Clinical experience with the TandemHeart percutaneous ventricular assist device

The TandemHeart percutaneous ventricular assist device can be used to support patients in cardiogenic shock (until cardiac recovery occurs or as a bridge to definitive therapy) or as a temporary application during high-risk coronary interventions. The TandemHeart is a left atrial-to-femoral artery bypass system comprising a transseptal cannula, arterial cannulae, and a centrifugal blood pump. The pump can deliver flow rates up to 4.0 L/min at a maximum speed of 7500 rpm. From May 2003 through May 2005, the TandemHeart was used to support 18 patients (11 in cardiogenic shock and 7 undergoing high-risk percutaneous transluminal coronary angioplasty). The patients in cardiogenic shock were supported for a mean of 88.8 +/- 74.3 hours (range, 4-264 hr) at a mean pump flow rate of 2.87 +/- 0.56 L/min (range, 1.8-3.5 L/min). The mean cardiac index improved from 1.57 +/- 0.31 L/min/m2 before support to 2.60 +/- 0.34 L/min/m2 during support. The mean duration of support for the high-risk percutaneous transluminal coronary angioplasty patients was 5.5 +/- 8.3 hours (range, 1-24 hr). The mean flow rate was 2.42 +/- 0.55 L/min (range, 1.5-3.0 L/ min). The overall 30-day survival rate was 61%. In our experience, the TandemHeart device was easy to insert and provided a means either to cardiac recovery or to continued support with an implantable left ventricular assist device.     

Percutaneous left ventricular assist device: "TandemHeart" for high-risk coronary intervention.

Patients undergoing percutaneous coronary intervention (PCI) with severely compromised left ventricular systolic function and complex coronary lesions, including multivessel disease, left main disease, or bypass graft disease, are at higher risk of adverse outcomes from hemodynamic collapse. The TandemHeart percutaneous ventricular assist device may provide circulatory support during high-risk PCI. We implanted the TandemHeart device in eight patients who underwent high-risk PCI. The patients were considered to be at exceptionally high risk for decompensation due to procedural complexity combined with underlying LV dysfunction. The mean ejection fraction was 30% +/- 9% and five patients were turned down for surgical revascularization. Seven patients underwent multivessel PCI, including three patients who underwent unprotected left main coronary artery PCI. There was 100% procedural success. The TandemHeart was removed immediately post-PCI with no groin complications. Six patients are event- and symptom-free at 189 +/- 130 days; one patient died 10 days post-PCI after lower extremity bypass surgery and another developed acute renal failure postprocedure, requiring hemodialysis. Our initial clinical experience with the TandemHeart ventricular assist device demonstrates that hemodynamic support can be rapidly achieved percutaneously during high-risk PCI, with excellent procedural success in highly complex and critically ill patients.     

Percutaneous left ventricular assist device, TandemHeart, for high-risk percutaneous coronary revascularization. A single centre experience

Patients with severe depression of left ventricular ejection fraction and high-risk coronary lesions are at risk of developing complications during percutaneous coronary interventions (PCI). Intra-aortic balloon pump (IABP) is a support that helps the interventionalist in such hemodynamic complications during high-risk PCI, but it does not offer complete circulatory support. Instead, TandemHeart (Cardiac Assist, Pittsburg, PA, USA) is a percutaneous left ventricular assist device (pLVAD) that gives total left circulatory support and can be used for patients in cardiogenic shock or for elective PCI at high-risk. TandemHeart is a percutaneous transseptal ventricular assist device that allows a rapid percutaneous left ventricular support without the need for surgical implantation. Between November 2003 and April 2005, 6 patients admitted to our coronary care unit (CCU) underwent either emergency (n = 3) or elective (n = 3) placement of the TandemHeart device before a high-risk procedure. From our initial experience we conclude that the percutaneous transseptal ventricular assist device, TandemHeart, can be easily and rapidly deployed either in emergency or in elective high-risk PCI to achieve complete cardiac assistance.     

First Canadian experience with high-risk percutaneous coronary intervention with assistance of a percutaneously deployed left ventricular assist device

Mechanical assist devices play an increasing role in high-risk percutaneous coronary intervention (PCI) in highly complex and critically ill patients. The Impella Recover LP 2.5 is a minimally invasive left ventricular assist device that is inserted percutaneously via a 13 Fr sheath. The device is engineered to provide a significant increase in cardiac output in patients with severe left ventricular impairment as well as in patients undergoing high-risk coronary intervention, and may provide substantive circulatory support when severe hemodynamic compromise occurs. It can potentially be maintained in situ for five to seven days. Canada's first implantations of an Impella device providing circulatory support in patients undergoing complex, high-risk PCI are reported. Larger studies will be required to identify whether a survival benefit or improvement in left ventricular function can be achieved when using the Impella device to support patients undergoing high-risk PCI or those in cardiogenic shock.     

Use of Impella Recover 2.5 left ventricular assist device in patients with cardiogenic shock or undergoing high-risk percutaneous coronary intervention procedures: experience of a high-volume center

AIM: Percutaneous coronary interventions are increasingly applied to high-risk patients. The availability of hemodynamic support devices offers a promising option to prevent and treat low-output syndrome in these patients. The aim of this study was to evaluate the feasibility, safety and efficacy of the Impella Recover' LP 2.5 left ventricular assist device in patients with cardiogenic shock or undergoing high-risk percutaneous coronary interventions. METHODS: Eleven patients presenting cardiogenic shock (N=6) or scheduled for high-risk percutaneous revascularization (N=5) were evaluated. The Impella pump was successfully implanted in all patients, except one. When implanted, the device was correctly positioned in the left ventricle and remained in a stable position. RESULTS: Bleedings occurred in 7 patients (5 of them presented cardiogenic shock), while renal failure and severe thrombocytopenia were observed in 4 and 1 patients respectively, all with cardiogenic shock. During high-risk procedures, the Impella pump succeeded in obtaining hemodynamic stability, while in only two patients with cardiogenic shock the device determined a significant improvement of hemodynamic variables. All elective patients and two patients with cardiogenic shock were discharged from the hospital and were still alive at 30-day follow-up. CONCLUSION: These data, although preliminary due to the limited sample size, demonstrated the feasibility, safety and efficacy of the Impella Recover(R) LP 2.5 during high-risk percutaneous procedures, even though the benefits of prophylactic deployment of such a system have to be further investigated. The use of Impella Recover(R) LP 2.5 in patients with cardiogenic shock is feasible and safe, however it maybe insufficient in reversing an advanced cardiogenic shock which, probably, has to be treated with more powerful left ventricular assist devices.     

The impella recover 2.5 and TandemHeart ventricular assist devices are safe and associated with equivalent clinical outcomes in patients undergoing high‐risk percutaneous coronary intervention

Objectives: To compare the practical use, safety, and clinical outcomes associated with the TandemHeart (TH) versus Impella Recover 2.5 (IR2.5) devices when used for circulatory support during high‐risk percutaneous coronary intervention (PCI). Background : Small studies and registries suggest safety and efficacy for the TH and IR2.5 percutaneous‐left ventricular assist devices (P‐LVADs). However, these P‐LVADs differ markedly in their insertion, operation, and manner of circulatory augmentation. To date, no study has compared these devices. Methods : We identified 68 patients (49 males, 19 females; age 71.1 ± 12.1 years) from our single‐center database that underwent “high‐risk” PCI with P‐LVAD support from April 2005 to June 2010 (32 with TH, 36 with IR2.5). Relevant data were extracted for analysis. Results : Baseline demographics were similar, including low LVEF (overall mean 31.0 ± 13.7%) and elevated STS mortality risk score (4.2 ± 3.7%). Angiographic characteristics were also similar, with a mean of 2.4 ± 1.0 lesions treated per patient, and 29% undergoing left main PCI. PCI success rates were 99% in both groups, with similar in‐hospital outcomes and a combined 7% major vascular access site complication rate. A single episode of left atrial perforation occurred during TH use. No patient required emergent CABG and no in‐hospital deaths occurred. The 30‐day MACE rate (death, myocardial infarction, target lesion revascularization) was 5.8%. There were no differences between the IR2.5 and TH groups with respect to short‐ or long‐term clinical outcomes. Conclusions: The IR2.5 and TH assist devices are safe, equally effective, and associated with acceptable short‐ and long‐term clinical outcomes in patients undergoing “high‐risk” PCI. © 2013 Wiley Periodicals, Inc.     

Time to reperfusion in high-risk patients with myocardial infarction undergoing primary percutaneous coronary intervention

IntroductionTimely reperfusion with primary percutaneous coronary intervention (PPCI) in ST-segment elevation myocardial infarction (STEMI) improves patient outcomes. In recent years, the Stent for Life (SFL) initiative in Portugal developed an action plan to improve timely access to PPCI. This study aims to evaluate performance indicators in high-risk populations (elderly, female, and diabetic patients).MethodsData on 1340 patients with suspected STEMI who were admitted to 18 Portuguese interventional cardiology centers were collected during a one-month period every year from 2011 to 2016. The risk of longer patient and system delay in elderly, female, and diabetic patients was assessed by logistic regression analysis.ResultsPatient and system delays were longer in elderly patients (incremental median 32 and 40 min; p=0.001 and p<0.001, respectively). Median system delay was also longer in women (incremental median 25 min; p<0.001). Consequently, times to revascularization were longer in elderly patients (incremental median 92 min; p<0.001) and women (incremental median 67 min; p<0.001). There was no significant difference in reperfusion delay in diabetic patients.After adjustment for gender and diabetes, elderly age was an independent predictor of patient delay longer than the median (OR 1.64; 95% CI 1.22-2.20; p=0.001) and system delay >90 min (OR 2.95; 95% CI 1.84-4.72; p<0.001).ConclusionElderly patients showed longer patient and system delays, regardless of gender and presence of diabetes. These data suggest that the elderly subgroup should be the target of a new action by the SFL initiative.     

First use of the TandemHeart percutaneous left ventricular assist device as a short-term bridge to cardiac transplantation

Advanced heart failure may be refractory despite aggressive support with inotropic agents and intra-aortic balloon pumping. Implantable left ventricular assist devices are increasingly being used as bridges to cardiac transplantation or as destination therapy because of the limited availability of donor organs. We report the 1st use of the TandemHeart percutaneous ventricular assist device as a short-term bridge to cardiac transplantation.     

Percutaneous cardiopulmonary bypass support in high-risk patients undergoing percutaneous transluminal coronary angioplasty

Fifty-one consecutive patients in whom percutaneous cardiopulmonary bypass support was instituted to enhance the safety of high-risk elective coronary angioplasty were studied. All patients had a low ejection fraction, a large amount of viable myocardium perfused by the target artery(s) or both. Thirty-five men and 16 women, mean age 63 years, with Canadian Cardiovascular Society class III angina (23 patients) or class IV (28 patients) were studied. There was a history of myocardial infarction in 45 (88%), bypass surgery in 14 (27%) and congestive heart failure in 17 (33%). Forty-six (90%) had impaired left ventricular function. Twenty (39%) had an ejection fraction of less than or equal to 25%. Left main stenosis was present in 9 (18%), 3-vessel disease in 48 (94%) and 2-vessel disease in 2 (4%). Twenty (39%) were considered at a prohibitive risk for bypass surgery (14 were turned down for surgery). Bypass was instituted percutaneously with flows ranging from 2 to 5 liters/min (mean 3.6). Angioplasty was successful in 115 of the 117 lesions attempted with the culprit vessel dilated in all. Dilatation of the only remaining vessel was performed in 14 (27%). Inflation times up to 10 minutes were well tolerated. Bypass was discontinued after a mean bypass time of 37 minutes. Hemostasis was achieved by external clamp compression in 50. There were 3 hospital deaths unrelated to bypass. Patient follow-up at 2 to 8 months (mean 4.9) disclosed 1 late death, 31 (66%) asymptomatic patients, 12 (26%) patients in class I and 4 patients (9%) in class II. Thus, this study demonstrates the safety and efficacy of percutaneous bypass support in selected patients undergoing high-risk coronary angioplasty.