Hōʻike ka haʻawina hou i ka mālama ʻana no ka atrial shunt therapy

A HOLD Hoʻokuʻu ʻole 4 | eTurboNews | eTN
i kakauia ma Linda Hohnholz

ʻO Corvia Medical, Inc, kahi hui i hoʻolaʻa i ka hoʻololi ʻana i ka mālama ʻana i ka hōʻino ʻole o ka naʻau (HF), i kēia lā ua hoʻolaha i nā hopena mai kāna REDUCE LAP-HF II randomized clinical trial, e noiʻi ana i ka palekana a me ka pono o ka Corvia® Atrial Shunt i nā poʻe maʻi puʻuwai me ka mālama ʻia. (HFpEF) a i ʻole i hōʻemi iki ʻia (HFmrEF).

ʻOiai ʻaʻole kū ʻole ka hopena holoʻokoʻa o ka hoʻokolokolo, hōʻike ka ʻikepili i nā poʻe maʻi me ka hoʻomaʻamaʻa maʻamau pulmonary vascular resistance (PVR) a me ka ʻole o ka pacemaker, e hōʻike ana i kahi pūʻulu pane e loaʻa ana i ka pono lapaʻau koʻikoʻi, e hana ana i ka atrial shunting i ka lāʻau implantable mua e hōʻike i ka pono ma HFpEF . Ua hōʻike ʻia nā hopena i kēia lā ma ka hui ʻo Technology and Heart Failure Therapeutics (THT) 2022 a ua paʻi ʻia nā hopena mua ma ka pūnaewele ma The Lancet. Ke kali ʻia nei ka hoʻolaha ʻana o ka loiloi pūʻulu pane.     

"Ma kēia ʻano hoʻāʻo mua o kāna ʻano hana no kahi ʻano paʻakikī a heterogenous o ka puʻuwai puʻuwai, ua ʻike mākou i kahi heluna kanaka pane kūpono me ka pōmaikaʻi koʻikoʻi. ʻO ka hiki ke wānana i ka poʻe pane a me nā mea pane ʻole he mea hoʻohaʻahaʻa a ua hoʻonui nui i ko mākou ʻike i ke kuleana o ka atrial shunting i HFpEF, "wahi a Sanjiv Shah, MD, Polofesa o Medicine, Luna Hoʻokele no ka Bluhm Cardiovascular Institute, a me Luna Hoʻokele. o ka Polokalamu HFpEF ma Northwestern University Feinberg School of Medicine a me ka mea noiʻi poʻokela o ka hoʻokolokolo REDUCE LAP-HF II.

ʻO ka hoʻāʻo ʻo REDUCE LAP-HF II ka hoʻāʻo mua o ka pae III o ka honua no ka loiloi ʻana i kahi atrial shunt i nā poʻe maʻi hiki ʻole i ka puʻuwai e hōʻemi i nā hōʻailona HF, hoʻemi i nā halemai pili i ka HF a hoʻomaikaʻi i ka maikaʻi o ke ola ma o ka hoʻemi ʻana i ke kaomi atrial hema (LAP). He 626 mau mea maʻi i hoʻopaʻa ʻia ma nā kikowaena 89 ma waena o US, Kanada, ʻEulopa, Australia, a me Iapana. ʻO nā maʻi me ka PVR hoʻoikaika maʻamau, e hōʻike ana i ka loaʻa ʻole o ka maʻi pulmonary vascular disease (PVD), a me ka ʻole o ka pacemaker, loaʻa i ka pōmaikaʻi koʻikoʻi koʻikoʻi, me ka hōʻemi ʻana i nā hanana hōʻeha puʻuwai i hoʻohālikelike ʻia me sham (0.12 vs. 0.22 hanana i kēlā me kēia makahiki hoʻomanawanui, p= 0.007) a he ʻokoʻa koʻikoʻi a koʻikoʻi hoʻi i ka hoʻomaikaʻi ʻana i ke kūlana olakino ma mua o ka sham (+5.5 mau helu) e like me ka loiloi ʻia e ka Kansas City Cardiomyopathy Questionnaire (KCCQ).

"Ma mua o kēia noiʻi ʻana, ʻike mākou i nā mea maʻi me ka PVD koʻikoʻi ʻaʻole paha e pōmaikaʻi mai ka mālama ʻana i ka atrial shunt. Eia nō naʻe, ʻaʻole mākou i mahalo nui i ke kuleana koʻikoʻi o ka hoʻomaʻamaʻa hoʻomaʻamaʻa invasive i ka wehe ʻana i ke kiʻekiʻe o ka PVD e hiki ai i nā poʻe maʻi ke pōmaikaʻi mai ka atrial shunting, "i hoʻohui ʻia ʻo Barry Borlaug, MD, Professor of Medicine and Director of Circulatory Failure Research ma Mayo. Halemai. "ʻOiai e pono ana ke aʻo hou ʻana, me ke koho ʻana i ka mea maʻi kūpono, ʻo ka atrial shunting paha kahi koho maikaʻi loa no nā poʻe maʻi HFpEF me ka ʻole o kahi ʻano PVD. Ma REDUCE LAP-HF II, ua hoʻopaʻa ʻia nā maʻi i mālama ʻia me ka pulmonary vasculature maʻamau ma o ka hoʻomaʻamaʻa ʻana, ʻoi aku ka nui o ka loaʻa ʻana o ka pōmaikaʻi lapaʻau ma mua o ka hoʻomalu sham, me ka haʻahaʻa o ka hanana HF a me ka hoʻomaikaʻi KCCQ koʻikoʻi.

ʻOi aku ma mua o 26 miliona poʻe ma ka honua i loaʻa ka puʻuwai puʻuwai, 2 a ʻoi aku ka hapa o ka poʻe i loaʻa iā HFpEF, 3 i wehewehe ʻia ʻo ia ka pono nui loa i hoʻokō ʻole ʻia i ka lāʻau lapaʻau cardiovascular. "He mau manaʻo koʻikoʻi kēia mau ʻikepili ʻaʻole wale no ka Corvia Atrial Shunt, akā no nā hoʻāʻo hoʻomau a me ka wā e hiki mai ana e hoʻohana ana i nā mea hana atrial shunt a me nā kaʻina hana e mālama ai i ka pau ʻole o ka naʻau," wahi a Martin Leon, MD, Professor of Medicine a me Luna Hoʻokele o Interventional Cardiovascular Care ma Columbia University ʻO Irving Medical Center a me ka mea noiʻi kumu nui o ka hoʻokolokolo REDUCE LAP-HF II.

"Haʻaheo mākou ua alakaʻi ʻo REDUCE LAP-HF II iā mākou i kahi hōʻailona hōʻailona nui ma HFpEF a ke hana pū nei mākou me kā mākou mau ʻōlelo aʻoaʻo lapaʻau a me nā mea hoʻoponopono e hoʻonui i ke komo ʻana i kēia therapy novel," i ʻōlelo ai ʻo Jan Komtebedde, Hope Pelekikena Nui a me nā Kauka Lapaʻau Nui. Luna o Corvia Medical. Hoʻohui ʻo George Fazio, Luna Nui o Corvia Medical, "No nā makahiki he 12 i hala iho nei, ua hoʻolaʻa ʻia ʻo Corvia Medical i ka lawe ʻana i ka atrial shunting i nā miliona o nā maʻi maʻi puʻuwai hiki ke pōmaikaʻi, a ʻo mākou i kēia manawa hoʻokahi ala nui e kokoke ana i ka hoʻokō ʻana i kā mākou misionari. .”

He aha e lawe ʻia mai kēia ʻatikala:

  • The REDUCE LAP-HF II trial is the world’s first phase III trial to evaluate an atrial shunt in heart failure patients to reduce HF symptoms, decrease HF-related hospitalizations and improve quality of life through a reduction in left atrial pressure (LAP).
  • While the overall outcome of the trial was neutral, the data suggests patients with normal exercise pulmonary vascular resistance (PVR) and without a pacemaker, represent a responder group that derives significant clinical benefit, making atrial shunting the first implantable therapy to demonstrate effectiveness in HFpEF.
  • In REDUCE LAP-HF II, treated patients with normal pulmonary vasculature confirmed through exercise, had a significantly greater likelihood of clinical benefit than sham control, with a lower HF event rate and a significant and clinically meaningful KCCQ improvement.

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Linda Hohnholz

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