Periprocedural Death Research Articles

Impella support following emergency percutaneous balloon aortic valvuloplasty in patients with severe aortic valve stenosis and cardiogenic shock

BackgroundTo investigate the feasibility and outcomes of Impella 2.5 support in patients with severe aortic valve stenosis (AS) and cardiogenic shock (CS), who underwent emergency percutaneous balloon aortic valvuloplasty (BAV) with or without percutaneous coronary intervention (PCI). Methods and resultsWe retrospectively analyzed a consecutive series of patients with severe AS and CS who underwent Impella 2.5 support following emergency BAV with or without subsequent PCI. Outcome data included 30-day outcomes, periprocedural as well as throughout the circulatory support period complications. Eight patients with severe AS and CS were identified. Impella 2.5 implantation was successful following emergency BAV in all patients attempted. Additional PCI was performed in four patients. No periprocedural deaths or periprocedural neurologic events occurred. Mean procedure time was 125.9 min (range 64–210 min). Mortality at 30 days was 50%. ConclusionsImpella 2.5 can be used as hemodynamic support in patients with severe AS and CS following emergency percutaneous BAV and may help to improve tolerability of PCI in these high-risk patients.

Revascularization of radiation-induced carotid artery stenosis with carotid endarterectomy vs. carotid artery stenting: A systematic review and meta-analysis.

The incidence of carotid artery stenosis after head and neck radiation is anticipated to rise due to the increasing survival of patients with head and neck malignancies. It remains unclear whether carotid artery stenting (CAS) or endarterectomy (CEA) is the best treatment strategy for radiation-induced carotid artery stenosis. This study was performed according to the PRISMA and MOOSE guidelines. Eligible studies were identified through a comprehensive search of PubMed, Scopus and Cochrane Central until July 20, 2017. A meta-analysis of random effects model was conducted. The I-square statistic was used to assess for heterogeneity. Five studies and 143 patients were included. Periprocedural stroke, myocardial infarction (MI) and death rates were similar between the two revascularization approaches. However, the risk for cranial nerve (CN) injury was higher in the CEA group (OR: 7.09; 95% CI: 1.17-42.88; I2 = 0%). CEA was associated with lower mortality rates after a mean follow-up of 50 months (OR: 0.29; 95% CI: 0.09-0.97; I2 = 0%). No difference was identified in long-term restenosis rates between CEA and CAS. Patients with radiation-induced carotid artery stenosis can safely undergo both CAS and CEA with similar risks of periprocedural stroke, MI and death. However, patients treated with CEA have a higher risk for periprocedural CN injuries and a lower risk for long-term mortality.

Comparison of Enoxaparin versus Heparin among Patients Undergoing Elective Coronary Angiography via Radial Artery Access

Background: Radial artery occlusion (RAO) is one of the few postprocedural complications of transradial approach (TRA) which may be symptomatic in some cases. The aim of this study was to investigate the safety and efficacy of enoxaparin compared with unfractionated heparin (UFH) for preventing RAO among patients who underwent elective diagnostic coronary artery angiography (CAG) via TRA. Patients and Methods: This randomized clinical trial study was conducted on patients who underwent TRA for elective diagnostic CAG. Then, the patients included were randomly divided into 2 groups. A group received 0.75 mg enoxaparin intravenously and the second group received 70–100 IU/Kg UFH single-bolus dose intravenously. During 24 h after the procedure and 3 months later, all the participants were monitored for the occurrence of RAO, access hematoma, periprocedural myocardial infarction, stroke, and death. Results: From 189 patients with mean age of 52.52 ± 6.23 years old, 95 patients received UFH (70–100 IU/kg), and the other group (n = 94) received enoxaparin after radial sheath insertion. After 24 h, decrease in radial pulse was observed in 17.6% patient (14.9% in UFH group and 20.2% in enoxaparin group) and only one patient had absent radial pulse in UFH group. There were no significant differences between UFH group compared with enoxaparin group in the reduction of the radial pulse that examined with reverse Allen test (P = 0.359). Furthermore, other complications did not differ significantly between the two groups. Conclusion: This study demonstrates that intravenous enoxaparin administration compared with intravenous UFH during diagnostic CAG via TRA is a safe and effective strategy for preventing RAO at 24 h after the procedure.

Initial experience with percutaneous edge-to-edge transcatheter mitral valve repair in a tertiary medical center in Taiwan

BackgroundThe transcatheter edge-to-edge mitral valve repair, using MitraClip, has been a safe and effective treatment for severe mitral regurgitation (SMR) in the westerners. However, the therapeutic results of the MitralClip in Taiwan remained elucidated. MethodsPatients with symptomatic SMR were evaluated by the heart team. For those with high or prohibitive surgical risks, transcatheter mitral valve repair was performed in hybrid operation room. During procedure, continuous hemodynamic monitoring was conducted. Transthoracic echocardiography (TTE), blood tests, and six-minute walk test (6MWT) were performed before and 1-month after surgery. ResultsA total of 20 patients (73.4 ± 11.1 years, 85% male) with a mean Euroscore II of 13.2 ± 17.7% and a mean STS score of 8.7 ± 9.0% for mortality were enrolled. After a mean procedural time of 239 ± 95 min, an average of 1.8 ± 0.7 clips were used in each procedure. The procedural successful rate was 95% to achieve mild residual mitral regurgitation. Cardiac output was increased from 3.6 ± 0.9 to 4.6 ± 1.4 (p = 0.008) and V-wave of left atrial pressure declined from 24.4 ± 9.8 to 19.3 ± 7.1 (p = 0.030) immediately during the index procedure. There was no peri-procedural death, myocardial infarction, stroke or any events requiring emergent cardiac surgery. All patients experienced significant improvement in heart failure symptoms. The 6-min walk distance increased from 219.6 ± 118.4 m to 279.1 ± 111.6 (p = 0.04) at 1 month. The echocardiogram further showed significant improvements of mitral regurgitation, pulmonary artery systolic pressure, and the left ventricular end-diastolic volume. ConclusionTrans-catheter edge-to-edge mitral valve repairs are safe and effective in Asians with symptomatic SMR, regarding the improvements of clinical symptoms and exercise capacities. MitraClips is also associated with reverse remodeling of pulmonary hypertension and left ventricular size in patients with SMR.

Proximal embolic protection versus distal filter protection versus combined protection in carotid artery stenting: A systematic review and meta-analysis.

Proximal embolic protection devices (P-EPD) and distal filters (DF) are used to prevent distal cerebral embolizations during carotid artery stenting (CAS). We compared their comparative effectiveness in regards to prevention of intraprocedural and periprocedural adverse events, including ischemic lesions (ipsilateral and contralateral), stroke, transient ischemic attacks (TIA) and death. We also compared the combination of the two neuroprotection strategies vs. a single strategy in regards to ischemic lesions and stroke. This study was performed according to the PRISMA and MOOSE guidelines and eligible studies were identified through search of PubMed, Scopus and Cochrane Central. A meta-analysis was conducted with the use of a random effects model. The I-square statistic was used to assess for heterogeneity. Twenty-nine studies involving 16,307 patients were included. There was a significant reduction in ischemic lesions with the use of P-EPD among observational studies (RR: 0.66 [0.45-0.97]). There were no statistically significant differences for the other outcomes between the two treatment groups. There is a number of studies reporting outcomes on the comparison between P-EPD and DF for CAS. P-EDP can reduce distal embolization phenomena resulting into ischemic lesions when compared to DF based on the results from real-world studies. P-EPD was not superior however, in regards to periprocedural stroke, TIA and death. Further studies are anticipated to provide a clear answer to this debate.

Pediatrics Spanish Registry of Percutaneous Melody Pulmonary Valve Implantation in Patients Younger Than 18 Years

Introduction and objectivesA decade has passed since the first Spanish percutaneous pulmonary Melody valve implant (PPVI) in March 2007. Our objective was to analyze its results in terms of valvular function and possible mid-term follow-up complications. MethodsSpanish retrospective descriptive multicenter analysis of Melody PPVI in patients < 18 years from the first implant in March 2007 until January 1, 2016. ResultsNine centers were recruited with a total of 81 PPVI in 77 pediatric patients, whose median age and weight were 13.3 years (interquartile range [IQR], 9.9-15.4) and 46kg (IQR, 27-63). The predominant cardiac malformation was tetralogy of Fallot (n = 27). Most of the valves were implanted on conduits, especially bovine xenografts (n = 31). The incidence of intraprocedure and acute complications was 6% and 8%, respectively (there were no periprocedural deaths). The median follow-up time was 2.4 years (IQR, 1.1-4.9). Infective endocarditis (IE) was diagnosed in 4 patients (5.6%), of which 3 required surgical valve explant. During follow-up, the EI-related mortality rate was 1.3%. At 5 years of follow-up, 80% ± 6.9% and 83% ± 6.1% of the patients were free from reintervention and pulmonary valve replacement. ConclusionsMelody PPVI was safe and effective in pediatric patients with good short- and mid-term follow-up hemodynamic results. The incidence of IE during follow-up was relatively low but was still the main complication.

Comprehensive evaluation of the effectiveness and safety of balloon pulmonary angioplasty for inoperable chronic thrombo-embolic pulmonary hypertension: long-term effects and procedure-related complications

Although balloon pulmonary angioplasty (BPA) improves haemodynamics and short-term prognosis in patients with inoperable chronic thrombo-embolic pulmonary hypertension (CTEPH), the long-term effects of BPA, and procedure-related complications remain to be fully elucidated. From July 2009 to October 2016, we performed a total of 424 BPA sessions in 84 consecutive patients with inoperable CTEPH. We used 3D reconstructed computed tomography to determine target lesions of pulmonary arteries and optical computed tomography to select balloon size, if needed. In 77 patients (92%) who completed the BPA treatment [65 ± 14 (SD) years-old, male/female 14/63], haemodynamics and exercise capacity were examined at 6 months after last BPA and in the chronic phase [>12 months after first BPA, 31 (20, 41) months]. The BPA treatment significantly improved mean pulmonary arterial pressure (38 ± 10 to 25 ± 6 mmHg), pulmonary vascular resistance (7.3 ± 3.2 to 3.8 ± 1.0 Wood units), and 6-minute walk distance (380 ± 138 to 486 ± 112 m) (all P < 0.01), and the improvements persisted throughout the follow-up period (43 ± 27 months) (N = 53). In the 424 sessions, haemoptysis was noted in 60 sessions (14%), and non-invasive positive pressure ventilation (NPPV) was used to treat haemoptysis and/or hypoxemia in 33 sessions (8%). Furthermore, 5-year survival was 98.4% (only one patient died of colon cancer) with no peri-procedural death. These results indicate that BPA improves haemodynamics and exercise capacity in inoperable CTEPH patients with acceptable complication rate and that the beneficial haemodynamic effects of BPA persist for years with resultant good long-term prognosis.

Reduced periprocedural mortality and bleeding rates of radial approach in ST-segment elevation myocardial infarction. Propensity score analysis of data from the ORPKI Polish National Registry.

We sought to evaluate bleeding complications and periprocedural outcomes of the radial approach (RA) as compared to the femoral approach (FA) during percutaneous coronary intervention (PCI) in "real-world" patients with ST-segment elevation myocardial infarction (STEMI). The study group consisted of 22,812 consecutive patients with STEMI treated with PCI and stent implantation between January 2014 and June 2015 in 151 tertiary invasive cardiology centres in Poland (the ORPKI Polish National Registry). Patients treated using the RA and FA were compared using a propensity score analysis to avoid possible selection bias. The analysis was carried out in an "as-treated" manner. The FA was used in 9,334 (40.9%) and the RA in 13,478 (59.1%) patients. After propensity score matching, a higher total amount of contrast (191.8±8.0 vs. 174.8±68.8 ml; p=0.001) and lower radiation doses (1,279.5±1,346.3 vs. 1,182.6±887 mGy; p=0.02) were reported in FA. More access-site-related bleeding complications after both angiography (0.17% vs. 0.02%; p=0.004) and PCI (0.23% vs. 0.09%; p=0.049) were reported in the FA group. Periprocedural death (1.94% vs. 0.93%; p=0.001) was more common after PCI performed with the FA. The radial approach was associated with a lower incidence of periprocedural death in STEMI patients as well as a significant reduction of bleeding complications at the access site.

Association between operator specialty and outcomes after carotid artery revascularization

ObjectiveTo examine the association between operator specialty and 30-day outcomes among patients undergoing carotid endarterectomy and carotid artery stenting. MethodsWe conducted a population-based, observational cohort study of all individuals who underwent carotid endarterectomy or stenting in Ontario, Canada (population, 13.6 million) between April 1, 2002, and March 1, 2015, using administrative claims databases. We stratified endarterectomy and stenting patients according to operator specialty, and followed them for 30 days after the procedure. For carotid endarterectomy, we compared outcomes between vascular surgeons and nonvascular surgeons. For carotid artery stenting, we compared outcomes between radiologists and neurosurgeons. We built multilevel multivariable logistic regression models adjusted for patient demographics, comorbidities, carotid artery symptom status, and annual institutional and operator volume to examine rates of 30-day stroke or death. ResultsA total of 16,544 patients were studied (n = 14,301 endarterectomy and n = 2243 stenting). Vascular surgeons performed the majority (55.7%) of carotid endarterectomy procedures, followed by neurosurgeons (21.0%), general surgeons (15.3%), and cardiac surgeons (7.9%). Radiologists (82.5%) and neurosurgeons (17.5%) performed carotid artery stenting. In the endarterectomy group, the risk of stroke or death was higher among patients treated by nonvascular surgeons (4.0%) compared with vascular surgeons (2.9%; adjusted odds ratio [OR], 1.32; 95% confidence interval [CI], 1.08-1.62; P = .008). This difference was driven by a higher rate of stroke among nonvascular surgery-treated patients (3.6%) compared with vascular surgery-treated patients (2.5%; adjusted OR, 1.38; 95% CI, 1.11-1.71). The risk of death was similar between the two groups. With respect to specific nonvascular surgery specialties, the rate of 30-day stroke or death was higher in endarterectomy patients treated by neurosurgeons (4.1%; adjusted OR, 1.27; 95% CI, 1.00-1.61) and cardiac surgeons (4.4%; adjusted OR, 1.54; 95% CI, 1.04-2.30) compared with vascular surgeons (2.9%). Patients who underwent carotid artery stenting by radiologists vs neurosurgeons experienced 30-day stroke or death at similar rates (8.0% vs 7.9%, respectively; adjusted OR, 1.07; 95% CI, 0.66-1.74; P = .79). ConclusionsThe risk for periprocedural stroke or death was significantly higher among carotid endarterectomy patients treated by nonvascular surgeons (neurosurgeons and cardiac surgeons) compared with vascular surgeons. Operator specialty did not seem to have a significant effect on periprocedural outcomes among patients who underwent carotid artery stenting. These results can have implications for physician referral practices and local policies.

Registro español de implante percutáneo de la válvula pulmonar Melody en menores de 18 años

Introduction and objectivesA decade has passed since the first Spanish percutaneous pulmonary Melody valve implant (PPVI) in March 2007. Our objective was to analyze its results in terms of valvular function and possible mid-term follow-up complications. MethodsSpanish retrospective descriptive multicenter analysis of Melody PPVI in patients < 18 years from the first implant in March 2007 until January 1, 2016. ResultsNine centers were recruited with a total of 81 PPVI in 77 pediatric patients, whose median age and weight were 13.3 years (interquartile range [IQR], 9.9-15.4) and 46kg (IQR, 27-63). The predominant cardiac malformation was tetralogy of Fallot (n = 27). Most of the valves were implanted on conduits, especially bovine xenografts (n = 31). The incidence of intraprocedure and acute complications was 6% and 8%, respectively (there were no periprocedural deaths). The median follow-up time was 2.4 years (IQR, 1.1-4.9). Infective endocarditis (IE) was diagnosed in 4 patients (5.6%), of which 3 required surgical valve explant. During follow-up, the EI-related mortality rate was 1.3%. At 5 years of follow-up, 80% ± 6.9% and 83% ± 6.1% of the patients were free from reintervention and pulmonary valve replacement. ConclusionsMelody PPVI was safe and effective in pediatric patients with good short- and mid-term follow-up hemodynamic results. The incidence of IE during follow-up was relatively low but was still the main complication.Full English text available from:www.revespcardiol.org/en

Visual Aids for Improving Patient Decision Making in Severe Symptomatic Carotid Stenosis

Because of the large amount of information to process and the limited time of a clinical consult, choosing between carotid endarterectomy (CEA) and carotid angioplasty with stenting (CAS) can be confusing for patients with severe symptomatic internal carotid stenosis (ICA). We aim to develop a visual aid tool to help clinicians and patients in the decision-making process of selecting between CEA and CAS. Based on pooled analysis from randomized controlled trials including patients with symptomatic and severe ICA (SSICA), we generated visual plots comparing CEA with CAS for 3 prespecified postprocedural time points: (1) any stroke or death at 4 months, and (2) any stroke or death in the first 30 days and ipsilateral stroke thereafter at 5 years and (3) at 10 years. A total of 4574 participants (2393 assigned to CAS, and 2361 to CEA) were included in the analyses. For every 100 patients with SSICA, 6 would develop any stroke or death in the CEA group compared with 9 undergoing CAS at 4 months (hazard ratio [HR] 1.53; 95%CI 1.20-1.95). At 5 years, 7 patients in the CEA group would develop any periprocedural stroke or death and ipsilateral stroke thereafter versus 12 undergoing CAS (HR 1.72; 95%CI 1.24-2.39), compared with 10 patients in the CEA and 13 in the CAS groups at 10 years (HR 1.17; 95%CI 0.82-1.66). Visual aids presented in this study could potentially help patients with severe symptomatic internal carotid stenosis to better weigh the risks and benefits of CEA versus CAS as a function of time, allowing for the prioritization of personal preferences, and should be prospectively assessed.

Pre-operative Carotid Plaque Echolucency Assessment has no Predictive Value for Long-Term Risk of Stroke or Cardiovascular Death in Patients Undergoing Carotid Endarterectomy

IntroductionIn patients with carotid stenosis receiving medical treatment, carotid plaque echolucency has been thought to predict risk of future stroke and of other cardiovascular events. This study evaluated the prognostic value of pre-operative plaque echolucency for future stroke and cardiovascular death in patients undergoing carotid endarterectomy in the first Asymptomatic Carotid Surgery Trial (ACST-1).MethodsIn ACST-1, 1832/3120 patients underwent carotid endarterectomy (CEA), of whom 894 had visual echolucency assessment according to the Gray-Weale classification. During follow-up patients were monitored both for peri-procedural (i.e. within 30 days) death, stroke, or MI, and for long-term risk of stroke or cardiovascular death. Unconditional maximum likelihood estimation was used to calculate odds ratios of peri-procedural risk and Kaplan-Meier statistics with log-rank test were used to compare cumulative long-term risks.ResultsOf 894 operated patients in whom echolucency was assessed, 458 plaques (51%) were rated as echolucent and peri-procedural risk of death/stroke/MI in these patients was non-significantly higher when compared with patients with non-echolucent plaques (OR 1.48 [95% CI 0.76–2.88], p = .241). No differences were found in the 10 year risk of any stroke (30/447 [11.6%] vs. 29/433 [11.0%], p = .900) or cardiovascular (non-stroke) death (85/447 [27.9%] vs. 93/433 [32.1%], p = .301).ConclusionIn ACST-1, carotid plaque echolucency assessment in patients undergoing CEA offered no predictive value with regard to peri-operative or long-term stroke risk or of cardiovascular (non-stroke) death.

Direct results of a prospective randomized study comparing ablation with the nMARQ catheter and the PVAC catheter used with and without a 3D system (MAPER 3D Study).

IntroductionOur aim was to compare in a prospective randomized study the safety, direct results and periprocedural data of ablation using an nMARQ catheter, a PVAC catheter used with the EnSite system, or a PVAC catheter only under fluoroscopy control.Material and methodsOne hundred two patients (70 male, 57 ±11 years) with atrial fibrillation (AF) were prospectively randomized to: group 1 – ablation performed with an nMARQ catheter and the CARTO 3 system; group 2 – a PVAC catheter used with the EnSite system; group 3 – ablation with a PVAC catheter without a 3D system.ResultsComplete isolation of 400/402 pulmonary veins (PV) (99.5%). Linear ablation was performed in 23 patients in group 1 (small distance between lines isolating PV), in 3 patients in group 2, in 1 patient in group 3. The superior vena cava was isolated in 1 patient, 9 patients, and 9 patients respectively. Duration of fluoroscopy and dose area product were significantly smaller in group 1 (6.5 ±2.9 min/808.8 ±393.9 cGy/cm2 vs. 13.6 ±5.6 min/1662.6 ±677.8 cGy/cm2 and 18.8 ±7.6 min/2327.9 ±975.5 cGy/cm2; p < 0.001). Procedure duration was shorter in group 1 (82.9 ±18.8 min vs. 101.2 ±19.6 min, p < 0.001 and 99.8 ±20.8 min, NS). Contrast injection was necessary in 2 patients in group 1, in 8 patients in group 2 and in all patients in group 3. Because nMARQ is a thermocool catheter, the volume of fluid injection was significantly greater (2348.5 ±543.5 ml vs. 1077.9 ±280.5 ml and 1076.5 ±375.6 ml, p < 0.001). There were no periprocedural deaths. We observed no cardiac tamponade, neurological complications and no atrioesophageal fistula during follow-up.ConclusionsThe lowest radiological exposure was observed during ablation performed with an nMARQ catheter. 3D systems reduced fluoroscopy duration and the necessity of contrast injection. The nMARQ catheter requires injection of a large volume of fluid.

Carotid Artery Stenting Versus Endarterectomy for Stroke Prevention: A Meta-Analysis of Clinical Trials

BackgroundData conflict regarding the relative effectiveness of carotid artery stenting (CAS) and carotid artery endarterectomy (CEA) for the prevention of stroke due to carotid artery stenosis. ObjectivesThe authors performed an updated meta-analysis evaluating the efficacy and safety of CAS versus CEA, given recently published clinical trial data. MethodsDatabases were searched through April 30, 2016. Randomized trials with ≥50 patients, that had exclusive use of embolic-protection devices, and that compared CAS against CEA for the treatment of carotid artery stenosis were selected. We calculated summary odds ratios (ORs) and 95% confidence intervals (CIs) using a random-effects model. ResultsWe analyzed 6,526 patients from 5 trials with a mean follow-up of 5.3 years. The composite outcome of periprocedural death, stroke, myocardial infarction (MI), or nonperiprocedural ipsilateral stroke was not significantly different between therapies (OR: 1.22; 95% CI: 0.94 to 1.59). The risk of any periprocedural stroke plus nonperiprocedural ipsilateral stroke was higher with CAS (OR: 1.50; 95% CI: 1.22 to 1.84). The risk of higher stroke with CAS was mostly attributed to periprocedural minor stroke (OR: 2.43; 95% CI: 1.71 to 3.46). CAS was associated with significantly lower risk of periprocedural MI (OR: 0.45; 95% CI: 0.27 to 0.75); cranial nerve palsy (OR: 0.07; 95% CI: 0.04 to 0.14); and the composite outcome of death, stroke, MI, or cranial nerve palsy during the periprocedural period (OR: 0.75; 95% CI: 0.60 to 0.93). ConclusionsCAS and CEA were associated with similar rates of a composite of periprocedural death, stroke, MI, or nonperiprocedural ipsilateral stroke. The risk of long-term overall stroke was significantly higher with CAS, and was mostly attributed to periprocedural minor stroke. CAS was associated with lower rates of periprocedural MI and cranial nerve palsy than CEA.

CREST-2: Identifying the Best Method of Stroke Prevention for Carotid Artery Stenosis: National Institute of Neurological Disorders and Stroke Organizational Update.

One of the great achievements of modern medicine is the successful prevention of stroke and other cardiovascular diseases. Although the incidence of stroke has substantially declined over the last 30 years, ≈200 000 preventable stroke deaths still occur annually in the United States. According to a recent study based on the Greater Cincinnati/Northern Kentucky Stroke Study, annually ≈41 000 strokes in the United States are attributed to extracranial internal carotid artery stenosis. Early revascularization for symptomatic carotid stenosis—that is, in patients with recent ipsilateral stroke or TIA—is well established as effective at preventing ipsilateral stroke. Carotid stenosis in the absence of symptoms is extremely common, but the best treatment is unclear. While 2 randomized trials showed a benefit of carotid endarterectomy (CEA) over antiplatelet therapy with aspirin, the number needed to treat approaches 200. Does aggressive risk factor control change that balance? Population screening for carotid stenosis followed by revascularization is considered to cause net harm. Are complication rates from endarterectomy and stenting now low enough to justify expanding their indications in asymptomatic patients? The National Institute of Neurological Disorders and Stroke (NINDS)–funded CREST-2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) is an ambitious attempt to further refine the treatment of asymptomatic carotid stenosis. As one of the largest randomized stroke prevention trials, the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) was designed to compare the safety and efficacy of 2 stroke prevention procedures for carotid artery narrowing—CEA and carotid artery stenting (CAS)—in symptomatic and asymptomatic individuals. Starting in December 2000, this NINDS-funded trial enrolled >2500 patients at 117 sites in the United States and Canada. Because of slow enrollment, the trial took 9 years to complete. In 2010, the results of CREST indicated that the 2 revascularization procedures were equivalent for …

Vascular Access Site and Outcomes Among 26,807 Chronic Total Coronary Occlusion Angioplasty Cases From the British Cardiovascular Interventions Society National Database

ObjectivesThe aim of this study was to assess, using a national percutaneous coronary intervention (PCI) database, access-site choice and outcomes after chronic total occlusion (CTO) PCI. BackgroundGiven the influence of access site on outcomes, the use of radial access in CTO PCI warrants further investigation. MethodsData were analyzed from the British Cardiovascular Intervention Society dataset of 26,807 elective CTO PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regression was used to identify predictors of access-site choice and its association with outcomes. ResultsThere was a significant decrease in femoral artery (FA) access from 84.6% in 2006 to 57.9% in 2013. Procedural factors associated with FA access included dual access (odds ratio [OR]: 3.89; 95% confidence interval [CI]: 3.45 to 4.32), CrossBoss/Stingray (OR: 1.87; 95% CI: 1.43 to 2.12), intravascular ultrasound (OR: 1.32; 95% CI: 1.21 to 1.53), and microcatheter use (OR: 1.18; 95% CI: 1.03 to 1.39). There was an association between FA access and the number of CTO devices used (p = 0.001 for trend). Access-site complications (1.5% vs. 0.5%; p < 0.001), periprocedural myocardial infarction (0.5% vs. 0.2%; p = 0.037), major bleeding (0.8% vs. 0.2%, p < 0.001), transfusion (0.4% vs. 0%; p < 0.001), and 30-day death (0.6% vs. 0.1%; p = 0.002) were more frequent in patients undergoing CTO PCI using FA access. An access-site complication during CTO PCI was associated with significant increases in transfusion (8.0% vs. 0.1%; p < 0.001), procedural coronary complication (17.3% vs. 5.8%; p < 0.0001), major bleeding (8.4% vs. 0.3%; p < 0.001), and mortality at all time points. ConclusionsFA access remains predominant during CTO PCI, with case complexity and device size associated with its use. Access-site complications were more frequent with FA use and strongly correlated with adverse outcomes.

Diastolic Blood Pressure is a Risk Factor for Peri-procedural Stroke Following Carotid Endarterectomy in Asymptomatic Patients

Objective/BackgroundCarotid endarterectomy (CEA) prevents future stroke, but this benefit depends on detection and control of high peri-operative risk factors. In symptomatic patients, diastolic hypertension has been causally related to procedural stroke following CEA. The aim was to identify risk factors causing peri-procedural stroke in asymptomatic patients and to relate these to timing of surgery and mechanism of stroke.MethodsIn the first Asymptomatic Carotid Surgery Trial (ACST-1), 3,120 patients with severe asymptomatic carotid stenosis were randomly assigned to CEA plus medical therapy or to medical therapy alone. In 1,425 patients having their allocated surgery, baseline patient characteristics were analysed to identify factors associated with peri-procedural (< 30 days) stroke or death. Multivariate analysis was performed on risk factors with a p value < .3 from univariate analysis. Event timing and mechanism of stroke were analysed using chi-square tests.ResultsA total of 36 strokes (27 ischaemic, four haemorrhagic, five unknown type) and six other deaths occurred during the peri-procedural period, resulting in a stroke/death rate of 2.9% (42/1,425). Diastolic blood pressure at randomisation was the only significant risk factor in univariate analysis (odds ratio [OR] 1.34 per 10 mmHg, 95% confidence interval [CI] 1.04–1.72; p = .02) and this remained so in multivariate analysis when corrected for sex, age, lipid lowering therapy, and prior infarcts or symptoms (OR 1.34, 95% CI 1.05–1.72; p = .02). In patients with diastolic hypertension (> 90 mmHg) most strokes occurred during the procedure (67% vs. 20%; p = .02).ConclusionIn ACST-1, diastolic blood pressure was the only independent risk factor associated with peri-procedural stroke or death. While the underlying mechanisms of the association between lower diastolic blood pressure and peri-procedural risk remain unclear, good pre-operative control of blood pressure may improve procedural outcome of carotid surgery in asymptomatic patients.

The impact of multiphase post-mortem CT- angiography (MPMCTA) for investigating fatal outcomes of medical interventions

Abstract Post-mortem imaging - predominantly computed tomography (PMCT) - has proven its suitability in reported casework experience of suspected fatal medical errors to become an integral part of routine pre-autopsy forensic investigations. However, its role in mortality analysis within the context of hospital quality management is still under consideration. Post-mortem imaging combined with angiography procedures can effectively assist forensic autopsy investigations of unexpected and periprocedural deaths as they both offer a significant improvement in documenting medical complications. They help to identify misplaced medical devices, sources of haemorrhages, vascular patency, and unimpaired perfusion after general and cardiovascular surgery, complications after transvascular catheter-directed interventions or distinctive and potentially contributing features of vascular anatomy. Complications in transplant surgery demonstrate the significant impact of multiphase CT angiography (MPMCTA) as a standardised method of post-mortem opacification of the vasculature in the evaluation of bleeding complications following complex vascular surgery. Complicated transcatheter aortic valve implantations (TAVI) serve as examples for the application of MPMCTA in order to clarify fatal outcomes of catheter-guided minimal invasive interventions. Single casework experience favours that PMCT and PMCTA assist forensic or clinical autopsies to reconstruct adverse medical events with fatal outcomes or contribute substantially to prove a non- complicated interventional approach.

A comparison of results of carotid endarterectomy in octogenarians and nonagenarians to younger patients from the Mid-America Vascular Study Group and the Society for Vascular Surgery Vascular Quality Initiative

ObjectiveCarotid endarterectomy (CEA) reduces stroke risk in selected patients. However, CEA risk profile may be different in older patients. We compared characteristics and outcomes of octogenarians and nonagenarians with those of younger patients. MethodsDeidentified data from CEA patients were obtained from the Society for Vascular Surgery Vascular Quality Initiative (VQI) database. Prior CEA, carotid artery stent, or combined CEA and coronary artery bypass were excluded, yielding 7390 CEAs in octogenarians and nonagenarians (≥80 years of age) and 35,303 CEAs in younger patients (<80 years of age). We compared post-CEA outcomes, including periprocedural cerebral ischemic events and death, and details such as operative time, bleeding, and return to surgery. ResultsOctogenarians and nonagenarians were more likely to have pre-CEA neurologic symptoms (51.4% vs 45.6%; P < .001) and to have never smoked (37.8% vs 22.0%; P < .001), and they were slightly more likely to have required urgent CEA (16.1% vs 13.4%; P < .001). Stenosis ≥70% was similar (octogenarians and nonagenarians, 94.2%; younger patients, 94.4%; P = .45). Perioperative ipsilateral neurologic events and ipsilateral stroke were slightly more common among octogenarians and nonagenarians (1.6% vs 1.1% [P < .001] and 1.2% vs 0.8% [P = .002]). Multivariate modeling (logistic regression) showed that pre-CEA neurologic symptoms (odds ratios, 1.35 [P = .005] and 1.42 [P = .007]), pre-CEA ipsilateral cortical ischemic event (odds ratios, 1.18 [P < .001] and 1.20 [P < .001]), and urgency (odds ratios, 1.75 [P < .001] and 1.67 [P < .001]) remained strong predictors of any ipsilateral neurologic event and any ipsilateral stroke, respectively. However, age ≥80 years remained a significant predictor of these outcomes (odds ratios, 1.37 [P = .003] and 1.44 [P = .004]). Kaplan-Meier estimated survival was lower for octogenarians and nonagenarians at 30 days and 1 year (98.6% vs 99.4% and 93.7% vs 97.0%; log-rank, P < .001). Age ≥80 years was also associated with a greater rate of discharge to other than home after CEA, a difference that was only partially explained by comorbidities in multivariate modeling. ConclusionsCEA was performed with low rates of perioperative neurologic events and mortality. Multivariate testing showed that the higher rate of neurologic complications in octogenarians and nonagenarians appeared partially related to symptomatic status and urgent surgery; but after adjusting for these factors, age ≥80 years still predicted a slightly higher rate. Periprocedural CEA outcomes appear similar in comparing older and younger patients, although longer term survival is lower for older patients, and older patients are at greater risk of discharge to other than home. CEA was associated with slightly higher risk of neurologic complications in older patients but may be considered appropriate for selected octogenarians and nonagenarians.

Transcutanous aortic valve replacement with Medtronic CoreValve in a publicprivate partnership hospital complex

Objective: The aim of this study was to assess the initial experience of transcutaneous aortic valve implantation (TAVI) in a high risk aortic stenosis population not suitable for conventional surgical valve replacement. Background: No data exist for TAVI with Medtronic CoreValve in South Africa and especially not in a public private partnership hospital complex. Methods: Retrospective data regarding severe aortic stenosis evaluation, risk stratifi cation and management were evaluated over a 24 month period. Results: A total of 106 patients were evaluated of whom 17 were accepted for surgical valve replacement (SVR) while TAVI was attempted in 25. The CoreValve was successfully implanted in 96% (24/25) of the cases. No procedural or peri-procedural deaths occurred. Three patients required permanent pacemaker insertion in the peri-procedural period and 2 patients had vascular access complications requiring blood transfusion only. Median hospital stay was 3.7days (range: 2 - 7). Aortic valve gradient showed a signifi cant reduction after valve implantation, which was sustained during follow-up (p<0.001). NYHA class symptomatology also improved from a median of 3.3 to 1.0 (p<0.001). During follow-up there were 4 late deaths, not related to the procedure, occurring after 78 to 193 days. Average cost for private and government patients were R268 000.00 and R163 000.00 respectively. Conclusions: The CoreValve can be implanted with a high success rate. Short term mortality and morbidity are acceptable. Signifi cant symptomatic improvement is gained at follow-up. The fi nancial implications are important.