Objectives We evaluated the efficacy and safety of the percutaneous ventricular assist device (pVAD) in patients in severe refractory cardiogenic shock (SRCS) despite intra-aortic balloon pump (IABP) ...and/or high-dose vasopressor support. Background SRCS is associated with substantial mortality despite IABP counterpulsation. Until recently, there was no rapid, minimally invasive means of providing increased hemodynamic support in SRCS. Methods A total of 117 patients with SRCS implanted with TandemHeart pVAD (CardiacAssist, Inc., Pittsburgh, Pennsylvania) were studied, of whom 56 patients (47.9%) underwent active cardiopulmonary resuscitation immediately before or at the time of implantation. Data was collected regarding clinical characteristics, hemodynamics, and laboratory values. Results Eighty patients had ischemic and 37 patients had nonischemic cardiomyopathy. The average duration of support was 5.8 ± 4.75 days. After implantation, the cardiac index improved from median 0.52 (interquartile range IQR: 0.8) l/(min·m2 ) to 3.0 (IQR: 0.9) l/(min·m2 ) (p < 0.001). The systolic blood pressure and mixed venous oxygen saturation increased from 75 (IQR: 15) mm Hg to 100 (IQR: 15) mm Hg (p < 0.001) and 49 (IQR: 11.5) to 69.3 (IQR: 10) (p < 0.001), respectively. The urine output increased from 70.7 (IQR: 70) ml/day to 1,200 (IQR: 1,620) ml/day (p < 0.001). The pulmonary capillary wedge pressure, lactic acid level, and creatinine level decreased, respectively, from 31.53 ± 10.2 mm Hg to 17.29 ± 10.82 mm Hg (p < 0.001), 24.5 (IQR: 74.25) mg/dl to 11 (IQR: 92) mg/dl (p < 0.001), and 1.5 (IQR: 0.95) mg/dl to 1.2 (IQR: 0.9) mg/dl (p = 0.009). The mortality rates at 30 days and 6 months were 40.2% and 45.3%, respectively. Conclusions The pVAD rapidly reversed the terminal hemodynamic compromise seen in patients with SRCS refractory to IABP and vasopressor support.
Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in ...pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes.
We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly.
A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
Mortality in acute pulmonary embolism (PE) is believed to be principally due to the subgroup of PEs that are massive. Systemic thrombolysis is the therapeutic mainstay for acute massive PE, despite ...evidence suggesting limited survival benefits. Both catheter-based therapies (CBT) and surgical pulmonary embolectomy (SE) are well-accepted alternatives to treat acute PE. However, the comparative effectiveness of these approaches is difficult to study. We conducted a systematic review of CBT and SE for acute PE.
The PubMed database was queried for CBT- and SE-related publications between January 1998 and June 2017. A minimum of 10 patients undergoing intervention(s) was required for inclusion, and studies must not have excluded patients with massive PE. End points examined included hospital mortality, and additionally for CBT, procedural success rate.
A total of 75 studies (41 of CBT, 34 of SE) were identified, with 1650 patients undergoing CBT and 1101 undergoing SE. Patients undergoing SE were more critically ill than those undergoing CBT (massive PE, 545 out of 975 55.9% for SE vs 742 out of 1553 47.8% for CBT). Cardiopulmonary resuscitation (CPR) was required in 217 out of 1015 patients undergoing SE (21.4%) versus 38 out of 983 patients undergoing CBT (4.0%). The hospital mortality of SE was 14.0%, versus 5.6% for CBT, in the entire patient group. However, the hospital mortality of SE in patients with pre-SE CPR was 46.3%, whereas it was 6.8% in those patients without pre-SE CPR. Although CPR was associated with an increased risk of mortality both for CBT and SE, it accounted for all of the mortality effect on SE (the adjusted odds ratio for CPR in a random effects model with treatment considered was 9.79 (95% confidence interval, 4.98-19.17; P < .0001). The adjusted odds ratio for mortality for SE relative to CBT was 1.36 (95% confidence interval, 0.80-2.32; P = .84). Moreover, CBT was associated with a procedural failure rate of 8.3%.
Both CBT and SE were associated with satisfactory published outcomes. SE is associated with greater absolute postprocedure mortality than CBT, but has been undertaken in more critically ill populations. The markedly higher incidence of CPR in SE accounts for the differential mortality between the patients undergoing SE and those undergoing CBT. Decision making with respect to best therapy must take into account potential needs for periprocedure artificial mechanical right ventricle and lung support, institutional experience and outcomes, anticipated therapeutic efficacy and benefit, and approach-specific risks.
PURPOSE OF REVIEWPercutaneous ventricular assist devices (pVADs) are being increasingly used in patients with cardiogenic shock. They offer a means of instituting rapid and adequate cardiac support ...in patients with cardiogenic shock unresponsive to inotropes/vasopressors and intraaortic balloon pumps (IABPs). However, there is considerable debate on the appropriate use of these devices given the difficulty of conducting randomized trials in patients with cardiogenic shock, lack of clear guidelines on indications, device selection, and cost-effective care of patients implanted with these devices.
RECENT FINDINGSSeveral centers have recently reported data on the use of these devices for cardiogenic shock in a variety of different settings, including myocardial ischemia and its complications, high-risk percutaneous coronary intervention, myocarditis, and refractory arrhythmias. Recent randomized trials have compared the use of IABP with different pVADs evaluating hemodynamic outcomes as well as short-term mortality.
SUMMARYWe review the current evidence on the use of pVADs (Tandemheart pVAD, Impella, percutaneous extracorporeal membrane oxygenation), their indications, relative merits, and adverse effects, and discuss the current approach to the appropriate use of pVADs in patients with cardiogenic shock. We also propose an algorithm for device selection tailored to each patientʼs needs based on severity of cardiogenic shock, amount of support needed, and the overall clinical scenario.
Data on comparative outcomes and readmissions after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with end-stage renal disease (ESRD) are ...scarce because these patients were excluded from major TAVR trials (1). Primary outcomes of interest were in-hospital mortality, in-hospital complications (permanent pacemaker implantation and blood transfusion), post-procedure length of stay, discharge disposition, cost of hospitalization, and 30-day readmission rates. Table 1Pre- and Post-Propensity−Matched Baseline Demographics and Outcomes Comparing TAVR and SAVR in ESRD PatientsValues are % unless otherwise indicated.ESRD = end-stage renal disease; SAVR = surgical aortic valve replacement; TAVR = transcatheter valve replacement. Pre-Propensity Match Post-Propensity Match TAVR (n = 158) SAVR (n = 546) p Value TAVR (n = 119) SAVR (n = 244) p Value Mean age, yrs 76.27 67.08 <0.001 74.32 74.32 1.00 Female 41.1 33.5 <0.001 35.3 35.3 0.986 Charlson Comorbidity Index, mean 3.97 3.90 0.540 3.99 4.1 0.450...
Lung transplantation with or without cardiac transplantation offers the only hope of long-term, symptom-free survival for patients with advanced idiopathic pulmonary arterial hypertension. We ...describe a patient who underwent an emergency pulmonary embolectomy. During surgery, it was discovered that the patient had idiopathic pulmonary arterial hypertension. After the patient was weaned from cardiopulmonary bypass, pulmonary hypertension caused right-sided heart failure, and a right ventricular assist device was inserted to compensate. Because of profound bleeding from the endotracheal tube, the patient was placed on extracorporeal membrane oxygenation in the hope of bridging the patient to heart-lung transplantation. Extracorporeal membrane oxygenation was required for 10 days until a donor heart and lung became available. The patient recovered from the transplant operation and was discharged home 76 days later.
Implantation of a HeartMate II or a Jarvik 2000 FlowMaker left ventricular assist system (LVAS) usually involves a mid-line sternotomy and the use of cardiopulmonary bypass (CPB). In patients with ...numerous co-morbid conditions, however, surgical trauma may be minimized by implanting the LVAS via a minimally invasive approach, preferably without CPB.
In 6 patients with end-stage heart failure and other serious co-morbidities, we implanted a HeartMate II (n = 3) or a Jarvik 2000 FlowMaker (n = 3) LVAS via a right mini-thoracotomy and a left sub-costal incision. Patients included 3 men and 3 women with a mean age of 41 years. In 3 cases, the LVAS was implanted without CPB.
After a mean follow-up period of 6 months, 5 patients are alive and well and on the transplant waiting list. Seven months after LVAS implantation, the remaining patient developed a hemorrhagic stroke necessitating Jarvik 2000 replacement with a new pump of the same type.
In this small series, the combined sub-costal and mini-thoracotomy incision proved safe and technically feasible. It may be useful for other LVAS candidates who have serious co-morbidities that preclude traditional implant operations.
The TandemHeart percutaneous left ventricular assist device is a left atrial–to–femoral artery bypass system that can be implanted percutaneously within 30 minutes and provides active circulatory ...support. The TandemHeart has been used mainly for temporary hemodynamic assistance during high-risk coronary interventions and postcardiotomy heart failure. This report describes initial experience with this device as a successful bridge to cardiac recovery in 3 patients with acute myocarditis. All patients presented with severe cardiogenic shock (mean cardiac index 1.1 L/min/m2 ), and end-organ perfusion could not be maintained despite intra-aortic balloon counterpulsation and the maximal use of vasopressive agents. The patients were successfully bridged to myocardial recovery with the TandemHeart (mean duration of support 5 days, range 2 to 8). The only complication was a short episode of ventricular fibrillation during device placement in 1 patient, which did not result in any morbidity or mortality. All patients were discharged home (mean duration of stay 15 days). In conclusion, the TandemHeart proved to be a safe and effective bridge to myocardial recovery in these patients with acute myocarditis.
Aortic annular rupture is a rare and much dreaded complication of transcatheter aortic valve replacement. Device oversizing to prevent post-procedural paravalvular leak is the most commonly ...identified cause of this complication. However, mechanical stress in a heavily calcified non-compliant vessel can also lead to annular rupture in this older population. We describe a case of aortic annular rupture with involvement of right coronary artery ostium leading to cardiac tamponade and cardiac arrest, successfully managed by extracorporeal membrane oxygenation support, open drainage of the pericardial space, pericardial patching of the defect and bypass of the affected vessel with excellent post-procedural results.
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