bluuebunny/crossref_metadata_2025 huggingface dataset:
Additional clinical impact of plaque analysis for on-site CT-derived FFR in coronary CT angiography on midterm prognosis
Authors: Nozaki Y , Fujimoto S , Takahashi D , Kawaguchi Y O , Kudo A , Aoshima C , Kamo Y , Takamura K , Hiki M , Dohi T , Tomizawa N , Minamino T
Published: October 2022

Background

We previously reported that per-patient on-site computed tomography-fractional flow reserve (CT-FFR), which can be acquired on-site workstation using fluid structure interaction during the multiple optimal diastolic phases measured 1 to 2 cm distal to a target lesion may be feasible for risk stratification based on future cardiac events for patients who did not undergo planned revascularization. However, per-vessel CT-FFR and the additional impact of plaque analysis on CT-FFR have not been evaluated.

Purpose

The aim of this study is to assess the clinical and additional impact of novel plaque analysis using labeling method for per-vessel CT-FFR on midterm prognosis.

Methods

A total of 254 consecutive patients with 354 vessels showing 50–90% stenosis but not revascularized within 90 days from coronary CT angiography (CCTA) on 320-row CT were retrospectively analyzed and followed during a median follow up 3.6 years. Plaque characteristics by labeling method (necrotic core/total plaque volume (% necrotic core), non-calcified plaque (NCP)/vessel volume (%NCP), and total plaque/vessel volume (%total plaque) for both total vessel volume (mm3) and at minimum lumen area (MLA, mm2)), positive remodeling (PR) and CT-FFR were analyzed on per-target vessels. The endpoint was vessel oriented-composite outcome (VOCO), including cardiac death, non-fatal MI, and unplanned revascularization.

Results

The incidence of VOCO occurred in 6.8% (24/354). In the cox proportional hazard model, a multivariate analysis identified CT-FFR≤0.80 was the most associated factor with VOCO (all values <0.01 for other plaque morphologies), but %necrotic core, %NCP, %total plaque at MLA and PR were significantly independent of CT-FFR≤0.80. (%necrotic core HR; 3.43 (p<0.01 [95% confidence interval (CI) 1.42–8.29]), %NCP HR; 4.05 (p=0.03 [95% CI 1.19–13.71]), %total plaque at MLA HR; 2.82 (p=0.02 [95% CI 1.18–6.76]), and PR HR; 2.90 (p<0.01 [95% CI 1.30–6.51]), respectively.)

Conclusion

From a view point of clinical outcomes for vessels with moderate to severe stenosis but not revascularized at initial CCTA, CT-FFR demonstrated the significant impact on per-vessel analysis. Moreover, %necrotic core, %NCP and %total plaque at MLA analyzed by labeling method provided better prognostic value in addition to CT-FFR.

Funding Acknowledgement

Type of funding sources: None.
Volume-outcome relationship in emergency transcatheter aortic valve implantations in Germany
Authors: Oettinger V , Heidenreich A , Kaier K , Zehender M , Bode C , Duerschmied D , Von Zur Muehlen C , Stachon P
Published: October 2022

Background

An inverse volume-outcome relationship in transcatheter aortic valve implantation (TAVI) has been demonstrated in the literature but little is known about emergency cases.

Methods

All isolated balloon-expandable and self-expanding transfemoral TAVI in 2018 were identified using German national electronic health records. Additionally, those patients with an emergency admission were selected.

Results

A total of 17,295 patients received TAVI, 1,682 of these cases had an emergency admission. Of the emergency cases, 49.2% were female, mean age was 81.2 years and logistic EuroSCORE was 23.3%. Relatively more emergency cases were treated in lower volume centers than in higher volume centers (p<0.001): Centers performing <50 TAVI had an emergency admission rate of ∼15% while centers performing >200 TAVI were associated with a rate of ∼11%. Analyzing the outcomes for a volume increase per 10 emergency cases using propensity score adjustment, higher volume centers showed significantly better results than lower volume centers for in-hospital mortality (OR=0.872, p=0.043), major bleeding (OR=0.772, p=0.001), stroke (OR=0.816, p=0.044), mechanical ventilation >48h (OR=0.749, p=0.001), length of hospital stay (risk adjusted difference in days of hospitalization per 10 emergency admissions: −1.01 days, p<0.001), and reimbursement (risk adjusted difference in reimbursement per 10 emergency admissions: −€314.89, p<0.001). No correlation was seen in acute kidney injury (OR=0.951, p=0.104), postoperative delirium (OR=0.975, p=0.480), and permanent pacemaker implantation (OR=1.010, p=0.732).

Conclusion

In transfemoral TAVI, lower volume centers treat relatively more emergency cases in Germany, but higher volume centers provide significantly better outcomes regarding in-hospital mortality and complication rates as well as resource utilization parameters.

Funding Acknowledgement

Type of funding sources: None.
Vascular closure device in TAVI with a dedicated endovascular plug-based device – experience from a high-volume tertiary center
Authors: Albuquerque F , Gomes D , De Araujo Goncalves P , Lopes P , Goncalves M , Felix Oliveira A , Brito J , Leal S , Raposo L , Mesquita Gabriel H , Campante Teles R , De Sousa Almeida M , Mendes M
Published: October 2022

Background

Vascular complications at the access site are important adverse events during transcatheter aortic valve implantation (TAVI). Effective, reproducible, and safe closure of large bore arteriotomies remains challenging as management strategies vary among centers and operators. MANTAÒ is a dedicated plug-based vascular closure device (VCD) recently approved for percutaneous access site closure. This study aimed to describe our experience and to determine the safety and effectiveness of MANTAÒ for large bore arteriotomies during transfemoral TAVI.

Methods

Single center retrospective analysis on prospectively collected data of all consecutive patients who underwent transfemoral TAVI from 2018 to 2020. The primary safety outcomes were access-related vascular injury and bleeding complications according to VARC-3 criteria. Technical success was defined as puncture closure obtained with MANTAÒ without the use of unplanned endovascular or surgical intervention. A secondary analysis according to center experience was performed.

Results

Of the 535 patients that underwent transfemoral TAVI during the study period (median age = 84 [IQR 80–87], 39.4% male; median EuroSCORE II of 3.89% [IQR 2.62–5.39]), MANTAÒ VCD was deployed in 320 (59.8%). Overall, 32 (10.0%) patients suffered an access-related vascular injury and 22 (6.6%) had a bleeding complication (Figure 1A). Technical success was achieved in most cases (n=298; 93.1%). 30-day mortality rate was 1.6% (n=5). Since the first deployment in mid-2018, the rates of MANTA-related complications decreased with increasing experience and a steep learning curve effect was noted (Figure 1B).

Conclusions

MANTAÒ was rapidly adopted as the default strategy for vascular access site closure after TAVI at our center. A relatively steep learning was observed, suggesting that few procedures are required to acquire device proficiency. In addition, our results suggest that MANTA Ò can effectively close large bore arteriotomies with a low risk of severe complications.

Funding Acknowledgement

Type of funding sources: None.
Use of a digital application to optimize the clinical trajectory of patients in a TAVI program
Authors: Bellemare M , Perrin N , Dorval J F , Durreleman N , Bonan R , Asgar A , Ibrahim R , Ben Ali W
Published: October 2022

Background/Purpose

Application-based technology has been studied for patient engagement and collecting patient-reported outcomes (PROs) in several one-day surgical specialties with limited research in transcathether valve therapies program. The aim of study was to determine the effectiveness of app-based technology for collecting PROs, improving the patient experience, and reducing health services utilization in a transcatheter valve implantation (TAVI) program.

Methods

Patients accessed an interactive app via smartphones. Patients were guided from their visit to the TAVI clinic via reminders, tasks, PRO surveys, and evidence-based education. They received notifications and health surveys 2 days before the procedure to ensure they were ready for the procedure. In the postoperative period, patients were engaged with daily health surveys to track warning signs and recovery milestones for 7 days. Based on the patient's signs and symptoms, the app escalated lower risk issues to self-care education or higher risk issues to the care team (TAVI program's nurse coordinator). Follow-up surveys and Kansas City Cardiomyopathy Questionnaire (KCCQ12) were sent to patients at 1, 3, 6 and 12 months to evaluate their functional recovery. All data are reported with median and interquartile range.

Results

227 patients underwent a TAVI procedure at the MHI from December 2020 to October 2021. 99 patients (44%) accepted to use the application and formed the digital application group. The two groups (digital application group vs. non-digital application group) were comparable in terms of age (76 years old (72, 81) vs 77 years old (71,82)), STS (Society of Thoracic Surgeons' risk model) score (6,1% vs 6,7%), vascular complications (8,1 vs 7.8%) and post procedure pacemakers (10,1% vs 10.9%). In the digital application group, 93% recommended the application, 95% said it helped them feel more confident before the procedure and 84%, after the procedure. KCCQ12 score (PRO) improved from 34/70 (28, 41) at baseline to 54/70 (48,62) at 1 month after the procedure and remained stable over the 12 months. Digital application use helped to reduce emergency visits by 33.5% (7.9 vs 11.9%) and rehospitalizations related to the procedure by 50.1% (7.9% vs 15.9%) in the month following the TAVI procedure.

Conclusion

App-based technology for patient engagement is an effective modality to enhance the patient experience, better understand the trajectory of recovery, gather PRO and reduce unnecessary health services utilization in aging population of a TAVI program.

Funding Acknowledgement

Type of funding sources: None.
Trends in outcomes, complications and readmission rates in patients undergoing transcatheter aortic valve implantation: a nationwide analysis from 2012 to 2019
Authors: Goel A , Malik A , Bandyopadhyay D , Gupta R , Hajra A , Krishnan A M , Singhal M , Ahmad H
Published: October 2022

Background

Transcatheter aortic valve implantation (TAVI) has evolved over the years from a procedure requiring surgical vascular access and general anesthesia, to one that can be completed entirely percutaneously with conscious sedation. Advancement in procedural techniques and operator experience has resulted in better outcomes for patients undergoing TAVI.

Purpose

The purpose of our study was to analyze the trends over the years in outcomes, complications and unplanned readmission rate in patients undergoing TAVI.

Methods

The United States Nationwide Readmission Database for the years 2012 to 2019 was queried to identify all adult patients who underwent elective TAVI. The primary outcome of the study was inpatient mortality during TAVI hospitalization. Secondary outcomes included periprocedural complications (like acute kidney injury, bleeding requiring transfusion, need for permanent pacemaker implantation, stroke), length of stay, hospitalization cost, and unplanned 30-day readmission rate. Appropriate International Classification of Diseases (ICD-9 and ICD-10) codes were used to identify comorbidities and complications.

Results

A total of 283,409 patients who underwent TAVI were included in the study. The baseline characteristics of these patients are shown in picture 1. The inpatient mortality during TAVI admission declined steadily and significantly from 5.3% in the year 2012 to 0.0% in the year 2019 (p value for trend <0.001). There was a significant reduction in peri-TAVI occurrence of acute kidney injury (from 18.1% in 2012 to 8.7% in 2019), bleeding requiring transfusion (from 28.0% in 2012 to 4.3% in 2019), and stroke (from 1.8% in 2012 to 0.1% in 2019) (p value for trend <0.001 for all). Periprocedural conduction abnormalities requiring permanent pacemaker implantation increased from 7.4% in 2012 to 12.1% in 2015, before coming down to 8.9% in 2019 (p value for trend <0.001). The mean length of hospital stay and inflation-adjusted costs during admission for TAVI decreased from 9.6 days and $64,695 in the year 2012, to 3.6 days and $49,710 in the year 2019, respectively (p value for both <0.001). The unplanned 30-day all-cause readmission rate after TAVI also reduced steadily and significantly from 18.2% in 2012 to 11.5% in 2019 (p value <0.001).

Conclusion

Over the years, there has been a significant reduction in inpatient mortality, periprocedural complications (such as acute kidney injury, need for blood transfusion, stroke), length of hospital stay, and inflation-adjusted hospital costs in patients undergoing transcatheter aortic valve implantation. Furthermore, there has been a significant decline in the 30-day unplanned readmission rate after transcatheter aortic valve implantation.

Funding Acknowledgement

Type of funding sources: None.
Large multicenter evaluation of clinical outcomes of transcatheter aortic valve implantation in different age groups: results from the Israeli TAVI registry
Authors: Maller T , Jubeh R , Perel N , Barbash I M , Segev A , Kornowski R , Vaknin Assa H , Finkelstein A , George J , Perlman G , Guetta V , Asher E , Karameh H , Glikson M , Dvir D
Published: October 2022

Introduction

Transcatheter aortic valve implantation (TAVI) is becoming the preferred treatment for elderly patients with severe aortic stenosis. Clinical outcomes of these patients according to different age groups and especially in the very old population are under reported.

Purpose

To describe clinical characteristics at baseline, according to different age groups, and to compare clinical outcomes in the very old population with other patients undergoing the procedure.

Methods

Data was extracted from the Israeli National TAVI Registry. Clinical outcomes in very old patients (above the age of 90 years) were compared with younger patients. Multivariable analysis for 30-day and 1-year mortality were performed. Procedural complication was defined as one or more of the following: need for permanent pacemaker, major vascular complication, severe acute kidney injury and major stroke.

Results

A total of 5,936 patients who underwent TAVI from 2008 to 2021 were analyzed (age 81.6±7.1 years, 50.6% female). Patients older than 90 years of age had more comorbidities than the younger population (STS score for mortality 6.4%±3.8% vs. 4.1%±4.8%, p<0.001). Independent correlates for 30-day mortality included STS score (OR=1.01, 95% CI [1.03–1.13], p<0.001) and procedural complication (OR=4.29, 95% CI [2.24–8.20], p<0.0001). Independent correlates for 1-year mortality included chronic obstructive pulmonary disease (OR=1.83, 95% CI [1.28–2.60]; p=0.001), atrial fibrillation (OR=1.71, 95% CI [1.31–2.23]; p<0.001 (STS score); OR=1.13 95% CI [1.09–1.18]; p<0.001), and procedural complication) OR=2.58, 95% [1.89–3.50]; p<0.001).

Conclusions

Although older patients undergoing TAVI had a higher risk profile, short- and long-term survival of these patients were associated significantly more with procedural complications than with patient age. It seems that extreme patient age alone should not be viewed as a consideration for not performing valve replacement, as long as the risk for procedural complications does not seem to be severely elevated.

Funding Acknowledgement

Type of funding sources: None.
Predictors and outcomes of acute, sub-acute and early stroke following transcatheter aortic valve implantation
Authors: Van Nieuwkerk A C , Alfonso F , Tchetche D , De Brito Jr F S , Barbanti M , Latib A , Kornowski R , D'Onofrio A , Ribichini F , Mehran R , Delewi R
Published: October 2022

Background

Stroke is one of the most devastating complications after transcatheter aortic valve implantation (TAVI). The recent third Valve Academic Research Consortium (VARC-3) proposes new stroke terminology according to time between TAVI and stroke onset.

Purpose

We aimed to identify predictors and assessed mortality in patients undergoing transfemoral TAVI complicated by acute, sub-acute and early stroke.

Methods

Patients undergoing transfemoral TAVI were included in a global patient level database. Acute stroke was defined as stroke occurring ≤24 hours after the index procedure. Sub-acute stroke was defined as stroke occurring between >1 day and ≤30 days and early stroke as >30 and ≤365 days following TAVI, according to VARC-3. We identified predictors for these complications using multivariate logistic regression analysis and assessed mortality outcomes in these patients.

Results

A total of 11230 patients underwent transfemoral TAVI. Mean age was 81.5±7.0 years, 58% was female and median STS-PROM score was 6.5% (4.0%-13.2%). A total of 405 (3.6%) experienced stroke during the first year after TAVI. Of these 93 (23%) had acute stroke, 195 (46%) sub-acute stroke and 117 (27%) early stroke. One year mortality was highest after acute stroke (56.9%), followed by sub-acute stroke (41.7%), and early stroke (29.0%), but one-year mortality in all stroke patients was higher than in non-stroke patients (40.5% vs 15.8%, p<0.001). Glomerular filtration rate was an independent predictor for acute stroke (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.9–1.0, p=0.03). Previous cerebrovascular events independently predicted sub-acute stroke (OR 2.1, 95% CI 1.4–3.1, p=0.001). Independent predictors for early stroke were age (OR 1.0 per year, 95% CI 1.0–1.0, p=0.04) and peripheral vascular disease (OR 2.0, 95% CI 1.4–3.0, p<0.001).

Conclusions

Patients undergoing transfemoral TAVI complicated by stroke showed higher one-year mortality than non-stroke patients. Earlier timing of post-TAVI stroke was associated with increased mortality. Acute stroke was predicted by renal impairment; sub-acute stroke by previous cerebrovascular events and early stroke by age and peripheral vascular disease, suggesting different pathways leading to stroke in these patients.

Funding Acknowledgement

Type of funding sources: Foundation. Main funding source(s): Hartstichting
Cardiac arrhythmias and conduction disorders monitoring after transcatheter aortic valve replacement procedure, using a mobile electrocardiogram 6 lead device
Authors: De Lucia R , Giannini C , Parollo M , Costa G , Barletta V , Giannotti Santoro M , Primerano C , De Carlo M , Angelillis M , Zucchelli G , Petronio A S
Published: October 2022

Background

In the early post transcatheter aortic valve replacement (TAVR) discharge era, rate of readmission for permanent pacemaker implantation (PPM-I) due to delayed conduction disturbances (CDs) has significantly increased. This issue has powered post procedural ambulatory electrocardiogram (AECG) monitoring by using implantable cardiac monitors or mobile cardiac telemetry devices, despite several disadvantages as frequent electrode changes and costs.

Purpose

In this scenario we aimed to evaluate the incidence of post-TAVR new onset arrhythmias and delayed CDs, performing an AECG monitoring through a 30s spot digital ECG (AeECG), by using a mobile electrocardiogram 6 lead (ME6L) device in a 30 days period after a TAVR procedure.

Methods

Between March 2021 and February 2022 we consecutively enrolled all patients undergoing a TAVR at the University Hospital of Pisa, excepting who already had a PM. At discharge, all patients received ME6L device and were asked to record a spot eECG for 1 month: 1 eECG per day during the first week and then 1 eECG per week. Clinical and follow-up data were collected and analyzed, and eECG scheduling compliance and quality recordings were explored.

Results

Among 185 consecutive TAVR patients, 12 were excluded due to pre-existing pacing device and 33 due to PPM-I <2 days post TAVR; 3 died before enrollment and 10 refused the enrollment; 18 were excluded because failed the ME6L training phase, 6 for severe postprocedural complications and the last 3 because affected by isolated aortic regurgitation.The remaining ones (100) had 30-day AeECG data. Delayed CDs with a Class I/IIa indications for PPM-Ioccurred in 8 patients with a median of 6 days (range 4–8 days) post-TAVR. New onset documented arrhythmias were AT/AF in 3 patients, isolated PVCs in 10 patients, and competitive transitory junctional rhythm in 2 patients. Delayed PPM-I versus non-delayed PPM-Ipatients were more likely to have a non-self-expandable valve (3 vs 69; p=0.02) and longer PR and QRS intervals at discharge (250.00±53,29 ms vs 179.17±39.17 ms; p=0,003; 125±33.38 ms vs 102.55±30.48 ms; p=0,04). The overall eECG schedule level compliance was 96.5%. Out of a total of 965 sent eECGs, 950 (98,4%) have been correctly recorded and transmitted.

Conclusion

Delayed CDs requiring PPM-I are the most important drawback of TAVR procedure. In our study, AeECG was seen to be safe and helpful in the identification and treatment of delayed CDs requiring PPM-I, with a very high eECG schedule level of compliance and quality. Further prospective studies are needed to better identify patient selection for outpatient monitoring, making safer and safer the early post TAVR discharge approach.

Funding Acknowledgement

Type of funding sources: None.
Impact of periprocedural pulmonary hypertension on outcomes after TAVR: novel risk stratification from the OCEAN-TAVI Registry
Authors: Miyamoto J , Ohno Y , Ikari Y , Tada N , Naganuma T , Yamawaki M , Yamanaka F , Shirai S , Mizutani K , Tabata M , Ueno H , Takagi K , Watanabe Y , Yamamoto M , Hayashida K
Published: October 2022

Aim

There are limited data on prognostic impact of periprocedural pulmonary hypertension (PH) after transcatheter aortic valve replacement (TAVR). The aim of this study was to investigate the prognostic impact of normalized, new-onset, and residual PH after TAVR.

Methods and results

OCEAN-TAVI registry is an ongoing, multicenter Japanese registry which includes 2588 patients who underwent TAVR. Patients were classified into 4 groups according to periprocedural systolic pulmonary artery pressure (sPAP) by echocardiography: pre-no PH/post-no PH (no PH) group, pre-PH/post-no PH (normalized PH) group, pre-no PH/post-PH (new-onset PH) group, and pre-PH/post-PH (residual PH) group. PH was defined as sPAP>36mmHg. Primary endpoint was all-cause mortality at 2 years. Logistic regression analysis was used to identify the clinical predictors of residual and new-onset PH. In total, 1872 patients were divided into 4 groups: 1027 patients (54.9%) in the no PH, 257 patients (13.7%) in the normalized PH, 280 patients (15.0%) in the new-onset PH, and 308 patients (16.5%) in the residual PH group, respectively. There was a significant difference in all-cause mortality among the 4 groups at 2 years (11.0%, 12.8%, 18.6%, and 24.7%, respectively; P<0.01). Among 565 patients who had pre-procedural PH, 257 patients (45.5%) experienced normalization of PH with mortality comparable with no PH group. In multivariable logistic regression analysis, predictors of residual PH after TAVR were atrial fibrillation and baseline tricuspid regurgitation>moderate, whereas prosthesis-patient mismatch (PPM) was a predictor of new-onset PH.

Conclusions

Risk stratification based on improvement in PH or new-onset/residual PH after TAVR can identify patients at increased mortality after TAVR. PPM was identified as a novel predictor of new-onset PH.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): The OCEAN-TAVI registry is supported by Edwards Lifesciences, Medtronic Japan, Boston Scientific, Abbott Medical, and Daiichi-Sankyo company.
Combined strategy for large-bore arteriotomy closure after transcatheter aortic valve implantation
Authors: Sluka M , Ostransky J , Nykl R
Published: October 2022

Background

The access site vascular complications remain a relevant complication following transcatheter aortic valve implantation (TAVI). They are frequently associated with vascular closure device failure (VCD). Incidence of vascular complications depends on different factors such as patient's characteristics and clinical risk profile, femoral morphology, access sheath size or technical procedural experience. Their rate is reported between 4–19% [1]. Vascular complications negatively affect morbidity and mortality following TAVI [2]. VCDs that are most commonly used include the suture-based ProGlide and the plug-based MANTA. ProGlide was originally developed for small-bore vessel closure between 6–8F, but a combination of 2 or more devices is suitable for large-bore vessel closure >12F. The MANTA device is originally dedicated for large-bore vessel closure. The MANTA device was not superior to the use of 2 ProGlides in their direct comparison in terms of access site–related vascular complications or access site bleedings. Plug-based VCDs required fewer, but a different kind of bailout maneuvers [3,4]. The alternative and less frequently used strategy is intentional combination of one suture-based VCD – ProGlide with small-bore plug-based VCD AngioSeal. The data supporting this approach are very limited, but showing this concept as a safe, with lower risk of vascular or bleeding complications. Moreover, this strategy requires less additional endovascular interventions when compared with vascular closure using two suture-based VCDs [5].

Methods

Retrospectively analysed single centre comparison of two different large-bore vessel closure strategies: two suture-based ProGlides (SB group) vs. intentional combination of one ProGlide with plug-based AngioSeal 8F (CB group). The primary endpoint was occurrence of access site–related vascular complications at 30-days.

Results

71 consecutive patients treated between Aug/2020 and May/2021 (SB group) were compared with 68 consecutive patients treated between May/2021 and Jan/2022 (CB group). There wasn`t any significant difference in patient's characteristics between both groups: mean age 80 vs. 81 years, females 53,8% vs. 54,9%, STS score 3,46% vs. 3,47%. The only difference was higher proportion of the patients treated oral anticoagulation in SB group (46,4% vs. 38,5%). The lower rate of vascular complication was observed in CB group 2,9% vs. 7,1%. Moreover, we had to use additional VCD in 14 cases among patients from SB group to achieve haemostasis.

Conclusion

The intentional combination of one suture-based VCD with one plug-based VCD is effective and safe. This combined strategy was associated with lower rate of vascular complication compare the use of 2 suture-based VCDs in our patient's cohort following TAVI.

Funding Acknowledgement

Type of funding sources: None.
Predictors of mitral valve hemodynamics after mitral valve repair for degenerative mitral regurgitation: a subanalysis of the CAMRA randomized trial
Authors: Rumman R , Verma S , Chan V , Mazer D , Quan A , De Varennes B E , Chu M W A , Latter D , Teoh H , Yanagawa B , Leong-Poi H , Connelly K
Published: October 2022

Introduction

Intra-operative predictors of mid-to-late mitral valve dysfunction after surgical repair of mitral regurgitation (MR) caused by prolapse remain poorly characterized. This study aims to evaluate the effect of annuloplasty prosthesis size on post-operative MV hemodynamics at rest and during exercise, and to identify perioperative predictors of MV dysfunction.

Methods

104 patients were randomly assigned to resection and preservation for surgical treatment of posterior leaflet prolapse in the Canadian Mitral Research Alliance CardioLink-2 study. Echocardiograms were performed at baseline and 1 year postoperatively. Intraoperative TEE was performed to assess immediate MV gradients. Exercise TTE was performed 1 year after repair. Linear regression analysis was used to identify associations between MV indices (rest and peak exercise gradients) at 12 months, and perioperative echocardiographic and clinical factors.

Results

Mean age of participants was 65±10 years, and 83% were male. Larger annuloplasty size was associated with lower transmitral gradients at rest and during peak exercise. In multivariable analysis, annuloplasty size ≥34mm was associated with lower mean and peak rest and exercise gradients at 12 months, after adjustment for repair type, age, sex, and BSA (p<0.001). Higher pre-operative pulmonary artery pressures were associated with reduced functional capacity post-operatively. Intra-operative TEE gradients predict resting and exercise MV hemodynamics at 1 year.

Conclusion

Annuloplasty size ≥34mm is associated with improved MV hemodynamics at rest and during peak exercise 1 year post MV repair. MV repair prior to onset of pulmonary hypertension confers favourable post operative functional capacity. Finally, intra-operative TEE can be used to identify patients at risk of mitral valve dysfunction within 1 year of repair.

Funding Acknowledgement

Type of funding sources: Other. Main funding source(s): The Heart and StrokeFoundation of Ontario (GIA 16-00014666)
Echocardiographic predictors of operative outcome for transapical off-pump mitral valve repair with neochord implantation
Authors: Perez Camargo D , Cobiella Carnicer J , Mahia Casado P , Carnero Alcazar M , Campelos Fernandez P , Montero Cruces L , Maroto Castellanos L C
Published: October 2022

Introduction

Transapical off-pump mitral valve repair with artificial neochord implantation (TOP-MINI) is safe and effective for the treatment of primary mitral regurgitation12, however, the current literature regarding echocardiographic criteria prior to the procedure is scarce.

Objective

To identify preoperative echocardiographic predictors of technical success after TOP-MINI for severe primary mitral regurgitation.

Methods

All consecutive patients who underwent TOP-MINI for severe primary mitral regurgitation from 2017 to 2022 were included. Preoperative echocardiographic evaluation included transthoracic and transesophageal echocardiography. Transesophageal evaluation included 2D measurements of mitral valve annulus, mitral leaflets, flail gap, and 3D mitral valve reconstruction among others, the leaflet-to-annulus index was estimated in all patients. Mitral valve morphology was classified as: Type A (Central posterior leaflet prolapse/flail) or non-Type A (Type B: posterior multisegment involvement; type C: anterior leaflet prolapse; type D: paracommissural or calcified leaflet). Technical success was defined according to the Mitral Valve Academic Research Consortium criteria. Independent echocardiographic predictors for the primary outcome were identified using a multivariate logistic regression model.

Results

Fifty-five patients were included. Mean age was 66.7 years (SD 12.9). Technical success with MR <2+ was achieved in 48 (87.27%) patients. Significant predictors for technical success were the leaflet-to-annulus index (OR 1.09; p=0.012; 95% CI: 1.02–1.15), with an optimal cutoff value of 1.26 (sensitivity 73.3%, specificity 85.7%); and a non-type A valve morphology (OR 0.04; p=0.024; 95% CI: 0.01–0.65). The model showed good discrimination (AUC = 0.92) and calibration (Hosmer-Lemeshov p=0.21).

Conclusion

A thorough preoperative echocardiographic evaluation is key to improve outcomes in TOP-MINI. In this study, a leaflet-to-annulus index >1.26 was associated with technical success, whether a non-type A valve morphology was associated with technical failure. These parameters could help to identify proper candidates for this technique.

Funding Acknowledgement

Type of funding sources: None.
18F-sodium fluoride positron emission tomography and coronary plaque radiomics derived from computed tomography angiography for prediction of myocardial infarction
Authors: Kwiecinski J , Kolossvary M , Tzolos E , Meah M N , Adamson P D , Joshi N V , Williams M C , Van Beek E J R , Berman D S , Maurovich-Horvat P , Newby D E , Dweck M R , Dey D , Slomka P
Published: October 2022

Background

Assessments of coronary disease activity with 18F-sodium fluoride positron emission tomography (18F-NaF PET) and radiomics-based precision coronary plaque phenotyping derived from contrast-enhanced computed tomography (CT) have both been shown to enhance risk stratification in patients with coronary artery disease (CAD). To date, no study has investigated whether these two promising methods (which can be obtained during a single imaging session on a hybrid PET/CT scanner) are interchangeable or can provide superior predictive performance when used in combination.

Purpose

We sought to investigate whether the prognostic information provided by latent morphological radiomic coronary plaque features and assessments of disease activity by 18F-NaF PET are complementary in prediction of myocardial infarction.

Methods

Patients with known CAD underwent coronary 18F-NaF PET and CT angiography on a hybrid PET/CT scanner. Coronary 18F-NaF uptake was determined by the coronary microcalcification activity (CMA). We performed quantitative plaque analysis of coronary CT angiography datasets. Additionally, coronary plaque segmentations on CT angiography were used to extract 1103 radiomic features. Using weighted correlation network analysis we derived latent morphological features of coronary plaques which were aggregated to patient-level radiomic normograms to predict myocardial infarction using univariate and multivariate Cox proportional hazard models.

Results

The study cohort comprised of 260 patients with established CAD (age: 65±9 years; 84% men); 179 (69%) participants showed increased coronary 18F-NaF activity (CMA >0). Over 53 [40–59] months of follow-up 18 patients had a myocardial infarction. Using weighted correlation network analysis, from the 1103 radiomic features we derived 15 distinct eigen radiomic features representing latent morphological coronary plaque patterns. On univariate cox modelling 7 of these emerged as predictors of myocardial infarction (Figure). Following adjustments for calcified, noncalcified and low-density noncalcified plaque volumes and 18F-NaF CMA 4 radiomic features (related to texture and geometry) remained independent predictors of myocardial infarction (Figure).

Conclusion(s)

In patients with established CAD latent morphological features of coronary plaques are predictors of myocardial infarction above and beyond plaque volumes and 18F-NaF uptake. Comprehensive plaque analysis with radiomics may enhance risk stratification of CAD patients.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): NIH, Wellcome Trust
4 year outcomes in a prospective evaluation of transcatheter mitral valve-in-valve, valve-in-ring and valve-in-mitral annular calcification: results from the MITRAL trial
Authors: Guerrero M , Eleid M F , Wang D D , Pursnani A , Kodali S , George I , Palacios I , Makkar R , Satler L , Kaptzan T , Lewis B , Thaden J , Oh J , O'Neill W , Rihal C
Published: October 2022

Background

The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves) evaluates the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with severe mitral valve disease with mitral annular calcification (MAC), failed surgical rings or failed bioprostheses.

Purpose

We sought to evaluate 4-year outcomes of patients enrolled in the MITRAL trial.

Methods

This is a prospective study that enrolled 91 high surgical risk patients at 13 sites in the U.S. 30 patients underwent Mitral Valve-in-Valve (MViV), 30 Valve-in-Ring (MViR) and 31 Valve-in-MAC (ViMAC). 4-year outcomes of these patients were evaluated in this analysis. Primary endpoints and key serious adverse events including deaths were adjudicated by an independent Clinical Events Committee. Cardiac computed tomography (CT) and echocardiographic images were evaluated by independent CT and Echocardiographic Core Laboratories.

Results

Mean age was 74.3±8.9 years. Most patients undergoing MViV and ViMAC were female (MVIV=63.3%, MViR=36.7% and ViMAC=71%). Mean STS score was 9.2±6.6% (MViV 10.2±6.5%, MViR 8.7±4.7%, ViMAC=8.6±8.2%). All-cause mortality at 4 years was higher for ViMAC and MViR: MViV=6.9% (cardiovascular 3.4%), MViR=48.1% (cardiovascular 18.5%), ViMAC=51.9% (cardiovascular 29.6%), p=0.002 (Figure 1). At 4 years, all survivors had ≤1+ mitral regurgitation and most had none or trace mitral regurgitation (MViV=87.5, MViR=33.3% and ViMAC=100%). Mean mitral valve gradients remained stable (MViV=5.9±2.2 mmHg, MViR= 6.6±5.1 mmHg, ViMAC=5.1±1.0 mmHg), Figure 2. Most survivors experienced significant improvement of symptoms and were in NYHA class I-II at 4-year follow-up (MViV=78.9%, MViR=66.7% and ViMAC=66.7%).

Conclusions

MViV is associated with excellent outcomes at 4 years. MViR and ViMAC were associated with higher mortality at 4 years. However, most survivors in all groups experienced sustained improvement of symptoms and stable THV performance at 4 years. Whether survival bias had an impact on THV performance and improved symptoms at follow-up is not known and deserves further evaluation.

Funding Acknowledgement

Type of funding sources: Private company. Main funding source(s): Unrestricted Research Grant from Edwards Lifesciences.
Infective endocarditis of mitral valve, valve replacement or repair?- a meta-analysis of 10,965 patients
Authors: Fathy M H , Elnagar M A , Elbadawi M A , Awad A K
Published: October 2022

Background

Being characterized by high mortality and recurrence rates, native mitral valve infective endocarditis (IE) constitutes a burden on both patients and surgeons from its poor prognosis and debatable interventions. Mitral valve repair (MVRr) and mitral valve replacement (MVRp) are two main surgical methods. Nevertheless, which of them carries an outweigh benefit over the other is still controversial. Thus, in our meta-analysis we aimed to further investigate the efficacy of each technique on both short term and long-term outcomes.

Methods

Our search strategy was applied on several databases including the PubMed, Scopus, Web of science, and Cochrane literature databases to compare MVP and MVR, with data extracted for baseline characteristics, mortality, survival, recurrent endocarditis, and valve reoperation. Risk and hazard ratio (RR and HR) and 95% confidence interval (CI) were pooled and analyzed using RevMan 5.0.

Results

A total of 22 relevant publications with a total population of 10,965 patients, with 3,557 patients having undergone MVRr and 7,408 patients having undergone MVRp, respectively, were analyzed. Patients who underwent MVP may benefit from a lower risk of early mortality (RR 0.44; 95% CI, 0.38–0.51; p<0.00001; I2=0%), a higher long-term survival rate (HR 0.56; 95% CI, 0.36–0.76; p<0.001; I2=0%), and a lower risk of recurrence (RR 0.66; 95% CI, 0.40–0.93; p=0.05; I2=0%). Although the risk of reoperation was observed lower for MVRr, it was not statistically significant (RR, 0.86; 95% CI, 0.36–1.36; p=0.76; I2=37%).

Conclusion

Our results suggests that MVRr showed superiority in the terms of in hospital mortality and long-term survival. Furthermore, it has lower risk of recurrence and valve reoperation. Therefore, MVRr is an appropriate as a primary treatment choice and should be considered whenever possible in most IE patients.

Conclusion

Our results suggests that MVRr showed superiority in the terms of in hospital mortality and long-term survival. Furthermore, it has lower risk of recurrence and valve reoperation. Therefore, MVRr is an appropriate as a primary treatment choice and should be considered whenever possible in most IE patients.

Funding Acknowledgement

Type of funding sources: None.
Validation of expert criteria proposed by the “German Cardiac Society” for predicting procedural complexity in transcatheter edge-to-edge mitral valve repair
Authors: Metze C , Kavsur R , Sugiura A , Tanaka T , Becher U , Nickenig G , Baldus S , Koerber M I , Pfister R , Iliadis C
Published: October 2022

Background

Following up on the original EVEREST criteria and several years of procedural experience, the German Cardiac Society (GCS) proposed refined criteria indicating morphological complexity in transcatheter edge-to-edge mitral valve repair (TEER) procedures which so far have not been validated.

Methods

In a retrospective analysis of transesophageal echocardiography images of consecutive patients undergoing TEER in two high-volume centres, complexity was classified according to GCS criteria as optimal (neither characteristics of “complex” nor “very complex', see Table 1), complex (any of the “complex” criteria but no “very complex” criteria) and very complex (any of the “very complex” criteria). Associations with the procedural outcome, reintervention, survival, and heart failure rehospitalization were tested.

Results

633 patients (mean age 79 years, range 50 to 96 years, 59% male) were included, with 35% having dominant primary and 65% having dominant secondary mitral regurgitation (MR). 19% of patients were classified as having optimal, 40% as complex, and 41% as very complex morphologies. Successful clip implantation and reduction in MR ≤2 at discharge were achieved in 100% and 97% in the optimal, in 96% and 88% in the complex, and in 95% and 88% in the very complex morphologies, respectively (p for difference 0.13 and 0.42). The rate of successful clip deployment was significantly lower and the rate of reintervention significantly higher in patients with a mitral valve orifice area ≤3 cm2, compared to patients with a mitral valve orifice area >3 cm2. Pathology extent of MR likely requiring >2 clips was significantly associated with a lower rate of MR reduction to grade ≤2. Midterm (median follow-up time 640 days) mortality or hospitalization due to heart failure was significantly higher in patients with a posterior mitral leaflet length of 7–10 mm.

Conclusion

In the setting of experienced heart valve centres only a few of the complexity criteria proposed by the GCS impact on procedural and clinical outcomes. Even in the case of complex or very complex mitral valve morphology, TEER can be performed effectively with reduction of MR to ≤2 in 88% of cases.

Funding Acknowledgement

Type of funding sources: None.
Staging heart failure patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair
Authors: Stolz L , Karam N , Von Bardeleben R S , Pfister R , Petronio A , Butter C , Melica B , Praz F , Massberg S , Kalbacher D , Lurz P , Adamo M , Metra M , Bax J J , Hausleiter J
Published: October 2022

Background

Heart failure with reduced ejection fraction (HFrEF) and secondary mitral regurgitation (SMR) are closely related. Progression of HFrEF-SMR is associated with characteristic pathophysiological changes. Recently, staging of HFrEF-SMR patients showed prognostic value in a SMR cohort on medical therapy. Whether these stages are prognostic for SMR patients undergoing transcatheter edge-to-edge mitral valve repair (M-TEER) in addition to drug therapy is unknown.

Purpose

The present study aimed at classifying HFrEF-SMR patients undergoing M-TEER into progressive disease stages based on cardiac and extracardiac involvement. We sought to evaluate the impact of the disease stages on survival outcome and symptomatic improvement after M-TEER

Methods

Based on echocardiographic transthoracic evaluation, patients were assigned into one of the following subsequent HFrEF-SMR stages representing disease progression (Figure 1): left ventricular (LV) dysfunction alone (Stage 1, LV end diastolic volume ≥159 ml and/or LV ejection fraction <50%); left atrial (LA) involvement (Stage 2, history of atrial fibrillation and/or indexed LA volume >34 ml/m2); right ventricular (RV) pressure/volume overload (Stage 3, tricuspid regurgitation ≥3+ and/or systolic pulmonary artery pressure >65 mmHg); biventricular failure (Stage 4, RV to pulmonary artery coupling <0.274 mm/mmHg). A Cox regression model was implemented to investigate the impact of HFrEF-SMR stages on two-year all-cause mortality and symptomatic outcome was assessed with New York Heart Association (NYHA) functional class at follow-up.

Results

Among a total of 849 included patients who underwent M-TEER for symptomatic MR from 2008 until 2019, 9.5% (n=81) presented with LV dysfunction alone, 46% (n=393) with LA involvement, 15% (n=129) with pressure/volume overload and 29% (n=246) with biventricular failure. At baseline and follow-up, successive HFrEF-SMR stages were associated with more severe heart failure symptoms as expressed by NYHA functional class. An increase in HFrEF-SMR stage was associated with increased two-year all-cause mortality rates after M-TEER (Hazard ratio 1.39, confidence interval 1.23–1.58, p<0.01, Figure 2).

Conclusions

Classifying HFrEF-SMR patients undergoing M-TEER into subsequent disease stages provides prognostic value regarding heart failure symptoms and survival.

Funding Acknowledgement

Type of funding sources: None.
Outcome of trans-catheter edge-to-edge mitral valve repair in patients with severe left ventricular dilatation
Authors: Raphael R , Makmal N M , Silbermintz N S , Faierstein K F , Moeller C M , Canetti M C , Maor E M , Kuperstein R F , Hai I H , Butnaru A B , Oren D O , Guetta V G , Fefer P F
Published: October 2022

Introduction

The COAPT trial established the benefit of trans-catheter edge-to-edge mitral valve repair (TEER) for patients with symptomatic secondary mitral regurgitation (MR). However, patients with severe LV dilatation were excluded from this study. Furthermore, disproportionate LV dilatation has been proposed as a possible explanation for the lack of benefit in the Mitra-FR trial.

Purpose

The purpose of this study was to evaluate the safety and efficacy of TEER in patients with severe LV dilatation.

Methods

We categorized patients with secondary MR and severe LV dilatation based on LVEDD/BSA ratio using a cut-off of >3.6cm/m2 in men and >3.7cm/m2 in women.

Results

We included 121 patients, 25 patients with severe LV dilatation (S) and 96 without (NS). Mean LVEDD was 68.9±6.6mm in the S group vs 58.5±6.5mm in the NS group. Compared to the NS patients, patients with severe LV dilatation were younger (age 69±10 vs 74±10 years), had lower LVEF (37+14% vs 29+7%), and lower GFR (44±21 vs 55±26). There was no significant difference in MR grade (3.3 vs 3.3), however the S group had numerically greater EROA (EROA 0.45 vs 0.35). No significant differences were noted in NYHA class (2.8 vs 2.76) or SPAP (59mmHg for both). Peri-procedural adverse events were rare in both groups. One peri-procedural death was noted, 2 patients underwent urgent dialysis, 1 had cardiogenic shock, and 2 had prolonged ventilation after the procedure, all of these occurred in the NS group. At 1-year follow-up, there was marked improvement in MR grade (2.4±1.4 vs 2.2±1.2 for S and NS respectively). Both groups had a small reduction in LVEDD of about 3mm. Patients in the S group had improved GFR at 1-year follow-up (44±21 to 51±32). No differences were noted in 1, 2, or 5 year mortality between groups (Figures).

Conclusion

Trans-catheter edge-to-edge mitral valve repair in patients with severe LV dilatation is safe and seems to provide similar short-and long-term outcomes compared to patients with less severe dilatation. Further studies are needed to establish the efficacy of TEER for these patients.

Funding Acknowledgement

Type of funding sources: None.