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\begin{document}

\title{Patients' Experience after Cryoballoon Ablation Under Moderate Sedation
and General Anesthesia}



\author[1]{Youssef Jalloul}%
\author[1]{Marwan Refaat}%
\affil[1]{American University of Beirut Medical Center}%


\vspace{-1em}



  
  \date{May 17, 2024}


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In 1999, Paul Myles et al. published an important paper outlining the
details of a novel assessment tool to measure patients' quality of
recovery (QoR) post-anesthesia and surgery.{[}1{]} The following year,
Paul Myles et al. published another article outlining the QoR-40. This
study, as well as multiple other studies, further studied QoR-40's
validity, reliability, internal consistency, test-retest reliability,
inter-rater reliability, and split-half coefficient.{[}1--3{]} It can be
completed in a relatively short period (around five minutes).{[}3,4{]}
However, its administration by the investigators provides more complete
and timely data as compared to self-administration.{[}4{]} It has been
translated into multiple languages and validated by these languages as
well.{[}5{]} However, even though the QoR-40's score has a maximum score
of 200 with a range of 160, the minimal clinically important difference
is only 4.8 units to translate into clinically relevant change. The
difference between the mean QoR-40 scores post-cardiac surgery (with and
without complications) was only four units while maintaining a wide
standard deviation within groups.{[}5,6{]} QoR's utility lies in its
correlation with patient satisfaction as well as with another measure of
patient well-being, the quality of life (QoL) score.{[}3{]} Furthermore,
the QoR-40's score three days post-cardiac surgery correlated well with
the SF-36's measure of QoL 3 months after the operation. Hence QoR-40 is
helpful in assess patient's short-term prognosis.{[}7{]} These findings
hold even three years after the operation; however, the correlation
level does decrease. {[}8{]}

In this issue of the journal of cardiovascular electrophysiology,
Wasserlauf et al. utilized the QoR-40 to measure the impact of the
anesthesia used during cryoballoon ablation of paroxysmal atrial
fibrillation.{[}9{]} Catheter ablation has become a common procedure for
the management of paroxysmal atrial fibrillation with minor procedural
complication. {[}10,11{]} Patients undergoing cryoballoon ablation for
atrial fibrillation experience less pain than radiofrequency ablation.
{[}12{]}

Multiple sedative modalities can be utilized for cardiac catheter
ablation. One modality is the use of a light anesthetic: It alerts the
physician of patient discomfort, it comforts the physician and nursing
staff and carries a lower risk of drug overdose. However, it does
increase the patients' intraoperative motion.{[}13{]} Other modalities
include general anesthesia and deep sedation. However, it should be
noted that conscious sedation does carry a risk of hypoventilation and
aspiration. {[}14{]} In a previous study, no significant difference in
complication rate was present following ventricular tachycardia ablation
during minimal as compared to deep sedation. {[}15{]} Also, in another
study, patients undergoing percutaneous epicardial access (for
ventricular tachycardia or premature ventricular complex) had similar
complication rates regardless of whether they did the procedure under
general anesthesia or moderate/deep sedation. {[}16{]} Furthermore, in a
study by Tang et al., patients who underwent non-conscious sedation
during catheter ablation for atrial fibrillation had more transient
anesthetic complications as compared to conscious sedation. However,
these two groups did not reveal a difference in the procedure-related
complication/success rates. {[}17{]} Finally, Wasserlauf et al. found
moderate sedation to carry a lower procedure time without jeopardizing
the complication and recurrence rate up to a median follow-up duration
of 0.9 years. This paper studied patients undergoing cryoballoon
ablation for paroxysmal atrial fibrillation. {[}18{]}

Given the previously reported evidence supporting the use of conscious
anesthesia during atrial fibrillation catheter ablation, Wasserlauf et
al. set on a task to expand our knowledge of patients' tolerance of
moderate sedation during cryoballoon ablation. {[}9{]} Consequently,
they studied patients undergoing cryoballoon ablation for paroxysmal
atrial fibrillation under general anesthesia or moderate sedation.
Within 24 hours after the procedure, patients would provide the QoR-40
and their likelihood to recommend the procedure and sedation method. The
mean QoR-40 was greater than 180 in the two groups with a difference of
less than 5 unites. Furthermore, the difference in the QoR-40 scores was
not statistically significant. {[}9{]} These scores were better than
scores observed by Myles in minor surgeries (178 \selectlanguage{ngerman}± 17) and cardiac
surgeries without complications (176 ± 16). {[}6{]} Moreover, patients
reported a high satisfaction rate with a high likelihood to recommend
the procedures (83\% and 89\%) and a high likelihood to recommend the
sedation method (94\% and 85\%) depending on the sedation method
(general anesthesia and moderate sedation respectively). However, the
difference was not statistically significant.{[}9{]} This result is
similar to a previous study that found that 96\% of patients would
recommend radiofrequency ablation for atrial fibrillation.{[}19{]} What
these results mean is that they support the use of moderate sedation as
compared to general anesthesia, given the similar patient experience,
but different procedure time, expense, and possible complications from
general anesthesia. {[}9{]}

This study, however, does have limitations. It was a single-center
non-randomized study. The QoR-40 has sections that are heavily dependent
on the medical center and staff; hence this is an important issue to
consider. Furthermore, the assignment to anesthesia groups was not
standardized, and the decision was dependent on physician and patient
preference. Though understandable, the physician preference can be made
to be dictated by a predefined set of criteria to minimize nonrandom
assignment. Finally, we note that the QoR-40 scores presented by
Wasserlauf et al. were the means and standard deviations. {[}9{]} When
calculating the 95\% confidence intervals of the difference of the mean
QoR-40 scores of the two groups, we find that there is no statistically
significant difference between the two groups.

In conclusion, Wasserlauf et al. have added to our knowledge of
cryoballoon ablation under moderate sedation which might become the more
frequently adopted anesthesia strategy during AFib cryoablation.

References:

1. Myles PS, Hunt JO, Nightingale CE, et al. Development and
psychometric testing of a quality of recovery score after general
anesthesia and surgery in adults. Anesth Analg. 1999;88(1):83-90.
doi:10.1097/00000539-199901000-00016

2. Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and
reliability of a postoperative quality of recovery score: The QoR-40. Br
J Anaesth. 2000;84(1):11-15. doi:10.1093/oxfordjournals.bja.a013366

3. Gornall BF, Myles PS, Smith CL, et al. Measurement of quality of
recovery using the QoR-40: A quantitative systematic review. Br J
Anaesth. 2013;111(2):161-169. doi:10.1093/bja/aet014

4. Gower ST, Quigg CA, Hunt JO, Wallace SK, Myles PS. A comparison of
patient self-administered and investigator-administered measurement of
quality of recovery using the QoR-40. Anaesth Intensive Care.
2006;34(5):634-638. doi:10.1177/0310057x0603400514

5. Myles PS. Measuring quality of recovery in perioperative clinical
trials. Curr Opin Anaesthesiol. 2018;31(4):396-401.
doi:10.1097/ACO.0000000000000612

6. Myles PS. Clinically Important Difference in Quality of Recovery
Scores. Anesth Analg. 2016;122(1):13-14.
doi:10.1213/ANE.0000000000001060

7. Myles PS, Hunt JO, Fletcher H, Solly R, Woodward D, Kelly S. Relation
between quality of recovery in hospital and quality of life at 3 months
after cardiac surgery. Anesthesiology. 2001;95(4):862-867.
doi:10.1097/00000542-200110000-00013

8. Myles PS, Viira D, Hunt JO. Quality of life at three years after
cardiac surgery: Relationship with preoperative status and quality of
recovery. Anaesth Intensive Care. 2006;34(2):176-183.
doi:10.1177/0310057x0603400220

9. Wasserlauf, Jeremiah; Kaplan, Rachel; Walega, David; Arora, Rishi;
Chicos, Alexandr; Kim, Susan; Lin, Albert; Verma, Nishant; Patil,
Kaustubha; Knight, Bradley; Passman R. Patient-Reported Outcomes After
Cryoballoon Ablation Are Equivalent Between Moderate Sedation And
General Anesthesia. J Cardiovasc Electrophysiol. 2020.

10. Chung MK, Refaat M, Shen WK, Kutyifa V, Cha YM, Di Biase L,
Baranchuk A, Lampert R, Natale A, Fisher J, Lakkireddy DR. Atrial
Fibrillation: JACC Council Perspectives. J Am Coll Cardiol. Apr 2020; 75
(14): 1689-1713.

11. D'Avila A, Ptaszek LM, Yu PB, Walker JD, Wright C, Noseworthy PA,
Myers A, Refaat M, Ruskin JN: Left Atrial-Esophageal Fistula After
Pulmonary Vein Isolation. Circulation May 2007; 115(17): e432-3.

12. Attanasio P, Huemer M, Shokor Parwani A, et al. Pain Reactions
during Pulmonary Vein Isolation under Deep Sedation: Cryothermal versus
Radiofrequency Ablation. PACE - Pacing Clin Electrophysiol.
2016;39(5):452-457. doi:10.1111/pace.12840

13. Defaye P, Kane A, Jacon P, Mondesert B. Cryoballoon for pulmonary
vein isolation: Is it better tolerated than radiofrequency?
Retrospective study comparing the use of analgesia and sedation in both
ablation techniques. Arch Cardiovasc Dis. 2010;103(6-7):388-393.
doi:10.1016/j.acvd.2010.06.004

14. Calkins H, Kuck KH, Cappato R, et al. 2012 HRS/EHRA/ECAS Expert
Consensus Statement on Catheter and Surgical Ablation of Atrial
Fibrillation: Recommendations for Patient Selection, Procedural
Techniques, Patient Management and Follow-up, Definitions, Endpoints,
and Research Trial Design. Heart Rhythm. 2012;9(4):632-696.e21.
doi:10.1016/j.hrthm.2011.12.016

15. Wutzler A, Mueller A, Loehr L, et al. Minimal and deep sedation
during ablation of ventricular tachycardia. Int J Cardiol.
2014;172(1):161-164. doi:10.1016/j.ijcard.2013.12.175

16. Killu AM, Sugrue A, Munger TM, et al. Impact of sedation vs. general
anaesthesia on percutaneous epicardial access safety and procedural
outcomes. Europace. 2018;20(2):329-336. doi:10.1093/europace/euw313

17. Tang RB, Dong JZ, Zhao W Du, et al. Unconscious sedation/analgesia
with propofol versus conscious sedation with fentanyl/midazolam for
catheter ablation of atrial fibrillation: A prospective, randomized
study. Chin Med J (Engl). 2007;120(22):2036-2038.
doi:10.1097/00029330-200711020-00018

18. Wasserlauf J, Knight BP, Li Z, et al. Moderate Sedation Reduces Lab
Time Compared to General Anesthesia during Cryoballoon Ablation for AF
Without Compromising Safety or Long-Term Efficacy. PACE - Pacing Clin
Electrophysiol. 2016;39(12):1359-1365. doi:10.1111/pace.12961

19. Ezzat VA, Chew A, McCready JW, et al. Catheter ablation of atrial
fibrillation - Patient satisfaction from a single-center UK experience.
J Interv Card Electrophysiol. 2013;37(3):291-303.
doi:10.1007/s10840-012-9763-5

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