University Clinical Center Rijeka Case Study

UNLOCK EP LAB CAPACITY WITH MEDTRONIC CRYOBALLOON

TREAT MORE PATIENTS. SAVE TIME. REDUCE STRESS.

University Clinical Center Rijeka, Croatia

The Arctic Front Advance™ Cardiac Cryoablation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. ATRIAL FIBRILLATION: THE CURRENT EPIDEMIC

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting 1–2% of the general population around the world.1,2 In Europe, there are over six million people diagnosed with AF,2 although the actual number is estimated to be much higher since so many cases remain undiagnosed. With the aging population and increasing life expectancy across Europe, it is estimated that the prevalence of AF will continue to increase with age, from 0.5% at 40–50 years of age to 5–15% at 80 years of age. Given the comparable demographic landscape in Croatia and the assumption that the prevalence of AF is similar to that of the rest of Europe, it is estimated that there are currently 40–50 thousand patients with AF in Croatia.3 Today, there are seven centers in Croatia treating atrial fibrillation patients with pulmonary vein isolation (PVI) via catheter ablation. In 2017, there were 778 AF ablations performed in Croatia, 23% of which were performed with Cryoballoon ablation and 77% with point-by-point radiofrequency (RF) ablation.

FIRE AND ICE,4 the largest multicenter, prospective, outcomes were less operator- and volume- randomized trial to compare the efficacy and safety dependent.5 Cryoballoon ablation results were of Cryoballoon ablation and RF ablation, met its more consistent regardless of center or operator primary safety and efficacy endpoints with shorter, experience. As a result, the outcomes in less more consistent procedure times. Secondary experienced centers favored cryoablation, reflecting analyses results highlight clinically meaningful its shorter learning curve and greater reproducibility.5 outcomes that are highly impactful to patients. A single-center study also demonstrated that RF Relative to RF ablation, Cryoballoon ablation ablation procedure durations are more variable demonstrated 21% fewer all-cause hospitalizations, than Cryoballoon ablations.6 In absolute terms, 34% fewer cardiovascular hospitalizations (including 28.6% of RF procedures proved to be more than AF hospitalizations), 50% fewer direct current 30 minutes longer than the median duration, while cardioversions, and 33% fewer repeat ablations.4 for Cryoballoon ablation procedures, only 4.4% Studies also demonstrate that Cryoballoon ablation of procedures exceeded the median by over 30 procedures are more reproducible and have more minutes. Since a procedure with increased variability consistent outcomes compared to RF.5 can lead to less efficient resource planning related to cath lab space and staffing, it can be presumed For instance, a French prospective multicenter survey that procedure duration variability results in more comparing the safety and efficacy of Cryoballoon resource requirements and therefore, higher costs. and RF ablation demonstrated that both techniques Cryoballoon ablation can thus be considered more resulted in similar rates of freedom from AF (68–80% resource efficient than RF ablation.6 at 18 months), although the Cryoballoon procedure

EP RESOURCES The cardiology department at University Clinical Center (UCC) Rijeka is comprised of two cath labs, one of which is also an EP lab. The EP team at UCC Rijeka consists of three nurses, one radiology technician, one experienced EP specialist who is performing AF ablations, and two EP fellows who are still in training. Together, this team performs diagnostic coronarography, PCI, endovascular valve implantation or repair, EVAR, TEVAR, LA appendage occlusion, device implantation and extraction, electrophysiology, and catheter ablation procedures. Given the diversity of the procedures performed and the department resource constraints, it is essential that procedures are managed efficiently and according to a strict schedule. THE GROWING DEMAND FOR AF ABLATIONS The EP team at UCC Rijeka started performing AF of endovascular procedures. Given this context, it ablations two and a half years ago. To support access is extremely important to manage EP procedures to AF ablations for the increasing number of people efficiently and to thoughtfully plan the procedure with AF, the hospital team hosts educational events schedule in advance and in detail. Any changes in for general practitioners and cardiologists about AF procedure durations affect the schedule, which ablation therapy and the types of patients who are can then cause increased idle time, longer cath indicated for the treatment. With growing awareness lab occupancy time per procedure, or the need of the AF ablation outcomes in the local medical to postpone or cancel procedures altogether. community, and as word of mouth from patients Therefore, in addition to the need for a procedure spreads, more and more patients are being referred that is effective, with a low complication and repeat to UCC Rijeka for AF ablations every year. To meet ablation rate, it is also very important for the selected the growing demand for AF ablations, UCC Rijeka has method to have a predictable procedure duration. been steadily increasing the number of AF ablation This helps to ensure optimal utilization of hospital procedures performed per year. The EP team resources and prevents unforeseen overtime hours performed 35 AF ablation procedures the first year, for staff. To optimize cath lab time and reduce 75 the second year, and this year the EP team plans operator idle time, block scheduling is used by the arrhythmologic team. Four days per week, one to perform 120 AF ablations. cath lab is reserved for the arrhythmologic team EFFICIENT PROCEDURE MANAGEMENT performing catheter ablation or device-related Scheduling constraints coupled with the increasing procedures. Usually two days are reserved for demand for AF ablation makes it very important to catheter ablation and the other two days for device- have a simple and predictable AF ablation approach related procedures. Depending on the waiting list to avoid long waiting lists and unplanned overtime for and resource availability, both catheter ablations and staff. Cost effectiveness is also critical in managing device-related procedures can be performed on such an increase in procedures, since resources are the same day. By planning ahead, any unexpected divided between several different teams and fields changes to the schedule can be addressed in time.

This case study represents one hospital’s experience in Croatia. It is provided for general educational purposes only, and at all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Knowing the schedule in advance also gives teams To improve pathway and workflow efficiency, enough time to perform any additional tests required effective communication among ward personnel for patients undergoing AF ablation before their is very important. For instance, it can significantly scheduled procedure to avoid any unnecessary reduce patient changeover time and reduce idle complications or delays. time in the cath lab when the next patient is brought from the ward to the preparation room next to THE PATIENT PATHWAY the cath lab where final preparations are made at The patient admission protocol is as follows: the final stage of the preceding patient. Patient n Physical examination turnover efficiency is also supported by the fact that n ECG Cryoballoon ablation procedures are performed with analgosedation, rather than general anesthesia. n Routine blood tests n Blood coagulation tests n Blood type (in case of complications requiring urgent blood transfusion) n Transesophageal echocardiography n Adequate preprocedural anticoagulation therapy planning

THE CRYOBALLOON ABLATION LEARNING CURVE

The first AF ablation at UCC Rijeka was performed on the 11th of April 2016 using Cryoballoon and since then, 167 AF ablations have been performed with either cryoablation or point-by-point RF ablation. Although both technologies are used at the hospital, the learning curve was different for each technology. New operators at UCC Rijeka began performing cryoablation procedures independently after only two proctorship sessions. The straightforwardness of the Cryoballoon ablation procedure, together with the fact that the safety of the patient was not compromised even in the early learning phase helped to save time, reduce costs, and enable an efficient adoption process. This is supported by findings from a single-center study in which new operators were able to perform PVIs successfully and with short procedure and fluoroscopy durations after performing 20–30 procedures.7

PERFORMING EIGHT PROCEDURES IN ONE LAB IN ONE DAY

Despite limitations including limited available cath lab time and a lack of staff, the arrhythmology team initiated a project of performing four AF ablations and four complex device-related procedures in one cath lab in a single day.

The planning process was extremely important,as the team needed to ensure that the procedures were completed in a limited time frame with the same level of efficacy and safety for the patients. This included detailed planning of the patient preparation process, respecting standardized procedure steps, mapping system, made it possible to switch between and carefully coordinating patient turnover post- AF ablations and device-related procedures without procedure. It was also very important to know the an increase in patient turnover and lab occupancy expected duration and cath lab occupation time time. This made performing eight different, complex for each procedure in order to minimize possible procedures in a limited time frame possible. setbacks and procedure duration variations. Because of the effective team communication and Because of the simplicity and the short, predictable strict adherence to procedure protocols, the team procedure duration and lab occupation time, successfully performed four cryoablations, two cryoablation was the method chosen for AF ablation. complex device extraction procedures with general The simple setup of the CryoConsole™, and the fact anesthesia, and two high power device implantation that cryoablation does not require a complex procedures in one cath lab

THE AF ABLATION WORKFLOW AT UCC RIJEKA

OPTIMIZING LAB OCCUPANCY TIME procedures using the mapping system. On the other At UCC Rijeka, cryoablation procedures are managed hand, the setup for Cryoballoon ablation is much efficiently, with a protocol that seeks to reduce or simpler and can be easily performed before or after eliminate potential idle time in the cath lab. The different types of procedures without significant average time from the point when the patient patient turnover prolongation, which is extremely enters the EP lab until the procedure begins with important for the hybrid cath lab. the injection of local anesthetics is 28 minutes for CRYOBALLOON ABLATION PROTOCOL cryoablation and 42 minutes for RF ablation. The average procedure time for cryoablation was The variation in duration between the two 82 minutes, with the shortest procedure time being approaches is largely due to the time needed to set 57, and the longest 105 minutes. The average RF up the 3D mapping system used for RF ablation. Due ablation procedure time was 121 minutes, with a to the complex setup required for the 3D mapping shortest procedure time of 76 minutes, and a longest system, it is very difficult and time-consuming to of 163 minutes. However, the average fluoroscopy switch between procedures using the mapping time for Cryoballoon ablation was 18 minutes, while system and those that are performed without it, the average fluoroscopy time for RF ablation was forcing the EP team to reserve days in the EP lab for 9 minutes.

3 Once the material is prepared, the patient is brought into the EP lab and the nurse administers the analgosedation in predetermined doses.

4 The procedure is usually started by an EP fellow, with procedure support from the radiology technician and an EP specialist present at the bedside. The EP nurse is at the EP recording station while another nurse assists with the procedure, as needed. Once the initial procedure steps are complete, the EP specialist proceeds with the more complex procedure steps, while the EP fellow assists him or her at the bedside.

5 When the Cryoballoon is inserted, the radiology technician leaves the bedside and works at the EP station while an EP nurse operates the CryoConsole. It is important to stress that staff nurses and the radiology technician are both educated in every step of the procedure and can share duties.

6 A nurse in the EP lab informs the ward nurse (who is with the next patient) to begin preparing the patient for the next procedure during the final steps of the ongoing procedure (catheter removal).

7 The groin puncture site is closed with a figure-of-eight suture. 8 A transthoracic echocardiogram (TTE) is performed to exclude pericardial effusion. 9 The patient is then transferred to the ward, where he or she is continuously monitored by a central monitoring system for the next eight hours and regularly checked by nurses and physicians.

CONCLUSION

UCC Rijeka has been performing AF ablation Rijeka, ablation using Cryoballoon has proven to be procedures with both point-by-point RF ablation a relatively simple procedure with a short learning and Cryoballoon ablation for the past two and a curve. With thoughtful planning, efficient patient half years. With limited resources available for preparation, and operational protocols, a significant catheter ablation and an increased demand for number of procedures can be performed, even in a the procedure, the arrhythmology team is facing context with resource and time limitations. With only many challenges, which they can help to address four days per week when the cath lab is available, with precise planning, efficient cath lab utilization, the arrhythmology team performs approximately and procedure duration predictability. Cryoballoon 500 device implantations, 25–30 lead extraction ablation has proven to be an effective procedure with procedures, which are complex and time consuming, a low complication rate, short preparation time, and and 250–300 catheter ablations, including AF a short, predictable procedure duration.4 At UCC ablations, annually.

This case study represents one hospital’s experience in Croatia. It is provided for general educational purposes only, and at all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. References 1 Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features 5 Providencia R, Defaye P, Lambiase PD, et al. Results from a multicentre of chronic atrial fibrillation: the Framingham study. N Engl J Med. April comparison of cryoballoon vs. radiofrequency ablation for paroxysmal 1982;306(17):1018-1022. atrial fibrillation: is cryoablation more reproducible? Europace. January 2 Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, 2017;19(1):48-57. and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 6 Monnickendam G, de Asmundis C. Why the distribution matters: Using November 2001;86(5):516-521. discrete event simulation to demonstrate the impact of the distribution 3 Manola S, Pavlovic N. Ablation of atrial fibrillation in the Republic of Croatia. of procedure times on hospital operating room utilisation and average Cardiol Croat. 2016;11(5-6):159-161. procedure cost. Oper Res Health Care. March 2018;16:20-28. 4 Kuck KH, Furnkranz A, Chun KR, et al. Cryoballoon or radiofrequency 7 Velagić V, de Asmundis C, Mugnai G, et al. Learning curve using the ablation for symptomatic paroxysmal atrial fibrillation: reintervention, second-generation cryoballoon ablation. J Cardiovasc Med (Hagerstown). rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. July 2017;18(7):518-527. Eur Heart J. October 2016;37(38):2858-2865.

See the device manual for detailed information regarding the instructions times, it is the professional responsibility of the practitioner to exercise for use, indications, contraindications, warnings, precautions, and potential independent clinical judgment in a particular situation. Changes in a patient’s adverse events. For further information, contact your local Medtronic disease and/or medications may alter the efficacy of a cryoablation procedure representative or consult the Medtronic website at medtronic.com. and results may vary. The product functionality described in this case study is based on Medtronic products and can be referenced in the published product This case study is provided for general educational purposes only and should manuals. not be considered the exclusive source for this type of information. At all

Brief Statement Arctic Front Advance Pro™ Cardiac Cryoablation Catheter Indications: The Arctic Front Advance Pro cardiac cryoablation catheter Damage to the lung or tracheobronchial tree has been observed in some systems are indicated for the treatment of drug refractory recurrent subjects who have undergone left atrial ablation with the Arctic Front family. symptomatic paroxysmal atrial fibrillation. The physician should consider appropriate medical strategies to minimize Contraindications: Use of the cryoballoon is contraindicated: 1) In the the risk of damage to the lung or tracheobronchial tree. To avoid nerve injury, ventricle because of the danger of catheter entrapment in the chordae place a hand on the abdomen in the location of the diaphragm to assess for tendineae, 2) In patients with one or more pulmonary vein stents, 3) In changes in the strength of the diaphragmatic contraction or loss of capture. patients with cryoglobulinemia, 4) In patients with active systemic infections, In case of no phrenic nerve capture, frequently monitor diaphragmatic and 5) In conditions where the manipulation of the catheter within the heart movement using fluoroscopy. Stop ablation immediately if phrenic nerve TM would be unsafe (e.g., intracardiac mural thrombus). impairment is observed. The Arctic Front and Arctic Front Advance cryoballoons were not studied for safety of changes in anticoagulation Warnings/Precautions: Do not re-sterilize this device for purpose of reuse. therapy in patients with paroxysmal atrial fibrillation. This equipment should Use only a compatible Medtronic 12 Fr inner diameter sheath with the Arctic be used only by or under the supervision of physicians trained in left atrial Front Advance Pro cryoballoon. Using another sheath may damage the cryoablation procedures. Cryoablation procedures should be performed only catheter or balloon segment. Do not inflate the balloon inside the sheath. in a fully equipped facility. Always verify with fluoroscopy or by using the proximal shaft visual marker that the balloon is fully outside the sheath before inflation to avoid catheter Potential Complications: Potential complications/adverse events from damage. Do not position the cryoballoon catheter within the tubular portion cardiac catheterization and ablation include, but are not limited to the of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins following: Access site complications (e.g., bruising, ecchymosis); Anemia; stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator Anxiety; Arrhythmia (e.g., atrial flutter, bradycardia, heart block, tachycardia); or use it to deliver RF energy because this may cause catheter malfunction or Back pain; Bleeding from puncture sites; Bronchial constriction; Bronchial patient harm. The catheter contains pressurized refrigerant during operation; fistula; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; release of this gas into the circulatory system due to equipment failure or Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; misuse could result in gas embolism, which can occlude vessels and lead to Coronary artery spasm; Cough; Death; Diarrhea; Dizziness; Embolism; tissue infarction with serious consequences. Always advance and withdraw Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; components slowly to minimize the vacuum created and therefore minimize Hemoptysis; Hypotension/Hypertension; Infection (e.g., pericarditis, the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, sepsis, urinary); Lightheadedness; Myocardial infarction; Nausea/vomiting; or console while the catheter is frozen to the tissue, this may lead to tissue Perforation; Pericardial effusion; Phrenic nerve injury; Pleural effusion; injury. Do not advance the balloon beyond the guide wire to reduce the risk Pneumonia; Pneumothorax; Pseudoaneurysm; Pulmonary edema; Pulmonary of tissue damage. Do not pass the catheter through a prosthetic heart valve hemorrhage; Pulmonary vein dissection; Pulmonary vein stenosis; Shivering; (mechanical or tissue) to avoid damage to the valve, valvular insufficiency, Shortness of breath; Sore throat; Transient ischemic attack; Vagal nerve injury or premature failure of the prosthetic valve. Always inflate the balloon in the (e.g., gastroparesis); Vasovagal reaction; Visual Changes (e.g., blurred vision). atrium then position it at the pulmonary vein ostium to avoid vascular injury. Refer to the device technical manual for detailed information regarding the Do not ablate in the tubular portion of the pulmonary vein. Use continuous procedure, indications, contraindications, warnings, precautions, and potential phrenic nerve pacing throughout each cryoablation application in the right complications/adverse events. For further information, please call Medtronic at pulmonary veins. Esophageal ulcerations have been observed in some 1-800-328-2518 and/or consult the Medtronic website at medtronic.com. subjects who have undergone left atrial ablation with the Arctic Front family. Caution: Federal law (USA) restricts this device to sale by or on the order of As with other forms of left atrial ablation, the physician should consider a physician. appropriate medical strategies to minimize the risk of esophageal injury.

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