Interventional cardiologist perceptions about PCI without surgical backup-Results of an international survey.

BACKGROUND: Percutaneous coronary intervention (PCI) without surgical backup is becoming increasingly common in the United States. Additionally, a recent SCAI expert consensus document has liberalized recommendations for performing PCI without cardiac surgery on site (SOS). AIMS: The current study sought to understand practice patterns and operator preferences with regard to performing PCI without SOS. METHODS: Two internet-based surveys were distributed to interventional cardiologists worldwide. Survey items asked about operator demographics, procedural preferences when performing PCI without SOS, self-judged personality traits, and history of malpractice. RESULTS: Between March 2021 and May 2021, 517 interventional cardiologists completed the survey; 341 of whom perform elective PCI without SOS (no-SOS operators), and 176 who perform elective PCI with surgical backup (SOS operators). Most operators were male 473 (91.5%). There was a greater proportion of SOS operators in academic practice (86 vs. 75, p < 0.001) and greater proportion of no-SOS operators in hospital-owned practices (158 vs. 56, p < 0.001). Lesion characteristics (left main, chronic total occlusions, and need for atherectomy) were the most important procedural attributes for no-SOS operators, and international operators reported higher comfort levels with PCI on high-risk lesions. Cumulative personality profile scores were similar between SOS and no-SOS operators. SOS operators expressed more concern with legal ramifications of performing PCI without SOS (2.57 vs. 2.34, p = 0.049). CONCLUSIONS: In the absence of surgical backup, lesion characteristics were the most important consideration for PCI patient selection for operators worldwide. Compared to the United States, international operators were more confident in performing high-risk PCI without surgical backup.

A Heart Team Approach to Assessing Frailty in the Cardiac Catheterization Laboratory.

INTRODUCTION: Frailty is a well-documented risk factor for increased morbidity and mortality among patients undergoing percutaneous coronary intervention (PCI). There remains a lack of knowledge regarding the impact of patient frailty in cardiac patient management and outcomes. Thus, this study examined whether the Heart Team, without using frailty assessments, made decisions regarding coronary interventions [medical management (MM) vs. PCI vs. coronary artery bypass grafting (CABG)] that aligned with formally quantified frailty status. MATERIAL AND METHODS: This cross-sectional quality-improvement (QI) study was performed at a single, large, urban Veterans Affairs Hospital. From September 2019 to November 2020, heart team nurses approached patients prior to coronary angiograms and assessed for frailty using the Risk Analysis Index Questionnaire (RAIC). Interventional cardiologists were blinded to the results. This study's independent variable was RAI-C score. The outcome variables were "intervention performed" (MM, PCI, or CABG) and presence of a "reduced invasiveness intervention" (RI). RESULTS: Ninety-five of the 182 participants had obstructive coronary artery disease. Among them, there were 69 PCIs, 10 CABGs, and 16 MMs. 26 received RIs. The primary outcomes demonstrated that frailty score was positively associated with receiving RI [adjusted OR = 1.13, 95% CI = 1.02-1.24, p = 0.02] and MM [adjusted OR = 1.13, CI = 1.02-1.25, p = 0.02], and negatively associated with receiving PCI [adjusted OR = 0.94, CI = 0.88-0.998, p = 0.04]. There was no significant association between frailty and the likelihood of undergoing CABG [AOR = 0.95, CI = 0.81-1.10, p = 0.47]. CONCLUSION: This study demonstrated that the Heart Team and patients at baseline reduced high-risk interventions in frailer patients. A Heart Team, shared-decision-making model utilizing the RAI-C was found to be efficient and effective at measuring frailty in coronary angiogram patients and should be considered for use in the clinical setting.

Radiation protection in the cardiac catheterization laboratory.

The trend towards more minimally invasive procedures in the past few decades has resulted in an exponential growth in fluoroscopy-guided catheter-based cardiology procedures. As these techniques are becoming more commonly used and developed, the adverse effects of radiation exposure to the patient, operator, and ancillary staff have been a subject of concern. Although occupational radiation dose limits are being monitored and seldom reached, exposure to chronic, low dose radiation has been shown to have harmful biological effects that are not readily apparent until years after. Given this, it is imperative that reducing radiation dose exposure in the cardiac catheterization laboratory remains a priority. Staff education and training, radiation dose monitoring, ensuring use of proper personal protective equipment, employment of shields, and various procedural techniques in minimizing radiation must always be diligently employed. Special care and consideration should be extended to pregnant women working in the cardiac catheterization laboratory. This review article presents a practical approach to radiation dose management and discusses best practice recommendations in the cardiac catheterization laboratory.

Medicolegal Characteristics of Cardiac Tamponade Litigation: A Review of the LexisNexis Academic Database.

OBJECTIVE: To review, describe, and analyze medicolegal literature involving cases of cardiac tamponade. BACKGROUND: Currently, there are no studies known to these authors assessing the outcome patterns of medicolegal cases involving patients with cardiac tamponade. This potentially lethal condition may have serious consequences on both patients and clinicians. Thus, the literature was reviewed for patterns of liability and medical outcomes in patients who developed cardiac tamponade. METHODS: Legal case opinions were reviewed from LexisNexis Academic that contained the search term "tamponade"; case characteristics, litigation outcomes, and medical outcomes were identified. RESULTS: 230 case opinions were reviewed. 143 involved cardiac tamponade. Of these cases, 77 were medical malpractice cases, 30 were criminal cases, 11 were insurance claims, and the rest were other types. In malpractice cases, 35 (45%) patients were male, 69 (90%) formally named at least one doctor as a defendant, 54 (70%) claimed iatrogenicity as a cause of tamponade, and surgeons were the most commonly named defendants at 36 cases (47%). Open surgical drainage was the most common treatment at 28 (36%) cases and death was the outcome in 60 (78%) cases. Judgements were in favor of at least one doctor in 29 (42%) cases, against at least one doctor in 13 (19%) cases, and 12 (17%) cases involved a settlement by a physician. CONCLUSIONS: This study describes previously unknown medicolegal characteristics of cardiac tamponade cases.

Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis.

BACKGROUND: We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. METHODS: We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. RESULTS: In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P<.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P=.0035) and HL (63.72%, P<.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P<.0001) and smoking (38.41%, P=.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P<.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (ß<0.02) statistically significant temporal trends over time, except for sex. CONCLUSIONS: There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.

Association Between Chronic Kidney Disease and Rates of Transfusion and Progression to End-Stage Renal Disease in Patients Undergoing Transradial Versus Transfemoral Cardiac Catheterization-An Analysis From the Veterans Affairs Clinical Assessment Reporting and Tracking (CART) Program.

BACKGROUND: Patients with chronic kidney disease (CKD) are at increased risk for bleeding, transfusion, and dialysis after cardiac catheterization. Whether rates of these complications are increased in this high-risk population undergoing transradial access compared with transfemoral access is unknown. METHODS AND RESULTS: From the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking program, we identified 229 108 patients undergoing cardiac catheterization between 2007 and 2014, of which 48 155 (21.0%) had baseline glomerular filtration rate (GFR) between 15 and 59 mL/min. We used multivariable Cox modeling to determine the independent association between transradial access and postprocedure transfusion as well as progression to new dialysis by degree of renal dysfunction. Overall, 35 979 (15.7%) of patients underwent Transradial access. Transradial patients tended to be slightly younger, but, overall, had similar rates of CKD compared to transfemoral patients (24.3% vs 27.1%). Transradial patients had longer fluoroscopy times (7.2 vs 6.0 minutes; P<0.001), but lower contrast use (85.0 vs 100.0 mL; P<0.001). The estimated rate of blood transfusion within 48 hours was lower among transradial patients (0.85% vs 1.01%) as were rates of new dialysis at 1 year (0.58% vs 0.71%). After multivariable adjustment, transradial access was associated with lower rates of progression to dialysis at 1 year overall (hazard ratio [HR], 0.83; 95% CI, 0.70-0.98), with no trend of increased risk for dialysis by degree of CKD compared with transfemoral access. Transradial access was associated with greater reduction in transfusion rates with increasing degree of CKD (P value for trend=0.04: non-CKD: HR, 0.99; 95% CI, 0.73-1.34; GFR 45-59 mL/min: HR, 0.93; 95% CI, 0.70-1.23; GFR 30-44 mL/min: HR, 0.73; 95% CI, 0.51-1.03; GFR 15-29 mL/min: HR, 0.43; 95% CI, 0.20-0.90). CONCLUSIONS: Among patients undergoing cardiac catheterization in the VA health system, transradial access was associated with lower risk for postprocedure transfusion within 48 hours among patients with more-severe CKD, and with lower risk of progression to end-stage renal disease at 1 year compared with transfemoral access. These data provide additional evidence that transradial access may provide significant benefit in this high-risk population.

Image noise reduction technology reduces radiation in a radial-first cardiac catheterization laboratory.

BACKGROUND: Transradial coronary angiography (TRA) has been associated with increased radiation doses. We hypothesized that contemporary image noise reduction technology would reduce radiation doses in the cardiac catheterization laboratory in a typical clinical setting. METHODS AND RESULTS: We performed a single-center, retrospective analysis of 400 consecutive patients who underwent diagnostic and interventional cardiac catheterizations in a predominantly TRA laboratory with traditional fluoroscopy (N=200) and a new image noise reduction fluoroscopy system (N=200). The primary endpoint was radiation dose (mGy cm2). Secondary endpoints were contrast dose, fluoroscopy times, number of cineangiograms, and radiation dose by operator between the two study periods. Radiation was reduced by 44.7% between the old and new cardiac catheterization laboratory (75.8mGycm2±74.0 vs. 41.9mGycm2±40.7, p<0.0001). Radiation was reduced for both diagnostic procedures (45.9%, p<0.0001) and interventional procedures (37.7%, p<0.0001). There was no statistically significant difference in radiation dose between individual operators (p=0.84). In multivariate analysis, radiation dose remained significantly decreased with the use of the new system (p<0.0001) and was associated with weight (p<0.0001), previous coronary artery bypass grafting (p<0.0007) and greater than 3 stents used (p<0.0004). TRA was used in 90% of all cases in both periods. Compared with a transfemoral approach (TFA), TRA was not associated with higher radiation doses (p=0.20). CONCLUSIONS: Image noise reduction technology significantly reduces radiation dose in a contemporary radial-first cardiac catheterization clinical practice.

Radiation Exposures Associated With Radial and Femoral Coronary Interventions.

OPINION STATEMENT: The volume of cardiac diagnostic procedures involving the use of ionizing radiation has increased rapidly in recent years, and the radiation exposure experienced by patients undergoing any medical imaging procedure has recently obtained a growing attention. Transradial (TR) access is being increasingly used worldwide for diagnostic coronary angiography (CA), and percutaneous coronary interventions, since it offers several benefits as compared to transfemoral (TF) access, such as by reducing hemostasis time and vascular complications, increased patient comfort, reduced hospital stay, and lower cost. In contrast, TR CA is thought to be associated with increased radiation exposure parameters compared with the traditional TF access. Although experienced operators may almost counterbalance this shortcoming, the increase in radiation exposure associated with TR approach seems not to be present in most clinical settings.

Radiation safety and vascular access: attitudes among cardiologists worldwide.

OBJECTIVES: To determine opinions and perceptions of interventional cardiologists on the topic of radiation and vascular access choice. BACKGROUND: Transradial approach for cardiac catheterization has been increasing in popularity worldwide. There is evidence that transradial access (TRA) may be associated with increasing radiation doses compared to transfemoral access (TFA). METHODS: We distributed a questionnaire to collect opinions of interventional cardiologists around the world. RESULTS: Interventional cardiologists (n=5332) were contacted by email to complete an on-line survey from September to October 2013. The response rate was 20% (n=1084). TRA was used in 54% of percutaneous coronary interventions (PCIs). Most TRAs (80%) were performed with right radial access (RRA). Interventionalists perceived that TRA was associated with higher radiation exposure compared to TFA and that RRA was associated with higher radiation exposure that left radial access (LRA). Older interventionalists were more likely to use radiation protection equipment and those who underwent radiation safety training gave more importance to ALARA (as low as reasonably achievable). Nearly half the respondents stated they would perform more TRA if the radiation exposure was similar to TFA. While interventionalists in the United States placed less importance to certain radiation protective equipment, European operators were more concerned with physician and patient radiation. CONCLUSIONS: Interventionalists worldwide reported higher perceived radiation doses with TRA compared to TFA and RRA compared to LRA. Efforts should be directed toward encouraging consistent radiation safety training. Major investment and application of novel radiation protection tools and radiation dose reduction strategies should be pursued.

Perceptions of advantages and barriers to radial-access percutaneous coronary intervention in VA cardiac catheterization laboratories.

BACKGROUND/PURPOSE: Compared with trans-femoral percutaneous coronary intervention (TFI), trans-radial PCI (TRI) has a lower risk of bleeding, access site complications and hospital costs, and is preferred by patients. However, TRI accounts for a minority of PCIs in the US, and there is currently little research that explores why. METHODS/MATERIAL: We conducted a national survey in February 2013 to assess perceptions of TRI vs. TFI, and barriers to TRI adoption and implementation among interventional cardiologists employed by the US Veterans Health Administration (VHA), and linked these data to site-level TRI annual rates for 2013. RESULTS: We received 78 completed surveys (32% response rate). Respondents at sites that perform few or no TRIs identified increased radiation exposure as the greatest barrier while at sites that perform a high percentage of TRIs respondents identified the steep learning curve as the greatest barrier. Majorities of survey respondents at all sites rated TRI as superior on 5 of 7 criteria, including patient comfort and bleeding complications, but rated TFI as superior on procedure time and procedure success. CONCLUSIONS: Even interventional cardiologists at sites that perform few or any TRIs recognized the superiority of TRI for patient comfort and safety, but rated it inferior to TFI on procedure time and technical results. Interventional cardiologists at high-TRI labs rated TRI as equivalent on procedure time and technical results. Efforts to increase TRI adoption and implementation may be more successful if they emphasize that procedure times and technical results depend on achieving proficiency.

Temporal trends in percutaneous coronary intervention--associated acute cerebrovascular accident (from the 1998 to 2008 Nationwide Inpatient Sample Database).

Acute cerebrovascular accident (CVA) after percutaneous coronary intervention (PCI) for acute coronary syndrome and coronary artery disease is associated with high rates of morbidity and mortality. Nationwide Inpatient Sample from 1998 to 2008 was used to identify 1,552,602 PCIs performed for acute coronary syndrome and coronary artery disease. We assessed temporal trends in the incidence, predictors, and prognostic impact of CVA in a broad range of patients undergoing PCI. The overall incidence of CVA was 0.56% (95% confidence interval [CI] 0.55 to 0.57). The incidence of CVA remained unchanged over the study period (adjusted p for trend=0.2271). The overall mortality rate in the CVA group was 10.76% (95% CI 10.1 to 11.4). The adjusted odds ratio (OR) of CVA for in-hospital mortality was 7.74 (95% CI 7.00 to 8.57, p<0.0001); this remained high but decreased over the study period (adjusted p for trend<0.0001). Independent predictors of CVA included older age (OR 1.03, 95% CI 1.02 to 1.03, p<0.0001), disorder of lipid metabolism (OR 1.31, 95% CI 1.24 to 1.38, p<0.001), history of tobacco use (OR 1.21, 95% CI 1.10 to 1.34, p=0.0002), coronary atherosclerosis (OR 1.56, 95% CI 1.43 to 1.71, p<0.0001), and intra-aortic balloon pump use (OR 1.39, 95% CI 1.09 to 1.77, p=0.0073). A nomogram for predicting the probability of CVA achieved a concordance index of 0.73 and was well calibrated. In conclusion, the incidence of CVA associated with PCI has remained unchanged from 1998 to 2008 in face of improved equipment, techniques, and adjunctive pharmacology. The risk of CVA-associated in-hospital mortality is high; however, this risk has decreased over the study period.

Myocardial infarction due to intracoronary embolization of percutaneous coronary intervention packaging.

Intracoronary device loss is occasionally encountered and removal is commonly performed at the time of the procedure. We report a case of removal of a retained coronary balloon protective plastic tubing inadvertently left in the coronary artery for a month and associated with myocardial infarction. Optical coherence tomography was used to visualize the foreign body prior to removal with a snare. To our knowledge this is the first report of a removal of disposable packaging equipment after prolonged intracoronary dwell time.

A review of radiation exposures associated with radial cardiac catheterisation.

Transradial (TR) cardiac catheterisation is thought to be associated with an increased exposure to radiation compared with the traditional transfemoral (TF) access. This paper provides a review of current literature describing these reported associations. Although several studies have reported an increase in radiation exposure to both operator and patient with TR compared with TF access, others have reported findings suggesting no significant difference, even reporting decreased exposure with TR access. Ultimately, increased radiation exposure appears likely with TR access; however, in consideration of the many benefits associated with TR access, radiation exposure remains only one of many considerations when deciding between routes of access.

Medicolegal characteristics of cardiac catheterization litigation in the United States, 1985 to 2009.

There are few assessments of patterns of medicolegal cases involving cardiac catheterizations. This descriptive study reviews the patterns of liability and medical outcomes involving cardiac catheterization litigation from the LexisNexis Academic database and the Physician Insurers Association of America registry. From 1985 to 2009, the Physician Insurers Association of America registry documented 1,361 closed coronary angiography claims. The cardiovascular disease specialty was involved in 699 with other specialties involved in the remaining cases. Of the 1,361 closed claims, 301 (22%) resulted in payments to the plaintiff (average indemnity of $230,987). The most common alleged error was for improper performance (35.4%; average indemnity of $255,542). The alleged error with the highest average indemnity of $270,916 was errors in diagnosis. Not performing an indicated procedure had the highest ratio of paid to closed claims (41%) with an average indemnity of $246,988. In regard to the severity of injury, death was the most common outcome (44%). The highest ratio of paid to total closed claims (43%) was for grave injuries (highest average indemnity of $555,625). Of the 116 LexisNexis cases, litigation against physicians occurred in 90.5% of cases with judgments in favor of the patients in 29.5%. When death was the outcome (31% of cases), physicians were highly likely to be sued (97%) and the judgment was more likely in the plaintiffs' favor (44%). In conclusion, in litigation related to cardiac catheterizations, most cases are due to medical malpractice and physicians are sued in a high percentage of cases. Cardiologists should recognize these patterns of litigation as these may impact and improve processes of care.