Fracture with the newer bioresorbable vascular scaffolds.

Bioresorbable vascular scaffolds (BVS) are being increasingly used in complex, real-world lesions. The possibility of strut fractures is a rare entity with the use of drug eluting stents (DES), but has not yet been adequately described for the BVS technology. In this report, we present a case of scaffold fracture of DEsolve BVS (Elixir Medical Corporation, USA) that was diagnosed both angiographically and by optical coherence tomography(OCT). Scaffold fracture with the newer BVS is a new Achilles' heel in the BVS technology. This gap in knowledge about the etiology such as over-expansion and potential predictors of strut fracture need to be deeply investigated before a widespread use of such technologies is adopted. © 2017 Wiley Periodicals, Inc.

Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry.

OBJECTIVES: With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. BACKGROUND: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. METHODS: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. RESULTS: A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. CONCLUSIONS: In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

The utility and effectiveness of the newer generation high-resolution coronary computed tomography angiography in the evaluation of coronary in-stent restenosis.

BACKGROUND: The importance of coronary computerized tomography angiography (CCTA) in detecting native coronary artery stenosis has been established. However, very few studies investigated the efficacy of CCTA in the assessment of in-stent restenosis (ISR) in symptomatic patients after percutaneous coronary intervention (PCI). AIM OF THE STUDY: To evaluate the value of CCTA in diagnosing ISR. METHODS: We included 102 symptomatic patients with stable angina, presented one to five years after PCI. All patients were subjected to CCTA, and the patients with significant coronary artery disease were directed for invasive coronary angiography (ICA). CCTA results were compared to ICA as the gold standard tool for detecting ISR. RESULTS: In 88 (86.3 %) patients, CCTA could successfully exclude ISR together with the ICA (true negative), but in two cases, ICA detected an ISR which was not detected by CCTA (false negative). In eight patients, CCTA detected ISR. These were confirmed by ICA (true positive) and revascularized. In four patients (3.9 %), ISR was suspected by CCTA but excluded by ICA (false positive). In our study, according to the agreement of CCTA in detection or exclusion of ISR, sensitivity, specificity, PPV, NPV and accuracy were 80.0 %, 96.65 %, 66.67 %, 97.78 %, 94.12 %, respectively. These results were statistically significant (P < 0.001). CONCLUSIONS: In up to 86 % of symptomatic patients with previous PCI, ISR was accurately excluded by CCTA. CCTA was demonstrated by this study as a high yielding tool for ruling out ISR, abolishing the need for more invasive and expensive diagnostic procedures.

The predictive value of precipitating factors on clinical outcomes in hospitalized patients with decompensated heart failure: insights from the Egyptian cohort in the European Society of Cardiology Heart Failure long-term registry.

BACKGROUND: Knowledge of the frequency of precipitating factors for acute heart failure (AHF) is important (either new-onset heart failure [NOHF] or worsening heart failure [WHF]), as this can guide strategies for prevention and treatment. Most data come only from Western Europe and North America; nevertheless, geographic differences do exist. We set out to study the prevalence of precipitating factors of AHF and their connection to patient characteristics and in-hospital and long-term mortality in patients from Egypt hospitalized for decompensated HF. Using the ESC-HF-LT Registry which is a prospective, multicenter, observational study of patients confessed to cardiology centers in the nations of Europe and the Mediterranean, patients presenting with AHF were recruited from 20 centers all over Egypt. Enrolling physicians were requested to report possible precipitants from among several predefined reasons. RESULTS: We included 1515 patients (mean age 60 ± 12 years, 69% males). The mean LVEF was 38 ± 11%. Seventy-seven percent of the total population had HFrEF, 9.8% had HFmrEF, and 13.3% had HFpEF. The commonly reported precipitating factors for AHF hospitalization among study population were as follows (in decreasing order of frequency): infection in 30.3% of patients, acute coronary syndrome/myocardial ischemia (ACS/MI) in 26%, anemia in 24.3%, uncontrolled hypertension in 24.2%, atrial fibrillation (AF) in 18.3%, renal dysfunction in 14.6%, and non-compliance in 6.5% of patients. HFpEF patients had significantly higher rates of AF, uncontrolled hypertension, and anemia as precipitants for acute decompensation. ACS/MI were significantly more frequent in patients with HFmrEF. WHF patients had significantly higher rates of infection and non-compliance, whereas new-onset HF patients showed significantly higher rates of ACS/MI and uncontrolled hypertension. One-year follow-up revealed that patients with HFrEF had a significantly higher rate of mortality compared to patients with HFmrEF and HFpEF (28.3%, 19.5, and 19.4%, P = 0.004). Patients with WHF had a significantly higher rates of 1-year mortality when compared to those with NOHF (30.0% vs. 20.3%, P < 0.001). Renal dysfunction, anemia, and infection were independently connected to worse long-term survival. CONCLUSIONS: Precipitating factors of AHF are frequent and substantially influence outcomes after hospitalization. They should be considered goals for avoiding AHF hospitalization and depicting those at highest risk for short-term mortality.

The impact of asymptomatic ventricular arrhythmias on the outcome of heart failure patients with reduced ejection fraction.

BACKGROUND: Ventricular arrhythmias cause a significant proportion of sudden deaths. Several studies demonstrate a high prevalence of ventricular arrhythmias in patients with heart failure regardless of the etiology. The aim of this study was to determine the prevalence of silent ventricular arrhythmias in ambulatory heart failure patients with reduced left ventricular ejection fraction (HFrEF) and its correlation to the prognosis. RESULTS: Four hundred (400) ambulatory HFrEF patients on maximum tolerated doses of heart failure medications were included. Holter monitoring for 7 days was done in all patients searching for silent ventricular arrhythmias. The patients were followed-up for one year to detect the occurrence of major adverse cardiovascular events. We divided the study population into 2 groups based on an LVEF cutoff value of 30% (Group A < 30%, Group B ≥ 30%). Holter monitoring revealed ventricular arrhythmias in 304 patients. Patients with left ventricular ejection fraction (EF) < 30% (Group A) had more complex ventricular arrhythmias in the form of frequent Premature ventricular contractions (PVCs) of ≥ 5% and or non-sustained ventricular tachycardia (NSVT) runs. Furthermore, Among Group A, more major cardiovascular events were observed. Multivariate regression analysis showed that frequent PVCs and severely reduced LVEF were the strongest independent predictors of major cardiovascular events. CONCLUSIONS: ventricular arrhythmias are common in HFrEF patients even in the compensated status. Both, left ventricular systolic function and the PVCs burden were found to be the strongest predictors of major adverse cardiovascular events.

Distal radial approach between theory and clinical practice.. Time to go distal!

BACKGROUND: Transradial access (TRA), which has a minimal risk of problems such as radial artery occlusion (RAO), hemorrhage, spasm, and so on, is now considered the standard procedure for cardiac catheterization. The aim of the study is to present the distal transradial access (d-TRA) as a possible promising novel technique in the field of cardiac coronary interventions comparing it to the standard conventional TRA using primary and secondary endpoints, exploring its benefits and drawbacks as a new experience in Alexandria University. One hundred cases with variable indications for coronary interventions were randomized to two arms using systematic random sampling method, coronary interventions in the first one were done via d-TRA (50 patients) and in the second arm via conventional TRA group (50 patients). RESULTS: Technically, there were highly statistically significant differences between the two arms in favor of TRA regarding procedural success, number of punctures taken, Access time, Total procedural time, vasodilator used, and crossover to another access site; meanwhile safety profile parameters have showed statistically significant differences in favor of d-TRA regarding post-operative hematoma, AV fistula, post-operative pain and compression time, and there were no statistically significant differences regarding RAO although it occurred more in TRA group. CONCLUSIONS: In the realm of cardiac intervention, the distal radial approach is a promising technique. When compared to TRA, we found it to be a viable and safe method for coronary angiography and interventions and it could be a real option for the interventionists in the near future, with a lower risk of radial artery blockage and no significant differences in wrist hematoma and radial artery spasm. The success rate of d-TRA is proportional to the steepness of the operator's learning curve and the quality of the examples chosen.

Left Atrial Appendage Closure During Cardiac Surgery for Atrial Fibrillation: A Meta-Analysis.

BACKGROUND: Left atrial appendage closure (LAAC) during cardiac surgery in atrial fibrillation (AF) patients has been investigated in multiple studies with variable safety and efficacy results. METHODS: A comprehensive review was performed of all studies comparing LAAC and placebo arm during cardiac surgery in AF patients. A random-effect model was used to calculate risk ratios, mean differences, and 95% confidence intervals. RESULTS: Five randomized controlled trials and 22 observational studies were included with a total of 540,111 patients. The LAAC group had significantly decreased postoperative stroke/embolic events as compared to the no LAAC group with all cardiac surgeries (3.74% vs 4.88%, p = 0.0002), isolated valvular surgery (1.95% vs 4.48%, p = 0.002). However, CABG insignificantly favored the LAAC group for stroke/embolic events (6.72% vs 8.30%, p = 0.07). There was no difference between both groups in all-cause mortality in the perioperative period (p = 0.42), but was significantly lower in the LAAC arm after two years (14.1% vs 18.3%, p = 0.02). There was no difference in major bleeding, all-cause rehospitalizations, or cross-clamp time between both groups (p = 0.53 and p = 0.45). The bypass and the cross-clamp time were longer in the LAAC group (4 and 9 min, respectively). CONCLUSION: In AF patients, LAAC during cardiac surgery had a decreased risk of stroke and long-term all-cause mortality. Additionally, there was no difference in major bleeding, all-cause rehospitalizations, or cross-clamp time.

Radial artery perforation: when a friend turns against you.

BACKGROUND: Radial artery approach is currently the most common access site for coronary angiography and percutaneous coronary intervention. It rarely results in complications, improves patient comfort, and reduces the duration of hospitalization. CASE PRESENTATION: A 91-year-old woman presented to our institution with ST-segment elevation myocardial infarction (STEMI). The right radial access was chosen for the performance of percutaneous coronary intervention. After the introduction of 6 F sheath, there was difficulty in the advancement of 0.035 J wire that was exchanged with a Terumo hydrophilic wire. After the procedure and before sheath removal, radial arteriography was done and revealed perforation. Protamine sulfate was administered and prolonged balloon inflation was attempted but failed to seal the perforation, so a 7-F-long vascular sheath was inserted to internally tamponade the vessel, and the patient was sent to the coronary care unit for monitoring. Over the next 3 days, serial radial angiographies were done revealing the persistence of the perforation, and on the fourth day, angiography revealed multiple thrombi. Thrombus aspiration was done using Pronto V4 extraction catheter (Vascular Solutions, USA) and was followed by the deployment of a covered stent. The stent was dislodged and successfully snared. Finally, the perforation was sealed spontaneously and there were no signs of intra-arterial thrombi. CONCLUSION: Despite the very low complication rate of radial approach, the interventional cardiologist should be aware of any possible complication, and how to avoid or, eventually, manage it.

The impact of the use of bioresorbable vascular scaffolds and drug-coated balloons in coronary bifurcation lesions.

BACKGROUND: Despite the improvement in techniques and tools, coronary lesions involving a bifurcation are still challenging and the outcome with drug-eluting stents is not always optimal. The role of bioresorbable vascular scaffolds (BVS) and drug-coated balloons (DCB) in this setting has not been adequately investigated yet. RESULTS: From the databases of 6 italian centers with high proficiencies in newer technologies, we retrospectively collected all consecutive cases of coronary bifurcations managed or attempted with the implantation of at least one BVS in the main vessel and the use of one DCB in the side branch (SB). Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE) at the longest available follow-up. Fourty patients fulfilled the enrollment criterion, 22.5% had diabetes and 50% an acute coronary syndrome. Average syntax score was 15.04 ± 7.18, all lesions were de novo, and 27 patients (67.5%) had a type 1,1,1 Medina lesion. Twenty-three lesions (57.5%) involved the proximal left anterior-descending artery/first diagonal branch. Only 32.5% of patients underwent an intravascular imaging-guided angioplasty. Average lesion length was 21.4 mm in the main vessel and 11.49 mm in the SB. MV was always predilated and BVS received a postdilation in 100% of the cases. In 42.5% of the cases, the DCB was used during final kissing balloon inflation, and in no cases, a stent/BVS was required in the SB. Procedural success was achieved in 100% of the cases. After an average follow-up of 15.5 (± 11.5) months, we observed no MACE with only one case of target vessel revasularization (2.5%). CONCLUSIONS: Management of coronary bifurcation lesions with the use of newer technologies including BVS and DCB seems feasible and effective at mid-term and long-term clinical follow-up.

Treatment of coronary bifurcation lesions: current knowledge and future perspectives.

Coronary lesions at bifurcation sites are frequent and still remain a challenging subset for the interventional cardiologist. Although in the last years the provisional stenting technique has shown more consistent results, coronary bifurcation interventions still share a worse procedural success rate and increased rates of mid- and long-term cardiac events. Most of the dedicated devices proposed in the last few years have failed to show improved results when compared with standard devices. The broader use of imaging techniques, such as intravascular ultrasound and optical coherence tomography, lead to a better understanding of the real anatomy of bifurcations and has shown to be a great tool for percutaneous coronary intervention optimization. Preliminary results come from drug-coated balloons and bioresorbable vascular scaffolds, especially for the 'leave nothing behind' concept, particularly interesting in this setting of lesions.

Occurrence and management of bioresorbable vascular scaffold failure in real-life studies.

Bioresorbable vascular scaffold (BVS) has emerged as a new technology aiming at overcoming some drawbacks of the conventional metallic stent. In spite of the initial promising results, this technology stumbled upon numerous challenges, which were revealed in the real world studies. Thanks to real world trials and registries findings, our knowledge about the BVS has grown over time, thus we have understood on BVS behavior in various settings and formulated better implantation techniques. In this article, we will review the incidence of BVS failure in real world studies, its different etiologies and management strategies.

First experience of drug-coated balloons for treatment of bioresorbable vascular scaffold restenosis.

OBJECTIVES: The aim of this study is to evaluate the role of drug-coated balloons (DCB) for the management of bioresorbable vascular scaffold (BVS) restenosis. METHODS AND RESULTS: In a series of 25 BVS restenosis discovered during systematic angiographic follow up of 246 consecutive BVS implantations at our institution, DCB was used as a primary therapeutic tool in 9 patients and 3 different types of DCB were used. Follow-up coronary angiography at 12months after DCB treatment was performed to all the patients. Among the 9 patients treated with DCB, angiographic follow up revealed failure in two patients that experienced type III restenosis (both of them treated with the same type of DCB). Both patients were treated with drug eluting stent implantation. CONCLUSIONS: In this case series of consecutive patients with BVS restenosis, the use of certain types of DCB is safe and effective in order to maintain vessel patency at mid-term follow up. Despite the small sample size and the study limitations, DCB can provide therefore an alternative treatment option in this setting, avoiding the implantation of further metallic stents in a patient where a different strategy was initially planned.

Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry.

BACKGROUND AND PURPOSES: Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet. METHODS AND RESULTS: FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five percent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up. CONCLUSIONS: SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.