Mid-term survival after continuous-flow left ventricular assist device versus heart transplantation.

There is a paucity of data about mid-term outcome of patients with advanced heart failure (HF) treated with left ventricular assist device (LVAD) in Europe, where donor shortage and their aging limit the availability and the probability of success of heart transplantation (HTx). The aim of this study is to compare Italian single-centre mid-term outcome in prospective patients treated with LVAD vs. HTx. We evaluated 213 consecutive patients with advanced HF who underwent continuous-flow LVAD implant or HTx from 1/2006 to 2/2012, with complete follow-up at 1 year (3/2013). We compared outcome in patients who received a LVAD (n = 49) with those who underwent HTx (n = 164) and in matched groups of 39 LVAD and 39 HTx patients. Patients that were treated with LVAD had a worse risk profile in comparison with HTx patients. Kaplan-Meier survival curves estimated a one-year survival of 75.5 % in LVAD vs. 82.3 % in HTx patients, a difference that was non-statistically significant [hazard ratio (HR) 1.46; 95 % confidence interval (CI) 0.74-2.86; p = 0.27 for LVAD vs. HTx]. After group matching 1-year survival was similar between LVAD (76.9 %) and HTx (79.5 %; HR 1.15; 95 % CI 0.44-2.98; p = 0.78). Concordant data was observed at 2-year follow-up. Patients treated with LVAD as bridge-to-transplant indication (n = 22) showed a non significant better outcome compared with HTx with a 95.5 and 90.9 % survival, at 1- and 2-year follow-up, respectively. Despite worse preoperative conditions, survival is not significantly lower after LVAD than after HTx at 2-year follow-up. Given the scarce number of donors for HTx, LVAD therapy represents a valid option, potentially affecting the current allocation strategy of heart donors also in Europe.

Long-term results of lung cancer after heart transplantation: single center 20-year experience.

OBJECTIVE: The present study analyses, long-term lung cancer survival rate in the Niguarda heart transplant population and the results of surgical treatments. METHODS: From November 1985 to December 2006, 786 heart transplants were performed in our Center; we underwent a retrospective review of patients developing primary lung cancer. RESULTS: Among 660 heart transplant recipients valuable in this study, 22 (3.3%) developed a primary lung cancer (20 male, 91%), their mean age at time of heart transplant was 54.5+/-5.2 years (range, 42-65). The mean time from transplantation to lung cancer diagnosis was 73.7+/-30 months. Eleven patients (50%) were in stage IIIB or higher at the time of presentation. The 5-year survival rate of the entire study population was 21.4%, with a median survival time (MST) of 10.1 months. Ten patients underwent surgical resection (9 lobectomies and 1 wedge resection) and demonstrated improved long-term survival with 5-year survival of 56% and MST 70.4 months, compared to patients who did not undergo any surgical procedure, all of whom died during follow-up, with 1-year survival of 33%. CONCLUSIONS: Long-term results following lung cancer surgery in heart transplant recipients are satisfactory when performed at the early stage of the disease. Preventive computed tomography screen should be considered as a routine method for early diagnosis in this group of high-risk patients.

Clinical outcome and bridge to transplant rate of left ventricular assist device recipient patients: comparison between continuous-flow and pulsatile-flow devices.

BACKGROUND: Long-term implantable continuous axial-flow pumps are increasingly used in bridging heart failure patients to heart transplant. Compared to pulsatile left ventricular assist devices (LVADs), they offer smaller dimensions, less surgical trauma and less thromboembolisms. However concerns still remain about the long-term effects of continuous-flow on patients' outcome. The aim of this study was to review our mechanical bridge to transplant experience to compare pre- and post-transplant outcomes between pulsatile and continuous-flow LVAD recipients. METHODS: Thirty-six patients with a continuous-flow device (Micromed DeBakey, Houston, TX or InCor Berlin Heart, Berlin, Germany--group A) were compared with 41 patients supported with a pulsatile device (Novacor, WorldHeart, Oakland, CA--group B). RESULTS: Mean age (48.6+/-12.4 vs 47.2+/-12.5) and LVAD duration (119.3+/-115.4 vs 128.3+/-198.3) were similar in the two groups. Group A recipients were smaller compared to group B (mean body surface area=1.77+/-0.18 vs 1.93+/-0.16; p<0.001). Idiopathic dilated cardiomyopathy was not significantly greater between the two groups (78% vs 58.3%; p=0.085). Successful bridging to transplantation was similar in group A compared to group B (52.8% vs 63.4%; p=non significant). On-VAD mortality was similar between the two groups (A vs B=33.3% vs 36.6%; p=non significant). Thirty-day mortality after HTx in group A was 10.5% compared to 7.7% in group B (p=non significant). First year post-transplant incidence of treated rejections (36.8% vs 46%; p=non significant) as the mean number of rejection/patient (0.38+/-0.5 vs 0.53+/-0.83; p=non significant) were similar in group A compared to group B. CONCLUSIONS: In our experience, when compared to pulsatile LVAD, continuous-flow pumps are similarly effective in transplant rate and post-transplant outcome.

A prospective comparison of mid-term outcomes in patients treated with heart transplantation with advanced age donors versus left ventricular assist device implantation.

OBJECTIVES: In Europe, the age of heart donors is constantly increasing. Ageing of heart donors limits the probability of success of heart transplantation (HTx). The aim of this study is to compare the outcome of patients with advanced heart failure (HF) treated with a continuous-flow left ventricular assist device (CF-LVAD) with indication as bridge to transplantation (BTT) or bridge to candidacy (BTC) versus recipients of HTx with the donor's age above 55 years (HTx with donors >55 years). METHODS: we prospectively evaluated 301 consecutive patients with advanced HF treated with a CF-LVAD (n = 83) or HTx without prior bridging (n = 218) in our hospital from January 2006 to January 2015. We compared the outcome of CF-LVAD-BTT (n = 37) versus HTx with donors >55 years (n = 45) and the outcome of CF-LVAD-BTT plus BTC (n = 62) versus HTx with donors >55 years at the 1- and 2-year follow-up. Survival was evaluated according to the first operation. RESULTS: The perioperative (30-day) mortality rate was 0% in the LVAD-BTT group vs 20% (n = 9) in the HTx group with donors >55 years (P = 0.003). Perioperative mortality occurred in 5% of the LVAD-BTT/BTC patients (n = 3) and in 20% of the HTx with donors >55 year group (P = 0.026). Kaplan-Meier curves estimated a 2-year survival rate of 94.6% in CF-LVAD-BTT vs 68.9% in HTx with donors >55 years [age- and sex-adjusted hazard ratio (HR) 0.25; 95% confidence interval (CI) 0.08-0.81; P = 0.02 in favour of CF-LVAD]. Considering the post-HTx outcome, a trend in favour of CF-LVAD-BTT was also observed (age- and sex-adjusted HR 0.45; 95% CI 0.17-1.16; P = 0.09 in favour of CF-LVAD), whereas CF-LVAD-BTT/BTC showed a similar survival at 2 years compared with HTx with donors >55 years, both censoring the follow-up at the time of HTx and considering the post-HTx outcome. CONCLUSIONS: Early and mid-term outcomes of patients treated with a CF-LVAD with BTT indication seem better than HTx with old donors. It must be emphasized that up to 19% of patients in the CF-LVAD/BTT group underwent transplantation in an urgent condition due to complications related to the LVAD. At the 2-year follow-up, CF-LVAD with BTT and BTC indications have similar outcome than HTx using old heart donors. These results must be confirmed in a larger and multicentre population and extending the follow-up.

Different clinical scenarios for circulatory mechanical support in acute and chronic heart failure.

Chronic heart failure (HF) is a leading cause of death in developed countries. Over the last 2 decades, mechanical circulatory support (MCS) devices have steadily evolved in the clinical management of end-stage HF and have emerged as a standard of care for the treatment of acute and chronic HF refractory to conventional medical therapy. Possible indications for using MCS are acute cardiogenic shock, as a bridge to transplantation, as a bridge to recovery, and more recently, as destination therapy in dilated cardiomyopathy, of either ischemic or idiopathic etiology. We reviewed the different clinical scenarios in which we think there are currently indications to implant different kinds of MCS systems.

Different applications for left ventricular mechanical support with the Impella Recover 100 microaxial blood pump.

The "Impella Recover 100" (IR100) is a new intravascular microaxial blood pump for use as short-term mechanical support for cases of acutely reduced left ventricular function. From September 2002 to April 2003, we used the IR100 to support 5 patients: 2 patients were bridged to heart transplant; 2 were being treated for fulminant acute myocarditis; and 1 for post-cardiotomy low-output syndrome. Only 1 patient with myocarditis died of septic shock, 2 had successful heart transplants; and the latter 2 were slowly weaned from the device and, at 3-month follow-up, showed moderate improvement of left ventricular (LV) function. Our initial experience with the IR100 as mechanical support for patients in cardiogenic shock of varying etiology has been positive, yielding good survival in a population of particularly compromised patients.

Right anterior mini-thoracotomy direct aortic self-expanding trans-catheter aortic valve implantation: A single center experience.

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) has been designed to treat elderly patients with severe aortic stenosis at high risk for surgery. These patients are also often affected by severe iliac-femoral arteriopathy, rendering the trans-femoral approach unusable. We report our experience with the direct-aortic approach to treat these patients. METHODS: From May 2008 to November 2013 two hundred and thirty-two patients (131 female, 56%) with severe symptomatic aortic stenosis and no reasonable surgical option due to excessive risk were evaluated for TAVI at our department. Of these patients, 202 were deemed eligible for TAVI. Of this group, 50 underwent CoreValve implantation by the direct aortic approach through a right anterior mini-thoracotmy (28 female, 56%), mean age 81.2±6.9. A combined team of cardiologists, cardiac surgeons with expertise in hybrid procedures, and anesthetists performed all the procedures. RESULTS: Twenty-eight (56%) patients were female and 11 (22%) were redo at TAVI. We used a 23-mm CoreValve Evolute in 3 patients (6%), and the most used valve size was the 29mm in 46% of patients. Mean hemodynamic trans-aortic gradient was less than 5mmHg. The paravalvular regurgitation was ≤ grade 1 in 46 patients as assessed by peri-procedural transesophageal echocardiography (TEE). Seven patients (7/43, 16%) required a permanent pacemaker implantation; 30-day mortality was 6% (3 patients). Seven patients (14.8%) died during follow-up. Actuarial survival at 2years is 84.7±5.3%. CONCLUSIONS: Transcatheter aortic valve implantation with the direct aortic approach is safe and feasible, offering a new attractive option to treat selected high-risk patients with severe aortic stenosis and peripheral vasculopathy, including those requiring a re-do procedure.

Surgical therapy in advanced heart failure.

Congestive heart failure (CHF) affects about 1% of adults in the United States and is a contributing factor in >250,000 deaths per year. In an increasingly elderly population, the surgical treatment of CHF made great progress during the past 3 decades, consuming enormous health care resources. Heart transplantation is still the most effective therapy for end-stage heart disease, with the 10-year survival rate after transplantation approaching 50%. Efforts to increase the supply of donor organs have failed to improve the shortage, underscoring the crucial need for alternatives to cardiac allotransplantation. Alternative surgical options to end-stage heart transplantation are rapidly evolving. Left ventricular assist devices have been used as a bridge to heart transplantation for patients who otherwise might die awaiting a new heart. There is also continued interest in the use of these devices either to bridge patients to full recovery or to destination therapy, without the need for heart replacement. Left ventricular reconstruction, including the Batista and Dor procedures, along with mitral valve repair, cardiomyoplasty, and extreme coronary artery bypass graft surgery, are now being increasingly performed as alternative options. The history, status, and personal experience of surgical treatment of end-stage heart disease are discussed.

Usefulness of chronotropic incompetence to dipyridamole in predicting myocardial perfusion defects in heart transplant recipients.

The aim of this report was to assess the relation between heart rate response to dipyridamole infusion and perfusion defects at quantitative sestamibi single-photon emission computed tomographic imaging. We demonstrated in 166 heart transplant recipients that chronotropic incompetence to dipyridamole is the only significant and independent predictor of perfusion defects.

Successful experience in bridging patients to heart transplantation with the MicroMed DeBakey ventricular assist device.

BACKGROUND: Pulsatile left ventricular assist devices are used with increasing frequency to bridge patients with end-stage heart failure to heart transplantation (HTx). Implantation of pulsatile devices is a cumbersome surgical procedure that is associated with major complications, such as bleeding, thromboembolism, and infection. Recently, a continuous axial flow left ventricular assist device (DeBakey ventricular assist device) has been introduced with the goal of reducing the incidence of major complications. METHODS: We reviewed our experience with 11 patients who received a DeBakey ventricular assist device axial flow pump for bridge to HTx from April 2000 through November 2001. RESULTS: Two patients (18.2%) died of multiple-organ failure while on left ventricular assist device support. Bleeding requiring thoracotomy occurred in 2 patients (18.2%). One patient had a minor neurologic event, and one patient developed left ventricular assist device thrombosis, which was successfully treated without pump exchange. Renal failure developed in 1 patient and hepatic dysfunction in 2 patients. There were no instances of right heart failure. No device, pocket, or drive-line infections occurred. Nine patients (9 of 11, 81.8%) had HTx within 51 +/- 49 days (range, 11 to 141 days) after left ventricular assist device implant. One patient died 29 days after HTx because of acute rejection. CONCLUSIONS: The continuous axial flow DeBakey ventricular assist device had reliable features, including a high rate of bridge to HTx. This device had low complication and system failure rates. We consider the DeBakey ventricular assist device a favorable alternative to pulsatile heart assist devices as a bridge to HTx.

Aortic complications after bicuspid aortic valve replacement: long-term results.

BACKGROUND: Bicuspid aortic valve (BAV) is a risk factor for aortic dissection and aneurysm. We studied patients with BAV and tricuspid aortic valve (TAV) to evaluate long-term changes in the ascending aorta after aortic valve replacement (AVR). PATIENTS AND METHODS: One hundred consecutive patients were allocated into two groups according to the presence of BAV (group A, 50 patients) or TAV (group B, 50 patients). Mean age was 51 +/- 12 years in group A, and 50 +/- years 12 in group B. No patients had hypertension or Marfan's syndrome. Until July 2001, mean follow-up was 234 +/- 47 months in group A and 241 +/- 43 months in group B. RESULTS: Five patients (10%, CL 5.7 to 13.9) in group A suffered late acute aortic dissection. Acute aortic dissection (5 vs 0, p = 0.0001) and sudden death (7 vs 0, p = 0.0001) occurred more frequently in patients with BAV. All survivors were assessed by echocardiogram. The mean diameter of the ascending aorta was 48.4 mm in group A and 36.8 mm in group B. Three patients in group A were operated on because of ascending aorta aneurysm more than 6 cm in diameter. CONCLUSIONS: As a result of our experience, we recommend a policy of prophylactic replacement of even a seemingly normal and definitely a mildly enlarged ascending aorta in cases of BAV at the moment of AVR, and consideration of a similar approach for any other cardiac surgical procedure in patients with BAV.

Echocardiographic approach in a new left ventricular assist device: Impella Recover 100.

Echocardiographic evaluation represents a basic tool for the treatment of patients undergoing ventricular assist device implant. Impella Recover 100 is a new left intraventricular assist device proposed for short-term mechanical circulatory support to be implanted without cardiopulmonary bypass. We report our experience with echocardiographic monitoring on a patient with ischemic cardiomyopathy who underwent Impella Recover 100 implant as a bridge to heart transplant. During the surgical procedure echocardiography had an essential role for anatomic evaluation of the heart and correct intraventricular positioning of the device. Moreover, during the whole period of assistance, echocardiography contributed to assessment of patient-device interaction and to check the device when malfunction was suggested.

Surgical treatment of acute myocardial infarction.

BACKGROUND: The role of surgical revascularization in the treatment of acute myocardial infarction (AMI) has changed considerably over the last 30 years along with improvement in intraoperative management and techniques of myocardial protection. The aim of this work was to analyze the long-term results of our experience of emergency myocardial surgical revascularization for AMI. METHODS: Between January 1986 and October 2003, 237 patients (85.3% males; mean age 59.6 +/- 9.6 years) underwent emergency coronary artery bypass graft for severe AMI. At admission 82 patients (34.6%) were in cardiogenic shock, while 124 patients (52.3%) presented major preoperative complications (acute pulmonary edema, mechanical ventilation, intra-aortic counterpulsation, cardiac arrest). Preoperative intra-aortic counterpulsation was performed in 125 patients (52.7%). The mean time interval between symptom onset and surgery was 9.4 hours. Three-vessel disease was detected in 107 patients (45%), with main left stenosis in 12.9%. RESULTS: There were overall 50 hospital deaths (21.1%). Amongst patients with major preoperative complications, mortality was 36.2% (45 cases out of 124); mortality for cardiogenic shock was 40.2% (33 patients out of 82). Survival of the first 140 patients undergoing operation and then discharged was 97.8% at 1 year and 79.6% at 5 years. The survival rate of the first 60 patients in cardiogenic shock operated on and then discharged is 98.8% at 1 year and 81.2% at 5 years. The ejection fraction in 102 echocardiographically controlled patients was 37.2 +/- 8.5% preoperatively and 44.0 +/- 10.1% at pre-discharge (p = 0.0001). CONCLUSIONS: Surgical revascularization for AMI, especially if complicated by cardiogenic shock, is a valid therapeutic option that carries a high periprocedural risk but that is balanced by a satisfactory late survival. A more precise patient's risk assessment at admission, improvement of surgical and myocardial protection techniques, extensive use of intra-aortic counterpulsation, and new circulatory support when needed, can improve outcomes and late survival.

Fulminant myocarditis during HIV seroconversion: recovery with temporary left ventricular mechanical assistance.

A 32-year-old male was admitted to our intensive care unit for low cardiac output syndrome. Echocardiography was suggestive of extensive hypokinesia and the ejection fraction was 0.22. Serological tests, including anti-HIV antibodies (ELISA), were negative. The patient was intubated and an intra-aortic balloon pump was inserted. Twenty-four hours after admission a paracorporeal left ventricular assist device (LVAD-MEDOS) was implanted. The left ventricular function showed progressive improvement with normalization of the ejection fraction on day 19. The device was removed on day 20. Before discharge, the patient admitted that he had had unprotected sex with numerous male acquaintances; anti-HIV testing turned positive. The final diagnosis was fulminant myocarditis during HIV seroconversion.

First successful bridge to recovery with the Impella Recover 100 left ventricular assist device for fulminant acute myocarditis.

A patient with septic and cardiogenic shock secondary to acute fulminant myocarditis was successfully treated by mechanical offloading of the left ventricle using the Impella Recover 100, a new implantable micro-axial blood pump designed for short-term circulatory support (for a maximum of 7 days). The possibility of implanting this device without using cardiopulmonary bypass allowed as to manage the septic shock, to reverse cardiac and hepatorenal failure and to wean the patient off treatment after 18 days of support. At 3 months the left and right ventricular function was satisfactory. The widespread application of this kind of support depends on the availability of an inexpensive "mini-invasive" blood pump, appropriate weaning protocols and emerging strategies to promote sustainable myocardial recovery.

[Comorbidity in surgical myocardial revascularization: risk factors or contraindications for surgery]. / Comorbilità nella rivascolarizzazione miocardica chirurgica: fattori di rischio, controindicazioni.

BACKGROUND: The worsening evolution of patients undergoing surgical myocardial revascularization makes it difficult the stratification of the preoperative mortality risk, a correct evaluation of results and the comparison of results of different centers. The aim of the study was to evaluate the prognostic weight of comorbidity in surgical myocardial revascularization. METHODS: We evaluated the characteristics of preoperative morbidity in 4999 patients who underwent surgical myocardial revascularization during four different periods (1979-1980, 1991-1992, 1994-1998, 1999-2002). We also evaluated the in-hospital results. RESULTS: By comparing the four different periods, an increase in older age, female sex, comorbidity, three-vessel disease, and severe left ventricular dysfunction was observed. Surgical mortality decreased to 2.3%. Multivariate analysis of the 1999-2002 period showed that only renal insufficiency was a risk factor for in-hospital mortality. CONCLUSIONS: Although the preoperative risk is higher, nowadays hospital mortality is reduced thanks to new cardiac-surgical techniques and approaches that increasing the capacity of controlling comorbidity in the pre-, intra- and postoperative course. For a correct decision-making process it is crucial to assess how much comorbidity may influence the long-term follow-up in these patients independently of surgical myocardial revascularization.

[Transesophageal and transthoracic echocardiography in the monitoring of a new endovascular left ventricle assist device]. / L'ecocardiografia transesofagea e transtoracica nel monitoraggio di un nuovo sistema endovascolare di assistenza ventricolare sinistra.

We report our experience with echocardiography to guide the placement of a new left ventricular assist device, the Impella Recover 100, and to monitor its functioning. We monitored the introduction of 4 Impella Recover 100 devices in 2 patients by means of the transesophageal approach in the operating room, and thereafter we monitored the functioning of the devices by means of the multisection transthoracic approach in the intensive coronary care unit. The first Impella placement was performed in a patient as a "bridge" to heart transplantation, whereas the other three placements were performed in a patient as "recovery" for acute myocarditis. In all patients transesophageal echocardiography turned out to be a valuable tool to monitor the introduction and the perioperative hemodynamic management of the Impella device. In the early postoperative phase, transthoracic echocardiography allowed us to assess any pump displacement, and optimize biventricular function and adequate inotropic support. In conclusion, transthoracic and transesophageal echocardiography resulted in a valuable method for monitoring the correct placement and functioning of the left ventricular assist device Impella Recover 100.

Current indications for heart transplantation and left ventricular assist device: a practical point of view.

Heart transplantation (HTx) is considered the "gold standard" therapy of refractory heart failure (HF), but it is accessible only to few patients because of the paucity of suitable heart donors. On the other hand, left ventricular assist devices (LVADs) have proven to be effective in improving survival and quality of life in patients with refractory HF. The challenge encountered by multidisciplinary teams in dealing with advanced HF lies in identifying patients who could benefit more from HTx as compared to LVAD implantation and the appropriate timing. The decision-making is based on clinical parameters, imaging-based data and risk scores. Current outcome of HF patients supported by LVAD (2-year survival around 70%) is rapidly improving and leads the way to a new therapeutic strategy. Patients who have a low likelihood to gain access to the heart graft pool could benefit more from LVAD implantation (defined as bridge to transplantation indication) than from remaining on HTx waiting list with the likely risk of clinical deterioration or removal from the list because patients are no longer suitable for transplantation. LVAD has also demonstrated to be effective in patients who are not considered eligible candidates for HTx with a destination therapy indication. HTx should be reserved to those patients for whom the maximum clinical benefit can be expected, such as young patients with no comorbidities. Here we discuss the current listing criteria for HTx and indications to implant of LVAD for patients with refractory acute and chronic HF based on the guidelines and the practical experience of our center.