Impact of heart failure severity on the mortality benefit of mitral transcatheter edge-to-edge valve repair.

BACKGROUND: To assess the interaction between heart failure (HF) severity and optimal reduction of secondary mitral regurgitation (SMR) on mortality in patients undergoing transcatheter edge-to-edge repair (M-TEER). METHODS AND RESULTS: Among 1656 patients included in the Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) 984 had SMR and complete data on advanced HF. Advanced HF was defined as NYHA class III or IV, left ventricular ejection fraction ≤ 30%, and > 1 HF hospitalization during the last 12 months. Optimal M-TEER was defined as residual SMR ≤ 1 + at discharge. One hundred sixteen patients (11.8%) had advanced HF. Achievement of an optimal SMR reduction was similar in patients with and without advanced HF (65% and 60% respectively). Advanced HF was an independent predictor of 2-year all-cause death (adjusted HR 1.52, 95% CI 1.09-2.10). Optimal M-TEER, as compared to a no-optimal M-TEER, was associated with a reduced risk of death both in patients with advanced (HR 0.55, 95% CI 0.32-0.97; p = 0.039) and no-advanced HF (HR 0.59, 95% CI 0.46-0.78; p < 0.001; p = 0.778 for interaction). CONCLUSIONS: Advanced HF is associated with poor outcome in patients undergoing M-TEER. However, an optimal SMR reduction reduces the risk of 2-year mortality regardless of HF severity.

Does optimal lesion preparation reduce the amount of acute recoil of the Absorbe BVS? Insights from a real-world population.

OBJECTIVES: To evaluate the acute recoil of the ABSORB bioabsorbable vascular scaffold (BVS) and its relationship with procedural characteristics in a real world population. BACKGROUND: In vivo acute recoil of the BVS was evaluated in selected patients. METHODS: Acute recoil was studied with videodensitometry in a consecutive series of patients treated by means of a BVS, and the results were compared with those obtained in subjects receiving an everolimus-eluting stent (EES). Recoil was defined as the difference between the mean diameter of the fully expanded balloon on which the device was mounted (or the mean diameter of the post-dilatation balloon), and the mean luminal diameter of the treated segment immediately after the final inflation. RESULTS: Recoil was assessed in 106 lesions treated with a BVS and 71 treated with an EES. The absolute and percent recoil of the BVS were significantly greater (0.32 ± 0.16 mm and 10% ± 5% vs. 0.17 ± 0.07 and 5% ± 3%; P < 0.001). Multiple regression analysis showed that BVS use was associated with acute recoil (ß = 0.477; P<0.001). Suboptimal lesion preparation (residual stenosis after balloon angioplasty >20%) (ß = 0.217; P = 0.027) and a small vessel reference diameter (ß = 0.335; P = 0.002) were associated with increased BVS but not EES recoil. CONCLUSIONS: In unselected patients, the acute recoil of the BVS was significantly greater than that of the metal EES. In the BVS group, residual stenosis after predilatation correlated with percent recoil, and so optimal lesion preparation seems to be mandatory in order to maximize the mechanical properties of the scaffold.

Clinical Comparison With Short-Term Follow-Up of Bioresorbable Vascular Scaffold Versus Everolimus-Eluting Stent in Primary Percutaneous Coronary Interventions.

Objective of this study was to assess the clinical performance of bioresorbable vascular scaffold (BVS) compared to everolimus-eluting stent (EES) in subjects with ST-segment elevation myocardial infarction (STEMI). We included all consecutive patients with STEMI who underwent percutaneous coronary intervention (PCI) with BVS implantation in centers participating to the Italian ABSORB Prospective Registry (BVS-RAI) and PCI with EES in the same centers during the same period. The 2 groups were compared. The primary end point was patient-oriented composite end point (POCE) including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at the longest available follow-up. BVS or EES thrombosis at follow-up was also evaluated. Of the 563 patients with STEMI included, 122 received BVS and 441 EES. Procedural success was obtained in 549 (97.5%) cases without significant differences between the 2 groups (BVS 99.3% vs EES 97.0%, p = 0.2). At a median of 220-day (interquartile range 178 to 369) follow-up, no significant differences were observed in terms of POCE (BVS 4.9% vs EES 7.0%, p = 0.4); death (BVS 0.8%, EES 2.0%, p = 0.4), MI (BVS 4.1%, EES 2.0%, p = 0.2), TLR (BVS 4.1%, EES 4.5%, p = 0.8), device thrombosis (BVS 2.5%, EES 1.4%, p = 0.4). All TLR cases were successfully managed with re-PCI in both groups. A propensity matching of the study populations showed no significant differences regarding POCE at the longest available follow-up (odds ratio 0.53, 0.1 to 4.3). In conclusion, in this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomized trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Immediate and midterm outcomes following primary PCI with bioresorbable vascular scaffold implantation in patients with ST-segment myocardial infarction: insights from the multicentre "Registro ABSORB Italiano" (RAI registry).

AIMS: In this multicentre prospective registry we sought to evaluate the immediate and midterm clinical outcomes following single or multiple overlapping bioresorbable vascular scaffold (BVS) implantation in the STEMI setting. METHODS AND RESULTS: A prospective cohort analysis was performed on all STEMI patients who underwent primary PCI with BVS implantation. Between December 2012 and February 2014, 1,232 STEMI patients underwent primary PCI at the participating centres. Of these, 74 (6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping. Procedural success was obtained in 72 (97.3%) cases without differences between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One patient experienced a reinfarction due to subacute BVS thrombosis which was successfully managed with balloon-only PCI while the other patient had a "slow-flow" phenomenon (final TIMI flow 2). At six-month follow-up, two non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and one subacute BVS thrombosis were reported in three patients (one [5.6%] overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the events were successfully managed with re-PCI. CONCLUSIONS: BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.

Usefulness of primary angioplasty in nonagenarians with acute myocardial infarction.

The optimal reperfusion strategy in very elderly patients with ST-segment elevation myocardial infarction is still a subject of debate. The aim of this multicenter study was to determine the medium-term outcomes of nonagenarians after primary percutaneous intervention for ST-segment elevation myocardial infarction. A systematic review of the databases of 7 Italian centers showed that these had performed 5,023 primary angioplasties over the previous 5 years, 100 of which (2%) involved patients > or =90 years old. Thirty-five subjects were in Killip class III or IV at time of presentation, 78 had multivessel coronary artery disease, and mean ejection fraction was 0.40 +/- 0.12%. In-hospital mortality was 19% and was significantly higher in patients with shock (58% vs 10%, p <0.001). Survival rate after 6 months was 68%: 16% in those with Killip class IV at admission and 81% in the remaining patients (p <0.001). Cox regression analysis identified 3 independent predictors of 6-month mortality: cardiogenic shock at presentation (hazard ratio [HR] 10.82, 95% confidence interval [CI] 4.51 to 25.93, p <0.001), Thrombolysis In Myocardial Infarction myocardial flow after percutaneous coronary intervention (HR 0.19, 95% CI 0.07 to 0.50, p = 0.001), and abciximab administration (HR 0.32, 95% CI 0.13 to 0.78, p = 0.01). In conclusion, the results of this multicenter study suggest that selected nonagenarians with acute myocardial infarction benefit from successful primary angioplasty. The treatment does not affect the poor prognosis of patients presenting with cardiogenic shock, but the administration of abciximab seems to have a positive effect on 6-month mortality.

Endovascular treatment of a symptomatic carotid artery aneurysm with a stent graft.

Endovascular methods have become more widespread and offer an alternative to surgery, which is often difficult in case of a hostile neck resulting from radiotherapy. Carotid pseudoaneurysm after laryngectomy is a very uncommon complication. We report a case of symptomatic carotid artery pseudoaneurysm treated using a stent graft.

Right coronary artery arising from the pulmonary trunk.

The right coronary artery (RCA) abnormally originating from the pulmonary trunk (PT) is a rare congenital anomaly. Our patient is a 62-year-old woman with longstanding systemic arterial hypertension and angina pectoris. Angiographic images documented the RCA arising from the PT, and coronary angiography showed severe stenosis (70%) on the distal tract of the left anterior descending artery. The primary treatment of the anomalous origin of RCA from the pulmonary artery is surgical technique. Our surgeons opted for coronary reimplantation; 6-month follow-up has shown very good results, with complete disappearance of symptoms.

Case report: a very large dissection in the left anterior descending coronary artery of a 56-year-old man.

Spontaneous coronary artery dissection (SCAD) is a rare condition that usually occurs in relatively young patients who are predominantly female. Seldom it could be a cause of acute myocardial ischemia leading to a sudden cardiac death. SCAD consists of intramural hematoma formation or, rarely, intimal tears that initiate and propagate the dissection in the vessel wall. In rare cases, the SCAD occurs in male patients. We report the case of a 56-year-old man with acute myocardial infarction who was successfully treated via systemic thrombolysis in a peripheral hospital. Associated conditions were thrombosis of right femoral artery in the past and high platelet count (800,000/mm3). After 1 month, elective coronary angiography revealed a very diffuse spiral dissection of the left anterior descending artery; hence, our choice of medical treatment consisted of double oral antiplatelet therapy (clopidogrel 75 mg plus aspirin 325 mg once daily). After a 2-year follow-up, there was absence of both angina and myocardial ischemia and there was a decrease in platelet count. Many strategies could be considered in patients with SCAD, such as PCI, bypass surgery, or conservative medical management. In general, the long-term prognosis of patients with SCAD is considered favorable if they survive the acute phase.

Safety and efficacy of low-dose unfractionated heparin during percutaneous coronary revascularisation and the relationship between activated clotting time and haemorrhagic or ischaemic complications: our results.

OBJECTIVE: An inverse relation between the degree of heparin anticoagulation and the subsequent risk of postprocedural thrombotic complications was observed in the era of conventional balloon angioplasty, but the optimal dose of heparin during percutaneous coronary intervention (PCI) using newer interventional equipment and glycoprotein IIb/IIIa receptor inhibition has not been clearly defined. Previous studies did not assess the increased risk of adverse cardiac events with an activated clotting time of <200 s using strategies of routine stent placement and glycoprotein IIb/IIIa receptor inhibition. We hypothesised that the efficacy and safety of PCI would be maintained, if not improved, especially when performed in conjunction with glycoprotein IIb/IIIa receptor inhibitors (abciximab, tirofiban or eptifibatide as a bolus plus infusion for 12-18 h) and oral antiplatelet therapy (clopidogrel 75 mg plus aspirin 325 mg/day) associated with low doses (5000-10 000 U) of unfractionated heparin using a target activated clotting time of

Variability in extent of platelet function inhibition after administration of optimal dose of glycoprotein IIb/IIIa receptor blockers in patients undergoing a high-risk percutaneous coronary intervention.

The Ultegra Rapid Platelet Function Assay was used to measure the inhibition of platelet aggregation at baseline and 10 minutes and 8 hours after starting therapy in 114 patients undergoing high-risk percutaneous coronary intervention with the planned use of a glycoprotein IIb/IIIa inhibitor. The abciximab-treated patients received a 0.25 mg/kg bolus, followed by a 0.125 microg/kg/min infusion for 12 hours; the eptifibatide-treated patients received 2 boluses of 180 microg/kg administered 10 minutes apart, followed by a 2 microg/kg/min infusion for 24 hours; the tirofiban-treated patients received a 25 microg/kg bolus, followed by a 0.15 microg/kg/min infusion for 18 hours. Ten minutes after starting therapy, the mean level of platelet inhibition was 86 +/- 9% for abciximab, 92 +/- 6% for eptifibatide, and 95 +/- 5% for tirofiban (p <0.001); > or =95% platelet inhibition was achieved in 29% of the patients treated with abciximab, 44% of those receiving eptifibatide, and 68% of the those receiving tirofiban (p = 0.02). In conclusion, at the evaluated doses, tirofiban seemed to be the most effective drug in achieving "optimal" platelet inhibition very early after percutaneous coronary intervention.

Downstream administration of a high-dose tirofiban bolus in high-risk patients with unstable angina undergoing early percutaneous coronary intervention.

BACKGROUND: The best treatment option for high-risk patients with unstable coronary syndrome is an early invasive strategy accompanied by intensive anti-platelet therapy. We tested the effect on clinical outcome of early coronary angioplasty using a high-dose bolus of tirofiban in patients with non-ST segment elevation acute coronary syndrome. METHODS: One hundred and forty consecutive patients with unstable coronary syndrome who underwent an immediate percutaneous coronary intervention with the administration of a high (25 microg/kg) dose bolus of tirofiban followed by an 18-h infusion of 0.15 microg kg(-1) min(-1) were compared with a matched control group of 162 patients treated with abciximab. The primary endpoint of the study was the 30-day incidence of major adverse cardiac events; the secondary endpoints were the incidence of major and minor bleeding. RESULTS: The time from admission to PCI was slightly shorter in the tirofiban group (3.9+/-4.8 vs. 4.5+/-4.4 h; P=0.26). The 30-day rate of major adverse cardiac events was similar in the two groups (6% with tirofiban and 8.6% with abciximab: OR=1.37, 95% CI=0.58-3.29, P=0.52). No major bleeding episodes were observed; the incidence of minor bleeding was 3.6% in the tirofiban group and 2.5% in the abciximab group (OR=0.68, 95% CI=0.18-2.59, P=0.74). CONCLUSIONS: In this preliminary study, the beneficial effect of the administration of a high-dose tirofiban bolus on 30-day clinical outcomes was similar to that of abciximab in high-risk patients with unstable angina undergoing immediate percutaneous coronary intervention. The results of this therapeutic strategy should be tested in a larger randomised study.

Compression repair versus low-dose thrombin injection for the treatment of iatrogenic femoral pseudoaneurysm: a retrospective case-control study.

BACKGROUND: It has been shown that thrombin injection is a safe and effective technique for the treatment of iatrogenic femoral pseudoaneurysm. The aim of this study was to evaluate and compare the use of ultrasound-guided low-dose thrombin injections with ultrasonographically-guided compression repair in the treatment of iatrogenic femoral arterial pseudoaneurysm. METHODS: We compared two cohorts of patients treated for iatrogenic femoral pseudoaneurysm: the first included 38 patients who underwent ultrasonographically-guided compression repair as a first-step approach between January 1998 and November 2002; the second included 21 patients treated with ultrasound-guided low-dose thrombin injection between December 2002 and December 2003. RESULTS: Both groups had similar demographic characteristics and aneurysm sizes (p = 0.72). Compression was successful in 24/38 patients (63%); the 14 persistent aneurysms were surgically repaired (37%). The primary thrombin injection of a mean dose of 185+/-95 U/ml (range 100-400 U/ml) successfully obliterated all of the 21 pseudoaneurysms (success rate 100 vs 63% in the compression group, p = 0.004). Thrombosis occurred within an average of 12+/-15 s of thrombin injection. Sedation was used in 42% of the patients undergoing compression and in none of those receiving thrombin (p = 0.001). The duration of hospitalization was significantly longer in patients undergoing compression therapy (9.8+/-5.6 vs 5.6+/-1.4 days, p = 0.001). CONCLUSIONS: Ultrasound-guided low-dose thrombin injection appears to be more effective in reducing the need for surgical repair when used to treat iatrogenic femoral pseudoaneurysm, is better tolerated by the patients, and requires a shorter hospital stay.

Endovascular treatment of a symptomatic aneurysm of the left subclavian artery.

Upper extremity ischemia is a rare entity usually due to emboli of arterial origin. Such thromboemboli produce acute symptoms of sufficient severity as to necessitate early surgical intervention. We report the case of a patient with severe ischemia in his left hand, in whom the embolic source was a mural thrombus localized at the level of a saccular aneurysm of the subclavian artery. After having excluded the presence of a thoracic outlet syndrome, the lesion was successfully treated by means of percutaneous implantation of a stent graft with the exclusion of the aneurysm and the sealing of the thrombus.

Six-month clinical and angiographic outcomes of the Tecnic Carbostent coronary system: the phantom IV study.

The aim of this multicenter, prospective, non-randomized study was to examine the procedural, in-hospital, and mid-term clinical and angiographic outcome of patients undergoing coronary angioplasty with the Tecnic Carbostent system. Between October 2001 and March 2002, 123 consecutive patients were treated with coronary implantation of the Tecnic Carbostent. Stable angina (54%), unstable angina (37%) and silent ischemia (9%) were clinical indications for revascularisation. The baseline lesion morphology was complex (Type B2 or C) in 59% of the cases, and the mean lesion length was 15+/-8 mm. A total of 179 stents were implanted in 149 lesions. The procedural success rate was 100%. Mean percent diameter of the stenosis decreased after the intervention from 75%+/-11% to 8%+/-4%. The mean cross-sectional area stent recoil was 8.8%+/-7.3%. No in-hospital or 30-day major adverse cardiac events were observed. During the 6-month follow-up period, there were no deaths or myocardial infarctions, whereas the incidence of target lesion revascularisation was 12.7%. The angiographic restenosis rate was 14.1%: a focal or limited pattern (class I or II) was found in 83% of cases, whereas the remaining 17% had a proliferative morphology (class III or IV). In conclusion, this study indicates that a good clinical and angiographic outcome may be obtained with the Tecnic Carbostent coronary system in consecutive patients with de novo coronary lesions.

Comparison in patients having primary coronary angioplasty of abciximab versus tirofiban on recovery of left ventricular function.

In patients treated with primary coronary angioplasty, the use of abciximab improves microvascular perfusion and enhances the recovery of contractile function. This study compared the effects of the new dose regimen of tirofiban (25-microg/kg bolus followed by an 18-hour infusion at 0.15 microg/kg/min) on left ventricular function with those of abciximab in patients who underwent direct angioplasty. One hundred patients who underwent primary coronary angioplasty were randomized to receive a standard dose of abciximab or a large-dose bolus of tirofiban. The primary end point of the study was change in the infarct-zone wall motion score index between the initial and 30-day follow-up echocardiographic studies. The secondary end points were procedural evaluations before and after Thrombolysis In Myocardial Infarction (TIMI) grade flow, TIMI grade myocardial perfusion, and corrected TIMI frame count. Baseline global and regional ventricular functions were similar in the 2 treatment groups. After the procedure, a TIMI grade 3 flow was obtained in 86% of patients treated with abciximab and 88% of those receiving tirofiban (p = 1.0), whereas TIMI grade 3 myocardial perfusion was present in 70% and 76%, respectively (p = 0.65); corrected TIMI frame count was 22.5 +/- 1.9 and 22.1 +/- 2.5 (p = 0.37). After 30 days, we obtained 87 paired echocardiographic studies. The infarct-zone wall motion score index decreased from 2.20 +/- 0.3 to 1.99 +/- 0.2 in the abciximab group and from 2.18 +/- 0.3 to 1.95 +/- 0.3 in the tirofiban group (p = 0.67). Thus, in patients who had primary coronary angioplasty, abciximab, and the large-dose bolus of tirofiban showed similar effects on the initial angiographic results and 30-day recovery of left ventricular function.

Effect of hypnotic sedation during percutaneous transluminal coronary angioplasty on myocardial ischemia and cardiac sympathetic drive.

Forty-six patients were randomized to receive drug (group 1) or hypnotic sedation (group 2) during percutaneous transluminal coronary angioplasty of the left anterior descending coronary artery. Intracoronary and standard electrocardiograms were continuously registered, and heart rate spectral variability was studied. Normalized units of low- and high-frequency components and the ratio of low to high frequency were measured during balloon inflations. The ST segment shifted at the first balloon inflation from 0.02 +/- 0.01 to 0.09 +/- 0.6 mm in group 1 and from 0.02 +/- 0.08 to 0.1 +/- 0.6 in group 2 mm (p <0.05). In group 1, the low-frequency band and the ratio of low to high frequency increased significantly during the first balloon inflation (from 59 +/- 10 to 75 +/- 10 normalized units and from 2.4 +/- 1.4 to 7.3 +/- 4.7, respectively; p <0.001). The increase of the ratio of low to high frequency was significantly related to ST shift (r = 0.706; p <0.01). In contrast, no significant variation of spectral parameters was found in group 2. The increase in cardiac sympathetic activity associated with balloon inflation and myocardial ischemia during percutaneous transluminal coronary angioplasty of the left anterior descending coronary artery was selectively eliminated by hypnosis but not by drug sedation.

Safety of a high bolus dose of tirofiban in patients undergoing coronary stent placement.

To overcome the suboptimal platelet inhibition induced by tirofiban in the first hour after a percutaneous coronary intervention, a new regimen of 25 microg/kg bolus followed by an 18-hr infusion of 0.15 microg/kg/min has been proposed. The aim of this study was to compare the effects of this high bolus dose of tirofiban with those of abciximab on bleeding risk and 30-day clinical outcome in patients undergoing coronary stenting. We compared two cohorts of patients who underwent coronary stent placement between January 2000 and December 2002. In the first cohort, the only available IIb/IIIa receptor inhibitor was abciximab, which was given to 280 (34.9%) out of 802 stented patients; in the second cohort, tirofiban was administered to 274 (38.3%) out of 716 treated patients. The primary endpoints were the proportion of patients with major bleeding and the rate of site access complications; the 30-day incidence of major adverse cardiac events (MACE) was also assessed. After the procedure, the patients were given ticlopidine for 4 weeks and aspirin indefinitely. Major bleeding episodes were observed in four patients receiving abciximab and in none receiving tirofiban (1.4% vs. 0%; P = 0.12); the rates of site access complications were similar (3.6% vs. 3.3%; P = 0.96). The 30-day incidence of MACE was 7.1% in the abciximab group and 5.8% in the tirofiban group (P = 0.65). In patients undergoing coronary stenting, the high bolus dose of tirofiban is safe and not associated with an increased risk of major bleeding or site access complications in comparison with abciximab.