Response to exercise is key to novel device therapy for the most common
type of heart failure

Date:
February 1, 2022
Source:
Northwestern Memorial HealthCare
Summary:
A new study suggests that some patients with HFpEF may benefit
from a novel, minimally invasive cardiac implant device called an
atrial shunt.

The study also offers new insight into the role exercise plays in
understanding, diagnosing and treating this type of heart failure.



FULL STORY ========================================================================== Heart failure with preserved ejection fraction (HFpEF), also called
diastolic heart failure, affects 3 million Americans. Despite being
the most common type of heart failure in the United States, effective treatments remain elusive, leading to high morbidity and mortality.


========================================================================== "HFpEF makes up half all heart failure cases, yet we have very limited treatment options," said Sanjiv Shah, MD,director of research at
the Bluhm Cardiovascular Institute and director of the Northwestern
Medicine HFpEF Program. "Most standard therapies for heart failure are ineffective in this condition, leaving a major unmet need for a large
patient population." This type of heart failure occurs when the left
ventricle is unable to relax, limiting the amount of blood filling
into the heart, which causes fluid to build up in the lungs and the
body, causing symptoms including shortness of breath, fluid retention, irregular heartbeat, and exercise intolerance.

A Northwestern Medicine-led study published in The Lancet suggests that
some patients with HFpEF may benefit from a novel, minimally invasive
cardiac implant device called an atrial shunt. The study also offers
new insight into the role exercise plays in understanding, diagnosing
and treating this type of heart failure.

"While the overall trial was neutral, in our subgroup analyses, we found
that what happens in the heart and lungs during exercise is of prime
importance in this type of heart failure," said Dr. Shah, international principal investigator of the trial. "The normal response to exercise is relaxation of the blood vessels in the lungs. Patients with HFpEF who
are able to relax the blood vessels in their lungs appear to do well
with the device, whereas those whose blood vessels can't relax appear
to do worse when an atrial shunt is implanted." An atrial shunt is
placed through a catheter, creating a small hole between the left and
right atria allowing blood to flow from the stiff left atrium to the
normal right atrium, potentially lowering pressure in the left atrium
and reducing the symptoms of HFpEF. The procedure is minimally invasive, low-risk and patients go home the next day.

"What we saw in this study is encouraging and suggests that future
clinical trials should specifically investigate the subgroup of patients
with HFpEF whose pulmonary blood vessels respond normally to exercise,"
said Dr. Shah. "If future trials validate what we found, the potential
is enormous. This subgroup comprises two thirds of people with this
type of heart failure -- that is 2 million people could benefit from
this innovative therapy. This simple, one- time procedure could reduce hospitalizations and significantly improve quality of life." While cardiovascular conditions such as coronary artery disease are routinely diagnosed with exercise testing, clinical assessment for HFpEF is done
at rest -- something that Dr. Shah hopes will change following this trial.

"This has potential to change the way we evaluate patients with this
condition and should guide how future clinical trials are conducted and
the criteria for enrollment," said Dr. Shah.

The Corvia REDUCE LAP-HF II pivotal trial is the largest device study
ever conducted in HFpEF and the first pivotal trial of interatrial
shunts completed.

The results were also presented today at the Cardiology Research
Foundation (CRF)'s Technology and Technology and Heart Failure
Therapeutics meeting.

========================================================================== Story Source: Materials provided by
Northwestern_Memorial_HealthCare. Note: Content may be edited for style
and length.


========================================================================== Journal Reference:
1. Sanjiv J Shah, Barry A Borlaug, Eugene S Chung, Donald E Cutlip,
Philippe
Debonnaire, Peter S Fail, Qi Gao, Gerd Hasenfuss, Rami Kahwash,
David M Kaye, Sheldon E Litwin, Philipp Lurz, Joseph M Massaro,
Rajeev C Mohan, Mark J Ricciardi, Scott D Solomon, Aaron L Sverdlov,
Vijendra Swarup, Dirk J van Veldhuisen, Sebastian Winkler, Martin
B Leon, Joseph Akar, Jiro Ando, Toshihisa Anzai, Masanori Asakura,
Steven Bailey, Anupam Basuray, Fabrice Bauer, Martin Bergmann,
John Blair, Jeffrey Cavendish, Eugene Chung, Maja Cikes, Ira
Dauber, Erwan Donal, Jean-Christophe Eicher, Peter Fail, James
Flaherty, Xavier Freixa, Sameer Gafoor, Zachary Gertz, Robert
Gordon, Marco Guazzi, Cesar Guerrero-Miranda, Deepak Gupta, Finn
Gustafsson, Cyrus Hadadi, Emad Hakemi, Louis Handoko, Moritz Hass,
Jorg Hausleiter, Christopher Hayward, Gavin Hickey, Scott Hummel,
Imad Hussain, Richard Isnard, Chisato Izumi, Guillaume Jondeau,
Elizabeth Juneman, Koichiro Kinugawa, Robert Kipperman, Bartek
Krakowiak, Selim Krim, Joshua Larned, Gregory Lewis, Erik Lipsic,
Anthony Magalski, Sula Mazimba, Jeremy Mazurek, Michele McGrady,
Scott Mckenzie, Shamir Mehta, John Mignone, Hakim Morsli, Ajith
Nair, Thomas Noel, James Orford, Kishan Parikh, Tiffany Patterson,
Martin Penicka, Mark Petrie, Burkert Pieske, Martijn Post, Philip
Raake, Alicia Romero, John Ryan, Yoshihiko Saito, Takafumi Sakamoto,
Yasushi Sakata, Michael Samara, Kumar Satya, Andrew Sindone, Randall
Starling, Jean-Noe"l Trochu, Bharathi Upadhya, Jan van der Heyden,
Vanessa van Empel, Amit Varma, Amanda Vest, Tobias Wengenmayer,
Ralf Westenfeld, Dirk Westermann, Kazuhiro Yamamoto, Andreas
Zirlik. Atrial shunt device for heart failure with preserved and
mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised,
multicentre, blinded, sham-controlled trial. The Lancet, 2022;
DOI: 10.1016/S0140-6736 (22)00016-2 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/02/220201115146.htm

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