MEETING THE GROWING DEMAND FOR ATRIAL FIBRILLATION ABLATION: ST. JOSEFS-HOSPITAL WIESBADEN, GERMANY GROWING DEMAND FOR AF ABLATION

Atrial fibrillation (AF) is the most common arrhythmia of clinical significance, with increased prevalence associated with demographic trends and lifestyle changes.1–5 It is estimated that one in four middle-aged adults in Europe will develop AF.6–8 By 2030, it is anticipated that there will be 14–17 million patients with AF in the European Union, with 120 000–215 000 newly diagnosed patients each year.9, 10

AF is associated with increased morbidity, such as stroke and failure. Studies show that 20–30% of patients with an ischaemic stroke have AF diagnosed before, during, or after the initial event.11–13

The rising incidence of AF is a growing burden on healthcare systems, with an estimated annual cost of €660 million to the German healthcare system,14 and 1% of the National Health Service budget in the United Kingdom.15

Pulmonary vein isolation (PVI) with ablation has been proven to be an effective treatment option for patients with AF.16 Studies have also demonstrated that PVI using cryoballoon ablation, rather than radiofrequency (RF), has been associated with reduced resource needs. This is due in part to the fact that cryoballoon procedures tend to be shorter and more predictable compared to RF procedures.17, 18

THE DEPARTMENT AT ST. JOSEFS-HOSPITAL

The hospital’s cardiology department had one hybrid operating room for TAVI procedures and a second cath lab for coronary angiography and device implantation. A third cath lab was operated by cardiologists in private practice and could be typically used by the hospital two days per week.

The hospital EP division was created in January 2015, when Prof. Dr. Joachim Ehrlich joined the cardiology department. To support EP procedures, one of the cath labs was initially turned into a mobile EP lab for EP studies and AF ablations. 2 3 BEFORE THE PROCESS THE PROCESS OPTIMISATION PROJECT OPTIMISATION PROJECT

Cryoballoon was adopted as an index procedure for Prof. Ehrlich became the head of the cardiology 2. Measure the problem patients with paroxysmal AF, since it was proven to department in August 2016, gaining the opportunity be a safe and effective approach to PVI, with shorter to optimise EP lab procedure management. In this To clearly identify and assess the inefficiencies and more reproducible procedures compared to capacity, he identified the potential to increase the delaying lab occupancy time per patient, all pre radiofrequency (RF). hospital’s EP lab efficiency to meet the growing and post-procedure steps were timed and outlined demand for AF ablations. on a value stream map. Prior to the implementation of the process optimisation project in August 2016, the roles and Given the recognised need to better optimise the The available EP lab time and average lab occupancy responsibilities for performing cryoballoon ablation management of cryoballoon procedures, the decision time was as follows: procedures were as follows: was made to work together with Medtronic to implement a process optimisation project based on ▪ Available EP lab time: 10 hours per day ▪ One nurse to prepare the procedure and monitor Lean Six Sigma methodology. the patient ▪ Lab occupancy time for cryoballoon In accordance with Lean Six Sigma methodology, procedures: 3 hours per patient ▪ Two electrophysiologists (EP) to perform the the project steps were as follows: cryoballoon procedure and manage the EP recording system Given the available lab time and the average lab 1. Define the project scope with an internal occupancy time per patient, the hospital had the process review Nurses available for cryoballoon ablations capacity to perform three procedures supported both EP lab and cath lab procedures. 2. Measure the problem via process cycle analyses per allocated cryoballoon day (3.33 patients). When the EP division was first created, Prof. Ehrlich 3. Analyse the sources of the problems was the only EP on staff, until he was joined by At the time, the average daily demand, was for five Dr. Kaess in April 2016. 4. Implement the solution procedures per cryoablation day. To meet their established objective, the team needed to reduce 5. Sustain the solution The EP lab was dedicated to cryoballoon procedures lab occupancy time per cryoballoon procedure from one day per week and the team performed an 180 minutes to 100 minutes. To sustain this change, average of three procedures on such days. 1. Define the project scope with an there was also the need to increase demand for internal process review the procedure.

The goal defined for this project was to double the 3. Identify the sources of delay number of AF procedures performed per allocated day from three to six in a single year. The process map on the following page (figure 1) outlines the current lab occupancy time required for To do so, there was a recognised need to address each step of the procedure cycle. Lab occupancy inefficiencies associated with patient transfers, times for each step of the procedure process procedure preparation, lab cleaning, and staff availability, are listed in dark blue and cycle durations without given the impact of such factors on lab occupancy time. waiting time are listed in light blue.

Opportunities for improvement are highlighted in green, to illustrate where there were gaps between the current lab occupancy time and the cycle time per patient without waiting time.

4 5 Figure 1: Value stream map 3.1 Analyse and address the problems D) Transesophageal (TEE) for thrombus exclusion and transseptal In accordance with the findings from the value stream puncture (TSP) Average lab occupany time per pt = 180 min map analysis (figure 1), the following delays were Average lab cycle time per pt (without waiting time) = 136 min identified throughout the procedure cycle: To further optimise lab occupancy time, the EPs decided that performing TEE-guided TSP was Improvement opportunity A) Lab preparation unnecessary, and that thrombi could be excluded in the echo lab on the day of the procedure, prior Time wasted during the procedure preparation stage to ablation. often resulted from a shortage of nurses available to LAB prepare the procedure material on time. This was due Therefore, the decision was made to stop routinely PREPARATION 27 – 33 FOR in part to resource constraints and to a lack of effective performing TEEs for TSPs. To further optimise this CYROABLATION communication within the team, which resulted in step of the procedure, the decision was made to nurses not being informed that they were needed to have a second EP prepare the cryoballoon material prepare the next procedure in due time. during the TSP. These changes reduced the time required for each procedure by an average of To address this issue, efforts were made to improve 11 minutes. START lines of communication within the team and to allocate a second nurse to material preparation for E) Cryoablation procedure LAB PATIENT IS PATIENT IS PHYSICIAN INITIAL TSP TRANSESOPHAGEAL each procedure. PREPARATION TRANSFERRED POSITIONED STARTS ECHOCARDIOGRAPHY FOR INTO THE LAB ON TABLE FOR PROCEDURE (TEE) FOR Procedure reproducibility and patient turnover were CYROABLATION PROCEDURE THROMBUS EXCLUSION B) Patient transfer from the ward to the lab identified by the team as areas for improvement. AND TRANSSEPTAL PUNCTURE (TSP) Inefficiencies associated with patient transfers typically To help reduce the variability of procedure times, resulted from a lack of effective communication within which was particularly relevant when a new EP the team and insufficient lead time for the initiation was being trained, the hospital implemented a 15 – 20 14 3 3 20 – 37 15 6 – 17 4 11 – 15 11 5 – 21 5 of the patient transfer. Given this challenge, the team standardised dosing protocol. This protocol reduced concluded that nurses responsible for the the duration of cryoapplications from an average management of patient transfers required a lead of four minutes to three minutes and eliminated time of at least 27 minutes. the need to apply additional cryoapplications if the pulmonary vein was isolated in less than one minute. To better optimise this step of the procedure cycle, a process was implemented wherein the next patient is To help facilitate the efficiency of the patient transferred to the lab during the ablation of the current turnover process at the end of each procedure, the END patient’s right pulmonary veins. decision was also made to stop propofol infusions PROCEDURE STOP PRESSURE PATIENT IS LAB CONTACT TIME before isolating the last pulmonary vein. BLEEDING OF BANDAGE TRANSFERRED CLEANING SPECIFIED FOR PUNCTURE SITE OUT OF DISINFECTANT C) Patient positioned on the table for the procedure THE LAB F) Lab cleaning process Delays related to patient positioning were generally associated with a lack of coordinated communications The process optimisation project helped to between the nurses and EPs. As a result, nurses often spotlight the fact that lab cleaning was not being had to wait in the EP lab for physicians to arrive so that performed as efficiently as it could be. This was due 50 – 101 46 15 – 38 15 5 5 3 3 15 – 33 10 5 – 10 5 the team could begin the procedure. in part to the fact that there was a lack of cleaning staff dedicated to the cath labs and EP lab and to To address this issue, the expectation was set for the fact that they were not consistently informed of physicians to remain in the lab as much as possible when they would be needed in the lab sufficiently during allocated cryoballoon days. A process was also in advance. implemented wherein nurses are expected to provide To address this problem, the hospital added a EPs with at least 5-10 minutes notice before they are needed for the procedure.

6 7 second cleaner for the labs and required that they be 4. Sustain the solution given sufficient notice before they are needed to clean a lab. To maintain the efficiency gains derived from the process optimisation project, a material preparation Resulting time savings checklist was created and processes related to the procedure were formalised. A team of four nurses Since implementing the solutions identified via the was designated to EP procedures as well, enabling the process optimisation project, the lab occupancy time creation of a specialised team who could collaborate for cryoballoon ablation procedures was decreased and communicate effectively and support procedures from 180 minutes to 100 minutes per patient. Such efficiently. Based on the learnings from the process ™ time savings enabled the team to meet their goal of optimisation project, subsequent cryoablation Arctic Front Advance performing six procedures in a single day, which they procedures were consistently performed according Cardiac Cryoablation Catheter continue to do consistently. The hospital even managed to the following steps: to perform eight procedures in a single lab, in a single day (07.30 to 18.00) by reducing the lab occupancy time to 90 minutes. 1. Patients are seen in the outpatient clinic for 7. A nurse in the EP lab informs the nurse who bloodwork a few weeks before the procedure is with the next patient to begin preparing to have the procedure explained, to sign the the patient for the next procedure during the consent form and to have necessary isolation of the right pulmonary veins. Propofol medication prescriptions. perfusion is stopped before the last PVI (unless is required) to help facilitate an 2. On the morning of the procedure, patients efficient patient turnover. are taken for an ECG. If the patient is in atrial fibrillation, a TEE is performed. 8. The groin puncture site is closed with a purse-string suture. 3. Two nurses work together to prepare the procedure material before each case.

4. The patient is prepared for the procedure in a room on the same floor as the EP lab.

5. Once the procedure material is prepared, the patient is brought into the lab and the nurse informs the EP that the procedure is nearly ready to begin. The nurse administers the propofol to the patient before the physicians arrive.

6. During the procedure, there is typically one electrophysiologist at the EP recording system and two EPs at the bedside for the cryoballoon 9. A TEE is performed to exclude preparation. Once the cryoballoon is inserted, pericardial effusion. the second EP leaves the EP lab. Two nurses will monitor the patient and support the procedure, 10. The patient is then transferred to the nearby as needed. An automated pump is used for recovery room on the same floor. contrast delivery to optimise and standardise the process as precisely as possible (adjusts contrast very precisely at a predefined speed).

8 9 AWARENESS EFFORTS

In parallel with the process optimisation Such efforts have resulted in a consistently higher project, Prof. Ehrlich collaborated with demand for AF ablation procedures and establishing Medtronic to organise educational events stronger relationships with referring physicians in for referring physicians. the area.

Such events sought to promote the benefits To meet this increased demand, the hospital associated with AF ablation and to build has since trained a third electrophysiologist and awareness of EP expertise and activities at established a second cryoablation day. A new EP St. Josefs-Hospital Wiesbaden. lab is also planned for 2024.

CONCLUSION

The process optimisation project and referral physician awareness efforts proved to be very successful, enabling St. Josefs-Hospital Wiesbaden to increase AF ablation demand and capacity. Prof. Ehrlich and his team perform an average of six procedures per cryoablation day, with the capacity to reach up to eight procedures per day.

The number of cryoballoon procedures performed per year also increased from 33 in 2015 to 125 in 2016 and to 210 in 2017.

Since the process optimisation measures were put in place, the EP team has hosted physicians from across Europe who are interested in optimising their AF ablation procedure management and applying learnings to their own EP labs. The EP lab management at St. Josefs-Hospital Wiesbaden is thus serving as a model to derive learnings from Germany and across much of Europe.

10 11 References: 1. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D’Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: The framingham heart study. Circulation. 2004; 110:1042–1046. [PubMed: 15313941] 2. Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: The rotterdam study. Eur Heart J. 2006; 27:949–953. [PubMed: 16527828] 3. Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the renfrew/paisley study. Heart. 2001; 86:516–521. [PubMed: 11602543] 4. Wolf PA, Benjamin EJ, Belanger AJ, Kannel WB, Levy D, D’Agostino RB. Secular trends in the prevalence of atrial fibrillation: The framingham study. Am Heart J. 1996; 131:790–795. [PubMed: 8721656] 5. Piccini JP, Hammill BG, Sinner MF, Jensen PN, Hernandez AF, Heckbert SR, Benjamin EJ, Curtis LH. Incidence and prevalence of atrial fibrillation and associated mortality among medicare beneficiaries, 1993–2007. Circ Cardiovasc Qual Outcomes. 6. Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006;27:949–953. 7. Lloyd-Jones DM,Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D’Agostino RB, Massaro JM, Beiser A,Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004;110:1042–1046. 8. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285:2370–2375. 9. Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J 2013;34: 2746–2751. 10. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014;6:213–220. 11. Kishore A, Vail A, Majid A, Dawson J, Lees KR, Tyrrell PJ, Smith CJ. Detection of atrial fibrillation after ischemic stroke or transient ischemic attack: a systematic review and meta-analysis. Stroke 2014;45:520–526. 12. Henriksson KM, Farahmand B, Asberg S, Edvardsson N, Terent A. Comparison of cardiovascular risk factors and survival in patients with ischemic or hemorrhagic stroke. Int J Stroke 2012;7:276–281. 13. Grond M, Jauss M, Hamann G, Stark E, Veltkamp R, Nabavi D, Horn M,Weimar C, Kohrmann M,Wachter R, Rosin L, Kirchhof P. Improved detection of silent atrial fibrillation using 72-hour Holter ECG in patients with ischemic stroke: a prospective multicenter cohort study. Stroke 2013;44:3357–3364. 14. McBride D, Mattenklotz A, Willich S, Brüggenjürgen B. The costs of care in atrial fibrillation and the effect of treatment modalities in Germany. Value Health. 2009;12:293–301 15. Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart. 2004;90:286–292. 16. Kirchhof P, Benussi S, Kotecha D et al., 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS, European Heart Journal 2016. 17. Monnickendam, Giles, and Carlo De Asmundis. Why the distribution matters: Using discrete event simulation to demonstrate the impact of the distribution of procedure times on hospital operating room utilisation and average procedure cost . Operations Research for Health Care 16 (2018) 20–28 18. Kowalski M. et al. J Invasive Cardiol. 2016 May;28(5): 176-82. 5:85–93. [PubMed: 22235070]

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