Abstract
Enhanced recovery after surgery (ERAS) protocols are gaining wide acceptance. We evaluated ERAS protocol implementation in transfemoral transcatheter aortic valve replacement (TAVR) patients. The ERAS protocol included (1) moderate sedation or general anesthesia with on-table extubation, (2) no pulmonary artery or urinary catheters, (3) arterial line removal within 4 hours, (4) no postoperative narcotics, (5) mobilization at 4 hours and ambulation within 8 hours, and (6) antihypertensive reinstitution without nodal blockers. Patients who received TAVR before and after ERAS implementation were compared (N = 121 and N = 368, respectively). The primary endpoint was total hospital length of stay (LOS). ERAS patients had a lower mean Society of Thoracic Surgeons predicted risk of mortality (6.7% vs 7.5%; P = 0.04). Unadjusted analysis demonstrated that ERAS was associated with significantly decreased mean LOS (2.8 vs 4.0 days, P < 0.001), decreased 30-day mortality (0.8% vs 5.0%; P = 0.003), and increased discharge home (90.2% vs 79.3%, P = 0.002) with no increase in 30-day readmission (11.1% vs 14.0%, P = 0.39). After risk adjustment, ERAS patients had a 1.87-day shorter LOS (P = 0.001) and trended toward increased discharge home (odds ratio 1.76, P = 0.078) without increased readmission (odds ratio 0.74, P = 0.4). An ERAS protocol for TAVR is safe and is associated with shorter LOS without increased readmission.
Keywords: Enhanced recovery after surgery, fast-track TAVR, minimalist TAVR, transcatheter aortic valve replacement
Patients with severe symptomatic aortic stenosis are increasingly being treated with transcatheter aortic valve replacement (TAVR).1–3 Perioperative care following TAVR was originally based on care pathways used for surgical aortic valve replacement (SAVR), including the use of general anesthesia and postoperative admission to the intensive care unit.4,5 However, as TAVR has become less invasive, there is a need to reevaluate the intensity and extent of perioperative care. Enhanced recovery after surgery (ERAS) protocols have gained wide acceptance to guide perioperative care in a variety of surgical subspecialties, including cardiac surgery.6 ERAS is a multimodal approach aimed at reducing perioperative stress in order to promote earlier and safer recovery for the patient.7 At our institution, we implemented an ERAS protocol to guide perioperative care for patients undergoing transfemoral (TF) TAVR. Herein, we report our experience and patient outcomes following implementation of ERAS for TF-TAVR.
METHODS
Institutional review board approval was obtained to conduct this retrospective review. All patients undergoing TAVR at our institution are evaluated by a heart team approach to determine suitability for this procedure. This assessment includes standard tests such as transthoracic echocardiography, computed tomography with reconstructions, pulmonary function testing, frailty assessments, basic laboratory testing, electrocardiogram, and clinical evaluation by at least one cardiologist and two cardiac surgeons. All procedures were performed by an interventional cardiologist and cardiac surgeon in the hybrid operating room or catheterization laboratory with full operating room capability, including a primed cardiopulmonary bypass pump and a perfusionist in attendance. All patients received anesthesia care by a cardiac anesthesiologist regardless of the anesthetic approach taken. A dedicated sonographer was present for all cases. Before implementation of ERAS, the standard of care was leaving patients intubated postoperatively, admission to the intensive care unit, and subsequent delayed extubation.
Our ERAS protocol consists of six key components: (1) preference for moderate sedation and no intubation, (2) no pulmonary artery or urinary catheters, (3) arterial line removal within 4 hours, (4) no postoperative narcotics, (5) mobilization within 4 hours and ambulation within 8 hours, and (6) restarting home antihypertensives except atrioventricular nodal blocking agents within 4 hours in order to reduce intravenous vasodilator therapy. A checklist for these components and additional details of the ERAS pathway are shown in Figure 1.
Figure 1.
Transfemoral TAVR ERAS pathway checklist.
Although our ERAS program emphasizes a preference for moderate sedation, it includes the option for general anesthesia with intubation if determined clinically appropriate. In these cases, an attempt is made to immediately extubate patients after TAVR in the operating room or catheterization laboratory. During the procedure, valve positioning is guided by fluoroscopy, as previously described.8 In patients undergoing general anesthesia, transesophageal echocardiography (TEE) is also used to evaluate postdeployment valve performance, unless a contraindication to TEE is present. For patients undergoing moderate sedation, postdeployment assessment is performed using transthoracic echocardiography and angiography.
Implementation of the ERAS protocol began on April 1, 2014. All patients with planned TF-TAVR were placed on the ERAS pathway, regardless of surgical risk or comorbid conditions. As such, deviations from the ERAS protocol were made only when clinically indicated by the individual patient condition, rather than based on an a priori preoperative decision that a patient did not qualify for ERAS. Given the changes in patient care instituted with the ERAS protocol, particularly with early ambulation following TF-TAVR, it took significant time (approximately 1 year) to ensure that the ERAS protocol was routinely followed in its entirety by the perioperative care team, including cardiologists, surgeons, anesthesiologists, and nursing staff.
Patients undergoing TF-TAVR were separated into two cohorts: (1) pre-ERAS (January 2012 to March 2014, N = 121 patients) and (2) ERAS (April 2015 to December 2016, N = 368 patients). Patients undergoing TF-TAVR from April 2014 through March 2015 were excluded. We treated this year as a washout period, during which the ERAS pathway was being fully implemented in the clinical setting. This washout period was necessary to ensure that the ERAS protocol was fully instituted for all patients in the analysis. Data reviewed included baseline patient demographics, intraoperative characteristics, and postoperative characteristics as well as 30-day outcomes. The primary outcome was total hospital length of stay (LOS). Secondary outcomes included postoperative complications, 30-day mortality, discharge to home, and 30-day readmission.
Continuous variables are presented as mean ± standard deviation and categorical variables as percentages. Chi-square analyses were performed between the groups. A linear regression using log-transformed LOS as the dependent variable was used, adjusting for Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) (using a three-knot restricted cubic spline function), vascular complications, requirement for new pacemaker, and general anesthesia. The adjusted difference in LOS and corresponding 95% confidence intervals (CI) were log-transformed back to the original scale for presentation of results. Separate logistic regression models were fitted with the same covariate adjustments used for the LOS model to assess differences in discharge home and 30-day readmission for ERAS vs pre-ERAS. Adjusted odds ratios for home discharge and 30-day readmission comparing ERAS to pre-ERAS were presented. All P values are reported from model Wald chi-squared tests. The association between ERAS and pre-ERAS and mortality was not assessed after adjustment, given the relatively low mortality rate in the study.
RESULTS
There was no significant difference between the pre-ERAS and ERAS population demographics in terms of age, gender, frailty, comorbidities, or prior interventions (Table 1). There were statistically significant differences in the baseline mean STS-PROM and risk level: ERAS patients had lower STS-PROM (6.7% vs 7.5%, P = 0.04) and were less likely to be deemed high risk for SAVR (66.6% vs 79.0%, P = 0.01) than pre-ERAS patients. ERAS patients were also found to have higher baseline hematocrit levels (37.5% vs 35.5%, P < 0.001), with a trend toward lower baseline creatinine levels (1.3 vs 1.5 mg/dL, P = 0.055).
Table 1.
Preoperative characteristics of pre-ERAS and ERAS patients
| Variable |
Pre-ERAS (N = 121) |
ERAS (N = 368) |
P value |
|---|---|---|---|
| Age (years) | 81.7 ± 9.2 | 81.0 ± 7.9 | 0.38 |
| Male | 60% | 54% | 0.23 |
| STS-PROM (%) | 7.5 ± 3.6 | 6.7 ± 3.7 | 0.04 |
| High risk | 79.0% | 66.6% | 0.01 |
| Intermediate risk | 21.0% | 29.6% | 0.08 |
| Low risk | 0% | 3.8% | 0.03 |
| Frailty | 29.75% | 31.8% | 0.67 |
| White, non-Hispanic | 90.9% | 94.0% | 0.82 |
| Diabetes mellitus | 41.3% | 48.1% | 0.19 |
| BMI (kg/m2) | 28.6 ± 6.4 | 28.5 ± 6.4 | 0.81 |
| Moderate/severe lung disease | 25.6% | 21.2% | 0.31 |
| Liver disease | 3.3% | 4.6% | 0.54 |
| Immunocompromised | 14.0% | 7.9% | 0.04 |
| Mediastinal radiation | 5.0% | 4.1% | 0.68 |
| Peripheral vascular disease | 31.4% | 32.1% | 0.89 |
| Cerebrovascular disease | 31.4% | 32.1% | 0.89 |
| Stroke | 18.2% | 13.3% | 0.19 |
| Hematocrit (%) | 35.3 ± 4.4 | 37.5 ± 5.0 | <0.0001 |
| Creatinine (mg/dL) | 1.5 ± 1.1 | 1.3 ± 0.5 | 0.055 |
| Previous MI | 18.2% | 26.4% | 0.07 |
| Previous PCI | 41.3% | 45.4% | 0.43 |
| Previous CABG | 35.5% | 31.3% | 0.38 |
| Prior SAVR | 0.8% | 2.2% | 0.34 |
| Prior TAVR | 0% | 0.3% | 0.57 |
| NYHA III/IV | 78.6% | 71.8% | 0.14 |
| LVEF (%) | 55.0 ± 12.3 | 54.6 ± 11.4 | 0.73 |
| Preop PPM/ICD | 24.8% | 19.0% | 0.17 |
Data presented as percentage or mean ± standard deviation.
BMI indicates body mass index; CABG, coronary artery bypass graft surgery; ERAS, enhanced recovery after surgery; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NYHA, New York Heart Association class; PCI, percutaneous coronary intervention; PPM/ICD, permanent pacemaker/implantable cardioverter-defibrillator; SAVR, surgical aortic valve replacement; STS-PROM, Society of Thoracic Surgeons predicted risk of mortality; TAVR, transcatheter aortic valve replacement.
Intraoperatively, ERAS patients underwent general anesthesia less frequently (58% vs 100%, P < 0.001). ERAS patients undergoing general anesthesia were more likely to be extubated in the operating room or catheterization laboratory following the procedure (90% vs 72%, P < 0.001). ERAS patients were more likely to have 14F sheaths used compared to pre-ERAS patients (52% vs 15%, P < 0.001). Sheaths >20F were used in 44% of pre-ERAS patients, but 22F or 24F sheaths were not utilized in any ERAS patients. ERAS cases were shorter in duration (62 vs 88 min, P < 0.001) (Table 2). Two patients in the ERAS group were emergently converted to sternotomy with cardiopulmonary bypass, but both were ultimately discharged with good outcomes.
Table 2.
Intraoperative characteristics of pre-ERAS and ERAS patients
| Variable |
Pre-ERAS (N = 121) |
ERAS (N = 368) |
P value |
|---|---|---|---|
| Elective | 94.2% | 98.6% | 0.006 |
| Procedure aborted | 0.8% | 0 | 0.08 |
| Balloon-expandable valve | 88% | 81% | 0.06 |
| Conversion to open surgery | 0.8% | 0.5% | 0.73 |
| Cardiopulmonary bypass | 1.6% | 0.5% | 0.24 |
| General anesthesia | 100% | 57.9% | <0.0001 |
| Extubated in OR | 71.9% | 90.1% | <0.0001 |
| Preoperative inotropes | 0 | 1.1% | 0.25 |
| Sheath size | |||
| 14F | 14.9% | 51.9% | <0.0001 |
| 16F | 15.7% | 20.9% | 0.21 |
| 18F | 19.0% | 22.6% | 0.41 |
| 19F | 0 | 1.4% | 0.2 |
| 20F | 5.8% | 3.3% | 0.21 |
| 22F | 19.0% | 0 | <0.0001 |
| 24F | 25.6% | 0 | <0.0001 |
| Procedure length (min) | 88 ± 56 | 62 ± 35 | <0.0001 |
| IABP | 1.7% | 0.5% | 0.24 |
Data presented as percentage or mean ± standard deviation.
IABP indicates intra-aortic balloon pump; OR, operating room.
ERAS patients had significantly decreased mean total hospital LOS (2.8 vs 4.0 days, P < 0.001). They also spent less time in the intensive care unit (34 vs 68 h, P < 0.001). ERAS patients had increased discharge within 1 and 2 days (1 day, 46% vs 10%; 2 days, 67% vs 29%; both comparisons P < 0.001) as compared to pre-ERAS patients. The discharge disposition of ERAS patients was more commonly home (90% vs 79%, P = 0.002) as opposed to a skilled nursing or rehabilitation facility (Table 3).
Table 3.
Postoperative and 30-day outcomes of pre-ERAS and ERAS patients
| Variable |
Pre-ERAS (N = 121) |
ERAS (N = 368) |
P value |
|---|---|---|---|
| Total LOS, days | 4.0 ± 3.6 | 2.8 ± 3.3 | <0.0001 |
| Total LOS ≤1 day | 9.9% | 45.7% | <0.0001 |
| Total LOS ≤2 days | 28.9% | 67.4% | <0.0001 |
| ICU LOS, hours | 68.4 ± 161.7 | 34.1 ± 49.2 | <0.0001 |
| Discharge location | |||
| Home | 79.3% | 90.2% | 0.002 |
| Other | 16.5% | 9.2% | 0.03 |
| Deceased | 4.1% | 0.5% | 0.004 |
| 30-day mortality | 5.0% | 0.8% | 0.003 |
| 30-day readmission | 14.0% | 11.1% | 0.39 |
| Stroke | 0 | 1.6% | 0.16 |
| TIA | 0 | 0 | 1 |
| AV reintervention | 0.8% | 0 | 0.08 |
| Surgical site infection | 0 | 0 | 1 |
| Vascular complications | 16.5% | 13.6% | 0.42 |
| New PPM | 26.4% | 24.2% | 0.67 |
| Significant EKG changes | 11.6% | 20.7% | 0.03 |
| Renal failure | 3.3% | 0.5% | 0.02 |
| New dialysis | 3.3% | 0.3% | 0.004 |
| Blood product transfusion | 21.5% | 11.4% | 0.006 |
| Readmission to ICU | 0 | 1.9% | 0.13 |
| Reoperation | |||
| Bleeding | 0 | 0.3% | 0.57 |
| Valve dysfunction | 0.8% | 0.5% | 0.73 |
| Cardiac | 0% | 0.3% | 0.57 |
| Other, noncardiac | 2.5% | 1.9% | 0.7 |
| VTE | 1.7% | 0.5% | 0.24 |
| Pleural effusion requiring drainage | 5.8% | 1.4% | 0.006 |
| Cardiac arrest | 5.8% | 0.8% | <0.001 |
| Anticoagulation event | 0.8% | 0.3% | 0.41 |
| Tamponade | 0.8% | 0 | 0.08 |
| GI event | 4.1% | 1.9% | 0.17 |
| Multisystem failure | 0 | 0.3% | 0.57 |
| Atrial fibrillation | 11.6% | 5.4% | 0.02 |
| Aortic insufficiency | |||
| None | 52.1% | 73.6% | <0.0001 |
| Trivial/trace | 6.6% | 9.5% | 0.33 |
| Mild | 9.1% | 5.7% | 0.19 |
| Moderate/severe | 3.3% | 3.8% | 0.81 |
Data presented as percentage or mean ± standard deviation. Neurologic events, reintervention, and surgical site infections were tracked to postoperative day 30; otherwise, complications were tracked only during index admission.
AV indicates aortic valve; EKG, electrocardiogram; GI, gastrointestinal; ICU, intensive care unit; LOS, length of stay; PPM, permanent pacemaker; TIA, transient ischemic attack; VTE, venous thromboembolism.
The ERAS cohort experienced a significantly lower unadjusted 30-day mortality (0.8% vs 5.0%, P = 0.003), and the two groups had similar 30-day readmission rates (Table 3). There were no differences in terms of vascular complications or new requirements for permanent pacemaker following TAVR. ERAS patients were less likely to have renal complications, including new renal failure (0.5% vs 3.3%, P = 0.02) and dialysis (0.3% vs 3.3%, P = 0.004). ERAS patients were statistically more likely to have no aortic insufficiency (either paravalvular or central leak) on postoperative echocardiogram (74% vs 52%, P < 0.001). ERAS patients were less likely to receive blood products during their hospitalization (11% vs 22%, P = 0.006). Otherwise, 30-day outcomes were similar in terms of stroke, transient ischemic attack, need for aortic valve reintervention, and surgical site infection.
A multivariate analysis was performed to adjust for STS-PROM, vascular complications, new pacemaker requirement, and general anesthesia. After adjustment, ERAS was associated with a decrease in LOS of 1.87 days (95% CI −2.63, −0.86; P = 0.001). A trend toward ERAS patients being more likely to discharge home was evident (odds ratio [OR] 1.76; 95% CI 0.94, 3.28; P = 0.078). ERAS patients were not at increased risk for 30-day readmission (OR 0.74; 95% CI 0.48; 1.38; P = 0.4).
DISCUSSION
The perioperative care of TAVR patients is becoming increasingly less invasive. ERAS protocols that have been successfully implemented for a variety of surgical procedures can inform evolution in the perioperative management of TAVR patients.6 Our ERAS protocol emphasizes more streamlined periprocedural care for the TF-TAVR patients to safely fast-track their recovery while ensuring flexibility to address clinical needs as they arise. Our results, even after adjustment for patient risk scores, suggest that implementation of the ERAS protocol was associated with a decreased total hospital LOS without any increase in postoperative complications or readmissions.
Our findings are notable for several reasons. ERAS is a comprehensive, perioperative management paradigm whose primary goal is to facilitate patient recovery to decrease LOS and reduce postoperative complications. ERAS programs are similar in many ways to so-called “fast-track” or “minimalist” protocols described by other TAVR centers.9–13 Importantly, however, ERAS builds upon these pathways to encompass a comprehensive management approach in a bundled fashion, rather than implement one or two “fast-track” items individually.8,14 Furthermore, ERAS is intended for use in all patients undergoing a designated procedure, leaving room for deviation from the pathway only once clinically indicated. This is in contradistinction to most other previously published reports on fast-track and minimalist TAVR programs, which select certain patients for inclusion in the accelerated pathway and exclude all others based on preoperative characteristics alone.15 After implementation of ERAS at our center, the total hospital LOS was reduced by nearly 2 days for all-comers.
Patients managed with our ERAS pathway had better outcomes than the pre-ERAS patients in terms of LOS, 30-day mortality, and postoperative renal complications, without any increase in other postoperative complication rates or 30-day readmission. However, there are other potential reasons, independent of ERAS management, that may also contribute to improved outcomes in ERAS patients. First, ERAS patients included more intermediate/low-risk patients with lower STS-PROM, suggesting that their preoperative characteristics alone may predict better outcomes independent of perioperative management strategies. The reduced risk profiles of the ERAS patients are a reflection of the evolving indications for TAVR during the study period, including commercial approval of TAVR in intermediate-risk patients and patient enrollment in the low-risk TAVR trials as well. However, even after adjustment for STS-PROM, the potential benefits associated with ERAS were largely confirmed.
Second, the development and availability of new, smaller delivery systems for the transcatheter valves was captured over the timeline of the study. Much larger sheath sizes were used in the pre-ERAS era, which undoubtedly contributed to longer LOS and increased blood transfusions in this group. Nevertheless, the development of less invasive delivery sheaths dovetails with the goals of an ERAS protocol and may even facilitate increased compliance with key ERAS components, most importantly early ambulation.
One potential concern with our ERAS approach was the inability to perform intraoperative TEE in patients undergoing moderate sedation, which comprised 42% of patients in this cohort. In these patients, valve positioning and postdeployment valve assessment were performed using fluoroscopy, angiography, and transthoracic echocardiography. Nevertheless, there was actually less aortic insufficiency (including paravalvular leak) observed on predischarged echocardiography in the ERAS group. While we do not believe that the ERAS protocol itself resulted in lower rates of aortic insufficiency—this is more likely due to improvements in the TAVR technology, including skirted valves, over the study era—these findings suggest that it is both safe and effective to deploy and to assess TAVR valves without TEE. It is important to note as well that, in the current era, the trend away from general anesthesia to conscious sedation has continued, with up to two-thirds of patients undergoing conscious sedation in recent years.16
Our analysis is subject to the standard biases introduced by single-center, retrospective analyses. Thus, our findings may not be generalizable to other TAVR centers. Moreover, we report on patients undergoing TAVR between 2012 and 2016, and TAVR valves and delivery systems have been incrementally improved both during and since this era. Nevertheless, we believe that ERAS protocols have the potential to enhance patient care above and beyond the improvements afforded by new technology, and thus our findings can contribute meaningfully to patient management strategies. In fact, improved TAVR technology has facilitated many of the components of our TAVR ERAS program, allowing increased compliance with early mobilization and the use of conscious sedation. Finally, many TAVR studies from the study era are best interpreted with caution for potential bias due to learning curves for TAVR. However, our cardiologists and surgeons had completed over 300 TAVRs before this study period, so it is unlikely that a learning curve biased our results in favor of the ERAS group.
The evolution of the TAVR procedure and technology has allowed for improved patient outcomes in an increasingly broad patient population. Implementation of an ERAS protocol for patients undergoing TF-TAVR is associated with shorter LOS and a trend toward more frequent discharge home, without increased readmission, even after adjustment for risk profiles.
DISCLOSURES
Michael Mack, MD, is co–principal investigator of the PARTNER 3 trial for Edwards Lifesciences (uncompensated). Molly Szerlip, MD, Katherine Harrington, MD, and William Brinkman, MD, are consultants for Edwards Lifesciences; Dr. Szerlip is also a consultant for Medtronic and Abbott. The other authors have no potential conflicts of interest to disclose.
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