Impact of mHealth application on adherence to cardiac rehabilitation guidelines after a coronary event: Randomised controlled clinical trial protocol.

Background: Coronary disease is the main cause of death around the world. mHealth technology is considered attractive and promising to promote behavioural changes aimed at healthy lifestyle habits among coronary patients. The purpose of this study is to evaluate the efficacy of an mHealth intervention regarding improved results in secondary prevention in patients after an acute myocardial infarction (AMI) or angina in terms of lifestyle, clinical variables and therapeutic compliance. Methods: Randomised clinical trial with 300 patients who underwent a percutaneous coronary intervention (PCI) with stent implant. They will be assigned to either the mHealth group, subject to a self-monitored educational intervention involving an internet application installed on their mobile phone or tablet, or to a control group receiving standard healthcare (150 patients in each arm). The primary outcome variables will be adherence to the Mediterranean diet, physical activity, smoking, therapeutic compliance, knowledge acquired, user-friendliness and satisfaction with the application. Measurements of blood pressure, heart rate, body weight, waist circumference (WC) and the 6-min walk test will be taken. Furthermore, the blood lipid profile, glucose and HbA1c will be evaluated. Clinical interview will be conducted, and validated questionnaires completed. The primary quantitative results will be compared using an analysis of covariance adjusted for age and sex. A multivariate analysis will be performed to examine the association of the intervention with lifestyle habits, the control of cardiovascular risk factors (CDRFs) and the results after the hospital discharge (major adverse events, treatment compliance and lifestyle). Conclusions: The study will provide evidence about the effectiveness of an mHealth intervention at improving the lifestyle of the participants and could be offered to patients with coronary disease to complement existing services. Trial registration: NCT05247606. [https://ClinicalTrials.gov]. 21/02/2022.

Coronary Flow Reserve and Myocardial Resistance Reserve Changes After Transcatheter Aortic Valve Implantation in Aortic Stenosis.

Aortic valve stenosis (AS) induces an alteration in hemodynamic conditions that are responsible for coronary microvasculature impairment. Relief of AS by transcatheter aortic valve implantation (TAVI) is expected to improve the coronary artery hemodynamic. We aimed to assess the midterm effects of TAVI in coronary flow reserve (CFR) and myocardial resistance reserve (MRR) by a continuous intracoronary thermodilution technique. At-rest and hyperemic coronary flow was measured by a continuous thermodilution technique in 23 patients with AS and compared with that in 17 matched controls, and repeated 6 ± 3 months after TAVI in 11 of the patients with AS. In patients with AS, absolute coronary flow at rest was significantly greater, and absolute resistance at rest was significantly less, than in controls (p <0.01 for both), causing less CFR and MRR (1.73 ± 0.4 vs 2.85 ± 1.1, p <0.01 and 1.95 ± 0.4 vs 3.22 ± 1.4, p <0.01, respectively). TAVI implantation yielded a significant 35% increase in CFR (p >0.01) and a 39% increase in MRR (p <0.01) driven by absolute coronary flow at rest reduction (p = 0.03). In patients with AS, CFR and MRR determined by continuous thermodilution are significantly impaired. At 6-month follow-up, TAVI improves these indexes and partially relieves the pathophysiologic alterations, leading to a partial restoration of CFR and MRR.

Radiation protection for the interventional cardiologist: Practical approach and innovations.

Use of ionizing radiation during cardiac catheterization interventions adversely impacts both the patients and medical staff. In recent years, radiation dose in cardiac catheterization interventions has become a topic of increasing interest in interventional cardiology and there is a strong interest in reducing radiation exposure during the procedures. This review presents the current status of radiation protection in the cardiac catheterization laboratory and summarizes a practical approach for radiation dose management for minimizing radiation exposure. This review also presents recent innovations that have clinical potential for reducing radiation during cardiac interventions.

Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

The radioprotective effect of the Cathpax® AIR cabin during interventional cardiology procedures.

BACKGROUND: The use of ionizing radiation during cardiac catheterization interventions adversely impacts the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has proven to significantly reduce radiation exposure in electrophysiological and neuroradiology interventions. Our objective was to analyze whether the Cathpax® RPC reduces radiation dose in coronary and cardiac structural interventions in unselected real-world procedures. METHODS AND RESULTS: In this nonrandomized all-comers prospective study, 119 consecutive cardiac interventional procedures were alternatively divided into two groups: the RPC group (n = 59) and the non-RPC group (n = 60). No significant changes in the characteristics of patients and procedures, average contrast volume, air kerma (AK), dose area-product (DAP) and fluoroscopy time between both groups were apparent. In the RPC group, the first-operator relative radiation exposure was reduced by 78% at the chest and by 70% at the wrist. This effect was consistent during different types of procedures including complex percutaneous interventions and structural procedures. CONCLUSIONS: Our study demonstrates, for the first time, that the Cathpax® cabin significantly and efficiently reduces relative operator radiation exposure during different types of interventional procedures, confirming its feasibility in a real-world setting.

Long-term clinical, angiographic, and optical coherence tomography findings of Mg-based bioresorbable scaffold in patients with acute coronary syndrome.

BACKGROUND: This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months. METHODS: Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%). RESULTS: At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse. CONCLUSIONS: At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

Contrast FFR plus intracoronary injection of nitro-glycerine accurately predicts FFR for coronary stenosis functional assessment.

BACKGROUND: Fractional flow reserve (FFR) is the "gold standard" for assessing the physiological significance of coronary disease. In the last decade, several alternative adenosine-free indexes have been proposed in order to facilitate the dissemination of the functional evaluation of coronary stenosis. Our aim was to investigate whether radiographic contrast plus intracoronary nitroglycerin (cFFR-NTG) can predict functional assessment of coronary stenosis offering superior diagnostic agreement with FFR compared to non-hyperemic indexes and contrast mediated FFR (cFFR). METHODS: Three hundred twenty-nine lesions evaluated with pressure wire in 266 patients were prospectively included in this multicenter study. RESULTS: The ROC curves for cFFR-NTG using an FFR≤0.80 showed a higher accuracy in predicting FFR (AUC=0.97) than resting Pd/Pa (AUC=0.90, P<0.01) and cFFR (AUC=0.93.5, P<0.01). A significant (P<0.01) strong correlation was found between FFR and the four analyzed indexes: Pd/Pa (r=0.78); iFR/RFR (r=0.73); cFFR(r=0.89) and cFFR-NTG (r=0.93). cFFR-NTG showed the closest agreement at Bland-Altman analysis. The cFFR-NTG cut off value >0.84 showed the highest negative predictive value (88%), specificity (91%), sensitivity (94%) and accuracy (92%) of the studied indexes. CONCLUSIONS: Submaximal hyperemic adenosine-free indexes are an efficient alternative to adenosine for the physiological assessment of epicardial coronary disease. The most accurate index in predicting the functional significance of coronary stenosis using FFR as reference was cFFR-NTG.

Continuous Thermodilution Method to Assess Coronary Flow Reserve.

Coronary flow reserve (CFR) is a well-validated flow-based physiological parameter that has shown value in clinical risk stratification. CFR can be invasively assessed, classically by Doppler and, more recently, by thermodilution with saline boluses (CFRthermo-bolus). Alternatively, continuous thermodilution is a novel operator-independent, highly-reproducible technique to invasively quantify maximum absolute coronary flow (AF). This study aimed to assess the feasibility of this method to quantify resting AF and to determine CFR (CFRThermo-infusion) as compared with CFRthermo-bolus. Sixty-two consecutive patients with suspicion of coronary disease and absence of significant epicardial lesions were prospectively investigated. AF at maximal hyperemia (20 mL/min) and at lower infusion rates (6-8-10-12 mL/min) were systematically measured using a dedicated catheter and a temperature/pressure guidewire. The absence of baseline Pd/Pa decrease at 6 (0.15 ± 0.2%), 8 (0.17 ± 0.18%) and 10 mL/min (0.2 ± 0.12%) demonstrated absence of hyperemia at ≤10 mL/min (all p = NS). However, at 12 mL/min hyperemia was confirmed by a significant decrease in Pd/Pa (1.3 ± 1.5%, p <0.01) and increase in AF from 10 mL/min to 12 mL/min (31.4 ± 28.1 mL, p <0.05). All curve tracings at 10 mL/min (129/129, 100%) were adequate versus only (7/15, 53%) and (15/18, 17%) at 6 mL/min, and 8 mL/min, respectively, and this infusion-rate was considered to determine resting-AF. CFRThermo-infusion was determined as the ratio of hyperemic-AF (20 mL/min) by resting-AF (10 mL/min). Mean CFRThermo-infusion was 2.56 ± 0.9 and CFRthermo-bolus 2.49 ± 1. Both parameters showed a good correlation (r = 0.76; p <0.001) and intraclass agreement (ICC = 0.76; p <0.001).The continuous thermodilution method enables to quantify resting-AF providing a novel clinical tool to determine CRF. CFRThermo-infusion shows a good correlation with CFRthermo-bolus..

Effective Reduction of Radiation Exposure during Cardiac Catheterization.

Exposure to ionizing radiation during cardiac catheterization can have harmful consequences for patients and for the medical staff involved in the procedures. Minimizing radiation doses during the procedures is essential. We investigated whether fine-tuning the radiation protocol reduces radiation doses in the cardiac catheterization laboratory. In January 2016, we implemented a new protocol with reduced radiation doses in the Hospital de Jerez catheterization laboratory. We analyzed 170 consecutive coronary interventional procedures (85 of which were performed after the new protocol was implemented) and the personal dosimeters of the interventional cardiologists who performed the procedures. Overall, the low-radiation protocol reduced air kerma (dose of radiation) by 44.9% (95% CI, 18.4%-70.8%; P=0.001). The dose-area product decreased by 61% (95% CI, 30.2%-90.1%; P <0.001) during percutaneous coronary interventions. We also found that the annual deep (79%, P=0.026) and shallow (62.2%, P=0.035) radiation doses to which primary operators were exposed decreased significantly under the low-radiation protocol. These dose reductions were achieved without increasing the volume of contrast media, fluoroscopy time, or rates of procedural complications, and without reducing the productivity of the laboratory. Optimizing the radiation safety protocol effectively reduced radiation exposure in patients and operators during cardiac catheterization procedures.

Early recruitment of coronary collateral circulation: impact in late presentation nonreperfused acute coronary occlusion.

BACKGROUND: Debate still remains on whether the presence of early recruited collateral circulation (ERCC) in the setting of an acute coronary occlusion (ACO) has a prognosis benefit. Some previous reports have shown lower mortality and morbidity rates in well-collateralized patients compared with those with poorly recruited collateral circulation (PCC), but others have not. In the primary angioplasty era, the role of collateral circulation in these studies may have been influenced by the effect of early reperfusion. The actual impact of ERCC in ACO can be clarified by studying its effect on nonreperfused patients. OBJECTIVE: This study aimed to compare the 1-year clinical outcome in nonreperfused late presentation ACO in a major coronary artery with ERCC versus PCC. PATIENTS AND METHODS: Between 2008 and 2015, we included 164 patients with a nonreperfused late presentation ACO. The patients were divided according to the presence of angiographic ERCC (Rentrop 2-3) or PCC (Rentrop 0-1). ERCC was present in 54% of patients. Patients with ERCC less often presented with cardiogenic shock (P=0.02) and the right coronary artery was the most frequent culprit vessel (P=0.02). The presence of PCC was associated independently with higher 1-year cardiovascular mortality [hazard ratio (HR): 6.92; 95% confidence interval (95%CI): 1.37-34.7; P=0.019], 1-year total mortality (HR: 5.79; 95%CI: 1.95-17.1; P=0.001), and 1-year major adverse cardiac event (HR: 8.05; 95%CI: 1.73-37.4; P<0.01). CONCLUSION: The presence of angiographically PCC in the setting of late presentation nonreperfused ACO is relatively infrequent (46%) and is associated with worse 1-year major clinical outcomes.