New Insights into Mortality-Related Risk Factors in Infective Endocarditis: Results from the Brandenburg State Endocarditis Register.

OBJECTIVE: Endocarditis as a potentially life-threatening disease with high complication and mortality rates. In recent years, an increase in the incident of endocarditis has been reported throughout Europe. In the aging society, successful treatment is complex and challenging owing to the high rate of multimorbidity. METHODS: We initiated a statewide prospective multicenter endocarditis registry in 2020. Perioperative risk factors, comorbidities, microbiological, laboratory and imaging diagnostics, complications, and mortality including 1-year follow-up were collected. The present midterm analysis includes factors influencing mortality in the first 313 patients. RESULT: In-hospital mortality and 1-year mortality were 28.4 and 40.9%, respectively. Preoperative risk factors include age (p < 0.001), EuroSCORE II (p < 0.001), coronary artery disease (p = 0.022), pacemaker probe infection (p = 0.033), preoperative left ventricular ejection fraction (LVEF), systemic inflammatory response syndrome (SIRS), pulmonary edema, heart failure, septic emboli, acute renal failure, impaired coagulation, hypalbuminemia (p < 0.001), and N-terminal prohormone of brain natriuretic peptide (NTproBNP) (p = 0.001). The presence of peri-annular abscess, perforation, and shunt were associated with increased mortality (p = 0.004, 0.001, and 0.004, respectively). In addition, cardiopulmonary bypass time influenced mortality (p = 0.002). The main postoperative causes of death were multi-organ failure, renal failure, vasoplegia, and low-output syndrome (p < 0.001). Previous endocarditis was 7.7%, while 35.5% were prosthetic valve recipients and 33.6% were redo surgeries. CONCLUSION: Our first registry data show the complexity of endocarditis patients and the challenging treatment. Some risk factors can be treated preoperatively. For instance, hypalbuminemia and the duration of the procedure can be controlled with adequate albumin substitution and carefully planned procedures restricted to the essential requirements, that is, hybrid approaches with consecutive interventions.

Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial.

BACKGROUND: In current guidelines, intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock. STUDY DESIGN: The IABP-SHOCK II study is a 600-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of IABP versus optimal medical therapy on the background of early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of IABP-SHOCK II is 30-day all-cause mortality. Secondary outcome measures, such as hemodynamic, laboratory, and clinical parameters, will serve as surrogate end points for prognosis. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed. Safety will be assessed, by the GUSTO bleeding definition, peripheral ischemic complications, sepsis, and stroke. CONCLUSIONS: The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction.

Cobalt-chrome MULTI-LINK VISION-stent implantation in diabetics and complex lesions: results from the DaVinci-Registry.

AIMS: Restenosis in bare-metal stents is in part related to stent design and material. Optimized strut design of cobalt-chrome (CoCr) stents may yield nearly comparable results to drug-eluting stents (DES) in selected lesions. The prospective multicenter DaVinci registry investigates the clinical outcome of a CoCr coronary stent (MULTI-LINK VISION), particularly in terms of patients with diabetes and complex lesions (B1, B2, C). METHODS AND RESULTS: The prospective internet-based registry included 1,344 patients (76% males, aged 66 +/- 10 years) undergoing stent implantation (n = 1,642) in 32 centres from July 2003 to June 2004. Follow-up data (median 9 +/- 1 months) of this cohort were available for 1,289 patients (98.1%). Of these patients 327 (26.2%) were diabetics. In total, 1,429 de-novo lesions (A 11.9%, B1 47.7%, B2 31.6%, C 8.8%) were treated with the CoCr stent. The predefined primary endpoint was defined as a composite of death, Q-wave myocardial infarction (STEMI), non-STEMI (NSTEMI), target vessel revascularization (TVR) by coronary bypass graft (CABG) or PCI at 270 days (target vessel failure, TVF). Secondary endpoints include death, time to the first myocardial infarction, TVR and CABG. The cumulative incidence of major adverse cardiac events (MACE) was 12.4% with 0.8% deaths, 1.5% non-fatal MI, and 9.7% TVR. TVF in the overall cohort was documented in 137 (10.8%) patients. For diabetics and complex lesions TVF was 13.8% (95% CI 4.2-18) and 11.4% (95% CI 2.0-13.3), respectively. CONCLUSION: This large registry confirms good acute and long-term success of CoCr stents making this strategy valuable, particularly in a special cohort (diabetics and complex lesions) as long as late stent thrombosis with DES plays a role and short-term antiplatelet therapy is favoured.

Supported high-risk percutaneous coronary intervention with the Impella 2.5 device the Europella registry.

OBJECTIVES: This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). BACKGROUND: Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump. METHODS: The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function. RESULTS: Patients were older (62% >70 years of age), 54% had an LV ejection fraction < or = 30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively. CONCLUSIONS: This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.

Effect of atrial lead position on atrial automatic capture verification.

INTRODUCTION: Optimizing atrial automatic capture verification based on atrial-evoked response (AER) detection requires maximizing the signal artifact ratio (SAR), that is, AER to stimulation artifact (ART). This study evaluated the effect of bipolar atrial lead position on sensed AER, ART, and SAR. METHODS AND RESULTS: A custom-made external research system (INSIGNIA(AC), Boston Scientific Corp. St Paul, MN, USA) was used to perform an automatic voltage step-down atrial pacing protocol at three different right atrial lead positions (A-appendage, L-lateral wall, and S-septal wall) in each studied patient. The atrial pacing and the AER sensing configurations were independent. The pacing was unipolar in an A(tip)-Can configuration while sensing was in A(ring)-I(ndiff). Data from 16 patients (mean age 71.1 +/- 9.6 years) and six-lead models from five different manufacturers were analyzed. Study results show that with all lead types, the atrial lead placement had no significant effect on AER(min), ART(max), and SAR(min) and only one patient had an SAR that was not sufficient to support successful automatic capture verification at all tested atrial pacing sites. CONCLUSION: The atrial pacing site has minimal effect on AER sensing when using an independent pace/sense configuration. The leads placed at all tested sites were found to have the parameters sufficient to support the atrial automatic capture verification in all but one patient.

Cardiac contractility modulation electrical signals improve myocardial gene expression in patients with heart failure.

OBJECTIVES: The objective of this study was to test whether cardiac contractility modulation (CCM) electric signals induce reverse molecular remodeling in myocardium of patients with heart failure. BACKGROUND: Heart failure is associated with up-regulation of myocardial fetal and stretch response genes and down-regulation of Ca(2+) cycling genes. Treatment with CCM signals has been associated with improved symptoms and exercise tolerance in heart failure patients. We tested the impact of CCM signals on myocardial gene expression in 11 patients. METHODS: Endomyocardial biopsies were obtained at baseline and 3 and 6 months thereafter. The CCM signals were delivered in random order of ON for 3 months and OFF for 3 months. Messenger ribonucleic acid expression was analyzed in the core lab by investigators blinded to treatment sequence. Expression of A- and B-type natriuretic peptides and alpha-myosin heavy chain (MHC), the sarcoplasmic reticulum genes SERCA-2a, phospholamban and ryanodine receptors, and the stretch response genes p38 mitogen activated protein kinase and p21 Ras were measured using reverse transcription-polymerase chain reaction and bands quantified in densitometric units. RESULTS: The 3-month therapy OFF phase was associated with increased expression of A- and B-type natriuretic peptides, p38 mitogen activated protein kinase, and p21 Ras and decreased expression of alpha-MHC, SERCA-2a, phospholamban, and ryanodine receptors. In contrast, the 3-month ON therapy phase resulted in decreased expression of A- and B-type natriuretic peptides, p38 mitogen activated protein kinase and p21 Ras and increased expression of alpha-MHC, SERCA-2a, phospholamban, and ryanodine receptors. CONCLUSIONS: The CCM signal treatment reverses the cardiac maladaptive fetal gene program and normalizes expression of key sarcoplasmic reticulum Ca(2+) cycling and stretch response genes. These changes may contribute to the clinical effects of CCM.

First use of cardiac contractility modulation (CCM) in a patient failing CRT therapy: clinical and technical aspects of combined therapies.

Cardiac contractility modulating (CCM) signals delivered by the OPTIMIZER System are being investigated as a treatment for medically refractory heart failure. Previous chronic studies of CCM have excluded patients with prolonged QRS and a cardiac resynchronization therapy (CRT) device. However, symptoms persist in more than 25% of these CRT patients. CCM may offer a therapeutic option for these non-responders. Here we report the first use of CCM signals in a patient who did not respond to treatment with a CRT-D device. We show that the implantation is technically feasible, that the OPTIMIZER and CRT-D devices can coexist without interference and that acute haemodynamic and clinical improvements can be observed. The results suggest that systematic investigation of CCM treatment in CRT non-responders is warranted.

Acute large pseudoaneurysm of the left anterior descending artery following bypass surgery: combined percutaneous approach with a PTFE-coated coronary stent and coil embolization.

Injury of a native coronary vessel during coronary artery bypass grafting (CABG) is very rare. We report a case of a 76-year-old patient who developed a large pseudoaneurysm of the left anterior descending artery following CABG. The patient was then successfully treated by polytetrafluorethylene (PTFE)-stent graft implantation and percutaneous coil embolization. A coronary artery pseudoaneurysm caused by intraoperative damage has not been described previously.

Closure of the subclavian artery puncture site with a percutaneous suture device after removal of an arterial pacemaker lead.

We describe the closure of a subclavian artery puncture site with a percutaneous suture device after removal of a pacemaker lead 1 week after its inadvertent positioning in the left ventricle via the subclavian artery. The lead was retracted from the left ventricle into the aorta and linked to a guiding catheter introduced via femoral artery access. The lead and the guiding catheter were removed from the artery to the subclavian area. This manoeuvre allowed the placement of a percutaneous arterial suture device (Perclose) to close the puncture site.