Lanz, Jonas

Okuno, Taishi

Pilgrim, Thomas

Praz, Fabien

Reineke, David

Siepe, Matthias

Stortecky, Stefan

Tomii, Daijiro

Windecker, Stephan

English

Bern Open Repository and Information System (BORIS)

source: https://doi.org/10.48350/182769 | downloaded: 7.8.20231Circ Cardiovasc Interv. 2023;16:e012796. DOI: 10.1161/CIRCINTERVENTIONS.122.012796 June 2023Circulation: Cardiovascular InterventionsRESEARCH LETTERStrategies for Treatment of Annular Rupture Complicating Transcatheter Aortic Valve Implantation: A Retrospective Analysis of the Bern TAVI RegistryDaijiro Tomii, MD; Thomas Pilgrim , MD, MSc; Taishi Okuno , MD; Jonas Lanz , MD, MSc; Fabien Praz , MD;  Stefan Stortecky , MD; Matthias Siepe , MD; Stephan Windecker , MD; David Reineke, MDAortic annular rupture is a life-threatening complica-tion of transcatheter aortic valve implantation (TAVI) requiring prompt rescue for hemodynamic stabiliza-tion. Transcatheter valve-in-valve implantation (TAV-in-TAV) has been suggested as rescue strategy to seal the site of annular rupture by increasing apposition of the first transcatheter prosthesis and extending the skirt-covered frame height by implantation of the second valve (Figure [A]).1 Available evidence is, however, limited to anecdotal reports. In this retrospective cohort study, we aimed to systematically review the clinical course of patients with TAVI with annular rupture according to the bailout strategy.Consecutive patients undergoing TAVI at a single institu-tion—Bern University Hospital, Switzerland—which is part of the nationwide SwissTAVI registry (https://www.clinicaltri-als.gov; Unique identifier: NCT01368250), were considered eligible for this study. The registry has been approved by the Bern Cantonal Ethics Committee, and patients provided writ-ten informed consent to participate. For the purpose of this study, any patient with annular rupture diagnosed by angi-ography or transesophageal echocardiography during TAVI was reviewed and categorized according to the manage-ment strategy: conservative management including isolated pericardial drainage and/or optimization of the coagulation status; rescue TAV-in-TAV to seal the annulus rupture site; and surgical bailout. Aortic root dimentions were evaluated in a dedicated Corelab using pre-procedural multidetector computed tomography as previously described.2 The cover index was calculated to determine the degree of valve over-sizing.3 Statistical analyses were performed using R for Win-dows 4.0.2 (R Foundation for Statistical Computing). The data underlying this article will be shared on reasonable request to the corresponding author.Among 3529 patients undergoing TAVI between August 2007 and May 2022 (balloon-expandable valves 52.4%; self-expanding valves 43.3%; and mechanically-expandable valves 4.2%), 18 patients (0.5%) experi-enced annular rupture complicating TAVI (Figure [B]). The incidence of annular rupture tended to decrease with time (0.93%, 0.56%, and 0.33%, respectively) when the study period was partitioned into tertiles (August 2007–June 2012; July 2012–May 2017; June 2017–May 2022). All TAV-in-TAV procedure were performed in 2021 and 2022. Among all patients with annular rupture, 12 patients (66.7%) were female, the median age was 84 years, and the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.7% (reference cohort without annular rupture: 48.6% female, 81 years of age, and 5.1% Society of Thoracic Surgeons Predicted Risk of Mortality Society of Thoracic Surgeons Predicted Risk of Mortality score). Moderate or greater left ven-tricular outflow tract calcification was observed in half of the patients with annular rupture, and 4 patients (23.5%) had multiple calcified nodules (reference cohort without  Correspondence to: Stephan Windecker, MD, Department of Cardiology, Inselspital, Bern University Hospital, Freiburgstrasse 18, CH-3010 Bern, Switzerland. Email stephan.windecker@insel.chFor Sources of Funding and Disclosures, see page xxx.© 2023 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.Circulation: Cardiovascular Interventions is available at www.ahajournals.org/journal/circinterventionsKey Words: aortic valve stenosis ◼ heart rupture ◼ thoracic surgery ◼ transcatheter aortic valve replacementDownloaded from http://ahajournals.org by on May 23, 20232Circ Cardiovasc Interv. 2023;16:e012796. DOI: 10.1161/CIRCINTERVENTIONS.122.012796 June 2023Tomii et al Rescue TAV-in-TAV implantationannular rupture: 22.3% and 6.8%, respectively). Most of the implanted transcatheter heart valves were balloon-expandable valves (83.3%). Relative oversizing of ≥10% and ≥20% of the cover index occurred in 7 (41.2%) and 1 (5.9%) patients, respectively (reference cohort without annular rupture: 38.8% and 4.7%, respectively). Postdila-tation was performed in 4 patients (22.2%; Figure [C]).All patients were hemodynamically unstable as a conse-quence of annular rupture. Among 18 patients with annu-lar rupture, 8 were managed conservatively, 5 underwent rescue TAV-in-TAV, and 5 patients were converted to bail-out surgery. Two patients were converted to surgery after rescue TAV-in-TAV (1 patient had insufficient percutaneous pericardial drainage, and 1 patient experienced type A aor-tic dissection with right coronary artery occlusion after TAV-in-TAV). The annular lesion, however, was in both converted patients sufficiently managed without the need to replace the valve surgically. Eight patients died within 30 days after TAVI; 5 in conservative management, 1 in rescue TAV-in-TAV, and 2 in bailout surgery, respectively (Figure [B]).Figure. Annular rupture complicating transcatheter aortic valve implantation.A, Angiography and transesophageal echocardiography showing extravasation indicative of annular rupture after first transcatheter heart valve deployment (solid red circle) with subsequent disappearance of the extravasation after rescue transcatheter valve-in-valve implantation (TAV-in-TAV; dotted red circle). B, Study flow chart. C, Baseline and procedural demographics in patients with annular rupture. LVOT indicates left ventricular outflow tract; MDCT, multidetector computed tomography; and STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality score.Downloaded from http://ahajournals.org by on May 23, 20233Circ Cardiovasc Interv. 2023;16:e012796. DOI: 10.1161/CIRCINTERVENTIONS.122.012796 June 2023Tomii et al Rescue TAV-in-TAV implantationOwing to improvements in TAVI technology, implanta-tion techniques, and increasing operator experience, the frequency of procedural complications requiring conver-sion to open heart surgery has declined during the past decade. Notwithstanding, annular rupture remains a feared and potentially fatal complication of TAVI requir-ing immediate attention. Previous studies suggested that annular rupture was associated with an increased risk for in-hospital death even among those undergoing bailout surgery.4,5 Moreover, patients with annular rupture may not be stabilized to undergo surgical bailout in view of rapid clinical deterioration. Our results suggest the feasibility of rescue TAV-in-TAV as a therapeutic measure to rapidly sta-bilize patients with annular rupture in suitable cases. This strategy, if successful, prevents hemodynamic deteriora-tion and may obviate the need for emergent sternotomy in some cases. The results also highlight that the outcome of emergency bailout surgery was favorable suggesting that on-site surgery is useful as part of a rescue strategy.The results should be interpreted with caution due to the small sample size and uncertainties regarding the type of rupture, patient selection, and clinical situations amenable for a TAV-in-TAV rescue strategy. Moreover, the choice between the treatment strategies was not systematic but driven at least in part by clinical context and patient condition rendering surgical conversion futile in selected cases. Therefore, a comparison of clinical outcomes between different strategies may be highly biased by the selection. Further studies are warranted to investigate the feasibility of rescue TAV-in-TAV for alternative treatment of annular rupture compared with routine surgical conversion.ARTICLE INFORMATIONAffiliationsDepartment of Cardiology (D.T., T.P., T.O., J.L., F.P., S.S., S.W.), and Department of Cardiac Surgery (M.S., D.R.), Cardiovascular Center, Bern University Hospital, Inselspital, University of Bern, Switzerland.Sources of FundingNone.DisclosuresDr Windecker reports research, travel or educational grants to the institution from Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, In-fraRedx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, V-Wave. He serves as unpaid advisory board member and/or unpaid member of the steer-ing/executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. He is also member of the steering/execu-tive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Pilgrim reports re-search grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik, personal fees from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Reineke reports travel expenses from Abbott, Edwards Lifesciences, and Medtronic. Dr Stortecky reports research grants to the institu-tion from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott and personal fees from Boston Scientific, Teleflex, and BTG. Dr Praz reports travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr Okuno reports speaker fees from Abbott. The other authors report no conflicts.REFERENCES 1. Yu Y, Vallely M, Ng MK. Valve-in-valve implantation for aortic annular rupture complicating transcatheter aortic valve replacement (TAVR). J Invasive Car-diol. 2013;25:409–410. 2. Okuno T, Asami M, Heg D, Lanz J, Praz F, Hagemeyer D, Brugger N, Gräni C, Huber A, Spirito A, et al. Impact of left ventricular outflow tract calcification on procedural outcomes after transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2020;13:1789–1799. doi: 10.1016/j.jcin.2020.04.015 3. Detaint D, Lepage L, Himbert D, Brochet E, Messika-Zeitoun D, Iung B, Vahanian A. Determinants of significant paravalvular regurgitation after trans-catheter aortic valve: implantation impact of device and annulus discongruence. JACC Cardiovasc Interv. 2009;2:821–827. doi: 10.1016/j.jcin.2009.07.003 4. Pineda AM, Harrison JK, Kleiman NS, Rihal CS, Kodali SK, Kirtane AJ, Leon MB, Sherwood MW, Manandhar P, Vemulapalli S, et al. Incidence and outcomes of surgical bailout during TAVR: insights from the STS/ACC TVT registry. JACC Cardiovasc Interv. 2019;12:1751–1764. doi: 10.1016/j.jcin.2019.04.026 5. Pasic M, Unbehaun A, Buz S, Drews T, Hetzer R. Annular rupture during transcatheter aortic valve replacement: classification, pathophysiology, diagnostics, treatment approaches, and prevention. JACC Cardiovasc Interv. 2015;8:1–9. doi: 10.1016/j.jcin.2014.07.020Downloaded from http://ahajournals.org by on May 23, 2023

Strategies for Treatment of Annular Rupture Complicating Transcatheter Aortic Valve Implantation: A Retrospective Analysis of the Bern TAVI Registry.

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Strategies for Treatment of Annular Rupture Complicating Transcatheter Aortic Valve Implantation: A Retrospective Analysis of the Bern TAVI Registry.

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