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Part III
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Interventions in Heart Failure
Interatrial Shunt Devices
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TaimurSafder, SanjivShah, andAkhilNarang
Abstract
Heart failure with preserved ejection fraction (HFpEF) remains difcult to manage while contributing to high morbidity and mortality. It is a complex disease state with a pathophys­iology based in a multitude of contributing factors. One common aspect of HFpEF is the presence of increased LV end diastolic pres­sure (LVEDP) resulting in elevated left atrial (LA) pressure. Increased LA pressure may also be the best guide in assessing if dyspnea is the result of elevated LA pressures leading to pulmonary congestion. In this chapter, we will discuss the evolving eld of interatrial shunt devices (IASD) which target elevated LA pressures as a possible therapeutic option in patients with HFpEF.This chapter will dis­cuss prevalence, morbidity and mortality of HFpEF, along with the pathophysiology of elevated left atrial pressures in HFpEF, and treatment options using interatrial shunt devices. Lastly, an example case of a patient
Supplementary Information The online version con­tains supplementary material available at https://doi.
org/10.1007/978- 3- 031- 50740- 3_9.
T. Safder · S. Shah (*) · A. Narang Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, IL, USA e-mail: Taimur.Safder@nm.org;
Sanjiv.Shah@northwestern.edu; Akhil.Narang@nm.org
undergoing an IASD placement with pre, intra and post procedural imaging guidance will be reviewed.
Keywords
Heart failure with preserved ejection fraction treatment · Heart failure with mild range ejection fraction treatment · Interatrial shunt device · Left atrial hypertension · Diastolic dysfunction
Abbreviations
ACEi Angiotensin-converting enzyme
inhibitors ARB Angiotensin II receptor blockers ARNI Angiotensin receptor-neprilysin
inhibitor CABG Coronary artery bypass graft CAD Coronary artery disease EF Ejection fraction HF Heart failure HFimrEF Heart failure with improved EF HFmrEF Heart failure with mildly reduced
ejection fraction HFrEF Heart failure with reduced ejection
fraction
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024 A. M. Kelsey et al. (eds.), Cardiac Imaging in Structural Heart Disease Interventions,
https://doi.org/10.1007/978-3-031-50740-3_9
245
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IAS Interatrial septum IASD Interatrial shunt device KCCQ Kansas City Cardiomyopathy
Questionnaire LA Left atrium LV Left ventricle LVEDP Left ventricle end diastolic pressure MRA Mineralocorticoid receptor
antagonists PA Pulmonary artery PCWP Pulmonary capillary wedge
pressure PVD Pulmonary vascular disease PVR Pulmonary vascular resistance RA Right atrium RV Right ventricle WU Wood units
Test your learning and check your under­standing of this book’s contents: use the “Springer Nature Flashcards” app to access questions using ▶ https://sn.pub/ambACS. To use the app, please follow the instruc­tions in the chapter “Transcatheter Aortic Valve Replacement.”
Learning Objectives
1. Review prevalence, morbidity and mortality
and the denitions of HFpEF.
2. Understand the interplay of HFpEF and left
atrial hypertension and how left atrial decom-
Background andDenitions
pression may be a viable and effective treat­ment option in patients with HFpEF.
3. Review the currently available literature in the
eld of interatrial shunts for HFpEF.
4. Understand the factors that are important to
identify in the pre-procedural stage that could make the imaging and the procedure more challenging.
5. Understand the key steps for a IASD proce-
dure and the optimal imaging needed to sup­port it.
6. Understand post procedural imaging goals
and possible complications that can occur.
Despite signicant advances in the eld of heart failure (HF) management, HF remains a chal­lenging diagnosis for clinicians. The combined prevalence of HFpEF and HFmrEF exceeds HFrEF and possess a signicant challenge to cli­nicians [15]. HFpEF, and to a certain extent HFmrEF, represent a distinct entity than HFrEF [6] (Table2). HFpEF, in particular, is a complex multiorgan syndrome that has layers of different pathophysiological mechanisms that are built upon the traditional diastolic heart failure para­digm. Despite this complex underpinning of
T. Safder et al.
Case Study
A 70-year-old male presents to clinic for worsening dyspnea. He has a history of CAD status post three vessel coronary artery bypass graft, HFpEF, permanent atrial brillation status post left atrial appendage occlusion device, hypertension, hyperlipidemia and obesity. Patient reports he can only walk 1–2 blocks before having signicant dyspnea that limits his activity.
Transthoracic echocardiogram was notable for normal LV size and function (LVEF 65%), mildly dilated RV, bi-atrial enlargement, no signicant valvular abnor­malities. LV global longitudinal strain
15%.
For further evaluation of etiology of the patient’s symptoms, a right heart catheter­ization (RHC) with exercise bike was done with results noted in Table1.
Table 1 RHC with exercise bike results prior to IASD
Rest Peak exercise RA (mean, mmHg) 6 22 RV (mean, mmHg) 8 PA (mean, mmHg) 29 51 PCWP (mmHg) 11 32 CI (L/min/m PVR (woods units) 3.5
2
) 2.5 3.6
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HFpEF, one common thread that binds these patients is elevated LVEDP and LA pressure at rest and/or with exercise [7]. Elevated LVEDP leads to an increased LA pressure and remodel­ing, which further leads to increased pulmonary pressures and lung gas exchange abnormalities resulting in the characteristic symptom of dys­pnea [8]. With modest success of medical thera­pies, one new focus of treatment in HFpEF and HFmrEF patients has become ways to help reduce the elevated LA pressure.
Left atrial decompression by a way of an iat­rogenic interatrial shunt is one strategy currently being investigated. This strategy developed from historical observations of patients with left sided valvular disease and atrial septal defects (ASD), such as Lutembacher syndrome. These patients
Table 2 Denitions of HF by LVEF, adapted from ACC/ AHA/HFSA 2022 HF guidelines
HF types Denition HF with reduced EF HF with improved
EF HF with mildly
reduced EF HF with preserved EF
LVEF 40% Previous LVEF 40% but now
LVEF 40% LVEF 41–49%
LVEF 50%
were found to tolerate their valvular disease bet­ter than patients with valvular disease but no ASD.In addition, closure of ASDs has shown to result in abrupt increases of LA pressure and HF exacerbations [1] (Fig.1). Utilizing this frame­work, this novel device-based treatment strategy of iatrogenic interatrial shunt is currently being pursued and several shunt devices are in various stages of development for patients with HF (Fig.2).
Data from clinical trials using the Corvia IASD device has been promising (Fig.3). Phase I data from the REDUCE LAP-HF trials demon­strated safety and efcacy of the Corvia IASD device in patients with LVEF 40% (Table3). Although the overall phase 3 randomized control trial failed to show an overall difference in the primary end point (CVD death or non-fatal isch­emic stroke at 12months, total HF events up to 24 months, and change in KCCQ overall sum­mary score at 12 months) between sham and treatment arm, the study did note a positive signal of benet in patients without PVD (PVR <1.8 WU). This may represent a subsegment of patients that may benet from IASD therapy [9]. At this stage, IASD therapy remains promising and further studies are needed to establish it as an evidence based therapy for HF patients.
Fig. 1 Left atrial pressure tracing showing increased LA pressures when ASD is occluded and decrease of LA pressures when ASD is opened
ECG
Left atrial pressure
ASD occluded ASD open
1 sec
v
a
v
a
60
[mmHg]
30
0
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Fig. 2 List of the current interatrial shunt devices/procedures under investigation
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Fig. 3 Proposed mode of action for Corvia device: dynamic decompression of overloaded LA chamber by shunting blood from LA RA (Qp:Qs 1.2–1.3)
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Summary of REDUCE LAP-HF trials
Table 3
Shah etal. REDUCE
LAP-HF II (2022) Baseline characteristics N 314 (treatment arm) Age (years) 73 (median) Male (%) 36 LVEF (%) 60 (median) PCWP at rest (mmHg)
Baseline Post-procedure
Functional status outcomes NYHA Baseline Post-procedure Median change in KCCQ (IQR) from baseline to 12months
*Not statistically signicant **Statistically signicant
Percent of patients
with:
PCWP <15 30%
PCWP >15 70%
Change in median
NYHA
0.5 (1 to 0)**
10.2 (1.8 to 26.8)*
Diagnosis andPre-procedural Assessment
When patients with suspected HFpEF are evalu­ated for IASD, their symptoms must be interro­gated fully as to delineate the etiology from other comorbidities that may be present in this patient population (i.e. anemia, COPD). Exercise stress echocardiogram can be a helpful tool in assessing diastolic dysfunction in patients presenting with unexplained dyspnea. After a comprehensive
T. Safder et al.
evaluation which excluded ischemia, anemia, or pulmonary disease in our patient, a RHC with exercise was obtained.
RHC with exercise is an important and often underutilized test for HFpEF. When done cor­rectly and interpreted accurately, the information can be revealing. Resting measurements of car­diac lling pressures alone often lack sensitivity for diagnosing HFpEF.Left sided cardiac lling pressures (i.e. PCWP) measured during exercise is likely to yield much better HF diagnostic and prognostic information [10]. Occasionally ele­vated left atrial pressures are only elicited during exercise with the patient having normal pressures at rest (Fig. 4). Exercise hemodynamics in patients with HFpEF can help classify their dis­ease phenotype and one such classication sys­tem is proposed in Fig.5.
The notable nding from our patients RHC notes a resting PCWP of 13 mmHg, which increases signicantly to 32mmHg at peak exer­cise (Table1). This nding of exercised induced LA hypertension categorizes our patient as type I HFpEF (Fig.5). Type I, and to a smaller extent type II, HFpEF patients represent the ideal candi­date for an IASD (Fig.6). Patients with signi­cant right heart failure and/or pulmonary arterial hypertension are unlikely to benet from an IASD and are poor candidates for shunt based therapy (these patients were also excluded from REDUCE LAP-HF II trials).
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b
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Fig. 4 Hemodynamic measurements at rest (Panel a) showing normal values and the same patient undergoing exercise with hemodynamic measurements (Panel b), showing signicant increase in the PCWP
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Fig. 5 Phenotype guided approach to HFpEF
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Fig. 6 Device based therapeutics for HFpEF