Standardized fractal bench test evaluation of coronary stents: Performances in bifurcation lesions treated by the re-proximal optimization technique.

BACKGROUND: Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly evolving, and so are angioplasty techniques. OBJECTIVES: The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re-proximal optimization technique (rePOT). METHODS: Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro-computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area. RESULTS: Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08). CONCLUSION: This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.

Standardized bench test evaluation of coronary stents: Biomechanical characteristics.

OBJECTIVES: The purpose of the study was to develop a standardized and global bench test protocol to evaluate the biomechanical characteristics of the most currently used drug-eluting coronary stents. BACKGROUND: The use of coronary stents has contributed to the reduction of cardiovascular mortality but can be associated with specific complications. Improving the biomechanical matching between the stents and the coronary anatomy may reduce these complications. METHODS: We assessed five commercially available drug-eluting stents: the Absorb, Orsiro, Resolute Onyx, Synergy, and Xience Alpine stents. Following stent deployment at nominal pressure in ambient air, radial elastic recoil and foreshortening were measured. Flexibility (crimped and deployed stents) and longitudinal and radial resistances were evaluated using a mechanical tester. RESULTS: Biomechanical characteristics were significantly different for all tested devices (ANOVA, P < 0.01). The Synergy, Orsiro, and Xience Alpine stents presented the lowest elastic recoil. The Synergy and Resolute Onyx stents were the most flexible devices. The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances. CONCLUSIONS: Drug-eluting coronary stents used in current clinical practice have very different biomechanical characteristics, which should be taken into consideration to select the most appropriate device for each clinical situation.

Mental stress test: a rapid, simple, and efficient test to unmask long QT syndrome.

Aims: QT prolongation during mental stress test (MST) has been associated with familial idiopathic ventricular fibrillation. In long QT syndrome (LQTS), up to 30% of mutation carriers have normal QT duration. Our aim was to assess the QT response during MST, and its accuracy in the diagnosis of concealed LQTS. Methods and results: All patients who are carrier of a KCNQ1 or KCNH2 mutations without QT prolongation were enrolled. A control group was constituted of patients with negative exercise and epinephrine tests. Electrocardiogram were recorded at rest and at the maximum heart rate during MST and reviewed by two physicians. Among the 70 patients enrolled (median age 41±2.1 years, 46% male), 36 were mutation carrier for LQTS (20 KCNQ1 and 16 KCNH2), and 34 were controls. KCNQ1 and KCNH2 mutation carriers presented a longer QT interval at baseline [405(389; 416) and 421 (394; 434) ms, respectively] compared with the controls [361(338; 375)ms; P < 0.0001]. QT duration during MST varied by 9 (4; 18) ms in KCNQ1, 3 (-6; 16) ms in KCNH2, and by -22 (-29; -17) ms in controls (P < 0.0001). These QT variations were independent of heart rate (P < 0.3751). Receiver operating characteristic curve analysis identified a cut-off value of QT variation superior to -11 ms as best predictor of LQTS. It provided 97% sensitivity and 97% specificity of QT prolongation in the diagnosis of LQTS. Conclusion: We identified a paradoxical response of the QT interval during MST in LQTS. Easy to assess, MST may be efficient to unmask concealed LQTS in patients at risk of this pathology.

Diagnostic Performance of a New Rapid Lateral Flow Immunoassay in Patients Suspected of Heparin-Induced Thrombocytopenia and Its Clinical Consequences.

We prospectively evaluated the diagnostic accuracy of a new rapid assay (STic Expert HIT) alone or in combination with a clinical score in 90 HIT-suspected patients. The 4Ts score was calculated, and ELISA and serotonin-release assay (SRA) were performed; the average time taken for test results were 2 and 5 days for ELISA and SRA, respectively. The STic test was performed in our laboratory as an evaluation exercise and the result was available in 1 hour, but results were not communicated to the clinicians so as to not influence management. Diagnostic performance of STic test was assessed, alone and in combination with 4Ts score. HIT was diagnosed in 19 patients. The sensitivity, specificity, and positive and negative predictive values for the STic test alone were 95%, 92%, 75%, and 98%, respectively, with an accuracy of 92%. The likelihood ratio for positive and negative results with the STic test was 11.2 and 0.06. The combination of the 4Ts score and the STic test results had a negative predictive value of 100% and a negative likelihood ratio of 0. The favorable performance of the STic test may allow for the rapid exclusion of HIT in combination with a low to intermediate pretest clinical probability. During the subsequent year, using the STic test in real time to rapidly exclude the diagnosis, we observed a 50% reduction in danaparoid administration in HIT-suspected patients.

Diagnostic accuracy of fetal rhesus D genotyping using cell-free fetal DNA during the first trimester of pregnancy.

BACKGROUND: Rhesus D genotyping with cell-free fetal DNA currently is used throughout the world. Although this technique has spread rapidly, its optimal use is still a matter of debate. This screening test has been introduced mainly for the treatment of RhD-negative pregnant women during the third trimester of pregnancy, thereby avoiding systematic anti-D prophylaxis, yet such a strategy has proved cost-ineffective. Publications reporting on fetal RHD genotyping with cell-free DNA in maternal plasma, specifically during the first trimester of pregnancy, are scarce in the scientific literature. OBJECTIVE: This study sought to assess the performance of noninvasive fetal Rhesus D genotyping in the first trimester of pregnancy with a single-exon real-time polymerase chain reaction assay. STUDY DESIGN: This was a retrospective observational multicenter study. Cell-free fetal DNA was extracted from maternal blood of both nonimmunized and immunized women at 10-14 weeks of gestation. RHD sequence was determined by quantitative polymerase chain reaction, with amplification of exon 10. Results were compared with RhD phenotype data that were obtained by cord blood sampling of neonates. RESULTS: In total, 416 serum samples from RhD-negative pregnant women were collected during the first trimester of pregnancy. The test's overall sensitivity and specificity were 100% (95% confidence interval, 96.9-100.0) and 95.2% (95% confidence interval, 90.5-97.6), respectively. The negative and positive predictive values were 99.8% (95% confidence interval, 94.9-100.0) and 97.1% (95% confidence interval, 94.2-98.6), respectively. Fetal RHD status was inconclusive in 9 cases (2.2%). CONCLUSION: Noninvasive fetal RHD determination by single-exon quantitative polymerase chain reaction during the first trimester of pregnancy exhibits high accuracy.

Ticagrelor vs Clopidogrel in Clopidogrel-Naive Patients With Chronic Coronary Syndrome.

BACKGROUND: Whether ticagrelor may reduce periprocedural myocardial necrosis after elective percutaneous coronary intervention (PCI) in patients with and without chronic clopidogrel therapy is unclear. OBJECTIVES: This study sought to compare ticagrelor vs clopidogrel in patients with and without chronic clopidogrel therapy before undergoing elective PCI. METHODS: In this prespecified analysis of the ALPHEUS (Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting) trial, patients were defined as clopidogrel(+) and clopidogrel(-) according to the presence and absence of clopidogrel treatment for ≥7 days before PCI, respectively. The primary endpoint was the composite of PCI-related myocardial infarction and major injury as defined by the third and fourth universal definition 48 hours after PCI. RESULTS: A total of 1,882 patients were included, 805 (42.7%) of whom were clopidogrel(+). These patients were older, had more comorbidities, and had more frequent features of complex PCI. The primary endpoint was less frequently present in clopidogrel(-) compared to clopidogrel(+) patients (32.8% vs 40.0%; OR: 0.73; 95% CI: 0.60-0.88), but no significant differences were reported for the risk of death, myocardial infarction, stroke, or transient ischemic attack at 48 hours or 30 days. Ticagrelor did not reduce periprocedural myocardial necrosis or the risk of adverse outcomes, and there was no significant interaction regarding the presence of chronic clopidogrel treatment. CONCLUSIONS: Clopidogrel-naive patients presented less periprocedural complications compared to clopidogrel(+) patients, a difference related to a lower risk profile and less complex PCI. The absence of clopidogrel at baseline did not affect the absence of a difference between ticagrelor and clopidogrel in terms of PCI-related complications supporting the use of clopidogrel as the standard of care in elective PCI in patients with or without chronic clopidogrel treatment.

Myocardial Infarction incidence during national lockdown in two French provinces unevenly affected by COVID-19 outbreak: An observational study.

BACKGROUND: A reduction of admission for MI has been reported in most countries affected by COVID-19. No clear explanation has been provided. METHODS: To report the incidence of myocardial infarction (MI) admission during COVID-19 pandemic and in particular during national lockdown in two unequally affected French provinces (10-million inhabitants) with a different media strategy, and to describe the magnitude of MI incidence changes relative to the incidence of COVID-19-related deaths. A longitudinal study to collect all MIs from January 1 until May 17, 2020 (study period) and from the identical time period in 2019 (control period) was conducted in all centers with PCI-facilities in northern "Hauts-de-France" province and western "Pays-de-la-Loire" Province. The incidence of COVID-19 fatalities was also collected. FINDINGS: In "Hauts-de-France", during lockdown (March 18-May 10), 1500 COVID-19-related deaths were observed. A 23% decrease in MI-IR (IRR=0.77;95%CI:0.71-0.84, p<0.001) was observed for a loss of 272 MIs (95%CI:-363,-181), representing 18% of COVID-19-related deaths. In "Pays-de-la-Loire", 382 COVID-19-related deaths were observed. A 19% decrease in MI-IR (IRR=0.81; 95%CI=0.73-0.90, p<0.001) was observed for a loss of 138 MIs (95%CI:-210,-66), representing 36% of COVID-19-related deaths. While in "Hauts-de-France" the MI decline started before lockdown and recovered 3 weeks before its end, in "Pays-de-la-Loire", it started after lockdown and recovered only by its end. In-hospital mortality of MI patients was increased during lockdown in both provinces (5.0% vs 3.4%, p=0.02). INTERPRETATION: It highlights one of the potential collateral damages of COVID-19 outbreak on cardiovascular health with a dramatic reduction of MI incidence. It advocates for a careful and weighted communication strategy in pandemic crises. FUNDING: The study was conducted without external funding.

Effect of oral anticoagulation on clinical outcomes and haemodynamic variables after successful transcatheter aortic valve implantation.

BACKGROUND: The effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear. AIMS: To evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation. METHODS: All patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥20mmHg or an increase of ≥10mmHg during echocardiographic follow-up. RESULTS: Of the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42-2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58 patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤23mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63-7.07). CONCLUSIONS: Baseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.

A comparative profitability analysis of transcatheter versus surgical aortic valve replacement in a high-volume French hospital.

BACKGROUND: Current scientific guidelines have extended the indication for transcatheter aortic valve replacement (TAVR) to patients who present an intermediate risk for surgery and have been so far considered for conventional surgery. We previously demonstrated that the TAVR procedure generated profits despite elevated costs, but comparison with surgery has not been performed. The objective of this study was to assess the profitability of the TAVR procedure compared with conventional surgery in a high-volume French hospital. Consecutive patients eligible for transfemoral TAVR or surgical aortic valve replacement (SAVR) were included retrospectively in this single-centre study between September 2014 and December 2015. The primary endpoint was the profitability of each procedure (defined as the ratio between the profit and total revenues), calculated for each patient. Secondary composite endpoints included major adverse events in the 30 days following procedure and breakdown of costs. RESULTS: Two hundred and thirty-eight patients were included in the TAVR group and 341 in the SAVR group. TAVR patients presented higher operative risk scores and more comorbidities. Compared with SAVR, TAVR was associated with higher profits (€2732 ± 1768 per patient vs. €2177 ± 2437 per patient, P < 0.001) but also higher costs (€27,778 ± 4961 vs. €17,813 ± 6071, P < 0.001) resulting in lower profitability (9.3 ± 5.7% vs. 11.7 ± 10.1%, P < 0.001). The price of the bioprosthesis represented 70% of the TAVR total cost. CONCLUSIONS: TAVR performed in carefully selected patients was associated with higher profits than SAVR, but also higher costs resulting in lower profitability.

Is the MitraClip® procedure profitable in a high-volume French hospital?

BACKGROUND: Mitral regurgitation is the second most frequent valvulopathy managed by surgery in Europe. For patients who have a contraindication to surgery or a high surgical risk, the percutaneous MitraClip® implantation procedure has emerged as a favourable alternative approach, but elevated procedural costs are a medicoeconomic concern. AIM: The objective of this study was to evaluate whether the MitraClip® procedure is profitable in a high-volume French hospital. METHODS: Patients eligible for mitral valve repair with a MitraClip® device, and covered by the French National Health Service, were included retrospectively in this single-centre study between September 2016 and June 2018. Subgroups were considered based on medicoeconomic severity level. The study primary endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary endpoints included profit based on severity level, breakdown of costs and adverse events during hospitalization. RESULTS: Twenty-two patients were included in the study. The mean hospital cost and revenue were €30,039±2476 and €30,331±2720 per patient, respectively, resulting in a profit of €292±2039 per patient. The total estimated profit was €6429 for the whole study period. The largest benefits were observed for patients assigned to the higher medicoeconomic severity levels (levels 2 and 3). Profit increased following a reduction in the device cost (€1136±2415 per patient). The price of the device represented 78% of the total costs. CONCLUSIONS: Percutaneous MitraClip implantation is a financially neutral procedure for a French university hospital, but this depends on patient severity level.

Incidence of, risk factors for and impact of readmission for heart failure after successful transcatheter aortic valve implantation.

BACKGROUND: The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear. AIMS: We sought to evaluate the incidence of, risk factors for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population. METHODS: All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality. RESULTS: A total of 1139 patients (mean age 82.4±7.7years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio [adjHR] 1.62, 95% confidence interval [CI] 1.09-2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11-2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13-2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17-2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20-3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95-4.94), along with increased Society of Thoracic Surgeons' score (adjHR 1.07, 95% CI 1.03-1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00-2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52-2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41-4.65). CONCLUSIONS: Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI≤35% are the main risk factors for readmission for heart failure.

Is transcatheter aortic valve replacement a profitable procedure in a high-volume French hospital?

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized the prognosis of inoperable patients with severe aortic valve stenosis. Yet, the implantation of expensive prostheses in patients with comorbidities may be questionable in an era when healthcare costs are becoming a major concern. AIM: The objective of this study was to assess whether the TAVR procedure is profitable in a high-volume French hospital. METHODS: Consecutive patients eligible for transfemoral TAVR using the SAPIEN bioprostheses (Edwards Lifesciences, Irvine, CA, USA) were included retrospectively in this single-centre study between September 2014 and December 2015. Three medicoeconomic severity-level subgroups were considered. The primary clinical endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary composite endpoints included major adverse events within 30 days and breakdown of costs. RESULTS: Overall, 189 patients were included in the analysis. Three patients died (two from non-cardiac causes) within 30 days of the procedure. The mean hospital cost was €27,530±3814 per patient, and the mean hospital income was €30,313±2681 per patient (P<0.001), resulting in a significant profit of €2783±1743 per patient. The total estimated profit was €525,000 for the whole study period. The largest benefits were observed for patients assigned to the lowest severity level. The price of the bioprosthesis represented 71% of the total costs. CONCLUSIONS: The TAVR procedure performed in carefully selected patients was profitable for the academic centre, regardless of the level of severity assigned to the patients.

Could anticoagulation avoid bioprosthesis subclinical thrombosis in patients undergoing transcatheter aortic valve replacement?

BACKGROUND: Despite a lack of clear evidence, current European guidelines recommend antiplatelet therapy after transcatheter aortic valve replacement (TAVR). Recent investigations suggest that bioprosthesis thrombosis after TAVR is not uncommon and may be prevented by anticoagulation, but not by antiplatelet therapy. AIMS: The study objective was to assess the impact of the antithrombotic regimen on post-TAVR early haemodynamics. METHODS: Patients eligible for TAVR with an Edwards SAPIEN 3 valve were included in this prospective observational study. Patients undergoing long-term anticoagulation before TAVR continued their treatment, whereas previously non-anticoagulated patients received antiplatelet therapy. The primary endpoint was the mean transaortic gradient assessed by transthoracic echocardiography at the first post-TAVR follow-up. Safety was assessed by two composite endpoints: bleeding/vascular complications and major adverse postoperative events. RESULTS: Among 135 included patients, 78 were discharged on antiplatelet therapy and 57 on anticoagulation. Both groups had similar baseline characteristics, except for supraventricular arrhythmia (7.7% on antiplatelets vs. 89.5% on anticoagulation; P<0.001). At 1-2months after TAVR, the mean transaortic gradient was significantly higher in the antiplatelet therapy group versus the anticoagulation group (13.0±4.0 vs. 9.0±2.8mmHg; P<0.001, independently of prosthesis size). Safety analyses showed no significant differences of the composite endpoints. CONCLUSION: Prolonged anticoagulation after TAVR was associated with lower early transaortic gradients than antiplatelet therapy. Anticoagulation treatment may limit clinical and subclinical thrombosis without increasing early postoperative complications.