Atrial fibrillation before and after transcatheter aortic valve implantation: short- and long-term clinical implications.

BACKGROUND: Patients with atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI) have been associated with worse short-term outcomes compared with patients in sinus rhythm but data on long-term outcomes are limited. The aim of our study was to evaluate the association between AF and short- and long-term outcomes in patients undergoing TAVI. METHODS: We retrospectively evaluated patients undergoing TAVI between 2012 and 2022 in four tertiary centres. Two different analyses were conducted: (i) in-hospital and (ii) postdischarge analysis. First, we evaluated the association between preexisting AF and short-term outcomes according to VARC-3 criteria. Second, we analyzed the association between AF at discharge (defined as both preexisting and new-onset AF occurring after TAVI) and long-term outcomes at median follow-up of 3.2 years (i.e. all-cause death, hospitalization and major adverse cardiovascular events). RESULTS: A total of 759 patients were initially categorized according to the presence of preexisting AF (241 vs. 518 patients). The preexisting AF group had a higher occurrence of acute kidney injury [odds ratio (OR) 1.65; 95%confidence interval ( CI) 1.15-2.38] and major bleeding (OR 1.86, 95% CI 1.06-3.27). Subsequently, the population was categorized according to the presence of AF at discharge. At the adjusted Cox regression analysis, AF was independently associated with an increased risk of all-cause death and cardiovascular hospitalization [adjusted hazard ratio (aHR) 1.42, 95% CI 1.09-1.86], all-cause death and all-cause hospitalization (aHR 1.38, 95% CI 1.06-1.78) and all-cause hospitalization (aHR 1.59, 95% CI 1.14.2.22). CONCLUSIONS: In a real-world cohort of patients undergoing TAVI, the presence of AF (preexisting and new-onset) was independently associated with both short- and long-term adverse outcomes.

Long-Term Results After Aortic Valve Replacement with Last-Generation Stentless Prostheses.

INTRODUCTION: The purpose of this study was to evaluate the long-term clinical and hemodynamic results in patients affected by severe aortic valve disease after aortic valve replacement with third-generation stentless aortic prostheses (3F® stentless equine pericardial [Medtronic plc, Minneapolis Minnesota] and Pericarbon Freedom™ stentless bovine pericardial [LivaNova plc, London, United Kingdom]) and to analyze the benefits and the drawbacks associated to their use. MATERIALS AND METHODS: Between June, 2003 and Sept, 2015 a cohort of 548 consecutive patients affected by aortic valve disease received an aortic valve replacement using a last-generation stentless pericardial aortic prosthesis at our unit. Respectively, 322 patients received a Pericarbon Freedom™ and 226 received a 3F® aortic valve. Size ranged between 19 and 29, with prevalence of 23 and 25 devices. Mean age at operation was 71± 11 years, 57% of patients were males, the mean logistic EuroScore was 8.9 ± 7.2 and 44.2% received concomitant procedures. The mean extracorporeal circulation (ECC) time was 119.2 ± 40.6. The mean cross clamp time was 90.5' ± 21.4'. In 30 patients, the aortic prosthesis was included in a Dacron tube straight graft for a Bentall operation. RESULTS: Early/in-hospital mortality was 2.55% (14 cases) for the entire cohort. In patients receiving isolated aortic valve replacement (AVR), it was 0.91% (5 cases). Follow up ranged between six months and 12 years (median follow-up time: 6.77 years). During follow up, 137 patients died of all causes (25%), of whom 32 patients died of cardiac causes (5.8%). Cardiac survival probability was 91% at 12 years. All surviving patients were in NYHA class I at last follow up. Actuarial freedom from structural valve deterioration was 86% at 12 years. Freedom from endocarditis was 95% at 12 years. Freedom from a valve-related reoperation at 12 years follow up was 95%. Mean residual transprosthetic gradient at 12 years was 10.3 ± 4.8MmHg. CONCLUSIONS: Last-generation stentless pericardial valves offer excellent hemodynamics and adequate durability and freedom from structural deterioration at 12 years follow up. The implantation technique of a stentless valve is a little more demanding when compared to a stented valve, but it can be easily reproduced after minimal training. Incidence of endocarditis and thromboembolic events is low and comparable to stented pericardial valves. Young and active patients, and patients with large BSA where a patient-prosthesis mismatch may be anticipated are, in our opinion, ideal candidates to receive these kinds of valves.

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.

Quantitative flow ratio-based outcomes in patients undergoing transcatheter aortic valve implantation quaestio study.

Background: Coronary artery disease (CAD) is common in patients with aortic valve stenosis (AS) ranging from 60% to 80%. The clinical and prognostic role of coronary artery lesions in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) remains unclear. The aim of the present observational study was to estimate long-term clinical outcomes by Quantitative Flow Ratio (QFR) characterization of CAD in a well-represented cohort of patients affected by severe AS treated by TAVI. Methods: A total of 439 invasive coronary angiographies of patients deemed eligible for TAVI by local Heart Teams with symptomatic severe AS were retrospectively screened for QFR analysis. The primary endpoint of the study was all-cause mortality. The secondary endpoint was a composite of cardiovascular mortality, stroke/transient ischemic attack (TIA), acute myocardial infarction (AMI), and any hospitalization after TAVI. Results: After exclusion of patients with no follow-up data, coronary angiography not feasible for QFR analysis and previous surgical myocardial revascularization (CABG) 48/239 (20.1%) patients had a QFR value lower or equal to 0.80 (QFR + value), while the remaining 191/239 (79.9%) did not present any vessel with a QFR positive value. In the adjusted Cox regression analysis, patients with positive QFR were independently associated with an increased risk of all-casual mortality (Model 1, HR 3.47, 95% CI, 2.35-5.12; Model 2, HR 5.01, 95% CI, 3.17-7.90). In the adjusted covariate analysis, QFR+ involving LAD (37/48, 77,1%) was associated with the higher risk of the composite outcome compared to patients without any positive value of QFR or non-LAD QFR positive value (11/48, 22.9%). Conclusions: Pre-TAVI QFR analysis can be used for a safe, simple, wireless functional assessment of CAD. QFR permits to identify patients at high risk of cardiovascular mortality or MACE, and it could be considered by local Heart Teams.

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.

Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study.

BACKGROUND: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. METHODS: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. RESULTS: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%-7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. CONCLUSIONS: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice.

Ventricular and Atrial Remodeling after Transcatheter Edge-to-Edge Repair: A Pilot Study.

BACKGROUND: The aim of this study was to determine the impact of transcatheter edge-to-edge repair (TEER) on left and right ventricular (LV, RV) and left and right atrial (LA, RA) remodeling according to the mechanism of mitral regurgitation (MR) and history of atrial fibrillation (AF). METHODS: Twenty-four patients (mean age 78.54 years ± 7.64 SD; 62.5% males) underwent TEER at our center. All the patients underwent echocardiography 1.6 ± 0.9 months before the procedure and after 5.7 ± 3.5 months; functional MR accounted for 54% of cases. RESULTS: Compared to baseline, a statistically significant improvement in LV end-diastolic diameter (LVEDD), LV indexed mass (ILVM), LV end-diastolic and end-systolic volumes (LVEDV, LVESV), indexed LA volume (iLAV), and morpho-functional RV parameters was recorded. LVEDD and LVEDV improved in primary MR cohort, whereas in secondary MR, a significant reduction in LVEDV and LVESV was found without a significant functional improvement. LA reverse remodeling was found in organic MR with a trend toward ameliorated function. Furthermore, a significant reduction of LA volumetry was detected only in patients without history of AF (AF baseline 51.4 mL/m2 IQR 45.6-62.5 mL/m2 f-u 48.9 mL/m2 IQR 42.9-59.2 mL/m2; p = 0.101; no AF baseline 43.5 mL/m2 IQR 34.2-60.5 mL/m2 f-u 42.0 mL/m2 IQR 32.0-46.2 mL/m2; p = 0.012). As regards right sections, the most relevant reverse remodeling was obtained in patients with functional MR with a baseline poorer RV function and more severe RA and RV dilation. CONCLUSION: TEER induces reverse remodeling involving both left and right chambers at mid-term follow-up. To deliver a tailored intervention, MR mechanism and history of AF should be considered in view of the impact on remodeling process.

Surgical Options for Physiological Treatment of Aortic Root Dilatation Either Isolated or Associated with Aortic Valve Disease.

Patients affected by severe aortic root pathology require an operation to replace the dilated aortic root and repair or replace the aortic valve, which is very frequently involved in the disease. Among the surgical options available for aortic root replacement, the Bentall operation and the David aortic valve reimplantation procedure are the most commonly used by surgeons. This article provides an overview of the Bio-Bentall and David operations. It illustrates their surgical details and discusses the correct indications for both procedures to achieve excellent long-term outcomes. Finally, the authors present their experience with the physiologic treatment of aortic root pathology by using stentless Bio-conduits and David reimplantation in a cohort of patients with long-term follow-up. A comparative analysis of early and late results along with an evaluation of possible benefits and drawbacks related to each technique concluded that both procedures were effective in correcting the aortic root pathology, and the results were adequate and stable over time. Since hemodynamic performance was more improved after the David operation, it should be preferred, whenever feasible, in younger and active patients.

Coronary Computed Tomography Angiography for the Assessment of Sirolimus-Eluting Resorbable Magnesium Scaffold.

BACKGROUND: Little evidence to date has described the feasibility and diagnostic accuracy of coronary computed tomography angiography (CCTA) with noninvasive fractional flow reserve (CT-FFR) in coronary vessels with resorbable magnesium scaffold (RMS). METHODS: The SHERPA-MAGIC is a prospective study enrolling patients receiving RMS. The present analysis considered patients undergoing CCTA 18 months after the index procedure. CCTA images were employed to investigate reabsorption status, luminal measurements, and noninvasive FFR. Three-year follow-up was available for all patients. RESULTS: Overall, 26 patients with a total of 29 coronary arteries treated with 35 RMS were considered. The most frequently involved vessel was left anterior descendent (LAD). Median stent length was 25 (20-25) mm, with a median diameter of 3 (3-3.5) mm. At 18-month CCTA, all scaffolded segments were patent. Complete RMS reabsorption was observed in 27 (93%, 95% CI 77-99%) cases. Median minimal lumen diameter (MLD) and area (MLA) of the scaffolded segments were 2.5 [2.1-2.8] mm and 6.4 [4.4-8.4] mm2, respectively. Median CT-FFR was 0.88 [0.81-0.91]. Only one (3.5%) vessel showed a flow-limiting CT-FFR value ≤0.80. During the 3-year follow-up, only one (4%) adverse event was observed. Conclusions: In patients undergoing RMS implantation, CCTA including noninvasive CT-FFR evaluation is feasible and allows investigation of long-term RMS performance.

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.

Impact of body mass index on the outcome of elderly patients treated with transcatheter aortic valve implantation.

Underweight or overweight patients with cardiovascular diseases are associated with different outcomes. However, the data on the relation between body mass index (BMI) and outcomes after transcatheter aortic valve implantation (TAVI) are not homogeneous. The aim of this study was to assess the role of low BMI on short and long-term mortality in real-world patients undergoing TAVI. We retrospectively included patients undergoing TAVI for severe aortic valve stenosis. Patients were classified into three BMI categories: underweight (< 20 kg/m2), normal weight (20-24.9 kg/m2) and overweight/obese (≥ 25 kg/m2). Our primary endpoint was long-term all-cause mortality. The secondary endpoint was 30-day all-cause mortality. A total of 794 patients were included [mean age 82.3 ± 5.3, 53% females]. After a median follow-up of 2.2 years, all-cause mortality was 18.1%. Patients in the lowest BMI group showed a higher mortality rate as compared to those with higher BMI values. At the multivariate Cox regression analysis, as compared to the normal BMI group, BMI < 20 kg/m2 was associated with long-term mortality independently of baseline risk factors and postprocedural adverse events (hazard ratio [HR] 2.29, 95% confidence interval [CI] 1.30-4.03] and HR 2.61, 95% CI 1.48-4.60, respectively). The highest BMI values were found to be protective for both short- and long-term mortality as compared to lower BMI values even after applying the same adjustments. In our cohort, BMI values under 20 kg/m2 were independent predictors of increased long-term mortality. Conversely, the highest BMI values were associated with lower mortality rates both at short- and long-term follow-up.

Effects of sildenafil on right ventricle remodelling in Portopulmonary hypertension.

Portopulmonary hypertension (PoPH) is a clinical condition associated with end-stage liver disease, described by the coexistence of pulmonary arterial hypertension (PAH) and portal hypertension. In PoPH patients, there is a right ventricle (RV) remodeling to compensate for the increased resistance in the lung circulation. There are no studies on the effects of the PAH-targeted pharmacological treatment on the RV dimension and function. The present study summarizes our experience in patients with PoPH treated with sildenafil in a period of 6 years (from 2013 to 2019). We enrolled 64 consecutive patients identified as PoPH, all treated with sildenafil (57.6% in monotherapy; in the other cases in association with macitentan; in 19.0% with initial combination therapy). A hemodynamic invasive cardiopulmonary study was performed at baseline and after 6 months of sildenafil treatment. In our population we showed a significative improvement in RV performance, with a significant increase in RV stroke volume (+33%), RV ejection fraction (+31%) and RV stroke work index (+17.5%). We registered the reduction of the RV cavity dimension over time in all patients treated with sildenafil (RV end diastolic diameter decreased by 15% after 6 months of follow-up). Regarding diastolic function, we highlighted a very significant reduction in RV end-diastolic pressure (-50% concerning baseline). Sildenafil was effective both when used as monotherapy and in combination with macitentan. In conclusion, Sildenafil had a positive impact on RV systolic and diastolic function in patients with PoPH and was able to conditionate the reverse remodeling of the RV.

Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study.

INTRODUCTION: Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy. METHODS: The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke. RESULTS: At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively. CONCLUSIONS: CSR implantation is safe and reduces angina in patients with refractory angina.

Red blood cell distribution width in patients undergoing transcatheter aortic valve implantation: Implications for outcomes.

BACKGROUND: Red cell distribution width (RDW) is recently emerging as a prognostic indicator in many cardiovascular diseases. However, less is known about its predictive role in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: We retrospectively included very high-risk patients with severe aortic valve stenosis undergoing TAVI between February 2012 and December 2019. Patients were classified according to RDW tertiles. Our primary endpoint was long-term all-cause mortality. The secondary endpoint was a composite of in-hospital major adverse events as defined by the Valve Academic Research Consortium 2 criteria and/or long-term all-cause mortality. RESULTS: A total of 424 patients [median age 83.5 years, 52.6% females] were analysed. After a median follow-up of 1.55 years, all-cause mortality was 25.5%. At the multivariate-adjusted Cox regression analysis, patients in the highest RDW tertile were associated with a higher risk for all-cause mortality [hazard ratio [HR] 1.73, 95%confidence interval [CI] 1.02-2.95] compared with the lowest tertile. When considering RDW as a continuous variable, we found an 11% increased risk in overall mortality [HR 1.11, 95% CI 1.00-1.24] for each increased point in RDW. The highest RDW tertile was also independently associated with the occurrence of the composite endpoint [odds ratio [OR] 2.10, 95% CI 1.17-3.76] compared with lower tertiles. CONCLUSIONS: In our cohort, elevated basal RDW values were independent predictors of increased long-term mortality and higher rate of in-hospital adverse events. The inclusion of a routinely available biomarker as RDW, may help the pre-operative risk assessment in potential TAVI candidates and optimise their management.

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.

Usefulness of Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris.

The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center's protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life.

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.