Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Accuracy of Fractional Flow Reserve Derived From Coronary Angiography.

BACKGROUND: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio. METHODS: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity. RESULTS: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%. CONCLUSIONS: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

Immature Platelet Fraction and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

INTRODUCTION: Immature platelets or reticulated platelets are newly released thrombocytes. They can be identified by their large size and high RNA cytoplasm concentration. Immature platelet fraction (IPF) represents the percentage of immature circulative platelets relative to the total number of platelets. The role of IPF in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. The aim of the current trial was to assess the levels of IPF in patients undergoing TAVI and correlation with clinical outcomes. MATERIAL AND METHODS: Immature platelet fraction levels were measured 3 times in all patients (preprocedure, 1-2 days post-procedure and 1-month post-procedure). Immature platelet fraction measurement was carried out using an autoanalyzer (Sysmex XE-2100). Patients were followed for 12 months. Primary outcomes were defined as complications during hospitalizations, rehospitalization, and mortality. RESULTS: Fifty-one patients were included in the study. Mean age was 79.8 (±9.6), and 28 (55%) were women. Twenty-one patients (41%) had complications: Of them, 6 of 21 (29%) occurred during hospitalizations (2-vascular complications; 2-sepsis, 2-implantation of a pacemaker), 9 of 21 (43%) patients were rehospitalized after the index admission, and 6 patients died during the follow-up period. Multivariate Cox regression analysis found that IPF < 7% in at least one of the 3 tests was associated with worse outcomes (hazard ratio 3.42; 95% CI 1.11-10.5, P = .032). CONCLUSION: Immature platelet fraction >7% in patients undergoing TAVI is associated with worse outcomes. Further studies are needed to better understand this phenomenon.

Culprit Lesion Coronary Intervention Before Complete Angiography in ST-Elevation Myocardial Infarction: A Randomized Clinical Trial.

Importance: Rapid reperfusion during primary percutaneous coronary intervention (PCI) is associated with improved outcomes among patients with ST-elevation myocardial infarction (STEMI). Although attempts at reducing the time from STEMI diagnosis to arrival at the catheterization laboratory have been widely investigated, intraprocedural strategies aimed at reducing the time to reperfusion are lacking. Objective: To evaluate the effect of culprit lesion PCI before complete diagnostic coronary angiography (CAG) vs complete CAG followed by culprit lesion PCI on reperfusion times among patients with STEMI. Design, Setting, and Participants: This open-label, prospective, randomized clinical trial was conducted between April 1, 2021, and August 31, 2022, among patients admitted to a tertiary center in Jerusalem, Israel, with a diagnosis of STEMI undergoing primary PCI. All patients were followed up for 1 year. Analysis was on an intention-to-treat basis. Intervention: Patients were randomized in a 1:1 ratio to undergo either culprit lesion PCI before complete CAG or complete CAG followed by culprit lesion PCI. Main Outcomes and Measures: A needle-to-balloon time of 10 minutes or less. Results: A total of 216 patients were randomized, with 184 patients (mean [SD] age, 62.9 [12.2] years; 155 men [84.2%]) included in the final intention-to-treat analysis; 90 patients (48.9%) were randomized to undergo culprit lesion PCI before CAG, and 94 (51.1%) were randomized to undergo to CAG followed by PCI. Patients who underwent culprit lesion PCI before complete CAG had a shorter mean (SD) needle-to-balloon time (11.4 [5.9] vs 17.3 [13.3] minutes; P < .001). The primary outcome of a needle-to-balloon time of 10 minutes or less was achieved for 51.1% of patients (46 of 90) who underwent culprit lesion PCI before CAG and for 19.1% of patients (18 of 94) who underwent complete CAG followed by culprit lesion PCI (odds ratio, 4.4 [95% CI, 2.2-9.1]; P < .001). Rates of adverse events were similar between groups. In a subgroup analysis, the effect of culprit lesion PCI before complete CAG on the primary outcome was consistent. There were no differences in rates of in-hospital, 30-day, and 1-year all-cause mortality. Conclusions and Relevance: In this randomized clinical trial of patients with STEMI, culprit lesion PCI before complete CAG resulted in shorter reperfusion times. Larger trials are needed to validate these results and to evaluate the effect on clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05415085.

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.

Mechanical Circulatory Support Devices for the Treatment of Cardiogenic Shock Complicating Acute Myocardial Infarction-A Review.

Cardiogenic shock complicating acute myocardial infarction is a complex clinical condition associated with dismal prognosis. Routine early target vessel revascularization remains the most effective treatment to substantially improve outcomes, but mortality remains high. Temporary circulatory support devices have emerged with the aim to enhance cardiac unloading and improve end-organ perfusion. However, quality evidence to guide device selection, optimal installation timing, and post-implantation management are scarce, stressing the importance of multidisciplinary expert care. This review focuses on the contemporary use of short-term support devices in the setting of cardiogenic shock following acute myocardial infarction, including the common challenges associated this practice.

Prevalence, Predictors, and Outcomes of Patients With ST-Elevation Myocardial Infarction and Angiographically Significant Coronary Artery Disease of Non-Infarct-Related Artery.

Patients with ST-elevation myocardial infarction (STEMI) can present with angiographically significant coronary artery disease (CAD) of non-infarct-related artery (IRA) or with IRA-only CAD. This study aimed to evaluate the prevalence, predictors, and outcome of patients with STEMI and angiographically significant CAD of non-IRA. All consecutive patients with STEMI who underwent primary percutaneous coronary intervention between 2000 and 2020 were included. Angiographically significant CAD was defined as >50% stenosis of the left main coronary artery and/or >90% stenosis for all other coronary arteries. A total of 2,663 patients had IRA-only CAD (80.2%) and 657 had angiographically significant non-IRA CAD (19.8%). Independent predictors for non-IRA CAD were male gender (odds ratio [OR] 1.34, 95% confidence interval [CI] 1.05 to 1.70, p = 0.021), age >50 years (OR 1.45, 95% CI 1.11 to 1.91, p = 0.007), and diabetes mellitus (OR 1.56, 95% CI 1.29 to 1.9, p <0.001), whereas smoking (OR 0.83, 95% CI 0.68 to 0.99, p = 0.004) and family history of CAD (OR 0.78, 95% CI 0.62 to 0.98, p = 0.032) were found to be negatively associated with non-IRA CAD. In-hospital 30-day and 1- and 5-year all-cause mortality were higher in patients with non-IRA CAD compared with IRA-only CAD (5.8% vs 2.5%, 8.5% vs 3.3%, 18.4% vs 7.6% and 36.3% vs 20.3%, respectively; p for all <0.001). In conclusion, 20% of patients with STEMI had angiographically significant non-IRA CAD. Older age, male gender, and diabetes mellitus were independent predictors for non-IRA CAD, whereas smoking and family history of CAD predicted IRA-only CAD. The presence of non-IRA CAD was associated with higher short- and long-term all-cause mortality rates.