A quality framework for the role of invasive, non-interventional cardiologists in the present-day cardiac catheterization laboratory: A multidisciplinary SCAI/HFSA expert consensus statement.

The present-day cardiac catheterization laboratory (CCL) is home to varied practitioners who perform both diagnostic, interventional, and complex invasive procedures. Invasive, non-interventional cardiologists are performing a significant proportion of the work as the CCL environment has evolved. This not only includes those who perform diagnostic-only cardiac catheterization but also heart failure specialists who may be involved in hemodynamic assessment and in mechanical circulatory support and pulmonary hypertension specialists and transplant cardiologists. As such, the training background of those who work in the CCL is varied. While most quality metrics in the CCL are directed towards evaluation of patients who undergo traditional interventional procedures, there has not been a focus upon providing these invasive, noninterventional cardiologists, hospital/CCL administrators, and CCL directors a platform for quality metrics. This document focuses on benchmarking quality for the invasive, noninterventional practice, providing this physician community with guidance towards a patient-centered approach to care, and offering tools to the invasive, noninterventionalists to help their professional growth. This consensus statement aims to establish a foundation upon which the invasive, noninterventional cardiologists can thrive in the CCL environment and work collaboratively with their interventional colleagues while ensuring that the highest quality of care is being delivered to all patients.

Heart Team: Joint Position of the Swiss Society of Cardiology and the Swiss Society of Cardiac Surgery.

The Swiss Society of Cardiology (SSC) and the Swiss Society of Cardiac and ThoracicVascular Surgery (SSCTVS) have formulated their mutual intent of a close, patient-oriented, and expertise-based collaboration in the Heart Team Paper. The interdisciplinary dialogue between the SSC and SSCTVS reflects an attitude in decision making, which guarantees the best possible therapy for the individual patient. At the same time, it is a cornerstone of optimized process quality, placing individual interests into the background. Evaluation of the correct indication for a treatment is indeed very challenging and almost impossible to verify retrospectively. Quality in this very important health policy process can therefore only be assured by the use of mutually recognized indications, agreed upon by all involved physicians and medical specialties, whereby the capacity of those involved in the process is not important but rather their competence. These two medical societies recognize their responsibility and have incorporated international guidelines as well as specified regulations for Switzerland. Former competitors now form an integrative consulting team able to deliver a comprehensive evaluation for patients. Naturally, implementation rests with the individual caregiver. The Heart Team Paperof the SGK and SGHC, has defined guide boards within which the involved specialists maintain sufficient room to maneuver, and patients have certainty of receiving the best possible therapy they require.

Radiation dose benchmarks in pediatric cardiac catheterization: A prospective multi-center C3PO-QI study.

OBJECTIVES: This study sought to update benchmark values to use a quality measure prospectively. BACKGROUND: Congenital Cardiac Catheterization Outcomes Project - Quality Improvement (C3PO-QI), a multi-center registry, defined initial radiation dose benchmarks retrospectively across common interventional procedures. These data facilitated a dose metric endorsed by the American College of Cardiology in 2014. METHODS: Data was collected prospectively by 9 C3PO-QI institutions with complete case capture between 1/1/2014 and 6/30/2015. Radiation was measured in total air kerma (mGy), dose area product (DAP) (µGy*M2 ), DAP per body weight, and fluoroscopy time (min), and reported by age group as median, 75th and 95th %ile for the following six interventional procedures: (1) atrial septal defect closure; (2) aortic valvuloplasty; (3) treatment of coarctation of the aorta; (4) patent ductus arteriosus closure; (5) pulmonary valvuloplasty; and (6) transcatheter pulmonary valve implantation. RESULTS: The study was comprised of 1,680 unique cases meeting inclusion criteria. Radiation doses were lowest for pulmonary valvuloplasty (age <1 yrs, median mGy: 59, DAP: 249) and highest in transcatheter pulmonary valve implantation (age >15 yrs, median mGy: 1835, DAP: 17990). DAP/kg standardized outcome measures across weights within an age group and procedure type significantly more than DAP alone. Radiation doses decreased for all procedures compared to those reported previously by both median and median weight-based percentile curves. These differences in radiation exposure were observed without changes in median fluoroscopy time. CONCLUSIONS: This study updates previously established benchmarks to reflect QI efforts over time. These thresholds can be applied for quality measurement and comparison. © 2017 Wiley Periodicals, Inc.

Fiberoptic Contact-Force Sensing Electrophysiological Catheters: How Precise Is the Technology?

BACKGROUND: Contact-force (CF) sensing catheters are increasingly used in electrophysiological procedures due to their efficacy and safety profile. As data about the accuracy of fiberoptic CF technology are scarce, we sought to quantify it using in vitro experiments. METHODS AND RESULTS: A force sensor was built with a flexible membrane to allow exact reference force measurements for each set of experiments. A TactiCath Quartz (TCQ) ablation catheter was brought in contact with the force sensor membrane in order to compare the TCQ force measurements to sensor reference force measurements. Measurements were performed at different tip angles (0°/perpendicular contact, 45°, 90°/parallel contact), with fluid irrigation, different degrees of catheter deflection, and using a sheath. The accuracy of the TCQ force measurements was 0.9 ± 0.9 g (0°), 0.8 ± 0.8 g (45°) and 1.2 ± 1.3 g (90°), 0.8 ± 0.7 g (irrigation), 0.8 ± 0.8 g (deflection), and 0.8 ± 0.9 g (sheath); this was not significantly different among all experimental conditions. The precision was ≤3.8%. CONCLUSION: CF measurements using a fiberoptic sensing technology show a high level of accuracy and precision, without being significantly influenced by tip angle, fluid irrigation, catheter deflection or use of a sheath.

Optimizing the management of acute coronary syndromes in sub-Saharan Africa: A statement from the AFRICARDIO 2015 Consensus Team.

BACKGROUND: Whereas the coronary artery disease death rate has declined in high-income countries, the incidence of acute coronary syndromes (ACS) is increasing in sub-Saharan Africa, where their management remains a challenge. AIM: To propose a consensus statement to optimize management of ACS in sub-Saharan Africa on the basis of realistic considerations. METHODS: The AFRICARDIO-2 conference (Yamoussoukro, May 2015) reviewed the ongoing features of ACS in 10 sub-Saharan countries (Benin, Burkina-Faso, Congo-Brazzaville, Guinea, Ivory Coast, Mali, Mauritania, Niger, Senegal, Togo), and analysed whether improvements in strategies and policies may be expected using readily available healthcare facilities. RESULTS: The outcome of patients with ACS is affected by clearly identified factors, including: delay to reaching first medical contact, achieving effective hospital transportation, increased time from symptom onset to reperfusion therapy, limited primary emergency facilities (especially in rural areas) and emergency medical service (EMS) prehospital management, and hence limited numbers of patients eligible for myocardial reperfusion (thrombolytic therapy and/or percutaneous coronary intervention [PCI]). With only five catheterization laboratories in the 10 participating countries, PCI rates are very low. However, in recent years, catheterization laboratories have been built in referral cardiology departments in large African towns (Abidjan and Dakar). Improvements in patient care and outcomes should target limited but selected objectives: increasing awareness and recognition of ACS symptoms; education of rural-based healthcare professionals; and developing and managing a network between first-line healthcare facilities in rural areas or small cities, emergency rooms in larger towns, the EMS, hospital-based cardiology departments and catheterization laboratories. CONCLUSION: Faced with the increasing prevalence of ACS in sub-Saharan Africa, healthcare policies should be developed to overcome the multiple shortcomings blunting optimal management. European and/or North American management guidelines should be adapted to African specificities. Our consensus statement aims to optimize patient management on the basis of realistic considerations, given the healthcare facilities, organizations and few cardiology teams that are available.

Using Data to Improve Quality: the Pediatric Cardiac Care Consortium.

A program to collect and analyze cardiac catheterization, electrophysiologic studies and cardiac operations in children was initiated in 1982. The purpose was to help centers compare their experience and outcomes with a group of centers to determine areas where their performance might improve. Cardiac centers became members of the Pediatric Cardiac Care Consortium and submitted demographic data and copies of procedure reports regularly to a central office. Data were extracted from the reports, coded by trained coders and entered into a computer database. Annually, the data were analyzed to compare the experience of an individual center with that of the entire group of centers. The annual data were adjusted for severity on the basis of eight factors selected after discussion with participants in the Consortium. Adjustment was by multivariate analysis. Reports were prepared for each center and distributed at an annual meeting. The data were used by centers to review operations where the mortality rate exceeded +2 standard deviations of the group. With discussion, the center staff often initiated changes to improve outcome. The outcome could then be monitored by the annual reports. Our data were also utilized in the creation of the Risk Adjustment for Surgery for Congenital Heart Disease (RACHS)-1 categories of disease severity. The mortality rates of our centers were comparable with the combined hospital discharge data from New York, Massachusetts, and California. From 1982 through 2007, the mortality rates of our centers dropped for each RACHS-1 category, falling to less than 1% for categories 1 and 2 for the last 5-year period. During the 25 years, we received data from 52 centers about 137 654 patients who underwent 117 756 cardiac operations.

Major complications and mortality within 30 days of an electrophysiological procedure at an academic medical center: implications for developing national standards.

BACKGROUND: Despite growing attention to performance and quality measures, national standards for reporting of outcomes after all electrophysiology (EP) procedures have not yet been developed. We sought to characterize the incidence and timing of adverse events up to 30 days after EP procedures at a tertiary academic medical center. METHODS AND RESULTS: We prospectively followed all patients undergoing EP procedures between January 2010 and September 2012. All were followed for 30 days postprocedure either in clinic or by telephone. Major complications were defined as events related to the procedure that led to prolongation of hospital stay or readmission, required additional procedural intervention, or resulted in death or significant injury. These were further categorized as intraprocedure, postprocedure, or postdischarge events. Seven EP physicians collectively adjudicated whether complications were directly related to the procedure. A total of 3,213 procedures were performed. Major complications occurred in 2.2% of patients; 49% of these events occurred after discharge. Death occurred in 0.6% of patients; 73% of these deaths were found to be secondary to worsening of the patient's underlying comorbid conditions and unrelated to the procedure. CONCLUSIONS: When considering national standards for reporting outcomes of all EP procedures, continued follow-up after discharge is important. In our cohort, half of major complications occurring within 30 days occurred after discharge. In addition, three-quarters of deaths within 30 days were not directly related to the procedure and caution should be used in using all-cause mortality as an outcome measure for EP procedures.

Rotor stability separates sustained ventricular fibrillation from self-terminating episodes in humans.

OBJECTIVES: This study mapped human ventricular fibrillation (VF) to define mechanistic differences between episodes requiring defibrillation versus those that spontaneously terminate. BACKGROUND: VF is a leading cause of mortality; yet, episodes may also self-terminate. We hypothesized that the initial maintenance of human VF is dependent upon the formation and stability of VF rotors. METHODS: We enrolled 26 consecutive patients (age 64 ± 10 years, n = 13 with left ventricular dysfunction) during ablation procedures for ventricular arrhythmias, using 64-electrode basket catheters in both ventricles to map VF prior to prompt defibrillation per the institutional review board-approved protocol. A total of 52 inductions were attempted, and 36 VF episodes were observed. Phase analysis was applied to identify biventricular rotors in the first 10 s or until VF terminated, whichever came first (11.4 ± 2.9 s to defibrillator charging). RESULTS: Rotors were present in 16 of 19 patients with VF and in all patients with sustained VF. Sustained, but not self-limiting VF, was characterized by greater rotor stability: 1) rotors were present in 68 ± 17% of cycles in sustained VF versus 11 ± 18% of cycles in self-limiting VF (p < 0.001); and 2) maximum continuous rotations were greater in sustained (17 ± 11, range 7 to 48) versus self-limiting VF (1.1 ± 1.4, range 0 to 4, p < 0.001). Additionally, biventricular rotor locations in sustained VF were conserved across multiple inductions (7 of 7 patients, p = 0.025). CONCLUSIONS: In patients with and without structural heart disease, the formation of stable rotors identifies individuals whose VF requires defibrillation from those in whom VF spontaneously self-terminates. Future work should define the mechanisms that stabilize rotors and evaluate whether rotor modulation may reduce subsequent VF risk.

Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures.

Despite the advent of non-fluoroscopic technology, fluoroscopy remains the cornerstone of imaging in most interventional electrophysiological procedures, from diagnostic studies over ablation interventions to device implantation. Moreover, many patients receive additional X-ray imaging, such as cardiac computed tomography and others. More and more complex procedures have the risk to increase the radiation exposure, both for the patients and the operators. The professional lifetime attributable excess cancer risk may be around 1 in 100 for the operators, the same as for a patient undergoing repetitive complex procedures. Moreover, recent reports have also hinted at an excess risk of brain tumours among interventional cardiologists. Apart from evaluating the need for and justifying the use of radiation to assist their procedures, physicians have to continuously explore ways to reduce the radiation exposure. After an introduction on how to quantify the radiation exposure and defining its current magnitude in electrophysiology compared with the other sources of radiation, this position paper wants to offer some very practical advice on how to reduce exposure to patients and staff. The text describes how customization of the X-ray system, workflow adaptations, and shielding measures can be implemented in the cath lab. The potential and the pitfalls of different non-fluoroscopic guiding technologies are discussed. Finally, we suggest further improvements that can be implemented by both the physicians and the industry in the future. We are confident that these suggestions are able to reduce patient and operator exposure by more than an order of magnitude, and therefore think that these recommendations are worth reading and implementing by any electrophysiological operator in the field.

Variation in postoperative care following stage I palliation for single-ventricle patients: a report from the Joint Council on Congenital Heart Disease National Quality Improvement Collaborative.

BACKGROUND AND METHODS: The National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) has established a national data registry for patients with hypoplastic left heart syndrome and its variants undergoing staged palliation. The goal of this collaborative is to better understand current care practices and to improve outcomes in children with these severe and complex forms of congenital heart disease. In this study, we describe the postoperative intensive care course, and its variations, for the first 100 patients enrolled into the registry. RESULTS: Patients were enrolled from 21 contributing sites and were discharged home after stage I palliation between July 2008 and February 2010. Following stage I palliation, enrolled participants remained in the intensive care unit for a median duration of 11 days (range: 3-68 days). Duration of intensive care unit stay varied and was greatest for those patients with aortic atresia versus aortic hypoplasia (P= 0.04) and for those who underwent a modified Blalock-Taussig shunt as part of their palliation. The duration of intensive care unit stay also varied by contributing site (medians ranged from 8 to 18 days). Participants requiring reoperation had significantly prolonged lengths of stay (P= .0003). Inotropic agent use among univentricular registry participants also varied by site. The majority of recipients received milrinone (87%), dopamine (64%), and epinephrine (62%). Cardiac catheterization following surgery occurred in 20 patients. Fifteen percent of participants underwent an interventional procedure. Complication following stage I palliation was also fairly common. CONCLUSIONS: Considerable variation exists in the postoperative course and management of univentricular patients following stage I palliation. Variation in length of intensive care unit stay, inotropic agent use, need for reoperation or cardiac catheterization, and postoperative complications are described. Further studies to determine etiologies for observed variation may result in improved standards of care and better outcomes during the interstage period.

Tratamiento percutáneo de las bioprótesis aórticas disfuncionantes con la prótesis CoreValve® / Percutaneous treatment of a dysfunctional aortic bioprosthesis with the coreValveW prosthesis

El implante valvular aórtico percutáneo ha surgido recientemente como alternativa terapéutica para pacientes con estenosis aórtica severa sintomática y alto riesgo quirúrgico. Se presenta la experiencia inicial en el tratamiento de la disfunción de la bioprótesis aórtica mediante el implante percutáneo de prótesis aórtica CoreValve en 4 pacientes, tanto con estenosis como con insuficiencia aórtica, y se analiza los resultados hospitalarios y a medio plazo. El procedimiento se realizó con anestesia local y guiado por angiografía. Se implantaron con éxito en todos los casos, si bien uno precisó una segunda prótesis por posicionamiento alto de la primera. No hubo complicaciones mayores. Tras un seguimiento medio de 7±4,7 meses, todos los pacientes se encuentran asintomáticos (AU)

Recently, percutaneous aortic valve replacement has emerged as a therapeutic option for patients with severe symptomatic aortic stenosis and a high surgical risk. We report our initial experience in four patients with percutaneous implantation of a CoreValve aortic prosthesis to treat aortic bioprosthesis dysfunction involving aortic stenosis or regurgitation. In-hospital and medium-term outcomes were analyzed. The procedure was performed under local anesthesia and guided by angiography. The prosthesis was implanted successfully in all patients, although a second prosthesis was required in one case because the first was positioned too high. There were no major complications. After a mean followup of 7 months (SD, 4.7), all patients remained asymptomatic (AU)

Anesthesia in the cardiac catheterization laboratory and electrophysiology laboratory.

Procedures and interventions in the cardiac catheterization laboratory (CCL) and electrophysiology laboratory (EPL) are more complex and involve acutely ill patients. Safely caring for this growing patient population in the CCL and EPL is now a concern for all anesthesiologists and cardiologists. Anesthesiologists are uniquely trained to care for this complex patient population, allowing the cardiologist to focus on completing the interventional procedure successfully.

[Interventional cardiology in Latvia from 1993 to 2003]. / Invasive Kardiologie in Lettland von 1993 bis 2003.

A nationale programme for combatting cardiovascular diseases is being implemented in Letvia. A milestone was reached in 1993 with the establishment of a Letvian Centre for Cardiology. Within 10 years the only cardiac catheterization unit in the country has developed into a centre of excellence. But to meet the cardiological needs for all of Letvia requires at least three additional units for left heart catheterization and one for paediatric a cardiac catheterization.

Cath lab credentialing ... it's not just for nurses anymore!

Despite the many ups and downs, departmental credentialing for the CCL is a success and is here to stay. There is no difference with respect to performance expectations for RNs and CVTs in our lab. The differences between professional nursing and technical staff lie in their approaches to direct patient care. Nurses offer a holistic approach to care delivery in the cath lab, while CVTs approach care from a procedure-oriented viewpoint. It is our belief that the blending of these two approaches offers the highest quality of patient care and teamwork in this highly stressful environment. Our staff demonstrates that RNs and CVTs work well together and form a cohesive team because they not only share information, but also teach each other necessary skills. Credentialing provides objective documentation to support their efforts and hard work.