Vincenzo Tarzia

Colchicine for Prevention of Postpericardiotomy Syndrome and Postoperative Atrial Fibrillation: The COPPS-2 Randomized Clinical Trial

IMPORTANCE Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients ≥70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01552187.

First quantification of alpha-Gal epitope in current glutaraldehyde-fixed heart valve bioprostheses

Glutaraldehyde fixation does not guarantee complete tissue biocompatibility in current clinical bioprosthetic heart valves (BHVs). Particularly, circulating anti‐αGal human antibodies increase significantly from just 10 days after a BHV implantation. The inactivation of such epitope should be mandatory to meet the requirements for a perspectively safe clinical application; nevertheless, its quantitative assessment in commercially available BHVs has never been carried out.

PCI versus CABG for multivessel coronary disease in diabetics

Objectives: To explore the clinical performance of a strategy of revascularization by percutaneous coronary intervention (PCI) with drug‐eluting stent (DES) in diabetic patients with multivessel disease (MVD) compared with coronary artery bypass graft (CABG), when it is based on clinical judgment. Background: Diabetes mellitus (DM) is a major risk factor for poor outcome after PCI. However, PCI may result in better outcome if the choice of revascularization (PCI versus CABG) is based on the physician decision, rather than randomization. Limited experiences have compared revascularization by DES‐PCI versus CABG in DM patients with MVD. Methods: From August 2004 to August 2005, 220 consecutive DM patients with MVD underwent DES‐PCI (93) or CABG (127) at our Institution. The type of revascularization was dependent on patient and/or physician choice. Major adverse cardiac and cerebrovascular events (MACCE) included death, myocardial infarction, repeat coronary revascularization, and stroke. Results: Compared with PCI patients, CABG patients had higher prevalence of 3‐vessel disease (P < 0.001), significant LAD involvement (P < 0.001), presence of total occlusions (P = 0.04), collateral circulation (P < 0.001). At 2‐year follow‐up, MACCE were not different between CABG group and DES‐PCI group (OR 1.2; P = 0.6) and, only when the clinical judgment on the revascularization choice was excluded at propensity analysis, DES‐PCI increased the risk of 24‐month MACCE in total population (OR 1.8; P = 0.04). Conclusions: For patients with DM and MVD, a clinical judgment‐based revascularization by DES‐PCI is not associated with worse 2‐year outcome compared with CABG.

HeartWare Ventricular Assist Device as Bridge to Transplant in Children and Adolescents

Limited options do exist for mechanical circulatory support as a bridge to transplantation in the pediatric population. This is especially true when it comes to intracorporeal technologies. We describe our successful experience with the use of HeartWare ventricular assist devices (HeartWare, Inc., Framingham, MA, USA) in three patients <16 years of age, as a successful and feasible bridge to transplant in patients weighing greater than 20 kg.

Less invasive surgical and perfusion technique for implantation of the Jarvik 2000 left ventricular assist device.

Left ventricular assist device implantation might require extensive surgical incision and use of cardiopulmonary bypass. Less invasive implantation using smaller incision and extracorporeal membrane oxygenation perfusion in critically ill patients can decrease the rate of complications. One patient with cardiomyopathy received the Jarvik 2000 FlowMaker through an upper T-inverted ministernotomy and left minithoracotomy. The outflow-graft was connected to the ascending aorta, and the Jarvik 2000 was inserted through the apex of the left ventricle on beating heart. The power cable was routed percutaneously through the neck to a retroauricular skull-mounted pedestal.

Hemorrhage and thrombosis with different LVAD technologies: a matter of flow?

BACKGROUND Much of the morbidity and mortality associated with ventricular assist devices (VADs) is due to haemorrhagic and thrombotic complications. To manage antithrombotic therapy, interactions between the patient and pump should be better understood. METHODS We have compared the Jarvik 2000, an axial flow left ventricular assist device (LVAD), with the HeartWare ventricular assist device (HVAD) centrifugal pump, regarding conventional laboratory findings, thromboelastometric and aggregometric tests. RESULTS Patients with the Jarvik 2000 experienced a significant reduction in platelet count following implantation, a phenomenon not seen with the HeartWare model. Conversely, we observed that levels of platelet activation, as assessed by a platelet function analyzer, and activation of the coagulation system, as assessed by thromboelastometry, were significantly greater in the HeartWare group. CONCLUSIONS It seems that axial flow pumps, being more destructive on blood cells, tend to reduce platelet numbers. On the other hand, centrifugal flow is associated with a hypercoagulable state, possibly resulting from the activation of the coagulation system in the absence of platelet destruction.

Impact of vacuum-assisted closure therapy on outcomes of sternal wound dehiscence †

OBJECTIVES Sternal wound dehiscence (SWD) after cardiac surgery is a rare but serious condition associated with considerable costs and morbidity. We sought to evaluate the results of the introduction of vacuum-assisted closure (VAC) therapy in the management of sternal wound dehiscence, compared with those of previous conventional treatments. METHODS We retrospectively collected 7148 patients who underwent cardiac surgery at our institution between January 2002 and June 2012. A total of 152 (2.1%) patients had a sternal wound dehiscence: 107 were treated with conventional treatments (Group A) and 45 were managed with VAC therapy (Group B). Patients were stratified according to preoperative risk factors and type of sternal wound dehiscence (superficial or deep; infected or not) and compared by means of a propensity-matched analysis. A cost analysis was also performed. RESULTS Forty-five patients of each group matched for all preoperative risk factors and type of sternal wound dehiscence. SWD-related mortality rate was significantly lower in Group B (11 vs 0%; P = 0.05). Incidence of mediastinitis (P < 0.0001), sepsis (P = 0.04), delayed SWD infection (P = 0.05), other complication (P = 0.05), surgical sternal revision (P = 0.04) and surgical superficial revision (P < 0.0001) were all significantly lower in Group B. Mean patient cost was 31 106€ in Group A and 24 383€ in Group B, thus achieving a mean saving of 6723€ per patient. CONCLUSIONS In our experience, the use of VAC therapy for the management of SWD was considerably effective in decreasing mortality (SWD related), incidence of complications and need for surgical procedures; thus, leading to a significant reduction of costs.

Nitinol Flexigrip Sternal Closure System and Chest Wound Infections: Insight From a Comparative Analysis of Complications and Costs

BACKGROUND We sought to assess the efficiency of two different sternal closure techniques in preventing sternal wound complications (SWC). A cost analysis was also considered. METHODS Between January 2008 and April 2010, 1,644 consecutive cardiac surgery patients who underwent cardiac surgery in our institute were prospectively collected. A total of 1,072 patients received a standard parasternal wiring technique (group A), and 572 patients received a new method of sternal closure based on the use of thermoreactive nitillium clips (Flexigrip; Praesidia SRL, Bologna, Italy [group B]). We investigated, by a propensity matched analysis, whether the use of standard or nitinol clip closure would impact on sternal wound outcome. RESULTS In all, 464 patients of each group were matched for 17 available risk factors. Overall incidence of SWC was significantly higher in group A (4.1% versus 1.7%; p=0.03). Sternal surgical revision to treat a thoracic instability was required in a significantly higher number of patients in group A (9 patients, 1.9%) and in none of group B (p=0.004). The incidence of sternal instability, secondary to wound infection, was significantly lower in group B (p=0.05). Overall costs were €7,407,296 and €6,896,432 in group A and group B, respectively. Thus, nitinol clip closure technique offered a €510,864 cost saving compared with standard steel wiring technique. CONCLUSIONS The Flexigrip assured a lower incidence of SWC. The use of the nitinol clip favored an improved sternal closure technique preventing mediastinitis. Additionally, the nitinol clip system proved to be cost effective in cardiac surgery.

Valve surgery in octogenarians: does it prolong life?

OBJECTIVES Age-related degenerative heart-valve disease is a health issue in the present era. Octogenarians are frequently affected by concomitant diseases and, with the present lack of resources, the risk/benefit of valvular replacement therapy poses serious medical, economical and political challenge. We analysed the long-term survival of 346 octogenarians who underwent 352 operations between 1 January 1987 and 1 January 2009 and we compared it with the survival of the general population, matched for age, sex and operative year. METHODS The total follow-up was of 1352 years, maximum 15.7 years and was nearly complete except for a single foreigner. Heart diseases, concomitant pathologies, complications and actuarial survival of this study group were compared with 4649 younger counterparts, who received 5416 operations during the same time frame. Octogenarians were sorted by age, sex and operative year and the expected survival was calculated by applying US survival rate and added to the Kaplan-Meier plot for visual comparison. RESULTS A total of 279 aortic, 38 mitral and 35 mitro-aortic valves were replaced or repaired using 357 bioprostheses, 18 mechanical prostheses, 12 reparative operations and 24 re-operations. A total of 75% of patients were younger than 84 years, 95% were younger than 87 years and 99% younger than 90 years. Sex prevalence was 215 female versus 131 male. Operative (30 days) mortality was 5.5% and overall survival was 84.3% at 1 year, 65.4% at 5 years, 27.3% at 10 years and 5.4% at 15 years. The expected survival of the age-, sex-, operative year-matched population was 26.9% at 10 years and 7.9% at 15 years. Female operative mortality was 5.9% and survival was respectively 86.3%, 70.2%, 27.5% and 9.1%, male mortality was 4.5% and survival was respectively 81%, 56.7%, 28.8% and 0% (p=0.16). Expected female survival was 30% at 10 years and 10% at 15 years versus 22% and 5.6%, respectively, in males. Six octogenarians underwent re-operation, with one death. CONCLUSIONS Despite the highest prevalence of concomitant diseases and the requirement of additional resources for the detection and neutralisation of risk factors, heart-valve operations in octogenarians offer excellent results that compare favourably with the expected survival of the age-, sex- and operative year-matched population, particularly after primary operations.

Bilateral mini-thoracotomy off-pump Jarvik 2000 implantation in regional asymmetric paravertebral analgesia

We describe the surgical technique and treatment of a 59-year-old male with cardiogenic shock, who underwent a minimally invasive off-pump ventricular assist device (VAD) implantation with the aid of paravertebral regional analgesia in bilateral mini-thoracotomies as first procedure described in the literature. He was extubated soon after the procedure, in the operating room, with the aim to reduce the right ventricle impairment. These issues are particularly true for patients suffering from pulmonary hypertension and disease, in whom the shortest time of postoperative intubation is fundamental to allow self-inotropic support and recovery of the right ventricle. We illustrate how a minimally invasive implant may improve the clinical outcomes of VAD patients shortening their return time to active life.