Del Nido vs. Cold Blood Cardioplegia for High-Risk Isolated Coronary Artery Bypass Grafting in Patients with Reduced Ventricular Function.

INTRODUCTION: The evidence for using del Nido cardioplegia protocol in high-risk patients with reduced ejection fraction undergoing isolated coronary surgery is insufficient. METHODS: The institutional database was searched for isolated coronary bypass procedures. Patients with ejection fraction < 40% were selected. Propensity matching (age, sex, infarction, number of grafts) was used to pair del Nido (Group 1) and cold blood (Group 2) cardioplegia patients. Investigation of biomarker release, changes in ejection fraction, mortality, stroke, perioperative myocardial infarction, composite endpoint (major adverse cardiac and cerebrovascular events), and other perioperative parameters was performed. RESULTS: Matching allowed the selection of 45 patient pairs. No differences were noted at baseline. After cross-clamp release, spontaneous sinus rhythm return was observed more frequently in Group 1 (80% vs. 48.9%; P=0.003). Troponin values were similar in both groups 12 and 36 hours after surgery, as well as creatine kinase at 12 hours. A trend favored Group 1 in creatine kinase release at 36 hours (median 4.9; interquartile range 3.8-9.6 ng/mL vs. 7.3; 4.5-17.5 ng/mL; P=0.085). Perioperative mortality, rates of myocardial infarction, stroke, or major adverse cardiac and cerebrovascular events were similar. No difference in postoperative ejection fraction was noted (median 35.0%; interquartile range 32.0-38.0% vs. 35.0%; 32.0-40.0%; P=0.381). There was a trend for lower atrial fibrillation rate in Group 1 (6.7% vs. 17.8%; P=0.051). CONCLUSION: The findings indicate that del Nido cardioplegia provides satisfactory protection in patients with reduced ejection fraction undergoing coronary bypass surgery. Further prospective trials are required.

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.

Del Nido vs. Cold Blood Cardioplegia for High-Risk Isolated Coronary Artery Bypass Grafting in Patients with Reduced Ventricular Function

ABSTRACT Introduction: The evidence for using del Nido cardioplegia protocol in high-risk patients with reduced ejection fraction undergoing isolated coronary surgery is insufficient. Methods: The institutional database was searched for isolated coronary bypass procedures. Patients with ejection fraction < 40% were selected. Propensity matching (age, sex, infarction, number of grafts) was used to pair del Nido (Group 1) and cold blood (Group 2) cardioplegia patients. Investigation of biomarker release, changes in ejection fraction, mortality, stroke, perioperative myocardial infarction, composite endpoint (major adverse cardiac and cerebrovascular events), and other perioperative parameters was performed. Results: Matching allowed the selection of 45 patient pairs. No differences were noted at baseline. After cross-clamp release, spontaneous sinus rhythm return was observed more frequently in Group 1 (80% vs. 48.9%; P=0.003). Troponin values were similar in both groups 12 and 36 hours after surgery, as well as creatine kinase at 12 hours. A trend favored Group 1 in creatine kinase release at 36 hours (median 4.9; interquartile range 3.8-9.6 ng/mL vs. 7.3; 4.5-17.5 ng/mL; P=0.085). Perioperative mortality, rates of myocardial infarction, stroke, or major adverse cardiac and cerebrovascular events were similar. No difference in postoperative ejection fraction was noted (median 35.0%; interquartile range 32.0-38.0% vs. 35.0%; 32.0-40.0%; P=0.381). There was a trend for lower atrial fibrillation rate in Group 1 (6.7% vs. 17.8%; P=0.051). Conclusion: The findings indicate that del Nido cardioplegia provides satisfactory protection in patients with reduced ejection fraction undergoing coronary bypass surgery. Further prospective trials are required.

Determinants of Inadequate Cardioprotection in Adult Patients with Left Ventricular Dysfunction.

BACKGROUND: Perioperative cardioprotection is essential for achieving satisfactory clinical outcomes in heart failure patients. It is important to understand the factors affecting perioperative cardioprotection. METHODS: The institutional database was searched for patients with reduced ejection fraction (EF, < 40%) who underwent surgery with cardioplegia-induced arrest. Patients were divided into del Nido cardioplegia (DN) and cold blood cardioplegia (CB) groups. The relationships between age, preoperative blood parameters, creatinine, cross-clamp time (CCT), extracorporeal circulation time (ECT), and postoperative troponin values at 12 hours or deterioration of EF (≥5%) were evaluated. Baseline characteristics, operative parameters, and outcomes were analyzed. RESULTS: There were 508 patients with reduced EF (331 DN and 177 CB). In the entire cohort, anemic patients had greater troponin values (p = 0.004) as well as in the DN group (p = 0.002). However, this was not detected in the CB group (flat regression line; p = 0.674). Patients with high leukocyte values had greater troponin release (entire cohort: p < 0.001; DN group: p < 0.001; CB group: steep regression line with p = 0.042). Longer CCT and ECT were associated with greater troponin release (entire cohort; both groups) and greater risk of fall in EF. In a direct comparison, fewer patients had significant deterioration of EF in the DN group than CB group (3.9 vs. 11.9%; p < 0.001). CONCLUSION: The use of CB cardioplegia may be beneficial in anemic patients, whereas the use of DN cardioplegia may be beneficial for expected long CCT and high leukocytosis.

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.

One-shot cardioplegia for minimally invasive mitral valve repair-a comparison of del Nido and Bretschneider Histidine-Tryptophan-Ketoglutarate solutions.

BACKGROUND: Minimally invasive procedures are demanding in terms of cardioprotection. In many leading centres Bretschneider HTK solution is used for mitral valve surgery. The study was designed to provide comparison of the del Nido and Bretschneider HTK protocol. METHODS: Patients who underwent minimally invasive mitral valve repair for primary mitral regurgitation and received single delivery of either del Nido (Group 1) or Bretschneider HTK cardioplegia (Group 2) were matched on basis of age, gender and length of the cross-clamp time. The groups were compared in terms of major adverse cardiac and cerebrovascular events (death, myocardial infarction, stroke), high sensitivity troponin T (hs-TnT) and creatine kinase- MB isoenzyme (CK-MB) release at 12 h and 24 h following the surgery, incidence of low cardiac output syndrome (LCOS), postoperative arrhythmia, transfusions and postoperative renal function. RESULTS: Case control matching selected 38 pairs of patients. None of patients died, nor suffered from myocardial infarction or stroke. Troponin values did not differ at 12 h (median: 281.0 pg/mL vs 313.0 pg/mL; p = .38) and 24 h (median: 261.0 pg/mL vs 299.0 pg/mL; p = .54), as well as CK-MB at 12 h (median: 25.0 ng/mL vs 29.0 ng/mL; p = .31) and 24 h (median: 11.0 ng/mL versus 9.6 ng/mL; p = .46). Difference in occurrence of LCOS was insignificant (2 vs 7; 5.2% vs 18.4%; p =.15). No difference was shown in incidence of postoperative arrhythmia, transfusions and renal function. CONCLUSIONS: Del Nido cardioplegia can be used safely as an alternative for Bretschneider HTK for minimally invasive mitral valve surgery.

The impact of del Nido cardioplegia solution on blood morphology parameters.

BACKGROUND: Crystalloid cardioplegic solutions are believed to reduce hemoglobin significantly and increase the transfusion rate. However, recent reports indicate that the del Nido cardioplegia may preserve blood morphology parameters. METHODS: In "The del Nido versus cold blood cardioplegia in aortic valve Replacement" trial patients undergoing aortic valve replacement were randomized into the del Nido (DN) or cold blood cardioplegia (CB) group. For the subanalysis, patients who underwent blood transfusions were excluded from the study. Red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count and platelet (PLT) count were measured before the surgery, 24-, 48-, and 96 hours postoperatively. Furthermore, percental variation in first-last measure was compared in groups. In addition, indexed normalized ratio (INR) and activated partial thromboplastin time (aPTT) were compared preoperatively and 24 hours after the surgery. RESULTS: Eighteen (24%) patients from the del Nido group and 22 (29.3%) patients from the CB group received blood product transfusions (p = 0.560) and were excluded from further analysis. As such, 57 patients remained in DN group and 53 patients remained in CB group. No difference was found in RBC, hemoglobin, WBC, and platelet count in time intervals. Percental variation in first-last measure revealed higher fall in RBC (p = 0.0024) and hemoglobin (p = 0.0028) in the CB group. No difference was shown in preoperative and 24-hour postoperative INR and aPTT. CONCLUSIONS: The del Nido cardioplegia does not decrease blood morphology parameters when compared to cold blood cardioplegia and may be used alternatively regardless of bleeding and coagulopathy risk.

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.

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.

One-stage hybrid coronary revascularization for the treatment of multivessel coronary artery disease- Periprocedural and long-term results from the "HYBRID-COR" feasibility study.

Background: The constant growth of interest in hybrid coronary artery revascularization (HCR) is apparent. Yet, few studies report outcomes of the one-stage HCR. Consequently, the status of such procedures is not adequately supported in clinical guidelines. The aim of this study was to report the safety, feasibility, and long term-outcomes of the one-stage HCR. Methods and results: Patients were enrolled in the prospective one-stage hybrid coronary revascularization program (HYBRID-COR). They underwent a one-stage hybrid revascularization procedure while on double antiplatelet therapy (DAPT) with Ticagrelor: endoscopic atraumatic coronary artery bypass grafting (EACAB) for revascularization of the left anterior descending (LAD) artery and percutaneous intervention in non-LAD arteries with contemporary drug-eluting stents. The composite primary endpoint included MACCE (major adverse cardiac and cerebrovascular events: death, myocardial infarction, stroke, and repeated revascularization) in long-term observation. The study cohort consisted of 30 patients (68% male) with stable coronary artery disease (26.7%) and unstable angina (73.3%). Procedural success was 100%. No death, myocardial infarction (MI), or stroke were observed in the perioperative period. One patient (3.3%) required chest revision and blood transfusion due to surgical bleeding. Kidney injury was noted in two patients (6.6%). In a long-term follow-up (median; IQR: 4.25; 2.62-4.69 years), two patients (6.6%) underwent repeated revascularization and one patient (3.3%) died due to MI. The overall primary endpoint rate was 9.9%. Conclusion: One-stage hybrid revascularization, on DAPT, is a feasible, safe, and efficient way of achieving complete revascularization in selected patients. The complication rate is low and acceptable. Further randomized trials are required.

Del Nido versus Bretschneider cardioplegic solution in valve replacement for severe aortic stenosis - a case-control pilot study.

Introduction: The adequate protection provided by the del Nido cardioplegia has already been proven in trials comparing the solution with blood cardioplegia. However, evidence regarding comparison to the Bretschneider HTK solution is limited. Aim: To determine the efficacy of the del Nido cardioplegia when compared to Bretschneider HTK solution in patients undergoing aortic valve replacement for severe aortic stenosis. Material and methods: Ten patients undergoing isolated aortic valve replacement for severe aortic stenosis using the del Nido solution (group 1) were case-control matched to patients undergoing aortic valve replacement (AVR) using the Bretschneider solution (group 2). The observation included: cardioplegia dosage, time to cardiac arrest, cross-clamp and extracorporeal circulation time, ventricular fibrillation (VF) after removing the cross-clamp, gasometry parameters, creatinine kinase (MB isoenzyme - CK-MB) at 24 and 48 h following the surgery and troponin (highsensitivity troponin T - hsTnT) at 24 and 48 h. Results: Patients were no different in terms of comorbidities. Higher incidence of VF occurred in group 2 (3 vs. 9, 30% vs. 90%; p = 0.02). Blood sodium measurements after removing the cross-clamp were significantly higher in group 1 (median 137.0 vs. 130.0; p = 0.0004). Biomarker release trended toward lower values in group 1, but not significantly (median troponin at 24 h: 223.1 pg/ml vs. 294.8 pg/ml; p = 0.4 and 48 h: 208.0 pg/ml vs. 242.5 pg/ml; p = 0.7, median CK-MB at 24 h: 16.6 ng/ml vs. 17.3 ng/ml; p = 0.6, and 48 h: 6.7 ng/ml vs. 5.08 ng/ml; p = 0.3). Peak creatinine trended towards lower values in group 2, but not significantly (1.35 mg/dl vs. 1.05 mg/dl; p = 0.09). Conclusions: Both del Nido and Bretschneider cardioplegia provide satisfactory myocardial protection. However, del Nido cardioplegia reduces the incidence of VF after declamping the aorta. Further studies are required.

Transcatheter Versus Surgical Valve Replacement: A 24-months Propensity-matched Analysis of the SILCARD Registry.

BACKGROUND: Data concerning the comparison between transcatheter aortic valve implantation and surgical aortic valve replacement in a real-world setting are scarce and in Central and Eastern Europe no such data exist. In this study, we aimed at analyzing retrospectively the characteristics and outcome of patients with aortic stenosis treated either with surgical aortic valve replacement or transcatheter aortic valve implantation between 2006 and 2016 in the Silesian Province, Poland in a representative real-world cohort. METHODS: In the Silesian Cardiovascular Database we retrospectively identified 5186 patients who received either transcatheter aortic valve implantation or surgical aortic valve replacement in 1 of 3 tertiary cardiovascular centers. Baseline characteristics, including relevant clinical history, and outcomes were compared before and after propensity-score matching of both groups, with 348 pairs of patients constituting the propensity-matched study cohort. The primary end-point was 24-month all-cause mortality. RESULTS: Preoperative characteristics of propensity-matched groups were similar. There was no difference between transcatheter aortic valve implantation and surgical aortic valve replacement groups with respect to the death rate at 2 years (19.9% vs. 15.6%; P =.479). In the transcatheter aortic valve implantation group, cardiac resynchronization therapy devices were more frequently implanted after the procedure (3.7% vs. 0.0, P <.001). The groups had similar rates of myocardial infarction, stroke, and re-hospitalization. Hospital stay in the matched groups was shorter after transcatheter aortic valve implantation: 14.1 versus 15.7 days (P <.001). CONCLUSIONS: At 24 months, transcatheter aortic valve implantation patients had similar outcomes as surgical aortic valve replacement except for a higher rate of cardiac resynchronization therapy device implantation and shorter hospital stay.

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model.

Objectives: The aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing. Methods: A surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15-16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed. Results: There was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation. Conclusion: This preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted.

Age- and gender-related differences in the del Nido cardioprotection protocol.

BACKGROUND: The evidence regarding the impact of patient's age and gender on del Nido cardioplegia cadio-protection capability in adults is strongly limited. METHODS: A group of 75 patients undergoing aortic valve replacement (AVR) with del Nido cardioplegia was divided into Group 1 (male) and Group 2 (female). Creatine kinase (CK-MB isoenzyme) and high sensitivity troponin T (hs-TnT) values at 24 hours and 48 hours, occurrence of cardiac activity during crossclamp and ventricular fibrillation (VF) during reperfusion were compared. The impact of age on hs-TnT,CK-MB, VF during reperfusion and cardiac activity during crossclamp was investigated using regression models. RESULTS: No difference between the groups was reported in 24-hour CK-MB (median 15.57 ng/mL; IQR 12.13-22.82 ng/mL vs. 13.97; 12.09-17.147 ng/mL; P=0.168), 48-hour CK-MB (6.19; 4.22-7.71 ng/mL vs. 6.07;4.56-7.06 ng/mL; P=0.707), 24-hour hs-TnT (259.2; 172.0-376.9 pg/mL vs. 193.0; 167.8-351 pg/mL.1; P=0.339), 48-hour hs-TnT (169.1; 124.9-293.0 pg/mL vs. 159.2; 123.12-211.77 pg/mL; P=0.673), VF during reperfusion (25% vs. 18,5%; P=0.774) and cardiac activity during arrest (39.6% vs. 37.1%; p= 1.0). Values of CK-MB at 24 hours, hs-TnT at 24 hours and hs-TnT at 48 hours were not dependent on age. The CK-MB at 48 hours was dependent on age (P=0.039). Probit regression failed to reveal the impact of patients' age on postclamp VF occurrence (P=0.11) or electrical activity during arrest (P=0.57). CONCLUSIONS: Considering our study results, it can be hypothesized that the del Nido cardioplegia provides adequate myocardial protection in AVR patients regardless of age and gender.

Long­term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical-risk patients with severe aortic stenosis: a single-center single-valve registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long­term outcomes are still limited. AIMS: The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure­related factors influencing long­term survival. METHODS: Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ­expanding Medtronic valve implantation at American Heart of Poland in Bielsko­Biala were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium­2 (VARC­2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population. RESULTS: The median (interquartile range) follow­up was 3.4 (2.5-4.6) years, and the longest follow­up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow­up. The Kaplan-Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long­term mortality. CONCLUSIONS: TAVI with a self­expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.

Short and long-term results of endoscopic atraumatic coronary artery off-pump bypass grafting in patients with left anterior descending artery stenosis.

BACKGROUND: To perform a retrospective analysis of patients who underwent endoscopic atraumatic coronary artery off-pump bypass grafting (EACAB) in a single center over a period of 11 years. METHODS: Data was acquired from the hospital registry and patient medical records. In order to determine changes in clinical profile, patients were subdivided into three groups regarding year of surgery: 1998-2002 (group 1), 2003-2005 (group 2), 2006-2009 (group 3). In-hospital analysis up to 30 days and long-term observation were conducted. RESULTS: The study cohort consisted of 714 patients (581 male). Procedural success accounted for 99% of all patients. No mortality was observed up to 30 days. Complications in the early period included pleural effusion (7.6%), cardiac arrhythmias (3.6%), bleeding related revision (2.7%) and wound infection (1.6%). Mean follow-up was 6 years (2132 ± 1313 days; median: 1918.5). Nineteen (2.7%) patients died, of which 52.6% (10 patients) were due to heart related conditions. Overall frequency of major adverse cerebral and cardiovascular events (MACCE) was 10.8% (77 patients). The Kaplan-Meyer analysis defined survival rate and event-free survival in long-term observation of 96.1% and 85.3%, respectively. Ejection fraction (EF) < 50% was the only independent factor of mortality (OR: 3.35). Regarding cumulative MACCE, older age (OR: 1.72), lower EF (OR: 3.03), the history of percutaneous coronary intervention (OR: 2.13) and higher New York Heart Association class (OR: 2.63) influenced the incidence rate. CONCLUSIONS: The presented short and very long-term results confirm that EACAB is an efficient alternative for patients requiring revascularization of the left anterior descending artery. The elimination of cardiopulmonary bypass significantly reduces the number of complications.

Long-term echocardiographic evaluation of asymptomatic patients undergoing minimally invasive valve repair for severe primary mitral regurgitation.

BACKGROUND: Asymptomatic patients with newly diagnosed severe primary mitral regurgitation (MR) may not be candidates for surgery according to clinical guidelines. AIMS: We aimed to determine whether asymptomatic patients with severe primary MR benefit from minimally invasive mitral valve repair. METHODS: This prospective registry study assessed consecutive asymptomatic patients who underwent mitral valve repair using right minithoracotomy. Left ventricular ejection fraction, end­diastolic and end­­systolic volumes, end­diastolic and end­systolic diameters, as well as left atrial (LA) area and volume were measured. Major adverse cardiovascular and cerebrovascular events (MACCEs) were assessed at 6, 12, and 24 months after surgery. RESULTS: The study included 114 patients, of whom 16 (14%) were lost to follow­up (except the endpoint of death). No deaths were reported during follow­up. A comparison of median echocardiographic parameters at baseline and 24 months revealed significant reverse remodeling: left ventricular ejection fraction, 68% vs 60% (P <0.001); end­diastolic volume, 165 cm3 vs 107.5 cm3 (P <0.001); end­systolic volume, 51 cm3 vs 43.5 cm3 (P = 0.02), end­diastolic diameter, 58 mm vs 49 mm (P <0.001); end­systolic diameter, 35 mm vs 30 mm (P <0.001); LA area, 26 cm2 vs 18 cm2 (P <0.001); and LA volume, 96 cm3 vs 49.5 cm3(P <0.001). There were 9 MACCEs (9.2%): 2 reoperations (2%), 1 hospitalization for heart failure (1%), and 6 cases of new­onset atrial fibrillation (6.1%). CONCLUSIONS: Minimally invasive mitral valve repair is safe and effective in asymptomatic patients with severe primary MR. It should be recommended regardless of ventricular and atrial dimensions.

Low molecular weight heparin in surgical valve procedures: When and how much for an optimal prophylaxis?

BACKGROUND: Periprocedural antithrombotic prophylaxis in patients undergoing surgical valve procedures (SVP) is insufficiently investigated. Low molecular weight heparin (LMWH) has been considered as an alternative to unfractionated heparin (UFH). However, safety and efficacy of this prophylaxis strategy is unknown. This study aimed to investigate safety and efficacy of periprocedural LMWH prophylaxis and determine optimal dosage and timing for periprocedural cessation and initiation. METHODS: The present study is a retrospective, single-center observational analysis of 388 patients who underwent SVP (valve replacement or valvuloplasty) between 2015 and 2016. In-hospital endpoints were bleeding, transfusions, reoperation due to bleeding, and thromboembolic events. RESULTS: Giving the first dose of LMWH on the day of SVP was a risk factor for bleeding (OR 1.07; 95% CI 1.04-1.10; p < 0.001), transfusions (OR 1.04; 95% CI 1.01-1.07; p = 0.008) and reoperation due to bleeding (OR 1.20; 95% CI 1.12-1.28; p < 0.001), with > 40 mg/day as a predictor. A higher dosage of LMWH premedication was an independent risk factor for bleeding (OR 1.02; 95% CI 1.00-1.04; p = 0.03) and transfusion (OR 1.03; 95% CI 1.01-1.05; p = 0.01), with > 60 mg/day as a predictor for these events. LMWH dosed within 24 h prior to SVP increased the risk of transfusion (AUC 0.636; 95% CI 0.496-0.762; p = 0.04). CONCLUSIONS: Bleeding is an important early concern after surgical valve procedures. Safety and efficacy of periprocedural prophylaxis with LMWH depends on dosage and the timing of its administration. The most optimal periprocedural prophylaxis in the SVP population appears to be LMWH in dosage of 40-60 mg/day, which is recommended for deep vein thrombosis prophylaxis, ceased at least one day before SVP.

Incidence and Prognostic Impact of Atrial Fibrillation After Discharge Following Revascularization for Significant Left Main Coronary Artery Narrowing.

The incidence, recurrence rate, and prognostic significance of atrial fibrillation or flutter (AF) following hospital discharge after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown. We sought to determine the 3-year incidence and clinical impact of postdischarge AF in patients with LMCAD treated with PCI or CABG. In the EXCEL trial, 1,905 patients with LMCAD were randomized to PCI versus CABG. We analyzed the occurrence of postdischarge AF through 3 years and its time-adjusted association with adverse outcomes. A total of 1,802 patients without AF at baseline comprised the study cohort. Within 3 years, 227 episodes of AF occurred (29 [12.8%] in the PCI arm and 198 [87.2%] in the CABG arm, p <0.0001); of those, 63 (27.7%) occurred following discharge from the index hospitalization in 57 patients. In-hospital AF predicted postdischarge AF (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.42 to 6.10, p = 0.004). By multivariable analysis, time-updated postdischarge AF was an independent predictor of 3-year cardiovascular death (HR 4.91, 95% CI 1.92 to 12.60, p = 0.0009), stroke (HR 4.87, 95% CI 1.12 to 21.12, p = 0.035), and the composite outcome of death, stroke or myocardial infarction (HR 3.09, 95% CI 1.56 to 3.6-6.11, p = 0.001). Among patients with postdischarge AF, the rate of the primary composite outcome did not vary according to presence or absence of in-hospital AF (21.0% vs 23.8%, p = 0.78). In conclusion, postdischarge AF following CABG or PCI for LMCAD is associated with increased mortality and stroke. In-hospital atrial fibrillation is an independent predictor of AF following discharge.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).