Implementation of a Night Service of Helicopter Transportation to Reduce the Time to Revascularization in STEMI Patients in a Mountainous Region: Impact on Outcomes.

Background: Treatment delays are the most easily audited index of quality of care in the setting of ST-segment elevation myocardial infarction; among the components of ischemia time, system delay has been demonstrated to be a predictor of outcomes, and in a mountainous region it relies mostly upon helicopter rescue service. Aim: The aim of the study is to analyze the impact of the activation of helicopter rescue service for the nighttime for urgent transportation of patients on the time to revascularization and on the outcomes of STEMI patients. Methods: Data were prospectively collected in a database and retrospectively split into two different cohorts, based on the presentation date in the 18 months before, or after, the first day of implementation of the new organizational model. The patients were also split into two groups based on the place of STEMI diagnosis, either the chief town territory or the rest of the region, and retrospectively evaluated for vital status at 30 days and 2 years after index event. Results: The number of patients included was 751. For patients coming from outside Trento, an improvement in ST-segment resolution was shown (ST-segment elevation reduction >50% in 54.0% of the patients vs. 36.4%, p < 0.01). Moreover, a reduction in diagnosis-to-reperfusion median time has been demonstrated (from 105 to 97 min, p < 0.01), mainly driven by a reduction during the night shift (from 119 to 100 min, p = 0.02). With regard to 30-day and 2-year mortality, no statistically significant differences were achieved. Discussion: The organizational effort has translated into a significant reduction in the treatment delay for patients coming from outside the chief town. However, although a longer diagnosis to reperfusion time has been related to a higher mortality, a significant reduction in mortality was not demonstrated in our study. However, an improvement in ST-segment elevation resolution was shown for patients coming from outside the city of Trento, a result that could have other potential clinical benefits. Conclusions: Implementation of night flight proved to be effective in reducing the time between the diagnosis and the treatment of patients in the setting of STEMI, improving ST-segment elevation resolution, although no impact was shown on short- and long-term mortality.

How to keep the cath-lab of a COVID-free hub center during the pandemic in a hub and spoke cardiology network: a single center's experience.

BACKGROUND: Northern Italy has been one of the most affected area in the world by the novel severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). The healthcare system has been overwhelmed by the huge number of patients in need of mechanical ventilation or intensive care, resulting in a delay of treatment of patients with acute coronary syndrome (ACS), due to a crash in STEMI networks and closure of a certain number of hub centers, and to a delay in patients' seeking for medical evaluation for chest pain or angina-equivalent symptoms. METHODS: In the Trentino region, a mountainous area with about 500,000 inhabitants, very close to Lombardy that was the epicenter of the pandemic in Italy, to avoid these dramatic consequences, we developed a new protocol tailored to our specificity to keep our institution, and above all the cath-lab, clean from the SARS-CoV-2 infection, to ensure full operativity for cardiologic emergencies. RESULTS: Applying this protocol during the two months of the peak of the infection in Italy no one of the staff members of the cath-lab, the ICCU or the cardiology ward tested positive to nasal swab for SARS-CoV-2 and the same result was obtained for all the patients admitted to our units. CONCLUSIONS: Our real-world experience shows that during the COVID-19 pandemic, quick activation of an appropriate protocol defining specific pathways for patients with a medical urgency is effective in minimizing healthcare personnel exposure and to preserve full operativity of the hub centers. This issue will be of a crucial importance, now that we are facing the second wave of the pandemic.

Sex differences in clinical and angiographic characteristics in spontaneous coronary artery dissection.

Background: Spontaneous coronary artery dissection (SCAD) is an increasingly recognized cause of acute coronary syndrome, mostly in women; however, differences between the sexes should be investigated. Materials & methods: Hundred consecutive patients affected by SCAD were identified; coronary lesions were classified according to the most recent classification and clinical and angiographic data of men and women were compared. Results: Men were significantly younger than women, with more cardiovascular risk factors. Lesions were prevalently classified as type 2A, type 2B or type 1; an angiographic pattern compatible with the presence of an intimal tear (types 1 and 1/2) was more represented in males. Conclusion: Sex-related differences in clinical and angiographic characteristics could help in shedding light on mechanisms that contribute to SCAD.

Identifying a better strategy for ad hoc percutaneous coronary intervention in patients with anticipated unfavorable radial access: the Little Women study.

BACKGROUND: Transradial percutaneous coronary intervention (PCI) offers important advantages over transfemoral PCI, including better outcomes. However, when there is indication to ad hoc PCI, a 6 French workflow is a common default strategy, hence potentially influencing vascular access selection in patients with anticipated small size radial artery. METHODS: A multidimensional evaluation was performed to compare two ad hoc interventional strategies in women <160cm: a full 6 French workflow (namely 6 French introducer sheath, diagnostic catheters and guiding catheter) with a modified workflow consisting in the use of 5 French diagnostic catheters preceded by the placement of a 6 French sheath introducer and followed by a 6 French guiding catheter use for PCI. RESULTS: Overall 120 women (68±11years) were enrolled in the study. Coronary angiography has been performed using 5 French or 6 French diagnostic catheters in 57 (47.5%) and 63 (52.5%) cases, respectively. Radial spasm and switch to another access occurred more frequently among women who underwent coronary angiography with 6 French rather than 5 French diagnostic catheters (43% vs. 25%, p=0.03 and 2% vs. 11%, p=0.04, respectively). Total time to guidewire lesion crossing was also significantly higher when PCI has been preceded by 6 French rather than 5 French coronary angiography (23±11min vs 16±7min, p=0.013). CONCLUSIONS: In patients with anticipated unfavorable radial access, a workflow consisting in 6 French introducer sheath placement, 5 French coronary angiography, and 6 French coronary intervention is on multiple parameters the most straightforward and effective strategy.

First optical coherence tomography follow-up of coronary bifurcation lesions treated by drug-eluting balloons.

BACKGROUND: A strategy of percutaneous bifurcation intervention with provisional bare-metal stent (BMS) implantation followed by drug-eluting balloon (DEB) treatment represents a valuable opportunity in patients not compliant with long-duration dual-antiplatelet therapy. We used optical coherence tomography (OCT) to assess coronary bifurcation lesions treated by BMS and DEB, and secondarily, to better explore the association between stent geometry and tissue coverage. METHODS: Twelve patients underwent frequency-domain OCT 6 months after undergoing percutaneous bifurcation intervention with BMS implantation followed by kissing DEB. The same type of BMS was correspondingly implanted in silicone bifurcation models and scanned by microcomputed tomography. RESULTS: Overall, a total 2914 struts were analyzed, revealing 0.6% malapposed struts and 3.1% uncovered struts, with neointimal thickness of covered struts measured at 0.19 ± 0.13 mm. Findings were homogeneous among patients with the exception of one outlier who presented a significant distortion of the stent geometry, suggesting proximal cell rewiring prior to kissing DEB, as supported by the microcomputed tomography model. This pattern was not present in the other cases, which showed struts optimally apposed and nicely scaffolding the side-branch ostium. CONCLUSION: This is the first study describing the effects of DEB in percutaneous bifurcation interventions according to OCT parameters. The results show that a strategy of kissing DEB following BMS is associated with low neointimal thickness and high rate of covered stent struts. Moreover, these results appear to be dependent on the quality of bifurcation intervention, with distal cell rewiring more favorable than proximal cell rewiring.

Vascular imaging balloon with local drug delivery for the treatment of renal artery recurrent in-stent restenosis.

Renal artery stenosis is a common finding among patients with atherosclerotic disease and its percutaneous treatment with stent implantation is frequently performed by interventional cardiologists and vascular radiologists. However, renal artery in-stent restenosis is not a rare complication and its management is not straightforward. We describe and report angiographic follow-up of an innovative approach to renal artery in-stent restenosis based on combined intravascular ultrasound and drug-eluting balloon treatment.

Resolute zotarolimus-eluting stent to treat bifurcated lesions according to the provisional technique: a procedural performance comparison with sirolimus- and everolimus-eluting stents.

OBJECTIVES: Different drug-eluting stents (DES) may have different performance in bifurcation PCI. Thus, we compared the performance of a novel zotarolimus-eluting stent (ZRS) with that obtained using two other DES in bifurcation PCI. METHODS AND RESULTS: Consecutive patients with bifurcated lesions undergoing DES implantation were treated by a provisional approach with sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) during a former period, and then by ZRS in a second period. The PCI procedural details were prospectively recorded and angiographic results were evaluated by a 3-dimensional quantitative coronary analysis software. Primary procedural end-point was "side-branch (SB) trouble" (occurrence, after MV stenting, of: SB TIMI flow<3 or need of specific wires for SB rewiring, or failure to re-wire/dilate the SB). Primary angiographic end-point was post-PCI minimal-lumen-diameter at SB-ostium. During the study, 225 patients were enrolled and treated by ZRS (n=75), by SES (n=75) or by EES (n=75). Among procedural characteristics, "SB trouble" occurred in 4% of patients treated by ZRS, a figure significantly lower compared to SES (16%, P=0.014) and non-significantly lower compared to EES (11%, P=0.12). At multivariable analysis, DES type, pre-PCI SB flow <3 and bifurcation complexity were the only predictors of "SB trouble". After the procedure, minimal-lumen-diameter at SB ostium was significantly larger with ZRS compared to SES (1.94 vs. 1.64 mm, P=0.008) and similar to that of EES. CONCLUSIONS: ZRS is associated to improved performance and SB angiographic results compared to SES. These results support the hypothesis that DES selection may influence the procedural course and the acute angiographic result of bifurcation PCI.

Comparison of two- and three-dimensional quantitative coronary angiography to intravascular ultrasound in the assessment of intermediate left main stenosis.

Angiographic evaluation of intermediate left main coronary artery stenosis (LMS) is often limited. Three-dimensional (3D) quantitative coronary angiography has recently developed to overcome 2-dimensional (2D) quantitative coronary angiographic (QCA) limitations. In patients with angiographically intermediate LMS, we investigated whether 3D quantitative coronary angiography was superior to 2D quantitative coronary angiography in predicting the presence of a significant LMS, defined as a minimum luminal area <6 mm(2) at intravascular ultrasound (IVUS). 2D and 3D quantitative coronary angiography were compared in their measurements of minimum luminal area, percent area stenosis, minimum luminal diameter, and percent diameter stenosis and in their prediction of an IVUS minimum luminal area <6 mm(2). In total 58 target lesions were interrogated, 25 (43%) of which had an IVUS minimum luminal area <6 mm(2). Correlation between 3D-QCA minimum luminal area and IVUS minimum luminal area was stronger than the correlation between 2D-QCA minimum luminal area (or minimum luminal diameter) and IVUS minimum luminal area (R = 0.67, p = 0.0001, and R = 0.40, p = 0.001, respectively, p = 0.04 for comparison). To predict IVUS minimum luminal area <6 mm(2), the most accurate 2D-QCA measurement was minimum luminal diameter (area under curve 0.81, cutoff 2.2 mm, p = 0.0001), and the most accurate 3D-QCA measurement was minimum luminal area (area under curve 0.86, cutoff 5.6 mm(2), p = 0.0001). 2D-QCA percent diameter stenosis did not significantly predict IVUS minimum luminal area <6 mm(2) (area under curve 0.56, cutoff 38%, p = 0.45). In conclusion, the accuracy of quantitative coronary angiography in predicting LM IVUS minimum luminal area <6 mm(2) is limited. When IVUS is not available or contraindicated, 3D quantitative coronary angiography may assist in the evaluation of intermediate LMS. Among 2D-QCA parameters, minimum luminal diameter is more accurate than percent diameter stenosis in predicting significant LMS.

Prospective evaluation of myocardial ischemia related to post-procedural side-branch stenosis in bifurcated lesions treated by provisional approach with drug-eluting stents.

OBJECTIVES: To prospectively assess the impact of post-procedural side-branch (SB) stenosis on inducible myocardial ischemia in patients with bifurcated lesions undergoing percutaneous interventions. BACKGROUND: Provisional-stenting with drug-eluting stents (DES) is the recommended strategy to treat percutaneously bifurcated lesions but is associated to variable degrees of residual SB stenosis. The role of SB residual stenosis on post-procedural myocardial ischemia is uncertain. METHODS: Patients with bifurcations treated by DES according to provisional-stenting technique were enrolled in the study if they had no other untreated lesion. Patients were divided into two groups according to post-procedural 3D-quantitative coronary analysis (3DQCA): group OR (optimal result: stenosis < 50% of SB lumen area at 3DQCA) and group SR, suboptimal result: (stenosis ≥ 50% of SB lumen area at 3DQCA). Treadmill exercise stress test (EST) was performed within 1 week from PCI. The primary study endpoint was myocardial ischemia (≥1 mm ST-segment depression at EST). RESULTS: Sixty patients were enrolled: 49 (81.7%) comprised group OR and 11 (18.3%) group SR. Post-PCI myocardial ischemia at EST was inducible in 17 (34.7%) patients of group OR versus 10 (90.9%) patients of group SR (P = 0.0007). During the follow-up, patients of Group SR (vs. Group OR) had a significantly higher occurrence of inducible myocardial ischemia during late (>8 weeks) stress tests (P < 0.001). CONCLUSIONS: In patients with bifurcated lesions treated by a provisional-stenting technique, residual SB stenosis ≥ 50% at 3DQCA is associated with post-procedural inducible myocardial ischemia at EST.

Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series.

Coronary bifurcation restenoses are especially challenging lesions to treat. In this report, four cases are described in which an innovative approach consisting of the simultaneous inflation of two drug-eluting balloons has been successfully applied to treat different kinds of bifurcation restenoses following both provisional and complex stenting strategies. These selected cases illustrate the concept and the advantages of a kissing drug-eluting balloon strategy for the treatment of virtually any kind of bifurcation restenosis.

IVUS rings mapping a patient's history.

We describe the case of a patient presenting with a stent thrombosis and an intravascular ultrasound image of three concentric strut layers of progressively worse expanded stents resembling a tree's growth rings.

Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach.

OBJECTIVES: This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions. BACKGROUND: Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI. METHODS: Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure. RESULTS: A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57). CONCLUSIONS: In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Kissing inflation is feasible with all second-generation drug-eluting balloons.

OBJECTIVE: To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. METHODS: Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. RESULTS: A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). CONCLUSION: At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996).

Baseline C-reactive protein serum levels and in-stent restenosis pattern after m-TOR inhibitors drug-eluting stent implantation.

BACKGROUND: A diffuse pattern of in-stent restenosis (ISR) has been shown to have a worse prognosis when compared to a focal pattern. It is still unknown whether baseline C-reactive protein (CRP) levels predict ISR pattern. METHODS: Our database was searched retrospectively for patients presenting with ISR after m-TOR inhibitor drug-eluting stent (DES) implantation from January 2007 to December 2009. Angiographic restenosis patterns were evaluated according to the simplified Mehran classification and patients were allocated either to the diffuse or focal pattern group. Predictors of restenosis pattern were assessed among clinical, angiographic, procedural and laboratory data, including baseline high-sensitivity CRP, recorded at the time of the first percutaneous intervention. RESULTS: 72 patients (age, 65 ± 9 years; male sex, 64%) found to have ISR after DES implantation were enrolled. 34 patients presented with a focal pattern, whereas 38 patients presented with a diffuse pattern. At multivariate analysis, CRP levels were the only independent predictor of a diffuse ISR pattern [odds ratio, 2.5; 95% confidence interval, 1.4-4.3; p = 0.001)]. Rising CRP tertiles were associated with an increased rate of diffuse pattern (13% versus 26% versus 61%; p for trend = 0.0001). CONCLUSION: Baseline CRP serum levels are associated with a diffuse ISR pattern after m-TOR inhibitor DES implantation. These findings suggest that baseline inflammatory reactivity may contribute to aggressive restenosis occurring despite drug elution.

Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry.

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.