Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study.

BACKGROUND The C-Pulse System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. MATERIAL AND METHODS We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. RESULTS Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support. CONCLUSIONS The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time.

Effects of passive cardiac containment on left ventricular structure and function: verification by volume and flow measurements.

BACKGROUND: The cardiac support device (CSD, Acorn) is a compliant, textile-mesh graft placed around the ventricles to prevent further dilatation and to improve function in congestive heart failure. The aim of this study was to verify post-operative changes in left ventricular volumes, ejection fraction, blood flow, and myocardial mass. METHODS: Fourteen patients underwent contrast-enhanced, electrocardiography-triggered electron-beam computerized tomography before and 6 to 9 months after CSD implantation. We measured volume and flow using the slice-summation method and the indicator-dilution technique. RESULTS: We found significant changes for the following parameters: end-diastolic volume decreased from 382.9 +/- 140.2 ml to 311.3 +/- 138.7 ml, end-systolic volume from 310.4 +/- 132.4 ml to 237.4 +/- 133.8 ml, end-diastolic diameter from 75.3 +/- 7.8 mm to 70.7 +/- 11.6 mm, end-systolic diameter from 65.8 +/- 7.8 mm to 60.0 +/- 14.0 mm, and myocardial mass from 298.6 +/- 79.6 g to 263.1 +/- 76.8 g. Ejection fraction increased from 20.3% +/- 6.4% to 27.8% +/- 13.1%. We found no significant differences for stroke volume (from 72.5 +/- 24.6 ml to 73.8 +/- 23.6 ml), heart rate (from 80.5 +/- 11.0 beats per minute to 76.5 +/- 6.8 beats per minute), and total cardiac output (from 5.8 +/- 1.9 liter/min to 5.6 +/- 1.8 liter/min). Mitral regurgitation fraction decreased from 30.5% +/- 15.5% to 15.6% +/- 12.8%, increasing antegrade cardiac output from 3.8 +/- 0.9 liter/min to 4.7+/-1.5 liter/min. For most parameters, pre- and post-operative values in these patients differed significantly from those in an age- and gender-matched control group. In each patient, we observed a small hyperdense stripe along the pericardium after surgery, but we observed no local complications. CONCLUSION: Three-dimensional structural and functional data obtained by computerized tomography volume and flow measurements confirm the safety and efficacy of CSD implantation.

Ross operation with a tissue-engineered heart valve.

BACKGROUND: The Ross procedure has gained increasing acceptance due to excellent hemodynamic results by replacing the diseased aortic valve with the viable autologous pulmonary valve. Consequently, the right ventricular outflow tract (RVOT) has to be reconstructed. In this report a viable heart valve was created from decellularized cryopreserved pulmonary allograft that was seeded with viable autologous vascular endothelial cells (AVEC). METHODS: A 43-year-old patient suffering from aortic valve stenosis underwent a Ross operation on May 20, 2000, using a tissue engineered (TE) pulmonary allograft to reconstruct the RVOT. Four weeks before the operation a piece of forearm vein was harvested to separate, culture, and characterize AVEC. Follow-up was completed at discharge, 3, 6, and 12 months postoperatively by clinical evaluation, transthoracic echocardiography (TTE), and magnetic resonance imaging (MRI). Additionally, at 1-year follow-up a multislice computed tomographic scan was performed. RESULTS: After four weeks of culturing 8.34 x 10(6) AVEC were available to seed a 27-mm decellularized pulmonary allograft. Trypan blue staining confirmed 96.0% viability. Reendothelialization rate after seeding was 9.0 x 10(5) cells/cm2. TTE and MRI revealed excellent hemodynamic function of the TE heart valve and the neoaortic valve as well. Multislice computed tomography revealed no evidence of valvular calcification. CONCLUSIONS: After 1 year of follow-up the patient is in excellent condition without limitation and exhibits normal aortic and pulmonary valve function.

Recombinant factor VIIa after aortic valve replacement in a patient with osteogenesis imperfecta.

A 26-year-old man with osteogenesis imperfecta and severe aortic regurgitation was scheduled for aortic valve replacement. As previously described by other authors the operation was difficult owing to the friability and weakness of the tissues. Mean blood losses of 153 mL per hour during the first 7 postoperative hours were observed. Despite normal coagulation indicators the bleeding did not stop and recombinant factor VIIa was applied at 40 microg/kg. Bleeding was successfully stopped after this single application.

Biventricular assist device in extreme anorexia nervosa.

Low body mass index is an independent risk factor in cardiac surgery. Cardiac function may be severely impaired in the case of extreme malnutrition and require cardiac assistance if cardiac surgery is necessary. We report a case of the successful use of a biventricular assist device in a patient with an extreme low body mass index (6.7) due to anorexia nervosa for recovery after mitral valve replacement due to endocarditis after infusion therapy for nutrition.

Bridge-to-recovery from acute myocarditis in a 12-year-old child.

Fulminant myocarditis causes substantial morbidity and mortality, especially in children and young adults. Mechanical circulatory support has become the standard therapy to bridge patients with intractable heart failure to either transplantation or myocardial recovery. Yet, successful weaning from biventricular support with full recovery is extremely rare in the pediatric population. This report describes the successful use of the MEDOS HIA ventricular assist device to bridge a 12-year-old girl to myocardial recovery in a biventricular bypass configuration. The left and right ventricle were completely off-loaded by the pumps and the device provided sufficient cardiac output to normalize end-organ function. Anticoagulation was maintained with i.v. heparin infusion. No neurological complications were detectable and the pump system was free of any macroscopic thrombi. After 19 days of support, cardiac function had recovered and the patient was successfully weaned from the device. Following physical rehabilitation, the patient was discharged home.

Treatment of severe pulmonary hemorrhage after cardiopulmonary bypass by selective, temporary balloon occlusion.

Severe pulmonary bleeding causes frequent mortality, particularly if this event occurs during separation from extracorporeal circulation during cardiac surgery. We present a new approach to treat this life-threatening complication: temporary balloon occlusion of the pulmonary artery feeding the involved lobe. On attempting to wean a 71-yr-old female patient from cardiopulmonary bypass after aortic valve replacement, she lost more than 2 L of blood through her trachea over approximately 15 min and severe gas embolism into the left atrium was visualized on transesophageal echocardiography. As the bleeding was too vigorous to be localized by fiberoptic bronchoscopy, an interventional cardiologist was consulted. After localizing the affected lobe using fluoroscopy, he inflated a balloon dilating catheter in the lower lobe artery. This effectively stopped the bleeding. Separation from extracorporeal circulation was uneventful using one-lung ventilation to prevent further gas embolism. Sixteen hours after the end of surgery the catheter could be deflated and removed without any further intervention. The patient made an excellent recovery.

Effect of partial left ventriculectomy on left and right ventricular volumes and function as assessed with electron beam tomography: preliminary results.

Our objective was to determine if left ventricular reduction surgery affects left and right ventricular volumes and function. Twenty-three patients with end-stage heart failure underwent contrast-enhanced electron beam tomographic function studies before and twice after partial left ventriculectomy (PLV). The PLV was combined with other cardiosurgical procedures in 20 of 23 patients. Left and right ventricular enddiastolic volume (LVEDV, RVEDV), stroke volume (LVSV, RVSV), ejection fraction (LVEF, RVEF), and enddiastolic diameter (LVEDD, RVEDD) were determined by manual tracing of endo- and epicardial borders at enddiastole and endsystole. Patients were scanned 31 days (+/-34) before and 18 days (+/-13) and 8 months (+/-4) after PLV. Mean pre- and early and late postoperative values for LVEDV, LVSV, LVEF, and LVEDD were 387.9 ml (+/-125.5 ml), 255.6 ml (+/-79.3 ml; p<0.01), and 253.7 ml (+/-97.8 ml; p<0.05), 79.7 ml (+/-25.2 ml), 74.8 ml (+/-17.9; n.s.), and 79.1 ml (+/-26.5 ml; n.s.), 21.6% (+/-7.3%), 31.9% (+/-13.4%; p<0.05), and 34.1% (+/-14.1%; p<0.05), and 72.0 mm (+/-10.6 mm), 64.3 mm (+/-8.5 mm; p<0.05), and 63.5 mm (+/-9.4 mm; p<0.05), respectively. Mean pre- and postoperative values for RVEDV, RVSV, RVEF, and RVEDD were 177.7 ml (+/-72.8 ml), 172.4 ml (+/-59.2 ml; n.s.), and 178.9 ml (+/-60.8 ml; n.s.), 60.3 ml (+/-21.6 ml), 68.8 ml (+/-19.9 ml; n.s.), and 78.3 ml (+/-25.3 ml; n.s.), 38.1% (+/-15.4%), 43.7% (+/-16.3%; p<0.05), and 45.1% (+/-11.2%; n.s.), and 50.4 mm (+/-10.9 mm), 48.1 mm (+/-8.7 mm; n.s.), and 48.5 mm (+/-9.8 mm; n.s.), respectively. The PLV may induce a significant early reduction of left ventricular volumes and improvement of biventricular function; however, our results must be judged carefully as the majority of patients in this study underwent additional cardiosurgical procedures, the contributory effect of which on the overall outcome remains unclear.