Meta-long Papyrus: Meta-analysis of mid to long-term outcomes of PK Papyrus covered stent.

BACKGROUND: Although covered stents (CS) represent a potentially life-saving intervention for coronary perforation (CAP), their application has expanded to other contexts, including coronary aneurysms (CAA). However, data regarding mid- and long-term outcomes of CS in these settings scenarios remains limited. AIMS: This meta-analysis aims to evaluate major adverse cardiac events (MACE) from discharge through long-term follow-up in patients undergoing percutaneous coronary intervention with the new generation polyurethane-covered cobalt-chromium PK Papyrus CS. METHODS: We conducted a meta-analysis of data from three observational trials that included long-term follow-up of patients who underwent PK Papyrus CS implantation: Papyrus-Spain, SOS PK Papyrus, and PAST-PERF registry. RESULTS: 332 patients underwent PK Papyrus CS implantation, 236 (71.1%) for CAP, 70 (21.1%) for CAA and 26 (7.8%) for other indications. After a mean follow-up of 16.2 months, the MACE was 14.3%, with Target Lesion Revascularization (TLR) being the most frequent (8.5%), followed by stent thrombosis (ST), 3.3% and cardiac death (CD), 2.6%. Comparing CAP and CAA subgroups, the MACE rate in CAA was significantly higher than CAP (21.4% vs 9.7%, p < 0.01), primary driven by ST (CAA: 8.6% vs CAP: 1.3%; p = 0.0015). CONCLUSIONS: The clinical outcomes following PK Papyrus CS implantation are deemed acceptable, considering the challenging scenarios and the existing alternative treatments. However, MACE rates in patients with CAA who received Papyrus PK CS were significantly higher than in those with CAP, underscoring the importance of meticulous patient selection and optimization of CS in these complex patients and coronary anatomies.

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

OBJECTIVES: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). BACKGROUND: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. METHODS: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). RESULTS: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. CONCLUSIONS: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Thrombocytopenia after transcatheter aortic valve implantation. A comparison between balloon-expandable and self-expanding valves.

BACKGROUND: Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon-expandable (BEV) and self-expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes. METHODS: We retrospectively analyzed patients undergoing TAVI. Platelet counts after TAVI were collected. Two groups were created: DPC ≤ 30% and DPC > 30%. VARC-2 criteria were used to define outcomes. RESULTS: Study population was composed of 195 patients (age 77.5 ± 6.7, 57.4% males). All of them but one experienced DPC (mean DPC 31.9 ± 15.3%). DPC was significantly higher among the patients treated with BEV compared to those treated with SEV (36.3 ± 15.1% vs 27.7 ± 14.4, P < 0.001). After multivariate analysis, the use of BEV was independently associated with a higher rate of DPC > 30% (67.4% vs 36.0%; OR 3.4; 95% CI, 1.42-8.16). At 30 days, the DPC > 30% was associated with a higher rate of life-threatening/major bleeding, major vascular complications, in-hospital sepsis and mortality. At one year, there were no statistically significant differences in the mortality rate between groups (6.35% vs 10.0%, HR 1.54; 95% CI, 0.56-4.25). CONCLUSIONS: In this study, the use of BEV was associated with a higher risk of DPC after TAVI. A DPC rate > 30% was associated with an increased risk of major complications at 30 days.

Long-term outcomes of rotational atherectomy of underexpanded stents. A single center experience.

OBJECTIVES: To analyze the procedural and long-term outcomes of the use of rotational atherectomy (RA) in underexpanded stents in our cohort and to provide an overview of currently available data on this technique. BACKGROUND: Stent underexpansion (SU) has been related to stent thrombosis and restenosis. RA has been used to treat undilatable SU as a bail-out strategy with encouraging results. METHODS: This is an observational, single-center study. We included patients who underwent stentablation between 2013 and 2017. Baseline demographics, procedural results, in-hospital major adverse cardiac events (MACE), and long-term follow-up MACE were retrospectively collected. RESULTS: A total of 11 patients (90.9% males, mean age 65.4 ± 18.6) were included in this study. Median left ventricle ejection fraction was 53.5% [46.2-55]. Median calculated Syntax score was 16 [9-31] and 45.5% of patients were admitted for acute coronary syndrome. Radial approach was used in 63.6% of cases. Most patients only required one burr (45% used a 1.5 mm diameter burr) during the intervention. Procedural success was achieved in 90.9% of the cases. Acute lumen gain was 42.7% [30.7-61.49]. There were no in-hospital deaths or MACE. At a median follow-up of 26 months, only one patient (9.1%) suffered MACE in the context of acute coronary syndrome, and two patients (18.2%) required non-target lesion revascularization. No deaths were reported. CONCLUSIONS: RA of under expanded stents is a feasible option with a high rate of procedural success. At long-term follow-up, all of them were alive and 90.9% of patients remained free from MACE.

Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new-generation covered stents.

OBJECTIVES: To compare outcomes in patients receiving polytetrafluoroethylene (PTFE) and polyurethane (PL) covered stents (CS) after coronary artery perforation (CAP). BACKGROUND: The prognosis of CAP has improved with the advent of CSs. Information is scarce about the outcomes of new-generation CSs. METHODS: Sixty-one patients were treated with CSs in a 5-years period (age = 77 ± 8.75% males). Procedural and clinical data were retrospectively collected. The primary endpoint was procedural success. Secondary endpoints included death and major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, target vessel, and lesion revascularization and need for surgical repair). RESULTS: Twenty-two (36%) received PL-CSs and 39 (65%) PTFE-CSs. There were no differences in procedural success (86% vs 69%, P = 0.216). Time to deliver was shorter with PL-CS despite larger length of stents (8[11] vs 15[16] min, P = 0.001; 20[5] vs 16[3] mm, P < 0.001). This group had lower rate of pericardial effusion and cardiac arrest (41% vs 72%, P = 0.028; 5% vs 26%, P = 0.045). At 1-year follow-up, MACE rates were similar (58% vs 56%, P = 1.000) with atrend toward TVR in the PL-CS arm (21% vs 5%, P = 0.083). No differences were found in mortality (26% vs 41%, P = 0.385). Each group had 1 stent thrombosis and in-stent restenosis trended higher in the PL-CS group (12% vs 3%, P = 0.223). CONCLUSIONS: Time to deliver was shorter with the PL-CS and resulted in lower rate of pericardial effusion and cardiac arrest. However, there were no significant differences in procedural success and 1-year follow-up MACE in patients treated with PL-CS or PTFE-CS.

MitraClip® Repair in Cardiogenic Shock Due to Acute Mitral Regurgitation: From Near-Death to Walking.

A patient with ischemic myocardiopathy who had undergone resynchronization therapy was admitted to the authors' institution with progressive dyspnea. Echocardiography demonstrated a left ventricular ejection fraction (LVEF) of 25%, with a massive mitral regurgitation (MR) secondary to anterior leaflet prolapse and posterior leaflet restriction. Despite intensive medical treatment, the patient developed cardiogenic shock and required mechanical ventilation, inotropic support and intra-aortic balloon pumping. The patient was rejected for surgery due to the high operative risk, but subsequently underwent a successful percutaneous repair with two MitraClip® devices. Immediately after the intervention there was a progressive improvement that allowed the patient to be discharged, such that the clinical outcome was favorable at the six-month follow up (NYHA class II/IV). This case report describes the benefits of minimally invasive therapy in selected patients who are at very high surgical risk and who, despite being in a critical condition and with low LVEF, experience an outstanding clinical improvement following the resolution of a massive MR.

Comparison of the Frequency of Thrombocytopenia After Transfemoral Transcatheter Aortic Valve Implantation Between Balloon-Expandable and Self-Expanding Valves.

Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to worse clinical outcomes. Comparison of platelet kinetics among different types of valves is limited. Our objectives were to analyze the differences in drop platelet count (DPC) between balloon-expandable valves (BEVs) and self-expanding valves and their prognostic implications after TAVI. Patients who underwent transfemoral TAVI from 2008 to 2016 were included. Exclusion criteria were severe baseline thrombocytopenia and periprocedural death. Postprocedural platelet counts were collected. Two groups were created: DPC ≤30 and DPC >30%. Valve Academic Research Consortium-2 criteria were used to define outcomes. Study population included 609 patients (age 84.7 ± 6.0, 46.6% males). The mean DPC was 32.5 ± 13.9%. The DPC was higher in the BEV arm (33.9 ± 14.2 vs 30.7 ± 13.4%, p = 0.006), and the nadir was reached later in comparison to the self-expanding valve arm (3.0 ± 1.3 vs 2.5 ± 1.1 days, p <0.001). After multivariable analysis, the use of BEV, known coronary artery disease, and left ventricle ejection fraction were the factors associated with a higher rate of DPC >30%. At 30 days, the DPC >30% was related with a higher rate of life-threatening and/or major bleeding (6.8 vs 2.1%, p = 0.009) and death (3.5 vs 0.8%, p = 0.036). At 1 year, the difference in mortality disappeared. In conclusion, in this cohort of patients, the use of BEV seems to be associated with a higher risk of DPC after TAVI. A DPC ≥30% was related with increased risk of life-threatening and/or major bleeding and death at 30 days. Larger and prospective studies are needed to understand this phenomenon.

Out-of-hospital cardiac arrest and stent thrombosis: Ticagrelor versus clopidogrel in patients with primary percutaneous coronary intervention under mild therapeutic hypothermia.

BACKGROUND: Out-of-Hospital Cardiac Arrest (OHCA) and mild therapeutic hypothermia (MTH) have been linked to increased risk of Stent Thrombosis (ST) in comatose survivors who undergo percutaneous coronary intervention (PCI). In this sense, there is no formal recommendation about which antiplatelet regimen should be used in patients with acute coronary syndromes (ACS) after OHCA. AIMS: To compare the incidence of probable/definite ST and bleeding events between ticagrelor and clopidogrel, in patients with ACS under MTH after an OHCA. METHODS AND RESULTS: From January 2010 to August 2016, 144 patients underwent MTH after an OHCA. Overall, 114 had an ACS (79%) and 98 (67,3%) were treated with primary PCI and stent implantation. Among them, 61 (62,2%) were treated with clopidogrel, and 32 (32,6%) with ticagrelor. During hospitalization, the incidence of probable or definite ST was significantly higher in patients receiving clopidogrel compared to ticagrelor (11,4% vs. 0%; p: 0.04), and no significant differences in any (28,6% vs. 25%; p: 0.645) or major bleeding (BARC 3 or 5) (11,4% vs. 12,5%; p: 0.685) were found. Hospital mortality did not differ between groups (26,2% vs. 25%; p: 0.862). CONCLUSIONS: In this study, as compared to clopidogrel, ticagrelor was associated with a lower rate of ST, without differences in haemorrhagic events in patients with OHCA for an ACS under MTH. Similarly to other settings, ticagrelor might be a valid alternative to clopidogrel in these patients.

Bioresorbable vascular scaffolds in clinical practice: state-of-the-art.

Coronary bioresorbable vascular scaffolds (BVS) are a new appealing therapeutic option in interventional cardiology. To date, the Absorb BVS™ (Abbott Vascular, Santa Clara, CA, USA) is the most used and studied device. Its backbone is made of poly-L-lactide and coated by a thin layer of poly-D,L-lactide; everolimus is released and the scaffold is fully degraded to H2O and CO2 in 2-3 years. The BVS technology seems to offer several theoretical advantages over metallic stent implantation. It gives temporary mechanical support to vessel wall, without permanently caging it. Hence, long-term endothelial function may be restored and natural vasomotion in response to external stimuli may be recovered. Finally, an eventual future surgical revascularization is not conditioned. Several observational and randomized trials assessing the performance and clinical outcomes of BVS have been recently published. The main aim of this review is to carry out a systematic analysis and to evaluate long-term efficacy and safety of the Absorb BVS™.

Late Right Coronary Ostium Occlusion After Percutaneous Aortic Paravalvular Leak Closure: Immediate Results Do Not Always Predict Long-Term Performance.

We present an 83-year-old woman with history of two aortic valve replacements; 2 years after the last replacement, she developed heart failure and severe paravalvular leak (PVL) was detected. Percutaneous PVL closure was completed with a single Amplatzer Vascular Plug III. Two months later, the patient presented with late coronary obstruction requiring emergent surgical revascularization. To the best of our knowledge, this is the first report of late coronary obstruction after percutaneous PVL closure.

Overtime evaluation of the vascular HEALing process after everolimus-eluting stent implantation by optical coherence tomography. The HEAL-EES study.

PURPOSE: Second-generation drug-eluting stent (DES) have shown a better safety and efficacy as compared to first generation DES due to an improved vascular healing process. This process has not been so far evaluated in vivo in an overtime fashion by optical coherent tomography (OCT). We sought to evaluate the vascular healing process after everolimus-eluting stent (EES) implantation at 6, 9 and 12months, by OCT. METHODS: Consecutive 36 patients undergoing percutaneous coronary intervention with EES were randomized 1:1:1 to receive OCT imaging at 6 (group A), 9 (group B) or 12-month follow-up (group C). One patient from group C was excluded because of target lesion revascularization at 1-month, whereas 5 patients withdraw the informed consent. Finally, 30 patients were analyzed. RESULTS: Neointimal thickness was not different between 3 groups (group A: 99.50 [94.06-127.79] µm, group B: 107.26 [83.48-133.59] µm, group C: 127.67 [102.51-138.49] µm; p=0.736). Although the percentage of "uncovered struts" was significantly higher in group A as compared to the other groups (8.0% vs. 4.4% vs. 2.9%, respectively; p=0.180), the ratio of uncovered to total struts per section <30% was similar between 3 groups (0.3% vs. 0.3% vs. 0%, respectively; p=1.000). CONCLUSION: Healing process following EES implantation seems almost completed at 6-month follow-up. These data, which need to be confirmed in a larger study, may support the decision to shorten dual antiplatelet therapy.

Minimally Invasive Transradial Percutaneous Closure of Aortic Paravalvular Leaks: Following the Steps of Percutaneous Coronary Intervention.

Two patients with severe aortic paravalvular leaks (PVLs) in a mechanical prosthesis were percutaneously treated. Procedures were performed with mild sedation, angiographic guidance, and a 6-French right radial artery approach with good final results. Percutaneous PVL treatment is routinely performed with general anaesthesia, transesophageal echocardiographic guidance, and femoral access. Although another case of radial aortic PVL closure has been previously reported, it was performed with an 8-French radial sheath, transesophageal echocardiographic guidance, and general anaesthesia. According to our initial experience, aortic PVLs could be treated in a minimally invasive way. Larger studies should be conducted to confirm these observations.

Safety of glycoprotein IIb/IIIa inhibitors in patients under therapeutic hypothermia admitted for an acute coronary syndrome.

BACKGROUND: Mild therapeutic hypothermia (MTH) is associated with an increased risk of both thrombotic and bleeding events. Although little is known about the use of Glycoprotein IIb-IIIa inhibitors (GPi) in this setting, the early action and the intravenous administration of these agents in patients who cannot swallow might potentially translate into clinical benefits in patients with acute coronary syndromes (ACS). AIMS: To assess the incidence of bleeding/thrombotic events in patients with ACS under MTH after an Out-of-hospital cardiac arrest (OHCA) who received GPi or not. METHODS AND RESULTS: From January 2010 to September 2015, 110 patients were treated with MTH after an OHCA. Among them, 88 (80%) had an ACS and 71 patients (80.6%) underwent percutaneous coronary intervention (PCI). In 17 (24%) GPi were administered in the cath-lab. During hospitalization, 11.7% in the GPi and 9.25%in the non GPi group presented thrombotic events (stent thrombosis, deep vein thrombosis, pulmonary embolism) without significant differences between groups (p= 0.762). The incidence of any bleeding (64.7% vs. 14.8%; p<0.0001), and major bleeding (41.1% vs. 3.7; p<0.0001) was significantly higher in patients receiving GPi. Finally, in-hospital mortality did not differ between groups (24% vs. 35, 2%; p=0.385). CONCLUSIONS: In this study, the use of GPi in patients with ACS undergoing PCI under MTH was associated with an increased bleeding risk without reduction of thrombotic events. According to these results, the use of GPi should be carefully considered in this setting.

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.