Top

Published in:

01-09-2019 | Heart Failure

Novel percutaneous interventional therapies in heart failure with preserved ejection fraction: an integrative review

Authors: Alexandru Burlacu, Paul Simion, Ionut Nistor, Adrian Covic, Grigore Tinica

Published in: Heart Failure Reviews | Issue 5/2019

Abstract

Heart failure with preserved ejection fraction (HFpEF) is a common disorder generating high mortality and important morbidity prevalence, with a very limited medical treatment available. Studies have shown that the pathophysiological hallmark of this condition is an elevated left intra-atrial pressure (LAP), exertional dyspnea being its clinical manifestation. The increasing pressure from LA is not based on volume overload (such as in heart failure with reduced ejection fraction) but on a diastolic left ventricular (LV) dysfunction combined with an inter-atrial dyssynchrony mimicking a pseudo-pacemaker syndrome. In this review, we aimed to summarize current knowledge and discuss future directions of the newest interventional percutaneous therapies of HFpEF. Novel interventional approaches developed to counter these mechanisms are as follows: LA decompression (inter-atrial shunt devices), enhancement of LV compliance (LV expanders), and inter-atrial resynchronization therapy (LA permanent pacing). To date, inter-atrial shunt devices (IASD) are the most studied, being the only devices currently tested in a phase 3 trial. Recent data showed that IASD are feasible, safe, and have a short-term clinical benefit in HFpEF patients. LV expanders and LA pacing therapy present with a smaller clinical benefit compared with IASD, but they are safe, without any major adverse outcomes currently noted. With further development and improvement of these mechanism-specific devices, it will be interesting to determine in the future whether a complex intervention of multiple HFpEF device implantation will be safe and have further benefits in HFpEF patients.

Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM (2006) Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med 355(3):251–259. https://doi.org/10.1056/NEJMoa052256 CrossRefPubMed

Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE (2010) Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation 121(12):1393–1405. https://doi.org/10.1161/circulationaha.109.909614 CrossRefPubMed

Lam CSP, Voors AA, de Boer RA, Solomon SD, van Veldhuisen DJ (2018) Heart failure with preserved ejection fraction: from mechanisms to therapies. Eur Heart J 39(30):2780–2792. https://doi.org/10.1093/eurheartj/ehy301 CrossRefPubMed

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P (2016) 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 37(27):2129–2200. https://doi.org/10.1093/eurheartj/ehw128 CrossRefPubMed

Roh J, Houstis N, Rosenzweig A (2017) Why don’t we have proven treatments for HFpEF? Circ Res 120(8):1243–1245. https://doi.org/10.1161/circresaha.116.310119 CrossRefPubMedPubMedCentral

Borlaug BA (2014) The pathophysiology of heart failure with preserved ejection fraction. Nat Rev Cardiol 11(9):507–515. https://doi.org/10.1038/nrcardio.2014.83 CrossRefPubMed

van Heerebeek L, Borbely A, Niessen HW, Bronzwaer JG, van der Velden J, Stienen GJ, Linke WA, Laarman GJ, Paulus WJ (2006) Myocardial structure and function differ in systolic and diastolic heart failure. Circulation 113(16):1966–1973. https://doi.org/10.1161/circulationaha.105.587519 CrossRefPubMed

Paulus WJ, Tschope C (2013) A novel paradigm for heart failure with preserved ejection fraction: comorbidities drive myocardial dysfunction and remodeling through coronary microvascular endothelial inflammation. J Am Coll Cardiol 62(4):263–271. https://doi.org/10.1016/j.jacc.2013.02.092 CrossRefPubMed

Zile MR, Baicu CF, Gaasch WH (2004) Diastolic heart failure--abnormalities in active relaxation and passive stiffness of the left ventricle. N Engl J Med 350(19):1953–1959. https://doi.org/10.1056/NEJMoa032566 CrossRefPubMed

10.

Westermann D, Kasner M, Steendijk P, Spillmann F, Riad A, Weitmann K, Hoffmann W, Poller W, Pauschinger M, Schultheiss HP, Tschope C (2008) Role of left ventricular stiffness in heart failure with normal ejection fraction. Circulation 117(16):2051–2060. https://doi.org/10.1161/circulationaha.107.716886 CrossRefPubMed

11.

Kulkarni SS, Sakaria AK, Mahajan SK, Shah KB (2012) Lutembacher’s syndrome. Journal of Cardiovascular Disease Research 3(2):179–181. https://doi.org/10.4103/0975-3583.95381 CrossRefPubMedPubMedCentral

12.

Masutani S, Senzaki H (2011) Left ventricular function in adult patients with atrial septal defect: implication for development of heart failure after transcatheter closure. J Card Fail 17(11):957–963. https://doi.org/10.1016/j.cardfail.2011.07.003 CrossRefPubMed

13.

Ewert P, Berger F, Nagdyman N, Kretschmar O, Dittrich S, Abdul-Khaliq H, Lange P (2001) Masked left ventricular restriction in elderly patients with atrial septal defects: a contraindication for closure? Catheter Cardiovasc Interv 52(2):177–180CrossRefPubMed

14.

Reddy YNV, Carter RE, Obokata M, Redfield MM, Borlaug BA (2018) A simple, evidence-based approach to help guide diagnosis of heart failure with preserved ejection fraction. Circulation 138(9):861–870. https://doi.org/10.1161/circulationaha.118.034646 CrossRefPubMedPubMedCentral

15.

De Rosa R, Piscione F, Schranz D, Citro R, Iesu S, Galasso G (2017) Transcatheter implantable devices to monitoring of elevated left atrial pressures in patients with chronic heart failure. Transl Med UniSa 17:19–21PubMed

16.

Amat-Santos IJ, Nombela-Franco L, Garcia B, Tobar J, Rodes-Cabau J, San Roman JA (2015) The V-Wave device for the treatment of heart failure. Initial experience in Europe. Rev Esp Cardiol 68(9):808–810. https://doi.org/10.1016/j.rec.2015.04.015 CrossRefPubMed

17.

Amat-Santos IJ, Bergeron S, Bernier M, Allende R, Barbosa Ribeiro H, Urena M, Pibarot P, Verheye S, Keren G, Yaacoby M, Nitzan Y, Abraham WT, Rodes-Cabau J (2015) Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. EuroIntervention 10(9):1127–1131. https://doi.org/10.4244/eijy14m05_07 CrossRefPubMedPubMedCentral

18.

Rodes-Cabau J, Bernier M, Amat-Santos IJ, Ben Gal T, Nombela-Franco L, Garcia Del Blanco B, Kerner A, Bergeron S, Del Trigo M, Pibarot P, Shkurovich S, Eigler N, Abraham WT (2018) Interatrial shunting for heart failure: early and late results from the first-in-human experience with the V-Wave system. J Am Coll Cardiol Intv 11(22):2300–2310. https://doi.org/10.1016/j.jcin.2018.07.001 CrossRef

19.

Del Trigo M, Bergeron S, Bernier M, Amat-Santos IJ, Puri R, Campelo-Parada F, Altisent OA, Regueiro A, Eigler N, Rozenfeld E, Pibarot P, Abraham WT, Rodes-Cabau J (2016) Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. Lancet 387(10025):1290–1297. https://doi.org/10.1016/s0140-6736(16)00585-7 CrossRefPubMed

20.

ClinicalTrials.gov UNIoH REducing Lung Congestion Symptoms Using thE V-wavE Shunt in Advanced Heart Failure (RELIEVE-HF). https://clinicaltrials.gov/ct2/show/NCT03499236. Accessed 4 Dec 2018

21.

Kaye D, Shah SJ, Borlaug BA, Gustafsson F, Komtebedde J, Kubo S, Magnin C, Maurer MS, Feldman T, Burkhoff D (2014) Effects of an interatrial shunt on rest and exercise hemodynamics: results of a computer simulation in heart failure. J Card Fail 20(3):212–221. https://doi.org/10.1016/j.cardfail.2014.01.005 CrossRefPubMed

22.

Sondergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M, Franzen O, Neuzil P, Ihlemann N, Gustafsson F (2014) Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. Eur J Heart Fail 16(7):796–801. https://doi.org/10.1002/ejhf.111 CrossRefPubMed

23.

Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM (2016) A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet 387(10025):1298–1304. https://doi.org/10.1016/s0140-6736(16)00704-2 CrossRefPubMed

24.

Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C (2016) One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction. Circ Heart Fail 9(12). https://doi.org/10.1161/circheartfailure.116.003662

25.

Feldman T, Mauri L, Kahwash R, Litwin S, Ricciardi MJ, van der Harst P, Penicka M, Fail PS, Kaye DM, Petrie MC, Basuray A, Hummel SL, Forde-McLean R, Nielsen CD, Lilly S, Massaro JM, Burkhoff D, Shah SJ (2018) Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in patients With Heart Failure]): a phase 2, randomized, sham-controlled trial. Circulation 137(4):364–375. https://doi.org/10.1161/circulationaha.117.032094 CrossRefPubMed

26.

Health UNIo A study to evaluate the Corvia Medical, Inc. IASD® System II to reduce elevated left atrial pressure in patients with heart failure https://clinicaltrials.gov/ct2/show/NCT03088033. Accessed 4 Dec 2018

27.

Health.ClinicalTrials.gov UNIo A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE elevated left atrial pressure in patients with heart failure with reduced ejection fraction. https://clinicaltrials.gov/ct2/show/NCT03093961. Accessed 4 Dec 2018

28.

Patel MB, Samuel BP, Girgis RE, Parlmer MA, Vettukattil JJ (2015) Implantable atrial flow regulator for severe, irreversible pulmonary arterial hypertension. EuroIntervention 11(6):706–709. https://doi.org/10.4244/eijy15m07_08 CrossRefPubMed

29.

Gupta A, Bailey SR (2018) Update on devices for diastolic dysfunction: options for a no option condition? Curr Cardiol Rep 20(10):85. https://doi.org/10.1007/s11886-018-1027-2 CrossRefPubMed

30.

Rajeshkumar R, Pavithran S, Sivakumar K, Vettukattil JJ (2017) Atrial septostomy with a predefined diameter using a novel occlutech atrial flow regulator improves symptoms and cardiac index in patients with severe pulmonary arterial hypertension. Catheter Cardiovasc Interv 90(7):1145–1153. https://doi.org/10.1002/ccd.27233 CrossRefPubMed

31.

Health.ClinicalTrials.gov UNIo The prelieve trial- pilot study to assess safety and efficacy of a novel atrial flow regulator (AFR) in heart failure patients (PRELIEVE). NCT03030274 https://clinicaltrials.gov/ct2/show/NCT03030274. Accessed 3 Dec 2018

32.

T S (2010) Reversing heart failure: diastolic recoil in a proposed cardiac support device

33.

M K Heart Failure With Preserved EFx: Corassist. In: TCT 2012, San Francisco (2012)

34.

A E (2013) First in man implantation of intra-ventricular device for diastolic heart failure. TCT 2013, San Francisco

35.

Health.ClinicalTrials.gov UNIo (2015) CORolla® TAA for heart failure with preserved ejection fraction (HFpEF) and diastolic dysfunction (DD). https://clinicaltrials.gov/ct2/show/NCT02499601. Accessed 3 Dec 2018

36.

TCT-481: Diastolic heart failure – innovative extra and intra ventricular solutions (2011) J Am Coll Cardiol 58 (20 Supplement):B131. https://doi.org/10.1016/j.jacc.2011.10.492

37.

Morris DA, Gailani M, Vaz Perez A, Blaschke F, Dietz R, Haverkamp W, Ozcelik C (2011) Left atrial systolic and diastolic dysfunction in heart failure with normal left ventricular ejection fraction. J Am Soc Echocardiogr 24(6):651–662. https://doi.org/10.1016/j.echo.2011.02.004 CrossRefPubMed

38.

Maass AH, Van Gelder IC (2012) Atrial resynchronization therapy: a new concept for treatment of heart failure with preserved ejection fraction and prevention of atrial fibrillation? Eur J Heart Fail 14(3):227–229. https://doi.org/10.1093/eurjhf/hfs014 CrossRefPubMed

39.

Daubert C, Leclercq C, Le Breton H, Gras D, Pavin D, Pouvreau Y, Van Verooij P, Bakels N, Mabo P (1997) Permanent left atrial pacing with a specifically designed coronary sinus lead. Pacing Clin Electrophysiol 20(11):2755–2764CrossRefPubMed

40.

Sanchis L, Vannini L, Gabrielli L, Duchateau N, Falces C, Andrea R, Bijnens B, Sitges M (2015) Interatrial Dyssynchrony may contribute to heart failure symptoms in patients with preserved ejection fraction. Echocardiography 32(11):1655–1661. https://doi.org/10.1111/echo.12927 CrossRefPubMed

41.

Liu S, Guan Z, Zheng X, Meng P, Wang Y, Li Y, Zhang Y, Yang J, Jia D, Ma C (2018) Impaired left atrial systolic function and inter-atrial dyssynchrony may contribute to symptoms of heart failure with preserved left ventricular ejection fraction: a comprehensive assessment by echocardiography. Int J Cardiol 257:177–181. https://doi.org/10.1016/j.ijcard.2017.12.042 CrossRefPubMed

42.

Eicher JC, Laurent G, Mathe A, Barthez O, Bertaux G, Philip JL, Dorian P, Wolf JE (2012) Atrial dyssynchrony syndrome: an overlooked phenomenon and a potential cause of ‘diastolic’ heart failure. Eur J Heart Fail 14(3):248–258. https://doi.org/10.1093/eurjhf/hfr169 CrossRefPubMed

43.

Laurent G, Eicher JC, Mathe A, Bertaux G, Barthez O, Debin R, Billard C, Philip JL, Wolf JE (2013) Permanent left atrial pacing therapy may improve symptoms in heart failure patients with preserved ejection fraction and atrial dyssynchrony: a pilot study prior to a national clinical research programme. Eur J Heart Fail 15(1):85–93. https://doi.org/10.1093/eurjhf/hfs150 CrossRefPubMed

44.

Kleemann T (2015) Cardiac contractility modulation. A new form of therapy for patients with heart failure and narrow QRS complex? Herz 40(7):945–951. https://doi.org/10.1007/s00059-015-4362-8 CrossRefPubMed

45.

Abi-Samra F, Gutterman D (2016) Cardiac contractility modulation: a novel approach for the treatment of heart failure. Heart Fail Rev 21(6):645–660. https://doi.org/10.1007/s10741-016-9571-6 CrossRefPubMedPubMedCentral

46.

Pappone C, Augello G, Rosanio S, Vicedomini G, Santinelli V, Romano M, Agricola E, Maggi F, Buchmayr G, Moretti G, Mika Y, Ben-Haim SA, Wolzt M, Stix G, Schmidinger H (2004) First human chronic experience with cardiac contractility modulation by nonexcitatory electrical currents for treating systolic heart failure: mid-term safety and efficacy results from a multicenter study. J Cardiovasc Electrophysiol 15(4):418–427CrossRefPubMed

47.

Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M (2016) Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol 203:1061–1066. https://doi.org/10.1016/j.ijcard.2015.10.208 CrossRefPubMed

48.

Borggrefe M, Mann DL (2018) Cardiac contractility modulation in 2018. Circulation 138(24):2738–2740. https://doi.org/10.1161/circulationaha.118.036460 CrossRefPubMed

49.

Health.ClinicalTrials.gov UNIo (2017) CCM in heart failure with preserved ejection fraction (CCM-HFpEF). https://clinicaltrials.gov/ct2/show/NCT03240237?titles=CCM+HFPEF&rank=1. Accessed 3 Dec 2018

50.

Yap SC (2015) Atrial fibrillation and stroke after atrial septal defect closure. Is earlier closure warranted? Heart 101(9):661–662. https://doi.org/10.1136/heartjnl-2015-307554 CrossRefPubMed

51.

Mojadidi MK, Zaman MO, Elgendy IY, Mahmoud AN, Patel NK, Agarwal N, Tobis JM, Meier B (2018) Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol 71(9):1035–1043. https://doi.org/10.1016/j.jacc.2017.12.059 CrossRefPubMed

52.

McCambridge J, Witton J, Elbourne DR (2014) Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol 67(3):267–277. https://doi.org/10.1016/j.jclinepi.2013.08.015 CrossRefPubMedPubMedCentral

53.

Burkhoff D, Maurer MS, Joseph SM, Rogers JG, Birati EY, Rame JE, Shah SJ (2015) Left atrial decompression pump for severe heart failure with preserved ejection fraction: theoretical and clinical considerations. JACC Heart Fail 3(4):275–282. https://doi.org/10.1016/j.jchf.2014.10.011 CrossRefPubMed

54.

Granegger M, Dave H, Knirsch W, Thamsen B, Schweiger M, Hubler M (2018) A valveless pulsatile pump for the treatment of heart failure with preserved ejection fraction: a simulation study. Cardiovasc Eng Technol 10:69–79. https://doi.org/10.1007/s13239-018-00398-8 CrossRefPubMed

Title: Novel percutaneous interventional therapies in heart failure with preserved ejection fraction: an integrative review
Authors: Alexandru Burlacu
Paul Simion
Ionut Nistor
Adrian Covic
Grigore Tinica
Publication date: 01-09-2019
Publisher: Springer US
Keyword: Heart Failure
Published in: Heart Failure Reviews / Issue 5/2019
Print ISSN: 1382-4147
Electronic ISSN: 1573-7322
DOI: https://doi.org/10.1007/s10741-019-09787-0

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The STEP trials

Springer Medicine

Novel percutaneous interventional therapies in heart failure with preserved ejection fraction: an integrative review

Abstract

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 5/2019

Invasive therapies for patients with concomitant heart failure and atrial fibrillation

Speckle tracking echocardiography in cardiac amyloidosis

Targeting transcriptional machinery to inhibit enhancer-driven gene expression in heart failure

Pathogenesis and pathophysiology of heart failure with reduced ejection fraction: translation to human studies

Right ventricular function after cardiac surgery: the diagnostic and prognostic role of echocardiography

The left atrium and the right ventricle: two supporting chambers to the failing left ventricle

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page