The Coronary Sinus Reducer; 5-year Dutch experience.

BACKGROUND: Refractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5­year Dutch experience regarding safety and efficacy of the CSR. METHODS: One hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6­month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events. RESULTS: Eighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported. CONCLUSION: The CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.

First report of a comparative patient-oriented perspective on the use of non-vitamin-K oral anticoagulants or vitamin-K antagonists in atrial fibrillation: patients' experiences, side-effects and practical problems leading to non-adherence.

BACKGROUND: Non-vitamin­K oral anticoagulants (NOACs) are recommended as the first-choice therapy for stroke prevention in patients with non-valvular atrial fibrillation (AF). However, the lack of monitoring may impact patients' adherence, and non-adherence to medication is a potential hazard to safe and efficacious use. This is the first report with a 'comparative patient-oriented perspective' regarding the use of anticoagulant medication in the NOACs era. Our aim was to compare patients' self-reported practical problems, adverse events and non-adherence to anticoagulation therapy. METHODS: A survey was conducted among patients with AF on either NOACs or vitamin­K antagonists (VKAs). The outcomes were self-reported non-adherence to anticoagulant medication, and patients' experiences, adverse events and practical problems correlated with the intake of the drug itself. RESULTS: A total of 765 patients filled out the questionnaire, of which 389 (50.9%) were on VKAs and 376 (49.1%) on NOACs. Age (70.6 ± 8.8 vs 70.3 ± 9.1 years) and male gender (70.4% vs 64.6%) were similar in the two groups. A significantly higher proportion of VKA users than NOAC users reported having frequent (16.2% vs 3.7%, p > 0.001) or occasional (4.1% vs 1.3%, p > 0.001) practical issues with medication intake. Self-reported non-adherence was significantly higher (24.4% vs 18.1%, p = 0.03) among VKA users. The incidence of self-reported adverse events was similar. CONCLUSION: Patient experiences support the current guideline recommendations for NOACs as the first-choice therapy: NOAC therapy resulted in a higher practical feasibility and better adherence when compared with VKA therapy, with a similar incidence of adverse events in both groups.

Effects of Aortic Valve Replacement on Left Ventricular Diastolic Function in Patients With Aortic Valve Stenosis.

The afterload increase imposed by severe aortic valve stenosis (AS) creates concentric left ventricular (LV) remodeling and diastolic dysfunction (DD), which are both markers of poor clinical outcome. Ideally, a correctly timed surgery for isolated AS can reverse the LV remodeling. However, data on LV DD after aortic valve replacement (AVR) are sparse and contrasting. Aims of the study are to define the markers of a favorable evolution of the DD at follow-up. Patients with severe isolated AS, scheduled for AVR were prospectively enrolled. Transthoracic echocardiography with DD assessment was performed before surgery, and at 12 months after surgery. Global LV longitudinal and circumferential strain, peak atrial longitudinal and contraction strain (PALS, PACS) were obtained at baseline. LV septal biopsy to assess fibrosis was performed at the time of AVR. Sixty-seven patients were enrolled, age 72 ± 8 years, 66% female, ejection fraction 61 ± 8%, E/e' 13 ± 6, PALS 23 ± 7%. Normal estimated left atrial pressure was detected in 19/67 (28%) versus 43/67 (64%) at follow-up (p <0.0001). In the 37 patients with biopsy available, fibrosis was 24 ± 12%. PALS and AS severity were correlated with LV fibrosis (R2 = 0.19; p = 0.006, and R2 = 0.15; p = 0.02, respectively). PALS (odds ratio: 1.19 [1.05 to 1.41], p = 0.02) and PACS (odds ratio: 1.24 [1.06 to 1.50], p = 0.006) were the only baseline noninvasive parameters independently associated with normal left atrial pressure at follow-up. Mean follow-up time was 791 ± 245 days, and 8 (12%) patients had cardiovascular events (death, hospital admission due to heart failure or ischemic disease, and onset of atrial fibrillation). Myocardial fibrosis (p = 0.05), baseline PALS (p = 0.004), and PACS (p = 0.03) were associated with cardiovascular events. In conclusion, LV diastolic function generally improves after AVR for severe AS. Baseline PALS, PACS, and LV fibrosis were related to the DD and clinical outcome at follow-up; these parameters might cue a better diastolic response to the afterload correction.

Appropriate use criteria for optical coherence tomography guidance in percutaneous coronary interventions : Recommendations of the working group of interventional cardiology of the Netherlands Society of Cardiology.

INTRODUCTION: Optical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria. METHODS: Twenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring. RESULTS: Twenty-six indications were rated 'Appropriate', eighteen indications 'May be appropriate', and five 'Rarely appropriate'. Use of OCT was unanimously considered 'Appropriate' in stent thrombosis, and 'Appropriate' for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered 'Rarely Appropriate' on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery. CONCLUSIONS: The use of OCT in stent thrombosis is unanimously considered 'Appropriate' by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings.

Veno-arterial extracorporeal membrane oxygenation in addition to primary PCI in patients presenting with ST-elevation myocardial infarction.

INTRODUCTION: Primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI) can cause great haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide haemodynamic support in patients with STEMI but data on outcome and complications are scarce. METHODS: An in-hospital registry was conducted enrolling all patients receiving VA-ECMO. Patients were analysed for medical history, mortality, neurological outcome, complications and coronary artery disease. RESULTS: Between 2011 and 2016, 12 patients underwent pPCI for STEMI and received VA-ECMO for haemodynamic support. The majority of the patients were male (10/12) with a median age of 63 (47-75) years and 4 of the 12 patients had a history of coronary artery disease. A cardiac arrest was witnessed in 11 patients. The left coronary artery was compromised in 8 patients and 4 had right coronary artery disease. All patients were in Killip class IV. Survival to discharge was 67% (8/12), 1­year survival was 42% (5/12), 2 patients have not yet reached the 1­year survival point but are still alive and 1 patient died within a year after discharge. All-cause mortality was 42% (5/12) of which mortality on ECMO was 33% (4/12). Patient-related complications occurred in 6 of the 12 patients: 1 patient suffered major neurological impairment, 2 patients suffered haemorrhage at the cannula site, 2 patients had limb ischaemia and 1 patient had a haemorrhage elsewhere. There were no VA-ECMO hardware malfunctions. CONCLUSION: VA-ECMO in pPCI for STEMI has a high survival rate and neurological outcome is good, even when the patient is admitted with a cardiac arrest.

Is TAVI superior to surgery in high-risk patients? Insight into the concept of individual risk assessment.

The prevalence of aortic valve stenosis (AS) is growing in developed countries because its prevalence increases with age. A growing number of elderly patients are currently referred to specialized centres to be evaluated for potential therapeutic strategies. Indeed, two techniques are nowadays able to treat high-risk AS patients: TAVI and surgical replacement (AVR). It is the purpose of the present review to summarize current knowledge on safety and efficacy of AVR and TAVI in high-risk patients; to focus on some aspects of recently published guidelines; to emphasize the growing importance of pre-operative individual risk assessment, which is considered the real crucial point for patient selection and trial's comparisons. Indeed, it is worth of noting that currently adopted risk-scores do not show satisfactory performances. Accordingly, it becomes of utmost importance to investigate several baseline but still neglected patients' characteristics (e.g. frailty, functional status, co-morbid conditions, etc.), as well as their pathogenetic relationships with interventional results and follow-up prognosis. All these items are emphasized in the present review. Finally, we have tried to anticipate future scenarios in terms of both ongoing clinical trials and improvements of risk-scores.