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Heart, Lung and Circulation

Imaging-Based, Patient-Specific Three-Dimensional Printing to Plan, Train, and Guide Cardiovascular Interventions: A Systematic Review and Meta-Analysis

Open AccessPublished:June 06, 2022DOI:https://doi.org/10.1016/j.hlc.2022.04.052

      Background

      To tailor cardiovascular interventions, the use of three-dimensional (3D), patient-specific phantoms (3DPSP) encompasses patient education, training, simulation, procedure planning, and outcome-prediction.

      Aim

      This systematic review and meta-analysis aims to investigate the current and future perspective of 3D printing for cardiovascular interventions.

      Methods

      We systematically screened articles on Medline and EMBASE reporting the prospective use of 3DPSP in cardiovascular interventions by using combined search terms. Studies that compared intervention time depending on 3DPSP utilisation were included into a meta-analysis.

      Results

      We identified 107 studies that prospectively investigated a total of 814 3DPSP in cardiovascular interventions. Most common settings were congenital heart disease (CHD) (38 articles, 6 comparative studies), left atrial appendage (LAA) occlusion (11 articles, 5 comparative, 1 randomised controlled trial [RCT]), and aortic disease (10 articles). All authors described 3DPSP as helpful in assessing complex anatomic conditions, whereas poor tissue mimicry and the non-consideration of physiological properties were cited as limitations. Compared to controls, meta-analysis of six studies showed a significant reduction of intervention time in LAA occlusion (n=3 studies), and surgery due to CHD (n=3) if 3DPSPs were used (Cohen’s d=0.54; 95% confidence interval 0.13 to 0.95; p=0.001), however heterogeneity across studies should be taken into account.

      Conclusions

      3DPSP are helpful to plan, train, and guide interventions in patients with complex cardiovascular anatomy. Benefits for patients include reduced intervention time with the potential for lower radiation exposure and shorter mechanical ventilation times. More evidence and RCTs including clinical endpoints are needed to warrant adoption of 3DPSP into routine clinical practice.

      Keywords

      Introduction

      Cardiac imaging using cardiac magnetic resonance imaging (CMR) and cardiac computed tomography (CCT) has undergone a rapid development within the last decades, today depicting cardiac anatomy and physiology with excellent temporal and spatial resolution. Four-dimensional (4D) image datasets, as well as advanced post-processing techniques, have laid the basis for the large number of personalised invasive structural cardiac interventions, available today. Translation of imaging data to patient-specific models is the next frontier in this respect that could facilitate further refinements and patient-specific tailoring of interventions. Three dimensional (3D) printing, also known as rapid prototyping or additive manufacturing, is a promising technology well-established for individualisation of treatment in orthopedic surgery [
      • Levesque J.N.
      • Shah A.
      • Ekhtiari S.
      • Yan J.R.
      • Thornley P.
      • Williams D.S.
      Three-dimensional printing in orthopaedic surgery: a scoping review.
      ], whereas its use in cardiovascular medicine is yet to be defined. Extension in the field of cardiovascular medicine needs to take into consideration varying size of structures according to the cardiac cycle, difficult delineation of soft-tissues and the cardiac valves and the inclusion of functional properties [
      • Vukicevic M.
      • Mosadegh B.
      • Min J.K.
      • Little S.H.
      Cardiac 3D printing and its future directions.
      ]. Patient-specific 3D printed phantoms (3DPSP) meeting these requirements cannot only enhance medical and patient education, but can also be used to plan, train, simulate, and guide cardiovascular interventions. Obtaining accurate 3DPSP of complex anatomic structures allows ex vivo visualisation and delineation of complex spatial relationships in various cardiovascular disease settings [
      • Noecker A.M.
      • Chen J.F.
      • Zhou Q.
      • White R.D.
      • Kopcak M.W.
      • Arruda M.J.
      • et al.
      Development of patient-specific three-dimensional pediatric cardiac models.
      ]. Although the translation of clinically indicated cardiac imaging to 3DPSP does not expose the patient to additional risk, several challenges remain to be overcome before 3D printing will meet widespread clinical acceptance for individualisation of cardiovascular interventions. The scope of this systematic review is to analyse utility of 3D printing in cardiovascular interventions as well as its limitations. Current applications and future directions will be discussed to help interventional cardiologists and surgeons find the ideal targets for 3D printing.

      Methods

      Two (2) independent reviewers (i.e., authors B.B. and J.I.) conducted a systematic literature query on the databases Medline and EMBASE using the key terms “3D printing,” “3D phantom,” or “additive manufacturing,” plus one of the terms “cardiovascular,” “cardiac,” “aorta,” “aortic-, mitral-, tricuspid-, or pulmonary valve,” “coronary arteries,” “left atrial appendage,” “congenital heart disease,” or “hypertrophic cardiomyopathy” for “All fields” search (Figure 1). All fields search tools also included Medical Subject Headings (MeSH) terms . Any inconsistencies were discussed and reconciled by a third reviewer (i.e., author C.G.). Inclusion criteria were the prospective use of at least one 3DPSP in cardiovascular intervention, published between 1 January 2005 and 1 May 2021, and the investigation of human data as the subject in a peer-reviewed article. Cardiovascular intervention was defined as open surgery or transcatheter intervention of the heart and its structures, the ascending aorta, the aortic arch, and the descending aorta above the coeliac trunk. Studies that printed 3D models for other purposes than personalised medicine (e.g., non-personalised models for validation of imaging modalities) and articles about tissue engineering or bioprinting were excluded, as well as reviews and case reports on applications that had previously been investigated by other studies. Included studies were screened for cross-references fulfilling our inclusion criteria.
      Figure thumbnail gr1
      Figure 1Consort flow of the study selection process. Non-personalised three-dimensional (3D) prints also included animal studies, and articles using personalised 3D models for validation of imaging modalities. Prospective interventional studies were defined by the production and the use of a 3D printed model prior to the intervention. Case reports with less than 5 patients were excluded if larger studies in the same setting existed.
      Meta-analysis and forest plotting were performed using Meta-Essentials Version 1.5 for Microsoft Excel [
      • Suurmond R.
      • van Rhee H.
      • Hak T.
      Introduction, comparison, and validation of Meta-Essentials: a free and simple tool for meta-analysis.
      ]. Combined effect size is provided by Cohen’s d (mean difference/standard deviation), which was determined by a random-effect model. Weak effects are represented by d<0.3; d=0.3–0.8 indicates medium effect size, whereas strong effects are mirrored by d>0.8. In this model, we included all studies that provided data for mean intervention time and its standard deviation in a group with 3DPSP compared to a control group without 3DPSP. For studies that provided median intervention time and its range, we estimated mean and variance according to Hozo et al. [
      • Hozo S.P.
      • Djulbegovic B.
      • Hozo I.
      Estimating the mean and variance from the median, range, and the size of a sample.
      ]. The extent of heterogeneity was estimated by Q-statistics (“Cochran’s Q” test). I2 and T2 were provided to quantify inconsistencies of results across studies as an estimate of the standard deviation of the distribution of effect sizes [
      • Higgins J.P.
      • Thompson S.G.
      Quantifying heterogeneity in a meta-analysis.
      ]. Although no clearly defined cut-off exits, I2=30%–60% usually refers to moderate heterogeneity, whereas substantial heterogeneity might be indicated by I2>60%. Results were considered significant if the two-sided p-value was ≤0.05. This review was conducted in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [
      • Liberati A.
      • Altman D.G.
      • Tetzlaff J.
      • Mulrow C.
      • Gøtzsche P.C.
      • Ioannidis J.P.
      • et al.
      The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.
      ], and ethical approval was waived, as no human subjects are involved in this study.

      Results

      After removing duplicate records, we identified 2,227 articles corresponding to our key search terms, of which a total of 86 articles fulfilled inclusion criteria (Figure 1). Another 21 studies were added via cross-references, resulting in a total of 107 included studies. The number of newly published articles on the use of 3DPSP in cardiovascular intervention has been constantly rising within the last 16 years with approximately half of the identified study being published after 2017 and a trend towards an increase in the number of models obtained in each study using December 2017 as a cutoff (6.4±9.1 vs 8.9±11.8; p=0.241) (Figure 2). The included studies with cumulative 814 3DPSP encompass case reports with one patient included (n=38), case series with less than 10 patients (n=38), larger observational and descriptive studies (n=18), comparative studies with a control group with no 3DPSP (n=12), and one randomised controlled trial (Table 1).
      Figure thumbnail gr2
      Figure 2Number and cohort size of articles prospectively investigating 3DPSP in cardiovascular intervention in this review. Abbreviations: 3DPSP, three-dimensional printed patient-specific phantom; CHD, congenital heart disease; HCM, hypertrophic cardiomyopathy; LAA, left atrial appendage; MVR, mitral valve repair or replacement; TAVI, transcatheter aortic valve implantation.
      Table 1Studies included in this systematic review.
      First AuthorYearnTypeImaging ModalitySettingComments
      Ngan et al. [
      • Ngan E.M.
      • Rebeyka I.M.
      • Ross D.B.
      • Hirji M.
      • Wolfaardt J.F.
      • Seelaus R.
      • et al.
      The rapid prototyping of anatomic models in pulmonary atresia.
      ]
      20066Systematic studyCCTCHD3DPSP to plan surgery in pulmonary atresia
      Sodian et al. [
      • Sodian R.
      • Weber S.
      • Markert M.
      • Rassoulian D.
      • Kaczmarek I.
      • Lueth T.C.
      • et al.
      Stereolithographic models for surgical planning in congenital heart surgery.
      ]
      20072Case seriesCCT or CMRCHD3DPSP for surgical planning in various settings
      Mottl-Link et al. [
      • Mottl-Link S.
      • Hübler M.
      • Kühne T.
      • Rietdorf U.
      • Krueger J.J.
      • Schnackenburg B.
      • et al.
      Physical models aiding in complex congenital heart surgery.
      ]
      20081Case reportCMRCHD3DPSP to assess intracardiac anatomy in complex CHD
      Sodian et al. [
      • Sodian R.
      • Schmauss D.
      • Markert M.
      • Weber S.
      • Nikolaou K.
      • Haeberle S.
      • et al.
      Three-dimensional printing creates models for surgical planning of aortic valve replacement after previous coronary bypass grafting.
      ]
      20081Case reportCCTOthers3DPSP to plan SAVR after previous coronary artery bypass
      Sodian et al. [
      • Sodian R.
      • Weber S.
      • Markert M.
      • Loeff M.
      • Lueth T.
      • Weis F.C.
      • et al.
      Pediatric cardiac transplantation: three-dimensional printing of anatomic models for surgical planning of heart transplantation in patients with univentricular heart.
      ]
      20082Case seriesCCT or CMRCHD3DPSPs to guide heart transplantation due to severe CHD
      Jacobs et al. [
      • Jacobs S.
      • Grunert R.
      • Mohr F.W.
      • Falk V.
      3D-imaging of cardiac structures using 3D heart models for planning in heart surgery: a preliminary study.
      ]
      20083Case seriesCCT or CMROthers3DPSP in ventricular aneurysm or malignant cardiac tumour
      Kim et al. [
      • Kim M.S.
      • Hansgen A.R.
      • Wink O.
      • Quaife R.A.
      • Carroll J.D.
      Rapid prototyping: a new tool in understanding and treating structural heart disease.
      ]
      20084Case seriesCCTCHD3DPSP guidance on surgical revision of VSD and various other cases
      Sodian et al. [
      • Sodian R.
      • Schmauss D.
      • Schmitz C.
      • Bigdeli A.
      • Haeberle S.
      • Schmoeckel M.
      • et al.
      3-dimensional printing of models to create custom-made devices for coil embolization of an anastomotic leak after aortic arch replacement.
      ]
      20091Case reportCCTAorta3DPSP to guide closure of an anastomotic leak after aortic arch replacement
      Riesenkampff et al. [
      • 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.
      ]
      200911Case seriesCCT or CMRCHD3DPSP to assess intracardiac anatomy in complex CHD prior surgery
      Shiraishi et al. [
      • 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.
      ]
      201012Case seriesCCTCHDRubber-like urethane 3DPSP to train cutting and suturing prior CHD-surgery
      Schmauss et al. [
      • Schmauss D.
      • Gerber N.
      • Sodian R.
      Three-dimensional printing of models for surgical planning in patients with primary cardiac tumors.
      ]
      20131Case reportCMROthers3DPSP in the resection of a cardiac fibroma
      Schmauss et al. [
      • Schmauss D.
      • Juchem G.
      • Weber S.
      • Gerber N.
      • Hagl C.
      • Sodian R.
      Three-dimensional printing for perioperative planning of complex aortic arch surgery.
      ]
      20141Case reportCCTAorta3DPSP for planning surgery in complex aortic arch aneurysm.
      Dankowski et al. [
      • Dankowski R.
      • Baszko A.
      • Sutherland M.
      • Firek L.
      • Kałmucki P.
      • Wróblewska K.
      • et al.
      3D heart model printing for preparation of percutaneous structural interventions: description of the technology and case report.
      ]
      20141Case reportCCTMVRProduction of a 3DPSP prior percutaneous mitral annuloplasty
      Farooqi et al. [
      • Farooqi K.M.
      • Gonzalez-Lengua C.
      • Shenoy R.
      • Sanz J.
      • Nguyen K.
      Use of a three dimensional printed cardiac model to assess suitability for biventricular repair.
      ]
      20151Case reportCMRCHD3DPSP for planning in a patient with double outlet right ventricle
      Valverde e al. [
      • Valverde I.
      • Gomez G.
      • Coserria J.F.
      • Suarez-Mejias C.
      • Uribe S.
      • Sotelo J.
      • et al.
      3D printed models for planning endovascular stenting in transverse aortic arch hypoplasia.
      ]
      20151Case reportCMRCHD3DPSP to guide stenting of transverse aortic arch hypoplasia
      Watanabe et al. [
      • Watanabe H.
      • Saito N.
      • Tatsushima S.
      • Tazaki J.
      • Toyota T.
      • Imai M.
      • et al.
      Patient-specific three-dimensional aortocoronary model for percutaneous coronary intervention of a totally occluded anomalous right coronary artery.
      ]
      20151Case reportCCTOthers3DPSP to plan percutaneous coronary intervention in occluded RCA
      Yang et al. [
      • Yang D.H.
      • Kang J.W.
      • Kim N.
      • Song J.K.
      • Lee J.W.
      • Lim T.H.
      Myocardial 3-dimensional printing for septal myectomy guidance in a patient with obstructive hypertrophic cardiomyopathy.
      ]
      20151Case reportCCTHCMGuidance of a 3DPSP on septal myectomy
      Otton et al. [
      • Otton J.M.
      • Spina R.
      • Sulas R.
      • Subbiah R.N.
      • Jacobs N.
      • Muller D.W.
      • et al.
      Left atrial appendage closure guided by personalized 3d-printed cardiac reconstruction.
      ]
      20151Case reportCCTLAALAA occlusion guiding and occlusion device sizing on 3DPSP
      Son et al. [
      • Son K.H.
      • Kim K.W.
      • Ahn C.B.
      • Choi C.H.
      • Park K.Y.
      • Park C.H.
      • et al.
      Surgical planning by 3d printing for primary cardiac schwannoma resection.
      ]
      20151Case reportCCTOthers3DPSP in the resection of a cardiac schwannoma
      Fujita et al. [
      • Fujita T.
      • Saito N.
      • Minakata K.
      • Imai M.
      • Yamazaki K.
      • Kimura T.
      Transfemoral transcatheter aortic valve implantation in the presence of a mechanical mitral valve prosthesis using a dedicated TAVI guidewire: utility of a patient-specific three-dimensional heart model.
      ]
      20151Case reportCCTTAVITraining of TAVI on a 3DPSP
      Lazkani et al. [
      • Lazkani M.
      • Bashir F.
      • Brady K.
      • Pophal S.
      • Morris M.
      • Pershad A.
      Postinfarct VSD management using 3D computer printing assisted percutaneous closure.
      ]
      20151Case reportCCTOthers3DPSP to guide surgical therapy of a post-infarct VSD
      Schmauss et al. [
      • Schmauss D.
      • Haeberle S.
      • Hagl C.
      • Sodian R.
      Three-dimensional printing in cardiac surgery and interventional cardiology: a single-centre experience.
      ]
      20158Case seriesCCT or CMROthers3DPSP in perioperative planning in various cardiac disease
      Ma et al. [
      • Ma X.J.
      • Tao L.
      • Chen X.
      • Li W.
      • Peng Z.Y.
      • Chen Y.
      • et al.
      Clinical application of three-dimensional reconstruction and rapid prototyping technology of multislice spiral computed tomography angiography for the repair of ventricular septal defect of tetralogy of Fallot.
      ]
      201535Systematic studyCCTCHD3DPSP to guide VSD repair
      Kiraly et al. [
      • Kiraly L.
      • Tofeig M.
      • Jha N.K.
      • 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.
      ]
      20161Case reportCCTCHD3DPSP in surgical repair of Norwood-1 complex aortic arch obstruction
      Bharati et al. [
      • Bharati A.
      • Garekar S.
      • Agarwal V.
      • Merchant S.A.
      • Solanki N.
      MRA-based 3D-printed heart model-an effective tool in the pre-surgical planning of DORV.
      ]
      20161Case reportCMRCHDPlanning surgery due to double outlet right ventricle on 3DPSP
      Izzo et al. [
      • Izzo R.L.
      • O'Hara R.P.
      • Iyer V.
      • Hansen R.
      • Meess K.M.
      • Nagesh S.V.S.
      • et al.
      3D printed cardiac phantom for procedural planning of a transcatheter native mitral valve replacement.
      ]
      20161Case reportCCTMVR3DPSP for planning of transcatheter MVR
      Al Jabbari et al. [
      • Al Jabbari O.
      • Abu Saleh W.K.
      • Patel A.P.
      • Igo S.R.
      • Reardon M.J.
      Use of three-dimensional models to assist in the resection of malignant cardiac tumors.
      ]
      20162Case seriesCCTOthers3DPSP to guide resection of secondary malignant cardiac tumours
      Pellegrino et al. [
      • Pellegrino P.L.
      • Fassini G.
      • DI Biase M.
      • Tondo C.
      Left atrial appendage closure guided by 3d printed cardiac reconstruction: emerging directions and future trends.
      ]
      20162Case seriesCCTLAALAA occlusion guiding by 3DPSP
      Hossien et al. [
      • Hossien A.
      • Gelsomino S.
      • Maessen J.
      • Autschbach R.
      The interactive use of multi-dimensional modeling and 3d printing in preplanning of type a aortic dissection.
      ]
      20163Case seriesCCTAorta3DPSP guidance on treatment of type A aortic dissection
      Garekar et al. [
      • Garekar S.
      • Bharati A.
      • Chokhandre M.
      • Mali S.
      • Trivedi B.
      • Changela V.P.
      • et al.
      Clinical application and multidisciplinary assessment of three dimensional printing in double outlet right ventricle with remote ventricular septal defect.
      ]
      20165Case seriesCCT or CMRCHDEvaluation of the accuracy of 3DPSP in complex CHD
      Tam et al. [
      • Tam M.D.
      • Latham T.R.
      • Lewis M.
      • Khanna K.
      • Zaman A.
      • Parker M.
      • et al.
      A pilot study assessing the impact of 3-d printed models of aortic aneurysms on management decisions in EVAR planning.
      ]
      20166Case seriesCCTAortaEvaluation the impact of 3DPSP on decision making in EVAR
      Wang et al. [
      • Wang Z.
      • Liu Y.
      • Xu Y.
      • Gao C.
      • Chen Y.
      • Luo H.
      Three-dimensional printing-guided percutaneous transcatheter closure of secundum atrial septal defect with rim deficiency: first-in-human series.
      ]
      20166Case seriesCCTCHDPlanning percutaneous transcatheter closure of ASD on 3DPSP
      Liu et al. [
      • 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.
      ]
      20168Case series3DTOELAA3DPSPs for sizing of LAA occlusion devices
      Olivieri et al. [
      • Olivieri L.J.
      • Su L.
      • Hynes C.F.
      • Krieger A.
      • Alfares F.A.
      • Ramakrishnan K.
      • et al.
      “Just-In-Time” Simulation Training Using 3-D Printed Cardiac Models After Congenital Cardiac Surgery.
      ]
      201610Systematic studyCCT or CMRCHD3DPSP to enhance postoperative intensive care of patients with CHD
      Benke et al. [
      • Benke K.
      • Barabás J.I.
      • Daróczi L.
      • Sayour A.A.
      • Szilveszter B.
      • Pólos M.
      • et al.
      Routine aortic valve replacement followed by a myriad of complications: role of 3D printing in a difficult cardiac surgical case.
      ]
      20171Case reportCCTAorta3DPSP to plan surgery due to aortic pseudoaneurysm
      Pluchinotta et al. [
      • Pluchinotta F.R.
      • Giugno L.
      • Carminati M.
      Stenting complex aortic coarctation: simulation in a 3D printed model.
      ]
      20171Case reportCCTAortaSimulated stenting of aortic coarctation on a 3DPSP
      Biglino et al. [
      • Biglino G.
      • Koniordou D.
      • Gasparini M.
      • Capelli C.
      • Leaver L.K.
      • Khambadkone S.
      • et al.
      Piloting the use of patient-specific cardiac models as a novel tool to facilitate communication during cinical consultations.
      ]
      20171Case reportCCTCHDPlanning surgery in CHD and educate patients and parents on 3DPSP
      Hamatani et al. [
      • Hamatani Y.
      • Amaki M.
      • Kanzaki H.
      • Yamashita K.
      • Nakashima Y.
      • Shibata A.
      • et al.
      Contrast-enhanced computed tomography with myocardial three-dimensional printing can guide treatment in symptomatic hypertrophic obstructive cardiomyopathy.
      ]
      20171Case reportCCTHCMTraining and guidance of a 3DPSP on septal myocardial ablation
      Sardari Nia et al. [
      • Sardari Nia P.
      • Heuts S.
      • Daemen J.
      • Luyten P.
      • Vainer J.
      • Hoorntje J.
      • et al.
      Preoperative planning with three-dimensional reconstruction of patient's anatomy, rapid prototyping and simulation for endoscopic mitral valve repair.
      ]
      20171Case report3DTOEMVR3DPSP to plan of endoscopic MV repair
      Smith et al. [
      • Smith M.L.
      • McGuinness J.
      • O'Reilly M.K.
      • Nolke L.
      • Murray J.G.
      • Jones J.F.X.
      The role of 3D printing in preoperative planning for heart transplantation in complex congenital heart disease.
      ]
      20171Case reportCCTCHDUse of a 3DPSP prior heart transplantation due to severe CHD
      Hermsen et al. [
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      Scan, plan, print, practice, perform: development and use of a patient-specific 3-dimensional printed model in adult cardiac surgery.
      ]
      20172Case seriesCCTHCMGuidance of a 3DPSP on septal myectomy
      McGovern et al. [
      • McGovern E.
      • Kelleher E.
      • Snow A.
      • Walsh K.
      • Gadallah B.
      • Kutty S.
      • et al.
      Clinical application of three-dimensional printing to the management of complex univentricular hearts with abnormal systemic or pulmonary venous drainage.
      ]
      20173Case seriesCCTCHD3DPSP in the management of patients with univentricular circulation
      Vodiskar et al. [
      • Vodiskar J.
      • Kütting M.
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      • Vazquez-Jimenez J.F.
      • Sonntag S.J.
      Using 3D physical modeling to plan surgical corrections of complex congenital heart defects.
      ]
      20173Case seriesCCTCHD3DPSP in planning surgery for complex CHD
      Velasco Forte et al. [
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      • Byrne N.
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      • et al.
      3D printed models in patients with coronary artery fistulae: anatomical assessment and interventional planning.
      ]
      20174Case seriesCCT or CMROthers3DPSP to plan intervention in patients with coronary artery fistulae
      Kappanayil et al. [
      • Kappanayil M.
      • Koneti N.R.
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      Three-dimensional-printed cardiac prototypes aid surgical decision-making and preoperative planning in selected cases of complex congenital heart diseases: early experience and proof of concept in a resource-limited environment.
      ]
      20175Case seriesCMRCHD3DPSP to plan prior surgery in complex CHD.
      Bhatla et al. [
      • Bhatla P.
      • Tretter J.T.
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      • Latson Jr., L.A.
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      • et al.
      Utility and scope of rapid prototyping in patients with complex muscular ventricular septal defects or double-outlet right ventricle: does it alter management decisions?.
      ]
      20176Case seriesCCT or CMRCHD3DPSP to guide management decisions in patients with CHD
      Hell et al. [
      • Hell M.M.
      • Achenbach S.
      • Yoo I.S.
      • Franke J.
      • Blachutzik F.
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      • et al.
      3D printing for sizing left atrial appendage closure device: head-to-head comparison with computed tomography and transoesophageal echocardiography.
      ]
      201722Comparative studyCCTLAA3DPSP to size the occlusion device prior LAA closure
      Valverde et al. [
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      • Gomez-Ciriza G.
      • Hussain T.
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      • Velasco-Forte M.N.
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      Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study.
      ]
      201740Comparative studyCCT or CMRCHDMulticentre study evaluating the impact of 3DPSP on decision making in CHD
      Li et al. [
      • Li H.
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      • Wang X.
      • et al.
      Application of 3D printing technology to left atrial appendage occlusion.
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      201721RCTCCTLAARCT evaluating the use of 3DPSP in the setting of LAA occlusion
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      20175Systematic studyCCT or CMRTrainingHands-on surgical training on 3DPSP of patients with CHD
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      201718Systematic study3DTOELAA3DPSP to guide LAA occlusion
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      201729Systematic studyCCTLAA3DPSP to guide LAA occlusion device sizing
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      3D printed cardiac fistula: guiding percutaneous structural intervention.
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      20181Case reportCCTCHD3DPSP to plan percutaneous closure of a cardiac fistula
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      20182Case seriesCCT or CMROthersGuidance on pediatric tumour debulking by a 3DPSP
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      Virtual and real septal myectomy using 3-dimensional printed models.
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      20182Case seriesCCTHCMCombination of virtual simulated myectomy and 3DPSP in HCM
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      20185Case seriesAngiographyCHDProducing 3DPSP from angiography for interventions in CHD
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      Patient-specific three-dimensional printing for Kommerell's diverticulum.
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      20185Case seriesCCTCHDPlanning intervention on 3DPSP in patients with Kommerell's diverticulum
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      Use of 3D printing in preoperative planning and training for aortic endovascular repair and aortic valve disease.
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      20186Case seriesCCTAorta3DPSP to guide endovascular repair in various aortic disease
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      201825Case seriesCCTAortaUse of 3DPSP to plan and guide aortic surgery
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      20188Comparative studyCCTCHD3DPSP to plan surgery in complex CHD
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      201813Comparative studyCCTLAA3DPSPs for sizing of LAA occluders
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      201821Comparative studyCCTLAAComparison of a pro- and retrospective use of 3DPSP in LAA-occlusion
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      201833Comparative studyCCT or CMRCHDComparison of the procedure time of CHD-surgery dependent on 3DPSP use
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      20185Systematic studyCCTMVR3DPSP for outcome-prediction and valve sizing in MVR
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      20187Systematic studyCCTHCM3DPSP for planning and patient educating prior septal myectomy
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      20191Case reportCCTCHDCombination of virtual reality and 3DPSP to guide surgery in CHD
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      20191Case reportCCTOthersLVAD cannula placement with the help of a 3DPSP
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      20191Case reportCCTOthers3DPSP to guide transapical closure of a LVOT pseudoaneurysm
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      20191Case reportCCTOthersGuidance on LV pseudoaneurysm closure by a 3DPSP
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      20194Case seriesCCT or CMROthersComplex cases of cardiac fistulae repair guided by 3DPSP
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      201915Case seriesCCTCHD3DPSP in planning surgery for anomalous pulmonary venous connection
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      201917Case seriesCCTCHD3DPSP to plan surgery in complex CHD
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      20196Comparative studyCCTCHDComparison of the procedure time of CHD surgery dependent on 3DPSP use
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      20197Comparative studyCCTCHD3DPSP to guide percutaneous closure of patent ductus arteriosus
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      201915Comparative studyCCTLAA3DPSP for sizing of LAA occlusion devices
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      20191Case reportCCTOthers3DPSP to plan repair of an aorto-right ventricular fistula
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      201932Comparative study3DTOELAALAA occlusion guiding and occlusion device sizing on 3DPSP
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      201930Systematic studyCCTHCMCombination of virtual simulated myectomy and 3DPSP in HCM
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      20201Case reportCCTOthersUse of a 3DPSP to plan surgical revision of cardiac myxoma
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      20201Case reportCCTOthers3DPSP to plan percutaneous coronary intervention in coronary anomaly
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      Percutaneous coronary intervention of an anomalous coronary chronic total occlusion: the added value of three-dimensional printing.
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      20201Case reportCCTOthers3DPSP for development of a new catheter in occluded RCA
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      20201Case reportCCTOthers3DPSP to simulate LVAD implantation in a failing systemic RV
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      20201Case reportCCTOthersPlanning CRT-D implantation in complex CHD
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      20201Case reportCCTOthersTranscatheter closure of paravalvular regurgitation guided by 3DPSP
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      20201Case reportCCTOthersUse of a 3DPSP to plan tricuspid valve-in-valve replacement
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      20201Case reportCMROthers3DPSP to guide surgical closure of submitral aneurysm
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      20201Case reportCCTTAVI3DPSP to achieve a TAVI valve-in-valve procedure
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      20202Case series3DTOEMVRPlanning paravalvular leak interventions after MVR on 3DPSP
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      20202Case seriesCCTOthers3DPSP to guide Ozaki repair of bicuspid aortic valve
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      20203Case seriesCCT or 3DTOEOthers3DPSP for planning Mitraclip implantation
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      Feasibility of device closure for multiple atrial septal defects with an inferior sinus venosus defect: procedural planning using three-dimensional printed models.
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      20205Case seriesCCTCHDClosure of multiple ASD guided by a 3DPSP
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      Three-dimensional congenital heart models created with free software and a desktop printer: assessment of accuracy, technical aspects, and clinical use.
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      20206Case seriesCCT or CMRCHD3DPSP-guidance on surgical revision of complex CHD
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      ]
      20203Case seriesCCTOthersGuidance on LV pseudoaneurysm closure by a 3DPSP
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      Personalized three-dimensional printing and echoguided procedure facilitate single device closure for multiple atrial septal defects.
      ]
      202030Comparative studyCCTCHDComparison of 3DPSP- and TOE guided ASD closure to fluoroscopic guidance
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      Three-dimensional printing of congenital heart disease models for cardiac surgery simulation: evaluation of surgical skill improvement among inexperienced cardiothoracic surgeons.
      ]
      20201Systematic studyCCTTrainingRepetitive training of VSD closure on 3DPSP
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      Quantitative assessment of technical performance during hands-on surgical training of the arterial switch operation using 3-dimensional printed heart models.
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      20201Systematic study-TrainingRepetitive training of arterial switch procedure on 3DPSP
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      The incorporation of hands-on surgical training in a congenital heart surgery training curriculum.
      ]
      20201Systematic study-TrainingRepetitive surgical training on 3DPSP of CHD
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      Effectiveness of a patient-specific 3-dimensional printed model in septal myectomy of hypertrophic cardiomyopathy.
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      202012Systematic studyCCTHCMTraining septal myectomy on 3DPSP
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      Three-dimensional virtual and printed models for planning adult cardiovascular surgery.
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      202014Systematic study-Others3DPSP to plan adult cardiovascular surgery
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      Surgical repair for primary tricuspid valve disease: individualized surgical planning with 3-dimensional printing.
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      20204Case seriesCCTOthers3DPSP to tailor surgical tricuspid valve repair
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      Use of 3D printing to guide creation of fenestrations in physician-modified stent-grafts for treatment of thoracoabdominal aortic disease.
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      202034Systematic studyCCTAorta3DPSP to fenestrate stent grafts in aortic disease
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      Novel resectable myocardial model using hybrid three-dimensional printing and silicone molding for mock myectomy for apical hypertrophic cardiomyopathy.
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      20213Case seriesCCTHCM3DPSP in pre-interventional planning and training in HCM
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      Three-dimensional printing, virtual reality and mixed reality for pulmonary atresia: early surgical outcomes evaluation.
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      20215Case seriesCCTCHDCombination of virtual reality and 3DPSP in pulmonary atresia
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      Morphology display and hemodynamic testing using 3D printing may aid in the prediction of LVOT obstruction after mitral valve replacement.
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      202156Comparative studyCCTMVR3DPSP to predicted LVOT obstruction after MVR.
      Abbreviations: 3DPSP, three-dimensional printed patient specific phantom; ASD, atrial septum defect; CCT cardiac computed tomography; CHD, congenital heart disease; CMR, cardiac magnetic resonance imaging; CRT-D, cardiac resynchronisation therapy–dual; EVAR, endovascular aortic repair; HCM, hypertrophic cardiomyopathy; LAA, left atrial appendage; LVAD, left ventricular assist device; LVOT, left ventricular outflow tract; MVR, mitral valve replacement/repair; RCA, right coronary artery; RCT, randomised controlled trial; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation; TOE, transoesophageal echocardiography; VSD, ventricular septal defect.

      Congenital Heart Disease

      A total of 38 studies prospectively investigating 3DPSP to guide cardiovascular intervention in congenital heart disease (CHD) of which six studies systematically compared 3DPSP to standard therapy and included a control group without 3DPSP. Across all studies, 329 3DPSP were manufactured, rendering CHD the field with the widest application of 3DPSP in cardiovascular interventions. Mottl-Link et al. [
      • Mottl-Link S.
      • Hübler M.
      • Kühne T.
      • Rietdorf U.
      • Krueger J.J.
      • Schnackenburg B.
      • et al.
      Physical models aiding in complex congenital heart surgery.
      ] reported one of the first cases in which a 3DPSP was considered to impact patient management in CHD. A CMR-derived 3DPSP was intraoperatively shown to the surgeon to identify the location of coronary arteries and other structures enabling a complex operation. Valverde et al. [
      • Valverde I.
      • Gomez G.
      • Coserria J.F.
      • Suarez-Mejias C.
      • Uribe S.
      • Sotelo J.
      • et al.
      3D printed models for planning endovascular stenting in transverse aortic arch hypoplasia.
      ] extended the use of 3DPSP to the field of transcatheter cardiovascular interventions and reported 3DPSP being a valuable adjunct in planning and simulating endovascular stenting in transverse aortic arch hypoplasia. Following this approach, feasibility of 3DPSP to identify the optimal prosthesis in terms of size for transcatheter closure of atrial septal defect or patent ductus arteriosus was demonstrated [
      • Wang Z.
      • Liu Y.
      • Xu Y.
      • Gao C.
      • Chen Y.
      • Luo H.
      Three-dimensional printing-guided percutaneous transcatheter closure of secundum atrial septal defect with rim deficiency: first-in-human series.
      ,
      • Matsubara D.
      • Kataoka K.
      • Takahashi H.
      • Minami T.
      • Yamagata T.
      A patient-specific hollow three-dimensional model for simulating percutaneous occlusion of patent ductus arteriosus.
      ]. Also, 3DPSP can enrich patient counselling [
      • Biglino G.
      • Capelli C.
      • Leaver L.K.
      • Schievano S.
      • Taylor A.M.
      • Wray J.
      Involving patients, families and medical staff in the evaluation of 3D printing models of congenital heart disease.
      ,
      • Biglino G.
      • Capelli C.
      • Wray J.
      • Schievano S.
      • Leaver L.K.
      • Khambadkone S.
      • et al.
      3D-manufactured patient-specific models of congenital heart defects for communication in clinical practice: feasibility and acceptability.
      ,
      • Biglino G.
      • Koniordou D.
      • Gasparini M.
      • Capelli C.
      • Leaver L.K.
      • Khambadkone S.
      • et al.
      Piloting the use of patient-specific cardiac models as a novel tool to facilitate communication during cinical consultations.
      ] and affect clinical decision making [
      • Valverde I.
      • Gomez-Ciriza G.
      • Hussain T.
      • Suarez-Mejias C.
      • Velasco-Forte M.N.
      • Byrne N.
      • et al.
      Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study.
      ]. In the largest multicentre case-crossover study of CHD to date, decisions on the therapeutic management made by review of imaging data only were compared to decisions based on imaging data and an additional 3DPSP. In nearly half of the included 40 patients (n=19), application of 3DPSP changed the surgical decision and helped to redefine the surgical approach [
      • Valverde I.
      • Gomez-Ciriza G.
      • Hussain T.
      • Suarez-Mejias C.
      • Velasco-Forte M.N.
      • Byrne N.
      • et al.
      Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study.
      ]. Compared to standard therapy without 3DPSP, 3DPSP-guided surgery due to CHD might affect operation duration [
      • Han F.
      • Co-Vu J.
      • Lopez-Colon D.
      • Forder J.
      • Bleiweis M.
      • Reyes K.
      • et al.
      Impact of 3D printouts in optimizing surgical results for complex congenital heart disease.
      ,
      • Ryan J.
      • Plasencia J.
      • Richardson R.
      • Velez D.
      • Nigro J.J.
      • Pophal S.
      • et al.
      3D printing for congenital heart disease: a single site's initial three-yearexperience.
      ], aortic cross-clamp time, mechanical ventilation time, and intensive care unit time [
      • Matsubara D.
      • Kataoka K.
      • Takahashi H.
      • Minami T.
      • Yamagata T.
      A patient-specific hollow three-dimensional model for simulating percutaneous occlusion of patent ductus arteriosus.
      ,
      • Zhao L.
      • Zhou S.
      • Fan T.
      • Li B.
      • Liang W.
      • Dong H.
      Three-dimensional printing enhances preparation for repair of double outlet right ventricular surgery.
      ]. A benefit of 3DPSP in terms of outcome was reported in a retrospective analysis of 30 patients who underwent device closure for multiple atrial septal defects. Compared to a control group using fluoroscopic guidance, patients treated after previous training on 3DPSP showed lower frequency of occluding device replacement and prevalence of residual shunts, which is also associated with lower costs [
      • Li P.
      • Fang F.
      • Qiu X.
      • Xu N.
      • Wang Y.
      • Ouyang W.B.
      • et al.
      Personalized three-dimensional printing and echoguided procedure facilitate single device closure for multiple atrial septal defects.
      ]. Allocation to the use of 3DPSP was in none of the latter studies randomised and results should therefore interpreted with caution. Heterogeneity between studies and the wide spectrum of CHD reduces the generalisability of the findings; nevertheless, CHD is the setting with the largest experience and the broadest body of evidence for the use of 3DPSP in cardiovascular intervention.

      Left Atrial Appendage Closure

      The size, shape, and position of the left atrial appendage (LAA) are highly variable, which predisposes utilisation of 3DPSP in the setting of LAA closure. Available evidence from 11 studies, including one RCT demonstrated the value of a total of 182 3DPSP for device sizing and a reduction of intervention time. Liu et al. [
      • 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.
      ] reported in a case series of eight patients that the device size predicted by the 3DPSP is fully consistent with the device size chosen during the intervention and was able to predict technical challenges during the intervention as well as the presence of peri-device leaks. Additional studies corroborated these findings with high agreement and showed that device sizing by 3DPSP does better predict the final implanted device size (accurate in 95%, 100%, 100%, and 96.9%, respectively) than transoesophageal echocardiography, which underestimated the final size in 10, 4, 7, and 13 cases (45%, 45%, 47%, and 40.6%, respectively) [
      • Hell M.M.
      • Achenbach S.
      • Yoo I.S.
      • Franke J.
      • Blachutzik F.
      • Roether J.
      • et al.
      3D printing for sizing left atrial appendage closure device: head-to-head comparison with computed tomography and transoesophageal echocardiography.
      ,
      • Obasare E.
      • Mainigi S.K.
      • Morris D.L.
      • Slipczuk L.
      • Goykhman I.
      • Friend E.
      • et al.
      CT based 3D printing is superior to transesophageal echocardiography for pre-procedure planning in left atrial appendage device closure.
      ,
      • Hachulla A.L.
      • Noble S.
      • Guglielmi G.
      • Agulleiro D.
      • Müller H.
      • Vallée J.P.
      3D-printed heart model to guide LAA closure: useful in clinical practice?.
      ,
      • Fan Y.
      • Yang F.
      • Cheung G.S.
      • Chan A.K.
      • Wang D.D.
      • Lam Y.Y.
      • et al.
      Device sizing guided by echocardiography-based three-dimensional printing is associated with superior outcome after percutaneous left atrial appendage occlusion.
      ]. Comparative studies observed a decrease in intervention and fluoroscopy time and an increased likelihood for the absence of peri-device leak if a 3DPSP was considered peri-interventional [
      • Obasare E.
      • Mainigi S.K.
      • Morris D.L.
      • Slipczuk L.
      • Goykhman I.
      • Friend E.
      • et al.
      CT based 3D printing is superior to transesophageal echocardiography for pre-procedure planning in left atrial appendage device closure.
      ,
      • Fan Y.
      • Yang F.
      • Cheung G.S.
      • Chan A.K.
      • Wang D.D.
      • Lam Y.Y.
      • et al.
      Device sizing guided by echocardiography-based three-dimensional printing is associated with superior outcome after percutaneous left atrial appendage occlusion.
      ,
      • Ciobotaru V.
      • Combes N.
      • Martin C.A.
      • Marijon E.
      • Maupas E.
      • Bortone A.
      • et al.
      Left atrial appendage occlusion simulation based on three-dimensional printing: new insights into outcome and technique.
      ]. Li et al. [
      • Li H.
      • Qingyao Bingshen
      • Shu M.
      • Lizhong
      • Wang X.
      • et al.
      Application of 3D printing technology to left atrial appendage occlusion.
      ] performed the only RCT that prospectively investigated 3DPSP in cardiovascular intervention where 42 patients were randomised to undergo LAA occlusion guided by 3DPSP or standard therapy guided by transoesophageal echocardiography and CCT. In the 3DPSP group, no residual shunts occurred and radiation exposure was significantly reduced compared to the control group in which three mild residual shunt cases were observed [
      • Li H.
      • Qingyao Bingshen
      • Shu M.
      • Lizhong
      • Wang X.
      • et al.
      Application of 3D printing technology to left atrial appendage occlusion.
      ].

      Aortic Disease

      3DPSP can be applied in the planning and guiding of catheter-based, as well as in surgical treatment of various aortic disease and influence decision-making in planning endovascular aortic repair (EVAR). Review on an additional 3DPSP was reported to change the management decision in 20% of cases compared to review of the CCT images alone in patients with aortic aneurysm [
      • Tam M.D.
      • Latham T.R.
      • Lewis M.
      • Khanna K.
      • Zaman A.
      • Parker M.
      • et al.
      A pilot study assessing the impact of 3-d printed models of aortic aneurysms on management decisions in EVAR planning.
      ]. Training residents in EVAR on 3DPSP prior to the intervention was demonstrated to reduce fluoroscopy and intervention time, and lower contrast agent application compared to a control group without training (n=10) [
      • Torres I.O.
      • De Luccia N.
      A simulator for training in endovascular aneurysm repair: The use of three dimensional printers.
      ]. It remains to be determined whether similar associations might have been observed if a non-personalised model had been used. Larger case series evaluated 3DPSP as a valuable instrument in catheter-based, as well as in the surgical treatment of complex aortic disease [
      • Marone E.M.
      • Auricchio F.
      • Marconi S.
      • Conti M.
      • Rinaldi L.F.
      • Pietrabissa A.
      • et al.
      Effectiveness of 3D printed models in the treatment of complex aortic diseases.
      ,
      • Gomes E.N.
      • Dias R.R.
      • Rocha B.A.
      • Santiago J.A.D.
      • Dinato F.J.S.
      • Saadi E.K.
      • et al.
      Use of 3D printing in preoperative planning and training for aortic endovascular repair and aortic valve disease.
      ]. Tong et al. [
      • Tong Y.H.
      • Yu T.
      • Zhou M.J.
      • Liu C.
      • Zhou M.
      • Jiang Q.
      • et al.
      Use of 3D printing to guide creation of fenestrations in physician-modified stent-grafts for treatment of thoracoabdominal aortic disease.
      ] demonstrated feasibility to fenestrate stent-grafts on 3DPSP before endovascular repair of aortic aneurysm in 34 patients. Before the intervention stents were implanted into a 3DPSP to identify the positions of branches requiring fenestration. With the novel approach, only two branch arteries of 107 fenestrations secured by 102 bridging stent grafts were lost across the intervention.
      Available evidence consistently demonstrated safety, reliability, and accuracy of 3DPSP in aortic disease, and paved the way for comparative studies or RCT that could support broader applications of 3DPSP in aortic disease.

      Mitral Valve Repair and Replacement

      In the included six studies investigating 3DPSP in mitral valve (MV) interventions, 66 3DPSP were evaluated with only one study including more than five cases. Izzo et al. [
      • Izzo R.L.
      • O'Hara R.P.
      • Iyer V.
      • Hansen R.
      • Meess K.M.
      • Nagesh S.V.S.
      • et al.
      3D printed cardiac phantom for procedural planning of a transcatheter native mitral valve replacement.
      ] demonstrated the use of a 3DPSP to size the valve prosthesis prior to transcatheter MV replacement. Furthermore, 3DPSP were evaluated for risk assessment of left ventricular outflow tract obstruction (LVOTO) after MV replacement. Combined with virtual models, it was possible to predict LVOTO by simulation of MV implantation into the 3DPSP [
      • El Sabbagh A.
      • Eleid M.F.
      • Matsumoto J.M.
      • Anavekar N.S.
      • Al-Hijji M.A.
      • Said S.M.
      • et al.
      Three-dimensional prototyping for procedural simulation of transcatheter mitral valve replacement in patients with mitral annular calcification.
      ,
      • Wang H.
      • Song H.
      • Yang Y.
      • Wu Z.
      • Hu R.
      • Chen J.
      • et al.
      Morphology display and hemodynamic testing using 3D printing may aid in the prediction of LVOT obstruction after mitral valve replacement.
      ]. Simulated MV replacement on a flexible silicone 3DPSP and testing it in a mock circulatory system was superior in terms of LVOTO-prediction if compared to a digital model, a rigid anatomical 3DPSP made of resin, or the flexible silicone models without dynamic testing [
      • Wang H.
      • Song H.
      • Yang Y.
      • Wu Z.
      • Hu R.
      • Chen J.
      • et al.
      Morphology display and hemodynamic testing using 3D printing may aid in the prediction of LVOT obstruction after mitral valve replacement.
      ]. However, the lack of cardiac cycle simulation must be considered as a limitation of 3DPSP in this setting.

      Hypertrophic Cardiomyopathy

      Eight (8) studies were identified prospectively enrolling patients undergoing 3DPSP guided intervention for hypertrophic cardiomyopathy (HCM). Case reports demonstrated feasibility of 3DPSP to train and guide septal myectomy [
      • Hermsen J.L.
      • Burke T.M.
      • Seslar S.P.
      • Owens D.S.
      • Ripley B.A.
      • Mokadam N.A.
      • et al.
      Scan, plan, print, practice, perform: development and use of a patient-specific 3-dimensional printed model in adult cardiac surgery.
      ,
      • Yang D.H.
      • Kang J.W.
      • Kim N.
      • Song J.K.
      • Lee J.W.
      • Lim T.H.
      Myocardial 3-dimensional printing for septal myectomy guidance in a patient with obstructive hypertrophic cardiomyopathy.
      ,
      • Hamatani Y.
      • Amaki M.
      • Kanzaki H.
      • Yamashita K.
      • Nakashima Y.
      • Shibata A.
      • et al.
      Contrast-enhanced computed tomography with myocardial three-dimensional printing can guide treatment in symptomatic hypertrophic obstructive cardiomyopathy.
      ] and for patient education prior intervention [
      • Guo H.C.
      • Wang Y.
      • Dai J.
      • Ren C.W.
      • Li J.H.
      • Lai Y.Q.
      Application of 3D printing in the surgical planning of hypertrophic obstructive cardiomyopathy and physician-patient communication: a preliminary study.
      ]. Andrushchuk et al. [
      • Andrushchuk U.
      • Adzintsou V.
      • Nevyglas A.
      • Model H.
      Virtual and real septal myectomy using 3-dimensional printed models.
      ] developed an innovative approach in which a 3D print of the severely hypertrophic septum was conducted as a first step. In a second step, computer simulation was used to model the same septum after an optimal virtual myectomy. Thus, the targeted septum, as well as the resected part, were reprinted as 3D model. Both models, the native and the virtually treated one with its resected fragment guided the surgeon during the intervention in two cases. Besides these case reports, three prospective studies including more than five subjects systematically investigated 3DPSP before myectomy [
      • Guo H.C.
      • Wang Y.
      • Dai J.
      • Ren C.W.
      • Li J.H.
      • Lai Y.Q.
      Application of 3D printing in the surgical planning of hypertrophic obstructive cardiomyopathy and physician-patient communication: a preliminary study.
      ,
      • Wang Y.
      • Guo H.
      • Wang S.
      • Lai Y.
      Effectiveness of a patient-specific 3-dimensional printed model in septal myectomy of hypertrophic cardiomyopathy.
      ,
      • Andrushchuk U.
      • Adzintsou V.
      • Niavyhlas A.
      • Model H.
      • Ostrovsky Y.
      Early results of optimal septal myectomy using 3-dimensional printed models.
      ]. Authors evaluated them as a helpful tool in the planning of the intervention and for intraoperative guiding to achieve optimal septum thickness, whereas comparative studies are lacking.

      Transcatheter Aortic Valve Implantation

      Most studies investigating 3DPSPS in transcatheter aortic valve implantation (TAVI) were conducted retrospectively and are not part of this systematic review. They could prove the concept of valve sizing and prediction of paravalvular regurgitation on a 3DPSP [
      • Ripley B.
      • Kelil T.
      • Cheezum M.K.
      • Goncalves A.
      • Di Carli M.F.
      • Rybicki F.J.
      • et al.
      3D printing based on cardiac CT assists anatomic visualization prior to transcatheter aortic valve replacement.
      ,
      • Hosny A.
      • Dilley J.D.
      • Kelil T.
      • Mathur M.
      • Dean M.N.
      • Weaver J.C.
      • et al.
      Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing.
      ,
      • Reiff C.
      • Zhingre Sanchez J.D.
      • Mattison L.M.
      • Iaizzo P.A.
      • Garcia S.
      • Raveendran G.
      • et al.
      3-dimensional printing to predict paravalvular regurgitation after transcatheter aortic valve replacement.
      ,
      • Qian Z.
      • Wang K.
      • Liu S.
      • Zhou X.
      • Rajagopal V.
      • Meduri C.
      • et al.
      Quantitative prediction of paravalvular leak in transcatheter aortic valve replacement based on tissue-mimicking 3d printing.
      ]. Two (2) prospective case reports demonstrated feasibility to train TAVI on a 3DPSP [
      • Fujita T.
      • Saito N.
      • Minakata K.
      • Imai M.
      • Yamazaki K.
      • Kimura T.
      Transfemoral transcatheter aortic valve implantation in the presence of a mechanical mitral valve prosthesis using a dedicated TAVI guidewire: utility of a patient-specific three-dimensional heart model.
      ,
      • Basman C.
      • Seetharam K.
      • Pirelli L.
      • Kliger C.A.
      Transcatheter aortic valve-in-valve-in-valve implantation with three-dimensional printing guidance: a case report.
      ]. Basman et al. [
      • Basman C.
      • Seetharam K.
      • Pirelli L.
      • Kliger C.A.
      Transcatheter aortic valve-in-valve-in-valve implantation with three-dimensional printing guidance: a case report.
      ] described successful valve-in-valve implantation in a 65-year-old man guided by a 3DPSP. Prior ex vivo implantation of different valves on the model and consecutive seal analysis helped to choose an adequate valve size and lead to a satisfying result in this patient. Further studies on 3DPSP in the setting of TAVI are warranted. The potential of 3DPSP comprises the selection of optimal valve type and size, and the prediction of annulus rupture and coronary artery obstruction (also see Figure 3), particularly in case of valve-in-valve TAVI [
      • Hatoum H.
      • Lilly S.M.
      • Crestanello J.
      • Dasi L.P.
      A case study on implantation strategies to mitigate coronary obstruction in a patient receiving transcatheter aortic valve replacement.
      ]. 3DPSP of the aortic root and the vascular access may provide further guidance on the feasibility of transfemoral TAVI or if alternative access or surgical aortic valve replacement should be favoured.
      Figure thumbnail gr3
      Figure 3Selected 3DPSP used for the planning of cardiovascular interventions. (A) CCT images of a patient with coronary anomaly translated into a 3D printed phantom (compliant PolyJet 3DPSP) for planning of complex percutaneous coronary artery intervention. (B) Silicone casted aortic root model made from a fused deposition modelling negative used for simulated transcatheter aortic valve implantation and postprocedural testing of paravalvular leakage with dye injection. (C) Compliant multi-material printed PolyJet 3DPSP aortic root translated from CCT imaging for planning transcatheter aortic valve implantation.
      Abbreviations: 3DPSP, three-dimensional printed patient-specific phantom; CCT, cardiac computed tomography.

      Cardiac Tumours

      Cardiac and pericardial tumours represent a rare, but large spectrum of different entities with highly variable location, anatomy, and haemodynamic consequences [
      • Bussani R.
      • Castrichini M.
      • Restivo L.
      • Fabris E.
      • Porcari A.
      • Ferro F.
      • et al.
      Cardiac tumors: diagnosis, prognosis, and treatment.
      ]. Involved structures are difficult to delineate and might be anatomically inaccessible which often complicates planning of surgery and defining the optimal extent of tumour debulking. In such settings 3DPSP were applied to guide surgery in pediatric cardiac tumours (n=2) [
      • Riggs K.W.
      • Dsouza G.
      • Broderick J.T.
      • Moore R.A.
      • Morales D.L.S.
      3D-printed models optimize preoperative planning for pediatric cardiac tumor debulking.
      ], cardiac schwannoma (n=1) [
      • Son K.H.
      • Kim K.W.
      • Ahn C.B.
      • Choi C.H.
      • Park K.Y.
      • Park C.H.
      • et al.
      Surgical planning by 3d printing for primary cardiac schwannoma resection.
      ], cardiac myxoma (n=1) [
      • Ali M.
      • Pham A.N.
      • Pooley R.A.
      • Rojas C.A.
      • Mergo P.J.
      • Pham S.M.
      Three-dimensional printing facilitates surgical planning for resection of an atypical cardiac myxoma.
      ], cardiac fibroma (n=1) [
      • Schmauss D.
      • Gerber N.
      • Sodian R.
      Three-dimensional printing of models for surgical planning in patients with primary cardiac tumors.
      ], high-grade sarcoma (n=1) [
      • Jacobs S.
      • Grunert R.
      • Mohr F.W.
      • Falk V.
      3D-imaging of cardiac structures using 3D heart models for planning in heart surgery: a preliminary study.
      ], as well as secondary cardiac tumours (n=2) [
      • Al Jabbari O.
      • Abu Saleh W.K.
      • Patel A.P.
      • Igo S.R.
      • Reardon M.J.
      Use of three-dimensional models to assist in the resection of malignant cardiac tumors.
      ]. All authors described an enhancement of the preoperative management of these patients and found 3DSPS helpful in the planning of the optimal interventional approach. However, no comparative study and no case series including more than two patients exists that systematically investigated 3DPSP in the setting of cardiac tumours.

      Training of Interventions

      Four (4) studies systematically investigated 3DPSP for training of cardiovascular interventions. In the largest study to date, surgeons (n=50) evaluated the quality of the models as acceptable (88%) and agreed that the model provided necessary information on the pathology (>85%). However, consistency and elasticity of the materials, especially of valves was mostly rated as different to human tissue [
      • Yoo S.J.
      • Spray T.
      • Austin 3rd, E.H.
      • Yun T.J.
      • van Arsdell G.S.
      Hands-on surgical training of congenital heart surgery using 3-dimensional print models.
      ]. Repetitive training on a 3DPSP led to shorter operation time in a simulated ventricular septal defect (VSD)-closure [
      • Nam J.G.
      • Lee W.
      • Jeong B.
      • Park E.A.
      • Lim J.Y.
      • Kwak Y.
      • et al.
      Three-dimensional printing of congenital heart disease models for cardiac surgery simulation: evaluation of surgical skill improvement among inexperienced cardiothoracic surgeons.
      ], arterial switch procedure [
      • Hussein N.
      • Honjo O.
      • Haller C.
      • Coles J.G.
      • Hua Z.
      • Van Arsdell G.
      • et al.
      Quantitative assessment of technical performance during hands-on surgical training of the arterial switch operation using 3-dimensional printed heart models.
      ], and various other CHD interventions [
      • Hussein N.
      • Honjo O.
      • Barron D.J.
      • Haller C.
      • Coles J.G.
      • Yoo S.J.
      The incorporation of hands-on surgical training in a congenital heart surgery training curriculum.
      ].

      Other Interventions

      Other applications of 3DPSP in cardiovascular interventions have been described in case reports and case series only. Four (4) articles described cumulative seven 3DPSP in coronary artery interventions and evaluated them positively with high impact on decision-making [
      • Velasco Forte M.N.
      • Byrne N.
      • Valverde Perez I.
      • Bell A.
      • Gómez-Ciriza G.
      • Krasemann T.
      • et al.
      3D printed models in patients with coronary artery fistulae: anatomical assessment and interventional planning.
      ,
      • Watanabe H.
      • Saito N.
      • Tatsushima S.
      • Tazaki J.
      • Toyota T.
      • Imai M.
      • et al.
      Patient-specific three-dimensional aortocoronary model for percutaneous coronary intervention of a totally occluded anomalous right coronary artery.
      ,
      • Young L.
      • Harb S.C.
      • Puri R.
      • Khatri J.
      Percutaneous coronary intervention of an anomalous coronary chronic total occlusion: the added value of three-dimensional printing.
      ,
      • Niizeki T.
      • Iwayama T.
      • Kumagai Y.
      • Ikeno E.
      • Saito N.
      • Kimura T.
      Preprocedural planning using a three-dimensional printed model for percutaneous coronary intervention in an anomalous coronary artery.
      ]. Furthermore, 3DPSP were evaluated as helpful in the planning of adult cardiothoracic surgery [
      • Borracci R.A.
      • Ferreira L.M.
      • Alvarez Gallesio J.M.
      • Tenorio Núñez O.M.
      • David M.
      • Eyheremendy E.P.
      Three-dimensional virtual and printed models for planning adult cardiovascular surgery.
      ], post-infarct VSD [
      • Lazkani M.
      • Bashir F.
      • Brady K.
      • Pophal S.
      • Morris M.
      • Pershad A.
      Postinfarct VSD management using 3D computer printing assisted percutaneous closure.
      ], cardiac resynchronisation device lead implantation [
      • Kanawati J.
      • Kanawati A.J.
      • Rowe M.K.
      • Khan H.
      • Chan W.K.
      • Yee R.
      Utility of 3-D printing for cardiac resynchronization device implantation in congenital heart disease.
      ], or the treatment of complex cardiac fistulae [
      • Aroney N.
      • Markham R.
      • Putrino A.
      • Crowhurst J.
      • Wall D.
      • Scalia G.
      • et al.
      Three-dimensional printed cardiac fistulae: a case series.
      ]. Other case reports and case series described the emerging role of 3DPSP in left ventricular pseudoaneurysm [
      • Pizzuto A.
      • Santoro G.
      • Baldi C.
      • Celi S.
      • Cuman M.
      • Anees A.J.
      • et al.
      3D model-guided transcatheter closure of left ventricular pseudoaneurysm: a case series.
      ,
      • Mohamed E.
      • Telila T.
      • Osaki S.
      • Jacobson K.
      Percutaneous closure of left ventricle pseudoaneurysm using 3D printed heart model for procedure planning: a novel approach.
      ,
      • Al-Hijji M.A.
      • Guerrero M.
      • Rihal C.S.
      • Eleid M.F.
      Transapical percutaneous closure of rapidly expanding post-surgical left ventricular outflow tract pseudoaneurysm.
      ] and aneurysm of congenital origin [
      • Shetty I.
      • Lachma R.N.
      • Manohar P.
      • Rao P.S.M.
      3D printing guided closure of submitral aneurysm-an interesting case.
      ]. Successful planning of valve interventions others than CHD, TAVI, and mitral valve repair/replacement (MVR) on 3DPSP were described during Ozaki repairs of the aortic valve [
      • Shearn A.I.U.
      • Ordoñez M.V.
      • Rapetto F.
      • Caputo M.
      • Biglino G.
      Rapid prototyping flexible aortic models aids sizing of valve leaflets and planning the Ozaki repair.
      ], tricuspid valve-in-valve replacement [
      • Spring A.M.
      • Pirelli L.
      • Basman C.L.
      • Kliger C.A.
      The importance of pre-operative imaging and 3-D printing in transcatheter tricuspid valve-in-valve replacement.
      ], surgical tricuspid valve repair [
      • Harb S.C.
      • Spilias N.
      • Griffin B.P.
      • Svensson L.G.
      • Klatte R.S.
      • Bakaeen F.G.
      • et al.
      Surgical repair for primary tricuspid valve disease: individualized surgical planning with 3-dimensional printing.
      ], and transcatheter tricuspid valve repair by MitraClip (Abbott, Menlo Park, CA, USA) implantation [
      • Vukicevic M.
      • Faza N.N.
      • Avenatti E.
      • Durai P.C.
      • El-Tallawi K.C.
      • Filippini S.
      • et al.
      Patient-specific 3-dimensional printed modeling of the tricuspid valve for mitraclip procedure planning.
      ]. In the setting of surgical aortic valve replacement (SAVR), 3DPSP was used to plan surgery after previous coronary artery bypass graft [
      • Sodian R.
      • Schmauss D.
      • Markert M.
      • Weber S.
      • Nikolaou K.
      • Haeberle S.
      • et al.
      Three-dimensional printing creates models for surgical planning of aortic valve replacement after previous coronary bypass grafting.
      ], or transcatheter closure of paravalvular regurgitation after SAVR [
      • ElGuindy A.
      • Osman A.
      • Elborae A.
      • Nagy M.
      The utility of 3D printed models in complex percutaneous paravalvular leak interventions.
      ,
      • Motwani M.
      • Burley O.
      • Luckie M.
      • Cunnington C.
      • Pisaniello A.D.
      • Hasan R.
      • et al.
      3D-printing assisted closure of paravalvular leak.
      ]. Moreover, 3DPSP can be used to simulate left ventricular assist devices implantation [
      • Miller J.R.
      • Singh G.K.
      • Woodard P.K.
      • Eghtesady P.
      • Anwar S.
      3D printing for preoperative planning and surgical simulation of ventricular assist device implantation in a failing systemic right ventricle.
      ], and ease left ventricular inflow cannula placement with the help of a 3D printed exoskeleton [
      • Barabás I.J.
      • Hartyánszky I.
      • Kocher A.
      • Merkely B.
      A 3D printed exoskeleton facilitates HeartMate III inflow cannula position.
      ].

      Meta-Analysis on the Impact of 3DPSP on Intervention Time

      Seven (7) studies reported data about intervention times after 3DPSP application compared to controls without 3DPSP use. One (1) study [
      • Matsubara D.
      • Kataoka K.
      • Takahashi H.
      • Minami T.
      • Yamagata T.
      A patient-specific hollow three-dimensional model for simulating percutaneous occlusion of patent ductus arteriosus.
      ] provided only mean and interquartile range of procedural times and hence was not eligible for inclusion. Among the remaining six studies (Table 2), three investigated 3DPSP in LAA occlusion [
      • Li P.
      • Fang F.
      • Qiu X.
      • Xu N.
      • Wang Y.
      • Ouyang W.B.
      • et al.
      Personalized three-dimensional printing and echoguided procedure facilitate single device closure for multiple atrial septal defects.
      ,
      • Obasare E.
      • Mainigi S.K.
      • Morris D.L.
      • Slipczuk L.
      • Goykhman I.
      • Friend E.
      • et al.
      CT based 3D printing is superior to transesophageal echocardiography for pre-procedure planning in left atrial appendage device closure.
      ,
      • Fan Y.
      • Yang F.
      • Cheung G.S.
      • Chan A.K.
      • Wang D.D.
      • Lam Y.Y.
      • et al.
      Device sizing guided by echocardiography-based three-dimensional printing is associated with superior outcome after percutaneous left atrial appendage occlusion.
      ] and three in surgery due to CHD [
      • Han F.
      • Co-Vu J.
      • Lopez-Colon D.
      • Forder J.
      • Bleiweis M.
      • Reyes K.
      • et al.
      Impact of 3D printouts in optimizing surgical results for complex congenital heart disease.
      ,
      • Ryan J.
      • Plasencia J.
      • Richardson R.
      • Velez D.
      • Nigro J.J.
      • Pophal S.
      • et al.
      3D printing for congenital heart disease: a single site's initial three-yearexperience.
      ,
      • Zhao L.
      • Zhou S.
      • Fan T.
      • Li B.
      • Liang W.
      • Dong H.
      Three-dimensional printing enhances preparation for repair of double outlet right ventricular surgery.
      ]. Taking into account heterogeneity between the settings and the range of intervention times we forwent determining a weighted mean difference and analysed data by the combined effect size instead. Including these studies into a random-effects model, we found a significant association between the use of 3DPSP and a reduction in the intervention time (Cohen’s d=0.54; 95% confidence interval 0.13–0.95; p=0.001, I2 53.3%) (Figure 4).
      Table 2Studies included into meta-analysis.
      AuthorsYSettingNControl Arm ImagingMean Intervention Time (min±SD)Mean Difference (min)
      3DPSPControl3DPSPControl
      Zhao et al. [
      • Zhao L.
      • Zhou S.
      • Fan T.
      • Li B.
      • Liang W.
      • Dong H.
      Three-dimensional printing enhances preparation for repair of double outlet right ventricular surgery.
      ]
      2018Surgical repair of double outlet right ventricle817CCT and echocardiography251.7±35.8285.1±83.4-33.4
      Obasare et al. [
      • Obasare E.
      • Mainigi S.K.
      • Morris D.L.
      • Slipczuk L.
      • Goykhman I.
      • Friend E.
      • et al.
      CT based 3D printing is superior to transesophageal echocardiography for pre-procedure planning in left atrial appendage device closure.
      ]
      2018LAA occlusion1392D TOE70±20107±53-37
      Ryan et al. [
      • Ryan J.
      • Plasencia J.
      • Richardson R.
      • Velez D.
      • Nigro J.J.
      • Pophal S.
      • et al.
      3D printing for congenital heart disease: a single site's initial three-yearexperience.
      ]
      2018Surgery due to complex CHD33113CMR or CCT220±111229.3±102-9.3
      Han et al. [
      • Han F.
      • Co-Vu J.
      • Lopez-Colon D.
      • Forder J.
      • Bleiweis M.
      • Reyes K.
      • et al.
      Impact of 3D printouts in optimizing surgical results for complex congenital heart disease.
      ]
      2019Surgery due to complex CHD66CCT256.3±49.5304.3±102.4-48
      Fan et al. [
      • Fan Y.
      • Yang F.
      • Cheung G.S.
      • Chan A.K.
      • Wang D.D.
      • Lam Y.Y.
      • et al.
      Device sizing guided by echocardiography-based three-dimensional printing is associated with superior outcome after percutaneous left atrial appendage occlusion.
      ]
      2019LAA occlusion32723D TOE41.7±7.273.7±37.9-32
      Li et al. [
      • Li H.
      • Qingyao Bingshen
      • Shu M.
      • Lizhong
      • Wang X.
      • et al.
      Application of 3D printing technology to left atrial appendage occlusion.
      ]
      2017LAA occlusion2121CCT and TOE96.4±12.5101.2±13.6-4.8
      Abbreviations: 3DPSP, three-dimensional printed patient specific phantom; CCT, cardiac computed tomography; CHD, congenital heart disease; CMR, cardiac magnetic resonance imaging; LAA, left atrial appendage; TOE, transoesophageal echocardiography.
      Figure thumbnail gr4
      Figure 4Forest plot for combined effect size on a reduction of intervention time with three-dimensional printed patient-specific phantom (3DPSP).

      Discussion

      The salient findings of the present analysis can be summarised as follows (Figure 5). There has been increasing interest in applying 3DPSP to cardiovascular interventions during the last decade, as indicated by a large and increasing number of studies since 2017. All reports consistently evaluated 3DPSP as helpful and enhancing in the planning and guiding of cardiovascular interventions, however no effect on clinical endpoints has been shown. Comparative studies indicate shorter procedure- and fluoroscopy times if the intervention is trained, planned, or guided by 3DPSP. This observation is confirmed by our meta-analysis with regard to intervention time. Only one RCT exists to date, which supports the use of 3DPSP in the setting of LAA closure, confirming previous findings in terms of a decline in radiation exposure.
      Figure thumbnail gr5
      Figure 5Current applications of prospectively used 3D printed patient-specific phantoms (3DPSP) in cardiovascular intervention.
      Abbreviations: HCM, hypertrophic cardiomyopathy; LAA, left atrial appendage. (modified from freely available Servier Medical Art templates, smart.servier.com)
      Despite these encouraging findings, several limitations of 3DPSP require attention. Most studies were of descriptive and observational character and no prospective study exists that included more than 100 patients. No study demonstrated an effect on clinical outcomes including mortality, need for re-intervention, or hospitalisations. 3DPSP can only depict information that was assessed by the imaging modality they are derived from. Hence, the quality of the image acquisition directly affects the anatomic accuracy of 3DPSP, and limits the gain of knowledge they might provide when compared to imaging data alone and virtual 3D models. Poor imitation of tissue characteristics is another important limitation, especially in the setting of direct printing techniques using rigid materials [
      • Hermsen J.L.
      • Yang R.
      • Burke T.M.
      • Dardas T.
      • Jacobs L.M.
      • Verrier E.D.
      • et al.
      Development of a 3-D printing-based cardiac surgical simulation curriculum to teach septal myectomy.
      ]. Depicting of deformations within the cardiac cycle as well as of cardiac valves is often lacking, particularly in single-material models [
      • Yoo S.J.
      • Spray T.
      • Austin 3rd, E.H.
      • Yun T.J.
      • van Arsdell G.S.
      Hands-on surgical training of congenital heart surgery using 3-dimensional print models.
      ]. Furthermore, availability of high-quality 3D printers is limited [
      • Illmann C.F.
      • Hosking M.
      • Harris K.C.
      Utility and access to 3-dimensional printing in the context of congenital heart disease: an international physician survey study.
      ]. High costs for 3D printing, but also for finalised commercially available models, might be a deterrent, in particular for complex multi-material models that might be up to USD$2,500 [
      • Ho D.R.
      • Luery S.E.
      • Ghosh R.M.
      • Maehara C.K.
      • Silvestro E.
      • Whitehead K.K.
      • et al.
      Cardiovascular 3-d printing: value-added assessment using time-driven activity-based costing.
      ]. Quantification and generalisation of total cost is challenging since most 3D prints are conducted in the research environment in which a quantification of costs is often not possible and also vary greatly due to different requirements on the finalised models and the experience of the printing team (going along with the time required for printing). Costs for buying 3D printers and segmentation software and also personal costs are the main determinants in the calculation, whereas in comparison, clearly definable costs for printing materials are often negligible. However, also low-cost printed heart models have proven to show excellent correlation to anatomical structures [
      • Lau I.
      • Wong Y.H.
      • Yeong C.H.
      • Abdul Aziz Y.F.
      • Md Sari N.A.
      • Hashim S.A.
      • et al.
      Quantitative and qualitative comparison of low- and high-cost 3D-printed heart models.
      ].
      Irrespective of these limitations, the reviewed studies demonstrate the technical feasibility of 3D printing to plan and guide cardiovascular interventions. Two-dimensional visualisation of 3D models on a screen cannot provide the same information and ease of orientation to understand complex anatomic relationships like a printed model of high quality [
      • Sun L.
      • Fukuda T.
      • Tokuhara T.
      • Yabuki N.
      Differences in spatial understanding between physical and virtual models.
      ]. Moreover, the opportunity for tactile feedback makes 3DPSP an accessible tool in clinical decision-making in a user-friendly fashion. Becoming familiar with patient-specific conditions in a training or planning process on a 3DPSP prior to intervention speeds up interventional procedures. This might especially apply to interventions with highly variable anatomic structures such as the LAA or in the setting of CHD. The reduction of mechanical ventilation time, aortic cross-clamp time, as well as of fluoroscopy time, and dose might favourably impact on patient outcomes. 3DPSP can be derived from clinically indicated standard imaging not going along with longer scanning time or increased radiation exposure, hence no potential harm is expected for patients. Although the advantage of 3DPSP is difficult to measure and remains subjective in most cases, we conclusively see the strengths of 3DPSP in: I. the simulation of the individual patient anatomy prior cardiovascular intervention thereby improving outcomes and providing safety (i.e., prevention of device embolisation in LAA- or valve interventions or visualisation of rare anatomy in CHD prior surgery); II. device selection and modification (i.e., choosing the optimal type and optimal size of LAA-occluders or prosthetic valves in order to prevent paravalvular leak or size mismatch, or the modification of aortic stent grafts); and III. education and training of fellows in cardiovascular interventions.

      Limitations of This Review and Meta-Analysis

      The findings of this review should be interpreted in light of several limitations that go beyond the limitations of the individual studies included. Although search terms tried to cover the full spectrum of research on 3DPSP in cardiovascular intervention, rare fields of applications may have been missed by our keywords search. Exclusion of studies that retrospectively investigated 3DPSP in cardiovascular intervention was necessary to reduce the large number of studies meeting our inclusion criteria but might result in missing important findings. Furthermore, a possible publication bias should also be considered. Cases in which manufacturing 3DPSP in an adequate quality has failed or the models were not considered to be helpful might not be published or did not reach significance for acceptance in journals. Our meta-analysis is based on only six studies with a small total number of patients (n=113, 3DPSP vs 238 controls) in different settings (LAA closure and surgery due to CHD), hence heterogeneity should be taken into account and reduces generalisability of our findings to other cardiovascular interventions guided by 3DPSP. Local expertise and volume in imaging and the intervention, as well as operator's experience might bias our findings. Although I2=53.3% referred to moderate heterogeneity, Cochran’s Q was not significant, indicating that the association of 3DSPS to reduced intervention time was consistent across studies.

      Conclusions

      Three-dimensional patient-specific phantoms is helpful to plan, train, and guide interventions in patients with complex cardiovascular anatomy. Benefits for patients include reduced intervention time, with the potential to lower radiation exposure and shorten mechanical ventilation. More evidence is needed to warrant adoption of 3DPSP into routine clinical practice although future applications are vast.

      Conflicts of Interest

      Dr. Windecker has received research grants to his institution from Abbott, Amgen, Boston, Biotronik, and St. Jude Medical, he has received no speaker fee. Dr. Pilgrim has received research grants to his institution from Edwards Lifesciences, Symetis, and Biotronik; has received speaker fees from Boston Scientific; and has received reimbursement for travel expenses from St. Jude Medical. Dr. Praz is a consultant for Edwards Lifesciences. Dr. Gräni received research funding from Swiss National Science Foundation and Innosuisse outside of the submitted work. Further Dr. Gräni received travel fees from Amgen and Bayer outside of the submitted work. All other authors report no conflicts.

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