Chronic extra-aortic balloon counterpulsation: first-in-human pilot study in end-stage heart failure.

BACKGROUND: Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60%) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway. CONCLUSIONS: Although feasibility of this device is suggested by this pilot study, safety and efficacy will need to be examined in a larger cohort with longer follow-up.

Cerebral protection by lidocaine during cardiac operations: a follow-up study.

BACKGROUND: A previous study showed less postoperative neurocognitive impairment in open-chamber cardiac surgery patients given lidocaine for 48 hours after induction of anesthesia. In the present study, we aimed to test the benefit of a 12-hour infusion in a broader group of cardiac surgery patients, including those undergoing coronary artery bypass graft surgery. METHODS: This was a randomized, double-blind, intention-to-treat trial. Before cardiac surgery, 158 patients completed 7 neurocognitive tests and a self-rating scale for memory. They received a 12-hour infusion of either lidocaine in a standard antiarrhythmic dose or placebo, beginning at induction of anesthesia. The cognitive tests and memory scale were repeated at postoperative weeks 10 and 25. A deficit in any cognitive test was defined as a decline in score by more than or equal to the preoperative group standard deviation. RESULTS: All tests were completed by 118 and 107 patients at 10 and 25 weeks, respectively. The proportions of patients in the lidocaine and placebo groups exhibiting a deficit in one or more tests were as follows: 45.8% versus 40.7% at 10 weeks, and 35.2% versus 37.7% at 25 weeks (not significant). There were no significant differences between groups in self-ratings of memory function or length of intensive care unit or hospital stay. CONCLUSIONS: Lidocaine was not neuroprotective. The result of the previous trial may represent a type 1 error. Alternatively, benefit may be more likely for open-chamber surgery patients exposed to larger numbers of emboli or with a longer lidocaine infusion.

Extra-aortic implantable counterpulsation pump in chronic heart failure.

Extra-aortic counterpulsation for the management of chronic heart failure is a novel approach. We report the use of an extra-aortic implantable counterpulsation pump in the management of a 73-year-old patient with severe heart failure refractory to medical therapy. The implantable counterpulsation pump prolonged his life and greatly improved its quality. The patient lived almost 7 months after the implantation of the device and died of septic complications secondary to gas line infection.

Extra-ascending aortic versus intra-descending aortic balloon counterpulsation-effect on coronary artery blood flow.

BACKGROUND: Diastolic counterpulsation has been used to provide circulatory augmentation for chronic heart failure or for short-term cardiac support. Recently an extra-aortic balloon (EAB) counterpulsation device has been proposed. AIM: To compare the circulatory effects of counterpulsation using the EAB or an intra-aortic balloon (IAB) in the acute pig model. METHODS: In six anaesthetized great white pigs (paced at 100 bpm), ECG, arterial and central venous pressures, flow in the coronary circulation and descending thoracic aorta were measured. Baseline data was collected, then with the EAB or an IAB fitted using 1:1 and 1:2 counterpulsation modes. Baseline data was compared to EAB and IAB data in 1:1 mode. Assisted beat data compared to unassisted beat data was also analysed in 1:2 mode. RESULTS: Both devices augmented peak diastolic arterial pressure, and decreased afterload. EAB counterpulsation increased diastolic coronary flow in both the 1:1 mode by 69% (p < 0.05) and in the 1:2 mode by 63% (assisted versus unassisted beat, p < 0.05). The IAB significantly increased diastolic coronary flow only in the 1:2 mode by 28% (p < 0.01). Both devices augmented total coronary flow and some augmentation of aortic flow was observed. CONCLUSION: The circulatory effect of the EAB and IAB counterpulsation were comparable. This suggests the EAB could be used as a non-blood contacting heart assist device in patients suffering moderate-severe heart failure.

Extra-aortic balloon counterpulsation: an intraoperative feasibility study.

BACKGROUND: Current methods of counterpulsation or ventricular assistance have significant vascular and limb complications. The aim of this study was to determine the safety and performance of a new method of non-blood-contacting counterpulsation using an inflatable cuff around the ascending aorta (extra-aortic balloon [EAB]). METHODS AND RESULTS: In 6 patients undergoing first time off-pump coronary bypass surgery via sternotomy, the EAB was secured around the ascending aorta and attached to a standard counterpulsation console. At baseline and with 1:2 and 1:1 augmentation, hemodynamic and echocardiographic parameters of ventricular function and coronary flow were measured. High-intensity transient signals were measured using transcutaneous Doppler over the right common carotid artery. No complications occurred. With EAB there was no significant change in heart rate or blood pressure and no increase in high-intensity transient signals. There was a 67% increase in diastolic coronary blood flow (mean left-main diastolic velocity time integral 15.3 cm unassisted versus 25.1 cm assisted, P<0.05). Measurements with transesophageal echocardiography at baseline and with 1:1 counterpulsation demonstrated a 6% reduction in end-diastolic area (P=NS), a 16% reduction in end-systolic area (P<0.01), a 31% reduction in left ventricular wall stress (P<0.05), and a 13% improvement in fractional area change (P<0.005). CONCLUSIONS: EAB counterpulsation augments coronary flow and reduces left ventricular afterload. Further testing is warranted to assess the use of the EAB for chronic non-blood-contacting support of the failing heart.

Cardiopulmonary bypass in pregnancy: possible new role for the intra-aortic balloon pump.

Cardiopulmonary bypass (CPB) during pregnancy is associated with a maternal mortality similar to the nonpregnant population; however, fetal morbidity and mortality are high. Various strategies to improve fetal survival have been advocated. Alteration in uterine artery flow velocity has been reported during nonpulsatile CPB; however, roller pump-generated pulsatile flow for CPB remains controversial. We report use of the intra-aortic balloon pump (IABP) in two cases of pregnancy. In the first, the IABP was inserted after termination of a long bypass, specifically in an attempt to improve uterine perfusion and thereby relieve a profound fetal bradycardia. In the second, the IABP was used electively to provide pulsatile flow during the bypass period primarily to benefit fetal hemodynamics.

Asymmetric primary ringless repair of mitral valve endocarditis: a case report.

The case is presented of a patient with a large mitral valve vegetation. A technique of mitral valve repair involving ringless annuloplasty repair following bileaflet resection of the infected regions of the valve is described. No pledgets or prosthetic material were used in the repair. The patient recovered uneventfully, with trivial mitral regurgitation documented on post-repair echocardiography. This technique may suggest a method for early intervention in mitral endocarditis.