V. Vivian Dimas

2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia intervencion; Affirmation of value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care

AbstractAlthough historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially availab...

Management of Single‐Ventricle Patients With Berlin Heart EXCOR Ventricular Assist Device: Single‐Center Experience

There are minimal data regarding chronic management of single-ventricle ventricular assist device (VAD) patients. This study aims to describe our centers multidisciplinary team management of single-ventricle patients supported long term with the Berlin Heart EXCOR Pediatric VAD. Patient #1 was a 4-year-old with double-outlet right ventricle with aortic atresia, L-looped ventricles, and heart block who developed heart failure 1 year after Fontan. She initially required extracorporeal membrane oxygenation support and was transitioned to Berlin Heart systemic VAD. She was supported for 363 days (cardiac intensive care unit [CICU] 335 days, floor 28 days). The postoperative course was complicated by intermittent infection including methicillin-resistant Staphylococcus aureus, intermittent hepatic and renal insufficiencies, and transient antithrombin, protein C, and protein S deficiencies resulting in multiple thrombi. She had a total of five pump changes over 10 months. Long-term medical management included anticoagulation with enoxaparin, platelet inhibition with aspirin and dipyridamole, and antibiotic prophylaxis using trimethoprim/sulfamethoxazole. She developed sepsis of unknown etiology and subsequently died from multiorgan failure. Patient #2 was a 4-year-old with hypoplastic left heart syndrome who developed heart failure 2 years after bidirectional Glenn shunt. At systemic VAD implantation, he was intubated with renal insufficiency. Post-VAD implantation, his renal insufficiency resolved, and he was successfully extubated to daytime nasal cannula and biphasic positive airway pressure at night. He was supported for 270 days (CICU 143 days, floor 127 days). The pump was upsized to a 50-mL pump in May 2011 for increased central venous pressures (29 mm Hg). Long-term medical management included anticoagulation with warfarin and single-agent platelet inhibition using dipyridamole due to aspirin resistance. He developed increased work of breathing requiring intubation, significant anasarca, and bleeding from the endotracheal tube. The family elected to withdraw support. Although both patients died prior to heart transplantation, a consistent specialized multidisciplinary team approach to the medical care of our VAD patients, consisting of cardiothoracic surgeons, heart transplant team, hematologists, pharmacists, infectious disease physicians, psychiatrists, specialty trained bedside nursing, and nurse practitioners, allowed us to manage these patients long term while awaiting heart transplantation.

Transcatheter atrial septal defect closure: Modified balloon sizing technique to avoid overstretching the defect and oversizing the Amplatzer septal occluder

The objective of this study was to evaluate a new technique of sizing atrial septal defects (ASDs) for transcatheter device closure. ASD closure using the Amplatzer septal occluder (ASO) device is commonly performed. Complications, including arrhythmias, pericardial effusions, and perforations, may be related to oversizing ASDs and choosing larger devices. Two methods were used to size ASDs using a compliant balloon. In some patients, the balloon was inflated until a waist was visible [(+)waist]; in others, only until no shunting was demonstrable by echocardiogram [echo; (−)waist]. The device was selected and implanted using standard procedure and echo guidance. One hundred seventeen patients underwent secundum ASD closure with an ASO device. There were 43 patients in the (−)waist group and 74 in the (+)waist group. All devices were implanted successfully. The initial echo ASD diameter was larger in the (−)waist group compared to the (+)waist group (P = 0.01). There was a smaller difference between the initial echo and balloon‐sized ASD diameters in the (−)waist group (P < 0.02). ASO device size implanted (in mm greater than echo ASD diameter) was smaller in the (−)waist group (P < 0.01). There were 0/43 complications in the (−)waist group and 5/74 in the (+)waist group. The complete closure rate was the same in both groups. Sizing an ASD by inflating a compliant balloon just until shunting is eliminated, and not until a waist is visible, results in less overstretching of the ASD and selection of a smaller ASO device, achieving similar closure rates and potentially fewer complications. Catheter Cardiovasc Interv 2005;.

Outcomes of transcatheter occlusion of patent ductus arteriosus in infants weighing ≤ 6 kg.

OBJECTIVES We sought to analyze the outcomes of transcatheter patent ductus arteriosus (PDA) occlusion using a variety of devices in infants weighing ≤6 kg. BACKGROUND Indications for transcatheter closure of a PDA in infancy include congestive heart failure and/or failure to thrive. Devices available for small infants may be problematic for various reasons, including sheath size, stiffness of delivery system, and anchoring and retrievability characteristics of the device. The Amplatzer Ductal Occluder is approved by U.S. Food and Drug Administration for children weighing >6 kg and older than 6 months of age. METHODS We performed a multicenter, retrospective analysis of children weighing ≤6 kg in whom transcatheter PDA occlusion was attempted between January 1995 and November 2005 at Texas Childrens Hospital and January 2001 to November 2005 at Childrens Hospital of San Diego. RESULTS A total of 62 patients underwent attempted closure. The mean age at catheterization was 4.7 ± 2.8 months with a mean weight at catheterization of 4.6 ± 0.9 kg. Successful device placement was achieved in 58 of 62 patients (94%). Among those receiving a device, complete occlusion was noted in all 58 patients at either catheterization or last available follow-up. CONCLUSIONS Percutaneous closure of PDA should be considered even in infants ≤6 kg.

2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology–Association Canadienne de Cardiologie d'intervention)∗

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines.

Frequency of cardiac death in children with idiopathic dilated cardiomyopathy.

The prognosis in children with idiopathic dilated cardiomyopathy (IDC) is guarded, with the 5-year mortality rate ranging from 14% to 50%, owing to sudden cardiac death (SCD) or pump failure. The risk factors for SCD in adults with IDC include asymptomatic nonsustained ventricular tachycardia and poor left ventricular function. It is unclear whether these findings can be extrapolated to the pediatric population. A retrospective review of all patients with the diagnosis of IDC seen at a single institution from 1990 to 2004 was performed. A total of 85 patients (46 males), with a median age of 3.8 years (0 days to 17.3 years) were studied. The mean left ventricular ejection fraction was 25 +/- 12% (median 23%, range 45% to 45%) at presentation. The following arrhythmias occurred at presentation or during the initial hospitalization: nonsustained ventricular tachycardia in 6, sustained ventricular tachycardia or fibrillation in 1, supraventricular arrhythmias in 6, and both atrial and ventricular arrhythmias in 1. During a subsequent hospitalization or outpatient follow-up, 7 patients had the following arrhythmias: supraventricular arrhythmias in 2, nonsustained ventricular tachycardia in 4, and both atrial and ventricular arrhythmias in 1. The cumulative survival rate was 40% at a mean follow-up of 6.2 years (95% confidence interval 4.4 to 8.1). One single episode of SCD occurred in 1 patient without a history of sustained arrhythmias. In conclusion, in children with IDC, despite the low left ventricular ejection fraction and presence of ventricular arrhythmias, only one episode of SCD occurred in this group of patients. Given the 1% incidence of SCD in this cohort, the use of implantable cardioverter-defibrillators as primary prevention in children with IDC might not be indicated.

Utilization of the impella 2.5 micro-axial pump in children for acute circulatory support

Percutaneous circulatory support is widely available for use in adult patients. Options remain limited in the pediatric population due to limitations of vessel and patient size, resulting in the use of more invasive means of circulatory support. We present a case series of pediatric patients in whom the Impella 2.5 axial flow pump was able to be placed utilizing a hybrid approach that allowed for adequate distal perfusion while providing successful short‐term hemodynamic support.

Vasopressin rescue for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing: a prospective feasibility pilot trial.

Objectives: To assess the feasibility of a large, randomized controlled trial of combination epinephrine-arginine vasopressin for in-pediatric intensive care unit cardiopulmonary arrest refractory to initial epinephrine dosing. Design: Prospective, pilot, matched controlled clinical trial using exception from informed consent. Setting: Pediatric intensive care unit in a university-affiliated tertiary care children’s hospital. Patients: All patients <18 yrs of age admitted to the pediatric intensive care unit with cardiopulmonary arrest requiring chest compressions and epinephrine (0.01 mg/kg) were eligible. Interventions: Patients who remained in cardiopulmonary arrest despite an initial dose of epinephrine received arginine vasopressin (0.8 U/kg) rescue as the second vasopressor, followed by additional epinephrine if needed. Measurements and Main Results: Outcome variables included return of spontaneous circulation (≥20 min), survival at 24 hrs, survival to hospital discharge, and neurologic status at discharge. Favorable neurologic status was defined as Pediatric Cerebral Performance Categories 1, 2, and 3, or no change from admission. Data were compared to a retrospective, matched cohort of patients who experienced cardiopulmonary arrest requiring ≥ two doses of vasopressor, and did not receive arginine vasopressin (n = 20). Of 2,654 patients admitted to the pediatric intensive care unit, 29 (1.1%) had refractory cardiopulmonary arrest: five patients were excluded, 14 missed for inclusion, and ten were enrolled. There was increased 24-hr survival (80% vs. 30%, odds ratio 9.33, 95% confidence interval 1.51-57.65) in arginine vasopressin patients. There was no significant difference in return of spontaneous circulation, survival to hospital discharge, or favorable neurologic status at discharge. Conclusions: These pilot data provide support for a larger randomized controlled trial of arginine vasopressin therapy during cardiopulmonary resuscitation for in-hospital pediatric cardiac arrest.

Serum Cystatin C as an Early Marker of Neutrophil Gelatinase‐associated Lipocalin‐positive Acute Kidney Injury Resulting from Cardiopulmonary Bypass in Infants with Congenital Heart Disease

OBJECTIVE Acute kidney injury (AKI) is a common complication resulting from cardiopulmonary bypass in infants. Urinary neutrophil gelatinase-associated lipocalin (NGAL) is a sensitive and specific marker of such injury. In this study, we compared the performance of serum cystatin C (Cys C) and serum creatinine (Cr) as early markers of renal dysfunction in infants undergoing cardiac surgery under bypass. STUDY DESIGN, SETTING, AND PATIENTS The study was designed as a prospective observational study. The study was conducted in the cardiac intensive care unit (ICU) of a tertiary, academic childrens hospital in the United States. Infants (age <1 year) undergoing cardiac surgery under cardiopulmonary bypass were included in the study. OUTCOME MEASURE Acute kidney injury was defined based on postoperative urinary NGAL. RESULTS A total of 17 infants were included in the study, and five of them developed AKI. Serum Cys C and Cr levels were measured postoperatively on days 1, 2, and 3, and compared with baseline levels. On postoperative day 2, infants with AKI showed significant change from baseline in serum Cys C levels compared with non-AKI infants (28% vs. -9%, P = .03). The two groups did not show significant differences with respect to rise in serum Cr on any of the 3 postoperative days. Serum Cr on days 1 and 2 showed nonspecific increases in both AKI and non-AKI groups. The area under the receiver operating characteristic curve for day 2 Cys C was 0.87 (95% CI 0.67-1.00) in recognizing NGAL-positive AKI. CONCLUSIONS Postoperative serum Cys C appears to be a more specific and sensitive biomarker for NGAL-positive AKI resulting from cardiopulmonary bypass surgery in infants undergoing cardiac surgery.