Dissections after bioresorbable vascular scaffold implantation in the POLAR ACS Registry.

Introduction: Percutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel. Aim: The aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size. Material and methods: Based on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients' demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified. Results: A group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure. Conclusions: The occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up.

Mechanical circulatory support. An expert opinion of the Association of Intensive Cardiac Care and the Association of Cardiovascular Interventions of the Polish Cardiac Society.

Mechanical circulatory support (MCS) methods are used in patients with both acute and chronic heart failure, who have exhausted other options for pharmacological or surgical treatments. The purpose of their use is to support, partially or completely, the failed ventricles and ensure adequate organ perfusion, which allows patients to restore full cardiovascular capacity, prolonging their life and effectively improving its quality. The three most popular devices include an intra-aortic balloon pump (IABP), percutaneous assist devices (including Impella, TandemHeart), and venoarterial extracorporeal membrane oxygenation (VA-ECMO). A multidisciplinary approach with the special participation of the Heart Team is required to determine the proper MCS strategy, the choice of the supporting method, and the time of its use. The studies published so far do not allow us to determine which MCS method is the safest and the most effective. Thus, the site experience and accessibility of the method seem to matter most today. MCS finds particular application in patients with acute coronary syndromes complicated by refractory cardiogenic shock, as well as in patients with acute heart failure of the high potential for reversibility. It can also serve as a backup for percutaneous coronary interventions of high risk (complex and high-risk indicated percutaneous coronary intervention [PCI], complex and high-risk indicated PCI [CHIP]). The use of appropriate supportive drugs, precise hemodynamic and echocardiographic monitoring, as well as optimal non-invasive or mechanical ventilation, are extremely important in the management of a patient with MCS. The most serious complications of MCS include bleeding, thromboembolic events, as well as infections, and hemolysis.

Levosimendan in the treatment of patients with acute cardiac conditions: an expert opinion of the Association of Intensive Cardiac Care of the Polish Cardiac Society.

Levosimendan is a new inodilator which involves 3 main mechanisms: increases the calcium sensitivity of cardiomyocytes, acts as a vasodilator due to the opening of potassium channels, and has a cardioprotective effect. Levosimendan is mainly used in the treatment of acute decompensated heart failure (class IIb recommendation according to the European Society of Cardiology guidelines). However, numerous clinical trials indicate the validity of repeated infusions of levosimendan in patients with stable heart failure as a bridge therapy to heart transplantation, and in patients with accompanying right ventricular heart failure and pulmonary hypertension. Due to the complex mechanism of action, including the cardioprotective and anti- -aggregating effect, the use of levosimendan may be particularly beneficial in acute coronary syndromes, preventing the occurrence of acute heart failure. There are data indicating that levosimendan administered prior to cardiac surgery may improve outcomes in patients with severely impaired left ventricular function. The multidirectional mechanism of action also affects other organs and systems. The positive effect of levosimendan in the treatment of cardiorenal and cardiohepatic syndromes has been shown. It has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis. However, with inconclusive results of previous studies, there is aneed for awell-designed multicenter randomized placebo-­controlled study, including an adequately large group of outpatients with chronic advanced systolic heart failure.

Management of bleeding in patients hospitalized in the intensive cardiac care unit: expert opinion of the Association of Intensive Cardiac Care and Section of Cardiovascular Pharmacotherapy of the Polish Cardiac Society in cooperation with specialists in other fields of medicine.

Nowadays, the intensive cardiac care unit (ICCU) provides care for patients with acute coronary syndrome, acute and exacerbated chronic heart failure, cardiogenic shock, sudden cardiac arrest, electrical storm, as well as with indications for urgent cardiac surgical treatment. Most of these patients require the use of 1, 2, or frequently even 3 drugs that act on the blood coagulation pathway. While antithrombotic drugs prevent thromboembolic events, they are associated with a higher risk of bleeding. In this population of patients, bleeding may often have a worse impact on prognosis than the primary disease. In this expert opinion of the Association of Intensive Cardiac Care, we presented practical guidelines on the management of bleeding in patients hospitalized at the ICCU, including bleeding risk reduction and treatment recommendations. Because of multiple comorbidities and diverse organs that may be the source of bleeding, we provided also recommendations from specialists in other fields of medicine. We hope that this document will facilitate the management of one of the most challenging populations at the ICCU.

Long-term clinical outcomes of direct absorb bioresorbable vascular scaffold implantation in acute coronary syndrome.

BACKGROUND: Preferred technique for bioresorbable vascular scaffold (BVS) implantation included high pressure predilation. Data about direct BVS implantation in acute coronary syndrome (ACS) patients are scarce. METHODS: Analysis of 90 consecutive patients with acute myocardial infarction (MI) treated with primary PCI with Absorb deployment between 2013-2016 in a single center. In 45 patients, scaffolds were implanted in the direct technique, other 45 patients underwent Absorb deployment after balloon predilation. RESULTS: Follow-up was available in 100% of patients with mean duration of 32±11 months. No cardiac death or scaffold thrombosis were observed in both groups. In the direct group, no target lesion revascularization (TLR) was reported. In the predilation arm, TLR occurred in 4 (9%) patients (P=0.12). Target vessel revascularization (TVR) was observed in 1 (2%) case in the direct group and in 6 (13%) patients from the predilation group (P=0.11). Target vessel MI was reported in one patient from each group. In an intention to treat analysis, we observed significantly higher rates of TVR (15% vs. 2%; P<0.043) and TLR (10% vs. 0%; P=0.038) in the predilation arm. Kaplan-Meier survival analysis did not show significant differences in TLR, TVR and device oriented composite endpoint (a combination of cardiac death, target vessel MI and ischemia driven TLR) between patients treated with both methods. CONCLUSIONS: Direct Absorb implantation in patients with ACS may be feasible and safe.

Direct Absorb bioresorbable scaffold implantation in acute coronary syndrome.

BACKGROUND: Direct stent implantation is a preferred technique for primary percutaneous coronary intervention (PCI). For the deployment of a bioresorbable vascular scaffold (BVS), the current guidelines recommend aggressive predilatation. Data about direct BVS implantation in patients with acute coronary syndrome (ACS) are scarce. AIM: We sought to assess procedural characteristics and immediate outcomes of direct Absorb BVS implantation in ACS patients. METHODS: A total of 91 patients with acute myocardial infarction (MI) requiring urgent coronary revascularisation were enrolled. Among them, 50 patients underwent an attempt of direct Absorb implantation. The control group consisted of 41 patients treated with PCI with BVS deployment after elective predilatation. RESULTS: In the direct group BVS deployment was successful in 91% of lesions, and in the remaining 9% of lesions direct implantation failed. In the control group scaffolds were successfully deployed after predilatation in 98% of lesions. In one case Absorb implantation failed even after balloon angioplasty. Type C lesions with severe tortuosity and angulation > 90° were associated with failure in direct Absorb deployment. Quantitative coronary analysis showed similar final percentages of diameter stenosis in the study and control groups. Flow analyses did not show significant differences between both methods. During hospitalisation no recurrent MI, scaffold thrombosis, or target lesion revascularisation was reported in either group. CONCLUSIONS: Direct Absorb implantation in ACS patients may be feasible in a suitable lesion anatomy.

Vasomotor Response to Nitroglycerine Over 5 Years Follow-Up After Everolimus-Eluting Bioresorbable Scaffold Implantation.

OBJECTIVES: This study investigated the vasomotor response to nitroglycerine (NTG) up to 5 years after ABSORB implantation. BACKGROUND: There are no data regarding long-term vasomotor response after everolimus-eluting bioresorbable vascular scaffold ABSORB implantation. METHODS: We performed quantitative coronary angiography of the scaffolded and proximal and distal adjacent segments of patients from ABSORB Cohort B study before and after 200 µg of intracoronary NTG at 2, 3, and 5 years of follow-up. The mean changes of maximal and mean lumen diameters in the scaffolded and adjacent segments were calculated. RESULTS: The mean in-scaffold lumen diameter change in response to NTG showed a trend to increase over time with absolute values of 0.03 ± 0.09 mm, 0.05 ± 0.12 mm, and 0.07 ± 0.08 mm at 2, 3, and 5 years, respectively (p = 0.40). The maximal in-scaffold lumen diameter change significantly increased with values of 0.03 ± 0.14 mm, 0.06 ± 0.16 mm, and 0.11 ± 0.1 mm at 2, 3, and 5 years, respectively (p = 0.03). The normalized mean lumen diameter change after NTG in the scaffold relative to the adjacent segments was 51.9 ± 54.8% at 5 years of follow-up (p = 0.60). CONCLUSIONS: Although there was a numerical increase of the vasomotor response to NTG after ABSORB implantation measured by quantitative coronary angiography with mean lumen diameter, the change was not statistically significant. However, the maximal lumen diameter changes increased over time from 2 to 5 years and attained statistical significance. The vasomotor response to NTG after ABSORB implantation moderately trended to increase, which is consistent with the progressive degradation and bioresorption of the scaffold, but the degree of vasomotor response remained lower in comparison with adjacent segments.

Use of bioresorbable vascular scaffolds in patients with stable angina and acute coronary syndromes. Polish National Registry.

BACKGROUND: Current revascularisation guidelines recommend coronary stenting with either a bare metal stent or a drug eluting stent. The results of bioresorbable vascular scaffold (BVS) implantation in the setting of both stable angina and acute coronary syndrome (ACS) have proven to be both safe and efficacious. AIM: To describe current use and real life experience among Polish percutaneous coronary intervention (PCI) operators in using BVS since they were made commercially available on our market. METHODS: We performed a one-arm retrospective observational registry study which enrolled patients in 30 invasive cardiology centres in Poland who had their PCI procedure performed between October 2012 and November 2013. All patients who received at least one BVS stent during index PCI were included in the registry. There were no additional inclusion or exclusion criteria. RESULTS: There were 591 patients enrolled in the registry in 30 centres in Poland. Of these, 48% were with stable angina (CCS I-III) and 52% with ACS (23% unstable angina, 18% NSTEMI and 11% STEMI). Radial access for PCI was used in 70% of cases. Left anterior descending was the target lesion in 48% of patients and predilatation used in 90%. PCI complications occurred very rarely with dissection in 2.9% of patients, slow-flow in 0.5%, no-reflow in 0.17%, and side branch occlusion in 0.33%. Technical success, defined as successful BVS delivery to the lesion, was achieved in all cases (100%). There were no periprocedural deaths. CONCLUSIONS: The early in-hospital results of this large scale national registry of 'real world' utilisation of BVS in Poland present excellent device performance in a properly selected group of patients with appropriate lesion preparation.

Bioresorbable vascular scaffolds in patients with acute coronary syndromes: the POLAR ACS study.

INTRODUCTION: The results of the ABSORB trial showed the efficacy and safety of bioresorbable vascular scaffolds (BVS) and their unique advantage, namely, the restoration of vasomotion after full biodegradation. OBJECTIVES: The aim of the registry was to evaluate procedural issues, angiographic results, and clinical outcomes of patients with acute coronary syndrome (ACS) treated with BVS implantation. PATIENTS AND METHODS: The study included 100 patients. Cohort 1 comprised 46 patients with unstable angina; cohort 2, 38 patients with non-ST-segment elevation myocardial infarction; and cohort 3, 16 patients with ST-segment elevation myocardial infarction. RESULTS: Predilation was performed in 93% of the patients. The final Thrombolysis In Myocardial Infarction (TIMI) 3 flow was achieved in 99% of the patients. In all patients, BVS was successfully implanted. In 81% of the patients, postdilation was performed with a balloon catheter with the same diameter as BVS; in 11%, with a balloon catheter with a diameter of 0.25 mm larger than BVS; and in 7%, with a balloon catheter with a diameter of 0.5 mm larger than BVS. We observed no no-reflow phenomenon, 1 distal embolization, and 2 slow-flow phenomena. Two major adverse cardiac events were reported, namely, periprocedural myocardial infarction in 2 patients. During 1-year follow-up, we observed only 1 additional myocardial infarction caused by stent thrombosis as well as 1 target lesion revascularization. CONCLUSIONS: In our study, BVS in patients with ACS showed to be a safe and effective procedure.  

[Acute coronary syndrome (NSTEMI) in patient with coronary artery anomaly]. / Ostry zespól wiencowy (zawal serca bez uniesienia odcinka ST) u pacjenta z anomalia tetnic wiencowych.

Congenital abnormalities of the coronary arteries are found in 0.6-1.5% of patients in coronary angiographies and most of them are benign. Their presence may prolong the time of the examination which is important especially in patients with acute coronary syndromes (ACS). The incidence of coronary artery anomaly with critical stenosis in the anomalous vessel may impose technical problems during percutaneous coronary intervention (PCI). We report the case of a patient with one of the most common coronary anomaly and ACS treated with multivessel PCI.

[Mild induced hypothermia in patient with acute myocardial infarction after cardiac arrest]. / Zastosowanie lagodnej hipotermii terapeutycznej u pacjenta z zawalem serca powiklanym naglym zatrzymaniem krazenia.

Mild induced hypothermia is recommended by both European and American cardiological associations as well as European and Polish Recuscitation Council as a standard therapy in comatose patients resuscitated from cardiac arrest. We report a case of a 60 year-old male patient resuscitated from out-of-hospital cardiac arrest treated with mild hypothermia. The use of hypothermia improved patient's neurological prognosis and outcome by preventing severe brain injury.

Biodegradable vascular scaffold ABSORB BVS™ - scientific evidence and methods of implantation.

Since 2006, over 600 biodegradable vascular scaffolds (BVS) have been implanted worldwide in clinical trials such as ABSORB cohort A and B, ABSORB Extend and ABSORB II RCT. Due to completely changed construction and mechanical properties of BVS, the choice of proper scaffold diameter and its implantation differ significantly from those used in the case of metal stents (bare metal stent (BMS) or drug eluting stent (DES)). Furthermore, all data concerning BVS efficacy and safety come from clinical trials, conducted in a selected group of patients. In 2012 BVS ABSORB™ was approved as the first biodegradable scaffold for the treatment of coronary artery disease in EU and other countries, with a limitation of use only for experienced and trained interventional cardiologists. As one of the most experienced clinical centers in Europe and the first one that in 2006 implanted BVS ABSORB™ in Poland we have a great pleasure and honor to share our experience with interventional cardiologists who would like to prepare for BVS ABSORB™ implantation in their centers. In this article we wanted to summarize the clinical data from already finished and ongoing trials, give a short overview of patient selection, and provide a detailed description of the implantation process with tips which could be helpful during BVS use.

[Left ventricular free wall rupture as a mechanical complication in ST-segment elevation acute myocardial infarction]. / Zawal serca sciany dolnej z uniesieniemodcinka ST powiklany peknieciemwolnej sciany lewej komory.

The development of cath-lab network providing interventions in acute coronary syndromes led not only to significant reduction of major adverse cardiac events, but also reduced incidence of myocardial infarction (MI) mechanical complications in acute phase. In the pre-interventional era one of the most common complication of ST elevation MI was left ventricular free wall rupture (LVFWR). Currently it became a rare complication, but despite the advances in cardiosurgical treatment is still associated with high mortality rate. We report the case of a 75-year-old woman with inferior wall MI and LVFWR of atypical presentation.

Regeneration of vessel wall functionality and vascular restoration therapy with biodegradable stents -- current status.

The novel vascular solution, the bioresorbable scaffold, has already been called Vascular Regeneration Therapy (VRT), providing a new quality in interventional cardiology. This new generation of stents gives a potential advantage over the permanent metal prosthesis, mainly restoration of vasomotion after full biodegradation. In the article we summarize the latest achievements in stent technologies allowing complete regeneration of arterial wall functions after implantation of biodegradable scaffold.

[ST-segment elevation myocardial infarction due to anaphylactic shock triggered by contrast medium]. / Zawal serca z uniesieniem odcinka ST w przebiegu wstrzasu anafilaktycznego w trakcie koronarografii.

We present a case of a 57 year-old patient who developed inferior wall myocardial infarction as a consequence of anaphylactic shock, which occurred as a reaction to contrast medium. The patient was discharged home fully recovered after 14 days with recommendation of further allergology diagnostics.

Early abciximab administration before transfer for primary percutaneous coronary interventions for ST-elevation myocardial infarction reduces 1-year mortality in patients with high-risk profile. Results from EUROTRANSFER registry.

BACKGROUND: There are conflicting data on the clinical benefit from early administration of abciximab from a large randomized trial and a registry. However, both sources suggest that a benefit may depend on the baseline risk profile of the patients. We evaluated the role of early abciximab administration in patients with ST-segment-elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention stratified by the STEMI Thrombolysis In Myocardial Infarction (TIMI) risk score. METHODS: A total of 1,650 patients were enrolled into the EUROTRANSFER Registry. One thousand eighty-six patients received abciximab (66%). Abciximab was administered early in 727 patients (EA) and late in 359 patients (LA). We used the TIMI risk score for risk stratification. Patients with scores >or=3 constituted the high-risk group of 616 patients (56.7%), whereas 470 patients formed the low-risk cohort. Factoring in the timing of the abciximab administration resulted in 4 groups of patients who were compared for mortality at 1 year: EA/high-risk (n = 413); LA/high-risk (n = 203); EA/low-risk (n = 314); LA/low-risk (n = 156). Baseline difference was accounted for by means of propensity score. RESULTS: In high-risk patients, 1-year mortality was significantly lower with early abcximab compared to late administration (8.7% vs 15.8%; odds ratio 0.51, CI 0.31-0.85, P = .01). In multivariable Cox regression analysis, both early abciximab administration and patients' risk profile (TIMI score >or=3) were identified as independent predictors of 1-year mortality. CONCLUSIONS: Early abciximab administration before transfer for percutaneous coronary intervention in STEMI shows lower mortality at 1-year follow-up. This effect is confined to patients with higher risk profile as defined by TIMI risk score >or=3.

Renal insufficiency increases mortality in acute coronary syndromes regardless of TIMI risk score.

BACKGROUND: Non ST-segment elevation acute coronary syndromes (NSTE ACS) are the most frequent cause of admission to intensive care units. Early risk assessment and implementation of optimal treatment are of special importance in these patients. Previous studies have demonstrated that renal insufficiency is an independent risk factor in patients with cardiovascular disease. AIM: To assess the effects of renal function on the course of treatment and prognosis in patients with NSTE ACS admitted to hospitals without on-site invasive facilities but with a possibility of immediate transfer to a reference centre with a catheterisation laboratory. METHODS: Twenty-nine community hospitals without on-site invasive facilities participated in the Krakow Registry of Acute Coronary Syndromes - a prospective, multicentre, web-based, observational registry. Renal insufficiency (RI) was defined as creatinine clearance (CrCl) <60 ml/min. RESULTS: NSTE ACS was diagnosed in 1396 patients. Renal insufficiency was diagnosed in 34% of all patients. Only 17% of them had been diagnosed with RI prior to admission. Transfer for invasive treatment was undertaken in 10% of RI patients as compared to 16% of patients with CrCl >60 ml/min (NS). In-hospital mortality among patients remaining on conservative treatment in community hospitals was significantly higher among RI patients (4.0 vs. 0.6%; p <0.001). Thienopyridines were less frequently used in RI patients (46 vs. 54%; p <0.05). In-hospital mortality among RI patients remaining in community hospitals and treated conservatively was higher than among non-RI patients in each TIMI risk score group: 7.3 vs. 2.4% (p <0.05) in the high risk group, 4.1 vs. 1.4% (NS) in the moderate and 3.6 vs. 0% (p <0.001) in the low risk group. Multivariate logistic regression analysis identified reduced creatinine clearance and a history of heart failure as independent factors influencing mortality. CONCLUSIONS: Renal insufficiency was present in one-third of NSTE ACS patients. Patients with renal insufficiency had worse clinical risk profile and received less aggressive treatment. Patients with NSTE ACS and renal insufficiency treated conservatively had higher in-hospital mortality. Renal insufficiency modifies mortality irrespective of the TIMI risk score. Creatinine clearance should be considered in modification of the TIMI risk score scale.

[Long term follow-up after intracoranary brachytherapy due to in stent restenosis]. / Odlegle wyniki leczenia po zabiegach brachyterapii wewnatrzwiencowej z powodu rozlanej restenozy w stencie.

BACKGROUND: Intarcoronary brachytherapy with radioactive source is the method of choice to treat in stent restenosis. Currently, we have data available from randomized clinical trials, yet every day practice and routine results of barchytherapy are not completely defined. METHODS: We studied 50 patients treated due to in stent restenosis. Procedures were performed by means of beta radiation, and the delivered dose was equal to 2000 cGy. RESULTS: All patient were observed during hospitalization and long term follow-up (from 4 to 21 months). Diffuse and proliferative in stent restenosis (22.02 +/- 21.41 mm) was the most common type of lesions which were treated. Procedure success was 100%, and barchytherapy success was 98%. Median time of hospitalization was one day. Frequency of geographical miss was 7.8%. During in hospital period there were no cases of death, myocardial infarction nor need for revascularization. In long term follow-up 2 myocardial infarctions (4%), 1 bypass grafting (2%) and 9 target vessel revascularizations took place. The cumulative survival without event was 76%. Long term follow-up showed that adverse events occurred in the later period of observation, i.e., up to 6 months after brachytherpy. Median event free survival was 246.5 days. CONCLUSIONS: Routine intracoronary brachytherapy due to in stent restenosis is safe and characterized by a high percentage of procedure success in long term follow-up.