Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Performance of a novel artificial intelligence software developed to derive coronary fractional flow reserve values from diagnostic angiograms.

BACKGROUND: Although invasive measurement of fractional flow reserve (FFR) is recommended to guide revascularization, its routine use is underutilized. Recently, a novel non-invasive software that can instantaneously produce FFR values from the diagnostic angiograms, derived completely from artificial intelligence (AI) algorithms has been developed. We aim to assess the accuracy and diagnostic performance of AI-FFR in a real-world retrospective study. METHODS: Retrospective, three-center study comparing AI-FFR values with invasive pressure wire-derived FFR obtained in patients undergoing routine diagnostic angiography. The accuracy, sensitivity, and specificity of AI-FFR were analyzed. RESULTS: A total of 304 vessels from 297 patients were included. Mean invasive FFR was 0.86 vs. 0.85 AI-FFR (mean difference: -0.005, P  = 0.159). The diagnostic performance of AI-FFR demonstrated sensitivity of 91%, specificity 95%, positive predictive value 83% and negative predictive value 97%. Overall accuracy was 94% and the area under curve was 0.93 (95% CI 0.88-0.97). 105 lesions fell around the cutoff value (FFR = 0.75-0.85); in this sub-group, AI-FFR demonstrated sensitivity of 95%, and specificity 94%, with an AUC of 0.94 (95% CI 88.2-98.0). AI-FFR calculation time was 37.5 ±â€…7.4 s for each angiographic video. In 89% of cases, the software located the target lesion and in 11%, the operator manually marked the target lesion. CONCLUSION: AI-FFR calculated by an AI-based, angio-derived method, demonstrated excellent diagnostic performance against invasive FFR. AI-FFR calculation was fast with high reproducibility.

Predictors of Adverse Outcome in High-Risk Percutaneous Coronary Interventions Patients.

BACKGROUND: Identifying high-risk percutaneous coronary intervention (PCI) patients is challenging. We aimed to evaluate which high-risk patients are prone to adverse events. METHODS: We performed a retrospective study including consecutive high-risk PCIs from 2005 to 2018 in a large tertiary medical centre. Patients with unprotected left main (LM) disease, last patent coronary vessel, or 3-vessel coronary artery disease with left ventricular ejection fraction < 35% were included. A predictive 30-day major adverse cardiac events (MACE) score consisting of any myocardial infarction, all-cause death, or target-vessel revascularisation was constructed. RESULTS: From 2005 to 2018, a total of 1890 patients who underwent PCI met the predefined high-risk PCI criteria. Mortality rate was 8.8% at 30 days and 20.7% at 1 year, and 30-day MACE rate was 14.2% and 33.5% at 1 year. Predictors of short-term MACE were New York Heart Association functional class (NYHA) 4 (hazard ratio [HR] 6.65; P < 0.001), systolic blood pressure (SBP) < 90 mm Hg (HR 4.93; P < 0.001), creatinine > 1.3 mg/dL (HR 3.57; P < 0.001), hemoglobin < 11.0 g/dL (HR 3.07; P < 0.001), pulmonary artery systolic pressure > 50 mm Hg (HR 2.06; P < 0.001), atrial fibrillation (HR 1.74; P < 0.001), and LM disease (HR 2.04; P < 0.001) or last patent vessel (HR 1.70; P = 0.002). A score constructed from these parameters reached a sensitivity of 90% and a specificity of 81% with areas under the receiver operating characteristic curve of 0.92 for MACE and 0.94 with 89% sensitivity and 87% specificity for all-cause mortality. CONCLUSIONS: Specific features such as LM lesion or last patent conduit, pulmonary hypertension, atrial fibrillation, anemia, and renal failure, along with low SBP and NYHA 4, aid risk stratification and consideration of further treatment measures.

Nonobstructive coronary atherosclerosis is associated with adverse prognosis among patients diagnosed with myocardial infarction without obstructive coronary arteries.

BACKGROUND AND AIMS: The prognostic impact of nonobstructive coronary artery disease (CAD), as opposed to normal coronary arteries, on long-term outcomes of patients with myocardial infarction with no obstructive coronary arteries (MINOCA) is unclear. We aimed to address the association between nonobstructive-CAD and major adverse events (MAE) following MINOCA. METHODS: We conducted a retrospective cohort study of consecutive MINOCA patients admitted to a large referral medical center between 2005 and 2018. Patients were classified according to coronary angiography as having either normal-coronaries or nonobstructive-CAD. The primary outcome was MAE, defined as the composite of all-cause mortality and recurrent acute coronary syndrome (ACS). RESULTS: Of the 1544 MINOCA patients, 651 (42%) had normal coronaries, and 893 (58%) had CAD. The mean age was 61.2 ± 12.6 years, and 710 (46%) were females. Nonobstructive-CAD patients were older and less likely to be females, with higher rates of diabetes, hypertension, dyslipidemia, atrial fibrillation, and chronic renal-failure (p < 0.05). At a median follow-up of 7 years, MAE occurred in 203 (23%) patients and 67 (10%) patients in the nonobstructive-CAD and normal-coronaries groups, respectively (p < 0.01). In multivariable models, nonobstructive -CAD was significantly associated with long-term MAE [adjusted-hazard-ratio (aHR):1.67, 95% confidence-interval (95%CI):1.25-2.23; p < 0.001]. Other factors associated with a higher MAE-risk were older-age (aHR:1.05,95%CI:1.03-1.06; p < 0.001) and left ventricular ejection-fraction<40% (aHR:3.04,95%CI:2.03-4.57; p < 0.001), while female-sex (aHR:0.72, 95%CI: 0.56-0.94; p=0.014) and sinus rhythm at presentation (aHR:0.66, 95%CI: 0.44-0.98; p=0.041) were associated with lower MAE-risk. CONCLUSIONS: In MINOCA, nonobstructive-CAD is independently associated with a higher MAE-risk than normal-coronaries. This finding may promote risk-stratification of patients with nonobstructive-CAD-MINOCA who require tighter medical follow-up and treatment optimization.

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

Comparison of Transcatheter Aortic Valve Implantation Devices in Aortic Stenosis: A Network Meta-Analysis of 42,105 Patients.

Background: In recent years, trans-catheter aortic valve implantation (TAVI) has emerged as an excellent alternative to surgical aortic valve replacement (SAVR). Currently, there are several approved devices on the market, yet comparisons among them are scarce. We aimed to compare the various devices via a network meta-analysis. Methods: We performed a network meta-analysis including randomized controlled trials (RCTs) and propensity-matched studies that provide comparisons of either a single TAVI with SAVR or two different TAVI devices and report clinical outcomes. Results: We included 12 RCT and 13 propensity-matched studies comprising 42,105 patients, among whom 27,134 underwent TAVI using various valve systems (Sapien & Sapien XT, Sapien 3, Corvalve, Evolut & Evolut Pro, Acurate Neo, Portico). The mean follow-up time was 23.4 months. Sapien 3 was superior over SAVR in the reduction of all-cause mortality (OR = 0.53; 95%CrI 0.31-0.91), while no significant difference existed between other devices and SAVR. Aortic regurgitation was more frequent among TAVI devices compared to SAVR. There was no significant difference between the various THVs and SAVR in cardiovascular mortality, myocardial infarction, NYHA class III-IV, and endocarditis. Conclusions: Newer generation TAVI devices, especially Sapien 3 and Evolut R/Pro are associated with improved outcomes compared to SAVR and other devices of the older generation.

High Post-Procedural Transvalvular Gradient or Delayed Mean Gradient Increase after Transcatheter Aortic Valve Implantation: Incidence, Prognosis and Associated Variables. The FRANCE-2 Registry.

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

Identification of coronary calcifications in optical coherence tomography imaging using deep learning.

Coronary calcifications are an obstacle for successful percutaneous treatment of coronary artery disease patients. The optimal method for delineating calcifications extent is coronary optical coherence tomography (OCT). To identify calcification on OCT and subsequently tailor the appropriate treatment, requires expertise in both image acquisition and interpretation. Image acquisition consists from system calibration, blood clearance by a contrast agent along with synchronization of the pullback process. Accurate interpretation demands careful review by the operator of a segment of 50-75 mm of the coronary vessel at steps of 5-10 frames per mm accounting for 375-540 images in each OCT run, which is time consuming and necessitates some expertise in OCT analysis. In this paper we developed a new deep learning algorithm to assist the physician to identify and quantify coronary calcifications promptly, efficiently and accurately. Our algorithm achieves an accuracy of 0.9903 ± 0.009 over the test set at size of 1500 frames and even managed to find calcifications that were not recognized manually by the physician. For the best knowledge of the authors our algorithm achieves high accuracy which was never achieved in the past.

Early Feasibility of Automated Artificial Intelligence Angiography Based Fractional Flow Reserve Estimation.

Despite the evidence of improved patients' outcome, fractional flow reserve (FFR) is underused in current everyday practice. We aimed to evaluate the feasibility of a novel automated artificial intelligence angiography-based FFR software (AutocathFFR) as a decision supporting tool for interventional cardiologists. AutocathFFR was performed on angiographic images of patients who underwent coronary angiography with a pressure wire FFR measurement. Sensitivity and specificity for detection of FFR cut-off of 0.8 were calculated. Thirty-one patients were included in the present study, with a mean age of 64 ± 10 years, 80% were males, 32% patients had diabetes, 39% had previous percutaneous coronary intervention. The left anterior descending artery was the target vessel in 80% of patients. Automatic lesion detection was successful in all of the lesions with FFR value of ≤0.8. The sensitivity of AutocathFFR for predicting a wire based FFR ≤0.8 was 88% and the specificity for FFR >0.8 was 93%, with a positive predictive value of 94% and negative predictive value of 87%, indicating an accuracy level of 90% and area under the curve of 0.91. AutocathFFR has excellent accuracy in prediction of wire based FFR and is a promising technology that may facilitate appropriate decision and treatment choices for coronary artery disease patients.

Association of Right Ventricular Longitudinal Strain with Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Conventional right ventricular (RV) echocardiographic measurements of systolic function (SF) have demonstrated conflicting results when their association with long-term outcomes after transcatheter aortic valve replacement (TAVR) is evaluated. RV free-wall (FW) longitudinal strain (LS) is a novel, single parameter to measure RV SF and may provide a better evaluation than fractional area change, tricuspid annular plane systolic excursion, and myocardial velocity (S'). The value of RV FW LS in patients undergoing TAVR and its association with 1-year mortality are unknown. The aim of this study was to test the hypothesis that RV FW LS would be associated with 1-year all-cause mortality in patients undergoing TAVR. METHODS: Consecutive patients who underwent TAVR between 2007 and 2014 in whom RV FW LS was measurable were included; a subgroup that had 1-year follow-up echocardiographic evaluation of RV FW LS was analyzed. FW LS was derived from speckle-tracking analyses. The standard reference was determined as normal or impaired RV SF, the latter defined as the presence of ≥50% of tricuspid annular plane systolic excursion < 1.7 cm, S' < 9.5 cm/sec, and fractional area change < 35%. Cox proportional-hazards regression analysis was used to assess the association of RV FW LS with 1-year all-cause mortality. RESULTS: Of 612 patients, 334 were included for RV FW LS analysis on pre-TAVR echocardiography (feasibility 55%); exclusion criteria included atrial fibrillation (n = 92 [15%]), pacemaker (n = 73 [12%]), and poor image quality (n = 113 [18%]). Baseline impaired RV SF was present in 19% of cases. RV FW LS did not change significantly at 1-year follow-up, in both the groups with baseline impaired and normal function. Cox regression analysis showed that RV FW LS was associated with all-cause mortality at 1 year (hazard ratio, 1.06; 95% CI, 1.01-1.11). For each unit increase in RV FW LS, there was a 6% higher risk for 1-year mortality. CONCLUSIONS: In a high-risk TAVR population, RV FW LS should be considered a single echocardiographic parameter for the assessment of RV SF. When measurable, RV FW LS is associated with all-cause mortality at 1 year after TAVR.

Analysis of weather exposure 7 days before occurrence of ST-segment elevation myocardial infarction.

BACKGROUND: Several studies have highlighted the relationship between weather patterns and the occurrence of ST-elevation myocardial infarction (STEMI). AIM: To evaluate the statistical association between the occurrence of STEMI and meteorological variables over the preceding 7 days. METHODS: This was a retrospective study, using prespecified data from the ORBI (Breton Regional Observatory on Myocardial Infarction) registry, which includes all consecutive patients hospitalized for STEMI in the geographical area of Brest, France. Over a 7-year period, we compared the number of STEMIs per week with the mean values of meteorological variables over the preceding 7 days. RESULTS: Overall, 7517 patients with STEMI were recorded in the ORBI registry between January 2009 and January 2016. After exclusion of patients not living in the geographical area of interest, 742 patients were included. The weekly incidence of STEMI ranged from 0 to 7 (median 2, interquartile range 1-3). In the univariate analysis, air temperature (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.005-1.01 per 1°C decrease; P=0.03) and atmospheric pressure (OR 1.03, 95% CI 1.01-1.06 per 1 hPa increase; P=0.008) were associated with the weekly incidence of STEMI. In the multivariable analysis, air temperature (OR 1.06, 95% CI 1.01-1.10 per 1°C decrease; P=0.01), atmospheric pressure (OR 1.05, 95% CI 1.02-1.08 per 1 hPa increase; P<0.001) and duration of humidity>80% (OR 1.09, 95% CI 1.02-1.15 per 1hour increase; P=0.007) in the previous 7 days were associated with the occurrence of STEMI. CONCLUSIONS: In this specific geographical area, occurrence of STEMI was statistically associated with a decrease in air temperature, an increase in atmospheric pressure and an increase in humidity over the preceding 7-day period.

Impact of Baseline Left Ventricular Diastolic Dysfunction in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

We sought to assess the impact of diastolic dysfunction (DD) grade, as per the 2016 American Society of Echocardiography/European Association of Cardiovascular Imaging guidelines, on survival of patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI). We included consecutive patients with severe AS who underwent TAVI in our institution. DD grading was determined retrospectively according to the 2016 ASE DD guidelines and categorized to grade I-III and indeterminate grade I-II DD. Comparison of 1-year survival according to DD grade was performed by Kaplan-Meier analysis, and evaluation of DD at 1 year was performed in a subset of patients. Among 606 TAVI patients, 394 (65%) had sufficient data for DD grading. Seventy-seven (20%) had grade I DD, 191 (48%) had grade II, 60 (15%) had grade III, and 66 (17%) had an indeterminate grade between I and II. Baseline characteristics indicate higher rates of atrial fibrillation, brain natriuretic peptide level, pulmonary artery systolic pressure, and indexed left ventricular mass as DD grade increases (all p ≤0.01). In conclusion, comparison of 1-year survival revealed a higher rate of mortality in patients with grade III DD that remained statistically significant following adjustment in a multivariate Cox proportional hazard model. DD grade after TAVI improved in patients with grades II and III. Severe AS patients with grade III DD have higher risk for 1-year mortality after TAVI compared with milder degrees of DD. Further research is warranted to explore a potential benefit for aortic valve therapy at an earlier stage of the disease process.

Usefulness of Longitudinal Strain to Assess Remodeling of Right and Left Cardiac Chambers Following Transcatheter Aortic Valve Implantation.

Remodeling after transcatheter aortic valve implantation (TAVI) has been well characterized for the left ventricle (LV) but not for the other cardiac chambers. We aimed to describe conventional indices of cardiac remodeling and novel longitudinal strain (LS) in all 4 cardiac chambers post-TAVI and to explore gender remodeling disparities. Consecutive patients with significant aortic stenosis who underwent TAVI were included if echocardiograms in sinus rhythm before and 1-year postprocedure were available. Speckle tracking analysis was performed retrospectively to evaluate size and function of the 4 cardiac chambers. Baseline and 1-year data were compared. From a total of 612 patients who underwent TAVI, 213 were included in this study (82 ± 9 years old, 42% men). Although no significant size or function changes were seen for right cardiac chambers at follow-up, significant improvements were seen for ejection fraction (EF) and LS in both the LV and left atrium (LA) (p < 0.05 for both). The absolute percentage of LV and LA function improvement was higher for LS than for EF (p < 0.05). Women had smaller LV and right ventricular (RV) size, whereas parameters of LV and RV function were higher. All 1-year remodeling parameters were similar for men and women. Conventional LV remodeling parameters (LV mass) failed to improve 1 year after TAVI. However, novel strain-derived parameters of size and function showed remodeling of left chambers but not of RV or right atrium. The degree of LV and LA remodeling by LS is almost twice that of EF. Remodeling was similar for both genders.

Role of contractile reserve as a predictor of mortality in low-flow, low-gradient severe aortic stenosis following transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS. METHODS: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm2 or AVAi ≤ 0.6 cm2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE. RESULTS: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69). CONCLUSION: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year.