Ábendingar og árangur ósæðarlokuísetningar með þræðingartækni (TAVI) á Íslandi

Abstract

INNGANGUR Ósæðarlokuþrengsl eru algengasti lokusjúkdómurinn á Vesturlöndum. Hefðbundin meðferð við alvarlegum þrengslum hefur verið opin ósæðarlokuskipti en síðastliðin ár hefur ósæðarlokuísetning með þræðingartækni (TAVI) rutt sér til rúms hér á landi sem erlendis. Markmið rannsóknarinnar var að kanna árangur TAVI-aðgerða á Íslandi með áherslu á ábendingar, fylgikvilla og lifun. EFNIVIÐUR OG AÐFERÐIR Rannsóknin var afturskyggn og tók til allra TAVI-aðgerða sem framkvæmdar hafa verið á Íslandi frá janúar 2012 til loka júní 2020. Skráðir voru bakgrunnsþættir sjúklinga, afdrif og fylgikvillar en einnig heildarlifun sem borin var saman við íslenskt viðmiðunarþýði af sama kyni og aldri. Meðal eftirfylgd var 2,4 ár. NIÐURSTÖÐUR Alls voru framkvæmdar 189 aðgerðir (meðalaldur 83 ± 6 ár, 41,8% konur), allar með sjálfþenjandi lífrænni gerviloku. Flestir sjúklingar (81,5%) höfðu alvarleg hjartabilunareinkenni (NYHA-flokkar III-IV) og miðgildi EuroSCORE-II var 4,9 (bil 0,9-32). Á hjartaómskoðun fyrir aðgerð var hámarks þrýstingsfallandi að meðaltali 78 mmHg og lokuflatarmál 0,67 cm2. Rúmlega fjórðungur (26,5%) sjúklinga þurfti ísetningu varanlegs gangráðs í kjölfar TAVI-aðgerðar. Aðrir fylgikvillar voru oftast æðatengdir (13,8%), en hjartaþröng greindist í 3,2% tilfella og heilablóðfall í 2,6%. Mikill randstæður leki við gerviloku sást hjá 0,5% sjúklinga. Dánartíðni innan 30 daga frá aðgerð var 1,6% (n=3) og lifun einu ári frá aðgerðadegi 93,5% (95% ÖB: 89.8-97.3). Heildarlifun var sambærileg lifun viðmiðunarþýðis af sama kyni og sama aldri (p=0,23). ÁLYKTANIR Árangur TAVI-aðgerða hér á landi er mjög góður, ekki síst þegar litið er til lágrar 30 daga dánartíðni og heildarlifunar sem var sambærileg og hjá viðmiðunarþýði. Auk þess var tíðni alvarlegra fylgikvilla lág. INTRODUCTION: Surgical aortic valve replacement (SAVR) has been the standard of treatment for aortic stenosis but transcatheter aortic valve implantation (TAVI) is increasingly used as treatment in Iceland and elsewhere. Our objective was to assess the outcome of TAVI in Iceland, focusing on indications, complications and survival. MATERIAL AND METHODS: This retrospective study included all TAVI-procedures performed in Iceland between January 2012 and June 2020. Patient characteristics, outcome and complications were registered, and overall estimated survival compared to an age and sex matched Icelandic reference-population. The mean follow-up was 2.4 years. RESULTS: Altogether 189 TAVI procedures (mean age 83±6 years, 41.8% females), were performed, all with a self-expanding biological valve. Most patients (81.5%) had symptoms of severe heart failure (NYHA-class III-IV) and median EuroSCORE-II was 4.9 (range: 0.9-32). Echocardiography pre-TAVI showed a mean aortic-valve area of 0.67 cm2 and a max aortic-valve gradient of 78 mmHg. One out of four patients (26.5%) needed permanent pacemaker implantation following TAVI. Other complications were mostly vascular-related (13.8%) but cardiac cardiac temponade and stroke occurred in 3.2 and 2.6% of cases, respectively and severe paravalvular aortic valve regurgitation in 0.5% cases. Thirty-day mortality was 1.6% (n=3) with one-year survival of 93.5% (95% CI: 89.8-97.3). Finally long-term survival survival of TAVI-patients was similar to the matched reference population (p=0.23). CONCLUSIONS: The outcome of TAVI-procedures in Iceland is good, especially regarding 30-day mortality and long-term survival that was comparable to a reference population. Incidence of major complications was also low.

INTRODUCTION: Surgical aortic valve replacement (SAVR) has been the standard of treatment for aortic stenosis but transcatheter aortic valve implantation (TAVI) is increasingly used as treatment in Iceland and elsewhere. Our objective was to assess the outcome of TAVI in Iceland, focusing on indications, complications and survival. MATERIAL AND METHODS: This retrospective study included all TAVI-procedures performed in Iceland between January 2012 and June 2020. Patient characteristics, outcome and complications were registered, and overall estimated survival compared to an age and sex matched Icelandic reference-population. The mean follow-up was 2.4 years. RESULTS: Altogether 189 TAVI procedures (mean age 83?}6 years, 41.8% females), were performed, all with a self-expanding biological valve. Most patients (81.5%) had symptoms of severe heart failure (NYHA-class III-IV) and median EuroSCORE-II was 4.9 (range: 0.9-32). Echocardiography pre-TAVI showed a mean aortic-valve area of 0.67 cm2 and a max aorticvalve gradient of 78 mmHg. One out of four patients (26.5%) needed permanent pacemaker implantation following TAVI. Other complications were mostly vascular-related (13.8%) but cardiac cardiac temponade and stroke occurred in 3.2 and 2.6% of cases, respectively and severe paravalvular aortic valve regurgitation in 0.5% cases. Thirty-day mortality was 1.6% (n=3) with one-year survival of 93.5% (95% CI: 89.8-97.3). Finally long-term survival survival of TAVI-patients was similar to the matched reference population (p=0.23). CONCLUSIONS: The outcome of TAVI-procedures in Iceland is good, especially regarding 30-day mortality and long-term survival that was comparable to a reference population. Incidence of major complications was also low.