Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis: The NOTION-2 Trial.

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤ 75 years of age, including both tricuspid and bicuspid AS. METHODS: The NOTION-2 trial enrolled and 1:1 randomized low-risk patients aged ≤ 75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke or rehospitalization (related to the procedure, valve or heart failure) at 12 months. RESULTS: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group (absolute risk difference 3.1%; 95% confidence interval [CI], -2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3). Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation and moderate-or-greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8, 95% CI: 0.8 to 18.5) treated with TAVI or surgery, respectively (P for interaction=0.1). CONCLUSIONS: Among low-risk patients aged ≤ 75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI and surgery. TAVI outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Long-term multimodality imaging follow-up of ST-segment elevation myocardial infarction patients treated with bioresorbable vascular scaffold: advantages and challenges.

BACKGROUND: Multislice computed tomography (MSCT) offers a non-invasive method of imaging bioresorbable scaffolds (BRS). OBJECTIVES: To investigate the advantages and challenges using MSCT in the follow-up after BRS implantation. METHOD: The BRS cohort consisting of 31 patients in the 'BRS in STEMI' trial was examined by multimodality imaging and followed long-term. Minimum lumen area (MLA) and average lumen area (ALA) were examined 12 and 36 months after BRS implantation with MSCT. Optical coherence tomography (OCT) at 12 months was used as a reference. RESULTS: Measured by MSCT, the mean MLA was 0.05 ±â€…1.32 mm² ( P  = 0.85), but ALA was 1.32 (±2.59 mm², P  = 0.015) greater than by OCT. ALA and MLA did not change significantly from 12 to 36 months. MSCT identified all cases of restenosis but missed one patient with massive malapposition. CONCLUSION: Our data support using MSCT in the follow-up after BRS implantation. Invasive investigation should still be considered for patients with unexplained symptoms.

Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.

Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II.

BACKGROUND: Patients with diabetes have increased rates of major adverse cardiac events (MACEs). We hypothesized that this is explained by diabetes-associated differences in coronary plaque morphology and lipid content. METHODS: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), 898 patients with acute myocardial infarction with or without ST-segment elevation underwent 3-vessel quantitative coronary angiography and coregistered near-infrared spectroscopy and intravascular ultrasound imaging after successful percutaneous coronary intervention. Subsequent MACEs were adjudicated to either treated culprit lesions or untreated nonculprit lesions. This substudy stratified patients by diabetes status and assessed baseline culprit and nonculprit prevalence of high-risk plaque characteristics defined as maximum plaque burden ≥70% and maximum lipid core burden index ≥324.7. Separate covariate-adjusted multivariable models were performed to identify whether diabetes was associated with nonculprit lesion-related MACEs and high-risk plaque characteristics. RESULTS: Diabetes was present in 109 of 898 patients (12.1%). During a median 3.7-year follow-up, MACEs occurred more frequently in patients with versus without diabetes (20.1% versus 13.5% [odds ratio (OR), 1.94 (95% CI, 1.14-3.30)]), primarily attributable to increased risk of myocardial infarction related to culprit lesion restenosis (4.3% versus 1.1% [OR, 3.78 (95% CI, 1.12-12.77)]) and nonculprit lesion-related spontaneous myocardial infarction (9.3% versus 3.8% [OR, 2.74 (95% CI, 1.25-6.04)]). However, baseline prevalence of high-risk plaque characteristics was similar for patients with versus without diabetes concerning culprit (maximum plaque burden ≥70%: 90% versus 93%, P=0.34; maximum lipid core burden index ≥324.7: 66% versus 70%, P=0.49) and nonculprit lesions (maximum plaque burden ≥70%: 23% versus 22%, P=0.37; maximum lipid core burden index ≥324.7: 26% versus 24%, P=0.47). In multivariable models, diabetes was associated with MACEs in nonculprit lesions (adjusted OR, 2.47 [95% CI, 1.21-5.04]) but not with prevalence of high-risk plaque characteristics (adjusted OR, 1.21 [95% CI, 0.86-1.69]). CONCLUSIONS: Among patients with recent myocardial infarction, both treated and untreated lesions contributed to the diabetes-associated ≈2-fold increased MACE rate during the 3.7-year follow-up. Diabetes-related plaque characteristics that might underlie this increased risk were not identified by multimodality imaging. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02171065.

Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial.

BACKGROUND: Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal. OBJECTIVE: The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA). METHODS: The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images. RESULTS: Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44-5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22-7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3. CONCLUSION: The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups.

Paradoxical sinus deceleration during dobutamine stress echocardiography: case series and review of the literature.

Background: Dobutamine stress echocardiography is an established diagnostic modality for assessing myocardial ischaemia in patients with known or suspected coronary artery disease. Dobutamine infusion causes dose-dependent increase in heart rate and contractility. However, in some cases, it induces paradoxical sinus deceleration, whose underlying mechanism and clinical significance are not fully understood. Case summary: We present episodes of paradoxical sinus deceleration observed during dobutamine stress echocardiography in six (four males and two females) patients and described its patterns of occurrence and clinical and echocardiographic characteristics. Discussion: Paradoxical sinus deceleration occurred mostly at maximal dobutamine infusion was accompanied with a decline in blood pressure and resolved spontaneously following cessation of dobutamine infusion. Individuals experiencing paradoxical sinus deceleration had in common abnormal left ventricle geometry but differed with regard to age, sex, and cardiometabolic risk factors.

Guideline-Recommended Time Less Than 90 Minutes From ECG to Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction Is Associated with Major Survival Benefits, Especially in Octogenarians: A Contemporary Report in 11 226 Patients from NORIC.

Background Using contemporary data from NORIC (Norwegian Registry of Invasive Cardiology) we investigated the predictive value of patient age and time from ECG diagnosis to sheath insertion (ECG-2-sheath) in primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction (STEMI). Methods and Results Data from 11 226 patients collected from all centers offering 24/7/365 primary percutaneous coronary intervention service were explored. For patients aged <80 years the mortality rates were 5.6% and 7.6% at 30 days and 1 year, respectively. For octogenarians the corresponding rates were 15.0% and 24.2%. The Cox hazard ratio was 2.02 (1.93-2.11, P value <0.0001) per 10 years of patient age. Time from ECG-2-sheath was significantly associated with mortality with a 3.6% increase per 30 minutes of time. Using achievement of time goal <90 minutes in patients aged >80 years and mortality at 30 days, mortality was 10.5% and 17.7% for <90 or ≥90 minutes, respectively. The number needed to prevent 1 death was 39 in the whole population and 14 in the elderly. Restricted mean survival gains during median 938 days of follow-up in patients with ECG-2-sheath time <90 minutes were 24 and 76 days for patients aged <80 and ≥80 years, respectively. Conclusions Time from ECG-diagnosis to sheath insertion is strongly correlated with mortality. This applies especially to octogenarians who derive the most in terms of absolute mortality reduction. Registration URL: https://helsedata.no/en/forvaltere/norwegian-institute-of-public-health/norwegian-registry-of-invasive-cardiology/.

Right ventricular postsystolic shortening: Resolution after opening a totally occluded right coronary artery.

Acute myocardial ischemia induces reduced systolic shortening and causes postsystolic shortening (PSS). Right ventricular (RV) PSS in coronary artery disease has been less studied. We present here the case of a 51-year-old woman admitted with a non-ST segment elevation myocardial infarction and significant PSS in the RV free-wall segments on two-dimensional speckle tracking echocardiography, suggesting ongoing ischemia. A cardiac CT demonstrated occluded proximal right coronary artery with a low-attenuated/soft plaque, confirmed by coronary angiography which was treated by percutaneous coronary intervention. At 3-week follow-up, there was complete resolution of the RV-PSS, with a more synchronized pattern of maximum myocardial shortening at systole.

Thrombus characteristics evaluated by acute optical coherence tomography in ST elevation myocardial Infarction.

AIMS: ST elevation myocardial infarction (STEMI) is caused by an occlusive thrombosis of a coronary artery. We wanted to assess if the thrombus can be characterized according to erythrocyte content and age using intravascular optical coherence tomography (OCT) in a clinical setting. METHODS AND RESULTS: We performed manual thrombus aspiration in 66 STEMI patients. OCT was done of the thrombus remnants after aspiration. A light intensity ratio was measured through the thrombus. Forty two of the aspirates had thrombus which could be analyzed histomorphologically for analysis of erythrocyte and platelet content, and to determine the age of thrombus as fresh, lytic or organized. There were 11 red, 21 white and 10 mixed thrombi. Furthermore, 36 aspirates had elements of fresh, 7 of lytic and 8 of organized thrombi. There was no correlation between colour and age. OCT appearance could not predict erythrocyte or platelet content. The light intensity ratios were not significantly different in fresh, lytic or organized thrombi. CONCLUSION: OCT could not differentiate between red and white thrombi, nor determine thrombus age.

Shared Decision-Making and Patient-Reported Outcome Measures in Valvular Heart Disease.

Patient-centered health care emphasizes shared decision-making (SDM), incorporating both clinical evidence and patient preferences and values. SDM is important in heart valve disease, both because there might be more than one treatment option and due to the importance of adherence after intervention. We aimed to describe patient information and involvement in decision-making about care and recording of patient-reported outcome measures (PROMs) in valve interventions. The opinion piece and recommendations are based upon literature review and our own experience from specialist valve clinics. Before a valve intervention, adequate patient information, discussion of the various treatment options and exploring patient preferences, in line with the concept of SDM, may improve post-intervention quality of life. After intervention, patients with prosthetic heart valves require adequate counseling and close follow-up to make them more confident and competent to manage their own health, as well as to maintain the efficacy of treatment provided. PROMs inform SDM before and improve care after valve intervention, focusing on outcomes beyond mortality and morbidity. SDM may improve post-intervention quality of life. Formal PROMs questionnaires inform SDM, quantify patient centered changes and should be used more often in clinical practice and research. A thorough assessment of baseline frailty status in patients scheduled for valve intervention is essential and may affect postoperative outcome.

Sex Differences in Right Ventricular Systolic Function and All-Cause Mortality in Tricuspid Regurgitation.

INTRODUCTION: Sex differences have been poorly studied in patients with right-sided heart valve disease. The principal aim of the current study was to explore the impact of sex differences on right ventricular (RV) hemodynamics and all-cause mortality in patients with moderate or severe tricuspid regurgitation (TR). METHODS: This is a retrospective study of 209 patients with significant TR. All patients were clinically profiled at baseline and underwent a transthoracic echocardiogram. The cohort was followed up for clinical events for a median duration of 80 months (mean ± SD 69.4 ± 33.4 months). RESULTS: There were 117 women with a mean (± SD) age of 72.6 ± 13 years and 92 men with a mean (± SD) age of 70.8 ± 15.8 years. There were no sex differences between the individual measures of RV systolic function (tricuspid annular plane systolic excursion [TAPSE], systolic pulmonary artery pressure, and RV S'), but overall RV systolic dysfunction (TAPSE <16 mm and/or RV S' <10 cm/s) and left ventricular ejection fraction <50% were more common in men. Mean (± SD) RV wall tension (RV WT) was 3,170 ± 1,220 mm Hg × mm in women and 3,817 ± 1,499 mm Hg × mm in men (p = 0.002). There was no difference in all-cause mortality between women and men (Log-Rank p = 0.528). Age and increased RV WT were independent predictors of all-cause mortality both in women (hazard ratio [HR] 2.61) and men (HR 3.01). CONCLUSIONS: In this cohort of patients with significant TR, women more frequently had preserved RV systolic function than men. There was no sex-difference in all-cause mortality. An increased RV WT and higher age were independent predictors of all-cause mortality in both women and men.

Long-term echocardiographic follow-up of a patient with constrictive pericarditis treated with antituberculosis drugs and pericardiectomy.

A middle-aged man presented to the Department of Medicine of our hospital due to exertional dyspnoea, ascites and peripheral oedema. He was later transferred to the Department of Heart Disease as his echocardiography indicated constrictive pericarditis, confirmed by cardiac MRI and cardiac catheterisation. After a thorough investigation, his constrictive pericarditis was assumed to be caused by tuberculosis. He was treated with antituberculosis therapy followed by successful surgical subtotal pericardiectomy, leading to immediate improvement of haemodynamics, regression of symptoms and recovery of cardiac function. The patient remained stable at 5-year echocardiographic follow-up with no evidence of diastolic dysfunction.

Acute Myocardial Infarction Due to Microvascular Obstruction in a Young Woman Who Recently Recovered from COVID-19 Infection.

Although cardiovascular complications are common in hospitalized COVID-19 patients, those with milder cases who recovered at home are less studied. Here, we report the case of a young woman who recently recovered from COVID-19 at home. A week after recovery, she was admitted to our institution with acute chest pain, signs of ischemia on the electrocardiogram and elevated cardiac troponins. Coronary angiography showed normal epicardial coronary arteries, but the cardiac magnetic resonance showed transmural late gadolinium enhancement (LGE) in the mid-ventricular level of the lateral wall. The findings were strongly suggestive of a minor transmural myocardial infarction. This case report highlights the role of multimodality imaging in detecting cardiac injury in COVID-19 patients as well as the fact that mild COVID-19 cases who recovered at home are also exposed to thromboembolic events during the convalescent period.

Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study.

BACKGROUND: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). METHODS: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. FINDINGS: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55-70] years). Median follow-up was 3·7 (IQR 3·0-4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0-15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2-10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25-4·13) and non-culprit lesion-specific MACEs (7·83, 4·12-14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0-10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4-17·6). INTERPRETATION: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. FUNDING: Abbott Vascular, Infraredx, and The Medicines Company.

The clinical significance and prognostic value of right ventricular wall tension in moderate or severe tricuspid regurgitation.

Background: We aim to explore the determinants of right ventricular wall tension (RV base-to-apex length multiplied by systolic pulmonary artery pressure [RV WT] and association with all-cause mortality in patients with moderate-to-severe tricuspid regurgitation. Materials & methods: Of total, 180 patients (71 ± 15 years, 54% females) were included. An increased RV WT was defined as >3300 mmHg x mm. Results: Patients with increased RV WT (n = 85, 47%) were more likely to be male and taller than patients with normal RV WT. In a multivariable-adjusted model, increased RV WT was associated with a 2.6-fold higher risk of all-cause mortality (HR: 2.59, 95% CI: 1.65-4.06). Conclusion: In patients with significant tricuspid regurgitation, an increased RV WT was common, and associated with a 2.6-fold higher risk of all-cause mortality. Male sex was the only independent determinant.

The electrocardiogram: Still a useful marker for LV fibrosis in aortic stenosis.

Left ventricular (LV) strain on the electrocardiogram (ECG) (down-sloping, convex ST-segment depression with asymmetric T-wave inversion in leads V5 and V6) reflects fibrosis as a result of subendocardial ischemia. It is associated with a significantly increased risk of cardiovascular events independent of the presence of LV hypertrophy on the echocardiogram or cardiac magnetic resonance (CMR) scan. Ongoing studies of early aortic valve replacement in asymptomatic patients with severe aortic stenosis are using ECG changes as a marker of possible fibrosis shown by midwall late gadolinium enhancement on CMR. However, until these studies report, it is still reasonable to respond to LV strain on the ECG by tightening control of systemic hypertension and consider intervention in cases where indications are otherwise in borderline.