104172InterventionalCardiology1000623 ID: 854964
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1 General anesthesia versusconscious sedat
General anesthesia versusconscious sedation intranscatheter aortic valvereplacement: experience from agrowing structural cardiologyprogram in the Midwest % L V K D O % K D Q G D U L 0 D Q M D U L 5 H J P L $ E G L V D P D G , E U D K L P % D V P D $ O E D V W & D P H U R Q . R H V W H U 3 U L \ D Q N D 3 D U D M X O L 0 R K D P P D G $ O $ N F K D U 0 L F K D H O % X K Q H U N H P S H $ O H [ D Q G H U : R U L [ $ E K L V K H N . X O N D U Q L ' H S D U W P H Q W R I , Q W H U Q D O 0 H G L F L Q H 6 R X W K H U Q , O O L Q R L V 8 Q L Y H U V L W \ 6 F K R R O R I 0 H G L F L Q H 6 S U L Q J I L H O G , / 6 R X W K H U Q , O O L Q R L V 8 Q L Y H U V L W \ 6 F K R R O R I 0 H G L F L Q H 6 S U L Q J I L H O G , / ' H S D U W P H Q W R I & D U G L R O R J \ 6 R X W K H U Q , O O L Q R L V 8 Q L Y H U V L W \ 6 F K R R O R I 0 H G L F L Q H 6 S U L Q J I L H O G , / \r $ X W K R U I R U & R U U H V S R Q G H Q F H ( P D L O E K D Q G D U L E # J P D L O F R P 7 H O 5 H F H L Y H G G D W H - D Q X D U \ $ F F H S W H G G D W H - D Q X D U \ 3 X E O L V K H G G D W H ) H E U X D U \ Introduction: Transcatheter Aortic Valve Replacement (TAVR) has been established as a viablealternative to surgical aortic valve replacement (SAVR) when treating symptomatic aorticstenosis in intermediate and high risk patients. Historically, general endotracheal anesthesia(GETA) has been the primary form of patient sedation during TAVR. Recently, conscioussedation (CS) has been utilized as a safe option. As there are limited data available comparingthese two modalities, it would be helpful to investigate this question further.Methods: To determine the potential benets of using conscious sedation compared togeneral anesthesia, 3 outcomes were compared in patients experiencing each method: (1)Total hospital length of stay (LOS), (2) ICU LOS, and (3) occurrence of adverse events (AEs)during hospitalization.Results: Hospital LOS and ICU LOS were found to have a correlation with anesthesia method.CS was correlated with shorter hospital and ICU stays compared to GETA. There were nosignicant dierences between CS and GETA in terms of occurrence of AEs, indicating that therisk of complications was similar for both anesthesia methods.Conclusion: Conscious sedation compared to general anesthesia could potentially be thebetter alternative for TAVR with no increased adverse events.IntroductionTranscatheter Aortic Valve Replacement(TAVR) has become an integral part of thetreatment modality of severe aortic stenosis.TAVR has showed similar mortality ratesand comparable clinical outcomes to thoseundergoing surgical aortic valvereplacements (SAVR) [1]. It has been shownthat TAVR is a reasonable alternative tosurgical aortic valve replacement in a patientwith intermediate to prohibitive risk patient[2]. A combination of improved patientselection, pre-procedural evaluations andincreased operator expertise may be thereasons behind the improvement ofoutcomes since the proceduresintroduction. Historically, generalendotracheal anesthesia (GETA) has beenthe pri
2 mary form of patient sedation duringTAVR
mary form of patient sedation duringTAVR, but conscious sedation (CS) orMonitored Anesthesia Care (MAC) hasbeen found to be feasible in recent times[3]. ere is no randomized controlled trialthat has evaluated the outcome dierencesin terms of general anesthesia v/s conscioussedation to this date. Couple retrospectivestudies have shown encouraging outcomesfor conscious sedation cohort [3,4].TAVR can be safely performed under bothconscious sedation and general anesthesia.Under moderate or conscious sedation, thepatients respiratory drive remains intact,they are safely able to maintain their airway,and their brainstem re¯exes continue to befunctional. Conscious sedation also providespatients who are poor general anesthesiacandidates the opportunity to undergo thispotentially lifesaving intervention. Ourretrospective, cohort study aims to compareconscious sedation to general anesthesia inrespect to length of hospitalization, 5 H V H D U F K $ U W L F O H 10.4172/Interventional-Cardiology.1000623 2019 Interv. Cardiol. (2019) 11(1) ,14-18ISSN 1755-530214Keywords: Transcatheter aortic valve replacement; General anesthesia; Conscious Sedation; Hospital stay. utilization of intensive care units, and occurrence ofadverse events.MethodsOur study was based on TAVR performed at a 500 bedhospital in the Midwest, US. Study was approved byIRB (Institutional Review Board) committee. Patientswho underwent TAVR from January 2016 to August2018 were included on the study (74 total patients).All the procedures were done using GETA untilSeptember 2017. Our study included 71 total patients(40 GETA and 31 CS) and excluded 3 patients.Patients who had massive retroperitoneal bleed,displaced valve, or death after complications fromprolonged hospital stay were excluded. To determinethe potential bene®ts of using conscious sedation asopposed to general anesthesia during TAVR, wecompared 3 outcomes in patients experiencing eachanesthesia method: (1) total hospital length of stay(LOS), (2) ICU LOS, and (3) occurrence of adverseevents (AEs) during hospitalization. Patients who werenot admitted to the ICU had values of zero for ICUlength of stay. Adverse events included potential eventsrelated to the procedure (i.e., hematoma, left bundlebranch block, pacemaker implantation, pericardialeusion, phrenic nerve/hemidiaphragm and bloodtransfusion).To control for additional factors that may in¯uenceour outcomes of interest, we also included age, sex,atrial ®brillation, history of CABG (coronary arterybypass surgery), and PVD (peripheral vascular disease)in a multivariate regression model along with the maineect of anesthesia group. Initial attempts to controlfor these factors using propensity score weightingyielded higher imbalance between the anesthesiagroups. Instead we included all factors in a regressionmodel to adjust for confounding factors while assessingthe impact of anesthesia method on our outcomes ofinterest. Because LOS was measured in days andhospital LOS was over-dispersed in the generalanesthesia group (Figure 1), LOS outcomes wereanalyzed using a negative binomial regression. Becausemultiple AEs were rare, AEs were treated as a binary(yes/no) variable and analyzed using logistic regression.Exponentiating the model coecients for a negativebinomial and logistic regression yields the e
3 xpectedpercentage change in LOS and odds
xpectedpercentage change in LOS and odds-ratio (OR) of anAE for a one unit change in the predictor, respectively.All analyses were carried out in R statistical software.ResultsOur results showed that patients who underwentconscious sedation had signi®cantly shorter hospitaland ICU length of stay. CS was associated with 69%shorter hospital stays (mean of 1.8 v/s. 6.5 days forgeneral anesthesia; Tables 1 and 2). Patients receivingconscious sedation had 55% shorter ICU stays (meanof 13 v/s. 39 hours for general anesthesia; Tables 1 and3). ICU LOS was found to be signi®cantly associatedwith history of CABG and PVD as well (Table 3).ose with PVD had 114% longer ICU stays (Table4). ose with a history of CABG had 87% shorterICU stays. ere were no statistical dierences foundon occurrence of adverse events, indicating that therisk of complications was similar for both anesthesiamethods. * ( 7 $ 0 $ & D O O / 2 6 F R X Q W $ Q H V W K H V L D * ( 7 $ 0 $ & D O O Figure 1: Histogram of the number of patients experiencing dierent hospital LOS when all patients are considered together (blue),or when separated by anesthesia method general anesthesia (red) or conscious sedation (green). 5 H V H D U F K $ U W L F O H 15 VariableGETAMAC/CSp-valueAortic valve area, cm2, mean (SD)1.81 (6.55)0.85 (0.25)0.47Mean aortic valve gradient, mmHg, mean (SD)40.4 (15.52)34.65 (13.41)0.126LVEF (Left ventricular Ejection Fraction), percent, mean (S D)55.77 (11.29)57.23 (14.76)0.641Total Costs, $,mean (SD)65586.71 (8946.13)57921.04 (13781.29)0.006Age, Years, mean (SD)81.42 (8.33)81.26 (6.58)0.927Hospital LOS, DAYS, mean (SD)6.5 (4.56)1.83 (1.29)ICU LOS, HOURS, mean (SD)38.88 (29.04)13.2 (26.88)Presence of moderate/severe MR (mitral regurgitation), N (%)6 (15.00)11 (39.29)0.052Permanent pacemaker, N (%)8 (20.00)6 (19.35)1Atrial brillation, N (%)10 (25.00)12 (38.71)0.299Previous MI (myocardial Infarction), N (%)11 (27.50)10 (32.26)0.792History of CABG, N (%)2 ( 5.00)6 (19.35)0.067PCI (Percutaneous Coronary intervention), N (%)13 (32.50)6 (19.35)0.274Stroke, N (%)7 (17.50)3 ( 9.68)0.499PVD, N (%)9 (22.50)3 ( 9.68)0.209COPD on O2, N (%)3 ( 7.50)3 ( 9.68)1&#x 0.0;ÄSerum Creatinine1.5, N (%)8 (20.00)8 (25.81)0.571Need for Ventillation post procedure, N (%)2 ( 5.13)0 (0)0.516Sex, MALE, N (%)20 (50.00)18 (58.06)0.642ANY Complications, N (%)13 (32.50)6 (19.35)0.2891P-value from a t-test without adjusting for confounding factors. 7 D E O H 0 X O W L Y D U L D W H Q H J D W L Y H E L Q R P L D O U H J U H V V L R Q P R G H O R I K R V S L W D O / 2 6 , Q F L G H Q W U D W H U D W L R V Z H U H F D O F X O D W H G E \ H [ S R Q H Q W L D W L Q J P R G H O F R H I I L F L H Q W V VariableCoecientIncidentRateRatioSEp-valueIntercept0.19-0.830.82Age0.021.020.010.06Sex, Male0.141.140.150.37Atrial brillation0.071.070.160.67History of cabg-0.30.740.290.31PVD0.291.330.180.11 Anesthesia, MAC-1.190.310.18 7 D E O H 0 X O W L Y D U L D W H Q H J D W L Y H E L Q R P L D O U H J U H V V L R Q P R G H O R I , & 8 / 2 6 , Q F L G H Q W U D W H U D W L R V Z H U H F D O F X O D W H G E \ H [ S R Q H Q W L D W L Q J P R G H O F R H I I L F L H Q W V Variable
4 CoecientIncidentRateRatioSEp-valueInter
CoecientIncidentRateRatioSEp-valueIntercept-1.19-1.230.33Age0.021.020.010.25Sex, Male0.31.340.230.19Atrial brillation-0.150.860.250.56History of cabg-2.050.131.020.04PVD0.762.140.240.0021 5 H V H D U F K $ U W L F O H % K D Q G D U L % 5 H J P L 0 , E U D K L P $ H W D O 16 Interv. Cardiol.(2019) 11(1) 7 D E O H & R P S D U L V R Q R I S D W L H Q W F K D U D F W H U L V W L F V I R U L Q G L Y L G X D O V X Q G H U J R L Q J J H Q H U D O D Q H V W K H V L D D Q G F R Q V F L R X V V H G D W L R Q Anesthesia, MAC-0.790.450.280.01 7 D E O H 0 X O W L Y D U L D W H O R J L V W L F U H J U H V V L R Q P R G H O R I W K H R F F X U U H Q F H R I $ ( V 2 G G V U D W L R V Z H U H F D O F X O D W H G E \ H [ S R Q H Q W L D W L Q J P R G H O F R H I I L F L H Q W V VariableCoecientOddsRatioSEp-valueIntercept0.003-3.031Age-0.010.990.040.77Sex, Male-0.180.840.570.76Atrial brillation0.381.460.60.53History of cabg-0.550.571.180.64PVD0.521.690.70.46Anesthesia, MAC-0.620.540.60.3 DiscussionTAVR has evolved as an important strategy in thetreatment of severe symptomatic aortic stenosis servingas an alternative to surgical correction in intermediateto prohibitive risk patients. A multi-disciplinary teamis tasked with an extensive evaluation of the patient todetermine candidacy, appropriate access, and anticipatepossible complications. Part of this evaluation includesthe choice of anesthesia. Traditionally, GETA has beenused for patients undergoing TAVR, with only 5 % ofprocedures being done using CS in North Americaaccording to a study in 2013 [5]. However, withadvancement in medical technology and requirementof less cardiovascular and respiratory monitoring, CS isgaining popularity [6-9]. Advantages of the CSincludes less catecholamine use, decreasedhemodynamic instability, fewer respiratory infectionsand complications, shorter procedure duration, andbetter recovery [6,8,9]. Some of these bene®ts werehighlighted by our study as well. ere are norandomized controlled trial comparing modes ofanesthesia and TAVR. Our study will shed more lightinto bene®ts of conscious sedation in terms of lengthof hospital stay, ICU stay and dierences in adverseevents between these two modalities.Our data strongly suggested an association betweenmode of anesthesia and length of hospital stay. CSgroup had signi®cant 69% and 55% shorter hospitaland ICU stay respectively. Fr hlich et al. performed ameta-analysis which looked at seven studies thatcompared CS vs GETA in TAVR [6]. ey looked atlength of hospital stay and procedural time which wereboth signi®cantly shorter for CS group. Similarly,Toppen et al. studied patients who underwent TAVR(147 GETA and 68 CS) and found that CS had lessnumber of hospital and ICU stay compared to GETAgroup [8]. eir mean dierence in length of hospitalstay was about 5.5 days compared to 4.7 days in ourstudy. Shorter LOS with CS is likely multifactorialsuch as shorter procedure time, no need for intubation,less hemodynamic monitoring, less postoperativeinfections and management [6,7].It is also important to assess health care outcomes inthese patients for patient safety and adverse outcomes.Our study could not identify any statisticallysigni®cant dierence in the rate of
5 adverse eectsbetween CS and GETA. Comm
adverse eectsbetween CS and GETA. Common adverse eventoutcomes were hematoma at the entry site, new leftbundle branch block, pacemaker implantation,pericardial eusion, phrenic nerve/hemi diaphragm,and blood transfusion. Meta-analysis by Fr hlich et al.[6] found no statistical dierence between occurrencepost procedure stroke, AKI or postoperative sepsis inboth the groups. Nevertheless, it stated that there was8% more association pneumonia in GETA v/s CSwhich was statistically signi®cant. It is also importantto note that no other variable like age or history ofCABG and PVD was found to have any signi®cantcorrelation with the adverse eect outcome.Given health care cost and concerns for aordability,eective and cost ecient health care model is a bigemphasis. Study by Toppen et al. showed reduced totalcost by about 25% in patients undergoing CS vsGETA in TAVR [8]. Higher length of hospital stays aswell as higher cost of GETA likely contributes tohigher health care cost for patients undergoing GETA.Given no signi®cant dierences in adverse outcomes,the advantages of conscious sedation approach seemlogically appealing.ConclusionConscious sedation is associated with shorter hospitaland ICU length of stay with comparable adverseoutcomes when compared with general anesthesia.Reduced hospital stay and hemodynamic monitoringof CS is tied to more cost eective approach forTAVR.Conicting InterestsNoneReferences1.Burrage M, Moore P, Cole C, et al. Transcatheter aortic valvereplacement is associated with comparable clinical outcomesto open aortic valve Surgery but with a reduced length of in-patient hospital stay: a systematic review and meta-analysis ofrandomised trials. Heart. Lung. Circ. 26(3):285-95 (2017).2.ourani Vh, Neravetla SR. Transcatheter versus surgicalaortic-valve replacement in high-risk patients. In: Bernard J.Gersh. Yearbook of Cardiology. Philadelphia, Elsevier HealthSciences, United States of America. pp: 178179 (2012).3.Motloch LJ, Rottlaender D, Reda S, et al. Local versus generalanesthesia for transfemoral aortic valve implantation. Clin.Res. Cardiol. 101:45-53 (2012). 5 H V H D U F K $ U W L F O H 17 4.Mayr NP, Michel J, Bleizier S, et al. Sedation or generalanesthesia for transcatheter aortic valve implantation (TAVI).J. orac. Dis. 7(9):15181526 (2015).5.Bufton KA, Augoustides JG, Cobey FC. Anesthesia fortransfemoral aortic valve replacement in north america andEurope. J. Cardiothorac. Vasc. Anesth. 27(1):46-9 (2013).6.Fr hlich GM, Lansky AJ, Webb J, et al. Local versus generalanesthesia for transcatheter aortic valve implantation (TAVR) systematic review and meta-analysis. BMC. Med. 10:12-41(2014).7.Mayr NP, Michel J, Bleizier S, et al. Sedation or generalanesthesia for transcatheter aortic valve implantation (TAVI).J. orac. Dis.7(9):1518-26 (2015).8.Toppen W, Johansen D, Sareh S, et al. Improved costs andoutcomes with conscious sedation vs general anesthesia inTAVR patients: Time to wake up? PLoS One.12(4):e0173777(2017).9.Tchetche D, Biase CD. Local Anesthesia-Conscious Sedation:e Contemporary Gold Standard forTranscatheter Aortic Valve Replacement. JACC. Cardiovasc.Interv. 11(6):579-580 (2018). 5 H V H D U F K $ U W L F O H % K D Q G D U L % 5 H J P L 0 , E U D K L P $ H W D O 18 Interv. Cardiol.(2019) 11(1)