Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

Prognostic role of pre- and postinterventional myocardial injury in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Chronic pre-procedural and acute post-procedural myocardial injury are frequently observed in patients with aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The aim of our study was to investigate the prognostic role of high sensitivity cardiac troponins (hs-cTns) elevation before and after TAVI. METHODS: 106 patients with severe aortic stenosis who underwent TAVI were enrolled. High sensitivity cardiac troponin T (hs-cTnT) was measured before and after TAVI (6, 24, 48, 72 hours). Post-procedural myocardial damage was defined as a 15-fold rise in hs-cTnT upper reference limit (URL) after TAVI. The clinical endpoints were all cause death, cardiovascular death and re-hospitalization at 24 months follow-up. RESULTS: Before TAVI, hs-cTnT median value was 0.03 µg/L (2.3±2.1 fold over URL). After TAVI procedure, myocardial damage (MD), as defined by VARC-2 criteria, was observed in 40 patients (38%) (MD group). In our population, logarithmically transformed hs-cTnTs were independently associated with all-cause mortality at 24 months F/U (pre-TAVI hs-cTnT: Hazard ratio [HR] 2.2, 95% confidence interval [CI]: 1.1 to 4.4, P=0.027). No significant differences were observed between the MD and non-MD groups for the three endpoints of all cause death (p log rank: 0.15), cardiovascular death (p log rank: 0.86) and re-hospitalization (p log rank: 0.87). CONCLUSIONS: Only baseline hs-cTnT levels correlated with outcomes at 24 months of follow-up. Chronic pre-procedural myocardial injury significantly affects prognosis after TAVI.

Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry.

BACKGROUND: Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy. AIMS: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification. METHODS: This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE). RESULTS: Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain. CONCLUSIONS: Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

ECG evaluation in 11 949 Italian teenagers: results of screening in secondary school.

AIM: There is lack of evidence regarding the screening role of ECG for sudden cardiac death (SCD) prevention. Our aim was to evaluate the prevalence of ECG abnormalities among teenagers according to sport participation and competitive status. METHODS: Eleven thousand nine hundred and forty-nine Italian pupils from 179 secondary schools (13-19 years) were consecutively enrolled. ECG abnormalities were divided into minor and major. Medical history, clinical examination and sport activity information were acquired. Further evaluations were suggested in case of major ECG abnormalities. Follow-up was performed at 2 years. RESULTS: N = 1945 (16%) pupils had ECG abnormalities. Major ECG abnormalities were detected in 13% of the cohort, minor in 34%. ECG abnormalities were more common in nonathletes compared with athletes. A diagnosis of cardiac disease was reached in 25 (1.6%) of the pupils with major ECG abnormalities. CONCLUSION: ECG abnormalities are common among young populations and more prevalent in nonathletes. Among pupils with major ECG abnormalities 1.6% had a cardiac disease diagnosis. Our results are in line with the data supporting ECG screening in the general young population.

Myocardial contractility recovery following acute pressure unloading after transcatheter aortic valve intervention (TAVI) in patients with severe aortic stenosis and different left ventricular geometry: a multilayer longitudinal strain echocardiographicanalysis.

Aim of the present study was to describe the left ventricular longitudinal strain (LS) in all myocardial layers in patients with severe aortic stenosis (AS), preserved left ventricular ejection fraction (LVEF) in different LV geometry and to compare LS analysis before and early after acute LV unloading provided by transcatheter aortic valve implantation (TAVI). 68 patients were enrolled. LS was measured from the endocardial layer (Endo-LS), epicardial layer (Epi-LS) and full thickness of myocardium (Transmural-LS) before and after TAVI. Patients were divided in two groups accordingly with relative wall thickness (RWT): concentric LV hypertrophy (cLVH) vs eccentric LV hypertrophy (eLVH). Less impaired values of LS at baseline were observed, in all layers, in patients with cLVHas compared to patients with eLVH (Endo-LS was - 13.2 ± 2 vs - 11.1±3 %, p = 0.041; Epi-LS was - 11.8 ± 1.8 vs - 9.9 ± 3 %, p = 0.043; Transmural-LS was - 12.3 ± 1.8 vs - 10.49 ± 3.3 %, p = 0.02, respectively). A significant improvement in endocardial LS (Endo-LS) after TAVI was detected only in cLVH(- 13 ± 2 vs - 14 ± 2, p = 0.011). Our findings documented that concentric LVH had better basal strain function and showed a better myocardial recovery after TAVI compared to eLVH.

The Role of Ranolazine for the Treatment of Residual Angina beyond the Percutaneous Coronary Revascularization.

INTRODUCTION: Despite a successful percutaneous coronary intervention (PCI), several studies reported that the recurrence of angina after revascularization, even complete, is a particularly frequent occurrence in the first year after PCI. METHODS: The aim was to evaluate the efficacy of treatment with ranolazine in addition to conventional anti-ischemic therapy in patients who underwent coronary angiography for persistent/recurrent angina after PCI and residual ischemia only due to small branches not suitable for further revascularization. Forty-nine consecutive patients were included in our registry, adding the ranolazine (375 mg b.i.d) to optimal medical therapy (OMT). The Exercise ECG Test (EET) was performed in all patients before to start the therapy (baseline BL) and at 30 days (T1) after enrollment. RESULTS: The average duration of the exercise was increased after the therapy with ranolazine comparing to baseline (RG 9'1'' ± 2' versus BL 8'10'' ± 2', p = 0.01). Seven (14.3%) patients after receiving ranolazine had not crossed the threshold of six minutes (75 watts) compared to 20 (40.8%) of BL (p = 0.0003). Stress angina appeared more frequently at BL than at 30 days (T1 4.1% versus BL 16.3%, p = 0.04) as well as exercise-induced arrhythmias (BL 30.6% versus T1 14.3%, p = 0.05). CONCLUSIONS: The addition of ranolazine to standard anti-ischemic therapy showed a significant improvement in EET results after one month of therapy, including reduced exercise angina, increased exercise tolerance, and reduced exercise arrhythmias.

Arrhythmic Risk in Elderly Patients Candidates to Transcatheter Aortic Valve Replacement: Predictive Role of Repolarization Temporal Dispersion.

BACKGROUND/AIM: Degenerative aortic valve stenosis (AS) is associated to ventricular arrhythmias and sudden cardiac death, as well as mental stress in specific patients. In such a context, substrate, autonomic imbalance as well as repolarization dispersion abnormalities play an undoubted role. Aim of the study was to evaluate the increase of premature ventricular contractions (PVC) and complex ventricular arrhythmias during mental stress in elderly patients candidate to the transcatheter aortic valve replacement (TAVR). METHODS: In eighty-one elderly patients with AS we calculated several short-period RR- and QT-derived variables at rest, during controlled breathing and during mild mental stress, the latter being represented by a mini-mental state evaluation (MMSE). RESULTS: All the myocardial repolarization dispersion markers worsened during mental stress (p < 0.05). Furthermore, during MMSE, low frequency component of the RR variability increased significantly both as absolute power (LFRR) and normalized units (LFRRN U) (p < 0.05) as well as the low-high frequency ratio (LFRR/HFRR) (p < 0.05). Eventually, twenty-four (30%) and twelve (15%) patients increased significantly PVC and, respectively, complex ventricular arrhythmias during the MMSE administration. At multivariate logistic regression analysis, the standard deviation of QTend (QTesd), obtained at rest, was predictive of increased PVC (odd ratio: 1.54, 95% CI 1.14-2.08; p = 0.005) and complex ventricular arrhythmias (odd ratio: 2.31, 95% CI 1.40-3.83; p = 0.001) during MMSE. The QTesd showed the widest sensitive-specificity area under the curve for the increase of PVC (AUC: 0.699, 95% CI: 0.576-0.822, p < 0.05) and complex ventricular arrhythmias (AUC: 0.801, 95% CI: 0.648-0.954, p < 0.05). CONCLUSION: In elderly with AS ventricular arrhythmias worsened during a simple cognitive assessment, this events being a possible further burden on the outcome of TAVR. QTesd might be useful to identify those patients with the highest risk of ventricular arrhythmias. Whether the TAVR could led to a QTesd reduction and, hence, to a reduction of the arrhythmic burden in this setting of patients is worthy to be investigated.

Role of cardiac 123I-mIBG imaging in predicting arrhythmic events in stable chronic heart failure patients with an ICD.

BACKGROUND: Despite therapeutic improvement, the prognosis of chronic heart failure (CHF) remains unfavorable partly due to arrhythmia and sudden cardiac death (SCD). This prospective study evaluated myocardial 123I-meta-iodobenzylguanidine (123I-mIBG) scintigraphy as a predictor of arrhythmic events (AE) in CHF patients. METHODS: 170 CHF patients referred for implantable cardioverter-defibrillator (ICD) implantation for both primary and secondary prevention were enrolled. All patients underwent planar and SPECT imaging. Early and late heart-to-mediastinum (H/M) ratio, 123I-mIBG washout (WO), early and late summed SPECT scores were calculated The primary endpoint was an AE: sustained ventricular tachycardia, resuscitated cardiac arrest, appropriate ICD therapy or SCD. The secondary endpoint was appropriate ICD therapy. RESULTS: During a median follow-up of 23.3 months, 69 patients experienced an AE. Early summed score (ESS) was the only independent predictor of AE [HR 1.023 (1.003-1.043)]. Focussing on only patients with an ICD for primary prevention, ESS was the only independent predictor of AE [HR 1.028 (1.007-1.050)]. 123I-mIBG-derived parameters failed to be independent predictors of appropriate ICD therapy. However there was a "bell-shaped" relation between 123I-mIBG scintigraphy-derived parameters and AE and appropriate ICD therapy, i.e., those with intermediate 123I-mIBG abnormalities tended to be at higher risk of events. CONCLUSION: Although SPECT 123I-mIBG scintigraphy was associated with AE in CHF patients with ICD implantation for primary and secondary prevention, no association was found between 123I-mIBG scintigraphy-derived parameters and appropriate ICD therapy.