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Objectives

The aim of this study was to assess mortality and rehospitalization in patients with new bundle branch block (BBB) and/or permanent pacemaker (PPM) after transcatheter aortic valve replacement (TAVR).

Background

Previous studies have provided inconsistent results on the clinical impact of new BBB or new PPM after TAVR.

Methods

A total of 816 consecutive patients without pre-procedural BBB or PPM undergoing TAVR between 2007 and 2017 were followed for 5 years or until data extraction in September 2017. Data on vital status and hospitalization were obtained through national registries.

Results

Within 30 days post-TAVR, new BBB without PPM and new PPM occurred in 247 (30.3%) and 132 (16.2%) patients, respectively, leaving 437 patients (53.6%) without conduction abnormalities. Median follow-up was 2.5 years (interquartile range: 1.0 to 4.9 years). One-year all-cause mortality was increased for new BBB (hazard ratio [HR]: 2.80; 95% confidence interval [CI]: 1.18 to 3.67) but not for new PPM (HR: 1.64; 95% CI: 0.72 to 3.74) compared with patients with no conduction abnormalities. The risk for late all-cause mortality (≥1 year after TAVR) was higher both for patients with new BBB (HR: 1.79; 95% CI: 1.24 to 2.59) and for those with new PPM (HR: 1.58; 95% CI: 1.01 to 2.46) compared with patients with no conduction abnormalities. Patients with new BBB (HR: 1.47; 95% CI: 1.02 to 2.12) and new PPM (HR: 1.66; 95% CI: 1.09 to 2.54) had a higher risk for heart failure hospitalization and reduced left ventricular ejection fraction (p < 0.0001 for both groups) during follow-up.

Conclusions

New BBB and new PPM developed frequently after TAVR. New BBB was associated with increased early and late all-cause mortality, whereas new PPM was associated with late all-cause mortality. Furthermore, both new BBB and new PPM increased the risk for heart failure hospitalizations.  相似文献   

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目的:旨在观察左束支区域起搏(LBBAP)纠正右束支阻滞(RBBB)的临床效果及心电图特点.方法:本研究为单中心、前瞻性观察性研究,纳入2018年4月至2019年12月间入院有心室起搏指征,存在基线RBBB图形且QRS波群时限≥120 ms、左心室射血分数>50%并接受LBBAP的患者,分析LBBAP纠正RBBB的临床...  相似文献   

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AV Conduction After TAVI and SAVR . Introduction: Atrioventricular conduction abnormalities (AVCA) may complicate transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). The aim of this study was to prospectively evaluate AVCA after TAVI and SAVR. Methods and Results: Among 50 patients undergoing TAVI and 25 patients undergoing SAVR a continuous 7‐day Holter electrocardiogram (ECG) was recorded after the procedure. ECGs during TAVI and 12‐lead ECGs before and 1 and 7 days after TAVI and SAVR were analyzed. At baseline, TAVI patients were older (mean 82.1 vs 75.4, P < 0.001), had a longer PR interval (median 200 milliseconds vs 175 milliseconds, P = 0.004) and broader QRS width (median 100 milliseconds vs 80 milliseconds, P = 0.007) than SAVR patients. New AVCA were observed among 29 TAVI patients (58%), mostly new left bundle branch block (76%). Predilatation induced new AVCA in 14 TAVI patients (28%). New AVCA resolved within 24 hours in 15 TAVI patients (30%), and persisted in 14 TAVI (28%) and 3 SAVR patients (12%, P = 0.12). Among patients with persistent QRS width <120 milliseconds during the first 24 hours after TAVI, QRS width remained stable during the remainder of the observation period. During Holter monitoring complete AV block was observed in 4 TAVI patients (8%) and 3 SAVR patients (12%; P = 0.68). Conclusions: Almost half of AVCA during TAVI are induced by predilatation, but half of them resolve within 24 hours. Persistent AVCA are more frequently observed after TAVI than SAVR. If QRS width is below 120 milliseconds the first day after TAVI, the risk of late AVCA seems low. (J Cardiovasc Electrophysiol, Vol. 23 pp. 1115‐1122, October 2012)  相似文献   

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Objectives

This study sought to determine predictors of advanced conduction disturbances requiring late (≥48 h) permanent pacemaker replacement (PPM) after transcatheter aortic valve replacement (TAVR).

Methods

Data of consecutive patients were identified by retrospective review of a TAVR database of a single center in Milan, Italy, between October 2007 and July 2015. We defined delta PR (ΔPR) and delta QRS (ΔQRS) interval as the difference between the last PR and QRS length available 48 h after TAVR and the baseline PR and QRS length.

Results

Overall population included 740 patients. We excluded 78 patients who already had a PPM and 51 patients who received a PPM <48 h after TAVR. The final analysis included 611 patients. Fifty-four patients (8.8%) developed an advanced conduction disturbance requiring PPM ≥48 h following TAVR. Patients who required a late PPM implant had a wider QRS width (113 ± 25 ms vs. 105 ± 23 ms; p = 0.009) and a higher prevalence of baseline right bundle branch block (12.9% vs. 5.3%; p = 0.026) and were more likely to have a self-expandable valve implanted (51.8% vs. 31.9%; p = 0.003). The ΔPR was 40 ± 51 ms (p = 0.0001) and the ΔQRS was 22 ± 61 ms (p = 0.001). Multivariable analysis revealed that baseline right bundle branch block (odds ratio: 3.56; 95% confidence interval: 1.07 to 11.77; p = 0.037) and ΔPR (odds ratio for each 10-ms increase: 1.31; 95% confidence interval: 1.18 to 1.45; p = 0.0001) are independent predictors of delayed advanced conduction disturbances.

Conclusions

This analysis showed that baseline right bundle branch block and the amount of increase of PR length after TAVR are independent predictors of late (≥48 h) advanced conduction disturbances requiring PPM replacement after TAVR in this cohort. A simple ECG analysis could help in detecting potentially lethal advanced conduction disturbances that could occur more than 48 h after TAVR.  相似文献   

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LBBB and Heart Block . Background: Patients with left bundle branch block (LBBB) undergoing right heart catheterization can develop complete heart block (CHB) or right bundle branch block (RBBB) in response to right bundle branch (RBB) trauma. We hypothesized that LBBB patients with an initial r wave (≥1 mm) in lead V1 have intact left to right ventricular septal (VS) activation suggesting persistent conduction over the left bundle branch. Trauma to the RBB should result in RBBB pattern rather than CHB in such patients. Methods: Between January 2002 and February 2007, we prospectively evaluated 27 consecutive patients with LBBB developing either CHB or RBBB during right heart catheterization. The prevalence of an r wave ≥1 mm in lead V1 was determined using 118 serial LBBB electrocardiographs (ECGs) from our hospital database. Results: Catheter trauma to the RBB resulted in CHB in 18 patients and RBBB in 9 patients. All 6 patients with ≥1 mm r wave in V1 developed RBBB. Among these 6 patients q wave in lead I, V5, or V6 were present in 3. Four patients (3 in CHB group and 1 in RBBB group) developed spontaneous CHB during a median follow‐up of 61 months. V1 q wave ≥1 mm was present in 28% of hospitalized complete LBBB patients. Conclusions: An initial r wave of ≥1 mm in lead V1 suggests intact left to right VS activation and identifies LBBB patients at low risk of CHB during right heart catheterization. These preliminary findings indicate that an initial r wave of ≥1 mm in lead V1, present in approximately 28% of ECGs with classically defined LBBB, may constitute a new exclusion criterion when defining complete LBBB. (J Cardiovasc Electrophysiol, Vol. pp. 781‐785, July 2010)  相似文献   

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Objectives

This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.

Background

The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.

Methods

This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.

Results

The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.

Conclusions

The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)  相似文献   

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Objectives

This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.

Background

The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device.

Methods

The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2).

Results

A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%.

Conclusions

TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.  相似文献   

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Objectives

The authors assessed the effect of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) followed by bioprosthetic valve fracture (BVF), testing different transcatheter heart valve (THV) designs in an ex vivo bench study.

Background

Bioprosthetic valve fracture can be performed to improve residual transvalvular gradients following VIV TAVR.

Methods

The authors evaluated VIV TAVR and BVF with the SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) and ACURATE neo (Boston Scientific Corporation, Natick, Massachusetts) THVs. A 20-mm and 23-mm S3 were deployed in a 19-mm and 21-mm Mitroflow (Sorin Group USA, Arvada, Colorado), respectively. A small ACURATE neo was deployed in both sizes of Mitroflow tested. VIV TAVR samples underwent multimodality imaging, and hydrodynamic evaluation before and after BVF.

Results

A high implantation was required to enable full expansion of the upper crown of the ACURATE neo and allow optimal leaflet function. Marked underexpansion of the lower crown of the THV within the surgical valve was also observed. Before BVF, VIV TAVR in the 19-mm Mitroflow had high transvalvular gradients using either THV design (22.0 mm Hg S3, and 19.1 mm Hg ACURATE neo). After BVF, gradients improved and were similar for both THVs (14.2 mm Hg S3, and 13.8 mm Hg ACURATE neo). The effective orifice area increased with BVF from 1.2 to 1.6 cm2 with the S3 and from 1.4 to 1.6 cm2 with the ACURATE neo. Before BVF, VIV TAVR with the ACURATE neo in the 21-mm Mitroflow had lower gradients compared with S3 (11.3 mm Hg vs. 16 mm Hg). However, after BVF valve gradients were similar for both THVs (8.4 mm Hg ACURATE neo vs. 7.8 mm Hg S3). The effective orifice area increased from 1.5 to 2.1 cm2 with the S3 and from 1.8 to 2.2 cm2 with the ACURATE neo.

Conclusions

BVF performed after VIV TAVR results in improved residual gradients. Following BVF, residual gradients were similar irrespective of THV design. Use of a small ACURATE neo for VIV TAVR in small (≤21 mm) surgical valves may be associated with challenges in achieving optimum THV position and expansion. BVF could be considered in selected clinical cases.  相似文献   

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Objectives

The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices.

Background

The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR.

Methods

The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)–2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles.

Results

A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.

Conclusions

In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.  相似文献   

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Objectives

The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.

Background

The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported.

Methods

From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium–2 outcomes were reported.

Results

Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity.

Conclusions

TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.  相似文献   

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Background: Increasing QRS duration may be of prognostic significance in patients with right bundle branch block (RBBB) and may assist in predicting overall cardiovascular risk. Methods: To test this hypothesis, we examined the Computerized Patient Records of patients with complete and persistent RBBB. Primary and secondary end points were all‐cause and cardiac mortality. The effects of QRS duration on death rates were analyzed using the Cox proportional hazards regression model (P < 0.05). We identified 52,852 patients with EKGs and selected all those with diagnosis of RBBB (QRS ≥ 120 ms) between January 2000 and January 2004. Some patients had EKG records confirming RBBB since 1987. The QRS durations were categorized into four groups: 120–129, 130–139, 140–149, and ≥ 150 ms. Results: A total of 997 (1.9%) patients (mean age 68.9 ± 10 years) with RBBB were followed for 1–226 (median 45) months. All‐cause mortality occurred in 344 (34.5%), cardiac deaths in 59 (5.9%), noncardiac in 191 (19.2%), and unknown causes in 94 (9.4%) patients. Mean left ventricular EF for cardiac patients was 38 ± 15%. In patients with cardiac deaths, QRS duration was associated with increased morality (P < 0.007). For every 10 ms increase in QRS duration, the risk of death rose by 26.6%. The effect of QRS duration on all cause mortality was not statistically significant (P < 0.43). Conclusion: Increasing QRS duration was an independent predictor of cardiac mortality in patients with RBBB, but had no influence on all‐cause mortality. QRS duration has added prognostic information to the presence of right bundle branch block.  相似文献   

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Introduction and objectives

The incidence of permanent pacemaker implantation (PPI) and new conduction abnormalities (CA) with the ACURATE neo (Symetis S.A., Eclubens, Switzerland) has not been studied in detail. We aimed to analyze their predictors, evaluating patient- and device-related factors, including implantation depth and device-to-annulus ratio (DAR).

Methods

Two analyses of a multicenter population were performed: new PPI in pacemaker-naive patients (n = 283), and PPI/new-CA in patients without prior CA or pacemaker (n = 232).

Results

A new PPI was required in 9.9% of patients, who had a higher body mass index, higher rate of right bundle branch block and bradycardia. Neither implantation depth nor DAR differed in patients with PPI compared with those without. In the multivariable analysis neither DAR (OR, 1.010; 95%CI, 0.967-1.055; P = .7) nor implantation depth (OR, 0.972; 95%CI, 0.743-1.272; P = .8) predicted PPI. Only high body mass index, bradycardia and right bundle branch block persisted as independent predictors. PPI/new-onset CA occurred in 22.8% of patients and was associated with a higher logistic EuroSCORE. Neither implantation depth nor DAR differed in patients with PPI/new-CA vs those without (7.3 ± 1.9 vs 7.1 ± 1.5 mm; P = .6 and 41.0 ± 7.9 vs 42.2 ± 10.1%; P = .4). The only predictor of PPI/new-CA was a higher logistic EuroSCORE (OR, 1.039; 95%CI, [1.008-1.071]; P = .013).

Conclusions

New PPI and new-onset CA rates were low with the ACURATE neo. These were mainly influenced by patient characteristics and not by device-depending factors.  相似文献   

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Background

Atrioventricular (AV) conduction disturbances requiring permanent pacemaker (PPM) implantation may complicate transcatheter aortic valve replacement (TAVR). Available evidence on predictors of PPM is sparse and derived from small studies.

Objectives

The objective of this study was to provide summary effect estimates for clinically useful predictors of PPM implantation after TAVR.

Methods

We performed a systematic search for studies that reported the incidence of PPM implantation after TAVR and that provided raw data for the predictors of interest. Data on study, patient, and procedural characteristics were abstracted. Crude risk ratios (RRs) and 95% confidence intervals for each predictor were calculated by use of random effects models. Stratified analyses by type of implanted valve were performed.

Results

We obtained data from 41 studies that included 11,210 TAVR patients, of whom 17% required PPM implantation after intervention. The rate of PPM ranged from 2% to 51% in individual studies (with a median of 28% for the Medtronic CoreValve Revalving System [MCRS] and 6% for the Edwards SAPIEN valve [ESV]). The summary estimates indicated increased risk of PPM after TAVR for men (RR: 1.23; p < 0.01); for patients with first-degree AV block (RR: 1.52; p < 0.01), left anterior hemiblock (RR: 1.62; p < 0.01), or right bundle branch block (RR: 2.89; p < 0.01) at baseline; and for patients with intraprocedural AV block (RR: 3.49; p < 0.01). These variables remained significant predictors when only patients treated with the MCRS bioprosthesis were considered. The data for ESV were limited. Unadjusted estimates indicated a 2.5-fold higher risk for PPM implantation for patients who received the MCRS than for those who received the ESV.

Conclusions

Male sex, baseline conduction disturbances, and intraprocedural AV block emerged as predictors of PPM implantation after TAVR. This study provides useful tools to identify high-risk patients and to guide clinical decision making before and after intervention.  相似文献   

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