Periprocedural Death Research Articles

03:36 PM Abstract No. 27 Factors influencing clinical success following the endovascular management of type 2 endoleaks

To study outcomes and factors that predict success of transarterial (TA) and translumbar (TL) embolization of type 2 endoleaks following endovascular aortic aneurysm repair (EVAR). One-hundred-thirty patients (mean age, 71.4y; range, 53-95) with type 2 endoleaks referred for TA or TL embolization from August 2003 to December 2017 were retrospectively reviewed. A total of 179 procedures were performed via TA (N=137) and TL (N=42) approaches, with 36 patients undergoing multiple embolizations. Clinical success was defined as absence of endoleak and/or aneurysm sac enlargement on follow-up imaging. Medical comorbidities, procedural data including fluoroscopy times, embolic agents used, location of endoleak, number of vessels embolized, presence of successful nidus embolization, and 30-day morbidity and mortality were collected. T-test and Chi square tests were used to assess statistical significance. Mean fluoroscopy time was 32.9±18.4 vs. 23.8±12.4min for TA and TL approaches respectively (p=0.004). Mean time from EVAR to first endoleak embolization was 576±463 days. Clinical success rates were 55% (N=76/137) and 67% (N=28/42) for TA and TL procedures respectively (p=0.20). For patients who underwent one embolization, clinical success rates were similar between the approaches (TA 79%, N=62/79; TL 80%, N=12/15; p=0.90). In cases requiring re-intervention, the TA approach had a lower clinical success rate of 42% (N=10/24) vs. 75% (N=18/24) for TL procedures (p=0.019). For TL approaches, clinical success rates were higher when both the nidus and branch vessels were embolized (N=13/17, 76%) compared to when only the nidus was embolized (N=11/25, 44%) (p=0.037). The 30-day complication rate for all patients was 1.5%(N=2/130), 2.3%(N=3/130), and 3.1%(N=4/130) for grade A, B, and C complications respectively, as per the SIR classification system. No periprocedural deaths were recorded. Clinical success in the endovascular management of type 2 endoleaks is multifactorial. Preliminary analysis in this retrospective review identified improved clinical success rates post reintervention using a TL approach, as well as superior efficacy of combined nidus and branch embolization.

Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data

The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes. We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial. In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3). Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future. None.

Abstract 42: CAS versus CEA Treatment Differences in Long-Term Outcomes and Post-Procedural Durability: the Carotid Stenosis Trialist Collaboration (CSTC)

Introduction: A 3.4% (95% CI: 2.1% to 4.7%) higher peri-procedural stroke and death risk has been previously documented for those treated with carotid artery stenting (CAS) relative to those treated with carotid endarterectomy (CEA). However, the CAS versus CEA treatment differences in long-term outcomes and the post-procedure durability have not been described. Methods: Data from the 4 largest CAS-versus-CEA randomized trials for treatment of symptomatic carotid atherosclerosis (EVA-3S, SPACE, ICSS, and CREST) were pooled, and treatment differences assessed for the outcome of any stroke or death during a 120-day peri-procedural period, plus ipsilateral stroke afterward. Results: Long-term follow-up was analysed for 4754 patients. Median length of follow-up across the studies ranged from 2.0 to 6.9 years, with 88 peri-procedural and 55 post-procedural events among those CEA-treated, and 169 and 64 for those CAS-treated. After the peri-procedural period, the annual rates of stroke following CAS was 0.6% (95% CI: 0.5 to 0.8) and following CEA 0.6% (95% CI: 0.5 to 0.8), resulting in non-significant durability differences of less than 1% over the period extending up to 9 years (see Table). The previously-documented 3.4% higher peri-procedural event rate in the CAS group contributed to a significant 3.1% (95% CI: 1.6% to 4.7%) treatment difference at 1-year, and the aforementioned similar durability implied that this significant difference remained relatively constant over the period extending up to 9 years (see table). Conclusions: The post-procedure durability of CAS and CEA were similar, both with event rates below 1%. The similarity of post-procedure events rates implies that the previously-documented higher peri-procedural in the CAS group is “carried forward” with a higher risk of outcomes extending to 9-years.

The Role of Myofibroblast Senescence in Arrhythmogenesis of the Aged Infarcted Heart

Aging increases risk of Sudden Cardiac Death (SCD) by more than 10-20 fold. Prior myocardial infarction (MI) increases short- and long-term SCD risk. Cellular senescence is an irreversible cell cycle arrest process which regulates tumor suppression and wound healing, however, accumulation of senescent cells in various tissues is thought to drive aging pathology. We hypothesize that with age, persistent cardiac myofibroblast (CMF) senescence promotes persistent inflammation in the scar and thereby facilitating arrhythmogenesis. Our laboratory has established that the infarcted New Zealand White rabbit model of cardiac aging recapitulates pathology observed in aging humans, namely cardiac fibrosis, abnormal conduction, ryanodine receptor oxidation, and spontaneous and inducible ventricular arrhythmias post-MI. Here, we show that aged infarcted rabbits display increased peri-procedural arrhythmic death, prolonged action potential duration and slowed conduction at the IBZ compared to young, which correlates with anchoring of higher frequency ventricular fibrillation in the IBZ of aged rabbits. We show no change in scar geometry between young and aged rabbits in the first 3 weeks post-MI. However, we observed delayed and persistent CMF senescence in the aged scar, even until 12 weeks post-MI. We also demonstrate increased expression of senescence-associated markers in the aged IBZ and scar compared to young, and colocalization of senescent CMFs and inflammatory macrophages in the aged scar and IBZ. In conclusion, we demonstrate the infarcted aged heart heals differently than young, including delayed and persistent scar CMF senescence, increased VT/VF, and electrophysiological remodeling. Our data support our hypothesis that altered CMF senescence with age induces pathological tissue remodeling post-MI, underlying the increased risk of SCD.

Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial

BackgroundMost carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were always asymptomatic (AA). MethodsWe compared the periprocedural and 4-year risks of PS vs AA patients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) randomized to carotid endarterectomy (CEA) or carotid artery stenting (CAS)/angioplasty. Proportional hazards models adjusting for age, sex, and treatment were used to assess the risk of periprocedural stroke and/or death (S+D; any S+D during periprocedural period), stroke and death at 4 years (any S+D within the periprocedural period and ipsilateral stroke out to 4 years) and the primary end point at 4 years (any stroke, death, and myocardial infarction within the periprocedural period and ipsilateral stroke out to 4 years). Analysis was performed pooling the CEA-treated and CAS-treated patients, and separately for each treatment. ResultsOf 1181 asymptomatic patients randomized in CREST, 1104 (93%) were AA and 77 (7%) were PS. There was no difference in risk when comparing the AA and PS cohorts in the pooled CAS+CEA population for periprocedural S+D (2.0% vs 1.3%), S+D at 4 years (3.6% vs 3.2%), or the primary end point (5.2% vs 5.8%). There were also no differences among those assigned to CEA (periprocedural S+D, 1.5% vs 0%; S+D at 4 years, 2.7% vs 0%; or primary end point, 5.1% vs 2.4%) or CAS (periprocedural S+D, 2.5% vs 2.8%; S+D at 4 years, 4.4% vs 6.9%; or primary end point, 5.3% vs 9.8%) when analyzed separately. ConclusionsIn CREST, only a small minority of asymptomatic patients had previous ipsilateral symptoms. The outcomes of periprocedural S+D, periprocedural S+D, and ipsilateral stroke up to 4 years, and the primary end point did not differ for AA patients compared with PS patients.

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.

Significance of the CAPRI score to predict heart failure recurrence after TAVI: The CAPRI-HF study

Predictors of heart failure (HF) recurrence after Transcatheter aortic valve implantation (TAVI) are insufficiently characterized. The newly developed CAPRI score encompassing aortic calcification burden, is predictive of 1-year post-TAVI cardiovascular and all-cause mortalities (Lantelme et al., JACC Img 2018). 1) to assess the prognostic significance of CAPRI score for HF recurrence during the first year after TAVI; 2) to test this prognostic significance according to aortic gradient. The CAPRI-HF is an ancillary study of the C4CAPRI trial ( NCT02935491 ) including 409 consecutive patients from Rouen and Lyon University hospitals, treated between 2010 and 2014. The primary outcome was defined as hospitalization for HF during the first year after TAVI. The prognostic value of the CAPRI score was assessed by cox regression; an interaction between mean aortic gradient and CAPRI score was further tested. Among the 409 patients, 392 were finally included (14 peri-procedural deaths and 3 lost of follow-up). Seventy-eight patients (19.9%) experienced HF during the first year after TAVI. In multivariate cox analysis adjusted for diabetes, atrial fibrillation, vascular route, pacemaker implantation, aortic regurgitation, transfusion, post-TAVI pulmonary pressure, only CAPRI score was predictive of HF: Hazard Ratio (HR) 1.89, 95% Confidence Interval (CI) [1.23–2.87]. A significant interaction between CAPRI score and mean aortic gradient was found ( P < 0.05). When restricting the analysis to low-flow-low-gradient aortic stenosis, CAPRI score was a stronger predictor of HF (HR 2.68, 95% CI [1.34–5.35]). In the overall cohort, a CAPRI score above a 25% cardiovascular mortality threshold was associated with a 36% rate of HF in comparison to 18.8% HF rate when the score was below ( P < 0.05). The CAPRI score is the only score able to predict both mortality and HF after TAVI. It should now belong to the panoply of the Heart-Team.

Immediate Results of Percutaneous Mitral Balloon Valvuloplasty in Patients with Mitral Stenosis

Introduction: Mitral stenosis is a prevalent valvular disease in developing countries. Percutaneous mitral balloon valvuloplasty (PMBV) is the gold standard treatment. The main objective of this study was to assess the initial results of PMBV in patients with mitral stenosis during 16 years (2002-2018) in Mashhad, Iran. Materials and Methods: From April 2002 to March 2018, 770 patients underwent PMV in department of cardiology. PMV was performed by the antegrade transseptal method using the Inoue balloon. Results: The obtained success rate was 97%. In this study, the valve area increased from 0.9±1.1 to 1.8±0.2 cm2 (P<0.0001). There was no case of peri-procedural death or cardiac tamponade. Additionally, 0.25% of the patients required mitral valve replacement. Severe mitral regurgitation occurred in 0.9% of the subjects. There was no case of cerebrovascular accident, transient ischemic attack, embolic myocardial infarction, or cardiac perforation. Supraventricular tachycardia occurred in 2.59% of the patients. Conclusion: The PMBV by the Inoue technique is a feasible and easy procedure with a short crossing times and low complications.

Safety of outpatient cardiac catheterisation in infants with single-ventricle or shunt-dependent biventricular congenital heart disease.

We aimed to investigate the incidence and causes of readmission of infants with single-ventricle and shunt-dependent biventricular CHD following routine, outpatient cardiac catheterisation. Cardiac catheterisation is commonly performed in patients with single-ventricle and shunt-dependent biventricular CHD for haemodynamic assessment and surgical planning. Best practices for post-procedural care in this population are unknown, and substantial variation exists between centres. Outpatient catheterisation reduces parental anxiety and decreases cost. Our institutional strategy is to discharge patients following a 4- to 6-hour post-procedure observation period. Retrospective cohort study using the Society of Thoracic Surgeons Database identified patients 23 hours. There were no differences in baseline characteristics between discharged and admitted patients. Patients who underwent intervention were more likely to be admitted. Patients with hypoplastic left heart syndrome did not have major adverse events or readmissions. No intra- or peri-procedural deaths occurred. Outpatient cardiac catheterisation may be a safe option for infants with single-ventricle and shunt-dependent biventricular CHD, with low readmission rates and minimal morbidity.

Ablation of Atrial Arrhythmias After the Atriopulmonary Fontan Procedure: Mechanisms of Arrhythmia and Outcomes.

This study sought to describe atrial arrhythmia mechanisms, acute outcomes, and long-term arrhythmia burdens following catheter ablation in adult atriopulmonary (AP) Fontan patients. Atrial arrhythmias are a significant cause of morbidity and mortality in the AP Fontan population. Sixty consecutive atrial arrhythmia ablations were reviewed in 42 AP Fontan patients (31 ± 8 years of age), performed between 1998 and 2017. The number of induced and ablated tachycardias was recorded for each case, as wellas the ability to ablate the suspected clinical tachycardia. Longer-term arrhythmia burden was assessed by using a 12-point clinical arrhythmia severity score. Intra-atrial re-entrant tachycardia (IART) was induced in 93% of cases (n= 56), atrioventricular re-entrant tachycardia in 2 (3%) and atrioventricular nodal re-entrant tachycardia in a single case. The mean number of tachycardias induced per case was 2.3. The critical isthmus for IART was mapped to the lateral (n= 10), inferolateral (n= 8), posterior/posterolateral (n= 16), or septal (n= 10) systemic venous atrium, or to the pulmonary venous atrium (n= 4). Ablation of all inducible tachycardias was achieved in 62%, ablation of at least one (but not all) inducible tachycardias in 25%, with failure to ablate any tachycardias in 13%. The suspected clinical arrhythmia was ablated in 50 cases (83%). Catheter ablation resulted in a significant reduction in arrhythmia score at 3 to 6, 12, and 24 months, irrespective of whether all inducible tachycardias were ablated, or the suspected clinical arrhythmia only. Twelve patients (29%) underwent at least one repeat ablation procedure, with a mean time between ablations of 2.7 ± 3.0 years. There were no cases of periprocedural death, stroke or cardiac tamponade. Catheter ablation can be a safe and effective intervention that will significantly reduce arrhythmia burden in the AP Fontan patient.

Rate of complications due to carotid angioplasty in a tertiary university hospital

Introduction: Stenoses greater than 50% in the cervical internal carotid artery cause up to 8% of all ischemic strokes. Carotid artery stenting (CAS) is an effective alternative to prevent cerebrovascular events to occur. According to recommendations from the American Heart Association/American Stroke Association, CAS is indicated for symptomatic patients with internal carotid stenosis greater than 70% (measured by non-invasive methods), as long as the risk for periprocedural stroke or death is less than 6%. There is few information about complication rates of CAS in developing countries. Objectives: The primary goal of this study was to evaluate the frequency of any stroke or death until hospital discharge after CAS in symptomatic patients with carotid stenosis in a tertiary university hospital. Other complication rates were also assessed as secondary aims. Methods: A single-center retrospective study based on the analysis of charts from patients submitted to CAS between April 2011 and March 2016. Inclusion criteria were: age ≥ 18 years old, admission and follow-up by neurologists from the Neurology Ward, performance of CAS according to the hospital´s protocol (carotid stenosis ≥70%, patients with transient ischemic attack (TIA), amaurosis fugax or minor stroke in the last 180 days, and life expectancy greater than a year). Patients not followed by neurologists after CAS were excluded. Results: A total of 65 patients were included: 3 (4.6%) suffered stroke or death after CAS. Two of these patients presented ischemic strokes and one, an hemorrhagic stroke that lead to death. Myocardial infarctions were not identified, as well as carotid ruptures or dissections, hyperperfusion syndrome, artery perforations, stent thrombosis or encephalopathy. Minor complication rates were: 12.3% for hypotension, 9.2% for bradycardia, 1.5% for TIA, 3.1% for carotid vasospasm and 6.2% for acute kidney injury. The total rate of minor complications was 23.1%, and none of then led to permanent harm. Conclusions: The rate of stroke or death in a reference tertiary service in a developing country was in line with international recommendations.

Anticoagulation and the risk of complications in ventricular tachycardia and premature ventricular complex ablation.

Many patients undergoing ventricular tachycardia (VT) or premature ventricular complex (PVC) ablation receive antithrombotic medications. Their uninterrupted use has the potential to affect complication rates. We assessed the incidence of complications in a large cohort of patients undergoing these procedures, according to antithrombotic medication use. From June 2014 to June 2016, 201 VT and PVC ablations were performed at a single center. We allocated patients to three groups: (A) anticoagulation group (international normalized ratio≥1.5 or non-vitamin K anticoagulant or full-dose low-molecular-weight (LMW) heparin on day of procedure); (B) antithrombotic group (antiplatelet therapy and/or prophylactic LMW heparin on day of procedure); and (C) no antithrombotics group. We assessed periprocedural complication rates in each group. Multivariable analysis was performed. Group A (47 patients) had 8.5% procedural complication rate: one stroke, one pseudoaneurysm, one femoral artery occlusion, and one access site hematoma. In this group, 37 patients had femoral arterial and 18 had epicardial access. In Group B (46 patients), the complication rate was 6.5%: two cardiac tamponades and one pericardial effusion without compromise. Group C (108 patients) had a 5.6% complication rate: three cardiac tamponades (with one periprocedural death and one concomitant gastric vessel injury), one pericardial effusion without compromise, one stomach perforation, and two access site hematomas. Multivariable analysis did not show any significant predictors of complications, though age approached significance. Complication rates were not significantly different between groups. These findings suggest that VT and PVC ablation can be performed safely in patients with uninterrupted antithrombotic medications.

Issue Highlights

Issue Highlights

Safety and efficacy of the reducer: A multi-center clinical registry - REDUCE study

BackgroundThe coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. MethodsOne hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events. ResultsProcedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ± 0.97 vs 2.17 ± 0.95; p = 0.003). ConclusionsIn a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.

Impact of On-Site Surgical Backup on Periprocedural Outcomes of Primary Percutaneous Interventions in Patients Presenting With ST-Segment Elevation Myocardial Infarction (From the ORPKI Polish National Registry)

Conflicting data exist regarding the associations between on-site surgical backup and outcomes after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Thus, we sought to assess the impact of such a backup on periprocedural outcomes of primary PCI using data from the Polish National Registry of PCI. From 2014 to 2016 data on 66,707 patients presenting with STEMI undergoing primary PCI from 154 centers were collected. Patients were divided into 2 groups based on the presence of on-site surgical backup. Of 66,707 patients, 15,040 (22.6%) patients were treated in 28 centers with on-site surgical backup. On-site surgical backup was associated with a higher center PCI annual volume (662.4 ± 301.8 vs 1098.7 ± 483.5; p <0.001), but a lower operator PCI annual volume (226.7 ± 126.0 vs 207.8 ± 96.6; p <0.001). The periprocedural mortality (1.60% vs 1.09%; p <0.001) was lower in patients from centers with on-site cardiac surgery and both on-site surgical backup (odds ratio [95% confidence interval], 0.618 [0.517; 0.738]; p <0.001) and the mean number of PCIs by operator per year (odds ratio per 10 [95% confidence interval], 0.990 [0.984; 0.996]; p = 0.001] were independent predictors of periprocedural death. In conclusion, results of our study suggest that periprocedural mortality in patients undergoing primary PCI for STEMI is lower in centers than without on-site cardiac surgical backup. Whether this effect on mortality is attributable to such backup itself and/or whether surgical backup is a marker ofoverall better medical care and adherence to professional guidelines, this needs clarification in further studies.

Long-term safety and outcome of intravenous treprostinil via an implanted pump in pulmonary hypertension.

We examined safety and long-term outcomes of intravenous treprostinil administered via the implantable LENUS Pro pump in patients with severe pulmonary hypertension (PH). Patients with PH undergoing pump implantation between December 2009 and October 2016 in German referral centers were retrospectively analyzed (end of follow-up: May 2017). The primary objective was to determine long-term safety of the implantable pump. Secondary end points were 3-year survival and prognostic relevance of pre-implantation hemodynamics. We monitored 129 patients (120 with pulmonary arterial hypertension, 1 with PH due to lung diseases, and 8 with inoperable chronic thromboembolic PH) for 260 patient-years (median follow-up, 19 months; interquartile range, 11-34 months). There were 82 complications/peri-procedural events in 60 patients; of these, 57 were serious adverse events (0.60 per 1,000 treatment-days), including 2 periprocedural deaths due to right heart failure. The incidence of complications related to the pump, catheter, infection, and pump pocket per 1,000 treatment-days was 0.074, 0.264, 0.032 (3 local infections; no bloodstream infections), and 0.380, respectively. Three-year overall and transplant-free survival were 66.5% and 55.7%, respectively (39 patients died; 16 underwent lung transplantation). Baseline cardiac index independently predicted transplant-free survival (multivariate hazard ratio, 1.90; 95% confidence interval, 1.11-3.28; p = 0.019; n = 95). Our data suggest that intravenous treprostinil via the LENUS Pro pump in advanced PH is associated with a very low risk of bloodstream infections, but other serious adverse events may occur. Therefore, this therapy needs standardization and should be offered in specialized PH centers only. Further technical advances of the pump system and prospective studies are needed.

Patient and physician preferences for attributes of coronary revascularization.

BackgroundPatients with a diagnosis of coronary artery disease (CAD) may face important decisions regarding treatment options, with the “right choice” depending on the relative weights of risks and benefits. Studies performed as discrete choice experiments are used to estimate these weights, and attribute selection is an essential step in the design of these studies. Attributes not included in the design cannot be analyzed. In this study, we aimed to elicit, rank, and rate attributes that may be considered important to patients and physicians who must choose between angioplasty and surgery for coronary revascularization.MethodsThe elicitation process involved performing a systematic review to search for attributes cited in declared preference studies in addition to face-to-face interviews with cardiologists and experts. The interviews were audio-recorded in digital format, and the collected data were transcribed and searched to identify new attributes. The criterion used to finish the data collection process was sampling saturation.ResultsA systematic review resulted in the selection of the following 14 attributes: atrial fibrillation, heart failure, incision scar, length of stay, long-term survival, myocardial infarction, periprocedural death, postoperative infection, postprocedural angina, pseudoaneurysm, renal failure, repeat coronary artery bypass grafting, repeat percutaneous coronary intervention, and stroke. The interviews added no new attributes. After rating, we identified significant differences in the values that patients and cardiologists placed on renal insufficiency (p<0.001), periprocedural death (p<0.001), and long-term survival (p<0.001).ConclusionDecisions regarding the best treatment option for patients with CAD should be made based on differences in risk and the patient’s preference regarding the most relevant endpoints. We elicited, ranked, and rated 14 attributes related to CAD treatment options. This list of attributes may help researchers who seek to perform future preference studies of CAD treatment options.

Abstract 347: Significant Association Between the Qualifying Neurologic Event and the In-hospital Risk of Stroke or Death Following Carotid Endarterectomy and Carotid Artery Stenting

Objectives: The purpose of this observational study was to analyze the association between the initial neurological status and the risk of any in-hospital stroke or death in patients treated with carotid endarterectomy (CEA) or carotid artery stenting (CAS) under routine conditions in Germany. Methods: Secondary data analysis based on the German statutory quality assurance database for carotid procedures between 2009-2014. The primary outcome was any periprocedural stroke or all-cause death until discharge. To analyze the association between initial neurological status and outcome, a multilevel multivariable regression analyses adjusting for confounders was performed. Results: From a total of 182,033 patients documented between 2009 and 2014, 144,347 patients treated with CEA and 14,794 patients treated with CAS were included in the analysis. In total, there 68% were men and the mean age of the cohort was 70.5±9.1 years. The risk of any in-hospital stroke or death in patients treated with CEA was 2.0% (n=2923/144,347). The raw risk of any in-hospital stroke or death was 1.4% in asymptomatic patients and 3.0% in symptomatic patients treated with CEA. Within the group of symptomatic patients, risk of any in-hospital stroke or death after CEA increased from 1.2% (amaurosis fugax, AFX), 2.3% (TIA), 2.8% (minor stroke), 4.4% (major stroke), 4.8% (crescendo TIA, cTIA) to 9.0% (stroke in evolution, SIE). The risk of any in-hospital stroke or death in patients treated with CAS was 3.6% (n=538/14,794). The raw risk of any in-hospital stroke or death was 1.7% in asymptomatic patients and 6.1% in symptomatic patients treated with CAS. Within the group of symptomatic patients, risk of any in-hospital stroke or death increased from 1.0% (AFX), 4.1% (TIA), 4.1% (minor stroke), 5.4% (major stroke), 5.2% (cTIA) to 11.7% (SIE). Regression analysis revealed that the severity of initial neurologic symptoms was associated with an increased risk of any in-hospital stroke or death in both patients treated for CEA and CAS. Conclusion: Periprocedural risk for any stroke or death did not significantly differ between asymptomatic patients and patients with AFX but between asymptomatic patients and patients with TIA, stroke, cTIA or SIE.

Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10cm in length and >50% stenosis in subjects with Rutherford classification peripheral arterial disease stages 2-4. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30days, 9months, and 1, 2, and 3years after procedure. The primary outcome measured was the major adverse event (MAE) rate at 9months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9months after procedure. Secondary outcomes included primary patency rate at 9months, clinically driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30days and 9months. Device success was defined as the ability to deploy the stent as intended at the treatment site. The MAE rate at 9months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, MIs, or amputations were reported. Primacy patency at 9months was 95.8%. Freedom from CD-TVR was 98.6% at 9months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries.

Risk of Stroke or Death Is Associated With the Timing of Carotid Artery Stenting for Symptomatic Carotid Stenosis: A Secondary Data Analysis of the German Statutory Quality Assurance Database.

BackgroundSubgroup analyses from randomized trials indicate that the time interval between the neurologic index event and carotid artery stenting is associated with periprocedural stroke and death rates in patients with symptomatic carotid stenosis. The aim of this article is to analyze whether this observation holds true under routine conditions in Germany.Methods and ResultsSecondary data analysis was done on 4717 elective carotid artery stenting procedures that were performed for symptomatic carotid stenosis. The patient cohort was divided into 4 groups according to the time interval between the index event and intervention (group I 0‐2, II 3‐7, III 8‐14, and IV 15‐180 days). Primary outcome was any in‐hospital stroke or death. For risk‐adjusted analyses, a multilevel multivariable regression model was used. The in‐hospital stroke or death rate was 3.7% in total and 6.0%, 4.4%, 2.4%, and 3.0% in groups I, II, III, and IV, respectively. Adjusted analysis showed a decreased risk for any stroke or death in group III, a decreased risk for any major stroke or death in groups III and IV, and a decreased risk for any death in groups II and III compared to the reference group I.ConclusionsA short time interval between the neurologic index event and carotid artery stenting of up to 7 days is associated with an increased risk for stroke or death under routine conditions in Germany. Although results cannot prove causal relationships, carotid artery stenting may be accompanied by an increased risk of stroke or death during the early period after the index event.