Real-world 1-Year Results of Tricuspid Edge-to-Edge Repair from the bRIGHT Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES: To report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system in a contemporary, real-world setting. METHODS: The bRIGHT post-approval study is a prospective, single-arm, open-label, multicenter, post-market registry conducted at 26 sites in Europe with central event adjudication and echocardiographic core-lab assessment. RESULTS: Enrolled subjects were elderly (79±7 years) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR and 80% percent of subjects were in NYHA class III/ IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA class (21% to 75% I/II, P<0.0001) and KCCQ score (19±26-point improvement, P<0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects that achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline RV TAPSE were independently associated with mortality at 1 year (OR: 2.169, 95% CI: [1.494, 3.147], P<0.0001; OR: 0.636, 95% CI: [0.415, 0.974], P=0.0375). Mortality was not associated with baseline TR grade, nor with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse, real-world population.

Comparison of cardiac output estimates obtained from the Antares oscillometric pulse wave analysis algorithm and from Doppler transthoracic echocardiography.

BACKGROUND: In cardiology, cardiac output (CO) is an important parameter for assessing cardiac function. While invasive thermodilution procedures are the gold standard for CO assessment, transthoracic Doppler echocardiography (TTE) has become the established method for routine CO assessment in daily clinical practice. However, a demand persists for non-invasive approaches, including oscillometric pulse wave analysis (PWA), to enhance the accuracy of CO estimation, reduce complications associated with invasive procedures, and facilitate its application in non-intensive care settings. Here, we aimed to compare the TTE and oscillometric PWA algorithm Antares for a non-invasive estimation of CO. METHODS: Non-invasive CO data obtained by two-dimensional TTE were compared with those from an oscillometric blood pressure device (custo med GmbH, Ottobrunn, Germany) using the integrated algorithm Antares (Redwave Medical GmbH, Jena, Germany). In total, 59 patients undergoing elective cardiac catheterization for clinical reasons (71±10 years old, 76% males) were included. Agreement between both CO measures were assessed by Bland-Altman analysis, Student's t-test, and Pearson correlations. RESULTS: The mean difference in CO was 0.04 ± 1.03 l/min (95% confidence interval for the mean difference: -0.23 to 0.30 l/min) for the overall group, with lower and upper limits of agreement at -1.98 and 2.05 l/min, respectively. There was no statistically significant difference in means between both CO measures (P = 0.785). Statistically significant correlations between TTE and Antares CO were observed in the entire cohort (r = 0.705, P<0.001) as well as in female (r = 0.802, P<0.001) and male patients (r = 0.669, P<0.001). CONCLUSIONS: The oscillometric PWA algorithm Antares and established TTE for a non-invasive estimation of CO are highly correlated in male and female patients, with no statistically significant difference between both approaches. Future validation studies of the Antares CO are necessary before a clinical application can be considered.

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. METHODS: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. RESULTS: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm. CONCLUSION: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Invasively measured and estimated central blood pressure using the oscillometric algorithm Antares in patients with and without obesity.

BACKGROUND: Obesity is a global health concern and risk factor for cardiovascular disease. The assessment of central blood pressure (cBP) has been shown to improve prediction of cardiovascular events. However, few studies have investigated the impact of obesity on cBP in adults, and invasive data on this issue are lacking. This study aimed to evaluate cBP differences between patients with and without obesity, identify cBP determinants, and evaluate the accuracy of the algorithm Antares for non-invasive cBP estimation. METHODS: A total of 190 patients (25% female; 39% with BMI ≥30kg/m2; age: 67±12 years) undergoing elective cardiac catheterization were included. cBP was measured invasively and simultaneously estimated non-invasively using the custo screen 400 device with integrated Antares algorithm. RESULTS: No significant cBP differences were found between obese and non-obese patients. However, females, especially those with obesity, had higher systolic cBP compared to males (P<0.05). Multiple regression analysis showed that brachial mean arterial pressure, pulse pressure, BMI, and heart rate predicted cBP significantly (adjusted R2 = 0.82, P<0.001). Estimated cBP correlated strongly with invasive cBP for systolic, mean arterial, and diastolic cBP (r = 0.74-0.93, P<0.001) and demonstrated excellent accuracy (mean difference <5 and SD <8 mmHg). CONCLUSIONS: This study discovered no significant difference in cBP between obese and non-obese patients. However, it revealed higher cBP values in women, especially those with obesity, which requires further investigation. Additionally, the study highlights Antares' effectiveness in non-invasively determining cBP in obese individuals. This could improve the diagnosis and treatment of hypertension in this special patient population.

Transcatheter Aortic Valve Implantation: Addressing the Subsequent Risk of Permanent Pacemaker Implantation.

Transcatheter aortic valve implantation (TAVI) is now a commonly used therapy in patients with severe aortic stenosis, even in those patients at low surgical risk. The indications for TAVI have broadened as the therapy has proven to be safe and effective. Most challenges associated with TAVI after its initial introduction have been impressively reduced; however, the possible need for post-TAVI permanent pacemaker implantation (PPI) secondary to conduction disturbances continues to be on the radar. Conduction abnormalities post-TAVI are always of concern given that the aortic valve lies in close proximity to critical components of the cardiac conduction system. This review will present a summary of noteworthy pre-and post-procedural conduction blocks, the best use of telemetry and ambulatory device monitoring to avoid unnecessary PPI or to recognize the need for late PPI due to delayed high-grade conduction blocks, predictors to identify those patients at greatest risk of requiring PPI, important CT measurements and considerations to optimize TAVI planning, and the utility of the MInimizing Depth According to the membranous Septum (MIDAS) technique and the cusp-overlap technique. It is stressed that careful membranous septal (MS) length measurement by MDCT during pre-TAVI planning is necessary to establish the optimal implantation depth before the procedure to reduce the risk of compression of the MS and consequent damage to the cardiac conduction system.

Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. OBJECTIVES: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. RESULTS: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. CONCLUSIONS: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089).

Successful management of a bleeding complication during transaxillary transcatheter aortic-valve implantation: a case report.

Background: The axillary artery is an alternative access route for transcatheter aortic-valve implantation (TAVI) in patients who have unfavourable femoral arteries as well as comorbidities which preclude surgery. Transaxillary TAVI (TAx-TAVI), with a complete non-transfemoral approach, is a feasible and safe alternative even if complications like vascular closure device failure with bleeding occurs. Case summary: We describe here a simplified non-transfemoral TAx-TAVI approach in a 71-year-old patient with pulmonary oedema due to severe symptomatic aortic stenosis with a prohibitively high surgical risk (Society of Thoracic Surgeons Mortality 11.9%) and extensive peripheral artery disease that rendered the femoral arteries unsuitable for access. Importantly, this strategy also allows for successful management of bleeding events, particularly those associated with vascular closure device failure, by the use of a new covered stent device. The patient was discharged on Day 6 after admission in stable conditions. In short-term follow-up (30 days), he is asymptomatic with normal left-ventricular function. Discussion: The TAx-TAVI is a promising alternative to transfemoral TAVI approach. Patient safety, even during bleeding complications, can be guaranteed with appropriate preparation.

Contemporary results of transcatheter mitral valve procedures: bi-centric retrospective analysis.

BACKGROUND: Transcatheter mitral valve-in-valve (TMVIV) or valve-in-ring (TMVIR) replacement offer an alternative therapy for high risk patients. We aimed to highlight the operative and postoperative results of TMVIV and TMVIR procedures. RESULTS: We included all patients underwent TMVIV and TMVIR procedures between 2017 and 2020 at two heart centers in Germany. We included a total of 36 high risk patients in our study where 12 received TMVIV and 24 received TMVIR. All patients underwent TMVIV or TMVIR with Edwards Sapien XT or S3 transcatheter valves (Edwards Lifesciences). The mean age was 79 (75-83 years old). The median (IQR) preoperative STS score was 9 (7-13)% and EuroSCORE II was 14.5% (12-16). The majority of our patients were operated via transapical approach (n = 26) and the minority via transseptal approach (n = 10). Out of our records, none of our patients required reopening for bleeding or any other surgical complications. None of our patients required reintervention during the 6 months follow-up period. One mortality was recorded on fifth postoperative day due to low cardiac output syndrome (obviously because of LVOT obstruction by the anterior mitral leaflet). The average blood loss was 200 ml in the first 24 h in patients underwent transapical approach. Average operative time was 93 min and all patients were immediately extubated after the procedure in the operating room (even the patient with echocardiographically documented LVOT obstruction who died on the fifth postoperative day). Length of Intensive Care Unit stay was 2 ± 1.2 days and length of hospital stay was 4.1 ± 1.2 days. In the follow up period, echocardiograms showed normal prosthetic valve function with low transvalvular gradients, no LVOT obstruction in TMVIR cases and no evidence of valve migration or thrombosis (except in one patient). Concerning 6 months readmission, it was recorded in 2 patients due to right sided heart failure symptoms due to preexisting high degree of tricuspid valve regurge which did not disappear or even decrease after the operation and the other patient due to gastrointestinal bleeding. CONCLUSIONS: TMVIV and TMVIR offer an efficient, safe and less invasive alternative in high surgical risk patients.

Extensive calcification of the mitral valve annulus in transcatheter aortic valve implants.

OBJECTIVES: This study sought to report the calcification pattern of the mitral valve annulus and its implications for procedural and safety outcomes in transcatheter aortic valve implantation. METHODS: Between November 2018 and September 2019, a total of 305 patients had transcatheter aortic valve implants at our institution. The extent of calcification of the mitral valve annulus was analysed, and the impact on safety outcomes was evaluated. RESULTS: The prevalence of mitral annular calcification (MAC) was 43%. Calcification of the mitral valve annulus was either less than or at least one-third of the posterior annulus (34% and 32%), the whole posterior annulus (28%) or the extension to the attachment of the anterior leaflets (7%). Severe circumferential MAC revealed moderate paravalvular leaks in 5/8 (63%) patients and was associated with right branch bundle block [odds ratio (OR) 2.01 (0.39-3.06); P = 0.098] and low cardiac output [OR 3.12 (1.39-7.04); P = 0.033]. Subannular calcification at the anterolateral trigonum represented a risk factor for left ventricular outflow tract injury [OR 3.54 (1.38-8.27); P = 0.001] in balloon-expandable valves, associated with relevant rhythm disorders [OR 2.26 (1.17-5.65); P = 0.014] and female gender (7/8, 88%). The 30-day all-cause mortality in circumferential MAC reaching into the anterior annulus (grade IV) compared to patients with less MAC (grade I-III) was 13% vs 2% with a mean valve size of 24.6 vs 25.7 mm. CONCLUSIONS: Extensive MAC was associated with moderate paravalvular leaks, with implications for the prosthesis size and survival in transcatheter aortic valve implants. In severe MAC, we recommend implanting oversized self-expandable prostheses, the goal being to reduce the risk of right branch bundle block and paravalvular leaks. SUBJ COLLECTION: 122, 125.

Pre-procedural predictors for multiple clips in percutaneous edge-to-edge mitral valve repair.

BACKGROUND: Percutaneous mitral valve (MV) clipping for mitral regurgitation (MR) revolutionized MV repair; however, valve anatomies and pathologies vary. Often multiple clips are required, and predicting this pre-procedurally would be useful. We evaluated pre-procedural predictors for multiple clips. RESULTS: We retrospectively analyzed 127 severe MR patients treated by mitral clipping between January 2011 and August 2018. Patients were grouped according to the use of a single (group I) or multiple clips (group II) and pre-procedure echocardiographs compared. No demographic differences existed except group II had more males (68.1%) than group I (48.3%). Mean left atrial diameter was larger in group II, 51 ± 9 mm, than group I, 48 ± 5 mm, p = 0.026. Mean mitral annular diameter differed: 34 ± 4mm (group II) versus 33 ± 3 mm (group I), p = 0.017. The vena contracta was broader in group II than group I (6.6 ± 1 mm vs. 6 ± 0.9 mm, p = 0.001). Severe mitral annular calcification occurred more in group I (36.2%) than group II (10.1%), p = 0.0001. On multivariate analysis, vena contracta width correlated positively with multiple clips (B 0.125, p = 0.013), but severe annular calcification correlated inversely (B - 0.35, p = 0.002). CONCLUSIONS: Vena contracta width and severe annular calcification are factors to consider when planning MV clipping.

Thromboembolic complications in transfemoral aortic valve implantation due to aortic wall thrombus and shaggy aorta syndrome.

OBJECTIVES: Aortic wall thrombus (AWT) can affect suitability to endovascular repair, while its most aggressive entity is better known as shaggy aorta syndrome. Primary objective was to study the procedural and clinical outcome with regard to atherothrombotic AWT in transfemoral aortic valve implantation. METHODS: In a retrospective, single-centre analysis, a qualitative 0-10 AWT score classification system was used. The most severely affected aortic area in computed tomography angiography cross-section was assessed for the number of affected segments, thrombus type, thickness, area and circumference. Primary endpoints were 30-day mortality, neurologic, renal and pulmonary events and signs of solid organ infarction. RESULTS: Between November 2017 and September 2019, 604 patients underwent transfemoral transcatheter aortic valve implantation in our institution. Computed tomography-guided analysis revealed AWT in 11.3% and shaggy aorta syndrome in 6 patients (1.0% with 83.3% male). AWT was mainly present in the descending thoracic and abdominal aorta and was associated with acute renal failure (11.8% vs 3.2%, P ≤ 0.001) and a seven-fold increased rate of disabling peri-interventional stroke (4.4% vs 0.6%, P ≤ 0.001). In all patients with disabling peri-interventional stroke a balloon-expandable prosthesis was used (P ≤ 0.001). In case of shaggy aorta, mortality was more than six-fold increased (2.8% vs 16.7%, P = 0.046). CONCLUSIONS: Severe and irregular thrombus of the descending thoracic and abdominal aorta has been strongly associated with acute respiratory failure and peri-interventional stroke in transfemoral aortic valve implantation, being more likely using balloon-expandable devices. Our results imply important changes with regard to device design and present international transcatheter aortic valve implantation guidelines.

Pulmonary vein isolation using second-generation single-shot devices: not all the same?

INTRODUCTION: Single-shot devices have been developed to simplify pulmonary vein isolation (PVI). Randomized studies of the second-generation cryoballoon (CB 2nd) demonstrated excellent results. There are limited data comparing results of circular pulmonary vein ablation catheter (PVAC) with conventional RF ablation or CB for PVI. OBJECTIVE: Using a sequential registry cohort and a prospective randomized study, we aimed to compare the acute and long-term results of CB 2nd and PVAC Gold. METHODS: In the registry, consecutive patients with paroxysmal atrial fibrillation (AF) undergoing their first PVI were included. The preferred method used was PVAC Gold in 2014 and CB 2nd in 2015. Subsequently, a randomized study (PVAC vs. CB 2nd) was performed. Ablation success was measured as freedom of AF or atrial tachycardias (AT) off antiarrhythmic drugs. RESULTS: In the registry cohort, PVAC Gold was used in 60 patients and CB 2nd in 56 patients (age 66 ± 11 years, 52% male, LAD 43 ± 6). In the randomized study, 20 patients were treated with PVAC Gold and 22 with CB 2nd (age 67 ± 9; 43% men, LAD 40 ± 7 mm). During a mean follow up of 13.2 ± 3.6 months, success was 54% in PVAC Gold patients and 81% in CB 2nd cases (p = 0.001). In the randomized study 12 months success was 50% versus 86%, p < 0.05. Complications occurred rare in both groups. CONCLUSIONS: Our registry data and the randomized study both suggest superiority of PVI using CB 2nd as compared with PVI using PVAC Gold.

The novel use of retrograde CTO PCI techniques as a rescue strategy for an acute right coronary artery occlusion due to iatrogenic dissection.

Coronary artery dissection is a known complication of percutaneous coronary intervention (PCI). Such dissections are often treated by antegrade PCI. When antegrade PCI fails, the options become limited to conservative management or coronary artery bypass grafting (CABG). CABG comes with its own risks, and conservative management can result in a potentially larger infarct. Here we present a novel use of retrograde chronic total occlusion (CTO) PCI techniques to treat an iatrogenic, type D dissection of the right coronary artery in a young male with an acute coronary syndrome. Reentrance of the true lumen by standard antegrade approaches failed. The rescue strategy using a retrograde CTO PCI approach not only had advantages over surgery and conservative management, but also over antegrade PCI. A soft wire, designed for collaterals, was used to "surf" the dissection and reach the antegrade guiding catheter. Thus, the true lumen could be used. This novel approach provided the advantages both of preserving major side branches, which are often lost with antegrade PCI approaches, and of not unnecessarily puncturing the dissection membrane. .

One-Year Outcomes after PCI Strategies in Cardiogenic Shock.

BACKGROUND: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year. METHODS: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure. RESULTS: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04). CONCLUSIONS: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study).

PURPOSE: The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). METHODS: In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L). RESULTS: Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. CONCLUSIONS: No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation. TRIAL REGISTRATION: NCT01420744.

PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.

BACKGROUND: In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial. METHODS: In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke. RESULTS: At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups. CONCLUSIONS: Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Low rate of access site complications after transradial coronary catheterization: A prospective ultrasound study.

BACKGROUND: Transradial artery (TRA) left heart catheterization is an increasingly used technique for both diagnostic and interventional coronary procedures. This study evaluates the incidence of access site complications in the current interventional era. METHODS AND RESULTS: A total of 507 procedures were performed under standardized conditions. Each procedure was performed using high levels of anticoagulation, hydrophilic sheaths, and short post-procedural compression times. Vascular complications were assessed one day after TRA catheterization using Duplex sonography and classified according to the necessity of additional medical intervention. A simple questionnaire helped identifying upper extremity neurologic or motor complications. Vascular complications were detected in 12 patients (2.36%): radial artery occlusion was detected in 9 patients (1.77%), 1 patient developed an AV-fistula (0.19%), and 2 patients had pseudoaneurysms (0.38%). None of the patients required specialized medical or surgical intervention. Under our procedural conditions, small radial artery diameter was the only significant predictor for the development of post-procedural vascular complications (2.11 ± 0.42 mm vs 2.52 ± 0.39 mm, p = 0.001). None of the previously reported risk factors, namely, advanced renal failure, diabetes, acuteness/complexity of procedure, or sheath and catheter size significantly influenced the rate of vascular complications. No major hematoma or local neurologic or motor complications were identified. CONCLUSIONS: Using current techniques and materials, we report a very low rate of local complications associated with TRA catheterization.

Spatial Relationship of Focal Impulses, Rotors and Low Voltage Zones in Patients With Persistent Atrial Fibrillation.

INTRODUCTION: Focal impulses (FI) and rotors are sources associated with the initiation and maintenance of atrial fibrillation (AF). Their ablation results in a lower recurrence rate. The aim of this study was to characterize for the first time the spatial relationship between such sources and atrial low voltage zones (LVZ) representing fibrosis. METHODS: Twenty-five consecutive patients undergoing their first ablation for persistent AF were included. Voltage mapping of both atria was done during AF. Endocardial mapping of FI and rotors (sources) was performed using a basket catheter and displayed using RhythmView(TM) (Topera Inc.) before ablation. Spatial relationship of LVZ and sources was analyzed. RESULTS: LVZs covered 13 ± 12% of right atrial (RA) endocardial surface and 33 ± 25% of left atrial (LA) endocardial surface. The median number of sources was 1 [1-3] in RA and 3 [1-4] in LA. Of LA sources, 18 (30%) were definitely not associated with LVZs or pulmonary vein (PV) antra. Of RA sources, 32 (84%) were remote from LVZ. During ablation of such sources substantial cycle length (CL) prolongation or AF conversion occurred in 11/23 patients (48%). Altogether, 8/11 (73%) of these pertinent sources were located remotely from LVZ and PV antra. CONCLUSIONS: There is a wide discrepancy in distribution of LVZ areas and sites of identified rotors. Site and incidence of FIRM sources appear to be unpredictable with atrial substrate mapping. Further prospective, randomized studies are necessary to elucidate the impact of additional ablation of such sources in patients with persistent or longstanding persistent AF.

Changes in renal function in congestive heart failure.

Both cardiovascular and renal diseases are common and frequently coexist in the same patient. Indeed, renal dysfunction has been shown to be a more powerful independent predictor of poor outcomes in heart failure (HF) than left ventricular ejection fraction or functional class. Furthermore, acute kidney injury is a frequent therapeutic concern in heart failure. Consequently, there has been much interest in developing new renoprotective treatments and novel biomarkers to monitor renal function. Additionally, given the crucial cardiorenal interaction and interdependence, the concept of a cardiorenal syndrome with five different subtypes has been advanced to better categorize patients and facilitate research.