Same-Day Discharge Post-Transcatheter Aortic Valve Replacement During the COVID-19 Pandemic: The Multicenter PROTECT TAVR Study.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic. BACKGROUND: The COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands. METHODS: Patient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation. RESULTS: From March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106). CONCLUSIONS: SDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.

Percutaneous versus surgical transaxillary access for transcatheter aortic valve replacement: a propensity-matched analysis of the US experience.

BACKGROUND: As transaxillary (TAx) access has become the most common alternative to transfemoral (TF) transcatheter aortic valve replacement (TAVR), there is increasing use of a percutaneous approach. AIMS: This study sought to determine whether there are differences in outcomes using a percutaneous access versus cutdown for TAx TAVR. METHODS: Using data from the STS/ACC TVT Registry, consecutive patients undergoing TAx TAVR with balloon-expandable valves between July 2015 and December 2020 were included. Propensity score-based matching was performed to evaluate the association between method of TAx access and outcomes. RESULTS: Of 4,219 patients, 1,140 (27.0%) underwent percutaneous access and 3,079 (73.0%) had surgical cutdown for TAx TAVR, with the proportion of percutaneous cases increasing over time. After propensity matching, there were no significant baseline differences between patients undergoing TAx access by either approach. At 30 days, there were similar rates of all-cause mortality (4.8% in percutaneous patients vs 4.1% in surgical patients; p=0.40) and stroke (7.7% vs 6.5%; p=0.25). Those undergoing percutaneous TAx access were more likely to receive conscious sedation and have less need for the intensive care unit (ICU). Percutaneous access was associated with a higher rate of major vascular complication (3.0% vs 1.5% in surgical patients; p=0.02) but not life-threatening bleeding (0.3% vs 0.1%; p=0.31). CONCLUSIONS: This study supports the safety and efficacy of percutaneous TAx TAVR compared to traditional surgical cutdown. Percutaneous access was associated with a shorter ICU stay and a higher rate of major vascular complication without an increase in life-threatening bleeding.

Strategies for Reducing Vascular and Bleeding Risk for Percutaneous Left Ventricular Assist Device-supported High-risk Percutaneous Coronary Intervention.

In patients at high risk for haemodynamic instability during percutaneous coronary intervention (PCI), practitioners are increasingly opting for prophylactic mechanical circulatory support, such as the Impella® heart pump (Abiomed, Danvers, MA, USA). Though Impella-supported high-risk PCI (HRPCI) ensures haemodynamic stability during the PCI procedure, access-related complication rates have varied significantly in published studies. Reported variability in complication rates relates to many factors, including anticoagulation practices, access and closure strategy, post-procedure care and variations in event definitions. This article aims to outline optimal strategies to minimize vascular and bleeding complications during Impella-supported HRPCI based on previously identified clinical, procedural and postprocedural risk factors. Practices to reduce complications include femoral skills training, standardized protocols to optimize access, closure, anticoagulation management and post-procedural care, as well as the application of techniques and technological advances. Protocols integrating these strategies to mitigate access-related bleeding and vascular complications for Impella-supported procedures can markedly limit vascular access risk as a barrier to appropriate large-bore mechanical circulatory support use in HRPCI.

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention.

Complex, high-risk percutaneous coronary intervention (HR-PCI) is increasingly being performed, often with mechanical circulatory support (MCS), though to date, there are limited randomised data on the efficacy of MCS for HR-PCI. The majority of MCS is provided by intra-aortic balloon pumps, but increasingly Impella® (Abiomed, Danvers, MA, USA) heart pumps are being used. While the Impella pumps provide greater increases in cardiac output, these devices require large bore access, which has been associated with an increased risk of bleeding and vascular complications. Decisions regarding the use of Impella are often based on risk-benefit considerations, with Impella-related bleeding risk being a major factor that can impact decisions for planned use. While bleeding risk related to large bore access is a concern, published data on the risk have been quite variable. Thus, the goal of this article is to provide a comprehensive review of reports describing bleeding and vascular complications for Impella-supported HR-PCI.

Outcomes Following Subclavian and Axillary Artery Access for Transcatheter Aortic Valve Replacement: Society of the Thoracic Surgeons/American College of Cardiology TVT Registry Report.

OBJECTIVES: The aim of this study was to analyze the frequency and outcomes of patients who underwent transsubclavian or transaxillary (TAx) transcatheter aortic valve replacement (TAVR) using the balloon-expandable SAPIEN 3 prosthesis compared with traditional alternative access, transapical (TA) and transaortic (TAo). BACKGROUND: The transsubclavian and TAx approaches for TAVR are rapidly growing alternatives in the setting of hostile iliofemoral arteries, yet few data exist. METHODS: The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was queried for all patients undergoing TAx TAVR with the SAPIEN 3 prosthesis from June 2015 to February 2018. Secular trends over time were evaluated. Logistic regression analyses used to assess risk-adjusted outcomes. Propensity score matching was used to compare TAx access with TA and TAo access. RESULTS: In total, 3,628 patients (5.7%) underwent nontransfemoral access with the SAPIEN 3. Overall, TAx TAVR accounted for 1,249 of these patients (34.4%). There has been rapid recent growth in TAx TAVR (from 20.2% in the third quarter of 2015 to 49.0% in the fourth quarter of 2017; p < 0.001 for trend) and a concomitant decrease in TA and TAo access (from 61.9% in the third quarter of 2015 to 35.3% in the fourth quarter of 2017; p < 0.001 for trend). The median number of TAx TAVR cases per hospital during the study period was 2, and 78.2% of centers performed ≤5 TAx TAVR procedures. The device success rate was 97.3%, and the major vascular complication rate was 2.5%. After propensity matching, TAx access had lower 30-day mortality (5.3% vs. 8.4%; p < 0.01), shorter lengths of intensive care unit and hospital stay, but a higher stroke rate (6.3% vs. 3.1%; p < 0.05) compared with TA and TAo access. CONCLUSIONS: TAx access has become the most frequent alternative access route for balloon-expandable TAVR procedures. Outcomes following TAx TAVR appear positive despite the relatively early experience of most centers performing these cases.

Supraclavicular Subclavian access for Sapien Transcatheter aortic valve replacement- a novel approach.

BACKGROUND: Within the trans-subclavian approach, procedural techniques can vary widely, and reported access generally refers to an infraclavicular axillary approach. We describe and report the use of a novel supraclavicular true subclavian approach for transcatheter aortic valve replacement (TAVR) exclusively for implantation of Sapien 3 valves. CASE PRESENTATION: We report our first five consecutive patients undergoing TAVR with a Sapien 3 valve using a standardized subclavian approach at a single center. In-hospital and 30-day complications were reported. The use of this approach resulted in successful implantation in 100% of patients in a safe manner with 0% mortality, stroke, and vascular injury during hospitalization and at 30 day follow-up. The in-hospital pacemaker implantation rate was 20%. The average length of stay was 3 days. CONCLUSIONS: TAVR with Sapien implant can be safely performed with a standardized supraclavicular subclavian approach in patients with unfavorable femoral access.

Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter.

OBJECTIVE: An unmet need is represented in angioplasty catheters that permit the predilation stage of treating complex coronary anatomy oftentimes not amenable to conventional device therapies. BACKGROUND: Lesion preparation with balloon angioplasty prior to stent placement remains the most common method of percutaneous coronary revascularization. METHODS: Clinical and angiographic outcomes were evaluated following a treatment strategy of coronary artery disease that included predilation with a low-profile, 1.25-mm angioplasty catheter prior to stent placement. The study primary end point of procedural success was defined as successful device delivery and lesion treatment, including the absence of clinically significant perforation, arrhythmia, flow-limiting dissection, or reduction in baseline Thrombolysis In Myocardial Infarction (TIMI) grade with final achievement of TIMI 3 flow. RESULTS: Among 51 patients (54 lesions), predilation using a 1.25 mm angioplasty catheter was associated with procedural and device-related success rates of 100%. In-hospital target lesion failure occurred in one patient (2.0%) related to postprocedural myocardial infarction. Patient and angiographic characteristics included diabetes, 43.1%; lesion length ≥ 20 mm, 20.4%; bifurcation lesion, 31.5%; lesion classification B2/C, 74.1%; and baseline TIMI 0/1 flow, 13.0%. No subsequent in-hospital adverse events occurred. CONCLUSIONS: Percutaneous coronary revascularization involving a predilation strategy with a low profile, 1.25-mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective initial treatment for complex coronary anatomy.

Loop diuretics can cause clinical natriuretic failure: a prescription for volume expansion.

Ultrafiltration enhances volume removal and weight reduction vs diuretics. However, their differential impact on total body sodium, potassium, and magnesium has not been described. Fifteen patients with congestion despite diuretic therapy had urine electrolytes measured after a diuretic dose. Ultrafiltration was initiated and ultrafiltrate electrolytes were measured. The urine sodium after diuretics (60+/-47 mmol/L) was less than in the ultrafiltrate (134+/-8.0 mmol/L) (P=.000025). The urine potassium level after diuretics (41+/-23 mmol/L) was greater than in the ultrafiltrate (3.7+/-0.6 mmol/L) (P=.000017). The urine magnesium level after diuretics (5.2+/-3.1 mg/dL) was greater than in the ultrafiltrate (2.9+/-0.7 mg/dL) (P=.017). In acute decompensated heart failure patients with congestion despite diuretic therapy, diuretics are poor natriuretics and cause significant potassium and magnesium loss. Ultrafiltration extracts more sodium while sparing potassium and magnesium. The sustained clinical benefits of ultrafiltration compared with diuretics may be partly related to their disparate effects on total body sodium, potassium, and magnesium, in addition to their differential efficacy of volume removal.

A practical guide for ultrafiltration in acute decompensated heart failure.

Acute decompensated heart failure is the most common reason for inpatient hospital admission. Most patients admitted for decompensated heart failure are by definition diuretic-resistant. The therapeutic objective for these patients is volume and sodium removal and restoration of diuretic sensitivity. In a significant proportion of patients, this objective is not met, subjecting patients to readmission for recurrent heart failure decompensation. Ultrafiltration therapy offers the potential of greater volume and sodium removal as compared with conventional therapies in a more expeditious manner. Ultrafiltration can be safely and effectively accomplished in a non-intensive care setting but relies on earlier discharge with reduced readmission rates to be economically feasible. This paper reviews the current data regarding ultrafiltration therapy and provides a practical guide to patient selection, implementation and management of this therapy.

Large volume ultrafiltration for acute decompensated heart failure using standard peripheral intravenous catheters.

BACKGROUND: Ultrafiltration for decompensated heart failure has recently generated significant clinical interest with the development of a portable machine that does not require an intensive care or dialysis unit. This case series was designed to demonstrate the feasibility and effectiveness of performing large volume ultrafiltration via peripherally inserted standard intravenous (IV) catheters in patients with acute decompensated heart failure. METHODS AND RESULTS: Nine hospitalized patients with decompensated heart failure underwent peripheral ultrafiltration (PUF) therapy with peripheral IV catheters. The mean length of time of PUF therapy was 33.3 +/- 20.0 hours with a mean volume removed of 7.0 +/- 4.9 L. All patients experienced a statistically significant mean weight loss of 6.2 +/- 5.0 kg, P = .01. There was no statistically significant change in renal function. CONCLUSION: We report the first successful implementation of ultrafiltration via standard peripheral IV catheters to remove a large volume of fluid over an extended period of time reliably in a small group of patients. The ability to use PUF therapy via peripheral IV catheters will potentially allow this therapy to be implemented more easily in a variety of care settings to treat patients with resistant heart failure.

Extrapericardial cardiac compression syndrome.

A case report is described of a patient presenting with extrapericardial cardiac compression resulting from massive ascites. The history and electrocardiographic findings initially obscured the proper diagnosis. Extrapericardial cardiac compression syndromes resulting from massive ascites pose a particular challenge in that even when the diagnosis of tamponade is made, failure to recognize the true cause of impaired cardiac filling can lead to unnecessary instrumentation of an otherwise incidental pericardial effusion. This unique case is discussed with other group of conditions of pericardial compressive syndromes.