Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Who Should do it? Ehtisham Mahmud, MD, FACC, FSCAI Professor and Division Chief, Cardiovascular Medicine Director, Sulpizio Cardiovascular Center University of California, San Diego
Disclosures • No relevant disclosures
Surgical Principles • Well established 1,2 – Median sternotomy – Cardiopulmonary bypass – Circulatory arrest – Bilateral endarterectomy – Identification of the plane – Complete endarterectomy 1-Jamieson et al. Cur Prog Surg 2000, 37:165-252 2-Madani et al. Op Tech in Tho & Card Surg 2006, 11:264-274
UCSD PTE: Pre & Post-op Hemodynamics (N>3000) 45.9 897 50 1000 26 40 800 30 600 20 245 400 10 200 0 0 Mean PA (mm Hg) PVR (dynes/sec/cm-5) 79 5.8 80 6 3.6 45 60 4 40 2 20 0 0 Sys PA (mm Hg) C.O. (Lit/min) Pre-op Post-op
Surgical Classification of CTEPH
Courtesy Irene Lang, MD
Balloon Pulmonary Angioplasty • First case report 1988 CHEST 1988 94:1249-53 • First Case Series 2001 • Circulation 2001;103:10-13 • 18 Patients mPAP 43.0+/-12.1 to 33.7+/-10.2 mmHg ( P 0.007) vessels remained patent on follow-up • (61%) → RPE • (17%) → Mechanical Ventilation • (5.6%) → Mortality
Okayama Experience with BPA for CTEPH Circ Cardiovasc Interv. 2012;5:748-755. • 68 patients – 255 sessions • 4 (2-8) sessions per patient • Vascular injury 60% • 6% required mechanical ventilation • 1 death (1.5% mortality)
Pre and Post BPA Left Lower Lobe (A8,9,10): Pressure Gradient Based A8 A9 A10
Pre and Post BPA Left Lower Lobe (A8,9,10): Pressure Gradient Based A8: BPA with 2.0 and 3.0 Maverick A8 A9: Pd/Pa based with improvement from 0.40 to 0.52 to 0.82 with 2.0 to 3.0 to 4.0 balloons A9 A10: BPA with 2.0 and 3.0 balloons A10
Pre and Post BPA Left Lower Lobe (A8,9,10): Pressure Gradient Based A8 A9 A10
Image Guided Treatment: ?IVUS or OCT Lang et al. Eur Respir Rev 2017; 26: 160119
Physiology Guided Treatment: Pd/Pa Inami et al. J Am Coll Cardiol Intv 2014;7:1297 – 306
Mahmud et al. J Am Coll Cardiol 2018;71:2468-86
UC San Diego Equipment and Approach (2018) • Single plane angiography (biplane for diagnostic) • 8-9F venous access sheath: femoral rather than internal jugular • 6-7F long sheath telescoped through 9F introducing sheath • 6F guide catheter: multipurpose, Judkins right, Hockeystick, EBU • Anticoagulation: heparin with ACT 200-250s • Contrast: 50/50 • 0.014” guide wires; no polymer jacketed wires • 2-5 mm compliant; NC or Sculpting balloon catheters for recalcitrant • IVUS and OCT rarely used • Increasingly using resting pressure gradients (Pd/Pa) to target and optimize Mahmud et al. Interv Cardiol Clin 2018;7:103-117
Tools for Balloon Pulmonary Angioplasty Yes No • Pressure wire/catheter • Polymer jacketed wires • Cutting balloon • Sculpting/scoring balloons
BPA Complications – Hemoptysis • Early Signs – New Cough – Hypoxia • Vascular injury – Wire – Balloon – Contrast • Imaging – Vascular leak or stain. – New consolidation in treated areas – Reperfusion pulmonary edema – Radiation Injury
Management of Acute Hemoptysis During BPA 1. Immediate balloon tamponade of the injured vessel 2. Oxygenation management including oropharyngeal suctioning, supplemental oxygen, non-invasive positive pressure ventilation (mechanical ventilation/ECMO) 3. Cessation/reversal of anticoagulation 4. Repeat prolonged balloon tamponade as necessary 5. For persistent pulmonary hemorrhage consider bailout transcatheter coil embolization, covered stent implantation, and/or gelfoam/adipose injection Mahmud et al. Interv Cardiol Clin 2018;7:103-117
Approach to Pouch Occlusions: Antegrade Wire Escalation Be Conservative!!
Restoration of Flow to Pouch Occlusions Works: One Year Later AP LAO 30
Long-term Outcomes after BPA for CTEPH Inami et al. Circulation 2016;134:2030 – 2032
Japan: Clinical and Hemodynamic Data WHO-FC mPAP Cardiac Index PVR p<0.001 p=0.002 p<0.001 p<0.001 p=0.002 p<0.001 p=0.002 p<0.001 p<0.001 p<0.001 p<0.00 p=0.002 4.0 1 1500 60 73 1 1 Ⅳ Cardiac index (L/min/m 2 ) 1250 3.5 PVR (dyne/sec/cm 5 ) 50 WHO functional class 43.2 ± 11.0 2.9 ± 0.7 mPAP (mmHg) 6 1000 192 34 853.7 ± 450.7 Ⅲ 3.0 2.6 ± 0.8 2.8 ± 0.6 40 750 359.5 ± 222.6 2.5 130 Ⅱ 56 181 30 24.3 ± 6.4 500 22.5 ± 5.4 288.1 ± 194.5 2.0 20 250 27 46 Ⅰ 0 0 0 0 Before After Follow-up Before After Follow-up After After Follow-up Before Follow-up Before Ogawa A et al. Circulation Cardiovasc Outcomes 2017 Nov;10(11). pii: e004029
UC San Diego BPA Registry Hemodynamics Pre-BPA Post-BPA P Value RA (mmHg) 7.9 ± 3.2 PA systolic (mmHg) 74.6 ± 12.9 PA diastolic (mmHg) 24.9 ± 4.9 PA mean (mmHg) 43.4 ± 6.1 PCWP (mmHg) 9.7 ± 3.4 Cardiac output (L/min) 5.7 ± 1.7 Cardiac index (L/m/m 2 ) 2.9 ± 0.7 PVR (WU) 6.4 ± 2.7 *For subjects with baseline mPAP >30 and ≥3 BPA procedures (n=28)
UC San Diego BPA Registry Hemodynamics Pre-BPA Post-BPA P Value RA (mmHg) 7.9 ± 3.2 5.5 ± 2.3 <0.01 PA systolic (mmHg) 74.6 ± 12.9 56.1 ± 13.2 <0.01 PA diastolic (mmHg) 24.9 ± 4.9 17.5 ± 4.4 <0.01 PA mean (mmHg) 43.4 ± 6.1 32.5 ± 6.4 <0.01 PCWP (mmHg) 9.7 ± 3.4 9.0 ± 3.4 <0.01 Cardiac output (L/min) 5.7 ± 1.7 5.9 ± 1.2 0.27 Cardiac index (L/m/m 2 ) 2.9 ± 0.7 3.1 ± 0.5 0.08 PVR (WU) 6.4 ± 2.7 4.0 ± 1.7 <0.01 *For subjects with baseline mPAP >30 and ≥3 BPA procedures (n=28)
UC San Diego BPA Registry Adverse Events N = 252 sessions (60 subjects) Hemoptysis 23 (9.1%) Lung vascular injury 9 (3.6%) Reperfusion lung edema 0 Non-invasive PPV 0 Intubation 0 Acute kidney injury 0 Inpatient death 0
UC San Diego BPA Registry WHO Functional Class 100% 90% 80% WHO class I 70% WHO class II 60% WHO class III 50% WHO class IV 40% 30% P <0.01 20% 10% 0% Pre-BPA Post-BPA *For subjects with mPAP >30 and ≥3 BPA procedures
UC San Diego BPA Registry 6-Minute Walk Distance 600 500 400 420 361 Meters 300 200 P <0.01 100 0 Pre-BPA Post-BPA *For subjects with mPAP >30 and ≥3 2 BPA procedures
Conclusions • BPA is a feasible therapeutic option for CTEPH patients with: --inoperable disease --segmental/subsegmental disease --post PTE residual disease • BPA should be performed as a part of a multidisciplinary CTEPH team • BPA should be physiology based: perfusion scans and invasive hemodynamic measurements • Future investigation for BPA to focus on: --optimal patient selection and acquisition of objective adjudicated data --standardized technique and procedural endpoints --long-term patency and clinical success --registries and randomized controlled trials
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