European Initial Hands-On Experience with HEMOPATCH, a Novel Sealing Hemostatic Patch: Application in General, Gastrointestinal, Biliopancreatic, Cardiac, and Urologic Surgery.

Topical hemostatic agents that can seal tissues and assist in the coagulation cascade of patients undergoing surgery have been readily available for several decades. Using either synthetic or animal/plant-derived materials, these agents represent a powerful tool to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient. Recently, a novel sealing hemostatic patch, HEMOPATCH (Baxter International, Deerfield, IL), was developed. The device is a thin and flexible patch consisting of a specifically-formulated porous collagen matrix, coated on one side with a thin protein-binding layer. This gives the patch a dual mechanism of action, in which the two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body's own clotting mechanisms. Here we present a series of case reports that outline the quick, effective hemostatic sealing of HEMOPATCH in a variety of clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries. Essentially a feasibility study, these reports demonstrate how HEMOPATCH can be applied to seal almost any bleeding surface encountered during a range of procedures. Our results show that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. In conclusion, our cases document the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and paves the way for future randomized clinical trials with more extensive follow-up.

[Coronary ventricular fistula as a late complication of permanent pacing]. / Fistola coronaro-ventricolare come complicanza tardiva di elettrostimolazione ventricolare definitiva.

A coronary angiography performed for the occurrence of atypical chest pain allowed us to discover a coronary-right ventricular fistula as a rare complication of myocardial penetration by a tined ventricular catheter implanted some years earlier.

Left ventricular support device for cardiogenic shock during myocardial infarction due to stent thrombosis: a single centre experience.

BACKGROUND: Stent thrombosis (ST) is a new, rare, cause of STEMI. Few data are available about incidence and clinical impact of shock complicating acute myocardial infarction due to ST (st-STEMI). METHODS: From January 2004 to March 2007, 92 st-STEMI patients were observed: 14 (15.2%) of them presented with cardiogenic shock and were evaluated in the present analysis. In particular, clinical and angiographic characteristics of survivors and non-survivors to PCI were compared. RESULTS: St-STEMI was related to left main or multivessels stent thrombosis in 35.7% of cases; whereas in 93% of cases st-STEMI occurred in a territory with previous myocardial infarction. All patients underwent IABP implantation immediately before coronary angiography, whereas Impella LP 2.5 pump was used in 21% of cases when persistent cardiac low-output signs were recorded. PCI was successful in 80% of cases. In-hospital survival was 28.6%. Death occurred within the first 48 h in the majority of patients. At six-months all patients survived to the acute phase were alive. Survivors had significantly lower thrombus grade after wire passage (p=0.03) and, albeit not significant, they showed a higher rate of very late ST, longer times from symptoms onset to revascularization, and higher TIMI flow grade either before and after PCI. CONCLUSION: The incidence of cardiogenic shock in st-STEMI is high, particulary it seems to be two times higher than the rate reported during myocardial infarction. One third of cases is related to left main or multiple vessels ST. Shock in st-STEMI represents a dramatic event with very low in-hospital and early survival.

Severe diffuse coronary artery spasm in the early phase of cardiogenic shock.

Coronary artery vasospasm rarely appears as a diffuse phenomenon that involves all the coronary tree. We present a clinical case of acute myocardial infarction complicated by ventricular fibrillation and cardiogenic shock. Urgent coronary angiography showed occlusion of proximal Circumflex coronary artery and a TIMI I flow in the left anterior descending artery due to severe, diffuse coronary vasospasm. Patient was successfully treated with intra-aortic balloon pump and intracoronary bolus of nitroglycerin with restoration of flow in left coronary branches and complete resolution of shock.

Comparison of primary angioplasty in rural and metropolitan areas within an integrated network.

AIMS: To compare reperfusion times and in-hospital outcome of patients with STEMI treated with primary percutaneous coronary intervention (PCI) in a teaching hospital (TH) with or without inter-hospital transfer and in community hospitals. METHODS AND RESULTS: We performed a retrospective analysis of 536 patients with STEMI treated between January 2005 and December 2006 with primary PCI. Three groups were identified. A: 207 patients presented to the TH. B: 121 patients transferred to TH from metropolitan area hospitals (MAH). C: 208 patients presented in two rural area hospitals (RAH) with primary PCI capability. Baseline characteristics were similar. Door-to-balloon (DtB) times were significantly (p<0.001) higher in group B (median 120, range 90-180 min) both compared to group A (median 60, range 45-90 min) and C (median 73, range 55-99 min). In group B 79,5% of patients present a DtB > 90 min. In-hospital mortality was 4.9%, 3.3% and 4.3% respectively in group A, B and C without significant differences. CONCLUSIONS: The expansion of primary PCI to RAH achieves reperfusion delays similar to that of patients admitted to TH. Transferred patients present very higher DtB when compared to patients treated on-site. In-hospital outcome are similar but further studies are warranted.

Percutaneous coronary implantation of sirolimus-eluting stents in unselected patients and lesions: clinical results and multiple outcome predictors.

BACKGROUND: Sirolimus-eluting stents (SES) prevent restenosis and repeat percutaneous coronary intervention (PCI), but safety data in unselected patients are limited, especially for intermediate-term follow-up. METHODS: All patients undergoing SES implantation at 4 Italian centers were enrolled into a dedicated database. Baseline, procedural, and outcome data at discharge and at follow-up were abstracted. Outcomes of interest were the occurrence of major adverse cerebrocardiovascular events (MACCE) at 6 months, as well as long-term event-free survival and multivariable event predictors. RESULTS: One thousand four hundred twenty-four patients were enrolled (2,915 lesions, treated with 3,305 stents). Specifically, 1,074 (75.4%) subjects had multivessel disease, 399 (28.1%) had diabetes, 89 (6.3%) had ST-elevation myocardial infarction, and 44 (3.1%) underwent unprotected left main intervention. At 6 months, MACCE had occurred in 121 (9.0%) patients. After a median of 48.7 months (first-third quartile 41.8-55.3), MACCE-free survival was 69.2%+/-2.6%, with definite stent thrombosis occurring acutely in 6 (0.4%), subacutely in 11 (0.8%), after 30 days in 12 (0.8%), and cumulatively in 28 (2.0%). Major multivariable outcome predictors were diabetes (target lesion revascularization [TLR], MACCE), ejection fraction (TLR, MACCE), and maximal balloon length (TLR). CONCLUSIONS: This large cohort of unselected patients supports the overall safety of unrestricted percutaneous SES implantation, as shown by the low rates of stent thrombosis. Event attrition remains, however, high at long-term follow-up, driven mainly by target vessel revascularization, with diabetes and ejection fraction as the most important prognostic factors.

[Percutaneous rheolytic thrombectomy with AngioJet for pulmonary embolism: methods and results in the experience of a high-volume center]. / Trombectomia reolitica percutanea con AngioJet nell'embolia polmonare: metodologia e risultati nell'esperienza di un centro ad alto volume.

BACKGROUND: Pulmonary embolism is a common disease with significant mortality. Anticoagulant and thrombolytic therapies are a mainstay in the management of acute pulmonary embolism, especially with hemodynamic compromise. However, systemic drugs cannot achieve timely and effective treatment of acute pulmonary embolism in all patients. Recently, rheolytic thrombectomy has been proven to be effective in the treatment of massive thrombosis in vein grafts. The purpose of this study was to describe the rheolytic thrombectomy procedure and to evaluate the efficacy of thrombus removal using the AngioJet catheter in patients with acute massive and submassive pulmonary embolism. METHODS: Thirty consecutive patients (16 men, 14 women, mean age 67.9 +/- 13.5 years) with massive or submassive pulmonary embolism were treated with rheolytic thrombectomy. The Miller index and the systolic pulmonary pressure were evaluated pre- and post-rheolytic thrombectomy. In-hospital results were analyzed according to the learning curve of operators. RESULTS: Technical success was achieved in 93.3% of patients. Eleven patients received adjunctive loco-regional thrombolytic agent (alteplase) or abciximab. A significant improvement in the obstruction, perfusion and Miller indexes and in the systolic pulmonary pressure was observed after rheolytic thrombectomy (p <0.0001) in all patients. The achievement of a larger experience by the operators was associated with a less procedural complication rate (i.e. post-procedural increase in creatinine, cardiac arrest during the procedure, post-procedural hemoptysis, and in-hospital mortality). Total in-hospital mortality occurred in 5 patients (16.7%), 60% of them presented with cardiogenic shock. All patients were alive at the 12-month follow-up, except one who died after 3 months for myocardial infarction. CONCLUSIONS: Percutaneous rheolytic thrombectomy using the AngioJet catheter may be a valid treatment option for patients with massive or submassive pulmonary embolism with rapid and significant hemodynamic improvement and encouraging results at early and long-term follow-up. Greater laboratory and operator experience yield better clinical results.

ST-segment elevation myocardial infarction due to early and late stent thrombosis a new group of high-risk patients.

OBJECTIVES: The aim of this retrospective study was to compare clinical and angiographic outcomes between patients presenting with ST-segment elevation myocardial infarction (STEMI) due to stent thrombosis (ST) and de novo coronary thrombosis. BACKGROUND: There are limited data for procedural and mid-term outcomes of patients with ST presenting with STEMI. METHODS: From January 2004 to March 2007, 115 definite ST patients were observed: 92 (80%) of them presented as STEMI and were compared with a consecutive group of 98 patients with de novo STEMI. All patients underwent primary percutaneous coronary intervention. Primary end points were successful angiographic reperfusion and distal embolization. Major adverse cardiovascular and cerebrovascular events (MACCE), evaluated at 6-month follow-up, were defined as death, nonfatal myocardial reinfarction, target vessel revascularization, and cerebrovascular accident. RESULTS: Successful reperfusion rate was lower in patients with ST (p < 0.0001), whereas distal embolization rate was higher (p = 0.01) in comparison with patients with de novo STEMI. Stent thrombosis proved to be an independent predictor of unsuccessful reperfusion at propensity-adjusted binary logistic regression (odds ratio 6.8, p = 0.004). In-hospital MACCE rate was higher in patients with ST (p = 0.003), whereas no differences were observed at 6-month follow-up among hospital survivors between the 2 groups (p = 0.7). CONCLUSIONS: Stent thrombosis identifies a subgroup of patients with STEMI with poor angiographic and early clinical outcomes, suggesting that the management of these patients should be improved.

Early and long-term clinical results of AngioJet rheolytic thrombectomy in patients with acute pulmonary embolism.

Anticoagulant and thrombolytic therapies are a mainstay in the management of acute pulmonary embolism (PE), especially when hemodynamic compromise is present. However, systemic drugs cannot achieve timely and effective treatment of acute PE in all patients. In such a setting, mechanical removal of thrombus from the pulmonary circulation holds the promise of significant clinical benefits, although it remains untested. We report early and long-term outcome of patients with massive or submassive acute PE treated with rheolytic thrombectomy by means of the 6Fr Xpeedior AngioJet device at our institution. Three main groups were defined pre hoc: subjects with severe (i.e., shock), moderate, or mild hemodynamic compromise. Technical and procedural successes, obstruction, perfusion and Miller indexes, and clinical events were appraised. In total 25 patients were treated with thrombectomy (8 in severe, 12 in moderate, and 5 in mild hemodynamic compromise). Technical and procedural successes were obtained in all patients, as confirmed by the significant improvement in obstruction, perfusion and Miller indexes overall, and in each subgroup (all p values <0.001). Improvement in obstruction, perfusion, and Miller indexes at the end of the procedure could also be confirmed in patients (n = 8) treated with local fibrinolysis and in the absence of concomitant thrombolysis (n = 17, p <0.05). Four patients died in hospital, all other patients but 1 were safely discharged after an appropriate hospital stay, and all were alive at long-term follow-up (median 61 months). In conclusion, this study supports at early and long-term follow-up the effectiveness and safety of rheolytic thrombectomy for PE.

[Percutaneous treatment of anomalous left anterior descending coronary artery with double catheter technique and direct stenting: a case report]. / Trattamento percutaneo dell'arteria interventricolare anteriore ostiale ad origine anomala mediante tecnica del doppio catetere e stenting diretto: un caso clinico.

We report the case of a patient with absence of the left main coronary artery associated with close origin of the left coronary branches and a subocclusive proximal lesion of the left anterior descending coronary artery involving the ostium. Two guiding catheters were used for selective cannulation of the separated ostium and wiring of both branches was obtained. This approach allowed us to recognize the optimal stent position and then to correctly deploy it on the proximal left anterior descending coronary artery. The absence of the left main coronary artery is a relatively rare finding and experiences concerning ostial stenting in patients with anomalous origin of the left anterior descending and circumflex coronary arteries are limited. In this case report we suggest and discuss about a new procedure that allows the treatment of such condition by direct stenting.

Outlook of drug-eluting stent implantation for unprotected left main disease: insights on long-term clinical predictors.

BACKGROUND: Percutaneous coronary intervention (PCI) has been increasingly employed to treat unprotected left main coronary artery (LMCA) stenosis, with variable success. This strategy has been applied to patients undergoing drug-eluting stent (DES) implantation for unprotected LMCA stenosis. METHODS: From April 2003 to June 2006, 114 consecutive patients with de novo unprotected LMCA stenosis underwent PCI with DES, and were followed over a mean period of 17.1 +/- 9.1 months. The primary endpoint of the study was the occurrence of major adverse cardiovascular events (MACE) (cardiac death, myocardial infarction [MI] or target lesion revascularization [TLR]). RESULTS: LMCA stenting was successfully performed in all patients. In-hospital mortality was 3.5%, with no in-hospital non-fatal MI or emergency coronary artery bypass grafts. During the follow-up period, the all-cause mortality rate was 7.9%, with 3.5% cardiac-related deaths. TLR was performed in 7.9% of patients, and the MACE rate was 14.9%. All non-surviving patients were at high surgical risk (EuroSCORE > 6) and had a significantly higher EuroSCORE than surviving patients that patients with a EuroSCORE < or = 11 had significantly improved survival rates over those with a EuroSCORE > 11 (p < 0.0001). Moreover, most of the patients who died of cardiac causes were diabetic (71.4% vs. 26.6%; p < 0.05). Acute coronary syndromes, as clinical presentation, and non-ostial LMCA disease were also significantly more common within non-surviving patients (100% vs. 67%; p < 0.05, and 92.3% vs. 66.3%; p = 0.05, respectively). CONCLUSIONS: Stenting of unprotected LMCA appears to be associated with a favorable mid-term outlook, especially in selected patients.

Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION).

OBJECTIVES: To evaluate the superiority of the paclitaxel-eluting stent (PES) in reducing neointimal hyperplasia (NIH) over its corresponding bare metal stent (BMS) during primary percutaneous coronary intervention (PCI). BACKGROUND: Primary PCI with stent implantation is the repercussion strategy of choice for ST-elevation myocardial infarction (STEMI); nonetheless restenosis rate is still high. Drug-eluting stents have been proven to reduce restenosis rate in many settings, but their use during primary PCI is still controversial. METHODS: Consecutive patients with STEMI <12 hours were randomized to receive PES or BMS. The primary end-point was the percentage of the stent volume obstructed by neointimal proliferation (NIH) measured by intravascular ultrasound (IVUS) at a 7-month angiographic follow-up. Secondary end-points were binary restenosis rate and major adverse cardiac events (MACE, i.e., death, nonfatal myocardial infarction, and target lesion revascularization). RESULTS: Eighty patients with STEMI were randomized into the PES or BMS group. Patients were well matched for baseline characteristics and the index procedure was always successful. In-hospital and 1-month MACE were 2.5% per group. NIH at 7 months was 4.6% versus 20% (P< 0.01), late lumen loss 0.1 versus 1.01 mm (P = 0.01). MACE were 7.5% versus 42.5% (P = 0.001) with no difference in death and recurrent myocardial infarction rates. Late-acquired incomplete stent apposition (ISA) rate was 5.1% versus 2.7% (P = 0.65). One subacute stent thrombosis was reported in each group. CONCLUSIONS: PES was superior to its corresponding BMS in reducing NIH in the STEMI setting without any increase in early and long-term clinical adverse events.

Thrombus aspiration with export catheter in ST elevation myocardial infarction.

BACKGROUND: Many thrombectomy devices have failed to confirm initial promising results during primary angioplasty. This may be due to device complexity and operator experience. The objective of this study was to assess the safety and efficacy of the EXPORT catheter for thrombus aspiration in patients with ST elevation myocardial infarction (STEMI). METHODS: EXPORT catheter was used in patients with STEMI and angiographic evidence of thrombus in vessels with a reference diameter > or =1.5 mm. Direct stenting and glycoprotein IIb/IIIa inhibitors were liberally employed to optimize angiographic and clinical results. Epicardial and myocardial angiographic parameters, in-hospital major adverse cardiac events (MACE, i.e., cardiac death, myocardial infarction, target vessel revascularization) were assessed. RESULTS: EXPORT catheter was used in 129 patients without any device-related complications. Angiographic analysis following thrombus aspiration revealed a significant improvement in TIMI frame count (P = 0.0001), myocardial perfusion (P = 0.0001), TIMI thrombus grade (P = 0.0001), and TIMI flow (P = 0.0001). Stent implantation did not significantly improve myocardial perfusion, TIMI thrombus grade, or TIMI flow, but improved TIMI frame count, minimal lumen, and reference vessel diameter. When compared to a historical STEMI control group not undergoing thrombus aspiration, our EXPORT population showed significant improvements in reperfusion parameters. In-hospital MACE were uncommon (4.5%) despite high-risk patient characteristics. CONCLUSIONS: Our study demonstrates that routine use of EXPORT catheter in patients with STEMI and coronary thrombosis is feasible, safe, and associated with significant improvements in flow-related angiographic parameters. The relative simplicity of this approach makes it an attractive option in this challenging situation.

Incidence, predictors, and outcomes of coronary dissections left untreated after drug-eluting stent implantation.

AIMS: Coronary dissections left untreated after percutaneous coronary intervention are associated with unfavourable outcomes. However, their role after drug-eluting stent (DES) implantation is still undescribed. We assessed incidence, predictors, and outcomes of residual dissections in DES-treated lesions. METHODS AND RESULTS: Consecutive patients undergoing DES implantation were enrolled in four Italian centres, with baseline, procedural, and outcome data entered into a dedicated database. Residual dissections were classified according to the National Heart Lung and Blood Institute criteria. End-points of interest were in-hospital, 1-month, and 6-month major adverse cardiovascular events (MACE, i.e. death, myocardial infarction, or target vessel revascularization), and stent thrombosis (ST). Among the 2418 included patients (4630 lesions), a total of 77 (1.7%) final dissections occurred in 67 (2.8%) subjects. Dissections were more frequent in longer and complex lesions and in the left anterior descending, and were associated with increased rates of in-hospital (11.9 vs. 5.2%, P=0.017) and 1-month MACE (13.4 vs. 6.0%, P=0.013), with similar 6-month trends. Cumulative ST was also greater in patients with dissections (6.3 vs. 1.3%, P=0.011). Even non-obstructive dissections with thrombolysis in myocardial infarction 3 flow conferred a significantly worse prognosis. CONCLUSION: This study, reporting for the first time on incidence, predictors, and outcomes of residual dissections in DES-treated coronary lesions, demonstrates their adverse clinical impact and supports the pursuit of a strategy of sealing dissection flaps with other DES.

Safety and efficacy of the AngioJet in patients with acute myocardial infarction: results from the Florence Appraisal Study of Rheolytic Thrombectomy (FAST).

OBJECTIVES: To assess the safety and efficacy of the AngioJet coronary device, given the uncertain risk-benefit balance of rheolytic thrombectomy in patients with acute myocardial infarction (AMI). BACKGROUND: Current risk of inadequate myocardial perfusion for thrombus embolization in primary coronary interventions is not negligible. The AngioJet thrombectomy device showed promising results in terms of safety and efficacy, but failed to confirm them in a large, multicenter, randomized trial, and the risk-benefit balance is still uncertain. METHODS: The AngioJet device was employed in 116 consecutive patients with AMI and angiographic evidence of extensive thrombosis in a vessel with a reference diameter > 2.5 mm. Stents and glycoprotein IIb/IIIa inhibitors were liberally used. Epicardial and myocardial reperfusion angiographic parameters, and in-hospital major adverse cardiac events (MACE, i.e., cardiac death, myocardial infarction, target vessel revascularization) were assessed. RESULTS: The AngioJet was successfully used in all patients. Angiographic analysis showed that the AngioJet significantly improved epicardial coronary flow (p < 0.01), frame count (p < 0.01) and myocardial blush (p < 0.01), while stenting yielded significant improvements only in diameter stenosis, minimum lesion diameter and correlated vessel parameters (p < 0.01). In-hospital MACE were uncommon [9 (8%)], despite the patientsO characteristics. When compared to an AMI population with similar thrombus burden but not undergoing thrombectomy, our AngioJet population showed significant improvement of reperfusion parameters. Moreover, there was greater AngioJet benefit in the high versus moderate thrombus burden subset; laboratory and operator experience also correlated significantly with final angiographic results. CONCLUSIONS: Our study supports the favorable risk-benefit profile of AngioJet device use in selected patients with AMI when used in experienced laboratories and by trained operators.

Validation of predictors of intraprocedural stent thrombosis in the drug-eluting stent era.

Although predictors of acute intraprocedural stent thrombosis (IPST) in the drug-eluting stent era have been proposed, external validation is lacking. We thus analyzed the occurrence of IPST in the RECIPE study and found that, among 1,320 patients who underwent drug-eluting stent implantation, IPST occurred in 6 (0.5%), with in-hospital major adverse events in 4 (67%). IPST was predicted by number and total length of implanted stents, baseline minimal lumen diameter, and, in a pooled analysis that incorporated values from the present study and a previous study, use of elective glycoprotein IIb/IIIa inhibitors. Such results may provide useful information to guide prevention of this complication.

Early outcome after paclitaxel-eluting stents in patients with acute and subacute myocardial infarction. A clinical study.

BACKGROUND: Paclitaxel-eluting stents (PES) have been proven to prevent in-stent restenosis in patients submitted to elective percutaneous coronary intervention. No data are so far available about the safety and efficacy of PES in acute and subacute myocardial infarction. The aim of the present investigation was to evaluate the occurrence of in-hospital adverse events in patients with acute and subacute myocardial infarction submitted to PES implantation. METHODS: From June 1 to July 31, 2003, we implanted 53 PES in 43 consecutive patients with acute (34 patients) and subacute (9 patients) myocardial infarction. RESULTS: In 65.1% of the patients the culprit lesion was located in the left anterior descending artery. Direct stenting was performed in 27.9% and glycoprotein IIb/IIIa inhibitors were used in 74.4%. Before the procedure a TIMI flow 0-1 was present in 46.5% while post-procedural TIMI flow 3 was achieved in all patients. A pre-procedural TIMI thrombus grade 2 to 5 was present in 67.8%. No death, reinfarction, early post-infarction angina or any other episode referable to in-stent thrombosis were observed during hospitalization. No patient was submitted to target lesion revascularization. At short-term follow-up with a mean duration of 118 +/- 75 days from discharge no cardiac or noncardiac death, reinfarction or any other major adverse coronary events were reported in the study population and no target lesion revascularization was performed. CONCLUSIONS: In this study, PES implant in patients with acute and subacute myocardial infarction was safe, with an early outcome comparable to conventional standard stents and no adverse events related to acute or subacute thrombosis.