Impact of flow, gradient, and left ventricular function on outcomes after transcatheter aortic valve replacement.

OBJECTIVES: To assess the impact of low flow with and without preserved left ventricular ejection fraction (LVEF) on outcomes after transcatheter aortic valve replacement (TAVR). BACKGROUND: Prior studies have shown that patients with low flow, AVG, and LVEF have worse outcomes after TAVR. It is unclear whether low AVG and LVEF remain prognostic after adjusting for flow, and how the outcomes of patients with low flow with and without preserved LVEF compare after TAVR. The goal of this study was to provide insight into these open questions. METHODS: Data from 340 TAVR patients at Brigham and Women's Hospital from 2011 through 2015 were analyzed. Low flow was defined as stroke volume index (SVI) ≤35 mL/m2 , low AVG as mean gradient < 40 mmHg, and reduced LVEF as < 50%. RESULTS: Low flow was present in 96 (28.2%) patients, 48 (50.0%) of whom also had reduced LVEF. At 1 year, low flow was associated with increased mortality (21.9 vs 7.4%; P = 0.0002) and heart failure (HF) (20.8 vs 5.3%; P = 0.0113). Among patients with low flow, those with preserved LVEF had increased mortality (HR 5.17, 95% CI 2.73-9.80; P < 0.001) and HF (HR 7.69, 95% CI 3.86-15.31; P < 0.001). After adjusting for clinical factors, patients with low flow had increased mortality (HR 6.51, 95% CI 2.98-14.22; P < 0.001) and HF (HR 5.52, 95% CI 2.34-12.98; P < 0.001), while neither low AVG nor low LVEF were associated with increases in mortality or HF. CONCLUSIONS: In patients undergoing TAVR, low flow was an independent predictor of 1-year mortality and HF, and a stronger predictor than either low AVG or LVEF. Patients with low flow and preserved EF had increased mortality and HF at 1-year, while those with low flow and reduced EF had outcomes similar to patients with normal flow.

Clinical Significance of Greater Implantation Height with SAPIEN 3 Transcatheter Heart Valve.

BACKGROUND: A lower rate of permanent pacemaker (PPM) has been linked to a target aortic implantation height (AIH) >0.70, following transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. Based on clinical experience, it was hypothesized that a higher AIH (≥0.85) would lower the rate of PPM implantation. METHODS: A total of 127 patients (66 females, 61 males; mean age 82 ± 8 years) underwent TAVR with the SAPIEN 3 valve between May 2015 and July 2016. AIH was defined as the proportion of the valve frame above the aortic annulus in the post-deployment aortogram. A target AIH (≥0.70) was achieved in 113 patients (89%). Cases were stratified into a High Implantation (HI) group (AIH ≥0.85; 33 patients) or a Standard Implantation (SI) group (AIH <0.85; 94 patients). RESULTS: The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of all patients was 6.4 ± 3.5%. Preoperative right bundle branch block (RBBB) was prevalent in 13% of SI patients, and in 18% of HI patients (p = 0.56). There were no significant differences in operative mortality (3.2% versus 0%), median length of stay (2 days versus 3 days) and incidence of moderate-to-severe paravalvular leak (3.2% versus 0%; all p >0.410) between SI and HI patients, respectively. Likewise, the incidence of new PPM did not differ between the two groups (12% in HI versus 13% in SI; p ≥0.99). The mean AIH was similar for patients with PPM implantation (0.80 ± 0.08) compared to those without (0.78 ± 0.06; p = 0.520). Preoperative RBBB was significantly associated with PPM implantation (odds ratio (OR) 10.1; p = 0.002), and patients who underwent PPM implantation had a higher operative mortality (12.5% versus 1%; p = 0.040). CONCLUSIONS: Among TAVR patients who received the SAPIEN 3 heart valve, a higher AIH (≥0.85) was not associated with a lower rate of PPM implantation or increased operative mortality. Prior RBBB was the only independent risk factor for new PPM implantation. Long-term follow up is crucial in determining the clinical significance of PPM implantation.

SCAI/SVM expert consensus statement on carotid stenting: Training and credentialing for carotid stenting.

Carotid artery stenting (CAS) has become an integral part of the therapeutic armamentarium offered by cardiovascular medicine programs for the prevention of stroke. The purpose of this expert consensus statement is to provide physician training and credentialing guidance to facilitate the safe and effective incorporation of CAS into clinical practice within these programs. Since publication of the 2005 Clinical Competence Statement on Carotid Stenting, there has been substantial device innovation, publication of numerous clinical trials and observational studies, accumulation of extensive real-world clinical experience and widespread participation in robust national quality improvement initiatives [5]. Collectively, these advances have led to substantial evolution in the selection of appropriate patients, as well as in the cognitive, technical and clinical skills required to perform safe and effective CAS. Herein, we summarize published guidelines, describe training pathways, outline elements of competency, offer strategies for tracking outcomes, specify facility, equipment and personnel requirements, and propose criteria for maintenance of CAS competency.

Extracorporeal Femoro-Carotid Shunt for Transcarotid Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement may be performed with a transcarotid approach when peripheral vascular disease is prohibitive for transfemoral access. In this case, a patient who presented in cardiogenic shock secondary to severe aortic stenosis developed electroencephalographic changes during transcarotid TAVR. A temporary extracorporeal femoro-carotid shunt permitted successful TAVR.

Femoral artery percutaneous revascularization for patients with critical limb ischemia: outcomes compared to patients with claudication over 2.5 years.

Patients with critical limb ischemia have higher rates of death and amputation after revascularization compared to patients with intermittent claudication. However, the differences in patency after percutaneous revascularization of the superficial femoral artery are uncertain and impact the long-term risk of amputation and function in critical limb ischemia. We identified 171 limbs from 136 consecutive patients who had angioplasty and/or stenting for superficial femoral artery stenoses or occlusions from July 2003 through June 2007. Patients were followed for primary and secondary patency, death and amputation up to 2.5 years, and 111 claudicants were retrospectively compared to the 25 patients with critical limb ischemia. Successful percutaneous revascularization occurred in 128 of 142 limbs (90%) with claudication versus 25 of 29 limbs (86%) with critical limb ischemia (p = 0.51). Overall secondary patency at 2.5 years was 91% for claudication and 88% for critical limb ischemia. In Cox proportional hazards models, percutaneous revascularization for critical limb ischemia had similar long-term primary patency (adjusted hazard ratio = 1.1, 95% CI = 0.4, 2.6; p = 0.89) and secondary patency (adjusted hazard ratio = 1.1, 95% CI = 0.2, 6.0; p = 0.95) to revascularization for claudication. Patients with critical limb ischemia had higher mortality and death rates compared to claudicants, with prior statin use associated with less death (p = 0.034) and amputation (p = 0.010), and prior clopidogrel use associated with less amputation (p = 0.034). In conclusion, percutaneous superficial femoral artery revascularization is associated with similar long-term durability in both groups. Intensive treatment of atherosclerosis risk factors and surveillance for restenosis likely contribute to improving the long-term outcomes of both manifestations of peripheral artery disease.

Percutaneous revascularization of long femoral artery lesions for claudication: patency over 2.5 years and impact of systematic surveillance.

BACKGROUND: Angioplasty and stenting are preferred treatments for revascularizing femoral artery lesions up to 100 mm, but surgical bypass is recommended for longer lesions. We assessed long-term patency after percutaneous revascularization of long femoral artery lesions for claudication with intensive out-patient surveillance. METHODS: We followed a cohort of 111 consecutive patients receiving angioplasty or stenting in 142 limbs in two institutions. Patients were followed for 2.5 years, and event curves and multivariable survival analysis used to compare outcomes in three groups according to lesion length (< 100 mm, 100-200 mm, and greater than 200 mm). Failed patency was defined as recurrence of symptoms with a decline in ankle brachial index, or stenosis identified by duplex ultrasound, or reintervention. RESULTS: Compared to lesions less than 100 mm, longer lesions had higher failed primary patency (100-200 mm: HR = 2.0, P = 0.16, >200 mm: HR = 2.6, P = 0.03). Failed secondary patency was similar for short and intermediate lesions (< 5% incidence), but trended higher for lesions >200 mm (HR = 4.2, P = 0.06). An initial procedure residual stenosis greater than 20% was the only significant multivariable factor related to poorer long-term patency (HR = 15.8, P = 0.003). Compared to short lesions, the gain in long-term patency with out-patient surveillance and reintervention was higher for longer lesions and significantly so for intermediate lesions (100-200 mm = 23% versus <100 mm = 8%, P = 0.041). CONCLUSION: Percutaneous treatment of long femoral artery lesions can provide acceptable long-term patency for patients with claudication when out-patient surveillance is used to identify patients who require repeat interventions. Future long-term studies should consider overall patency encompassing more than one percutaneous reintervention.

Acute Myocardial Infarction Within 24 Hours After COVID-19 Vaccination.

COVID-19 vaccination was launched in the United States in mid-December 2020. There are limited data on the risk of thrombotic events related to COVID-19 vaccines. In conclusion, we report 2 cases of acute myocardial infarction with onset <24 hours after the first dose of a COVID-19 vaccine in patients presenting with shoulder pain.

Short-Term Outcomes of Transcatheter Versus Isolated Surgical Aortic Valve Replacement for Mediastinal Radiation-Associated Severe Aortic Stenosis.

BACKGROUND: Surgical aortic valve replacement (SAVR) is associated with adverse outcomes in patients with radiation-associated aortic stenosis. Transcatheter aortic valve replacement (TAVR) may improve outcomes in this population. METHODS: We evaluated 1668 TAVR and 2611 patients with SAVR enrolled in the Society of Thoracic Surgeons' database between 2011 and 2018. Multiple logistic regression was used to compare 30- day outcomes between TAVR and SAVR. Propensity-matched analysis was performed to confirm results of the overall cohort. Additionally, the cohort was stratified into early (2011-2014) versus contemporary (2015-2018) TAVR eras, and 30-day outcomes for TAVR and SAVR were compared. Finally, outcomes with transfemoral TAVR versus SAVR were compared. RESULTS: In the overall cohort, TAVR was associated with significantly reduced 30-day mortality (odds ratio [OR]TAVR/SAVR=0.60 [0.40-0.91]). Postoperative atrial fibrillation, pneumonia, pleural effusion, renal failure, and bleeding also occurred less frequently with TAVR. Stroke/transient ischemic attack (TIA; ORTAVR/SAVR, 2.03 [1.09-3.77]) and pacemaker implantation (ORTAVR/SAVR, 1.62 [1.21-2.17]) were higher with TAVR. Propensity-matched analysis yielded similar results as the overall cohort. Following stratification by era, TAVR versus SAVR was associated with reduced 30-day mortality in the contemporary but not early era (OREarly, 0.78 [0.48-1.28]; ORContemporary, 0.31 [0.14-0.65]). Pacemaker implantation was higher with TAVR versus SAVR in both eras (OREarly, 1.60 [1.03-2.46]; ORContemporary, 1.64 [1.10-2.45]). There was also a nonsignificant trend towards increased stroke/TIA with TAVR during both eras (OREarly, 1.39 [0.58-3.36]; ORContemporary, 2.46 [0.99-6.10]). Finally, transfemoral TAVR (N=1369) versus SAVR revealed similar findings as the overall cohort; however, the association of TAVR with stroke/TIA was not statistically significant (ORStroke/TIA, 1.57 [0.79-3.09]). CONCLUSIONS: TAVR provides an effective and evolving alternative to SAVR for radiation-associated severe aortic stenosis and was associated with lower 30-day mortality and postoperative complications. TAVR was associated with increased pacemaker implantation and a trend towards increased stroke/TIA. In this unique population with extensive valvular and vascular calcifications, the risk of stroke/TIA with TAVR requires careful consideration and further investigation.

A step-by-step guide to transseptal valve-in-valve transcatheter mitral valve replacement.

With the recent success of transcatheter aortic valve replacement (TAVR), transcatheter options for the management of mitral valve pathology have also gained considerable attention. Valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR) is one such technique that has emerged as a safe and effective therapeutic option for patients with degenerated mitral valve bioprostheses at high-risk for repeat surgical mitral valve replacement. Several access strategies, including trans-apical, transseptal, trans-jugular, and trans-atrial access have been described for ViV-TMVR. Initial experiences were performed primarily via a trans-apical approach through a left mini-thoracotomy because it offers direct access and coaxial device alignment. With the advancements in TMVR technology, such as the development of smaller delivery catheters with high flexure capabilities, the transseptal approach via the femoral vein has emerged as the preferred option. This technique offers the advantages of a totally percutaneous approach, avoids the need to enter the thoracic cavity or pericardial space, and provides superior outcomes compared to a trans-apical approach. In this review, we outline key aspects of patient selection, imaging, procedural techniques, and examine contemporary clinical outcomes of transseptal ViV-TMVR.

A step-by-step guide to trans-axillary transcatheter aortic valve replacement.

The application of transcatheter aortic valve replacement (TAVR) has expanded rapidly over the last decade as a less invasive option for the treatment of severe aortic stenosis. In order to perform successful TAVR, vascular access must be obtained with a large-bore catheter to deliver the transcatheter valve to the aortic annulus. Several techniques have been developed for this purpose including transfemoral (TF), trans-aortic, trans-apical, trans-caval, trans-carotid, and trans-axillary (TAx) with varying degrees of success. Among them, TF access is the most common and preferred method owing to its superior and well-established outcomes. However, in the setting of diseased iliofemoral arterial vessels, severe tortuosity, or iliofemoral arteries of insufficient caliber, TF access may not be possible. In these scenarios, one of the aforementioned alternative access routes needs to be considered. TAx-TAVR is an attractive alternative because it can be accomplished via access to a peripheral vessel as opposed to needing to enter the pericardial space or thoracic cavity. In addition, the open surgical cut-down procedure used to expose the axillary artery is familiar to cardiac surgeons who are accustomed to cannulating it for cardiopulmonary bypass. With advancements in TAVR technology including the evolution of delivery systems and corresponding smaller sheath sizes, total percutaneous access via the axillary artery is gaining substantial attention. In this review, we outline key aspects of patient selection, imaging and procedural techniques, and examine contemporary clinical outcomes with this approach.

Comparison of Sex-Based Differences in Home or Nonhome Discharge Utilization of Rehabilitative Services and Outcomes Following Transcatheter Aortic Valve Implantation in the United States.

Sex-based differences in outcomes have been shown to affect caregiving in medical disciplines. Increased spending due to postacute care transfer policies has led hospitals to further scrutinize patient outcomes and disposition patterns after inpatient admissions. We examined sex-based differences in rehabilitative service utilization after transcatheter aortic valve implantation (TAVI). We queried all TAVI discharges in the National Inpatient Sample database from 2012 to 2014 (n = 40,900). Thirteen thousand eight hundred fifteen patients were discharged to home and 12,175 patients were discharged to rehabilitation facility; those not discharged routinely or to a rehabilitation facility were excluded. Patients with nonhome discharges were older (83.3 vs 79.0 years) and female (58.3% vs 37.7%) with a greater number of chronic conditions (9.91 vs 9.03) and number of Elixhauser co-morbidities (6.5 vs 5.8, all p < 0.05). Nonhome discharge patients also had a significantly longer length of stay (LOS) (11.3 days vs 5.3 days) and higher hospitalization costs ($66,246 vs $48,710, all p < 0.001) compared to home-discharged patients. Overall in-hospital mortality for female patients who underwent TAVI was higher compared to males (4.6% vs 3.6%, p < 0.05). On multivariable logistic regression, female sex was an independent predictor for disposition to rehabilitation facilities after TAVI (odds ratio 2.17; 95% confidence interval: 1.88 to 2.50; p < 0.001). Other independent predictors for females discharged to rehabilitation included the presence of rheumatoid arthritis and collagen vascular disease, body mass index greater than 30 kg/m2, depression, and sum of Elixhauser co-morbidities (all p < 0.001). In conclusion, nonhome discharge TAVI patients added LOS and hospital costs compared to home discharge TAVI patients, and female sex was one of the major predictors despite the lower co-morbidities.

Ultrasound-assisted catheter-directed thrombolysis compared with anticoagulation alone for treatment of intermediate-risk pulmonary embolism.

It is unclear if ultrasound-assisted catheter-directed thrombolysis (UACDT) confers benefit over anticoagulation (AC) alone in the management of intermediate-risk ("submassive") pulmonary embolism (PE), defined by evidence of right ventricular (RV) dysfunction in hemodynamically stable patients. This study sought to evaluate any lasting advantage of UACDT on mortality and resolution of RV dysfunction in intermediate-risk PE at a large academic medical center. Adults aged ≤ 86 years admitted with intermediate-risk PE from 2011 to 2016 were retrospectively identified. Patients were excluded if there was a history of cancer, pre-existing pulmonary hypertension, pregnancy or postpartum status, contraindication to AC, or treatment with systemic thrombolysis. Baseline Pulmonary Embolism Severity Index (PESI) scores were computed. Outcomes including length of stay (LOS), bleeding complications, resolution of RV dysfunction, and mortality were compared between patients who received UACDT and those managed with AC alone. A total of 104 patients met inclusion criteria, 65 of whom underwent UACDT. The cohorts had similar PESI scores ( P = 0.45) and no clearly imbalanced confounding variables. There was no significant difference in LOS ( P = 0.11). UACDT was associated with more bleeding complications (exact P = 0.04). Follow-up transthoracic echocardiograms performed in 54 UACDT and 24 AC patients demonstrated similar rates of resolution of RV dysfunction (61% in UACDT patients versus 75% in AC patients, P = 0.25). Overall one-year mortality was approximately 5% in both groups (exact P > 0.99). In this limited retrospective analysis of intermediate-risk PE patients, UACDT treatment was not associated with mortality benefit or increased resolution of RV dysfunction.

Outcomes of surgical and transcatheter aortic valve replacement in the octogenarians-surgery still the gold standard?

BACKGROUND: Contemporary options for aortic valve replacement (AVR) include transcatheter and surgical approaches (TAVR and SAVR). As evidence accrues for TAVR in high and intermediate risk patients, some clinicians advocate that all patients aged over 80 years should only receive TAVR. Our aim was to investigate the utility of SAVR and minimally invasive AVR (mAVR) among octogenarians in the current era of TAVR. METHODS: From 2002 to 2015, 1,028 octogenarians underwent isolated AVR; 306 TAVR and 722 SAVR, of which 378 patients underwent mAVR. Logistic regression and Cox modeling were used to evaluate overall operative mortality and mid-term survival, respectively. Patients were stratified based on procedural approaches (mAVR or full sternotomy for SAVR, and transfemoral or alternate access for TAVR). Median follow-up was 35 [interquartile range (IQR) 14-65] months. RESULTS: Compared to SAVR patients, TAVR patients were relatively older (86.2 versus 84.2 years) with co-morbidities such as chronic kidney disease (CKD), diabetes mellitus (DM), cerebrovascular disease (CVD), and prior myocardial infarction (MI), all P<0.05. The mean STS-PROM for the TAVR group was statistically higher, 6.81 versus 5.58 for the SAVR group (P<0.001). The median in-hospital LOS was statistically higher for the SAVR group (P<0.05). Cox proportional hazard modeling, adjusted for temporal differences in procedure and patient selection, identified age, New York Heart Association (NYHA) class III/IV, preoperative creatinine, severe chronic lung disease, prior cardiac surgery as significant predictors of decreased survival (all P<0.05), while type of intervention (approach) was non-contributory. Adjusted operative mortality stratified by procedure approaches was similar between full sternotomy SAVR and mAVR, and between alternative access and transfemoral TAVR. CONCLUSIONS: After adjusting for confounders, TAVR (regardless of approach), SAVR, and mAVR had comparable operative mortality and mid-term survival. Treatment decisions should be individualized with consensus from a multi-disciplinary heart team, taking into account patient co morbidities, frailty, and quality of life. We believe certain patient groups will still benefit from SAVR even in this elderly population.

Usefulness of Intracoronary Brachytherapy for Patients With Resistant Drug-Eluting Stent Restenosis.

In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.

Outcomes in patients undergoing percutaneous ventricular assist device implantation for cardiogenic shock.

BACKGROUND: Percutaneous ventricular assist devices (PVADs) offer an important but resource-intensive option for management of severe cardiogenic shock (CS). Optimal selection of patients for PVAD support remains undefined. We investigated outcomes, including characteristics associated with in-hospital survival, during PVAD support for CS. METHODS: We established a prospective quality improvement program among patients undergoing TandemHeart PVAD implantation for CS at Brigham and Women's Hospital (Boston, MA). We evaluated 65 consecutive patients between 2006 and 2014, analyzing demographic, clinical, laboratory, hemodynamic, and survival data. RESULTS: Thirty-two patients (49.2%) survived to hospital discharge, of which 12 received destination surgical therapy. Baseline characteristics associated with survival included younger age (47 ± 15 years vs 61 ± 11 years; p<0.001), non-ischemic cardiomyopathy (NICMP) vs ischemic CMP (survival 70.4% vs 34.2%, p=0.004), and, paradoxically, lower presenting left ventricular ejection fraction (LVEF) (survival 66.7% for LVEF ⩽15%, 41.2% for LVEF 16-25%, 25.0% for LVEF >25%; p=0.010). Younger age (p=0.026) and NICMP (p=0.034) remained independent predictors of survival. Twenty-four hours after PVAD placement, a more modest increase in cardiac index (⩽0.75 L/min/m(2)) was associated with higher in-hospital mortality (OR 6.3, 95% CI 1.8-22.1), as was lack of improvement in serum anion gap (⩽2 mEq/L; OR 5.1, 95% CI 1.6-16.6). CONCLUSIONS: Despite intensive care and provision of circulatory support, survival is poor in severe CS. Patients in CS with younger age and NICMP were more likely to survive to hospital discharge. Less robust hemodynamic improvement and persistent acidosis after 24 hours of PVAD support also identified patients less likely to survive.