Safety and Feasibility of Same Day Discharge after Transcatheter Aortic Valve Replacement Post COVID-19

Transcatheter Aortic Valve Replacement (TAVR) remains a complex procedure with the potential for life-threatening complications including heart block, bleeding from vascular access sites, and pericardial tamponade. Nevertheless, in the face of this complexity, it has been shown that TAVR can be safely performed across a large spectrum of centers.1Russo MJ McCabe JM Thourani VH et al.Case volume and outcomes after TAVR with balloon-expandable prostheses. Insights from TVT registry.J Am Coll Cardiol. 2019; 73 (doi:10.1016/j.jacc.2018.11.031.): 427-440Google Scholar Further, the safety of next-day discharge (NDD) after TAVR is now well established2Wood DA Lauck SB Cairns JA et al.The Vancouver 3M (Multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study.JACC Cardiovasc Interv. 2019; 12 (March 11, doi:10.1016/j.jcin.2018.12.020.): 459-469Google Scholar and has become the standard at many centers including our own, with more than 70% of patients discharged home on post-procedure day 1. During the Coronavirus (COVID) pandemic, numerous changes to inpatient surgical care generated discussion within the Structural Heart community regarding the possibility of same day discharge (SDD) after TAVR. Considering the impact of the COVID surge on our region, our heart team weighed the risks and benefits of SDD and implemented a strategy to offer SDD to well-selected patients. In this report, we describe a series of three patients who safely underwent SDD after transfemoral (TF) TAVR at our institution on a single day. Given our center’s location in New Jersey, our patients and program faced a significant challenge during the surge. For a period of nearly 6 weeks, treatment at our center was limited to the highest acuity patients. The cumulative effects of the surge in our region were measurable. It is estimated that during the COVID surge in NJ (mid-March to early May), 800 more people died of heart disease than were expected based on death rates during the same timeframe in previous years.3Lu, D. There has been an increase in other causes of deaths, not just Coronavirus. https://www.nytimes.com/interactive/2020/06/01/us/coronavirus-deaths-new-york-new-jersey.html. Assessed June 14, 2020.Google Scholar This occurred because patients were either unwilling or unable to obtain needed cardiovascular care. As we reopened our program to less acute patients, significant concerns remained. Even after the height of the surge, many areas of our hospital where TAVR patients are typically managed had been repurposed to manage COVID patients and remained at high capacity or were fully unavailable for alternative use. Furthermore, the population of patients undergoing TAVR are predominantly advanced in age with a high prevalence of hypertension and diabetes and therefore are at extremely high risk for adverse outcomes if infected with the severe acute respiratory syndrome coronavirus −2 (SARS-CoV-2). Moreover, to protect patients, families, and staff, visitors were not allowed in the hospitl; thus, all hospitalized patients remained separated from their loved ones for the duration of their inpatient stay. Given limitations in hospital beds and other essential resources, concerns for in-hospital transmission of COVID, and hesitancy of patients to seek care, we sought ways to minimize resource utilization, limit the inpatient footprint, and reduce length of stay. As each patient-provider encounter and room-to-room transfer presents an independent risk of transmission and consumes already scarce personal protective equipment (PPE), we hypothesized that the strategy of same day discharge in well-selected patients would decrease the risk of inpatient transmission, conserve hospital beds and PPE, and encourage patients to pursue needed treatment. Three patients with aortic stenosis (AS) who had tested negative for the SARS-CoV-2 infection were scheduled for TAVR on a single day. Demographic, clinical characteristics, and outcomes of patients are given in Table 1. There were two males and one female who were 67, 85, and 74 years old, respectively.Table 1Baseline demographic, clinical/procedural characteristics, and outcomes.VariablePatient 1Patient 2Patient 3Age677485SexMFMRace/EthnicityCaucasianAsianCaucasianBMI (kg/m2)28.118.922.5NYHA classIIIIIIIVSTS risk score (%)1.33.11.4Frailty (EFT)3/53/51/5ECG featuresPR interval (ms)152156200QRS duration (ms)1669490RBBB/LBBBRBBBNoneNoneRhythmNSRNSRNSRCo-morbid conditionsHypertensionYesYesYesHLDYesYesYesCADYesNoYesCKDNoNoNoDMYesYesNoAtrial fibrillationNoYesYesCOVID-19NegativeNegativeNegativeIndication for TAVRFrailty, advanced stage cancerSurgical Risk based on STS, frailty, and cachexiaAdvancedagePre-procedure echocardiographic parametersAVA (cm2)0.890.450.91LVEF (%)606660MRMildMildMildARMildMildModerateMean gradient (mmHg)487633Procedural characteristicsApproachTransfemoralTransfemoralTransfemoralValve typeS3S3S3Valve size232326Device side vascular closureProglide x 2 + BO x 5 mProglide x 2Proglide x 2Diagnostic vascular closureAngiosealAngiosealAngiosealBLE pulse examUnchangedUnchangedUnchangedPericardial effusionNoneNoneNoneCardiac functionGrossly unchangedGrossly unchangedGrossly unchangedPVLNoneNoneNonePost-procedure assessment (>4 h)Pericardial effusionNoneNoneNoneAVA (cm2)1.71.82LVEF (%)60–6555–6055–60MRTraceNoneMildPVLNoneNoneNoneMean gradient (mmHg)876Peak velocity (m/s)2.181.831.71PR interval (ms)158154196QRS duration (ms)1749096RBBB/LBBBRBBBNoneNoneRhythmNSRNSRNSRBLE pulse examUnchangedUnchangedUnchangedPPMNoNoNoVascular compNoNoNoPVLNoneNoneNoneStrokeNoNoNoProcedural successYesYesYesValve-in-valveNoNoNoIn-hospital mortalityNoNoNoRe-admission (24 days)NoNoNoNotes. BMI, body mass index; NYHA, New York Heart Association; STS, Society of Thoracic Surgery; LHC, left heart catheterization; EKG, electrocardiogram; RBBB, right bundle branch block; LBBB, left bundle branch block; HTN, hypertension; HLD, hyperlipidemia; CAD, coronary artery disease; CKD, chronic kidney disease; AVA, aortic valve area; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; AR, aortic regurgitation; NSR, normal sinus rhythm. BLE, bilateral lower extremity; PVL, paravalvular leak. Open table in a new tab Notes. BMI, body mass index; NYHA, New York Heart Association; STS, Society of Thoracic Surgery; LHC, left heart catheterization; EKG, electrocardiogram; RBBB, right bundle branch block; LBBB, left bundle branch block; HTN, hypertension; HLD, hyperlipidemia; CAD, coronary artery disease; CKD, chronic kidney disease; AVA, aortic valve area; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; AR, aortic regurgitation; NSR, normal sinus rhythm. BLE, bilateral lower extremity; PVL, paravalvular leak. As is standard at our institution, all cases were performed in the hybrid operating room (OR) under conscious sedation via a transfemoral approach. The Sapien 3 transcatheter heart valve (Edwards Lifesciences) of sizes 23, 23, and 26 were used in patients 1, 2, and 3, respectively. There was no evidence of paravalvular or valvular aortic regurgitation, pericardial effusion, or vascular access site complication in any of the patients. Post-operatively, patients were transferred to the post-operative care unit and monitored over a duration of two to four hours. Patients underwent continuous telemetry, O2 saturation, heart rate, and blood pressure (BP) monitoring. Serial EKGs were recorded immediately post-procedure and prior to discharge. All patients were clinically stable in normal sinus rhythm or baseline AF without evidence of new or deteriorating conduction abnormality. Patients were discharged home on the same day within 5 hours post-procedure. The loss of even a single patient due to complications resulting from premature discharge should be a never event. Therefore, meticulous procedural technique and implementation of safety nets are required for any rapid discharge protocol. Important technical and management issues include:(1)Vascular access. Appropriate arterial access was obtained with ultrasound and micro puncture at the mid-femoral head and confirmed with a limited angiogram in each of the three cases. This was done on both the device and diagnostic catheter side. After valve deployment and removal of the delivery sheath, two Proglides (Perclose Proglide, Abbott vascular) were deployed on the device side. A completion angiogram with runoff was then performed to confirm artery patency and hemostasis. It is our practice that if more than a small leak persists, the vessel is large, and the vessel is without obvious injury, a third proglide is deployed. Alternatively, as was required in 1 of the cases, if there is more than a slight leak from the vessel and/or the vessel is compromised, we cross over from the diagnostic side to the device side and perform balloon occlusion at the access site with an appropriate sized Mustang balloon (Mustang Balloon dilation catheter, Boston Scientific), typically for 5 minutes. After hemostasis was confirmed on the device side, an angioseal (Angio-seal closure device, Abbott vascular) was used to achieve hemostasis on the diagnostic side. At the completion of the case, bilateral lower extremity (BLE) pulse checks were performed to ensure pulses were unchanged compared to baseline.(2)Post-deployment cardiac assessment. To confirm valve position and assess PVL, cardiac function, and hemodynamic result, as well as to rule out pericardial effusion and/or tamponade, a TTE was performed immediately after valve deployment in each of the three patients. In each case, the valve position was as expected, PVL was trace to none, cardiac function was unchanged, and there was no evidence of tamponade.(3)Conduction. Consideration for SDD should be limited to patients with short PR and narrow QRS intervals or those with a preexisting PPM. Any changes in conduction post-procedurally should serve as a contraindication to the SDD. This is determined by continuous EKG monitoring throughout the procedure. In each of the three patients, our standard rapid discharge protocol was applied. The patients were transferred from the hybrid OR to the PACU, and in-hospital post-procedure evaluation included the following:(1)Serial EKGs. Each patient had a 12-lead EKG upon arrival to the PACU and at 4 hours post-procedure to confirm new changes in conduction related to PR and QRS intervals as well as new LBBB or RBBB. In each case, PR and QRS intervals were unchanged compared to baseline, and there was no evidence of new EKG changes.(2)Repeat TTE at ≥ 4 hrs. Each patient underwent a bedside TTE to rule out change in cardiac function, valve migration, or evidence of new pericardial effusion. None of these complications were observed.(3)Ambulation at 4 hours. Each patient was ambulated at 4 hours post-procedure.(4)BLE Pulse exams. No changes were noted. After SDD, each of the three patients were followed for 7 days with remote home monitoring with continuous EKG using the Zio system (Zio AT iRhythm, San Francisco, CA). This system functions to alert the patient and provider to conduction changes in real time. At our center, this is standard follow-up for all patients discharged within 5 days of catheter-based or open surgical valve replacement. In these 3 patients, there were no events of advanced AV block or bradycardia (HR <40 BPM) detected by the Zio system. In addition, each patient had a virtual follow-up visit on post-procedure days 1 and 2. After a follow-up duration of 24 days, there were no reports of death or re-hospitalization. The strategy of rapid discharge with real-time home monitoring may play an important role in the post-surge period as well as throughout seasonal pandemic fluctuations. Criteria for SDD should take into consideration baseline clinical characteristics imaging features and post-procedure related outcomes. For this unique cohort, only patients without significant comorbidities including but not limited to end-stage renal disease and anemia (Hemoglobin <9 mg/dl) without poor functional status (New York Heart Association Class ≥ III) should be considered. Same day discharge can be considered in patients with LVEF > 30%. Post-procedure, there should be no advanced conduction abnormalities or vascular access issues such as bleeding, and the patient should be willing to go home on the same day [Figure 1]. In conclusion, we describe a series of three patients who underwent TAVR and were discharged uneventfully on the same day. More data is needed to assess the safety and benefits of SDD. Treatment-related metrics should encompass morbidity/mortality, including COVID conversion. Utilization metrics should comprise provider encounters, length of stay, and proportion of same day or next day discharges. To better define optimal imaging protocols, workflow, and the role of telehealth in this population, it will be imperative to assess patients’ willingness to schedule telemedicine consults; rates of successful consult completion; need for in-person consult with same provider; significance of tele monitoring parameters; and the ability of home monitoring systems to alert providers to late adverse events. The authors have no funding to report.

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.