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1.
JACC Cardiovasc Interv ; 15(6): 590-598, 2022 03 28.
Article in English | MEDLINE | ID: covidwho-1747832

ABSTRACT

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.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Transcatheter Aortic Valve Replacement , Aftercare , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/etiology , Aortic Valve Stenosis/surgery , Humans , Pandemics , Patient Discharge , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
3.
PLoS One ; 16(10): e0258963, 2021.
Article in English | MEDLINE | ID: covidwho-1496521

ABSTRACT

OBJECTIVE: Transcatheter aortic valve implantation (TAVI) provokes early injury response, represented in part by dynamic changes in the inflammatory markers. The association of self-expanding valves (SEVs) and balloon-expandable valves (BEVs) with the consequent inflammatory response remains uncertain. MATERIALS AND METHODS: Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI: SEVs or BEVs, from January 2010 to December 2019 were enrolled. Whole white blood cells (WBC) and subpopulation dynamics as well the neutrophil to lymphocyte ratio (NLR) were evaluated. RESULTS: Three-hundred seventy consecutive patients (mean age 81.75 ± 6.8 years, 199 women's) were enrolled. In the entire population, significant kinetic changes in the WBC response (p <0.0001) between admission and first 24 hours post procedure, with a significant increase in total WBC (7.46 ± 2.26 to 10.08 ± 3.55) and absolute neutrophil count (4.97 ± 2.06 to 8.19 ± 3.43), NL ratio (3.72 ± 2.8 to 9.76 ± 7.29), and a meaningful decrease in absolute lymphocytes count (1.67 ± 1.1 to 1.1 ± 0.76). When compared between the types of valves, SEVs were associated with a more pronounced inflammatory response than BEVs, with total WBC (10.44 ± 3.86 vs. 9.45 ± 3.19) neutrophils (8.56 ± 3.75 vs. 7.55 ± 3.06) with p 0.016 and 0.012 respectively. CONCLUSION: This is the first description of a differential inflammatory response between the two leading delivery systems. SEV appears to trigger a more robust inflammatory response as compared to BEV. Clinical studies are warranted to assess the long term effect of our findings.


Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Inflammation/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve Stenosis/blood , Female , Humans , Inflammation/blood , Lymphocytes , Male , Neutrophils , Postoperative Complications/blood , Postoperative Complications/etiology , Treatment Outcome
4.
Clin Cardiol ; 44(10): 1344-1353, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1453560

ABSTRACT

BACKGROUND: The use of transcatheter aortic valve implantation (TAVI) for treating aortic stenosis (AS) has increased exponentially in recent years. Despite the availability of clinical practice guidelines for the management of valvular heart disease, disparities in quality of care (QoC) for TAVI patients remain widespread across Europe. Tailored QoC measures will help to reduce resource utilization and improve patient outcomes without compromising patient safety. Using a clear set of QoC measures, the BENCHMARK registry aims to document the progress that can be achieved if such tailored QoC measures are implemented. METHODS: The BENCHMARK registry (BENCHMARK) is a non-interventional, multicenter registry in patients with severe symptomatic AS undergoing TAVI with a 1- and 12-months follow-up. BENCHMARK will be conducted at 30 centers across Europe and will enroll a total of 2400 consecutive TAVI patients. Patients suffering from severe symptomatic AS who undergo TAVI with a balloon-expandable transcatheter aortic valve will be included. The registry will comprise four phases: (1) a retrospective baseline evaluation phase; (2) an education phase; (3) an implementation phase; and (4) a prospective effect documentation phase (prospective phase). The registry's primary objectives are to reduce the length of hospital stay and accelerate the post-procedural patient recovery pathway, but without compromising safety. The study started in April 2021 and has an estimated completion date of May 2023. DISCUSSION: BENCHMARK will establish QoC measures to reduce resource utilization, intensive care unit bed occupancy, and overall length of hospitalization with uncompromised patient safety post-TAVI (ClinicalTrials.gov Identifier: NCT04579445).


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Benchmarking , Europe , Humans , Prospective Studies , Registries , Retrospective Studies , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
5.
Cardiovasc Revasc Med ; 28S: 68-71, 2021 07.
Article in English | MEDLINE | ID: covidwho-1176553

ABSTRACT

In 2020, the coronavirus disease 2019 (COVID-19) pandemic has led to a decrease in interventional treatment for structural heart disease worldwide. In this context, the management of patients with symptomatic severe aortic stenosis (AS) or bioprosthetic valve dysfunction (BVD) represents a clinical challenge, as a delay in aortic valve replacement procedures may increase short-term morbidity and mortality. We report four cases of TAVR performed in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. All of them were discharged in good clinical conditions and no adverse events were reported at 30 days follow-up. Our experience suggests that in selected patients with mild SARS-CoV-2 infection and symptomatic native AS or BVD, TAVR has a favorable short-term outcome.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Feasibility Studies , Humans , Risk Factors , SARS-CoV-2 , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
6.
Catheter Cardiovasc Interv ; 98(3): E478-E482, 2021 09.
Article in English | MEDLINE | ID: covidwho-1074302

ABSTRACT

The COVID-19 pandemic has resulted in the cancellation of many elective surgical procedures. This has led to reports of an increase in mortality for patients with non-Covid health conditions due to delayed definitive management. Patients with severe aortic stenosis have a high annual mortality if left untreated. These patients are at risk due to the reduced number of surgical aortic valve replacements and competition for intensive care facilities during the COVID-19 pandemic. This case series suggests that the minimally invasive transcatheter aortic valve implantation is safe to continue during the COVID-19 pandemic with adjustments to the patient pathway to minimize hospital stay and to reduce patient and staff exposure. This helps to reduce the delay of definitive treatment for patients with severe aortic stenosis.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/adverse effects , Humans , Pandemics , Risk Factors , SARS-CoV-2 , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
7.
Catheter Cardiovasc Interv ; 98(5): E733-E736, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1059412

ABSTRACT

OBJECTIVES: The current report describes a single operator's experience of the first use of smartglass technology as a facilitator of virtual support during TAVR proctoring. BACKGROUND: Restricted gatherings and containment measures during the ongoing COVID-19 pandemic have a major impact on daily clinical practice. Interaction between peers is crucial in science, clinical practice, and education. In addition, there is also a growing importance of proctoring in interventional cardiology for structural heart disease. Virtual support may facilitate the wide implementation of remote proctoring. METHODS: A collaboration between a smartglass provider (Rods & Cones) and self-expandable transcatheter aortic heart valve system (Medtronic) was initiated and tested extensively prior to TAVR procedures. Two cases were randomly selected for remote support. The light-weight smartglass consisted of a full HD central camera, a 720p ×5 optical zoom camera, built-in LED light, speaker and earphone jack, and an external visor to project data in a nonobstructive manner in the operators' view. RESULTS: Preprocedural detailed discussion of the cases between the proctor and the operator occurred via teleconferencing. Successful procedural virtual support was determined by the presence of a session coordinator, high quality of the central camera, high-speed and stable wireless internet connection. Limitations were the relative discomfort of the earpieces, discordance between the central and zoom camera and the absence of visual fixation during head motions. CONCLUSION: In a highly complex and demanding context such as TAVR, remote proctoring by means of virtual support is feasible and efficacious.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Humans , Pandemics , Risk Factors , SARS-CoV-2 , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
8.
Cardiovasc Revasc Med ; 31: 26-31, 2021 10.
Article in English | MEDLINE | ID: covidwho-956955

ABSTRACT

BACKGROUND: The risk of nosocomial COVID-19 infection for vulnerable aortic stenosis patients and intensive care resource utilization has led to cardiac surgery deferral. Untreated severe symptomatic aortic stenosis has a dismal prognosis. TAVR offers an attractive alternative to surgery as it is not reliant on intensive care resources. We set out to explore the safety and operational efficiency of restructuring a TAVR service and redeploying it to a new non-surgical site during the COVID-19 pandemic. METHODS: The institutional prospective service database was retrospectively interrogated for the first 50 consecutive elective TAVR cases prior to and after our institution's operational adaptations for the COVID-19 pandemic. Our endpoints were VARC-2 defined procedural complications, 30-day mortality or re-admission and service efficiency metrics. RESULTS: The profile of patients undergoing TAVR during the pandemic was similar to patients undergoing TAVR prior to the pandemic with the exception of a lower mean age (79 vs 82 years, p < 0.01) and median EuroScore II (3.1% vs 4.6%, p = 0.01). The service restructuring and redeployment contributed to the pandemic-mandated operational efficiency with a reduction in the distribution of pre-admission hospital visits (3 vs 3 visits, p < 0.001) and the time taken from TAVR clinic to procedure (26 vs 77 days, p < 0.0001) when compared to the pre-COVID-19 service. No statistically significant difference was noted in peri-procedural complications and 30-day outcomes, while post-operative length of stay was significantly reduced (2 vs 3 days, p < 0.0001) when compared to pre-COVID-19 practice. CONCLUSIONS: TAVR service restructuring and redeployment to align with pandemic-mandated healthcare resource rationalization is safe and feasible.


Subject(s)
Aortic Valve Stenosis , COVID-19 , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/surgery , Humans , Pandemics , Prospective Studies , Retrospective Studies , Risk Factors , SARS-CoV-2 , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
9.
Ann Thorac Surg ; 111(2): 701-722, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-935431

ABSTRACT

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).


Subject(s)
Registries , Transcatheter Aortic Valve Replacement/statistics & numerical data , Aged , Aged, 80 and over , Cardiopulmonary Bypass , Female , Health Status , Humans , Length of Stay , Male , Pacemaker, Artificial , Stroke/epidemiology , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , United States/epidemiology
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