Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk.

BACKGROUND: The aim of this meta-analysis was to compare the impact of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis (AS) at low surgical risk. METHODS: All randomized controlled trials (RCTs) and observational studies (Obs) published from January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the site https://www. CLINICALTRIALS: com. The relative risk (RR) with the 95% confidence interval (CI) was used to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3, major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation. RESULTS: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI 0.45-0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87; 95% CI 2.01-3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83-13.81, p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence of major bleeding (RR = 0.38; 95% CI 0.27-0.54, p < 0.00001, I2 = 0%) and of acute kidney injury was observed (RR = 0.33; 95% CI 0.19-0.56, p < 0.0001, I2 = 0%) in TAVI. CONCLUSIONS: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable. In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as routine therapeutic procedure in the treatment of patients with low surgical risk AS.

Glutathione Infusion Before and 3 Days After Primary Angioplasty Blunts Ongoing NOX2-Mediated Inflammatory Response.

Background Glutathione is a water-soluble tripeptide with a potent oxidant scavenging activity. We hypothesized that glutathione administration immediately before and after primary angioplasty (primary percutaneous coronary intervention) could be effective in modulating immune cell activation, thereby preventing infarct expansion. Methods and Results One hundred consecutive patients with ST-segment-elevation myocardial infarction, scheduled to undergo primary percutaneous coronary intervention were randomly assigned before the intervention to receive an infusion of glutathione (2500 mg/25 mL over 10 minutes), followed by drug administration at the same doses at 24, 48, and 72 hours elapsing time or placebo. Total leukocytes, NOX2 (nicotinamide adenine dinucleotide phosphate oxidase 2) activation, NO bioavailability, cTpT (serum cardiac troponin T), hsCRP (high-sensitivity C-reactive protein), and TNF-α (tumor necrosis factor α) levels were measured. Left ventricular size and function were assessed within 120 minutes, 5 days, and 6 months from percutaneous coronary intervention. Following reperfusion, a significant reduction of neutrophil to lymphocyte ratio (P<0.0001), hsCRP generation (P<0.0001), NOX2 activation (P<0.0001), TNF-α levels (P<0.001), and cTpT release (P<0.0001) were found in the glutathione group compared with placebo. In treated patients, blunted inflammatory response was linked to better left ventricular size and function at follow-up (r=0.78, P<0.005). Conclusions Early and prolonged glutathione infusion seems able to protect vital myocardial components and endothelial cell function against harmful pro-oxidant and inflammatory environments, thus preventing maladaptive cardiac repair and left ventricular adverse remodeling. Registration URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2014-004486-25.

Hypothermia during Surgical Treatment of Type A Aortic Dissection: A 16 Years' Experience.

Acute aortic dissection (AAD) is among the most challenging cases for surgical treatment and requires procedural expertise for its safe conduct. Aortic surgery has undergone several changes over the last years, especially concerning cerebral protection. The brilliant results obtained with the aid of selective anterograde cerebral perfusion led to a progressive increase of circulatory arrest temperature, with the rise of safe time along with a reduction of the extracorporeal circulation time and hypothermia-related side effects. However, there is still no definitive consensus concerning the optimal range of temperature to be used during circulatory arrest. Objectives. This is a retrospective observational study, and we examined 16-year trends in the presentation, diagnosis, hospital outcome and treatment of A AAD type. In our Cardiac Surgery Unit in Policlinico Umberto I of Rome, our analysis focused on patients, who received ACP during aortic surgery and we analyzed the differences between two distinct groups based on the lowest temperature reached during CPB conduction: Lower Temperature Group (LT) (T < 24°C) versus Higher Temperature Group (HT) (T ≥ 24°C) arrest circulation temperature. Methods. Data from 241 patients enrolled between August 2002 and March 2018 were analyzed. Patients were divided according to the lowest temperature reached into 2 groups: Lower Temperature group (LT) (94 patients) and Higher Temperature Group (HT) (147 patients). Results. Our results showed a significant reduction of in-hospital mortality and in-hospital results in patients with higher CPB temperature. The global incidence of complications was statistically reduced in HT group: we found a statistical significant reduction of intestinal ischemia, and a similar trend also for other complications analyzed, such as infections. Since the two groups were similar for type of surgical procedures, we considered these differences depending on the lower temperature value reached, according to the current literature. Conclusions. We found a significantly higher mortality in patients with lower temperature during CPB and a global reduction of complications and in particular a significant reduction of intestinal ischemia in patients with higher temperature during CPB. We found a similar trend in other fields of investigations, so we can conclude that circulatory arrest performed at temperature ≥24°C nasopharyngeal temperature associated with ACP is a safe strategy for aortic surgery for AAD.

Clopidogrel plus indobufen in acute coronary syndrome patients with hypersensitivity to aspirin undergoing percutaneous coronary intervention.

The prescription of aspirin (acetylsalicylic acid (ASA)) to patients with a history of hypersensitivity to this drug could prove harmful. The aim of the study was to assess the antiplatelet activity and safety of a combined antiplatelet treatment with indobufen and clopidogrel in acute coronary syndrome (ACS) patients with hypersensitivity to aspirin, undergoing coronary stenting. Forty-two consecutive ACS patients treated with stent implantation were randomly assigned to receive clopidogrel 75 mg daily (loading dose 300 mg) plus indobufen 100 mg twice a day (group A), or clopidogrel 75 mg daily, after 300 mg of loading dose (group B). Platelet activity and safety were monitored in both groups at 1, 3, 6, 12, and 18 months with laboratory and clinical evaluation. A lower value of max % platelet aggregation to arachidonic acid and collagen was found in group A compared to group B (31.79 ± 27.33 vs. 73.67 ± 19.92; p < 0.0001 and 28.53 ± 21.32 vs. 73.58 ± 17.71; p < 0.0001, respectively). There was no difference in max % of platelet inhibition to adenosine diphosphate between the two groups (14.23 ± 18.92 vs. 10.30 ± 18.97; p = 0.23). In the population that was under indobufen treatment, the serum thromboxane B2 (TXB2) production at 1 week and 1 month was very low (2.6 ± 1.6 ng/ml and 3.0 ± 2.7 ng/ml, respectively; p = 0.82). The combined treatment was well tolerated in group A patients. This study suggests that the combined antiplatelet treatment with clopidogrel and indobufen could be a good option in ACS patients with hypersensitivity to aspirin undergoing coronary stenting.

Ambulatory blood pressure monitoring in prehypertensive subjects.

BACKGROUND: Although treatment of prehypertensives is feasible and effective, it is unclear how to define those who may benefit. We hypothesized that ambulatory blood pressure monitoring (ABPM) might be a tool for selecting prehypertensive subjects, classified according to the JNC 7, who later develop drug-treated hypertension. METHODS: Prehypertensives (n=107; 62 M, 45 F; age 50 ± 14 years) with or without cardiovascular risk factors were assessed for drug-treated hypertension development. They underwent ABPM at entry examination and were clinically followed-up for an average of 99 ± 42 months. Thereafter, subjects were divided into 2 groups according to the development of drug-treated hypertension. Stepwise logistic regression (LR) analysis was performed to assess the role of factors contributing independent prediction of outcome (i.e. drug-treated hypertension onset). RESULTS: In LR analysis body mass index [odds ratio (OR)=1.29, confidence intervals (CI)95% 1.03-1.62], female gender (OR=11.10, CI95% 2.66-46.30), total cholesterol (OR=1.03, CI95% 1.01-1.05), smoking (OR=3.90, CI95% 0.94-16.20), daytime SBP (OR=1.10, CI95% 1.01-1.19) and 24h DBP (OR=1.23, CI95% 1.08-1.41) predicted the development of hypertension. The criteria combining BP and clinical variables were superior to BP or clinical criteria alone in the correct classification of true positives and true negatives. Altogether there was an improvement of 14.02% (p < 0.01) in comparison to only clinical criteria. CONCLUSIONS: In the setting of global cardiovascular risk assessment, ABPM, in the early diagnosis of hypertension in prehypertensive individuals, appears as a useful tool, both diagnostically and prognostically, to index subjects who are suspected to be masked hypertensives.

Comparative application of multivariate models developed in Italy and Europe to predict early (28 days) and late (1 year) postoperative death after on- or off-pump coronary artery bypass grafting.

OBJECTIVES: The aim of this study was to compare the risk of death predictive performances of the OP-RISK, EuroSCORE, and Italian coronary artery bypass grafting (CABG) Outcome studies' functions when applied to a southern Italian cardiac surgery center (Sant'Anna hospital in Catanzaro [SAHCZ]), which contributed data to the Italian CABG Outcome study, and to see if this predictive index may be applied to on- and off-pump interventions. METHODS: The OP-RISK study data set was used to derive Weibull and logistic functions to predict early (28 days) and late (1 year) death rates following CABG based on ejection fraction, heart rate, age, and aortic cross-clamping time. Then the data of 385 CABG patients who underwent operations in 2003 in SAHCZ were collected with 1-year follow-up data, which also included data used to obtain EuroSCORE and Italian CABG Outcome study risk indices. RESULTS: Short- and long-term observed mortality rates after CABG were 2.59% and 5.88% in the SAHCZ series, largely dependent on whether CABG was alone (1.26% and 3.55%) or associated with ventriculoplasty (4.87% and 10.81%) or valve surgery (15.38% and 28.57%). There was a significant increasing trend (P = .002) of observed death rates in equinumeric tertiles of either OP-RISK (both Weibull and logistic) or EuroSCORE in the short term, whereas the trend was not significant for the Italian CABG Outcome study index. OP-RISK functions were significantly predictive for the long term (P < .005), as well as when only ejection fraction, heart rate, and age were considered (P < .011). CONCLUSIONS: It is essential to use clinical data following CABG when outcome prediction is concerned. OP-RISK and EuroSCORE indices are equally predictive in our experience, and a statistically significant (P = 0.02) difference was observed with the Italian CABG Outcome study index, whose trend in tertiles of calculated risk was not apparent, which is unexpected and unexplained. OP-RISK functions were adequate for long-term prediction. Since aortic cross-clamping time may be absent from tested predictive functions (for both short and long term), off-pump CABG mortality may also be predicted as similar to on-pump intervention mortality.

Myocarditis in hypertrophic cardiomyopathy patients presenting acute clinical deterioration.

AIM: We sought to determine whether myocarditis can be a major cause of acute electrical instability or clinical deterioration in HCM patients. METHODS AND RESULTS: A total of 119 HCM patients (69 M/50F, mean age 41 +/- 8), 42 with acute clinical deterioration and 77 clinically stable, underwent cardiac catheterization with left ventricular endomyocardial biopsy and gene analysis of major sarcomeric proteins. Endomyocardial tissue was processed for histology, immunohistochemistry, and polymerase chain reaction for the most common cardiotropic viruses. Controls were surgical samples from 50 patients with mitral stenosis. All 119 patients showed histological findings suggestive of HCM. In addition, CD45RO+ lymphocytes (> or =14/mm(2)) with focal necrosis of the adjacent severely hypertrophied and often disorganized myocytes, consistent with an overlapping active myocarditis, were observed in 28 of 42 unstable and none of 77 stable HCM patients. A viral genome was detected in 14 of 28 patients with myocarditis and in none of HCM patients without and in none of controls. No correlation between sarcomeric protein gene mutations and HCM clinical profile was observed. CONCLUSION: Myocarditis, often viral, represents a common cause of acute clinical deterioration in HCM. Its recognition can potentially affect disease prognosis and treatment.

Age-related variations of varicose veins anatomy.

BACKGROUND: Primary varicose veins are commonly considered a progressive disease starting from the saphenous junctions and extending to tributaries in a retrograde fashion along the saphenous trunks. This theory has been criticized by studies indicating different patterns of development and progression of varicose veins. To contribute to the understanding of the pathogenesis of the disease, the anatomy of the venous bed was comparatively evaluated by duplex sonography in patients with varicose veins with a marked difference in age. METHODS: The study included 100 varicose limbs in 82 patients aged < 30 years and 238 limbs in 183 patients aged > 60 years. Veins were designated as saphenous veins (SVs), tributaries of the SVs (STVs), and veins not connected with the SVs (NSVs). Four main anatomic patterns were comparatively evaluated: (1) varicose changes only along SVs, (2) varicose changes along SVs and STVs, (3) varicose changes only in STVs, and (4) varicose changes only in NSVs. RESULTS: SVs were normal in 44% of varicose limbs. In most limbs from young subjects, varicose changes afflicted only SVTs (25%) and NSVs (36%). Varicose SVs were more frequent in the older group (62%) than in younger one (39%) owing to a higher prevalence of limbs with combined SV and STV varicosities (respectively, 59% and 37%). In the older group, varicosities in the STVs were more frequently observed in association with incompetence of the SV trunks. CONCLUSION: The frequent occurrence of normal SVs in varicose limbs of all patients does not support the crucial role commonly credited to SVs in the pathogenesis of primary varicosities. Moreover, the SV trunks were normal in most varicose limbs from young patients. These findings suggest that varicose disease may progressively extend in an antegrade fashion, spreading from the STVs to the SVs. This hypothesis suggests that the saphenous trunks could be spared in the treatment of a relevant number of varicose legs. Prospective longitudinal studies with serial duplex evaluations of large series of extremities are necessary to confirm this hypothesis.