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True First-Line Local-Anesthesia Only Protocol for Transfemoral TAVI
Abstract: Aims. To evaluate the safety and feasibility of transcatheter aortic valve implantation (TAVI) via femoral access under local anesthesia only (without concomitant sedation) as the initial strategy. Methods and Results. Patients undergoing planned transfemoral TAVI without routine general anesthesia between May 2005 and December 2013 were identified. Baseline characteristics, procedural outcomes, and a 30-day clinical follow-up were obtained. A total of 215 patients underwent TAVI with local anesthesia only as the initial strategy (LA group). Of these patients, 40 (18.6%) received additional sedation (LAS group) during the procedure due to inadequate pain control or agitation and 7 patients (3.3%) underwent conversion to general anesthesia (GA group). TAVI was successfully performed in 211 cases (98.2%). When 30-day outcomes for patients requiring only local anesthesia were compared with patients requiring additional sedation, there was a significantly longer duration of Intensive Care Unit (ICU) stay in the group with additional sedation (LAS, 5.0 days [range, 3.0-6.0 days] vs LA 3 days [range, 2.0-5.0 days]; P=.02) and general anesthesia (GA 7.0 days [range, 2.5-18.0 days] vs LA 3 days [range, 2.0-5.0]; P=.04). Conclusion. Our study suggests that TAVI with LA only as the initial strategy is a feasible alternative to GA, with potential benefit of this strategy over using routine concomitant sedation. LA only may be considered a primary option in many patients.
J INVASIVE CARDIOL 2015;27(11):501-508
Key words: TAVR, TAVI, local anesthesia, severe aortic stenosis, high surgical risk, transfemoral
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As a result of an aging society, aortic stenosis is one of the most frequently acquired valvular heart diseases (2%-4% of patients >65 years) in Western countries.1,2 Traditionally, surgical aortic valve replacement has been the therapy of choice for patients with severe symptomatic aortic stenosis, but several studies have demonstrated at least equivalent outcomes with transcatheter aortic valve implantation (TAVI) in high-risk patients.3 Initially, TAVI was performed under general anesthesia (GA).4 Lower-profile femoral access systems have allowed the performance of fully percutaneous transfemoral TAVI. Consequently, many centers have changed their anesthesia strategy from GA to local anesthesia with sedation (LAS).5 Avoiding GA may potentially be associated with a lower cardiac and pulmonary risk, earlier patient mobilization, and improvement in neuromuscular function and independence scores.6,7
The feasibility of TAVI with only local anesthesia (LA) has been reported.8-12 However, patients included in these studies frequently received concomitant analgesic, sedative, or antiemetic agents. We sought to evaluate outcomes of patients who underwent TAVI with only LA as a first strategy.
Methods
Records of patients accepted for transfemoral TAVI from May 2005 to December 2013 were retrospectively reviewed, and baseline demographic, preprocedural, procedural, and clinical follow-up data were collected. All patients undergoing transfemoral TAVI had symptomatic severe aortic stenosis and were considered to be at high surgical risk or non-surgical candidates. Patients undergoing primary (planned) GA were excluded; this included patients who presented in cardiogenic shock and were already intubated at time of referral. Figure 1 illustrates the selection process of our study population.
Operative mortality was predicted using the Society of Thoracic Surgeons (STS) risk calculator13 and the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II).14 The decision for TAVI was made by a heart-team including interventional cardiology and cardiothoracic surgery. Preprocedural clinical diagnostic studies included transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and in later cases, computerized tomography (CT) scans used to estimate the correct valve size. Angiography was used to estimate the degree of aortic calcification, to ensure an adequate distance from the aortic annulus to the coronary arteries, and to assess suitability of the pelvic and femoral vasculature for large-bore access.
Specific technical information regarding TAVI procedure is available elsewhere.15-18 All patients were treated with either a self-expandable Medtronic CoreValve (Medtronic, Inc) or a balloon-expandable Edwards Sapien valve prosthesis (Edwards Lifesciences). Valve choice was based on cardiac and vascular anatomy, as well as physician preference. All patients were paced during implantation. Information on procedural success, correct valve deployment, paravalvular leaks, and hemodynamic measurements was collected in all cases. TEE was not used in this patient population; information on paraprosthetic leak was collected using both angiography and TTE at the end of the procedure. An available closing device (ie, Prostar or Perclose ProGlide suture-mediated closure system; Abbott Vascular) was used in all cases to seal the access site. Periprocedural and postprocedural adverse events were assessed according to the updated Valve Academic Research Consortium classification.19 Dual-antiplatelet therapy was continued for 3 months post procedure followed by continuous aspirin intake.
Anesthesia strategy. Patients received LA only at the start of the case, defined as 10-15 mL of 2% lidocaine subcutaneously at the femoral access site. Patients were fully awake and could be addressed at any time during the procedure and did not receive empiric sedation in intravenous or oral form. When patients had pain or discomfort that was not alleviated by injection of larger amounts of LA or when agitation interfered with safe performance of the procedure, intravenous sedation was initiated. Sedation consisted of analgesic and sedative medications (morphine, fentanyl, tramadol, midazolam, or propofol alone or in combination). Each patient’s discomfort and pain level was only subjectively evaluated. Cases were advanced to GA for complication management when the percutaneous approach was not possible or when access was changed from transfemoral to other access routes (eg, transapical or transaortic). Patients were divided into three groups: those who required local anesthesia only (LA group), those who required sedation in addition to local anesthesia (LAS group), and those who required general anesthesia (GA group). The three groups were statistically compared across collected characteristics. Of note, procedural duration included time from first vascular access to final access closure.
Postprocedural assessments. Thirty-day follow-up was performed, and included an evaluation of symptoms, physical examination, electrocardiogram, TTE, and adverse events. Information on patients who were followed externally was collected through reports from referring cardiologist and direct phone contact.
Statistical analysis. Continuous variables are expressed as median (first-third quartile; IQR). Categorical data are expressed as numbers and percentages of total. The data set was evaluated for normal distribution using the Kolmogoroff-Smirnoff-Lilliefors test. Differences between groups were determined by Chi-square testing (with Yates correction) or Fisher’s exact test for discrete variables. Continuous variables were evaluated using the Wilcoxon-Mann-Whitney U-test. Three-way interactions between groups were statistically compared using the Kruskal Wallis test. All tests were two sided and P<.05 was considered significant. Statistical analysis was performed using BiAS version 10.12 (epsilon GbR Publishing).
Results
Baseline characteristics as divided by strategy. A total of 215 patients underwent transfemoral TAVI performed during the time period. Mean age, logistic EuroSCORE II, STS score, and aortic valve area (AVA) were 82.0 years (IQR, 77-85 years); 5.1 (IQR, 3.0-8.4); 5.4 (IQR, 3.5-8.0); and 0.7 cm2 (IQR, 0.6-0.8 cm2), respectively. Almost all patients (212; 98.6%) presented with New York Heart Association class III or IV symptoms. Poor left ventricular systolic function (<30%) was found in 11 cases (5.1%). Baseline characteristics are outlined in Table 1 for all patients as well as subdivided into the LA and LAS groups. The groups were similar for all baseline characteristics aside from atrial fibrillation (more in LA vs GA), creatinine level (more in LA vs GA), statin use, and angiotensin-antagonist intake (more in LAS vs LA).
Procedure and hospitalization outcomes. Procedural information is illustrated in Table 2. A total of 168 patients (78.1% of 215 patients) required only LA throughout the procedure and comprise the LA group; 40 patients (18.6% of 215 patients) required sedation in addition to local anesthesia during the course of the procedure and comprise the LAS group. Seven patients received general anesthesia (3.3% of 215 patients) and comprise the GA group.
More patients received CoreValve than Edwards Sapien valves (LA 89.3% vs 10.7%; LAS 92.5% vs 7.5%; GA 71.4% vs 28.6%), with no difference between the three groups. Likewise, there was no difference between the groups regarding fluoroscopy duration or contrast amount. However, procedure duration was significantly shorter in the LA group vs the GA group (91.5 minutes for the LA group [IQR, 72.0-120.0 minutes] vs 150 minutes for the GA group [IQR, 97.0-210.0 minutes]; P<.01). A second valve was required in 7% of cases (3 cases required valve-in-valve; the rest were retrieved or left in the descending aorta). There was a high rate of successful valve implantation (98.2%).
Total hospital and intensive care unit (ICU) length of stay was compared between the three groups. Lengths of stay differed significantly between the groups (Figure 3). The overall length of stay was 10 days (IQR, 8.0-14.0 days), with a trend toward a slightly increased length of stay in patients in the LAS group (11 days [IQR, 8.00-14.8 days]; P=.06) and in the GA group (18 days [IQR, 7.0-25.0 days]; P=.30) compared with the LA group (9 days [IQR, 7.0-13.0 days]). The three-way interaction was not significant (P=.10). Length of ICU stay was significantly longer in patients in the LAS and GA groups compared with patients in the LA group (3.0 days in the LA group [IQR, 2.0-5.0 days] vs 5.0 days in the LAS group [IQR, 3.0-6.0 days; P=.02] and 7.0 days in the GA group [IQR, 2.5-18.0 days; P=.04]). The three-way interaction was not significant (P=.06).
A total of 7 patients required GA (Table 3). Time to intubation was not available. Two patients had conversion to GA due to intraprocedural identification of unsuitable femoral or iliac vasculature (inability to advance the access sheath). An alternative access route was chosen after initiation of GA and TAVI was performed successfully with uncomplicated hospital courses. In 4 patients, major adverse events required escalation to GA; coronary artery occlusion in 1 patient and aortic annulus rupture in 1 patient resulted in 2 procedural deaths. Intubation was performed in 2 patients because of tamponade and hypotension. In addition, 1 patient was intubated because of hypoxia; eventually, the patient was difficult to wean from the ventilator due to pneumonia and received a tracheostomy.
Thirty-day results are displayed in Table 4. There was no difference between the LA, LAS, and GA groups regarding hemodynamics, ejection fraction, mortality, vascular complications, aortic regurgitation, congestive heart failure, or pacemaker rate. Mortality was higher in the GA group compared with the LA group (28.6% vs 2.4%, respectively; P=.01). There were more strokes in the GA group than the LA group (28.6% vs 4.2%, respectively; P<.01). An overview is provided in Figure 2.
Discussion
In the present study, we examined an initial strategy of LA only in patients undergoing transfemoral TAVI. The vast majority of patients required only true LA. The procedural outcomes were similar, as were 30-day outcomes when groups were compared. The results demonstrate that transfemoral TAVI can safely be performed with an initial LA-only strategy. However, there was a significant increase in ICU length of stay in patients receiving either GA or conscious sedation when compared with patients who received LA alone. This raises the question of whether additional sedation may be associated with increased ICU length of stay in patients presenting for transfemoral TAVI.
Prior studies have described results with LA, but on closer examination, the studies often include concomitant use of sedation. Greif et al12 reported 461 patients undergoing transfemoral TAVI receiving “local anesthesia.” However, all patients received not only 15-30 mL subcutaneous 1% lidocaine but also piritramide (7.5-15 mg according to patient weight), and 62 mg demenhydriate with 10 mg metrocloperamide hydrochloride as standard medications. Yamamoto et al8 studied 130 patients with local anesthesia and sedation, defined as subcutaneous injection of 1% lidocaine and target-controlled infusion of remifentanil and/or propofol. Likewise, Durand et al10 reported 151 patients who underwent TAVI, with LA defined as 20-30 mL of subcutaneous 2% lidocaine and routine intravenous administration of nalbuphine (5 mg) and midazolam (1 mg). In contrast, in our study, the strategy was initial LA with addition of sedation only if pain control remained inadequate or agitation jeopardized procedure safety. With this strategy, TAVI could be performed with LA alone in 78.1% of patients, a true “first-line” LA-only study. To our knowledge, only Wiegerinck et al20 reported a similar strategy. Their study population consisted of 174 patients, of which 115 (65.5%) required LA with sedation and 59 required LA alone. However, preprocedural sedation with benzodiazepines was performed in 76% of the treated population. Outcomes were similarly favorable, as described in our cohort.
When comparing our LA group with patients from the aforementioned studies of TAVI under LA with sedation, bleeding and major vascular complication rates are lower, but the pacemaker implantation and acute kidney injury rates are higher in our study. Of note, the 30-day mortality rate in our LA group is lower than in other studies using LA with sedation. However, these findings may be related to different baseline patient characteristics.
Our data demonstrated a longer ICU length of stay in patients who required conscious sedation or GA compared with those who required LA. Sedation is not without risk, especially in the elderly high-risk and inoperable TAVI population. Sedatives included opioid derivatives (morphine, fentanyl, tramadol), benzodiazepines (midazolam in all cases), as well as propofol and piritramide. Side effects from these medications are prevalent, particularly in the elderly population.21-23 This may be due to decreased clearance or drug-drug interactions. Delirium (especially in elderly patients)and cardiodepressive effects may contribute to prolonged ICU and total hospital stays. Although there were no listed sedative-specific complications, the increased ICU length of stay can be a marker of increased patient needs, resources, and costs.
The use of LA may obviate the need for TEE guidance for valve positioning. However, safety and efficacy of implanting the valve without TEE monitoring has been shown repeatedly.24,25 At our center, TAVI is performed using TTE, with TEE available when needed. Another often-stated drawback of an LA strategy is the perceived inability to react to complications. Major complications include stroke, cardiac complications (conduction disturbances, coronary obstruction, tamponade, and chamber/root rupture), and vascular complications (perforation, dissection, and abrupt vessel closure). Diagnosis of these complications can be made by evaluation of hemodynamic changes, patient discomfort, or angiographic findings. In fact, sedation or GA may mask early symptoms of vascular complications or stroke, thereby delaying recognition and prompt intervention. If pericardial tamponade or severe aortic regurgitation is suspected, TTE or (when images are suboptimal) TEE can be performed.
Most complications can be managed percutaneously without the need for GA. The majority of vascular complications can be treated with manual compression, inflation of a balloon, or implantation of a covered stent. Conduction disorders can be treated with temporary or permanent pacemaker implantation and coronary obstruction by emergent percutaneous coronary intervention. Chamber or root rupture with tamponade can be diagnosed based on hemodynamics and TTE, and after initial pericardiocentesis, usually requires surgery. Importantly, LA can be rapidly converted to GA when necessary.
Our strategy requires close communication between the anesthesiologist, interventional cardiologist, cardiac surgeon, cardiac catheterization lab team, and intensive care team, as well as patient awareness from the outset. Patients should be encouraged to vocalize discomfort to receive more local anesthesia. There should be clear and explicit indications for when to switch to sedation, and this should be limited to not mask patient interaction with the implanter. LA should be given prior to access and before each sheath exchange, with pauses to allow sufficient time for anesthetic effect. Patients’ pain levels should be monitored throughout the procedure and communicated to the anesthesiologist and implanting physicians. In our case, this was performed subjectively. For sheath insertion, which can be the period associated with the most discomfort, the patient was prepared with generous LA. Continual contact with maintained with the patient and positive feedback was given. This was highly effective in allowing sheath insertion without need for additional sedation in many cases. In our experience, a true first-line LA-only strategy is not associated with a high level of discomfort in patients. A plan should be in place for complication management that includes anesthesia acceleration if needed. GA still remains a common practice, but more centers are switching to LA-only or LAS strategies.4,5,26,27
Study limitations. There are multiple limitations to this study. It is a non-randomized, single-center experience with a limited number of patients. The implanting team has significant experience with LA, complex structural heart procedures outside of TAVI, as well as endografting and peripheral interventions. Most importantly, it is not a comparison between an initial strategy of LA vs LA with routine concomitant routine sedation. Instead, a single strategy of initial LA alone was used in all patients. Some required LA only, whereas others received additional sedation during the course of the procedure and outcomes of patients who received only LA were compared to those who required additional sedation. Hence, concomitant characteristics associated with the need for sedation may have contributed to longer ICU stays rather than sedation itself. Of note, comfort and pain levels were not calculated objectively before and after the procedure.
Conclusion
This study shows that TAVI with an initial strategy of LA alone is feasible and safe. Only a minority of patients required additional sedation or GA. ICU lengths of stay were shorter in those patients who did not require additional sedation.
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From the CardioVascular Center (CVC) Frankfurt, Frankfurt, Germany.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sievert reports ownership interest, consulting fees, travel expenses, or study honoraria from Abbott, Access Closure, AGA, Angiomed, Aptus, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Contego, Covidien, CSI, CVRx, EndoCross, ev3, FlowCardia, Gardia, Gore, Guided Delivery Systems, Hemoteq, InSeal Medical, Lumen Biomedical, HLT, Lifetech, Lutonix, Maya Medical, Medtronic, NDC, Occlutech, Osprey, Ostial, PendraCare, pfm Medical, Recor, ResMed, Rox Medical, SentreHeart, Spectranetics, SquareOne, Svelte Medical Systems, Trireme, Trivascular, Vascular Dynamics, Venus Medical, Veryan, and Vessix. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted May 11, 2015, provisional acceptance given June 15, 2015, final version accepted July 31, 2015.
Address for correspondence: Prof Dr med Horst Sievert, CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany. Email: info@cvcfrankfurt.de
