Angelo M. Dell'Aquila

Reoperation After Surgical Correction of Acute Type A Aortic Dissection: Risk Factor Analysis

BACKGROUND Aortic dissection is an evolving process that may require one or several reoperations after its initial repair. We conducted a study to evaluate risk factors and define the incidence and locations of reoperations after surgical correction of acute type A aortic dissection (AAD). METHODS Between 1998 and 2008, 250 consecutive patients (mean age 62.5±12.4 years) underwent surgery for AAD at our institution. Replacement of the ascending aorta was done in 173 cases, composite graft replacement in 61 cases, separate aortic valve and ascending aorta replacement in 2 cases, and arch replacement required by distal repair in 14 cases. Mean follow-up time was 4.7±5.6 years. RESULTS Freedom from reoperation was 99%, 82%, and 79% at 1, 5, and 10 years, respectively. Twenty-five patients required 25 reoperations at a mean interval of 4.7 years after initial surgery for the correction of AAD. Reoperations included 21 procedures on the proximal aorta (ascending aorta, aortic root, or valve) and 4 procedures on the distal aorta (arch or descending aorta). Cox regression analysis identified the use of gelatin-resorcinol-formaldehyde (GRF) glue (p=0.0270), and nonreplacement of the aortic root at the time of initial AAD repair (p=0.0004), as a significant risk factor for proximal reoperation, and a patent false lumen (p=0.0107) as a significant risk factor for distal reoperation. CONCLUSIONS A patent false lumen, the use of GRF glue, and aortic root preservation at initial operation influence the risk for surgical correction in patients undergoing surgery for AAD. These patients need long-term follow-up.

Better Short-Term Outcome by Using Sutureless Valves: A Propensity-Matched Score Analysis

BACKGROUND Sutureless aortic valve prostheses have the potential of shortening ischemic time. However, whether shorter operative times may also result in improved patient outcomes and have an effect on hospital costs remains to be established. METHODS From March 2010 to April 2013, 566 patients underwent aortic valve replacement with bioprostheses; of these, 166 received a sutureless valve, and 400 received a stented valve. Redo and associated procedures were included. A propensity-score analysis was used to create two groups (sutureless and stented) with 82 matched pairs with comparable preoperative characteristics. Hospital outcome, follow-up, and health care resource consumption were compared. RESULTS There were 3 hospital deaths in the stented group and 2 in the sutureless group (p=0.65). Aortic cross-clamp, cardiopulmonary bypass, and operation times were significantly shorter in the sutureless group (p<0.001). Patients in the sutureless group required blood transfusion less frequently (1.2±1.3 vs 2.5±3.7 units, p=0.005), with a similar need for reexploration for bleeding (2 vs 5, p=0.221). The sutureless group had a shorter intensive care unit stay (2.0±1.2 vs 2.8±1.3 days, p<0.001), hospital stay (10.9±2.7 vs 12.4±4.4 days, p=0.001) and intubation time (9.5±4.6 vs 16.6±6.4 hours, p<0.001), and a lower incidence of postoperative atrial fibrillation (p=0.015), pleura effusions (p=0.024), and respiratory insufficiency (p=0.016). Pacemaker implantation and occurrence of neurologic events were similar between groups (p>0.05). A lower rate of postoperative complications resulted in reduced resource consumption in the sutureless group for diagnostics (€2,153 vs €1,387), operating room (€5,879 vs €5,527), and hospital stay (€9,873 vs €6,584), with a total cost saving of approximately 25% (€17,905 vs €13,498). CONCLUSIONS A shorter procedural time in the sutureless group is associated with better clinical outcomes and reduced hospital costs.

Sutureless aortic valve replacement with Perceval bioprosthesis: are there predicting factors for postoperative pacemaker implantation?

OBJECTIVES Aortic valve replacement (AVR) with sutureless bioprostheses has become an alternative to conventional AVR for patients with intermediate to high operative risk. However, this technique is associated with an increased risk of postoperative conduction disorders. METHODS We analysed 258 patients who underwent AVR with the Perceval prosthesis from July 2010 to September 2014 at our centre. Electrocardiography were obtained at baseline to record preoperatively the presence of conduction disorders. Preoperative risk factors, intraoperative procedures and complications (61 variables) were compared between patients with permanent pacemaker (PPM group) and without (no-PPM group) need for postoperative PPM implantation. RESULTS One hundred and sixty-nine patients underwent isolated AVR with the Perceval bioprosthesis, 89 patients had associated surgery and 23 patients underwent redo operations. The mean age was 77.7 ± 5 years, 139 patients were female (46%) and the mean logistic EuroSCORE was 13.2 ± 11%. At baseline, 8 patients had already an implanted pacemaker. Postoperatively, 27 patients (10.5%) required new PPM implantation due to complete atrioventricular block. On univariate analysis, age (PPM vs no-PPM group: 80 ± 5 vs 77 ± 5 years, P = 0.009) and preoperative presence of right bundle branch block (RBBB) [overall n = 20 (7.8%); PPM vs no-PPM group: 9 vs 11 (33 vs 4.8%); P < 0.001] were identified as independent predictors of postoperative conduction disorders, but only pre-existing RBBB persisted on multivariate analysis (odds ratio 11.3-C-statistic 0.74, error estimate 0.064, confidence interval 0.672-0.801; P = 0.0002). Among patients undergoing sutureless AVR, the rate of PPM implantation was high. CONCLUSIONS The analysis of the data collected made it possible to identify preoperatively a subset of patients undergoing sutureless AVR at higher risk of postoperative atrioventricular block. Additional surgical precautions should be implemented to prevent the occurrence of conduction disorders after sutureless AVR.

Clinical and echocardiographic outcomes after implantation of the Trifecta aortic bioprosthesis: an initial single-centre experience.

OBJECTIVES The Trifecta valve (St. Jude Medical) was introduced into clinical practice as a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. The present study aims to evaluate the preliminary results with this new bioprosthesis. METHODS Seventy patients underwent aortic valve replacement (AVR) with the Trifecta valve between August 2010 and December 2011. Thirty-three patients were male and 37 were female (52.9%). Mean age was 74.65 ± 7.63 (range 47-90 years). Prevalent cause of AVR was aortic stenosis in 64 (91.43%) patients. The mean preoperative pressure gradient was 50 ± 17 (range 20-84 mmHg), and the mean aortic valve area was 0.77 ± 0.33. Five (7.14%) patients were operated on due to aortic valve endocarditis. One patient was operated on due to isolated, severe aortic insufficiency. All patients were in New York Heart Association functional class III or IV. Twenty-eight (40%) patients underwent concomitant procedures. RESULTS Concomitant procedures were coronary artery bypass grafting (n = 25), mitral valve replacement (n = 1), ablation of atrial fibrillation (n = 1) and septal myomectomy (n = 1). There were no intraoperative deaths. The 30-day in-hospital mortality was 2.85% (2 of 70). One late death occurred during the in-hospital stay due to a multiorgan failure on postoperative day 60. There were 2 (2.85%) perioperative strokes. Mean pressure gradient decreased significantly from a preoperative value of 50 ± 17 mmHg to an intraoperative gradient of 9 ± 4 mmHg (Table 3). The mean gradients were 14, 11, 11, 8 and 6 mmHg for the 19, 21, 23, 25 and 27 mm valve size, respectively. No prosthesis dislocation, endocarditis, valve thrombosis or relevant aortic regurgitation was observed at discharge. CONCLUSIONS The initial experience with the Trifecta valve bioprosthesis shows excellent outcomes with favourable early haemodynamics. Further studies with longer follow-up are needed to confirm those preliminary results.

Initial Clinical Experience With the HeartWare Left Ventricular Assist System: A Single-Center Report

BACKGROUND The HeartWare ventricular assist device (HVAD) system (HeartWare International Inc, Framingham, MA) is a new centrifugal continuous-flow ventricular assist device. The aim of the present study is to review our institutional experience with this novel device. METHODS We reviewed the files of 50 patients (39 men, 11 women) with a mean age of 50.6 ± 11.8 years (range, 19 to 70 years) who underwent HVAD implantation between July 2009 and November 2011. Two patients underwent HeartWare BIVAD implantation. The underlying heart diseases were end-stage ischemic heart disease (n = 12), acute myocardial infarction (n = 9), dilated cardiomyopathy (n = 27) and acute myocarditis (n = 2). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles were level 1 (n = 11), 2 (n = 5), 3 (n = 10), and 4 (n = 24). RESULTS After a cumulative support duration of 11,086 days, Kaplan-Meier analysis revealed a survival of 82.0%, 77.9%, 75.5%, at 1, 12, and 24 months, respectively. Causes of early death were right heart failure (n = 4), multiorgan failure (n = 2), septic shock (n = 2), and major neurologic complications (n = 4). One late death occurred due to a right heart failure. Comparison between patients operated on in cardiogenic shock (INTERMACS 1 and 2) and patients who underwent elective HVAD implantation (INTERMACS 3 and 4) revealed a survival of 61.5% and 44.1% for the INTERMACS 1 and 2 group and 90.3% and 87.1% for the INTERMACS 3 and 4 group at 1 and 12 months, respectively (odds ratio, 4.67; p = 0.003). One patient was weaned from the system after 2 years. Eleven patients (22%) were successfully bridged to transplantation. Mean time to transplantation was 209 days (range, 72 to 427 days). Posttransplant survival at the 1-year follow-up was 90.9% (11 patients). CONCLUSIONS Our experience with HVAD shows satisfying results with an excellent posttransplantation survival. Moreover, the stratified survival based on the level of preoperative stability shows better outcomes in patients undergoing elective HVAD implantation.

Prospective study of everolimus with calcineurin inhibitor-free immunosuppression after heart transplantation: results at four years.

BACKGROUND Immunosuppression is necessary after transplantation but it is associated with distinct adverse side effects. These negative effects could at least partially be overcome with the mammalian target of Rapamycin (mTOR) inhibitor everolimus. Few studies have examined everolimus therapy with calcineurin inhibitor (CNI) withdrawal in maintenance heart transplant patients (HTx). METHODS In this prospective, single-arm, single-center study, maintenance patients after HTx were converted from CNI to everolimus. They were followed for 48 months. Primary endpoints were kidney-function and arterial hypertension. RESULTS Forty-eight patients were recruited (mean post-transplant time 5.4 ± 3.5 years). Of these, 36 were followed for the entire 4-year period. Median calculated glomerular filtration rate increased from 40.7 (32.4 to 59.1) mL/minute at baseline to 48.9 (29.7 to 67)) mL/minute at month 48 (p = not significant). Median systolic and diastolic blood pressure, triglycerides, and high-density lipoprotein and low-density lipoprotein cholesterol, did not change significantly in a comparison of the values at baseline and at 48 months. Early resolution of most non-renal CNI-related adverse events was sustained. Due to adverse events, CNI therapy had to be reintroduced in 6 patients (12.5%). No significant changes in cardiac function parameters were observed. CONCLUSIONS Calcineurin inhibitor-free immunosuppression with everolimus is an effective and safe option in selected maintenance HTx patients. Most adverse effects under everolimus occurred early after conversion and in most cases resolved without intervention within a few weeks. Refining selection criteria may help both in identifying patients who will profit most from switching and in alleviating the need to reintroduce CNI therapy.

Survival results after implantation of intrapericardial third-generation centrifugal assist device: an INTERMACS-matched comparison analysis.

Reports on third-generation centrifugal intrapericardial pumps (HeartWare International, Inc., Framingham, MA, USA) have shown better survival results than the previous-generation devices. However, outcomes depending on the preoperative level of stability can substantially differ, resulting in a limited analysis of potentialities and drawbacks of a given device. In the present study we sought to compare in our single-center experience the survival results of this third-generation device with previous left ventricular systems taking into account the different preoperative Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels. Between February 1993 and March 2012, 287 patients underwent assist device implantation in our university hospital (INTERMACS Level 1-2 = 158 patients; INTERMACS Level 3-4-5 = 129 patients). Assist devices implanted were: Group A (HVAD HeartWare, n = 52), group B (previous continuous-flow ventricular assist device [VAD], InCor [Berlin Heart, Berlin, Germany], n = 37; VentrAssist [VentraCor, Inc., Chatswood, NSW, Australia], n = 7; DeBakey [MicroMed Cardiovascular, Inc., Houston, TX, USA], n = 32), and group C (pulsatile systems, n = 159). After cumulative support duration of 54 436 days and a mean follow-up of 6.21 ± 7.46 months (range 0-45.21 months), log-rank analysis revealed a survival for group A of 82.0%, 70.4%, and 70.4%; for group B of 84.0%, 48.2%, 33.7%; and for group C of 71.6%, 46.1%, 33.8%, at 1, 12, and 24 months respectively, with a significantly (P = 0.013) better outcome for group A. When stratifying the survival on the basis of INTERMACS level, no significant survival improvement was observed among all patients who underwent VAD implantation in INTERMACS 1-2 (P = 0.47). However, among patients who underwent elective VAD implantation (INTERMACS 3-4-5), group A had a significantly better outcome (P = 0.005) compared with the other INTERMACS-matched groups (B,C) with a survival rate of 88.8% in group A versus 34.2% in group B and 45.6% in group C at 24 months, respectively. Elective HVAD system implantation shows improved survival benefit over the other INTERMACS-matched devices. Moreover, preoperative unstable hemodynamics resulted in a poor prognosis independently from the pump generation.

Everolimus therapy is associated with reduced lipoprotein-associated phospholipase A2 (Lp-Pla2) activity and oxidative stress in heart transplant recipients

BACKGROUND Several studies demonstrated decreased severity and incidence of cardiac allograft vasculopathy (CAV) in heart transplant recipients receiving immunosuppressive therapy with everolimus. However, data regarding the influence of everolimus on risk factors predisposing to CAV are hitherto limited. We here systematically evaluated cardiovascular risk factors in heart transplanted patients, who underwent conversion to everolimus or were maintained on conventional therapy with calcineurin inhibitors (CNI). METHODS 50 Patients receiving everolimus and 91 patients receiving CNI in addition to mycophenolate mofetil and low-dosed steroids were included in the study. CAV risk factors were determined in plasma or urine using standard enzymatic or immunochemical methods. RESULTS No significant differences were observed between both groups with regard to lipid (total, LDL- and HDL-cholesterol), metabolic (glucose, insulin), inflammatory (C-reactive protein, IL-6, myeloperoxidase) and cardiac (troponin I, NT-proBNP) risk factors. However, significantly lower activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) and a negative correlation between the Lp-PLA2 activity and the everolimus concentration were observed in plasmas from everolimus-treated patients. Conversion to everolimus significantly lowered Lp-PLA2 activity in heart transplant recipients. Studies in vitro revealed reduced Lp-PLA2 expression in hepatocytes and macrophages pre-exposed to everolimus. In addition, reduced plasma markers of oxidative stress including oxidized LDL, 8-iso-prostaglandin F2α and protein carbonyls were noted in heart transplant recipients receiving everolimus therapy. CONCLUSION Our results suggest that everolimus specifically lowers plasma activity and cellular production of Lp-PLA2 and thereby dampens oxidative stress. These effects may additionally contribute to the reduced CAV incidence observed in heart transplant recipients receiving everolimus therapy.

Is Implantation of a Left Ventricular Assist Device in Patients With Critical or Impending Cardiogenic Shock an Absolute Contraindication? Looking Back at Our Past Experience Trying to Identify Contraindicative Risk Factors.

Poor survival has been demonstrated after ventricular assist device (VAD) implantation for Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 and 2 patients compared with more stable levels. However, risk factors within this high-risk cohort have not been determined so far. The aim of the present study was to identify risk factors associated with this very high mortality rate. Between February 1993 and January 2013, 298 patients underwent VAD implantation in our institution. One hundred nine patients were in INTERMACS level 1 and 49 patients were in INTERMACS level 2 and were therefore defined as hemodynamically critical (overall 158 patients). Assist devices implanted were: HVAD HeartWare n = 18; Incor n = 11; VentrAssist n = 2; DeBakey n = 22; and pulsatile systems n = 105. After cumulative support duration of 815.35 months, Kaplan-Meier analysis revealed a survival of 63.9, 48.8, and 40.3% at 1, 6, and 12 months, respectively. Cox regression analyses identified age > 50 (P = 0.001, odds ratio [OR] 2.48), white blood cell count > 13.000/μL (P = 0.01, OR 2.06), preoperative renal replacement therapy (P = 0.001, OR 2.63), and postcardiotomy failure (P < 0.001, OR 2.79) as independent predictors of mortality. Of note, last generation VADs were not associated with significantly better 6-month survival (P = 0.59). Patients without the aforementioned risk factors could yield a survival of 79.2% at 6 months. This single-center experience shows that VAD implantation in hemodynamically unstable patients generally results in poor early outcome, even in third-generation pumps. However, avoiding the aforementioned risk factors could result in improved outcome.

Aortic Valve Replacement with Smaller Prostheses in Elderly Patients: Does Patient Prosthetic Mismatch Affect Outcomes?

To evaluate the influence of patient‐prosthesis mismatch (PPM) on survival, and quality of life (QOL) after aortic valve replacement (AVR) in elderly patients with small prosthesis size.