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\begin{document}

\title{Real-World Evidence Demonstrates an Appropriate Atrial Fibrillation
Population for Hybrid Convergent Approach versus Stand-Alone Cryoballoon
Ablation: A Long-Term Safety and Efficacy Study}



\author[1]{Christian Lorenzo}%
\author[1]{Yahaira Ortiz-Gonzalez}%
\author[1]{Dustin Hill}%
\author[1]{Jennifer Kinaga}%
\author[1]{Lauren Filart}%
\author[1]{David Bello}%
\author[1]{Aurelio Duran}%
\author[1]{Jeffery Bott}%
\author[1]{Roland Filart}%
\affil[1]{Orlando Regional Medical Center}%


\vspace{-1em}



  
  \date{June 16, 2024}


\begingroup
\let\center\flushleft
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\endgroup





\selectlanguage{english}
\begin{abstract}
\textbf{Introduction:} A hybrid convergent approach (endocardial and
epicardial ablation) demonstrated superior effectiveness in a recent
randomized study for long-standing persistent atrial fibrillation
(LSPAF). Yet, there is a lack of real-world, long-term evidence as to
which patients are best candidates for a hybrid convergent approach
compared to standard endocardial cryoballoon pulmonary vein isolation
(CB PVI). \textbf{Methods and Results:} This single-center,
retrospective analysis spanning from 2010 to 2015 compared two
distinctly different atrial fibrillation (AF) cohorts; one treated with
stand-alone cryoablation and one treated with a hybrid convergent
approach. Baseline characteristics described candidates for each
approach. The following criteria were utilized to determine CB PVI
candidacy: 1) paroxysmal AF (PAF) with failed class I/III antiarrhythmic
drug (AAD) or 2) persistent/LSPAF with failed class I/III AAD unwilling
to undergo hybrid procedure. Selection criteria for the hybrid procedure
included: 1) PAF refractory to both class I/III AAD and prior CB PVI or
2) persistent/LSPAF with failed class I/III AAD agreeable to hybrid
procedure. Prior sternotomy was excluded. Serial electrocardiograms and
continuous monitoring evaluated primary efficacy outcome of
time-to-first recurrence of atrial arrhythmia after a 90-day blanking
period. Secondary outcomes were procedure-related complications and AAD
use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated
arrhythmia recurrence. Of 276 patients, 197 (64.2 \selectlanguage{ngerman}± 10.6 years old;
66.5\% male; 74.1\% PAF; 18.3\% persistent AF; 1.0\% LSPAF; 6.6\%
undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5\%
male; 41.8\% PAF; 45.5\% persistent AF; 12.7\% LSPAF) underwent hybrid
procedure. Arrhythmia freedom through 36 months was 55.2\% for CB PVI
and 50.4\% for hybrid (p =0.32). Class I AAD utilization at discharge
occurred in 38 (19.3\%) patients in the CB PVI group and 5 (6.3\%)
patients in the hybrid group (p=0.01). CB PVI class I AAD utilization at
12 months occurred in 14 (9.0) patients versus 0 patients for hybrid
convergent (p=0.004). Patients with one or more adverse event were as
follows: two (1.0\%) in the CB PVI group (both transient phrenic nerve
palsy) and three (3.7\%) in the hybrid group (two with significant
bleeding and one with wound infection) (p=0.14). \textbf{Conclusion:}
This study demonstrated that patients with more complex forms of AF (PAF
refractory to both AAD and index endocardial ablation or
persistent/LSPAF) could be well managed with a convergent approach.
Moreover, outcomes match safety and efficacy thresholds achieved by
patients with an early, less complex AF etiology treated by CB PVI
alone.%
\end{abstract}\selectlanguage{ngerman}%



\sloppy


\textbf{Title:} Real-World Evidence Demonstrates an Appropriate Atrial
Fibrillation Population for Hybrid Convergent Approach versus
Stand-Alone Cryoballoon Ablation: A Long-Term Safety and Efficacy Study

\textbf{Short Title:} Real-World Evaluation of Convergent Procedure

Christian Lorenzo, MD\textsuperscript{1}; Yahaira Ortiz-Gonzalez,
MD\textsuperscript{1}; Dustin Hill, MD\textsuperscript{1}; Jennifer
Kinaga MD\textsuperscript{1}; Lauren Filart BS\textsuperscript{1}, David
Bello MD\textsuperscript{1}; Aurelio Duran MD\textsuperscript{1};
Jeffery Bott MD\textsuperscript{1}; Roland Filart, MD,
FHRS\textsuperscript{1}

Orlando Health Heart and Vascular Institute Department of Cardiology and
Electrophysiology. Orlando, FL USA

Corresponding Author:

Name: Christian Lorenzo

Address: 21 W. Columbia Street \textbar{} Ste 102 \textbar{} Orlando, FL
32806

Email: Christian.lorenzo@orlandohealth.com

Phone: (321) 841-5145

\textbf{Abstract Word Count:} 398

\textbf{Word Count (without references):} 3103

\textbf{Abstract}

\textbf{Introduction:} A hybrid convergent approach (endocardial and
epicardial ablation) demonstrated superior effectiveness in a recent
randomized study for long-standing persistent atrial fibrillation
(LSPAF). Yet, there is a lack of real-world, long-term evidence as to
which patients are best candidates for a hybrid convergent approach
compared to standard endocardial cryoballoon pulmonary vein isolation
(CB PVI).

\textbf{Methods and Results:} This single-center, retrospective analysis
spanning from 2010 to 2015 compared two distinctly different atrial
fibrillation (AF) cohorts; one treated with stand-alone cryoablation and
one treated with a hybrid convergent approach. Baseline characteristics
described candidates for each approach. The following criteria were
utilized to determine CB PVI candidacy: 1) paroxysmal AF (PAF) with
failed class I/III antiarrhythmic drug (AAD) or 2) persistent/LSPAF with
failed class I/III AAD unwilling to undergo hybrid procedure. Selection
criteria for the hybrid procedure included: 1) PAF refractory to both
class I/III AAD and prior CB PVI or 2) persistent/LSPAF with failed
class I/III AAD agreeable to hybrid procedure. Prior sternotomy was
excluded. Serial electrocardiograms and continuous monitoring evaluated
primary efficacy outcome of time-to-first recurrence of atrial
arrhythmia after a 90-day blanking period. Secondary outcomes were
procedure-related complications and AAD use (at discharge, 12, and 36
months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276
patients, 197 (64.2 \selectlanguage{ngerman}± 10.6 years old; 66.5\% male; 74.1\% PAF; 18.3\%
persistent AF; 1.0\% LSPAF; 6.6\% undetermined) underwent CB PVI and 79
(61.4 ± 8.1 years old; 83.5\% male; 41.8\% PAF; 45.5\% persistent AF;
12.7\% LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36
months was 55.2\% for CB PVI and 50.4\% for hybrid (p =0.32). Class I
AAD utilization at discharge occurred in 38 (19.3\%) patients in the CB
PVI group and 5 (6.3\%) patients in the hybrid group (p=0.01). CB PVI
class I AAD utilization at 12 months occurred in 14 (9.0) patients
versus 0 patients for hybrid convergent (p=0.004). Patients with one or
more adverse event were as follows: two (1.0\%) in the CB PVI group
(both transient phrenic nerve palsy) and three (3.7\%) in the hybrid
group (two with significant bleeding and one with wound infection)
(p=0.14).

\textbf{Conclusion:} This study demonstrated that patients with more
complex forms of AF (PAF refractory to both AAD and index endocardial
ablation or persistent/LSPAF) could be well managed with a convergent
approach. Moreover, outcomes match safety and efficacy thresholds
achieved by patients with an early, less complex AF etiology treated by
CB PVI alone.

\textbf{Keywords:} Atrial Fibrillation, Convergent Procedure,
Cryoballoon Ablation

\textbf{Abbreviations:}

AAD = Antiarrhythmic Drug

AF = Atrial Fibrillation

CB = Cryoballoon

EKG = Electrocardiogram

LAA = Left Atrial Appendage

LA = Left Atrium

IVC = Inferior Vena Cava

LSPAF = Long-Standing Persistent Atrial Fibrillation

LVEF = Left Ventricular Ejection Fraction

PAF = Paroxysmal Atrial Fibrillation

PVI= Pulmonary Vein Isolation

SILS = Single Incision Laparoscopic Surgery

\textbf{Introduction}

Atrial fibrillation (AF), a frequently encountered clinical dysrhythmia,
accounts for nearly half a million US hospitalizations yearly and has
been reported to increase annual US healthcare costs by \$26
billion.\textsuperscript{1} These detriments have been mitigated by the
maintenance of sinus rhythm with innovative, guideline-supported means
of catheter and surgical ablation.\textsuperscript{2} The convergent
hybrid procedure demonstrated safe and superior effectiveness compared
to standard catheter ablation for the treatment of persistent and
longstanding persistent atrial fibrillation (LSPAF) in the CONVERGE
trial.\textsuperscript{3} Apart from this assessment by DeLurgio and
colleagues, few additional contemporary studies define AF populations
who would benefit from the expansion beyond standard pulmonary vein
isolation (PVI).

Furthermore, a recent meta-analysis showed that when the hybrid
procedure was studied, the longest follow-up assessed thus far was only
24 months. The same publication describes only two major studies that
evaluated the use of the hybrid approach utilizing cryoablation; only
one of which utilized it exclusively.\textsuperscript{4} Clearly,
long-term, ''real-world'' evidence to guide the use of
cryotherapy-predominant convergent ablation is lacking. To supplement
this deficit, this retrospective study with up to 48-month-follow-up,
aims to describe a ``real-world'' AF patient population that can benefit
from hybrid ablation. Furthermore, it will compare the safety and
efficacy observed with this group to a cohort of early AF treated with a
standard, PVI-alone approach.

\textbf{Methods}

\textbf{Study Design} :

This retrospective, single-center, observational study was conducted
with the goal of improvement of patient care and safety at Orlando
Health Heart and Vascular Institute. The study was approved by the
Orlando Health Institutional Review Board. Data of patients who
underwent either conventional cryoballoon pulmonary vein isolation (CB
PVI) or hybrid convergent ablation at Orlando Regional Medical Center
from January 2010 through December 2015 were recorded at the time of the
procedure. Proceduralists included three electrophysiologists and one
cardiothoracic surgeon. Patients in the registry consented to the
procedure.

\textbf{Patient Population} :

Patients considered for study were adults with all forms of AF,
including patients with prior failed CB PVI. At least one outpatient
evaluation 90 days post-procedure (blanking period) was required during
follow-up. The following criteria were utilized to determine who was
treated by convergent procedure: 1) PAF with failed class I/III
antiarrhythmic drug (AAD) therapy and previously failed CB PVI ablation
or 2) persistent and LSPAF with failed class I/III AAD willing to
undergo the hybrid procedure. The following criteria were utilized to
determine who was treated by CB PVI: 1) PAF with failed class I/III AAD
or 2) persistent and LSPAF with failed class I/III AAD; unwilling to
undergo hybrid procedure. Exclusion criteria included valvular disease
that, in the opinion of the surgeon, needed surgical correction.
Additionally, prior sternotomy was excluded. Previously documented
pericarditis was not an absolute contraindication and all of these cases
were successfully ablated.

\textbf{Hybrid Procedure:}

The hybrid convergent procedure has been previously described in
detail.\textsuperscript{3,5,6} To briefly summarize our surgical
experience, preoperative evaluation included an echocardiogram and an
ischemic evaluation. General anesthesia was used for all cases.
Initially, a laparoscopic approach with an upper midline abdominal
incision and the placement of a single incision laparoscopic surgery
(SILS) Port was used. Insufflation and two working ports (including a
grasper and a harmonic scalpel via the SILS port) allowed us to gain
access into the pericardial space via the bare area of diaphragm just
medial to the falciform ligament, above the left lobe of the liver.
After a year or so, our approach changed. We were able to perform a
similar subxiphoid incision without laparoscopy (saving time and cost)
by packing the stomach and omentum off to the patient's left with a
moist sponge and using two appendiceal retractors to expose the bare
area of the diaphragm. A long-tipped low-power Bovie was used to divide
the diaphragm and access the pericardial space.

Once access was obtained with the cannula and laparoscope, the ablation
was carried out beginning at the pericardial reflection against the
medial side of the right superior pulmonary vein (PV). We moved from
superior to inferior along the left atrium (LA), medial to the right PV
and down to the level of the inferior vena cava (IVC). This movement was
repeated on the patient's left. We ablated to the coronary sinus, taking
care to overlap lesions. We then moved underneath the left inferior PV
and attempted ablation on the left anterior portion of the left PVs. In
approximately two-thirds of cases, we could observe catheter placement
up to the base of the left atrial appendage (LAA). In one-third of
cases, we could not see the anterior portion of the left PVs due to
hemodynamic instability. For these cases, we would place three or four
lesions blindly.

After left anterior PV ablation, we ablated the anterior portion of the
right PVs. With each ablation, we instilled 25 cc of room-temperature
saline into the pericardial wall through the cannula to avoid thermal
conduction to other mediastinal structures. Once finished, we placed a
silastic drain through a separate incision. We infused 500 mg of
solumedrol through the drain and let it sit while we closed the incision
in a standard manner. The drain was hooked to bulb suction and removed
on the day of discharge. After the surgeon completed the epicardial
ablation, all chest incisions and drains were covered in a sterile
fashion. Then, the endocardial evaluation and intervention by the
electrophysiologist commenced.

After baseline intervals and pacing thresholds were measured, RA and RV
pacing at fixed incremental cycle lengths were performed. The first half
of the initial heparin bolus was then given, and the maintenance
infusion was started after the diagnostic catheters were in position.
The cryoballoon (CB) process of PV isolation began after transvenous
access and transeptal puncture. At that point, an exchange length wire
was advanced to the left superior PV to exchange for a 12F FlexCath
sheath in place of a SL-1 sheath. The second half of the heparin bolus
was given after the left atrium was entered. A preoperative computed
tomography scan with contrast of the LA and PVs was used to evaluate LA
size, PV anatomy (including any anomalies), and the PV ostium. Depending
on the size of the ostium, a 23/28mm Artic Front CB catheter with a
spiral 15/20mm Achieve wire was advanced sequentially to all PVs, the
anterior and posterior walls of the LA, and the roof of the LA. Using a
field filter of 0.1 mV, each area was mapped to evaluate for isolation.
Pacing, using the Achieve catheter, was performed to verify non-capture
at the antrum/ostium of each PV as well as the posterior wall. Entrance
and exit block were confirmed in all pulmonary veins. A 3D anatomical
map was performed of the LA (specifically the roof), posterior walls,
and all PVs. This was done to verify PV and posterior wall isolation.
Posterior wall isolation was homogenous, starting at the level of the
superior PVs down to the level of the right and left inferior PVs.

It was generally identified that the anterior/superior turnaround
borders of the left and right superior PVs were not completely isolated,
especially the ridge between the left superior PV and the LAA. Rarely,
the inferior/posterior borders of the left and right inferior PV were
also still connected. When the PVs were not completely isolated,
cryo-energy was delivered to complete the isolation. Care was taken to
verify that the esophageal temperature probe was positioned directly
behind the PV we were isolating or the posterior wall we were ablating.
The goal was to achieve approximately -40 degrees Celsius for 4 minutes.
When PV signals were present on the Achieve catheter, we strove to
isolate these signals or eliminate them altogether within the first 60
seconds. If this was not achieved, we would reposition the balloon
catheter to find a better fit and seal. Care was taken to verify that
the esophageal temperature did not fall below -30 degrees Celsius.

When delivering cryo-energy along the right-sided PVs, a quadripolar
catheter was often positioned in the right subclavian vein to pace the
right phrenic nerve. A fetal monitor was placed on the patient's abdomen
to audibly monitor right hemidiaphragm contractility. Cryo-energy
delivery to the right-sided pulmonary veins was stopped when the
intensity of diaphragmatic contractility began to diminish. When the
endocardial posterior roof line was not complete, a 4 mm tipped
deflectable, irrigated tipped electrode was used to deliver
radiofrequency using 20-25 watts for 30-60 seconds. If the esophageal
temperature probe temperature rose \textgreater{} 1 degree Celsius,
ablation was stopped, and the area was allowed to return to baseline
temperature before another ablation lesion was delivered nearby, but not
in the same location. The goal was elimination of endocardial signals
\textgreater{} 0.1 mV and lack of pacing response from the ablated area.

When all PVs and the posterior wall were isolated and the posterior
roofline was completed, we would continue to pace and remap for 20
minutes after the last ablation. Isoproterenol up to 5 mcg/min was often
infused during this waiting period. Sometimes intravenous adenosine 6
and 12 mg were used after the 20-minute waiting period. If there was no
reconnection of PVs or posterior wall, then the ablation was terminated.
Post ablation, no significant signals above 0.1 mV were observed.
Likewise, pacing along the line failed to capture atrial tissue. After
PVI, RA, and RV incremental pacing and programmed stimulation were
performed. No arrhythmias were inducible. Intracardiac echocardiography
was used to rule out pericardial effusion as well as to measure PV
velocities pre- and post-procedure. Heparin was reversed with
intravenous protamine by the anesthesia service.

\textbf{Patient follow-up and Study Endpoints:}

Patient demographics and co-morbidities, including salient details of
the patient's AF, baseline left ventricular ejection fraction (LVEF),
and medications were recorded. Standard follow-up protocol included a
1-week post-procedure electrocardiogram (EKG) and a 24--48-hour Holter
monitor at 1, 3, 6, 12, 24, and 48 months. At minimum, an EKG was
obtained on every follow up visit. The primary outcome was defined as
freedom of arrhythmia outside of the 90-day blanking period. Secondary
outcomes included AAD at discharge, 12, and 36 months as well as the
following procedure-related complications: incidence of complications;
bleeding requiring \textgreater{}2 units PRBCs; wound infection;
transient phrenic nerve palsy; and atrioesophageal fistula.

\textbf{Statistical Analysis}

Continuous variables are summarized as mean ± standard deviation and
dichotomous variables are presented as the number and percent of
subjects. Baseline and procedural characteristics are summarized as
means. Kaplan-Meier methods were used to estimate the 36-month freedom
from atrial arrhythmia. Standard error was calculated with Greenwood's
formula. Values of p \textless{}0.05 were considered statistically
significant. Statistical analyses were performed with Statistics
Kingdom.

\textbf{Results}

The baseline characteristics of the 276 patients (197 CB PVIs with an
average age of 64.2 ± 10.6 years and 79 hybrid procedures with an
average age of 61.4 ± 8.1 years) did have some significant differences
among the two subgroups (table 1). Both cohorts were composed of mostly
men, representing 66.5\% of the CB PVI group and 83.5\% of the hybrid
group (p=\textless{}0.01). PAF represented 74.1\% of the CB PVI group
and 41.8\% of the hybrid group (p=\textless{}0.001) while persistent AF
was encountered in 18.3\% of the CB PVI group vs. 45.6\% of the hybrid
group. LSPAF patients composed 1.0\% of the CB PVI group and 12.7\% of
the hybrid group (p=\textless{}0.001). Generally, the CB PVI group had a
much shorter duration of AF (4.4 ± 4.3 years) when compared to the
hybrid group 9.4 ± 7.9 years (p=\textgreater{}0.001).

Both groups, on average had preserved LVEF.
CHA\textsubscript{2}DS\textsubscript{2}-VASc scores were significantly
higher in the CB PVI group (2.3 ± 1.6) when compared to the hybrid group
(1.7 ± 1.3) (p=0.01). The hybrid group more frequently had both prior
ablation and prior cardioversions (58.2\% and 83.5\% respectively) in
comparison to the CB PVI group (18.3\% and 44.7\% respectively) (p =
\textless{}0.001). There was no significant difference in the prevalence
of the following comorbidities: heart failure, hypertension, diabetes
mellitus, stroke or transient ischemic attack, and coronary/peripheral
artery disease. Regarding primary outcomes, freedom from arrhythmia
post-procedure at 6 months (CB PVI: 82.4\% vs. hybrid: 85.1\%), 12
months (CB PVI: 74.5\% vs. hybrid: 66.5\%), 24 months (CB PVI: 64.5\%
vs. Hybrid: 61.4\%), and 36 months (CB PVI: 55.2\% vs. Hybrid: 50.4\%),
was similar in both groups. Some patients were able to be followed
through 48 months and again, arrhythmia occurrence was similar in both
arms (CB PVI: 49.5\% vs. Hybrid: 39.2\%) (figure 1).

As listed in table 2, there were two procedure-related perioperative
complications in the CB PVI group and three in the hybrid group
(p=0.14). AAD utilization is listed in table 3. Class I AAD utilization
at discharge occurred in 38 (19.3\%) patients in the CB PVI group and 5
(6.3\%) in the hybrid convergent group (p=0.01). CB PVI Class I AAD
utilization at 12 months occurred in 14 (9.0) patients versus 0 patients
for hybrid convergent (0.004). There was no additional AAD utilization
difference noted at discharge, 12, or 36 months.

\textbf{Discussion}

This retrospective study showed that despite a longer duration of AF and
a more frequent prevalence of prior AF ablation, prior cardioversions,
and persistent/LSPAF, the hybrid convergent cohort demonstrated success
similar to the results seen in a much less complex cohort of primarily
PAF treated with early, stand-alone cryoballoon ablation. This was not
at the expense of more frequent perioperative complications. Moreover,
the hybrid cohort received significantly less class I AAD prescriptions
at 12 months when compared to the cryoballoon group.

At the time of study initiation, there were no efficacy data from large,
randomized, multicenter clinical trials using cryoablation in AF. Many
of the non-randomized clinical trials using radiofrequency or
cryo-energy in patients with PAF reported outcomes between 38\% to 78\%
for a single ablation and one-year success rates of 54\% to 80\% for
multiple ablations\textsuperscript{7}. The experience at our center
using first generation cryoablation catheters for PAF was similar, with
success rates of greater than 70\%. We found recurrence of PAF was
generally due to difficult pulmonary vein anatomy (i.e., large common PV
on the left or large ovoid PV ostium) or more likely extrapulmonary vein
triggers (i.e., posterior wall or carina). To minimize multiple
procedures, we collaborated with our cardiovascular surgical colleagues
on the hybrid convergent ablation technique to address extrapulmonary
vein triggers and substrate modification to improve efficacy after a
second ablation procedure.

On the contrary, non-randomized persistent AF trials from that time
demonstrated single procedure efficacy of 22 to 45\%. The majority of
centers reported efficacy rates of less than 30\%\textsuperscript{7}. In
line with these results, our single procedure success rate for
persistent AF using a first generation cryoballoon catheter to only
isolate the pulmonary veins was also approximately less than 50\% at one
year. Consequently, to minimize repeat ablations and maximize outcomes
in this patient population, we collaborated with our surgeons on the
hybrid/convergent ablation technique as an initial approach.

While an atrial fibrosis-guided AF ablation approach showed theoretical
promise, the negative DECAAF2 trial illuminates the importance of
PVI.\textsuperscript{8} Despite different explored ablation strategies
for persistent AF, none have previously proven superior effectiveness
over PVI.\textsuperscript{9--11} Recently however, in patients with
persistent and LSPAF, DeLurgio et al showed superior effectiveness over
endocardial ablation with the convergent
approach.\textsuperscript{3}Moreover, Makati and colleagues summarize
these techniques, describing ``best practices.\textsuperscript{5}''
Nevertheless, there is still a lack of real-world, long-term evidence on
the convergent approach; especially with the utilization of cryotherapy
ablation. In fact, many of the long-term follow-up data in
``real-world,'' community settings, are either for PVI in early AF
disease or demonstrate PVI in advanced AF disease with room for efficacy
improvement.

In comparison to a meta-analysis which included 551 patients across six
studies, our cohort was noted to have a similar rate of freedom from
atrial arrhythmia occurrence (67\% vs 69\%) but less class I/Class III
AAD utilization at one year (39\% vs 50\%). In alignment with the six
major studies, we shifted from a transdiaphragmatic surgical approach to
a subxiphoid, pericardial approach early in our study. Similarly, our
hybrid ablation was performed in the same setting as opposed to two
separate visits. Importantly, only three studies specify inclusion of
patients with prior PVI, whereas in our study, these patients composed
the majority of the hybrid cohort. Our hybrid patients notably had a
longer preprocedural mean duration of AF (9.4 years vs 2-5.1 years).
Monitoring methods for arrhythmia detection such as serial EKGs and
continuous monitoring were comparable to the majority of previously
published studies\textsuperscript{4}. A key distinguishing factor is
that we present a study with two intentionally different cohorts with
different complexities across the AF spectrum.

Isolating comparison to the only study which utilized cryoballoon
exclusively (Makati et al), our hybrid group included much more PAF
patients (41.8\% vs 1.5\%), a similar amount of persistent AF patients
(45.5\% vs 38.1\%) and less LSPAF patients (12.7\% vs 60.4\%). Age, sex,
and CHADS2VASc scores were comparable (table 1). Our hybrid cohort had a
higher prevalence of prior cardioversions (83.5\% vs 58\%) and we
reported similar periprocedural complication rates (3.7 \% vs 6\%).
Notably, our study provides longer follow up (up to 48 months vs up to
24 months). Freedom from atrial arrhythmia at designated follow up
intervals is compared between our study and the study performed by
Makati et al as follows: 6 month (85.1\% vs 91.1); 12 month (66.5\% vs
82.4\%); 24 months (61.4\% vs 51.7\% ).\textsuperscript{12}

A major limitation to our study includes selection bias. The high
prevalence of PAF in the hybrid cohort may lead to possible improved
outcomes given a lower complexity of AF. However, patients selected for
study needed to have previously failed both class I/III AAD and CB PVI
ablation. This study intentionally evaluated cohorts with different
complexities of AF and therefore should not be seen as a traditional,
``standard of care vs novel intervention'' study. The retention rate in
this longitudinal cohort study gradually declined over the course of 48
months however this pattern has also been appreciated in previously
published projects. Future studies in this field would be those designed
to elucidate the differences in patient characteristics and clinical
outcomes in patients undergoing hybrid ablation who have had prior PVI
ablation vs not. Findings would likely uncover additional insight into
the reasons for AF recurrence therefore add clinical utility to the
provider.

\textbf{Conclusion}

A recently completed randomized clinical trial demonstrated the safety
and efficacy of the convergent approach.\textsuperscript{3} Yet,
real-world, long-term evidence is generally lacking. This study
demonstrated that patients with more complex forms of AF (PAF refractory
to both AAD and index cryoballoon ablation and persistent/LSPAF) could
be well managed with a convergent approach. Moreover, outcomes match
safety and efficacy thresholds achieved by patients with an early, less
complex AF etiology treated by cryoballoon PVI-alone.

Acknowledgements: None

Disclosures: None

\textbf{References:}

1. Calkins H, Hindricks G, Cappato R, et al. 2017
HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and
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\textbf{Figure Legend}\selectlanguage{english}
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