Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial.

BACKGROUND: Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients. METHODS: In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged ≥40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033. FINDINGS: Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1·0 [95% CI 0·8-1·2]; p=0·85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (pinteraction=0·002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (pinteraction=0·012 [≥29·7 mL/m2, worse outcomes]), and sex (pinteraction=0·02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0·11). INTERPRETATION: Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%. FUNDING: Corvia Medical.

Dual Antiplatelet Therapy Versus Aspirin in Patients With Stroke or Transient Ischemic Attack: Meta-Analysis of Randomized Controlled Trials.

Background and Purpose: Antiplatelet therapy is key for preventing thrombotic events after transient ischemic attack or ischemic stroke. Although the role of aspirin is well established, there is emerging evidence for the role of short-term dual antiplatelet therapy (DAPT) in preventing recurrent stroke. Methods: We conducted a systematic review and study-level meta-analyses of randomized controlled trials comparing outcomes of early initiation of short-term DAPT (aspirin+P2Y12 inhibitor for up to 3 months) versus aspirin alone in patients with acute stroke or transient ischemic attack. Primary efficacy outcome was risk of recurrent stroke and primary safety outcome was incidence of major bleeding. Secondary outcomes studied were risk of any ischemic stroke, hemorrhagic stroke, major adverse cardiovascular events, and all-cause death. Pooled risk ratios (RRs) and CIs were calculated using a random-effects model. Results: Four trials with a total of 21 459 patients were included. As compared to aspirin alone, DAPT had a lower risk of recurrent stroke (RR, 0.76 [95% CI, 0.68­0.83]; P<0.001; I2=0%) but a higher risk of major bleeding events (RR, 2.22 [95% CI, 1.14­4.34], P=0.02, I2=46.5%). Patients receiving DAPT had a lower risk of major adverse cardiovascular events (RR, 0.76 [95% CI, 0.69­0.84], P<0.001, I2=0%) and recurrent ischemic events (RR, 0.74 [95% CI, 0.67­0.82], P<0.001, I2=0%). Conclusions: As compared to aspirin alone, short-term DAPT within 24 hours of high-risk transient ischemic attack or mild-moderate ischemic stroke reduces the risk of recurrent stroke at the expense of higher risk of major bleeding.

Hybrid approach to postmyocardial infarction ventricular septal defect repair.

Postinfarction ventricular septal rupture is a rare and devastating complication of myocardial infarction. Despite attempts at acute surgical and percutaneous defect closure, morbidity and mortality remain high. Herein, we describe a hybrid surgical and catheter-based approach to defect closure in a 63-year-old woman with postinfarction ventricular septal rupture and cardiogenic shock.

Multimodality imaging to guide transcatheter treatment of severe degenerative tricuspid regurgitation with tricuspid valve-in-ring implantation and paravalvular leak closure.

Tricuspid valve (TV) degeneration after surgical repair with an annuloplasty ring is problematic as redo operation carries high mortality. This can be addressed with transcatheter therapies to implant a valve within in prior ring (tricuspid valve-in-ring). When an incomplete ring is present, paravalvular leak is commonly encountered after tricuspid valve-in-ring (TViR) implant; however, this can be addressed with paravalvular leak closure devices. Multimodality imaging including cardiac computed tomography and three-dimensional (3D) transesophageal echocardiography (TEE) are important for successful TViR implant. We report a case of tricuspid regurgitation after tricuspid repair with an incomplete annuloplasty ring and subsequent paravalvular leak closure.

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial.

BACKGROUND: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%. METHODS: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise. RESULTS: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control (P=0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group (P=0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group (P=1.0). CONCLUSIONS: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02600234.

Novel shunt modification with an adjustable stent-embedded "fenestrated" septal occluder in a patient with pulmonary hypertension.

A 60-year-old woman with progressive dyspnea and cyanosis, O2-dependent pulmonary hypertension despite optimal medical therapy and remote atrial septostomy presented with worsening cyanosis and right-to-left shunting. The creation of a "fenestrated" ASD closure device with the insertion of a peripheral stent through an AMPLATZER™ ASD closure device was deployed to minimize right to left shunting and allow for enlargement of the shunt if needed. This case demonstrates the benefit of diminishing a right to left shunt with a self-fabricated fenestrated AMPLATZER device to improve symptoms in pulmonary hypertension patients with a pre-existing ASD.

Conduction recovery following pacemaker implantation after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly used to treat severe aortic stenosis. A frequent complication of TAVR is high-grade or complete atrioventricular (AV) block requiring a permanent pacemaker (PPM). There are little data on the long-term dependency on pacing after TAVR. The objective of this study was to determine the proportion of patients receiving a PPM for high-grade or complete AV block after TAVR who remain dependent on the PPM in follow-up and to determine any risk factors for, particularly the effect of postballoon dilation (PBD) on, pacemaker dependency. METHODS: Of 594 consecutive patients without prior PPM undergoing TAVR (81.9% balloon-expandable, 18.1% self-expandable valve), 67 (13.1%) received a PPM after TAVR. PPM dependency was defined as AV block with a ventricular escape rate of ≤ 40 beats/min. Patient and procedural characteristics were examined according to PPM dependency status. RESULTS: Of the 67 patients who received a PPM within 10 days after TAVR, 27/67 (40.3%) were dependent at first follow-up and only 9/41 (21.9%) at 1 year. PPM dependency was more common after a self-expanding valve (76.9% vs 31.5%, P < 0.01), in those who underwent PBD (66.7% vs 24.4%, P < 0.01), and in patients in persistent complete AV block at PPM implantation (62.5% vs 7.4%, P < 0.01). CONCLUSIONS: Fewer than half of patients who receive a new PPM following TAVR are pacemaker dependent at early follow-up (< 30 days). The use of self-expanding valves and PBD are associated with a markedly increased risk of PPM dependency.

Endovascular repair of ventricular assist device outflow cannula stenosis.

This report describes a case of endovascular repair of an outflow cannula obstruction in a heart failure patient with biventricular assist devices. The patient presented with cardiogenic shock and was diagnosed via multimodality imaging with outflow cannula obstruction of the left ventricular assist device, likely from a hematoma. A transesophageal echocardiogram-guided endovascular approach was undertaken. A 10.0 mm × 38 mm covered stent was successfully deployed and post-dilated. Normal flow in the outflow cannula was restored. Hemodynamic and left ventricular flow parameters returned close to baseline post-procedure. The growth in ventricular assist device implantation and associated complications will create new opportunities for endovascular repair. © 2016 Wiley Periodicals, Inc.

The impact of operator experience during institutional adoption of trans-radial cardiac catheterization.

OBJECTIVES: We studied the impact of operator experience on trans-radial (TR) cardiac catheterization performance in contemporary practice. BACKGROUND: TR cardiac catheterization offers advantages over trans-femoral (TF) cardiac catheterization, but the TR approach has been slowly adopted in the United States. METHODS: We reviewed all cases of attempted TR cardiac catheterization at a single tertiary care medical center from May 2008 until April 2015. We classified the attending operator TR case experience at the time of each case, and the control group constituted cases performed by operators with >300 TR cases. Study endpoints were TR cannulation failure, TF cross-over, contrast medium dose, and fluoroscopy time. RESULTS: Over the study period, 4177 attempted TR cardiac catheterization cases were performed. The percentage of TR cases performed with percutaneous coronary intervention (PCI) increased from 14.0% in 2009 to 30.2% in 2015 (P-trend <0.001). The rate of TR cannulation failure decreased from 4.3% in 2009 to 2.0% in 2015 (P-trend = 0.071), and the rate of TF cross-over decreased from 4.3% in 2009 to 3.2% in 2015 (P-trend = 0.034). Operators with over 100 cases had the lowest odds of TR cannulation failure, while operators with over 200 cases had the lowest odds of TF cross-over. Operators with over 200 cases used the lowest mean contrast medium dose and mean fluoroscopy time. CONCLUSIONS: Increasing operator TR experience is associated with lower odds of TR cannulation failure and TF cross-over, as well as lower contrast medium dose and fluoroscopy time. © 2016 Wiley Periodicals, Inc.

The impact of delirium on healthcare utilization and survival after transcatheter aortic valve replacement.

OBJECTIVES: We assessed whether post-operative delirium is associated with healthcare utilization and overall survival after trans-catheter aortic valve replacement. BACKGROUND: Delirium, a common syndrome among hospitalized older adults, is associated with increased morbidity and mortality. METHODS: We reviewed 294 transcatheter aortic valve replacement cases between June 2008 and February 2015 at a tertiary care academic medical center. Post-operative delirium was identified by confusion assessment method screening and clinician diagnosis. RESULTS: Delirium was identified in 61 patients (21%). Non-femoral access for trans-catheter aortic valve replacement was more common in delirious patients than in non-delirious patients (41% vs. 27%, P = 0.04). Delirious patients had diminished overall survival after trans-catheter aortic valve replacement compared to non-delirious patients (1-year survival 59% vs. 84%, log-rank P = 0.002). After adjusting for age, Society of Thoracic Surgeons predicted 30-day mortality, and access type; delirium remained independently associated with diminished overall survival (hazard ratio 2.01, 95% confidence interval 1.21-3.33, P = 0.007). The delirium group had longer mean hospital stay (13.3 ± 9.5 days vs. 6.7 ± 3.8 days, P < 0.001) and a higher rate of discharge to a rehabilitation facility (61% vs. 27%, P < 0.001), but there was no difference in 30-day hospital re-admission rates or 30-day mortality based on delirium status. CONCLUSIONS: Delirium occurs in one out of five patients after trans-catheter aortic valve replacement and is associated with diminished survival and increased healthcare utilization. Further studies are needed to clarify whether strategies aimed at reducing delirium after trans-catheter aortic valve replacement may improve outcomes in this high-risk subset. © 2016 Wiley Periodicals, Inc.

Temporal trends and procedural safety of transcatheter mitral valve repair with mitraclip in patients with hypertrophic cardiomyopathy: Insights from the national inpatient sample.

Data on utilization and safety of mitral Transcatheter Edge-to-Edge Repair (TEER) among hypertrophic cardiomyopathy (HCM) patients is limited. Our study aimed to assess the national utilization, safety, and clinical outcomes of TEER procedures among HCM patients using a nationwide real-world cohort. HCM patients undergoing TEER hospitalizations between 2015-2020 were identified using ICD-10 (International Classification of Diseases, (ICD-10-CM/PCS). HCM-TEER and HCM No-TEER formed the two comparison groups. Demographic characteristics, baseline comorbidities, procedural complications, inpatient mortality, length of stay (LOS), and cost of hospitalization were compared between the propensity-matched cohorts. Numeric values of 10 or less were not reported per NIS data use agreements. A total of 39,625 weighted cases of TEER were identified from 2015-2020. Of the included patients, 335 patients had the HCM diagnosis. The median age of the HCM-TEER group was 74 (70-79) vs. 79 (72-85) for the no-TEER cohort. The TEER procedure was more frequently performed among Caucasians (86.57%) and females (53.73%). The TEER procedure among HCM patients had similar in-hospital mortality (Adjusted odds ratio: aOR 1.50, 95% CI [0.68-3.29]; p = 0.30) and net adverse cardiac events (NACE) (aOR 1.16, 95% CI [0.73-1.85]; p = 0.51). TEER among HCM was associated with higher odds of gastrointestinal/hematological (aOR 2.33, 95% CI [1.29-4.19]; p = 0.003) complications. However, the odds of cardiac complications (aOR 0.57, 95% CI [0.33-0.96]; p = 0.03) were not higher. The median length of stay was similar in both the groups (median: 2 vs. 2, p = 0.74), although TEER among HCM was associated with higher costs of hospitalization ($44729.36 vs. $40513.82, p < 0.01). TEER is a minimally invasive procedure and could be a safe option for symptomatic HCM patients with significant MR who are poor surgical candidates. Mitral TEER among HCM has been increasingly utilized in recent years in the United States more commonly in obstructive HCM and is associated with no difference in mortality and net adverse cardiac events but higher odds for gastrointestinal/hematological complications than non-HCM patients.

A Case of Valve-in-Valve-in-Valve for Severe Aortic Regurgitation: Is Lifetime Management Upon Us?

BACKGROUND: The incremental use of transcatheter aortic valve replacement will inexorably lead to structural valve deterioration and the need for both a second and third valvular interventions, raising the question of feasibility. CASE SUMMARY: We present the case of a 76-year-old man that presented with cardiogenic shock refractory to inotropic support. His workup revealed severe bioprosthetic aortic regurgitation 5 years after undergoing transcatheter aortic valve-in-valve implantation. After confirming anatomical suitability with multimodality imaging, he underwent uncomplicated valve-in-valve-in-valve (ViViV) implantation of a 23 mm Edwards S3 Ultra valve with rapid clinical improvement. CONCLUSIONS: Whether in the form of stenosis or severe regurgitation as in our patient, ViViV is feasible. Careful preprocedural planning and confirmation of anatomical suitability with multimodality imaging are key for success and safety.

Mortality in Patients Hospitalized With Acute Myocardial Infarction Without Standard Modifiable Risk Factors: The ARIC Study Community Surveillance.

Background Prevention strategies targeting standard modifiable cardiovascular risk factors (SMuRFs; diabetes, hypertension, smoking, hypercholesterolemia) are critical to improving cardiovascular disease outcomes. However, acute myocardial infarction (AMI) among individuals who lack 1 or more SMuRFs is not uncommon. Moreover, the clinical characteristics and prognosis of SMuRFless individuals are not well characterized. Methods and Results We analyzed AMI hospitalizations from 2000 to 2014 captured by the ARIC (Atherosclerosis Risk in Community) study community surveillance. AMI was classified by physician review using a validated algorithm. Clinical data, medications, and procedures were abstracted from the medical record. Main study outcomes included short- and long-term mortality within 28 days and 1 year of AMI hospitalization. Between 2000 and 2014, a total of 742 (3.6%) of 20 569 patients with AMI were identified with no documented SMuRFs. Patients without SMuRFs were less likely to receive aspirin, nonaspirin antiplatelet therapy, or beta blockers and less often underwent angiography and revascularization. Compared with those with one or more SMuRFs, patients without SMuRFs had significantly higher 28-day (odds ratio, 3.23 [95% CI, 1.78-5.88]) and 1-year (hazard ratio, 2.09 [95% CI, 1.29-3.37]) adjusted mortality. When examined across 5-year intervals from 2000 to 2014, the incidence of 28-day mortality significantly increased for patients without SMuRFs (7% to 15% to 27%), whereas it declined for those with 1 or more SMuRFs (7% to 5% to 5%). Conclusions Individuals without SMuRFs presenting with AMI have an increased risk of all-cause mortality with an overall lower prescription rate for guideline-directed medical therapy. These findings highlight the need for evidence-based pharmacotherapy during hospitalization and the need to discover new markers and mechanisms for early risk identification in this population.

Temporal trends and outcomes of patients with chronic limb-threatening ischemia with and without history of coronary artery disease: insights from the us national inpatient sample database.

BACKGROUND: The burden and prognostic significance of coronary artery disease (CAD) in adults with peripheral artery disease and chronic limb-threatening ischemia (CLTI) is unknown. METHODS: Temporal trends in prevalence of significant CAD (history of myocardial infarction or coronary revascularizations) in hospitalizations for CLTI were determined using the 2000 to 2018 National Inpatient Sample (NIS) database. A multivariable regression analysis of outcomes was performed based on presence or absence of CAD. RESULTS: Among 13 575 099 hospitalizations for CLTI (41% female, 69% white, mean age 69 years), 23% had concomitant CAD, of which 11% underwent lower extremity arterial revascularization (43.6% endovascular and 56.4% surgical). The prevalence of concomitant CAD with CLTI increased from 15.3% in 2000 to 23.1% in 2018. Furthermore, the frequency of endovascular revascularization in adults with CAD and CLTI increased from 15.1% to 48.3%, while there was a decreasing trend of surgical revascularization, from 84.9% to 51.7%. After multivariate adjustments, CLTI with CAD was associated with increased risk of in-hospital mortality (OR, 1.40; 95% CI, 1.32-1.47; P less than .0001) and bleeding requiring transfusion (OR, 1.10; 95% CI, 1.06-1.12; P less than .0001) compared with patients with CLTI without CAD. As compared with surgical revascularization, endovascular revascularization was associated with lower risk of in-hospital mortality in both patients with CLTI with CAD (OR, 0.69; 95% CI, 0.63-0.76; P less than .001) and CLTI without CAD (OR, 0.71; 95% CI, 0.67-0.76; P less than .001). CONCLUSIONS: Prevalence of CAD has increased in adults presenting with CLTI and is associated with poor outcomes, warranting the need for effective interventions and secondary prevention in this high-risk population.

Clinical Profiles, Outcomes, and Sex Differences of Patients With STEMI: Findings From the NORIN-STEMI Registry.

Background: Low- and middle-income countries account for most of the global burden of coronary artery disease. There is a paucity of data regarding epidemiology and outcomes for ST-segment elevation myocardial infarction (STEMI) patients in these regions. Objectives: The authors studied the contemporary characteristics, practice patterns, outcomes, and sex differences in patients with STEMI in India. Methods: NORIN-STEMI (North India ST-Segment Elevation Myocardial Infarction Registry) is an investigator-initiated prospective cohort study of patients presenting with STEMI at tertiary medical centers in North India. Results: Of 3,635 participants, 16% were female patients, one-third were <50 years of age, 53% had a history of smoking, 29% hypertension, and 24% diabetes. The median time from symptom onset to coronary angiography was 71 hours; the majority (93%) presented first to a non-percutaneous coronary intervention (PCI)-capable facility. Almost all received aspirin, statin, P2Y12 inhibitors, and heparin on presentation; 66% were treated with PCI (98% femoral access) and 13% received fibrinolytics. The left ventricular ejection fraction was <40% in 46% of patients. The 30-day and 1-year mortality rates were 9% and 11%, respectively. Compared with male patients, female patients were less likely to receive PCI (62% vs 73%; P < 0.0001) and had a more than 2-fold greater 1-year mortality (22% vs 9%; adjusted HR: 2.1; 95% CI: 1.7-2.7; P < 0.001). Conclusions: In this contemporary registry of patients with STEMI in India, female patients were less likely to receive PCI after STEMI and had a higher 1-year mortality compared with male patients. These findings have important public health implications, and further efforts are required to reduce these gaps.

Trends in Veno-Arterial Extracorporeal Life Support With and Without an Impella or Intra-Aortic Balloon Pump for Cardiogenic Shock.

Background Mechanical circulatory support devices, such as the intra-aortic balloon pump (IABP) and Impella, are often used in patients on veno-arterial extracorporeal life support (VA-ECLS) with cardiogenic shock despite limited supporting clinical trial data. Methods and Results Hospitalizations for cardiogenic shock from 2016 to 2018 were identified from the National Inpatient Sample. Trends in the use of VA-ECLS with and without an IABP or Impella were assessed semiannually. Multivariable logistic regression and general linear regression evaluated the association of Impella and IABP use with in-hospital outcomes. Overall, 12 035 hospitalizations with cardiogenic shock and VA-ECLS were identified, of which 3115 (26%) also received an IABP and 1880 (16%) an Impella. Use of an Impella with VA-ECLS substantially increased from 10% to 18% over this period (P<0.001), whereas an IABP modestly increased from 25% to 26% (P<0.001). In-hospital mortality decreased 54% to 48% for VA-ECLS only, 61% to 58% for VA-ECLS with an Impella, and 54% to 49% for VA-ECLS with an IABP (P<0.001 each). Most (57%) IABPs or Impellas were placed on the same day as VA-ECLS. After adjustment, there were no differences in in-hospital mortality or length of stay with the addition of an IABP or Impella compared with VA-ECLS alone. Conclusions From 2016 to 2018 in the United States, use of an Impella and IABP with VA-ECLS significantly increased. More than half of Impellas and IABPs were placed on the same day as VA-ECLS, and the use of a second mechanical circulatory support device did not impact in-hospital mortality. Further studies are needed to decipher the optimal timing and patient selection for this growing practice.

P2Y12 inhibitor versus aspirin monotherapy for secondary prevention of cardiovascular events: meta-analysis of randomized trials.

Aim: To compare the efficacy and safety of P2Y12 inhibitor or aspirin monotherapy for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD). Methods and results: Medline, Embase, and Cochrane Central databases were searched to identify randomized trials comparing monotherapy with a P2Y12 inhibitor versus aspirin for secondary prevention in patients with ASCVD (cardiovascular, cerebrovascular, or peripheral artery disease). The primary outcome was major adverse cardiac events (MACE). Secondary outcomes were myocardial infarction (MI), stroke, all-cause mortality, and major bleeding. A random-effects model was used to calculate risk ratios (RR) and the corresponding 95% confidence interval (CI) and heterogeneity among studies was assessed using the Higgins I2 value. A total of 9 eligible trials (5 with clopidogrel and 4 with ticagrelor) with 61 623 patients were included in our analyses. Monotherapy with P2Y12 inhibitors significantly reduced the risk of MACE by 11% (0.89, 95% CI 0.84-0.95, I2 = 0%) and MI by 19% (0.81, 95% CI 0.71-0.92, I2 = 0%) compared with aspirin monotherapy. There was no significant difference in the risk of stroke (0.85, 95% CI 0.73-1.01), or all-cause mortality (1.01, 95% CI 0.92-1.11). There was also no significant difference in the risk of major bleeding with P2Y12 inhibitor monotherapy compared with aspirin (0.94, 95% CI 0.72-1.22, I2 = 42.6%). Results were consistent irrespective of the P2Y12 inhibitor used. Conclusion: P2Y12 inhibitor monotherapy for secondary prevention is associated with a significant reduction in atherothrombotic events compared with aspirin alone without an increased risk of major bleeding.

Iatrogenic Atrial Septal Defect Closure Following Mitral Transcatheter Edge-to-Edge Repair: When Do You Close?

Transcatheter edge-to-edge repair has revolutionized the management of mitral regurgitation in the high surgical-risk population. Iatrogenic atrial septal defects (iASDs) are an obligatory consequence of the procedure. The long-term sequelae of persistent iASDs are unknown but are believed to be dependent on their size, directionality of flow, and underlying hemodynamics. We discuss an uncommon scenario of a post-transcatheter edge-to-edge repair iASD that required immediate closure. (Level of Difficulty: Intermediate.).

Aortic annular dimensions by non-contrast MRI using k-t accelerated 3D cine b-SSFP in pre-procedural assessment for transcatheter aortic valve implantation: a technical feasibility study.

To evaluate k-t accelerated 3D cine b-SSFP (balanced steady state free precession) as magnetic resonance imaging (MRI) technique for aortic annular area measurement in transcatheter aortic valve replacement (TAVR) planning compared to computed tomography angiography (CTA) and other non-contrast MRI sequences with reduced imaging time and without contrast administration. 6 volunteers and 7 TAVR candidates were prospectively enrolled. The volunteers underwent an MRI while TAVR candidates underwent an MRI and CTA. The following non-contrast MRI sequences were obtained at the level of the aortic root: 2D cine b-SSFP [GRAPPA (GeneRalized Autocalibrating Partially Parallel Acquisitions), R = 2], 3D cine b-SSFP [GRAPPA R = 2], navigator triggered 3D b-SSFP MRA [GRAPPA, R = 2] and k-t accelerated 3D cine b-SSFP [PEAK GRAPPA, R = 5]. Qualitative analysis and aortic annular area measurements in systole and diastole were obtained. k-t accelerated 3D cine b-SSFP provided image quality that is acceptable for confident diagnosis with very good interrater agreement. There was no statistically significant difference in aortic annular measurements between k-t accelerated 3D cine b-SSFP and CTA or other MRI sequences (p > 0.05). Bland-Altman analysis showed no systemic difference of annular area measurements between k-t accelerated 3D cine b-SSFP and each of the other techniques. There was excellent inter-rater agreement on aortic annular area measurements during systolic (ICC = 0.976, p < 0.001) and diastolic (ICC = 0.971, p < 0.001) phases using k-t accelerated 3D cine b-SSFP. K-t accelerated 3D cine b-SSFP is a promising alternative for the assessment of annular sizing in pre-TAVR evaluation while offering a reasonable combination of imaging parameters during one breath-hold.