Use of del Nido cardioplegia in acute coronary syndrome cases with decreased ejection fraction.

BACKGROUND: There has been increasing interest in using del Nido cardioplegia in adult cardiac surgery. However, there is limited evidence for its efficacy in patients with acute coronary syndrome and reduced ejection fraction. METHODS: This study examined patients with decreased ejection fraction (EF < 40%) who were hospitalized due to acute coronary syndrome and received either del Nido (DN) or cold blood cardioplegia (CB). The patients were matched based on age, gender, myocardial infarction at baseline, and number of conducted surgical procedures. An analysis was conducted on postoperative biomarker release (high-sensitivity troponin T and isoenzyme creatine kinase-MB (CK-MB)), changes in myocardial contractility and perioperative outcomes. RESULTS: 62 pairs of patients with similar baseline characteristics were selected. 51.6% of pairs underwent isolated coronary artery bypass grafting, while 48.4% underwent a complex procedure. Postoperative troponin values did not differ significantly at 12 h (median (IQR): 606.7 (381.4-974.8) pg/mL vs. 552 (231.8-1579.5) pg/mL; p = 0.913), nor did CK-MB (median (IQR): 24.3 (12.6-45.5) ng/mL vs. 23.7 (12.3-49.8) ng/mL; p = 0.972). The postoperative EF was similar between groups (median (IQR): 30% (30-35%) vs. 34% (30-38%); p = 0.323). No difference in perioperative mortality, myocardial infarction, stroke, or composite endpoint was noted. In a multivariate analysis, the cardioplegia protocol did not affect biomarker release or changes in ejection fraction. The first stage of acute kidney injury was more frequent in the CB group (28.5% vs. 9.7%, p = 0.033). CONCLUSIONS: Both del Nido and cold blood cardioplegia provide adequate cardioprotection in patients with acute coronary syndrome with decreased ejection fraction.

Nanospheres encapsulated everolimus delivery into arterial wall-the tissue pharmacokinetics and vascular response experimental study.

OBJECTIVE: This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres. BACKGROUND: Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile. METHODS: A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day. RESULTS: The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 ± 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points. CONCLUSIONS: The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Extracellular Matrix Proteomics Reveals Interplay of Aggrecan and Aggrecanases in Vascular Remodeling of Stented Coronary Arteries.

BACKGROUND: Extracellular matrix (ECM) remodeling contributes to in-stent restenosis and thrombosis. Despite its important clinical implications, little is known about ECM changes post-stent implantation. METHODS: Bare-metal and drug-eluting stents were implanted in pig coronary arteries with an overstretch under optical coherence tomography guidance. Stented segments were harvested 1, 3, 7, 14, and 28 days post-stenting for proteomics analysis of the media and neointima. RESULTS: A total of 151 ECM and ECM-associated proteins were identified by mass spectrometry. After stent implantation, proteins involved in regulating calcification were upregulated in the neointima of drug-eluting stents. The earliest changes in the media were proteins involved in inflammation and thrombosis, followed by changes in regulatory ECM proteins. By day 28, basement membrane proteins were reduced in drug-eluting stents in comparison with bare-metal stents. In contrast, the large aggregating proteoglycan aggrecan was increased. Aggrecanases of the ADAMTS (a disintegrin and metalloproteinase with thrombospondin motifs) family contribute to the catabolism of vascular proteoglycans. An increase in ADAMTS-specific aggrecan fragments was accompanied by a notable shift from ADAMTS1 and ADAMTS5 to ADAMTS4 gene expression after stent implantation. Immunostaining in human stented coronary arteries confirmed the presence of aggrecan and aggrecan fragments, in particular, at the contacts of the stent struts with the artery. Further investigation of aggrecan presence in the human vasculature revealed that aggrecan and aggrecan cleavage were more abundant in human arteries than in human veins. In addition, aggrecan synthesis was induced on grafting a vein into the arterial circulation, suggesting an important role for aggrecan in vascular plasticity. Finally, lack of ADAMTS-5 activity in mice resulted in an accumulation of aggrecan and a dilation of the thoracic aorta, confirming that aggrecanase activity regulates aggrecan abundance in the arterial wall and contributes to vascular remodeling. CONCLUSIONS: Significant differences were identified by proteomics in the ECM of coronary arteries after bare-metal and drug-eluting stent implantation, most notably an upregulation of aggrecan, a major ECM component of cartilaginous tissues that confers resistance to compression. The accumulation of aggrecan coincided with a shift in ADAMTS gene expression. This study provides the first evidence implicating aggrecan and aggrecanases in the vascular injury response after stenting.

Safety and feasibility of same-day early discharge after endovascular revascularization of lower extremities in elderly. SENIOR-ER registry.

OBJECTIVE: The aim of the study was to assess safety and feasibility of one-day early discharge (ODD) after endovascular revascularization (ER) of lower extremities in elderly. BACKGROUND: Safety and feasibility of ODD after ER have never been investigated in the elderly, despite the PAD rate has been rising in well-developed countries as their populations are getting older. METHODS: The consecutive data of 477 patients after ER who were intended to ODD were reviewed. The ER procedure (balloon angioplasty, atherectomy, stenting) was performed due to significant, angiographically confirmed arterial stenosis with at least Rutheford III claudication. The population was divided into two groups: ≥70 years old (y. o.) in which were 235 patients and 220 patients <70 y. o., the younger control cohort. The follow-up was performed 24 hr after (24FU) the procedure and 30 days (30FU) after discharge. RESULTS: There were no differences between the groups in the ratio of same-day discharge (99% vs 99.5%, P = 0.6) and the mean time to ambulation was 287.4 ± 43.4 min versus 285.8 ± 45.7 min (P = 0.603). The ODD was not applied in 2 patients ≥70 y. o. due to two pseudoaneurysms requiring surgical repairs and in one from the control group due to retroperitoneal bleeding. There was no MACE or creatinine increase at 24 hr in both groups. At 30 days, there was no incidence of MACE in the ≥70 y. o. group while 3 MACE occurred in the control. The ratio of access site complications was comparable between the groups. CONCLUSION: The study allows for a hypothesis that the advantages of ODD could be safely extended to the patients ≥70 y. o.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

BACKGROUND: The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. CONCLUSIONS: AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease.

Coronary atherosclerotic disease is highly prevalent in chronic kidney disease (CKD). Although revascularization improves outcomes, procedural risks are increased in CKD, and unbiased data comparing coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in CKD are sparse. To compare outcomes of CABG and PCI in stage 3 to 5 CKD, we identified randomized trials comparing these procedures. Investigators were contacted to obtain individual, patient-level data. Ten of 27 trials meeting inclusion criteria provided data. These trials enrolled 3993 patients encompassing 526 patients with stage 3 to 5 CKD of whom 137 were stage 3b-5 CKD. Among individuals with stage 3 to 5 CKD, mortality through 5 years was not different after CABG compared with PCI (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.67-1.46) or stage 3b-5 CKD (HR 1.29, CI 0.68-2.46). However, CKD modified the impact on survival free of myocardial infarction: it was not different between CABG and PCI for individuals with preserved kidney function (HR 0.97, CI 0.80-1.17), but was significantly lower after CABG in stage 3-5 CKD (HR 0.49, CI 0.29-0.82) and stage 3b-5 CKD (HR 0.23, CI 0.09-0.58). Repeat revascularization was reduced after CABG compared with PCI regardless, of baseline kidney function. Results were limited by unavailability of data from several trials and paucity of enrolled patients with stage 4-5 CKD. Thus, our patient-level meta-analysis of individuals with CKD randomized to CABG versus PCI suggests that CABG significantly reduces the risk of subsequent myocardial infarction and revascularization without affecting survival in these patients.

Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial.

BACKGROUND: There is limited comparative clinical data regarding the safety and efficacy profile of paclitaxel delivery via balloon versus stent-polymer matrix. In this study, we aimed to compare the clinical and angiographic results of two different methods of paclitaxel delivery among patients undergoing percutaneous coronary intervention (PCI) for single de novo coronary lesions. METHODS: A total of 202 patients undergoing PCI due to symptomatic heart disease and at least one significant coronary artery lesion were prospectively enrolled in a multicenter non-inferiority trial. Eligible patients were randomized to a revascularization with either a paclitaxel eluting stent (PES = Coroflex Please, B.Braun) or a bare metal stent (BMS) followed by a paclitaxel coated balloon (PCB) dilation (BMS = Coroflex + PCB = Sequent Please, B.Braun). Clinical follow-up was obtained at 9 months in all patients, whereas angiographic in a subset of 94 (46.5%) patients. RESULTS: The baseline characteristics were well balanced between groups. At 9 months, the primary endpoint of in-stent late lumen loss in BMS + PCB was comparable and non-inferior to PES (0.21 ± 0.5 vs. 0.30 ± 0.7 mm, respectively. P(non-inf) < 0.05). At 9 months, the incidence of MACE (7.0 vs. 6.9%, HR = 1, 95%CI: 0.3-2.8; P = 0.99), comprising the occurrence of myocardial infarction (4.9 vs. 3.0%, HR = 1.62, 95%CI: 0.4-6.5; P = 0.32), target lesion revascularization (6.9 vs. 5.0%, HR = 1.42, 95%CI: 0.4-4.4; p = 0.54) and stent thrombosis (4.9 vs. 3.0%, HR = 2.01, 95%CI: 0.5-7.4; P = 0.74) was comparable between BMS + PCB and PES, respectively. In the BMS + PCB group, thrombosis tended to occur within 30 days (3.9 vs. 1.0%; P = 0.38). CONCLUSIONS: Paclitaxel delivery via drug coated balloon or polymer-stent matrix achieved comparable angiographic and clinical results among patients with de novo coronary lesions. BMS + PCB revascularization was associated with a higher rate of stent thrombosis when compared to newer generation drug eluting stents, therefore, should be recommended as a bail-out for PCB alone angioplasty.

Experimental evaluation of pharmacokinetic profile and biological effect of a novel paclitaxel microcrystalline balloon coating in the iliofemoral territory of swine.

BACKGROUND: New paclitaxel coated balloons (PCB) developments have been proposed to maintain therapeutic levels of drug in the tissue while decreasing particle release. In this series of studies, we evaluated the pharmacokinetic profile and biological effects after paclitaxel delivery via novel microcrystalline PCB coating (mcPCB, Pax®, Balton) in porcine iliofemoral arteries. METHODS: Ten domestic swine were enrolled yielding 24 iliofemoral segments for evaluation. In the pharmacokinetic study, nine mcPCBs were dilated for 60 sec and animals sacrificed after 1 hr, 3 and 7 days. Studied segments were harvested and tissue paclitaxel concentration was analyzed utilizing HPLC. In the biological response evaluation, self-expandable stents were implanted followed by post dilation with either mcPCB (n = 10) or POBA (n = 5). After 28 days, angiography was performed, animals were sacrificed and stented segments harvested for histopathological evaluation. RESULTS: The 1-hr, 3 and 7 days vessel paclitaxel concentrations were 152.9 ± 154.5, 36.5 ± 49.5, and 0.9 ± 0.7 ng/mg respectively. In the biological response study, stents in the mcPCB group presented lower angiographic measures of neointimal hyperplasia as expressed by late loss when compared to POBA (-0.43 ± 0.9 vs. 0.23 ± 1.2; P = 0.24) at 28 days. In the histopathological evaluation, percent area of stenosis (%AS) was reduced by 42% in the mcPCB group (P < 0.05). The healing process in mcPCB group was comparable to POBA with regard to fibrin deposition (0.7 vs. 0.7; P = ns), neointimal maturity (1.97 vs. 1.93; P = ns), inflammation score (0.92 vs. 1; P = ns) and endothelialization score (1.77 vs. 1.73; P = ns). The mcPCB group did however display a greater tendency of medial cell loss and mineralization (60% vs. 0; P = 0.08). CONCLUSIONS: Delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel. However, this technological approach displayed reduced neointimal proliferation and favorable healing profile.

Need for repeat revascularisation in hybrid coronary revascularisation vs. percutaneous coronary intervention.

Hybrid coronary revascularisation (HCR), being a treatment path combining both coronary artery bypass grafting and percutaneous coronary intervention (PCI) approaches, offers the advantages of both methods in patients with multi-vessel coronary artery disease. Since available literature provides few studies comparing the need for repeat revascularisation (RR) after HCR in comparison to PCI, our review aimed at summarising the latest data on this topic from the last 5 years (2018-2023). The search was conducted within the PubMed and Embase databases, followed by application of inclusion and exclusion criteria and providing a summary of data and characteristics of eligible studies. On the basis of 7 records included in the final analysis, RR and/or follow-up target vessel revascularisation (TVR) were significantly less frequently required in the case of HCR than in PCI in 3 out of 7 records, whereas the remaining four provided no significant differences in analysed rates between the 2 therapeutic pathways. When it comes to lowering the necessity for follow-up TVR and/or RR in a fraction of instances, HCR demonstrates a significant advantage over PCI. The complexity of outcomes associated with these therapies is emphasised by the fact that no statistically significant differences were observed between the 2 methods in the remaining 4 records.

Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model.

BACKGROUND: The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. METHODS: Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. RESULTS: All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves. CONCLUSIONS: The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.

Comparable clinical safety and efficacy of biodegradable versus durable polymer paclitaxel eluting stents despite shorter dual antiplatelet therapy: insights from a multicenter, propensity score-matched registry.

BACKGROUND: The biodegradable polymer drug-eluting stents have been proposed as an alternative to durable polymer DES, theoretically improving vessel healing and reducing the need for prolonged double anti platelet therapy (DAPT), however clinical significance of this technology is under debate. Therefore, we sought to compare the clinical outcomes of two Paclitaxel eluting stents (PES) containing different polymer-based eluting matrices. METHODS: In this multicenter registry of 392 consecutive patients who underwent PCI between June 2006 and September 2008, we included patients with stable angina or NSTE-ACS displaying at least one significant lesion (>50% diameter stenosis) in native coronary arteries. RESULTS: Biodegradable polymer PES (BP-PES, LUC Chopin(2) , Balton, Poland) was implanted in 206 patients, whereas durable polymer PES (DP-PES, Taxus, Boston Scientific, USA) was implanted in 186 patients. There were no significant differences in baseline characteristics between groups with the exception of increased diabetes and number of lesions for BP-PES. In risk-unadjusted analysis at 1-year follow-up, there were no significant differences in TLR (BP-PES: 8.4% vs. DP-PES: 6%; P = 0.36), TVR (BP-PES: 11.1% vs. DP-PES: 8.4%; P = 0.36) and incidence of stent thromboses (BP-PES: 2.15% vs. DP-PES: 3.4%; P = 0.42) between groups. There was also no difference in MACCE between groups (17.6% vs. 14.4%, P = 0.49). The mean dual antiplatelet therapy (DAPT) compliance at 1 year was 77% for BP-PES versus 92% for DP-PES (P = 0.03). Kaplan-Meier analysis showed a significantly higher long-term stroke free survival in BP-PES (P = 0.04). After adjustment, this was sustained with an additional tendency toward higher MI free survival for BP-PES (P = 0.059). CONCLUSIONS: In this observational analysis, BP-PES were comparable to DP-PES, with regard to incidence of repeated revascularizations, stent thromboses and MACCE despite earlier DAPT discontinuation.

Long-term results of plaque excision combined with aggressive pharmacotherapy in high-risk patients with advanced peripheral artery disease (SAVE a LEG registry).

BACKGROUND: In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. METHODS: Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29-93) with SilverHawk(TM) plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR). RESULTS: The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with <30% residual stenosis achieved in 818 (98.9%) lesions. SilverHawk was used alone in 86.7%. No acute limb loss or major perforation occurred. Sixty (26.6%) patients had TLR. Long-term mortality was 16.4%. Seven (3.1%) patients had to undergo major amputations and 7 (3.1%) minor amputations. Seventy (31.1%) patients had a major adverse event. Atorvastatin 80 mg was found to be independent predictor of survival, and major amputation was found to be independent predictor of mortality. CONCLUSIONS: SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.

Hemostatic disorders in patients with infective endocarditis undergoing urgent surgical valve replacement - Rethinking current beliefs.

BACKGROUND: Although infective endocarditis (IE) represents a unique model of thrombo-inflammatory disease, the most frequent early complications of surgical valve replacement (SVR) in IE population are coagulopathy and bleeding. The hemostatic capacity and procedure-related coagulation disorders of IE patients undergoing SVR are unknown. The aims of this study were to test periprocedural hemostasis in IE patients undergoing urgent SVR, and to assess the association between disorders of hemostasis and early bleeding as well as with thromboembolic events. METHODS: A prospective, two-center, hypothesis generating, observational study was performed between Dec 2017 and Jan 2020. Periprocedural hemostasis of IE patients was assessed using Total Thrombus-formation Analysis System (T-TAS Plus) within 24 h before and 72 h post SVR. RESULTS: Overall, 25 patients with active IE undergoing urgent SVR were tested. Hemostatic capacity of IE patients was significantly impaired pre-SVR as well as post-SVR compared to normal values, in most aspects of T-TAS assays under high and low shear forces, including prolonged activation of coagulation (T10), final clot formation (OT) and clot strength (AUC30). Post-SVR T-TAS results were significantly associated with early bleeding and with red blood cell, platelet, and fresh frozen plasma administration. No association with thrombo-embolic events was found. CONCLUSIONS: Patients with active IE undergoing urgent SVR have significantly reduced hemostatic capacity before and after SVR. Hemostatic insufficiency post-SVR is related to bleeding and blood products transfusion. T-TAS may be helpful in assessment of periprocedural hemostasis in patients with IE undergoing SVR.

Del Nido versus cold blood cardioplegia in adult patients with impaired ejection fraction undergoing valvular and complex heart surgery.

BACKGROUND: There is sparse evidence on the efficacy of del Nido cardioplegia in high-risk patients with reduced ejection fraction undergoing valvular or complex heart surgery, and further investigation is required. METHODS: An institutional registry was searched for patients who underwent valvular or complex heart surgery and had an ejection fraction <40%. Subjects who received del Nido cardioplegia (DNC) and cold blood cardioplegia (CBC) were selected. Propensity matching was performed with age, gender, and number of conducted procedures as matching criteria. A comparative analysis was performed on primary endpoints of the troponin rise and changes in ejection fraction (EF). A composite endpoint of a troponin rise of ≥20× baseline or fall of EF≥5% was assessed in a multivariate analysis. Other perioperative complications are reported. RESULTS: One hundred patients from the DNC group were matched to the 100 patients in the CBC group. There were no differences between groups at baseline. Postoperatively, lower troponin values were observed in the DNC group at 12 hours (median; IQR: 523.2;349.1-740.4 pg/mL vs. 787.6;443.6-1689.0 pg/mL; P=0.016) and 36 hours (median; IQR: 426.1;337.2-492.1 pg/mL vs. 653.7;398.8-1737.5 pg/mL; P=0.044). Fewer patients in the DNC group had a fall in EF≥5% (7% vs. 16%; P=0.046). The multivariable analysis did not reveal a significant predictor of composite endpoint. CONCLUSIONS: In patients with impaired contractility undergoing valvular and complex procedures, the use of del Nido cardioplegia as an alternative to cold blood cardioplegia is associated with lower troponin release and improved preservation of ejection fraction.

Epicardial Pulsed Field Ablation of Ganglionated Plexi: Computational and Pre-Clinical Evaluation of a Bipolar Sub-Xiphoid Catheter for the Treatment of Atrial Fibrillation.

Epicardial pulsed field ablation (PFA) of ganglionated plexi (GPs) is being explored as a potential treatment for atrial fibrillation. Initial work using open-chest access with a monopolar ablation device has been completed. This study describes the early development work for a device that can be used with subxiphoid access and deliver bipolar ablation pulses. Electric field computational models have been used for the initial guidance on pulse parameters. An in vivo assessment of these ablation parameters has been performed in an open-chest canine study, while subxiphoid access and navigation of the device has been demonstrated in a porcine model. Results from this acute study have demonstrated the promising potential of this approach.

Safety and feasibility of minimally invasive coronary artery bypass surgery early after drug-eluting stent implantation due to acute coronary syndrome.

BACKGROUND: The evidence on performing minimally invasive coronary artery surgery early after drug-eluting stent (DES) implantation due to acute coronary syndrome (ACS) is limited. AIM: The study aimed to determine the safety and feasibility of this approach. METHODS: This registry included 115 (78% male) patients treated from 2013 to 2018, who underwent non-left anterior descending (LAD) percutaneous coronary intervention (PCI) due to ACS with contemporary DES implantation (39% diagnosed with myocardial infarction at baseline), followed by endoscopic atraumatic coronary artery bypass (EACAB) surgery within 180 days, after temporary P2Y12 inhibitor discontinuation. Primary composite endpoint of MACCE (major adverse cardiac and cerebrovascular events), defined as death, myocardial infarction (MI), cerebrovascular incident, and repeat revascularization was evaluated in long-term follow-up. The follow-up was collected via a telephone survey and in line with National Registry for Cardiac Surgery Procedures. RESULTS: The median (interquartile range [IQR]) time interval separating both procedures was 100.0 (62.0-136.0) days. Median (IQR) follow-up duration was 1338.5 (753.0-2093.0) days and was completed for all patients with regard to mortality. Eight patients (7%) died; 2 (1.7%) had a stroke; 6 (5.2%) suffered from MI, and 12 (10.4%) required repeat revascularization. Overall, the incidence of MACCE was 20 (17.4%). CONCLUSIONS: EACAB is a safe and feasible method of LAD revascularization in patients who received DES for ACS within 180 days before surgery despite early dual antiplatelet therapy discontinuation. The adverse event rate is low and acceptable.

Long-term outcomes of the Coordinated Care Program in Patients after Myocardial Infarction (KOS-MI).

BACKGROUND: The Coordinated Care in Myocardial Infarction Program (KOS-MI) was introduced to improve prognosis for patients after myocardial infarction (MI). The program includes complete revascularization followed by unrestricted access to rehabilitation, electrotherapy and cardiac care. AIM: The aim of this study was to assess major adverse cardiac and cerebrovascular events (MACCE) of patients enrolled in the KOS-MI at 3-year follow-up. METHODS: This is a retrospective, multicenter registry of patients treated for MI. Study group (KOS-MI) of 963 patients was compared to the control group (standard of care) of 1009 patients. At 3-year follow-up MACCE including death, MI, stroke and repeated revascularization were reported. Additionally, hospitalization due to heart failure (HF) was analyzed. Propensity score matching (PSM) was utilized for group baseline characteristics adjustment. RESULTS: Patients in the KOS-MI group were younger (65 vs. 68; P < 0.001), mostly men (70% vs. 62.9%; P < 0.001), admitted with ST-elevation myocardial infarction (STEMI) (44.6% vs. 36.2%; P < 0.001). Patients in the control group had more comorbidities and were admitted more often with non ST-elevation myocardial infarction (63.8% vs. 55.4%; P < 0.001) and acute HF (5.1% vs. 2.7%; P = 0.007). Following PSM 530 well matched pairs were selected. At three years (92.3% follow-up completeness), the relative risk reduction was: 25% in MACCE (P = 0.008), 38% in mortality (P = 0.008), 29% in repeated revascularization(P = 0.04) and 28% (P = 0.0496) in hospitalization for HF in the KOS-MI group. CONCLUSIONS: The combination of contemporary invasive techniques, complete revascularization, cardiac rehabilitation and ambulatory care included in the KOS-MI Program improves long-term prognosis of patients after MI up to 3-year follow-up.

Applied coronary physiology for planning and guidance of percutaneous coronary interventions. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology.

The clinical value of fractional flow reserve and non-hyperaemic pressure ratios are well established in determining an indication for percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD). In addition, over the last 5 years we have witnessed a shift towards the use of physiology to enhance procedural planning, assess post-PCI functional results, and guide PCI optimisation. In this regard, clinical studies have reported compelling data supporting the use of longitudinal vessel analysis, obtained with pressure guidewire pullbacks, to better understand how obstructive CAD contributes to myocardial ischaemia, to establish the likelihood of functionally successful PCI, to identify the presence and location of residual flow-limiting stenoses and to predict long-term outcomes. The introduction of new functional coronary angiography tools, which merge angiographic information with fluid dynamic equations to deliver information equivalent to intracoronary pressure measurements, are now available and potentially also applicable to these endeavours. Furthermore, the ability of longitudinal vessel analysis to predict the functional results of stenting has played an integral role in the evolving field of simulated PCI. Nevertheless, it is important to have an awareness of the value and challenges of physiology-guided PCI in specific clinical and anatomical contexts. The main aim of this European Association of Percutaneous Cardiovascular Interventions clinical consensus statement is to offer up-to-date evidence and expert opinion on the use of applied coronary physiology for procedural PCI planning, disease pattern recognition and post-PCI optimisation.

Long-term results of cephalad arteries percutanoeus transluminal angioplasty with stent implantation (The CAPTAS registry).

INTRODUCTION: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy. Moreover, percutaneous transluminal angioplasty (PTA) allows other cephalad arteries revascularization. The aim of this study was to evaluate late outcomes of cephalad arteries PTA. METHODS: This is an international multicenter registry of 434 consecutive patients in which 497 PTAs were performed. Patients with symptomatic >50% stenosis or asymptomatic >70% stenosis were enrolled. Stenting of 577 internal carotid arteries (ICA) and 13 common carotid arteries was performed, 20.7% procedures were complex in which bilateral carotid stenoses or carotid and vertebral arteries stenoses were revascularized at one stage. In 15.9% patients, one-stage coronary intervention was carried out. Distal protection devices were used in 69.6% of cases. PTAs were divided into high (n = 330) and low (n = 167) risk of major adverse coronary and cerebral events (MACCE). RESULTS: At 30 days, there were 15 (3.5%) cases of MACCE [0.9% deaths, 2.1% strokes, and 0.9% myocardial infarction (MI)]. TIAs were observed in 15 (3.9%) patients. There was no significant difference in stroke incidence between procedures with or without neuroprotection (1.8 vs. 3%; P = 0.66) as well as in MACCE occurrence between high and low-risk groups (4.3 vs. 2%; P = 0.34). Bilateral stenoses increased while hypertension decreased the risk of MACCE. Left ICA lesions increased the risk of cerebrovascular accidents (CVA). At 4 years (1-11 years), the mortality rate was 11.5%, 6% of patients had stroke, and 3% MIs. Restenosis occurred in 3%. There was a trend toward higher mortality rate (13.3 vs. 6.9%; P = 0.07) and MACCE risk in high-risk group (23.5 vs.14.7% P = 0.06). Age > 65 y.o. and stent length < 24 mm increased, while the statin therapy on admission decreased the risk of long-term death. Structural valve disease and stent length <30 mm increased the risk of MACCE, while implantation of Acculink stent decreased the risk of CVA. CONCLUSIONS: CAS is safe and successful procedure with low early and long-term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.