Effects of Ivabradine on Right Ventricular Systolic Function in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale.

Cor pulmonale is a clinical syndrome associated with pulmonary hypertension, frequently complicated by congestive heart failure, commonly caused by chronic obstructive pulmonary disease (COPD). Most patients with cor pulmonale have tachycardia. However, heart rate (HR) reduction represents a primary treatment goal to improve the survival and quality of life in these patients. Ivabradine can selectively slow HR at rest and during exercise. In this prospective study, we tested the hemodynamic effects, invasively determined using right-sided cardiac catheterization, of reducing HR with ivabradine. We selected 18 patients (13 men [72.2%], mean age 67 ± 10 years) with COPD and cor pulmonale, presenting with sinus tachycardia. All patients performed clinical evaluation, electrocardiogram, spirometry, echocardiogram, 6-minute walking distance, and right-sided cardiac catheterization within 1 month of enrollment. All tests were repeated after 6 months of ivabradine treatment (median assumed dose 11.9 mg/die). We noticed a significant decrease of HR (from 98 ± 7 to 77 ± 8 beats/min, p = 0.0001), with a concomitant reduction of the congestion index (from 25.9 ± 5.1 to 19.4 ± 5.7 mm Hg, p = 0.001), and the consequent improvement of the right ventricular systolic performance (right ventricular stroke volume augmented from 56.7 ± 7.9 to 75.2 ± 8.6 ml/beat, p = 0.0001). This allows an improvement in clinical status and exercise tolerance (Borg scale score decreased from 5.2 ± 1.4 to 4.1 ± 1.3, p = 0.01 and the 6-minute walking distance increased to 252 ± 65 to 377 ± 59 m, p = 0.001). In conclusion, HR reduction significantly improves hemodynamic and clinical status of patients with tachycardia affected by COPD and cor pulmonale.

The Importance of Mehran Score to Predict Acute Kidney Injury in Patients with TAVI: A Large Multicenter Cohort Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has developed as an alternative to surgery for symptomatic high-risk patients with aortic stenosis (AS). An important complication of TAVI is acute kidney injury. The purpose of the study was to investigate if the Mehran Score (MS) could be used to predict acute kidney injury (AKI) in TAVI patients. METHODS: This is a multicenter, retrospective, observational study including 1180 patients with severe AS. The MS comprised eight clinical and procedural variables: hypotension, congestive heart failure class, glomerular filtration rate, diabetes, age >75 years, anemia, need for intra-aortic balloon pump, and contrast agent volume use. We assessed the sensitivity and specificity of the MS in predicting AKI following TAVI, as well as the predictive value of MS with each AKI-related characteristic. RESULTS: Patients were categorized into four risk groups based on MS: low (≤5), moderate (6-10), high (11-15), and very high (≥16). Post-procedural AKI was observed in 139 patients (11.8%). MS classes had a higher risk of AKI in the multivariate analysis (HR 1.38, 95% CI, 1.43-1.63, p < 0.01). The best cutoff for MS to predict the onset of AKI was 13.0 (AUC, 0.62; 95% CI, 0.57-0.67), whereas the best cutoff for eGFR was 42.0 mL/min/1.73 m2 (AUC, 0.61; 95% CI, 0.56-0.67). CONCLUSIONS: MS was shown to be a predictor of AKI development in TAVI patients.

Anthropometric parameters and radiation doses during percutaneous coronary procedures.

PURPOSE: Body size is a major determinant of patient's dose during percutaneous coronary interventions (PCI). Body mass index, body surface area (BSA), lean body mass and weight are commonly used estimates for body size. We aim to identify which of these measures and which procedural/clinical characteristics can better predict received dose. METHODS: Dose area product (DAP, Gycm2), fluoroscopy DAP rate (Gycm2/min), fluoroscopy DAP (Gycm2), cine-angiography DAP (Gycm2), Air Kerma (mGy) were selected as indices of patient radiation dose. Different clinical/procedural variables were analysed in multiple linear regression models with previously mentioned patient radiation dose parameters as end points. The best model for each of them was identified. RESULTS: Overall 6623 PCI were analysed, median fluoroscopy DAP rate was 35 [IQR 2.7,4.4] Gycm2, median total DAP was 62.7 [IQR 38.1,107] Gycm2. Among all anthropometric variables, BSA showed the best correlation with all radiation dose parameters considered. Every 1 m2 increment in BSA added 4.861 Gycm2/min (95% CI [4.656, 5.067]) to fluoroscopy DAP rate and 164 Gycm2 (95% CI [145.3, 182.8]) to total DAP. Height and female sex were significantly associated to a reduction in fluoroscopy DAP rate and total DAP. Coronary angioplasty, diabetes, basal creatinine and the number of treated vessels were associated to higher values. CONCLUSIONS: Main determinants of patient radiation dose are: BSA, female sex, height and number of treated vessels. In an era of increasing PCI complexity and obesity prevalence, these results can help clinicians tailoring X-ray administration to patient's size.

Percutaneous pericardiocentesis for pericardial effusion: predictors of mortality and outcomes.

Pericardial effusion can dangerously precipitate patient's hemodynamic stability and requires prompt intervention in case of tamponade. We investigated potential predictors of in-hospital mortality, a composite outcome of in-hospital mortality, pericardiocentesis-related complications, and the need for emergency cardiac surgery and all-cause mortality in patients undergoing percutaneous pericardiocentesis. This is an observational, retrospective, single-center study on patients undergoing percutaneous pericardiocentesis (2010-2019). We enrolled 81 consecutive patients. Median age was 71.4 years (interquartile range [IQR] 58.1-78.1 years) and 51 (63%) were male. Most of the pericardiocentesis were performed in an urgency setting (76.5%) for cardiac tamponade (77.8%). The most common etiology was idiopathic (33.3%) followed by neoplastic (22.2%). In-hospital mortality was 14.8% while mortality during follow-up (mean 17.1 months) was 44.4%. Only hemodynamic instability (i.e., cardiogenic shock, hypotension refractory to fluid challenge therapy and inotropes) was associated with in-hospital mortality at the univariate analysis (odds ratio [OR] 7.2; 95% confidence interval [CI] 1.76-29.4). Non-neoplastic/non-idiopathic etiology and hemodynamic instability were associated with the composite outcome of in-hospital mortality, need for emergency cardiac surgery, or pericardiocentesis-related complications (OR 5.75, 95% CI 1.65-20.01, and OR 5.81, 95% CI 2.11-15.97, respectively). Multivariate Cox regression analysis adjusted for possible confounding variables (age, coronary artery disease, and hemodynamic instability) showed that neoplastic etiology was independently associated with medium-term mortality (hazard ratio [HR] 4.05, 95% CI 1.45-11.36). In a real-world population treated with pericardiocentesis for pericardial effusion, in-hospital adverse outcomes and medium-term mortality are consistent, in particular for patients presenting with hemodynamic instability or neoplastic pericardial effusion.

Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. However, the impact on outcome of AKI in TAVI-patients is not well established. METHODS: Inoperable patients with severe aortic stenosis (AS) undergoing TAVI in 2010-2018 were enrolled in this study. AKI and chronic kidney disease (CKD) were defined according to KDIGO guidelines. Patients were divided in two groups according to post-procedural AKI development. The primary endpoint was 30-day all-cause mortality across the two groups. RESULTS: A total of 373 patients (mean age 82.3 ± 6) were analyzed. Compared to non-AKI patients, those who developed AKI, were treated more frequently with trans-apical TAVI (66% vs 35%, p<0.01), with greater amount of contrast medium (200.6 vs 170.4 ml, p=0.02) and in presence of clinically significant peripheral artery disease (PAD, 33% vs 21%, p=0.04). Trans-apical access (OR 3.24, 95% CI 1.76-5.60, p<0.01) was associated with a 3-fold risk of AKI. After adjustment for age, Society of Thoracic Surgery risk score (STS), PAD, access type, EF and contrast medium amount, patients with AKI presented an increased risk of 30-day all-cause mortality (HR=1.25, 95%CI 1.09-1.69, p=0.008). Patients with CKD IV and V, who developed AKI, presented a 9-fold 30-day mortality risk (HR=9.71, 95% CI 2.40-39.2, p=0.001). CONCLUSION: In our analysis, AKI was a strong predictor of 30-day all-cause mortality. Particularly, patients with severe CKD with AKI showed the highest 30-day mortality risk. Thus, this group of patients might benefit from closer monitoring and specific kidney protection therapies.

Acute hemodynamic effects of intravenous adenosine in patients with associated pulmonary arterial hypertension: Comparison with intravenous epoprostenol.

Exogenous intravenous (IV) adenosine and epoprostenol are effective vasodilator agents, causing a substantial reduction in pulmonary vascular resistance in patients affected by idiopathic pulmonary arteriolar hypertension (PAH). Their action, in patients with PAH associated with other pathological conditions, is not well defined. In the present paper the authors retrospectively analyzed the acute hemodynamic effects of intravenous adenosine and epoprostenol in 30 consecutive patients (mean age: 58 ± 15 years; 21 females, and 9 males) affected by PAH associated with other pathological conditions, as determined by changes from baseline in systemic and pulmonary hemodynamic parameters. Acute IV administration of adenosine decreased pulmonary vascular resistance index (PVRI) by 3 Wood U/m2 (- 20%) compared to baseline (p = 0.02). We noted a slight, not significant, decrease in mean pulmonary artery pressure (mPAP) of 4 mmHg. Cardiac index (CI) increased by 0.5 L/min/m2 (15% increase respect to baseline; p = 0.03). The heart rate and mean systemic blood pressure (BP) did not change significantly. Acute IV administration of epoprostenol decreased PVRI by 6 mmHg (- 40%) respect to baseline (p < 0.0001). CI increased by 1.4 L/min/m2 (p < 0.0001); while mPAP decreased by 5 mmHg (nearly 10%) (p = 0.04). This decrease of mPAP was accompanied by a mean BP decrease of 11 mmHg compared to baseline (p = 0.003). Our results indicates that, in patients with PAH associated with other pathological conditions, adenosine is predominantly a positive inotropic agent; and epoprostenol a potent vasodilator of both pulmonary and systemic vessels, and a strong positive inotropic agent.

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield.

BACKGROUND: Occupational radiation exposure is a growing problem due to the increasing number and complexity of interventional procedures performed. Radial artery access has reduced the number of complications at the price of longer procedure duration. Radpad® scatter protection is a sterile, disposable bismuth-barium radiation shield drape that should be able to decrease the dose of operator radiation during diagnostic and interventional procedures. Such radiation shield has never been tested in a randomized study in humans. METHODS: Sixty consecutive patients undergoing coronary angiography by radial approach were randomized 1:1 to Radpad use versus no radiation shield protection. The sterile shield was placed around the area of right radial artery sheath insertion and extended medially to the patient trunk. All diagnostic procedures were performed by the same operator to reduce variability in radiation absorption. Radiation exposure was measured blindly using thermoluminescence dosimeters positioned at the operator's chest, left eye, left wrist, and thyroid. RESULTS: Despite similar fluoroscopy time (3.52 ± 2.71 min vs. 3.46 ± 2.77 min, P = 0.898) and total examination dose (50.5 ± 30.7 vs. 45.8 ± 18.0 Gycm(2), P = 0.231), the mean total radiation exposure to the operator was significantly lower when Radpad was utilized (282.8 ± 32.55 µSv vs. 367.8 ± 105.4 µSv, P < 0.0001) corresponding to a 23% total reduction. Moreover, mean radiation exposure was lower with Radpad utilization at all body locations ranging from 13 to 34% reduction. CONCLUSIONS: This first-in-men randomized trial demonstrates that Radpad significantly reduces occupational radiation exposure during coronary angiography performed through right radial artery access.

Mehran contrast-induced nephropathy risk score predicts short- and long-term clinical outcomes in patients with ST-elevation-myocardial infarction.

BACKGROUND: The Mehran Risk Score (MRS) has been demonstrated to be clinically useful for prediction of contrast-induced nephropathy (CIN) after nonurgent percutaneous coronary intervention. We aim to validate the MRS in the setting of Primary percutaneous coronary intervention for prediction of both CIN and short- and long-term clinical outcomes. METHODS AND RESULTS: We assigned 891 consecutive patients with ST-elevation-myocardial infarction undergoing primary percutaneous coronary intervention to 4 groups of risk of CIN (RC) according to MRS (low, medium, high, and very high risk). We evaluated CIN, death, and major cardiovascular and cerebrovascular events after 25 months' mean follow-up. At multivariable analysis, mortality in very high-risk group was more than 10-fold higher (hazard ratio [HR], 10.11; 95% confidence interval [CI], 4.83 to 21.1; P<0.001) when compared with the low-risk group and was also increased in the high-risk group (HR, 6.31; 95% CI, 3.28 to 12.14; P<0.001) and medium-risk group (HR, 3.18; 95% CI, 1.83 to 5.51; P<0.001). Similarly, an increasing effect was seen across MRS strata for major cardiovascular and cerebrovascular events both in the very high-risk group (HR, 3.79; 95% CI, 2.27 to 6.6.32; P<0.001), high-risk group (HR, 1.90; 95% CI, 1.31 to 2.75; P=0.001), and medium-risk group (HR, 1.42; 95% CI, 1.10 to 1.85; P=0.007). In addition, the HR for rehospitalization increased with the increasing RC groups (HR, 3.32; 95%CI, 1.96 to 5.63; P<0.001; HR, 3.11; 95% CI, 1.35 to 7.20; P=0.008; HR, 7.73; 95% CI, 2.97 to 20.10; P<0.001, respectively). The odds ratio for CIN was 2.84 (95% CI, 1.16 to 6.92; P=0.021) in the very high RC group, 1.33 (95% CI, 0.68 to 2.61; P=0.398) in the high RC group, and 1.10 (95% CI, 0.67 to 1.79; P=0.699) in the medium RC group, as compared with the lower one. CONCLUSIONS: The MRS may be applied in the primary angioplasty setting population and is able to predict CIN and to stratify patients for poor clinical outcomes both in the short- and long-term follow-up.

Rationale and study design of the OISTER trial: optical coherence tomography evaluation of stent struts re-endothelialization in patients with non-ST-elevation acute coronary syndromes--a comparison of the intrEpide tRapidil eluting stent vs. taxus drug-eluting stent implantation.

BACKGROUND: Drug-eluting stents (DES) have been designed to prevent restenosis, but long-term clinical outcome may be offset by an increased risk of stent thrombosis, which is associated with suboptimal stent implantation or delayed re-endothelialization. DES implantation has also been associated with local persistent endothelial dysfunction. Conversely, Trapidil is a potent anti-inflammatory, vasodilatator and antiproliferative drug and several studies have shown anti-restenotic effects, suggesting substantial clinical benefits through the use of Trapidil-eluting DES. STUDY DESIGN: This is a longitudinal, single-blind, double-arm, randomized multicenter study. Forty patients with non-ST-elevation acute coronary syndromes who present at the index procedure with multivessel coronary disease in the major epicardial coronary arteries will be enrolled. Patients should present a culprit lesion with stenosis 70% or more associated with another stenosis 70% or more in another coronary artery. Patients will be randomized in a 1: 1 fashion to receive either an Intrepide trapidil-eluting stent or a Taxus paclitaxel-eluting stent on the culprit lesion. After 90 days, the nonculprit lesion will be treated with the stent of the opposite randomization arm and optical coherence tomography (OCT) analysis of the index stented segment will be performed. Follow-up angiography, combined with vasomotor analysis of endothelial function by rapid atrial pacing, will be done at 12 months after the index procedure on both stents. To further characterize the status of the endothelium, serum measurement of vascular endothelial growth factor gradient between the aorta and 15 mm distal to the implanted stent will be performed at 12 months. The primary endpoint of the study is to compare stent struts re-endothelialization at 90 days by OCT. The secondary endpoint is to compare angiographic outcome and coronary endothelial function 12 months after the index procedure and to compare clinical outcome at 1 and 2 years between trapidil-eluting DES versus paclitaxel-eluting DES. CONCLUSION: We hypothesize that the utilization of trapidil-eluting DES in the setting of acute coronary syndromes will be characterized by a greater early re-endothelialization associated with an antiproliferative effect offering a similar efficacy with a better safety profile compared with first-generation DES.