Making a case for controlled organ donation after cardiac death: the story of Italy's first experience.

Donation after circulatory death (DCD) is a valuable option for the procurement of organs for transplantation. In Italy, organ procurement after controlled DCD is legally and ethically conceivable within the current legislative framework. However, although formal impediments do not exist, the health care team is faced with many obstacles that may hinder the implementation of such programs. We report the case of Italy's first controlled DCD, specifically discussing the role of the patient's family in the shared decision-making process. In our case, the death of the patient subsequent to the withdrawal of life-sustaining therapies was consistent with the patient's wishes, showing respect for his dignity and honoring his autonomy, as expressed to his family previously. By making donation possible, the medical team was able to fulfill the family's last request on behalf of the patient. This case should stimulate deliberation regarding the potential to shorten the 20-minute no-touch period currently in place in Italy. Such an action would not have injured this patient and would certainly have increased the quality of the procured organs.

Fracture of coronary artery sirolimus eluting stent with formation of four aneurysms.

Coronary stent fracture is a relatively rare but potentially serious complication of coronary artery stenting, in particular with sirolimus-eluting stents. It has been recognized as one possible cause of in-stent restenosis as well as acute stent thrombosis. The formation of coronary artery aneurysm is one of the critical complications after percutaneous coronary intervention and it has been described after a stent fracture too. We report here a case of formation of four coronary artery aneurysms associated with the fracture of a sirolimus-eluting stent.

[Feasibility and safety of same-day discharge after percutaneous coronary intervention with femoral access and AngioSeal closure device: a single-center experience]. / Fattibilità e sicurezza di procedure diagnostico- interventistiche coronariche con accesso femorale e chiusura con AngioSeal in regime di day-surgery: esperienza di un singolo centro.

BACKGROUND: Same-day discharge after coronary angiography or percutaneous coronary interventions (PCI) is safe. It allows a decrease in length of hospital stay, waiting list and operating expenses with increased patient satisfaction. The aim of this study was to evaluate the feasibility and safety of this approach in our center. METHODS: 798 selected patients considered suitable for same-day discharge were enrolled in our study and underwent coronary angiography and/or PCI procedures over a period of 5 years. All procedures were performed by femoral approach using the 6-8F AngioSeal closure device. A follow-up telephone interview was carried out in all patients after 7-10 days from discharge with particular regard to bleeding/vascular complications. RESULTS: After PCI procedures, 738 patients (92.4%) were discharged as day cases. The remaining 60 patients (7.6%) were kept in hospital for longer observation. Procedural success was achieved in 100% of patients. Hemostasis with the AngioSeal closure device was successfully obtained in 98.4% of cases. At follow-up, 6 patients developed mild size hematoma on femoral access site, without any other vascular complications or major bleeding needing blood transfusion. CONCLUSIONS: In our experience same-day discharge after coronary angiography or PCI was found to be feasible and safe in selected patients undergoing uncomplicated procedures performed by femoral approach using a closure device.

Percutaneous closure of patent foramen ovale in patients with anatomical and clinical high-risk characteristics: long-term efficacy and safety.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure, but no randomized study on its outcome in high-risk patients is available. Our aims were to determine the efficacy and safety of this procedure in a cohort of high-risk patients through the observation of clinical adverse events and residual shunt, to evaluate the impact of transesophageal echocardiography (TEE) guidance during the procedure, and investigate the relationship between the anatomical and clinical characteristics and the outcome. METHODS AND RESULTS: Ninety-five patients underwent PFO closure for cryptogenic cerebral ischemia; each of them presented one or more of the following risk factors: recurrent cerebral ischemia (9.5%), atrial septum aneurysm (ASA, 74.5%), prominent Eustachian valve (EV, 23.2%), severe basal shunt (9.5%), thrombophilic factors (20%), deep vein thrombosis (4.2%). The procedure was performed successfully in all patients. On median follow-up of 18 months, the neurologic recurrent events rate was 1.1% and the major adverse cardiac event (MACE) rate was 1.1%. At 6-month TEE follow-up, the residual shunt rate was 12.6% (3.1% moderate to severe). A significant correlation was found between residual shunt and prominent EV alone (P = 0.036) or in association with ASA (P = 0.021). All adverse events occurred in the first 8 months, and the event-free survival rate was 86.2%. CONCLUSIONS: Our study suggests that transcatheter PFO closure is a safe procedure even in a selected population of high-risk patients, presenting satisfactory efficacy and safety. The presence of a prominent EV alone or with ASA correlates positively with the occurrence of residual shunt.

[Current perspectives in cell therapy in cardiology: an overview of ongoing trials]. / Prospettive e difficoltà della terapia cellulare in Cardiologia: analisi critica delle sperimentazioni in corso.

BACKGROUND: Cardiac cell therapy is still restricted to experimental studies and clinical trials. This investigation is an analytic overview of worldwide ongoing trials and is aimed to show useful findings for planning new clinical trials. METHODS: Based on the online searching engine of the National Library of Medicine database for clinical trials (www.clinicaltrials.gov), all the ongoing studies registered were analyzed and classified. RESULTS: On May 30, 2009, 95 studies were registered worldwide: 40 of these were conducted in Europe and 4 in Italy. Phase 1, 2, 3 and 4 studies were 28%, 57%, 14% and 1%, respectively; observational and randomized studies were 22% and 78%, respectively. The clinical setting of enrolled patients was acute coronary syndrome in 43 studies (46%), heart failure in 29 studies (30%), chronic heart disease in 23 studies (24%). The treatment strategies investigated are cytokine-induced cell mobilization in 8% and cell implantation in 92%. The cell types used for direct implantation are mononuclear cells in 81%, endothelial precursor cells CD34+ in 11%, endothelial precursor cells CD133+ in 5%, myoblasts in 2% and adipoblasts in 1% of cases. CONCLUSIONS; The present snapshot of worldwide ongoing clinical trials provides useful information for planning an experimental clinical program on cardiac cell therapy.