Abstract Background The TRANSFORM (Multicen t er Experience With R apid Deployment Edw a rds I N TUITY Valve S ystem for Aortic Valve Replace m ent) trial ( NCT01700439 ) evaluated the performance of ...the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. Methods TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. Results Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively ( P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2 ; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively. Conclusions INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.
Current era minimally invasive aortic valve replacement: Techniques and practice Malaisrie, S. Chris, MD; Barnhart, Glenn R., MD; Farivar, R. Saeid, MD, PhD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
2014, January 2014, 2014-Jan, 2014-01-00, 20140101, Letnik:
147, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Background Since the first aortic valve replacement through a right thoracotomy was reported in 1993, upper hemisternotomy and right anterior thoracotomy have become the predominant approaches for ...minimally invasive aortic valve replacement. Clinical studies have documented equivalent operative mortality, less bleeding, and reduced intensive care/hospital stay compared with conventional sternotomy despite longer procedure times. However, comparative trials face challenges due to patient preference, surgeon bias, and the lack of a standardized minimally invasive surgical approach. Methods Twenty cardiothoracic surgeons from 19 institutions across the United States, with a combined experience of nearly 5000 minimally invasive aortic valve replacement operations, formed a working group to develop a basis for a standardized approach to patient evaluation, operative technique, and postoperative care. In addition, a stepwise learning program for surgeons was outlined. Results Improved cosmesis, less pain and narcotic use, and faster recovery have been reported and generally accepted by patients and by surgeons performing minimally invasive aortic valve replacement. These benefits are more likely to be verified with standardization of the procedure itself, which will greatly facilitate the design and implementation of future clinical studies. Conclusions Surgeons interested in learning and performing minimally invasive aortic valve replacement must have expertise in conventional aortic valve replacement at centers with adequate case volumes. A team approach that coordinates efforts of the surgeon, anesthesiologist, perfusionist, and nurses is required to achieve the best clinical outcomes. By first developing fundamental minimally invasive skills using specialized cannulation techniques, neck lines, and long-shafted instruments in the setting of conventional full sternotomy, the safest operative environment is afforded to patients.
Treatment of congenital heart disease may include placement of a right ventricle to pulmonary artery conduit that requires future surgical replacement. We sought to identify surgeon-modifiable ...factors associated with durability (defined as freedom from surgical replacement or explantation) of the initial conduit in children less than 2 years of age at initial insertion.
Since 2002, 429 infants were discharged from 24 Congenital Heart Surgeons' Society member institutions after initial conduit insertion. Parametric hazard analysis identified factors associated with conduit durability while adjusting for patient characteristics, the institution where the conduit was inserted, and time-dependent interval procedures performed after conduit insertion but before replacement/explantation.
In all, 138 conduit replacements (32%) and 3 explantations (1%) were performed. Conduit durability at a median follow-up of 6.0 years (range, 0.1 to 11.7) was 63%. After adjusting for interval procedures and institution, placement of a conduit with smaller z-score was associated with earlier replacement/explantation (p = 0.002). Moreover, conduit durability was substantially reduced with aortic allografts (p = 0.002) and pulmonary allografts (p = 0.03) compared with bovine jugular venous valved conduits (JVVC). The JVVC were 12 mm to 22 mm in diameter at insertion (compared with 6 mm to 20 mm for allografts); therefore, a parametric propensity-adjusted analysis of patients with aortic or pulmonary allografts versus JVVC with diameter of 12 mm or greater was performed, which verified the superior durability of JVVC.
Pulmonary conduit type and z-score are associated with late conduit durability independent of the effects of institution and subsequent interval procedures. Surgeons can improve long-term conduit durability by judiciously oversizing, and by selecting a JVVC.
Bipolar radiofrequency ablation (bRFA) has been used to create larger ablation lesions and to treat refractory arrhythmias. However, little is known about optimal bRFA settings.
The purpose of this ...study was to evaluate various bRFA settings, including active and ground catheter tip orientation and use of variable active and ground catheters during bRFA.
Two ablation catheters, 1 active and 1 ground, were oriented across from each other, with viable bovine myocardium in between. The catheter tips were placed in various combinations perpendicular or parallel to the myocardium. The active catheter was either a 3.5-mm externally irrigated or 8-mm tip, and the ground catheter was either a 4-mm, 3.5-mm irrigated, or 8-mm tip. Retrospective analysis was undertaken for all bRFA performed at University of Colorado.
The largest and deepest lesions were produced using irrigated active and ground tips, oriented perpendicularly. In 14 cases (10 patients) of bRFA for ventricular tachycardia and premature ventricular complexes, acute success was achieved in 13 of 14 procedures. Long-term success was achieved in 7 of 10 patients, but 3 patients required multiple bRFA ablations.
Active and ground catheter tip orientation and type are important determinants of lesion sizes during bRFA. The largest and deepest lesions, without a higher incidence of steam pops, were achieved using 2 irrigated catheters. As the largest published series to date, bRFA ablation can be performed safely and effectively in humans. Larger studies are necessary to better evaluate bRFA efficacy and safety.
Objective Risk algorithms were used to identify a high-risk population for transcatheter aortic valve implantation instead of standard aortic valve replacement in patients with aortic stenosis. We ...evaluated the efficacy of these methods for predicting outcomes in high-risk patients undergoing aortic valve replacement. Methods Data were collected on 638 patients identified as having isolated aortic valve replacement between January 1, 1998 and December 31, 2006, using The Society of Thoracic Surgeons (STS) database. Long-term survival was determined from the Social Security Death Index or family contact. Operative risk was calculated using the STS Predicted Risk of Mortality, the EuroSCORE logistic and additive algorithms, and the Ambler Risk Score. Patients at or above the 90th percentile of risk (8.38% for STS, 33.47% for logistic, 12% for additive, 14.3% for Ambler) were identified as high risk. We then compared actual with predicted mortality and each algorithm’s ability to identify patients with the worst long-term survival. Results Operative mortality was 24 of 638 (3.76%). An additional 121 (19.0%) patients died during the follow-up study period (mean 4.2 ± 2.7 years). Overall mortality was 145 of 638 (22.7%). Expected versus observed mortality for the high-risk group by algorithm was 13.3% versus 18.8% for STS, 50.9% versus 15.6% for logistic, 14.0% versus 11.9% for additive, and 19.0% versus 13.4% by Ambler. Long-term mortality, per high-risk group, was 64.1% in the STS Predicted Risk of Mortality, 45.3% in the logistic, 45.2% in the additive, and 40.2% in Ambler Risk Score. Logistic regression showed that the STS algorithm was the most sensitive in defining the patients most at risk for long-term mortality. Conclusion The STS Predicted Risk of Mortality most accurately predicted perioperative and long-term mortality for the highest risk patients having aortic valve replacement.
Purpose The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) is a multicenter, community-based cohort study of Hispanic/Latino adults in the United States. A diverse participant sample ...is required that is both representative of the target population and likely to remain engaged throughout follow-up. The choice of sample design, its rationale, and benefits and challenges of design decisions are described in this study. Methods The study design calls for recruitment and follow-up of a cohort of 16,000 Hispanics/Latinos 18–74 years of age, with 62.5% (10,000) over 44 years of age and adequate subgroup sample sizes to support inference by Hispanic/Latino background. Participants are recruited in community areas surrounding four field centers in the Bronx, Chicago, Miami, and San Diego. A two-stage area probability sample of households is selected with stratification and oversampling incorporated at each stage to provide a broadly diverse sample, offer efficiencies in field operations, and ensure that the target age distribution is obtained. Conclusions Embedding probability sampling within this traditional, multisite cohort study design enables competing research objectives to be met. However, the use of probability sampling requires developing solutions to some unique challenges in both sample selection and recruitment, as described here.
Background The impact of adjuvant chemotherapy and chemo-radiation therapy in the treatment of resectable gastric cancer remains varied. We sought to define the clinical impact of lymph node ratio on ...the relative benefit of adjuvant chemotherapy or chemo-radiation therapy among patients having undergone curative-intent resection for gastric cancer. Methods Using the multi-institutional US Gastric Cancer Collaborative database, 719 patients with gastric adenocarcinoma who underwent curative-intent resection between 2000 and 2013 were identified. Patients with metastasis or an R2 margin were excluded. The impact of lymph node ratio on overall survival among patients who received chemotherapy or chemo-radiation therapy was evaluated. Results Median patient age was 65 years, and the majority of patients were male (56.2%). The majority of patients underwent either subtotal (40.6%) or total gastrectomy (41.0%), with the remainder undergoing distal gastrectomy or wedge resection (18.4%). On pathology, median tumor size was 4 cm; most patients had a T3 (33.0%) or T4 (27.9%) lesion with lymph node metastasis (59.7%). Margin status was R0 in 92.5% of patients. A total of 325 (45.2%) patients underwent resection alone, 253 (35.2%) patients received 5-FU or capecitabine-based chemo-radiation therapy, whereas the remaining 141 (19.6%) received chemotherapy. Median overall survival was 40.9 months, and 5-year overall survival was 40.3%. According to lymph node ratio categories, 5-year overall survival for patients with a lymph node ratio of 0, 0.01–0.10, >0.10–0.25, >0.25 were 54.1%, 53.1 %, 49.1 % and 19.8 %, respectively. Factors associated with worse overall survival included involvement of the gastroesophageal junction (hazard ratio 1.8), T-stage (3–4: hazard ratio 2.1), lymphovascular invasion (hazard ratio 1.4), and lymph node ratio (>0.25: hazard ratio 2.3; all P < .05). In contrast, receipt of adjuvant chemo-radiation therapy was associated with an improved overall survival in the multivariable model (versus resection alone: hazard ratio 0.40; versus chemotherapy: hazard ratio 0.45, both P < .001). The benefit of chemo-radiation therapy for resected gastric cancer was noted only among patients with lymph node ratio >0.25 (versus resection alone: hazard ratio R 0.34; versus chemotherapy: hazard ratio 0.45, both P < .001). In contrast, there was no noted overall survival benefit of chemotherapy or chemo-radiation therapy among patients with lymph node ratio ≤0.25 (all P > .05). Conclusion Adjuvant chemotherapy or chemo-radiation therapy was utilized in more than one-half of patients undergoing curative-intent resection for gastric cancer. Lymph node ratio may be a useful tool to select patients for adjuvant chemo-radiation therapy, because the benefit of chemo-radiation therapy was isolated to patients with greater degrees of lymphatic spread (ie, lymph node ratio >0.25).
Some patients diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) are eventually found to have cardiac sarcoidosis (CS). Accurate differentiation between these 2 conditions has ...implications for immunosuppressive therapy and familial screening. We sought to determine whether cardiac magnetic resonance imaging (MRI) could be used to identify the characteristic findings to accurately differentiate between CS and ARVC. Consecutive patients with a diagnostic MRI scan indicating CS and/or ARVC constituted the cohort. All patients diagnosed with CS had histologic confirmation of sarcoidosis, and all patients with ARVC met the diagnostic task force criteria. The cardiac MRI data were retrospectively analyzed to identify possible differentiating characteristics. Of the patients, 40 had CS and 21 had ARVC. Those with CS were older and had more left ventricular scar. The presence of mediastinal lymphadenopathy or left ventricular septal involvement was seen exclusively in the patients with CS (p <0.001). A family history of sudden cardiac death was seen only in the ARVC group (p = 0.012). The right ventricular ejection fraction and ventricular volumes were also significantly different between the 2 groups. In conclusion, patients with CS have significantly different cardiac MRI characteristics than patients with ARVC. The cardiac volume, in addition to the degree and location of cardiac involvement, can be used to distinguish between these 2 disease entities. The presence of mediastinal lymphadenopathy and left ventricular septal scar favors a diagnosis of CS and not ARVC. Consideration of CS should be given if these MRI findings are observed during the evaluation for possible ARVC.
In the past decade, minimally invasive approaches have been developed for aortic valve surgery. We reviewed our data to determine if the use of the PORT ACCESS technique has improved hospital ...morbidity and mortality.
Data were collected on 90 patients who had a replacement of their aortic valve using PORT ACCESS procedures (PORT ACCESS aortic valve replacement PAVR). This group was then matched 1:4 to a control group having aortic valve replacement surgery using a standard sternotomy approach.
The two groups had no statistically significant differences in preoperative risk factors. The perioperative and 30-day outcomes from the matched AVR and PAVR groups showed no mortalities in the PAVR group and 3.1% in the AVR group. Mean length of stay was shorter for PAVR patients (7.2 +/- 5.0 days; median 6 days) compared with the mean stay in the sternotomy group (8.5 +/- 9.5 days; median 6 days), PAVR patients also had statistically significant shorter intensive care unit stays, and time on ventilator. The number of patients needing ventilator support postoperatively was significantly lower in the PORT ACCESS group. Cross-clamp and perfusion times were longer in the PAVR group. No other morbidity was significantly different between groups, except for postoperative tamponade (higher in PAVR group).
In this analysis of matched patients, the patients having aortic valve replacement using PORT ACCESS procedures, spent a shorter time in the intensive care unit and had less need for postoperative ventilator usage (both number of patients using a ventilator and the mean time of use) in comparison with patients undergoing conventional sternotomy.
A volume-outcome association has been shown for cardiovascular procedures such as coronary artery bypass grafting. The association of a volume-outcome relationship for aortic valve replacement ...procedures, however, has not been clearly defined. We evaluated the influence of surgeon volume on operative outcomes with isolated aortic valve replacement and aortic valve replacement with concomitant coronary artery bypass grafting.
One thousand six hundred thirty-five patients were identified as having either isolated aortic valve replacement or aortic valve replacement plus coronary artery bypass grafting between January 1, 2000, and December 31, 2009. Patients were divided into three equal terciles using their Society of Thoracic Surgery Predicted Risk of Mortality scores. Data were retrieved on 14 surgeons with complete data records in our Society of Thoracic Surgery database covering a minimum 5-year period (mean, 8.9 ± 1.5 years; median, 10 years).
Clinically significant increases are seen in operative mortality, permanent stroke, renal failure, prolonged ventilation, and hospital and intensive care unit lengths of stay in the high-risk compared with low-risk groups. The low-risk patient group has the smallest observed to expected ratio, less than 50%, whereas in the high-risk group the ratio is greater than 1. Odds ratios demonstrate that as surgeon volume increases, outcomes improve correspondingly (ie, odds ratio <1). In low-risk patients, five of ten major complications demonstrated improved outcomes with increased surgeon volume; in medium and high-risk groups eight of ten were improved.
Surgeon volumes have a significant influence on operative outcomes in high-risk patients undergoing aortic valve replacement or aortic valve replacement with coronary artery bypass grafting.
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