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Objectives

The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS).

Background

Oncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option.

Methods

A worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 “no-cancer” patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias.

Results

Cancer patients’ age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients.

Conclusions

TAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997)  相似文献   

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Objectives

The authors sought to compare clinical and hemodynamic outcomes in patients receiving transcatheter aortic valve replacement (TAVR) for low-gradient (LG) aortic stenosis in the CoreValve EUS (Expanded Use Study) versus those with high-gradient (HG) aortic stenosis from the CoreValve U.S. Pivotal Extreme Risk Trial and CAS (Continued Access Study).

Background

The EUS examined the impact of TAVR in patients unsuitable for surgical aortic valve replacement who were excluded from the U.S. Pivotal Extreme Risk Trial due to LG aortic stenosis.

Methods

EUS patients were stratified by left ventricular ejection fraction: normal (≥50%, LG–normal ejection fraction), and low (<50%, did not respond to dobutamine by generating a mean gradient >40 mm Hg and/or velocity >4.0 m/s, “nonresponders”), and compared with extreme-risk patients from U.S. Pivotal and CAS that had either low resting gradient and responded to dobutamine (“responders”), or a high resting gradient (HG) or velocity. The primary endpoint was all-cause mortality or major stroke at 1 year. Hemodynamics and quality of life are reported at 30 days and 1 year.

Results

At 30 days, patients with LG/low left ventricular ejection fraction (nonresponders and responders) had significantly higher rates of all-cause mortality or major stroke, all-cause mortality, and cardiovascular mortality than both HG and LG–normal ejection fraction patients. At 1 year, only the responders had higher rates of these outcomes in comparison to the other 3 groups. Mean gradient and effective orifice area improved significantly in all patients and were maintained through 1 year. New York Heart Association functional classification and Kansas City Cardiomyopathy Questionnaire overall summary scores improved (p < 0.05) in all cohorts through 1 year. When all 4 subgroups were pooled, both decreasing mean gradient and stroke volume index were associated with increased mortality. Pre-procedural mean gradient was the only hemodynamic independent predictor of 1-year mortality by multivariate analysis.

Conclusions

In this study, TAVR provided EUS patients significant hemodynamic relief with both 1-year survival and quality of life outcomes comparable to Pivotal and CAS patients (Safety & Efficacy Study of the Medtronic CoreValve System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement, NCT01675440; Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement, NCT01240902; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement, NCT01531374)  相似文献   

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Transcatheter aortic valve replacement (TAVR) with balloon‐expandable Edwards‐SAPIEN valve was superior to standard therapy in inoperable patients and noninferior to surgical aortic valve replacement in high surgical‐risk, but operable patients, with severe symptomatic aortic stenosis in the randomized controlled PARTNER trial. Since the first case of TAVR with a balloon‐expandable valve in 2002, several groups have reported their experience with balloon‐expandable valves with high‐procedural success. In the United States, the balloon‐expandable Edwards‐SAPIEN valve is the only transcatheter heart valve approved by the FDA for commercial use. Moreover, this is only in high‐risk inoperable patients. Despite increasing experience with the TAVR procedure, it can be associated with complications, which can be technically challenging, even for an experienced operator. Complications associated with TAVR include vascular complications, valve malpositioning, regurgitation, embolization, coronary compromise, conduction abnormalities, stroke/transient ischemic attack, acute kidney injury, cardiac tamponade, and hemodynamic collapse. A thorough understanding of the procedure is essential for pre‐emptive planning for procedural complications and early identification and management of complications are necessary for procedural success. We hereby review our experience of transfemoral TAVR with balloon‐expandable valves, offer practical tips to maximize the likelihood of procedural success, describe pre‐emptive strategies to prevent peri‐procedural complications and bailout measures to manage them, should they occur. © 2018 Wiley Periodicals, Inc.  相似文献   

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Historically, many patients with severe senile calcific aortic valve stenosis (AS) were not offered surgery, largely due to the perception that the risks of operation were prohibitive. Such patients have subsequently been formally designated as ‘high risk’ or ‘inoperable’ with respect to their suitability for surgical aortic valve replacement (SAVR) in the evolving lexicon of heart valve disease. The recent availability of transcatheter aortic valve replacement (TAVR) represents an alternative treatment option, and permits the opportunity to re-examine algorithms for assessing operative risk. As the experience with TAVR grows, expanded use in new patient populations can be anticipated. While TAVR in high risk AS patients has demonstrated benefits, the emerging indication in intermediate AS is less clear and conclusions will necessarily await the availability of results from ongoing clinical trials. This article will discuss current outcomes for SAVR among high- and intermediate-risk patients with AS as a barometer in assessing the results of nascent percutaneous therapies.  相似文献   

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Transcatheter aortic valve replacement (TAVR) has proven to be a viable tool for the high-surgical-risk population with severe aortic valve stenosis. Vascular access complications are not uncommon with TAVR and may increase early and late mortality. Avoiding these serious complications is the goal. With experience and careful screening, we are now able to risk-stratify patients who may be at increased risk of vascular complications. While the traditional iliofemoral access site remains the most common for TAVR, alternate access sites that have proven to be viable and safe alternatives include the transapical, direct-aortic, and subclavian techniques. TAVR teams should be familiar and comfortable with these approaches as each of them has its own advantages and weaknesses. The best option is usually one in which the procedure is tailored to the patient. The present review examines our current access planning and strategies for TAVR.  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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It could be argued that the European experience with transcatheter aortic valve replacement (TAVR) has been central to the success of this novel technology. After all, Europe provided the birthplace for the first clinical TAVR and allowed commercial approval of the early devices long before they were widely available elsewhere. Many of the largest registries are also European, helping to formulate contemporaneous guidelines with the backing of the influential cardiology and cardiothoracic societies. Despite the significant economic downturn that coincided with the availability of transcatheter technology, funding has been largely forthcoming and is increasing year on year. As we await the results of the randomised controlled trials examining TAVR in a lower risk cohort, the European adoption of the TAVR technology appears set to continue.  相似文献   

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Objectives

The aim of this study was to analyze the frequency and outcomes of patients who underwent transsubclavian or transaxillary (TAx) transcatheter aortic valve replacement (TAVR) using the balloon-expandable SAPIEN 3 prosthesis compared with traditional alternative access, transapical (TA) and transaortic (TAo).

Background

The transsubclavian and TAx approaches for TAVR are rapidly growing alternatives in the setting of hostile iliofemoral arteries, yet few data exist.

Methods

The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was queried for all patients undergoing TAx TAVR with the SAPIEN 3 prosthesis from June 2015 to February 2018. Secular trends over time were evaluated. Logistic regression analyses used to assess risk-adjusted outcomes. Propensity score matching was used to compare TAx access with TA and TAo access.

Results

In total, 3,628 patients (5.7%) underwent nontransfemoral access with the SAPIEN 3. Overall, TAx TAVR accounted for 1,249 of these patients (34.4%). There has been rapid recent growth in TAx TAVR (from 20.2% in the third quarter of 2015 to 49.0% in the fourth quarter of 2017; p < 0.001 for trend) and a concomitant decrease in TA and TAo access (from 61.9% in the third quarter of 2015 to 35.3% in the fourth quarter of 2017; p < 0.001 for trend). The median number of TAx TAVR cases per hospital during the study period was 2, and 78.2% of centers performed ≤5 TAx TAVR procedures. The device success rate was 97.3%, and the major vascular complication rate was 2.5%. After propensity matching, TAx access had lower 30-day mortality (5.3% vs. 8.4%; p < 0.01), shorter lengths of intensive care unit and hospital stay, but a higher stroke rate (6.3% vs. 3.1%; p < 0.05) compared with TA and TAo access.

Conclusions

TAx access has become the most frequent alternative access route for balloon-expandable TAVR procedures. Outcomes following TAx TAVR appear positive despite the relatively early experience of most centers performing these cases.  相似文献   

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Background

Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR).

Objectives

The aim of this study was to describe the incidence and pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry.

Methods

Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016.

Results

During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur ≤24 h after the TAVR procedure (47.4%; n = 18); 6 (15.8%) cases occurred between 24 h and ≤7 days, with the remaining 14 (36.8%) at ≥60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred ≤7 days from the index procedure (62.5% vs. 28.6%; p = 0.09).

Conclusions

DCO following TAVR is a rare phenomenon that is associated with a high in-hospital mortality rate. Clinicians should be aware that coronary obstruction can occur after the original TAVR procedure and have a low threshold for performing coronary angiography when clinically suspected.  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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ObjectivesThis study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV).BackgroundPPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient.MethodsA total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe (<0.65 cm2/m2) or moderate (0.65 to 0.85 cm2/m2) in the general population, and as severe (<0.60 cm2/m2) or moderate (0.60 to 0.90 cm2/m2) in the obese population (body mass index ≥30 kg/m2).ResultsPropensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%; p = 0.004; severe PPM, 6.7% vs. 15.6%; p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m2 had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m2. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year.ConclusionsSEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m2.  相似文献   

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Objectives

The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR).

Background

Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited.

Methods

The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined.

Results

Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality.

Conclusions

Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.  相似文献   

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Objectives

The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus.

Background

TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice.

Methods

The RESPOND (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data.

Results

One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients).

Conclusions

One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302)  相似文献   

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