3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

OCT utilization: Summary statistics from the LightLab clinical initiative.

OBJECTIVES: The study describes the evolution of optical coherence tomography (OCT) adoption and performance during percutaneous coronary intervention (PCI) following implementation of a standardized LightLab (LL) workflow. BACKGROUND: The purpose of the LL Clinical Initiative was to evaluate the impact of a standardized workflow on physician efficiency, decision making, and image quality. METHODS: The LL Clinical Initiative is a multicenter, prospective, observational clinical program. Data were collected from 48 physicians at 17 U.S. centers from 01/21/19 to 06/08/21. The study included 401 OCT-guided PCIs during the baseline phase and 1898 during the LL workflow phases. The baseline phase consisted of physicians utilizing OCT at their discretion. After completing the baseline phase, the workflow progressed through multiple phases culminating in the expansion phase, which focused on addressing greater procedural complexity. The LL workflow utilized OCT to assess plaque Morphology, lesion Length, and vessel Diameter before PCI, and optimized results by treating Medial edge dissection, stent mal-Apposition, and stent under-eXpansion (MLD MAX). High-level summary statistics were generated to elucidate trends. RESULTS: After program implementation, there was a rise in the number of PCIs where the LL workflow was utilized compared to the baseline phase (68% during the expansion phase vs. 41% at baseline; p for trend <0.0001). Adoption of the LL workflow was associated with progressively greater procedural and lesion complexity when OCT was performed pre- and post-PCI (87% vs. 52%, p < 0.0001; 55% vs. 37%, p < 0.0001, respectively). In addition, the quality of OCT imaging obtained improved after LL workflow introduction, with over 95% of pre- and post-PCI pullback quality considered usable during the expansion phase. Finally, there was a reduction in time spent on OCT interpretation, both pre-PCI (4.6 min vs. 7.5 min, p < 0.0001) and post-PCI (2.9 min vs. 5.3 min, p < 0.0001). CONCLUSIONS: After completion of the standardized OCT-guided workflow, there was greater uptake of OCT imaging, incorporation in more complex procedures, procedural efficiency, and image quality.

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique.

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.

Post hoc closure of large bore vascular access using the MANTA closure device.

Successful closure of large bore vascular access (≥12 Fr) is facilitated by the MANTA vascular closure device; however, it requires a critical first step of measuring "skin to arterial wall" depth of the access site using the depth locator before dilating the vessel above 8 Fr. It may be challenging at times to acquire the deployment depth at the onset of the procedure due to case urgency, delayed closure, or when large bore access is obtained at a different institution. We discuss a novel technique of measuring the deployment depth and successful delayed closure of large bore arterial access using the MANTA closure device.

Lessons for Treating Structural Heart Patients during the COVID-19 Pandemic and Beyond.

Background: We sought to compare characteristics and outcomes of structural heart disease (SHD) patients treated during the regional peak of the Coronavirus Disease 2019 (COVID-19) pandemic ("COVID era") compared with historical controls. During the COVID era, elective SHD procedures at Beth Israel Deaconess Medical Center were canceled but urgent cases were still performed. We enacted several practice changes in an effort to minimize complications, prevent COVID transmission, and decrease hospital stay during the pandemic. Methods: Baseline characteristics and outcomes were collected on all patients who underwent SHD procedures during the COVID era and compared with patients treated during the same time period in 2019. Results: Compared with SHD patients treated during 2019 (N = 259), those treated during the COVID era (N = 26) had higher left ventricular end diastolic pressure (LVEDP; 28 vs. 21 mmHg, p = 0.001), and were more likely New York Heart Association class IV (26.9% vs. 10.0%, p = 0.019), but had a lower rate of bleeding/vascular complications (0% vs. 16.2%, p = 0.013), a lower rate of permanent pacemaker implantation (0% vs. 17.4%, p = 0.019), and a greater proportion of patients were discharged on post-operative day 1 (POD#1; 68.2% vs. 22.2%, p < 0.001). Conclusion: Practice changes employed for patients treated during the COVID era were associated with fewer vascular complications, a greater proportion of patients discharged on POD#1, and a lower rate of pacemaker implantation despite more severe illness. As a result, we plan to continue these practices in the post-COVID era.

Case report: percutaneous closure of residual leak following left atrial appendage occlusion.

BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) using Watchman device has been demonstrated to be efficacious in decreasing stroke risk in patients with atrial fibrillation who are not suitable for long-term anticoagulation. Residual leaks are frequently encountered following LAAO procedures and their clinical implications and optimal management remain controversial. CASE SUMMARY: In this report, we describe a case of peri-Watchman device leak treated successfully with percutaneous device closure using an Amplatzer Vascular Plug II device. DISCUSSION: The clinical implications of peri-device leaks remain controversial with general consensus to continue anticoagulation along with serial imaging for larger leaks (>5 mm). As an alternative strategy, percutaneous closure of these leaks has been attempted in hope of avoiding anticoagulation and minimizing the risk of stroke and should be studied further.

Strategies for Successful Catheterization Laboratory Recovery From the COVID-19 Pandemic.

As the world slowly starts to recover from the coronavirus disease-2019 pandemic, health care systems are now thinking about resuming elective cardiovascular procedures, including procedures in cardiac catheterization laboratories. Rebooting catheterization laboratories will be an arduous process, in part because of limited health care resources, new processes, and fears stemming from the coronavirus disease-2019 pandemic. The authors propose a detailed phased-in approach that considers clinical, patient-centered, and operational strategies to safely and effectively reboot catheterization laboratory programs during these unprecedented times. This model balances the delivery of essential cardiovascular care with reduced exposure and preservation of resources. The guiding principles detailed in this review can be used by catheterization laboratory programs when restarting elective interventional procedures.

Preclinical comparative assessment of a dedicated pediatric poly-L-lactic-acid-based bioresorbable scaffold with a low-profile bare metal stent.

BACKGROUND: Polymer-based bioresorbable scaffolds (PBBS) have been assessed for coronary revascularization with mixed outcomes. Few studies have targeted pediatric-specific scaffolds. We sought to assess safety, efficacy, and short-term performance of a dedicated drug-free PBBS pediatric scaffold compared to a standard low-profile bare metal stent (BMS) in central and peripheral arteries of weaned piglets. METHODS: Forty-two devices (22 Elixir poly-L-lactic-acid-based pediatric bioresorbable scaffolds [BRS] [6 × 18 mm] and 20 control BMS Cook Formula 418 [6 × 20 mm]) were implanted in the descending aorta and pulmonary arteries (PAs) of 14 female Yucatan piglets. Quantitative measurements were collected on the day of device deployment and 30 and 90 days postimplantation to compare device patency and integrity. RESULTS: The BRS has a comparable safety profile to the BMS in the acute setting. Late lumen loss (LLL) and percent diameter stenosis (%DS) were not significantly different between BRS and BMS in the PA at 30 days. LLL and %DS were greater for BRS versus BMS in the aorta at 30 days postimplantation (LLL difference: 0.96 ± 0.26; %DS difference: 16.15 ± 4.51; p < .05). At 90 days, %DS in the aortic BRS was less, and PA BRS LLL was also less than BMS. Histomorphometric data showed greater intimal proliferation and area stenosis in the BRS at all time points and in all vessels. CONCLUSIONS: A dedicated PBBS pediatric BRS has a favorable safety profile in the acute/subacute setting and demonstrates characteristics that are consistent with adult BRSs.

Left atrial appendage occlusion using a Watchman device in a transplanted heart with biatrial anastomosis.

A percutaneous left atrial appendage (LAA) occlusion using a Watchman device was performed in a patient with prior biatrial anastomosis orthotopic heart transplant (OHT). Due to the anatomical changes following biatrial anastomosis, transesophageal echocardiography (TEE) imaging and transseptal puncture become technically challenging. We describe how the standard LAA views on TEE were obtained for device sizing, and how the transseptal puncture was modified to cross the scarred septum. This case demonstrates that LAA occlusion using a Watchman device in biatrial anastomosis OHT is safe and can successfully be done.