Carlo Maria De Filippo

Prospective, Randomized Clinical Trial of the FloSeal Matrix Sealant in Cardiac Surgery

BACKGROUND Topical hemostatic agents composed of a gelatin-based matrix and thrombin have been reported to be effective, in addition to traditional means, in terminating bleeding during cardiac operations. We compared a hemostatic matrix sealant agent (FloSeal; Baxter Inc, Deerfield, IL) with alternative topical hemostatic agents in a mixed cohort of elective cardiac and thoracic aortic operations. METHODS Following sample size calculation, in a prospective randomized study design, 209 patients were treated with FloSeal matrix sealant (FloSeal group) and 206 patients received alternative agents as topical hemostatic materials (comparison group). FloSeal is composed of a self-expandable gelatin matrix component and purified bovine thrombin. Comparisons included hemostatic patches or sponges composed of either oxidized regenerated cellulose or purified porcine skin gelatin. Study endpoints were the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay. RESULTS Statistically higher rates of successful hemostasis and shorter time-to-hemostasis were observed in the FloSeal group (p < 0.001 both). Time-to-event analysis confirmed this finding (p = 0.0025). Postoperative bleeding and rate of transfusion of blood products were statistically decreased in the FloSeal group (p < 0.001 both). Rates of revision for bleeding and of minor complications were not statistically different among groups in the overall cohort, but were significantly lesser in the FloSeal group if only patients with overt intraoperative bleeding are considered (p = 0.04 both). The advantages observed in the FloSeal group were not offset in patients undergoing systemic hypothermia. CONCLUSIONS The topical hemostatic agent used in the FloSeal group is effective in terminating intraoperative bleeding as an adjunct to traditional surgical methods for stopping bleeding. Its judicious use is associated with lesser need for transfusion of blood products and rate of revision for bleeding. Its cost-utility profile should be addressed in dedicated trials.

Endovascular Treatment of Persistent Sciatic Artery Aneurysm With the Multilayer Stent

Purpose To describe the successful management of a symptomatic persistent sciatic artery (PSA) aneurysm using the Multilayer Aneurysm Repair System (MARS). Case Report A 50-year-old man with history of smoking, hypertension, and hypercholesterolemia suddenly developed pain in the buttock radiating to the left lower limb, mimicking sciatica. The ∼57×54-mm incomplete type PSA aneurysm was treated with two 14×80- and 14×60-mm MARS devices through a surgical left axillary artery access. There were no periprocedural complications. Thirty-day imaging documented patency of the stents and a minor reduction (∼47×55 mm) in the aneurysm, with slightly hyperdense content and no signs of perfusion. At 6 months, duplex and computed tomographic angiography showed complete thrombosis of the sac, patency of the multilayer stents, and further aneurysm shrinkage (40×37 mm). Conclusion The multilayer stent can alter the hemodynamics inside a peripheral aneurysm to promote sac thrombosis and redirect flow to collaterals originating from the sac.

Pseudoaneurysm after patch-free carotid bifurcation endarterectomy: a case report.

The purpose of this report is to present the case of a 59-year-old man affected by multivessel coronary artery disease and sterile pseudoaneurysm of the right carotid bifurcation presenting as a pulsating neck mass 1 month after patch-free carotid endarterectomy. The surgical approach included median sternotomy and incision parallel to the anterior margin of the right sternocleidomastoid muscle. The pseudoaneurysm was excised after control of the brachiocefalic trunk and insertion of a Pruit-Inahara shunt, and the carotid vessels were directly sutured without using any prosthetic or autologous material. Concomitant coronary bypass grafting was performed. The postoperative course was uneventful and there was no evidence of recurrence of pseudoaneurysm at 6-month follow-up. On the basis of this experience and of pertinent literature, the options for the management of such rare entities are discussed.

Evaluation of less invasive method for saphenous vein harvest in patients with type II diabetes.

Background Diabetes mellitus is an established risk factor for leg wound healing complications after great saphenous vein harvest. Leg healing complications occur in 1–25% of coronary artery bypass graft patients, and are often underestimated. Patients and methods The records of 230 patients enrolled in a prospective trial to evaluate a minimally invasive approach compared with conventional longitudinal harvest were reviewed. Of 100 patients with diabetes, 49 had undergone minimally invasive harvest (group A). Forty-nine patients from the pool without diabetes who underwent minimally invasive harvest were selected using propensity scoring analysis (group B), and 46 diabetic patients operated using a conventional technique (group C) were matched to group A patients. Ninety-five patients with and 49 without diabetes finally entered the study. The quality of leg wound healing was quantified by ASEPSIS score by two independent surgeons in a blinded manner. The occurrence of complications was compared between groups. Results Fewer leg wound healing complications occurred in diabetic patients in the minimally invasive compared with the conventional group (P < 0.0001). Rates of complications were comparable among diabetic and non-diabetic patients operated using the minimally invasive technique. The intraoperative flow of vein grafts obtained by the minimally invasive technique was comparable to that of veins harvested using the conventional technique. Conclusion These data suggest that postoperative leg wound morbidity can be significantly attenuated by the adoption of a less invasive approach, even in high-risk patients with diabetes. The advantages are not offset by the co-existence of other cardiovascular risk factors or by a long history of diabetes.

Early and Mid-Term Results of Rapid-Deployment Valves: The Intuity Italian Registry (INTU-ITA)

BACKGROUND Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. METHODS Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. RESULTS A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. CONCLUSIONS Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

Spontaneous rectus sheath hematoma: The utility of CT angiography

We described the utility of computed tomography (CT) angiography in detection of bleeding vessels for a rapid percutaneous arterial embolization of the spontaneous rectus sheath hematoma. A 70-year-old woman comes to our attention with acute abdominal pain and a low hemoglobin level. An unenhanced CT was performed demonstrating a large rectus sheath hematoma. A conservative management was initially established. Despite this therapy, the abdominal pain increased together with a further decrease of hemoglobin values. A CT angiography was then performed, demonstrating an active bleeding within the hematoma and addressing the patient to a rapid percutaneous arterial embolization.

Dynamic sonographic examination of an ectopic sublingual goiter

Ectopic thyroid tissue is a rare finding that results from incomplete migration of thyroid precursors. The ectopic thyroid tissue can be found anywhere along the descending pathway of the thyroid gland: in the base of the tongue (lingual), between the geniohyoid and mylohyoid muscles (sublingual, suprahyoid), anterior to the larynx (prelaryngeal), or in the mediastinum. Cases of supradiaphragmatic (intrathoracic) and subdiaphragmatic ectopic thyroid tissue have also been reported. Ninety percent of cases of ectopic thyroid are of the lingual type. The thyroid gland is absent from its normal position in 70% of ectopic cases. The ectopic thyroid tissue can be totally asymptomatic or generate symptoms related to the specific location of the ectopic tissue, such as dyspnea, dysphonia, dysphagia, or hemoptysis. A 72-year-old-man patient, candidate for coronary artery bypass surgery, was referred to thyroid ultrasound because of subclinical hypothyroidism. The sonographic (ultrasound [US]) examination revealed the absence of thyroid tissue in its normal position and identified a wellcircumscribed, oval, midline, 3.63 3.43 2.2 cm, soft-tissue mass with its epicenter located on the cranial aspect of the mylohyoid muscle, close to the hyoid bone (Figure 1). The US appearance was consistent with an ectopic sublingual goiter, showing a nonhomogeneous echotexture inhomogeneous, with multiple echogenic and hypoechoic confluent nodules and peripheral vascularization on color Doppler examination. The absence of thyroid gland in its normal position, the location, and US appearance of the mass were consistent with an ectopic goiter. The US examination was completed with a dynamic study performed with protrusion of the tongue to obtain a better visualization of the root of the tongue, which is the most frequent location of ectopic thyroid tissue. In order to obtain a wider field of view, this dynamic study was conducted using a 2.8to 4-MHz convex array transducer (Figure 2). The US examination along with the clinical otorhinolaryngological evaluation confirmed the absence of an associated lingual thyroid, a condition that can cause serious complications during intubation. Finally, the US examination of the entire neck also excluded the presence of additional foci of ectopic thyroid tissue.

Baroflex Activation Therapy for Refractory Congestive Heart Failure: Anesthetic Implications

Department of Cardiovascular Disease, Fondazione di Ricerca e Cura Giovanni Paolo II, Campobasso, Italy Department of Anesthesiology, Fondazione di Ricerca e Cura Giovanni Paolo II, Campobasso, Italy Department of Cardiovascular Surgery, Università Cattolica del Sacro Cuore, Roma, Italy Department of Cardiovacular Medicine, IRCSS Multimediaca, Sesto San Giovanni MI, Italy Department of Molecular Medicine, University of Pavia, Pavia, Italy