One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial

Shah, Sanjiv J.; Feldman, Ted; Ricciardi, Mark J.; Kahwash, Rami; Lilly, Scott; Litwin, Sheldon E.; Nielsen, Chris; Harst, Pim van der; Hoendermis, Elke S.; Pěnička, Martin; Bartúnek, Jozef; Fail, Peter S.; Kaye, David M.; Walton, A.; Petrie, Mark C.; Walker, Niki L.; Basuray, Anupam; Yakubov, Steven; Hummel, Scott L.; Chetcuti, Stanley; Forde-McLean, Rhondalyn; Herrmann, Howard C.; Burkhoff, Daniel; Massaro, Joseph M.; Cleland, John G.F.; Mauri, Laura

doi:10.1001/jamacardio.2018.2936

Cited by 138 publications

(116 citation statements)

References 28 publications

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“…Analogously, the REDUCE LAP-HF I trial on a total of 64 patients recorded a reduction in left-atrial pressure during exercise with improvement in functional capacity and QOL after shunt implantation [143]. The latest 1-year results of REDUCE LAP-HF I showed no significant differences in major adverse cardiac, cerebrovascular, or renal events compared to patients who underwent sham procedure, suggesting this method to be safe [144]. In the future, the REDUCE-LAP-HF II trial, which focuses on clinical outcomes, will hopefully take up from these positive results (NCT03088033).…”

Section: Atrial Shunt Devicementioning

confidence: 95%

Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future

et al. 2020

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In contrast to the wealth of proven therapies for heart failure with reduced ejection fraction (HFrEF), therapeutic efforts in the past have failed to improve outcomes in heart failure with preserved ejection fraction (HFpEF). Moreover, to this day, diagnosis of HFpEF remains controversial. However, there is growing appreciation that HFpEF represents a heterogeneous syndrome with various phenotypes and comorbidities which are hardly to differentiate solely by LVEF and might benefit from individually tailored approaches. These hypotheses are supported by the recently presented PARAGON-HF trial. Although treatment with LCZ696 did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among HFpEF patients, subanalyses suggest beneficial effects in female patients and those with an LVEF between 45 and 57%. In the future, prospective randomized trials should focus on dedicated, well-defined subgroups based on various information such as clinical characteristics, biomarker levels, and imaging modalities. These could clarify the role of LCZ696 in selected individuals. Furthermore, sodium-glucose cotransporter-2 inhibitors have just proven efficient in HFrEF patients and are currently also studied in large prospective clinical trials enrolling HFpEF patients. In addition, several novel disease-modifying drugs that pursue different strategies such as targeting cardiac inflammation and fibrosis have delivered preliminary optimistic results and are subject of further research. Moreover, innovative device therapies may enhance management of HFpEF, but need prospective adequately powered clinical trials to confirm safety and efficacy regarding clinical outcomes. This review highlights the past, present, and future therapeutic approaches in HFpEF.

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Section: Atrial Shunt Devicementioning

confidence: 95%

Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future

et al. 2020

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“…On the other hand, SAX LAEF is an alternative if long axis images are degraded by artefact. Our findings are also important since LAEF represents a potential therapeutic target in HFpEF [8] where there are currently no effective therapies [9] and may also act as a trial endpoint [10].…”

Section: Discussionmentioning

confidence: 92%

Intra-study and inter-technique validation of cardiovascular magnetic resonance imaging derived left atrial ejection fraction as a prognostic biomarker in heart failure with preserved ejection fraction

Kanagala

Arnold

Singh

et al. 2020

Int J Cardiovasc Imaging

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The aim of this study was to assess the agreements of both biplane and short-axis Simpson's (SAX) methods for left atrial ejection fraction (LAEF) calculation utilising cardiovascular magnetic resonance imaging (CMR) in heart failure with preserved ejection fraction (HFpEF) and evaluate their relation to clinical outcomes. One hundred and thirty six subjects (HFpEF n = 97, controls n = 39) underwent CMR, six-minute walk tests and blood sampling in our prospective, observational, single-centre study. Overall, LAEF (%) was lower in HFpEF patients compared to controls (SAX 34 ± 13 vs 47 ± 8, biplane 34 ± 16 vs 51 ± 11; p < 0.0001 for both). Atrial fibrillation (AF) was present in 24% of HFpEF and was associated with higher LA volumes and lower LAEF compared to sinus rhythm (p < 0.0001) with both methods. Biplane LAEF correlated strongly with SAX measurements (overall Pearson's r = 0.851, sinus rhythm r = 0.651, AF r = 0.882; p < 0.0001). Biplane LAEF did not differ significantly compared to SAX LAEF (overall 34 ± 16 vs 34 ± 13%; p = 0.307) except in AF subjects in whom biplane LAEF was lower (mean difference 2 ± 4%, p = 0.013). There were 44 composite events (25 deaths, 19 HF hospitalizations) in HFpEF during median follow-up of 1429 days. LAEF below the median was associated with increased risk of composite endpoints (Log-Rank biplane p < 0.0001; SAX p = 0.009). In multivariable Cox proportional hazards regression analysis, both biplane LAEF (hazard ratio [HR] 0.604; 95% confidence interval [CI] (0.406-0.900); p = 0.013) and SAX LAEF (HR 0.636; CI 0.441-0.918; p = 0.016) remained independent predictors along with indexed extracellular volume. CMR LAEF, derived from either the short-axis or biplane method is lower in HFpEF compared to healthy controls and remains a strong marker of prognosis.

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“…The fact that Schueler et al reported patients with persistent iASDs had worse outcomes may argue against iASDs being beneficial long term in patients without diastolic heart failure or with systolic heart failure . There is an ongoing randomized clinical trial studying creation of an iatrogenic ASD in patients with heart failure with preserved ejection fraction to relieve elevated left atrial pressure; however, that trial has important exclusion criteria (including right ventricular dysfunction, pulmonary hypertension, prior stroke, and prior pulmonary embolism) and is thus not applicable to our patient population …”

Section: Discussionmentioning

confidence: 98%

“…5 There is an ongoing randomized clinical trial studying creation of an iatrogenic ASD in patients with heart failure with preserved ejection fraction to relieve elevated left atrial pressure; however, that trial has important exclusion criteria (including right ventricular dysfunction, pulmonary hypertension, prior stroke, and prior pulmonary embolism) and is thus not applicable to our patient population. 20 Certain limitations should be considered. This is an observational study, and thus, definitive conclusions regarding outcomes cannot be drawn as there was some variability in the characteristics of the patients in the two arms of the study.…”

Section: Discussionmentioning

confidence: 99%

Iatrogenic atrial septal defect closure after transseptal mitral valve interventions: Indications and outcomes

Beri

Singh

Smith

et al. 2019

Cathet Cardio Intervent

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Objectives Review indications and outcomes for transcatheter iatrogenic atrial septal defect (iASD) closure in patients undergoing MitraClip or transseptal (TS) mitral valve‐in‐valve/ring (ViV/ViR) procedures. Background Mitral valve transcatheter interventions require large‐diameter TS sheaths that can result in iASDs that necessitate post‐procedure transcatheter closure. Although the presence of iASD has been well‐described, indications for closure and outcomes after TS mitral valve interventions have not been reported. Methods Patients undergoing MitraClip repair and ViV or ViR transcatheter mitral valve replacement (TMVR) from February 14, 2014, to January 16, 2018, were studied retrospectively in this single center study. Results Seventeen patients had iASD closure: 11 MitraClip and 6 TMVR (5 ViV, 1 ViR). Indications for iASD closure included large iASD (n = 7), large left‐to‐right shunt (n = 9), pulmonary hypertension (n = 8), large right‐to‐left shunt (n = 1), severe RV dysfunction (n = 2), thin/aneurysmal septum (n = 2), and mobile material on pacemaker leads (n = 2). Closures were performed without complications using Amplatzer septal occluders. At 30 days, 94% of subjects (n = 16) were alive with one patient deceased from unknown causes. There were no myocardial infarctions or strokes. At 12 months, follow‐up was available for 14 of 17 patients, and 71% of patients (10/14) were alive. One patient died due to cardiac causes, two from noncardiac causes and one for unknown reasons. There was one myocardial infarction, one intraparenchymal hemorrhage, and no ischemic strokes. Conclusions The most common reasons for iASD closure after TS MV procedures are: large ASD unlikely to spontaneously close, large left‐to‐right shunt, and pulmonary hypertension. Patients who required iASD closure had low 30‐day mortality but higher one‐year mortality potentially reflecting a population with substantial comorbidities.

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One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial

Abstract: ClinicalTrials.gov identifier: NCT02600234.

Cited by 138 publications

References 28 publications

Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future

Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future

Intra-study and inter-technique validation of cardiovascular magnetic resonance imaging derived left atrial ejection fraction as a prognostic biomarker in heart failure with preserved ejection fraction

Iatrogenic atrial septal defect closure after transseptal mitral valve interventions: Indications and outcomes

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