Patent foramen ovale: diagnostic evaluation and the role of device closure.

Although seemingly benign, the presence of a patent foramen ovale (PFO) may play an important role in the pathophysiology of disease, specifically a paradoxical embolism leading to cryptogenic stroke. The European Society of Cardiology recently published guidelines detailing how PFOs are associated with paradoxical embolism and how they are diagnosed and managed. This review guides physicians in the diagnostic and referral process to a multidisciplinary team involved in PFO closure. It reviews the clinical trials comparing device closure with medical therapy and highlights the current NHS England commissioning process on PFO management. Finally, we give an overview of other conditions where PFO device closure may need to be considered.

One-year outcomes of percutaneous coronary intervention in native coronary arteries versus saphenous vein grafts in patients with prior coronary artery bypass graft surgery.

BACKGROUND: Patients with prior coronary artery bypass graft (CABG) surgery often require percutaneous coronary intervention (PCI). Data are still limited in regards to the outcomes of native saphenous vein graft (SVG) PCI after CABG. METHODS: We performed a retrospective study in a tertiary reference cardiac center of consecutive patients who underwent PCI after CABG. The data were collected for patients who underwent either native or graft PCI from January 2008 to December 2018. Arterial graft PCIs were excluded. Multivariable Cox regression analysis with propensity matching was performed, and major adverse cardiac events (MACE) outcomes including death or myocardial infarction (MI) or revascularization were assessed at 1-year after each index procedure. RESULTS: A total of 435 PCI were performed in 401 patients (209 had native PCI and 192 had graft PCI). Target lesions were classified as following: 235 (54%) native coronary arteries and 200 (46%) SVG. Propensity matching resulted in 167 matched pairs. In multivariable Cox regression graft PCI relative to native PCI was an independent risk factor for MACE (hazard ratio [HR] 1.725, 95% confidence interval [CI] 1.049-2.837) which was primarily driven by increased incidence in revascularization (HR 2.218, 95% CI 1.193-4.122) and MI (HR 2.248, 95% CI 1.220-4.142) and with no significant difference in mortality (HR 1.118, 95% CI 0.435-2.870). CONCLUSIONS: Compared with native coronary PCI, bypass graft PCI was significantly associated with higher incidence of MACE at 1-year and this was mainly driven by MI and revascularization.

Quality of Life Assessment in Patients Undergoing Trans-Catheter Aortic Valve Implantation Using MacNew Questionnaire.

The MacNew questionnaire is a disease-specific quality of life measure that has been used in patients with myocardial infarction and heart failure. We aimed to investigate the impact of transcatheter aortic valve implantation (TAVI) on health-related quality of life (HRQoL) using MacNew Questionnaire and identify predictors associated with a change in its score. This was a prospective multi-center study performed across 5 National Health Service hospitals in the United Kingdom performing TAVI between 2016 and 2018. HRQoL was assessed using MacNew Questionnaire, Euro Quality of Life-5D-5L, and Short Form 36 questionnaires collected at baseline, 3-, 6- and 12 months after the procedure. Out of 225 recruited patients, 19 did not have TAVI and 4 withdrew their consent, and hence 202 patients were included. HRQoL was assessed in 181, 161, and 147 patients at 3, 6, and 12 months, respectively. Using MacNew, there was a significant improvement in all domains of HRQoL as early as 3 months after TAVI which was sustained up to 12 months with improved discrimination of change in HRQoL compared with other scales. Poor mobility at baseline and history of myocardial infarction were independent predictors of reduced improvement in HRQoL at 3 months. HRQoL increased in all subgroups of patients including frail ones. In conclusion, the MacNew assessment tool performed well in a representative TAVI cohort and could be used as an alternative disease-specific method for assessing HRQoL change after TAVI.

Ultra-low contrast, complex left main coronary intervention case series using novel intravascular ultrasound technology.

BACKGROUND: Contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) carries a high morbidity and mortality. Ultra-low contrast percutaneous coronary intervention (ULPCI) has previously been described. Complex left main (LM) ULPCI using two-stent strategy guided by novel intravascular ultrasound (IVUS) co-registration software has not been described. We report a series of complex LM ULPCI using IVUS co-registration. CASE SUMMARIES: Five patients with estimated glomerular filtration rate ≤20 mL/min who presented with stable angina or non-ST segment elevation acute coronary syndrome underwent percutaneous coronary intervention (PCI). The patients previously had diagnostic angiography performed as a separate procedure. Successful LM ULPCI was performed in all patients with a provisional and two-stent bifurcation strategies. These were complex procedures, some of which required haemodynamic support and rotational atherectomy. DISCUSSION: This report describes the first ULPCI using a dedicated two-stent LM bifurcation strategy and using rotational atherectomy and IVUS co-registration. This technology facilitated complex PCI in this high-risk patient group with minimal contrast use (≤6 mL) with optimal results and no patients developed acute kidney injury after intervention. The adaptation of ULPCI to daily practice in patients at risk of CIN will improve treatment for this underserved patient group.

Mental Health Outcomes Among British Healthcare Workers-Lessons From the First Wave of the Covid-19 Pandemic.

OBJECTIVE: To ascertain the level of psychological distress, using validated psychology tools, among British National healthcare workers (HCW) during the first wave of the Covid-19 crisis. METHODS: A multi-centre, anonymized, all-comer staff survey across 3 hospitals in Lancashire, England during the Covid-19 first wave (April to June 2020), consisting of Patient Health Questionnaire (PHQ-9), Perceived Stress Scale-10 (PSS-10), Generalized Anxiety Disorder-7 (GAD-7), and Impact of Events Scale (IES-6). RESULTS: Among 1113 HCW, median (IQR) PHQ-9, GAD-7, PSS-10, and IES-6 score was 7 (3 to 11), 6 (3 to 11), 19 (13 to 24), and 9 (5 to 14), respectively. Potential predictors of higher levels of psychological distress included living alone, disabled dependents, history of depression/anxiety, and being female. CONCLUSIONS: The study indicates a high prevalence of psychological distress during the acute Covid-19 period among HCW, identifies groups at risk and areas of future research.

Meta-Analysis Comparing Direct Oral Anticoagulants to Vitamin K Antagonists for The Management of Left Ventricular Thrombus.

Introduction: To compare vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) treatment in patients with left ventricular (LV) thrombus. The primary outcome was stroke or systemic embolism (SSE). Secondary outcomes were thrombus resolution, bleeding, and death.Areas covered: Five observational studies were included (total n = 700; VKAs n = 480; DOACs n = 220). There was a trend toward less SSE with VKAs compared to DOACs (5.2% vs. 9%; odds ratio [OR] = 0.54, 95% confidence interval [CI] = 0.29-1.01, p = 0.05). No significant difference between VKAs and DOACs in rates of thrombus resolution (61.6% vs. 56.8%; OR = 1.00, 95% CI = 0.58-1.73, p = 0.99), bleeding (8.2% vs. 4.4%; OR = 1.62, 95% CI = 0.69-3.77, p = 0.27), or death (12.7% vs. 11.8%; OR = 1.09, 95% CI = 0.59-2.0, p = 0.79) was noted. In non-primary percutaneous coronary intervention setting, VKAs were associated with less SSE in prespecified analysis (5.2% vs.10.6%; OR = 0.48, 95% CI = 0.25-0.93, p = 0.03).Expert opinion: The current meta-analysis suggests a trend toward higher SSE with the use of DOACs compared to VKAs. Our recommendation is for VKAs to retain the preferred management of LV thrombus with cautious off-label use of DOACs.

Coronary artery calcium score and risk of cardiovascular events without established coronary artery disease: a systemic review and meta-analysis.

BACKGROUND: Coronary artery calcium (CAC) is an indicator of atherosclerosis, and the CAC score is a useful noninvasive assessment of coronary artery disease. OBJECTIVE: To compare the risk of cardiovascular outcomes in patients with CAC > 0 versus CAC = 0 in asymptomatic and symptomatic population in patients without an established diagnosis of coronary artery disease. METHODS: A systematic search of electronic databases was conducted until January 2018 for any cohort study reporting cardiovascular events in patients with CAC > 0 compared with absence of CAC. RESULTS: Forty-five studies were included with 192 080 asymptomatic 32 477 symptomatic patients. At mean follow-up of 11 years, CAC > 0 was associated with an increased risk of major adverse cardiovascular and cerebrovascular events (MACE) compared to a CAC = 0 in asymptomatic arm [pooled risk ratio (RR) 4.05, 95% confidence interval (CI) 2.91-5.63, P < 0.00001, I2 = 80%] and symptomatic arm (pooled RR 6.06, 95% CI 4.23-8.68, P < 0.00001, I2 = 69%). CAC > 0 was also associated with increased risk of all-cause mortality in symptomatic population (pooled RR 7.94, 95% CI 2.61-24.17, P < 0.00001, I2 = 85%) and in asymptomatic population CAC > 0 was associated with higher all-cause mortality (pooled RR 3.23, 95% CI 2.12-4.93, P < 0.00001, I2 = 94%). In symptomatic population, revascularization in CAC > 0 was higher (pooled RR 15, 95% CI 6.66-33.80, P < 0.00001, I2 = 72) compared with CAC = 0. Additionally, CAC > 0 was associated with more revascularization in asymptomatic population (pooled RR 5.34, 95% CI 2.06-13.85, P = 0.0006, I2 = 93). In subgroup analysis of asymptomatic population by gender, CAC > 0 was associated with higher MACE (RR 6.39, 95% CI 3.39-12.84, P < 0.00001). CONCLUSION: Absence of CAC is associated with low risk of cardiovascular events compared with any CAC > 0 in both asymptomatic and symptomatic population without coronary artery disease.

Hospital admission with non-alcoholic fatty liver disease is associated with increased all-cause mortality independent of cardiovascular risk factors.

Non-alcoholic fatty liver disease (NAFLD) is common and strongly associated with the metabolic syndrome. Though NAFLD may progress to end-stage liver disease, the top cause of mortality in NAFLD is cardiovascular disease (CVD). Most of the data on liver-related mortality in NAFLD derives from specialist liver centres. It is not clear if the higher reported mortality rates in individuals with non-cirrhotic NAFLD are entirely accounted for by complications of atherosclerosis and diabetes. Therefore, we aimed to describe the CVD burden and mortality in NAFLD when adjusting for metabolic risk factors using a 'real world' cohort. We performed a retrospective study of patients followed-up after an admission to non-specialist hospitals with a NAFLD-spectrum diagnosis. Non-cirrhotic NAFLD and NAFLD-cirrhosis patients were defined by ICD-10 codes. Cases were age-/sex-matched with non-NAFLD hospitalised patients. All-cause mortality over 14-years follow-up after discharge was compared between groups using Cox proportional hazard models adjusted for demographics, CVD, and metabolic syndrome components. We identified 1,802 patients with NAFLD-diagnoses: 1,091 with non-cirrhotic NAFLD and 711 with NAFLD-cirrhosis, matched to 24,737 controls. There was an increasing burden of CVD with progression of NAFLD: for congestive heart failure 3.5% control, 4.2% non-cirrhotic NAFLD, 6.6% NAFLD-cirrhosis; and for atrial fibrillation 4.7% control, 5.9% non-cirrhotic NAFLD, 12.1% NAFLD-cirrhosis. Over 14-years follow-up, crude mortality rates were 14.7% control, 13.7% non-cirrhotic NAFLD, and 40.5% NAFLD-cirrhosis. However, after adjusting for demographics, non-cirrhotic NAFLD (HR 1.3 (95% CI 1.1-1.5)) as well as NAFLD-cirrhosis (HR 3.7 (95% CI 3.0-4.5)) patients had higher mortality compared to controls. These differences remained after adjusting for CVD and metabolic syndrome components: non-cirrhotic NAFLD (HR 1.2 (95% CI 1.0-1.4)) and NAFLD-cirrhosis (HR 3.4 (95% CI 2.8-4.2)). In conclusion, from a large non-specialist registry of hospitalised patients, those with non-cirrhotic NAFLD had increased overall mortality compared to controls even after adjusting for CVD.

Impact of COVID-19 pandemic on patients with ST-segment elevation myocardial infarction: Insights from a British cardiac center.

The current study aimed to examine the impact of COVID-19 pandemic on patient-related delay with ST-segment elevation myocardial infarction (STEMI) at a tertiary center in the United Kingdom. The study demonstrated a significant delay in symptom-to-first medical contact and a higher cardiac troponin-I level on admission in patients with STEMI during the COVID-19 pandemic versus the pre-COVID era.

Meta-Analysis Comparing Percutaneous to Surgical Access in Trans-Femoral Transcatheter Aortic Valve Implantation.

To compare the outcomes in trans-femoral transcatheter aortic valve implantation (TF-TAVI) performed with percutaneous approach (PC) versus surgical cut-down (SC). In 13 trials including 5,859 patients (PC = 3447, SC = 2412), the outcomes based on Valve Academic Research Consortium criteria were compared between PC and SC in TF-TAVI. Compared with SC, PC was associated with similar major vascular complications (VCs) (8.7% vs 8.5%; odds ratio [OR] = 0.93, 95% confidence interval [CI] = 0.76 to 1.15, p = 0.53), major bleeding (OR = 1.09, 95% CI = 0.66 to 1.8, p = 0.73), perioperative mortality (5.7% vs 5.2%; OR = 1.13, 95% CI = 0.85 to 1.49, p = 0.4), urgent surgical repair (OR = 1.27, 95% CI = 0.81 to 2.02, p = 0.3), stroke (3.3% vs 3.9%; OR = 0.85, 95% CI = 0.53 to 1.36, p = 0.5), myocardial infarction (1.3% vs 1.1%; OR = 1.06, 95% CI = 0.53 to 2.12, p = 0.86), and renal failure (5.2% vs 5.9%; OR = 0.68, 95% CI = 0.38 to 1.22, p = 0.2), but shorter hospital stay (9.1 ± 8.5 vs 9.6 ± 9.5 days; mean difference = -1.07 day, 95% CI = -2.0 to -0.15, p = 0.02) and less blood transfusion (18.5% vs 25.7%; OR = 0.61, 95% CI = 0.43-0.86, p = 0.005). Minor VCs occurred more frequently in PC compared to SC (11.9% vs 6.9%; OR = 1.67, 95% CI = 1.04-2.67, p = 0.03). In conclusion, in TF-TAVI, PC is a safe and feasible alternative to SC, and adopting either approach depends on operator experience after ensuring that vascular access could be safely achieved with that specific technique.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Aspirin for Primary Prevention of Cardiovascular Events.

BACKGROUND: The efficacy and safety of aspirin for primary prevention of cardiovascular disease (CVD) remain debatable. OBJECTIVES: The purpose of this study was to examine the clinical outcomes with aspirin for primary prevention of CVD after the recent publication of large trials adding >45,000 individuals to the published data. METHODS: Randomized controlled trials comparing clinical outcomes with aspirin versus control for primary prevention with follow-up duration of ≥1 year were included. Efficacy outcomes included all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke, transient ischemic attack (TIA), and major adverse cardiovascular events. Safety outcomes included major bleeding, intracranial bleeding, fatal bleeding, and major gastrointestinal (GI) bleeding. Random effects DerSimonian-Laird risk ratios (RRs) for outcomes were calculated. RESULTS: A total of 15 randomized controlled trials including 165,502 participants (aspirin n = 83,529, control n = 81,973) were available for analysis. Compared with control, aspirin was associated with similar all-cause death (RR: 0.97; 95% confidence interval [CI]: 0.93 to 1.01), CV death (RR: 0.93; 95% CI: 0.86 to 1.00), and non-CV death (RR: 0.98; 95% CI: 0.92 to 1.05), but a lower risk of nonfatal MI (RR: 0.82; 95% CI: 0.72 to 0.94), TIA (RR: 0.79; 95% CI: 0.71 to 0.89), and ischemic stroke (RR: 0.87; 95% CI: 0.79 to 0.95). Aspirin was associated with a higher risk of major bleeding (RR: 1.5; 95% CI: 1.33 to 1.69), intracranial bleeding (RR: 1.32; 95% CI: 1.12 to 1.55), and major GI bleeding (RR: 1.52; 95% CI: 1.34 to 1.73), with similar rates of fatal bleeding (RR: 1.09; 95% CI: 0.78 to 1.55) compared with the control subjects. Total cancer and cancer-related deaths were similar in both groups within the follow-up period of the study. CONCLUSIONS: Aspirin for primary prevention reduces nonfatal ischemic events but significantly increases nonfatal bleeding events.

Routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes.

BACKGROUND: Data from prior studies have shown increased risk of adverse outcomes with bioresorbable vascular scaffolds (BVS) compared with drug-eluting stents. OBJECTIVE: The objective of this study was to study the long-term outcomes with routine use of optical coherence tomography (OCT) for optimization of BVS implantation. PATIENTS AND METHODS: Clinical, procedural, and outcome data were collected for all patients who received ABSORB BVS between February 2014 and March 2016 in our tertiary center (n=86). Preimplantation and postimplantation OCT was performed in all cases. Outcomes of interest included acute device success and long-term clinical outcomes including cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and scaffold thrombosis. RESULTS: A total of 86 patients were included (106 lesions, 115 BVS implanted). Mean age was 59.5±10.9 years, with 66% men. Mean lesion length was 25.2±15.6 mm and mean reference vessel diameter was 3.42±0.45 mm. Type B2/C accounted for 40% of the lesions. All scaffold implantations followed the predilation, proper sizing, and postdilation strategy. Of the 115 scaffolds analyzed, 11 (9.5%) required further intervention based on prespecified OCT endpoints. On multivariate regression analysis, complex coronary lesion (type B2/C) was the single independent predictor of OCT use in scaffold optimization (odds ratio=6.3, 95% confidence interval: 1.3-7.8, P=0.02). At a mean follow-up duration of 31±7.1 months, no cases of cardiac mortality, target vessel myocardial infarction, ischemia-driven target lesion revascularization, or scaffold thrombosis were reported. CONCLUSION: Operators may consider OCT use for optimization of BVS implantation particularly in patients with complex coronary lesions.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

Successful Transcatheter Aortic Valve Replacement Using Balloon-Expandable Valve for Pure Native Aortic Valve Regurgitation in the Presence of Ascending Aortic Dissection.

The use of balloon-expandable prosthesis in the treatment of native aortic valve regurgitation in the presence of ascending aortic dissection is described.

Long-term outcomes of patent foramen ovale closure or medical therapy after cryptogenic stroke: A meta-analysis of randomized trials.

OBJECTIVES: To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke. BACKGROUND: A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists. METHODS: An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined. RESULTS: Five RCTs with a total of 3,440 patients were included. At a mean follow-up of 4.02 ± 1.57 years, PFO closure was associated with less recurrence of stroke (RR = 0.43; 95% CI 0.19-0.91; P = .027) compared with medical therapy alone. No difference was observed between both strategies for TIA (P = .21), major bleeding (P = .69), serious adverse events (P = .35), and all-cause death (P = .48). However, PFO closure, was associated with increased new-onset AF/AFL (P < .001), risk of pulmonary embolism (P = .04), and device-related complications (P < .001). On a subgroup analysis, stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (Pinteraction = .50), or the presence of substantial shunt in the majority of study population (Pinteraction = .13). CONCLUSIONS: Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias.