A telemonitoring programme in patients with heart failure in France: a cost-utility analysis.

BACKGROUND: Certain telemedicine programmes for heart failure (HF) have been shown to reduce all-cause mortality and heart failure-related hospitalisations, but their cost-effectiveness remains controversial. The SCAD programme is a home-based interactive telemonitoring service for HF, which is one of the largest and longest-running telemonitoring programmes for HF in France. The objective of this cost-utility analysis was to evaluate the cost-effectiveness of the SCAD programme with respect to standard hospital-based care in patients with HF. METHODS: A Markov model simulating hospitalisations and mortality in patients with HF was constructed to estimate outcomes and costs. The model included six distinct health states (three 'not hospitalised' states, two 'hospitalisation for heart failure' states, both depending on the number of previous hospitalisations, and one death state). The model lifetime in the base case was 10 years. Model inputs were based on published literature. Outputs (costs and QALYs) were compared between SCAD participants and standard care. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainty in the input parameters of the model. RESULTS: The number of quality-adjusted life years (QALYs) was 3.75 in the standard care setting and 4.41 in the SCAD setting. This corresponds to a gain in QALYs provided by the SCAD programme of 0.65 over the 10 years lifetime of the model. The estimated total cost was €30,932 in the standard care setting and €35,177 in the SCAD setting, with an incremental cost of €4245. The incremental cost-effectiveness ratio (ICER) for the SCAD programme over standard care was estimated at €4579/QALY. In the deterministic sensitivity analysis, the variables that had the most impact on the ICER were HF management costs. The likelihood of the SCAD programme being considered cost-effective was 90% at a willingness-to-pay threshold of €11,800. CONCLUSIONS: Enrolment of patients into the SCAD programme is highly cost-effective. Extension of the programme to other hospitals and more patients would have a limited budget impact but provide important clinical benefits. This finding should also be taken into account in new public health policies aimed at encouraging a shift from inpatient to ambulatory care.

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.

Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention: meta-analysis of randomised controlled trials.

BACKGROUND: older patients undergoing percutaneous coronary intervention (PCI) represent a growing population sharing both a high ischemic and bleeding risk. Dual antiplatelet therapy (DAPT) reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding and subsequent mortality. Its optimal duration after PCI remains unclear. OBJECTIVE: to assess the impact of short-duration DAPT on both bleeding and ischemic events in the specific population of older patients undergoing PCI. METHODS: we performed a meta-analysis of randomised controlled trials comparing the safety and efficacy of standard versus very short duration (≤ 3 months, followed by P2Y12 inhibitor monotherapy) DAPT after PCI with a drug-eluting stent in older patients. RESULTS: four studies, representing 8,961 older patients, were finally included. Compared with standard duration, short-duration DAPT was associated with similar rates of major bleeding (relative risks, RR 0.70 [0.47; 1.05]) and the composite efficacy endpoint (RR 0.85 [0.63; 1.14]). There was a high level of heterogeneity between the studies (I2 = 68%) regarding major bleeding. CONCLUSION: our meta-analysis suggests that short DAPT may be a valid option in older patients after PCI but it also highlights the need for specific studies in such patients on optimal duration of antiplatelet therapy.

Residual atherothrombotic burden after primary percutaneous coronary intervention and myocardial reperfusion-An optical frequency domain imaging study.

OBJECTIVES: We aimed to assess the relationship between residual in-stent atherothrombotic burden (ATB) after primary percutaneous coronary intervention (PCI) measured by optical frequency domain imaging (OFDI) using different measurement methods and myocardial blush grade (MBG). BACKGROUND: The impact of residual ATB after primary PCI on myocardial reperfusion remains unclear. METHODS: We prospectively included 60 ST-elevation myocardial infarction patients pretreated with aspirin and ticagrelor. OFDI volumetric quantification using planimetry (with intervals every frame or every millimeter) and semiquantitative score were used to determine ATB. Patients were divided into two groups according to final MBG 3 or <3. RESULTS: The mean ATB was 10.08 ± 5.21%. ATB was lower in patients with final MBG 3 compared to those with impaired MBG, regardless of the measurement method (8.15 ± 5.58 vs. 11.77 ± 4.28%; p = .007 for quantification per frame; 7.8 ± 5.19 vs. 11.07 ± 4.07%; p = .009 for quantification per mm and 11.21 ± 11.75 vs. 22.91 ± 17.35; p = .003 for the semiquantitative thrombus score, respectively). CONCLUSION: Residual post-stenting ATB remains substantial after primary PCI in STEMI patients, even when pretreated with ticagrelor and aspirin. ATB appears as a significant correlate of suboptimal myocardial reperfusion, a known surrogate of clinical outcome.

A head-to-head comparison of three coronary fractional flow reserve measurement technologies: The fractional flow reserve-device study.

OBJECTIVES: To compare three FFR technologies: the electric-sensor Pressurewire® (P), the optic-sensor Comet® (C) guidewire, and the optic-sensor Navvus® (N) microcatheter. BACKGROUND: Different technologies are used to measure fractional flow reserve (FFR) for the functional assessment of coronary lesions with potential discrepancies. METHODS: Sixty-six FFR measurements performed on 32 lesions using each technology were used for a paired comparison of FFR on simultaneous measurements and in clinically relevant conditions (guidewires alone, N on a guidewire). RESULTS: Simultaneous measurements of FFR were significantly (p < .0001) correlated between systems (ρ = 0.88, 0.81 and 0.86 for P and N, P and C and, C and N, respectively). The presence of the N microcatheter, led to reduced values of FFR measured by P or C guidewires (p < .0001). The concomitant presence of P and C guidewires led to significantly lower FFR values (p < .0001) measured by P but not by C. In clinically relevant conditions, values of FFR measured by the optic-sensor C guidewire and N catheter were similar and lower than those measured by the P guidewire (p < .0001). The agreement between the three technologies (FFR ≤ 0.80) was 94%. CONCLUSIONS: FFR values simultaneously measured by three different technologies, are strongly correlated, and provide strongly concordant results. However, significant differences are found between values of FFR. The presence of N, but also C lead to a decrease of FFR measured by P. In clinically relevant conditions, the two optic-sensor technologies provide similar FFR measurements, lower than those measured by the piezo-electric technology suggesting a sensor-technology-related measurement variability. CLINICAL TRIAL REGISTRATION: NCT#03052803.

Evaluation of Left Main Coronary Artery Using Optical Frequency Domain Imaging and Its Pitfalls.

OBJECTIVES: We aimed to assess the quality of optical frequency domain imaging (OFDI) of the left main (LM) arterial wall and describe and analyse potential artefacts in this setting. BACKGROUND: OFDI is increasingly used to assess ambiguous lesions and optimize LM percutaneous coronary intervention. However, its ability to provide artefact-free high-quality images of coronary ostia and large segments such as the LM remains uncertain. METHODS: We included 42 consecutive patients who underwent OFDI, including LM imaging. Each OFDI frame was subdivided into four quadrants and analysed. The number of quadrants with artifacts was calculated within the proximal, mid, and distal LM and the first 5 mm of the left anterior descending artery (LAD) and/or left circumflex artery (LCX). RESULTS: The quadrants analysis showed an overall artifact rate of 8.9%, mostly out-of-field (45.1%) or residual blood (44.7%) artefacts. Most artifacts were located in the proximal LM (18.6%) with a stepwise reduction of artifact rates towards distal segments (mid LM 5.8%; distal LM 3.6%, ostial LAD 2.6%, and ostial LCX 0%; p < 0.001). While 20 (48.8%) patients had angiographically visible plaques, OFDI showed plaques in 32 patients (76.2%; p=0.007). CONCLUSION: OFDI can accurately evaluate the LM and detect and assess angiographically unvisualized atherosclerotic plaques providing accurate assessment of >90% of the quadrants of the LM and the ostia of its bifurcation branches. However, artifacts mainly located in the proximal LM and decreasing distally in a stepwise fashion should be considered in the interpretation of OFDI in this setting.

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.

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.

Plaque erosion versus rupture characterization by optical frequency domain imaging before and after coronary stenting following successful fibrinolysis for ST-segment elevation myocardial infarction.

Intracoronary thrombus burden affects the quality of myocardial reperfusion in the setting of ST-elevation myocardial infarction (STEMI). We aimed to study the characteristics of the plaque and thrombus assessed by intracoronary optical frequency domain imaging (OFDI) according to the presence of plaque rupture or erosion in STEMI patients treated with successful fibrinolysis. Pre-stenting thrombus and post-stenting atherothrombotic burden were compared between plaque rupture and erosion. Twenty-seven consecutive patients were included: 17 (63%) had OFDI-plaque rupture and 10 (37%) had OFDI-erosion. Thrombus volume and burden were significantly higher in case of rupture compared to erosion at baseline (13.4 ± 18.4 vs 2.8 ± 2.3 mm3; p = 0.03 and 33.8 ± 17.5 vs 17.5 ± 9.9%; p = 0.007, respectively). In the rupture group, the core of the thrombus consisted dominantly of red thrombus evenly distributed along the entire culprit plaque. In the erosion group, it consisted dominantly of white thrombus with a focal distribution near the minimal lumen area zone. After stenting, the atherothrombotic volume, burden and its distribution, as well as angiographic estimators of myocardial reperfusion were similar between groups. Our study showed that pre-PCI thrombus amount, typesetting and distribution are mainly linked to the underlying mechanism of STEMI. After stenting, the atherothrombotic burden and its distribution were similar between the groups.

Angles between the aortic root and the left ventricle assessed by MDCT are associated with the risk of aortic regurgitation after transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the impact of the angles quantified by multidetector computed tomography (MDCT) between the ascending aorta's long axis and, the left ventricular inflow long axis (LVLA), or the left ventricule outflow tract long axis, and the occurrence of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR). METHODS: We prospectively included 136 consecutive patients who underwent a transfemoral TAVR with a preoperative MDCT. The groups were defined according to AR <2 or ≥2 assessed by echocardiography at 1 month. RESULTS: AR ≥2 identified in 21 patients (15.4%), was associated with increased rates of mortality (p value 0.02) and heart failure (p value 0.001) at 1-year follow-up. The aorta-LVLA angle was significantly higher in patients with AR ≥2 (130.5° ± 8.8° vs. 124.6° ± 9.5°; p = 0.009). On univariate analysis, aorta-LVLA angle was predictive of AR ≥2 [OR 1.07 per degree (1.02-1.13); p = 0.011]. After adjustment on annular calcification extent, the percentage of prosthesis-annular mismatch and the type of prosthesis, the relationship between aorta-LVLA angle and the risk of AR ≥2 remained unchanged. CONCLUSIONS: We showed that increased angulation between the ascending aorta and the LVLA is associated with higher rates of AR post-TAVR independent of other potential correlates.

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.

Prehospital fibrinolysis versus primary percutaneous coronary intervention in ST-elevation myocardial infarction: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy in patients with ST-elevation myocardial infarction (STEMI), but its benefit over prehospital fibrinolysis (FL) is not clear. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials in which outcomes of patients with STEMI managed with FL early in the prehospital setting versus PPCI were compared. RESULTS: Compared with PPCI, FL was consistently associated with similar rates of short-term (30-90 days) death (relative risk [RR] 0.94, 95 % CI 0.67-1.31) and cardiovascular death (RR 0.95, 95 % CI 0.64-1.4), a decreased risk of cardiogenic shock (RR 0.67, 95 % CI 0.48-0.95), and an increased risk of any stroke (RR 3.57, 95 % CI 1.39-9.17) and hemorrhagic stroke (RR 4.37, 95 % CI 1.25-15.26). FL was also associated with similar rates of 1-year mortality (RR 1.01, 95 % CI 0.75-1.34) and major bleeding (RR 1.31, 95 % CI 0.96-1.78) in comparison with PPCI, but with a notable level (I 2 index 30.5 % and 59.8 %) of heterogeneity among studies. CONCLUSIONS: Our study suggests that, compared with PPCI, FL performed in the early prehospital setting is associated with similar mortality rates, lower rates of cardiogenic shock, and higher rates of stroke in patients with STEMI. Although the number of studies comparing the two strategies is relatively low, our results support prehospital FL and transfer to hub percutaneous coronary intervention (PCI) centers as a valid alternative to PPCI, allowing potential limitation of resources allocated to developing proximity 24/7 PCI facilities.

Remote management in patients with heart failure (from new onset to advanced): A practical guide.

Heart failure is a chronic condition that affects millions of people worldwide and is associated with high morbidity and mortality. Remote monitoring, which includes the use of non-invasive connected devices, cardiac implantable electronic devices and haemodynamic monitoring systems, has the potential to improve outcomes for patients with heart failure. Despite the conceptual and clinical advantages, there are still limitations in the widespread use of these technologies. Moreover, a significant proportion of studies evaluating the benefit of remote monitoring in heart failure have focused on the limited area of prevention of rehospitalization after an episode of acute heart failure. A group of experts in the fields of heart failure and digital health worked on this topic in order to provide a practical paper for the use of remote monitoring in clinical practice at the different stages of the heart failure syndrome: (1) discovery of heart failure; (2) acute decompensation of chronic heart failure; (3) heart failure in stable period; and (4) advanced heart failure. A careful and critical analysis of the available literature was performed with the aim of providing caregivers with some recommendations on when and how to use remote monitoring in these different situations, specifying which variables are essential, optional or useless.

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.

The prognostic value of the cardiopulmonary exercise test in patients with heart failure who have been treated with beta-blockers.

OBJECTIVES: The prevalence of chronic heart failure and a reduced ejection fraction (CHF-REF) has increased over the last decade. The cardiopulmonary exercise test (CPET) is an established tool for managing these patients. For patients who are administered beta-blockers, its predictive value is debated. The aim of this study was to assess the prognostic values of several parameters in patients with CHF-REF who were on beta-blockers. STUDY DESIGN: 390 patients with CHF-REF underwent CPET after cardiac rehabilitation and were followed for two years. RESULTS: The primary endpoints were all-cause mortality, cardiac-related mortality and major cardiovascular events (hospitalization for HF, heart transplantation and acute coronary syndrome or arrhythmia). The mean beta-blockers dosage was 68.9% of the target dose. The two-year mortality rate was 13%, while the mean age of the population was 57.1 years. In addition, most of the patients were men (85.5% vs. 14.5%). The resting LVEF was 35.7 ± 9.4 and the maximal oxygen uptake (peak VO2) was 19.5 ml/kg/min. The peak VO2, VE/VCO2 slope and circulatory power were significant predictors of risk. The prognosis was better when the initial linear VE/VCO2 slope was lower than 30, and the final steeper VE/VCO2 slope was lower than 32. There was no difference between the two slopes. The oxygen uptake efficiency slope, oxygen uptake, heart rate recovery, VE/VCO2/VO2 index and ventilatory threshold had no prognostic value. CONCLUSION: The peak VO2, circulatory power and VE/VCO2 slope were prognostic indicators for patients with CHF-REF who were on beta-blockers.

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).

Thrombus-aspiration through 5 Fr guiding catheter with transradial approach in acute coronary syndromes: feasibility of a mini-invasive strategy.

OBJECTIVES: The purpose of this study was to assess the feasibility and safety of thrombus-aspiration through a 5 Fr guiding catheter with transradial approach in acute coronary syndromes. BACKGROUND: The use of thrombus-aspirating devices improves myocardial reperfusion but requires at least a 6 Fr guiding catheter. Transradial coronary interventions using a 5 Fr guiding catheter are attractive to reduce bleeding complications. METHODS: We retrospectively selected patients presenting acute coronary syndromes with angiographically visible thrombus who underwent thrombus-aspiration through radial access using a 4 Fr multipurpose catheter in a 5 Fr guiding catheter. We described clinical and angiographic characteristics of the cohort, and the procedure's technique, success and complications. RESULTS: Among the 34 included patients, 29 presented ST-segment elevation myocardial infarction. Complete resolution of the ST-segment elevation was effective in 93% of these patients. TIMI flow grade after thrombus-aspiration was significantly improved compared to baseline TIMI flow grade or after passage of the guidewire (P < 0.001 for both). There was no dissection or perforation but we noted distal embolization in 5 cases probably explained by the high grade of intracoronary thrombus in our cohort. CONCLUSION: Thrombus-aspiration through a 5 Fr guiding catheter with transradial approach seems to be safe and effective in selected patients with acute coronary syndrome. This mini-invasive approach brought the advantages of the transradial access in 5 Fr but also its limitations.

Percutaneous balloon atrioseptostomy for left heart discharge in extracorporeal life support patients with persistent pulmonary edema.

AIMS: In severe myocardial dysfunction, extracorporeal life support (ECLS) can preserve organ perfusion. Occasionally, the high resulting afterload can lead to refractory pulmonary edema. We report our experience with percutaneous balloon atrioseptostomy used in this circumstance to discharge the left heart and prevent worsening pulmonary congestion. METHODS AND RESULTS: Between October 2002 and December 2009, 5 patients, with a mean age of 39 years, who were under peripheral ECLS underwent percutaneous balloon atrioseptostomy for refractory worsening pulmonary edema as determined by clinical, radiological, and echocardiographic criteria. Myocardial dysfunction was related to drug poisoning in 2 cases and to myocarditis in the 3 others. Atrioseptostomy successfully improved pulmonary edema and echocardiographic indices of left ventricular function in all cases. Four patients were eventually discharged. The fifth patient died in hospital due to multiorgan failure. CONCLUSIONS: In our experience, percutaneous balloon atrioseptostomy appeared to be a rapid, effective, and minimally invasive technique for offloading the left heart of patients with a reversible cardiac dysfunction under ECLS and suffering from refractory pulmonary edema.

An alternative approach in tortuous coronary artery and distal stenosis during transradial percutaneous coronary intervention: deep engagement by a 5-Fr guiding catheter.

Transradial approach for percutaneous interventions has emerged as an alternative to transfemoral access which is known to be more associated with vascular local complications. However, lack of guiding-catheter support via the radial access is one of the problems encountering the operators. Many solutions have been proposed to overcome this problem. We report on a 62-year-old man with tight stenosis of the distal part of the right coronary artery. He underwent coronary angiography and then percutaneous angioplasty via the right radial artery. During the procedure, attempts to advance a stent beyond a tortuosity at the level of the second segment failed due to lack of support of the 6-Fr Judkins right 4 guiding catheter, even with the buddy wire technique. Then, switching to a 5-Fr Judkins right 4 guiding catheter allowed safe deep engagement and resulted in successful advancement and deployment of the stent.

Impact of wait times on late postprocedural mortality after successful transcatheter aortic valve replacement.

Wait times are associated with mortality on waiting list for transcatheter aortic valve replacement (TAVR). Whether longer wait times are associated with long term mortality after successful TAVR remains unassessed. Consecutive patients successfully treated with elective TAVR in our center between January 2013 and August 2019 were included. The primary end point was one-year all-cause mortality. TAVR wait times were defined as the interval from referral date for valve replacement to the date of TAVR procedure. A total of 383 patients were included with a mean wait time of 144.2 ± 83.87 days. Death occurred in 55 patients (14.4%) at one year. Increased wait times were independently associated with a relative increase of 1-year mortality by 2% per week after referral (Adjusted Hazard Ratio 1.02 [1.002-1.04]; p = 0.02) for TAVR. Chronic kidney disease, left ventricular ejection fraction ≤ 30%, access site and STS score were other independent correlates of 1-year mortality. Our study shows that wait times are relatively long in routine practice and associated with increased 1-year mortality after successful TAVR. Such findings underscore the need of strategies to minimize delays in access to TAVR.