Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a standard therapeutic option for patients with severe aortic stenosis (AS) at high cardiac surgical risk. The aim of the NAUTILUS study was to investigate the safety and performance of the New Valve Technology (NVT) Allegra bioprosthesis in high-risk patients undergoing TAVI. METHODS: Twenty seven patients with severe, symptomatic AS at high surgical risk were prospectively enrolled, who underwent treatment using the novel self-expanding NVT Allegra bioprosthesis via transfemoral approach (TF-TAVI). The primary end-point was all-cause mortality at 30 days. RESULTS: Patients were elderly (83 years, range 75-89 years), and predominantly female (70.4%, n = 19). All patients were deemed to be at high surgical risk, with a mean logistic EuroSCORE of 12.4% (range, 2.8-31.8%). The bioprosthesis was successfully implanted in 96% of the cases (n = 25). The echocardiographic assessment confirmed good hemodynamic profile after implantation of the NVT Allegra bioprosthesis. Complications included cardiac tamponade (4%, n = 1) and the need for permanent pacemaker implantation (8%, n = 2). The analysis of procedural aspects showed a short learning effect related to the precise placement of the valve. A significant improvement in clinical symptoms were observed, and no patients died in-hospital or within 30 days of post-discharge observation. CONCLUSIONS: This prospective observation shows that the NVT Allegra bioprosthesis was associated with a satisfactory safety profile and a remarkable hemodynamic performance after implantation.

Opto-E-Dura: A Soft, Stretchable ECoG Array for Multimodal, Multiscale Neuroscience.

Soft, stretchable materials hold great promise for the fabrication of biomedical devices due to their capacity to integrate gracefully with and conform to biological tissues. Conformal devices are of particular interest in the development of brain interfaces where rigid structures can lead to tissue damage and loss of signal quality over the lifetime of the implant. Interfaces to study brain function and dysfunction increasingly require multimodal access in order to facilitate measurement of diverse physiological signals that span the disparate temporal and spatial scales of brain dynamics. Here the Opto-e-Dura, a soft, stretchable, 16-channel electrocorticography array that is optically transparent is presented. Its compatibility with diverse optical and electrical readouts is demonstrated enabling multimodal studies that bridge spatial and temporal scales. The device is chronically stable for weeks, compatible with wide-field and 2-photon calcium imaging and permits the repeated insertion of penetrating multielectrode arrays. As the variety of sensors and effectors realizable on soft, stretchable substrates expands, similar devices that provide large-scale, multimodal access to the brain will continue to improve fundamental understanding of brain function.

Evaluation of Local Tissue Reaction After the Application of a 3D Printed Novel Holdfast Device for Left Atrial Appendage Exclusion.

The left atrial appendage (LAA) is a small, finger-like extension of the left atrium and its exclusion is used as a treatment strategy to prevent ischemic stroke. Existing holdfast devices may damage the tissue, are unisized and not adjustable. A novel holdfast device for LAA exclusion devoid of these shortcomings was designed and 3D-printed using the Selective Laser Sintering (SLS) technology with polyamide powder and tested it on animal model. We selected the SLS 3D printing technology due to its wid14e availability and low production costs which could provide on-site 3D printing for specific patient. The purpose of this study was to evaluate the biocompatibility of the reported holdfast device and compare the histological results obtained for local tissue reactions to those obtained for an established grafting material. Thirty swine subdivided into two groups were examined. The LAA exclusion device was implanted and was either coated with a polyester vascular implant or not coated at all and the histological response to the device's presence was evaluated which is a standard approach to test the device biocompatibility. In all cases, complete occlusion was seen without any pathological findings during the incubation time. In both groups, the surface of the atrium under a holdfast device was smooth and shiny and had no clots. The foreign body reaction of the LAA holdfast device made of polyamide powder was insignificantly lower compared to the polyester graft. Thus, it fulfils the parameters of biocompatibility at the highest degree, and makes it suitable material for the manufacturing of LAA holdfast devices.

Long-term clinical outcomes from real-world experience of left atrial appendage exclusion with LARIAT device.

BACKGROUND: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure. METHODS: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group. RESULTS: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS2 and CHA2 DS2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group. CONCLUSIONS: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field.

Current methods for the assessment of skin microcirculation: Part 1.

Microcirculation accounts for about 99% of blood vessels in adults and mediates between the arterial and venous parts of the cardiovascular system, both structurally and functionally. Skin microcirculation consists of two vascular plexuses: superficial and deep. Microcirculation includes vessels with a diameter of less than 150 µm, i.e. arteries, small veins, lymphatic vessels and arteriovenous anastomoses, which build the microcirculation unit. Skin microcirculation may be affected both in systemic pathologies and specific skin disorders. Several non-invasive techniques are available to assess the skin microcirculation. The clinical value is recognised for capillaroscopy and videocapillaroscopy, laser Doppler flowmetry thermography and transcutaneous oxygen measurement. The list of methods that may be used in clinical research also includes: photoplethysmography, orthogonal spectral polarization, near infrared spectroscopy and tissue reflectance spectrophotometry and optical coherence tomography.

The Influence of Haemostatic Dressing Prototypes for the Emergency Services on the Histopathological Parameters of Porcine Muscle.

BACKGROUND/AIM: Haemostatic dressings for the uniformed and rescue services are an integral part of life-saving equipment for controlling post-traumatic haemorrhage. The aim of this study was to assess the influence of active constituent substances and materials of haemostatic dressings on muscle tissue and muscle regeneration after traumatic injury. MATERIALS AND METHODS: Three hemostatic dressing prototypes were analysed: OBR/G/S sponge: dressing material sponge made of Na-Ca chitosan/algal composite microfibers and nanofibers; OBR/MBT/S: tactic gauze modified with a polymer mixture of Na-Ca chitosan/algal composite microfibers and nanofibers, impregnated with a moderate amount of procoagulants (22.9 g/m2); and OBR/MS/S: seton gauze modified with a polymer mixture of Na-Ca chitosan/algal composite microfibers and nanofibers, impregnated with a moderate amount of procoagulants (18.0 g/m2), with chitosan (ChitoClearhqg 95) and sodium alginate (Protanal LF10/60 FT) as the coagulants. The experiment was conducted on 20 pigs which were euthanised 24 h, 7 or 14 days after wound dressing. Samples of porcine muscle tissue were subjected to qualitative histopathological analysis. RESULTS: Histopathological analysis of muscle tissues from the experimental pigs revealed that the application of modified seton (OBR/MS/S) produced the most satisfactory results. The observed changes were similar on all dates that samples were collected and in all experimental groups, and minor differences in their extent were observed between groups. Regenerative processes were most advanced, and retrograde changes were least apparent in animals treated with OBR/MS/S. CONCLUSION: Modified seton (OBR/MS/S) induced the least tissue reaction and was most effective in promoting tissue regeneration after injury.

The Effect of Haemostatic Dressing Prototypes for the Emergency Services in the Porcine Haemostatic System.

BACKGROUND/AIM: Coagulopathy can develop when hemostatic dressings are used to stop massive bleeding, even in patients without prior history of clotting disorders. The selection of procoagulants, which effectively control bleeding and prevent disseminated intravascular coagulation (DIC) and thrombosis, is a significant challenge. The aim of this study was to evaluate the effect of two prototypes of haemostatic dressing in the porcine haemostatic system. MATERIALS AND METHODS: The total number of animals used in our experiments was 24. Group I: pigs were treated with the developed prototype of sponge dressing, made of Na-Ca chitosan/algal composite of microfibers and nanofibers. Group II: animals were treated with a seton gauze modified with a polymer mixture of Na-Ca chitosan/algal composite of microfibers and nanofibers. Group III: animals were treated with non-hemostatic dressing and this group was the control. Blood was sampled five times to determine changes in the coagulation and fibrinolytic profiles: before injury: i) at 1 h, ii) at 24 h, iii) at 7, and iv) at 14 days following injury. RESULTS: Significant changes were observed in the coagulation parameters, in the total numbers of white blood cells and platelets in groups I and II, compared to controls. CONCLUSION: The modified haemostatic dressings used in this study produced a strong procoagulant effect in pigs. This, together with high fibrinogen concentrations, which can cause DIC, require further studying.

Left atrial appendage occlusion for stroke prevention in diabetes mellitus patients with atrial fibrillation: Long-term results.

BACKGROUND: Concomitant diabetes mellitus (DM) in atrial fibrillation (AF) may increase the risk of thromboembolism. Left atrial appendage occlusion (LAAO) is an alternative treatment in AF patients in whom antithrombotic therapy is ineffective or contraindicated. The aim of this study was to evaluate the long-term efficacy of LAAO in DM patients with AF. METHODS: A retrospective study was conducted in 139 patients who had undergone LAAO and were categorized into two groups: 28 patients with DM and 111 patients without DM. Overall, the follow-up period was 530 patient-years. RESULTS: Mean CHADS2 and CHA2 DS2 -VASc scores were higher in patients with than without DM (2.6 vs 1.7 [P < 0.001] and 3.5 vs 2.8 [P = 0.056], respectively). There were no significant differences between the two groups in terms of HAS-BLED scores and other patient factors (sex, age, heart failure, hypertension, previous stroke or transient ischemic attack, peripheral vascular disease) that may increase the risk of thromboembolism based on CHA2 DS2 -VASc. The mean follow-up period was 51.6 and 50 months in patients with DM and without DM, respectively. Comparing patients with and without DM, there were no significant differences in thromboembolic events (4% vs 1.9%), severe bleeding (0% vs 3.1%), or mortality (4% vs 5.9%). The estimated reductions in thromboembolic and bleeding risk were 77% and 100%, respectively, for patients with DM, compared with 85% and 62%, respectively, for patients without DM. CONCLUSION: The present study indicates that LAAO in AF patients with DM has similar safety endpoints and long-term efficacy as LAAO in patients without DM.

Long term outcomes after left atrial appendage closure with the LARIAT device-Stroke risk reduction over five years follow-up.

INTRODUCTION: Left atrial appendage closure (LAAC) with LARIAT offers an alternative to oral anticoagulation (OAC) for patients with atrial fibrillation. The aim of this study was to present long-term clinical outcomes of LAAC in these patients (AF). MATERIAL AND METHODS: A prospective, single-center study was performed in 139 patients undergoing LAAC with Lariat. Thromboembolic events, severe bleeding and mortality rate were recorded. The reduction in risk of thromboembolism and bleeding after LAAC was calculated. RESULTS: The mean CHADS2-score was 1.8 ± 1.0, mean CHA2DS2-VASc score was 2.9 ± 1.6 and HAS-BLED score was 3.1 ± 1.1. After 428.4 patient-years of follow-up (mean 4.2±1.0 years), the thromboembolism rate was 0.6% with a calculated thromboembolism risk reduction of 81%. The severe bleeding rate was 0.8%; calculated bleeding risk reduction was 78%. The overall mortality rate was 1.6%. CONCLUSIONS: Long-term outcomes show that LAAC with Lariat is a safe and effective treatment for stroke prevention and bleeding risk reduction in AF patients with a high level of underlying risk.

Health-related quality of life following transcatheter aortic valve implantation using transaortic, transfemoral approaches and surgical aortic valve replacement-a single-center study.

OBJECTIVE: To evaluate short- and long-term changes in quality of life (QoL) in patients undergoing transcatheter aortic valve implantation (TAVI) and to assess differences in patient QoL when using the TAVI transaortic (TAVI TAo) approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR). METHODS: Ninety-seven patients were assessed. Thirty-two patients underwent TAVI TAo, 31 underwent TAVI TF and 34 patients underwent SAVR. QoL was assessed using the EQ-5D-3L questionnaire at baseline, after one month and one year. RESULTS: Mean patient age was 80 years (range, 61-92 years) and the mean logistic EuroSCORE was 12.45% (range, 1.39%-78.98%). Declared health state at baseline was significantly lower in TAVI TF (P < 0.001) and after one month there were no differences between the three groups (P = 0.99). After one year, SAVR patient results of the EQ-5D-3L index value were lower in comparison to both TAVI patient groups (P < 0.05). The analysis also showed significant differences between the results of EQ-5D-3L index value over the one month and one year follow-up (TAVI TAo, P < 0.001; TAVI TF, P < 0.05; SAVR, P < 0.05). In all groups, the values significantly increased after one-month and one-year of follow-up in comparison to baseline value. Significant differences were also demonstrated between Visual Analogue Scale values (VAS). CONCLUSIONS: A significant improvement in QoL was observed in all three patient groups. Regardless of the TAVI approach, EQ-5D-3L and VAS values were significantly increased after one-month and one-year follow up; the SAVR patients however, reported lower health status when compared to the TAVI patients.

Clinical factors predicting blood pressure reduction after catheter-based renal denervation.

INTRODUCTION: Renal denervation (RD) can lead to a significant and sustained decrease in mean values of arterial blood pressure (BP). However, there is still a subset of patients without a significant BP drop after RD (non-responders). AIM: To compare characteristics of RD responders to RD non-responders and to identify the clinical predictors of BP reduction. MATERIAL AND METHODS: Thirty-one patients with diagnosed resistant hypertension underwent RD. Three years after RD the analysis of BP reduction was performed in regard to the baseline patient characteristics. RESULTS: After 3 years' follow-up a 10% or more reduction of systolic baseline BP was observed in 74% of patients. Ten percent or more reduction of diastolic baseline BP was observed in 71% of patients. Among responders we observed the following risk factors: hypercholesterolemia in 70%, body mass index (BMI) > 30 kg/m2 in 55%, diabetes mellitus in 35%, current smoking in 5%. Comorbidity included coronary artery disease (CAD) in 30%, cardiomyopathy in 10%, chronic obstructive pulmonary disease (COPD) in 10%, renal insufficiency in 10%, and ventricular arrhythmia in 5%. Among non-responders we observed the following risk factors: hypercholesterolemia in 38%, diabetes mellitus type 2 in 38% and BMI > 30 kg/m2 in 86%. Comorbidity included CAD in 50% and cardiomyopathy in 13% of patients. CONCLUSIONS: A 10% reduction of systolic baseline BP was observed in 74% of patients 3 years after renal denervation. Clinical factors like COPD, chronic kidney disease 3a, female sex and hypercholesterolemia increase the chances of effective reduction of BP.

Clinical, biochemical and genetic risk factors for 30-day and 5-year mortality in 518 adult patients subjected to cardiopulmonary bypass during cardiac surgery - the INFLACOR study.

There is increasing evidence that genetic variability influences patients' early morbidity after cardiac surgery performed using cardiopulmonary bypass (CPB). The use of mortality as an outcome measure in cardiac surgical genetic association studies is rare. We publish the 30-day and 5-year survival analyses with focus on pre-, intra-, postoperative variables, biochemical parameters, and genetic variants in the INFLACOR (INFLAmmation in Cardiac OpeRations) cohort. In a prospectively recruited cohort of 518 adult Polish Caucasians, who underwent cardiac surgery in which CPB was used, the clinical data, biochemical parameters, IL-6, soluble ICAM-1, TNFα, soluble E-selectin, and 10 single nucleotide polymorphisms were evaluated for their association with 30-day and 5-year mortality. The 30-day mortality was associated with: pre-operative prothrombin international normalized ratio, intra-operative blood lactate, postoperative serum creatine phosphokinase, and acute kidney injury requiring renal replacement therapy (AKI-RRT) in logistic regression. Factors that determined the 5-year survival included: pre-operative NYHA class, history of peripheral artery disease and severe chronic obstructive pulmonary disease, intra-operative blood transfusion; and postoperative peripheral hypothermia, myocardial infarction, infection, and AKI-RRT in Cox regression. Serum levels of IL-6 and ICAM-1 measured three hours after the operation were associated with 30-day and 5-year mortality, respectively. The ICAM1 rs5498 was associated with 30-day and 5-year survival with borderline significance. Different risk factors determined the early (30-day) and late (5-year) survival after adult cardiac surgery in which cardiopulmonary bypass was used. Future genetic association studies in cardiac surgical patients should account for the identified chronic and perioperative risk factors.

Mid-term follow-up after suture-less aortic heart valve implantation.

BACKGROUND: Aortic stenosis (AS) is the most common valve disease in the adult population and its prevalence increases with age. Unfortunately, older age and comorbidities significantly increase mortality, operative risk and worsen prognosis. In recent years, sutureless bioprosthesis [sutureless-aortic valve replacement (SU-AVR)] has become an alternative to standard AVR or TAVI in high-risk patients. Compared to standard AVR, the advantages of SU-AVR include shorter valve implantation, shorter aortic cross clamp (ACC) and cardiopulmonary bypass (CPB) times and higher valve EOA with more favorable hemodynamic parameters. Good early clinical and hemodynamic outcomes have been reported in several studies. However, although early SU-AVR results reported in the literature are encouraging, there are few results of long term follow-up. The aim of this study is to present long term echocardiographic hemodynamic outcomes of the Enable sutureless bioprosthesis. METHODS: The first human implantation of the Enable sutureless bioprosthesis was performed on the 13th January, 2005 by the authors of this manuscript. From that time until July 2008, 25 patients underwent isolated SU-AVR implantation. The median preoperative logistic EuroSCORE was 1.92±0.17 [standard deviation (SD)] and the STS score was 2.96±2.73. Preoperatively, 65.4% of patients were in NYHA class III or IV, the peak/mean gradient transaortic gradient was 84.6/52.1 mmHg. RESULTS: After the SU-AVR procedure, the average peak/mean aortic gradients were respectively: 12.9/7.1 mmHg at the intraoperative time; 18.1/9.5 mmHg at 3-6 months; 18.3/9.6 mmHg at 11-14 months; 16.9/9.3 mmHg at 2 years; 15.3/8 mmHg at 3 years; 13.4/7.1 mmHg at 4 years; 16.7/8.9 mmHg at 5 years follow-up. Other hemodynamic echocardiographic parameters such as LVOT diameter, LVOT peak velocity, LVOT TVI, valve peak velocity and valve TVI were stable during the follow-up period. CONCLUSIONS: In summary, sutureless bioprostheses are safe and effective treatments for valve stenosis with excellent outcomes and hemodynamic profile which remained stable during the follow-up period. The peak and mean gradients were 16.7 and 8.9 mmHg, respectively, over a 5-year follow-up period.

Ministernotomy or sternotomy in isolated aortic valve replacement? Early results.

INTRODUCTION: Aortic valve replacement (AVR) is the gold standard in treating symptomatic aortic valve defects. To improve the healing process and limit the trauma, the minimally invasive approach was introduced. AIM: To compare the peri- and post-operative results of aortic valve replacement performed via conventional full sternotomy (con-AVR) and of AVR performed via partial upper sternotomy (mini-AVR). MATERIAL AND METHODS: The total study population was divided into 2 demographically homogeneous groups: mini-AVR (n = 74) and con-AVR (n = 76). There were no statistically significant differences in preoperative echocardiography. RESULTS: Aortic cross-clamp time and cardiopulmonary bypass time were significantly longer in the mini-AVR group. Shorter mechanical ventilation time, hospital stay and lower postoperative drainage were observed in the mini-AVR group (p < 0.05). Biological prostheses were more frequently implanted in the mini-AVR group (p < 0.05). Patients from the mini-AVR group reported less postoperative pain. No significant differences were found in the diameter of the implanted aortic prosthesis, the amount of inotropic agents and painkillers, postoperative left ventricular ejection fraction (LVEF), medium and maximum transvalvular gradient or the number of transfused blood units. There were no differences in the frequency of postoperative complications such as mortality, stroke, atrial fibrillation, renal failure, wound infection, sternal instability, or the need for rethoracotomy. CONCLUSIONS: Ministernotomy for AVR is a safe method and does not increase morbidity and mortality. It significantly reduces post-operative blood loss and shortens hospital stay. Ministernotomy can be successfully used as an alternative method to sternotomy.

Improvement of quality of life following transcatheter aortic valve implantation in the elderly: a multi-centre study based on the Polish national TAVI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an effective therapeutic method for elderly high-risk patients with symptomatic severe aortic stenosis, not eligible for surgical treatment. AIM: The aim of the study was to evaluate short-term changes in elderly people's quality of life following TAVI, based on the POL-TAVI registry. METHODS: One hundred and eighty-four octogenarians' and nonagenarians' samples from the POL-TAVI database were included in the study. The quality of life status was assessed with EQ-5D-3L questionnaire at baseline and after one-month follow-up. RESULTS: The mean of patients' age was 84 (80-93) years. Logistic EuroSCORE mean was 19.83% (3.48-83.94%), and transaortic mean gradient was 54.99 (19.0-149.0) mm Hg. At baseline, up to 24.50% of patients declared severe problems in performing usual activities. 13.60% felt extreme pain or discomfort; 9.80% were unable to wash and dress by themselves; 8.20% were extremely anxious or depressed; and 7.10% of the patients in the study were confined to bed. After 30 days the percentage of patients declaring severe problems in each dimension did not exceed 4.00%. The comparison between quality of life data at baseline and after one-month follow-up showed a significant improvement in each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (p < 0.001). Patients' quality of life was increasing regardless of gender (female vs. male), the type of anaesthesia (general vs. local), and the type of procedure (TA vs. TF). CONCLUSIONS: Short-term quality of life in the elderly subjects was significantly improved after one-month follow-up following TAVI.

Complete atrioventricular block after isolated aortic valve replacement.

BACKGROUND: Temporary atrioventricular (AV) conduction disturbances are a common complication following cardiac surgery, especially involving the aortic valve. Permanent complete AV block is a serious and rare complication. Its prevalence has been estimated at 3-6% of all patients undergoing aortic valve replacement. Identification of factors that affect the occurrence of complete AV block requiring permanent pacemaker implantation might help reduce the risk of this problem in the future. AIM: To evaluate clinical, anatomical and surgical factors that might affect occurrence of complete AV, resulting in the need for permanent pacemaker implantation. METHODS: In our prospective study, we analysed clinical data of consecutive 159 patients operated due to isolated aortic valve disease between February 2011 and March 2012. Patients with a pacemaker implanted before that time were excluded from the study. The main indication for surgery was aortic stenosis (n = 114, 71.7%). Infectious endocarditis was an indication in 6 (3.8%) cases. Mean patient age was 65.3 ± 11.4 years, and the proportion of males to females was 56.6%/43.4%. Overall, 135 (84.9%) patients had sinus rhythm preoperatively. All operations were performed using median sternotomy, cardiopulmonary bypass, and hypothermia at 30-32°C. A biological prosthesis was implanted in 120 (70.4%) patients. Patients who needed an additional procedure such as another valve surgery, aortic surgery or coronary artery bypass grafting were excluded from the study. RESULTS: Permanent pacemaker implantation was required in 11 (6.9%) patients. The pacemaker was implanted after at least 7 days of complete AV block which was then considered permanent. Univariate analysis showed that permanent pacemaker implantation was associated with prolonged cardiopulmonary bypass time, prolonged aortic cross-clamp time, and the occurrence of electrolyte disturbances. Univariate logistic regression revealed that the need for permanent pacemaker implantation depended on 5 factors including prolonged cardiopulmonary bypass time, prolonged aortic cross-clamp time, larger size of the implanted valve prosthesis, endocarditis as the indication for surgery, and electrolyte disturbances. In both backward and forward stepwise multivariate regression models, two parameters, prolonged aortic cross-clamp time and the presence of electrolyte disturbances, correlated with the occurrence of complete AV block. CONCLUSIONS: Permanent complete AV block is a serious complication after aortic valve surgery. Of all analysed clinical, anatomical and surgical factors, prolonged cardiopulmonary bypass time, prolonged aortic cross-clamp time, larger size of the implanted valve prosthesis, endocarditis as the indication for surgery, and electrolyte disturbances were found to be statistically significant predictors of permanent pacemaker implantation.

Transaortic transcatheter aortic valve implantation: Results of the Polish arm of the ROUTE registry.

BACKGROUND: Transaortic (TAo) transcatheter aortic valve implantation (TAVI) is an alter-native approach in patients considered to be at high risk for classical open surgery with poor peripheral vessel access. The purpose of this study was to determine the feasibility of using TAo access for TAVI procedures employing the Edwards SAPIEN transcatheter heart valve. The primary objective was to determine overall 30-day mortality. METHODS: A total of 32 patients with severe aortic valve stenosis underwent TAo-TAVI using Edwards SAPIEN bioprostheses. Postoperative results were collected according to the Registry of the Utilization Of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) study protocol. Complications were assessed using Valve Academic Research Consortium- 2 (VARC-2) criteria. RESULTS: The mean age of the population was 80.9 ± 5.2 years, with 53.1% being female. All patients received either the SAPIEN XT or the SAPIEN 3 bioprosthesis (Edwards Lifesciences). Device success was achieved in 100% of cases. One (3.25%) patient subsequently suffered an aortic dissection and required ascending aorta replacement. Paravalvular leakage was absent or mild in 26 (81%) patients, and moderate in 6 (19%) patients. Other complications included permanent pacemaker implantation in 2 (6.5%), and transient post operative delirium in 2 (6.5%) patients. The total hospital stay was 6.7 ± 2.4 days. New York Heart Association class decreased significantly on follow-up. Thirty-day mortality rate was 2 (6.5%) patients. CONCLUSIONS: Use of TAo access for TAVI procedures has a reasonable clinical outcome and is a safe alternative to the transfemoral and transapical approaches, especially for patients with high-risk peripheral vessel access.

Retroperitoneal fibrosis as a rare cause of lower limb claudication.

The study presented a case of a 58-year-old male patient treated for retroperitoneal fibrosis, right hydronephrosis, and right common iliac artery stenosis and saccular aneurysm of the above-mentioned vessel. The patient was qualified for endovascular treatment. Stentgraft implantation was performed with good long-term patency during more than 3 years of follow-up. Complete relief of intermittent claudication was observed. However, the endovascular exclusion of the aneurysm did not influence the course of retroperitoneal fibrosis.