In 2020, the coronavirus disease 2019 (COVID-19) pandemic has led to a decrease in interventional treatment for structural heart disease worldwide. In this context, the management of patients with symptomatic severe aortic stenosis (AS) or bioprosthetic valve dysfunction (BVD) represents a clinical challenge, as a delay in aortic valve replacement procedures may increase short-term morbidity and mortality. We report four cases of TAVR performed in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. All of them were discharged in good clinical conditions and no adverse events were reported at 30 days follow-up. Our experience suggests that in selected patients with mild SARS-CoV-2 infection and symptomatic native AS or BVD, TAVR has a favorable short-term outcome.

Background:The 2015 European Society of Cardiology guidelines propose algorithms for faster rule-in or rule-out of AMI in patients admitted in the acute care setting, and for the management of NSTEMI.Serial measurements with high sensitivity troponin I assays will more accurately and precisely measure changes in cardiac troponin I (cTnI) concentrations providing useful data to assist with identifying acute versus chronic cTnI elevations, and providing acceptable rule-in and rule-out performance within 1 to 3-hours of presentation.The performance of Siemens high sensitivity troponin I assay1 (TNIH) being developed for use on the ADVIA Centaur family of immunoassay analyzers is presented.The assay is a dual-capture sandwich immunoassay using preformed magnetic latex particles, a proprietary acridinium ester for chemiluminescence detection, and three monoclonal antibodies.Method: The assay limit of blank, LoB, and limit of detection, LoD, were determined using 3 reagent lots on 2 ADVIA Centaur XP and 2 ADVIA Centaur XPT systems, collecting 60 replicate measurements for each of 10 serum and 10 lithium heparin samples per lot and per system.The limit of blank, LoB, was determined non-parametrically by rank order calculating the 95th percentile.99th percentile cutoff values were established non-parametrically using a well characterized population of apparently healthy subjects.Clinical correlation of cTnI levels above the 99% percentile to adjudicated AMI diagnosis was assessed in all-comer emergency department (ED) subjects in both lithium-heparin and serum samples.Results: The LoB results ranged from 0.11 to 0.90 ng/L with a typical value of 0.5 ng/L, and the LoD results ranged from 1.10 ng/L to 2.21 ng/L (95% Confidence Interval 1.05 to 2.54 ng/L).The assay measuring range is from the LoD to 25,000 ng/L.The limit of quantification, LoQ, defined as the cTnI concentration at 20% CV had a pooled value of 2.50 ng/L.The 99th percentile estimated with an apparently healthy population of n=2026 having an equal number of males and females had a gender-combined 99th percentile of 48 ng/L.The 99th percentile for females ranged from 37 to 41ng/L and for males 57 to 64 ng/L.There were no differences between matched Lithium Heparin plasma and Serum samples.The With-In Lab CV at the 99th percentile is less than 3%.Clinical sensitivity and clinical specificity in pooled-genders at 1, 2 and 3-hour post ED presentation ranged from 87.6%-93.2%and 90.0%-91.5% respectively. Conclusion:The ADVIA Centaur TNIH assay in development by Siemens has a 10% Total CV at a cTnI concentration 10-fold lower than the 99th percentile.This new assay allows the establishment of gender specific 99th percentile cutoffs and shows acceptable clinical utility in an all-comer ED population.[1] Under development.Future availability cannot be guaranteed.

The regurgitation of the native aortic valve in patient with previous David operation may represent a clinical challenge because the morbidity and mortality risk of re-operation is not negligible. Here we describe the case of a patient suffering from late severe aortic regurgitation, many years after David operation, efficaciously treated with transfemoral transcatheter aortic valve implantation. To the best of our knowledge, this is the first description of such treatment in a patient with aortic regurgitation and previous David operation.

Bioresorbable vascular scaffold (BVS) implantation appears to be a potentially beneficial therapeutic option in chronic total coronary artery occlusions (CTO). The available data on BVS use in this challenging subset of lesions is limited. RAI registry (Registry Absorb Italian, [ClinicalTrials.gov

BACKGROUND:The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. METHODS/DESIGN:The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. CONCLUSIONS:The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.

Patients with multivessel coronary artery disease and severe left ventricular dysfunction are considered to be at high risk for percutaneous coronary intervention, and often are poor surgical candidates because of severe comorbidity. We report a case of high-risk percutaneous coronary intervention in a 67-year-old man with a severe left ventricular dysfunction and three-vessel coronary artery disease using a novel left ventricular assist device.

Contrast-enhanced transthoracic echocardiography (CE-TTE) during adenosine infusion is a new noninvasive method for determination of coronary flow reserve (CFR) in the left anterior descending coronary artery (LAD). To assess its potential role as a marker of cardiac allograft vasculopathy (CAV) severity/diffusion, we studied 30 heart transplant (HT) patients (pts) with angiographic CAV (28 male, aged 50± 10 years at HT, follow-up 9.6± 4.1 years). CAV was defined as any stenosis ≥10%. The coronary tree was divided into 17 traits; a CAV severity/diffusion index (SI) was calculated for each patient summing up the scores assigned to all stenoses (10%=1; 20%=2, 30%=3; 40%=4; 50%=5; 60%=6; 70%=7; 80%=8; 90%=9; 100%=10). Coronary blood flow velocity in the LAD was detected at rest and during i.v. infusion of adenosine (0.14 mg/kg/min). CFR was obtained as the ratio of hyperaemic diastolic mean velocity (DMV) to resting DMV. CFR was 2.3± 0.7 and inversely related with SI (r=-0.428, p=0.01). CFR was lower in multivessel CAV (1.8± 0.5 in 3−, 2.1± 0.4 in 2-, 2.8± 0.7 in 1-vessel CAV, p=0.003). By ROC analysis for separation of the presence or absence of multivessel (3- or 2- vs 1-vessel) CAV, the area under the curve of 0.828 had a SE of 0.085, 95% CI 0.661–0.994 (p=0.003). A CFR cutpoint of≤ 2.5, identified as optimal by ROC curve, was 73% specific, 84% sensitive and 80% accurate, with positive and negative predictive values of 84% and 73% respectively (p=0.002). Thus, CFR impairment was inversely related to angiographic scores of CAV severity/diffusion. A CFR cutoff> 2.5 provided 80% accuracy to rule out 3-vessel CAV. Noninvasive CFR assessment by CE-TTE may reduce the need for routine coronary angiography in HT.

To assess whether cyclosporine A (CsA) 2-h peak (C2) is superior to trough levels (C0) for Neoral dose monitoring in heart transplantation (HT), we studied 928 C0-C2 paired determinations from 313 stable HT patients (257 male, aged 50 +/- 14 years at HT, follow-up 6.9 +/- 4 years), on a C0-based regimen. Our target C0 levels (ng/ml) were 150-400 (first 3 months), 150-300 (4-12 months), 100-250 (>12 months). Mean C0 and C2 levels were 268 +/- 80 and 1031 +/- 386, respectively (first 3 months); 230 +/- 49 and 955 +/- 239 (4-12 months); 157 +/- 53 and 745 +/- 236 (>12 months). For patients within the target C0, the corresponding C2 were 600-1500 (first 3 months), 600-1300 (4-12 months), 400-1100 (>12 months). C2 correlated with C0 (r = 0.64, P = 0.0001). C2 correlated better with CsA dose than C0 (r = 0.41, P = 0.0001 vs. r = 0.33, P = 0.0001). Between patients, CsA dose varied by a factor of 9.3; the C/dose ratio varied by a factor of 8.5 for C2 and of 15.6 for C0. Patients with higher C2 (>740) had higher severe rejection score at 2 years (P = 0.02) than patients with lower C2. This did not apply to C0. Both C2 and C0 correlated with blood urea (r = -0.18, P = 0.0001; r = -0.12, P = 0.0002) and creatinine (r = -0.19, P = 0.0004; r = -0.19, P = 0.0001 respectively). By logistic regression higher C2 (>740) was associated with higher total severe rejection score at 2 years (P = 0.006). C2 showed better correlation with CsA dose, renal function, rejection profile and less variability between patients than C0. C2 may improve CsA-based immunosuppression in HT.

Abnormally high myocardial performance index (MPI) is a Doppler-derived marker of combined systolic and diastolic left ventricular (LV) dysfunction. To identify early stage allograft dysfunction by MPI, we studied 154 long-term heart transplantation (HT) recipients (131 male, aged 51 +/- 13 years at HT, mean follow up 8.4 +/- 3.5 years), with normal left ventricular ejection fraction (LVEF) and free from acute rejection (AR), and 25 normals (13 male, aged 39 +/- 16 years). Rejection score (RS) on endomyocardial biopsy was calculated in the first year. MPI was prolonged (0.45 +/- 0.18 vs. 0.28 +/- 0.10, P = 0.0001) in patients and directly related with mean time from HT (P = 0.001), higher cumulative dosages of cyclosporine at 3 months (P = 0.01), 6 months (P = 0.03), 1 year (P = 0.02), 3 years (P = 0.04) and with cumulative dosage of methylprednisolone at 1 year (P = 0.002). The index was inversely related with mean age at HT (P = 0.002) and tended to be directly related with RS at 1 year (P = 0.05). Thus, MPI is abnormal in long-term HT recipients with normal LVEF. Its direct relation with time from HT as well as immunosuppressive load suggests an early stage of graft dysfunction because of chronic rejection. Extended prospective studies are warranted to clarify its potential role as a negative prognostic marker in HT.

Autopsy is useful to confirm causes of death in heart transplantation (HT) and identify risk factors. At our Center 507 patients (pts) underwent HT between 1985 and 2000 (415 male, aged 48±15 yrs at HT). Death occurred in 160 (31.5%); 96 (60%) underwent autopsy. Mean follow-up from HT to death was 65±52 mo. All endomyocardial biopsies, performed for rejection monitoring, were reviewed. A rejection score (RS) was assigned based on a modification of the ISHLT grading : 1A=1, 1B=2, 2=3, 3A=4, 3B=5, 4=6. We calculated for each patient: RS in the total follow-up (TRS); RS in the 1st year (RS1yr); TRS including only severe grades (>=3A) (sevTRS).All scores were normalized for the number of biopsies taken in each patient. Causes of death at autopsy were acute graft failure (GF) in 19%, acute rejection (AR) in 14%, infection in 14%, chronic rejection (CR) in 12%, malignancy in 10%, poor preoperative conditions in 7%, intraoperative complications in 5%, pulmonary hypertension and right cardiac failure in 4% and other in 15%. GF, AR and infections were most common in the first 6 mo, CR and malignancy thereafter. Univariate risk factors for total mortality were: higher TRS (p=0.02) and higher sevTRS (p=0.0001); RS1yr tended to be significant (p=0.07). Univariate risk factors for cardiovascular (CV) death were: high steroid dosage at 3 mo (p=0.0001), 6 mo (p=0.001) and 1 yr (p=0.001); higher TRS (p=0.004), higher RS1yr (p=0.01), higher sevTRS (p=0.0001); younger age at HT (p=0.02). Risk factors for total and CV death (Cox analysis) were higher RS1yr (p=0.01, RR=1.69, CI 1.1-2.5) and younger age at HT (p=0.003, RR=4.4, CI 1.7-11.7) respectively. Thus AR and CR were leading causes of death post-HT. Accordingly, higher RS1yr was an independent risk factor for death as well as younger age, a feature known to be associated with high rejection risk.

Non-invasive monitoring of acute rejection (AR) in heart transplantation (HT) remains an elusive goal. Aim of this study was to retrospectively evaluate the role of drop in surface ECG summated QRS voltage amplitude (leads D1, D2, D3, V1, V6) (SVAEG), as non-invasive predictor of AR. We studied 213 HT patients (age at HT 52±14 years, 82% male) on immunosuppressive therapy with cyclosporin A, azathioprine and prednisone. The baseline SVAEG (in mm) were from 4062 ECGs taken in the absence of biopsy proven AR (3A or higher). These were compared with the corresponding ECGs taken during AR. The SVAEG were computed by the transplant physician, prior to histological diagnosis in all cases. To evaluate the predictive role of SVAEG we calculated any drop (less than 0%), as well as cutoff values from the literature (≤10%, ≤20% and ≤25% from baseline). The finding of AR was associated with SVAEG drop of ≤20% (p = 0.0001) as well as with drop of ≤25% (p = 0.009), but not with any drop or with ≤10% reduction. SVAEG sensitivities were of 47% (190/402), 23% (93/402), 10% (39/402), 5% (20/402) for any drop, ≤10%, ≤20%, ≤25% drops respectively. Conversely SVAEG specificities were of 54% (1974/3660), 79.5% (2912/3660), 95% (3475/3660), 97% (3566/3660) for any drop, ≤10%, ≤20%, ≤25% drops respectively. Positive predictive value (PPV) was of 10% (190/1876), 11% (93/841), 17% (39/224), 17% (20/114) and negative predictive value (NPV) of 90% (1974/2186), 90% (2912/3221), 90.5% (3475/3838), 90% (3566/3948) for any drop, ≤10%, ≤20%, ≤25% drops respectively. In conclusion, SVAEG was a highly specific predictor of AR, although sensitivity was poor at all cutoffs (47% was the highest at any drop). The most useful cut-off was that of ≤25%, with 97% specificity and 90% NPV. New ECG amplification techniques may be of interest in non-invasive monitoring of AR in HT.