D. Onsager

The Subclavian Intraaortic Balloon Pump: A Compelling Bridge Device for Advanced Heart Failure

BACKGROUND A subclavian intraaortic balloon pump (SC-IABP) can help to optimize patients with advanced congestive heart failure as a bridge to definitive therapy. We retrospectively reviewed our experience to assess the application and safety of this technique. METHODS We studied 88 patients with decompensated advanced congestive heart failure who received SC-IABP placement between January 2011 and December 2014. The SC-IABP was placed through a graft in the subclavian artery. The intended therapeutic goals for SC-IABP were bridge to transplant (n = 61), mechanical circulatory support (n = 21), or recovery (n = 6). Success was defined as stroke-free survival, achievement of therapeutic goal, and maintenance or improvement in renal function, hemodynamics, and physical conditioning through ambulation and rehabilitation. RESULTS Eighty patients were successfully bridged to the next therapy (transplant 93.4%, mechanical circulatory support 95.3%, recovery 50%). There was no mortality related to SC-IABP placement. Duration of SC-IABP support was 4 to 135 days (median 21). Failure was attributed to escalation of support (n = 5), stroke (n = 2), and sepsis (n = 1). Mean pulmonary artery pressure significantly improved from 33 ± 11 mm Hg to 28 ± 8 mm Hg (p < 0.05). Eighty-four patients (95.5%) ambulated more than 3 times a day. Two-minute step test demonstrated significant improvement, from 50 ± 9 steps to 90 ± 23 steps (n = 16, p < 0.001). Specific complications of SC-IABP included exchange/repositioning (n = 26, 29.5%), subclavian artery thrombosis (n = 1, 1.1%), and reexploration for hematoma (n = 4, 4.5%) and infection (n = 2, 2.3%). No distal thromboembolic events were observed. CONCLUSIONS The SC-IABP provided excellent hemodynamic support with minimal morbidity and mortality, allowed for extensive rehabilitation, and permitted more than 90% of patients to receive their intended therapy. Therefore, SC-IABP is a compelling bridge device for patients with advanced congestive heart failure.

“Age” in lung transplantation: factors related to outcomes and other considerations

The age of lung transplant recipients is steadily increasing. Older donors are more frequently considered. The risk factors associated with advanced age in lung transplantation warrant discussion to ensure optimal outcomes in this complex endeavor. This report provides a summary of the pertinent topics and available evidence.

The first-in-human experience with a minimally invasive, ambulatory, counterpulsation heart assist system for advanced congestive heart failure

BACKGROUND The intravascular ventricular assist system (iVAS) is a new, minimally invasive, ambulatory counterpulsation heart assist system delivered via the subclavian artery and powered by a portable driver. It is designed for recovery, bridge to transplantation (BTT) or for prolonging medical therapy. We report the first-in-human (FIH) experience with iVAS. METHODS This is a prospective, non-randomized single arm, U.S. Food and Drug Administration (FDA)-approved early feasibility trial in patients listed for cardiac transplantation. The primary end-point was survival to transplant or stroke-free survival at 30 days. RESULTS Fourteen patients were enrolled and 13 (92.8%) were treated with iVAS. At time of implant, the average age was 58 ± 6.7 years; 85% were male; 28% had ischemic cardiomyopathy; and 3 were Interagency Registry for Mechanically Assisted Devices (INTERMACS) Level 2, 9 were Level 3, and 1 was Level 4. The mean left ventricular ejection fraction was 22%, left ventricular internal diameter diastole was 7.13 mm, and 69% had moderate or severe mitral regurgitation. There were no intra-operative complications. Intensive care unit stay after implant was 6 ± 6 days. All patients were transplanted after 32 ± 21 days. There were no deaths or thromboembolic events: 1 patient required escalation of mechanical support, and post-implant complications included pleuritis/pericarditis (n = 1) and neuropathy (n = 2). No intra-operative blood transfusions were required. CONCLUSIONS This study demonstrates a high rate of successful outcomes with an excellent risk-to-benefit profile. This FIH experience reveals that the iVAS can be successfully inserted in a standardized approach, provide hemodynamic support, can be interrupted for short periods, and allows for ambulation. A multicenter trial to investigate effectiveness and safety is warranted.

Positional Obstruction of the Superior Mesenteric Artery by an Intra-aortic Balloon Pump Placed Through Subclavian Artery Approach

Patients awaiting orthotropic heart transplant (OHT) often require temporary mechanical circulatory support. Although the intra-aortic balloon pump (IABP) placed through percutaneous femoral arteriotomy is the most commonly used form of mechanical circulatory support in the United States, this approach requires the patient to remain immobile, making it suboptimal for extended use. Our center recently developed a novel technique to insert an IABP through the subclavian artery (SCA),1 allowing the patient to ambulate. Briefly, a polytetrafluoroethylene graft is anastomosed in an end-to-side fashion to the right or left SCA. A valve is secured within the other end of the graft, and the IABP is advanced through the graft into the descending aorta. The proximal radio-opaque IABP marker is positioned 2 cm superior to the carina with the distal marker near the L2 vertebra. Although several groups have reported various techniques for SCA IABP insertion,2,3 no consensus exists regarding the optimal position of the distal tip. We report 2 cases of IABP migration into the superior mesenteric artery (SMA) with associated bowel ischemia. A 60-year-old, 180 cm tall man with a Maquet 8F 50cc right SCA IABP complained of nonbloody diarrhea and severe abdominal pain radiating to the back 6 days after implant. He denied urinary symptoms and had no history of pancreatic, hepatic, or ulcerative disease. On physical examination, there was diffuse abdominal tenderness without peritoneal signs or distention. Bowel sounds were intact. Laboratories and ultrasonography of the liver, pancreas, and biliary system were unremarkable. Anteroposterior chest x-ray showed the …

Consequences of Retained Defibrillator and Pacemaker Leads After Heart Transplantation—An Underrecognized Problem

BACKGROUND Cardiovascular implantable electronic devices (CIEDs) are common in patients undergoing heart transplantation (HT), and complete removal is not always possible at the time of transplantation. METHODS We retrospectively assessed the frequency of retained CIED leads and clinical consequences in consecutive HT patients from 2013 to 2016. Clinical outcomes included bacteremia, upper-extremity deep venous thrombosis (UEDVT), lead migration, and inability to perform magnetic resonance imaging (MRI). RESULTS A total of 138 patients (55 ± 11 years of age, 76% male) were identified; 37 (27%) had retained lead fragments (RLFs) at discharge. Patients with RLFs were older, had longer lead implantation time before HT, and a higher prevalence of dual-coil CIED leads compared with those without RLFs (P < .05 for all). Lead implantation time was identified as an independent predictor for RLFs (P < .05). Patients with RLFs had a higher frequency of DVT compared with the non-RLF group during the 1-year study period (42% vs 21%; P < .04). There was no difference in bacteremia. Fourteen patients (38%) could not undergo clinically indicated MRI. CONCLUSION RLFs after HT occur commonly and are associated with a higher rate of UEDVT and limit the use of MRI. Although no significant difference was found in the rates of bacteremia between the groups, this finding might be explained by the overall low incidence. Patients with risk factors for RLFs should be identified before transplantation, and complete lead removal should be considered with a multidisciplinary approach.