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1.
Cardiovasc Revasc Med ; 60: 35-40, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37838620

ABSTRACT

BACKGROUND: The Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters. AIMS: The CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice. METHODS: The CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution. RESULTS: A total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported. CONCLUSIONS: In this "real world" registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation.


Subject(s)
Heart Failure , Heart Valve Prosthesis Implantation , Mitral Valve Annuloplasty , Mitral Valve Insufficiency , Humans , Male , Aged , Aged, 80 and over , Female , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Prospective Studies , Echocardiography , Heart Valve Prosthesis Implantation/adverse effects , Mitral Valve Annuloplasty/adverse effects , Registries , Treatment Outcome
2.
N Engl J Med ; 389(14): 1286-1297, 2023 Oct 05.
Article in English | MEDLINE | ID: mdl-37634145

ABSTRACT

BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).


Subject(s)
Extracorporeal Membrane Oxygenation , Myocardial Infarction , Shock, Cardiogenic , Humans , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/mortality , Myocardial Infarction/complications , Myocardial Infarction/therapy , Retrospective Studies , Risk , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Treatment Outcome , Myocardial Revascularization
3.
Am Heart J ; 234: 1-11, 2021 04.
Article in English | MEDLINE | ID: mdl-33428901

ABSTRACT

BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.


Subject(s)
Extracorporeal Membrane Oxygenation , Myocardial Infarction/therapy , Myocardial Revascularization/methods , Coronary Artery Bypass/methods , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/methods , Fibrinolytic Agents/therapeutic use , Humans , Myocardial Infarction/complications , Myocardial Infarction/mortality , Prognosis , Prospective Studies , Quality of Life , Sample Size , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality
4.
Clin Res Cardiol ; 110(2): 292-301, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33219854

ABSTRACT

AIMS: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region. METHODS AND RESULTS: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures. CONCLUSION: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.


Subject(s)
COVID-19 , Cardiac Catheterization/trends , Cardiovascular Diseases/mortality , Cardiovascular Diseases/therapy , Hospitalization/trends , Percutaneous Coronary Intervention/trends , Aged , Cardiac Catheterization/adverse effects , Cardiac Catheterization/mortality , Cardiovascular Diseases/diagnosis , Cause of Death/trends , Female , Germany , Hospital Mortality/trends , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Risk Factors , Time Factors
5.
Herz ; 46(Suppl 1): 15-23, 2021 Apr.
Article in German | MEDLINE | ID: mdl-31938804

ABSTRACT

The regulation of coronary flow is mainly located in the resistance vessels of the microcirculation, so that the functional relevance of a coronary stenosis arises from the interaction between the epicardial stenosis and the downstream microcirculation. These complex interactions are precisely detectable by physiological measurements, such as the instantaneous wave-free ratio (iwFR) or the fractional flow reserve (FFR). In contrast, the purely visual assessment of the coronary anatomy could lead to misinterpretation and possibly to incorrect revascularization decisions. Consequently, in the current guidelines on myocardial revascularization of the European Society of Cardiology (ESC) the measurement of iwFR and FFR has a class IA indication in intermediate stenoses with unclear hemodynamic relevance. Despite this clear recommendation, physiological measurements are not yet regularly used in the clinical routine. Besides the purely hemodynamic assessment, novel methods such as co-registration and coronary mapping can be used for virtual planning of percutaneous coronary interventions, especially in vessels with diffuse lesions and serial stenoses. Furthermore, invasive flow measurements are also helpful for risk stratification between conservative and interventional treatment of patients with acute coronary syndrome, where additional factors of flow limitation, such as coronary spasm, thrombus and acute disturbance of the microcirculation play an important role.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Fractional Flow Reserve, Myocardial , Cardiac Catheterization , Catheters , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Stenosis/diagnostic imaging , Coronary Vessels/diagnostic imaging , Humans , Laboratories , Predictive Value of Tests , Severity of Illness Index
6.
J Echocardiogr ; 18(1): 47-56, 2020 03.
Article in English | MEDLINE | ID: mdl-31630329

ABSTRACT

BACKGROUND: Untreated symptomatic high-grade aortic stenosis remains a lethal disease requiring individually adapted valve replacement. High-risk surgical patients benefit from transcatheter aortic valve replacement (TAVR), but there is no uniform standard for patient selection and valve sizing and it is still unclear whether transthoracic (TTE) or transesophageal (TEE) echocardiography is superior in preprocedural aortic annulus sizing. As preprocedural sizing of the native aortic annulus diameter is crucial to outcome and survival, we report the results of a direct comparison between preprocedural sizing with TTE and TEE including subsequent outcomes in a high-risk TAVR population. METHODS: A total of 149 TAVR patients were enrolled for TTE and TEE comparison, and an additional 15 patients without structural heart disease were investigated as control group to determine the influence of aortic valve calcification on TTE and TEE aortic annulus diameter measurements. RESULTS: Overall standardized TTE and TEE measurements for aortic annulus sizing showed excellent correlation at good image quality (p < 0.01, r = 0.934). Calcification of the aortic annulus diameter was not found to exert a noteworthy negative influence on measurements for both standardized TTE and TEE and complication rates did not differ for mortality, periprocedural stroke and paraprosthetic regurgitation. CONCLUSIONS: Transthoracic echocardiography and TEE are both equally suitable methods of preprocedural aortic annulus size evaluation in preparation of TAVR procedures.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve/diagnostic imaging , Calcinosis/diagnostic imaging , Echocardiography , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/instrumentation , Adult , Aged , Aged, 80 and over , Aortic Valve/pathology , Aortic Valve Stenosis/surgery , Echocardiography, Transesophageal , Female , Humans , Male , Middle Aged , Organ Size , Patient Selection , Preoperative Period , Retrospective Studies , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
7.
Clin Cardiol ; 41(8): 1055-1061, 2018 Aug.
Article in English | MEDLINE | ID: mdl-30019381

ABSTRACT

BACKGROUND: Aim of this study was to evaluate the predictors of hs-cTnT in a non-ACS patient cohort admitted to the emergency department. HYPOTHESIS: Atrial fibrillation and hypertension may not always be sufficient for elevation for hs-cTnT. METHODS: We performed a retrospective, single center study encompassing in total 1003 patients. Individuals were retrospectively divided in ACS- and non-ACS patients by two independent investigators reviewing the medical records. In order to identify predictors of hs-cTnT elevation hazard ratios were calculated for age, gender, vital signs, cardiovascular risk factors, LVEF, serum levels of CRP, hemoglobin, and creatinine. Elevation of hs-cTnT was defined by exceeding 14 ng/L (upper reference limit [URL]). RESULTS: About 987 patients were included while 25 patients were excluded because of missing data. 307 patients (31.4%) met the current guideline requirements of diagnosing an ACS, whereas 671 patients (68.6%) were hospitalized with excluded ACS. In the multivariate analysis age, anemia, CRP, creatinine, and reduced systolic left ventricular ejection fraction were independent predictors of elevated troponin T levels in the non-ACS group. However, hypertensive systolic blood pressure, atrial fibrillation and tachycardia were not predictive for Troponin T elevation in non-ACS patients in this multivariate analysis. CONCLUSIONS: In an unselected, non-ACS patient cohort age, chronic renal failure, inflammatory state, and reduced left ventricular systolic function were associated with hs-cTnT levels above the upper reference limit. Rather, often supposed predictors as atrial fibrillation, hypertension, and tachycardia cannot sufficiently explain increased hs-cTnT in our study. Hence, further studies are needed to assess whether isolated hypertension, tachycardia, or atrial fibrillation sufficiently explain elevated hs-cTnT.


Subject(s)
Acute Coronary Syndrome/diagnosis , Atrial Fibrillation/blood , Emergency Service, Hospital , Hypertension/blood , Kidney Failure, Chronic/blood , Troponin T/blood , Acute Coronary Syndrome/blood , Adolescent , Adult , Aged , Aged, 80 and over , Atrial Fibrillation/diagnosis , Biomarkers/blood , Female , Follow-Up Studies , Humans , Hypertension/diagnosis , Kidney Failure, Chronic/diagnosis , Male , Middle Aged , Patient Selection , Retrospective Studies , Risk Factors , Young Adult
8.
Acad Radiol ; 23(11): 1402-1411, 2016 11.
Article in English | MEDLINE | ID: mdl-27639627

ABSTRACT

RATIONALE AND OBJECTIVES: Invasive coronary angiography (ICA) with fractional flow reserve (FFR) assessment is the reference standard for the detection of hemodynamically relevant coronary lesions. We have investigated whether coronary computed tomography angiography (cCTA)-derived FFR (fractional flow reserve from coronary computed tomographic angiography [CT-FFR]) measurement improves diagnostic accuracy over cCTA. METHODS AND RESULTS: A literature search was performed for studies comparing invasive FFR, cCTA, and CT-FFR. The analysis included three prospective multicenter trials and two retrospective single-center studies; a total of 765 patients and 1306 vessels were included in the meta-analysis. Compared to invasive FFR on a per-lesion basis, CT-FFR reached a pooled sensitivity, specificity, positive predictive value, and negative predictive value of 83.7% (95% confidence interval [CI]: 78.1-89.3), 74.7% (95% CI: 52.2-97.1), 64.8% (95% CI: 52.1-77.5), and 90.1% (95% CI: 80.8-99.3) compared to 84.6% (95% CI: 78.1-91.1), 49.7% (95% CI: 31.1-68.4), 39.0% (95% CI: 28.0-50.1), and 87.3% (95% CI: 72.5-100.0) for cCTA alone. In 634 vessels with intermediate stenosis (30%-70%), sensitivity, specificity, positive predictive value, and negative predictive value were 81.4% (95% CI: 70.4-92.9), 71.7% (95% CI: 54.5-89.0), 59.4% (95% CI: 35.5-83.4), and 89.9% (95% CI: 85.0-94.7) compared to 90.2% (95% CI: 80.6-99.9), 35.4% (95% CI: 23.5-47.3), 50.7% (95% CI: 30.6-70.8), and 82.5% (95% CI: 64.5-100.0) for cCTA alone. The summary area under the receiver operating characteristic curve of CT-FFR was superior to cCTA alone on a per-vessel (0.90 [95% CI: 0.82-0.98] vs 0.74 [95% CI: 0.63-0.86]; P = .0047) and for intermediate stenoses (0.76 [95% CI: 0.65-0.88] vs 0.57 [95% CI: 0.49-0.66]; P = .0027). CONCLUSION: CT-FFR significantly improves specificity without noticeably altering the sensitivity of cCTA with invasive FFR as a reference standard for the detection of hemodynamically relevant stenosis.


Subject(s)
Computed Tomography Angiography/methods , Coronary Angiography/methods , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/physiopathology , Fractional Flow Reserve, Myocardial , Female , Hemodynamics , Humans , Male , Middle Aged , Prospective Studies , ROC Curve , Retrospective Studies , Sensitivity and Specificity
9.
J Am Heart Assoc ; 5(6)2016 05 31.
Article in English | MEDLINE | ID: mdl-27247332

ABSTRACT

BACKGROUND: The adoption of the transradial (TR) approach over the traditional transfemoral (TF) approach has been hampered by concerns of increased radiation exposure-a subject of considerable debate within the field. We performed a patient-level, multi-center analysis to definitively address the impact of TR access on radiation exposure. METHODS AND RESULTS: Overall, 10 centers were included from 6 countries-Canada (2 centers), United Kingdom (2), Germany (2), Sweden (2), Hungary (1), and The Netherlands (1). We compared the radiation exposure of TR versus TF access using measured dose-area product (DAP). To account for local variations in equipment and exposure, standardized TR:TF DAP ratios were constructed per center with procedures separated by coronary angiography (CA) and percutaneous coronary intervention (PCI). Among 57 326 procedures, we demonstrated increased radiation exposure with the TR versus TF approach, particularly in the CA cohort across all centers (weighted-average ratios: CA, 1.15; PCI, 1.05). However, this was mitigated by increasing TR experience in the PCI cohort across all centers (r=-0.8; P=0.005). Over time, as a center transitioned to increasing TR experience (r=0.9; P=0.001), a concomitant decrease in radiation exposure occurred (r=-0.8; P=0.006). Ultimately, when a center's balance of TR to TF procedures approaches 50%, the resultant radiation exposure was equivalent. CONCLUSIONS: The TR approach is associated with a modest increase in patient radiation exposure. However, this increase is eliminated when the TR and TF approaches are used with equal frequency-a guiding principle for centers adopting the TR approach.


Subject(s)
Coronary Angiography/methods , Coronary Care Units/standards , Percutaneous Coronary Intervention/statistics & numerical data , Radiation Exposure/statistics & numerical data , Clinical Competence/standards , Cohort Studies , Coronary Angiography/standards , Coronary Care Units/statistics & numerical data , Femoral Artery/radiation effects , Humans , Myocardial Revascularization/methods , Myocardial Revascularization/standards , Myocardial Revascularization/statistics & numerical data , Practice Patterns, Physicians'/standards , Radial Artery/radiation effects , Radiation Dosage
10.
Case Rep Cardiol ; 2016: 6218723, 2016.
Article in English | MEDLINE | ID: mdl-27119029

ABSTRACT

Intraventricular septum-hematoma is a rare complication following percutaneous coronary intervention (PCI). This complication may represent a challenge for accurate diagnosis and treatment. This case report is about a 60-year-old male patient being admitted with an acute coronary syndrome. Despite successful PCI with drug eluting stent implantation into the right coronary artery (RCA) the patient complained about recurrent angina pectoris according to Canadian Cardiovascular Society (CCS) class IV. Cardiac magnetic resonance imaging and transthoracic echocardiography revealed a massive 4.9 × 9.2 cm sized end-diastolic septum-hematoma, which compromised right ventricular cavity. Emergent recoronary angiography ruled out further contrast extravasation from the RCA. Conservative treatment was intended after discussion in the "heart-team." The patient completely recovered with nearly complete resolution of the hematoma after 6 months.

11.
Cardiovasc Revasc Med ; 17(3): 206-8, 2016.
Article in English | MEDLINE | ID: mdl-26916569

ABSTRACT

Intraprocedural device dislodgement of a 24-mm Watchman™ left atrial appendage (LAA) closure device occurred in a 83-year-old female with a wide left atrial appendage ostium (broccoli configuration) and a surgical mitral valve reconstruction. Device rested in the atrial cavity. A second stable 12French transseptal electrophysiological sheath and two snares were needed to stabilize, elongate and gently guide the device into the second sheath. One of the snares was unclamped at its proximal end and retrogradely pulled through. After successful retrieval, a 27-mm Watchman™ device could easily be implanted in the very same session via the left delivery sheath. Patient was discharged from hospital in good general health after regular turnaround time.


Subject(s)
Atrial Appendage , Atrial Fibrillation/therapy , Cardiac Catheterization/instrumentation , Device Removal/methods , Embolism/therapy , Foreign-Body Migration/therapy , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheters , Device Removal/instrumentation , Embolism/diagnostic imaging , Embolism/etiology , Equipment Design , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/etiology , Humans , Radiography, Interventional , Treatment Outcome
12.
Cardiovasc Revasc Med ; 17(2): 88-94, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26895953

ABSTRACT

BACKGROUND: Obesity with its worldwide growing prevalence is an established cardiovascular risk factor with increased morbidity and mortality. However, the phenomenon, that mild to moderate obesity seems to represent a protective effect on diseases has been termed the "obesity paradox". METHODS: We retrospectively assessed 529 patients (72.6% male, mean age 59.7±12.7years) admitted with ST-elevation myocardial infarction (STEMI). The female and male study populations were separated into four body mass index (BMI) groups: ≤24.9kg/m(2), 25.0-29.9kg/m(2), 30.0-34.9kg/m(2) and ≥35.0kg/m(2). Blood samples of high-density lipoprotein cholesterol (HDL-c) and low-density lipoprotein cholesterol (LDL-c) were analyzed. RESULTS: With increasing BMI group the rate of major adverse cardiac events (MACE) decreased in all patients (test for trend p=0.041). No gender difference between MACE and BMI could be noticed (p=0.16). A higher risk for MACE was indicated in group BMI ≤18.5kg/m(2) in comparison to group BMI 25.0-29.9kg/m(2) (OR: 7.93; 95% CI: 1.75-35.89; p=0.0091), whereas group BMI 30.0-34.9kg/m(2) was significant associated with a lower risk in comparison to group BMI 25.0-29.9kg/m(2) (OR: 0.65; 95% CI: 0.21-1.96; p=0.044). An association between HDL-c (p=0.55) or LDL-c (p=0.10) and MACE could not be detected. CONCLUSION: The study demonstrates that patients with STEMI and a BMI of 30.0-34.9kg/m(2) have a decreased risk for MACE compared to patients with normal BMI. No gender related differences were indicated. An association between MACE and lipoproteins could not be detected.


Subject(s)
Cholesterol, HDL/blood , Cholesterol, LDL/blood , Obesity/blood , Percutaneous Coronary Intervention/adverse effects , ST Elevation Myocardial Infarction/therapy , Aged , Biomarkers/blood , Body Mass Index , Chi-Square Distribution , Female , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Nutritional Status , Obesity/complications , Obesity/diagnosis , Obesity/physiopathology , Odds Ratio , Protective Factors , Retrospective Studies , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/etiology , Sex Factors , Time Factors , Treatment Outcome
13.
BMC Cardiovasc Disord ; 16: 25, 2016 Jan 28.
Article in English | MEDLINE | ID: mdl-26822890

ABSTRACT

BACKGROUND: Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices. METHODS: This single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm). RESULTS: In total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9% of patients (90.9% for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7% of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3% of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0% of all access-site complications). One patient died due to septic shock (non-procedure related). CONCLUSIONS: In daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Heart Atria/surgery , Prosthesis Implantation , Septal Occluder Device , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Echocardiography, Transesophageal , Female , Heart Atria/diagnostic imaging , Humans , Male , Postoperative Complications/epidemiology , Postoperative Hemorrhage/epidemiology , Prospective Studies , Prosthesis Failure , Shock, Septic/epidemiology , Treatment Outcome
14.
Angiology ; 67(3): 272-80, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26032849

ABSTRACT

Levels of C-reactive protein (CRP), uric acid (UA), and total bilirubin (TB) are associated with coronary artery disease and major adverse cardiac events (MACEs) in patients with ST-segment elevation myocardial infarction (STEMI). We retrospectively included 1167 patients with STEMI who underwent percutaneous coronary intervention and routine blood sampling. The study cohort consisted of 803 patients (73.1% male, mean age 62.5 ± 13.4 years). In men, the levels of CRP, TB, and UA were significantly higher in the MACE than in the non-MACE group (P < .05). The receiver-operating characteristic (ROC) analysis shows that CRP (area under the curve [AUC]: 0.59; 95% confidence interval [CI]: 0.53-0.66; P = .014) and TB (AUC: 0.58; 95% CI: 0.51-0.65; P = .019) are significantly associated with MACE but not UA (AUC: 0.61; 95% CI: 0.42-0.76; P = .083). Logistic regression revealed CRP (odds ratio [OR] 1.01; 95% CI: 1.00-1.01; P = .006) and TB (OR 2.03; 95% CI: 1.12-3.40; P = .007) as an independent predictor for MACE. In women, none of the biomarkers was associated with MACE by ROC analysis or logistic regression analysis. This study demonstrated that high CRP and TB serum levels have a prognostic association with in-hospital MACE in male patients with STEMI.


Subject(s)
Bilirubin/blood , C-Reactive Protein/analysis , Hospitalization , Myocardial Infarction/blood , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/adverse effects , Uric Acid/blood , Aged , Area Under Curve , Biomarkers/blood , Chi-Square Distribution , Female , Hospital Mortality , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/diagnosis , Myocardial Infarction/mortality , Odds Ratio , Percutaneous Coronary Intervention/mortality , Predictive Value of Tests , ROC Curve , Retrospective Studies , Risk Assessment , Risk Factors , Sex Factors , Treatment Outcome , Up-Regulation
15.
Clin Med Insights Cardiol ; 9: 97-103, 2015.
Article in English | MEDLINE | ID: mdl-26568686

ABSTRACT

BACKGROUND: Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes. METHODS: The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up. RESULTS: Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015. CONCLUSIONS: The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.

16.
In Vivo ; 29(6): 737-47, 2015.
Article in English | MEDLINE | ID: mdl-26546530

ABSTRACT

BACKGROUND: In patients with coronary artery disease (CAD), risk stratification remains a challenge. Recently, epicardial adipose tissue (EAT) assessed by cardiovascular magnetic resonance imaging (CMRI) has emerged as a new marker in patients with CAD. Thus, we aimed to investigate the association of CMR parameters with all-cause and cardiac mortality in patients with CAD. PATIENTS AND METHODS: CMRI examination was performed in 260 patients with CAD. RESULTS: In the 40 patients who died, left ventricular (LV) ejection fraction, right ventricular fractioning shortening, LV remodeling index and indexed EAT were significantly reduced, whereas LV mass index, LV end-diastolic volume index, LV end-systolic volume index, LV end-diastolic diameter and the extent of late gadolinium enhancement expressed as a percentage of the maximum possible score to estimate the extent of LGE relative to LV mass (LGE %), were significantly elevated. Using multivariate analysis, age, LV mass index, extent of LGE % and indexed EAT proved to be independently associated with all-cause and cardiac mortality. CONCLUSION: Age, LV mass index, the extent of LGE % and indexed EAT are independent predictors of mortality that might contribute to a more accurate risk stratification of patients with CAD.


Subject(s)
Coronary Artery Disease/diagnostic imaging , Heart Ventricles/diagnostic imaging , Magnetic Resonance Imaging, Cine/methods , Prognosis , Adipose Tissue/diagnostic imaging , Adipose Tissue/pathology , Aged , Coronary Artery Disease/mortality , Coronary Artery Disease/pathology , Epicardial Mapping , Female , Gadolinium/administration & dosage , Heart Ventricles/pathology , Humans , Male , Middle Aged , Radiography , Ventricular Remodeling/physiology
17.
EuroIntervention ; 10(12): 1468-73, 2015 Apr.
Article in English | MEDLINE | ID: mdl-24970670

ABSTRACT

AIMS: Transcatheter aortic valve implantation (TAVI) is an alternative therapeutic option for patients with severe aortic valve stenosis (AS) and elevated surgical risk. Previous studies have suggested that the occurrence of systemic inflammatory response syndrome (SIRS) in patients undergoing TAVI is associated with an unfavourable outcome. We sought to assess the impact of different interventional access routes (transapical [TA] vs. transfemoral [TF]) and valve types (Medtronic CoreValve® [CV] vs. Edwards SAPIEN XT® [ES]) on the incidence of SIRS. In addition, the prognostic value of SIRS was evaluated. METHODS AND RESULTS: Between January 2009 and July 2011 a total of 192 (out of 228) consecutive patients with severe aortic stenosis underwent TAVI at the University Hospital Frankfurt and were included in the current retrospective analysis. SIRS criteria were evaluated within the first 48 hours after TAVI. SIRS was defined according to existing definitions of the ACCP/SCCM Consensus Conference. A total of 75 (39.1%) patients developed SIRS at some time during the first 48 hours following TAVI. The occurrence of SIRS was independent from access route (TA 42.3% vs. TF 37.0%; p=0.28) as well as from type of valve used (ES 42.5% vs. CV 32.3%; p=0.11). However, the occurrence of SIRS was associated with a more than twofold higher one-year mortality rate (21.3%) compared to patients without SIRS in the first 48 hours (5.3%; p=0.04). CONCLUSIONS: The occurrence of SIRS in the first 48 hours post procedure is associated with impaired prognosis following TAVI, but is independent from the chosen valve type and access route.


Subject(s)
Aortic Valve Stenosis/surgery , Cardiac Catheterization/methods , Femoral Artery , Postoperative Complications/epidemiology , Systemic Inflammatory Response Syndrome/epidemiology , Thoracic Wall , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Cohort Studies , Female , Heart Valve Prosthesis , Humans , Incidence , Logistic Models , Male , Prognosis , Retrospective Studies , Risk Factors , Treatment Outcome
19.
Radiology ; 273(2): 373-82, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24877984

ABSTRACT

PURPOSE: To prospectively evaluate radiation and contrast medium requirements for performing high-pitch coronary computed tomographic (CT) angiography at 70 kV using a third-generation dual-source CT system in comparison to a second-generation dual-source CT system. MATERIALS AND METHODS: All patients gave informed consent for this institutional review board-approved study. Forty-five patients (median age, 52 years; 27 men) were imaged in high-pitch mode with a third-generation dual-source CT system at 70 kV (n = 15) or with a second-generation dual-source CT system at 80 or 100 kV (n = 15 for each). Tube voltage was based on body mass index: 80 or 70 kV for less than 26 kg/m(2) versus 100 kV for 26-30 kg/m(2). For the 80- and 100-kV protocols, 80 mL of contrast material was injected, versus 45 mL for the 70-kV protocol. Data were reconstructed by using a second-generation iterative reconstruction algorithm for second-generation dual-source CT and a recently introduced third-generation iterative reconstruction algorithm for third-generation dual-source CT. Objective image quality was measured for various regions of interest, and subjective image quality was evaluated with a five-point Likert scale. RESULTS: The signal-to-noise ratio of the coronary CT angiography studies acquired with 70 kV was significantly higher (70 kV: 14.3-17.6 vs 80 kV: 7.1-12.9 vs 100 kV: 9.8-12.9; P < .0497) than those acquired with the other two protocols for all coronary arteries. Qualitative image quality analyses revealed no significant differences between the three CT angiography protocols (median score, 5; P > .05). The mean effective dose was 75% and 108% higher (0.92 mSv ± 0.3 [standard deviation] and 0.78 mSv ± 0.2 vs 0.44 mSv ± 0.1; P < .0001), respectively, for the 80- and 100-kV CT angiography protocols than for the 70-kV CT angiography protocol. CONCLUSION: In nonobese patients, third-generation high-pitch coronary dual-source CT angiography at 70 kV results in robust image quality for studying the coronary arteries, at significantly reduced radiation dose (0.44 mSv) and contrast medium volume (45 mL), thus enabling substantial radiation dose and contrast medium savings as compared with second-generation dual-source CT.


Subject(s)
Coronary Angiography/methods , Coronary Disease/diagnostic imaging , Tomography, X-Ray Computed/methods , Adult , Aged , Aged, 80 and over , Algorithms , Cardiac-Gated Imaging Techniques , Contrast Media , Coronary Angiography/instrumentation , Electrocardiography , Female , Humans , Iopamidol/analogs & derivatives , Male , Middle Aged , Prospective Studies , Radiation Dosage , Radiographic Image Interpretation, Computer-Assisted , Tomography, X-Ray Computed/instrumentation
20.
Can J Cardiol ; 30(6): 696.e13-5, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24882545

ABSTRACT

We present the case of a 71-year-old patient with a chronic total occlusion of the right coronary artery (RCA) resulting in a retrograde aortic dissection as a complication of coronary intervention. Acute therapy consisted of coronary stent implantation into the proximal RCA to cover the dissection's entry. One day after, computed tomography-guided angiography revealed a progression of the intramural aortic hematoma with a residual dissection at the RCA ostium. Recurrent coronary angiography was performed to implant another stent covering the entry. Imaging at follow-up demonstrated complete coverage of the Dunning dissection and regression of the intramural aortic hematoma.


Subject(s)
Aorta/injuries , Aortic Diseases/diagnostic imaging , Cardiac Catheterization/adverse effects , Coronary Angiography , Hematoma/diagnostic imaging , Percutaneous Coronary Intervention/adverse effects , Aged , Aortic Diseases/therapy , Aortography , Coronary Occlusion/therapy , Drug-Eluting Stents , Hematoma/therapy , Humans , Male , Tomography, X-Ray Computed
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