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Background: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. Methods: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co–primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. Results: A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63–0.95]; P =0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45–0.67]; P P interaction =0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association. Conclusions: TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit. Registration: URL: https://www.crd.york.ac.uk/prospero ; Unique identifier: CRD42018109664.

Aims Routine revascularization in patients with ST-segment elevation myocardial infarction (STEMI) presenting >48 h after symptom onset is not recommended. Methods and results We compared outcomes of STEMI patients undergoing percutaneous coronary intervention (PCI) according to total ischaemic time. Patients included in the Bern-PCI registry and the Multicenter Special Program University Medicine ACS (SPUM-ACS) between 2009 and 2019 were analysed. Based on symptom-to-balloon-time, patients were categorized as early (48 h). Co-primary endpoints were all-cause mortality and target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1 year. Of 6589 STEMI patients undergoing PCI, 73.9% were early, 17.2% late, and 8.9% very late presenters. The mean age was 63.4 years, and 22% were female. At 1 year, all-cause mortality occurred more frequently in late vs. early [5.8 vs. 4.4%, hazard ratio (HR) 1.34, 95% confidence interval (CI) 1.01–1.78, P = 0.04] and very late (6.8%) vs. early presenters (HR 1.59, 95% CI 1.12–2.25, P < 0.01). There was no excess in mortality comparing very late and late presenters (HR 1.18, 95% CI 0.79–1.77, P = 0.42). Target lesion failure was more frequent in late vs. early (8.3 vs. 6.5%, HR 1.29, 95% CI 1.02–1.63, P = 0.04) and very late (9.4%) vs. early presenters (HR 1.47, 95% CI 1.09–1.97, P = 0.01), and similar between very late and late presenters (HR 1.14, 95% CI 0.81–1.60, P = 0.46). Following adjustment, heart failure, impaired renal function, and previous gastrointestinal bleeding, but not treatment delay, were the main drivers of outcomes. Conclusion PCI >12 h after symptom onset was associated with less favourable outcomes, but very late vs. late presenters did not have an excess in events. While benefits seem uncertain, (very) late PCI appeared safe.

Aims No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). Methods and results All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160–0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0–36) vs. 40 (6–115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100–0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. Conclusions In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.

ObjectiveGiven the complexities of testing the translational capability of new artificial intelligence (AI) tools, we aimed to map the pathways of training/validation/testing in development process and external validation of AI tools evaluated in dedicated randomised controlled trials (AI-RCTs).MethodsWe searched for peer-reviewed protocols and completed AI-RCTs evaluating the clinical effectiveness of AI tools and identified development and validation studies of AI tools. We collected detailed information, and evaluated patterns of development and external validation of AI tools.ResultsWe found 23 AI-RCTs evaluating the clinical impact of 18 unique AI tools (2009–2021). Standard-of-care interventions were used in the control arms in all but one AI-RCT. Investigators did not provide access to the software code of the AI tool in any of the studies. Considering the primary outcome, the results were in favour of the AI intervention in 82% of the completed AI-RCTs (14 out of 17). We identified significant variation in the patterns of development, external validation and clinical evaluation approaches among different AI tools. A published development study was found only for 10 of the 18 AI tools. Median time from the publication of a development study to the respective AI-RCT was 1.4 years (IQR 0.2–2.2).ConclusionsWe found significant variation in the patterns of development and validation for AI tools before their evaluation in dedicated AI-RCTs. Published peer-reviewed protocols and completed AI-RCTs were also heterogeneous in design and reporting. Upcoming guidelines providing guidance for the development and clinical translation process aim to improve these aspects.

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Introduction In patients with chronic coronary syndrome, percutaneous coronary intervention targets haemodynamically significant stenoses, that is, those thought to cause ischaemia. Intracoronary ECG (icECG) detects ischaemia directly where it occurs. Thus, the goal of this study was to test the accuracy of icECG during pharmacological inotropic stress to determine functional coronary lesion severity in comparison to the structural parameter of quantitative angiographic per cent diameter stenosis (%S), as well as to the haemodynamic indices of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR).Method The primary study endpoint of this prospective trial was the maximal change in icECG ST-segment shift during pharmacological inotropic stress induced by dobutamine plus atropine obtained within 1 min after reaching maximal heart rate(=220 - age). IcECG was acquired by attaching an alligator clamp to the angioplasty guidewire positioned downstream of the stenosis. For the pressure-derived stenosis severity ratios, coronary perfusion pressure and simultaneous aortic pressure were continuously recorded.Results There was a direct linear relation between icECG ST-segment shift and %S: icECG=−0.8+0.03*%S (r2=0.164; p

The aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC).Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC.Consecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints.Among 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months).In a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.

Percutaneous patent foramen ovale (PFO) closure has become a routine procedure and was proven to be safe and feasible. In a recently published pooled analysis of randomized trials, percutaneous PFO closure was shown to more effectively reduce recurrent stroke when compared with medical therapy in patients with cryptogenic strokes. However, procedural safety and closure rate are device dependent.We performed a propensity-score matched comparison of 28 patients undergoing percutaneous PFO closure using the Cera PFO occluder (CPO) with 28 patients who received the Amplatzer PFO occluder (APO). The main endpoints were procedural complications and closure rate at 6 months verified by transesophageal echocardiography.The implantation procedure using the CPO was successful and without complications in all cases. After propensity-score matching, there was no significant difference between groups for the primary endpoint of residual shunt at 6 months (7% in the CPO group vs 4% in the APO group; log-rank test P=.15).With regard to procedural safety and closure rate at 6 months, the performance of the CPO is comparable with the APO in this small patient cohort.

Non-randomized studies aim to reveal whether or not interventions are effective in real-life clinical practice, and there is a growing interest in including such evidence in the decision-making process. We evaluate existing methodologies and present new approaches to using non-randomized evidence in a network meta-analysis of randomized controlled trials (RCTs) when the aim is to assess relative treatment effects. We first discuss how to assess compatibility between the two types of evidence. We then present and compare an array of alternative methods that allow the inclusion of non-randomized studies in a network meta-analysis of RCTs: the naïve data synthesis, the design-adjusted synthesis, the use of non-randomized evidence as prior information and the use of three-level hierarchical models. We apply some of the methods in two previously published clinical examples comparing percutaneous interventions for the treatment of coronary in-stent restenosis and antipsychotics in patients with schizophrenia. We discuss in depth the advantages and limitations of each method, and we conclude that the inclusion of real-world evidence from non-randomized studies has the potential to corroborate findings from RCTs, increase precision and enhance the decision-making process. Copyright © 2017 John WileySons, Ltd.

This study sought to summarize available evidence on transcatheter aortic valve replacement (TAVR) for the treatment of native pure aortic regurgitation (AR).Surgical aortic valve replacement (SAVR) is the gold standard for the treatment of AR. However, case series of high-risk patients undergoing TAVR for native pure AR were reported.We systematically searched Medline, Embase, and Scopus for reports of at least 5 patients with native pure AR undergoing TAVR. Patients' and procedural characteristics were summarized. The primary outcome of interest was all-cause mortality. Pooled estimates were calculated using a random-effects meta-analysis. The study protocol was registered in PROSPERO (CRD42016038422).Thirteen reports including 237 patients were included in the analysis. Self-expandable prostheses were used in 79% of patients, whereas 21% of the patients were treated with a balloon-expandable valve. Device success ranged between 74% and 100%. Seventeen patients (7%) required the implantation of a second valve. Conversion to SAVR was reported in 6 (2.5%) cases. The rate of all-cause mortality at 30 days amounted to 7% (95% confidence interval [CI]: 3% to 13%; IAmong selected patients with native pure AR deemed at high risk for SAVR, TAVR is technically feasible and associated with an acceptable risk of early mortality.

This study evaluated the most appropriate percutaneous coronary intervention (PCI) for the treatment of stenoses in small coronary arteries.PCI in small coronary arteries is associated with an increased risk of lesion failure and restenosis.Randomized trials comparing different PCI strategies were identified through a broad search of published reports. Primary angiographic outcome was %DS (%DS). A pairwise meta-analysis was performed by using random effects model, followed by a network meta-analysis synthesizing direct and indirect evidence.Overall, 19 trials were eligible, which included 5,072 patients comprising a network without closed loops among 5 identified interventions (early generation sirolimus-eluting stents [SES], paclitaxel-eluting stents [PES], drug-coated balloons [DCB], bare-metal stents [BMS], and balloon angioplasty [BA]). No dedicated trial was identified evaluating new generation drug-eluting stents. Early generation SES yielded the best angiographic results according to %DS. For %DS, SES was ranked as the most effective treatment, followed by PES (standardized mean differences [SMD]: -0.44; 95% confidence interval [CI]: -0.92 to 0.05 vs. SES) and DCB (SMD: -0.89; 95% CI: -1.53 to -0.25 vs. SES). In terms of absolute differences, SES yielded a reduction of 18% in diameter stenosis compared to DCB. SES significantly reduced the risk of target-lesion revascularization compared to PES (odds ratio [OR]: 0.39; 95% CI: 0.16 to 0.93), DCB (OR: 0.34; 95% CI: 0.10 to 0.97), BMS (OR: 0.21; 95% CI: 0.13 to 0.36), and BA (OR: 0.16; 95% CI: 0.09 to 0.29).Early generation SES yielded the most favorable angiographic and clinical outcomes for the treatment of stenoses in small coronary arteries. New generation DES need to be evaluated against this standard in future randomized trials.

The aim of this study was to investigate whether the combination of conventional pulmonary vein isolation (PVI) by circumferential antral ablation with ganglionated plexi (GP) modification in a single ablation procedure, yields higher success rates than PVI or GP ablation alone, in patients with paroxysmal atrial fibrillation (PAF).Conventional PVI transects the major left atrial GP, and it is possible that autonomic denervation by inadvertent GP ablation plays a central role in the efficacy of PVI.A total of 242 patients with symptomatic PAF were recruited and randomized as follows: 1) circumferential PVI (n = 78); 2) anatomic ablation of the main left atrial GP (n = 82); or 3) circumferential PVI followed by anatomic ablation of the main left atrial GP (n = 82). The primary endpoint was freedom from atrial fibrillation (AF) or other sustained atrial tachycardia (AT), verified by monthly visits, ambulatory electrocardiographic monitoring, and implantable loop recorders, during a 2-year follow-up period.Freedom from AF or AT was achieved in 44 (56%), 39 (48%), and 61 (74%) patients in the PVI, GP, and PVI+GP groups, respectively (p = 0.004 by log-rank test). PVI+GP ablation strategy compared with PVI alone yielded a hazard ratio of 0.53 (95% confidence interval: 0.31 to 0.91; p = 0.022) for recurrence of AF or AT. Fluoroscopy duration was 16 ± 3 min, 20 ± 5 min, and 23 ± 5 min for PVI, GP, and PVI+GP groups, respectively (p0.001). Post-ablation atrial flutter did not differ between groups: 5.1% in PVI, 4.9% in GP, and 6.1% in PVI+GP. No serious adverse procedure-related events were encountered.Addition of GP ablation to PVI confers a significantly higher success rate compared with either PVI or GP alone in patients with PAF.

In scientific publications, laboratory and clinical images are part of the evidence on which authors base the interpretation and conclusions of their research. However, variability in biology, image acquisition and quality, standards for interpretation, training and experience of evaluators, and presence of artifacts can markedly reduce interrater and intrarater reliability. This variability in interpretation suggests that authors should support their claims with complete information about the image on which those claims are based. Yet, without appropriate guidelines, the documentation of these published images almost certainly will be incomplete and inconsistent. Here, we propose six principles for documenting clinical and laboratory images in publications: the clinical and laboratory images in publications (CLIP) principles. The principles were inspired by the CONSORT (Consolidated Standards of Reporting Trials) and related initiatives that are intended to improve the documentation of research through the use of guidelines. However, the CLIP principles are not formal guidelines, standards, or requirements but, rather, reminders about the information that may be needed to support interpretations and conclusions based on images. These principles organize the self-evident factors related to the nature, acquisition, reporting, and presentation of clinical and laboratory images. As imaging technologies become more complex, however, so too does the specific information needed to document how specific types of images are acquired. Thus, in addition to general direction for all authors, the CLIP principles give journals and professional societies a foundation, a direction, and some models to assist them in developing technology-specific guidelines for reporting the images common in their area of practice.