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Closure of Iatrogenic Atrial Septal Defect After Transcatheter Mitral Valve Repair

2020; Lippincott Williams & Wilkins; Volume: 143; Issue: 3 Linguagem: Inglês

10.1161/circulationaha.120.051989

1524-4539

Philipp Lurz, Matthias Unterhuber, Karl‐Philipp Rommel, Karl‐Patrik Kresoja, Tobias Kister, Christian Besler, Karl Fengler, Marcus Sandri, Ingo Daehnert, Hölger Thiele, Maximilian von Roeder, Stephan Blazek,

Infective Endocarditis Diagnosis and Management

HomeCirculationVol. 143, No. 3Closure of Iatrogenic Atrial Septal Defect After Transcatheter Mitral Valve Repair Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBClosure of Iatrogenic Atrial Septal Defect After Transcatheter Mitral Valve RepairThe Randomized MITHRAS Trial Philipp Lurz, MD, PhD, Matthias Unterhuber, MD, Karl-Philipp Rommel, MD, Karl-Patrik Kresoja, MD, Tobias Kister, MD, Christian Besler, MD, Karl Fengler, MD, Marcus Sandri, MD, Ingo Daehnert, MD, Holger Thiele, MD, Maximilian von Roeder, MD and Stephan Blazek, MD Philipp LurzPhilipp Lurz Philipp Lurz, MD, PhD, Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Struempellstrasse 39, D-04289 Leipzig, Germany. Email E-mail Address: [email protected] https://orcid.org/0000-0002-5993-4487 Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Leipzig Heart Institute, Germany (P.L., H.T.). Search for more papers by this author , Matthias UnterhuberMatthias Unterhuber https://orcid.org/0000-0002-8175-276X Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Karl-Philipp RommelKarl-Philipp Rommel https://orcid.org/0000-0002-2901-8138 Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Karl-Patrik KresojaKarl-Patrik Kresoja https://orcid.org/0000-0002-8616-6751 Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Tobias KisterTobias Kister Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Christian BeslerChristian Besler https://orcid.org/0000-0002-8082-6472 Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Karl FenglerKarl Fengler Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Marcus SandriMarcus Sandri Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Ingo DaehnertIngo Daehnert Department of Pediatric Cardiology (I.D.), Heart Center Leipzig at Leipzig University, Germany. Search for more papers by this author , Holger ThieleHolger Thiele Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. Leipzig Heart Institute, Germany (P.L., H.T.). Search for more papers by this author , Maximilian von RoederMaximilian von Roeder https://orcid.org/0000-0003-3939-2139 Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. *Drs von Roeder and Blazek contributed equally. Search for more papers by this author and Stephan BlazekStephan Blazek Department of Internal Medicine/Cardiology (P.L., M.U., K.-P.R., K.-P.K., T.K., C.B., K.F., M.S., H.T., M.v.R., S.B.), Heart Center Leipzig at Leipzig University, Germany. *Drs von Roeder and Blazek contributed equally. Search for more papers by this author Originally published15 Oct 2020https://doi.org/10.1161/CIRCULATIONAHA.120.051989Circulation. 2021;143:292–294Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: October 15, 2020: Ahead of Print Transcatheter mitral valve repair (TMVR) requires transseptal access to the left atrium, which creates a persistent iatrogenic atrial septal defect (iASD) in approximately 24% to 50% of patients.1,2 Post-TMVR iASD has been associated with right heart volume overload, as well as increased rates of heart failure (HF) hospitalization and death in some studies.1,2In contrast, other studies have shown an association between post-TMVR iASD and improved hemodynamics,3 a concept currently investigated in large-scale clinical trials in patients with HF.4The MITHRAS trial (Closure of Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair) is an investigator-initiated, single-center, randomized, open-label trial conducted at the Heart Center Leipzig at Leipzig University between January 2016 and September 2020 in patients with a relevant post-TMVR iASD comparing iASD transcatheter closure versus conservative therapy (CT; URL: https://www.clinicaltrials.gov, NCT03024268). The trial was approved by the local ethics committee, and all patients gave written informed consent.Consecutive patients underwent transthoracic and transesophageal echocardiography 30 days after TMVR and were eligible if a relevant iASD (fraction of pulmonary perfusion [Qp]/fraction of systemic perfusion [Qs] ≥1.3 and predominantly left-to-right shunt) was present. Exclusion criteria were interatrial shunt before TMVR, unsuccessful TMVR (no reduction in mitral regurgitation severity), additional valvular heart disease planned for surgery or intervention, malignancy limiting survival 0.05 for all).The 6-minute walk test distance did not differ between patients in the iASD closure and the CT groups (at randomization time point 272±124 versus 302±124 m and at follow-up 276±119 versus 301±118 m, Δ iASD occlusion 5±89 m versus Δ CT –1±83 m, P=0.75, P=0.92, P=0.76, respectively; Figure [B]). No significant differences in the change of NT-proBNP could be observed (iASD closure before versus after, 3105 [interquartile range, 1902 to 4134] versus 2259 [interquartile range, 1648 to 4804] Δ –846 CT before versus after 3653 [interquartile range, 1746 to 5848] versus 3374 [interquartile range, 1394 to 6065] Δ –279, P=0.44 for intergroup comparison). Transcatheter iASD closure was successful in all patients with a Qp/Qs of 1.0 at follow-up. Nineteen patients (46%) in the CT group demonstrated a reduction in Qp/Qs (<1.3), with a decrease in Qp/Qs ratio from 1.5 to 1.3 (P=0.02). There was no difference in HF rehospitalization and mortality (iASD occlusion versus CT, n=8 [21%] versus n=9 [23%], P=0.22).In conclusion, transcatheter iASD closure after TMVR was not superior to CT alone with respect to the primary or secondary end points. Positive effects of iASD closure on right-sided volume overload might be counterbalanced by negative implications of closure on left atrial pressures as shown by recent trials on iASD creation in patients with HF.4The inclusion criterion of Qp/Qs of ≥1.3 was based on the finding that a shunt fraction of 30% was proposed as the optimal balance between risks of right-sided volume overload and left atrial pressure reduction in patients with HF and previous trials on iASD creation.5 Results might differ in patients with larger intra-atrial left-to-right shunts.The finding of a relevant reduction in Qp/Qs in 45% in the CT group gives rise to the question of whether iASD closure at 1 month after TMVR might have been too early to differentiate patients who might benefit from closure as opposed to those patients with a certain likelihood of shunt reduction over time.The sample size of the randomized trial is small and based on previous assumptions that might have overestimated the intrinsic effect of iASD closure. Therefore, we cannot exclude a treatment effect that would be unraveled in a larger and more specific set of patients with post-TMVR iASD or at longer follow-up. Treatment effect might depend on left atrial and left ventricular filling pressures as well as degree of right ventricular failure and volume overload, but the actual sample size is too small for informative subgroup analysis.In this randomized, controlled trial involving patients with persistent iASD 1 month after TMVR, iASD closure did not improve functional or clinical midterm outcomes.AcknowledgmentsThe authors thank Martin Petzold, Margit Büttner, and Kai Trautmann for their support in the study organization.Sources of FundingThe study was supported by Leipzig Heart Institute and Occlutech.Disclosures Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifescience, Medtronic, ReCor, and Occlutech. The other authors report no conflicts.Footnotes*Drs von Roeder and Blazek contributed equally.https://www.ahajournals.org/journal/circData sharing: The data that support the findings of this study are available from the corresponding author on request.This work was presented as an abstract at Transcatheter Cardiovascular Therapeutics (TCT) Connect 2020, October 14–18, 2020.Philipp Lurz, MD, PhD, Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University, Struempellstrasse 39, D-04289 Leipzig, Germany. Email Philipp.[email protected]uni-leipzig.deReferences1. Schueler R, Öztürk C, Wedekind JA, Werner N, Stöckigt F, Mellert F, Nickenig G, Hammerstingl C. Persistence of iatrogenic atrial septal defect after interventional mitral valve repair with the MitraClip system: a note of caution.JACC Cardiovasc Interv.2015; 8:450–459. doi: 10.1016/j.jcin.2014.10.024CrossrefMedlineGoogle Scholar2. Toyama K, Rader F, Kar S, Kubo S, Shiota T, Nishioka T, Siegel RJ. Iatrogenic atrial septal defect after percutaneous mitral valve repair with the MitraClip system.Am J Cardiol.2018; 121:475–479. doi: 10.1016/j.amjcard.2017.11.006CrossrefMedlineGoogle Scholar3. Hoffmann R, Altiok E, Reith S, Brehmer K, Almalla M. Functional effect of new atrial septal defect after percutaneous mitral valve repair using the MitraClip device.Am J Cardiol.2014; 113:1228–1233. doi: 10.1016/j.amjcard.2013.12.035CrossrefMedlineGoogle Scholar4. Feldman T, Mauri L, Kahwash R, Litwin S, Ricciardi MJ, van der Harst P, Penicka M, Fail PS, Kaye DM, Petrie MC, et al.; REDUCE LAP-HF I Investigators and Study Coordinators. 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.2018; 137:364–375. doi: 10.1161/CIRCULATIONAHA.117.032094LinkGoogle Scholar5. Kaye D, Shah SJ, Borlaug BA, Gustafsson F, Komtebedde J, Kubo S, Magnin C, Maurer MS, Feldman T, Burkhoff D. Effects of an interatrial shunt on rest and exercise hemodynamics: results of a computer simulation in heart failure.J Card Fail.2014; 20:212–221. doi: 10.1016/j.cardfail.2014.01.005CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Maier O, Hellhammer K, Horn P, Afzal S, Jung C, Westenfeld R, Zeus T, Kelm M and Veulemans V (2021) Iatrogenic atrial septal defect persistence after percutaneous mitral valve repair: a meta-analysis, Acta Cardiologica, 10.1080/00015385.2021.1899484, 77:2, (166-175), Online publication date: 7-Feb-2022. 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