Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

BACKGROUND: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). METHODS: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. RESULTS: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. CONCLUSIONS: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Computed tomography guided tailored approach to transfemoral access in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Transfemoral approach (TFA) is the most common access route for transcatheter aortic valve implantation (TAVI). Percutaneous femoral access (PA) is preferred over the surgical approach (SA), however, may be associated with a higher risk of access site complications. Thus, we aimed to assess outcomes of computed tomography-guided tailored approach to percutaneous and surgical TFA in patients undergoing TAVI. METHODS: We evaluated data of 158 patients, who underwent TAVI via femoral route between January 2017 and December 2018. In the PA group, vascular closure was performed with the use of two percutaneous suture devices and an additional mechanical seal device. We compared complications rate and outcomes. RESULTS: Of the 158 patients (92%; mean age 79.6 years, 60.8% female), in 92 (61%) patients PA was performed and in 66 (39%) patients SA was used. Median (interquartile range) radiation exposure as well as contrast volume dose was higher in the PA group compared to the SA group 614.0 (410.0; 1104.0) mGy vs. 405 (240.5; 658.0) mGy (p < 0.001) and 150.0 (120.0; 180.7) mL vs. 130.0 (100.0; 160.0) mL (p = 0.04), respectively. Bleeding complications were similar in the PA group 11 (12.2%) compared to 5 (8.62%) in the SA group (p = 0.48). Median length of hospital stay was also similar in the PA and the SA group 6.00 (5.00; 8.00) days vs. 6.00 (4.00; 8.00) days, respectively (p = 0.31). CONCLUSIONS: Computed tomography-guided PA in TAVI may provide comparable procedural outcomes compared to the SA, despite a higher radiation dose and the use of contrast dye, while being less invasive.

Long-term survival following postoperative myocardial infraction after coronary artery bypass surgery.

BACKGROUND: Postoperative myocardial infraction (MI) is a serious complication among patients undergoing Coronary Artery Bypass Grafting (CABG). Data on the impact of postoperative MI on patients undergoing CABG, specifically with respect to their long term outcomes are sparse. METHODS: We retrospectively analyzed all patients who underwent isolated CABG between January 2014 and December 2016 and identified those who fulfilled the definition of the type 5MI following CABG according to the Fourth Universal Definition of Myocardial Infarction. RESULTS: A total of 4,642 CABG patients were identified, of whom 141 (3.04%) were diagnosed with postoperative MI. The mean follow-up time was 5.1±2.07 years (range, 4.4-6.9 years). Postoperative MI was more common in patients with recent acute coronary syndrome, when compared to stable angina (22.8% vs. 31.9%; P=0.011) and in those with non-elective versus planned surgery (28.4% vs. 18.4%; P=0.003). Postoperative MI after CABG was associated with an increased rate of postoperative complications, including cardiac tamponade and re exploration for bleeding. Mortality after postoperative MI was higher at short-term follow-up (up to one year) and long-term follow-up (up to five years). The risk factors for postoperative MI after CABG were incomplete revascularization (IR) [OR (95% CI): 2.25 (1.59-3.12), P=0.001], non-elective surgery [OR (95% CI): 1.68 (1.10-2.54), P=0.015] and female gender [OR (95% CI): 1.48 (1.01-2.18), P=0.045]. CONCLUSIONS: PMI after CABG is associated with reduced short- and long-term survival. The main risk factors for postoperative MI are IR, female gender, and non-elective surgery.

Hybrid techniques for myocardial regeneration: state of the art and future perspectives.

Myocardium has a limited proliferative capacity, and adult hearts are considered incapable of regenerating after injury. A significant loss in the viable myocardium eventually diminishes the heart's ability to contract synchronously, leading to heart failure. Despite the development in interventional and pharmacological treatment for ischemic heart disease and heart failure, there is a significant number of highly symptomatic patients. For these individuals, treatments that stimulate myocardial regeneration can offer alleviation of dyspnea and angina and improvement in quality of life. Stem cells are known to promote neovascularization and endothelial repair. Various stem cell lines have been investigated over the years to establish those with the highest potential to differentiate into cardiomyocytes, including bone marrow-derived mononuclear cells, mesenchymal stromal cells, CD34+, CD133+, endothelial progenitor cells, and adipose-derived mesenchymal stromal cells. Stem cell studies were based on several delivery pathways: infusion into coronary vessels, direct injection into the injured region of the myocardium, and delivery within the novel bioengineered scaffolds. Acellular materials have also been investigated over the years. They demonstrate the therapeutic potential to promote angiogenesis and release of growth factors to improve the restoration of critical components of the extracellular matrix. This review summarizes hybrid cardiac regeneration treatments that combine novel bioengineering techniques with delivery approaches that cardiac surgeons can provide.

Bilateral internal thoracic artery use in two-vessel disease does not increase the perioperative risk-A propensity score matched analysis.

BACKGROUND: Bilateral internal thoracic arteries (BITA) are uncommonly used in the every-day practice due to safety concerns and technical challenges with Y-grafts. We hypothesized that in-situ BITA use during coronary artery by-pass grafting (CABG) for two vessel disease is equally safe to standard strategy with left internal thoracic artery-left anterior descending artery revascularization and venous graft to other target vessels. METHODS: A propensity score matched analysis was used to compare elective on-pump CABG patients who received in-situ BITA (BITA-group), versus left internal thoracic artery graft to the left anterior descending artery plus vein (SITA-group). Primary end points were 30-days all-cause-mortality, major adverse cardiac events and incidents and deep sternal wound infections. RESULTS: A total of 50 matched pairs (c-statistics 0.769) were selected from patients operated on between January 2015 and April 2020 using BITA (n = 50) and SITA (n = 2170). There were no inter-group differences in demographics and basic clinical characteristics. The total operation time was longer in the BITA-group (4.0 vs 3.6 hours; p = 0.004). The rate of complete revascularization was similar, as was median aortic cross-clamp time, median extracorporeal circulation time, rate of re-explorations for bleeding, deep sternal wound infections or length of stay. One patient died in BITA group, 3 days after surgery, from a non-cardiac cause. After 36 months, the survival rate was 98% for BITA-group and 96% for controls (log-rank, p = 0.577). CONCLUSIONS: In-situ use of BITA during coronary revascularization for two-vessel disease is as safe and effective, as use of single ITA and vein graft. In-situ strategy abolishes allows to avoid the technically demanding composite graft configuration.

Early postoperative hemodynamic instability after heart transplantation - incidence and metabolic indicators.

BACKGROUND: Primary graft dysfunction (PGD) is the main cause of death in the first 30 days after heart transplantation (HTX), accounting for approximately 40% of mortality. The study's primary aim was to assess the incidence of PGD, following the International Society for Heart and Lung Transplantation consensus, and to compare it with the incidence of significant postoperative hypotension despite administration of high-dose inotropes and vasoconstrictors. The secondary aim of the study was to determine changes in biochemical markers that accompany the phenomenon. METHODS: Forty-five patients who underwent HTX between 2010 and 2015 were enrolled in this study, and detailed hemodynamic and metabolic data from the first 48 postoperative hours were collected and analyzed. Hemodynamic instability was defined as significant postoperative hypotension (mean arterial pressure (MAP) < 60 mmHg) combined with a high inotrope score (> 10). Data for long-term mortality were obtained from the population registration office. RESULTS: PGD incidence was relatively low (17.8%); however, hemodynamic instability was common (40%). Among unstable patients, MAP was insufficient for end-organ perfusion (51.4 ± 9.5 mmHg) but no decrease in left ventricular function was observed (cardiac index, 2.65 ± 0.6 l/min/m2; left ventricular ejection fraction, 52.9 ± 15.5%). Within this group, mean systemic vascular resistance index (961 ± 288 dyn*s*m2/cm5) was low despite receiving high doses of vasoactive agent (norepinephrine 0.21 (0.06-0.27) µg/kg/min during first 24 h postoperatively and 0.21 (0.01-0.27) µg/kg/min during next 24 h postoperatively). After HTX, serum lactate levels were initially significantly higher in patients with hemodynamic instability (p = 0.002); however, impaired lactate clearance was not observed (p = 0.366), and lactate levels normalized within the first 24 h postoperatively. Postoperative hemodynamic instability altered the long-term outcome and increased 5-year mortality after HTX (p = 0.034). CONCLUSIONS: Hemodynamic instability is a more common phenomenon than PGD. Only early postoperative serum lactate levels correspond with hemodynamic instability following HTX. Postoperative hemodynamic instability is associated with poor long-term survival among HTX recipients.

Inpatient Cardiac Rehabilitation after Transcatheter Aortic Valve Replacement Is Associated with Improved Clinical Performance and Quality of Life.

Cardiac rehabilitation (CR) provides multifactorial support and intervention for cardiac patients and improves quality of life (QoL). We aimed to assess clinical performance and QoL changes in patients undergoing transcatheter aortic valve replacement (TAVR) scheduled directly to inpatient CR (CR group) and those who were discharged home (DH group). The following patient-related outcomes were recorded: 5 m walk time (5MWT), 6 min walk test (6MWT), handgrip strength (HGS) with dynamometer, Katz index of Independence of Activities in Daily Living (KI of ADL), Hospital Anxiety and Depression Scores (HADS) Score. Quality of life was evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline data, 30-day and 6- and 12-month data were assessed. The CR group consisted of 52 patients and 53 were in the discharged home (DH group). When we compared outcomes between the groups, the 5MWT, 6MWT, HGS KI of ADL, and KCCQ were significantly better in the CR group at 30 days (p = 0.03, p = 0.01, p = 0.02, p = 0.048, respectively), and no difference was found in HADS scores. At 6 months, the effect of CR was sustained for 6MWT, HGS, KI of ADL, and KCCQ (p = 0.001, p = 0.001, p = 0.03, p = 0.003, respectively) but not for 5MWT. Interestingly, at 12 months, the CR group had better performance only in 6MWT and HGS compared with the DH group (p = 0.04, p = 0.03, respectively). We showed that inpatient CR is strongly associated with better clinical performance and QoL in patients undergoing TAVR. All patients may benefit from CR after TAVR. The most important aspect of inpatient CR after TAVR from the patient's perspective may be better performance in daily activities; however, performance was attenuated after 1 year.

Functional Recovery after Intramyocardial Injection of Adipose-Derived Stromal Cells Assessed by Cardiac Magnetic Resonance Imaging.

AIMS: A major clinical concern is the continuous increase in the number of patients diagnosed with advanced coronary artery disease, ischemic heart failure, and refractory angina, and one of the most promising treatment options for these conditions is stem cell-based therapy. The aim of this study was to assess the functional improvement following intramyocardial injection of adipose-derived stromal cells, using cardiac magnetic resonance. METHODS AND RESULTS: Thirteen patients with ischemic heart failure, reduced left ventricular ejection fraction, refractory angina, and who have been disqualified from any form of direct revascularization were enrolled in the study with transthoracic autologous adipose-derived stromal cell implantation. All patients underwent cardiac magnetic resonance prior to the procedure and after 12 months of follow-up. A significant increase in stroke volume (83.1 ± 8.5 mL vs 93.8 ± 13.8 mL, p = 0.025) and stroke volume index (43.3 ± 7.6 mL/m2 vs 48.7 ± 9.1 mL/m2, p = 0.019), a statistical trend toward an increase in left ventricle ejection fraction (36.7 ± 13.2 vs 39.7 ± 14.9, p = 0.052), and cardiac output improvement (5.0 ± 0.7 vs 5.5 ± 0.9, p = 0.073) was observed in the patient postprocedure. Enhanced relative regional thickening was noted in the segments with adipose-derived stromal cell implantation. CONCLUSIONS: Intramyocardial adipose-derived stromal cell implantation is a promising therapeutic option for selected, symptomatic patients with ischemic heart failure, who have preserved myocardial viability despite being unsuitable for direct revascularization.

Twelve-month outcomes of transapical transcatheter aortic valve implantation in patients with severe aortic valve stenosis.

INTRODUCTION: Transapical access (TA) transcatheter aortic valve implantation (TAVI) (TA-TAVI) represents one of the possible routes in patients with severe aortic stenosis (AS) who are not suitable for transfemoral access. AIM: To assess early- and mid-term clinical outcomes after TA-TAVI. MATERIAL AND METHODS: Patients with severe symptomatic AS undergoing TA-TAVI from November 2008 to December 2019 were enrolled. Clinical and procedural characteristics as well as clinical outcomes including all-cause mortality during 12-month follow-up were assessed. RESULTS: Sixty-one consecutive patients underwent TA-TAVI for native AS. Patients were elderly with median age of 80.0 (76.0-84.0) years; 55.7% were males. Median baseline EuroSCORE I and STS scores were 18.2% (11.6-27.7) and 4.8% (3.3-8.2), respectively. The procedural success rate was 96.7%. In-hospital, 30-day and 12-month mortality rates were 9.8%; 18.0% and 24.6%, respectively. The main periprocedural and in-hospital complications were bleeding complications (14.8%). The following factors were associated with 12-month mortality: previous cerebrovascular event (CVE), glomerular filtration rate (GFR), aortic valve area (AVA), right ventricular systolic pressure (RVSP) and serum level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (RR for CVE 3.17, 95% confidence interval (CI): 1.15-8.76: p = 0.026; RR for AVA per 0.1 cm2 1.28, 95% CI: 1.03-1.55: p = 0.024; RR for GFR per 1 ml/min 0.96: 95% CI: 0.94-0.99: p = 0.007; RR for NT-proBNP per 1000 pg/ml 1.07: 95% CI: 1.01-1.17: p = 0.033; RR for RVSP per 1 mm Hg 1.07: 95% CI 1.02-1.16: p = 0.011). CONCLUSIONS: Transapical TAVI in high-risk patients provides good hemodynamic results with acceptable outcomes.

Direct left ventricular wire pacing during transcatheter aortic valve implantation.

BACKGROUND: Rapid ventricular pacing is used during balloon aortic valvuloplasty, balloon­expandable transcatheter aortic valve implantation (TAVI), and for postdilatation. Right ventricular (RV) lead pacing has been regarded as a gold standard. Direct left ventricular (LV) wire pacing has recently been considered safe and effective in TAVI interventions. AIMS: This study aimed to analyze procedural outcomes of direct LV pacing compared with RV stimulation in unselected patients undergoing TAVI. METHODS: Direct LV wire pacing was provided via available preshaped guidewires and used only when no predictors of atrioventricular block were present. The primary study objective was the assessment of the efficacy of direct LV wire pacing. The secondary objectives included the evaluation of procedure duration and safety in comparison with the conventional method. A combined endpoint (major adverse cardiovascular event) was defined as the occurrence of death, stroke, venous puncture-related complications, and cardiac tamponade. RESULTS: In 2017 and 2018, 143 patients underwent transfemoral TAVI. Of these, 114 (79.7%) had self­ ­expandable valves implanted. Direct LV wire pacing was the dominant method of pacing (82 patients [57.3%]), and its efficacy reached 97.6%. The median (interquartile range) procedure time was shorter in the direct LV wire pacing group (80 [70-90] min vs 85 [70-95] min; P = 0.02). Major adverse cardiovascular events were more frequent in the RV lead pacing group (11.5% vs 4.9%), but no statistical significance was achieved (P = 0.13). CONCLUSIONS: Direct LV wire pacing during TAVI is a simple, reproducible, and safe technique, which provides reliable, sustained stimulation with a low complication rate and potential reduction of procedural time.