Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.

BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

Comparison of long term clinical outcomes, event free survival rates of patients undergoing enhanced external counterpulsation for coronary artery disease in the United States and Turkey.

OBJECTIVES: This study assessed the long-term efficacy of EECP (Enhanced External Counterpulsation) in Turkish (TR) patients initially and compared these results with the United States (US) in a real world setting. STUDY DESIGN: In this study, 2072 patients were treated and followed in the US and 82 patients were treated and followed in TR. The International EECP Patient Registry Phase I and II was initiated and coordinated at the University of Pittsburgh. The aim of the "registry" was to assess the outcomes of clinical trials in a real world setting. Another unique feature of this study was to enroll patients not only from university hospitals but also from private hospitals, educational hospitals, and treatment centers. RESULTS: TR patients had less diabetes, hypertension, and hyperlipidemia than US patients (p<0.01). TR patients also had a higher proportion of diastolic augmentation (p<0.001). Both groups showed a significant reduction in the severity of angina after a 35 h EECP course (p<0.001). Major Adverse Cardiac Events (MACE) rate (death, coronary artery bypass graft, percutaneous coronary intervention, myocardial infarction) was low in both groups during treatment (2.5% vs. 2.7%). At 1 year follow up, 84% of TR and 76% of US patients had maintained the improvement of angina. CONCLUSION: Patients presenting for EECP treatment from TR had different baseline profiles from US patients. However, despite the high risk baseline characteristics, both cohorts achieved similar reduction in angina. In the long term follow-up, the MACE rate was low and the improvement after EECP was sustained in most of the patients.

The efficacy and safety of enhanced external counterpulsation in patients with peripheral arterial disease.

Peripheral arterial disease (PAD) is common in patients with severe coronary artery disease (CAD) and is considered a relative contraindication to external enhanced counterpulsation (EECP), but there are no data that define the efficacy and safety of EECP in patients with PAD. The International EECP Patient Registry (IEPR) was used to compare initial post-therapy and 2-year follow-up clinical outcomes and adverse event rates in patients with and without PAD. From January 2002 to October 2004, 2126 patients were enrolled in the IEPR, of whom 493 (23%) had a history of PAD. Immediately following EECP, the reduction in angina (> or = 1 Canadian Cardiovascular Society class) was similar in patients with and without PAD (76.6% vs 79.0%, p = 0.27) as was improvement in the Duke Activity Score Index (DASI) score (+4.7% vs +6.1%, p < 0.001). Both angina reduction and DASI score improvement were sustained at 2 years. PAD patients discontinued EECP more frequently (12.0% vs 8.5%, p < 0.05), but lower extremity ulceration did not occur more frequently in patients with PAD (3.7% vs 2.7%, p = 0.26). Rates of death (17.1% vs 8.6%, p < 0.001) and myocardial infarction (9.5% vs 5.0%, p < 0.001) were, as expected, higher in patients with PAD compared to patients without PAD at 2 years. In conclusion, while PAD patients constitute a high-risk cohort with known higher adverse event rates, EECP led to similar short- and long-term improvements in angina and quality of life for individuals with PAD compared to those without PAD.

Contrapulsación intraaórtica en cirugía coronaria: factores predictivos de mortalidad hospitalaria / Intraaortic countenpulsation in coronary surgery: prediction factors of hospital mortality

La contrapulsación aórtica (CPIA) es el método más básico y difundido de asistencia circulatoria. Su utilidad en el síndrome de bajo gasto postcardiotomía aún comporta alta mortalidad. Pretendemos identiificar factores relacionados con el perfil preoperatoriodel paciente y el procedimiento realizado, que tenga carácter predictivo de mortalidad hospitalaria (MH) en la utilización de CPIA por bajo gasto tras cirugía coronaria. Entre septiembre de 1995 y abril de 1998 hemos intervenido 382 pacientes coronarios. Se utilizó CPIA en 54 casos (14 por ciento). Analizamos 50 variables pre e intraoperatorias de potencial carácter predictivo en el grupo A (29 supervivientes) y B (25 fallecidos). La MH por CPIA en coronarios fue del 46 por ciento. Todos los scores de riesgo preoperatorio fueron más elevados en el grupo B, aunque el score de Parsonnet mostró diferencias significativas (grupo A: 6 vs B: 12,9) (p<0,01). La mayor utilización de venas (grupo A:1,3 vs B:2) (p<0,05), el menor uso de injertos arteriales (A:79 por ciento vs B:56 por ciento) y el carácter emergente de la cirugía (A:7 por ciento vs B:20 por ciento) también se relacionaron con la MH. La CPIA en el sindrome postcardiotomía tras revascularización coronaria aún presenta altas cifras de MH. En nuestra experiencia la MH se asocia a un perfil de riesgo elevado del paciente, así como con el tipo de injerto empleado y con el carácter emergente de la cirugía

Contrapulsación intraaórtica en cirugía coronaria: factores predictivos de mortalidad hospitalaria / Intraaortic countenpulsation in coronary surgery: prediction factors of hospital mortality

La contrapulsación aórtica (CPIA) es el método más básico y difundido de asistencia circulatoria. Su utilidad en el síndrome de bajo gasto postcardiotomía aún comporta alta mortalidad. Pretendemos identiificar factores relacionados con el perfil preoperatoriodel paciente y el procedimiento realizado, que tenga carácter predictivo de mortalidad hospitalaria (MH) en la utilización de CPIA por bajo gasto tras cirugía coronaria. Entre septiembre de 1995 y abril de 1998 hemos intervenido 382 pacientes coronarios. Se utilizó CPIA en 54 casos (14 por ciento). Analizamos 50 variables pre e intraoperatorias de potencial carácter predictivo en el grupo A (29 supervivientes) y B (25 fallecidos). La MH por CPIA en coronarios fue del 46 por ciento. Todos los scores de riesgo preoperatorio fueron más elevados en el grupo B, aunque el score de Parsonnet mostró diferencias significativas (grupo A: 6 vs B: 12,9) (p<0,01). La mayor utilización de venas (grupo A:1,3 vs B:2) (p<0,05), el menor uso de injertos arteriales (A:79 por ciento vs B:56 por ciento) y el carácter emergente de la cirugía (A:7 por ciento vs B:20 por ciento) también se relacionaron con la MH. La CPIA en el sindrome postcardiotomía tras revascularización coronaria aún presenta altas cifras de MH. En nuestra experiencia la MH se asocia a un perfil de riesgo elevado del paciente, así como con el tipo de injerto empleado y con el carácter emergente de la cirugía (AU)

[Current role of intra-aortic diastolic balloon counterpulsation in heart surgery]. / Place actuelle de la contrepulsion diastolique par ballonnet intra-aortique en chirurgie cardiaque.

Intra-aortic balloon counterpulsation (IABP) is a relatively non-invasive method of circulating assistance, easy to use and which has benefitted from a number of technological improvements in recent years. This retrospective study over 4 years was undertaken to analyse the results of IABP and to determine its role in therapeutic arsenal against cardiac failure. Sixty five patients, 57 coronary and 8 valvular cases, with an average age of 61 +/- 10 years were included. The indications of IABP were: a bridge to transplantation (3 cases), complications of coronary angioplasty (4 cases), and low cardiac output after cardiopulmonary bypass (58 cases), where IABP was curative in 85% of cases and prophylactic in 15% of cases (patients with risk factors of low output state after CPB). Beforehand, 65% of patients had poor left ventricular function (LVEF < 40% and/or CI < 2.2 l/mn/m2). An Aries Medical M700 console was used. The percutaneous femoral approach was feasible in 87% of cases. The results were: improvement with discharge from intensive care unit in 60% of cases, transient improvement in 7% of cases, no improvement in 15% of cases and cardiac transplantation in 8% of cases. The outcome was worse when the preoperative LV function was poor and when high dose inotropic agents had to be used. Survival was 100% in those patients in whom IABP was a prophylactic measure. The average duration of IABP was 72 hours, survival being significantly lower in those in whom IABP was continued for over 3 days. The complications (12.7%) were thromboembolic.(ABSTRACT TRUNCATED AT 250 WORDS)

Intraaortic balloon counterpulsation: patterns of usage and outcome in cardiac surgery patients.

Between January 1, 1986, and May 6, 1991, 7,884 cardiac surgical procedures requiring cardiopulmonary bypass were performed at our institution, including 672 (9.8% of adult procedures) performed in 669 patients that were associated with preoperative (n = 240), intraoperative (n = 353), or postoperative (n = 79) use of an intraaortic balloon pump. The mean age of recipients was 65.3 years (range, 16 to 89 years). Intraaortic balloon pump usage increased during the study period from 6.4% of patients (83/1,298) in 1986 to 12.7% of patients (169/1,333) in 1990. The relative distribution between preoperative (mean, 35.7%), intraoperative (52.5%), and postoperative (11.8%) insertion remained nearly constant during the study period. The overall operative (30-day) mortality for patients with preoperative, intraoperative, or postoperative insertion of the intraaortic balloon pump was 19.6%, 32.3%, and 40.5%, respectively (X2 = 16.4; p less than 0.001). Although use of the intraaortic balloon pump in the intraoperative and postoperative settings is accompanied by a favorable outcome in most patients, the high associated mortality suggests the need for earlier use of the intraaortic balloon pump or other supportive measures such as the ventricular assist device.

Outcome and complications of prolonged intraaortic balloon counterpulsation in cardiac patients.

The risks and benefits of prolonged intraaortic balloon support for the management of refractory congestive heart failure and ischemia were studied in patients with end-stage heart disease who needed support for greater than or equal to 5 days. Fifty-two insertions were performed by the percutaneous femoral route in 49 patients. The duration of insertion ranged from 5 to 46 days (mean 11.3). Clinical outcome including hemodynamic parameters and complications were recorded. Mean systemic arterial pressure did not change with balloon insertion (74 +/- 19 vs 76 +/- 11 mm Hg; p = not significant). Both the mean pulmonary artery and pulmonary arterial wedge pressures decreased (33 +/- 8 to 26 +/- 9 mm Hg [p less than 0.01], and 25 +/- 8 to 17 +/- 6 mm Hg [p less than 0.01], respectively). Over time, both parameters tended to increase, but remained significantly less than those before insertion. Cardiac index increased from 1.6 +/- 0.4 to 2.2 +/- 0.5 liters/min/m2 on insertion and continued to increase to 2.7 +/- 0.5 liters/min/m2 (p less than 0.01) before removal. Definite balloon catheter infection developed in 7 patients, and hemorrhage occurred in an additional 7. Eleven patients had vascular compromise, with loss of pulse in 6, thrombosis of the femoral artery in 1, and pseudoaneurysm in 2. Lacerated femoral artery occurred in 1 patient, and mesenteric artery thrombosis in another. Twenty patients died from progressive heart failure and multiorgan system failure, and 19 survived to receive left ventricular assist device and heart transplantation. Only 10 patients were weaned off the balloon. In conclusion, prolonged intraaortic balloon pump support may be successfully used in end-stage heart disease.

Events associated with rupture of intra-aortic balloon counterpulsation devices.

Nineteen intra-aortic balloon (IAB) ruptures occurred in sixteen patients during a three-year period. Perforation occurred secondary to abrasion with material failure or mishandling of the device during insertion. To avoid serious sequelae, it is important to be aware of the possibility of IAB rupture and to remove any defective device immediately upon recognition of an event.