High-volume Operators Research Articles

"Simple" Transcatheter Aortic Valve Replacement With Conscious Sedation: Safety and Effectiveness in Real-World Practice.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to open surgical replacement. Strictly selecting low-risk patients and using conscious sedation during TAVR has enabled hospital stays to be safely shortened. We evaluated the safety and effectiveness of a less rigorous patient-selection process involving multidisciplinary case discussions, percutaneous procedures with the use of conscious sedation, and postprocedural care outside an intensive care unit, with the goal of discharging patients from the hospital early. We call this "simple TAVR." We retrospectively reviewed the records of patients who underwent TAVR from March 2015 through February 2020 at our center. The procedures were performed by 2 high-volume operators. Of 524 total procedures, 344 (65.6%) qualified as simple TAVR. All 344 procedures were successful. The highest 30-day complication rate was associated with new permanent pacemaker implantation (7.3%, 25 patients); the rates of major vascular complications, stroke, and all-cause death were less than 3% each. Of note, 252 patients (73.3%) were discharged from the hospital the day after TAVR, and 307 (89.2%) within 48 hours. Simple TAVR is safe, economical, and feasible in real-world practice, and it does not necessitate a rigorous perioperative protocol or patient-selection process.

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.

PurposeCatheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes.MethodsPatients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10–12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable.ResultsEnrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients.DiscussionReal-AF’s multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery.Trial registrationClinicaltrials.gov: NCT04088071 (registration date: September 12, 2019)Supplementary InformationThe online version contains supplementary material available at 10.1007/s10840-021-01031-w.

Operator Volumes and In-Hospital Outcomes: An Analysis of 7,740 Rotational Atherectomy Procedures Fromthe BCIS National Database.

The aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes. Whether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined. Data from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes. In total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p=0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95%CI: 0.975 to 0.993; p<0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95%CI: 0.939 to 0.991; p=0.008), arterial complications (OR: 0.975/case; 95%CI: 0.975 to 0.982; p<0.001) and in-hospital major bleeding (OR: 0.985/case; 95%CI: 0.977 to 0.993; p<0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of<4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold. In-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.

Reattempt Percutaneous Coronary Intervention of Chronic Total Occlusions after Prior Failures: A Single-Center Analysis of Strategies and Outcomes.

Objective The initial recanalization rate of coronary chronic total occlusions (CTOs) is >85% when performed by experienced operators, but only 10% of prior failed CTO patients receive reattempted recanalization. This retrospective study analyzed the success rate and strategies used in reattempt percutaneous coronary intervention (PCI) of CTOs after prior failures. Methods Overall, 206 patients with 212 CTOs were enrolled. All patients with prior recanalization failures received reattempt PCIs from January 2015 to March 2019 at Zhongshan Hospital, Fudan University. Data on clinical factors (age, sex, comorbidities, left ventricular ejection fraction, history of cigarette usage, and revascularization), angiographic characteristics of CTOs (target lesion, Japanese Chronic Total Occlusion (J-CTO) score, the morphology of CTO lesions, and collateral channel scale), strategies (procedural approach and use of devices), and major adverse events were obtained and analyzed. Results The mean age of enrolled patients was 60.96 ± 12.36 years, with a male predominance of 90.3%. Of the patients, 47.1% had a prior myocardial infarction and 70.4% underwent stent implantation previously, while the in-stent occlusion rate was 6.6%. CTOs were primarily localized in the left anterior descending artery (43.9%) and the right coronary artery (43.9%). 80.7% of lesions were classified as very difficult (J-CTO score ≥3), and the overall success rate was 81.1%. In multivariable regression analysis, J-CTO score, collateral channel scale, application of coronary multispiral computed tomography angiography, dual injection, intravascular ultrasound, active greeting technique, parallel wiring, and CTO morphology were predictors of recanalization success. There were no significant differences in rates of procedural complications between the final recanalization success and failure groups. Conclusions Recanalization of complex CTOs is associated with high success rate and low complication rates when performed by high-volume CTO operators and after multiple reattempts.

Impact of operator experience and volume on outcomes after complete repair for tetralogy of Fallot.

The aim of this study was to assess the impact of individual operator experience on outcomes after complete repair for tetralogy of Fallot. This is a retrospective cohort study. Consecutive patients who underwent TOF repair at a single institution were included and compared according to whether the primary operator was an experienced, high-volume operator (defined as an operator who performed at least 20 surgical procedures for congenital heart disease defined as complex by the Risk Adjustment for Congenital Heart Surgery classification per year for at least 3 consecutive years). The primary outcome was defined as a composite of death, or reintervention, or significant annular peak gradient, or significant pulmonary regurgitation. Multivariable logistic regression and Cox proportional-hazards model analyses were used to assess the relationships between operator experience and outcomes. From January 2012 to December 2017, a total of 1760 patients with primary diagnosis of TOF underwent TOF repair by 37 operators. Of these, 5 operators (13.5%) were considered experienced, and 32 (86.5%) were considered less experienced. Complete follow-up data were available for 1728 complete repair for TOF patients with a median follow-up duration of 49 months; in 611 patients (35.4%), the surgery was performed by experienced operators, and in 1117 patients (64.6%), the surgery was performed by less experienced operators. Adjusted risks for the primary outcome and significant pulmonary regurgitation were lower for patients who were treated by experienced operators, both at discharge [adjusted odds ratio 0.67, 95% confidence interval (CI) 0.50-0.90; adjusted odds ratio 0.54, 95% CI 0.37-0.78, respectively] and at follow-up (adjusted hazard ratio 0.82, 95% CI 0.68-0.97; adjusted hazard ratio 0.70, 95% CI 0.56-0.87, respectively). The trend for the primary outcome during follow-up remained unchanged, even in most subgroups. Increased surgeon experience is associated with improved risk-adjusted outcomes. These results have potentially important implications for individual training, quality improvement and hospital programmes in the context of complete repair for TOF. http://www.chictr.org.cn number, ChiCTR2000033234.

"Simple" Transcatheter Aortic Valve Replacement With Conscious Sedation: Safety and Effectiveness in Real-World Practice.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to open surgical replacement. Strictly selecting low-risk patients and using conscious sedation during TAVR has enabled hospital stays to be safely shortened. We evaluated the safety and effectiveness of a less rigorous patient-selection process involving multidisciplinary case discussions, percutaneous procedures with the use of conscious sedation, and postprocedural care outside an intensive care unit, with the goal of discharging patients from the hospital early. We call this "simple TAVR." We retrospectively reviewed the records of patients who underwent TAVR from March 2015 through February 2020 at our center. The procedures were performed by 2 high-volume operators. Of 524 total procedures, 344 (65.6%) qualified as simple TAVR. All 344 procedures were successful. The highest 30-day complication rate was associated with new permanent pacemaker implantation (7.3%, 25 patients); the rates of major vascular complications, stroke, and all-cause death were less than 3% each. Of note, 252 patients (73.3%) were discharged from the hospital the day after TAVR, and 307 (89.2%) within 48 hours. Simple TAVR is safe, economical, and feasible in real-world practice, and it does not necessitate a rigorous perioperative protocol or patient-selection process.

Editorial introductions.

Editorial introductions.

Device entrapment during percutaneous coronary intervention of chronic total occlusions: incidence and management strategies.

Equipment delivery in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can be challenging and it is associated with a higher risk of device entrapment. Data regarding the incidence of device entrapment during CTO PCI are lacking. The aim of this study was to describe the incidence and procedural characteristics of device entrapment in patients undergoing PCI for CTOs and discuss management strategies for dealing with it. Device entrapment was characterised in a large consecutive series of 2,361 CTO PCI cases performed by five high-volume CTO Italian operators between January 2015 and January 2020. Device entrapment occurred in 36 out of 2,361 cases (1.5%) and consisted of coronary guidewires in 13 (0.5%), microcatheters in 6 (0.2%), balloons in 6 (0.2%), rotational atherectomy burrs in 10 (0.4%) and guiding catheter extension in 1 patient (0.04%). Complete device retrieval was achieved in 63.9%, with at least partial removal of material in 97.2%. Vessel recanalisation was still possible in 86.1% of cases even after device entrapment. Intraprocedural myocardial infarction occurred in 3 patients (8.3%), tamponade with urgent pericardiocentesis in 1 (2.8%) and emergency surgical removal of the entrapped device in 1 patient (2.8%). Mean radiation dose was 4.7±2.3 Gy. At 30-day follow-up, one patient died with stent thrombosis of a non-target vessel and another required repeat percutaneous revascularisation. Device entrapment during CTO revascularisations is a rare but potentially severe complication. We describe and discuss current techniques of percutaneous retrieval that can be employed to achieve procedural success safely.

Printed titanium implants in UK craniomaxillofacial surgery. Part II: perceived performance (outcomes, logistics, and costs)

This second part explores perceptions and understanding of clinical performance, turnaround, and costs for printed titanium implants or plates in common procedures, evaluating both ‘in-house’ and ‘outsourced’ CAD-CAM pathways. A cross-sectional study, supported by the British Association of Oral and Maxillofacial Surgeons (BAOMS) and a national trainee-led recruitment team, was conducted over 14 weeks. A total of 132 participants took part (demographic data is reported in Part I). For fibular-flap mandibular reconstruction, most participants (69% - 91%) perceived printed titanium as superior to intraoperatively or preoperatively hand-bent plates for surgical duration, accuracy, dental restorability, and aesthetics. There was less agreement about complications and plate-failure risks. Most perceived printed plates to be superior to traditional wafer-based maxillary osteotomy for surgical duration (61%) and maxillary positioning (60%). For orbital floor repair, most perceived improvements in surgical duration (83%, especially higher-volume operators p=0.009), precision (84%), and ease of placement (69%). Rarely (less than 5%) was any outcome rated inferior to traditional techniques for any procedure. Perceived turnaround times and costs were variable, but the greatest consensus was for two-segment fibular-flap reconstructions and orbital floor repair. Industry estimates were generally consistent between two company representatives, but manufacturing-only costs differed when using in-house (departmental) designers. Costs and turnaround times are questionable barriers since few understand ‘real-world’ figures. Designing in-house can dramatically alter costs. Improved accuracy and surgical duration are common themes but biomechanical benefits are less-well understood. This study paints a picture of the potentially routine applications and benefits of printed titanium, capacity for uptake, understanding amongst surgeons, and areas for improvement.

Management of Percutaneous Coronary Intervention Complications: Algorithms From the 2018 and 2019 Seattle Percutaneous Coronary Intervention Complications Conference.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Percutaneous approaches for retrieval of an embolized or malpositioned left atrial appendage closure device: A multicenter experience

Experience with retrieval of a Watchman left atrial (LA) appendage (LAA) closure device (WD) is limited. An embolized or grossly malpositioned WD warrants retrieval to minimize the risk of thromboembolic complications and vascular occlusion. The purpose of this study was to report approaches for percutaneous retrieval of a WD from multicenter experience. Data on successful WD retrievals were obtained from high-volume operators. Data included clinical characteristics; structural characteristics of the LA and LAA; and procedural details of the deployment and retrieval procedure, type of retrieval (immediate: during the same procedure; delayed: during a separate procedure after the successful deployment), equipment used, complications, and postretrieval management. Ten successful percutaneous and 1 surgical retrievals comprised this study. Seven patients had immediate retrieval, while 4 had delayed retrieval. The median duration before delayed retrieval was 45 days (range 1-45 days). The median LAA diameter and size of a successfully deployed WD was 16 mm (range 14-24 mm) and 21 mm (range 21-30 mm), respectively. A WD was retrieved from the LA (n=1), LAA (n = 2), left ventricle (n = 2), and aorta (n = 6). The reason for retrieval from the LAA was inadequate deployment, resulting in a significant peri-device leak. Retrieval from the LA or LAA was successfully performed using snares (n = 2) and a Raptor grasping device (n = 1). Retrieval from the left ventricle was achieved with a snare (n = 1) and surgery (n = 1). Retrieval from the aorta required snares (n = 5) and retrieval forceps (n = 1). Five patients were successfully reimplanted with a larger size WD. The only complication during percutaneous retrieval was a pseudoaneurysm. Retrieval of an embolized or malpositioned WD is feasible, and familiarity with snares and grasping tools can facilitate a successful removal.

Percutaneous Coronary Intervention for Chronic Total Occlusion—The Michigan Experience: Insights From the BMC2 Registry

ObjectivesThe aim of this study was to describe the performance and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in Michigan. BackgroundCTO PCI has been associated with reduction in angina, but previous registry analyses showed a higher rate of major adverse cardiac events with this procedure. MethodsTo study uptake and outcomes of CTO PCI in Michigan, patients enrolled in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry (2010 to 2017) were evaluated. CTO PCI was defined as intervention in a 100% occluded coronary artery ≥3 months old. ResultsAmong 210,172 patients enrolled in the registry, 7,389 CTO PCIs (3.5%) were attempted, with 4,614 (58.3%) achieving post-procedural TIMI (Thrombolysis In Myocardial Infarction) flow grade 3. The proportion of PCIs performed on CTOs increased over the study period (from 2.67% in 2010 to 4.48% in 2017). Thirty of 47 hospitals performed >50 CTO interventions in 2017. Pre-procedural angina class ≤2 was present in one-quarter, and functional assessment for ischemia was performed in 46.6% of patients. Major complications occurred in 245 patients (3.3%) and included death (1.4%), post-procedural stroke (0.4%), cardiac tamponade (0.5%), and urgent coronary artery bypass graft surgery (1.3%). Procedural success improved modestly from 44.5% in 2010 to 54.9% in 2017 (p for trend < 0.001). Rates of in-hospital mortality (p for trend = 0.247) and major adverse cardiac event (p for trend = 0.859) for CTO PCI remained unchanged over the study period. ConclusionsThe rate of CTO PCI in Michigan increased over the study period. Although the success rate of CTO PCI has increased modestly in contemporary practice, it remained far below the >80% reported by select high-volume CTO operators. The rate of periprocedural major adverse cardiac events or death remained unchanged over time. These data suggest room for improvement in the selection and functional assessment of CTO lesions before subjecting patients to the increased procedural risk associated with CTO PCI.

Abstract 347: Can Radiation Exposure in the Catheterization Lab be Controlled With an Increasing Frequency of Complex and High Risk Procedures?

Background: Radiation [stochastic and deterministic] exposes patients and providers that must be balanced against the benefits achieved. Data derived from high exposure events has resulted in a goal of ALARA [as low as reasonably achievable] with concerns at 50 mSv [single event], 100 mSV [proximate exposures], 400 mSv [lifetime exposure]. Cath lab patients may receive high radiation as a consequence of high risk/ complex procedures, obesity, prior PCI/CABG and lesion complexity [ESRD, calcified, CTO], structural disease, supported interventions. Initiatives to reduce radiation exposure include: procedure staging, collimation, mapping, decrease fluoro frame rates and cine run number/length. Procedure: Radiation of patients with invasive procedures in 2018 and 2019 with high exposure stochastic risk [Dose Area Product ≥20,000 μGy* m 2 ( 200 Gy*cm 2 ) or Skin Dose deterministic risk &gt; 5 Gray were analyzed for associations and compared. Effective dose [0.23 mSy/Gy*m 2 ] provides a lifetime risk of fatal cancer related to radiation. Results: Interventional volume increased from 1431 to 1547 PCI. The number and frequency of high DAP exposures decreased [237 to 161] and for 10 of 11 high volume operators; there was no decrease in high Skin Dose cases [83 versus 119]. Associations with high DAP rates: Surgical turndowns [14/161; 9%], high risk/complex procedures (e.g. rotablator [42/161; 26.1%], CTOs [27/161; 16.8%]), Obesity [100/161; 62%; Morbid Obesity 31/161; 19%]. Single vessel PCI patients comprised 41/161; 25.5% of high exposures with 10/41 [24% having a prior CABG]. Single event Dose Area Products were as high as 167,235 μGy* m 2 [effective dose 368 mSv; lifetime risk of fatal cancer 0.92%]; repeat procedures [up to 5 returns/ year with cumulative doses 10/161 in the 100-200 mSv range [1:200 -1:400 lifetime fatal cancer risk]. 36 of the 161 patients were ≤ 60 years old. Despite Skin Doses as high as 14 Gray no skin sequelae occurred. Operators varied in the frequency of high radiation procedures [highest volume 56/268; 21%; all others 105/1547; 8%], influenced by patient selection and procedure, but also by technical variables [e.g. fluoro verus cine, frame rate, collimation]. Conclusions: Despite efforts, radiation exposure remains a concern, aggravated by the need for increasingly high risk, structural heart, and supported interventional procedures. Opportunities for improvement include: lab upgrade to improve imaging in progress, increase staging [CABG , multivessel PCI patients], limit runs/ frame rates, increase mapping, optimize collimation. Lifetime fatal cancer risk is higher in younger than older patients with similar exposures due to both the latency period for cancer development and the likelihood of repeat radiation exposure. Efforts are underway to limit and track the cumulative radiation exposure of patients.

Impact of treatment strategies on long-term outcome of CTO patients

BackgroundThe percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) remains debated. Therefore the aim of this large-scale observational multi-center registry was to compare the long-term outcome of CTO patients undergoing different therapeutic approaches comparing successful CTO revascularization either by PCI or coronary artery bypass graft (CABG), failed CTO-PCI and optimal medical therapy (OMT) alone. Methods and resultsA total of 6630 CTO patients were enrolled from two high-volume centers to compare different treatment strategies. All procedures were performed by high-volume CTO operators in tertiary university hospital. Successful CTO-PCI was performed in 3906 patients, failed CTO-PCI in 1479 patients, 412 patients underwent CABG surgery and 833 patients were treated with OMT. During the 5-year follow-up period, 1019 (15%) patients died. Kaplan-Meier analysis unveiled a significantly improved long-term outcome for CTO patients undergoing revascularization either by PCI or by CABG compared to patients with failed CTO-PCI or OMT alone (log-rank P < 0.001). In the multivariate Cox-regression analysis successful CTO-PCI was associated with significantly improved long-term outcome compared to patients under OMT (adj. HR 0.39, 95%CI 0.33–0.45, P < 0.001) or CABG (adj. HR 0.68, 95%CI 0.53–0.86, P = 0.002) independent of clinical confounders encompassing age, BMI, diabetes, kidney function and left ventricular function. ConclusionsThis study showed an improved long-term outcome for CTO revascularization compared to optimal medical therapy, independent from revascularization mode, with the highest survival rate in patients undergoing successful CTO-PCI.

Editorial introductions

Editorial introductions

Effect of Operator Volume on In-Hospital Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: Based on the 2014 Cohort of Korean Percutaneous Coronary Intervention (K-PCI) Registry.

Background and ObjectivesThe relationship between operator volume and outcomes of percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) has not been fully investigated. We aimed to investigate the relationship between operator PCI volume and in-hospital outcomes after primary PCI for STEMI.MethodsAmong the total of 44,967 consecutive cases of PCI enrolled in the Korean nationwide, retrospective registry (K-PCI registry), 8,282 patients treated with PCI for STEMI by 373 operators were analyzed. PCI volumes above the 75th percentile (>30 cases/year), between the 75th and 25th percentile (10–30 cases/year), and below the 25th percentile (<10 cases/year) were defined as high, moderate, and low-volume operators, respectively. In-hospital outcomes including mortality, non-fatal myocardial infarction (MI), stent thrombosis, stroke, and urgent repeat PCI were analyzed.ResultsThe average number of primary PCI cases performed by 373 operators was 22.2 in a year. In-hospital mortality after PCI for STEMI was 571 cases (6.9%). In-hospital outcomes by operator volume showed no significant differences in the death rate, cardiac death, non-fatal MI, and stent thrombosis. However, the rate of urgent repeat PCI tended to be lower in the high-volume operator (0.6%) than in the moderate-(0.7%)/low-(1.5%) volume operator groups (p=0.095). The adjusted odds ratios for adverse in-hospital outcomes were similar in the 3 groups. Multivariate analysis also showed that operator volume was not a predictor for adverse in-hospital outcomes.ConclusionsIn-hospital outcomes after primary PCI for STEMI were not associated with operator volume in the K-PCI registry.

Comparison of Left Radial Versus Femoral Approaches for Coronary Procedures in Patients with Previous Coronary Artery Bypass Grafts

Aims: Radial approach is gaining the momentum as a default technique for coronary procedures. Limited trails are available for post coronary artery bypass graft (CABG) patients to compare the merits of femoral &amp; radial access.&#x0D; Methods: It is a single-center study conducted in between January, 2013 to December, 2015. During this study period, post CABG patients were blindly assigned to its five high volume operators. Coronary angiography &amp; intervention procedures were performed by left radial or femoral approach as per assigned operator's choice. Contrast volume was the primary endpoint whereas the procedure &amp; fluoroscopy time, procedural success, access site major bleeding, pre discharge major adverse cardiac event (MACE) were the secondary endpoint both for coronary angiogram (CAG) &amp; percutaneous coronary intervention (PCI).&#x0D; Results: Total 380 post CABG patients were included in this study period. Radial access (n=155) was lower than femoral access (n=225). Compared with femoral access, diagnostic CAG required relatively lower contrast volume though statistically not significant via radial access (70±34 vs. 72±40 ml, p=0.267). Procedure time (25.2±10.7 vs. 26.9±6.8 min, p=0.735), fluoroscopy time (10.7±5.5 vs. 9.5±4.7 min, p=0.424) were almost similar in both access for CAG. Other secondary clinical endpoints were similar among both groups. Interestingly, adhoc PCI was more frequent in radial group (n=54 out of 155, 34.8%) than in femoral group (n=44 out of 225, 19.6%) with p=0.01. Contrast volume in between two groups was pretty similar with p=0.226. The incidence of other secondary endpoints was also not statistically significant.&#x0D; Conclusion: Coronary angiography for post CABG patients through left radial approach seems to be effective, non-inferior in terms of contrast volume, procedure &amp; fluoroscopy time &amp; other clinical end points comparing to femoral access.&#x0D; Anwer Khan Modern Medical College Journal Vol. 10, No. 1: Jan 2019, P 11-16

Point-of-care CD4 technology invalid result rates in public health care settings across five countries.

BackgroundSince 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.MethodsWe analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.ResultsAcross the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.ConclusionsOur analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.

Retrograde Versus Antegrade Approach for Coronary Chronic Total Occlusion in an Algorithm-Driven Contemporary Asia-Pacific Multicenter Registry: Comparison of Outcomes

The use of a retrograde approach and algorithm-driven CTO (chronic total occlusion) percutaneous coronary intervention (PCI) has become widespread, and many registries have reported good results. This study established a new algorithm and applied it to current CTO practice and collected a CTO registry to document the results. It compared the outcomes of a retrograde versus antegrade approach in a contemporary multicentre CTO registry. Between 1 January 2016 and 31 December 2016, consecutive patients who underwent CTO PCI performed by eight high-volume CTO operators were included in a registry. During this period, 485 patients with 497 CTOs were treated with technical and procedural success rates of 93.8% and 89.9%, respectively. Antegrade and retrograde technical success was 95.9% and 91.2% (p = 0.03), respectively. Procedural success for antegrade and retrograde was 94.4% and 84.6%, respectively (p < 0.001). The pure retrograde success rate was 80% and pure antegrade success rate was 75%. Technical success in different Japanese Chronic Total Occlusion (JCTO) score groups was 100% (JCTO 0), 96.2% (JCTO 1), 95.3% (JCTO 2), and 92.5% (JCTO ≥ 3), with no statistical difference in success rates between different JCTO scores. In-hospital major adverse cardiac event (MACE) was 3.8% and more common in the retrograde group (6.6% vs 1.5%). The retrograde approach, when used by experienced operators who have been well trained in retrograde approach, can produce higher retrograde success in complex CTO lesions. The use of an algorithm approach can improve procedural efficiency, reduce contrast and radiation dosage, and reduce the time spent in failure mode. These tools remain vital to the development of future CTO PCI.

Ocular radiation exposure during endoscopic retrograde cholangiopancreatography: a meta-analysis of studies.

The increasing complexity involved in procedures requiring fluoroscopy such as endoscopic retrograde cholangiopancreatography (ERCP) results in heightened screening times with attendant radiation exposure during these procedures. There is increasing awareness of tissue-reactions to the lens of the eye due to radiation exposure, with evidence suggesting that threshold doses may be lower than previously considered. A literature search was performed to identify studies involving ERCP in which radiation exposure was reported. Demographic data and data on fluoroscopy time and ocular exposure were extracted. Fixed and random-effects meta-analyses were conducted. Twenty-six studies (8016 procedures) were identified, of which 10 studies (818 procedures) contained data on ocular exposure. The mean screening time per procedure was 3.9 min with a mean of three images captured per procedure. On fixed effects meta-analysis, the point estimate for the effective ocular exposure dose per procedure was 0.018 (95% confidence interval: 0.017-0.019) mSv. On random-effects meta-analysis, the effective ocular exposure dose was 0.139 (0.118-0.160) mSv (Q=2590.78, I=99.5, P<0.001). On comparing these point estimates to the ocular dose limit of 20 mSv/year, 1111 ERCPs (using fixed effects data) and 144 ERCPs (using random-effects data), with a mean of 627 ERCPs/individual/year, could deliver an ocular radiation dose equivalent to this dose limit. Ocular radiation exposures in high-volume ERCP operators (>200 procedures/year) and operators performing complex ERCPs involving prolonged fluoroscopy, need to exercise caution in relation to ocular exposure. Shielding using lead-lined glasses may be reasonable in this group.