Transcatheter aortic valve implantation (TAVI) has become a high-volume procedure with increasing demands on hospital resources. Local anaesthesia with sedation supervised by an anaesthesiology team is the current standard of care. We aimed to describe our experience with a simplified, nurse-led sedation (NLS) protocol. This study enrolled 128 consecutive patients who underwent transfemoral TAVI with self-expandable Evolut R prosthesis between November 2019 and April 2021. Operators selected 50% of patients for NLS based on the clinical expectation of lower risk of procedural difficulties. Nurse-led sedation protocol demanded only mild to moderate levels of sedation. The clinical outcomes were determined from the local TAVI registry and the national mortality database. Baseline patient characteristics were similar in the NLS (n = 64) and anaesthesiologist-led sedation (ALS) (n = 64) groups except higher prevalence of diabetes mellitus (48.4% vs. 31.3%, P = 0.035) and peripheral vascular disease (20.3% vs. 7.8%, P = 0.036) in the ALS group. There was a trend for the larger prostheses used in the ALS group (P = 0.058). The procedural results did not differ, and coronary care team backup was rarely needed in the NLS group (6% of patients). The in-hospital outcomes were identical from both clinical and echocardiography perspectives, and 30-day mortality was low in both groups (1.5%). For the NLS group, preparation in the catheterization laboratory was quicker by 6.4 min (P = 0.01), and intensive care unit stay was shorter (2.03 vs. 3.48 days, P = 0.001). In conclusion, the NLS for the selected transfemoral TAVI population seems safe.

BACKGROUND:Severe burn injury is a specific type of trauma, which induces a unique complex of responses in the body and leads to an extreme increase in stress hormones and proinflammatory cytokines. These hypermetabolic and stress responses are desirable in the acute phase but can persist for several years and lead - due to several mechanisms - to many late complications, including myocardial dysfunction.METHODS:The databases of PubMed, ScienceDirect, National Institutes of Health (NIH) of the United States, and Google Scholar were searched. Studies relevant to the topic of late cardiovascular dysfunction after burn injury were compiled using key words.RESULTS:Burn-induced heart disease significantly increases morbidity and mortality and contributes to the reduction in the quality of life of patients after severe burn trauma. A variety of mechanisms causing myocardial dysfunction after burn trauma have been detailed but understanding all of the exact consequences is limited, especially regarding chronic cardiovascular changes.CONCLUSION:A detailed understanding of the pathophysiology of chronic cardiac changes can contribute to a comprehensive and preventive treatment plan and improve long-term outcomes of burn patients.

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P=0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm(2)/m(2), P=0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6years with log-rank test P=0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9-28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

Abstract Introduction MitraClip implantation is one possible method of treatment of patients with heart failure and severe mitral regurgitation. Goal. Analysis of clinical and echocardiographic data of patients 1 year after MitraClip implantation. Methods The first 63 consequtive patients whom underwent MitraClip implantation at our cardiocentre were analyzed. Implantation was performed after all possible conservative treatment options according to guidelines were exhausted. Each patient underwent careful clinical and echocardiographic examination before and 12 months after implantation. Results Average age of the patient population was 70,5 ± 7,4 years. Baseline average ejection fraction (EF) of left ventricle (LV) was 35,2 ± 12,6%, enddiastolic volume of LV 196 ± 53ml, 63 (100%) had mitral regurgitation (MR) ≥ 3/4, average ERO 27,4 ± 10,2cm2 RV 40,5 ± 12,9ml. During 1 year follow-up 11 (17%) of patients died, 1 (1,6%) from a periprocedural complication. In the patients who survived we observed a decreasing incidence of severe mitral MR , (MR ≥ 3/4 before procedure in 63 (100%) vs. 12 (19%) in patients after procedure). A significant improvement in functional class NYHA (NYHA II-IV before implantation in 63 (100%) patients vs. 17 patients (33%) at one year follow-up). Mortatility was mostly influenced by Euroscore (p 0,08), creatitnine level (p 0,10), from echocardiographic parameters LV EF (36,4% vs. 29,5% p 0,10) and TAPSE (17,8 vs. 15,2mm p 0,04). Conclusion One year mortality in our study population was comparable with previously published data from larger registries. Significant regression of mitral regurgitation and improvement of symptoms was observed in patients after implantation. Moratility was affected by comorbidities, and systolic function of left and right ventricle.

PURPOSE:Identification of clinical and laboratory predictors related to Infectious Complications (ICs) in patients after Out-of-Hospital Cardiac Arrest (OHCA).METHODS:Patients, aged >18, after an OHCA between 9/2013 and 11/2015, surviving >24h, were studied.RESULTS:Study group consisted of 42 patients (mean age 63.4years, 88.1% men). Forty percent of patients had IC; lower respiratory tract infections were most common (87.5% of cases). ICs were more common in patients receiving Targeted Temperature Management (50% vs. 10%; p=0.032). Antibiotics were used in 85.7% of patients. The mean time to therapy initiation was 9.6 (SD 7.1) hours after admission. The mean course of treatment was 9.0 (SD 6.2) days. Fifty-three percent of patients receiving early antibiotic treatment didn't have IC. Initial antibiotic therapy was changed more often in patients with IC (75% vs. 38.9%; p=0.045). C-Reactive Protein, Procalcitonin, Troponin and White Blood Cell count values were higher in patients with IC.CONCLUSION:Early initiated antibiotic treatment is overused in patients after OHCA. This practice is associated with necessitating antibiotic change in the majority of patients with IC. Assessment of clinical and laboratory parameters in the first days after OHCA increases the likelihood of appropriate ATB therapy.

Objective: This randomised, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data.Design and method: A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomised to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after one year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in 5 patients. Results: Similar and comparable reduction of 24-hour systolic blood pressure after RDN or spironolactone addition after randomisation was observed, 9.1 mmHg (p = 0.001) and 10.9 mmHg (p = 0.001), respectively. Similar decrease of office blood pressure was observed, 17.7 mmHg (p < 0.001) versus 14.1 mmHg (p < 0.001), while the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed non-significantly better efficacy of spironolactone addition in 24 h systolic and office systolic blood pressure reduction than RDN (3.7 mmHg, p = 0.27 and 4.6 mmHg in favour of spironolactone addition, p = 0.28, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, p = 0.001). Conclusions: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in blood pressure reduction over a period of 24 months. However, by contrast to the 12-month results, blood pressure changes are not significantly greater.

OBJECTIVES:The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data.METHODS:A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients.RESULTS:Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001).CONCLUSION:In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.

Background: Little is known about the valve degeneration process after transcutaneous aortic valve implantations (TAVI) that can have an important impact on patients' long-term prognosis.Aim: To evaluate degenerative changes of TAVI using computed tomography (CT) compared to findings in patients that underwent surgical aortic valve replacement (SAVR). Subsequently, to compare the level of immune and inflammatory markers in both groups and test their possible role in the valve degeneration process.Methods and results: 49 patients after TAVI and 29 patients in the control group after SAVR underwent 2 years of follow-up and 8 patients from the TAVI group and 7 patients after SAVR underwent five years of follow-up. CT was performed in all patients and calcifications on prosthesis cusps in both groups were measured using Agatson calcium score. TAVI patients were older compared to patients who underwent SAVR [82 (62;86) vs. 74 (64;84) years, p<0.001], and had more comorbidities - higher EuroScore I [21.0 (5.0;46.0) vs. 6.15 (2.54;11.17), p<0.001]. TAVI patients had more often concomitant coronary artery disease (69.4% vs. 13.8%, p<0.001) and previous history of cardiac surgery (32.7% vs. 0.0%, p<0.001). Slight calcifications (mean Agatson score 50.76) on prosthetic cusps were found in 2 patients 4-5 years after TAVI and in 1 patient 2 years after SAVR (p=NS). Even though significant differences were found in values of tumor necrosis factor-? and E-selectin before, 1 year, and 2 years after implantation, no significant changes in values of inflammatory markers were observed during follow-up period in both groups of patients. Detailed analysis revealed no significant difference between values of inflammatory markers of patients with and without calcifications present on CT.Conclusion: Minimal degenerative changes on TAVI prosthesis were observed in mid- and long-term follow-up. Systemic immune response did not differ between patients after TAVI and SAVR. (C) 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Objective: This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension (TRH) and assessed the effect of spironolactone addition. We present the 12-month data. Design and method: The entry criteria included office systolic blood pressure (BP) over 140 mmHg, ambulatory 24-hour mean systolic BP over 130 mmHg, treatment with at least 3 antihypertensive drugs including a diuretic, exclusion of secondary hypertension and excluding drug non-compliance. Thus, only patients with TRH were included after thorough examination in three tertiary hypertension centers. After randomization, patients selected for RDN were maintained on baseline medical therapy for 1 year unless changes were considered clinically necessary. Patients selected for intensified medical treatment received baseline medical therapy plus spironolactone (25 mg daily, as generally recommended), if tolerated, and if no contraindications were present. Results: A total of 106 patients with TRH were randomized: 52 patients to RDN and 54 patients to the spironolactone addition, with baseline systolic BP of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable 24-hour systolic BP decline of 6.4 mmHg, p = 0.001 in RDN versus 8.2 mmHg, p = 0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic BP decline between complete RDN (6.3 mmHg, p = 0.004) and the subgroup where spironolactone was added and this continued within the 12 months (15 mmHg, p = 0.003). See Figure. Renal artery CT angiograms before and after one year post-renal denervation did not reveal any relevant changes.Conclusions: This study shows that, over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of TRH with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in BP reduction.

BACKGROUND:Survival rates and outcomes after out-of-hospital cardiac arrest (OHCA) remain low despite investments of time and money. The goal of this analysis was to identify variables related to survival of patients transferred to our coronary care unit (CCU) after an OHCA.METHODS:102 consecutive OHCA patients, mean age 64.6 (SD 13.3), 70.6% men, between January, 2011 and December, 2013, who were transferred to our tertiary care CCU, were studied.RESULTS:Cardiac-cause OHCA was present in 84 patients (82.4%). Of these 60.7% had an acute coronary syndrome (ACS) - STEMI 35.7%; NSTEMI 23.8%. Coronary angiography was performed in 73 (71.6%) patients - 81% with cardiac- and 31.3% (5/16) with a non-cardiac cause. Percutaneous coronary intervention (PCI) was performed in 50 patients (68.5%), 49 with cardiac-cause, and succeeded in 92%. In-hospital mortality was 38.2%, one-year mortality was 51.5%. In-hospital and one-year mortality were related to age (p=0.002 resp. p=0.001), first ECG rhythm (p=0.001, resp. p=0.005), history of coronary artery disease (RR 2.1; p=0.026 resp. RR 1.71; p=0.029), and history of arrhythmia (supraventricular tachyarrhythmia, bradyarrhythmia) (RR 2.74; p=0.003 resp. RR 2.3; p=0.001). One-year mortality was also related to a history of diabetes mellitus (RR 1.89; p=0.006).CONCLUSION:Cardiac-cause was the most common cause of OHCA. Acute coronary syndrome was present in more than half of the cases. Availability of interventional facilities was a crucial factor in OHCA management. A history of coronary artery disease, diabetes mellitus, and arrhythmia were associated with worse survival.

Background. Surgical correction of mitral regurgitation (MR) can lead to postoperative low cardiac output state. We aimed to assess the acute hemodynamic changes after percutaneous MitraClip therapy (a unique model without influence of factors linked to surgical procedure) in patients with functional MR without the influence of general anaesthesia. Methods. We studied invasive hemodynamic parameters in 23 patients before procedure (conscious, nonsedated patients), during procedure (intubated patients), and the first day after MitraClip implantation (conscious, extubated patients). Results. Mitral valve clipping significantly increased cardiac index (CI) (from 2.0 ± 0.5 to 3.3 ± 0.6 L/min/m2; p<0.01). Conversely, there was significant reduction in the mean pulmonary capillary wedge pressure (PCWP) (from 18.6 ± 5.7 to 10.5 ± 3.8 mmHg; p<0.01), mean pulmonary artery pressure (from 29.8 ± 10.9 to 25.2 ± 10.3 mmHg; p=0.03), and pulmonary vascular resistance index (from 531 ± 359 to 365 ± 193 dyn·s·cm−5/m2; p=0.03). Conclusions. The functional MR therapy with percutaneous MitraClip device results in significant increase in CI (+66%) and concomitant decrease in PCWP (−42%). None of our patients developed low cardiac output state. Our results support the idea that significant part of low cardiac output state after cardiac surgery is due to surgery related factors rather than due to increase in afterload after MR elimination.

This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension and assessed the effect of spironolactone addition. We present here the 12-month data. A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable mean 24-hour systolic blood pressure decline of 6.4 mm Hg, P =0.001 in RDN versus 8.2 mm Hg, P =0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic blood pressure decline between complete RDN (6.3 mm Hg, P =0.004) and the subgroup where spironolactone was added, and this continued within the 12 months (15 mm Hg, P = 0.003). Renal artery computed tomography angiograms before and after 1 year post-RDN did not reveal any relevant changes. This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction.

Survivors after cardiac arrest (CA) due to AMI undergo PCI and then receive dual antiplatelet therapy. Mild therapeutic hypothermia (MTH) is recommended for unconscious patients after CA to improve neurological outcomes. MTH can attenuate the effectiveness of P2Y 12 inhibitors by reducing gastrointestinal absorption and metabolic activation. The combined effect of these conditions on the efficacy of P2Y 12 inhibitors is unknown. We compared the antiplatelet efficacies of new P2Y 12 inhibitors in AMI patients after CA treated with MTH. Forty patients after CA for AMI treated with MTH and received one P2Y 12 inhibitor (clopidogrel, prasugrel or ticagrelor) were enrolled in a prospective observational single-center study. Platelet inhibition was measured by VASP (PRI) on days 1, 2, and 3 after drug administration. In-hospital clinical data and 1-year survival data were obtained. The proportion of patients with ineffective platelet inhibition (PRI > 50 %, high on-treatment platelet reactivity) for clopidogrel, prasugrel, and ticagrelor was 77 vs. 19 vs. 1 % on day 1; 77 vs. 17 vs. 0 % on day 2; and 85 vs. 6 vs. 0 % on day 3 ( P < 0.001). The platelet inhibition was significantly worse in clopidogrel group than in prasugrel or ticagrelor group. Prasugrel and ticagrelor are very effective for platelet inhibition in patients treated with MTH after CA due to AMI, but clopidogrel is not. Using prasugrel or ticagrelor seems to be a more suitable option in this high-risk group of acute patients.

This prospective, randomized, open-label multicenter trial evaluated the efficacy of catheter-based renal denervation (Symplicity, Medtronic) versus intensified pharmacological treatment including spironolactone (if tolerated) in patients with true-resistant hypertension. This was confirmed by 24-hour ambulatory blood pressure monitoring after excluding secondary hypertension and confirmation of adherence to therapy by measurement of plasma antihypertensive drug levels before enrollment. One-hundred six patients were randomized to renal denervation (n=52), or intensified pharmacological treatment (n=54) with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. A significant reduction in 24-hour average systolic blood pressure after 6 months (−8.6 [95% cofidence interval: −11.8, −5.3] mm Hg; P <0.001 in renal denervation versus −8.1 [95% cofidence interval: −12.7, −3.4] mm Hg; P =0.001 in pharmacological group) was observed, which was comparable in both groups. Similarly, a significant reduction in systolic office blood pressure (−12.4 [95% cofidence interval: −17.0, −7.8] mm Hg; P <0.001 in renal denervation versus −14.3 [95% cofidence interval: −19.7, −8.9] mm Hg; P <0.001 in pharmacological group) was present. Between-group differences in change were not significant. The average number of antihypertensive drugs used after 6 months was significantly higher in the pharmacological group (+0.3 drugs; P <0.001). A significant increase in serum creatinine and a parallel decrease of creatinine clearance were observed in the pharmacological group; between-group difference were borderline significant. The 6-month results of this study confirmed the safety of renal denervation. In conclusion, renal denervation achieved reduction of blood pressure comparable with intensified pharmacotherapy.

Introduction: MitraClip therapy has become a therapeutic alternative for high surgical risk patients with symptomatic mitral regurgitation (MR). There are limited data about early and no data about later hemodynamic consequences after MR correction and about the impact of elimination of regurgitant flow on cardiac output state . Methods: We studied invasive hemodynamic parameters before operation (conscious non-sedated patients, T1), immediately after MitraClip implantation (still under general anaesthesia, T2) and on day 1 (late) after procedure (conscious, extubated patients, T3) using right heart cathetrization. Results: Of 25 MitraClip patients (72% male; mean age 70y) with functional MR, in 20 were performed invasive measurements in all time points. MitraClip implantation resulted in an increase in cardiac index (CI) from 1.8±0.5 (T1) to 2.4±0.5(T2) and to 3.2±0.5 L/min/m2 (T3), in a decrease in systemic vascular resistance index (SVRI) from 3759±847 (T1) to 2508±551 (T2) and to 1679±360 dyn.s.cm-5/m2 (T3), in a decreese in pulmonary capillary wedge pressure (PCWP) from 17±5 (T1) to 13±5(T2) and to 10±4mmHg(T3), in a decrease in pulmonary vascular resistance index (PVRI) from 598±362 (T1) to 532±260 (T2) and to 363±184 dyn.s.cm-5/m2 (T3), (all p<0.05). Conclusion: MR reduction after successful MitraClip implantation significantly increases CI immediately (27%) and late (75%) and leads to concomitant decrease in SVRI, PVRI and PCWP immediately (33%, 11% and 25%) and late (55%, 39% and 41%) after procedure. No patients showed worsening of cardiac output state immediately (T2) and late (T3) after MR correction.

Objective: The present study aimed to compare characteristics related to selection of a P2Y(12) antagonist, investigate initiation of therapy with new-generation drugs, and identify predictors of high on-treatment platelet reactivity (HTPR) in patients with acute coronary syndrome treated with stent percutaneous coronary intervention (PCI).Methods and Results: Data from 589 patients in the LAPCOR(Laboratory AntiPlatelet efficacy and Clinical Outcome Registry; ClinicalTrials.gov Identifier: NCT02264912) registry was analyzed. P2Y(12) receptor antagonist efficacy was measured by VASP phosphorylation 24 +/- 4 hours after a loading dose of clopidogrel (600 mg, N = 407), prasugrel (60 mg, N = 106), or ticagrelor (180 mg, N = 76) and expressed by platelet reactivity index (PRI). HTPR was defined as PRI >= 50%. Patients treated with prasugrel were significantly younger and had significantly higher hemoglobin levels than those who received clopidogrel or ticagrelor, while chronic kidney disease was significantly more prevalent in the ticagrelor group. Almost all invasively managed patients given new-generation drugs received a loading dose after coronary angiography. Mean residual PRI and HTPR were significantly higher after clopidogrel (44.2 +/- 23.1% and 42.2%, respectively) vs. prasugrel (17.7 +/- 18.0% and 9.4%, respectively) or ticagrelor (18.8 +/- 17.0% and 7.9%, respectively; all p < 0.001). Among multiple variables tested, HTPR in patients treated with the new agents significantly related only to platelet count (p = 0.014) and mean platelet volume (p = 0.03).Conclusion: Safety is the most important aspect under consideration in choosing new agents for an individual patient. Other than platelet count and mean platelet volume, factors known as predictors of higher platelet reactivity, did not influence the efficacy of new-generation P2Y(12) receptor antagonists. (C) 2015 Elsevier Ltd. All rights reserved.