Vascular Surgeons Are Not Adequately Valued by Traditional Productivity Metrics.

BACKGROUND: Reimbursements for professional services performed by clinicians are under constant scrutiny. The value of a vascular surgeon's services as measured by work relative value units (wRVUs) and professional reimbursement has decreased for some of the most common procedures performed. Hospital reimbursements, however, often remain stable or increases. We sought to evaluate fistulagrams as a case study and hypothesized that while wRVUs and professional reimbursements decrease, hospital reimbursements for these services increased over the same time period. METHODS: Medicare 5% claims data were reviewed to identify all fistulagrams with or without angioplasty or stenting performed between 2015 and 2018 using current procedural terminology codes. Reimbursements were classified into 3 categories: medical center (reimbursements made to a hospital for a fistulagram performed as an outpatient procedure), professional (reimbursement for fistulagrams based on compensation for procedures: work RVUs, practice expense RVU, malpractice expense RVU), and office-based laboratory (OBL, reimbursement for fistulagrams performed in an OBL setting). Medicare's Physician Fee Schedule was used to calculate wRVU and professional reimbursement. Medicare's Hospital Outpatient Prospective Payment System-Ambulatory Payment Classification was used to calculate hospital outpatient reimbursement. RESULTS: From 2015 to 2018, we identified 1,326,993 fistulagrams. During this study period, vascular surgeons experienced a 25% increase in market share for diagnostic fistulagrams. Compared with 2015, total professional reimbursements from 2017 to 2018 for all fistulagram procedures decreased by 41% (-$10.3 million) while OBL reimbursement decreased 29% (-$42.5 million) and wRVU decreased 36%. During the same period, medical center reimbursement increased by 6.6% (+$14.1 million). CONCLUSIONS: Vascular surgeons' contribution to a hospital may not be accurately reflected through traditional RVU metrics alone. Vascular surgeons performed an increasing volume of fistulagram procedures while experiencing marked reductions in wRVU and reimbursement. Medical centers, on the other hand, experienced an overall increase in reimbursement during the same time period. This study highlights that professional reimbursements, taken in isolation and without consideration of medical center reimbursement, undervalues the services and contributions provided by vascular surgeons.

Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.

BACKGROUND: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality. METHODS: Manufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed. RESULTS: A total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified. CONCLUSIONS: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.

Current status of long-term prognosis among all subtypes of pulmonary hypertension in Japan.

BACKGROUND: In the current era of treatment of pulmonary hypertension (PH) in Japan, combination therapy has been frequently used thanks to the medical insurance system. Additionally, pulmonary balloon angioplasty (BPA) is widely performed for chronic thromboembolic PH (CTEPH). METHODS: To elucidate the long-term prognosis and the prognostic factors among all five subtypes of PH in this new era, we examined the current status of management of PH from November 2012 to April 2016 in the multicenter registry by the Japanese Pulmonary Circulation Society. RESULTS: Among 1253 consecutive patients registered from 20 PH centers in Japan, we analyzed 997 patients with mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization. Transplant-free survival at 5 years in pulmonary arterial hypertension (PAH), PH due to left-heart disease, PH due to lung diseases, CTEPH, and miscellaneous PH were 74.0, 69.3, 63.7, 92.0, and 55.3%, respectively. Of note, 32% of PAH patients were treated with double combination therapy and 42% of those with triple combination therapy, and 66% of CTEPH patients with BPA. Although PAH patients with triple combination therapy had worse hemodynamic parameters than those with other medications, triple combination therapy showed the best prognosis. BPA in CTEPH improved survival even when adjusted for the key background factors. CONCLUSIONS: In the current era of PH treatment in Japan, the five-year transplant-free survival rate in this study was 74% for PAH and 92% for CTEPH, in which active combination medical therapy for PAH and higher performance rate of BPA for CTEPH may be involved.

Meta-analysis of use of balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension.

BACKGROUND: Current guidelines give balloon pulmonary angioplasty (BPA) a Class IIb recommendation for use in inoperable chronic thromboembolic pulmonary hypertension (CTEPH), as its safety and efficacy remain poorly defined. We conducted a systematic review and meta-analysis to evaluate BPA effectiveness. METHODS: Medline, Cochrane Library and Scopus were searched for original studies from database inception dates until 24th May 2018. Prospective studies reporting outcomes before and after BPA in inoperable CTEPH patients were included. Studies with <20 patients were excluded. Data were pooled using a random effects model represented as weighted mean differences with 95% confidence intervals (CIs). RESULTS: Seventeen noncomparative studies comprising 670 CTEPH patients (mean age 62 years; 68% women) were included. Meta-analysis showed significantly decreased mean pulmonary artery pressure (-14.2 mm Hg [95% CI -18.9, -9.5]), pulmonary vascular resistance (-303.5 dyn·s/cm5 [95% CI -377.6, -229.4]) and mean right atrial pressure (-2.7 mm Hg [95% CI -4.1, -1.3]) after BPA. Six-minute walk distance (67.3 m [95% CI 53.8, 80.8]) and cardiac output (0.2 l/min [95% CI 0.0, 0.3]) were significantly increased following BPA. From 12 studies reporting mortality with median follow-up of 9 months after BPA (range, 1-51 months), pooled incidence of short (≤1 month) and long-term mortality (>1 month) was 1.9% and 5.7%, respectively. CONCLUSION: This systematic review and meta-analysis suggests mildly improved hemodynamics and overall low mortality rates following BPA in inoperable CTEPH patients. This non-comparative evidence can be used to facilitate decision making until the results of larger, controlled studies become available.

Prolonged QRS duration as a predictor of right ventricular dysfunction after balloon pulmonary angioplasty.

BACKGROUND: Balloon pulmonary angioplasty (BPA) has shown beneficial effects for chronic thromboembolic pulmonary hypertension (CTEPH). However, previous studies have shown less cardiac output improvement and symptoms remaining after BPA, implying poor right ventricular (RV) function recovery. Therefore, we investigated the residual RV dysfunction after BPA to reveal risk factors, clinical effects, and possible underlying histopathological mechanisms. METHODS AND RESULTS: We investigated 61 consecutive CTEPH patients who underwent cardiovascular magnetic resonance before and 3 and 12 months after BPA series. Residual dysfunction (RD) of RV was defined as RV end-diastolic volume index >100 ml/m2 or RV ejection fraction (EF) <45% at 12-month follow-up. Patients were divided into RD (44%) and normalized dysfunction (ND) (56%) groups. Compared with the ND group, the RD group had significantly worse World Health Organization (WHO) functional class at follow-up. No significant hemodynamic differences were observed between the groups. On multivariable logistic regression analysis, male sex (odds ratio [OR] 12.5, p = 0.004) and prolonged QRS duration (OR 1.08, p = 0.029) were independently associated with residual RV dysfunction. Additionally, RV histopathology in 11 CTEPH autopsy cases showed that QRS duration was correlated with RV fibrosis area. CONCLUSIONS: Relatively high percentage (44%) of residual RV dysfunction with worse WHO functional class was observed in CTEPH patients even after BPA. Prolonged QRS duration may predict poor recovery in RV function after BPA.

Balloon pulmonary angioplasty for the treatment of residual or recurrent pulmonary hypertension after pulmonary endarterectomy.

BACKGROUND: Pulmonary endarterectomy (PEA) is the treatment of choice for chronic thromboembolic pulmonary hypertension (CTEPH). However, persistent pulmonary hypertension continues in 5-35% of patients after PEA. Recently, balloon pulmonary angioplasty (BPA) showed promise as a strategy for patients with non-operable CTEPH. Therefore, we investigated the usefulness of BPA for residual pulmonary hypertension after PEA. METHODS: Fifteen patients with residual pulmonary hypertension after PEA received 71 BPA sessions (4.7 ±â€¯1.4 sessions/patient). The mean time between the PEA and the first BPA session was 28.1 ±â€¯25.8 months. All patients underwent a comprehensive diagnostic work-up, including right heart catheterization, functional and laboratory tests, before, and 6-4 weeks after the BPA sessions. RESULTS: After BPA, the mean pulmonary arterial pressure decreased from 44.7 ±â€¯6.4 to 30.8 ±â€¯7.5 mm Hg (31% decline; p < 0.001). Pulmonary vascular resistance decreased from 551.9 ±â€¯185.2 to 343.8 ±â€¯123.8 dyn∗s/cm-5 (38% decline; p < 0.001). The 6-min walking distance increased from 383 ±â€¯104 to 476 ±â€¯107 m (mean change +93 m; p < 0.001). In two sessions (2.8%), serious periprocedural complications occurred. During a mean follow-up of 18 ±â€¯14.3 months, one patient died two months after the last BPA session. Fourteen patients survived. CONCLUSIONS: BPA could be a promising therapeutic strategy for persistent pulmonary hypertension after PEA in patients with CTEPH.

The evolving role of drug-coated balloons for the treatment of complex femoropopliteal lesions.

Conventional therapies for transcatheter treatment of patients with infrainguinal obstructive disease remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular scaffold and their inherent limitations. A systematic research of the medical databases (Pubmed) has been conducted for this up-to-date review. Key words, such as "drug-coated balloons" (DCB), "drug-eluting balloon," "in-stent-restenosis" (ISR), "de-novo stenosis," "plain old angioplasty," "atherectomy," "debulking," "superficial femoral artery," "popliteal artery," "above/below the knee," and "peripheral artery disease" have been used for literature search. Furthermore, data from reviews, original contributions, randomized controlled studies, observational studies, registries and single center experiences have been considered. Overall, an increasing level of evidence supports the use of DCB for the treatment of long, complex, heavily calcified femoropopliteal non-occlusive and occlusive lesions, including failure after BM stent implantation due to ISR. However, more studies will be necessary to investigate the long-term effects of DCB-treatment in these real-world lesions.

Advances in Percutaneous Therapies for Peripheral Artery Disease: Drug-Coated Balloons.

PURPOSE OF REVIEW: This review paper provides a summary on the use of drug-coated balloons in peripheral artery disease. It covers the main drug-coated balloon (DCB) trials. It is divided into categories of lesions: superficial femoral artery and popliteal lesions, infra-popliteal lesions and in-stent restenosis. It also includes an overview of the future of DCBs, highlighting the main ongoing trials. RECENT FINDINGS: The latest research on DCB focuses on newer types of DCBs, mainly paclitaxel-coated but with lower doses. Another area of latest DCB research is its use in superficial femoral artery and popliteal artery in-stent restenosis, with superior outcomes. Drug-coated balloons produce better outcomes than percutaneous transluminal angioplasty alone in de novo and in-stent restenosis lesions of superficial femoral artery and popliteal arteries. More data are needed to demonstrate efficacy and safety of DCBs in infrapopliteal disease. Newer DCBs and adjunctive therapy may provide improved outcomes for peripheral artery disease interventions.

State of the art: balloon catheter technologies - drug-coated balloon.

Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios.

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

BACKGROUND: Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. METHODS: One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. RESULTS: Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P=0.009) or DA (55±29%, P=0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. CONCLUSIONS: Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752.

Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon).

BACKGROUND: Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB. METHODS: This was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months. RESULTS: Patients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014). CONCLUSIONS: Superiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Future Directions in Chronic Thromboembolic Pulmonary Hypertension. Disease at a Crossroads?

In looking toward the future of chronic thromboembolic pulmonary hypertension, the following four clinical questions deserve careful consideration: (1) What is inoperable disease, and how is it defined? (2) Is there a role for targeted medical therapy in technically operable, proximal disease? (3) Where does balloon pulmonary angioplasty fit into the treatment algorithm? (4) How should we approach patients with symptomatic chronic pulmonary thromboembolism without pulmonary hypertension? The search for these answers will continue to propel this field forward. Consequently, the crossroads we find ourselves at signal opportunity and hope for future advances.

[Preliminary results and future perspectives of the Piedmont Adult Congenital Heart Disease Registry]. / Risultati iniziali e prospettive future del Registro Piemontese delle Cardiopatie Congenite dell'Adulto.

BACKGROUND: Adults with congenital heart disease are a relatively new population that progressively increases in size and complexity. In Italy, there are no accurate data concerning the distribution of congenital defects and the long-term outcome relating to both congenital heart disease per se and comorbidities, due to the aging process. METHODS: The Piedmont Adult Congenital Heart Disease Registry has been designed to investigate these aspects and to support a high quality healthcare development for grown-up congenital heart patients. Within 2 years, 459 consecutive patients routinely followed in 10 divisions of cardiology in Piedmont were included in the project. Electronic dedicated software has supported data collection. RESULTS: Mean age of patients is 35 ± 16 years. Septal defects are the most common type of congenital heart disease (35.3%). At baseline evaluation, 71.7% of patients reported a previous surgical and/or percutaneous treatment and 6.3% an electrophysiological procedure. Freedom from intervention is 44%, 81% and 56% at the age of 18, 30 and 45 years, respectively. Patients who had a treatment during infancy show a better intervention-free survival (p=0.038) compared with patients treated during adulthood. Despite the majority of the population had an almost preserved functional status, 27.5% had ≥1 long-term sequelae (arrhythmias 27.5%; pulmonary hypertension 5.2%; neurological problems 4.1%; cyanosis 4.8%; liver dysfunction 2.4%; enteropathy 2.4%; lung disease 2.2%). During 2 years of follow-up, the estimated mortality rate is 0.88%. CONCLUSIONS: Adults with congenital heart disease are a heterogeneous population of relatively young patients with relevant clinical and social problems. The late sequelae related to both the underlying heart disease and the advancing age require continuous monitoring and lifelong specialized care.

Experience with vertebral artery origin stenting and ostium dilatation: results of treatment and clinical outcomes.

BACKGROUND: The vertebral artery (VA) ostium (VAO) is a common stenosis site. Most patients with VAO stenosis refractory to medical treatment are treated endovascularly using stenting. To optimally cover the ostial plaque, which frequently extends into the adjacent subclavian artery, part of the stent must overhang in the subclavian artery. This configuration makes subsequent VA access very challenging in cases of in-stent or distal vertebrobasilar pathology; it also obstructs the distal subclavian artery. OBJECTIVE: To determine whether angioplasty at the ostium with a dual balloon (Flash Ostial) specially designed to allow the subclavian end of the stent to flare might circumvent these problems and, most importantly, provide optimal plaque coverage around the vertebral ostium. METHODS: Between June 2012 and July 2014, 11 patients with symptomatic VAO stenosis refractory to best medical therapy were treated with stenting and dual balloon Flash angioplasty. Demographics, results, and outcomes were reviewed. RESULTS: A total of 12 VAO stenting-dual balloon angioplasty procedures were performed (mean stenosis, 83.6%; range, 78-90%). Nine patients had mild-to-moderate (40-60%) contralateral VAO stenosis. The initial average modified Rankin Scale (mRS) score was 1.25. In all cases, immediate postangioplasty angiography showed excellent stent apposition against the VA and around the ostium in the subclavian artery. No permanent perioperative complications or deaths occurred. At a mean follow-up of 10.8 months (range 2-24), all patients had symptom resolution and no evidence of symptomatic restenosis on neuroimaging/Doppler studies; the average mRS score was 0.66. Three patients continued to have previously diagnosed mid-cervical VA stenosis; one of them had postprocedure dissection and an asymptomatic in-stent stenosis at 8 months. CONCLUSIONS: Safety and feasibility were demonstrated using the Ostial Flash system for VAO stenting and angioplasty. No permanent perioperative complications were seen.