03876964)|

||stroke volume due|||||3. ALIGN-AR|

||to chronic aortic|||||(NCT04415047)|

||regurgitation|||||4. ALIGN-AR EFS|

|||||||TRIAL|

|||||||(NCT02732704)|

||cardiomyocyte||delivered to the||||

||||septum of the||||

||||right ventricle dur-||||

||||ing the absolute||||

||||refractory period||||

||Remodeling of|Electrical microcurrent|Microcurrent stimu-|N|N A||

||cardiomyocytes|therapy with C-MIC|lation of cardio-||||

|||system (Berlin Heals)|myocytes resulting||||

||||in intracellular and||||

||||extracellular||||

||||changes with||||

||||reverse remodel-||||

||||ing of||||

||||cardiomyocytes||||

|Respiratory|Alteration of intra-|VisONE asymptomatic|Diaphragmatic stim-|N|N A||

|Modulators|thoracic pressure|diaphragmatic stimu-|ulation pulses||||

|||lation device (VisCar-|gated with cardiac||||

|||dia)|cycles leading to||||

||||modulation of||||

||||intrathoracic pres-||||

||||sure and enhance-||||

||||ment of preload,||||

||||afterload, and||||

||||stroke volume||||

||Central sleep apnea|remede System (Respi-|Phrenic nerve|Y|The remed e System|remede System|

||in heart failure|cardia)|stimulation||Pivotal Trial Study|Therapy Study|

|||||||(NCT03884660)|

|||3. Third generation|||ADVANCE trial||

|||devices (HeartWare|||(for HeartWare);||

|||and Heartmate 3|||and MOMENTUM||

||||||3 (for HeartMate 3)||

|||Next-generation|Left ventricular|N|N A||

|||durable mechanical|assist devices and||||

|||circulatory support|total artificial||||

|||devices (investiga-|hearts||||

|||tional devices):|||||

|||1. BrioVAD: a compact|||||

|||LVAD with a centrifu-|||||

|||gal totally magnetically|||||

|||levitated long blade|||||

|||rotor, a flat HQ curve|||||

|||(ie, allows for intrinsic|||||

|||flow pulsatility), and a|||||

|||narrow and flexible|||||

|||driveline, and a small|||||

|||outflow cannula|||||

|||2. BiVACOR: a com-|||||

|||pact continuous flow,|||||

|||electrically powered|||||

引用 / 出处

2024 HFSA科学声明：心力衰竭的器械治疗（更新版）. 2024.