Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Pre-Coronary Artery Bypass Grafting Computed Tomography-Based Fractional Flow Reserve Predicts Graft Failure: Implications for Planning Invasive Treatment of Coronary Artery Disease.

OBJECTIVE: The aim of the study is to evaluate whether a pre-coronary artery bypass grafting (CABG) coronary computed tomography-based fractional flow reserve (FFR-CT) result at the site of a future anastomosis would predict the graft failure in patients undergoing CABG. METHODS: In 43 patients who had coronary computed tomography angiography (CCTA) prior to the CABG, follow-up CCTA were acquired >12 months post-CABG procedure. The FFR-CT values were simulated on the basis of the pre-CABG CCTA. Based on follow-up CCTA, the anastomosis sites and the graft patency were determined. The graft failure was defined as either its stenosis >50% or occlusion. RESULTS: Ninety eight (44 saphenous, 54 left or right internal mammary artery) grafts were assessed. Eighteen grafts from 16 patients were dysfunctional on follow-up CCTA. The FFR-CT values at the location of future anastomosis were higher in dysfunctional than in normal grafts (0.77 [0.71-0.81] vs 0.60 [0.56-0.66], respectively, P = 0.0007). Pre-CABG FFR-CT (hazard ratio = 1.1; 95% CI: 1.012-1.1, P = 0.0230), and bypass graft to right coronary artery (hazard ratio = 3.7; 95% CI: 1.4-9.3 vs left anterior descending artery) were independent predictors of graft dysfunction during follow-up. The optimal threshold of FFR-CT to predict graft failure was >0.68 (sensitivity 88.9% (95% CI: 65.3-98.6), specificity 63.7% (95% CI: 52.2-74.2), positive predictive value 35.6% (95% CI: 28.3%-43.5%), negative predictive value 96.2% (95% CI: 87.2%-99.0%)). CONCLUSIONS: Pre-CABG functional FFR-CT predicts future coronary bypass graft failure. This shows utility of FFR-CT for guiding coronary revascularization and also suggests significance of physiological assessment prior to CABG.

Initial Invasive or Conservative Strategy for Stable Coronary Disease.

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Effects of initial invasive vs. initial conservative treatment strategies on recurrent and total cardiovascular events in the ISCHEMIA trial.

AIMS: The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial prespecified an analysis to determine whether accounting for recurrent cardiovascular events in addition to first events modified understanding of the treatment effects. METHODS AND RESULTS: Patients with stable coronary artery disease (CAD) and moderate or severe ischaemia on stress testing were randomized to either initial invasive (INV) or initial conservative (CON) management. The primary outcome was a composite of cardiovascular death, myocardial infarction (MI), and hospitalization for unstable angina, heart failure, or cardiac arrest. The Ghosh-Lin method was used to estimate mean cumulative incidence of total events with death as a competing risk. The 5179 ISCHEMIA patients experienced 670 index events (318 INV, 352 CON) and 203 recurrent events (102 INV, 101 CON). A single primary event was observed in 9.8% of INV and 10.8% of CON patients while ≥2 primary events were observed in 2.5% and 2.8%, respectively. Patients with recurrent events were older; had more frequent hypertension, diabetes, prior MI, or cerebrovascular disease; and had more multivessel CAD. The average number of primary endpoint events per 100 patients over 4 years was 18.2 in INV [95% confidence interval (CI) 15.8-20.9] and 19.7 in CON (95% CI 17.5-22.2), difference -1.5 (95% CI -5.0 to 2.0, P = 0.398). Comparable results were obtained when all-cause death was substituted for cardiovascular death and when stroke was added as an event. CONCLUSIONS: In stable CAD patients with moderate or severe myocardial ischaemia enrolled in ISCHEMIA, an initial INV treatment strategy did not prevent either net recurrent events or net total events more effectively than an initial CON strategy. CLINICAL TRIAL REGISTRATION: ISCHEMIA ClinicalTrials.gov number, NCT01471522, https://clinicaltrials.gov/ct2/show/NCT01471522.

Myocardial Infarction in the ISCHEMIA Trial: Impact of Different Definitions on Incidence, Prognosis, and Treatment Comparisons.

BACKGROUND: In the ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches), an initial invasive strategy did not significantly reduce rates of cardiovascular events or all-cause mortality in comparison with a conservative strategy in patients with stable ischemic heart disease and moderate/severe myocardial ischemia. The most frequent component of composite cardiovascular end points was myocardial infarction (MI). METHODS: ISCHEMIA prespecified that the primary and major secondary composite end points of the trial be analyzed using 2 MI definitions. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary definition used cardiac troponin. Procedural thresholds were >5 times the upper reference level for percutaneous coronary intervention and >10 times for coronary artery bypass grafting. Procedural MI definitions included (1) a category of elevated biomarker only events with much higher biomarker thresholds, (2) new ST-segment depression of ≥1 mm for the primary and ≥0.5 mm for the secondary definition, and (3) new coronary dissections >National Heart, Lung, and Blood Institute grade 3. We compared MI type, frequency, and prognosis by treatment assignment using both MI definitions. RESULTS: Procedural MIs accounted for 20.1% of all MI events with the primary definition and 40.6% of all MI events with the secondary definition. Four-year MI rates in patients undergoing revascularization were more frequent with the invasive versus conservative strategy using the primary (2.7% versus 1.1%; adjusted hazard ratio [HR], 2.98 [95% CI, 1.87-4.73]) and secondary (8.2% versus 2.0%; adjusted HR, 5.04 [95% CI, 3.64-6.97]) MI definitions. Type 1 MIs were less frequent with the invasive versus conservative strategy using the primary (3.40% versus 6.89%; adjusted HR, 0.53 [95% CI, 0.41-0.69]; P<0.0001) and secondary (3.48% versus 6.89%; adjusted HR, 0.53 [95% CI, 0.41-0.69]; P<0.0001) definitions. The risk of subsequent cardiovascular death was higher after a type 1 MI than after no MI using the primary (adjusted HR, 3.38 [95% CI, 2.03-5.61]; P<0.001) or secondary MI definition (adjusted HR, 3.52 [2.11-5.88]; P<0.001). CONCLUSIONS: In ISCHEMIA, type 1 MI events using the primary and secondary definitions during 5-year follow-up were more frequent with an initial conservative strategy and associated with subsequent cardiovascular death. Procedural MI rates were greater in the invasive strategy and with the use of the secondary MI definition. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

CT in Transcatheter-delivered Treatment of Valvular Heart Disease.

Minimally invasive strategies to treat valvular heart disease have emerged over the past 2 decades. The use of transcatheter aortic valve replacement in the treatment of severe aortic stenosis, for example, has recently expanded from high- to low-risk patients and became an alternative treatment for those with prohibitive surgical risk. With the increase in transcatheter strategies, multimodality imaging, including echocardiography, CT, fluoroscopy, and cardiac MRI, are used. Strategies for preprocedural imaging strategies vary depending on the targeted valve. Herein, an overview of preprocedural imaging strategies and their postprocessing approaches is provided, with a focus on CT. Transcatheter aortic valve replacement is reviewed, as well as less established minimally invasive treatments of the mitral and tricuspid valves. In addition, device-specific details and the goals of CT imaging are discussed. Future imaging developments, such as peri-procedural fusion imaging, machine learning for image processing, and mixed reality applications, are presented.

Predictors of outcome in the ISCHEMIA-CKD trial: Anatomy versus ischemia.

BACKGROUND: The ISCHEMIA-CKD (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches-Chronic Kidney Disease) trial found no advantage to an invasive strategy compared to conservative management in reducing all-cause death or myocardial infarction (D/MI). However, the prognostic influence of angiographic coronary artery disease (CAD) burden and ischemia severity remains unknown in this population. We compared the relative impact of CAD extent and severity of myocardial ischemia on D/MI in patients with advanced chronic kidney disease (CKD). METHODS: Participants randomized to invasive management with available data on coronary angiography and stress testing were included. Extent of CAD was defined by the number of major epicardial vessels with ≥50% diameter stenosis by quantitative coronary angiography. Ischemia severity was assessed by site investigators as moderate or severe using trial definitions. The primary endpoint was D/MI. RESULTS: Of the 388 participants, 307 (79.1%) had complete coronary angiography and stress testing data. D/MI occurred in 104/307 participants (33.9%). Extent of CAD was associated with an increased risk of D/MI (P < .001), while ischemia severity was not (P = .249). These relationships persisted following multivariable adjustment. Using 0-vessel disease (VD) as reference, the adjusted hazard ratio (HR) for 1VD was 1.86, 95% confidence interval (CI) 0.94 to 3.68, P = .073; 2VD: HR 2.13, 95% CI 1.10 to 4.12, P = .025; 3VD: HR 4.00, 95% CI 2.06 to 7.76, P < .001. Using moderate ischemia as the reference, the HR for severe ischemia was 0.84, 95% CI 0.54 to 1.30, P = .427. CONCLUSION: Among ISCHEMIA-CKD participants randomized to the invasive strategy, extent of CAD predicted D/MI whereas severity of ischemia did not.

Causes of cardiovascular and noncardiovascular death in the ISCHEMIA trial.

BACKGROUND: The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial demonstrated no overall difference in the composite primary endpoint and the secondary endpoints of cardiovascular (CV) death/myocardial infarction or all-cause mortality between an initial invasive or conservative strategy among participants with chronic coronary disease and moderate or severe myocardial ischemia. Detailed cause-specific death analyses have not been reported. METHODS: We compared overall and cause-specific death rates by treatment group using Cox models with adjustment for pre-specified baseline covariates. Cause of death was adjudicated by an independent Clinical Events Committee as CV, non-CV, and undetermined. We evaluated the association of risk factors and treatment strategy with cause of death. RESULTS: Four-year cumulative incidence rates for CV death were similar between invasive and conservative strategies (2.6% vs 3.0%; hazard ratio [HR] 0.98; 95% CI [0.70-1.38]), but non-CV death rates were higher in the invasive strategy (3.3% vs 2.1%; HR 1.45 [1.00-2.09]). Overall, 13% of deaths were attributed to undetermined causes (38/289). Fewer undetermined deaths (0.6% vs 1.3%; HR 0.48 [0.24-0.95]) and more malignancy deaths (2.0% vs 0.8%; HR 2.11 [1.23-3.60]) occurred in the invasive strategy than in the conservative strategy. CONCLUSIONS: In International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, all-cause and CV death rates were similar between treatment strategies. The observation of fewer undetermined deaths and more malignancy deaths in the invasive strategy remains unexplained. These findings should be interpreted with caution in the context of prior studies and the overall trial results.

Imaging risk features for device related pulmonary artery injury after left atrial appendage closure with Amplatzer™ Amulet™ device.

OBJECTIVES: This study aimed to find imaging risk features for device related-pulmonary artery (PA) injury (DR-PAI) in patients after left atrial appendage closure (LAAC). BACKGROUND: Cardiac tamponade resulting from DR-PAI is a rare but life-threatening complication of LAAC. METHODS: In vitro analysis of Amplatzer™ Amulet™ (Abbott, MN) device was done. Measurements of the distance between PA and Amplatzer lobe at its middle part, distal part, and along the stabilizing wires' trajectory (wires-to-PA distance) were taken in 100 consecutive patients on post-LAAC computed tomography (CT) studies. Clinical outcomes were collected. RESULTS: In vitro analysis indicated that both middle and distal lobe had to be in close PA proximity (<1.5 mm) for the stabilizing wires to cause risk for DR-PAI, configuration called ''cuddling lobe orientation''. On CT measurements middle lobe-PA distance was 4.7 mm (IQR = 2.7-9.5), with close proximity in 4 (4%) patients, and distal lobe-PA distance was 3.2 mm (IQR = 1.8-7.2 mm), with close proximity in 17 (17%) patients. Stabilizing wires were pointing toward PA in 47 patients (47%) with median wire-to-PA distance 5.7 mm (IQR = 3.6-8.5 mm). ''Cuddling'' was found in 2 (2%) patients and resulted in shorter wires-to-PA distance vs no ''cuddling'' group (2.3 vs 5.8 mm p <.01). At 2.9 ± 1.0 yrs of follow-up, the two patients with ''cuddling lobe orientation'' on post-LAAC CT scan developed late cardiac tamponades (p <.001). One of those required surgery, which confirmed DR-PAI. CONCLUSIONS: ''Cuddling lobe orientation'' of Amulet device with the PA was associated with short wires-to-PA distance and late pericardial effusions, including DR-PAI. Hence, such device-to-PA configuration should be avoided.

DASH diet decreases CXCL4 plasma concentration in patients diagnosed with coronary atherosclerotic lesions.

BACKGROUND AND AIMS: Aim of this study involved assessment of the intensive intervention concerning lifestyle based on the DASH diet model on plasma concentration of CXCL4 chemokine among patients with coronary atherosclerosis. METHODS AND RESULTS: The Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography Study randomized patients with stable CAD to an interventional group (n = 41), where DASH diet was implemented and the control group (n = 40) without dietary intervention. Dietary counselling was provided to DASH group during all 6 control visits within 6 months of observation. During the study, body weight and body composition were controlled using the bioimpedance method. CXCL4 concentration was determined with the use of ELISA test. Within the DASH group, a significant decrease in body weight, a decrease in high sensitivity C-reactive protein concentration (-0.32 ± 2.8 mg/l; p < 0.05), as well as a decrease in CXCL4 concentration (-3.35 ± 3.4 ng/ml; p < 0.0001) were observed. Occurring changes were not statistically significant within the control group. CONCLUSIONS: DASH diet lessens CXCL4 concentration among patients with a stable CAD, however, further research is necessary in order to confirm aforementioned results and evaluate the impact on atherosclerotic plaque. THIS TRIAL WAS REGISTERED AT: www.clinicaltrials.gov as NCT02571803.

A randomized comparison of modified subcutaneous "Z"-stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal.

OBJECTIVES: To compare subcutaneous "Z"-stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. BACKGROUND: Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. "Z"-stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. METHODS: This single center study randomized consecutive patients with femoral venous access sites requiring ≥10F sheaths to the "Z"-stitch or manual compression for hemostasis in a 2:1 fashion. There were three co-primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler-Duplex was performed with the stitch in place and after its removal. RESULTS: 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 ± 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10-22 F). Patients randomized to "Z"-stitch achieved hemostasis quicker [<1 min vs. 12.0 (IQR 10.0-15.0) min, P < 0.001] and ambulated sooner [7.0 (IQR 4.0-12.0) vs. 16.0 (IQR 11.8-20.3) hr post procedure, P < 0.001] when compared with manual compression alone. The "Z"-stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09-0.76, P = 0.01). All imaged veins were patent before and after stitch removal. CONCLUSIONS: The "Z"-stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. © 2017 Wiley Periodicals, Inc.

Patterns of Coronary Calcification and Their Impact on the Diagnostic Accuracy of Computed Tomography Coronary Angiography.

OBJECTIVE: Despite coronary calcifications being a major factor affecting the diagnostic accuracy of coronary computed tomography angiography (CTA), there is a lack of established criteria for categorizing calcifications. We aimed to evaluate patterns of coronary calcification based on quantitative radiodensity and size parameters to provide coronary calcium categories and assess their impact on the accuracy of coronary CTA. METHODS AND RESULTS: We analyzed length, maximum thickness, volume, mean density, and maximum density of coronary calcium and divided each of these parameters into tertiles. Subsequently, we summarized the tertiles for each individual calcification and divided them into 3 equal groups of: mild, moderate, and severe calcification. The accuracy of coronary CTA was defined as the difference between the measurements obtained on coronary CTA versus the reference of intravascular ultrasound (IVUS). We evaluated 252 coronary calcifications within 97 arteries of 60 patients. There was an expected increase in size and density values for mild versus moderate versus severe calcifications, but there was no difference in IVUS measured minimum lumen area among the 3 groups. Of note, coronary CTA significantly underestimated IVUS minimum lumen area measurement by 1.2 ± 1.6 mm (14.6 ± 23.1%, P < 0.001) for severe calcifications and by 0.5 ± 2.0 mm (3.7 ± 32.1%, P = 0.021) for moderate calcifications. Within mild calcifications, the difference was not significant. CONCLUSION: Based on their dimensional and radiodensity characteristics, our analysis revealed patterns of individual coronary artery calcifications that affected the accuracy of coronary CTA measurements; coronary CTA inaccuracy was associated with the presence of moderate or severe calcifications, but not mild calcifications.

Is Transcatheter Tricuspid Valve-In-Valve Implantation Feasible in the Presence of Right Atrial Thrombus?

The case is reported of a successful transcatheter implantation of an Edwards SAPIEN 3 valve (29 mm) into a failing tricuspid bioprosthesis (Sorin Pericarbon, 31 mm). The procedure was performed in a 69-year-old woman with post-rheumatic mitral and tricuspid valve disease. Multiple previous cardiac surgeries precluded the use of another surgical approach. A large, organized, two-piece thrombus in the enlarged right atrium was not considered an absolute contraindication to the procedure. The SAPIEN 3 valve was implanted under general anesthesia, via a femoral venous access, under three-dimensional transesophageal echocardiography guidance. Postoperatively, the systolic right ventricular pressure was increased from 35 to 52 mmHg, but good function of the implanted valve was confirmed with transthoracic echocardiography. The clinical outcome was favorable and the patient was discharged home 72 h after the intervention. Video 1: Transthoracic echocardiography. Tricuspid color Doppler flow after the procedure. Video 2: Fluoroscopy. Fully expanded Edwards SAPIEN 3 valve in the tricuspid position. Video 3: Fluoroscopy. Expansion of the Edwards SAPIEN 3 valve on the balloon. Video 4: Fluoroscopy. Introduction of the Edwards SAPIEN 3 valve into the right atrium. Video 5: Transthoracic echocardiography. Tricuspid color Doppler flow before the procedure.

Transcatheter Valve-in-Valve Implantation in a Degenerated Mitral Bioprosthesis Using a Trans-Septal Anterograde Approach and 3-D Transesophageal Echocardiography Guidance.

Degenerated and dysfunctional prosthetic valves are usually replaced surgically. However, repeated cardiac surgery can cause prohibitive risk, especially in patients with many associated co-morbidities. Transcatheter valve-in-valve implantation (TVIV) is a novel, technically very challenging, but less invasive alternative treatment for patients with unacceptably high surgical risk of degenerated prosthetic valves. The method is attractive because it takes advantage of the presence of the degenerated prosthesis, which serves as an anchoring zone. Here, the case is presented of TVIV in an 82-year-old female with significant stenosis of a biological mitral prosthesis. In 2011, Himbert et al. were the first to successfully insert a transcatheter heart valve in the mitral ring using a transfemoral approach. To date, only a small case series has been reported on the effectiveness of TVIV using a transfemoral venous access and a trans-septal anterograde approach. The present patient was the first in which TVIV was performed in Poland and Eastern Europe.

Utility of automated template matching for the interpretation of pace mapping in patients ablated due to outflow tract ventricular arrhythmias.

AIMS: One of the disadvantages of classic pace mapping (PM) is the operator's subjective interpretation. The aim of this single-centre retrospective study was to evaluate the value of automated template matching (AMT) in patients ablated due to ventricular outflow tract arrhythmias (OTAs). METHODS AND RESULTS: From an overall group of 105 patients with OTA who were scheduled for transcatheter ablation (TA), AMT was accessible in 42 patients [21 right ventricular outflow tract (RVOT), 21 left ventricular outflow tract (LVOT), 28 women, aged 51.5 ± 12.7 years]. We used AMT to compare spontaneous arrhythmia ORS (spontQRS) with paced QRS complexes during PM in sites where radiofrequency (RF) applications were successful and in sites where RF applications were unsuccessful. The concordance was presented in per cents as objective matching scores (OMS). Then, at the successful ablation sites, we examined the relationship between OMS and the visual interpretation of PM was presented as electrophysiologists matching scores (EMS). The OMS of PM at sites of successful ablation varied from 78 to 99% (mean 94.1 ± 3.8) and from 47 to 95% (mean 80.2 ± 12.6%) at sites of unsuccessful ablation. Pace mapping in unsuccessful RF sites was significantly less similar to spontQRS morphologies than in successful RF sites (P = 0.0001). There was a significant correlation between OMS and EMS (r = 0.82; P < 0.0001). The OMS that indicated optimal ablation site was 89% (sensitivity = 95%; specificity = 80%). The mean OMS for successful sites at RVOT (95.1 ± 1.8%) and LVOT (93.1 ± 4.9%) were not different (P = 0.0551). CONCLUSION: This analysis revealed that AMT is a valuable technique for the interpretation of PM and for the identification of successful ablation sites in OTA.

Percutaneous Edwards SAPIEN(™) valve implantation for significant pulmonary regurgitation after previous surgical repair with a right ventricular outflow patch.

BACKGROUND: Current indications for percutaneous pulmonary valve implantation (PPVI) are limited to patients who had their outflow tracts repaired with the use of a "full" condui-homograft. Patients after a patch repair are believed to have an unfavorable anatomy for PPVI. OBJECTIVES: To evaluate a novel use of Edwards SAPIEN(TM) valve for percutaneous treatment of moderate and severe pulmonary regurgitation after tetralogy of Fallot (TF) repair with a right ventricular outflow (RVOT) patch. METHODS: PPVI was intended in 10 patients (age 21-39 years, 2 ♂) with regurgitant fraction of 30-59%, measured by cardiac magnetic resonance imaging (CMRI) 16-30 years after repair with a RVOT patch. Balloon test-inflations were used for definitive measurements and location of the landing site for the valve. All RVOTs were prestented. RESULTS: Successful valve implantation was achieved in nine patients. In one patient a bare-metal stent used for prestenting embolized into pulmonary artery. A 26-mm valve was implanted in seven and a 23-mm in two patients. CMRI at 1-2 month follow-up (n = 8) demonstrated both, sustained relief of pulmonary incompetence (regurgitant fraction = 0-14%) and significant decrease of the right ventricular end-diastolic volume indexes (from 169.9 ± 43.8 to 140.0 ± 40.3 ml/m(2) , P < 0.001). At that follow-up no adverse event occurred. No stent fractures were observed. CONCLUSIONS: We report the first case series of patients with significant PR after a RVOT patch repair, successfully treated with a percutaneous Edwards SAPIEN(TM) valve implantation. The procedure is technically feasible and may be offered to patients with the outflow tracts larger than those limited by the Melody(®) system available currently.

Vascular complications after transcatheter aortic valve implantation (TAVI): risk and long-term results.

UNLABELLED: Vascular complications are the main safety limitations of transcatheter aortic valve implantation (TAVI). The aim of the study was to assess the incidents, predictors, and the impact of early vascular complications on prognosis after TAVI. This was a single-center analysis of vascular complications related to TAVI. Early vascular complications were defined as incidents within 30 days after TAVI and comprised complications related to transvascular: transfemoral/transsubclavian ,and transapical bioprosthesis implantation. Evaluated risk factors were: (1) clinical characteristics, (2) TAVI route, and (3) center experience. In patients with transvascular TAVI the impact of: (1) diameters of access arteries, vascular sheathes and difference between them, (2) arterial wall calcification, and (3) ProStar devices used for access site closure were assessed. Arterial wall calcification and arteries diameters were measured by 64-slice computer tomography. Arterial wall calcification was graded according to 5° scale. RESULTS: between 2009-2011; follow-up 1-23 months (12 ± 15.55), 83 consecutive patients, and 62-91 (81.10 ± 7.20) years, underwent TAVI: 67 (80.72%) patients had transvascular, and 16 (19.27%) patients had transapical bioprosthesis implantation. We noted 44 (53.01%) early vascular complications: 17 (20.48%) were major and 27 (32.53%) were minor incidents. Independent predictors of early vascular complications were: history of anaemia (OR 3.497: 95% CI [1.276-9.581]; p = 0.014), diabetes (OR 0.323: 95% CI [0.108-0.962]; p = 0.042), percutaneous coronary intervention performed as preparation for TAVI (OR 4.809: 95 % CI [1.172-19.736]; p = 0.029), and arterial wall calcification (OR 1.945: 95% CI [1.063-3.558]; p = 0.03). Of 6 (7.22%) in-hospital and 10 (12.98%) late deaths: 5 (83.33%) patients and 8 (80%) patients respectively had post-procedural vascular complications. Vascular complications, which occurred in 30-days after TAVI, predict late mortality (p = 0.036). Conclusions derived were: (1) TAVI patients with history of anaemia and diabetes required careful monitoring for early vascular complications. (2) If coronary intervention before TAVI is required, it should be performed in the time allowing vascular injuries to heal. (3) Calcification of access arteries is an independent predictor of post-procedural vascular complications; therefore, its estimation should be a regular element of preceding computer tomography. (4) Vascular complications seem to be predictors of late mortality after TAVI.

Electrocardiographic characteristics of the right ventricle following hemodynamic improvement after percutaneous pulmonary valve implantation, one year follow-up.

Percutaneous pulmonary valve implantation (PPVI) is an alternative to open-heart surgery in patients with congenital heart defect. The purpose of the study is to evaluate right ventricle (RV) electrocardiographic characteristics in relation with hemodynamic changes after PPVI. In 30 patients (16 males, aged 24±7years), ECG RV characteristics changes (R amplitude in V1 and aVR, Sokolow-Lyon index (SL) for RV hypertrophy, QRS duration) from before and 1year after PPVI were correlated with changes in RV end-diastolic volume (RVEDV), RV end-systolic volume (RVESV), RV ejection fraction (RVEF), RV mass in cardiac magnetic resonance (cMRI) and within pulmonary gradient in echocardiography. Significant correlations were observed: decrease R amplitude in aVR correlated to decrease RVESV and RV mass; decrease RVESV and pulmonary gradient to reduction in SL-V5; increase RVEF to reduction R aVR and SL-V5. Improvement of hemodynamic parameters in cMRI and echocardiography is parallel to that of electrocardiographic criteria of RV hypertrophy.

Biomarkers in Peripartum Cardiomyopathy-What We Know and What Is Still to Be Found.

Peripartum cardiomyopathy (PPCM) is a form of heart failure, often severe, that occurs in previously healthy women at the end of their pregnancy or in the first few months after delivery. In PPCM, the recovery of heart function reaches 45-50%. However, the all-cause mortality in long-term observation remains high, reaching 20% irrespective of recovery status. The incidence of PPCM is increasing globally; therefore, effort is required to clarify the pathophysiological background of the disease, as well as to discover specific diagnostic and prognostic biomarkers. The etiology of the disease remains unclear, including oxidative stress; inflammation; hormonal disturbances; endothelial, microcirculatory, cardiomyocyte and extracellular matrix dysfunction; fibrosis; and genetic mutations. Currently, antiangiogenic 16-kDa prolactin (PRL), cleaved from standard 23-kDa PRL in the case of unbalanced oxidative stress, is recognized as the main trigger of the disease. In addition, 16-kDa PRL causes damage to cardiomyocytes, acting via microRNA-146a secreted from endothelial cells as a cause of the NF-κß pathway. Bromocriptine, which inhibits the secretion of PRL from the pituitary gland, is now the only specific treatment for PPCM. Many different phenotypes of the disease, as well as cases of non-responders to bromocriptine treatment, indicate other pathophysiological pathways that need further investigation. Biomarkers in PPCM are not well established. There is a deficiency in specific diagnostic biomarkers. Pro-brain-type natriuretic peptide (BNP) and N-terminal BNP are the best, however unspecific, diagnostic biomarkers of heart failure at the moment. Therefore, more efforts should be engaged in investigating more specific biomolecules of a diagnostic and prognostic manner such as 16-kDa PRL, galectin-3, myeloperoxidase, or soluble Fms-like tyrosine kinase-1/placental growth factor ratio. In this review, we present the current state of knowledge and future directions of exploring PPCM pathophysiology, including microRNA and heat shock proteins, which may improve diagnosis, treatment monitoring, and the development of specific treatment strategies, and consequently improve patients' prognosis and outcome.