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Manufacturing Better Outcomes in Cardiovascular Intervention: 3D Printing in Clinical Practice Today

  • Imaging (Q Truong, Section Editor)
  • Published:
Current Treatment Options in Cardiovascular Medicine Aims and scope Submit manuscript

Abstract

Purpose of review

Describe and evaluate the integration of 3D printing-related innovations into current cardiovascular treatment paradigms and examine the state of regulatory and reimbursement hurdles ahead.

Recent findings

Mounting years of clinical experience have established the utility of printed models of patient anatomy in numerous treatment and teaching scenarios, most notably as pre- and intra-procedural planning tools guiding decision-making for congenital heart disease and catheter-based interventions. In part due to a continued lack of reimbursement and under-defined (and slow to evolve) regulatory status, these use cases remain largely investigational even as they grow increasingly routine. Patients, physicians, and/or imaging centers therefore remain burdened by the associated cost to create such models, and the perceptual and decision-making enhancements, while demonstrable and significant, still may not clearly or independently justify a potentially high cost.

Simulation and implantable device applications may represent a deeper well of unrealized value in cardiovascular intervention; however, further development of these applications relies on—and is throttled by—progress in material science and tissue-engineering research. The relevance of simulation applications in recent years is also now in competition with digital analogs including augmented and virtual reality. Innovative incorporation of alternative manufacturing processes such as porous scaffold infusion, injection molding, and vascular mesh forming can provide immediate access to more realistic tissue-mimicking materials and custom implantable devices, while comparable and directly printable materials continue to be developed. Tissue-engineering applications remain years if not decades away from a more substantive role in translatable clinical research. Regulatory challenges associated with in-house manufacture of implantable investigational devices are complex and subject to change, and the success of some in navigating these hurdles in non-cardiovascular applications is instructive and encouraging.

Summary

Complex geometries characterizing cardiovascular anatomy are an ideal use case for translating the perceptual advantages of printed models of patient anatomy into better decision-making, especially so in the setting of congenital or post-surgical anatomy. Procedural planning applications take further advantage of the demonstrably robust dimensional reproduction of patient anatomy, with notably rapid integration into surgical and catheter-based intervention workflows. Despite a continued lack of codification in the healthcare system, 2018 could be a milestone year for 3D printing services, pending a successful application for a CPT Category III designation.

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References and Recommended Reading

  1. Ogden KM, Aslan C, Ordway N, Diallo D, Tillapaugh-Fay G, Soman P. Factors affecting dimensional accuracy of 3-D printed anatomical structures derived from CT data. J Digit Imaging. 2015 Dec 16 [cited 2018 Jun 15];28(6):654–63. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636725/pdf/10278_2015_Article_9803.pdf

    Article  Google Scholar 

  2. Binder TM, Moertl D, Mundigler G, Rehak G, Franke M, Delle-Karth G, et al. Stereolithographic biomodeling to create tangible hard copies of cardiac structures from echocardiographic data in vitro and in vivo validation. J Am Coll Cardiol. 1999 [cited 2018 Jun 13];35:230–7. Available from: https://pdfs.semanticscholar.org/fc68/fc1387311e370d115dfad3777ed94670a7c6.pdf

    Article  CAS  Google Scholar 

  3. Ripley B, Kelil T, Cheezum MK, Goncalves A, Di Carli MF, Rybicki FJ, et al. 3D printing based on cardiac CT assists anatomic visualization prior to transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2016 [cited 2018 May 31];10:28–36. Available from: https://ac-els-cdn-com.ezproxy.med.cornell.edu/S1934592515300241/1-s2.0-S1934592515300241-main.pdf?_tid=5fc1f55a-9403-4661-ac84-7cbd85613de1&acdnat=1527795189_e6f36e28a4cc59f815161dab49d3e2cf.

    Article  Google Scholar 

  4. Shibata E, Takao H, Amemiya S, Ohtomo K. 3D-printed visceral aneurysm models based on CT data for simulations of endovascular embolization: evaluation of size and shape accuracy. Am J Roentgenol 2017 Aug;209(2):243–247. Available from: https://doi.org/10.2214/AJR.16.17694

    Article  Google Scholar 

  5. Olivieri LJ, Krieger A, Loke Y-H, Nath DS, Kim PCW, Sable CA. Three-dimensional printing of intracardiac defects from three-dimensional echocardiographic images: feasibility and relative accuracy. J Am Soc Echocardiogr. 2015 Apr [cited 2018 Jun 15];28(4):392–397. Available from: https://www-clinicalkey-com.ezproxy.med.cornell.edu/service/content/pdf/watermarked/1-s2.0-S089473171400995X.pdf?locale=en_US.

    Article  Google Scholar 

  6. Maragiannis D, Jackson MS, Igo SR, Schutt RC, Connell P, Grande-Allen J, et al. Replicating patient-specific severe aortic valve stenosis with functional 3D modeling. Circ Cardiovasc Imaging. 2015 Oct;8(10):e003626 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26450122.

  7. Goitein O, Fink N, Guetta V, Beinart R, Brodov Y, Konen E, et al. Printed MDCT 3D models for prediction of left atrial appendage (LAA) occluder device size: a feasibility study. EuroIntervention. 2017 Oct;13(9):e1076–9. Available from: http://www.pcronline.com/eurointervention/124th_issue/163

    Article  Google Scholar 

  8. Mosadegh B, Xiong G, Dunham S, Min JK. Current progress in 3D printing for cardiovascular tissue engineering. Biomed Mater. 2015 [cited 2018 May 31];10(3):034002. Available from: http://iopscience.iop.org.ezproxy.med.cornell.edu/article/10.1088/1748-6041/10/3/034002/pdf

    Article  Google Scholar 

  9. Kankala RK, Zhu K, Li J, Wang CS, Wang S Bin, Chen AZ. Fabrication of arbitrary 3D components in cardiac surgery: from macro-, micro- to nanoscale [Internet]. Vol. 9, Biofabrication 2017 [cited 2018 May 31]. Available from: https://doi.org/10.2214/AJR.16.17694

    Article  Google Scholar 

  10. Huotilainen E, Paloheimo M, Salmi M, Paloheimo K-S, Bjö Rkstrand R, Tuomi J, et al. Imaging requirements for medical applications of additive manufacturing. [cited 2018 Jun 15]; Available from: https://doi.org/10.1088/1758-5090/aa8113

    Article  Google Scholar 

  11. Farooqi K. Rapid prototyping in cardiac disease [Internet]. Farooqi KM, editor. Cham: Springer International Publishing; 2017 [cited 2018 May 31]. Available from: https://link-springer-com.ezproxy.med.cornell.edu/content/pdf/10.1007%2F978-3-319-53523-4.pdf

  12. Bramlet M, Olivieri L, Farooqi K, Ripley B, Coakley M. Impact of three-dimensional printing on the study and treatment of congenital heart disease. Circ Res 2017 Mar 17;120(6):904–907. Available from: https://doi.org/10.1161/CIRCRESAHA.116.310546

    Article  CAS  Google Scholar 

  13. Yang DH, Kang J, Kim N, Song J, Lee J, Lim T. Myocardial 3-dimensional printing for septal myectomy guidance in a patient with obstructive hypertrophic cardiomyopathy. Circulation [Internet]. 2015 Jul 28;132(4):300–1. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26216088, 301

    Article  Google Scholar 

  14. O’Neill B, Wang DD, Pantelic M, Song T, Guerrero M, Greenbaum A, et al. Transcatheter caval valve implantation using multimodality imaging: roles of TEE, CT, and 3D printing. JACC Cardiovasc Imaging. 2015;8(2):221–5 Available from: https://doi.org/10.1016/j.jcmg.2014.12.006.

    PubMed  Google Scholar 

  15. Valverde I, Gomez G, Coserria JF, Suarez-Mejias C, Uribe S, Sotelo J, et al. 3D printed models for planning endovascular stenting in transverse aortic arch hypoplasia. Catheter Cardiovasc Interv. 2015;85(6):1006–12 Available from: http://doi.wiley.com/10.1002/ccd.25810.

    Article  Google Scholar 

  16. Chaowu Y, Hua L, Xin S. Three-dimensional printing as an aid in transcatheter closure of secundum atrial septal defect with rim deficiency. Circulation. 2016;133(17):e608–10 Available from: http://circ.ahajournals.org/.

    Article  Google Scholar 

  17. Al Jabbari O, Abu Saleh WK, Patel AP, Igo SR, Reardon MJ. Use of three-dimensional models to assist in the resection of malignant cardiac tumors. J Card Surg. 2016;31(9):581–3 Available from: http://doi.wiley.com/10.1111/jocs.12812.

    Article  Google Scholar 

  18. Liu P, Liu R, Zhang Y, Liu Y, Tang X, Cheng Y. The value of 3D printing models of left atrial appendage using real-time 3D transesophageal echocardiographic data in left atrial appendage occlusion: applications toward an era of truly personalized medicine. Cardiology. 2016 [cited 2018 May 31];135(4):255–61. Available from: www.karger.com/crd

    Article  Google Scholar 

  19. Pellegrino PL, Fassini G, Di Biase M, Tondo C. Left atrial appendage closure guided by 3D printed cardiac reconstruction: emerging directions and future trends. J Cardiovasc Electrophysiol. 2016;27(6):768–71.

    Article  Google Scholar 

  20. Little SH, Vukicevic M, Avenatti E, Ramchandani M, Barker CM. 3D printed modeling for patient-specific mitral valve intervention repair with a clip and a plug. 2016 [cited 2017 Sep 21]; Available from: http://ac.els-cdn.com/S1936879816002831/1-s2.0-S1936879816002831-main.pdf?_tid=93cf9be8-9ed6-11e7-823b-00000aab0f6b&acdnat=1506003189_0e2628992f86e009f5bca84079d5c81d

  21. Farooqi KM, Saeed O, Zaidi A, Sanz J, Nielsen JC, Hsu DT, et al. 3D printing to guide ventricular assist device placement in adults with congenital heart disease and heart failure. JACC Hear Fail. 2016 Apr [cited 2018 May 31];4(4):301–311. Available from: http://www.acc.org/jacc-journals-cme

    PubMed  Google Scholar 

  22. Treasure T, Petrou M, Rosendahl U, Austin C, Rega F, Pirk J, et al. Personalized external aortic root support: a review of the current status. Eur J Cardio-Thoracic Surg. 2016 Sep [cited 2018 Jun 13];50(3):400–404. Available from: https://watermark.silverchair.com/ezw078.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAaMwggGfBgkqhkiG9w0BBwagggGQMIIBjAIBADCCAYUGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMrKojTp6Po63l9mBMAgEQgIIBVqgYVRmccWv1gqfJhLPpqHQwbaSXFYhYXsAGeGxPAwaOsOCe.

    Article  Google Scholar 

  23. Li H, Qingyao, Bingshen, Shu M, Lizhong, Wang X, et al. Application of 3D printing technology to left atrial appendage occlusion. Int J Cardiol. 2017 Mar [cited 2018 May 31];231:258–63. Available from: https://ac-els-cdn-com.ezproxy.med.cornell.edu/S0167527316324524/1-s2.0-S0167527316324524-main.pdf?_tid=786664e8-28c0-46bd-b970-95f5251c26b5&acdnat=1527797167_fc9d08f73da5daf8cfd33c4e4cfd4d08.

    Article  Google Scholar 

  24. Smith ML, McGuinness J, O’Reilly MK, Nolke L, Murray JG, Jones JFX. The role of 3D printing in preoperative planning for heart transplantation in complex congenital heart disease. Irish J Med Sci (1971 -). 2017 Aug 25 [cited 2018 May 31];186(3):753–756. Available from: https://link-springer-com.ezproxy.med.cornell.edu/content/pdf/10.1007%2Fs11845-017-1564-5.pdf

  25. Yoo S-J, van Arsdell GS. 3D printing in surgical management of double outlet right ventricle. Front Pediatr 2018 Jan 10;5(January):1–6. Available from: https://doi.org/10.3389/fped.2017.00289

  26. Giannopoulos AA, Mitsouras D, Yoo S-J, Liu PP, Chatzizisis YS, Rybicki FJ. Applications of 3D printing in cardiovascular diseases. Nat Rev Cardiol 2016;13(12):701–718. Available from: https://doi.org/10.1038/nrcardio.2016.170

    Article  CAS  Google Scholar 

  27. Sun Z. A systematic review of 3-D printing in cardiovascular and cerebrovascular diseases. Anatol J Cardiol. 2017 [cited 2018 May 31]; Available from: www.anatoljcardiol.com

  28. Valverde I. Three-dimensional printed cardiac models: applications in the field of medical education, cardiovascular surgery, and structural heart interventions. Rev Española Cardiol (English Ed. 2017 Apr [cited 2018 May 31];70(4):282–291. Available from: https://ac-els-cdn-com.ezproxy.med.cornell.edu/S1885585717300440/1-s2.0-S1885585717300440-main.pdf?_tid=72fe828a-a918-4244-8d4e-93b7726f9d2b&acdnat=1527798117_e58d8dd4bdfb7bbd8b79fb7708b81d80.

  29. El Sabbagh A, Eleid MF, Al-Hijji M, Anavekar NS, Holmes DR, Nkomo VT, et al. The various applications of 3D printing in cardiovascular diseases. Curr Cardiol Rep. 2018 Jun 10 [cited 2018 May 31];20(6):47. Available from: https://link-springer-com.ezproxy.med.cornell.edu/content/pdf/10.1007%2Fs11886-018-0992-9.pdf

  30. Shiraishi I, Yamagishi M, Hamaoka K, Fukuzawa M, Yagihara T. Simulative operation on congenital heart disease using rubber-like urethane stereolithographic biomodels based on 3D datasets of multislice computed tomography☆. Eur J Cardio-Thoracic Surg. 2009 Sep 15 [cited 2018 Jun 15]; Available from: https://watermark.silverchair.com/37-2-302.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAaswggGnBgkqhkiG9w0BBwagggGYMIIBlAIBADCCAY0GCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMb7Pj3Nq2qe9NtbiJAgEQgIIBXjQV8pt-ojc9PnSzvbw1kBCO0XrhnzQEJxFGhsb3qL-Hg3.

  31. Riesenkampff E, Rietdorf U, Wolf I, Schnackenburg B, Ewert P, Huebler M, et al. The practical clinical value of three-dimensional models of complex congenitally malformed hearts. J Thorac Cardiovasc Surg. 2009 Sep [cited 2018 Jun 22];138(3):571–580. Available from: https://www.jtcvs.org/article/S0022-5223(09)00412-7/pdf.

    Article  Google Scholar 

  32. Kiraly L, Tofeig M, Jha NK, Talo H. Three-dimensional printed prototypes refine the anatomy of post-modified Norwood-1 complex aortic arch obstruction and allow presurgical simulation of the repair. Interact Cardiovasc Thorac Surg. 2016 Feb [cited 2018 Jun 22];22(2):238–40. Available from: https://watermark.silverchair.com/ivv320.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAaMwggGfBgkqhkiG9w0BBwagggGQMIIBjAIBADCCAYUGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMZpEIIPV6gqxkVkHhAgEQgIIBVlxnjjjmz5LONdJwfk0Hy5Wo6L41UBjGmpqRnzFMRRQfHlTJwKdAqs1Gz_SpeMYrdyv1pH-RswCUrPt23AZAp-Ya-dWc0jc1hUNKyvrBvSiZrsTFoior5Za7B01b-2AVZcief2vXWuaUBAlB0qlIaln9VnSIwZDkrfWLX_E-7PEkAUYlmf4kZ_BN9eAug0nGMo0RwPZrTsZOtvX9aodywpPSPvj-F5qgli49oHPWINDZRUvb5fxbSVfTvZzGwa0y1D9ZoN-_dbG_-_UXznBkO1TVGiea1u56r5htPUufYO7B-oTUg-1iQIG0IyIRjz8iZGMwEFt10y2-6Pb43TZmenSFxf-G6y9PLbzkcAMvekvNoxfmBD4BKerBvyeox6BP1hQEB-Rix6zAjOLDK-B9LUj8egOm8CTzncV6zTExRjze75UpHyqcE-mwz9hUChrUtC8nkLkPnA.

  33. Yoo S-J, Spray T, Austin EH, Yun T-J, van Arsdell GS. Hands-on surgical training of congenital heart surgery using 3-dimensional print models. J Thorac Cardiovasc Surg. 2017 Jun [cited 2017 Sep 21];153(6):1530–40. Available from: https://www-clinicalkey-com.ezproxy.med.cornell.edu/service/content/pdf/watermarked/1-s2.0-S0022522317301848.pdf?locale=en_US.

    Article  Google Scholar 

  34. Mahmood F, Owais K, Taylor C, Montealegre-Gallegos M, Manning W, Matyal R, et al. Three-dimensional printing of mitral valve using echocardiographic data [Internet]. Vol. 8, JACC Cardiovasc Imaging 2015 [cited 2018 May 31]. p. 227–9. Available from: https://doi.org/10.1016/j.jcmg.2014.06.020, 229

    PubMed  Google Scholar 

  35. Hermsen JL, Burke TM, Seslar SP, Owens DS, Ripley BA, Mokadam NA, et al. Scan, plan, print, practice, perform: development and use of a patient-specific 3-dimensional printed model in adult cardiac surgery. J Thorac Cardiovasc Surg. 2017 Jan [cited 2018 May 31];153(1):132–140. Available from: https://www.jtcvs.org/article/S0022-5223(16)30937-0/pdf.

    Article  Google Scholar 

  36. ACEO® Technology GmbH- 3D Silicone Print Layer by Layer [Internet]. [cited 2018 Jun 10]. Available from: https://www.aceo3d.com/technology/

  37. Grant EK, Olivieri LJ. The role of 3-D heart models in planning and executing interventional procedures. Can J Cardiol. 2017 [cited 2018 Jun 15];33:1074–1081. Available from: https://ac-els-cdn-com.ezproxy.med.cornell.edu/S0828282X17300740/1-s2.0-S0828282X17300740-main.pdf?_tid=ce2b422f-8b9a-40c0-b7d4-debd05428a5e&acdnat=1529087141_a5ee3024df02948f20f64d7db20bd4ce.

    Article  Google Scholar 

  38. Kim Y, Kim H, Kim YO. Virtual reality and augmented reality in plastic surgery: a review. Archives of Plastic Surgery. 2017.

  39. FDA. Technical considerations for additive manufactured medical devices guidance for industry and Food and Drug Administration staff. [cited 2017 Dec 4]; Available from: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

  40. Materialise NV. First company to receive FDA clearance for diagnostic 3D-printed anatomical models | Materialise [Internet]. [cited 2018 Jun 15]. Available from: http://www.materialise.com/en/press-releases/materialise-first-company-to-receive-fda-clearance-for-diagnostic-3d-printed

  41. Beck JM, Jacobson MD. 3D printing: what could happen to products liability when users (and everyone else in between) become manufacturers. Minnesota J Law Sci Technol JL Sci Tech. 2017 [cited 2017 Dec 20];18(143). Available from: http://scholarship.law.umn.edu/mjlst

  42. Morrison RJ, Kashlan KN, Flanangan CL, Wright JK, Green GE, Hollister SJ, Weatherwax KJ Regulatory considerations in the design and manufacturing of implantable 3D-printed medical devices. Clin Transl Sci 2015;8(5):594–600. Available from: https://doi.org/10.1111/cts.12315

    Article  Google Scholar 

  43. WG-17: 3D Manufacturing – DICOM Standard [Internet]. [cited 2018 Jun 15]. Available from: https://www.638dicomstandard.org/wgs/wg-17/

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Authors and Affiliations

  1. Department of Radiology, Weill Cornell Medicine, New York City, USA

    James Shin MD, MSc & Quynh A. Truong MD, MPH

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Correspondence to James Shin MD, MSc.

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James Shin declares no potential conflicts of interest.

Quynh A. Truong is a section editor for Current Treatment Options in Cardiovascular Medicine.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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Shin, J., Truong, Q.A. Manufacturing Better Outcomes in Cardiovascular Intervention: 3D Printing in Clinical Practice Today. Curr Treat Options Cardio Med 20, 95 (2018). https://doi.org/10.1007/s11936-018-0692-1

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