Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.

BACKGROUND: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. AIMS: We aimed to evaluate the safety and efficacy of the R-One system for PCI. METHODS: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. RESULTS: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. CONCLUSIONS: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

Assessing a New Prescreening Score for the Simplified Evaluation of the Clinical Quality and Relevance of eHealth Apps: Instrument Validation Study.

BACKGROUND: In 2020, more than 250 eHealth solutions were added to app stores each day, or 90,000 in the year; however, the vast majority of these solutions have not undergone clinical validation, their quality is unknown, and the user does not know if they are effective and safe. We sought to develop a simple prescreening scoring method that would assess the quality and clinical relevance of each app. We designed this tool with 3 health care stakeholder groups in mind: eHealth solution designers seeking to evaluate a potential competitor or their own tool, investors considering a fundraising candidate, and a hospital clinician or IT department wishing to evaluate a current or potential eHealth solution. OBJECTIVE: We built and tested a novel prescreening scoring tool (the Medical Digital Solution scoring tool). The tool, which consists of 26 questions that enable the quick assessment and comparison of the clinical relevance and quality of eHealth apps, was tested on 68 eHealth solutions. METHODS: The Medical Digital Solution scoring tool is based on the 2021 evaluation criteria of the French National Health Authority, the 2022 European Society of Medical Oncology recommendations, and other provided scores. We built the scoring tool with patient association and eHealth experts and submitted it to eHealth app creators, who evaluated their apps via the web-based form in January 2022. After completing the evaluation criteria, their apps obtained an overall score and 4 categories of subscores. These criteria evaluated the type of solution and domain, the solution's targeted population size, the level of clinical assessment, and information about the provider. RESULTS: In total, 68 eHealth solutions were evaluated with the scoring tool. Oncology apps (22%, 20/90) and general health solutions (23%, 21/90) were the most represented. Of the 68 apps, 32 (47%) were involved in remote monitoring by health professionals. Regarding clinical outcomes, 5% (9/169) of the apps assessed overall survival. Randomized studies had been conducted for 21% (23/110) of the apps to assess their benefit. Of the 68 providers, 38 (56%) declared the objective of obtaining reimbursement, and 7 (18%) out of the 38 solutions seeking reimbursement were assessed as having a high probability of reimbursement. The median global score was 11.2 (range 4.7-17.4) out of 20 and the distribution of the scores followed a normal distribution pattern (Shapiro-Wilk test: P=.33). CONCLUSIONS: This multidomain prescreening scoring tool is simple, fast, and can be deployed on a large scale to initiate an assessment of the clinical relevance and quality of a clinical eHealth app. This simple tool can help a decision-maker determine which aspects of the app require further analysis and improvement.

Residual platelet reactivity, thrombus burden and myocardial reperfusion in patients treated by PCI after successful pre-hospital fibrinolysis compared to primary PCI.

We compared residual platelet reactivity and post PCI atherothrombotic burden using OFDI in patients successfully treated by primary PCI versus pharmacoinvasive approach (PI) defined as PCI after successful pre-hospital fibrinolysis. Despite pre-hospital P2Y12-inhibitor loading dose, high rates of high on-treatment platelet reactivity were found at the time of PCI in both groups. Primary PCI patients had higher post stenting thrombus burden and lower rates of final normal myocardial blush grade compared to PI. These findings support the use of a pharmacoinvasive reperfusion strategy especially when primary PCI cannot be timely performed.

Systematic review and meta-analysis of the prognostic impact of cancer among patients with acute coronary syndrome and/or percutaneous coronary intervention.

BACKGROUND: Patients with cancer admitted for an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) represent a growing and high-risk population. The influence of co-existing cancer on mortality remains unclear in such patients. We aimed to assess the impact of cancer on early and late, all-cause and cardiac mortality in the setting of ACS and/or PCI. METHODS: We performed a systematic review and meta-analysis of studies comparing outcomes of patients with and without a history of cancer admitted for ACS and/or PCI. RESULTS: Six studies including 294,528 ACS patients and three studies including 39,973 PCI patients were selected for our meta-analysis. Patients with cancer had increased rates of in-hospital all-cause death (RR 1.74 [1.22; 2.47]), cardiac death (RR 2.44 [1.73; 3.44]) and bleeding (RR 1.64 [1.35; 1.98]) as well as one-year all-cause death (RR 2.62 [1.2; 5.73]) and cardiac death (RR 1.89 [1.25; 2.86]) in ACS studies. Rates of long term all-cause (RR 1.96 [1.52; 2.53]) but not cardiac death were higher in cancer patients admitted for PCI. CONCLUSION: Cancer patients represent a high-risk population both in the acute phase and at long-term after an ACS or PCI. The magnitude of the risk of mortality should however be tempered by the heterogeneity among studies. Early and long term optimal management of such patients should be promoted in clinical practice.

Safety and efficacy of IIb/IIIa inhibitors in combination with highly active oral antiplatelet regimens in acute coronary syndromes: A meta-analysis of pivotal trials.

The risk and benefit of GP-IIb/IIIa Inhibition (GPI) in combination with recent antiplatelet regimens in acute coronary syndromes (ACS) remain unassessed. The advent of fast-acting highly active oral P2Y12 inhibitors questions the additional value and risk of their association with GPI. We studied the effect of GPI in combination with prasugrel and ticagrelor, compared to clopidogrel on major bleeding in pivotal randomized controlled trials in the setting of ACS, using a meta-analytic approach. A similar analysis, further including the comparison of a double versus standard dose clopidogrel regimen, was performed for the risk of the primary efficacy endpoint. The combination of GPI and recent P2Y12 inhibitors was associated with a similar risk of bleeding as compared with GPI and the standard clopidogrel regimen (RR 0.92 [0.74; 1.13]). The benefit of recent regimens, including double dose clopidogrel, in reducing the primary ischemic endpoint (RR 0.86 [0.78; 0.94]) persisted in those treated with GPI. Although GPI use was associated with a consistent increase in the risk of bleeding in both recent (RR 1.27 [1.05-1.55]) and standard regimens (RR 2.01 [1.64-2.47]), the relative magnitude of such an increase was lower in association with prasugrel or ticagrelor as compared with clopidogrel. The risk of bleeding using a combination of GPI and oral antiplatelet regimens is mainly related to the use of GPI and not the oral antiplatelet regimen. Considering the absence of increased risk of bleeding and the persistence of the benefit of recent P2Y12 regimens in combination with GPI as compared with the standard clopidogrel regimen, the use of such a combination within the guidelines is supported by our findings.

Rotational atherectomy for left main coronary artery disease in octogenarians: transradial approach in a tertiary center and literature review.

OBJECTIVES: The aim of this study was to appreciate the safety and effectiveness of transradial percutaneous coronary intervention (PCI) with rotational atherectomy for highly calcified left main coronary artery (LMCA) disease in octogenarians. BACKGROUND: Conventional surgery is still considered the preferred management for LMCA disease; but, when the lesion is severely calcified, and the patient is unsuitable for surgery, the interventional cardiologist faces a complex PCI traditionally approached by femoral access. METHODS: Between June 2004 and December 2010, octogenarians with calcified LMCA disease who were primary denied for surgical revascularization were enrolled. Procedural success and major adverse cerebral and cardiovascular events (MACCE) including death, nonfatal myocardial infarction, target lesion revascularization (TLR), or stroke during long-term follow-up were evaluated. RESULTS: Forty-two consecutive patients ≥80 years had undergone stenting for calcified LMCA disease (13 with rotational atherectomy, the "Rota" group, and 29 without rotational atherectomy, the "without Rota" group). Procedural success was good (92.3% vs. 96.6%, respectively, p = NS). Mean follow-up time was 25.7 ± 21.4 and 28 ± 32.3 months, respectively. There was a TLR in 25% and 11.1%, respectively; p = NS. No difference was detected in terms of overall in-hospital or long-term mortality or MACCE. CONCLUSION: Rotational atherectomy followed by stent implantation by transradial approach, when applied to heavily calcified lesions, appeared to be a safe and effective strategy for the treatment of LMCA disease in octogenarians who were refused for surgery.

Spontaneous coronary artery dissection: one entity with several therapeutic options.

Spontaneous coronary artery dissection is an unusual and a rare cause of acute coronary syndrome and sudden death with multiple predisposing factors. Prompt recognition is crucial for appropriate patient management, but specific guidelines for optimal treatment are lacking. We report four cases of women with spontaneous coronary artery dissection revealed by ST-segment elevation, three in women during postpartum and one case associated with a Marfan syndrome. Our cases span the different therapeutic options from medical treatment, stenting, to coronary artery bypass graft surgery.

Left main coronary stenting in a non surgical octogenarian population: a possible approach.

Coronary artery bypass grafting is conventionally considered the standard treatment for significant left main coronary artery (LMCA) disease. The management of LMCA disease in octogenarians is however still debated. The aim of this study was to appreciate the safety and effectiveness of percutaneous coronary intervention (PCI) for LMCA disease in octogenarians who were denied for surgical revascularization. The study included 70 consecutive patients ≥80 years of age who had undergone PCI for the treatment of LMCA and who were primary denied by our center's heart team for surgical revascularization. Mean age was 83.4±2.6 years. Mean Euroscore was 21.1±16.7 and mean Syntax score was 28.6±8.7. Overall in-hospital mortality was 11%. Mean follow-up time was 30.5±24.2 months. Overall mortality at the end of follow-up was 28%. Cardiac death was found in 18 patients and 2 patients died from terminal renal insufficiency. One patient (2%) presented with a new STEMI, 7 (11.3%) with a new non-STEMI, 13 (21%) with heart failure, and 2 (3.2%) had minor hemorrhage. There was a percutaneous target vessel revascularization in 6 (10%) patients. During follow-up, the total major adverse cerebral and cardiovascular event (MACCE including death, non-fatal acute myocardial infarction (AMI), target lesion revascularization (TLR), or stroke) was 27.4%. Stent implantation was relatively safely applied for the treatment of LMCA disease in octogenarians who were refused for surgery and who represented a high risk population. Despite a non-negligible rate of MACCE, the clinical long term outcome seems correct for this specific population with heavy basal status.

Thrombus in normal coronary arteries: retrospective study and review of case reports.

BACKGROUND: Myocardial infarction is rarely caused by non-occlusive thrombus in angiographically normal coronary arteries. The cases reported in the literature are scarce and follow-up was usually short. The efficacy and tolerability of the exclusively medical treatment strategy used in most cases remain unknown. AIMS: To evaluate efficacy of medical treatment and long-term prognosis in these patients. METHODS: We retrospectively selected and analysed patients hospitalized in our centre between 1998 and 2008 for myocardial infarction caused by non-occlusive thrombus in angiographically normal coronary arteries (defined as stenosis<30%), who were exclusively medically treated. A long-term follow-up was performed. A review of the literature regarding such cases was carried out. RESULTS: Sixteen patients were identified; apart from smoking, they had few conventional cardiovascular risk factors. Two patients died in hospital. The 14 survivors were followed up for an average of 4.9 years and only one death (non-cardiac cause) and one stroke (related to supraventricular arrhythmia) occurred in this period. Medical treatment included the use of glycoprotein IIb/IIIa inhibitors in 75% of cases. The literature review revealed 36 similar cases due to multiple aetiologies-particularly coronary artery spasm and prothrombotic coagulopathies. CONCLUSION: Patients with myocardial infarction secondary to non-occlusive thrombus in angiographically normal coronary arteries seem to have a good long-term prognosis after the acute phase when treated with an exclusively medical strategy. However, initial clinical presentation was often severe, leading to early in-hospital death.

Is direct coronary stenting the best strategy for long-term outcome? Results of the multicentric randomized benefit evaluation of direct coronary stenting (BET) study.

BACKGROUND: Preliminary trials of direct coronary stenting have demonstrated the benefits of this approach. It lowers procedural cost, time, and radiation exposure compared with predilatation. Nevertheless, the long-term outcome after direct stenting remains less well known. METHODS: Between January and September 1999, 338 patients were randomly assigned to either direct stent implantation (DS+, n = 173) or standard stent implantation with balloon predilatation (DS-, n = 165). Clinical follow-up was performed. RESULTS: Baseline characteristics were similar in the 2 groups. Procedural success was achieved in 98.3% of patients assigned to DS+ and 97.5% of patients assigned to DS- (not significant). Clinical follow-up was obtained in 99% of patients (mean 16.4 +/- 4.6 months). Major adverse cardiac events--defined as whichever of the following occurred first; cardiac death, myocardial infarction, unstable angina, new revascularization--were observed at a higher rate in the DS+ group than in the DS-, but this difference was not significant (11.3% vs 18.2%, P = not significant). The difference in target lesion revascularization rate in the DS+ group (7%) and DS- group (5.2%) was also not significant. Multivariate analysis showed that direct stenting had no influence on long-term major adverse cardiac events rate. Independent relationships were found between long-term major adverse cardiac events rate and final minimal lumen diameter <2.48 mm (relative risk [RR] 0.449, CI 0.239-0.845, P =.013), prior myocardial infarction (RR 2.028, CI 1.114-3.69, P =.02), and hypertension (RR 1.859, CI 1.022-3.383, P =.042). CONCLUSION: The main finding that emerges from this randomized study is that the influence of direct stenting on long-term need for new target lesion revascularization does not differ from that of stenting with balloon predilatation.

Mini-invasive strategy in acute coronary syndromes: direct coronary stenting using 5 Fr guiding catheters and transradial approach.

The purpose of this study was to assess the feasibility and safety of direct coronary stenting in acute coronary syndromes using 5 Fr guiding catheters by transradial approach. A series of 119 patients with an acute coronary syndrome (unstable angina, n = 55; acute myocardial infarction, n = 45; recent acute myocardial infarction, n = 19) explored by transradial approach and eligible for direct stenting were included. A large proportion of patients (52%) was treated during the procedure by platelet IIb/IIIa receptor blockade. Only Medtronic 5 Fr guiding catheters were used in this study. Direct coronary stenting was attempted in all 119 highly selected patients. Failure of direct stenting was observed in only five cases (3.9%) and the stent successfully retrieved in each case in the 5 Fr guiding catheter. In these five cases, balloon predilation was performed and then the stent implanted successfully. Different stents were used: ACS stent (54%), AVE stent (33%), Velocity stent (10%), Nir stent (3%), with diameter ranging from 2.5 to 4 mm. In four cases, the dilation was finally performed using 6 Fr guiding catheters because the backup of the 5 Fr catheter was considered to be too low (3%). No vascular access site complications occurred in this series of patients. We conclude that direct coronary stenting using transradial approach and 5 Fr guiding catheters yields excellent procedural success rate. In the setting of acute coronary syndromes requiring platelet IIb/IIIa receptor blockade or after failure of thrombolysis, this mini-invasive strategy is very attractive because of the low risk of access site complications.