Fractional flow reserve measurements and long-term mortality-results from the FLORIDA study.

Background: Randomized evidence suggested improved outcomes in fractional flow reserve (FFR) guidance of coronary revascularization compared to medical therapy in well-defined patient cohorts. However, the impact of FFR-guided revascularization on long-term outcomes of unselected patients with chronic or acute coronary syndromes (ACS) is unknown. Aims: The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided vs. angiography-guided treatment strategies in a large, real-world cohort. Methods: This study included patients enrolled into the German InGef Research Database. Patients undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Eligible patients had at least one inpatient coronary angiogram for suspected coronary artery disease between January 2014 and December 2015. Patients were stratified into FFR arm if a coronary angiography with adjunctive FFR measurement was performed, otherwise into the angiography-only arm. Matching was applied to ensure a balanced distribution of baseline characteristics in the study cohort. Patients were followed for 3 years after index date and primary endpoint was all-cause mortality. Results: In the matched population, mortality at 3 years was 9.6% in the FFR-assessed group and 12.6% in the angiography-only group (p = 0.002), corresponding to a 24% relative risk reduction with use of FFR. This effect was most pronounced in patients in whom revascularization was deferred based on FFR (8.7% vs. 12.3%, p = 0.04) and in high-risk subgroups including patients aged ≥75 years (14.9% vs. 20.1%, p < 0.01) and those presenting with ACS (10.2% vs. 14.0%, p = 0.04). Conclusions: FFR-based revascularization strategy was associated with reduced mortality at 3 years. These findings further support the use of FFR in everyday clinical practice.

Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results.

BACKGROUND: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. AIMS: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. METHODS: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. RESULTS: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. CONCLUSIONS: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.

Is the outcome of elective vs non-elective patients undergoing transcatheter aortic valve implantation different? Results of a single-centre, observational assessment of outcomes at a large university clinic.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. METHODS: This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. RESULTS: Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59-16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82-9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40-11.09; all p < 0.001, respectively) were confirmed as significant factors. CONCLUSIONS: While non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.

A Miniature Dual-Fiber Probe for Quantitative Optical Coherence Elastography.

OBJECTIVE: Optical coherence elastography (OCE) allows for high resolution analysis of elastic tissue properties. However, due to the limited penetration of light into tissue, miniature probes are required to reach structures inside the body, e.g., vessel walls. Shear wave elastography relates shear wave velocities to quantitative estimates of elasticity. Generally, this is achieved by measuring the runtime of waves between two or multiple points. For miniature probes, optical fibers have been integrated and the runtime between the point of excitation and a single measurement point has been considered. This approach requires precise temporal synchronization and spatial calibration between excitation and imaging. METHODS: We present a miniaturized dual-fiber OCE probe of 1 mm diameter allowing for robust shear wave elastography. Shear wave velocity is estimated between two optics and hence independent of wave propagation between excitation and imaging. We quantify the wave propagation by evaluating either a single or two measurement points. Particularly, we compare both approaches to ultrasound elastography. RESULTS: Our experimental results demonstrate that quantification of local tissue elasticities is feasible. For homogeneous soft tissue phantoms, we obtain mean deviations of 0.15 ms-1 and 0.02 ms-1 for single-fiber and dual-fiber OCE, respectively. In inhomogeneous phantoms, we measure mean deviations of up to 0.54 ms-1 and 0.03 ms-1 for single-fiber and dual-fiber OCE, respectively. CONCLUSION: We present a dual-fiber OCE approach that is much more robust in inhomogeneous tissues. Moreover, we demonstrate the feasibility of elasticity quantification in ex-vivo coronary arteries. SIGNIFICANCE: This study introduces an approach for robust elasticity quantification from within the tissue.

Prognostic impact of fractional flow reserve measurements in patients with acute coronary syndromes: a subanalysis of the FLORIDA study.

Randomized trials suggest benefits for fractional flow reserve (FFR)-guided vs. angiography-guided treatment strategies in well-defined and selected patient cohorts with acute coronary syndromes (ACS). The long-term prognostic value of FFR measurement in unselected all-comer ACS patients, however, remains unknown. This subanalysis of the Fractional FLOw Reserve In cardiovascular DiseAses (FLORIDA) study sought to investigate the long-term effects of FFR in the management of lesions in patients with acute coronary syndrome (ACS). FLORIDA was an observational all-comer cohort study performed in Germany, that was population-based and unselected. Patients enrolled into the anonymized InGef Research Database presenting with ACS and undergoing coronary angiography between January 2014 and December 2015 were included in the analysis. Patients were stratified into either the FFR-guided or the angiography-guided treatment arm, based on the treatment received. A matched cohort study design was used. The primary endpoint was all-cause mortality. The secondary endpoint was major adverse cardiovascular events (MACE), a composite of death, non-fatal myocardial infarction (MI), and repeat revascularization. Follow-up time was 3 years. Rates of 3-year mortality were 10.2 and 14.0% in the FFR-guided and the angiography-guided treatment arms (p = 0.04), corresponding to a 27% relative risk reduction for FFR in ACS patients. Rates of MACE were similar in both arms (47.7 vs. 51.5%, p = 0.14), including similar rates of non-fatal MI (27.7 vs. 25.4%, p = 0.47) and revascularization (9.9 vs. 12.1%, p = 0.17). In this large, all-comer observational study of ACS patients, FFR-guided revascularization was associated with a lower mortality at 3 years. This finding encourages the routine use of FFR to guide lesion revascularization in patients presenting with ACS.

Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres.

OBJECTIVE: Current guidelines recommend use of heart valve centres (HVCs) to deliver optimal quality of care for patients with valve disease but there is no evidence to support this. The hypothesis of this study is that patient care with severe aortic stenosis (AS) will differ in HVCs compared with satellite centres. We aimed to compare the treatment of patients with AS at HVCs (tertiary care hospitals with full access to AS interventions) to satellites (hospitals without such access). METHODS: IMPULSE enhanced is a European, observational, prospective registry enrolling consecutive patients with newly diagnosed severe AS at four HVCs and 10 satellites. Clinical characteristics, interventions performed and outcomes up to 1 year by site-type were examined. RESULTS: Among 790 patients, 594 were recruited in HVCs and 196 in satellites. At baseline, patients in HVCs had more severe valve disease (higher peak aortic velocity (4.3 vs 4.1 m/s; p=0.008)) and greater comorbidity (coronary artery disease (CAD) (44% vs 27%; p<0.001) prior myocardial infarction (MI) (11% vs 5.1%; p=0.011) and chronic pulmonary disease (17% vs 8.9%; p=0.007)) than those presenting in satellites. An aortic valve replacement was performed more often by month 3 in HVCs than satellites in the overall population (52.6% of vs 31.3%; p<0.001) and in symptomatic patients (66.7% vs 43.2%, p<0.001). One-year survival rate was higher for patients in HVCs than satellites (HR2.19; 95% CI 1.28 to 3.73 total population and 2.89 (95%CI 1.64 to 5.11) for symptomatic patients. CONCLUSIONS: Our data support the implementation of referral pathways that direct patients to HVCs performing both surgery and transcatheter interventions. TRIAL REGISTRATION NUMBER: NCT03112629.

Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

BACKGROUND: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. METHODS: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. FINDINGS: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054). INTERPRETATION: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events. FUNDING: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center.

HFA-PEFF score: prognosis in patients with preserved ejection fraction after transcatheter aortic valve implantation.

AIMS: Many transcatheter aortic valve implantation (TAVI) candidates have underlying heart failure with preserved ejection fraction (HFpEF) in addition to symptomatic aortic stenosis. Diagnosis of HFpEF is challenging. The Heart Failure Association of the European Society of Cardiology proposed the HFA-PEFF score as part of a novel diagnostic algorithm. This study assessed the prognostic value of the HFA-PEFF score in patients with preserved ejection fraction after TAVI. METHODS AND RESULTS: This single-centre study included 570 consecutive TAVI patients with a preserved left ventricular ejection fraction of ≥50%. Patients with an HFA-PEFF score of ≥5 [n = 239 (41.9%)] were compared with those with <5 points [n = 331 (58.1%)]. The primary outcome was a composite of all-cause mortality or first heart failure rehospitalization within 1 year after TAVI. Secondary endpoints were the individual components of the primary outcome. Patients with an HFA-PEFF score ≥ 5 had higher rates of comorbidities commonly associated with HFpEF, a higher rate of new pacemaker implantation after TAVI, were at increased risk of the primary composite endpoint (25.5% vs. 10.0%, P < 0.001), and rehospitalization for heart failure (11.7% vs. 3.9%, P < 0.001). Multivariable analysis confirmed an HFA-PEFF score ≥ 5 as an independent risk factor for the composite endpoint [hazard ratio 2.70, 95% confidence interval (CI) 1.70-4.28, P < 0.001] and for all-cause mortality (hazard ratio 2.58, 95% CI 1.46-4.53, P = 0.001). CONCLUSION: The HFA-PEFF score is associated with all-cause mortality and heart failure rehospitalization in patients with preserved ejection fraction after TAVI. This practical tool can easily be incorporated into risk stratification algorithms for TAVI patients.

Telemonitoring of Real-World Health Data in Cardiology: A Systematic Review.

BACKGROUND: New sensor technologies in wearables and other consumer health devices open up promising opportunities to collect real-world data. As cardiovascular diseases remain the number one reason for disease and mortality worldwide, cardiology offers potent monitoring use cases with patients in their out-of-hospital daily routines. Therefore, the aim of this systematic review is to investigate the status quo of studies monitoring patients with cardiovascular risks and patients suffering from cardiovascular diseases in a telemedical setting using not only a smartphone-based app, but also consumer health devices such as wearables and other sensor-based devices. METHODS: A literature search was conducted across five databases, and the results were examined according to the study protocols, technical approaches, and qualitative and quantitative parameters measured. RESULTS: Out of 166 articles, 8 studies were included in this systematic review; these cover interventional and observational monitoring approaches in the area of cardiovascular diseases, heart failure, and atrial fibrillation using various app, wearable, and health device combinations. CONCLUSIONS: Depending on the researcher's motivation, a fusion of apps, patient-reported outcome measures, and non-invasive sensors can be orchestrated in a meaningful way, adding major contributions to monitoring concepts for both individual patients and larger cohorts.

Procedural outcomes in patients with dual versus single antiplatelet therapy prior to transcatheter aortic valve replacement.

The impact of uninterrupted dual antiplatelet therapy (DAPT) on bleeding events among patients undergoing transcatheter aortic valve replacement (TAVR) has not been well studied. We conducted an analysis of 529 patients who underwent transfemoral TAVR in our centre and were receiving either DAPT or single antiplatelet therapy (SAPT) prior to the procedure. Accordingly, patients were grouped into a DAPT or SAPT group. Following current guidelines, patients in the SAPT group were switched to DAPT for 90 days after the procedure. The primary endpoint of our analysis was the incidence of bleeding events at 30 days according to the VARC-2 classification system. Any VARC-2 bleeding complications were found in 153 patients (28.9%), while major/life-threatening or disabling bleeding events occurred in 60 patients (11.3%). Our study revealed no significant difference between the DAPT vs. SAPT group regarding periprocedural bleeding complications. Based on multivariable analyses, major bleeding (HR 4.59, 95% CI 1.64-12.83, p = 0.004) and life-threatening/disabling bleeding (HR 8.66, 95% CI 3.31-22.65, p < 0.001) events were significantly associated with mortality at 90 days after TAVR. Both pre-existing DAPT and SAPT showed a comparable safety profile regarding periprocedural bleeding complications and mortality at 90 days. Thus, DAPT can be safely continued in patients undergoing transfemoral TAVR.

A Choosing Wisely top-5 list to support general practitioners in Austria.

From a pool of 147 reliable recommendations, ten experts from the Austrian Society of General Practice and Family Medicine selected 21 relevant recommendations as the basis for the Delphi process. In two Delphi rounds, eleven experts established a top­5 list of recommendations designed for Austrian family practice to reduce medical overuse. Three of the chosen recommendations address the issue of antibiotic usage in patients with viral upper respiratory tract infections, in children with mild otitis media, and in patients with asymptomatic bacteriuria. The other two "do not do" recommendations concern imaging studies for nonspecific low back pain and routine screening to detect prostate cancer. A subsequent survey identified the reasons for selecting these top­5 recommendations: the frequency of the issue, potential harms, costs, and patients' expectations. Experts hope the campaign will save time in educating patients and provide legal protection for omitting measures.

FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold: first report: final 5-year clinical outcomes

BACKGROUND The primary objective of the FANTOM II study was to evaluate the safety and performance of native coronary artery stent ing using the Fantom sirolimus-eluting bioresorbable coronary scaf fold (Tyrocore, Reva Medical LLC) by assessing the incidence of major adverse cardiac events (MACE) and late lumen loss. The Fantom scaffold is a fully resorbable scaffold, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine ana logs. Fantom is completely radiopaque and is composed of thin struts (125 microns) that facilitate device delivery and precise target-lesion treatment. METHODS The FANTOM II study is a prospective multicenter trial that enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length 20 mm. MACE through 48 months of follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n » 117) and 9 months (n » 123). Additional angiographic and optical coherence tomography serial imaging has been performed in a subset of patients at 24 months. RESULTS Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235 of 240), 95.8% (230 of 240), 99.1% (228 of 230) and 99.6% (227 of 228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25 0.40 mm and 0.33 0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients respec tively. Patient follow-up is now complete through the planned 60- month endpoint. Adjudication of all events is in process and final clinical outcomes through 60 months will be reported for the first time at the Transcatheter Cardiovascular Therapeutics (TCT) conference. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 5 years of follow-up. Longer-term follow-up in real-world clinical post-market evaluations is ongoing to examine the late out comes with this novel device.

FANTOM II long lesion study: initial safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold in long lesionsdfirst report: 2-year outcomes

BACKGROUND The primary objective of the FANTOM II Long Lesion study was to evaluate the safety and performance of native coronary artery stenting of lesions 20 mm in length using 1 or more Fantom sirolimus-eluting bioresorbable coronary scaffolds. Fantom is a fully resorbable scaffold, manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque, enabling multiple scaffolds to be placed in a precise edge-to-edge configuration, allowing complete coverage of longer target lesions. METHODS The FANTOM II Long Lesion study is a prospective, multicenter trial that enrolled 33 patients with de novo coronary stenosis with reference vessel diameters between 2.5 and 3.5 mm and lesion lengths 20 mm. In this study, all lesions were predilated using a 1:1 noncompliant balloon and then subsequently assessed to determine vessel diameter and lesion length. Once sizing was com plete, between 1 and 3 scaffolds were selected to enable complete target lesion coverage. RESULTS In this study, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 100% (33 of 33) in all cases. Angiographic imaging re sults from for all patients through 6 months of follow-up as well as major adverse cardiac events, target lesion failure, and scaffold thrombosis through 24 months of follow-up will be available in August and reported for the first time at the TCT conference. CONCLUSION As in the Fantom II trial, which was used as a basis for obtaining Conformité Européenne Mark approval, the Fantom siroli mus-eluting bioresorbable coronary scaffold demonstrated favorable initial acute safety in this first cohort of patients with more complex lesions. Longer term follow-up through 5 years is ongoing to examine late outcomes with this novel device.

[Bioresorbable vascular scaffolds - is therapy already at an end or is there a renaissance?] / Bioresorbierbare vaskuläre Scaffolds.

Bioresorbable vascular scaffolds - is therapy already at an end or is there a renaissance? Abstract. The principle of bioresorbable vascular scaffolds is a good approach to solving the residual problem of percutaneous coronary interventions, which despite the introduction and immense further development of metal stents have shown a continuous increase in undesirable events over the years. As an advantage, bioresorbable vascular scaffolds can on the one hand ensure the restoration of the physiological vascular properties; on the other hand - after resorption - in contrast to permanent metal implants, the cause of the development of in-stent re-stenoses or late stent thromboses, which still represent the greatest limitation of the metal stents, is resolved. The first real representative of the bioresorbable vascular scaffolds (Absorb) was able to deliver good results initially; but that could not be confirmed in the end, so that it was withdrawn from the market. However, important insights were gained from the error analyzes that influenced the further development of the currently approved scaffolds, so that scaffolds are now on the market that have a strut thickness comparable to metal stents and thereby produce good study results. Even if the number of patients treated and the quality of the studies are not yet sufficient to change the current European guidelines, which are solely based on the Absorb-data; there is a promising data situation now compared to 2018 when the guidelines were written. The promising results of the studies in the treatment of infrapopliteal stenosis and the attendance of manufacturers to work on further product generations show that the therapy with BRS is far from over but is - after a bumpy start - at the beginning of a renaissance.

Management of patients with severe aortic stenosis in the TAVI-era: how recent recommendations are translated into clinical practice.

OBJECTIVE: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. METHODS: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. RESULTS: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. CONCLUSIONS: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.

IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe.

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

Long-term serial functional evaluation after implantation of the Fantom sirolimus-eluting bioresorbable coronary scaffold.

BACKGROUND: Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS. METHODS: The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia. RESULTS: QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization. CONCLUSIONS: Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

FANTOM II Trial: safety and performance study of the fantom sirolimus-eluting bioresorbable coronary scaffolddfirst report: 4-year clinical outcomes

BACKGROUND The primary objective of the FANTOM II (Safety and Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold) was to evaluate the safety and performance of native coronary artery stenting using the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold by assessing the incidence of major adverse cardiac events and late lumen loss. The Fantom scaffold is a fully resorbable scaffold (Tyrocore, REVA Medical) that is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs. Fantom is completely radiopaque and is composed of thin struts (125 mm) that facilitate device delivery and precise target lesion treatment. METHODS The FANTOM II study is a prospective, multicenter trial that enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm and lesion length 20 mm. Major adverse cardiac events through 48-month follow-up were assessed. Angiographic follow-up was performed in consecutive pa tient cohorts at 6 months (n » 117) and 9 months (n » 123). Additional angiographic and optical coherence tomography serial imaging has been performed in a subset of patients at 24 months. RESULTS Acute delivery success, acute technical success, acute pro cedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235 of 240), 95.8% (230 of 240), 99.1% (228 of 230), and 99.6% (227 of 228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25 0.40 mm and 0.33 0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Patient follow-up is now complete through 48 months. Adjudication of all events is in process, and final clinical outcomes through 48 months will be re ported for the first time at the Transcatheter Cardiovascular Thera peutics 2020 annual meeting. CONCLUSION The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness perfor mance at 4 years of follow-up. Longer-term follow-up through 5 years is ongoing to examine the late outcomes with this novel device.