Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. METHODS: Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. RESULTS: The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. CONCLUSIONS: IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Patient-tailored antithrombotic therapy following percutaneous coronary intervention.

Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from either shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint on the use of different risk stratification methods alongside clinical judgement in current clinical practice.

Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in Acute Coronary Syndrome: Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials.

BACKGROUND: New randomized, controlled trials have become available on oral P2Y12 inhibitors in acute coronary syndrome. We aimed to evaluate current evidence comparing the efficacy and safety profile of prasugrel, ticagrelor, and clopidogrel in acute coronary syndrome by a meta-analysis of randomized controlled trials. METHODS: We performed a network meta-analysis and direct pairwise comparison analysis of efficacy and safety outcomes from 12 randomized controlled trials including a total of 52 816 patients with acute coronary syndrome. RESULTS: In comparison with clopidogrel, ticagrelor significantly reduced cardiovascular mortality (hazard ratio [HR], 0.82 [95% CI, 0.72-0.92]) and all-cause mortality (HR, 0.83 [95% CI, 0.75-0.92]), whereas there was no statistically significant mortality reduction with prasugrel (HR, 0.90 [95% CI, 0.80-1.01] and HR, 0.92 [95% CI, 0.84-1.02], respectively). In comparison with each other, there were no significant differences in mortality (HR prasugrel versus ticagrelor, 1.10 [95% CI, 0.94-1.29] and 1.12 [95% CI, 0.98-1.28]). In comparison with clopidogrel, prasugrel reduced myocardial infarction (HR, 0.81 [95% CI, 0.67-0.98]), whereas ticagrelor showed no risk reduction (HR, 0.97 [95% CI, 0.78-1.22]). Differences between prasugrel and ticagrelor were not statistically significant. Stent thrombosis risk was significantly reduced by both ticagrelor and prasugrel versus clopidogrel (28%-50% range of reduction). In comparison with clopidogrel, both prasugrel (HR, 1.26 [95% CI, 1.01-1.56]) and ticagrelor (HR, 1.27 [95% CI, 1.04-1.55]) significantly increased major bleeding. There were no significant differences between prasugrel and ticagrelor for all outcomes explored. CONCLUSIONS: Prasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ticagrelor only. There was no efficacy and safety difference between prasugrel and ticagrelor. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019155648.

Outcome of PCI with Xience versus other commonly used modern drug eluting stents: A SCAAR report.

OBJECTIVES: To analyze the clinical outcome of percutaneous coronary intervention (PCI) using the Xience drug eluting stent (DES) versus other modern DES. METHODS: This retrospective study based on the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) analyzed the outcome of PCI using Xience versus other commonly used modern DES, 2007 to 2017. The primary outcome measure was a combination of all-cause death, myocardial infarction (MI) and revascularisation with PCI. Angiographical outcome measures were in-stent restenosis (ISR) and stent thrombosis (ST). RESULTS: Rates of the primary outcome measure for Xience and other DES were 31.9% and 28.2% respectively, adjusted hazard ratio (HR) 0.99 (95% CI 0.95-1.03). Crude rates of ISR were 2.9% versus 2.1% over 4.3 and 2.9 years respectively, adjusted HR 0.93 (95% CI 0.81-1.06). Crude rates of ST were 0.9% versus 0.7%, adjusted HR 1.07 (95% CI 0.82-1.39). Results were consistent in all sensitivity analyses. CONCLUSIONS: This nationally complete, real-world study confirms that Xience is a safe and effective DES with low-event rates of ISR and ST. Compared with a control group containing a large proportion of thinner strut stents and absorbable polymers, Xience exhibits similar results in all important clinical endpoints.

Outcomes of three different new generation transcatheter aortic valve prostheses.

AIMS: To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices. BACKGROUND: Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices. METHODS: This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS: The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more-than-trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog-rank = 0.534). CONCLUSIONS: TAVI using new-generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more-than-trace PVR. At 1-year, MACCE rates were similar among the three groups.

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR).

AIMS: Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated. METHODS AND RESULTS: From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan-Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74-1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57-1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82-1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93-1.19; P = 0.404). CONCLUSION: In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up.

Strategies and Outcomes of Repeat Mitral Valve Interventions after Failed MitraClip Therapy.

Percutaneous mitral valve repair (PMVR) with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) is a valid therapeutic option for patients with severe mitral regurgitation (MR) deemed to be at high or prohibitive surgical risk. Despite the reassuring data on efficacy and long-term durability of the procedure, the proportion of patients with residual or relapsing severe MR after MitraClip therapy is not negligible. In light of the detrimental prognostic impact of severe MR, repeat interventions are increasingly performed in clinical practice using different techniques. In high-risk settings, percutaneous procedures have proven to be effective and safe at reducing MR. Building on this, we sought to summarize the current landscape and clinical experience of reinterventions after failed MitraClip therapy, so as to assist physicians facing the clinical hurdle of proper treatment management after failed PMVR.

Unusual interatrial membrane in the left atrium: A newer obstacle for transseptal-based percutaneous mitral valve repair techniques?

We present a case of a patient with severe mitral regurgitation referred to our Institution for an echocardiographic examination as part of the routine workup to assess the eligibility for mitral valve percutaneous repair with either the MitraClip or Cardioband systems. Echocardiography showed the presence of an unusual interatrial membrane in the left atrium that represented a contraindication for the puncture of the interatrial septum. The patient was finally deferred to percutaneous mitral valve replacement using transapical access.

Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-analysis.

BACKGROUND: The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are unclear. PURPOSE: To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either TAVI or SAVR. DATA SOURCES: MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations. STUDY SELECTION: Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR. DATA EXTRACTION: Two investigators independently extracted study data and rated risk of bias. DATA SYNTHESIS: 16 638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]). LIMITATION: The number of trials was limited, and study designs and patient characteristics were heterogeneous. CONCLUSION: Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk. PRIMARY FUNDING SOURCE: None.

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation.

BACKGROUND: The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy. METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.

Myocardial deformational adaptations to different forms of training: a real-time three-dimensional speckle tracking echocardiographic study.

The hemodynamic load due to physical activity leads to structural and functional cardiac adaptations known as "Athlete's heart". We aimed to compare myocardial performance in different groups of trained athletes by means of 3D echocardiography and 3D speckle tracking echocardiography (3D-STE). 66 athletes [26 strength-trained athletes (STA) and 40 endurance athletes (ETA)] were prospectively enrolled. A control group of 40 sedentary subjects (sedentary group) was also included. All subjects underwent both standard and 3D evaluation of left ventricular (LV) function including 3D-STE. Left ventricular mass indexed for body surface area, LV end-diastolic (LV Dd) thickness of interventricular septum and posterior wall thickness mean values were significantly increased in athletes (p < 0.001, p < 0.01 and p < 0.001, respectively). LV diastolic diameter index had a significantly higher mean value in ETA in respect to sedentary group (p = 0.001). Despite a preserved mean value of LV ejection fraction (LV EF) in all the groups, subjects in STA group showed a significant reduction of strain in the longitudinal, radial and circumferential directions (p < 0.05 for all). Area strain mean value was also reduced in STA group (p < 0.01). In the overall population, an inverse relationship between longitudinal strain and LV Dd index (r = -0.260, p = 0.008), the E/A ratio (r = -0.249, p = 0.010) and the E' velocity (r = -0.259, p = 0.009) has been identified. Sport-specific patterns of ventricular morphological and functional remodeling are present in athletes performing different kinds of training. 3D-STE is a useful and feasible echocardiographic technique for the assessment of sport-specific pattern of deformational adaptations.

Reference Values for Real Time Three-Dimensional Echocardiography-Derived Left Ventricular Volumes and Ejection Fraction: Review and Meta-Analysis of Currently Available Studies.

INTRODUCTION: Current guidelines recommend three-dimensional echocardiography (3DE) as the reference technique to assess left ventricular (LV) volumes and ejection fraction (EF). We performed a meta-analysis to identify normative reference values by real time 3DE in healthy subjects. METHODS: We searched MEDLINE and the Cochrane Library databases using the key search terms three-dimensional echocardiography, volumes, and healthy. Data were pooled using random-effects meta-analysis, and source of variation was investigated using meta-regression. After selection, 13 articles were included (2806 subjects). Four studies were conducted in children and young adolescents; one study provided data in an independent pediatric subgroup. RESULTS: In adults, pooled mean value for LV EDV was 98.4 mL (95%CI, 87-110 mL), while LV ESV mean value was 37.0 mL (95%CI, 32-42 mL). LV EF mean value was 62.9% (95%CI 61.7-64.2%). Male subjects showed a significant increase in both LV EDV index (mean difference 5.3 mL/m(2) ; P < 0.001) and LV ESV index (mean difference 3.3 mL/m(2) ; P < 0.001). LV EF was significantly higher in female subjects (P = 0.003). In pediatric studies, LV EDV pooled mean value was 53.1 mL (95%CI, 38.1-68 mL), while for LV ESV, it was 19.8 mL (95%CI, 14.8-24.8 mL); LV EF mean value was 63.3% (95%CI, 61.6-65%). Significant heterogeneity and inconsistency were noted among studies. Age, systolic blood pressure, and heart rate were identified as a source of between-studies variation for LV volumes. Body surface area was a predictor of nonindexed LV volumes. CONCLUSIONS: Data from available studies of normative values for 3DE were summarized. Our findings may increase the generalizability of LV normative data by 3DE.

Early cardiovascular remodelling in Fabry disease.

AIMS: Fabry disease (FD) is a rare X-linked genetic disorder caused by the deficiency or absent activity of lysosomal α-galactosidase A. Cardiovascular remodelling is a hallmark of FD. The present study aimed to comprehensively evaluate the cardiac, vascular and microvascular status in a population of patients with genetic mutations for FD without left ventricular hypertrophy (LVH). METHODS AND RESULTS: This study includes subjects carrying genetic mutations for FD (Fabry disease mutation-carrier, FDMC) without LVH (n = 19). A group of control subjects (n = 19) matched for age, sex, body mass index and cardiovascular risk factors were also included. All subjects underwent echocardiography, carotid ultrasound scan, endothelial flow-mediated dilatation (FMD) and nailfold capillaroscopy (NFC) assessment. When compared to the subjects in the control group, FDMC patients showed significantly lower mean values of systolic myocardial velocity (7.33 ± 1.28 vs. 10.08 ± 1.63 cm/s, p < 0.0001), longitudinal systolic strain (-18.07 ± 1.72 vs. -21.15 ± 2.22%, p < 0.0001), significantly higher E/E' mean values (7.15 ± 1.54 vs. 5.98 ± 1.27, p = 0.016) and intima-media thickness mean values (0.80 ± 0.20 vs. 0.61 ± 0.19 mm, p = 0.005), significantly lower FMD (8.3 ± 4.6 vs. 12.2 ± 5.0%, p = 0.02), more atypical capillaries and irregular NFC architecture in FDMC than control subjects (52.6 vs. 0%, p < 0.0001; 78.9 vs. 36.8%, p = 0.02 respectively). CONCLUSIONS: FD progressively involves cardiac, macrovascular and microvascular systems in an early stage. These features are present even in asymptomatic mutation carriers without LVH.

Fully independent external validation of the Transcatheter Aortic Valve Replacement 30-day (TAVR-30) hospital readmission model.

BACKGROUND: Early and late readmissions after Transcatheter Aortic Valve Replacement (TAVR) are common and associated with worse outcome. A risk prediction model (TAVR-30) was recently developed using readily available clinical variables to identify patients at risk for hospital readmission within 30 days after TAVR. We performed an independent external validation of the TAVR-30 model. METHODS: The Swedish TAVR-registry, linked together with other mandatory national registries was used to identify all TAVR procedures, variables from the original model, hospitalizations and deaths between the years 2008 to 2021. RESULTS: A total of 8459 patients underwent TAVR, 7693 patients had complete data and were included in the analysis. Out of these, 928 patients experienced a readmission within 30 days. Using the estimates from the original model, a concordance (c)-index of 0.51, a calibration slope of 0.07 and intercept of -0.62 were obtained respectively, overall implying poor model performance. CONCLUSIONS: This independent external validation indicates poor performance of the TAVR-30 model in a Swedish setting. Further research is needed to develop more reliable tools for predicting the risk of early hospital readmission after TAVR, as well as, for providing a deeper understanding of how to develop risk models that performs well in patients with multiple underlying comorbidities.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.