When & How I Use Rotational Atherectomy for When & How I Use Rotational Atherectomy for Unprotected Left Main Stem PCI: Unprotected Left Main Stem PCI:

A Personal Experience 2000 - 2006A Personal Experience 2000 - 2006

Joe MotwaniJoe MotwaniConsultant Cardiologist,Consultant Cardiologist,

Southwest Cardiothoracic Centre (SWCC),Southwest Cardiothoracic Centre (SWCC),Derriford Hospital,Derriford Hospital,

Plymouth, Devon, UKPlymouth, Devon, UK

Advanced Angioplasty 2007

NO CONFLICT OF INTEREST TO DECLARE

Rotational Atherectomy

• Developed early 1980s, David Auth PhDduring ‘new device era’

• Unique operating principle – differentialcutting of inelastic (calcified/fibrotic) tissue

• Fall from favour/use late 1990s –1. unfavourable restenosis data (ERBAC,ARTIST)2. regarded as time-consuming to use

However…However…

During past few years, scope of PCI has advanced greatly, During past few years, scope of PCI has advanced greatly, including several subsets:including several subsets:

Complex, calcified lesionsComplex, calcified lesions Very elderly patients (10% JGM PCI pts > 80yrs)Very elderly patients (10% JGM PCI pts > 80yrs) Patients with extensive comorbidity (CRF etc) turned Patients with extensive comorbidity (CRF etc) turned

down for CABGdown for CABG

that provide resurgent role for Rotablator in improving that provide resurgent role for Rotablator in improving procedural outcome.procedural outcome.

In 2006, 55 RA of 462 total PCIs (11.9%)In 2006, 55 RA of 462 total PCIs (11.9%)

Is there contemporary evidence to support this practice?Is there contemporary evidence to support this practice?

ROCCSTARROCCSTAR Trial Trial

RRandomisation andomisation OOf f CCalcified alcified CCoronary oronary SStenoses totenoses toTATAxus stenting with or without xus stenting with or without RRotational atherectomyotational atherectomy

132 patients – at least one moderate-severely 132 patients – at least one moderate-severely calcified lesion on fluoroscopycalcified lesion on fluoroscopy

Rotablation/DES vs DES aloneRotablation/DES vs DES alone Primary endpoint – 8 month binary angiographic Primary endpoint – 8 month binary angiographic

restenosisrestenosis Secondary endpoints – procedural success/MACE; Secondary endpoints – procedural success/MACE;

acute/subacute/late stent thrombosisacute/subacute/late stent thrombosis

ROCCSTAR – recruitment to dateROCCSTAR – recruitment to date

113 patients113 patients

57 Roto/DES57 Roto/DES 56 DES alone56 DES alone

34 large 34 large 23 small23 small 34 large34 large 22 22 smallsmall

(3mm or >)(3mm or >)

92% angiographic follow up92% angiographic follow up

ROCCSTAR – 2 observations to date re impact ofROCCSTAR – 2 observations to date re impact of

Rotablation on procedural outcome in calcified lesionsRotablation on procedural outcome in calcified lesions

1.1. In arriving at 56 pts in DES alone limb, of 64 pts In arriving at 56 pts in DES alone limb, of 64 pts intended for this limb, 8 intended for this limb, 8 (12.5%)(12.5%) unable to predilate unable to predilate fully (placed in ROCCSTAR Rotablator registry)fully (placed in ROCCSTAR Rotablator registry)

2.2. Subacute stent thrombosis 2/56 Subacute stent thrombosis 2/56 (3.6%)(3.6%) in DES in DES alone limb (both in small vessels) vs 0/57 in alone limb (both in small vessels) vs 0/57 in Roto/DES limbRoto/DES limb

0

1

2

3

4

5

6

7

8

9

10

2000 2001 2002 2003 2004 2005 2006

Unprot

LMS PCI

as

%

of

Total

PCI

Yr

Unprot LMS 8 2 17 22 38 32 46

Total PCI 292 322 362 434 459 379 462

2000 – 20062000 – 2006

Unprotected LMS PCI N = 165Unprotected LMS PCI N = 165

of whichof which

Rotablation unprotected LMS N = 44Rotablation unprotected LMS N = 44

(based on strict indication of moderate-severe (based on strict indication of moderate-severe calcification of LMS +/- LAD ostium +/- Cx ostium)calcification of LMS +/- LAD ostium +/- Cx ostium)

= 27% of total unprotected LMS= 27% of total unprotected LMS

Aspects of TechniqueAspects of Technique

Maximum burring duration 10-15 secs/passMaximum burring duration 10-15 secs/pass 42 pts – single burr; 2 pts – stepped approach (only 42 pts – single burr; 2 pts – stepped approach (only

necessary if v severe lesion in v large LMS)necessary if v severe lesion in v large LMS) Maximum burr:artery ratio in this LMS series 0.5 +/- 0.1, Maximum burr:artery ratio in this LMS series 0.5 +/- 0.1,

mean +/- SD (NB STRATAS, CARAT)mean +/- SD (NB STRATAS, CARAT)

1 pt 1 pt 2.25 mm burr2.25 mm burr

5 pts5 pts 2.0 mm burr2.0 mm burr

12 pts12 pts 1.75 mm burr1.75 mm burr

19 pts 19 pts 1.5 mm burr1.5 mm burr

7 pts7 pts 1.25 mm burr1.25 mm burr

Evidence favouring ‘conservative’Evidence favouring ‘conservative’burr:artery ratio also increases burr:artery ratio also increases applicability of Rotablationapplicability of Rotablationto radial/ulnar approaches:to radial/ulnar approaches:

Of 44 LMS RotablationOf 44 LMS Rotablation28 radial*28 radial*8 ulnar*8 ulnar*7 femoral (but none since July 03)7 femoral (but none since July 03)1 brachial1 brachial

*7F, 8F in 25 pts*7F, 8F in 25 pts

Aspects of Technique by LocationA. Body of LMS (N = 2/44) - simplest NB guidewire bias in eccentric lesion

PRE

POST

B. Ostial LMS (N = 6/44)

Ideally, use 7F non-support guide

PRE

POST

C. Distal LMS Medina 100, 110, 101 (N = 12/44)

Single (rota)wire, Rotablate & stent LMS +affected limb, leave other limb alone

PRE

POST

PRE

POST

D. Distal LMS Medina 111 Ca1 M

Beyond Medina – 2 other features to consider re RotablationA. One or both limbs calcified (Ca1, Ca2)B. Non-roto limb > or < 90% (M, S)

For Distal 111 Ca1 M, Rotablate singlelimb then T stent

PRE

POST

E. Distal LMS 111 Ca1 S

Non-roto limb is > 90%

Initial small balloon dilatationof this limb then roto LMS/calcified limb & T stent

PRE

POST

F. Distal LMS 111 Ca2

Rotablate both limbs then T stentNB with this level of anatomical complexity,use IABP irrespective of LV function – avoidance of hypotension is paramount

The most important classification of LMS Rotablation (or of The most important classification of LMS Rotablation (or of any complex PCI indication) is not the anatomical one but:any complex PCI indication) is not the anatomical one but:

Calcified LMSCalcified LMS

Pt has CABG optionPt has CABG option Pt has no CABG optionPt has no CABG option

Because:Because:1.1. Virtually all mortality is in CABG C/I group (based on Virtually all mortality is in CABG C/I group (based on

independently audited 30 day all cause mortality)independently audited 30 day all cause mortality)2.2. Even with optimal procedural results, one cannot avoid a Even with optimal procedural results, one cannot avoid a

5%-10% 30 day mortality in these CABG C/I pts5%-10% 30 day mortality in these CABG C/I pts3.3. LMS Rotablation defines a highly ‘concentrated’ population LMS Rotablation defines a highly ‘concentrated’ population

of CABG C/I patients of CABG C/I patients

0

10

20

30

40

50

60

70

HR NR HR NR

% HR – high risk(CABG C/I)

NR – normal risk(CABG possible)

Non-Rotablated Rotablated

Unprotected LMS Unprotected LMS

(n = 121) (n = 44)

33.9%

66.1% 68.2%

31.8%

cf for all PCI oversame period 2000 – 2006 (N = 2710), high risk (CABG C/I)= 10% total

Unprotected LMS Rotablation Series (N = 44)Unprotected LMS Rotablation Series (N = 44)

Age 73 Age 73 ± 8 yrs, range 51 – 86 yrs± 8 yrs, range 51 – 86 yrs

23% of pts 80 + yrs23% of pts 80 + yrs

High risk (CABG C/I) 30 ptsHigh risk (CABG C/I) 30 pts

Normal risk (CABG is an option) 14 ptsNormal risk (CABG is an option) 14 pts

EF 10% - 65%EF 10% - 65% mean EF 35%mean EF 35%

36 distal LMS36 distal LMS 6 ostial6 ostial 2 body2 body

DES – 34 pts (all pts since mid 2003)DES – 34 pts (all pts since mid 2003)

Non DES – 9 ptsNon DES – 9 pts POBA – 1 ptPOBA – 1 pt

Unprotected LMS Rotablation Series (N = 44)Unprotected LMS Rotablation Series (N = 44)

In-Lab procedural success (< 20% residual without In-Lab procedural success (< 20% residual without MACE) MACE) -- 43/44 pts (98%)43/44 pts (98%)One pt – unable to fully deploy LMS stent despite RAOne pt – unable to fully deploy LMS stent despite RAOne other pt: perforation in angulated Ca LAD beyond LMS,One other pt: perforation in angulated Ca LAD beyond LMS,tamponade successfully managed conservativelytamponade successfully managed conservatively

30 day all cause mortality – 2 pts (4.5%)30 day all cause mortality – 2 pts (4.5%) Ventricular rupture day 3 post-procedure in pt with EF Ventricular rupture day 3 post-procedure in pt with EF

20% & recent MI20% & recent MI Cardiogenic shock ppt by AF day 1 post-procedure in pt Cardiogenic shock ppt by AF day 1 post-procedure in pt

with EF 10%with EF 10%

Unprotected LMS Rotablation series (N = 44)Unprotected LMS Rotablation series (N = 44)

6 month follow up angiography (DES group)6 month follow up angiography (DES group)

19 pts to date19 pts to date

LMS restenosis (LMS restenosis (>> 50%) 50%) NilNil

Ostial LAD restenosisOstial LAD restenosis 1 pt1 pt

Ostial Cx restenosisOstial Cx restenosis 1 pt1 pt

ConclusionsConclusions

1.1. In this era of increasingly advanced PCI, rotational In this era of increasingly advanced PCI, rotational atherectomy expands the potential for safe and effective atherectomy expands the potential for safe and effective percutaneous treatment of the unprotected LMS, having percutaneous treatment of the unprotected LMS, having applicability in up to 25-30% of cases.applicability in up to 25-30% of cases.

2.2. The device is indicated particularly in high risk pts turned The device is indicated particularly in high risk pts turned down for CABG, in whom a number of the same down for CABG, in whom a number of the same comorbidites that preclude surgery also predispose to comorbidites that preclude surgery also predispose to LMS calcification.LMS calcification.

3.3. There may also be longer term benefits in reducing There may also be longer term benefits in reducing restenosis – improved stent deployment, reduced restenosis – improved stent deployment, reduced adventitial plaque, reduced plaque shift. Await final adventitial plaque, reduced plaque shift. Await final results of ROCCSTAR, LMS Rotablation Series. results of ROCCSTAR, LMS Rotablation Series.