Intra-aortic Balloon Pump Console Research Articles

Hemodynamical Evaluation of a New Surgically Implanted Pulsatile Right Ventricular Assist Device Driven by a Conventional Intra-Aortic Balloon Pump Console.

Severe right heart failure, often overlooked and challenging to manage, has prompted a growing interest in innovative approaches to provide functional support. This study uses experimentation in large porcine models to introduce a novel prototype of a pulsatile mechanical circulatory support device and document its effects when deployed as a right ventricular assist device (RVAD). The pulsatile ventricular assist platform (pVAP), featuring a membrane pump driven by an intra-aortic balloon pump console, actively generates pulsatile flow to propel right ventricular blood into the pulmonary artery. This novel prototype demonstrates promising potential in addressing the challenges of right heart failure management. After preliminary in vitro assessments, the pVAP was tested on seven porcine models in a healthy state and after the induction of right ventricular failure. During the procedure, a set of standard (ie, standard-of-care) hemodynamic measurements was obtained. Additionally, invasive pressure-volume loop analysis was employed to examine left ventricular hemodynamics. Results indicated that activation of the pVAP during right ventricular failure significantly improved systemic hemodynamics and enhanced left ventricular function. This study sheds light on the potential of the pVAP in managing right heart failure.

Intra-Aortic Balloon Pump for Patients with Cardiac Conditions: An Update on Available Techniques and Clinical Applications

In this paper, we present a review of the intra-aortic balloon pump, as well as the usage of it in the medical field today. An intra-aortic balloon pump (IABP) is a biomedical device that can assist the heart during unstable angina or after a heart attack. This pump is typically used in patients who suffer from ischemia of the heart tissue, due to an unbalanced level of myocardial oxygen supply or demand. Through counterpulsation, which is a technique to synchronize the external pumping of blood with the heart’s cycle, the device can balance the supply and demand of blood that is necessary for the heart to pump properly. The IABP is comprised of the following four components: a polyurethane balloon, a polyethylene or fiber-optic catheter, a transducer, and the intra-aortic balloon pump console. In the past, researchers have used other materials that have low biocompatibility and can cause complications within the body. This analysis will explain the complications and state changes that occurred due to them. Limitations of past designs and advantages of current designs will be acknowledged, for they can be used by researchers to enhance designs for the future. Consequently, the analysis of this device may lead to improved designs and treatment in the future for patients with cardiac conditions.

Salutary Effects of the PULVAD, a Novel Implantable Counterpulsation Assist Device, on Cardiac Mechanoenergetics.

The Pressure Unloading Left Ventricular Assist Vevice (PULVAD) is a novel implantable counterpulsation LVAD, designed to provide ventricular unloading with augmentation of LV performance and retention of pulsatility. We assessed the effects of the PULVAD on hemodynamics and LV mechanoenergetics in seven farm pigs with acute ischemic heart failure. The PULVAD was implanted in the thorax and was connected to the ascending aorta. The PULVAD was pneumatically driven by a standard intra-aortic balloon pump console and was electrocardiogram-synchronized to provide LV pressure unloading along with diastolic aortic pressure augmentation. Hemodynamics, indices of LV mechanoenergetics, and coronary blood flow were measured without and after brief PULVAD support. PULVAD support decreased LV afterload and improved LV mechanical performance (increased ejection fraction, stroke volume, cardiac output and maximum elastance). The PULVAD concurrently reduced LV energy consumption (decreased stroke work and pressure-volume area) and optimized LV energetic performance (improved the ratio of stroke work to pressure-volume area). PULVAD support increased mean coronary blood flow, through dramatic augmentation of diastolic blood flow. In conclusion, the PULVAD unloads the failing LV, optimizes LV mechanoenergetics, and augments coronary blood flow. These salutary effects of short-term PULVAD support provide the foundation for long-term testing.

Blood Pressure Monitoring During Intra-Aortic Balloon Pumping.

Blood Pressure Monitoring During Intra-Aortic Balloon Pumping.

The PulseCath iVAC 2L left ventricular assist device: conversion to a percutaneous transfemoral approach.

This technical report describes the essentials and practical implantation technique of the completely percutaneous PulseCath iVAC 2L left ventricular assist device. Percutaneously inserted mechanical left ventricular assist devices are used for circulatory support during cardiogenic shock or high-risk percutaneous coronary interventions. The PulseCath concept is a novel pulsatile design that consists of an extracorporeal membrane pump connected to a large-bore catheter which is inserted across the aortic valve retrogradely into the left ventricle. A genuine intra-aortic balloon pump (IABP) console drives the pulsatile pump. The percutaneous PulseCath iVAC 2L is driven by a genuine IABP console and provides more left ventricular support.

Intraaortic Balloon Pump Timing Discrepancies in Adult Patients

The objective of this clinical study was to quantify the incidence and magnitude of intraaortic balloon pump (IABP) inflation and deflation landmark discrepancies associated with the IABP catheter arterial pressure waveform. Cardiac surgery patients with an IABP inserted prior to surgery were recruited. Following cardiac exposure, a high-fidelity pressure catheter was inserted into the aortic root for digital recording. The radial artery pressure signal was simultaneously recorded from the patient monitor along with the arterial pressure and electrocardiogram waveforms from the IABP console while operating at 1:1 and 1:2 synchronization. In selected patients, recordings were obtained with the IABP timed to the high-fidelity aortic root waveform. In all 11 patients, inflation and deflation landmark delays were observed when comparing the aortic root waveforms to the IABP arterial pressure waveforms (inflation delay = 74 ± 29 [23-117] ms; deflation delay = 71 ± 37 [24-141] ms, mean ± standard deviation [min-max]). Delays were greater when compared to the radial artery waveform (inflation delay = 175 ± 50 [100-233] ms; deflation delay = 168 ± 52 [100-274] ms). In all cases, the landmark delays were statistically different from zero (P < 0.001). Diastolic augmentation and afterload reduction varied with waveform source. Conflicting indications of afterload reduction occurred in four patients. Timing to the aortic root waveform resulted in greater diastolic pressure augmentation and afterload reduction but mixed changes in stroke volume. Delay and distortion of the arterial waveform was consistently found when measured through the IABP catheter lumen. These delays can alter IABP efficacy and may be eliminated by using high-fidelity sensing of aortic pressure.

PulseCath iVAC 3LTM hemodynamic performance for simple assisted flow

The PulseCath iVAC 3L™ left ventricular assist device is an option to treat transitory left heart failure or dysfunction post-cardiac surgery. Assisted blood flow should reach up to 3l/min. In the present in vitro model exact pump flow, depending on various frequencies and afterload was examined. Optimal flow was achieved with inflation/deflation frequencies of about 70-80/min. The maximal flow rate was achieved at about 2.5l/min with a minimal afterload of 22mmHg. Handling of the device was easy due to the connection to a standard intra-aortic balloon pump console. With increasing afterload (up to a simulated mean systemic pressure of 66mmHg) flow rate and cardiac support are in some extent limited.

PulseCath, a new short-term ventricular assist device: our experience in off-pump coronary artery bypass graft surgery

We utilized a new ventricular assist device, the PulseCath catheter, to perform an off-pump bypass procedure in a patient with low ejection fraction. The 21 Fr PulseCath catheter, driven by a standard intra-aortic balloon pump console, can generate a pulsatile flow of 2-3 l/min. The PulseCath coupled with an intra-aortic balloon pump device is an important tool for left ventricular assistance.

Evaluating the Efficacy of Intra-Aortic Balloon Pump Timing Using the Auto-Timing Mode of Operation With the Datascope CS100

The intra-aortic balloon pump (IABP) was first introduced by Moulopoulos et al. in 1962 and was described clinically by Kantrowitz et al. in 1968. The subsequent development of the IABP has resulted in its widespread application, resulting in &gt;70,000 applications per year, making it the most common cardiac assist device after pharmacologic intervention. The correct timing of the inflation and deflation of this device is critical to it being clinically advantageous to the patient. The purpose of this study was primarily to examine the Datascope CS100 automated timing of inflation and deflation, and secondarily, to create an awareness of the risks of solely relying on technology for patient treatment decisions in lieu of clinical evaluative skills. Timing data were collected from 165 IABP patients from January 1, 2003 to March 31, 2005 using the Datascope series System 97, System 98, and CS100 IABP consoles. Timing criteria used in the evaluation of the IABP in this study included proper inflation, defined as inflation at the dicrotic notch of arterial pressure waveform, and proper deflation, resulting in a presystolic decrease of diastolic pressure by 5–10 mmHg. These parameters were evaluated by examining a printed strip from the IABP console after timing selection stabilization. Before implementation of the CS100, 78.6% of inflations and 53.6% of deflations were correct when using the criteria listed above. After implementation of the CS100, 83.3% of inflations were correct and 44.4% of deflations were correct. Although improvement in consistency of IABP inflation quality was observed, a net decrease in the quality of IABP deflations was also observed. Total reliance on the auto-timing operation mode of the CS100 may not be warranted, and imposing clinical judgment in therapeutic application is necessary to avoid dangerous timing errors. An awareness of the dangers of solely relying on technology for patient treatment decisions vs. the use of technology combined with clinical evaluative skills for assessing therapeutic intervention to improve patient care is discussed.

Acute in vivo studies of the Pittsburgh intravenous membrane oxygenator.

The efficacy of an innovative intravenous membrane oxygenator (IMO) was tested acutely (6-8 hrs) in seven calves. The IMO prototypes consisted of a central polyurethane balloon within a bundle of hollow fibers with a membrane surface area of 0.14 m2. The IMO devices were inserted through the external jugular vein into the inferior vena cava of anesthetized calves (68.9 +/- 2.3 kg). Rhythmic balloon pulsation (60-120 bpm) was controlled with an intra-aortic balloon pump console. Oxygen sweep gas was delivered through the device at 3.0 L/min. Gas concentrations were monitored continuously by mass spectroscopy. The principal results were as follows: 1) oxygen and carbon dioxide exchange ranged from 125 to 150 ml/min/m2 and 150 to 200 ml/min/m2, respectively; 2) there was at least a 30-50% augmentation of gas exchange with balloon pulsation; 3) maximum exchange occurred with 60-90 bpm balloon pulsations; and 4) hemodynamic parameters remained unchanged. There were no device related complications, and the feasibility of insertion of the device by a cervical cut-down was established. These acute in vivo experiments show that the Pittsburgh IMO device can exchange oxygen and carbon dioxide gases in vivo at levels consistent with this current prototype design, and that intravenous balloon pulsation significantly enhances gas exchange without causing any end-organ damage.

Small soft left ventricular assist device powered by intraaortic balloon pump console for infants: a less expensive option.

We have developed a pneumatically driven 20 cc soft ventricle for temporary right, left, or biventricular assist. The ventricle consists of a vacuum-formed soft housing, diaphragm, tricuspid outflow valve, and biflap inflow valve. All components including inflow and outflow valves were made with Pellethane. The advantages of this blood pump are as follows: it eliminates use of the quick connect system and therefore is less thrombogenic; the biflap inflow valve provides low inflow resistance; the soft ventricle is easy to implant; the polyurethane valves eliminate blood damage and thromboembolism and are low in cost compared with mechanical valves; and the vacuum-forming technique is reliable, fast, capable of mass production, and therefore inexpensive. We have already demonstrated in both in vitro and in vivo experiments that this ventricle has excellent hemodynamic performance with less blood damage and thrombogenesis. In this study, we evaluated the possible application of a well-defined and widely distributed intraaortic balloon pump (IABP) console to the 20 cc left ventricular assist device (LVAD) driver. The pump was tested in 6 mongrel dogs (6 to 10 kg) using an IABP console. The pump was connected between the left atrium and the ascending aorta, placed paracorporeally on the chest wall, and driven at a synchronous or fixed rate mode without using vacuum. The 20 cc ventricle could maintain the same output as the control output of the natural heart at filling pressures of 5 to 10 mm Hg during the entire observation time of 5 h. Thus, this 20 cc soft ventricle has the potential to be widely used for the treatment of severe heart failure in infants because of its excellent hemodynamic performance, simplicity, and low cost.

Evaluation of an extraaortic counterpulsation device in severe cardiac failure

A valveless, single-orifice polyurethane ventricle with a maximum stroke volume of 60 mL was implanted on the brachiocephalic artery just above the aortic arch in sheep (n = 14) to act as an extraaortic counterpulsation device. In parallel, an intraaortic balloon was placed in the descending thoracic aorta. Both devices were pneumatically driven with an intraaortic balloon pump console that was gated by the electrocardiogram to provide aortic diastolic augmentation at a stroke volume of 40 mL. To compare the efficacy of counterpulsation for each device during severe cardiac failure, biventricular block was induced by continuous infusion of esmolol (100 to 600 μg · kg −1 · min −1), titrated to reduce aortic flow and pressure to less than 75% of baseline. Pulsatile coronary and aortic flows were recorded with ultrasonic flow probes placed around their respective vessels. Aortic root and left ventricular pressures were recorded using micromanometers. The enhancement of hemodynamic variables for both devices were compared for optimal timing conditions, which were defined as inflation set just before the dicrotic notch and deflation bordering on isovolumetric systole. The extraaortic counterpulsation device was able to significantly augment aortic and coronary flows while simultaneously decreasing left ventricular tension time index and aortic end-diastolic pressure ( p < 0.02). The intraarotic balloon pump was able to significantly reduce only tension time index ( p < 0.002) to a lesser extent that the extraaortic counterpulsation device. All analysis was performed with the pairedsamples t test. The extraaortic counterpulsation device greatly improves the myocardial oxygen supply-consumption ratio of the left ventricle by increasing diastolic coronary flow and reducing left ventricular wall tension during systole. The salutary effects of the extraaortic counterpulsation device greatly exceed those of the intraaortic balloon pump, and it may, therefore, provide a viable alternative for patients in pump failure after cardiopulmonary bypass.

Implantable rate-responsive counterpulsation assist system

To apply the potential energy source available from skeletal muscle in cardiac assistance, we developed an implantable counterpulsation assist system. This study reports the results using this implantable counterpulsation assist system in an acute in vivo animal model. Twelve dogs had a dual-chambered, extraaortic counterpulsation pump anastomosed in parallel to the thoracic aorta. The left latissimus dorsi muscle was used to power the pump. A newly developed implantable stimulator was used to make the muscle contract in synchrony with the diastolic phase. The unique feature of this stimulator is its ability to adjust timing of muscle contraction according to changing heart rates. The stimulator is also able to detect arrhythmias, and as a safety measure, shuts down until a normal rhythm is resumed. During counterpulsation assist with the implantable counterpulsation assist system, diastolic pressure increased in average of 34 mm Hg from baseline, equivalent to a 69% augmentation. Systolic peak pressure decreased in average of 10 mm Hg, equivalent to an 11% unloading. With induced heart rate changes, the implantable counterpulsation assist system readjusted its timing, maintaining optimal counterpulsation without systolic interference. Induced ventricular tachycardia resulted in immediate shutdown of the stimulator until resumption of a normal rhythm. The feasibility of using an intraaortic balloon pump console as back-up was also demonstrated. Excellent counterpulsation was obtained with either muscle power or balloon pump console. We conclude that the implantable counterpulsation aasist system can provide effective counterpulsation assist and has the potential for continuous cardiac support.

A biolized implantable ventricular assist device compatible with IABP console.

A low pressure pneumatic pusher plate blood pump was developed for temporary right, left, or biventricular assist. Important features of this pump are its 1) driveability by the standard, easily available intraaortic balloon pump (IABP) console; 2) gelatin coated internal surface for blood compatibility; 3) essentially flat disc shape, 3 cm thick and 11 cm in diameter, for optimal anatomic fit; and 4) unique pusher plate guide mechanism to ensure linear motion without deflections of the diaphragm, and consequent uniform flow distribution into the pump. The guide telescopes into itself to avoid a housing protrusion for easy implantability; this controlled movement also provides a number of performance, control, and diagnostic benefits. The pump's 60 ml displacement gives up to 4.7 L/min at 80 bpm and 6.7 L/min at 120 bpm outputs in a mock loop. This VAD has been implanted in two calves for 43 to 84 days, continuously driven by a Datascope IABP console. An average 5 L/min pump output has been observed in both synchronous and fixed rate modes. No anticoagulation was required. We expect extensive clinical use of this VAD, based on its reliability, low cost, and simplicity.

A Biolized Implantable Ventricular Assist Device Compatible with IABP Console

A low pressure pneumatic pusher plate blood pump was developed for temporary right, left, or biventricular assist. Important features of this pump are its 1) driveability by the standard, easily available intraaortic balloon pump (IABP) console; 2) gelatin coated internal surface for blood compatibility; 3) essentially flat disc shape, 3 cm thick and 11 cm in diameter, for optimal anatomic fit; and 4) unique pusher plate guide mechanism to ensure linear motion without deflections of the diaphragm, and consequent uniform flow distribution into the pump. The guide telescopes into itself to avoid a housing protrusion for easy implantability; this controlled movement also provides a number of performance, control, and diagnostic benefits. The pump's 60 ml displacement gives up to 4.7 L/min at 80 bpm and 6.7 L/min at 120 bpm outputs in a mock loop. This VAD has been implanted in two calves for 43 to 84 days, continuously driven by a Datascope IABP console. An average 5 L/min pump output has been observed in both synchronous and fixed rate modes. No anticoagulation was required. We expect extensive clinical use of this VAD, based on its reliability, low cost, and simplicity.

Lengthened Intraaortic Balloon Tubing for Intraoperative Use

The intraaortic balloon pump (IABP) is being used with increasing frequency during surgical procedures. The standard length of balloon tubing requires the IABP console to be close to the operating table. This creates a possibility of contamination. A longer balloon tubing is described that permits an increased distance between console and operating table without decreasing effective augmentation.