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\begin{document}

\title{Single center, multi-surgeon experience with a sutureless rapid
deployment aortic valve prosthesis: A clinical and economic analysis in
the United States}



\author[1]{Kelly Ohlrich}%
\author[1]{Michael P. Robich}%
\author[2]{Catherine Raymer}%
\author[2]{David Robaczewski}%
\author[2]{Jaime Rabb}%
\author[2]{Dorothy J. Radziszewski}%
\author[3]{Alexander Iribarne}%
\author[3]{Shravanthi M. Seshasayee}%
\author[3]{Cathy Ross}%
\author[2]{Reed Quinn}%
\author[2]{Robert Kramer}%
\affil[1]{Tufts Medical Center}%
\affil[2]{Maine Medical Center}%
\affil[3]{Dartmouth-Hitchcock Medical Center}%


\vspace{-1em}



  
  \date{May 27, 2024}


\begingroup
\let\center\flushleft
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\selectlanguage{english}
\begin{abstract}
Background The Perceval S is a sutureless, rapid deployment, bovine
pericardial aortic prosthesis on a nitinol stent, which has limited data
on outcomes and cost from the United States. Methods We performed a
retrospective review of Perceval S implantation at a single center
between 2015 and 2018. After exclusion criteria, we compared 262
patients who underwent sutureless aortic valve (SLV) implantation with
394 patients who underwent standard sutured aortic valves (SAVR).
Hospital cost data was reviewed, and risk adjustment, done by propensity
score and inverse probability weighting, was used to compare outcomes.
Results The SLV group was older, had more females, and had a higher
proportion of multicomponent operations. For isolated AVR, partial upper
hemisternotomy was more frequent in SLV. The median cardiopulmonary
bypass and cross clamp times for isolated SLV were significantly lower
than SAVR. SLV had a risk-adjusted 11.3\% permanent pacemaker (PPM) rate
vs 6.1\% in SAVR (p=0.016). There were no differences in other
postoperative complications (postoperative atrial fibrillation, stroke,
renal failure, prolonged ventilation; P\textgreater{}.05 for all).
Mortality at any time did not differ between groups. Median hospital
costs were higher in the SLV group, likely due to permanent pacemaker
rate leading to longer length of stay. Conclusion Sutureless tissue
aortic valves can be used safely with lower cardiopulmonary bypass and
clamp times than sutured prostheses and facilitate use of minimally
invasive approaches with cost neutrality. This valve may be advantageous
in older, higher risk patients requiring complex operations.%
\end{abstract}%



\sloppy


Title:

\textbf{Single center, multi-surgeon experience with a sutureless rapid
deployment aortic valve prosthesis: A clinical and economic analysis in
the United States}

Authors:

Michael P. Robich\textsuperscript{1}, Kelly
Ohlrich\textsuperscript{1}Catherine Raymer\textsuperscript{2}, David
Robaczewski\textsuperscript{2}, Jaime Rabb\textsuperscript{2}, Dorothy
J. Radziszewski\textsuperscript{2}, Alexander
Iribarne\textsuperscript{3},
Shravanthi~M.~Seshasayee\textsuperscript{3}, Cathy S.
Ross\textsuperscript{3}, Reed D. Quinn\textsuperscript{2}, Robert S.
Kramer\textsuperscript{2}

\textsuperscript{1} Tufts Medical Center, 860 Washington St, Boston, MA

\textsuperscript{2} Maine Medical Center, 22 Bramhall Street, Portland,
ME,

\textsuperscript{3} Dartmouth-Hitchcock Medical Center, 1 Medical Center
Drive, Lebanon, NH

Running title: Sutureless Aortic Valve Economics

Funding: None

Conflicts:

M.P. Robich: Speaker Bureau/Honoraria LivaNova

R. Quinn: Consultant/Advisory Board, CryoLife, LivaNova

Classifications:

Word Count: 4,274

Corresponding Author:

Michael P. Robich

Department of Cardiac Surgery

Tufts University Medical Center

860 Washington St, Boston MA 02111

Tel: 617-636-0033 Fax: 617-636-5913

\emph{}

\emph{Background}

The Perceval S is a sutureless, rapid deployment, bovine pericardial
aortic prosthesis on a nitinol stent, which has limited data on outcomes
and cost from the United States.

\emph{Methods}

We performed a retrospective review of Perceval S implantation at a
single center between 2015 and 2018. After exclusion criteria, we
compared 262 patients who underwent sutureless aortic valve (SLV)
implantation with 394 patients who underwent standard sutured aortic
valves (SAVR). Hospital cost data was reviewed, and risk adjustment,
done by propensity score and inverse probability weighting, was used to
compare outcomes.

\emph{Results}

The SLV group was older, had more females, and had a higher proportion
of multicomponent operations. For isolated AVR, partial upper
hemisternotomy was more frequent in SLV. The median cardiopulmonary
bypass and cross clamp times for isolated SLV were significantly lower
than SAVR.

SLV had a risk-adjusted 11.3\% permanent pacemaker (PPM) rate vs 6.1\%
in SAVR (p=0.016). There were no differences in other postoperative
complications (postoperative atrial fibrillation, stroke, renal failure,
prolonged ventilation; P\textgreater{}.05 for all). Mortality at any
time did not differ between groups. Median hospital costs were higher in
the SLV group, likely due to permanent pacemaker rate leading to longer
length of stay.

\emph{Conclusion}

Sutureless tissue aortic valves can be used safely with lower
cardiopulmonary bypass and clamp times than sutured prostheses and
facilitate use of minimally invasive approaches with cost neutrality.
This valve may be advantageous in older, higher risk patients requiring
complex operations.

\emph{}

\emph{Introduction}

Interest and use of rapid deployment, sutureless aortic valve prosthesis
technology has grown quickly in recent years. The Perceval S is a
self-anchoring bovine pericardial aortic prosthesis mounted on a nitinol
stent. This valve has been approved for use in Europe since January
2011, and it received FDA approval in January 2016 for use in the United
States. The valve can be used in aortic annular diameters from 19 mm to
27 mm and is available in sizes small (19-21 mm), medium (21-23 mm),
large (23-25 mm) and extra-large (25-27 mm). Early European studies
suggested use of the valve was safe, shortened times in the operating
room and resulted in acceptable short term
outcomes.\textsuperscript{1-3}

In a study from Germany of 83 high risk patients (mean EuroSCORE 10\selectlanguage{ngerman}±8\%)
showed 1.2\% significant paravalvular leak rate, in-hospital mortality
of 2.4\%, 6\% PPM rate, and 12 month survival of
98\%.\textsuperscript{5} A more modern study from Spain in 2017 examined
448 patients undergoing Perceval implantation with EuroSCORE 11±8, and
showed 0.9\% paravalvular leak rate, 9\% PPM rate, and 12 month survival
98\%.\textsuperscript{6} The Perceval valve was offered as an option for
higher risk patients who may benefit from a shortened cross-clamp time.
Over time it was found to be valuable in other settings such as
facilitating minimally invasive approaches7\textsuperscript{,}8, small
annulus9\textsuperscript{,10}, active endocarditis\textsuperscript{11},
re-operative operations\textsuperscript{12}, as a platform for future
valve in valve transcatheter valve implantations\textsuperscript{13,14},
and use in calcified homografts and other hostile aortic root
situations\textsuperscript{15,16}.

There has been considerable international clinical data and some
European cost data presented. However, there is little in the way of
cost analysis from the United States where the financial impact of
adopting new technology is becoming more important. In this study we
sought to review our single center experience with three surgeons using
the Perceval valve. We examined our clinical and cost data to better
understand how this technology can fit into the toolbox of cardiac
surgeons in the United States in an era of increasing TAVR volume.

\emph{Materials and Methods}

Data Source Patients for this study were drawn from the Northern New
England Cardiovascular Disease Study Group (NNECDSG) Cardiac Surgery
Registry. Data in the NNECDSG registry are validated against billing
data from each hospital every 2 years to ensure complete capture of
cases and accurate vital status at discharge. The institutional review
boards at all but one of the seven hospitals have designated the NNECDSG
a quality improvement registry, and, for this reason, patient consent is
waived. The last hospital obtains patient consent. For information about
patient survival beyond hospital discharge, the NNECDSG data were linked
to the National Death Index (through 2001) and the Social Security
Administration Master Death File with complete data through the end of
2010. In 2012, the NNECDSG became a certified user of the Social
Security Administration data and, as such, receives monthly updates of
death data as well as death data from the departments of vital
statistics of Maine, New Hampshire, and Vermont.

Patient Groups and Operative Details

We compared 262 patients who underwent sutureless aortic valve (SLV)
implantation with 394 patients who underwent standard sutured aortic
valves (SAVR). These operations occurred between August 2015 and
December 2018 and were performed by three surgeons who use both valve
types at a single institution. Patients with mechanical valves or
homografts and those with endocarditis, aortic dissection or emergency
presentation were excluded. Hospital cost data (including the valve
cost) were reviewed.

Study End Points

The primary end point of this study was all-cause mortality among
patients undergoing aortic valve replacement. In addition, we examined
whether mortality outcomes differed based on type of operation and type
of valve used for the operation. Other outcomes studied included
operative times, postoperative morbidity (reoperation for bleeding,
perioperative stroke, acute kidney injury, mediastinitis or sternal
dehiscence, pneumonia, and prolonged ventilation), and length of
hospitalization.

Statistical Analysis

Baseline characteristics between groups were compared by using the c2
test for categorical variables and the Wilcoxon rank-sum test for
continuous variables. To account for differences between groups, a
non-parsimonious, multivariable propensity model was used. The model
included surgical procedure, age, sex, body surface area, preoperative
white blood cell count, prior percutaneous coronary intervention,
vascular disease, diabetes, chronic obstructive pulmonary disease,
congestive heart failure, preoperative dialysis or creatinine of 2 mg/dL
or more, New York Heart Association class 4, prior stroke, ejection
fraction, left main stenosis 50\% or greater, three-vessel coronary
disease, recent myocardial infarction (within 7 days), acuity at time of
operation, and hospital where operation was performed. Standardized
differences (std dif) of means are reported for the comparison between
the two groups in the unadjusted and inverse probability weighting
adjusted data. Hazard ratios (HRs) and 95\% confidence limits were
generated by using Cox proportional hazard regression models. All data
were analyzed with Stata statistical software, version 14.1 (Stata Corp,
College Station, TX).

\emph{Results}

Table 1 demonstrates the clinical characteristics in the population
before and after inverse probability weighting. Between August 2015 and
December 2018, the baseline population had 265 patients undergo SLV and
394 underwent SAVR at our institution, the IPW weighted population had
258 patients undergo SLV and 394 undergo SAVR. In the baseline
population, SLV patients had a greater mean age and were more likely to
have had prior PCI (p\textless{}0.001), diabetes (p=0.01), a history of
dialysis or creatinine \textgreater{}1.3 mg/dL (p=0.006), prior MI
(p=0.008), or three-vessel disease (p\textless{}0.001). They were also
more likely to have undergone a concomitant CABG with their SLV
procedure (p\textless{}0.001). With these characteristics weighted after
IPW, there were only significant differences found between SLV and SAVR
regarding three characteristics; SLV patients were more likely to have
prior PCI (p=0.01), prior CVA (p=0.05), and a history of three vessel
disease (p=0.02).

Operative characteristics of the SLV and SAVR groups with IPW weighting
are shown in Table 2. In the baseline population, SLV patients larger
mean valve size (p\textless{}0.001), had more patients undergo minimally
invasive approaches versus full sternotomy (p\textless{}0.001), shorter
cross-clamp (p\textless{}0.001), on-pump (p\textless{}0.001), and total
OR times (p=0.025).

There were few significant postoperative characteristic differences
between the two groups, which are reflected in Table 3. The baseline
population differed significantly only with SLV patients having a higher
rate of rhythm disturbance requiring a permanent device permanent
pacemaker or ICD (p=0.016), and longer median length of stay
(p\textless{}0.001). The weighted population differed significantly in
only one aspect; the SAVR group had a longer mean total ventilation time
when compared to SLV (p=0.04). There was no difference in permanent
pacemaker rate (10.7\% in SLV vs 6.3\% in SAVR, p=0.06). The pacemaker
rate in the SLV group decreased over the study period from 14\% to
4.2\%. There was also no difference in length of stay.

Table 4 represents our cost analysis. In the crude analysis, hospital
costs were higher for the SLV group, with a mean total cost of \$71,600
(vs \$61,100 in SAVR, p=0.018) and median total costs of \$57,390 (vs
\$46,700 in SAVR, p\textless{}0.001). For isolated valve procedure, the
mean cost was \$43,650 for SLV and \$38,914 in SAVR (p=0.003). For CABG
with valve procedure, the SLV group had a mean cost of \$61,487, while
the SAVR group had a mean cost of \$53,777 (p=0.07). The cost
subcategories in which SLV had higher costs were room costs
(p\textless{}0.001), pharmacy (p\textless{}0.001), total medical
supplies (p\textless{}0.001) (including sterile supply and implant
costs), ICU costs (p=0.002), radiology (p\textless{}0.001), respiratory
(p\textless{}0.001), professional fees (p=0.005), and other costs
(p=0.022). After IPW, there were no differences in median cost (\$68,023
in SLV and \$62,676 in SAVR; p=0.20).

\emph{Discussion}

This study presents the first examination of cost data on sutureless,
rapid deployment valves in the United States. Like many studies we
showed shorter cardiopulmonary bypass and aortic cross clamp times with
good outcomes. Also shown was an initially high permanent pacemaker rate
that declined over time. Hospital costs between SLV and standard sutured
valves were not different.

Overall, outcomes with SLV have been good. The Europeans have a longer
and more extensive experience. In reviewing that literature the early
reports in isolated AVR were encouraging, showing safety and good
hemodynamic results.\textsuperscript{4,5} In the Cavalier
Trial,\textsuperscript{17} Perceval valves were placed in 628 patients
in several European centers from 2010 to 2013 with a mean cross-clamp
time of 32 minutes and post-operative mean gradient of about 10 mmHg.
Thirty day overall and valve-related mortality rates were 3.7\% and
0.5\%, respectively. The valve explant rate was 0.6\%, and stroke rate
was 2.1\%. Five year data were presented by Shrestha, et al. in 2016 and
showed similar short-term outcomes in 731 patients undergoing AVR from
2007 to 2012.\textsuperscript{18} There was a 1\% incidence of late
major paravalvular leak. Early mortality was about 2\%, 1 year 8\% and 5
year was 25\%. The average mean gradient at 5 years was 7.8 mmHg.

The post-operative mean gradients reported in studies of rapid
deployment valves are interesting and may suggest a learning curve. When
an oversized SLV is placed the mean gradient may be elevated due to
decreased leaflet excursion. In a large German registry review of over
20,000 patients undergoing isolated SAVR three rapid deployment valves
were compared. The Perceval valve was less likely to be a smaller sized
valve (\selectlanguage{english}[?] 21 mm) (Perceval 10\% of patients, balloon expandable INTUITY
valve (Edwards Lifesciences, Irvine, California) 25\%, and
self-expanding, nitinol-based 3F Enable valve (Medtronic, Dublin,
Ireland) 27\%; P\textless{}.001). The median postoperative mean aortic
valve gradient was highest in the Perceval (14 mmHg, INTUITY 9 mmHg and
Enable 10 mmHg; P\textless{}.001), and permanent pacemaker was highest
with Perceval (11\%, INTUITY 7\% and Enable 7\%; P\textless{}.02). It is
common for surgeons to place the largest valve possible, but
right-sizing of this valve allows for optimal hemodynamics and avoidance
of permanent pacemaker. Subsequent studies have shown the PPM rate can
be reduced by changes in implantation technique.\textsuperscript{19}

Comparisons have been made to stented surgical valves and transcatheter
aortic valve replacements (TAVR). A 2014 study compared Perceval to
Carpentier-Edwards Perimount aortic prostheses showing lower CPB and
cross-clamp times with SLV.\textsuperscript{20} The post-operative peak
gradients were lower with SLV, but the average mean gradients were not
different in similarly sized valves (approximately 23 mm for both
groups). There was no difference in PPM in this small study. A 2015
study from France compared hemodynamic performance of small Perceval
prostheses in elderly patients with larger size Perceval valves and
found no difference in post-operative mean gradient (10.3 mmHg for small
valves and 11.3 mmHg for medium and large valves; P=.20), indexed
effective orifice area (0.84
cm\textsuperscript{2}/m\textsuperscript{2}for small and 0.86 ; P=.76) or
presence of patient prosthesis mismatch (absent in 45\% v. 43\%,
moderate in 45\% v. 39\% and severe in 10\% v. 20\%; P=0.6). At a median
follow up of 1.5 years the echo measurements and survival did not
differ. This suggests that a stentless valve in the small aortic root
can provide good hemodynamics.\textsuperscript{21}

Recently published industry sponsored clinical trials in low-risk
patients with severe aortic stenosis have shown that transcatheter
aortic valve replacement (TAVR) is at least comparable in short term
outcomes when compared to surgical aortic valve
replacement.\textsuperscript{22,23}In both trials TAVR resulted in less
stroke, bleeding, atrial fibrillation and shorter length of stay with
similar valve performance at one year. The type of surgical valve used
in these trials was left to the surgeon, and it is not clear if certain
prostheses have any advantage. There have been no randomized control
trials comparing sutureless valves to date. Several retrospective
studies comparing older TAVR technology showed some advantages to SAVR
with sutureless valves (lower rates of vascular complications,
paravalvular leak, permanent pacemaker, and renal failure) which have
been largely mitigated with advancements in TAVR technology.
Interestingly, two studies with mid-term patient matched outcome data
showed no difference in survival at one year, but a survival advantage
for Perceval at two years; 97.3\% vs. 86.5\%, P = .015 and 94.9\% vs.
79.5\%, P = .02.\textsuperscript{24,25}There is great interest in
understanding how TAVR will compare with SAVR in mid- and long-term
outcomes. Similar to our findings, a number of studies have demonstrated
that sutureless valve technology facilitates minimally invasive
approaches. The Sutureless and Rapid Deployment International Registry
published results of 1935 patients undergoing SAVR with sutureless and
rapid deployment valves and showed 73\% were implanted in a minimally
invasive fashion.\textsuperscript{26} In contrast, overall use of mini
approaches to SAVR have been reported to be 15\% in the United States,
12\% in the United Kingdom and 25\% in Germany.\textsuperscript{27} It
is clear that for SAVR to compete surgeons should work to improve
outcomes and utilize minimally invasive approaches for patients who are
not currently candidates for transcatheter technology.

There have been concerns raised about possible complications associated
with sutureless valve technology. There have been reports of
paravalvular leak, especially in the early
experience.\textsuperscript{28} The cause of paravalvular leak is often
due to incorrect sizing of the valve. There is certainly a learning
curve associated with new valve technology and ensuring proper sizing is
important. It has been the practice of our group to not accept more than
trace paravalvular leak on the intraoperative post implant
echocardiogram. Thrombocytopenia has also been described. In one study
the average platelet count at discharge after Perceval implantation was
102,000 +- 28,000 which was significantly lower than Edwards Intuity
rapid deployment valve.\textsuperscript{29} Another study compared
Perceval (n= 72 patients) to Perimount Magna Ease (n=101 patients) and
showed a greater maximum drop in platelet count at a mean of
post-operative day 2.3 (58\% in Perceval vs. 44\% in Magna Ease;
P=.0001), less likely recovery to pre-operative levels by discharge
(26\% in Perceval and 44\% in Magna Ease; P=.018), and more red blood
cell (P=.007) and platelet (P=.009) transfusion with Perceval. We did
not appreciate a significant difference in bleeding rates or
transfusion, and often treated the thrombocytopenia expectantly if there
were no bleeding complications. Migration is extremely rare, but has
been reported.\textsuperscript{30} Two clinical situations have been
described. The first is in double, aortic and mitral, valve replacement
where the two prostheses interact and the sutureless valve becomes
unstable. There appears to be potentially predictive factors including a
short aorticomitral curtain (\textless{}6 mm) and the angle of the aorta
and mitral annuli. These factors are currently being studied. The second
is infective endocarditis after sutureless valve placement. If there is
a large annular abscess the valve may become unstable, and at risk of
migration. Our experience with a single case has suggested that early
surgery in these cases may be beneficial. Durability of the valve is
being studied as well. It has been shown in the European literature that
the 5-year durability data is reasonable. In a 2016 multicenter paper,
Shrestha et al.\textsuperscript{18} showed a late (more than 30 days
after implant) explant rate of 1.5\%, major paravalvular leak rate of
1\%, endocarditis 1.6\% and AV block in 1.4\%. At the 2019 American
Association for Thoracic Surgery annual meeting Dr. Meuris presented
11-year data on 486 consecutive patients at Leuven University Hospital.
In their series there were no explants for structural valve
degeneration. The manuscript and additional long-term data are pending.
In our current series no valves have been explanted for structural valve
degeneration. However, It does appear that sutureless valves will offer
a good platform for future valve in valve TAVR as it is essentially a
stentless valve.\textsuperscript{31} For a small Perceval valve a 23 mm
Edwards S3 TAVR valve can be considered.

There are economic considerations when using new technology, and date
there have been no data on cost in the United States for this procedure.
Sutureless and rapid deployment valves often cost more than standard
aortic prostheses. At our institution, during the study period, the
Perceval valve cost approximately \$5,670 more than sutured valves. A
study from Germany showed use of sutureless valves resulted in lower
cost based on savings in diagnostics and hospital length of
stay.\textsuperscript{32} In our current study we found that a higher
pacemaker rate incurred extra cost. There have been excellent
descriptions of techniques to reduce pacemaker rate\textsuperscript{33},
and our group has been able to continue decreasing the need to
post-operative permanent pacemakers.

\emph{Limitations}

There are limitations to this study inherent to this type of
investigation. It is a retrospective review based on prospectively
collected data. We examined data from three surgeons performing both
types of aortic valve implantation concurrently, but there may be
remaining bias despite inverse probability weighting. Early in the
experience with SLV there was a conscious decision to place the valve in
older and sicker patients. As the outcomes were shown to be good and
experience improved, the SLV was used in a wider patient population.
There was also on ongoing learning curve and changes to the implantation
technique, as evidenced by decreasing need for PPM.

\emph{Conclusion}

We present the first analysis on cost of the implantation of sutureless
valves compared with standard aortic valve prostheses in the United
States and have demonstrated acceptable short-term outcomes. These rapid
deployment valves also facilitate the use of minimally invasive
approaches and result in lower cardiopulmonary bypass and cross-clamp
times, which may be beneficial in older patients and higher-risk
multicomponent operations. We have also demonstrated cost neutrality,
and the decreasing incidence of heart block over time likely due to
changes in implantation technique. We feel this valve offers another
tool for surgeons in an era of TAVR growth.

\emph{References}

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19. Vogt F, Dell'Aquila AM, Santarpino G. How to Prevent Pacemaker
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26. Berretta P, Andreas M, Carrel TP, et al. Minimally invasive aortic
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Table 1 -- Preoperative characteristics of baseline and IPW-weighted
populations in patients undergoing SLV vs SAVR\selectlanguage{english}
\begin{longtable}[]{@{}lllllllll@{}}
\toprule
& Baseline & Baseline & Baseline & Baseline & Weighted characteristics
after IPW & Weighted characteristics after IPW & Weighted
characteristics after IPW & Weighted characteristics after
IPW\tabularnewline
\midrule
\endhead
& \textbf{Perceval} & \textbf{SAVR} & p-value* & \textbf{SMD} &
\textbf{Perceval} & \textbf{SAVR} & p-value* &
\textbf{SMD}\tabularnewline
& N = 265 & N = 394 & & & N = 258 & N = 394 & &\tabularnewline
& \textbf{N (\%) or Mean (SD)} & & & & \textbf{Weighted \% or mean (SE)}
& \textbf{Weighted \% or mean (SE)} & &\tabularnewline
Primary procedure & & & \textless{}0.001 & 0.307 & & & 0.38 &
0.074\tabularnewline
Isolated valve & 107 (40.4) & 219 (55.6) & & & 45.63 & 49.31 &
&\tabularnewline
CABG + valve & 158 (59.6) & 175 (44.4) & & & 54.37 & 50.69 &
&\tabularnewline
Age at surgery, years & & & & & & & &\tabularnewline
Mean (SD) & 71.6 (8.3) & 68.0 (9.7) & \textless{}0.001 & 0.408 & 70.82
(0.56) & 69.4 (0.48) & 0.06 & 0.157\tabularnewline
\textless{} 50 & 2 (0.8) & 13 (3.3) & \textless{}0.001 & -0.181 & 0.6 &
2.26 & 0.55 & -0.118\tabularnewline
50 - 59 & 26 (9.8) & 65 (16.5) & & -0.198 & 11.98 & 13.59 & &
-0.048\tabularnewline
60 - 69 & 79 (29.8) & 143 (36.3) & & -0.138 & 33.13 & 33.77 & &
-0.014\tabularnewline
70 - 79 & 116 (43.8) & 140 (35.5) & & 0.169 & 41.68 & 38.5 & &
0.065\tabularnewline
[?] 80 & 42 (15.8) & 33 (8.4) & & 0.23 & 12.61 & 11.87 & &
0.023\tabularnewline
Female (\%) & 86 (32.5) & 112 (28.4) & 0.27 & 0.087 & 30.72 & 31.83 &
0.78 & 0.024\tabularnewline
Body Surface Area (BSA), m\textsuperscript{2} & & & & & & &
&\tabularnewline
Mean (SD) & 2.0 (0.2) & 2.0 (0.3) & 0.33 & -0.079 & 2.02 (0.01) & 2.03
(0.01) & 0.68 & -0.034\tabularnewline
\textless{} 1.70 & 29 (10.9) & 31 (7.9) & 0.38 & 0.105 & 9.51 & 9.1 &
0.69 & 0.014\tabularnewline
1.70-1.99 & 98 (37.0) & 145 (36.8) & & 0.004 & 39.41 & 36.26 & &
0.065\tabularnewline
[?] 2.00 & 138 (52.1) & 218 (55.3) & & -0.065 & 51.08 & 54.63 & &
-0.071\tabularnewline
Disease characteristics & & & & & & & &\tabularnewline
Preoperative WBC count \textgreater{} 12,000 mm\textsuperscript{3} & 9
(3.4) & 5 (1.3) & 0.063 & 0.141 & 2.18 & 1.96 & 0.85 &
0.015\tabularnewline
Prior CABG surgery & 4 (1.5) & 4 (1.0) & 0.57 & 0.044 & 1.12 & 1.08 &
0.96 & 0.004\tabularnewline
Prior valve surgery & 17 (6.4) & 18 (4.6) & 0.3 & 0.081 & 5.68 & 3.83 &
0.27 & 0.081\tabularnewline
Prior PCI & 52 (19.6) & 40 (10.2) & \textless{}0.001 & 0.268 & 18.77 &
11.4 & 0.01 & 0.209\tabularnewline
Comorbid disease & & & & & & & &\tabularnewline
Preoperative atrial fibrillation & 61 (23.0) & 79 (20.1) & 0.36 & 0.072
& 21.5 & 20.63 & 0.80 & 0.021\tabularnewline
Vascular disease & 127 (47.9) & 215 (54.6) & 0.094 & -0.133 & 49.11 &
51.08 & 0.64 & -0.039\tabularnewline
Diabetes & 122 (31.0) & 107 (40.4) & 0.013 & 0.197 & 36.31 & 34.18 &
0.59 & 0.045\tabularnewline
COPD & 57 (21.5) & 82 (20.8) & 0.83 & 0.017 & 20.73 & 20.96 & 0.94 &
-0.006\tabularnewline
Smoking & 27 (10.2) & 48 (12.2) & 0.43 & -0.063 & 10.47 & 11.51 & 0.69 &
-0.033\tabularnewline
Congestive Heart Failure & 111 (41.9) & 154 (39.1) & 0.47 & 0.057 &
38.92 & 39.4 & 0.91 & -0.01\tabularnewline
History of dialysis or creatinine \textgreater{}1.3 & 43 (16.2) & 36
(9.1) & 0.006 & 0.21 & 2.85 & 0.54 & 0.86 & 0.167\tabularnewline
Prior CVA & 22 (8.3) & 20 (5.1) & 0.096 & 0.129 & 8.84 & 4.81 & 0.05 &
0.161\tabularnewline
Prior Myocardial Infarction & & & 0.008 & & & & &\tabularnewline
No & 190 (71.7) & 323 (82.0) & & -0.167 & 73.83 & 79.51 & 0.21 &
-0.029\tabularnewline
[?] 7 days & 17 (6.4) & 17 (4.3) & & 0.093 & 5.62 & 5.52 & &
0.004\tabularnewline
\textgreater{} 7 days & 58 (21.9) & 54 (13.7) & & 0.135 & 20.55 & 14.97
& & 0.035\tabularnewline
Left main stenosis [?] 50\% & 42 (15.8) & 47 (11.9) & 0.15 & 0.113 & 14.5
& 14.75 & 0.93 & -0.007\tabularnewline
Three-vessel disease & 87 (32.8) & 72 (18.3) & \textless{}0.001 & 0.338
& 30.41 & 21.87 & 0.02 & 0.198\tabularnewline
Ejection fraction (\%) & & & & & & & &\tabularnewline
Mean (SD) & 56.4 (10.2) & 57.4 (10.1) & 0.23 & -0.096 & 56.87 (0.67) &
57.43 (0.52) & 0.51 & -0.055\tabularnewline
\textless{} 40 & 21 (7.9) & 29 (7.4) & 0.34 & 0.021 & 7.21 & 7.45 & 0.66
& -0.009\tabularnewline
40-49 & 24 (9.1) & 24 (6.1) & & 0.112 & 7.93 & 6.35 & &
0.06\tabularnewline
50-59 & 96 (36.2) & 133 (33.8) & & 0.052 & 36.38 & 33.11 & &
0.069\tabularnewline
[?] 60 & 124 (46.8) & 208 (52.8) & & -0.12 & 48.48 & 53.09 & &
-0.092\tabularnewline
Priority at surgery & & & 0.074 & -0.141 & & & 0.98 &
-0.002\tabularnewline
Urgent & 82 (30.9) & 97 (24.6) & & & 27.02 & 26.92 & &\tabularnewline
Elective & 183 (69.1) & 297 (75.4) & & & 72.98 & 73.08 &
&\tabularnewline
\bottomrule
\end{longtable}

Table 2- Intraoperative characteristics of baseline and IPW-weighted
populations in patients undergoing SLV vs SAVR\selectlanguage{english}
\begin{longtable}[]{@{}lllllllll@{}}
\toprule
& \emph{Baseline} & \emph{Baseline} & \emph{Baseline} & \emph{Baseline}
& \emph{Weighted characteristics after IPW} & \emph{Weighted
characteristics after IPW} & \emph{Weighted characteristics after IPW} &
\emph{Weighted characteristics after IPW}\tabularnewline
\midrule
\endhead
\emph{} & \textbf{Perceval} & \textbf{SAVR} & p-value* & \textbf{SMD} &
\textbf{Perceval} & \textbf{SAVR} & p-value** &
\textbf{SMD}\tabularnewline
& N = 265 & N = 394 & & & N = 258 & N = 394 & &\tabularnewline
\emph{} & \textbf{N (\%) or Mean (SD)} & \textbf{N (\%) or Mean (SD)} &
& & \textbf{Weighted \% or mean (SE)} & \textbf{Weighted \% or mean
(SE)} & &\tabularnewline
Operative charactertistics & & & & & & & &\tabularnewline
\emph{Aortic Valve Size} & & & & & & & &\tabularnewline
\emph{Mean (SD)} & 25.0 (1.9) & 24.0 (2.6) & \textless{}0.001* & 0.455 &
25.07 (0.12) & 23.77 (0.14) & \textless{}0.001* & 0.576\tabularnewline
\emph{19 - 21mm, small} & 16 (6.0) & 92 (23.4) & \textless{}0.001* &
0.425 & 6.11 & 26.37 & \textless{}0.001* & 0.536\tabularnewline
\emph{22-23mm, medium} & 65 (24.5) & 113 (28.7) & & & 23.2 & 28.92 &
&\tabularnewline
\emph{24-25mm, large} & 85 (32.1) & 93 (23.6) & & & 31.73 & 22.4 &
&\tabularnewline
\emph{26-27mm, extra-large} & 99 (37.4) & 72 (18.3) & & & 38.95 & 17.05
& &\tabularnewline
\emph{\textgreater{} 27mm} & 0 (0.0) & 24 (6.1) & & & 0 & 5.26 &
&\tabularnewline
\emph{Operative approach} & & & \textless{}0.001* & 0.282 & & &
\textless{}0.001* & 0.391\tabularnewline
\emph{Full sternotomy} & 216 (81.5) & 359 (91.1) & & & 78.68 & 92.01 &
&\tabularnewline
\emph{Minimally invasive approaches\textsuperscript{a}} & 49 (18.5) & 35
(8.9) & & & 21.32 & 7.99 & &\tabularnewline
\emph{Cardioplegia used} & & & 0.53 & 0.069 & & & 0.37 &
0.091\tabularnewline
\emph{None} & 0 (0.0) & 1 (0.3) & & & 0 & 0.18 & &\tabularnewline
\emph{Blood} & 54 (20.4) & 91 (23.1) & & & 20.22 & 24.04 &
&\tabularnewline
\emph{Crystalloid} & 2 (0.8) & 1 (0.3) & & & 0.85 & 0.27 &
&\tabularnewline
\emph{Both} & 209 (78.9) & 301 (76.4) & & & 78.93 & 75.52 &
&\tabularnewline
\emph{Cardioplegia delivery method} & & & 0.18 & -0.062 & & & 0.03 &
-0.185\tabularnewline
\emph{None} & 0 (0.0) & 1 (0.3) & & & 0 & 0.18 & &\tabularnewline
\emph{Antegrade} & 60 (22.6) & 73 (18.5) & & & 26.37 & 17.58 &
&\tabularnewline
\emph{Retrograde} & 5 (1.9) & 17 (4.3) & & & 1.98 & 3.85 &
&\tabularnewline
\emph{Both} & 200 (75.5) & 303 (76.9) & & & 71.65 & 78.38 &
&\tabularnewline
\emph{Median cross-clamp time (minutes)} & 74.0 (48.0-105.0) & 83.0
(64.0-110.0) & \textless{}0.001* & -0.302 & 77.23 (2.63) & 93.87 (2.18)
& \textless{}0.001* & -0.407\tabularnewline
\emph{Median pump time (minutes)} & 100.0 (69.0-144.0) & 110.0
(90.0-156.0) & \textless{}0.001* & -0.315 & 106.38 (3.32) & 129.13
(2.96) & \textless{}0.001* & -0.422\tabularnewline
\emph{Median OR Time (hours)} & 4.6 (3.6-5.7) & 4.7 (4.0-5.7) & 0.025* &
-0.159 & 4.71 (0.1) & 5.15 (0.08) & \textless{}0.001* &
-0.287\tabularnewline
\emph{Intraoperative blood transfusion} & 51 (19.2) & 61 (15.5) & 0.21 &
0.099 & 16.82 & 17.4 & 0.85 & -0.015\tabularnewline
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care
unit\tabularnewline
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}}\tabularnewline
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate\tabularnewline
**p-values for dichotomous and categorical variables are corrected,
weighted, pearson chi-squared statistics that account for weighted data
(design-based f statistic) & **p-values for dichotomous and categorical
variables are corrected, weighted, pearson chi-squared statistics that
account for weighted data (design-based f statistic) & **p-values for
dichotomous and categorical variables are corrected, weighted, pearson
chi-squared statistics that account for weighted data (design-based f
statistic) & **p-values for dichotomous and categorical variables are
corrected, weighted, pearson chi-squared statistics that account for
weighted data (design-based f statistic) & **p-values for dichotomous
and categorical variables are corrected, weighted, pearson chi-squared
statistics that account for weighted data (design-based f statistic) &
**p-values for dichotomous and categorical variables are corrected,
weighted, pearson chi-squared statistics that account for weighted data
(design-based f statistic) & **p-values for dichotomous and categorical
variables are corrected, weighted, pearson chi-squared statistics that
account for weighted data (design-based f statistic) & **p-values for
dichotomous and categorical variables are corrected, weighted, pearson
chi-squared statistics that account for weighted data (design-based f
statistic) & **p-values for dichotomous and categorical variables are
corrected, weighted, pearson chi-squared statistics that account for
weighted data (design-based f statistic)\tabularnewline
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald
tests\tabularnewline
\bottomrule
\end{longtable}

Table 3- Postoperative characteristics of baseline and IPW-weighted
populations in patients undergoing SLV vs SAVR\selectlanguage{english}
\begin{longtable}[]{@{}lllllllll@{}}
\toprule
& \emph{Baseline} & \emph{Baseline} & \emph{Baseline} & \emph{Baseline}
& \emph{Weighted characteristics after IPW} & \emph{Weighted
characteristics after IPW} & \emph{Weighted characteristics after IPW} &
\emph{Weighted characteristics after IPW}\tabularnewline
\midrule
\endhead
\emph{} & \textbf{Perceval} & \textbf{SAVR} & p-value* & \textbf{SMD} &
\textbf{Perceval} & \textbf{SAVR} & p-value** &
\textbf{SMD}\tabularnewline
& N = 265 & N = 394 & & & N = 258 & N = 394 & &\tabularnewline
\emph{} & \textbf{N (\%) or Mean (SD)} & \textbf{N (\%) or Mean (SD)} &
& & \textbf{Weighted \% or mean (SE)} & \textbf{Weighted \% or mean
(SE)} & &\tabularnewline
\emph{Mean total ventilation (hours)} & 18.32 (43.84) & 28.44 (115.96) &
0.18 & -0.115 & 16.33 (2.31) & 29.1 (5.72) & 0.04 &
-0.146\tabularnewline
\emph{Mean CTICU length of stay (hours)} & 55.38 (67.92) & 58.68
(117.61) & 0.68 & -0.034 & 52.28 (3.85) & 61.81 (6.37) & 0.2 &
-0.099\tabularnewline
\emph{Median CTICU length of stay (hours)} & 28.3 (20.5-61.5) & 25.275
(20-47.5) & 0.058 & & 33.23 & 37 & 0.34 & -0.079\tabularnewline
\emph{Postoperative blood transfusion} & 96 (36.2) & 132 (33.5) & 0.47 &
0.057 & 36.67 & 36.3 & 0.93 & 0.008\tabularnewline
\emph{Atrial fibrillation} & 102 (38.5) & 138 (35.0) & 0.36 & 0.072 &
2.41 & 2.49 & 0.95 & -0.005\tabularnewline
\emph{Permanent stroke} & 6 (2.3) & 10 (2.5) & 0.82 & -0.018 & 0.92 &
2.18 & 0.18 & -0.094\tabularnewline
\emph{In-hospital Mortality} & 3 (1.1) & 10 (2.5) & 0.2 & -0.105 & 0 &
0.66 & 0.1 & -0.108\tabularnewline
\emph{Renal failure or insufficiency (new STS defn)} & 0 (0.0) & 3 (0.8)
& 0.15 & -0.124 & 9.55 & 12.24 & 0.31 & -0.086\tabularnewline
\emph{Prolonged ventilation} & 27 (10.2) & 45 (11.4) & 0.62 & -0.04 &
10.67 & 6.33 & 0.06 & 0.154\tabularnewline
\emph{Permanent pacemaker or ICD} & 30 (11.3) & 24 (6.1) & 0.016 & 0.186
& 20.04 & 16.94 & 0.34 & 0.079\tabularnewline
\emph{Pleural effusion} & 58 (21.9) & 62 (15.7) & 0.045 & 0.158 & 8.48
(0.38) & 7.65 (0.34) & 0.1 & 0.132\tabularnewline
\emph{Median Length of stay (days)} & 7 (5-10) & 6 (5-8) &
\textless{}0.001* & 0.219 & & & &\tabularnewline
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care unit &
Abbreviation: savr - surgical aortic valve replacement; sd - standard
deviation; smd - standardized mean difference; cabg: coronary artery
bypass graft surgery; cticu -- cardiothoracic intensive care
unit\tabularnewline
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}} & \emph{\textsuperscript{\textbf{a}}\textbf{minimally
invasive approaches include partial sternotomy, right or left
parasternal incision, right thoracotomy, limited (mini) thoracotomy, and
other thoracotomy procedures}} &
\emph{\textsuperscript{\textbf{a}}\textbf{minimally invasive approaches
include partial sternotomy, right or left parasternal incision, right
thoracotomy, limited (mini) thoracotomy, and other thoracotomy
procedures}}\tabularnewline
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate & *p-values obtained from chi-squared
tests, wilcoxon rank-sum tests, or two sample t-tests as appropriate &
*p-values obtained from chi-squared tests, wilcoxon rank-sum tests, or
two sample t-tests as appropriate\tabularnewline
**p-values for dichotomous and categorical variables are corrected,
weighted, pearson chi-squared statistics that account for weighted data
(design-based f statistic) & **p-values for dichotomous and categorical
variables are corrected, weighted, pearson chi-squared statistics that
account for weighted data (design-based f statistic) & **p-values for
dichotomous and categorical variables are corrected, weighted, pearson
chi-squared statistics that account for weighted data (design-based f
statistic) & **p-values for dichotomous and categorical variables are
corrected, weighted, pearson chi-squared statistics that account for
weighted data (design-based f statistic) & **p-values for dichotomous
and categorical variables are corrected, weighted, pearson chi-squared
statistics that account for weighted data (design-based f statistic) &
**p-values for dichotomous and categorical variables are corrected,
weighted, pearson chi-squared statistics that account for weighted data
(design-based f statistic) & **p-values for dichotomous and categorical
variables are corrected, weighted, pearson chi-squared statistics that
account for weighted data (design-based f statistic) & **p-values for
dichotomous and categorical variables are corrected, weighted, pearson
chi-squared statistics that account for weighted data (design-based f
statistic) & **p-values for dichotomous and categorical variables are
corrected, weighted, pearson chi-squared statistics that account for
weighted data (design-based f statistic)\tabularnewline
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald tests &
*p-values for continuous variables obtained from adjusted wald
tests\tabularnewline
\bottomrule
\end{longtable}

Table 4- Cost analysis of baseline (crude) populations in patients
undergoing SLV vs SAVR\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
& \textbf{Perceval} & \textbf{SAVR} & \textbf{p-value*}\tabularnewline
\midrule
\endhead
& N = 265 & N = 394 &\tabularnewline
& \textbf{Median (IQR) {[}mean (SD) where noted{]}; All costs in USD} &
\textbf{Median (IQR) {[}mean (SD) where noted{]}; All costs in USD}
&\tabularnewline
\textbf{Total hospital costs (in \$10,000s)} & & &\tabularnewline
Mean (SD) & 71.60 (49.55) & 61.10 (59.35) & 0.018\tabularnewline
Median (IQR) & 57.39 (44.08-78.26) & 46.70 (37.09-62.02) &
\textless{}0.001\tabularnewline
By Procedure: & & &\tabularnewline
Isolated valve & 45.16 (39.35-67.24) & 41.16 (35.21-52.07) &
\textless{}0.001\tabularnewline
CABG + valve & 65.59 (51.47-88.35) & 55.55 (41.67-76.15) &
\textless{}0.001\tabularnewline
\textbf{Itemized costs (in \$s)} & & &\tabularnewline
Room costs, total & 5988.95 (3631.9-11256) & 5043.27 (3478.18-7509.26) &
\textless{}0.001\tabularnewline
Semi-private (two beds) & 5988.95 (4034.62-10977.6) & 5043.27
(3593.37-7986.34) & 0.001\tabularnewline
Recovery room & 200.95 (89.47-1074.82) & 146.24 (45.9-478.37) &
0.017\tabularnewline
Pharmacy & 4624.77 (3066.82-8399.08) & 3996.34 (2846.9-6625.02) &
0.012\tabularnewline
Medical supplies, total & 22847.96 (20094.91-28863.93) & 17596
(15128.1-22072.74) & \textless{}0.001\tabularnewline
General & 8617.33 (6756.24-10813.96) & 8628.13 (7055.87-10695.34) &
0.52\tabularnewline
Sterile supply & 58.97 (41.61-122.86) & 45.9 (25.7-105.12) &
0.014\tabularnewline
Pacemaker & 7462.96 (7109.36-7470.65) & 7470.65 (7154.99-7470.65) &
0.78\tabularnewline
Other implant & 14239.66 (12246-16612.05) & 8569.83 (7082.27-10406.36) &
\textless{}0.001\tabularnewline
ICU costs & 6008.37 (2972.66-13837.5) & 4621.24 (2774.95-10837.12) &
0.002\tabularnewline
Lab costs & 1459.67 (983.55-2653.66) & 1203.69 (883.5-2055.03) &
0.002\tabularnewline
Radiology & 634.19 (397.91-1149.22) & 532.44 (324.91-883.4) &
\textless{}0.001\tabularnewline
Operating room, total & 7832.11 (6096.34-10603.66) & 7899.97
(6326.13-10232.35) & 0.71\tabularnewline
General & 6449.29 (4987.75-9063.81) & 6474.15 (5179.32-8466.51) &
0.59\tabularnewline
Minor surgery & 216.98 (129.96-426.61) & 281.95 (144.66-281.95) &
0.83\tabularnewline
Anesthesia & 1439.07 (1133.23-1779.42) & 1406.59 (1201.95-1708.03) &
0.74\tabularnewline
RBC tranfusion costs, mean (SD) & 531.27 (1352.71) & 464.9 (1130.93) &
0.5\tabularnewline
Respiratory & 1913.32 (1372.99-3016.91) & 1524.3 (1183-2410.95) &
\textless{}0.001\tabularnewline
Emergency Room, mean (SD) & 188.9 (607.59) & 140.39 (387.46) &
0.21\tabularnewline
Cardiology & 518.36 (145.29-1698.91) & 538.17 (270.35-1425.34) &
0.74\tabularnewline
EKG/EEG & 84.6 (61.28-143.35) & 68.49 (58.25-112.79) &
0.004\tabularnewline
Other services, mean (SD) & 409.66 (1704.78) & 487.62 (5531.37) &
0.82\tabularnewline
Professional fees & 15.37 (9.07-143.64) & 11.11 (8.71-30.49) &
0.005\tabularnewline
Other costs, mean (SD) & 87.95 (351.48) & 39.57 (188.26) &
0.022\tabularnewline
\textbf{Abbreviations: SAVR - Surgical Aortic Valve Replacement; IQR -
interquartile range; SD - standard deviation; SMD - Standardized Mean
Difference; USD -- United States Dollar; CABG: Coronary Artery Bypass
Graft Surgery; EKG -- Electrocardiogram; EEG -- Electroencephalogram} &
& &\tabularnewline
Overall missing cost data: 47 semi-private room, 447 recovery room, 8
general medical supplies, 128 sterile medical supplies, 610 pacemaker,
13 other implant supplies, 9 general OR, 648 minor surgery, 8
anaesthesia & & &\tabularnewline
* p-values obtained from chi-squared tests, Wilcoxon rank-sum tests, or
two sample t-tests as appropriate & \textbf{Abbreviations: SAVR -
Surgical Aortic Valve Replacement; IQR - interquartile range; SD -
standard deviation; SMD - Standardized Mean Difference; USD -- United
States Dollar; CABG: Coronary Artery Bypass Graft Surgery; EKG --
Electrocardiogram; EEG -- Electroencephalogram} & &\tabularnewline
Overall missing cost data: 47 semi-private room, 447 recovery room, 8
general medical supplies, 128 sterile medical supplies, 610 pacemaker,
13 other implant supplies, 9 general OR, 648 minor surgery, 8
anaesthesia & & &\tabularnewline
* p-values obtained from chi-squared tests, Wilcoxon rank-sum tests, or
two sample t-tests as appropriate & \textbf{Abbreviations: SAVR -
Surgical Aortic Valve Replacement; IQR - interquartile range; SD -
standard deviation; SMD - Standardized Mean Difference; USD -- United
States Dollar; CABG: Coronary Artery Bypass Graft Surgery; EKG --
Electrocardiogram; EEG -- Electroencephalogram} & &\tabularnewline
Overall missing cost data: 47 semi-private room, 447 recovery room, 8
general medical supplies, 128 sterile medical supplies, 610 pacemaker,
13 other implant supplies, 9 general OR, 648 minor surgery, 8
anaesthesia & & &\tabularnewline
* p-values obtained from chi-squared tests, Wilcoxon rank-sum tests, or
two sample t-tests as appropriate & \textbf{Abbreviations: SAVR -
Surgical Aortic Valve Replacement; IQR - interquartile range; SD -
standard deviation; SMD - Standardized Mean Difference; USD -- United
States Dollar; CABG: Coronary Artery Bypass Graft Surgery; EKG --
Electrocardiogram; EEG -- Electroencephalogram} & &\tabularnewline
Overall missing cost data: 47 semi-private room, 447 recovery room, 8
general medical supplies, 128 sterile medical supplies, 610 pacemaker,
13 other implant supplies, 9 general OR, 648 minor surgery, 8
anaesthesia & & &\tabularnewline
* p-values obtained from chi-squared tests, Wilcoxon rank-sum tests, or
two sample t-tests as appropriate & & &\tabularnewline
\bottomrule
\end{longtable}

\selectlanguage{english}
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\end{document}

