Risk of Mortality Related to Recurrent Limb Events After Endovascular Revascularization of the Superficial Femoral Artery for Peripheral Artery Disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) Study.

Endovascular revascularization of the superficial femoral artery (SFA) may lead to recurrent ischemic syndromes, revascularization, or amputation. The impact of these events on mortality is unknown. We followed all patients having SFA endovascular revascularization for claudication or chronic limb-threatening ischemia in 2 cardiovascular (CV) divisions in Boston, Massachusetts. Any recurrent limb event after the initial SFA revascularization included recurrent claudication (67%), limb ulceration or gangrene (13%), repeat endovascular revascularization (61%), surgical revascularization (15%), or major (9%) or minor amputation (8%). We linked data to the National Death Index to ascertain cause of death grouped into CV mortality, or non-CV mortality. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) from Cox proportional hazards and sub-HRs from Fine-Gray competing risks analyses were clustered by patient. Overall, there were 202 patients with 253 index limb endovascular procedures. A recurrent limb event occurred in 123 limbs (49%) and 93 patients (46%). Patients with and without recurrent limb events had similar numbers of deaths over follow-up (76 [62%] vs 71 [55%], respectively). In multivariable models, recurrent limb event was not related to all-cause death (HR 0.92, 95% CI 0.64 to 1.33), CV death (HR 1.29, 95% CI 0.72 to 1.30), or non-CV death (HR 0.65, CI 0.39 to 1.07). Competing risk analyses suggested male gender and chronic limb-threatening ischemia were more strongly related to CV death, and chronic kidney more strongly related to disease to non-CV death. In conclusion, recurrent limb events, which contribute to patient morbidity, do not increase the risk of all-cause or cause-specific mortality, and should not discourage repeat revascularization to relieve symptoms or ischemia.

Patient and limb outcomes 10 years after endovascular revascularization of the superficial femoral artery for peripheral artery disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) study.

BACKGROUND: We aimed to describe patient and limb outcomes in the decade after endovascular revascularization for chronic lower-extremity peripheral artery disease (PAD). METHODS: We assessed outcomes in patients having endovascular revascularization of the superficial femoral artery in two centers between 2003 and 2011 and followed for a median 9.3 (25-75%: 6.8, 11.1) years. Outcomes included death, myocardial infarction, stroke, repeat limb revascularizations, and amputations. We used competing risks analysis with clustering by patient to determine the hazard ratios (HR) and 95% CI for patients, and procedural characteristics for cause of death, cardiovascular events, and major adverse limb events (MALE). RESULTS: There were 253 index limb revascularizations in 202 patients followed for a median 9.3 years. Patients had intensive medical treatment with 90% on statins and 80% on beta-blockers. During follow up there were 57 (28%) cardiovascular deaths and 62 (31%) noncardiovascular deaths. Of the 253 limbs, 227 (90%) were free of MALE over follow up and 93 (37%) had MALE or minor repeat revascularization. In multivariable models, cardiovascular death significantly associated with critical limb ischemia (HR = 3.21, 95% CI = 1.84, 5.61) and noncardiovascular death with chronic kidney disease (HR = 2.69, 95% CI = 1.68, 4.30), and smoking (HR = 2.75, 95% CI = 1.01, 7.52). MALE or minor repeat revascularization associated with critical limb ischemia (HR = 1.43, 95% CI = 0.84, 2.43), smoking (HR = 2.49, 95% CI = 1.26, 4.90), and lesion length > 200 mm (HR = 1.51, 95% CI = 0.98, 2.33). CONCLUSIONS: Among patients with intensive medical therapy, the risk of noncardiovascular death was high and similar to cardiovascular death. Endovascular intervention can have acceptable long-term results. Future studies should evaluate strategies to reduce both cardiovascular and noncardiovascular deaths.

Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.

AIMS: Based on randomized trials using first-generation devices, transcatheter aortic valve replacement (TAVR) is well established in the treatment of high-risk (HR) patients with severe aortic stenosis (AS). To date, there is a paucity of adjudicated, prospective data evaluating outcomes with newer generation devices and in lower risk patients. We report early outcomes of a large, multicentre registry of inoperable, HR, and intermediate-risk (IR) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve (THV). METHODS AND RESULTS: Patients with severe, symptomatic AS (583 high surgical risk or inoperable and 1078 IR) were enrolled in a multicentre, non-randomized registry at 57 sites in the USA and Canada. All patients received TAVR with the SAPIEN 3 system via transfemoral (n = 1443, 86.9%) and transapical or transaortic (n = 218, 13.1%) access routes. The rate of 30-day all-cause mortality was 2.2% in HR/inoperable patients [mean Society of Thoracic Surgeons (STS) score 8.7%] and 1.1% in IR patients (mean STS score 5.3%); cardiovascular mortality was 1.4 and 0.9%, respectively. In HR/inoperable patients, the 30-day rate of major/disabling stroke was 0.9%, major bleeding 14.0%, major vascular complications 5.1%, and requirement for permanent pacemaker 13.3%. In IR patients, the 30-day rate of major/disabling stroke was 1.0%, major bleeding 10.6%, major vascular complications 6.1%, and requirement for permanent pacemaker 10.1%. Mean overall Kansas City Cardiomyopathy Questionnaire score increased from 47.8 to 67.8 (HR/inoperable, P < 0.0001) and 54.7 to 74.0 (IR, P < 0.0001). Overall, paravalvular regurgitation at 30 days was none/trace in 55.9% of patients, mild in 40.7%, moderate in 3.4%, and severe in 0.0%. Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days, while aortic valve area increased from 0.69 to 1.67 cm(2). CONCLUSIONS: The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation. TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313.

Surgical Versus Percutaneous Femoral Access for Delivery of Large-Bore Cardiovascular Devices (from the PARTNER Trial).

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.

Transcatheter Aortic Valve Replacement via Left Anterior Thoracotomy in a Patient With Severe Pectus Excavatum.

With the development of the transcatheter aortic valve replacement, innovative approaches can be geared to atypical and challenging cases. We describe a case of transcatheter aortic valve replacement via a left anterior thoracotomy in a patient with pectus excavatum and unusual intrathoracic anatomy where surgical and traditional transcatheter aortic valve replacement approaches were deemed inapplicable.

Role of alternative interventional procedures when endo- and epicardial catheter ablation attempts for ventricular arrhythmias fail.

BACKGROUND: Ventricular tachycardia (VT) refractory to antiarrhythmic drugs and standard percutaneous catheter ablation techniques portends a poor prognosis. We characterized the reasons for ablation failure and describe alternative interventional procedures in this high-risk group. METHODS AND RESULTS: Sixty-seven patients with VT refractory to 4±2 antiarrhythmic drugs and 2±1 previous endocardial/epicardial catheter ablation attempts underwent transcoronary ethanol ablation, surgical epicardial window (Epi-window), or surgical cryoablation (OR-Cryo; age, 62±11 years; VT storm in 52%). Failure of endo/epicardial ablation attempts was because of VT of intramural origin (35 patients), nonendocardial origin with prohibitive epicardial access because of pericardial adhesions (16), and anatomic barriers to ablation (8). In 8 patients, VT was of nonendocardial origin with a coexisting condition also requiring cardiac surgery. Transcoronary ethanol ablation alone was attempted in 37 patients, OR-Cryo alone in 21 patients, and a combination of transcoronary ethanol ablation and OR-Cryo (5 patients), or transcoronary ethanol ablation and Epi-window (4 patients), in the remainder. Overall, alternative interventional procedures abolished ≥1 inducible VT and terminated storm in 69% and 74% of patients, respectively, although 25% of patients had at least 1 complication. By 6 months post procedures, there was a significant reduction in defibrillator shocks (from a median of 8 per month to 1; P<0.001) and antiarrhythmic drug requirement although 55% of patients had at least 1 VT recurrence, and mortality was 17%. CONCLUSIONS: A collaborative strategy of alternative interventional procedures offers the possibility of achieving arrhythmia control in high-risk patients with VT that is otherwise uncontrollable with antiarrhythmic drugs and standard percutaneous catheter ablation techniques.

Usefulness and safety of ultrasound-assisted catheter-directed thrombolysis for submassive pulmonary emboli.

The optimal treatment for intermediate-risk pulmonary embolism (PE) remains unclear. Our goal was to describe the safety and efficacy of the EkoSonic ultrasound-assisted catheter-directed thrombolysis system (EKOS Corporation, Bothell, Washington) in a real-world registry of patients with intermediate-risk PE. Fifty-three consecutive patients with intermediate-risk PE treated with ultrasound-assisted catheter-directed thrombolysis at Brigham and Women's Hospital from 2010 to 2014 were analyzed. The primary outcome was a change in directly measured pulmonary artery pressures as assessed using logistic regression with generalized estimating equations to account for serial measurements. Patients received an average of 24.6 ± 9 mg of alteplase using the EKOS catheter with an average treatment time of 15.9 ± 3 hours. After treatment, there was a 7.2- and a 11.4-mm Hg reduction in mean and systolic pulmonary artery pressure (95% confidence interval 4.7 to 9.7 mm Hg, p <0.001, and 95% confidence interval 7.8 to 15.0 mm Hg, p <0.001), respectively. In this cohort, 9.4% had any bleeding complication noted during their hospital stay. One patient's alteplase was prematurely discontinued for access site bleeding although no other interventions were required related to bleeding complications.

Transjugular approach in valve-in-valve transcatheter mitral valve replacement: direct route to the valve.

With the recent emergence of transcatheter valve replacement, high-risk cases of structural valve deterioration after mitral bioprosthesis can be treated with valve-in-valve transcatheter mitral valve replacement (TMVR). The transapical approach has become the principal access for TMVR, but we report an alternative direct access for TMVR--transjugular transseptal route--in an 81-year-old woman with a degenerated mitral bioprosthesis.

Reporting trends and outcomes in ST-segment-elevation myocardial infarction national hospital quality assessment programs.

BACKGROUND: For patients who undergo primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction, the door-to-balloon time is an important performance measure reported to the Centers for Medicare & Medicaid Services (CMS) and tied to hospital quality assessment and reimbursement. We sought to assess the use and impact of exclusion criteria associated with the CMS measure of door-to-balloon time in primary PCI. METHODS AND RESULTS: All primary PCI-eligible patients at 3 Massachusetts hospitals (Brigham and Women's, Massachusetts General, and North Shore Medical Center) were evaluated for CMS reporting status. Rates of CMS reporting exclusion were the primary end points of interest. Key secondary end points were between-group differences in patient characteristics, door-to-balloon times, and 1-year mortality rates. From 2005 to 2011, 26% (408) of the 1548 primary PCI cases were excluded from CMS reporting. This percentage increased over the study period from 13.9% in 2005 to 36.7% in the first 3 quarters of 2011 (P<0.001). The most frequent cause of exclusion was for a diagnostic dilemma such as a nondiagnostic initial ECG, accounting for 31.2% of excluded patients. Although 95% of CMS-reported cases met door-to-balloon time goals in 2011, this was true of only 61% of CMS-excluded cases and consequently 82.6% of all primary PCI cases performed that year. The 1-year mortality for CMS-excluded patients was double that of CMS-included patients (13.5% versus 6.6%; P<0.001). CONCLUSIONS: More than a quarter of patients who underwent primary PCI were excluded from hospital quality reports collected by CMS, and this percentage has grown substantially over time. These findings may have significant implications for our understanding of process improvement in primary PCI and mechanisms for reimbursement through Medicare.

Incidence and implications of idiopathic thrombocytopenia following transcatheter aortic valve replacement with the Edwards Sapien(©) valves: a single center experience.

OBJECTIVES: To determine the incidence and etiology of thrombocytopenia following transcatheter Aortic valve replacement (TAVR). BACKGROUND: the use of TAVR in the United States has grown rapidly. Anecdotally, thrombocytopenia following TAVR with the Sapien valves has been observed, though little is known about this phenomenon. METHODS: All patients treated with TAVR using a Sapien valve or who underwent isolated balloon aortic valvuloplasty (BAV) at Brigham and Women's Hospital from October 2009 through November 2012 were analyzed. Post-procedure thrombocytopenia severity was stratified as none (>150,000 cells/µL), mild (100-150,000), and moderate to severe (<100,000). Summary statistics and simple comparisons were evaluated. Linear regression models were used to identify patient or procedural factors associated with platelet count nadir. RESULTS: 112 TAVR and 105 BAV patients were analyzed. Following TAVR the prevalence of thrombocytopenia was 69% and the incidence of new thrombocytopenia was 45% compared to 37% and 17% respectively following BAV (P < 0.01). Similar results were found across all strata of thrombocytopenia severity. Post-TAVR platelet nadirs were greater by 1,840 cells/µL for each 1% increase in STS score (P = 0.03) and 670 cells/µL greater for each 1 mmHg increase in pre-TAVR mean aortic stenosis gradient. Among TAVR patients, thrombocytopenia appears to spontaneously resolve an average of 8 days post-procedure. No differences in clinical outcomes based on thrombocytopenia severity were observed except for an increased use of blood products (P = 0.05). CONCLUSIONS: Thrombocytopenia following TAVR with the Edwards' Sapien valves is a frequent but generally self-limited process. The etiology of this phenomenon is unknown.

Transcatheter aortic valve replacement using the Edwards SAPIEN transcatheter heart valves.

Transcatheter aortic valve replacement has a place in the therapy for valvular aortic stenosis in a selected population of patients with increased risk for standard aortic valve replacement. The SAPIEN family of balloon-expandable transcatheter heart valves is the prototype that initiated this therapy and has undergone rapid development and evolution. The SAPIEN system has taught cardiologists and cardiac surgeons much about the nature of aortic stenosis and the potential for less invasive therapy. This article will review the SAPIEN transcatheter heart valves and the clinical experience.

Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial.

OBJECTIVES: This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). BACKGROUND: VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. METHODS: From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. RESULTS: Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality. CONCLUSIONS: Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.

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.

Transcoronary ethanol ablation for recurrent ventricular tachycardia after failed catheter ablation: an update.

BACKGROUND: Despite substantial progress, radiofrequency catheter ablation (RFCA) fails in some patients. After encouraging results with transcoronary ethanol ablation (TCEA), we began offering TCEA routinely when endocardial and epicardial RFCA failed or a deep intramural substrate was likely. METHODS AND RESULTS: Among 274 consecutive patients who underwent 408 ventricular tachycardia (VT) ablation procedures, 27 patients (21 men; age, 63 ± 13 years; left ventricular ejection fraction, 30 ± 11%; ischemic cardiomyopathy, 14) had 29 TCEA procedures attempted. In 5 patients, TCEA was abandoned because of unfavorable anatomy. In 22 patients, a mean of 1.3 ± 0.6 arteries (range, 1-3 arteries) were targeted for TCEA. After ablation, the targeted VT was no longer inducible in 18 of 22 (82%) patients. Complete heart block occurred in 5 patients, and 3 patients with advanced heart failure died within 30 days of the procedure. After the last TCEA procedure, a VT recurred in 64% of patients, and overall, 32% of patients died. Of 11 patients with prior VT storm, 9 were free of VT storm. At repeat study in 8 patients who had a recurrence, 7 had a new QRS morphology of VT originating from the same general substrate region as the prior VT. CONCLUSIONS: In patients with difficult-to-control VT in whom RFCA fails, TCEA prevents all VT recurrences in 36% and improves arrhythmia control in an additional 27%. Inadequate target vessels, collaterals, and recurrence of modified VTs limit efficacy, but TCEA continues to play an important role for difficult VTs in these high-risk patients.

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.

Prolonged door-to-balloon time: is treatment delayed always treatment denied?

Rapid reperfusion following the onset of ST-segment elevation myocardial infarction has been shown to provide life-saving benefit. Both systemic fibrinolytic therapy and percutaneous coronary intervention have been shown to be effective in reducing mortality, and their effectiveness is greater the sooner they are applied. Percutaneous coronary intervention has become the dominant method of reperfusion and may offer benefit over systemic fibrinolysis in some patients. Accordingly, physicians, hospitals, and professional organizations have developed guidelines and algorithms to both speed and standardize care. In addition, the institutional rapidity of therapy-the mean or median door-to-balloon time-is often publically reported providing further impetus to rapid triage and treatment of ST-segment elevation myocardial infarction. However, some patients do not receive reperfusion within the time guidelines set out by professional organizations. In many instances, this delay relates to medical issues that exist in addition to the patient's myocardial infarction. These data raise the question of whether the most rapid reperfusion is always superior to more delayed but potentially more comprehensive therapy.