Targeting the safe zone: A quality improvement project to reduce vascular access complications.

OBJECTIVE: The aim of this study was to assess the effectiveness of a quality improvement (QI) program in reducing vascular complications during cardiac catheterization. BACKGROUND: Vascular access complications during cardiac catheterization are associated with higher morbidity and mortality. We implemented a QI program focused on using micropuncture techniques and targeting the "safe zone," an area below the inferior border of the inferior epigastric artery and above the inferior border of the femoral head, for femoral artery puncture. METHODS: Our catheterization laboratory implemented a protocol that required all operators to use micro puncture technique during diagnostic and/or percutaneous coronary interventions and to document arteriotomy in the "safe zone." We also encouraged use of vascular ultrasound, radial artery approach, and increased use of vascular closure devices (VCDS). We analyzed data on 3120 patients (2013, pre-QI cohort) and 3222 patients (2014, QI cohort). Data on vascular complications were prospectively collected and compared with the rate of complications that occurred during the same time one year prior when the QI project was not in effect. RESULTS: Baseline characteristics of two cohorts of patients were similar. Compliance with the protocol was excellent. Appropriate documentation of the wire exiting the needle was observed in 95% of cases. VCD use increased from 35% in 2013 to 60% in 2014 (P < 0.001) There were no significant differences in the overall number of complications after implementation of the QI project (1.03% complications before QI implementation and 0.96% after QI implementation. P = 0.79) but there was an absolute reduction in the number of hematomas (0.77 vs. 0.40% in 2013 vs. 2014, respectively, P = 0.06) and of pseudoaneurysms (0.35 vs. 0.19% P = 0.20). Correlates of major vascular complications included), age > 75 years (HR 3.1, P < 0.0001), and PCI (vs. diagnostic cath). CONCLUSIONS: Micropuncture technique in association with "safe zone targeting "did not significantly reduce vascular complications in patients undergoing cardiac catheterization, but a trend toward decrease of hematomas and pseudoaneurysms was noted. Factors such as age and type of procedure (PCI vs. diagnostic) play a significant role in the occurrence of vascular complications. © 2017 Wiley Periodicals, Inc.

A systematic review of reported cases of combined transcatheter aortic and mitral valve interventions.

OBJECTIVES: To summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI). BACKGROUND: CTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve-in-valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve-in-valve/valve-in-ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high-surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described. METHODS: We performed a systematic review of all the published articles from PUBMED and EMBASE. RESULTS: A total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6-365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post-procedure was rare. CONCLUSIONS: CTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta-analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR. METHODS AND RESULTS: We comprehensively searched EMBASE, PubMed, and Web of Science. Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs (confidence intervals) for dichotomous and continuous variables respectively. Twenty-six studies and 10,572 patients were included in the meta-analysis. The use of LA for TAVR was associated with lower overall 30-day mortality (RR, 0.73; 95% CI, 0.57-0.93; P = 0.01), use of inotropic/vasopressor drugs (RR, 0.45; 95% CI, 0.28-0.72; P < 0.001), hospital length of stay (LOS) (DM, -2.09; 95% CI, -3.02 to -1.16; P < 0.001), intensive care unit LOS (DM, -0.18; 95% CI, -0.31 to -0.04; P = 0.01), procedure time (DM, -25.02; 95% CI, -32.70 to -17.35; P < 0.001); and fluoroscopy time (DM, -1.63; 95% CI, -3.02 to -0.24; P = 0.02). No differences were observed between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major bleeding, procedural success, conduction abnormalities, and annular rupture. CONCLUSION: Our meta-analysis suggests that use of LA for TAVR is associated with a lower 30-day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support.

Ultrasound-guided cannulation of the femoral vein in electrophysiological procedures: a systematic review and meta-analysis.

AIMS: In an effort to minimize periprocedural stroke risk, increasingly, electrophysiological (EP) procedures are being performed on anticoagulation. The decrease in stroke has been accompanied by an increase in potentially devastating vascular access complications. Ultrasound guidance for femoral vein cannulation reduces complications in other applications. The aim of this study is to determine the utility of real-time two-dimensional (2D) ultrasound guidance for femoral vein cannulation in EP. METHODS AND RESULTS: A comprehensive literature search of Medline, Embase, Google Scholar, and the Cochrane Central Register of Controlled Trials was performed. Five years of conference abstracts from the Heart Rhythm Society, European Heart Rhythm Association, and European Cardiac Arrhythmia Society were reviewed. Two independent reviewers identified trials comparing ultrasound-guided with standard cannulation in EP procedures. Data were extracted on study design, study size, operator and patient characteristics, use of anticoagulation, vascular complication rates, first-pass success rate, and inadvertent arterial puncture. Four trials, with a total of 4065 subjects, were included in the review, with 1848 subjects in the ultrasound group and 2217 subjects in the palpation group. Ultrasound guidance for femoral vein cannulation was associated with a 60% reduction of major vascular bleeding (relative risk, 0.40; 95% confidence interval, 0.28-0.91). Additionally, there was a 66% reduction in minor vascular complications (relative risk, 0.34; 95% confidence interval, 0.15-0.78). CONCLUSION: The use of real-time 2D ultrasound guidance for femoral vein cannulation decreases access-related bleeding rates and life-threatening vascular complications.

Evidence-based medicine and contemporary certification: Analysis of the American Board of Vascular Medicine endovascular board examination.

Since 2005, the American Board of Vascular Medicine (ABVM) endovascular examination has been used to certify vascular practitioners. Annual rigorous review has confirmed it is psychometrically valid and reliable. However, the evidence basis underlying the examination items has not been studied systematically. The aim of this study was to adjudicate class of recommendation (COR) and level of evidence (LOE) for the 2015 ABVM endovascular examination and establish an additional feedback mechanism for examination improvement based on contemporary evidence-based guidelines. We performed a pooled consensus process to classify each of the 110 items in the 2015 ABVM endovascular examination by COR and LOE as detailed in the current guideline statements. We added additional categories for items that were not eligible for assignment using traditional current evidence-based metrics: 'COR X', cannot be determined, not applicable, or simple recognition; and 'LOE X', cannot be determined or not applicable. COR classifications were assigned in the following proportion: Class I=15%, Class II=40%, Class III=3%, COR X=42%. LOE classifications were assigned in the following proportion: Level A=12%, Level B=34%, Level C=32%, LOE X=22%. Our analysis showed that nearly half of the 2015 ABVM endovascular examination items were supported by strong scientific evidence or fact-based knowledge. COR and LOE analysis yielded notably different results. Use of alternate classification schema may be powerful tools for improving certification exams in healthcare.

Transcatheter Valve-in-Valve Implantation: Failing Tricuspid Bioprosthesis in a Patient with Ebstein’s Anomaly.

Transcatheter valve-in-valve (VIV) implantation has been recently proposed as an alternative to surgical reoperative aortic valve replacement in patients with a failing aortic bioprosthesis. Experience with transcatheter VIV implantation at other valve positions is very limited. Herein is reported the case of an 18-year-old man with Ebstein's anomaly and severe tricuspid valve (TV) regurgitation status after bioprosthetic valve replacement, who developed new dyspnea on exertion three years after the initial valve replacement. Transesophageal echocardiography showed a severely dilated right atrium and new TV stenosis with an immobile leaflet. The patient underwent successful VIV implantation of a 29-mm SAPIEN XT bioprosthetic valve, with resolution of symptoms and no residual TV regurgitation or stenosis at the two-year follow up. Video 1: Degenerative bioprosthetic tricuspid valve. TEE showing the degenerative bioprosthetic tricuspid valve, and color Doppler during systole showing severe tricuspid regurgitation. Video 2: Degenerative bioprosthetic tricuspid valve. Three-dimensional TEE showing stenosis with an immobile leaflet creating a coaptation defect, viewed from the right atrium. Video 3: Transcatheter VIV replacement with a 29-mm Edwards SAPIEN XT deployed within the tricuspid valve prosthesis. Final result after valve implantation, demonstrating a patent valve orifice, and appropriate apposition of transcatheter valve within a pre-existing surgical Carpentier-Edwards bioprosthetic valve, viewed from the right ventricle. Video 4: Transcatheter VIV replacement with a 29-mm Edwards SAPIEN XT deployed within the tricuspid valve prosthesis. Final result after valve implantation, demonstrating a patent valve orifice, and appropriate apposition of transcatheter valve within a pre-existing surgical Carpentier-Edwards bioprosthetic valve, viewed from the right atrium.

Percutaneous versus surgical cut-down access in transfemoral transcatheter aortic valve replacement: A meta-analysis.

BACKGROUND: The transfemoral (TF) approach has become the preferred approach for transcatheter aortic valve replacement (TAVR) because of its low risk profile. However, the relative safety of the percutaneous approach (PC) compared to surgical cut-down (SC) remains unclear. Our aim was to compare the outcomes between PC versus SC access in patients undergoing TF-TAVR using a meta-analysis. METHODS: We conducted a systematic electronic database search for studies reporting major and minor vascular complications (VC), major and minor bleeding, and perioperative all-cause mortality, in PC versus SC TF-TAVR cases. Complications were reported based on the Valve Academic Research Consortium criteria. A random-effects model was used to calculate odds ratios and 95% confidence intervals. RESULTS: Eight observational cohort studies and one randomized control trial (2513 patients in PC and 1767 patients in SC) were included in the analysis. Major and minor VC, as well as bleeding complications, were comparable between the two approaches. The need for surgical intervention for VC was comparable between PC and SC. There was no difference in perioperative all-cause mortality. CONCLUSIONS: PC and SC have similar safety profiles and outcomes when used appropriately in selected patients.

Impact of transcatheter aortic valve implantation on left atrial appendage flow velocities.

PURPOSE: Left atrial appendage (LAA) flow velocity has not been extensively studied in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the impact of TAVI on LAA flow velocity. METHODS: Medical records of consecutive TAVI recipients were reviewed retrospectively. Patients with persistent atrial fibrillation were excluded. LAA velocities were measured before and after TAVI by transesophageal echocardiography. RESULTS: Sixty-one patients were included. Mean LAA emptying (EV) and filling (FV) flow velocity before TAVI were 33 ± 16 cm/s and 31 ± 14 cm/s, respectively. They increased to 37 ± 20 (p = 0.0036) and 33 ± 13 cm/s (p = 0.047) after TAVI in the whole population sample, but not in patients with normal flow AS. In low-flow, low-gradient (LFLG) AS patients, EV and FV increased from 36 ± 22 to 47 ± 30 cm/s (p < 0.01), and from 29 ± 12 to 40 ± 15 cm/s (p < 0.01), respectively, after TAVI. There was no difference between normal flow and LFLG AS patients in the number of patients who achieved EV ≥ 40 cm/s post-TAVI (35% versus 47%, p = 0.54, respectively). CONCLUSIONS: LAA EV and FV were low prior to TAVI and increased significantly after TAVI only in patients with LFLG AS. © 2016 Wiley Periodicals, Inc. J Clin Ultrasound 44:375-382, 2016.

Iatrogenic Ventricular Septal Defect Following Transcatheter Aortic Valve Replacement: A Systematic Review.

BACKGROUND: Ventricular septal defects (VSD) are rarely reported as a complication following transcatheter aortic valve replacement (TAVR). We sought to characterise the patients, clinical management, and outcomes regarding this rare phenomenon. METHODS: Relevant articles were identified by a systematic search of MEDLINE and EMBASE databases from January, 2002 to September, 2015. RESULTS: A total of 18 case reports, including 20 patients, were identified. The median age was 83 years and six were male. Twelve were performed by trans-femoral approach. Pre-dilation was performed in 12 patients and post-dilation in four. Balloon expandable valves were used in the majority (85%) of cases. The clinical presentation varied from asymptomatic to progressive heart failure. The timing of the diagnosis also varied significantly from immediately post valve implantation to one year afterwards. There were two cases of Gerbode-type defect while the rest were inter-ventricular defects. The location was mostly membranous or perimembranous (79%) and adjacent to the valve landing zone. A total of seven interventions (one open surgery and six percutaneous closure) were performed. Four patients died during the same hospital admission. Sixteen survived past discharge (range 12 days to two years). CONCLUSIONS: Ventricular septal defects post-TAVR were seen more with balloon expandable valves and with pre-dilation or post-dilation. Percutaneous treatment of the VSD was preferred over open cardiac surgery given the high surgical risk in this patient population. Some, but not all, patients survived TAVR and VSD and had a good prognosis for both patient groups with or without VSD closure.

Endovascular medicine certification 2005-2014: report from the American Board of Vascular Medicine.

This report describes the methods used to develop and maintain the endovascular medicine certification examination, which has been offered by the American Board of Vascular Medicine (ABVM) to practicing physicians since 2005. The report covers the methods and findings used to develop examination specifications which ensure the content and construct validity of the examination assessment such that the examination is reflective of the job tasks associated with the endovascular medicine specialty, as well as being a meaningful indicator of whether a candidate possesses the knowledge and skills necessary for competent practice. Further, this report covers the procedures used to develop, maintain, and administer the examination, including a summary of the content review process and the use of statistical information. Based on psychometric evaluation of the examination's performance, the ABVM's endovascular medicine examination appears to be a valid assessment of professional competency in the specialty area; a finding that supports the inference that candidates who pass the examination are qualified to practice in a manner that protects patients.

The first 10 years of the American Board of Vascular Medicine.

The American Board of Vascular Medicine (ABVM) was conceived through the Society for Vascular Medicine and this year will complete 10 years of certifying physicians who practice vascular medicine and endovascular medicine. The value of certification to our physicians, patients, and field cannot be understated. This paper reviews the highlights of the test development process, quality assurance measures, and management of these high stakes examinations.

Management of Aortic Aneurysms: Is Surgery of Historic Interest Only?

Since its advent in 1991, endovascular aortic aneurysm repair (EVAR) has become a mainstay of treatment for abdominal aortic aneurysms (AAA). Studies such as the comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR 1) trial, have demonstrated the effectiveness of EVAR in reducing perioperative mortality. Technological improvements in graft design and delivery account for an increasing utilization of endovascular repair. Newer branch and fenestrated graft designs have allowed for treatment of patients with complex aortic anatomy that previously could not be treated with EVAR. Endovascular repair, while dominant, is unlikely to eliminate the need for open repair or to relegate open surgery for AAA to historical interest only. The unprecedented adoption of EVAR has led to complications and modes of failure that were not seen with open repair. The rate of failure is markedly increased when endografts are used outside of the instructions for use (IFU). The long-term durability of fenestrated and investigational branch devices remains to be established. The demand for an endovascular approach by patients and the willingness of physicians to place endografts outside the anatomic IFU criteria may have resulted in the pendulum swinging too far away from open surgical management. The consequence of reduced open aortic surgeries is a concern for both patient care as well as training for vascular surgery fellows. Vascular surgery training programs will require innovative changes in training to assure that vascular surgery trainees will have the requisite skill and experience required to competently perform open surgical repair on what will undoubtedly be some of the most complex aortic pathology.

Quality of care among patients undergoing lower extremity revascularization.

BACKGROUND: Compliance with guidelines for treating patients with peripheral artery disease (PAD) lags compliance for treating patients with coronary artery disease. We assessed the gap between guidelines and practice for patients with PAD who underwent lower extremity revascularization (LER) at our institution from 2007 to 2010. METHODS: Quality of care (QoC) was calculated by measuring provider performance on four indicators (antiplatelet therapy, dyslipidemia management, control of hypertension, and diabetes) derived from the ACCF/AHA PAD guidelines. The QoC score was calculated at the time of admission and at time of discharge for each patient, and reflects the proportion of indicated treatments received. RESULTS: Patients (n = 734, mean age 70±11, female 51%) were followed for a mean of 2.0±1.4 years (range 0-5.7) following LER. The indication for LER was claudication (24.8%), rest pain (16.7%), and tissue loss (58.4%). The percentage of patients with a perfect QoC score increased significantly during hospital admission (11% to 21%, p < 0.001). Significant multivariate predictors of perfect QoC score included race/ethnicity, Charlson score, severity of LE ischemia, and observation period (admission, discharge). Multivariate analysis demonstrated that age>75 years, heart failure, chronic kidney disease, rest pain, and tissue loss-but not compliance with four guideline-based therapies-were associated with decreased freedom from the composite endpoint of major amputation, repeat revascularization, and death. CONCLUSIONS: Although adherence to guidelines improved over time, we found a significant gap between guidelines and practice for this cohort of patients at increased risk for adverse cardiovascular events.

Carotid artery stenting after carotid endarterectomy.

Atherosclerotic carotid artery disease remains an important cause of cerebrovascular ischemic disease. We present a patient with residual stenosis of the distal internal carotid artery following carotid endarterectomy that was treated with stenting. The case highlights the potential complimentary benefits of carotid endarterectomy and carotid stenting.

Detection of common carotid artery stenosis using duplex ultrasonography: a validation study with computed tomographic angiography.

BACKGROUND: Severe stenosis of the common carotid artery (CCA), while uncommon, is associated with increased risk of transient ischemic attack and stroke. To date, no validated duplex ultrasound criteria have been established for grading the severity of CCA stenosis. The goal of this study was to use receiver-operating curve (ROC) analysis with computed tomographic angiography as the reference standard to establish duplex ultrasound criteria for diagnosing >or=50% CCA stenosis. METHODS: The study cohort included 64 patients (42 men, 22 women) with a mean age of 65 +/- 12 years (range, 16-89 years) who had CCA peak systolic velocity (PSV) >or=150 cm/sec and underwent computed tomographic angiography (CTA) of the cervical and intracerebral vessels within 1 month of the duplex examination. One study was excluded because the CTA was technically inadequate, whereas another was excluded because the patient underwent bilateral CCA stenting. The CCA ipsilateral to any of the following was excluded from the analysis: innominate artery occlusion (n = 1), previous stenting of the ICA or CCA (n = 7), carotid endarterectomy (n = 1), or carotid-to-carotid bypass (n = 1). Thus, the data set included 62 patients and 115 vessels. Bland-Altman analysis was used to examine the agreement between two measures of luminal reduction measured by CTA: percent diameter stenosis and percent area stenosis. Receiver operating characteristic (ROC) analysis was used to determine optimal PSV and EDV thresholds for diagnosing >or=50% CCA stenosis. RESULTS: Severity of CCA stenosis was <50% in 76 vessels, 50%-59% in eight, 60%-69% in eight, 70%-79% in nine, 80%-89% in three, 90%-99% in five, and occluded in six. Duplex ultrasonography identified six of six (100%) patients with 100% CCA occlusion by CTA. Bland-Altman analysis showed poor agreement between percent stenosis determined by vessel diameter compared with percent stenosis determined by reduction in lumen area. Therefore, subsequent analysis was performed using percent stenosis by area. ROC analysis of different PSV thresholds for detecting stenosis >or=50% showed that >182 cm/sec was the most accurate with a sensitivity of 64% and specificity of 88% (P < .0001). Sensitivity, specificity, and accuracy of carotid duplex were higher when the stenosis was located in the mid or distal aspects of the CCA (sensitivity 76%, specificity 89%, area under curve 0.84, P < .001) than in the intrathoracic and proximal segment of the artery (P = NS). ROC analysis of different EDV thresholds for detecting CCA stenosis >or=50% showed that >30 cm/sec was the most accurate with a sensitivity of 54% and a specificity of 74% (P < .0239). CONCLUSIONS: Duplex ultrasonography is highly sensitive, specific, and accurate for detecting CCA lesions in the mid and distal CCA. Use of peak systolic velocity may lead to improved detection of CCA disease and initiation of appropriate therapy to reduce the risk of stroke.

Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting.

BACKGROUND: We analyzed the risk of adverse events following carotid angioplasty and stenting (CAS) in patients <80 years (group I) compared with those > or = 80 years of age (group II). METHODS: Prospective data from 224 patients who underwent 235 consecutive CAS procedures at three participating institutions were reviewed retrospectively. All subjects were enrolled in Food and Drug Administration-approved clinical trials of CAS in high-risk patients or in institutional protocols. Procedural details and angiographic morphology were reviewed in all cases. All patients underwent independent neurological evaluation at 24hr and 30 days following CAS. RESULTS: Mean age was 69.9 years in the younger cohort and 83.5 years in the older group. Embolic protection devices were successfully deployed in 97.5% of cases in group I compared with 98.7% in group II (p=nonsignificant [NS]). Procedural success, defined as <30% residual stenosis after CAS, was achieved in all cases. Mean hospital stay was similar in the two groups. Transient ischemia attacks occurred in 1.9% in group I and 1.3% in group II (p=NS). Within 30 days of CAS, the risk of minor or major stroke (p=NS) as well as the composite risk of stroke (minor or major) and death was 2.5% in group I and 3.8% in group II (p=NS). Multivariate logistic regression analysis showed that absence of hypertension (odds ratioi [OR]=0.38, p=0.0352) and chronic renal insufficiency (OR=2.62, p=0.0238) were significant predictors of the composite end point of stroke and all-cause mortality. Kaplan-Meier analysis revealed that survival and freedom from the combined end point of stroke and all-cause mortality were similar for patients in groups I and II. CONCLUSION: Octogenarians are not at increased risk of periprocedural adverse events following CAS compared to younger patients. Exclusion of high-risk patients from CAS based on age alone is unjustified.

WITHDRAWN: Carotid Artery Stenting.

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Combined endovascular and open revascularization.

The last decade has borne witness to a transformation in the care of patients with vascular disease. There has been a rapid transition towards minimally invasive techniques as interventionalists obtain increasingly advanced catheter-based skills and access to newer and more sophisticated devices. Patients who are not candidates for completely percutaneous revascularization, or those felt to be at prohibitive risk for traditional surgical reconstruction, may benefit from hybrid therapy, a combination of open surgery and endovascular repair that offers patients the opportunity for complete revascularization with decreased morbidity and mortality. This review examines applications of hybrid procedures for treating patients with disabling claudication and limb-threatening ischemia, aortic arch disease, thoracoabdominal aneurysms, extra-cranial carotid disease, and coronary artery disease.