St.-Josefs Hospital Case Study - Medtronic

MEETING THEGROWING DEMANDFOR ATRIALFIBRILLATIONABLATION:ST. JOSEFS-HOSPITALWIESBADEN, GERMANY

The Arctic Front Advance™ cardiac cryoablation catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.

GROWINGDEMAND FORAF ABLATIONAtrial 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.1,2 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.6-8

AF is associated with increased morbidity, such as stroke and heart failure. Studies show that 20–30% of patients with an ischemic stroke have AF diagnosed before, during, or after the initial event.9-11

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,12 and 1% of the National Health Service budget in the United Kingdom.13

Pulmonary vein isolation (PVI) with catheter ablation has been proven to be an effective treatment option for patients with AF.14 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.15

THE CARDIOLOGYDEPARTMENT ATST. JOSEFS-HOSPITALThe 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 Joachim Ehrlich, M.D., 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.

This case study represents one hospital’s experience in Germany. 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.

BEFORE THE PROCESSOPTIMIZATION PROJECTCryoballoon was adopted as an index procedure forpatients with drug refractory symptomatic paroxysmal AF, since it was proven to be a safe and effective approach to PVI, with shorter and more reproducible procedures compared to radiofrequency.14,15

Prior to the implementation of the processoptimization project in August 2016, the roles andresponsibilities for performing cryoballoon ablationprocedures were as follows:n One nurse to prepare the procedure and

monitor the patientn Two electrophysiologists (EPs) to perform

the cryoballoon procedure and manage the EP recording system

Nurses available for cryoballoon ablationssupported both EP lab and cath lab procedures.When the EP division was first created, Dr. Ehrlichwas the only EP on staff, until he was joined byDr. Kaess in April 2016.

The EP lab was dedicated to cryoballoon proceduresone day per week and the team performed anaverage of three procedures on such days.


THE PROCESSOPTIMIZATIONPROJECTDr. Ehrlich became the head of the cardiologydepartment in August 2016, gaining the opportunityto optimize EP lab procedure management. In thiscapacity, he identified the potential to increase thehospital’s EP lab efficiency to meet the growingdemand for AF ablations.

Given the recognized need to better optimize themanagement of cryoballoon procedures, the decisionwas made to work together with Medtronic toimplement a process optimization project based onLean Six Sigma methodology.

In accordance with Lean Six Sigma methodology,the project steps were as follows:n Define the project scope with an internal

process review.n Measure the problem via process cycle analyses.n Analyze the sources of the problems.n Implement the solution.n Sustain the solution.

1. Define the project scope with an internal process review

The goal defined for this project was to double thenumber of AF procedures performed per allocated dayfrom three to six in a single year.

To do so, there was a recognized need to addressinefficiencies associated with patient transfers,procedure preparation, lab cleaning, and staff availability,given the impact of such factors on lab occupancy time.

2. Measure the problem

To clearly identify and assess the inefficienciesdelaying lab occupancy time per patient, all pre-and post-procedure steps were timed and outlinedon a value stream map.

The available EP lab time and average lab occupancytime was as follows:n Available EP lab time: 10 hours per dayn Lab occupancy time for cryoballoon

procedures: 3 hours per patient

Given the available lab time and the average laboccupancy time per patient, the hospital had thecapacity to perform three cryoablation proceduresper allocated cryoballoon day (3.33 patients).

At the time, the average daily demand was for fiveprocedures per cryoablation day. To meet theirestablished objective, the team needed to reducelab occupancy time per cryoballoon procedure from180 minutes to 100 minutes. To sustain this change,there was also the need to increase demand forthe procedure.

3. Identify the sources of delay

The process map on the following page (Figure 1)outlines the current lab occupancy time required foreach step of the procedure cycle. Lab occupancytimes for each step of the procedure processare listed in dark blue and cycle durations withoutwaiting time are listed in light blue.

Opportunities for improvement are highlighted ingreen, to illustrate where there were gaps betweenthe current lab occupancy time and the cycle timeper patient without waiting time.


Figure 1: Value stream map

Lab occupancy time per patient = 180 min

Average lab cycle time per patient (without waiting time) = 136 min

Improvement opportunity

PATIENT TRANSFERRED FROM THE WARD TO THE LAB

27–33

27

LAB PREPARATION FOR CRYOABLATION

PATIENT IS TRANSFERRED TO THE LAB

PATIENT IS POSITIONED ON THE TABLE FOR THE PROCEDURE

PHYSICIAN STARTS THE PROCEDURE

TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR THROMBUS EXCLUSION AND TRANSSEPTAL PUNCTURE (TSP)

TSP

START

END

15–20 14 3 3 20–37 15 6–17 4 11–15 11 5–21 5

CRYOBALLOONPROCEDURE

STOPPUNCTURESITEBLEEDING

APPLYPRESSUREBANDAGE

PATIENT ISTRANSFERREDOUT OFTHE LAB

LABCLEANING

CONTACT TIMESPECIFIED FORDISINFECTANT

50–101 46 15–38 15 5 5 3 3 15–33 10 5–10 5


4. Address the problems

In accordance with the findings from the value streammap analysis (Figure 1), the following delays wereidentified throughout the procedure cycle:

A) Lab preparationTime wasted during the procedure preparation stageoften resulted from a shortage of nurses available toprepare the procedure material on time. This was duein part to resource constraints and to a lack of effectivecommunication within the team, which resulted innurses not being informed that they were needed toprepare the next procedure in due time.

To address this issue, efforts were made to improvelines of communication within the team and toallocate a second nurse to material preparation foreach procedure.

B) Patient transfer from the ward to the labInefficiencies associated with patient transfers typicallyresulted from a lack of effective communication withinthe team and insufficient lead time for the initiationof the patient transfer. Given this challenge, the teamconcluded that nurses responsible for themanagement of patient transfers required a leadtime of at least 27 minutes.

To better optimize this step of the procedure cycle, aprocess was implemented wherein the next patient istransferred to the lab during the ablation of the currentpatient’s right pulmonary veins.

C) Patient positioned on the table for the procedureDelays related to patient positioning were generallyassociated with a lack of coordinated communicationsbetween the nurses and EPs. As a result, nurses oftenhad to wait in the EP lab for physicians to arrive so thatthe team could begin the procedure.

To address this issue, the expectation was set forphysicians to remain in the lab as much as possibleduring allocated cryoballoon days. A process was alsoimplemented wherein nurses are expected to provideEPs with at least 5–10 minutes’ notice before they are needed for the procedure.

D) Transesophageal echocardiography (TEE) for thrombus exclusion and transseptal puncture (TSP) To further optimize lab occupancy time, the EPs decided that performing TEE-guided TSP was unnecessary, and that thrombi could be excluded in the echo lab on the day of the procedure, prior to ablation.

Therefore, the decision was made to stop routinely performing TEEs for TSPs. To further optimize this step of the procedure, the decision was made to have a second EP prepare the cryoballoon material during the TSP. These changes reduced the time required for each procedure by an average of 11 minutes.

E) Cryoballoon procedure Procedure reproducibility and patient turnover were identified by the team as areas for improvement.

To help reduce the variability of procedure times, which was particularly relevant when a new EP was being trained, the hospital implemented a standardized dosing protocol. This protocol reduced the duration of cryoapplications from an average of four minutes to three minutes and eliminated the need to apply additional cryoapplications if the pulmonary vein was isolated in less than one minute.

To help facilitate the efficiency of the patient turnover process at the end of each procedure, the decision was also made to stop propofol infusions before isolating the last pulmonary vein.

F) Lab cleaning processThe process optimization project helped to spotlight the fact that lab cleaning was not being performed as efficiently as it could be. This was due in part to the fact that there was a lack of cleaning staff dedicated to the cath labs and EP lab and to the fact that they were not consistently informed of when they would be needed in the lab sufficiently in advance.


To address this problem, the hospital added a second cleaner for the labs and required that they be given suffcient notice before they are needed to clean a lab.

Resulting time savings Since implementing the solutions identified via the process optimization project, the lab occupancy time for cryoballoon ablation procedures was decreased from 180 minutes to 100 minutes per patient. Such time savings enabled the team to meet their goal of performing six procedures in a single day, which they continue to do consistently. The hospital even managed to perform eight procedures in a single lab, in a single day (7:30 a.m. to 6:00 p.m.) by reducing the lab occupancy time to 90 minutes.


5. Sustain the solution

To maintain the efficiency gains derived from the process optimization project, a material preparation checklist was created and processes related to the procedure were formalized. A team of four nurses was designated to EP procedures as well, enabling the creation of a specialized team that could collaborate and communicate effectively and support procedures efficiently. Based on the learnings from the process optimization project, subsequent cryoablation procedures were consistently performed according to the following steps:

1. Patients are seen in the outpatient clinic for blood work a few weeks before the procedure to have the procedure explained, to sign the consent form, and to have necessary medication prescriptions.

2. On the morning of the procedure, patients are taken for an ECG. If the patient is in atrial fibrillation, a TEE is performed.

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 preparation. Once the cryoballoon is inserted, the second EP leaves the EP lab. Two nurses will monitor the patient and support the procedure, as needed. An automated pump is used for contrast delivery to optimize and standardize the process as precisely as possible (adjusts contrast very precisely at a predefined speed).

7. A nurse in the EP lab informs the nurse who is with the next patient to begin preparing the patient for the next procedure during the isolation of the right pulmonary veins. Propofol perfusion is stopped before the last PVI (unless cardioversion is required) to help facilitate an efficient patient turnover.

8. The groin puncture site is closed with a purse-string suture.

9. A TEE is performed to exclude pericardial effusion.

10. The patient is then transferred to the nearby recovery room on the same floor.

Arctic Front Advance™

Cardiac Cryoablation Catheter



AWARENESS EFFORTSIn parallel with the process optimization project, Dr. Ehrlich collaborated with Medtronic to organize educational events for referring physicians.

Such events sought to promote the benefits associated with AF ablation and to build awareness of EP expertise and activities at St. Josefs-Hospital Wiesbaden.

CONCLUSIONThe process optimization project and referral physician awareness efforts proved to be very successful, enabling St. Josefs-Hospital Wiesbaden to increase AF ablation demand and capacity. Dr. 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 2017.16

Since the process optimization measures were put in place, the EP team has hosted physicians from across Europe who are interested in optimizing 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.

Such efforts have resulted in a consistently higher demand for AF ablation procedures and stronger relationships with referring physicians in the area.

To meet this increased demand, the hospital has since trained a third electrophysiologist and established a second cryoablation day. A new EP lab is also planned for 2024.

References 1 Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation:

The Framingham Heart Study. Circulation. August 2004;110(9):1042-1046.2 Heeringa J, van der Kuip DA, Hofman A, et al. Prevalence, incidence and lifetime risk of

atrial fibrillation: the Rotterdam study. Eur Heart J. April 2006;27(8):949-953.3 Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and

predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. November 2001;86(5):516-521.

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. April 1996;131(4):790-795.

5 Piccini JP, Hammill BG, Sinner MF, et al. Incidence and prevalence of atrial fibrillation and associated mortality among Medicare beneficiaries, 1993-2007. Circ Cardiovasc Qual Outcomes. January 2012;5(1):85-93.

6 Go AS, Hylek EM, Phillips KA, et al. 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. May 2001;285(18):2370-2375.

7 Krijthe BP, Kunst A, Benjamin EJ, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. September 2013;34(35):2746-2751.

8 Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. June 2014;6:213-220.

9 Kishore A, Vail A, Majid A, et al. Detection of atrial fibrillation after ischemic stroke or transient ischemic attack: a systematic review and meta-analysis. Stroke. February 2014;45(2):520-526.

10 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. June 2012;7(4):276-281.

11 Grond M, Jauss M, Hamann G, et al. Improved detection of silent atrial fibrillation using 72-hour Holter ECG in patients with ischemic stroke: a prospective multicenter cohort study. Stroke. December 2013;44(12):3357-3364.

12 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. March-April 2009;12(2):293-301.

13 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. March 2004;90(3):286-292.

14 Packer DL, Kowal RC, Wheelan KR, et al. Cryoballoon Ablation of Pulmonary Veins for Paroxysmal Atrial Fibrillation: First Results of the North American Arctic Front (STOP AF) Pivotal Trial. J Am Coll Cardiol. April 23, 2013;61(16):1713-1723.

15 Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. June 9, 2016;374(23):2235-2245.

16 Data provided by St. Josefs-Hospital. Wiesbaden, Germany. 2018.

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Brief Statement Arctic Front Advance Pro™ Cardiac Cryoablation CatheterIndications: The Arctic Front Advance Pro cardiac cryoablation catheter systems are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. Contraindications: Use of the cryoballoon is contraindicated: 1) In the ventricle because of the danger of catheter entrapment in the chordae tendineae, 2) In patients with one or more pulmonary vein stents, 3) In patients with cryoglobulinemia, 4) In patients with active systemic infections, and 5) In conditions where the manipulation of the catheter within the heart would be unsafe (e.g., intracardiac mural thrombus). Warnings/Precautions: Do not re-sterilize this device for purpose of reuse. Use only a compatible Medtronic 12 Fr inner diameter sheath with the Arctic Front Advance Pro cryoballoon. Using another sheath may damage the catheter or balloon segment. Do not inflate the balloon inside the sheath. 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 damage. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, this may lead to tissue injury. Do not advance the balloon beyond the guidewire to reduce the risk of tissue damage. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency, or premature failure of the prosthetic valve. Always inflate the balloon in the atrium then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. Esophageal ulcerations have been observed in some subjects who have undergone left atrial ablation with the Arctic Front family. As with other forms of left atrial ablation, the physician should consider appropriate medical strategies to minimize the risk of esophageal injury.

Damage to the lung or tracheobronchial tree has been observed in some subjects who have undergone left atrial ablation with the Arctic Front family. The physician should consider appropriate medical strategies to minimize the risk of damage to the lung or tracheobronchial tree. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The Arctic Front and Arctic Front Advance™ cryoballoons were not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility. Potential Complications: Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Access site complications (e.g., bruising, ecchymosis); Anemia; Anxiety; Arrhythmia (e.g., atrial flutter, bradycardia, heart block, tachycardia); Back pain; Bleeding from puncture sites; Bronchial constriction; Bronchial fistula; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Coronary artery spasm; Cough; Death; Diarrhea; Dizziness; Embolism; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension/Hypertension; Infection (e.g., pericarditis, sepsis, urinary); Lightheadedness; Myocardial infarction; Nausea/vomiting; Perforation; Pericardial effusion; Phrenic nerve injury; Pleural effusion; Pneumonia; Pneumothorax; Pseudoaneurysm; Pulmonary edema; Pulmonary hemorrhage; Pulmonary vein dissection; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Transient ischemic attack; Vagal nerve injury (e.g., gastroparesis); Vasovagal reaction; Visual Changes (e.g., blurred vision).Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative or consult the Medtronic website at medtronic.com.

This case study is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a cryoablation procedure 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 manuals.

Brief Statement Arctic Front Advance™ Cardiac Cryoablation CatheterIndications:The Arctic Front Advance™ Cardiac Cryoablation Catheter system is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. Contraindications: Use of Arctic Front Advance™ cryoballoon is contraindicated 1) In the ventricle because of the danger of catheter entrapment in the chordae tendineae, 2) In patients with one or more pulmonary vein stents, 3) In patients with cryoglobulinemia, 4) In patients with active systemic infections, and 5) In conditions where the manipulation of the catheter within the heart would be unsafe (e.g., intracardiac mural thrombus).Warnings/Precautions: Do not re-sterilize this device for purpose of reuse. Use only the 12 Fr FlexCath™ steerable sheath family with the Arctic Front Advance™ cryoballoon because using another sheath may damage the catheter or balloon segment. Do not inflate the balloon inside the sheath. 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 damage. Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein to minimize phrenic nerve injury and pulmonary veins stenosis. Do not connect the cryoballoon to a radiofrequency (RF) generator or use it to deliver RF energy because this may cause catheter malfunction or patient harm. The catheter contains pressurized refrigerant during operation; release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism, which can occlude vessels and lead to tissue infarction with serious consequences. Always advance and withdraw components slowly to minimize the vacuum created and therefore minimize the risk of air embolism. Do not pull on the catheter, sheath, umbilical cables, or console while the catheter is frozen to the tissue, this may lead to tissue injury. Do not advance the balloon beyond the guidewire to reduce the risk of tissue damage. Do not pass the catheter through a prosthetic heart valve (mechanical or tissue) to avoid damage to the valve, valvular insufficiency or premature

failure of the prosthetic valve. Always inflate the balloon in the atrium, then position it at the pulmonary vein ostium to avoid vascular injury. Do not ablate in the tubular portion of the pulmonary vein. Use continuous phrenic nerve pacing throughout each cryoablation application in the right pulmonary veins. To avoid nerve injury, place a hand on the abdomen in the location of the diaphragm to assess for changes in the strength of the diaphragmatic contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor diaphragmatic movement using fluoroscopy. Stop ablation immediately if phrenic nerve impairment is observed. The Arctic Front Advance™ cryoballoon was not studied for safety of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation. This equipment should be used only by or under the supervision of physicians trained in left atrial cryoablation procedures. Cryoablation procedures should be performed only in a fully equipped facility.Potential Complications: Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to the following: Anemia; Anxiety; Atrial flutter; Back pain; Bleeding from puncture sites; Blurred vision; Bradycardia; Bronchitis; Bruising; Cardiac tamponade; Cardiopulmonary arrest; Cerebral vascular accident; Chest discomfort/pain/pressure; Cold feeling; Cough; Death; Diarrhea; Dizziness; Esophageal damage (including esophageal fistula); Fatigue; Fever; Headache; Hemoptysis; Hypotension; Hypertension; Lightheadedness; Myocardial infarction; Nausea/vomiting; Nerve injury; Pericardial effusion; Pulmonary vein stenosis; Shivering; Shortness of breath; Sore throat; Tachycardia; Transient ischemic attack; Urinary infection; Vasovagal reaction; Visual changes.Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

St.-Josefs Hospital Case Study - Medtronic

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