Rate Of Disabling Stroke Research Articles

Long-term outcomes of transapical-transcatheter aortic valve replacement.

Transapical-transcatheter aortic valve replacement is one of the main interventions indicated for patients where access via peripheral vessels is challenging. However, there have been no reports on the long-term outcomes of this intervention. Here, we report the long-term outcomes of this intervention. Among 178 patients who underwent transapical-transcatheter aortic valve replacement between October 2009 and July 2023, 173 patients who underwent this intervention for native aortic stenosis were included in this study, and early and long-term results were evaluated. The mean age was 82.4 ± 6.4years, 52.6% were women, mean body area was 1.46 ± 0.17 m2, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 11.2 ± 9.9%. In-hospital mortality was observed in three patients (1.7%). Mean follow-up duration was 4.3 ± 2.8years, and the survival rates at 1-, 3-, 5-, and 8-years were 84.9%, 67.1%, 47.0%, and 22.1%, respectively. Freedom from cardiovascular mortality at 1, 3, 5, and 8-years was 92.9%, 86.1%, 75.8%, and 53.5%, respectively. The freedom from disabling stroke rates at 1, 3, 5, and 8-years were 95.0%, 92.4%, 92.4%, and 90.8%, respectively. Multivariate analysis revealed that male (Hazard Ratio 1.85, 95%Confidence Interval 1.27-2.70, p = 0.0012) and hemodialysis (Hazard Ratio 1.64, 95%Confidence Interval 1.00-2.67, p = 0.049) were significant poor prognosis factors. Long-term outcomes of transapical-transcatheter aortic valve replacement were satisfactory. Despite the variety of available approaches, the role of transapical-transcatheter aortic valve replacement, which has low vascular impact, has not been completely lost.

Characterization of Strokes Following Gore Thoracic Branch Endografting Requiring Zone 2 Landing

The GORE® TAG® Thoracic Branch Endoprosthesis (TBE)is the only currently FDA-approved branched device for the treatment of thoracic aortic pathology requiring landing in Zone 2 in the US. While the aneurysm cohort disabling stroke rate in the pivotal trial has previously been reported, a more complete and granular description has not yet been published. This is a descriptive series detailing the neurologic sequelae from the pivotal trial, out to 12 months. All patients underwent Modified Rankin Scale (MRS) assessment at screening, discharge, 1-, 6-, and 12-month intervals. A disabling stroke was defined as occurring within 30-days of the index procedure, combined with a MRS ≥2 with an increase from baseline of at least one grade. Descriptive statistics with important associations with aortic pathology, landing in native aorta versus Dacron graft, and intraoperative ballooning were noted. Further granularity with regard to the distribution and type of stroke are also reported, where available. A total of 238 patients were included in the pivotal trial. The treated aortic pathologies were: aneurysm (n=84), dissection (n=132), traumatic transection (n=9), other isolated lesions(n=13). Through 12 months, the overall stroke rate was 5.9%, with the highest rate of stroke in the aneurysm cohort (aneurysm-8.3%, dissection-4.6%, traumatic transection-0%, other-7.7%). The frequency of disabling strokes through 12 months were: aneurysm-4.3%, dissection-2.3%, other lesion-7.7%. Forty percent of strokes (n=6) occurred within 30 days and included both hemorrhagic (n=3) as well as ischemic (n=3) events. The distribution of strokes within 30 days included left carotid (n=1), posterior circulation (n=2), as well as unknown (n=3). The strokes occurring after 30 days were primarily ischemic (6/8), and included left carotid (n=2), right carotid (n=1), posterior circulation (n=1), posterior circulation and right carotid (n=1), posterior circulation and left and right carotid (n=1), and unknown location (n=1). The majority of patients suffering from stroke had aortic component landing in the native aortic arch, as well as ballooning of the aortic component (10/14). The TBE prosthesis is associated with comparable 30-day stroke rates to similar series of patients undergoing Zone 2 landing after debranching procedures. Stroke rates were highest in aneurysm pathology patients, with no strokes in the traumatic transection cohort. Perioperative strokes were hemorrhagic and ischemic, whereas those occurring after the perioperative period were primarily ischemic in nature. The distribution of stroke covered multiple territories, suggesting an embolic etiology. These data better define the neurologic risks associated with placement of this branched technology in the aortic arch.

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry

BackgroundThe latest iterations of devices for transcatheter aortic valve replacement (TAVR) have brought refinements to further improve patient outcomes. ObjectivesThis study sought to compare early outcomes of patients undergoing TAVR with the self-expanding (SE) Evolut PRO/PRO+ (Medtronic, Inc) or balloon-expandable (BE) Sapien 3 ULTRA (Edwards Lifesciences) devices. MethodsThe OPERA-TAVI (Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry collected data from 14 high-volume centers worldwide on patients undergoing TAVR with SE or BE devices. After excluding patients who were not eligible for both devices, patients were compared using 1:1 propensity score matching. The primary efficacy and safety outcomes were Valve Academic Research Consortium-3 device success and early safety, respectively. ResultsAmong 2,241 patients eligible for the present analysis, 683 pairs of patients were matched. The primary efficacy outcome did not differ between patients receiving SE or BE transcatheter aortic valves (SE: 87.4% vs BE: 85.9%; P = 0.47), but the BE device recipients showed a higher rate of the primary safety outcome (SE: 69.1% vs BE: 82.6%; P < 0.01). This finding was driven by the higher rates of permanent pacemaker implantation (SE: 17.9% vs BE: 10.1%; P < 0.01) and disabling stroke (SE: 2.3% vs BE: 0.7%; P = 0.03) in SE device recipients. On post-TAVR echocardiography, the rate of moderate to severe paravalvular regurgitation was similar between groups (SE: 3.2% vs BE: 2.3%; P = 0.41), whereas lower mean transvalvular gradients were observed in the SE cohort (median SE: 7.0 vs BE: 12.0 mm Hg; P < 0.01). ConclusionsThe OPERA-TAVI registry showed that SE and BE devices had comparable Valve Academic Research Consortium-3 device success rates, but the BE device had a higher rate of early safety. The higher permanent pacemaker implantation and disabling stroke rates in SE device recipients drove this composite endpoint.

Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry.

A total of 1001 subjects (82.0 years, 62.5% female, 63.7% NYHA III/IV at baseline) with severe aortic stenosis at high surgical risk were enrolled in the prospective CONFIDENCE registry and treated with a Portico™ transcatheter heart valve (THV) using either a first-generation delivery system (DS) or the FlexNav™ DS. The objective of this registry is to characterize the procedural safety and device performance of the Portico™ THV at 30 days. The study collected ‘standard-of-care’ clinical and device performance data, with adverse events adjudicated by an independent clinical event committee according to the Valve Academic Research Consortium-2 criteria. The implantation of a single Portico™ THV was successful in 97.5% of subjects. The 30-day all-cause mortality, cardiovascular mortality, and disabling stroke rates were 2.6%, 2.1%, and 1.8%, respectively. A new pacemaker was implanted in 19.0% of subjects at 30 days. At 30 days, the effective orifice area and mean gradient values were 1.82 cm2 and 7.1 mmHg, respectively. The 30-day rate of moderate paravalvular leak (PVL) was 2.1%, with no occurrence of severe PVL. The Portico™ THV demonstrated improved hemodynamic performance and low rates of safety events at 30 days in a large cohort of subjects implanted with the Portico™ THV with either the first-generation DS or FlexNav™ DS.

Carotid Artery Stenting in Patients with Symptomatic and Asymptomatic Stenosis: In-Hospital Clinical Outcomes at a Single Neurovascular Center.

Background: Carotid artery stenting (CAS) is a minimally invasive and proven percutaneous procedure that is widely used to treat patients with symptomatic and asymptomatic carotid artery stenosis. The purpose of this study was to characterize the in-hospital outcomes of symptomatic and asymptomatic patients undergoing CAS at a single neurovascular center. Methods: The study was conducted as a retrospective analysis of 1158 patients (asymptomatic, n = 636; symptomatic, n = 522; male, n = 816; median age, 71 years; NASCET method, 70–99% stenosis, n = 830) who underwent CAS between May 2009 and December 2020. In-hospital neurological outcomes, adverse reactions to iodinated contrast media, acute myocardial infarction, intraprocedural complications, and access-site issues were evaluated. The primary endpoints were disabling stroke (including disabling cerebral hyperperfusion syndrome [CHS]) and all in-hospital deaths. Results: A carotid stent could not be deployed in one patient due to calcified plaques (technical failure rate of 0.09%). Four patients (0.3%) experienced in-hospital, stroke-associated death, while five patients (0.4%) died from non-stroke-related causes. All stroke-associated deaths occurred in the symptomatic group and were due to CHS. The disabling stroke rate was 0.9% overall (n = 10; 0.5% versus 1.3% in asymptomatic versus symptomatic patients, respectively). Nineteen patients (1.6%) reached the in-hospital primary endpoint. More patients in the symptomatic group achieved this endpoint than in the asymptomatic group (2.5% versus 0.9%, respectively; p = 0.060). Conclusions: An evaluation was conducted on the in-hospital outcomes of 1158 patients at a single center who underwent CAS and was performed by trained physicians who were supervised by a senior neurovascular interventionist with over 20 years of experience, confirming the excellent safety profile of this procedure with a low rate of complications.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

BackgroundThe Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. ObjectivesThe goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. MethodsA total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. ResultsAn attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: −1.4%; 95% Bayesian credible interval: −4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. ConclusionsThe complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283)

Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial

Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.

Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study

BackgroundParavalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. MethodsThe Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. ResultsAt 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction. Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm2, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. ConclusionOutcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.

Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study.

The aim of this study was to investigate the procedural and short-term outcomes of transcatheter aortic valve implantation (TAVI) with the Portico™ self-expanding, resheathable TAVI system from an ongoing long-term multicentre study. A total of 941 patients (82.4±5.9 years, 65.7% female, STS score 5.8±4.9%) with severe symptomatic aortic stenosis underwent TAVI using the Portico bioprosthesis. Patients were clinically and echocardiographically assessed at implantation, discharge and 30 days post TAVI. An independent CEC and core laboratory adjudicated adverse events (according to VARC-2) and follow-up echocardiograms, respectively. Implantation was successful in 96.0% of patients. Thirty-day all-cause, cardiovascular mortality and disabling stroke rates were 2.7%, 2.4% and 1.6%, respectively. Major vascular complications and life-threatening bleeding occurred in 5.5% and 3.1% of patients, respectively. A new pacemaker was implanted in 18.7% of patients. Aortic valve area (0.70±0.33 cm2 vs. 1.79±0.48 cm2) and transvalvular gradient (49.7±15.3 mmHg vs. 8.6±3.9 mmHg) improved significantly. The 30-day rate of moderate or higher paravalvular leak (PVL) was 3.9%. The Portico TAVI system allows safe and effective treatment of aortic stenosis in patients at increased surgical risk. At 30 days, mortality was low, and good haemodynamic performance was indicated by low transvalvular gradient and a low rate of moderate or higher PVL.

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes

BackgroundThe new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk. ObjectivesThe purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system. MethodsThis ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated. ResultsA total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year. ConclusionsTranscatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788)

Wingspan stenting can effectively prevent long-term strokes for patients with severe symptomatic atherosclerotic basilar stenosis

To investigate the safety and long-term effect of using the Wingspan stent for severe symptomatic atherosclerotic basilar artery stenosis (≥70%). Between July 2007 and April 2013, we had 91 consecutive patients (age range 41-82 years old) with symptomatic severe basilar stenosis (70-99%) who underwent Wingspan stenting at our center. All patients had stenosis-related temporary ischemic attack or strokes. We analyzed the demographic data, pre- and post-procedural cerebral angiography, technical success rate, peri-procedural complications, and clinical and imaging follow-ups. The Wingspan stenting procedure was successful in all patients: The stenosis was reduced from 82.2% ± 5.8% pre-stenting to 15.9% ± 5.7% post-stenting. The 30-day peri-operative rate for stroke or death was 14.3%, which included ischemic stroke in 12 cases (12/91 = 13.2%) and subarachnoid hemorrhage in one case (1/91 = 1.1%), with a fatal or disabling stroke rate of 2.2%. Among the 77 patients with clinical follow-up assessment within 7-60 months (mean 31.3 ± 15.1 months) after stenting, four patients (5.2%) had posterior ischemia, including one patient with disabling ischemic stroke (1.3%) and three patients (3.9%) with temporary ischemic attack. The 2-year cumulative stroke rate was 16% (95% CI: 8.2-23.8%). Among 46 patients with imaging assessments at 3-45 months (mean, 9.5 ± 8.3) post-stenting, six (13.0%) patients had restenosis, including two (2/46 = 4.3%) with symptomatic restenosis. The benefit of stenting for patients with severe basilar artery stenosis (> 70%) may lie in lowering the long-term fatal and disabling stroke rate; and as long as the peri-operative stroke rate can be kept at a relatively lower level, patients with severe basilar stenosis can benefit from basilar artery stenting.

United Kingdom Carotid Artery Stent Registry: Short- and Long-Term Outcomes

Carotid artery stenting (CAS) has evolved to treat carotid artery disease with the intention of prevent stroke. The British Society of Interventional Radiologists developed a voluntary registry to monitor the practice of this novel procedure. We present the data from the United Kingdom (UK) CAS registry for short and long-term outcomes for symptomatic and asymptomatic carotid disease. The UK CAS registry collected data from 1998 to 2010 from 31 hospitals across the UK for 1,154 patients. All interventions were enrolled in the registry for both asymptomatic and symptomatic patients. Initial entry forms were completed for each patient entered with data including indications, demographic data, CAS data (including stents and protection device details) and 30-day outcomes. Complications were documented. Follow-up data were collected at yearly intervals. Nine hundred fifty-three (83 %) symptomatic and 201 (17 %) asymptomatic patients were enrolled into the registry. The 30-day all stroke and death rates for symptomatic patients were 5.5 and 2.2 % for those with asymptomatic disease. The 30-day mortality rate was 1.7 % for symptomatic and 0.6 % for asymptomatic patients. For symptomatic patients undergoing CAS, the 7-year all-cause mortality rate was 22.2 % and for asymptomatic patients 18.1 %. The 7-year all-cause mortality and disabling stroke rates were 25.3 and 19.4 %, respectively. These data indicate that outside of the tight constraints of a randomised trial, CAS provides effective prophylaxis against stroke and death.

An Institutional Approach to Maintenance of Excellent Outcomes for Carotid Endarterectomy in a Setting with Moderate-to-Low Procedure Volume

Institutions and surgeons with high procedure volumes have been reported to have lower morbidity and mortality rates for patients undergoing carotid endarterectomy. Demonstrating comparable results is essential for centers with moderate or low volume. If comparable results cannot be demonstrated, a low- to moderate-volume center should not perform the procedure. A prospective study of a program to achieve and sustain excellent outcomes after carotid endarterectomy was conducted at a single institution with low-to-moderate volumes. Results of this effort from January 1997 through December 2005 are reported. Key features of our approach include institutional control over which and how many surgeons can perform carotid endarterectomy. Surgeons must be experienced carotid surgeons and consistently perform more than 12 procedures annually and be continuously monitored. Surgical outcomes were independently audited through a mandated institutional carotid endarterectomy data registry. Surgeons with poor outcomes are barred from doing carotid endarterectomies; and annually updated outcomes data are posted on the Internet. This approach was used for 555 carotid endarterectomies in 503 patients. Our outcomes-with total death and disabling stroke rate of 1.6%-compare favorably with, and are not statistically different from, published benchmarks, despite volumes at our institution ranging from 44 to 81 patients annually and the participation of 8 surgeons during the study period. Surgeons should perform carotid endarterectomies only if excellent outcomes can be demonstrated. We conclude that by using an approach like ours, even institutions with moderate-to-low carotid endarterectomy volumes can achieve excellent outcomes. We propose that all institutions should assume responsibility for ensuring excellent carotid endarterectomy outcomes using a comprehensive outcomes-based approach with independent auditing similar to that presented here.

Effects of Abciximab as adjunctive therapy in primary percutaneous coronary intervention patients (results from the DANAMI‐2 trial)

Successful reperfusion at the epicardial level is not always accompanied by reperfusion of the microvasculature. Therapies targeted against 'no-flow' are often employed in patients receiving primary percutaneous coronary intervention (pPCI) after acute myocardial infarction. Abciximab as adjunctive to pPCI will improve ST-segment resolution used as a surrogate for optimal microvascular reperfusion, and improve prognosis. In the DANAMI-2 trial 309/790 (39%) patients treated with pPCI received abciximab at physician discretion. SigmaST-segment elevation at baseline, 90 min, 4 h, 12 h, 24 h after pPCI and at discharge was measured and ST-segment resolution grouped as: Complete (> or = 70 %); Partial (> or = 30 to < 70%); No (< 30%). Clinical endpoints were death, re-infarction and disabling stroke. Abciximab prescription varied from 24.4-60.3% in the different hospitals. Patients receiving abciximab had a higher risk profile. ST-segment resolution at 90 min and 24 h was identical in the two groups, but at 4 h and 12 h partial ST-segment resolution was more pronounced in patients receiving abciximab (P = 0.001, P = 0.026). In a multivariate analysis, adjusting for baseline differences abciximab was associated with improved partial ST-segment resolution at 12 h. Patients treated with abciximab had no re-infarction at 30 days (0% versus 2.8%, P = 0.003), but increased disabling stroke rate (2.3% versus 0.4%; P = 0.019) driven by cerebral infarctions, and not intracranial hemorrhage. There were no differences in death rates. In the DANAMI-2 trial with no age limit, the decreased re-infarction rates in patients receiving abciximab was offset by increased disabling stroke rates. Abciximab in conjunction with pPCI is associated with more pronounced partial ST-segment resolution after 4 h to 12 h suggesting improved microvascular reperfusion.

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Carotid Angioplasty with or without Stent Placement versus Carotid Endarterectomy for Treatment of Carotid Stenosis: A Meta-analysis

Carotid angioplasty with or without stent placement (CAS) has been proposed as an alternative method to carotid endarterectomy (CEA) for treatment of carotid stenosis. Small randomized trials have evaluated the comparative efficacy of both methods; however, definitive evidence is lacking. A search was made for randomized clinical trials comparing CAS and CEA for treatment of carotid stenosis. A literature search of MEDLINE, PubMed, and Cochrane databases was supplemented by a review of bibliographies of relevant articles and personal files. A meta-analysis was performed using a random effects model because significant heterogeneity was observed. Outcomes compared included 1-month composite rates of stroke or death, all strokes, disabling strokes, myocardial infarction, cranial nerve injury, and major bleeding and 1-year rates of both minor and major ipsilateral strokes. We analyzed five randomized trials totaling 1154 patients (577 randomized to CEA and 577 randomized to CAS). The composite end point of 1-month stroke or death rate was not different between patients treated with CAS compared with those treated with CEA (relative risk [RR], 1.3; 95% confidence interval [CI], 0.6-2.8; P = 0.5). The 1-month stroke rate (831 patients analyzed: RR, 1.3; 95% CI, 0.4-3.6; P = 0.7) and disabling stroke rate (831 patients analyzed: RR, 0.9; 95% CI, 0.2-3.5; P = 0.9) was similar for CAS and CEA. The 1-month rates of myocardial infarction (814 patients analyzed: RR, 0.3; 95% CI, 0.1-0.9) and cranial nerve injury (918 patients analyzed: RR, 0.05; 95% CI, 0.01-0.3) were significantly lower for CAS. No significant differences were observed in 1-year rates of ipsilateral stroke (814 patients analyzed: RR, 0.8; 95% CI, 0.5-1.2; P = 0.2). The 30-day stroke and death rates associated with CAS and CEA were not significantly different. Lower rates of myocardial infarction and cranial nerve injury were observed with CAS compared with CEA.

The impact of training in unselected patients on mortality and morbidity in carotid endarterectomy in a vascular training center and the recommendations of the European Board of Surgery Qualification in Vascular Surgery

Purpose: to investigate the impact of training of vascular fellows on the results of carotid endarterectomy (CEA) in unselected patients and to evaluate the recommendations of the European Board of Surgery Qualification in Vascular Surgery (EBSQ-VASC) concerning CEA. Methods: complication rates and selection criteria of all CEAs, performed between 1995 and 2000 (n = 200) were retrospectively analysed and correlated to operating surgeon; supervised, nonsupervised vascular trainees, and consultant vascular surgeons. The number of CEAs were compared with the required minimal procedures according to the EBSQ-VASC. Results: selection criteria for CEA did not differ significantly between operating surgeon groups, except that combined procedures were more performed by nonsupervised trainees and asymptomatic stenosis by consultant surgeons. The overall persistent disabling stroke rate and stroke-related mortality was 3%, with 4.3% in the supervised group, 0% in the unsupervised, and 2.8% in the consultant surgeon group, respectively. The amount of CEAs corresponded to the demands of the EBSQ-VASC. Conclusions: in our institution, no significant differences in neurological morbidity and mortality following CEA could be demonstrated in relation to surgeon training level. The number of CEAs performed by residents fulfil the criteria of the EBSQ-VASC. We conclude that CEA can be safely taught to vascular trainees in unselected patients in a vascular training centre.Eur J Vasc Endovasc Surg 26, 256-261 (2003)

Provision of training in carotid surgery does not compromise patient safety.

Vascular surgeons perceive that carotid endarterectomy carries a higher risk of stroke if performed by a surgical trainee. Accordingly, some trainees consider that they receive a less than adequate training in carotid surgery before taking up a consultant position. The aim of this study was to establish whether the stroke rate was adversely affected if carotid endarterectomy was performed by a surgical trainee under consultant supervision. This was a prospective study of 151 consecutive patients undergoing carotid endarterectomy between 1 January and 31 December 1996 using a standardized technique including intraoperative and postoperative transcranial Doppler monitoring and completion angioscopy. The overall mortality and/or disabling stroke rate was 0.7 per cent (one of 151 patients), whereas the mortality and/or any stroke rate was 1.3 per cent (two of 151). Surgical trainees performed 82 of 151 carotid endarterectomies, with a mortality rate of 1 per cent and a mortality and/or any stroke rate of 2 per cent. There was no significant difference in the incidence of retained thrombus or intimal flaps between trainees and consultants as detected by angioscopy. Vascular surgical trainees can receive a comprehensive training in carotid artery surgery without incurring an unacceptable increase in operative risk.

Endovascular intervention compared with carotid endarterectomy

Abstract Background Endovascular intervention has only recently been used for the treatment of carotid disease. The 30-day outcome of 226 endovascular carotid interventions for atherosclerosis performed since August 1993 is presented. Methods All patients were symptomatic apart from four (2 per cent) who underwent intervention before coronary artery bypass. The last presenting symptom was transient ischaemic attack (TIA) (40 per cent), amaurosis fugax (31 per cent), retinal artery occlusion (3 per cent) and stroke (24 per cent). A moderate stenosis (50–69 per cent; North American Symptomatic Carotid Endarterectomy Trial technique) was present in 24 patients (11 per cent), a severe stenosis (70–95 per cent) in 144 (64 per cent), and a preocclusive stenosis (more than 95 per cent) in 58 (26 per cent). The contralateral internal carotid artery was significantly diseased (greater than 70 per cent) or occluded in 65 patients (29 per cent). All patients were pretreated with aspirin; 5000 units heparin and 1·2 mg atropine were given during the procedure. Initially, stents were reserved for treating residual stenosis after angioplasty (16 of 108 procedures). Later, a change was made to primary stenting (116 procedures). A femoral approach was used for all patients. Results At 30 days there were four deaths (2 per cent) and eight disabling strokes (4 per cent) (death and disabling stroke rate 5 per cent; death and all-strokes rate 8 per cent). For angioplasty and selective stenting the death and disabling stroke rate and the death and all-strokes rate were 6 and 9 per cent respectively, compared with 5 and 8 per cent for primary stenting (P not significant). However, there was a significant difference between the incidence of all adverse events (31 versus 11 per cent) as a result of fewer TIAs associated with primary stenting. During the same interval, 300 carotid endarterectomies (similar indications and severity of disease) were performed. There were six deaths (2 per cent) and eight disabling strokes (3 per cent) (death and disabling stroke rate 5 per cent; death and all-strokes rate 6 per cent). The complications of both endovascular intervention and conventional endarterectomy seem to be improving with time. Conclusion These data confirm the feasibility of endovascular carotid intervention and highlight the need for a large randomized trial comparing it with conventional surgery. The benefit of stents and cerebral protection systems also requires further investigation.