Using a Dedicated Interventional Pulmonology Practice Decreases Wait Time Before Treatment Initiation for New Lung Cancer Diagnoses.

PURPOSE: While there is significant mortality and morbidity with lung cancer, early stage diagnoses carry a better prognosis. As lung cancer screening programs increase with more pulmonary nodules detected, expediting definitive treatment initiation for newly diagnosed patients is imperative. The objective of our analysis was to determine if the use of a dedicated interventional pulmonology practice decreases time delay from new diagnosis of lung cancer or metastatic disease to the chest to treatment initiation. METHODS: Retrospective chart analysis was done of 87 consecutive patients with a new diagnosis of primary lung cancer or metastatic cancer to the chest from our interventional pulmonology procedures. Demographic information and time intervals from abnormal imaging to procedure and to treatment initiation were recorded. RESULTS: Patients were older (mean age 69) and former or current smokers (72%). A median of 27 days (1-127 days) passed from our diagnostic biopsy to treatment initiation. A median of 53 total days (2-449 days) passed from abnormal imaging to definitive treatment. Endobronchial ultrasound-guided transbronchial needle aspiration was the most commonly used diagnostic procedure (59%), with non-small cell lung cancer the majority diagnosis (64%). For surgical patients, all biopsy-negative lymph nodes from our procedures were cancer-free at surgical excision. CONCLUSIONS: Compared to prior reports from international and United States cohorts, obtaining a tissue biopsy diagnosis through a gatekeeper interventional pulmonology practice decreases median delay from abnormal imaging to treatment initiation. This finding has the potential to positively impact patient outcomes and requires further evaluation.

Cardiac replacement with a total artificial heart as a bridge to transplantation.

BACKGROUND: The CardioWest Total Artificial Heart orthotopically replaces both native cardiac ventricles and all cardiac valves, thus eliminating problems commonly seen in the bridge to transplantation with left ventricular and biventricular assist devices, such as right heart failure, valvular regurgitation, cardiac arrhythmias, ventricular clots, intraventricular communications, and low blood flows. METHODS: We conducted a nonrandomized, prospective study in five centers with the use of historical controls. The purpose was to assess the safety and efficacy of the CardioWest Total Artificial Heart in transplant-eligible patients at risk for imminent death from irreversible biventricular cardiac failure. The primary end points included the rates of survival to heart transplantation and of survival after transplantation. RESULTS: Eighty-one patients received the artificial-heart device. The rate of survival to transplantation was 79 percent (95 percent confidence interval, 68 to 87 percent). Of the 35 control patients who met the same entry criteria but did not receive the artificial heart, 46 percent survived to transplantation (P<0.001). Overall, the one-year survival rate among the patients who received the artificial heart was 70 percent, as compared with 31 percent among the controls (P<0.001). One-year and five-year survival rates after transplantation among patients who had received a total artificial heart as a bridge to transplantation were 86 and 64 percent. CONCLUSIONS: Implantation of the total artificial heart improved the rate of survival to cardiac transplantation and survival after transplantation. This device prevents death in critically ill patients who have irreversible biventricular failure and are candidates for cardiac transplantation.

Total artificial heart bridge to transplantation: a 9-year experience with 62 patients.

BACKGROUND: The SynCardia CardioWest total artificial heart (CardioWest TAH) is a biventricular, orthotopic, pneumatic, pulsatile blood pump driven by an external console. For each ventricle, the length of the blood-flow path is shorter and the inflow and outflow valves are larger than in any other bridge-to-transplant device, resulting in greater blood flow at smaller pre-load. Such a device should be optimal for bridging transplant candidates who have biventricular failure and for whom all other therapies have failed. METHODS: From January 1, 1993, to April 1, 2002, we prospectively studied 62 consecutive CardioWest TAH implant recipients to document safety and efficacy in bridge to transplantation. We used multisystem monitoring and multidrug therapy for anti-coagulation in 58 patients starting September 1, 1994. RESULTS: Before implantation, patients were critically ill with biventricular heart failure. Mortality in this group from the time of implantation until transplantation was 23%. Causes of death during device support included multi-organ failure (6), sepsis (3), and valve entrapment (2). Forty-eight patients underwent transplantation (77%). Forty-two survived to hospital discharge (68% of the total, 88% of those undergoing transplantation). Adverse events included bleeding (20%), device malfunction (5%), fit complications (3%), mediastinal infections (5%), visceral embolus (1.6%), and stroke during support (1.6%). The linearized stroke rate was 0.068 events per patient-year. CONCLUSIONS: Sixty-eight percent of critically ill transplant candidates for whom medical therapy failed were bridged to transplantation with the CardioWest TAH and survived long-term. Most deaths that occurred during device support were related to pre-implant problems. Infection and stroke were rare events. Therefore, we recommend the CardioWest TAH as the biventricular bridge-to-transplant device of choice.

Successful management of empyema in a patient with a total artificial heart.

A description of successful management of a patient who developed an empyema as a postoperative complication following the insertion of a CardioWest total artificial heart (TAH) as a bridge to cardiac transplantation is presented. By using traditional methods of management, the patient recovered and went on to transplant.

Medical devices of the chest.

Chest devices are encountered on a daily basis by almost all radiologists. A multitude of extrathoracic materials, from intravenous catheters to oxygen tubing and electrocardiographic leads, frequently overlie the chest, neck, and abdomen. Chest tubes, central venous catheters, endotracheal tubes, and feeding tubes are very common. Cardiac surgery involves the use of many sophisticated devices and procedures, ranging from valve replacement to repair of complex congenital anomalies. Coronary artery bypass surgery is no longer considered unusual, and in many large medical centers, ventricular assist devices and total artificial hearts are frequently encountered. Breast implants are visible at standard chest radiography, and many ancillary devices not intended for treatment of cardiac or thoracic diseases are visible on chest radiographs. New devices are constantly being introduced, but most of them are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function, as well as to recognize the complications associated with its use.

Total artificial hearts: bridge to transplantation.

The CardioWest TAH was created and initially tested at the same time as the Thoratec, Novacor, and HeartMate devices. It was designed as a permanent artificial heart and was the first-ever mechanical circulatory device to be used as destination therapy. Twenty years have passed since that early experience. Pneumatic technology is still current and being developed as in existing or new implantable Thoratec VADs the pneumatic HeartMate, and the Abiomed BVS 5000 pumps. Portable pneumatic drivers have been available since 1982, and in recent times have allowed discharge to home of substantial numbers of patients, thus reducing the length of hospital stays and making mechanical device support less expensive to society and more tolerable to patients. Within months, a portable driver for the CardioWest will be available. The documented benefits of the CardioWest TAH include rescue of: critically ill patients with advanced heart failure; patients with biventricular failure especially those with significant right heart failure, elevated pulmonary vascular resistance, or pulmonary edema; patients with renal or hepatic failure secondary to low cardiac output; patients with massive myocardial damage such as those with post-\infarction VSD or irreversible cardiac graft rejection; patients with mechanical valves or native valve disease; and patients with intractable arrhythmias and heart failure. High device outputs with restoration of normal filling pressures result in high perfusion pressures that have led to dramatic recoveries, convalescence, and return to levels of activity compatible with normal life. The average device output with the CardioWest TAH is higher than any other approved or investigational device. The reason for this resides in design simplicity this device has the shortest and largest inflow pathway. Stroke, in the authors' own series, is rare with a linearized rate of 0.068 events per patient year. If the experiences of La Pitie and the University of Arizona are combined, there has been one stroke in 25 patient years (0.04 events/patient year). Serious infections have been rare (12% of patients). No clinical mediastinitis has occurred. Drivelines have healed in tightly and never caused an "ascending" infection. There has not been a case of device endocarditis. Using a broad definition of bleeding, including takeback reoperation for bleeding, bleeding more than 8 units in the first postoperative 24 hours or 5 units over any other 48-hour period, a 25% to 36% incidence has been documented. No cases of fatal exsanguination have resulted, as there have been with the HeartMate. The incidence of bleeding as an adverse event is about 17% lower than the rate reported for the HeartMate VE LVAD, and it is about the same as that reported for Novacor and for Thoratec. Implantation of this device is relatively easy and often done (with attending help) by the authors' residents. If one follows the guidelines for fitting the device, and takes the recommended advice for implantation, hemostasis is excellent and restoration of immediate cardiac function with high flows is nearly automatic. Use of a neopericardium of 0.1 mm EPTFE at the time of implantation assures atraumatic and relatively quick re-entry for transplantation and prevents the normal inflammatory mediastinal reaction that might be desirable in a destination application. In selected patients the CardioWest TAH is the device of choice for bridge to transplantation. When a portable driver becomes available, out of hospital management of CardioWest TAH patients will be feasible and consideration of use of this device for longer term applications, (e.g., "destination therapy,") will be reasonable. A wearable driver, even smaller than a portable, will improve quality of life and expand the patient population that may be therapeutically served with this system. In short, the CardioWest TAH has come nearly full circle. It was first used as a destination device. It has since been used as a bridge to transplantation in nearly 200 patients as the Jarvik-7/Symbion TAH and, since 1993, in over 225 patients as CardioWest. The results have improved with time. Thromboembolism and infection rates have been competitive with currently available devices. Device reliability and durability have been excellent. Survival rates have been very high in a group of perhaps the sickest patients to be supported with any pulsatile device. Pneumatic technology has improved with portability and miniaturization, and there is reason to believe that it will become even better. Application of modern manufacturing techniques to this very simple device raises the possibility of significant manufacturing cost reduction, in an era of prohibitive cost for other devices. All of this establishes the CardioWest as a valuable device for any program that is seriously interested in end-stage heart disease and a likely device for permanent use in appropriately selected patients.

Risk factor analysis for bridge to transplantation with the CardioWest total artificial heart.

BACKGROUND: Safety and efficacy studies of various mechanical circulatory support devices are important, but may not be strictly comparable. Lacking prospective randomized studies for different devices, we believe that comparison of risk factor analyses may give the surgeon a tool more powerful than current studies for matching a patient with an appropriate device. In this paper, we report risk factor profiles for bridge to transplantation with the CardioWest total artificial heart and summarize reports for other devices. METHODS: A multiinstitutional risk factor analysis of the CardioWest total artificial heart, as a bridge to transplantation in 81 patients, was conducted. Univariate analyses were performed on 43 preimplantation prognostic factors. From this group, eight factors were chosen for multivariate analysis. Our results were compared with all recent risk factor analyses for other devices. RESULTS: Independent predictors for death at three intervals by multivariate analysis were as follows: "implant to transplant": history of smoking (odds ratio, 34); "implant to 30 days after transplant": history of smoking (odds ratio, 10.00), prothrombin time greater than 16 seconds (odds ratio, 4.76); and "implant to 1 year after transplant": prothrombin time greater than 16 seconds (odds ratio, 3.85). The major difference between this experience and multiple reported experiences with left ventricular assist devices is that for left ventricular assist devices, but not for the temporary CardioWest total artificial heart, right heart failure, high central venous pressure, and being on a ventilator (with or without sepsis) were independent predictors of mortality. CONCLUSIONS: Risk factors for bridge to transplantation with the CardioWest total artificial heart are different from those reported for left ventricular assist devices. Recognition of these risk factor differences may facilitate appropriate device selection.

Pediatric bridge to heart transplantation: application of the Berlin Heart, Medos and Thoratec ventricular assist devices.

BACKGROUND: Bridge to transplantation (BTT) is an accepted option when a donor heart is not available. Extensive clinical study has been done with BTT in the adult population, but comparatively fewer data are available in the pediatric population with regard to pulsatile devices. METHODS: Ten pediatric patients are presented, all of whom underwent BTT or recovery with pneumatic paracorporeal systems. The Berlin Heart bi-ventricular assist device (BVAD) was utilized in 1 patient, the Medos VAD in 4 patients (1 left ventricular assist device [LVAD], 3 BVADs) and the Thoratec VAD in 5 patients (3 BVADs, 2 LVADs). The pediatric population consisted of 3 females and 7 males. Mean age of the population was 7.4 years, weight 25 kg and body surface area (BSA) 0.88 m(2). Etiology for heart failure consisted of 4 viral, 3 congenital and 3 idiopathic cardiomyopathies. Before implant, all patients had evidence of progressive cardiac failure despite inotropic support, and 2 patients had been on extracorporeal membrane oxygenation (ECMO). Mean duration on the device was 34.3 days (8 to 107 days). RESULTS: Two patients suffered stroke and recovered without sequelae. Two patients died of ischemic stroke and 1 of sepsis. Seven patients survived (6 transplanted and 1 weaned) for a survival rate of 70% compared with survival for ECMO as BTT, which was 40% to 50%. All survivors had complications related to bleeding, thromboembolic events and infections. CONCLUSIONS: The Thoratec VAD can be placed in small patients with large hearts that can accommodate the available cannulas. The Berlin Heart and the Medos VAD have a selection of ventricles with small stroke volumes. All 3 systems can be used successfully in the pediatric population as BTT with better survival than with ECMO.

CardioWest total artificial heart in a moribund adolescent with left ventricular thrombi.

Bridge to transplant is a well-known strategy to enable patients with congestive heart failure to live until transplant. A 15-year-old boy with Beckers' muscular dystrophy and cardiomyopathy was accepted for heart transplantation. He suffered a cardiac arrest and was placed on extracorporeal membrane oxygenator. A paracorporeal biventricular assist device and a total artificial heart were considered for bridge to transplant. A CardioWest total artificial heart was chosen because of the patient's size. Multiple left ventricular thrombi were identified at the time of the ventriculectomy. The patient did well with the total artificial heart was transplanted and discharged home. The unknown presence of significant left ventricular thrombi raises the question of outcome with a paracorporeal ventricular assist device.